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

      THE RECENT SALMONELLA OUTBREAK: LESSONS LEARNED AND CONSEQUENCES TO
                           INDUSTRY AND PUBLIC HEALTH
    =======================================================================

                                    HEARING

                                   BEFORE THE

                  SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                     OF THE

                        COMMITTEE ON ENERGY AND COMMERCE
                            HOUSE OF REPRESENTATIVES

                           ONE HUNDRED TENTH CONGRESS

                                 SECOND SESSION

                                   __________

                                 JULY 31, 2008

                                   __________

                               Serial No. 110-142

          Printed for the use of the Committee on Energy and Commerce

                            energycommerce.house.gov

                                  __________

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                        COMMITTEE ON ENERGY AND COMMERCE

                      JOHN D. DINGELL, Michigan, Chairman

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

                                     ______

                               Professional Staff

                     Dennis B. Fitzgibbons, Chief of Staff

                       Gregg A. Rothschild, Chief Counsel

                          Sharon E. Davis, Chief Clerk

                   David L. Cavicke, Minority Staff Director

                                     7_____

                  Subcommittee on Oversight and Investigations

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

                                      (ii)

                                 C O N T E N T S

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

        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:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Stupak. Thank you.
        Mr. Hubbard, we will turn to you for your opening
    statement. And we all talked about our ninth hearing, I think
    you have been here for all nine. We appreciate your work and
    willingness to work with us and your patience and your insight
    to this issue. So we look forward to your testimony, please.

    STATEMENT OF WILLIAM K. HUBBARD, SENIOR ADVISOR, COALITION FOR
                             A STRONGER FDA

        Mr. Hubbard. Thank you, Mr. Chairman. I do have written
    comments but I will make just a few oral ones.
        It is unfortunate that we are here yet again talking about
    yet another failure by the FDA. And I am sorry you are having
    to go through that but I think the public is sorrier.
        As you know, I have expressed the view that many of the
    problems have not been of FDA's doing, that there have been
    shortfalls other places that have caused FDA to be ineffective.
    And I think there are many issues for Congress to deal with in
    this particular outbreak, how the government is organized, how
    the FDA is organized, how federal/state relations occur, how
    well the industry can track and otherwise do its job. But I
    would like to focus my comments, if I could, just on three
    areas all dealing with FDA's capacities.
        First, the agency's food safety resources have not kept up
    with the responsibility they have been given. And in fact, we
    have been taking down the food safety system at FDA for several
    years. We are reducing staff at a time in which we need people
    even more at the agency. We need more inspections. We need the
    scientists to deal with these emerging pathogens. And it has
    been going the other way. So I think that is a tremendous piece
    of the problem at FDA. By taking down a program at a time it
    needs to be strengthened we are simply going the other way.
        But FDA also needs to be able to acquire a food process to
    implement a system of preventive control. We need to prevent
    these things from occurring, not just chase them after the
    fact. As you know, preventive control is a well-proven
    mechanism for keeping food safe in the first place from being
    contaminated. Mr. Dingell's bill attempts to do that. And I
    certainly wish you well in that effort.
        You may know that FDA tried to use its existing authority
    last year to impose preventive controls over produce. But the
    Administration rejected the recommendations of the agency
    scientists to do that. And I think that has proven to be a
    grievous mistake. Just think, we could be well on our way to
    having regulations for preventive control for produce in effect
    today but essentially we are nowhere because of that denial. So
    I think that was a tremendous mistake. And I urge Congress to
    proceed with its efforts to establish a system of preventive
    control.
        My third point relates to traceability. When Congress
    enacted the Bioterrorism Act in 2002 it intended to give the
    agency the authority to track these products so that you would
    have a rapid ability to follow up on a potential terrorism
    attack throughout the supply chain. But instead of having a
    robust recordkeeping system that allowed for rapid access to
    complete records by all participants, the agency got, ended up
    with delayed access to partial records from only some elements
    of the supply chain. So we have weakened those regulations
    tremendously.
        And I think the Salmonella incident demonstrates how the
    weakening of those rules essentially negated the intent of
    Congress.
        So just imagine, Mr. Chairman, if the Salmonella outbreak
    had been a terrorist attack and thousands or hundreds of
    thousands of people had been at risk from death and disease how
    much of a failure those rules, that recordkeeping requirement
    would have been. And I think we need to look at in that context
    for future consideration.
        Now, the good news is, as Ms. DeGette and others have said,
    there are effective technologies available to provide for
    successful trace-back. Some produce firms have demonstrated it.
    But the problem is we are only as strong as our weakest link.
    And those small firms that have not been able to do effective
    trace-back I think need to be addressed. So the means are
    available to improve the situation. And I hope you will be a
    strong supporter of those means.
        Now in conclusion, Mr. Chairman, we talk a good game about
    food safety. We say we care about it, we say we are going to do
    more, but we just have not backed it up, that rhetoric up with
    necessary support in my view for FDA. I do not believe we can
    make FDA an effective agency without giving it additional
    resources and authority. These problems that we are talking
    about are they going to keep going? We are going to have more
    of these outbreaks? This is going to be an endless process
    until we fix the system. So I hope Congress will agree with
    those and move to make it so.
        And thank you for giving me the opportunity, Mr. Chairman,
    to prevent those views.
        [The statement of Mr. Hubbard follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Stupak. Thank you, Mr. Hubbard.
        We will begin questioning. I guess the last 12 hours
    epitomize how this whole investigation has gone. About 9:00,
    10:00 last night we got a release from the FDA about jalapenos
    in Mexico. And about 10:15 we had a correction. And 8:00, 9:00
    o'clock this morning we had another one. So we have had about
    three releases in the last 12 hours on what is going on with
    this investigation. Now I do not know if that is the quality of
    the investigation or the fact we are having this hearing here
    today.
        But let me ask this question of this panel. Now, this
    investigation started out with Salmonella Saintpaul and
    detailing tomatoes. Has there been any Salmonella Saintpaul,
    Salmonella found in any tomatoes in the United States? I take
    it none; correct?
        None? OK.
        Then at the time when we started this May 22, the only
    State I understand that was growing tomatoes at the time would
    have been Florida; right?
        Mr. Brown. That is correct.
        Mr. Stupak. OK. So any other tomatoes would have had to
    come either from Florida or I guess Mexico would be the other
    source; right? OK.
        Mr. Brown. Florida.
        Mr. Stupak. I am sorry, put that up there, Mr. Brown. It
    would have been Florida?
        Mr. Brown. The primary source, Florida was the primary
    domestic supplier at that point.
        Mr. Stupak. Right. And then the other one would have been
    foreign countries----
        Mr. Brown. Other one was primarily Mexico.
        Mr. Stupak [continuing]. Mostly Mexico?
        Mr. Brown. And as a matter of fact, Mr. Chairman, the
    morning after we were informed there was concern we provided
    data for a period of 30, 60 days----
        Mr. Stupak. OK.
        Mr. Brown [continuing]. Prior to that where every tomato in
    the country came from.
        Mr. Stupak. OK. Now, we eventually get to the jalapenos,
    right, after Minnesota gets there. And believe it or not we got
    one today, OK. But Florida, Mr. Booth, you mentioned about
    Florida and, Mr. Brown, you mentioned it, your process you have
    for tomatoes, the box and all the markings. Did the FDA help
    you with that? I mean were they aware of your system? Did they
    help you develop it?
        Mr. Brown. We have had positive lot identity for round
    tomatoes in Florida for going on close to 20 years under a
    federal marketing order.
        Mr. Stupak. OK.
        Mr. Brown. We had worked with the FDA in working up on
    state regulatory program that we were voluntarily implementing
    and we now have under state regulation.
        Mr. Stupak. OK. But as of today tomatoes are still suspect;
    correct?
        Mr. Brown. Unfortunately.
        Mr. Stupak. Or as we call it, the vegetable of interest;
    right? The person of interest, it is still the vegetable of
    interest?
        Mr. Brown. Yes, sir. We are still indicted and convicted in
    the media.
        Mr. Stupak. OK. But yet we have never had any. And now we
    are at jalapenos from Mexico; right?
        Mr. Murphy. Do not touch it.
        Mr. Stupak. OK. I have a double dare with Shimkus, we are
    going to eat it yet today.
        This is a box we got today. There is no markings like you
    had to show your area; right? All this says is ``Produce of the
    United States, net weight 25 pounds.'' And just says tomatoes
    on it. OK, we got it at a local retailer here today.
        Now, Mr. Booth, your box had those markings on it. Is it
    legal to use your box? I mean you ship it to, let us say you
    ship it up here to Washington, D.C., OK. And can a grower take
    that box with those markings on put tomatoes in it even it was
    not from Florida? In other words can you re-use that box again
    and again and again?
        Mr. Booth. As long as they maintain the records.
        Mr. Stupak. OK. But they would have to wipe out the coding
    that you have on it?
        Mr. Booth. They would have--when a repacker takes that they
    are going to have to when they repack it they are going to have
    to take the original lot number----
        Mr. Stupak. OK.
        Mr. Booth [continuing]. The original information and put
    their own information on it.
        Mr. Stupak. OK. Now, only California and Florida have that
    system; right?
        Mr. Kawamura. Yes.
        Mr. Stupak. So the other 48 States are, they can be sending
    boxes like this here; correct?
        Mr. Brown. Mr. Chairman, this is why the industry has
    stepped forward in conjunction with FDA and the----
        Mr. Stupak. Correct.
        Mr. Brown [continuing]. Research community and created this
    document which would resolve and solve that issue in requiring
    that every person in the country that grows and handles
    tomatoes maintains that information, passes it up.
        Mr. Stupak. So you want a federal regulation saying----
        Mr. Brown. Yes, sir.
        Mr. Stupak [continuing]. You must do it this way?
        Mr. Brown. We want a double-phase procedure----
        Mr. Stupak. Whether it is tomatoes, jalapenos, whatever it
    might be?
        Mr. Brown [continuing]. Because the public trust is so
    important to us we cannot afford to do it any other way.
        Mr. Stupak. OK. What is the cost of doing that, of putting
    that code on there and have that trace-backs? Can anyone give
    me an estimate? Because that is always a question we ask, What
    is it going to cost us? Mr. Booth?
        Mr. Booth. Yes, it is----
        Mr. Stupak. Mr. Stenzel?
        Mr. Booth. I am not sure what the cost is. In the largest--
    --
        Mr. Stupak. Is it minimal or?
        Mr. Booth. It is minimal.
        Mr. Stupak. It is minimal?
        Mr. Booth. It is minimal.
        Mr. Stupak. OK.
        Mr. Booth. Anyway, the point being is that any size firm,
    large or small, can do this.
        Mr. Stupak. OK.
        Mr. Booth. It does not have to be fancy and it does not
    have to be expensive.
        Mr. Stupak. OK. Now, you said, Mr. Beckman, you traced back
    that tomato that you did in California for the staff and they
    learned a lot from you guys. That was all within California
    though; right?
        Mr. Beckman. It was. But----
        Mr. Stupak. So what if that tomato goes to Michigan where I
    am from?
        Mr. Beckman. We actually were able to produce for the
    investigative staff a number of trace-backs throughout the
    United States. That included product from California, Florida
    and Virginia going into multiple states. For example, one of
    the trace-backs was from California to Colorado.
        Mr. Stupak. How long did that take?
        Mr. Beckman. That one took about 5 hours.
        Mr. Stupak. OK.
        Mr. Beckman. But I can give you a story that took place
    yesterday if you would like?
        Mr. Stupak. OK. But the point is you can do it; right?
        Mr. Beckman. Yes, we can.
        Mr. Stupak. And there is minimal cost?
        Mr. Beckman. Cost actually that we can say it is a part of
    a business culture and it is not significant. The cost that we
    pay in California to validate our process runs about a penny a
    box.
        Mr. Stupak. OK. So let us go back to Florida, let us go
    back to May 22. We have Salmonella, Florida is the only place
    growing, but Florida has this system, right, to track
    everything? So if people were getting sick in New Mexico and
    Texas that seemed to be June 3 is when they put the place out,
    could they not have gone and said, OK, Florida, have you sent
    to Texas and New Mexico in this area, wherever it is? Could
    they have done that?
        Mr. Brown. Yes. They were advised in early conversations
    that the supply chain or supply system for tomatoes in the
    country is basically bifurcated by east and west.
        Mr. Stupak. Yes.
        Mr. Brown. Florida dominates the eastern supply system, the
    Mexican supply source dominates the western supply system. And
    because of the energy costs we do not move them back and forth
    very often.
        Mr. Stupak. Right.
        Mr. Brown. And there may have been some minimal amount of
    tomatoes in that marketplace but they would have been
    insignificant.
        Mr. Stupak. California then would have been the big
    supplier to Texas, New Mexico then at that time?
        Mr. Brown. Only when they come into production. And they
    follow us. We were at a transition zone between.
        Mr. Stupak. When does California go in production?
        Mr. Kawamura. California had started this year on May 17
    was the first field harvest of California.
        Mr. Stupak. OK. So we are on June 3, so they could have
    possibly been?
        Mr. Kawamura. No. At that point knowing what the initial
    outbreaks as they took place we knew that California had not
    been in production at that time and were able to verify that
    with FDA at the time.
        Mr. Stupak. So why did we make tomato vegetable of interest
    then?
        Mr. Kawamura. It was still a vegetable of interest
    throughout the rest of the production areas of the state. I
    know one of the early announcements from FDA was that
    California was not a part of this outbreak based upon the
    harvest schedules that we were aware of.
        Mr. Stupak. OK. Could country of origin labeling have
    narrowed the focus here in your estimation, anyone? Mr.
    Beckman, anyone, would that have helped?
        Mr. Beckman. It could perhaps help. But the problem was
    that the association was with all tomatoes. And so we had a
    scenario where all tomatoes were suspect. And then as the safe
    list was produced we are essentially trying to back individual
    states away from an association of guilt, and that is extremely
    difficult.
        Mr. Stupak. So the thing we need right now from the FDA is
    a firm statement that tomatoes are not even vegetable of
    interest, they have nothing to do with this Salmonella
    outbreak. Because we still, if I look at the last line here, it
    says, ``FDA announced that it has determined that fresh
    tomatoes now available in the domestic market are not
    associated with the current outbreak. As a result, the agency
    removed its June 7 warning.'' And my problem is with that is
    they never cleared tomatoes from the original outbreak.
        Mr. Beckman. Correct. You are correct, Mr. Chairman.
        Mr. Stupak. So we still have the suspicion over the----
        Mr. Bronson. Well, Mr. Chairman, if I----
        Mr. Stupak. Yes, go ahead.
        Mr. Bronson [continuing]. Might as well enter in this, one
    of the things that we noticed very early on was when the
    outbreak took place in Texas and New Mexico and began to go
    north of there we were selling tomatoes out of Florida all over
    the southern United States, all over Florida, but we did not
    have sicknesses in Florida. So we were suspicious right then--
    --
        Mr. Stupak. Right.
        Mr. Bronson [continuing]. That Florida tomatoes, grown
    tomatoes were not a part of this problem from the very
    beginning. And I think we need to while we have to follow the
    scientific method, we also should not throw away common sense
    and risk assessment that says if you know this is where the
    outbreak is the most seen there is a good chance it is coming
    either across the border or from within a state or two of that
    outbreak because the south had no cases at the time.
        And the other issue, Mr. Chairman, that I would like for
    you to consider, because someone from Florida goes to the
    doctor with a sickness that ends up being Salmonella Saintpaul
    they may have gotten it in Texas. They should not be----
        Mr. Stupak. Sure.
        Mr. Bronson. They should not be counted as a Florida
    sickness because it may have been picked up while they were
    traveling. And that is the case in a number of these cases.
        Mr. Stupak. Well, I am looking at the CDC investigation
    outbreak of infections caused by Salmonella Saintpaul, dated
    July 29. And when you look at it they have the breakdown of
    1,319 people, 1,319 people infected, only 11 are from
    California and 4 from Florida. So with the math of course being
    Texas with 502 and New Mexico 106, so I guess that proves your
    point.
        One question and my time is way over, and I just want to
    ask Mr. Hubbard a question. Because we are talking a lot about
    traceability here and suspect vegetables or not, but let me ask
    you this one. On July 25 the Associated Press ran an article
    entitled ``Food Industry Bitten by its Lobbying Success.
    Companies Oppose Electronic Tracking that Could Locate Outbreak
    Source.'' The gist of this article is that there were some with
    the FDA that were advocating a much stronger recordkeeping and
    trace-back system than what we currently have today underneath
    the Bioterrorism Act. However, due to heavy pressure from
    industry many of the requirements were watered down.
        Mr. Hubbard, you were an associate commissioner of policy
    at the FDA at that time. What systems were being proposed? And
    how did these systems differ from what we are using today or
    what we have seen in California and Florida?
        Mr. Hubbard. Well, as I said, I think the agency wanted a
    lot of the things that folks are talking about here now: lot
    numbers, rapid access, recordkeeping throughout the chain. I
    will not deny that the industry may have had a ``Come to
    Jesus'' moment in recent years, but in 2003 the message from
    the industry to the Office of Management and Budget which was
    reviewing the regulation was too expensive, too hard, do not do
    this.
        So again I am very gratified to hear the progress that has
    been made, but when FDA was doing its regulations it was being
    literally hammered for proposing things that were viewed by
    many members of the industry as too much.
        Mr. Stupak. One more. Mr. Beckman, did it not really say,
    tell our staff that to do that tracing on that box there is it
    not like a penny a box?
        Mr. Beckman. It is a penny a box for the verification. The
    actual costs are, again, insignificant.
        Mr. Stupak. OK. Mr. Shimkus for questions. Thank you,
    gentleman.
        Mr. Shimkus. Thank you, Mr. Chairman. Good round of
    questions. Maybe we should go ten minutes one round or
    whatever, so. Whatever.
        But it is all, you know, I like to talk about on the
    business end and talk about raising of capital, assumption of
    risk, return on the investment. And part of this is a payment
    to lower the risk. And obviously there has been a big loss.
    Now, the growers have intimated that obviously there should be
    some recovery. And there could be a debate on takings based
    upon response. And I do not know if and how that will resolve
    itself but, you know, the thing I want to focus on to begin
    with, I had a whole bunch of scribbled notes from the
    testimony, it is very good.
        But first-off for Mr. Bronson. And we have the time line
    here and so June 3, 2008, FDA warned consumers in New Mexico
    and Texas not to eat certain types of raw red tomatoes. Now,
    your opening statement said you were 99.9 percent sure it was
    not Florida. On June 3, how close to June 3 did you know there
    is no way it was a Florida tomato?
        Mr. Bronson. Congressman, we, because of our program that
    we implemented and third party verification which is as close
    to ``HASUP'' in most other fields of food safety as you can get
    the fact that we had no single person in the State of Florida
    that was showing Salmonella Saintpaul or any other kind of
    Salmonella that we were aware of because our people in our
    county and State health departments would have been in touch
    with us if it had shown up, we had that good a working
    relationship, and the fact that we were shipping all over the
    southeast United States and there was no cases.
        Mr. Shimkus. But what is the date? How close were you to
    that June 3 time frame you said it is not here? It highlights
    the communication of the FDA; that is the only reason why I am
    asking it.
        Mr. Bronson. June, well, I am saying, I am hearing now from
    my deputy commissioner who is in charge of food safety, around
    they were very sure by the time we analyzed what we were
    getting by the 15th of June----
        Mr. Shimkus. All right.
        Mr. Bronson [continuing]. There was no way Florida was
    responsible because no Florida tomatoes----
        Mr. Shimkus. Well, the only thing I am highlighting, we
    know there are areas to be fixed. One is communication, you all
    mentioned it, communication across the board with all agencies,
    transparency. And an early notification of information and
    acceptance could help limit losses I, you know, I think, and
    that is an issue.
        But I want to highlight, I mean we are all FDA, beat up
    FDA. Trace-back although it was slow, Mr. Stenzel, trace-back
    worked in this system, did it not?
        Mr. Stenzel. I think, Mr. Shimkus, that you have identified
    a very key part of our discussion here. The real issue where
    this started is in the identification of tomatoes at the CDC.
    Everything in trace-back would prove that tomatoes were not the
    cause. Everything that was traced back showed tomatoes came
    from different sources. There was no common point of
    contamination.
        Could that have been done more quickly, more effectively?
    If it could I want to know how. I want the FDA to show us where
    they ran into roadblocks. These types of systems that my
    colleagues have talked about are precisely in place also for
    many Mexican tomatoes. So many of the tomato products in this
    industry, because it has been bitten in the past, have done a
    fantastic job of putting in place extensive traceability. So we
    do not understand what that slowness was.
        But in this case traceability showed tomatoes were not the
    cause.
        Mr. Shimkus. 1,400 samples, not one--all right, one
    positive. And the key, you know, really we ought to have a
    hearing from the CDC and the State health departments. I mean
    that is the hearing today ought to be. I mean because that is
    where in this case the system failed.
        Mr. Stenzel. Mr. Shimkus, I think it is very difficult, and
    this is an issue that I think you have got to grapple with with
    the agencies, is how do they back away from an initial
    association? They still will not do it. They are still even in
    the press releases today clinging to the theoretical
    plausibility that perhaps tomatoes from near these Mexican
    farms might have been involved in the early stages.
        I guess that is still possible and we will have to hold
    judgment. But my goodness, we now know that the initial month
    of activity that said tomatoes are it and, by darn, we are
    going to prove tomatoes are it; they did not do it. They just
    found tomatoes were not it.
        Mr. Shimkus. Mr. Hubbard, you have to agree that as much as
    we are focused on FDA it is this issue of the CDC and the
    public health departments and why they did not--I am not a
    criminal investigator but, you know, when we were doing, I was
    doing the prep for this it was my understanding they limited
    the suspects instead of having all the suspects like, you know,
    everyone in the room instead of they focused on, they focused
    on a commodity product not all the commodity products?
        Mr. Hubbard. Absolutely. FDA chases the food that the CDC
    questionnaire process identifies. And epidemiology is an
    inexact science. And I am sure you will hear that from the CDC
    folks. I am sure they did the best they could but FDA was
    chasing down the results of the CDC recommendation.
        Mr. Shimkus. And let me go to Mr. Beckman real quick
    because I want to follow up. I think I made my point on the CDC
    and the public health departments. But this issue that we did
    on tracing the tomatoes to the retail location which was a Jack
    In The Box, the Chairman followed up with across state lines.
    The question I would ask is smaller mom and pop retail
    locations, family restaurants, or tomorrow is Friday, my
    American Legion Post 365 does a weekly fish fry. Of course the
    only way Illinoisans love to eat fish is cod and it is deep
    fried. So and they will have tomatoes. Can this process that we
    are talking about, obviously a major retailer, just that whole
    debate, have the resources, can do the IT, can do all the
    process. What about my local American Legion Post 365 that
    really relies on the fish fry to bring in income to help fellow
    veterans? Can they do that too?
        Mr. Beckman. Well, first let us look at the State of
    California and the fact that in the California code all
    tomatoes must be traceable at all points in the system. That
    includes the smaller players.
        But to answer your question as to outside of California,
    again referencing the Tomato Supply Chain Guidance document,
    what we looked at is where are the weaknesses in the
    Bioterrorism Act? Is there a weakness in the fact that an
    individual mom and pop restaurant is not required to maintain
    such a level of documentation?
        Trace-back can simply begin with an invoice, an invoice
    that we recommend in this document be held for at least 6
    months so that way we know where those tomatoes came from.
    There has to be that initial piece of paper. Right now those
    outlets are exempt from the Bioterrorism Act recordkeeping
    requirements.
        Mr. Shimkus. Let me go to Mr. Booth for a second and talk
    because you deal with all, you are a grower, you are a
    supplier, you are a repackager.
        Mr. Booth. Right.
        Mr. Shimkus. What about the repacking? Repackaging of the
    other thing in our research talked about sizing of tomatoes
    from maybe different growers; does that happen? And then how do
    you, say you are a repackager and you have a multitude of
    growers and so they are coming in your facility, you are
    repackaging by size and weight versus where it came from, so
    then in that box could there be more than one? And does that
    code then does it identify that this came from four different
    locations versus one location? Is that how that works?
        Mr. Booth. Yes, well maybe I can just take a minute and
    just give you an example of how that might work. We will buy at
    any given time from multiple growers. Today this minute Delta,
    our repack company, is actually purchasing product that we
    actually grow in multiple different fields. We are going to be
    purchasing this week product from other growers, competitors to
    our other baseline company Ace Tomato.
        The way we handle and the lot identification is identical
    whether it is our product coming from our fields or from
    another grower. And that grower could also come from Mexico. So
    it is identical.
        The product comes in to our repack facility. We run that
    product to size and spec, specifications that our customers
    give us, by lot. So that one lot goes all the way through our
    process. So in a box that I just showed you a few minutes ago
    you will have one lot of tomatoes in there, just one.
        Commingling has been talked about a lot. And I think that
    has been discussed and it is a little bit confusing as what
    commingling really is. If you do have multiple lots in one case
    you need to make sure that you have got the documentation to
    prove that there are multiple fields, multiple lots in that
    box. We do not want to do that. We really do not want to mingle
    a particular box.
        As I showed your congressional investigators, on a pallet
    you may have one case out of 80 that is from a different lot
    than the other 79 boxes. As long as you have the documentation
    that shows that that box came from a particular lot you are OK,
    you can trace that back. And if there is an outbreak or if
    there is a suspected outbreak of a particular case that goes to
    that restaurant you can again follow that all the way back to
    the lot.
        Mr. Shimkus. My time has expired, Mr. Chairman. Thank you
    again. I will want to end by saying CDC, state health
    departments, we have to bring them in the loop and empower them
    to make some better decisions.
        Mr. Stupak. Ms. DeGette for questions.
        Ms. DeGette. Thank you very much, Mr. Chairman.
        I really want to thank each of you on this panel because
    you have really, quite thoroughly explained to us that we can
    do traceability, that it is cost effective and we can do it
    even with mixed lots.
        What I want to talk about is why do we need to have some
    kind of a national system of traceability? Now, Commissioner
    Bronson, in your State you have mandatory traceability for
    tomatoes; correct?
        Mr. Bronson. That is correct.
        Ms. DeGette. And also, Secretary Kawamura, we have that
    mandatory traceability in your State as well for tomatoes;
    correct?
        Mr. Kawamura. Yes, we do.
        Ms. DeGette. And, Mr. Beckman, you talked today and also I
    met with you and you talked to me about how quickly and
    effectively we can trace tomatoes if we have a traceability
    system; right?
        Mr. Beckman. Correct.
        Ms. DeGette. In fact, the story you wanted to tell Mr.
    Stupak was you folks bought some sandwiches at Subway and went
    and ran a trace on those tomatoes at Subway and you were able
    to do it in a few hours; right?
        Mr. Beckman. Correct.
        Ms. DeGette. And that is because Subway requires
    traceability for its tomatoes; right?
        Mr. Beckman.
        Ms. DeGette. I am not sure that the whatever it is the fish
    fry people might have mandatory traceability. But that----
        Mr. Shimkus. No, I do not think we do. That is the whole
    point.
        Ms. DeGette. Exactly, that is the whole point. And so, Mr.
    Stenzel, you might be able to answer this broader. We are
    really clear on what is going on with tomato traceability but
    part of the problem we have is we do not have national tomato
    traceability; right, Mr. Beckman? I mean some industry, some
    producers have it, some industries, some states have it. But it
    is not a national system; right?
        Mr. Beckman. It is fair to say that if you are a major
    tomato grower and shipper and want to do business with major
    corporations you absolutely must have it. That is not to say
    that there are not some growers in some areas of this country
    that do not maintain traceability.
        Ms. DeGette. But in addition its traceability, it is
    vertical traceability not horizontal traceability because it is
    traceability for that grower? It is not a national system of
    traceability that the national tomato growers have instituted
    for everybody?
        Mr. Beckman. Well, traceability begins at the grower/
    shipper.
        Ms. DeGette. Well, can you--I am sorry, I do not have a lot
    of time.
        Mr. Beckman. OK.
        Ms. DeGette. Yes or no?
        Mr. Beckman. Please repeat the question.
        Ms. DeGette. Is it a national system of traceability that
    is interoperable for all of the tomato growers?
        Mr. Beckman. It is not a national system, no.
        Ms. DeGette. OK. Mr. Stenzel, now you represent broader
    numbers of growers. And I understand the way you trade a tomato
    may not be the same way that you would trace green beans or
    other produce; correct?
        Mr. Stenzel. Correct.
        Ms. DeGette. But there are other types of traceability
    systems that would work for almost any kind of commodity;
    correct?
        Mr. Stenzel. Yes, ma'am.
        Ms. DeGette. And so what I have been thinking about is this
    recent Salmonella outbreak. And it appears that what happened
    is people, let us step all the way back to the beginning, the
    public health sleuths talking to people found out that they had
    eaten probably salsa or something that had tomatoes and chili
    peppers in it; correct?
        Mr. Stenzel. Yes, ma'am.
        Ms. DeGette. And so if you were trying to do traceability
    on that it would be really helpful if you could break down the
    components of that and be able to trace them, whatever the
    system was; is that right?
        Mr. Stenzel. Certainly in any processed food or a mixture
    of different ingredients it gets much more complex, but you
    would want to be able to trace the individual ingredients.
        Ms. DeGette. And that would have helped us in this
    situation if--I mean it would have helped the tomato industry
    if the FDA investigators and the CDC would have said, OK, let
    us trace all of the tomatoes that were involved in this salsa.
    And if you had had a quick system you could have resolved the
    tomato problem much more quickly than it was resolved I would
    assume?
        Mr. Stenzel. Well, I think our concern, Congresswoman, is
    that we believe that across the board there are these systems
    in place, particularly in the tomato industry and that the
    trace-back actually showed that it was not the tomatoes.
        Ms. DeGette. OK.
        Mr. Stenzel. This was not a matter of inability to track
    tomatoes and where they came from.
        Ms. DeGette. Right.
        Mr. Stenzel. It was the confusion with other ingredients
    that perhaps were in the salsa.
        Ms. DeGette. Well, let us talk about that. So let us say we
    had a traceability system, a trace-back system for jalapeno
    peppers and cilantro and the other ingredients, if that would
    have moved faster we would have been able to resolve this
    situation much more quickly to the benefit of the growers of
    the vegetables that were not contaminated; right?
        Mr. Stenzel. Our industry had the highest incentive to
    resolve these things quickly to protect health and to prevent
    damage to the industry.
        Ms. DeGette. Exactly.
        Mr. Stenzel. If the CDC scientists had had any concerns
    about other ingredients they could have been tracked. Once the
    investigators started looking----
        Ms. DeGette. Do we have the same kind of system for
    jalapenos that we do for tomatoes?
        Mr. Stenzel. Not nearly as effective. But once they started
    looking for jalapenos they have tracked them extremely
    effectively.
        Ms. DeGette. Right. But if we----
        Mr. Stenzel. The fact that the individual farm in Mexico
    today with today's traceability with one of the most
    complicated small items that does not have these elaborate
    systems.
        Ms. DeGette. Right. But if we had a national system, not
    maybe one type of traceability but if everybody had to do it
    and it was interoperable we could have done this much more
    quickly; would that not be fair to say?
        Mr. Stenzel. I am not convinced that the traceability
    investigation of FDA was the lagging factor in this case.
        Ms. DeGette. OK.
        Mr. Stenzel. We definitely need----
        Ms. DeGette. You think it was the identification.
        Mr. Stenzel. We need to improve our traceability. And that
    is something the industry is taking very, very seriously.
        Ms. DeGette. OK.
        Mr. Stenzel. And a national program in the tomato industry
    I should also say is important.
        Ms. DeGette. OK.
        Mr. Stenzel. One key----
        Ms. DeGette. Excuse me, I am sorry, I do not have much time
    and I have one more topic I want to talk about with Mr.
    Hubbard.
        And welcome back.
        Mr. Hubbard. Thank you.
        Ms. DeGette. I was just telling staff I feel like we should
    just put you on the roster every time we have an FDA hearing.
        I want to talk to you about the 2002 Bioterrorism Act
    because some people have said that provides us with the federal
    tools we need to do traceability. And I know you do not
    entirely agree with that and I wanted to explore that with you.
    In your testimony you provide a side-by-side analysis, in you
    written testimony, of the key weak points introduced into the
    original legislation and regulation as it was reviewed and
    considered by administration reviewers. So I want to go through
    those because I think that kind of gives us some sense why
    maybe that act is not helping us trace as much as we want.
        What you say is what FDA wanted or needed in the final
    rule, that FDA wanted records by all sources and recipients,
    but farms and restaurants were excluded; correct?
        Mr. Hubbard. That's correct.
        Ms. DeGette. And FDA wanted foreign firms as well as U.S.
    but the foreign firms were excluded from the final
    recommendation?
        Mr. Hubbard. In the rulemaking process, yes.
        Ms. DeGette. They wanted a complete record of the food's
    movement but what ended up, and I think this is maybe the
    biggest flaw, is only one step up and one step back; correct?
        Mr. Hubbard. That is correct.
        Ms. DeGette. They wanted lot numbers for each shipment and
    that was denied in the rulemaking; correct, Mr. Hubbard?
        Mr. Hubbard. Absolutely. I mean the consumer groups pushed
    very hard for that but the industry view was that lot numbers
    would be too expensive to maintain.
        Ms. DeGette. And the FDA also wanted electronic records for
    speed, and that was denied; correct?
        Mr. Hubbard. Obviously, yes. If you can just go on the
    computer and punch it up you can do it a lot faster than going
    through thousands of pieces of paper.
        Ms. DeGette. They wanted records access within four hours
    and that was extended to 24 hours; is that correct?
        Mr. Hubbard. Right. Four hours during normal business
    hours, 8 hours if they asked in the middle of the night, but it
    got extended to 24.
        Ms. DeGette. They wanted a consistent record format, and
    that was denied; correct?
        Mr. Hubbard. Yes. I mean FDA inspectors----
        Ms. DeGette. Now why is that important?
        Mr. Hubbard. Well, FDA inspectors are now finding they will
    go into a firm and some of them will have great records and
    others will have just bills of lading. And I have had anecdotal
    examples given to me of people have records on a plain paper
    bag or other, you know, all kinds of different formats where
    you have got to really search through for the various
    information you need instead of it all being there rapidly
    accessible.
        Ms. DeGette. And that was part of the problem with this
    recent Salmonella outbreak is the records problem?
        Mr. Hubbard. Absolutely. I mean one anecdote was a Florida
    tomato packer I am told literally ran out of supply and could
    not get anymore Florida tomatoes so he bought some Mexican
    tomatoes. Imagine how that could complicate a trace-back by FDA
    to have this foreign product enter into the Florida main, into
    the Florida stream when, you know, that could just be a
    tremendous fly in the ointment as they say.
        Ms. DeGette. Furthermore, the FDA wanted authority to
    verify the keeping of records, and that was also denied; right?
        Mr. Hubbard. I am sorry, I----
        Ms. DeGette. The FDA wanted the authority to verify keeping
    of records?
        Mr. Hubbard. Yes, the problem here is the way the rule was
    set up if an inspector goes in to do a routine food inspection
    they say, well, let me see your records in case there is ever
    an outbreak, the firm can say, no, you can only see the records
    if there is an outbreak. So the inspectors are not able to
    confirm that the industry is doing what they need to do to
    prepare for when there is an outbreak. And that is kind of nuts
    if you ask me but that is the way the rule came out.
        Ms. DeGette. Now let me ask you this, when you say the FDA
    wanted or needed, that sounds like a pretty good description of
    a national traceability system as these gentleman have been
    describing today, does it not?
        Mr. Hubbard. Oh, absolutely.
        Ms. DeGette. If we gave them these authorities, let me just
    ask you in your opinion, would this investigation and further
    investigations have been expedited so that we could protect
    public health and also industry?
        Mr. Hubbard. I think that to the extent trace-back was the
    issue they could have much more rapidly identified that
    tomatoes were being excluded and then the industry would have
    been spared a huge expense and they could have gotten to the
    peppers more quickly and a lot of people would have been saved
    a lot of distress, absolutely.
        Ms. DeGette. Thank you very much, Mr. Chairman.
        Mr. Stupak. Thank you.
        Mr. Burgess for questions, 10 minutes.
        Mr. Burgess. Thanks, Mr. Chairman.
        Mr. Stenzel, I apologize for being in and out but for the
    other hearing going on. In response to a question by Ms.
    DeGette of Colorado you said that traceability was not the
    lagging factor. You started to tell us what that was, so would
    you tell us what that was?
        Mr. Stenzel. Yes, sir, thank you.
        The initial identification of tomatoes as the sole source
    of contamination really sent us down, you know, the wrong path.
    As Mr. Hubbard said, it is FDA's responsibility then to
    investigate precisely what CDC has already identified as the
    villain or the vegetable of interest if you will. In that
    process we have heard claims that there was slowness or slow in
    traceability. But as you have heard from other witnesses here
    on the panel, we do not understand where that slowness would
    have occurred. We need to see the specific examples, not the
    anecdotal stories.
        It is not uncommon for growers to substitute new product
    from other regions but they can keep track of that quite well
    in the systems that are in place. So we do not understand where
    that slowness would have occurred.
        The initial time that FDA did a trace-back from someone who
    was ill in Virginia and it went to a Florida farm and then they
    did a trace-back of someone who was ill in Illinois and it went
    to a Mexican farm, they should have known it was not a common
    source. That could have happened in the first day, the very
    first day we could have done trace-backs, I think we did do
    trace-backs. And I would like to understand what trace-backs
    were done to confirm that there was not a common source of
    contamination.
        Why did it then take 3 week or 4 weeks? There was a bias, I
    believe, in terms of we must prove it is tomatoes because that
    is what CDC has said, that was their epidemiological evidence.
    Until we got off that horse and realized that there was
    something else that we had not figured out early enough, by
    well-meaning scientists but we had not figured it out early
    enough that it was really something else causing the illnesses.
        Mr. Burgess. We talk a lot up here about things like
    mandatory recalls. Going down the wrong path like that, had
    there been a mandatory recall it might have in fact been more
    deleterious to the industry; is that correct?
        Mr. Stenzel. I cannot imagine it would have been worse. We
    have a mandatory ban of all tomatoes, so we pretty much
    suffered.
        Our industry, the produce industry, supports mandatory
    recall authority for the FDA. But their press releases are
    pretty darn effective too.
        Mr. Burgess. OK. Let me, Mr. Hubbard, again, and thank you
    for being here. Like Ms. DeGette I feel like you are part of
    the committee you are here so frequently. You mentioned in your
    testimony, and I was watching it on television upstairs, you
    said that we are only as strong as our weakest link, and this
    thing under the Bioterrorism Act, the exception for a company
    that has 10 or fewer employees keeps coming up. Do you have an
    opinion as to how that weak link might be tightened up so that
    we do not face these problems?
        Mr. Hubbard. Sure. This is an old story at the FDA that
    small firms tend to drive rulemaking because even though small
    firms, in this case I imagine 90 percent of the fresh produce
    is managed by large firms, but there is usually a large number
    of small firms and they make a powerful argument that a strict
    regulation could drive them out of business or adversely affect
    them.
        Here I would think with the kind of technology Ms.
    DeGette's talking about available I would hope there would be
    ways to identify----
        Mr. Shimkus. Will the gentleman yield? Off of the record
    this is Diana DeGette.
        Ms. DeGette. Thank you.
        Mr. Hubbard. I apologize.
        Mr. Shimkus. So, my colleague from Texas and Mr. Hubbard.
    Now we are on the record.
        Mr. Hubbard. I apologize.
        Ms. DeGette. It kind of sounds more exotic though.
        Mr. Burgess. It does. That is why I used it.
        Mr. Hubbard. There could be off-the-shelf technology or
    other inexpensive ways to give the smaller firms access to the
    kind of tracing mechanisms that Ms. DeGette has mentioned as
    the proper way to do it and reduce some of those costs. But
    clearly the costs are going to drive decision making here
    unless we can help the small manufacturers, and in this case
    the small produce producers.
        Mr. Burgess. Is it an issue of being able to provide them
    the funding or the back-up for those systems or is it just
    simply getting them into the process?
        Mr. Hubbard. Well, I think it is more the latter. Imagine
    you are, you know, you are the small producer and you are not
    sophisticated in technology, you do not have the funding to
    have an expert come in an create a system from scratch, but
    someone says, look, there is established software and hardware
    that you can purchase and get into the system with the big
    guys, I would think that that would much, much lower the cost
    for those if they had easily off-the-shelf access to the
    technology.
        Mr. Burgess. Let me ask another question. I mean you heard
    my anxiety about the inability to actually do something
    definitive on the Friday where this was all finally sorted out
    that peppers are the culprit. And again on T.V. we are hearing
    the FDA's recommendation is you ask where the peppers came
    from. And that seemed like a fairly incomplete response to be
    delivered.
        Is there something better we can do when we find there is a
    problem? And we talked about mandatory recalls and let us do
    everything that they do. But at the same time we have to have a
    way, I think, from stopping that stuff from coming in the
    country. Our border has to be secure from preventing what we
    have now identified as a contaminated product from entering in
    the stream of commerce.
        Mr. Hubbard. Well, first of all, in terms of communication
    to the public, imagine CDC or FDA had said we are 90 percent
    certain it is tomatoes, or 80 percent or whatever, and they did
    not tell anybody because they wanted to be 100 percent, and it
    turned out it was tomatoes. You know, you would be having a
    different hearing but you would still be having a hearing.
        Mr. Burgess. Sure.
        Mr. Hubbard. And it would be really ugly.
        Mr. Burgess. In fact, we had that situation with Heparin in
    some respects.
        Mr. Hubbard. Sure. So I think that the agencies are in a
    bind and the key is for them to eliminate a given commodity
    very rapidly. And that is where things like trace-back and
    recordkeeping come into play so that these investigations do
    not run for weeks, they run for days. And then you cut it off
    and you are done and, you know, and you have solved the
    problem.
        Mr. Burgess. OK. That point of cutting it off, again Friday
    they found the problem but there was not really the ability to
    cut off that product. I mean how do we know how much product
    came across the border over the weekend? How do we know that by
    Monday morning we had not had more bushel baskets of
    contaminated peppers entering the stream of commerce?
        Mr. Hubbard. Well, as we discussed, the import problem is a
    tremendously problematic one. Conditions on these Mexican farms
    can be horrendous with farm animals traipsing through. And I
    understand that one of these farms that is the subject here
    even though they were told in advance FDA was coming when the
    inspectors got there they found all kind of problems, animals
    in the irrigation ditches. They only had two port-a-potties for
    the entire farm, and one of those had just been stolen. So, you
    know, you have got fundamental violations of preventive control
    technology that I would hope we do not see in the United States
    but we certainly do see in Latin America.
        Mr. Burgess. But as far as securing it at the level of the
    border is there a authority that the FDA could have that they
    are lacking at this point?
        Mr. Hubbard. Well, the only authority they have is to
    examine the product as it comes across the border. And as the
    committee has found, FDA does very little of that. They need
    the authority to put preventive controls in place back to the
    Mexican producer so that they meet the same standards U.S.
    producers make.
        Mr. Burgess. And I would not disagree with that except
    that, as you correctly point out, time after time there are
    violations and the standards do not seem to be where we would
    want them. It just seems to me that we have to have a way,
    there has to be a failsafe at the border when we discover we
    have a problem on a Friday afternoon that we do not just let it
    run then for the next couple of days until we can get someone
    down there on the farms and inspect it. There has to be, I
    think, and I think the American people want us to have the way
    to stop that from entering the stream of commerce the minute we
    detect that there is a problem. It may only be temporary. We
    may have to within a certain time period come back and address
    that. But we have to have the ability to stop that when we
    discover there is a problem.
        And, Mr. Chairman, in the interest of time I am going to
    yield back.
        Mr. Stupak. We are shocked but great.
        Ms. Schakowsky for questions please.
        Ms. Schakowsky. Thank you. I apologize very much for not
    being here for your testimony. There are a lot of hearings
    going on. But through the magic of my assistance from staff I
    find myself able to ask questions nonetheless.
        So let me start with some questions for you, Mr. Stenzel.
    Let me walk you through a key points of your testimony. Is it
    true that throughout the outbreak investigation you and your
    members really could not determine who was in charge of the
    investigation and this left local, State, federal officials
    vying for leadership?
        Mr. Stenzel. Yes, Congresswoman, in many of our
    conversations with officials from both CDC and FDA it was
    unclear who was making the decisions on public advisories, at
    what point in time which agency had the authority to advise
    consumers not to eat these tomatoes or this type of tomato. We
    saw repeatedly concerns between those two agencies.
        As far as the State and locals, this is probably more that
    we have discerned from our members, people doing investigations
    in the field who said that sometimes they heard from their
    State health departments a disagreement with the federals in
    terms of, gosh, we do not think it is tomatoes, I do not know
    why we are still chasing this.
        Ms. Schakowsky. Is it not also true that as a result of
    this various agencies related to this investigation, as you
    say, were--well, I guess you answered that--were pursuing
    different priorities which added to the confusion. So the
    priorities were both instructions for consumers, the source of
    the problem, those kinds of things?
        Mr. Stenzel. Yes, that is correct.
        Ms. Schakowsky. OK. Was not one of your chief concerns in
    this outbreak that field investigators across various agencies
    were not coordinated so it was difficult for your members to
    understand what kind of information authorities were seeking
    and what they could do to help the investigation?
        Mr. Stenzel. This is another important lesson I think as we
    look at trace-back as well. The field investigative staff while
    doing their best were not experts in produce, certainly not
    experts in produce distribution. We have anecdotal stories, as
    Mr. Hubbard told, of an investigator going into a warehouse in
    Philadelphia who said that they had been investigating heart
    transplant and heart valves the day before and now they are
    looking for tomatoes in a warehouse.
        We have cases where an investigator on contract to FDA
    comes in and says, give me all your records. It almost sounded
    like a ``go fish'' game. No wonder we cannot trace it with that
    kind of an approach. But with a very targeted, well-organized
    effort.
        Commissioner Bronson raised an important point I do not
    want to forget, the ability to task State departments of
    agriculture who are much more familiar with our systems to help
    in those investigations might, you know, be a very good lesson
    out of this hearing.
        Ms. Schakowsky. You suggest that Congress should consider
    how to put into place a command and control system with a clear
    chain of command during food outbreak investigations. So you
    are thinking that we ought to think more broadly and include
    state agriculture departments or that we should look at that
    chain of command more broadly as well as more efficiently?
        Mr. Stenzel. I think realistically we are going to have to
    have a collection of different agencies of local, State and
    federal working together. I do not simply see, you know, a
    total revolution at hand in change in our public health
    structure. But there does need to be some type of command
    structure I would suggest.
        I use the analogy of the National Transportation and Safety
    Board investigating an accident. You know that someone who
    flies to the scene, that person is in charge. Everything else
    flows through that investigation. There is one spokesperson to
    the press. The analogy, this one seems to be going in fits and
    starts in many directions. How we can pull that together in one
    more cohesive fashion.
        Ms. Schakowsky. Well, there is also industry expertise. And
    I know another primary concern of your members was that the
    government failed to use that expertise during the course of
    the outbreak investigation. What role should industry experts
    play?
        Mr. Stenzel. We believe that there has to be a very clear
    precaution taken. We do not suggest that industry run an
    investigation. But there is a lot of knowledge and expertise.
    You can hear it from these tomato people. There is expertise in
    jalapenos out there in the industry. And to be able to bring
    them in in an appropriate way for FDA and CDC to call on those
    resources.
        An example would be we mentioned the illnesses. There were
    very few in California, there were very few in some of the
    Mountain West States. We began to look at the distribution
    patterns of food distributors and could start to see why and
    where product may have been coming from. The jalapenos we
    discerned were probably coming on the east side of Texas, not
    the west side of Texas just because of the distribution
    patterns coming up through the Mississippi to Illinois. So that
    type of expertise.
        Ms. Schakowsky. Are there some legal constraints that
    regulatory agencies may have in sharing data or that you may
    have in sharing data?
        Mr. Stenzel. There may be. We are not familiar with what
    those are.
        Ms. Schakowsky. OK.
        Mr. Stenzel. But I think it is something the agencies ought
    to look at. And if there are impediments, is there a way that
    Congress could help them have a legal means to get that
    expertise.
        Ms. Schakowsky. I have a few more minutes so let me ask,
    Mr. Beckman, you communicated to committee staff that you
    believe in the future the FDA should attempt to use industry to
    assist in an outbreak investigation because they understand
    with regard to players and the complex distribution chain, as
    Mr. Stenzel just said. Let me ask your opinion on how you think
    industry could help the FDA?
        Mr. Beckman. Well, to give you an example, within the first
    24 hours of our being informed of this outbreak it was brought
    to our attention by FDA that they were interested in
    ingredients that went into the production of salsa. There were
    follow-up discussions that continued.
        We did not fully understand though where this investigation
    was going and what information we provided if it would be acted
    upon. Really it seemed like there was a greater level of
    outreach by FDA but we were not able to ask the important
    questions to help connect the dots. There were some but we
    tried to shoot blindly----
        Ms. Schakowsky. You were not asked?
        Mr. Beckman [continuing]. Trying to understand where FDA
    was going with this investigation. That was part of the
    problem. And it is my understanding that there are
    confidentiality issues that prevent them from disclosing
    specific points of the trace-back during the investigation.
        Ms. Schakowsky. Well, that is what I am wondering in the
    recommendations, perhaps both of you, because there are
    statutes, including the Trade Secrets Act, portions of the
    Federal Food, Drug and Cosmetic Act, even the Freedom of
    Information Act that makes it difficult to share information
    with industry. So in the face of those information-sharing
    limitations that govern the FDA do various associations
    represented here in conjunction with other produce industries
    plan to consider ways that would allow more industry assistance
    during outbreak investigations?
        Mr. Beckman. We would welcome any form of involvement that
    would include the restriction of the release of any
    confidential data. Any involvement that we can possibly have to
    help move FDA forward on a trace-back investigation. And we
    would welcome being held to any form of confidentiality law
    regarding our involvement.
        Ms. Schakowsky. OK. Mr. Stenzel?
        Mr. Stenzel. If I may, I suggested the possibility of a
    security clearance or some type of pre-vetting of industry
    experts that could be officially authorized and stand at the
    ready that FDA could call. They have already been preapproved
    and they would come 24/7 to help in an investigation like this.
        Ms. Schakowsky. Mr. Kawamura, did you want to respond as
    well?
        Mr. Kawamura. I would like to add that in my testimony you
    will note in the written testimony that we mentioned the leafy
    green marketing agreement which took place in California and
    now Arizona as well as a nice template for industry working
    collaboratively with governments both at the State level, as
    was mentioned earlier, and the federal level, both at USDA and
    also with FDA as a partnership to look at how we can bring
    those resources together, create standards and practices that
    allow for documentation for traceability. And I think that kind
    of effort shows that I think all parties want to move forward.
        Our discussion today continues to be on what happened in
    the past, but in moving forward on what can happen in the
    future the diagnostics that we are working with are incredible.
    To be able to trace genetically these different strains to a
    source back at a watering hole or in the field, these are the
    kinds of things that we should really be celebrating in our
    system. It is not to say that the system is not perfect, but I
    will continue to submit that this system is getting better
    because none of the groups that are represented here can
    sustain these kind of outbreaks and this kind of damage to the
    growers.
        I know we have not talked about compensation today for
    those growers. When you are unfairly pointed, unfairly
    implicated or incorrectly implicated in an outbreak I hope that
    becomes part of the testimony today as well. But I think what
    we want to do is how do we move forward hand in hand.
        I continue to say that for the amazing job that is done
    domestically in our country, the misunderstanding still comes
    with the lack of confidence or the collapse of confidence. How
    do we rebuild confidence with the American public that consumes
    ever day a billion meals a day, if you will, how do we
    recapture that confidence and show that the system is moving
    forward?
        Ms. Schakowsky. And you are suggesting that California may
    provide some model and some suggestions for us at the federal
    level?
        Mr. Kawamura. I believe both California and Florida have
    some models that can easily be used and put into place.
        Ms. Schakowsky. Thank you so much. I yield back.
        Mr. Stupak. Thank you.
        I have called on the FDA to do a post-mortem here on what
    went right and what went wrong with this investigation. Would
    you all be willing to serve on that panel if asked?
        Mr. Brown. We would love that opportunity.
        Mr. Beckman. Absolutely. We are ready to go.
        Mr. Stupak. Let me ask this. It came up and I am still a
    little confused. Tomatoes is the only one that really has this
    traceability that we have? Does jalapenos have them? Does
    spinach have it? Some are shaking heads yes, some are shaking
    heads no.
        Mr. Kawamura. In California the leafy green marketing
    agreement takes all those leafy vegetables and they do have a
    very comprehensive traceability and identification package.
        Mr. Stupak. OK. So the leafy greens, that would be the
    spinach that we have had problems with in the past.
        Mr. Kawamura. And many other, and many other of our
    products as well from California.
        Mr. Stupak. OK. Florida?
        Mr. Bronson. We do not have a full set yet but we are
    working on all the leafy greens to match what we are doing in
    tomatoes.
        But let me, Mr. Chairman, if I might let me say to you that
    even with the new law that has passed on country of origin,
    where these groups were found and the reason why we began to
    see that Florida was not a part of this was around a restaurant
    situation.
        Mr. Stupak. Right.
        Mr. Bronson. You understand that even with the new country
    of origin labelling it does not have to follow to the
    restaurant.
        Mr. Stupak. Correct.
        Mr. Bronson. And that is where one of the problems was in
    this outbreak.
        Mr. Stupak. Country of origin label is really an old law.
    We are just waiting for it to be implemented by the
    Administration.
        Mr. Bronson. Florida has had it for 20 years.
        Mr. Stupak. I know. I know.
        Mr. Bronson. That has worked for us.
        Mr. Stupak. I know.
        Mr. Bronson. I am glad it is coming into place.
        Mr. Stupak. I do not know why we cannot get it done up
    here.
        Let me ask this question. Let me ask this question. Because
    I want to go back to what I said earlier about those three
    press releases the last 12 hours sort of epitomize this
    investigation because we still have so many questions. If I am
    growing a tomato--and I am not a farmer, so bear with me--if I
    am growing tomatoes to I rotate my crop every other year and
    put a different crop in there to keep the ground good? I do
    that. What would be the other crop?
        Mr. Booth. Absolutely. For tomatoes you will rotate that
    every two or three years.
        Mr. Stupak. OK. What would I substitute then when I am not
    growing tomatoes in that field?
        Mr. Booth. It could be wheat. Wheat is a very good, a very
    common crop to.
        Mr. Stupak. OK.
        Mr. Brown. In contrasting it, Congressman, in Florida we
    basically grow tomatoes on the same piece of land year after
    year after year with the technology we have in place.
        Mr. Stupak. OK. Because going back to these press releases
    that I mentioned it says, you know, ``previously FDA inspectors
    collected a positive sample of jalapeno pepper from a produce
    distribution center owned in McAllen, Texas. The FDA continues
    to work on pinpointing where and how in the supply chain this
    first positive jalapeno pepper sample became contaminated. It
    originated from a different farm in Mexico than the positive
    samples of serrano pepper and irrigation water.''
        So this tells me, OK, we still have not cleared off
    tomatoes yet, as we talked about earlier. And the pepper we had
    one farm, now we have another farm and it could be the
    irrigation. So it could be all the farms that use that
    irrigation source or water source; correct?
        Mr. Stenzel. That is what it sounds like to us. I think the
    FDA panel will obviously be able to answer those questions
    better than us.
        Mr. Stupak. OK. Because it is a different farm in Mexico
    than what the original positive samples back on, what did we
    say, July 21. And so, OK.
        Mr. Hubbard, you said you had some, what your understanding
    is this farm that they had had deplorable conditions, sanitary
    conditions?
        Mr. Hubbard. Yes, but again I think conditions in Latin
    America in produce operations tend to be fairly consistently
    substandard. And again, the farm knew they were coming and
    still there were substandard conditions. So one would suspect
    that perhaps they were even worse earlier.
        Mr. Stupak. We have inspectors, FDA inspectors in Mexico,
    do we not, doing produce, looking at the farms?
        Mr. Hubbard. Usually only for cause. There is not, there is
    not normally a routine.
        Mr. Stupak. Not a normal routine inspection going on?
        Mr. Hubbard. There are lots of attempts to educate though,
    good agricultural practices, that sort of thing.
        Mr. Stupak. Mr. Booth, you wanted to say something there?
        Mr. Booth. Thank you. I just want to make sure that we are
    not painting a broad brush with Mexico and other Latin American
    countries that they are substandard. There are many, many
    exceptional growers in Mexico. We deal with those directly.
        Mr. Stupak. Right, and I think some testimony was they have
    a trace-back system----
        Mr. Booth. Absolutely.
        Mr. Stupak [continuing]. In some parts of Mexico.
        Mr. Booth. Absolutely.
        Mr. Stupak. Depending on the grower and who they are
    working with in the United States?
        Mr. Booth. Yes, sir, that is right.
        Mr. Stupak. OK. Someone said earlier that a major consumer,
    let us say like if--who is a major? Jack In The Box, OK, they
    would have certain requirements for tomatoes which are more
    towards how they are handled, shipped, grown. Are they
    different than what you are doing in Florida and California? I
    mean are you having trouble with corporations saying, do this?
    You say, well, this is not part of our system. Is that a
    concern?
        Mr. Bronson. Mr. Chairman, we are not having a problem
    because we have one of the highest standards, probably the
    highest standard in America. So we are not having problem with
    any of our people who are buying, major corporations that are
    buying our tomatoes.
        Mr. Stupak. Well, some of the farmers are telling us that
    some of the concerns that some of these corporations are
    putting on them in order to buy their tomato or jalapeno or
    whatever it is, are things like benzene and things like that
    that really has nothing to do with the growing of this tomato.
    And so I just want to see if you get push-back from
    corporations who are more geared towards risk assessment from
    an insurance financial point of view as to risk assessment from
    a food safety point of view?
        Mr. Bronson. Well, I agree now, now that you have expounded
    on that, there are certain companies that will say we do not
    want tomatoes that have a certain product or whatever put on
    them. And there is usually a third party evaluation of that
    tomato before that company will buy that particular tomato.
        Mr. Stupak. Sure.
        Mr. Bronson. But we have not had problems in Florida.
    Whatever the standard is we usually can meet it.
        Mr. Stupak. You think no problem in California like that,
    Mr. Kawamura?
        Mr. Kawamura. That is the same. You may know that
    California provides 50 percent of the fruits, vegetables and
    nuts that are domestically produced in the United States for
    the rest of the country.
        Mr. Stupak. Let me ask this question, if you know. I
    understand that this type of Salmonella Saintpaul is usually
    associated with poultry; is that right?
        Mr. Kawamura. Not necessarily.
        Mr. Stupak. Not necessarily, OK.
        OK, Mr. Stenzel, you mentioned something about who was in
    charge, command center. Can you expound a little bit on that?
    Should we have, like if you have a natural disaster you have a
    command center, someone comes in, boom, you know who is in
    charge, very rigid?
        Mr. Stenzel. That is precisely the example, Mr. Chairman,
    that between CDC and FDA in particular throughout this
    investigation we have noted tension, rivalries, defensiveness
    between the two positions of individuals within the agencies.
    We feel that that is an important thing to look at of putting
    someone clearly in charge.
        Mr. Stupak. Some kind of an incident command center.
        Mr. Stenzel. Where CDC fingers the culprit but then FDA is
    left to investigate it whether they agree with it or not, it is
    kind of strange.
        Mr. Stupak. OK. Thank you.
        Mr. Shimkus.
        Mr. Shimkus. Thank you, Mr. Chairman. I am going to be
    brief. As I received the testimony I just want to reiterate we
    are still looking for this Salmonella-tainted tomato. And once
    we focused on peppers 18 days to identify the pepper, four days
    to find the location. And had we identified the right vegetable
    at the beginning, the losses would have been limited. You still
    would have had losses.
        Go ahead, Mr. Bronson.
        Mr. Bronson. Yes, Congressman, let me say that if we had
    been given in Florida, and I am sure all the States involved,
    California including, if we had been given the right
    information and not withheld information from us we could have
    gotten to the point very quickly on how to help them in
    Florida. Every State may be a little different but in Florida
    if they would have told us what they were looking for, exactly
    what their suspicions were we could have gone and verified that
    or denied that we had the problem in Florida which would have
    cleared it.
        Now, I hold a commission with FDA, so does Dr. Brown, so
    does Dr. Aller in our laboratory. But I am not sure what that
    commission means because I can hear on national news more than
    what I was being, we were being told at the state level in
    these conferences. So we cannot help if we do not know what we
    are supposed to be looking for.
        Mr. Shimkus. Mr. Brown, you want to answer in response?
        Mr. Brown. Trace-back works wonderfully and that is an
    excellent example in the case of the jalapeno. But when you
    identify the wrong culprit you cannot ever find the trace-back.
        Mr. Shimkus. Right. And I want to follow-up on this.
    Because we are going to have a debate about giving the FDA
    mandatory recall authority. And when this is touched on and
    also recovery of damages, I am not a lawyer. We have some on
    the panel. Are any of you all lawyers? What makes a more
    convincing case, to get cost recovery from a warning or get
    cost recovery because the government did a mandatory recall
    that was in error?
        I have got to believe that we will be on the hook on a
    mandatory recall, especially when it was in error. And I think
    that is one of the problems that we might have in this debate
    as we move forward.
        I think we all are in agreement, transparency,
    communication, someone responsible and hold them accountable. I
    mean I am a military guy, that is kind of the way it works. You
    have to have a chain of command. And this fusion center we call
    it in terrorism and connecting the dots, we have heard that
    numerous times since September 11. We did not do well. The
    State agencies are getting together where you have people in
    the same room. That is probably something, Mr. Chairman, we
    also ought to consider is making sure that we empower everybody
    to help us solve the case sooner rather than later. And I think
    we are going to get that in other panels.
        So with that I really appreciate it, it is a great panel.
    We have more to come. And I yield back my time.
        Mr. Stupak. Thank you.
        Ms. DeGette, have you got some questions?
        Ms. DeGette. I just have a couple quick questions, Mr.
    Chairman, thank you.
        Mr. Stenzel, your industry has endorsed mandatory recall;
    correct?
        Mr. Stenzel. Yes, we have.
        Ms. DeGette. Mr. Beckman, I think your industry has too;
    correct?
        Mr. Beckman. Correct.
        Ms. DeGette. And just so you know, I think most of the
    industries have endorsed mandatory recall. Most consumers think
    that we have it now because they read the recall notices and
    they think they are mandatory.
        Mr. Beckman, I just wanted to ask you quickly about your
    document that you flourished during your testimony which is
    Exhibit 11 in the notebook. That is someone that your
    organization helped create called Commodity Specific Food
    Safety Guidelines for the Fresh Tomato Supply Chain. It is my
    understanding that this document lays out a number of best
    practices to be used throughout all the levels of the tomato
    distribution chain, including traceability requirements. Is
    that correct?
        Mr. Beckman. That is correct.
        Ms. DeGette. And it is also my understanding that you
    believe that national regulations governing the tomato industry
    should be enacted. Is that correct?
        Mr. Beckman. That is correct.
        Ms. DeGette. And if your document Exhibit 11 were used,
    then the whole tomato industry, not just bits and pieces, would
    be required to implement comprehensive systems for tracing
    their products through the supply chain. Is that correct?
        Mr. Beckman. That is correct.
        Ms. DeGette. And I also know that the FDA has seen this
    document. And you would be in favor of the FDA modeling a
    national regulation based on the contents; is that correct?
        Mr. Beckman. That is correct.
        Ms. DeGette. And, Mr. Stenzel, just to clarify with you, I
    think a lot of what you said is really important and has some
    nuance that this committee needs to understand. I just want to
    clarify one thing. Is it the position of your organization that
    more stringent traceability requirements should be enacted
    beyond what is currently required in the Bioterrorism Act of
    2002?
        Mr. Stenzel. We believe that with traceability as well as
    preventive food safety controls they need to be commodity-
    specific and based on risk. So for the tomato industry we are
    the co-author of these----
        Ms. DeGette. Right.
        Mr. Stenzel [continuing]. Guidelines and certainly support
    that in the tomato industry or other products or commodities
    that FDA would determine to be at higher risk.
        Ms. DeGette. OK. And you think that those requirements
    should be more stringent than the Bioterrorism Act of 2002?
        Mr. Stenzel. We believe that these requirements in the
    tomato guidelines would be more stringent.
        Ms. DeGette. And you would support that?
        Mr. Stenzel. Yes, ma'am.
        Ms. DeGette. Thank you very much, Mr. Chairman.
        Mr. Stupak. Thank you.
        Ms. Schakowsky, any questions?
        Ms. Schakowsky. No further questions.
        Mr. Stupak. Well let me thank this panel. It has been most
    interesting. You have been most helpful. And appreciate your
    time and your attention to this. And as I said earlier, Mr.
    Dingell has a bill, most of us are on it, and negotiations are
    going on between both sides and industry, and hopefully some of
    the suggestions you made can be part of that.
        Mr. Shimkus. If the Chairman will yield.
        Mr. Stupak. Sure.
        Mr. Shimkus. I will now say that we are also in the room
    and----
        Mr. Stupak. Right.
        Mr. Shimkus [continuing]. There are negotiations in good
    faith going on on a bipartisan basis.
        Mr. Stupak. So hopefully we can get something done here yet
    this Congress. So thank you very much. We will dismiss the
    panel. Thank you.
        [Witnesses excused.]
        Mr. Stupak. Our second panel of witnesses come forward. One
    our second panel we have Dr. David Acheson, who is Assistant
    Commissioner for Food Protection in Food and Drug
    Administration, also known as the Food Czar; Dr. Lonnie King,
    who is Director of the National Center for Zoonotic and Vector-
    Borne, and Enteric Diseases at the Centers for Disease Control
    and Prevention; Dr. Kirk Smith, who is the Supervisor of
    Foodborne, Vectorborne, and Zoonotic Disease Unit, Acute
    Disease Investigation and Control Section at the Minnesota
    Department of Health; and Dr. Timothy Jones, who is a State
    Epidemiologist for Communicable and Environmental Disease
    Services at Tennessee's Department of Health.
        Welcome, gentlemen. It is the policy of this subcommittee
    to take all testimony under oath. Please be advised that
    witnesses have the right under the rules of the House to be
    advised by counsel during your testimony.
        Do any of you wish to be represented by counsel during your
    testimony?
        [No response.]
        Mr. Stupak. Everyone is shaking their head no, so I will
    take that as a no.
        So therefore I am going to ask you to please rise and raise
    your right hand to take the oath.
        [Witnesses sworn.]
        Mr. Stupak. Let the record reflect each witness answered in
    the affirmative. They are now under oath.
        And we will start with opening statements. If you would
    like to submit a longer statement for the record we will
    include it in the hearing record but we try to hold it to 5
    minutes.
        Dr. Acheson, do you want to start, please?

     STATEMENT OF DAVID W.K. ACHESON, M.D., ASSISTANT COMMISSIONER
        FOR FOOD PROTECTION, FOOD AND DRUG ADMINISTRATION, U.S.
                DEPARTMENT OF HEALTH AND HUMAN SERVICES

        Dr. Acheson. My pleasure.
        Good afternoon, Chairman Stupak and members of the
    subcommittee. I am Dr. David Acheson, Associate Commissioner
    for Foods at the FDA, which is part of the Department of Health
    and Human Services. Thank you for the opportunity to discuss
    the recent food-borne illness outbreak associated with fresh
    produce contaminated with Salmonella Saintpaul and the measures
    FDA is taking to enhance the safety of fresh produce and to
    enhance traceability.
        There is no question that the Salmonella Saintpaul outbreak
    investigation has been one of the most complex in recent
    memory. I assure you that FDA is committed to working with all
    our food safety partners to expedite trace-backs and to ensure
    that America's food supply continues to be amongst the safest
    in the world.
        For this outbreak alone we are FDA have conducted nearly
    450 inspections or investigations together with our State
    partners. FDA labs have analyzed nearly 450 samples, including
    samples of produce as well as environmental samples. To support
    coordination we have hosted or participated in 40
    teleconferences with the States as well as CDC.
        The number of illnesses associated with fresh produce is a
    continuing concern for FDA and we have worked on a number of
    initiatives to reduce the presence of pathogens in foods. Some
    of these activities include working with industry to develop
    guidance on ways to prevent or minimize potential
    contamination, conducting educational outreach to consumers on
    safe food handling practices, sampling and analyzing both
    domestic and imported produce for pathogens, and working with
    industry in foreign countries to promote the use of good
    growing, harvesting, packing, transporting and processing
    practices. We are also conducting research to improve the
    identification and detection of disease-causing agents in a
    variety of foods.
        I would now like to provide a brief description of a
    typical trace-back process. CDC along with State and local
    officials will through its epidemiological investigations
    identify possible food or foods associated with an outbreak.
    And at that point CDC notifies FDA.
        From that point FDA begins our trace-back investigation to
    identify the source of the contamination. We work with industry
    and with local, State and Federal officials and, when needed,
    foreign governments to identify the source of the
    contaminations. We do this by tracing the food suspected of
    being the vehicle for transmitting the pathogen back through
    the supply chain from the retailer or restaurant and inspecting
    or investigating points throughout that supply chain to
    determine where the contamination most likely occurred.
        Tracing food requires us to find and examine documentation
    such as bills of lading and invoices for the product right
    throughout the supply chain. We also obtain information on the
    practices and conditions under which the product was stored and
    handled at each point.
        The current outbreak investigation which initially focused
    on certain types of raw tomatoes provides an example of one of
    the most difficult kinds of trace-back investigations. It was
    on May 31 that the CDC advised FDA of the significant
    statistical association between the consumption of certain
    types of tomatoes and a multi-state outbreak of Salmonella
    Saintpaul infections. Raw tomatoes are a perishable commodity
    and thus are unlikely to be in a consumer's home after a
    consumer becomes ill, obtains a diagnosis, and the outbreak is
    identified.
        Further, raw tomatoes are often sold loose without any form
    of packaging. In the current investigation we learned that many
    tomatoes had been shipped to washing, packing and repacking
    facilities where they were or might have been commingled with
    other tomatoes from different sources.
        A further complicating factor was caused by entities in the
    supply chain using different terminology to describe the
    tomatoes.
        Since May 31 many FDA employees in the field and
    headquarters have been working on the outbreak investigation to
    identify the source. To help the public distinguish tomatoes
    not associated with the outbreak, FDA adopted the policy of
    specifically designating the types of tomatoes implicated in
    the outbreak as well as listing growing areas that were not
    part of the outbreak. On July 17 FDA updated its consumer
    advice, announced that tomatoes currently on the market are not
    considered to be a possible source of illness.
        On July 21 FDA announced it had found a genetic match with
    an outbreak serotype Salmonella Saintpaul in jalapeno peppers
    we tested from a distribution center in Texas. This finding of
    a genetic match was an important break in the investigation.
    Upon further investigation we determined that the contamination
    of the pepper occurred in Mexico, not at the plant in Texas
    and, accordingly, on July 25, updated our advisory, announced
    that there was no indication that domestically grown jalapeno
    or serrano peppers were implicated in the outbreak.
        Yesterday FDA laboratory analysis confirmed that both a
    sample of serrano peppers and a sample of reservoir water used
    for irrigation contained the Salmonella Saintpaul strain that
    was a genetic match for the outbreak strain. These samples came
    from a farm in Mexico but not the same farm that produced the
    first positive jalapeno samples from the distribution center in
    Texas.
        Our current advice is to consumers to avoid jalapeno and
    serrano peppers grown, harvested or packed in Mexico. In
    addition, domestically grown raw jalapeno and serrano peppers,
    canned, pickled and cooked jalapeno and serrano peppers from
    any and all locations are not connected with this outbreak. We
    will continue to refine our consumer message as our
    investigation continues.
        The current trace-back has worked but was slow, requiring
    review of many paper records. While sectors of the produce
    industry may keep electronic records, as we have just heard on
    the previous panel, and be able to do rapid trace-backs, this
    is not a uniform practice. And many of the plants FDA visited
    only had paper records, bills of lading or invoices. To better
    understand the universe of track and trace systems and best
    industry practices for traceability FDA has reached out to a
    variety of external entities. We plan to hold a public meeting
    in the fall to further exchange of information on available
    technology and best practices for enhanced traceability.
        To enhance safety across a range of imported consumer
    products, last November Secretary Leavitt presented to the
    President the Action Plan for Import Safety. In conjunction
    with the Action Plan, FDA released the Food Protection Plan,
    which provides a framework to identify and counter potential
    hazards with respect to both domestic and imported food. Both
    plans build in safety measures across a product's life cycle,
    from the time a food is produced to the time it is distributed,
    and encompass the elements of prevention, intervention, and
    response.
        The Food Protection Plan identified ten legislative
    authorities necessary for achieving full implementation. And we
    appreciate the work this committee is doing to draft
    legislation intended to help provide these authorities. We look
    forward to continuing to work with you to develop this
    important legislation.
        FDA is working hard to ensure the safety of food, in
    collaboration with our partners. As a result of this effective
    collaboration, the American food supply continues to be amongst
    the safest in the world. However, the Salmonella Saintpaul
    food-borne illness underscores the challenges that we face. We
    have been making progress and we are moving forward with the
    implementation of the plans, but more does need to be done. To
    that end, FDA is exploring used its Science Board to convene a
    group of State, industry and academic and other experts to
    examine lessons learned from the outbreak.
        I would like to thank you for the opportunity to discuss
    FDA's continuing efforts to enhance food safety and
    traceability. And I am happy to answer any questions.
        Thank you.
        [The statement of Dr. Acheson follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Stupak. Thank you.
        Dr. King please, if you will.

    STATEMENT OF LONNIE J. KING, D.V.M., DIRECTOR, NATIONAL CENTER
     FOR ZOONOTIC, VECTOR-BORNE, AND ENTERIC DISEASES, CENTERS FOR
     DISEASE CONTROL AND PREVENTION, U.S. DEPARTMENT OF HEALTH AND
                             HUMAN SERVICES

        Dr. King. Yes. Good afternoon. Chairman Stupak and members
    of the committee, thank you for this invitation to address this
    subcommittee today. I am Dr. Lonnie King, Director of the
    National Center for Zoonotic, Vector-borne, and Enteric
    Diseases at the Centers for Disease Control and Prevention.
        First let me offer my sympathies to all the families who
    have been adversely affected by this outbreak. Also I
    understand the frustration of many in the food producing and
    serving industries who work so very hard to produce safe
    produce that we have heard about today. CDC leads federal
    efforts to gather data and to investigate food-borne illnesses.
    Much of what CDC does depends on the critical relationships
    with a broad range of partners: food safety regulatory
    agencies, in particular with FDA and USDA, USDA's Food Safety
    and Inspection Service, and with State and local public health
    departments.
        Salmonella is a group of bacteria with over 2,500 subtypes
    that is widespread in the intestines of birds, reptiles and
    mammals. Salmonella is the second most common bacterial cause
    of food-borne diseases in this country. The current outbreak is
    called by Salmonella serotype Saintpaul, a relatively uncommon
    serotype causing only about 1 percent of all reported
    Salmonella infections each year. This outbreak is the largest
    food-borne outbreak in the United States in the past decade.
    This investigation ha been especially complex, difficult and
    prolonged.
        CDC first learned about this outbreak on May 22 in 2008
    when New Mexico Department of Health reported illnesses in four
    persons confirmed with Salmonella Saintpaul. New Mexico posted
    the information about the unusual number of Salmonella
    Saintpaul cases through PulseNet, a national network of public
    health and regulatory agency laboratories used to detect food-
    borne disease outbreaks. This information allowed State
    laboratories to compare specific DNA fingerprints found in New
    Mexico to their own cases of Salmonella that had been reported
    with matching fingerprints.
        The next day Texas and Colorado reported cases of matching
    fingerprints. Investigators in New Mexico, Texas and CDC began
    a multi-state investigation. Epidemiologists conducted in-depth
    interviews with ill persons to collect information about what
    might be a possible source of infection. Results of this first
    series of interviews indicated raw tomatoes were the most
    commonly consumed food, leading to the hypothesis that they
    were a possible source of this illness.
        Following these initial interviews, case control studies
    comparing what ill and health persons reported eating were then
    conducted. By May 31 preliminary results of the first case
    control study showed that the illness was significantly
    associated with the consumption of raw tomatoes.
        On June 4 CDC received the first report of a possible
    cluster or any restaurant cluster and subsequently learned of
    additional clusters after that. Between June 18 and June 20
    there was a large surge in reported cases in Texas. The
    geographic concentration of illness in the Southwest and in
    Native American and Hispanic persons, along with a strong
    association with the consumption of Mexican-style foods in
    restaurants and the apparent continuation of this outbreak
    after the alert regarding the tomatoes led to the hypothesis
    that a food item commonly consumed with tomatoes could also be
    causing this illness.
        Investigations then focused on the recently identified
    clusters and a second multi-state case control study of persons
    who became ill after June 1 was initiated. The results of the
    case control study indicated a strong link to fresh produce
    items used in Mexican cuisine but did not point clearly to one
    specific item. After additional epidemiologic investigations of
    a cluster of illness in Texas, the FDA began their trace-backs
    on peppers on July 21 and the FDA announced that they had
    isolated the outbreak strain of Salmonella Saintpaul from
    serrano peppers and water irrigation samples from a farm in
    Mexico.
        The outbreak investigation unfortunately continues. The
    active field investigations by CDC, State and local health
    departments, focusing on identifying clusters of cases and the
    FDA trace-backs now on jalapenos, serranos, tomatoes and other
    possible sources are providing new information daily. This
    outbreak has been particularly challenging. First, there is
    inherent delay between when persons become ill with Salmonella
    infection and when results of the testing are reported to
    PulseNet. For half the cases in this outbreak it took more than
    16 days from illness onset to posting the test results on
    PulseNet.
        Second, people have difficulty remembering exactly what
    foods they ate. And remembering specific ingredients in those
    foods is even more difficult, especially if the dish was
    prepared by someone else.
        Third, the foods in question are often eaten together so
    exposure to one item often means exposure to all the items.
        And, finally, perishable foods consumed by ill persons were
    often not available for testing.
        As of June 29 at 9:00 p.m., 1,319 cases where Salmonella
    Saintpaul have been identified in 43 States, the District of
    Columbia, 255 persons have been hospitalized, and two deaths
    were possibly linked to this outbreak. At present we believe
    that jalapeno peppers and serrano peppers are linked to some of
    these clusters and could be two of several food vehicles,
    including tomatoes and other possible vehicles, as we continue
    to explore and investigate. The outbreak is ongoing but there
    are fortunately fewer illnesses being reported.
        In conclusion, this outbreak illustrates the importance of
    existing public health networks: the laboratories performing
    PulseNet, fingerprinting, epidemiologists who conduct the
    investigations, the multi-disciplinary approach to these
    investigations and the close communication and collaboration
    among State, local and federal officials. We balance the rapid
    release of information on sources of illness against the
    potential negative consequences to consumers, food growers,
    producers and industry. CDC is prepared to continue to work
    with regulatory agencies, State and local partners, food and
    environmental microbiologists, and certainly the food industry
    to find long-term solutions to this challenging problem.
        I thank you for the invitation to testify and will be happy
    to answer questions that you may have.
        [The statement of Dr. King follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Stupak. Thank you.
        Dr. Smith please.

    STATEMENT OF KIRK SMITH, D.V.M., PH.D., SUPERVISOR, FOODBORNE,
         VECTORBORNE, AND ZOONOTIC DISEASE UNIT, ACUTE DISEASE
    INVESTIGATION AND CONTROL SECTION, DEPARTMENT OF HEALTH, STATE
                              OF MINNESOTA

        Dr. Smith. Good afternoon. Chairman Stupak and members of
    the subcommittee, my name is Kirk Smith, and I am Supervisor of
    the Foodborne Diseases Unit at the Minnesota Department of
    Health. Thank you for inviting me to speak on our role in the
    Salmonella Saintpaul investigation. We were not highly involved
    in the national investigation early on. Then, from June 23
    through June 27 our State Public Health Laboratory received 10
    Salmonella Saintpaul isolates from ill Minnesota residents who
    had gone to the doctor and been tested for Salmonella at a
    clinical laboratory. Our foodborne disease epidemiology staff
    immediately began the process of interviewing these patients.
    By June 30, several patients had reported eating at the same
    restaurant. That same day, we visited the restaurant to assess
    illness in foodworkers, determine the exact ingredients in
    various menu items, and request credit card receipts to
    identify other potentially exposed individuals to interview.
        Ill and non-ill patrons were interviewed in detail about
    the menu items and ingredients they had consumed. By
    identifying what ingredients were in each menu item we knew if
    an individual ate fresh tomatoes, jalapenos, or cilantro, etc.,
    even if they could not discern or recall all of the specific
    ingredients in a menu item. Then we statistically compared
    foods eaten by ill people to those eaten by non-ill people.
        The ingredient-specific analysis indicated that diced
    jalapenos were the cause of our restaurant outbreak. We sent
    our preliminary statistics to CDC on July 3, 3 days after we
    identified the restaurant as the source through patient
    interviews. Statistics were updated and provided to CDC daily
    as the scope of our investigation grew. By July 8, 5 days
    later, we had interviewed 19 restaurant-associated cases and 52
    non-ill controls, and unequivocally implicated jalapenos.
        On our first visit to the restaurant on Jun 30, we also
    requested vendor invoices for produce items served on the
    implicated meal dates. Those invoices were given to the
    Minnesota Department of Agriculture, which conducted trace-
    backs. On July 3, we provided CDC and FDA with information on
    the possible sources of the jalapenos, all the way back to
    farms or distributors in Mexico. This part of the trace-back
    took 3 days.
        So why were we able to solve our outbreak so quickly in
    Minnesota? In short, we have an efficient, rapid, and thorough
    system. By law, when a clinical laboratory isolates Salmonella
    or another reportable food-borne bacteria from a patient, the
    lab is required to submit the isolate to our State Public
    Health Laboratory. Our lab confirms, serotypes, and DNA
    fingerprints all Salmonella isolated in real time; and this is
    not done in many other public health laboratories. There is
    excellent communication between our lab and epidemiology staff;
    every day the lab provides us with a report of every isolate
    they have worked on.
        Another reason for our success is that food-borne disease
    investigations in Minnesota are centralized at the State level.
    We routinely interview all reported Salmonella cases with a
    detailed questionnaire, and are able to re-interview patients
    with specific questions quickly as needed. In many other
    States, Salmonella cases are not routinely interviewed in a
    timely manner, and if they are, initial interviews are often
    done at the county level and may not contain sufficient detail.
    Centralized surveillance and investigations, coordinated at the
    level of State or large city health departments, are especially
    critical during multi-state outbreaks due to commercially
    distributed food items.
        Food-borne disease surveillance and investigation in the
    U.S. need to be improved. State and federal funding for these
    activities in public health departments has decreased
    throughout this decade, and I believe that this affected the
    national investigation.
        State and local health departments need to be able to
    rapidly confirm and type every Salmonella and E. coli 0157
    isolate that is submitted. This is how we can learn that an
    outbreak is happening as early as possible. But many State
    public health laboratories cannot currently do this.
        Secondly, State and local health departments need to be
    able to rapidly interview every patient with Salmonella and E.
    coli 0157 with a detailed questionnaire, and to conduct cluster
    investigations rapidly. Again, this currently is not being done
    in most localities.
        As we have heard, the trace-back efforts of federal
    agencies can only be as good as the quality and timeliness of
    epidemiologic information coming from State and local health
    departments.
        The investment in food-borne disease surveillance will not
    prevent food contamination from happening, but it will enable
    outbreaks to be detected and the source identified much
    earlier. This will help limit the size of outbreaks, minimize
    the impact on the involved food industry, and identify the
    types of food products on which to focus our prevention
    measures.
        Thank you.
        [The statement of Dr. Smith follows:]

                            Statement of Kirk Smith

        Chairman Stupak and Members of the Subcommittee,
        My name is Kirk Smith, and I am Supervisor of the Foodborne
    Diseases Unit at the Minnesota Department of Health. Thank you
    for inviting me to speak on our role in the Salmonella
    Saintpaul investigation. We were not highly involved in the
    national investigation early on. Then, from June 23rd through
    June 27th, our state Public Health Laboratory received 10
    Salmonella Saintpaul isolates from ill Minnesota residents who
    had gone to the doctor and been tested for Salmonella at a
    clinical laboratory. My foodborne disease epidemiology staff
    immediately began the process of interviewing these patients.
    By June 30th, several patients had reported eating at the same
    restaurant. That same day, we visited the restaurant to assess
    illness in foodworkers, determine the exact ingredients in
    various menu items, and request credit card receipts to
    identify other potentially exposed individuals to interview.
        Ill and non-ill patrons were interviewed in detail about
    the menu items and ingredients they had consumed. By
    identifying what ingredients were in each menu item, we knew if
    an individual ate fresh tomatoes, jalapenos, or cilantro, etc.,
    even if they couldn't discern or recall all of the specific
    ingredients in a menu item. Then we statistically compared
    foods eaten by ill people to those eaten by non-ill people.
        The ingredient specific analysis indicated that diced
    jalapenos were the cause of our restaurant outbreak. We sent
    our preliminary statistics to CDC on July 3rd, 3 days after we
    identified the restaurant as the source through patient
    interviews. Statistics were updated and provided to CDC daily
    as the scope of our investigation grew. By July 8th, 5 days
    later, we had interviewed 19 restaurant-associated cases and 52
    non-ill controls, and unequivocally implicated jalapenos.
        On our first visit to the restaurant on June 30th, we also
    requested vendor invoices for produce items served on the
    implicated meal dates. Those invoices were given to the
    Minnesota Department of Agriculture, which conducted
    tracebacks. On July 3rd , we provided CDC and FDA with
    information on the possible sources of the jalapenos, all the
    way back to farms or distributors in Mexico. This part of the
    traceback took 3 days.
        Why were we able to solve our outbreak so quickly in
    Minnesota? In short, we have an efficient, rapid, and thorough
    system. By law, when a clinical laboratory isolates Salmonella
    or another reportable foodborne bacteria from a patient, the
    lab is required to submit the isolate to our state Public
    Health Laboratory. Our lab confirms, serotypes, and DNA
    fingerprints all Salmonella isolates in real time; this is not
    done in many other public health laboratories. There is
    excellent communication between our lab and epidemiology staff;
    every day the lab provides us with a report of every isolate
    they have worked on.
        Another reason for our success is that foodborne disease
    investigations in Minnesota are centralized at the state level.
    We routinely interview all reported Salmonella cases with a
    detailed questionnaire, and are able to re-interview patients
    with specific questions quickly as needed. In many other
    states, Salmonella cases are not routinely interviewed in a
    timely manner, and if they are, initial interviews are often
    done at the county level and may not contain sufficient detail.
    Centralized surveillance and investigations, coordinated at the
    level of state or large city health departments, are especially
    crucial during multistate outbreaks due to commercially
    distributed food items.
        Foodborne disease surveillance and investigation in the
    U.S. need to be improved. State and federal funding for these
    activities in public health departments has decreased
    substantially throughout this decade, and I believe that this
    affected the national investigation.
        State and local health departments need to be able to
    rapidly confirm and type every Salmonella or E. coli O157:H7
    isolate that is submitted. This is how we can learn that an
    outbreak is happening as early as possible. But many state
    public health laboratories cannot currently do this. Secondly,
    state and local health departments need to be able to rapidly
    interview every patient with Salmonella and E. coli O157:H7
    with a detailed questionnaire, and to conduct cluster
    investigations rapidly. Again, this currently is not being done
    in most localities. The traceback efforts of federal agencies
    can only be as good as the quality and timeliness of
    epidemiologic information coming from state and local health
    departments.
        The investment in foodborne disease surveillance will not
    prevent food contamination from happening, but it will enable
    outbreaks to be detected and the source identified much
    earlier. This will help limit the size of outbreaks, minimize
    the impact on the involved food industry, and identify the
    types of food products on which to focus our prevention
    measures.
        Thank you.

                                    Summary

        A restaurant-associated outbreak of Salmonella Saintpaul
    infections occurred in late June in Minnesota. The outbreak was
    quickly identified by the Minnesota Department of Health. Diced
    jalapeno peppers were implicated and traced back to multiple
    possible sources in Mexico within 3 days of the identification
    of the outbreak. This information was provided to the CDC and
    FDA on July 3. This successful investigation was enabled by a
    strong, centralized foodborne disease surveillance and
    investigation system at the Minnesota Department of Health,
    which collaborated closely with the Minnesota Department of
    Agriculture.
        The large, nationwide outbreak illustrates that foodborne
    disease surveillance and investigation activities in the United
    States need to be improved. Effective investigations by federal
    regulators depend in large part on the timeliness and quality
    of epidemiologic information provided by state and local
    investigators. The Minnesota system could act as a model for
    foodborne disease surveillance and investigation in the United
    States. All state and local health departments should be able
    to confirm, serotype (Salmonella) and DNA fingerprint all
    submitted Salmonella and E. coli O157 isolates in real time,
    and they should be able to interview all cases with a detailed
    questionnaire in real time (this currently cannot be done in
    most localities). This would help identify outbreaks much more
    rapidly, which would limit the size of the outbreaks, minimize
    the impact on the involved food industry, and identify the
    types of food products on which to focus prevention measures.
                                  ----------

        Mr. Stupak. Thank you, Dr. Smith.
        Dr. Jones, your opening statement please, sir.

        STATEMENT OF TIMOTHY JONES, M.D., STATE EPIDEMIOLOGIST,
    COMMUNICABLE AND ENVIRONMENTAL DISEASE SERVICES, DEPARTMENT OF
                       HEALTH, STATE OF TENNESSEE

        Dr. Jones. Mr. Chairman and members of the subcommittee,
    thank you for the opportunity to be here today.
        The recent nationwide outbreak of Salmonella associated
    with produce demonstrates challenges and opportunities for
    improvement in the nation's food safety infrastructure. A
    typical American meal includes foods from six different
    countries, and fresh produce travels a mean of 1,500 miles to
    get to our plates. Dramatic statistics demonstrate the rapidly
    changing environment in which outbreaks are occurring.
    Outbreaks increasingly involve multiple States and widely-
    distributed products, in part reflecting improvements in
    detection and investigation. Recent remarkable successes have
    led to high expectations which realistically cannot be met in
    all investigations.
        Epidemiologists, such as those at State and local health
    departments and CDC, and regulatory agencies, must all work
    together well for outbreak investigations to be effective. 50
    State health departments in the U.S. work under independent
    public health laws. A handful of States have successfully
    investigated a disproportionately large number of multi-state
    outbreaks, reflecting large discrepancies in the resources
    available to them to respond. Most outbreaks are detected and
    investigated entirely at the State and local levels. As in the
    early stages of this Salmonella outbreak, CDC is often in the
    position of reviewing and integrating results of investigations
    done by State and local agencies rather than doing de novo
    investigations.
        State and local public health epidemiologist frequently
    interact directly with the public during outbreak
    investigations, rapidly assessing data to identify the cause.
    They do not routinely do things like inspect facilities,
    perform trace-backs, and do recalls. Federal regulatory
    agencies have very different missions, legal restrictions and
    relationships with industry. Investigators must constantly
    balance the risk of continuing disease due to delays in action
    with the risk of economic damage to the food industry that
    might be mitigated by waiting for more specific data. And,
    clearly, it is impossible to meet all of these expectations.
        Faster product trace-backs would clearly have helped bring
    this outbreak to a more satisfying conclusion. Many
    epidemiologists I think view federal regulatory agencies as a
    black box into which data are sent but from which results are
    received frustratingly late or never. Federal regulatory
    agencies often must operate under such restrictive legal
    constraints that they are unable to share important data such
    as trace-back information, names of facilities, and brand names
    as quickly and as fully as many of us would like.
        In a different outbreak recently, a regulatory agency had
    information that would have allowed State public health
    officials to contact consumers at risk of disease but were
    prohibited from sharing it with us. It is possible for
    epidemiologists to become commissioned by the FDA to be allowed
    to receive confidential data, but most of my colleagues have
    refused to pursue this, specifically to avoid the untenable
    moral predicament of having access to data which we would then
    be legally unable to act on.
        To their credit, USDA and FDA have recently undertaken a
    number of regulatory interventions based entirely on
    epidemiologic data prior to laboratory confirmation of
    pathogens in a food or production facility. And I hope that
    these recent experiences will not dissuade those agencies from
    acting rapidly on strong epidemiologic data in the future.
        My message is not all gloom and doom. Americans today have
    access to one of the safest, most diverse, and cheapest food
    supplies in the history of mankind. And a variety of groups,
    such as the Multi-Agency Council to Improve Foodborne Outbreak
    Response, or CIFOR, are working toward the common goal of food
    safety. I think there are a number of opportunities for
    continued improvement of the nation's food safety
    infrastructure. Solutions require addressing barriers at the
    local, State and federal levels. Federal regulatory agencies
    must have the authority and expectation to share actionable
    information with public health partners promptly and fully to
    protect the public's health, and that may require changes in
    the laws governing them.
        It is critical to support development of information
    technology adequate to sustain food safety activities,
    including improved technology for produce trace-backs, which
    was available for the recent packaged spinach outbreak, for
    example, but not necessary for the produce involved in this
    outbreak. Opportunities for improved coordination with industry
    should be explored. Industry has access to food testing data
    and information contained in frequent shopper cards, for
    example, that is often unavailable to investigators.
        And, finally, public health agencies are pitifully under
    funded. Outbreak response capacity, at least at the State
    level, has been subsidized heavily by funding for successive
    waves of high-profile crises from bioterrorism to West Nile
    Virus, SARS and, recently, pandemic influenza. And funding for
    these is dropping dramatically. Americans eat a billion meals a
    day, day in and day out, and 75 million of us fall victim to
    food-borne illness every year. Adequate and consistent funding
    and resources must be dedicated to sustain effective public
    health programs commensurate with the true risks that they
    address.
        Thank you.
        [The statement of Dr. Jones follows:]

                           Statement of Timothy Jones

        Mr. Chairman and Members of the Subcommittee, thank you for
    the opportunity to be before you today.
        The recent nationwide outbreak of Salmonella associated
    with produce, which began in late April, demonstrates
    challenges and opportunities for improvement in the nation's
    food safety infrastructure. The global distribution, intensive
    production, and rapidity of transport of our food supply are
    markedly increasing the challenges faced during outbreak
    investigations. A typical American meal includes foods from six
    different countries, fresh produce travels a mean of 1500 miles
    to get to our plates, feedlots can hold 300,000 head of cattle,
    outbreaks involving several hundred victims no longer shock us.
    a long list of dramatic statistics demonstrate the changing
    environment in which outbreaks are occurring. Recognized
    foodborne disease outbreaks increasingly involve multiple
    states and widely distributed products, including several
    recent examples associated with fresh produce. Much of this
    change reflects improvements in the surveillance and
    investigation of outbreaks, and the capacity of state and local
    health departments to successfully identify contaminated foods,
    prevent additional illness, and subsequently make the food
    supply safer.
        Such outbreaks also highlight the interdependence of
    multiple agencies at all levels of government in responding to
    these events. Epidemiologists (such as those at CDC and state
    and local health departments), environmental health programs,
    laboratories, and regulatory agencies (such as FDA, USDA and
    state Departments of Agriculture) at the local, state and
    federal level must all communicate well and coordinate
    activities rapidly for outbreak investigations to be effective.
        Outbreak investigations typically go through a number of
    stages, at which various agencies have different levels of
    involvement. Outbreaks are typically recognized by
    epidemiologists and laboratories at the state and local levels.
    Epidemiologists generally work to identify the contaminated
    food, and regulators then participate in further characterizing
    the food vehicle and its distribution. Public notification is a
    critical part of this, at least for outbreaks that may be
    ongoing, and is usually handled by epidemiologists, regulators
    or both. It is important to understand that federal agencies
    (such as the CDC) do not typically initiate investigations of
    this sort. Thus, CDC is often in the position of reviewing and
    integrating the results of investigations done by state and
    local agencies, rather than doing de novo investigations.
        The outbreak being discussed today has been particularly
    frustrating for all involved. It demonstrates the complexity of
    epidemiologic investigations, difficulties inherent in
    investigations of novel foods not typically implicated,
    statistical limitations in identifying one food item which is
    commonly consumed with other foods (salsa for example),
    inherent complexities of tracebacks of fresh produce, and
    challenges in public communication. Recent remarkable successes
    in investigations of spinach and lettuce-associated outbreaks
    and a number of other widely distributed products have led to
    high expectations which realistically can't be met in all
    investigations.
        There are important differences in the ``cultures'' of the
    many different agencies that must work together in
    investigating outbreaks, with widely disparate missions,
    mandates, legal authorities, and organizational structures.
    While these are generalizations, state and local public health
    epidemiologists frequently interact directly with the public
    during outbreak investigations, rapidly assessing data to allow
    identification of the cause of an outbreak and make
    recommendations for preventing additional disease. Federal
    epidemiologists typically collate information from multiple
    states, but may not if there are only a few involved. CDC is
    generally called upon to assess epidemiologic data before
    federal regulatory agencies will act. Epidemiologists do not
    routinely do things like inspect facilities, perform
    tracebacks, or do product recalls. Epidemiologic, laboratory
    and environmental data are used to inform regulatory agencies,
    such as the FDA and USDA, in carrying out their functions.
    These federal agencies have very different responsibilities,
    priorities, relationships with industry, and legal mandates and
    restrictions.
        Because of the very different ``cultures'' and working
    environments of these groups, widely varying perspectives on
    the challenges and weaknesses in outbreak investigations are
    inevitable. Consumers might be expected to desire immediate
    intervention to prevent potential disease, erring on the side
    of caution by acting on data that may be quite preliminary. On
    the other hand, many food producers would not want to see their
    business suffer because of poorly substantiated suspicions, and
    would expect public intervention to occur only on the basis of
    comparatively definitive data. Investigating agencies must
    constantly balance the risk that delays in action might lead to
    additional preventable disease, with the risk of economic
    damage to large sectors of the food industry that might be
    mitigated by waiting for more specific data. Clearly it is
    impossible to satisfactorily meet all of these demands and
    expectations, and every outbreak requires making judgments
    based on unique circumstances and data, quickly and under great
    pressure.
        While there may be room for improvement, it is important to
    acknowledge that there are no rules, policies, or legal or
    administrative interventions which will obviate the need for
    difficult human decision-making in these situations. Moreover,
    it is important to realize that these decisions are not made by
    a single federal agency. States can and do act independently
    when ongoing risks are suspected, though it would be rare for
    that to happen without notification and consultation with
    federal agencies, particularly for products that are
    distributed across state lines. In addition, communication with
    industry may occur at the state or federal level.
        There are over 3000 local health departments in this
    country, and 50 state health departments working under 50
    independent sets of public health laws. Not unexpectedly, there
    is tremendous variability in the capacity to respond to disease
    outbreaks among different jurisdictions. A cursory review of
    outbreaks in recent years will demonstrate that a small handful
    of states appear to have successfully investigated a
    disproportionately large number of multi-state outbreaks. This
    is not an accident, and it is highly unlikely that those states
    really have more disease than others. Rather, this reflects
    discrepancies in the resources available, as well as the
    capacity and inclination to detect and investigate outbreaks.
    CDC does not in most cases have jurisdiction to come into
    states and investigate outbreaks without invitation. The large
    majority of outbreaks are detected and investigated entirely at
    the local and state levels, without any need for federal agency
    involvement. State health departments of course have very
    different thresholds for consulting with federal partners and
    requesting their assistance. In this recent Salmonella
    outbreak, for example, the initial disease clusters were
    recognized and investigated by local and state public health
    authorities. As the scope of the outbreak grew, CDC was invited
    in, initially to help evaluate data already collected by other
    agencies, and subsequently to become increasingly involved in
    designing and directing the investigations. Likewise, the FDA
    became progressively more deeply involved as the investigation
    evolved. At all stages in this fluid continuum, participants
    are necessarily dependent on data already collected by others
    previously, and must wait as additional data are collected,
    which invariably takes more time than any of us would like.
        I think that it is safe to say that many public health
    epidemiologists view regulatory agencies such as the FDA and
    USDA as a ``black box'', into which data are sent, but from
    which results are received frustratingly late, or never. There
    are many examples of situations in which state health
    departments have proceeded with their own product testing or
    limited tracebacks, and gathered important data long before
    information was available from the federal regulatory agency
    involved in the investigation. I don't believe that these
    agencies are purposely withholding critical information from
    public health partners, but I do think that they are required
    to operate under such restrictive legal constraints that they
    are unable or unwilling to share data as fully and as quickly
    as we would all like, even in urgent situations. Federal
    regulatory agencies are frequently prohibited from sharing
    proprietary information and ``trade secrets'' obtained during
    the course of their investigations, which can include names of
    facilities, suppliers, traceback information, brand names, etc.
    I also acknowledge that tracebacks and regulatory
    investigations are far more time-consuming and complex than
    many epidemiologists appreciate, and our expectations of prompt
    results from an understaffed, underfunded and overworked agency
    are unrealistic. All that being said, I think it is inarguable
    that faster product tracebacks and better communication would
    have helped bring this outbreak to a more prompt and satisfying
    conclusion. In order for this to be possible, however,
    investigating agencies must have adequate resources to get the
    work done, and the legal authority to collect and share their
    data promptly and appropriately.
        I was recently involved in another outbreak which
    highlights similar limitations. During the investigation of a
    contaminated product under the FDA's jurisdiction,
    investigators in that agency had information in their
    possession that would have allowed state public health
    officials to quickly identify and contact consumers at risk of
    serious disease. However, because of policies restricting
    sharing of proprietary data and information collected through
    related mechanisms, they were prohibited from sharing it with
    us. The situation was as frustrating for the FDA personnel
    involved as it was for us, but we find these types of
    restrictions during outbreak investigations unconscionable. Of
    note, it is possible for public health epidemiologists to
    become ``commissioned'' by the FDA to be allowed to receive
    confidential data such as those to which I just referred. Most
    of my colleagues have refused to pursue this, expressly to
    avoid the untenable moral predicament of having access to data
    which they would be legally unable to act upon.
        To their credit, it is notable that both FDA and USDA have
    undertaken tracebacks and regulatory interventions in a number
    of recent outbreaks, based entirely on epidemiologic data,
    without first having laboratory confirmation of pathogens in a
    food or production facility. This has not been the norm in the
    past, and this growing acceptance of epidemiologic data has led
    to much prompter interventions to stop outbreaks and prevent
    additional disease. Clearly, careful consideration of the
    weight and implications of all data is critical, but I hope
    that the experience of the outbreak currently under discussion
    will not dissuade these federal agencies from acting rapidly on
    strong epidemiological data in the future to protect the public
    health.
        Suspected produce-associated outbreaks are particularly
    difficult to investigate, from both the public health and
    regulatory perspectives. Typical produce items pass through a
    myriad of hands along the ``farm to fork'' continuum. While
    large food service corporations and their suppliers often have
    excellent quality-control programs with impeccable records,
    many other companies don't, and product tracebacks are
    susceptible to complete breakdown at the weakest link in the
    chain. Produce is generally purchased by consumers unlabeled,
    with no information on its origin. Produce from more than one
    source is often mixed at different distribution points. Many
    consumers have difficulty identifying subtle differences in
    varieties of produce. Such items are frequently consumed as
    ingredients in other foods (salsa, for example), or in
    foodservice establishments where consumers can't know a food's
    origin, and may not even be aware of what they are eating. Even
    if very detailed information from victims can be supplied by
    public health investigators to a regulatory agency (which is
    frustratingly difficult in and of itself), the challenges to
    performing subsequent tracebacks through such a complex food-
    handling chain are formidable.
        It is important to delineate the jurisdiction and
    responsibilities of various agencies during outbreak
    investigations. Food safety is reportedly overseen by 14
    federal entities, administering over 35 separate food safety
    laws, with the involvement of 28 congressional committees. That
    open-faced sandwiches are regulated by one agency and closed-
    faced sandwiches another, or jurisdiction differs based on
    whether a product contains more or less than 2% meat, can be
    complicated. I have been involved in outbreak investigations in
    which both FDA and USDA had regulatory authorities within the
    same production plant, and indeed the same production line,
    depending on the type of food topping being used that day, and
    each agency has strikingly different regulatory policies.
        A substantial underlying cause of many of the problems I
    have described is a limitation of resources available to
    agencies responsible for responding to foodborne outbreaks. We
    are all familiar with the dramatic statistics describing the
    FDA's understaffing and responsibilities far exceeding their
    capacity to meet them, including the fact that only 50 staff
    are dedicated to inspecting all imported foods, and well under
    1% of these products undergoes even cursory examination. CDC
    suffers from similar underfunding. More than one outbreak was
    occurring at this time, as is usually the case. Even with
    excellent staff, the agency simply cannot do its job if
    overtaxed. State and local public health agencies are likewise
    pitifully underfunded. Although the front line in outbreak
    investigations is at the state and local levels, most of those
    agencies receive the large majority of their funding from
    federal grants.
        Our outbreak-response capacity is in large part supported
    by funding granted for successive waves of high-profile crises,
    from bioterrorism and anthrax, to West Nile virus, followed by
    SARS, then pandemic influenza. These resources have subsidized
    a wide array of core public health functions, notably disease
    surveillance and outbreak investigation activities, which
    otherwise would be impossible to sustain. In recent years
    ``preparedness'' funding has been cut repeatedly, leading not
    only to the obvious direct effects, but also to adverse impacts
    on our capacity to respond to events like foodborne disease
    outbreaks, which do not usually attract national attention but
    occur daily and affect millions of Americans annually. I
    obviously recognize the importance of disaster preparedness,
    but also believe that we need to realistically apportion
    resources to address public health threats in a logical manner.
    When the ``red phone'' rings for a bioterrorism attack it is
    important that we be prepared to respond, but while the
    likelihood of such an event is impossible to measure, Americans
    eat a billion meals a day, day in and day out, and 75 million
    of us fall victim to foodborne disease every year.
        My message is not all ``gloom and doom''. Americans today
    have access to one of the safest, most diverse and inexpensive
    food supplies in the history of mankind. Public health,
    regulatory agencies and industry work remarkably well together
    toward the common goal of food safety. Huge strides are being
    made in our capacity to identify, respond to and prevent
    foodborne disease. FoodNet, a cooperative program among 10
    states, the Centers for Disease Control and Prevention, USDA's
    Food Safety and Inspection Service, and FDA's Center for Food
    Science and Nutrition, performs internationally-recognized
    studies of a wide variety of foodborne disease issues.
    PulseNet, a CDC-based system for sharing of molecular
    ``fingerprinting'' data from foodborne pathogens with a variety
    of agencies has markedly improved disease surveillance and
    rapid recognition of foodborne outbreaks. OutbreakNet is a CDC-
    coordinated group of foodborne disease epidemiologists from all
    50 states, as well as representatives from other food safety
    agencies, that is focused on ways to improve communication and
    response to outbreaks. Outbreak-response training programs are
    available, including Epi-Ready, which is a national effort to
    bring environmental health, laboratory, regulatory and
    epidemiology personnel together for coordinated training. The
    Food Safety Research Consortium is a non-governmental
    organization pursuing a variety of projects including a recent
    report, ``Harnessing Knowledge to Ensure Food Safety:
    Opportunities to Improve the Nation's Food Safety Information
    Infrastructure''. A variety of other academic, consumer-
    advocacy and industry groups are engaged in similarly important
    efforts to address many of the issues that have been discussed
    today.
        The Council to Improve Foodborne Outbreak Response (CIFOR)
    is another important example of successful efforts to address
    barriers in the food safety infrastructure. CIFOR is a
    multidisciplinary working group convened in 2006 to increase
    collaboration among the various public health agencies involved
    in the investigation, control and prevention of foodborne
    illness. The Council of State and Territorial Epidemiologists
    (CSTE) and the National Association of County and City Health
    Officials (NACCHO) are co-chairing CIFOR with support from the
    Centers for Disease Control and Prevention (CDC). Epidemiology,
    laboratory, environmental health and regulatory agencies at the
    local, state and federal levels are represented. CIFOR is now
    exploring ways to increase involvement of industry
    representatives appropriately into its activities. Recent CIFOR
    projects have included establishment of an online clearinghouse
    of foodborne-disease response resources, development of
    guidelines for responding to multi-jurisdictional outbreaks,
    development of performance indicators for assessment of
    outbreak-response programs, and writing comprehensive
    guidelines for multi-agency investigations of foodborne disease
    outbreaks.
        I believe that there are a number of opportunities for
    continued improvement of the Nation's food safety
    infrastructure:
        -Adequate and consistent funding and resources must be
    dedicated explicitly to sustain effective public health and
    food safety programs, commensurate with the true risks
    associated with the public health threats they address.
        -Federal regulatory agencies must have the authority and
    expectation to share actionable information with public health
    partners promptly and fully, to the extent necessary to protect
    the public's health. This may require changes in laws governing
    those agencies, and trust among public health partners and
    industry that sensitive and propriety information will be used
    only for protection of the public's health.
        -Though I do not believe that federal public health
    epidemiology programs should be merged administratively with
    federal regulatory agencies, there is great potential benefit
    to reviewing jurisdiction of food types, facilitating improved
    communication among these agencies, including developing
    mutually accessible databases, ensuring rapid sharing of data
    during public health emergencies, and continuing to develop
    inter-agency training opportunities.
        -It is critical to support development of information
    technology adequate to sustain outbreak detection and response
    activities. This includes resources for the development of
    state-based disease surveillance databases that both serve
    state needs and that allow for the sharing of essential
    information with other states and federal agencies, electronic
    laboratory reporting from commercial laboratories to public
    health agencies, and open data standards that allow data
    sharing among all food safety and public health agencies.
        -Opportunities for improved coordination with food
    industries should be explored. Many food industries conduct
    testing which could be valuable in identifying the sources and
    causes of foodborne illness and outbreaks. Data sharing by
    industry should be encouraged. In addition, while outbreak
    investigators require appropriate independence, the food
    industry has access to data that can be important to
    investigations. One example is the detailed information often
    contained in ``frequent shopper cards'', which can include
    contact information and precise data on dates and products
    purchased. A limited number of stores have been very
    cooperative in sharing such data with public health
    investigators, but unfortunately this is not currently the
    norm. Many grocery chains enter into contracts with consumers
    that they interpret to prohibit unilateral disclosure of sales
    information to public health agencies.
        In summary, I believe that our nation's food safety
    infrastructure is strong, but substantial barriers to continued
    improvement remain. Important strides are being made to improve
    foodborne disease outbreak response, and with adequate support
    there are many additional opportunities for improvement. I
    applaud today's meeting as recognition of the importance of
    pursuing these goals. Thank you for the opportunity to discuss
    these issues with you today.

                                    Summary

        -Improving the nation's food safety infrastructure, and
    capacity to respond to outbreaks, will require addressing
    barriers in epidemiology, laboratory, environmental health and
    regulatory agencies, at the local, state and federal levels.
        -Adequate and consistent funding and resources must be
    dedicated explicitly to sustain effective public health and
    food safety programs, commensurate with the true risks
    associated with the public health threats they address.
        -Federal regulatory agencies must have the authority and
    expectation to share actionable information with public health
    partners promptly and fully, to the extent necessary to protect
    the public's health.
        -Formal mechanisms to facilitate effective communication,
    sharing of data, and inter-agency training among agencies, and
    with industry, should be developed.
        -An adequate information technology infrastructure is
    critical to ensuring successful outbreak responses.
        -Mechanisms should be developed to support and take maximum
    advantage of successful efforts, including those of non-
    governmental, academic, consumer and industry organizations, to
    improve the food safety infrastructure.
                                  ----------

        Mr. Stupak. Well, thank you. And thank you all for your
    testimonies. Now we will begin questions.
        Dr. Acheson, I have been talking about these 3 releases in
    the last 12 hours because I think it adds more confusion as to
    what was going on. The first one 9:00 o'clock last night was on
    jalapenos. The one at 10:15 I think or 10:30 was on cilantro.
    And then the one today sort of expands and talks a little bit
    about this farm and the location down there in Mexico. And one
    of the questions I asked the other one is, the other panel was
    you still have not cleared the tomatoes. Are tomatoes still a
    suspect or vegetable of interest as we were calling it on the
    first panel or are they cleared now?
        Dr. Acheson. FDA has investigated tomatoes. We have done a
    lot of testing with States and other federal agencies. We have
    not found a positive sample. We have inspected farms and----
        Mr. Stupak. So why do you not clear the tomato?
        Dr. Acheson. At this point there is nothing for FDA to say
    that would indicate the evidence that CDC and the States
    generated early on in this investigation is incorrect. FDA
    based on that information did its trace-back.
        Mr. Stupak. Right.
        Dr. Acheson. And it is not up to FDA to say that that
    original case control study was----
        Mr. Stupak. Well, then who clears the tomato then? If it is
    not up to the FDA you have no Saintpaul Salmonella or
    Salmonella Saintpaul in any tomato product. We have cilantro
    suspect and now we have peppers for sure; right?
        Dr. Acheson. Right. Correct.
        Mr. Stupak. Well, so who would clear it then I mean?
        Dr. Acheson. We have made it very clear that there are no
    tomatoes that are currently available on the market from
    anywhere in the world that are linked to the outbreak.
        Mr. Stupak. Currently. But how about tomatoes from the
    original suspect? That is what the last panel was concerned
    about, that that hangover effect still exists as to tomatoes.
        Dr. Acheson. Are you suggesting that FDA go back and say
    that that original conclusion was incorrect? Because that is
    not FDA's role. FDA picks this up at the point----
        Mr. Stupak. OK, so if the FDA makes a mistake you never
    say, I might have made a mistake?
        Dr. Acheson. Of course we would. But we did not make a
    mistake. FDA----
        Mr. Stupak. How do you get Saintpaul Salmonella with the
    tomato then.
        Dr. Acheson. Let me try this again.
        Mr. Stupak. Yes.
        Dr. Acheson. FDA begins its trace-back----
        Mr. Stupak. Correct.
        Dr. Acheson [continuing]. Based on information----
        Mr. Stupak. From the CDC and others, right.
        Dr. Acheson. Right.
        Mr. Stupak. All right.
        Dr. Acheson. We do that in good faith based on the
    science----
        Mr. Stupak. Right.
        Dr. Acheson [continuing]. That CDC has undertaken.
        Mr. Stupak. And in your trace-back you found nothing to
    implicate the tomato?
        Dr. Acheson. And we have said that. And we have said that
    tomatoes that are currently on the market are safe to consume.
        Mr. Stupak. On behalf of the tomato, they want their good
    name back, I think you should put out something a little more
    firmer on that.
        Let me ask you this. These farms in Mexico that you now
    suspect with the jalapenos----
        Dr. Acheson. Yes.
        Mr. Stupak [continuing]. Do any of them grow tomatoes?
        Dr. Acheson. Yes, they do. There is at least one farm.
        Mr. Stupak. OK, at least one. Then the irrigation water
    that is suspect is that irrigation water being used on tomatoes
    then?
        Dr. Acheson. The farm that grows tomatoes also grows
    serrano and jalapeno peppers.
        Mr. Stupak. OK.
        Dr. Acheson. That is the farm where the original peppers
    that were positive in McAllen, Texas, traced back to.
        Mr. Stupak. OK. That's the one that Minnesota had; right?
    No?
        Dr. Acheson. That is, the Minnesota part is just one piece
    of this.
        Mr. Stupak. OK. OK. So the farm, there is at least one farm
    in Mexico that grows jalapenos and tomatoes that we have
    positive for Salmonella Saintpaul; correct?
        Dr. Acheson. Let me try this again. There is----
        Mr. Stupak. If I am confused the American people are really
    confused.
        Dr. Acheson. FDA found a positive sample of jalapeno
    peppers at a distribution center in Texas.
        Mr. Stupak. Texas.
        Dr. Acheson. OK.
        Mr. Stupak. You traced it back to a farm in----
        Dr. Acheson. We traced--can I finish?
        Mr. Stupak. Sure.
        Dr. Acheson. That may clarify your confusion. We traced
    that positive sample of jalapeno peppers back to a farm in
    Mexico. That farm grows jalapenos, serranos and tomatoes.
        Mr. Stupak. Tomatoes, OK.
        Dr. Acheson. As part of the investigation in Mexico we were
    investigating other farms and we took samples on other farms.
        Mr. Stupak. Correct.
        Dr. Acheson. And found the outbreak strain on a different
    farm that grows jalapeno peppers and serrano peppers but does
    not grow tomatoes.
        Mr. Stupak. OK.
        Dr. Acheson. Now one question that is out there, which I
    think you are getting at is, is there a connection between
    those two farms?
        Mr. Stupak. Well, where is the water source coming from?
        Dr. Acheson. That is a good question and that is part of
    what we would try to determine while we are there.
        Mr. Stupak. Would these two farms use the same water
    source?
        Dr. Acheson. Do not know. Do not know. But what I can tell
    you is that those two farms do send their produce through a
    single distribution center.
        Mr. Stupak. How far apart are these farms?
        Dr. Acheson. I believe they are about 3 hours drive but I
    do not know specifically how many miles apart they are.
        Mr. Stupak. OK. Then let me ask this question I asked of
    the previous panel and they were not real clear on it or did
    not quite: is Salmonella Saintpaul usually associated with
    poultry?
        Dr. Acheson. Salmonella, yes, typically with turkey.
        Mr. Stupak. Turkey?
        Dr. Acheson. Yes.
        Mr. Stupak. OK. Are there turkey farms down there near this
    area in Mexico?
        Dr. Acheson. Not aware of any turkey farms down there.
        Mr. Stupak. OK. Let me ask this: any reason why you could
    not clear domestically grown tomatoes then?
        Dr. Acheson. We have already stated that domestically grown
    tomatoes, tomatoes from anywhere are perfectly OK to consume.
        Mr. Stupak. OK, let me ask you this. Let me go to Dr.
    Smith. You said, and I am going to come right back to you, you
    said when you did the jalapeno and you nailed it there you
    traced it back to the farms in Mexico?
        Dr. Smith. There were multiple possible sources of these
    jalapenos and they were all in Mexico.
        Mr. Stupak. OK. I am sure you gave that information to the
    FDA.
        Dr. Smith. Yes.
        Mr. Stupak. So are we talking about the same farms then
    that Minnesota suspected?
        Dr. Acheson. Yes. They crossed into our systems, into what
    we were tracing back.
        Mr. Stupak. OK. How many farms or possible sources did you
    find?
        Dr. Smith. Well, we could not get back all the way to the
    farm level.
        Mr. Stupak. OK.
        Dr. Smith. All of the farms. But we had three different
    possible trace-back farms.
        Mr. Stupak. OK.
        Dr. Smith. And they all went back to Mexico and one of them
    only could we get back to a distributor.
        Mr. Stupak. OK. So you found these three farms you have at
    least two farms about 3 hours apart and the water source we are
    still not sure about yet; right? Is that correct, Dr. Acheson?
        Dr. Acheson. We found two farms, yes, but we have been--
    there are many other farm distribution centers that have
    crossed over in this trace-back. It is not as simple as just
    two farms in a distribution center.
        Mr. Stupak. OK. How many, if you know, how many farms use
    this water source that has suspect with Salmonella Saintpaul?
        Dr. Acheson. I do not know.
        Mr. Stupak. OK. OK. Let me ask this question. You mentioned
    you are going to have a fall conference, Secretary Leavitt has
    called a fall conference. Will the FDA be running a post-mortem
    on what went right, what went wrong on this recall? Will you be
    doing that?
        Dr. Acheson. We are proposing two things: one is a public
    meeting in the fall that will be focused on issues around
    traceability. We have had a lot of discussion earlier, it is
    very important.
        Mr. Stupak. OK.
        Dr. Acheson. What I said is that right now we are exploring
    using our Science Board as a mechanism to set up a subcommittee
    of the Science Board that could involve industry, State,
    federal, academic experts to help----
        Mr. Stupak. Right.
        Dr. Acheson [continuing]. Ask questions about what can we
    do better? What went wrong? What are the lessons learned?
        Mr. Stupak. Why would you not just use the folks involved
    in this one because this one is the largest Salmonella outbreak
    we have had in the last 10 years, last decade? Why would you
    not use the folks in the first panel to help do it as proposed?
        Dr. Acheson. We very well may. It just needs to be done
    through the mechanisms of the Science Board. As you have raised
    earlier or has been raised in terms of information that we can
    share and the Federal Advisory Committee Act, laws that are
    around, discussions, etc., it has to be done according to the
    law.
        Mr. Stupak. Right.
        Dr. Acheson. And doing it through the Science Board is a
    process that allows us to do that.
        Mr. Stupak. OK.
        Dr. Acheson. The experts----
        Mr. Stupak. OK, last Science Board on review in the FDA
    though and the things you had there it was limited to they
    could not talk about budget, so I would hope that this Science
    Board would be given full review of the information so they can
    put forth recommendations to help assist with this.
        Let me ask you this, with any crisis you learn from your
    weaknesses in the existing system. What have you learned from
    this investigation that requires legislative changes? Because
    in your testimony you said Congress is drafting. We are past
    drafting, we are actually negotiating between all the parties,
    and I know the FDA has been involved. So and we are getting, we
    are on the food part right now on food safety. So what
    legislative changes have you learned that we need to help you
    with this kind of investigation?
        Dr. Acheson. Of the 10 legislative proposals that we have
    discussed previously as part of the Food Protection Plan,
    probably the one that is most important is the one that
    requires preventative controls. I do not think anybody would
    disagree that the key answer to this is not to react faster but
    is to prevent the problems in the first place. That is
    absolutely critical across the board. So that is a very
    important one.
        There are other components in there in terms of the other
    legislative proposals that would help somewhat. Another one,
    for example, is the requirement for certification for certain
    imported products. That is a federal to federal agreement. But
    that is another example that could help us.
        And then I think as the questions around lessons learned
    unfold here, and we are still focusing on stopping the outbreak
    as opposed to focusing on what are the lessons learned after,
    but obviously there needs to be lessons learned and discussion
    around traceability and whether there needs----
        Mr. Stupak. Right.
        Dr. Acheson [continuing]. To be a legislative fix around
    that.
        Mr. Stupak. Well, we had the Bioterrorism Act of 2002 which
    was supposed to give the Secretary of HHS the tools necessary
    to have rapid trace-back of a food commodity through a
    distribution chain. Did the Bioterrorism Act work here?
        Dr. Acheson. The Bioterrorism Act worked as written. We
    rarely ran into a problem where people were not keeping records
    of people who were supposed to. That did not slow it down.
    Contrary to what you heard on the first panel, what we learned
    in this outbreak is that it was many of the small producers,
    the small restaurants, much like Mr. Shimkus' example of the
    little restaurant that he goes to on a Friday night that were
    involved in this, they do not have electronic systems. The vast
    majority of the information we got was paper, it was invoices,
    it was bills of lading. That has to be worked through by a
    person just working their way through, looking for the
    connectivity.
        Mr. Stupak. Should not the farm be included in the
    Bioterrorism Act? Right now it is exempt, farms and
    restaurants. Would that not have really helped you out if they
    were part of the Bioterrorism Act?
        Dr. Acheson. Currently the Bioterrorism Act does not cover
    you from farm----
        Mr. Stupak. Right.
        Dr. Acheson [continuing]. All the way through to
    restaurant.
        Mr. Stupak. Right. Should they not be included?
        Dr. Acheson. It certainly would expedite the process if
    they were.
        Mr. Stupak. OK, let me go to Dr. Smith, I have a question
    or two. I read from an Associated Press article, and I want to
    go back to that, on July 23 Associated Press ran an article
    entitled, and I am quoting, ``A Hot Lead in the Hunt of
    Salmonella Source: Minnesota Pinpointed jalapenos While Feds
    Fruitlessly Chased Tomatoes.'' I presume you have read this
    article?
        Dr. Smith. Yes.
        Mr. Stupak. OK, then let me ask you this. The article
    suggests that the State of Minnesota was using certain outbreak
    investigation techniques that the CDC and FDA were not using.
    Are there certain things that you believe that the State of
    Minnesota did in this outbreak that key federal agencies did
    not do?
        Dr. Smith. Well, first of all I should say you know the
    types of things that we do are the types of things that need to
    be done in other State and local health departments.
        Mr. Stupak. Right. But what about CDC and FDA, should they
    be using those things too? And what are they?
        Dr. Smith. Well, OK, so what makes I think us so successful
    is that our laboratory confirms and types all Salmonella
    isolates that they get right away. It takes 2 or 3 days. And
    then they give that information to epidemiologists right away.
    And then we interview these patients right away.
        Mr. Stupak. So that the rapid response from the
    investigation of the slide to your local health to the
    interviews?
        Dr. Smith. I think it is the rapid response. But it is also
    the level of response. We get very detailed information from
    all of these patients. And I also have epidemiologists who work
    only on food-borne disease. They are evaluating clusters every
    day and so they are very experienced.
        Mr. Stupak. So in the first panel when they said, well,
    yesterday I was working on heart stents, today I am working on
    tomatoes, that does not lead to good investigative work?
        Dr. Smith. Yes, certainly it is better if you have got
    people that are just dedicated and focused on one thing. And we
    are fortunate to have enough resources to be able to have
    epidemiologists that are dedicated to food-borne disease. And a
    lot of these resources are from federal programs such as Food
    Net.
        Mr. Stupak. OK. Just one last question before I turn to Mr.
    Shimkus. Dr. Acheson, it came up in the first panel, it sort of
    came up here, Dr. Jones mentioned it, if this were bio-
    terrorism how would you have acted differently?
        Dr. Acheson. If this was deliberate the process would have
    been the same.
        Mr. Stupak. So even information sharing would have been the
    same? There has been complaints about information sharing and
    whether a person would be commissioned or non-commissioned
    because there is a concern about information sharing. No
    command, incident command center, no one was in charge was the
    other allegation. So you would handle it the same? That is not
    a good idea.
        Dr. Acheson. There was a lot of information sharing that
    went on, a lot of work was done. In fact, with the State of
    Florida, as Commissioner Bronson talked about, we did use
    Florida labs, we did use Florida inspectors when we were down
    in Florida. So we actually did what he was suggesting that we
    did not do.
        Mr. Stupak. But Florida is mad at you for banning their
    tomatoes when they could provide traceability with a system
    that FDA helped develop. So I do not think Florida is
    especially happy with the FDA or the way information was
    shared. Their traceability would have showed because of the
    outbreaks that----
        Dr. Acheson. I am pointing out that we did share a lot of
    information with Florida and we did use the Florida resources,
    as the Commissioner suggested we should. We did, we used their
    labs and we used their inspectors.
        Mr. Stupak. Well, I hope if we suspect a bio-terrorism we
    are not going to treat it the same way, that there would be a
    little bit more urgency to it.
        Dr. Acheson. The trace-back process would be the same. It
    is what it is.
        Mr. Stupak. So then it is a major hole in our national
    safety, whether it is bio-terrorism or Salmonella Saintpaul?
        Dr. Acheson. If somebody has done something deliberate that
    is involving the same type of products in the same type of
    restaurants and retailers it would be no different, it could
    not be different. It is still right now paper, invoices, bills
    of lading. You have to go and get them, you have to go and pick
    them up. That is what could be a focus of making it faster if
    there was a deliberate act.
        Now, obviously if this was deliberate there would be
    different federal authorities involved. Homeland Security would
    have a lead if it was a bio-terrorism event. It would be run
    differently. I am simply focusing on FDA's role with the
    traceability. It is what it is. I mean and it worked, it was
    just slow.
        Mr. Stupak. Mr. Shimkus please.
        Mr. Shimkus. Thank you, Mr. Chairman.
        I want to go back. I think we are pounding on FDA but FDA
    spent all this time going after the wrong suspect because it
    was not identified properly to begin with. And once we got
    identification with the help of a public health department, 18
    days plus 4 to find the location. And so I think there are ways
    that we think we can make things better. And my questions are
    going to be in that.
        But we have got to keep this in focus. I think the original
    panel identified that. We just got taken off in the wrong
    direction and the FDA went. Traceability worked, maybe not as
    quickly as would like, but it worked. And the reality is,
    Diana, the reality is tomatoes first time for this disease is
    infinity. We are still looking, we cannot find it. When it was
    identified in peppers, 18 days to find the pepper, 4 days to
    find the location. I think that is a success. What went wrong
    was that and the issue is the CDC and the public health
    department.
        So I would like to ask first, we have two public health
    departments, how big is the State of Minnesota population-wise?
        Dr. Smith. About 5 million people.
        Mr. Shimkus. And, sir, your state?
        Dr. Jones. Six million.
        Mr. Shimkus. And so what is the budget, Dr. Smith, of
    yours, of the State Public Health Department?
        Dr. Smith. I basically have one food-borne disease
    epidemiologist for every million people in the State.
        Mr. Shimkus. One for every million. And, Dr. Jones?
        Dr. Jones. Same order of magnitude, yes.
        Mr. Shimkus. And we do not have to name States, but you
    probably know States that have one epidemiologist for how many?
        Dr. Smith. Every 24 million people.
        Mr. Shimkus. Twenty-four million. And I guess Texas, I mean
    and we are talking about this starting in Texas or New Mexico.
    I guess Texas was the second point. And I do not want to even
    ask about my State. So but if we had a bio-terrorism attack it
    would be identified first by who?
        Dr. Smith. It would be identified in exactly the same way
    as a natural contamination would, exactly.
        Mr. Shimkus. And it would go once you had identified the
    convergence, the commodity, you would then go to the CDC?
        Dr. Smith. Absolutely.
        Mr. Shimkus. And then in conjunction we would then have to
    raise a concern to start finding where this thing started from.
    And again, if we are using this as a case study we just
    identified it wrong. So I think part of this debate is public
    health, public health departments get them funded, get them
    technologically advanced. And then probably, Dr. King, probably
    working with CDC to get you all fully funded and up to speed
    and staffing, would you not agree?
        Dr. King. I certainly agree that many of the states are
    under-resourced when it comes to many public health problems,
    including food safety. I think that was one of the inherent
    problems and lessons learned here is that they were poorly
    resourced and could not respond just because they did not have
    the resources to put into this.
        When you talk about, Congressman, about the States talking
    to CDC, there is a system in place called PulseNet. And
    PulseNet is in place. All the States have PulseNet
    capabilities. There are counties and cities that also have
    PulseNet. So concurrently and simultaneously we can through the
    States, local and CDC actually look across the 50 States and
    even further into those States, into cities, with a system that
    is standardized to say, oh, this is Salmonella Saintpaul, this
    is the variety that has caused outbreak over New Mexico and
    Texas and Illinois. That gives us then the capability to say
    this is a multi-state outbreak. There is a source here that we
    did not know about.
        The CDC's role then--and by the way, the States can look at
    this just as quickly as CDC can--CDC then is involved in that
    coordination when asked. Last year there was 1,260, right,
    outbreaks that came to CDC's notice. Of those, about 120 CDC
    was actually involved in giving advice, helping where asked. 12
    of those we actually took a lead role. 90 percent of what is
    happening in the food safety area is at the local and State
    level. 1 percent of the time CDC actually gets involved in a
    lead situation. That is why these States need to have proper
    resources.
        Mr. Shimkus. And I mean this is a tough position because
    you make a call, there are people ill. Make the wrong call then
    you have got the culprit still out there. People are sick,
    people are dying. It is an honorable profession and we applaud
    your work, we are just trying to get it better.
        Dr. Jones, and this is also in preparation for the hearing,
    I want to know what are the barriers, these legal barriers, and
    I want to know some specifics of what are the legal barriers
    that are limiting our ability to more quickly, clearly identify
    culprits and the like? Do you have any that you can
    specifically give me?
        Dr. Jones. I am not aware of any legal barriers to sharing
    epidemiologic data. And I think that that occurs quite rapidly
    in both directions and goes to the regulatory agencies fairly
    quickly. I guess the examples that I am familiar with have to
    do, and again I am not an attorney, have to do with legal
    restrictions on federal regulatory agencies not being able to
    share potentially, you know, proprietary information.
        Mr. Shimkus. Yes, give me an example. We want to, I would
    think the committee would want to find out exactly what those
    are. And as we are doing legislation to say when there is a
    national public health risk we have to tear these down and we
    have to ensure that the federal agencies protect the propriety
    while we are finding information.
        So, Mr. Chairman, as we continue this I think this is a key
    area. And I mean does anyone, can anyone share? Dr. Acheson?
        Dr. Acheson. Part of the problem here is proprietary
    information that is deemed to be commercial confidential. There
    is a mechanism through commissioned individuals at the State
    level that that can be shared with. And we----
        Mr. Shimkus. Well, we heard about commissioned
    individuals----
        Dr. Acheson. Yes.
        Mr. Shimkus [continuing]. In the first panel. And they did
    not seem to have much power or control or input.
        Dr. Acheson. No, we are able to share information with
    commissioned individuals, and we do. And I think to that point
    if a commissioned individual in a State is saying, we think
    there is something going on and we would like some information,
    nothing to stop them picking up the phone and saying, can you
    help us here because we have some questions, if they are
    commissioned.
        Mr. Shimkus. Well, we are going to, I know on our side we
    are going to try to dig in, Mr. Chairman, on this issue because
    we are the legislative branch. You know, we can--Dr. King, do
    you want to add?
        Dr. King. There is one piece of information I know the
    industry was hoping to get and could not get and was critical
    of it, and that was identification of cases by county. And that
    is something that through our legal counsel when a State shares
    information with us first of all the data and information is
    the State's. When it is shared voluntarily with CDC it becomes
    part of the federal record. It is also then under the authority
    of Privacy Act and also under Freedom of Information Act and
    agency policy. And it has been consistent and the
    recommendation of our general counsel that when you get down to
    the county level that that gets too close and patients, to
    protect patients' rights we will not give that information out.
        And so there is a case where you get States with very--not
    very populated and maybe have one hospital, all right, that is
    the information then could actually get back. And those patient
    rights need to be protected. So there is a case.
        Mr. Shimkus. Yes, again I am going to keep, we are going to
    keep following up on this line of work because I think where
    there are some legislative fixes here and where we can protect
    propriety and carve out provisions because we need information.
    And I think the first panel talked about transparency when
    there is a national emergency. If we are talking about bio-
    terrorism and the risk of millions of people we surely do not
    want privacy considerations to trump the health and welfare of
    the nation.
        So and the Chairman's position also was if we get sent down
    the wrong path, as this case is happening, how do we clear the
    product that has now lost immediate dollars and potentially
    market share, how do we, who calls it and says lay off the
    tomatoes? Dr. King.
        Dr. King. Thank you, Congressman. You know, we respectfully
    disagree that tomatoes were not involved. And so if you give me
    a little bit of time to talk about what happened in that case
    control study if you would like for me to explain that, to talk
    about the science and the epidemiology behind it, that is your
    call.
        Mr. Shimkus. Well, my time expired. If the Chairman wants
    to hear it I would be happy to hear it.
        Mr. Stupak. Well, yes, let us hear it. Because how do you
    prove a negative? You put a negative out there and you still
    cannot prove that negative.
        Dr. King. It is an important point to make, so let me go
    back. And, you know, I apologize for the terms in the
    epidemiology, I do not apologize for the science.
        So initially when we had these cases in New Mexico, New
    Mexico went ahead and went back to ill people and did what they
    call hypothesis-generating interviews. And that hypothesis
    generating, I think your committee had copies of this.
        Mr. Stupak. It is all right here, Yes.
        Dr. King. Absolutely. Was pretty comprehensive. It included
    at least 200 different sources of food.
        Mr. Stupak. But even at that time you knew tomatoes coming
    from South Florida does not go to New Mexico. That is the
    traceability thing that they are arguing with you. And if you
    will not give them the county they cannot help you.
        Dr. King. Yes, sir. You know, it is what you know at that
    point in time.
        Mr. Stupak. Right.
        Dr. King. So, you know, at that point----
        Mr. Stupak. Well, you knew that South Florida was the only
    place that there was producing tomatoes for distribution in the
    United States, there and Mexico. So if Florida has this great
    traceability why did you not work with them so they could show
    that was not Florida tomatoes to we could have protected the
    domestic tomato industry which has lost $100 million and
    counting?
        Dr. King. So let me just go back and explain the ep--the
    trace-backs are part of what FDA does, not what----
        Mr. Stupak. Well, that is part of epidemiology, is it not?
        Dr. King. It informs trace-backs for sure, absolutely. And
    they go together. So you are absolutely right.
        So through the hypothesis-generating interviews and through
    the case control studies that followed, right, and the case
    control studies were done by Texas, New Mexico, and the Indian
    Health Service, and the analysis of the data strongly
    associated tomatoes as the possible cause of this outbreak. And
    when I say strongly associated, you have to understand what
    that is in epidemiologic terms. When we did the calculations,
    epidemiologist statisticians, right, that means that people
    that were ill with this form Salmonella Saintpaul that was in
    this particular pulse field were 7 times more likely to have
    eaten raw tomatoes.
        And when you did further probabilities of the calculation,
    right, they do what is called a P value. This is the
    probability that came up with .001. That was 10 times greater
    in terms of what it would take to publish the scientific data.
    So with that information in mind and epidemiologists and
    talking to other people that do this and which we have done for
    30 years, right, that is a strong association.
        Mr. Stupak. Agreed. But when you made that strong
    association, May 22 is when CDC and State health officials
    identified outbreak of Salmonella Saintpaul, and within a few
    days you said tomatoes was the probable one; right?
        Dr. King. Had the strongest association.
        Mr. Stupak. Sure, strongest association. OK. But then if it
    is tomatoes is not the next question where the tomatoes come
    from? And we know from all the testimony the only place is
    Southern Florida which has the strongest, as they say,
    traceable product of tomatoes. And they say you would not work
    with them. The first line of Mr. Bronson's testimony. Give me
    the first line of that testimony. His first line of his
    testimony, written testimony which he gave us was, his first
    line was, ``FDA did not share or solicit critical information
    from State food safety agencies. State resources could have
    augmented FDA's effort.''
        So if you are--and I understand epidemiology, I understand
    statistics, also understand doing crime scenes. When you got a
    crime scene everyone is a suspect but the infant probably can
    be cleared immediately because they do not have the means to
    cause the harm. So for the tomato industry I guess I am saying
    if you knew it was South Florida, you knew it was tomato, South
    Florida's tomatoes were not going there, they could trace that,
    they could prove that to you, then what went wrong after that?
    We just kept focusing on the tomato. I understand that but
    domestically-produced tomatoes?
        Dr. King. Well, CDC does not do the trace-back by the way,
    so.
        Mr. Stupak. Agreed. But you do the epidemiology; right?
        Dr. King. The epidemiology. We do the lab.
        Mr. Stupak. Correct. And you give it to the FDA then do the
    trace-back.
        Dr. King. And FDA is informed by what we have with that
    conversation and it certainly leads them to----
        Mr. Stupak. Correct.
        Dr. King [continuing]. Some indication of best bets in
    terms of trace-back.
        Mr. Stupak. Well, what would the information would the FDA
    receive from the CDC on tomatoes to make it think it is
    domestically-grown tomatoes when we know it is only coming from
    a very small part of our company which has trace-back laws?
        Dr. Acheson. When we were looking at the clusters and the
    sporadic cases that the CDC and the locals were investigating
    in the States, that is our start point. And initially in this
    outbreak we did not have clusters, we were dealing with
    sporadic cases and individuals. You are dependent on their
    memory. And they say, well, we bought our tomatoes at such and
    such a retail outlet. So we would go there and we would trace
    it back.
        Mr. Stupak. Correct.
        Dr. Acheson. And then we are, to your point, asking where
    could those tomatoes have been distributed? This year what we
    learned from industry was that because of weather or economic
    conditions Florida tomatoes were going all across the United
    States, they were going as far as California.
        Mr. Stupak. Well that is not what the first panel said.
        Dr. Acheson. Well, that was what our information.
        Mr. Stupak. And if they are Florida tomatoes would you not
    think you would have some sick people in Florida about this
    same time? These were only West, right, New Mexico and Texas
    was the only two places the first outbreaks were. If it's
    Florida tomatoes I would think Florida people would be getting
    sick. What did we have 4, 4 people this whole time out of
    Florida and 11 in California I think it was, and 500 in Texas
    and 100-and-some in New Mexico? Anyway, OK, did you want to add
    anything more on that, on what you did there?
        Dr. King. Yes, Chairman. Thank you.
        Mr. Stupak. Yes.
        Dr. King. Just to put it in a little bit of a context, so I
    just went back to 2006 and I looked at 10 outbreaks, right: E.
    coli in spinach, shredded lettuce botulism, Salmonella in
    tomatoes, E. coli in frozen pizza, Salmonella in peanut butter,
    Salmonella in----
        Mr. Stupak. Yes, we have done all those hearings.
        Dr. King. Done all of those hearings.
        Mr. Stupak. Yes.
        Dr. King. Let me point out that actions were taken on the
    basis of epidemiologic investigations on all those in the
    advance of any product cultures that were done.
        Mr. Stupak. OK.
        Dr. King. So the idea that this one is not different than
    what we usually find.
        Mr. Stupak. I understand you have a suspect, but you have
    to put the suspect at the scene of the crime, and you guys sure
    did not do a very good job I do not think. And I think that is
    where your problem is.
        Mr. Shimkus. I will yield back my time here, Mr. Chairman.
        Mr. Stupak. Yes. Ms. DeGette for questions.
        Ms. DeGette. Dr. Acheson, do you think that the trace-back
    in this most recent Salmonella outbreak was done in the best
    and most timely way it could have been done?
        Dr. Acheson. With the system?
        Ms. DeGette. Yes.
        Dr. Acheson. With the system that we currently have in
    place, yes.
        Ms. DeGette. Do you think it is the best system that we
    could have?
        Dr. Acheson. I think it could be improved in terms of
    increasing its speed.
        Ms. DeGette. And if it was improved then would we have if
    we had a better system, which I will get into, would we have
    been able to identify, at least eliminate tomatoes as a
    potential source and move and try to identify the sources more
    quickly?
        Dr. Acheson. I believe that a faster system, and you could
    talk about what that would look like, but I believe that a
    faster system would allow you to exclude products faster and to
    get back to potential areas where factors are crossing over to
    give you a source faster.
        Ms. DeGette. Now, let me ask you this. We heard on the last
    panel that there are a number of voluntary industry
    associations for trace-back and also a number of companies have
    trace-back systems. Are those going to do the job that you are
    talking about for speed and efficiency if they do not link up
    with each other and cross-reference each other?
        Dr. Acheson. No, not entirely. No.
        Ms. DeGette. And is a voluntary trace-back system in which
    only some market players participate going to be adequate to
    give the speed and comprehensiveness that we need in a trace-
    back system?
        Dr. Acheson. No.
        Ms. DeGette. Now, I have learned in recent months that many
    larger companies do have the ability to track their food and
    probably in a better way than smaller firms because at larger
    companies brand preservation is almost always a key to
    survival. So my question is if you have a purely voluntary
    trace-back system will that be as successful as it could be if
    some market players, particularly smaller market players,
    cannot participate in the system?
        Dr. Acheson. Like any system it is as strong as its weakest
    point. So if you put in a great system and only 99 percent of
    the industry is using it and you have a problem with that 1
    percent, all bets are off, it is not going to work.
        Ms. DeGette. The whole thing falls apart at that point?
        Dr. Acheson. It does, yes.
        Ms. DeGette. Now, I would like to know if the FDA currently
    has the legal authority to do what some of our panelists on the
    last panel were talking about which would be to use a numerical
    unique identifier that can travel with the product and
    instantaneously identify relevant tracking information like
    location, time, date, etc., vector in the field. Does the FDA
    currently have that authority to develop that comprehensive
    system?
        Dr. Acheson. Well, bearing in mind that I am not an
    attorney but my interpretation of that is that we do not have
    explicit authority to require the level of detail that you are
    asking for.
        Ms. DeGette. OK.
        Dr. Acheson. But it may be better if we get you a written
    response to that.
        Ms. DeGette. You betcha. I would love it.
        And I also, not to rag on you because you have been very
    cooperative with my office, but I have made about 10 or 12
    requests to the FDA, other parts of the agency, in the last
    year and I must say I have not gotten responses. So I am sure
    you will respond to my question.
        Dr. Acheson. I sure will.
        Ms. DeGette. Now, I wanted to ask a few questions about the
    other end of this, the identification of the food-borne illness
    because it seems to me that the problems that we have had in
    this investigation it is true we do not have the comprehensive
    traceability system that we could or should have, and it is
    also true that if we had had a national interoperable system of
    traceability I believe we could have identified, we could have
    eliminated foods in areas that were not affected which would
    have been financially beneficial to those portions of the
    industry. And we could have also identified the source of the
    contamination more quickly which would be good for public
    health.
        But the other, so the traceability is what I have been
    focusing on in my legislation. But in truth, really the
    identification of the situation is of great concern to me and
    the rest of us because people started getting sick in April,
    and here we are now at the end of July still trying to figure
    out exactly where that contamination came from. I think some of
    it does come from the CDC and the State health departments, so
    I want to focus on that for a few minutes.
        And I wanted to ask you, Dr. Jones, is it true that you
    believe that there are some sizeable communication problems
    between State agencies, which are often on the frontlines of
    the outbreaks, and the CDC and the FDA?
        Dr. Jones. I do. And I think your point is an important
    one. You know, the farm to fork continuum has all along that
    continuum there are places for improvement. And there are
    States that investigate hundreds of outbreaks every year and
    there are States that investigate a half dozen. And, you know,
    I think the food is just as safe in both of those States. And
    if outbreaks cannot be detected and investigated at the local
    level then we will never know we have a multi-state issue on
    our hands and be able to even discuss it with CDC or FDA.
        Ms. DeGette. And I guess I could ask you, Dr. Smith, and
    you, Dr. Jones, the same question. Do you think all States have
    enough resources to do that investigation that they need to do?
        Dr. Jones. Absolutely not.
        Ms. DeGette. Dr. Smith is nodding yes.
        Dr. Smith. I agree 100 percent.
        Ms. DeGette. And is there something at the CDC, maybe Dr.
    King you can answer, or somebody, is there some resource
    management at the CDC that works with those States that have
    less resources to be able to identify these situations? And if
    it is incomplete what can we in Congress do to help improve our
    identification system in this country? Dr. Jones?
        Dr. Jones. I think there are a number of things. And, yes,
    CDC will respond and provide assistance to any State health
    department that asks for it. And there is obviously wide
    variability in what, you know, when a State will pull the
    trigger.
        I think there are some very important ways that CDC has
    provided a lot of support to State health departments. Both of
    our States are among a group of 10 that are in this Food Net
    system which gives us, and it all federal resources, it comes
    through CDC, which supports the half dozen epidemiologists that
    we talked about. I think that if all 50 States had a system
    like that that a lot of the problem that we are talking about
    today would not exist.
        Ms. DeGette. But, you know, I will say that, I will say
    that it is all well and good to have the States asking for
    resources, but when you are talking about identifying either a
    food-borne disease or a bio-terrorist attack if they do not
    have the resources to identify the problem in the first place
    they do not know, it is a real chicken and an egg kind of a
    problem. Dr. Smith is again nodding yes.
        You are my favorite witness of the day, you just nod in
    agreement but you do not ramble on, so good work.
        Dr. Jones, you mentioned in your testimony that a lot of
    the reason why critical communication between the federal and
    the local health agencies is not occurring because of policies
    that restrict the sharing of proprietary data and information
    collected in the course of an investigation; is that true?
        Dr. Jones. Yes.
        Ms. DeGette. I am wondering, Dr. King or Dr. Acheson, if
    you can comment on how much of that proprietary information is
    hurting your agency's ability to collect data and to find the
    causes of these diseases?
        Dr. Acheson. Certainly from FDA's perspective we do have a
    mechanism through commissioned officers at the State level to
    share that information. But I think as we have addressed, if we
    can find ways to break down these barriers and these silos, not
    just with the State partners but with industry because there is
    no question that they have a significant piece to bring to bear
    that would be helpful.
        Ms. DeGette. You know, but part of the problem is, as Dr.
    Jones states in his written testimony, even though public
    health epidemiologists can become commissioned by the FDA, he
    says, ``Most of my colleagues have refused to pursue this,
    expressly to avoid the untenable moral predicament of having
    access to data which they would be legally unable to act
    upon.''
        I am wondering, Dr. Jones or Dr. Acheson or anyone else, if
    you would have any comment on how we can solve that problem if
    we are going to be able to more quickly to respond to these
    issues?
        Dr. Acheson. I would suggest that the way is how do we
    build these partnerships to be actually successful so that you
    are not----
        Ms. DeGette. That is a good paraphrase of my questions.
        Dr. Acheson. And I think that that is the process that we
    have got to address. I do not know what that is going to be. We
    have got a process that we are going to begin in August. We are
    meeting with States and locals, FDA, with CDC to look at how
    can we better build partnerships around protecting the food
    supply in the United States. There is a lot to b e done.
        Ms. DeGette. Does anybody else have an idea how we can
    break some of those problems? This is not very encouraging to
    me because it seems to me that one of the keys towards
    identifying towards having State and federal agencies working
    together to identify these issues is, is there going to be
    coordination? If we have barriers right now we need to figure
    out how to break that. And we sit here as a Congress ready to
    help you, but you are the experts, so I think that we need to
    figure out how to break these barriers.
        One last question, Dr. Jones. Do you have examples of
    actual cases where the barriers of data sharing or other forms
    of communication between State public health agencies and these
    federal agencies, the CDC and the FDA, made it difficult to
    rapidly solve a food outbreak case or quickly act in the
    interests of public health?
        Dr. Jones. Yes. and I think I alluded to one fairly
    generally in my testimony. But, you know, we did have a recent
    situation where a federal regulatory agency had collected the
    names of people who had purchased a product which we knew was
    contaminated. And I know that this frustrated them as much as
    it did us, but they were not able to hand us the list of the
    contact information of those patients, victims, for us to be
    able to call them and talk to them.
        Ms. DeGette. Thank you very much.
        Thank you very much, Mr. Chairman.
        Mr. Stupak. But you were the front line collecting that
    information; right?
        Dr. Jones. Some. This came through a mechanism where----
        Mr. Stupak. Sure.
        Dr. Jones [continuing]. Consumers can call in to the FDA
    hotline----
        Mr. Stupak. Right.
        Dr. Jones [continuing]. And ask them questions. And we do
    not have access to that system.
        Mr. Stupak. Mr. Dingell for questions, please.
        Mr. Dingell. Mr. Chairman, again I thank you for your
    courtesy and commend you for your labors in this matter.
        These questions to Dr. Acheson. These will be yes or no
    questions. FDA had over 4,000 field investigators in the year
    2003 to investigate contamination of food outbreaks and inspect
    food facilities; true or false?
        Dr. Acheson. In 2003?
        Mr. Dingell. In 2003, had 4,000.
        Dr. Acheson. I would have to check.
        Mr. Dingell. Please check.
        And in 2008, FDA's field force of investigators had been
    reduced to about 3,300 investigators, that is a loss of 700
    investigators; true or false?
        Dr. Acheson. I believe that is true.
        Mr. Dingell. Tracking food-borne contamination outbreaks is
    labor intensive?
        Dr. Acheson. I am sorry, say again?
        Mr. Dingell. Tracking food-borne contamination outbreaks is
    very labor intensive?
        Dr. Acheson. Yes, agree.
        Mr. Dingell. What level of food-related resources,
    inspectors, scientists, etc., do you believe that Food and Drug
    currently needs? You may submit that, the response to that
    question for the record. But it would be fair to say that the
    number is rather larger than you have now, is it not true?
        Dr. Acheson. I would agree.
        Mr. Dingell. We are now learning that the probable or
    possible source of contamination in the jalapeno peppers and
    tomatoes is Mexico; is that true?
        Dr. Acheson. Correct.
        Mr. Dingell. FDA has minimal resources to inspect food
    imports at the border?
        Dr. Acheson. It depends how you define minimal.
        Mr. Dingell. Minimal. All right, is Food and Drug's
    resources in these matters adequate?
        Dr. Acheson. No.
        Mr. Dingell. They can inspect, as I understand it, about 1
    percent of----
        Dr. Acheson. That is correct.
        Mr. Dingell [continuing]. The food?
        Dr. Acheson. That is correct.
        Mr. Dingell. Clearly that is not adequate; is that right?
        Dr. Acheson. That is correct. But as we said before, you
    cannot inspect your way through this. It has got to be a risk-
    based approach.
        Mr. Dingell. All right. Now, it is also true that Food and
    Drug has almost no resources that it can dedicate to inspect
    foreign firms, foreign farms that handle food; is that true?
        Dr. Acheson. In 2007 the FDA conducted about 95 inspections
    of those types of facilities.
        Mr. Dingell. Do you know how many facilities there are?
        Dr. Acheson. There are a little over 200,000 that are part
    of the bio-terrorism registration database.
        Mr. Dingell. And you inspected, as I understand, 95 of
    those 200,000?
        Dr. Acheson. Correct. And do not ask me the percentage
    because I cannot work that out in my head, please.
        Mr. Dingell. Is a fair comment minimal?
        Dr. Acheson. It depends how you define minimal.
        Mr. Dingell. All right. Now, if Food and Drug had had
    sufficient resources for inspecting imported produce or actual
    sources of that produce we could have detected this contaminant
    much sooner, could we not?
        Dr. Acheson. I suspect not.
        Mr. Dingell. Suspect no?
        Dr. Acheson. No. I think not, because inspections and
    sampling as a mechanism to ensure that it is safe is not
    realistic. You just could not sample enough to make it
    realistic.
        Mr. Dingell. Right.
        Dr. Acheson. The answer is the preventative controls; that
    is the fix.
        Mr. Dingell. Now, would you agree that FDA needs
    considerably more resources to conduct foreign and domestic
    inspection of food processors?
        Dr. Acheson. Yes. And we are getting some of those in 2008
    and hopefully 2009.
        Mr. Dingell. Now, does Food, would you agree that Food and
    Drug needs considerably more resources to inspect actual
    imports at the border?
        Dr. Acheson. Yes.
        Mr. Dingell. If you turn to page--I am sorry. I guess that
    constitutes my questions. Mr. Chairman, I thank you for your
    courtesy. Thank you, sir.
        Dr. Acheson. Thank you.
        Mr. Stupak. Thank you.
        Mr. Inslee for questions, please.
        Mr. Inslee. Thank you. I think we all agree that our trace-
    back and investigatory systems are inadequate. But I want to
    ask what is more inadequate, our after-the-fact trace-back
    investigatory system or preventative systems of agricultural
    practices that prevent, and packaging and distribution
    practices that would prevent these instances from happening?
    What is sicker? What is more ailing? What is more porous? What
    is most, what is the most glaring weakness between those two
    approaches, either pre- or post-injury?
        Dr. Acheson. If I could respond first I would say the most
    critical is the preventative controls. That is what counts the
    most, building the safety in up front so whether it be a
    domestically grown or an imported product, manufactured,
    whatever it is, build that safety in up front to a standard
    that is adequate. You have obviously got to have strong
    reactive capabilities when things do go wrong. But having a
    reactive system, however well it works, is just not a good way
    to protect public health.
        Mr. Inslee. Well, I would agree with that. And that is why
    I hope those who are interested in this subject will be very
    anxious, as I am, to get legislation through to finally adopt
    best practices in the industry in the field and in the farm and
    in the packaging plant to prevent these repeated instances. I
    have to tell you this is very frustrating to sit at this dais
    time after time after time to see these incidents and we still
    have not successfully got the industry totally to agree to
    standards that will prevent these things from happening.
        So I hope that this continued incident will encourage
    others to work with us as soon as humanly possible to pass
    practices that will prevent this from happening. We know this
    can happen. We have had substantial improvement in the meat
    industry. We have not had improvement in the produce industry
    in practices in the field. And I just hope that others agree
    with Dr. Acheson and myself on the importance of those
    preventative measures so we can move forward.
        Dr. Jones, I want to ask you about State measures. I think
    even a cursory review would show that a relatively small
    handful of States have been most successful in investigating a
    disproportionate number of these incidents. And I just want to
    ask you to, to the extent you can, tell us what do those States
    have in common, what have they done well? Is it resources? Is
    it practices? Is it, you know, gubernatorial leadership? What
    is it and what can we do to get more states to either emulate
    those efforts or federally remove the necessity of them?
        Dr. Jones. Unfortunately I think the basic answer is
    resources. You know, Dr. Smith has mentioned some other things.
    I mean States that have a very centralized public health and
    epidemiology structure tend to get information a little bit
    faster. Laboratories that are well funded and can do their
    testing quickly and get their results to epidemiologists
    quickly help. But all of that requires manpower and resources.
        Mr. Inslee. We were looking for an easier answer actually.
        Dr. Jones. Sorry.
        Mr. Inslee. I appreciate that.
        Dr. Smith, your team had a relatively rapid identification
    of jalapenos through genetic systems. And, you know, basically
    what did they do differently than the FDA? What can we do to
    replicate that on a federal level?
        Dr. Smith. Right. Well, again I think it needs to be
    replicated more on the State level because I mean CDC and FDA
    are kind of limited by the information they are getting from
    State health departments. And so I think our system or
    something like it needs to be implemented more at different
    state levels.
        Again, our laboratory is confirming and typing bacteria in
    real time, giving that information to our epidemiologists right
    away. And our epidemiologist are interviewing these patients
    extensively, again in real time. And so we are asking people
    about what they ate 2 weeks ago. And that is hard to get
    detailed information at that point. But it is much easier and
    you get much better information than if you waited until you
    ask them about 4 weeks ago or 6 weeks ago.
        And that is what happens in some States is like some
    laboratories physically cannot type all the bacteria in real
    time and so they can only do it once every 2 weeks or once
    every month. And then by the time they do that and get that
    information to their epidemiologists, you know, it is 4 or 6
    weeks later, you know, when the interviews are being started.
        So the whole key is just, you know, it is not really that
    hard, it is the resources to do stuff right away and to do it
    in detail and that will get you the detailed interview
    information that you need to solve an investigation.
        Mr. Inslee. So what would you say to the federal
    government, the agencies, to match that State input early? Is
    there something that has to change?
        Dr. Smith. Well, I mean I know for a fact that CDC could
    use more resources in PulseNet to track all the isolates that
    are being submitted by State health departments into that. And
    I also know there are epidemiologists that are helping to
    coordinate multi-state outbreaks get stretched awfully thin.
    And so, again, I know that they could use more resources at the
    federal level to go ahead and assimilate the information that
    is coming in from the States.
        Mr. Inslee. Anyone else want to add to that?
        [No response.]
        Mr. Inslee. With that, thank you very much, I yield back.
        Mr. Stupak. Ms. DeGette had a question?
        Ms. DeGette. Mr. Chairman, I just had a follow-up question.
    I am trying to, I am still trying to think about how we could
    improve our identification of these outbreaks. And, Dr. King, I
    wanted to ask you in particular about this Salmonella outbreak.
    Now, patients were given or people who we thought ate the
    tainted foods were given questionnaires by the State of New
    Mexico and also the CDC; is that correct?
        Dr. King. Yes.
        Ms. DeGette. We have been provided copies of these
    questionnaires by the CDC and I am wondering are these
    confidential, these forms? I know the ones filled out are
    confidential. But I am looking at them, I see no reason why
    these would be confidential in any way.
        Dr. King. The forms?
        Ms. DeGette. Yes.
        Dr. King. No, not at all.
        Ms. DeGette. OK. And the first form, which is a very
    extensive form that was provided by New Mexico to patients,
    talked about fresh tomatoes and it had a long list of different
    foods. And it did not highlight jalapeno peppers or serrano
    peppers, just simply had a space for other peppers.
        And then the form that was given out by the CDC, which is a
    form much more targeted at the salsa that was suspected asked
    questions about salsa, homemade salsa, store bought salsa. It
    talked about onions, tomatoes, where you ate tomatoes, a lot of
    questions about tomatoes. That form never asked one question
    about peppers. And I am wondering why? Or, for that matter, any
    other ingredients other than onions that are in salsa.
        Dr. King. There are two different forms. The first one is
    this hypothesis generating form.
        Ms. DeGette. It is the larger form provided by New Mexico
    which has a whole bunch of stuff on it.
        Dr. King. Right. And I think red peppers, green peppers or
    other peppers.
        Ms. DeGette. Correct.
        Dr. King. Also, the people doing the interviews it was
    open-ended so you would also ask people are there other things
    are not on this list that you could remember that you had. So
    that is one thing.
        Ms. DeGette. OK.
        Dr. King. When you get down into case control, which is the
    second form----
        Ms. DeGette. OK.
        Dr. King [continuing]. It also was done by the State,
    actually two States.
        Ms. DeGette. And that is like a smaller format.
        Dr. King. The difference then is that because the
    hypothesis has been generated, right, then we are able to focus
    into this looks like it is food, looks like this type of food.
    And so the questionnaire then becomes more focused based on
    that information to try to pinpoint more accurately the
    different types of foods and ingredients.
        Ms. DeGette. That makes sense to me. So who develops that
    second form? And that is like a follow-up set of questions that
    is asked?
        Dr. King. Yes, ma'am. That is correct, Congresswoman.
        Ms. DeGette. And who develops that form?
        Dr. King. Well, the States will actually have some changes
    in those depending on what they do. There is kind of a template
    that is being used but States will add to those as they----
        Ms. DeGette. So the State of New Mexico would have
    developed that second form?
        Dr. King. They would have.
        Ms. DeGette. OK.
        Dr. King. For the case control study we actually were
    involved in helping them with that.
        Ms. DeGette. Well, and the reason I am concerned is this:
    it may be that after the initial survey that people did not
    focus in on pepper. However, if you look at this second follow-
    up form they were focused in on salsa; right? Now, I will tell
    you as someone who myself is from the Southwest, I never made
    salsa without putting peppers in it. That is one of the key
    ingredients of salsa. So if in fact salsa was suspected and you
    ask the question tomatoes, and extensively tomatoes and onions,
    why was not the question about peppers asked on that follow-up
    questionnaire? It may have helped you much more quickly
    identify the serranos and the jalapenos?
        Dr. King. Now I have to look at the questionnaire. Again it
    was--no, I understand that you are looking at that. So I would
    look at the second----
        Ms. DeGette. I will tell you----
        Dr. King. Yes.
        Ms. DeGette [continuing]. Without misleading you that
    peppers are not mentioned whatsoever on this second form. There
    are many questions about tomatoes. Did you eat any raw
    tomatoes? Did you eat tomatoes at a restaurant? Where did you
    purchase them? It seems like what happens was the State of New
    Mexico and the CDC focused right in laser-like on tomatoes. But
    yet, if they thought the problem was salsa maybe they should
    not have, maybe they went off down the wrong road too fast.
        Dr. King. That is, you know, that is part of something we
    would look at. The second case control study certainly did
    focus at peppers as we gained more information as we went.
        Ms. DeGette. OK. I do not think we have that in our--oh
    here. Here is Mexican food exposure. Then would that have been
    the next thing after that?
        Dr. King. That is correct.
        Ms. DeGette. OK. When was that given to them, after the
    tomatoes were eliminated as a suspect?
        Dr. King. As we gained more information then we were able
    then to focus more and peppers became something of more concern
    for us and with stronger association. And consequently the
    questioning and the questionnaires reflected it.
        Ms. DeGette. Do you think we might have been better off if
    we focused on all the ingredients of salsa right at the time
    that we thought salsa might be a problem rather than just going
    down the tomato road?
        Dr. King. It may have been. And I can certainly go back and
    review that.
        Ms. DeGette. Thank you very much.
        Mr. Stupak. Dr. Acheson, you have indicated then, and I
    know we have been down this pass before on Heparin and China
    and all this with the FDA, but you said that the best way to
    handle these issues is to build up the safety first, in other
    words make sure the farm is growing a healthy product; correct?
        Dr. Acheson. A safe product, yes.
        Mr. Stupak. Safe product. How many inspectors, full-time
    inspectors do you have in Mexico then checking farms?
        Dr. Acheson. Nobody is, no FDA employees are permanently
    stationed in Mexico.
        Mr. Stupak. So then the only chance to make sure that you
    have the safety of the product coming in is catching it at the
    border then; right?
        Dr. Acheson. Under the current system, yes. It is based on
    inspection and sampling at the border. As part of the Food
    Protection Plan, FDA beyond our borders, we are looking at
    establishing FDA presence in a number of countries which would
    include Central and South America.
        Mr. Stupak. OK. But you are establishing it in China, are
    you not?
        Dr. Acheson. Yes, we are in the process.
        Mr. Stupak. Did you not have the memorandum that was on the
    pet food?
        Dr. Acheson. We are in the process of establishing an
    office in China, that is correct, yes.
        Mr. Stupak. So do you have any food inspectors outside the
    borders of the United States?
        Dr. Acheson. Not currently, no. Not permanently. Not
    permanently. They would go out usually for cause. If we know of
    a problem that needs to be checked on.
        Mr. Stupak. Correct. There has to be a problem first before
    you will send them off over shores, offshores?
        Dr. Acheson. Typically, yes, there does.
        Mr. Stupak. So but to get to your safety, build up the
    safety, as you have said----
        Dr. Acheson. Yes.
        Mr. Stupak [continuing]. You really should have the
    inspectors in other countries, especially like in the winter
    months we know we get most of our produce at least south of our
    border.
        Dr. Acheson. It is not all about inspections, it is about
    building in the preventative controls. So we have got to set
    the standards, we have got to work with industry to do that,
    and we have to find a way to ensure that they are meeting those
    standards. Some of that would be FDA inspections. As I know you
    are aware, an area that we are exploring as a mechanism here is
    an FDA-audited third party certification system.
        Mr. Stupak. Correct.
        Dr. Acheson. Simply because, as I said to Congressman
    Dingell, we are looking at 200,000 foreign manufacturers. And
    it is like let us focus on those that are high risk and let us
    leverage every possible mechanism to be able to ensure that
    they are building the safety in up front.
        Mr. Stupak. OK. Now, Dr. King, if I may ask you, who is in
    charge of coming up with the source here of the Salmonella, the
    vegetable of interest if you will, the CDC?
        Dr. King. The original epidemiology CDC is actually, that
    is our responsibility.
        Mr. Stupak. OK. So CDC told FDA look at tomatoes?
        Dr. King. Yes.
        Mr. Stupak. OK. Then who made the call to change the focus
    to peppers, CDC or FDA?
        Dr. King. It came through further investigations. By the
    way, we do not do this kind of by ourselves, we do this through
    conversations back and forth.
        Mr. Stupak. Correct.
        Dr. King. Our investigations and the epidemiology led us to
    look more and more toward peppers. And I know Dr. Acheson and
    folks at FDA. That was from our investigations then that led
    them to further trace-backs down that track.
        Mr. Stupak. OK. Who is the agency in charge then when you
    have a food-borne illness outbreak, CDC or FDA?
        Dr. King. It depends on what part of the outbreak. So we do
    surveillance, we do epidemiology, we do outbreak investigation
    and the laboratory. We do not do the trace-backs.
        Mr. Stupak. Right.
        Dr. King. So that is the bifurcation. FDA does the trace-
    backs, the work on the food, or USDA depending on what the
    product is, and so they are clearly in charge of that part of
    it. We are clearly in charge of the other part of it. We talk
    all the time, meet all the time. But that is how the
    delineation is.
        Mr. Stupak. You say you talk all the time but yet when I
    hear Dr. Jones talk it sounds like no one talks to the State
    officials who are really the frontline people, who really do
    your epidemiology and stuff that Ms. DeGette went over, the
    forms. Because I am still bemused by the fact that Dr. Jones
    testified if they have an outbreak you know the names and
    addresses, or FDA does, of the people who are being sick but
    they cannot tell the frontline people, Dr. Jones, to warn them
    or to try to at the local level take care of the issue. I just
    find that amazing.
        Dr. King. Thank you. And I will talk to Dr. Jones about
    that. And I am sure he has good reasons to say that.
        There are three systems that we have kind of in effect. One
    is called Outbreak Net where we actually have the
    epidemiologists in every state and CDC involved. The other are
    daily conference calls during this outbreak with all the States
    involved. And the other is CIFOR, which is this council to
    improve food outbreaks. And that involves States and
    epidemiologists. So there are three systems in place where I
    think the dialogue continues fairly readily.
        Mr. Stupak. Three systems in place. So would it not really
    indicate that you need an incident command center that would
    include State, local, federal, industry reps, science experts,
    especially when you get an outbreak as big as this, 43 States,
    District of Columbia, Canada?
        Dr. King. I think that is something to take a look at. And
    I appreciate your observation on that.
        Mr. Stupak. Go ahead, Mr. Shimkus.
        Mr. Shimkus. Yes. And just if this was a bio-terrorism
    attack and then that is, and this is what we are all, a lot of
    us are concerned with and you, we have said the system works
    the same, but as far as the command and incident center does
    the Department of Homeland Security get involved in that debate
    then?
        Dr. King. Yes.
        Mr. Shimkus. Is that the command and control center that we
    lack here?
        Dr. Acheson. If there is--well, thankfully we have not had
    to deal with one of those since----
        Mr. Shimkus. That is true. But I mean we have to be--
    hopefully we do not--but we need to start, we cannot shy away
    from the risk and we have to ask these questions.
        Dr. Acheson. Yes.
        Mr. Shimkus. And this case study is a good case study to
    help us look at that.
        Dr. Acheson. If it was a deliberate act and we knew it was
    deliberate, and I want to add that if somebody was putting
    Salmonella in the food supply the chances are that they would
    be treated exactly the same as this because it happens,
    unfortunately, too often. If it was anthrax, which clearly
    happens never, then it would be, the suspicion would be much
    higher, law enforcement would be involved very early, and I
    think the whole thing would be different.
        Mr. Shimkus. But they would call upon you all for your
    expertise in the public health departments?
        Dr. Acheson. Oh yes.
        Mr. Shimkus. In your trace-back?
        Dr. Acheson. Yes.
        Mr. Shimkus. And CDC.
        Dr. Acheson. But I think your point and Chairman Stupak's
    point is an incident command type approach for dealing with
    these is one that seriously needs to be looked at as a
    mechanism that involves at the very least the regulatory
    individuals that are seated here, and others. The industry
    piece is more complex because of the sharing of confidential
    information. And I would love for us to break down those
    barriers, it could only help.
        Mr. Shimkus. And that is what we want to do.
        Mr. Stupak. But following up on that question, if it is a
    bio-terrorism attack how does--does law enforcement then and
    security of our country trump those privacy concerns we have?
    Does it trump the Privacy Act? Does it trump the agency chief
    counsel who do not allow you to share that information? When
    reading the Bioterrorism Act I do not see an exception for
    that. So it would have been done the same way, not sharing
    information.
        Dr. Acheson. From FDA's perspective I do not think anything
    changes. It may be different for Department of Justice, law
    enforcement and FDA. I just----
        Mr. Stupak. But you do not have any opportunity though if
    it is a bio-terrorism attack to waive the privacy law, the
    confidentiality, the trade secrets, whatever you want to call
    it, proprietary interests I think was the words used earlier?
        Dr. Acheson. Not that I am aware of but I will take that
    back.
        Mr. Stupak. No, I have not seen it either, so.
        Dr. Acheson. And if there is something in the act to that
    effect then I will obviously get back to you.
        Mr. Stupak. And, Doctor, you quoted a legal opinion. Can
    you provide that to the committee for the record?
        Dr. King. I would be glad to. That has to do with the
    county information, yes.
        Mr. Stupak. Right. That is kind of the direction we want to
    head. So thanks.
        Let me thank this panel and thank you again for your time
    and testimony. And we will continue on this issue.
        [Witnesses excused.]
        Mr. Stupak. I would like to invite our third panel of
    witnesses to come forward.
        On our third panel we have Mr. Michael R. Taylor, J.D., who
    is the Research Professor of Health Policy at George Washington
    University School of Public Health and Health Services; Mr.
    Hank Giclas, who is Vice President for Strategic Planning,
    Science and Technology at Western Growers Association; Dr.
    Donna Garren, who is Vice President for Health and Safety
    Regulatory Affairs at National Restaurant Association; and Dr.
    Robert Brackett, who is the Senior Vice President and Chief
    Science and Regulatory Affairs Officer at the Grocery
    Manufacturers Association.
        Thank you all for coming. It is the policy of this
    subcommittee to take all testimony under oath. Please be
    advised that witnesses have the right under the rules of the
    House to be advised by counsel during their testimony. Do any
    of you four wish to be represented by counsel at this time?
        [No response.]
        Mr. Stupak. Everyone indicating no. Then I will ask you to
    please rise, raise your right hand, take the oath.
        [Witnesses sworn.]
        Mr. Stupak. Let the record reflect the witnesses applied in
    the affirmative. You are each now under oath. We will now hear
    your opening statement, 5-minute opening statement. You may
    submit a longer statement for inclusion in the hearing record.
        Professor Taylor, let us start with you, sir.

      STATEMENT OF MICHAEL R. TAYLOR, J.D., RESEARCH PROFESSOR OF
      HEALTH POLICY, THE GEORGE WASHINGTON UNIVERSITY, SCHOOL OF
                   PUBLIC HEALTH AND HEALTH SERVICES

        Mr. Taylor. Thank you, Mr. Chairman, I appreciate the
    opportunity to testify today. I have submitted a written
    statement, the purpose of which was to demonstrate that we have
    a system problem here. And I think it is fair to say that the
    testimony you have heard so far really demonstrates that, I
    think really demonstrates we need a system solution. And I look
    forward hopefully this panel can have some time to talk about
    some of those solutions. But in my written testimony I tick off
    really 7 elements of preparedness and planning for outbreak
    response and investigation that are really lacking in the
    current system. And I think we have heard about all of these
    today:
        And it is focused federal leadership and accountability, it
    is somebody being in charge.
        It is well-defined institutional roles across the system,
    federal, State, and local, which we really do not have
    formalized today, it is very ad hoc.
        Adequate expertise in capacity, the funding issue that we
    have talked about; clearly an element of this.
        Prompt trace-back. And I think we can talk about some
    specifics there. This issue of standardized data collection and
    seamless data sharing I mean I think is really central to being
    able to manage these outbreaks and also to deal with prevention
    in a systematic way. And we do not have that provided for.
        We have also heard about the need for active industry
    engagement, which I absolutely agree with. And then coordinated
    public communication is obviously essential.
        I guess one thing I really want to emphasize is that
    Congress has to act to address these problems. I think these
    problems are built into our current system, the current
    fragmentation organizationally in our food safety system at the
    national level. It goes beyond outbreak investigation and
    response, it really goes to the whole way in which we manage
    our food safety system and it needs to be transformed.
        As this committee well knows, we are operating at FDA under
    a food safety law that is 70 years old that contains no mandate
    for prevention, it contains no mandate to take an integrated
    systems approach. I think the legislation you are working on
    will address that.
        The other element, of course, of the broader problem is
    resources. We have talked about that today.
        I would just like to emphasize the organizational issue.
    And there has been an extensive study of this by the Government
    Accountability Office, by the National Academy of Sciences, the
    fragmented structure of the government's food safety system,
    particularly at the federal level, but then also as we have
    heard today, State and local agencies. It is health departments
    at State and local level, it is regulatory agencies, it is
    Departments of Agriculture, all of whom play roles without any
    sense of how we or any clear directive. It could be a national
    leadership role in seeing that entities work in an integrated
    way.
        So Congress really has to address this organizational, this
    structural issue and really drive the development of an
    integrated system. I would start that organizational reform at
    the Department of Health and Human Services personally. Within
    HHS we have food safety agencies, multiple components really of
    the Food and Drug Administration as well as CDC, you know, all
    of which work in their own traditional ways with their own
    particular charges. They have their own cultures and ways of
    dealing. None of them have the charge or the stature within the
    government system to really exert leadership, nationally and
    internationally for that matter, towards a more integrated
    preventive approach.
        So one of the things I would hope this committee would
    consider in due course is unifying and elevating within HHS all
    of the components of HHS working on food safety so that single
    office, a single official can be in charge and accountable for
    all HHS food safety activities, including outbreak response and
    investigation, but going beyond that to include all the things
    we need to do to build a preventive, integrated food safety
    system in the country.
        So with that I look forward to the opportunity to discuss
    any of these ideas and solutions to some of the problems that
    have been identified here today.
        [The statement of Mr. Taylor follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Stupak. Thank you.
        Mr. Giclas please.

    STATEMENT OF HENRY GICLAS, VICE PRESIDENT, STRATEGIC PLANNING,
          SCIENCE AND TECHNOLOGY, WESTERN GROWERS ASSOCIATION

        Mr. Giclas. Thank you, Chairman Stupak, members of the
    committee. Western Growers is a trade association representing
    growers, shippers and handlers of fresh fruits, nuts and
    vegetables in California and Arizona. Our 3,000 members produce
    approximately half of the United States' total production of
    fresh fruits, nuts and vegetables. We appreciate the
    opportunity to speak before you today on our activity and
    learnings related to food safety.
        The industry has a long history of implementing and
    improving our food safety programs and defense capabilities to
    protect public health as well as business interests. In the
    early 1990s we led to develop the first ever Good Agricultural
    Practices document that recommended key areas and strategies
    for reducing risk. These guidelines addressed production,
    harvest, cooling, processing, transportation, and retail and
    food service handling. They later became the basis for the
    FDA's Guide to Minimized Microbial Food Safety Standards for
    Fresh Fruits and Vegetable--excuse me, Hazards. Today that is
    the baseline for all food safety guidance.
        When the Guide was published our emphasis shifted to one of
    education of extension. A cottage industry of third party food
    safety consulting and auditing firms began to grow. These
    programs have driven a high level of implementation as buyers
    demand audits as a condition of doing business in the
    marketplace. This benchmark set of guidelines and food safety
    paradigm has evolved significantly over the last few years for
    select commodities. Today, commodity-specific guidance has been
    developed for lettuce and leafy greens, tomatoes as you saw
    this morning, and cantaloupes. And there is work under way on
    green onions and herbs. These are each grounded in the FDA
    Guide and utilize an approach based on hazard identification,
    assessment and control.
        Despite the continuing improvement in guidance there have
    also been continuing outbreaks. The 2006 outbreak in spinach
    drove the industry to move far beyond existing paradigms to
    even more prescriptive sets of best practices. California and
    Arizona now have established uniform GAPs and a corresponding
    verification program that requires implementation of food
    safety measures developed in concert with public health
    authorities and private sector experts. These newer generation
    guidelines include specific requirements for risk assessment,
    sampling and analysis of inputs, safety response measures and
    requirements for documentation. Compliance with these
    requirements is verified by government inspectors in the field.
    And we believe this model should provide direction for broader
    national and international efforts to improve food safety.
        The model program brings together the strengths of State
    and federal government, the national and international research
    community and the industry itself in a coordinated fashion to
    ensure science-based best practices for preventing or reducing
    the potential for contamination. The Health and Human Service
    agencies are in a key position to identify the areas that
    industry must address based on the data and information they
    have gathered and analyzed in epidemiological investigations
    and trace-back. Addressing these risks in turn becomes the
    focus for enhanced best practices.
        Verification can rely on inspectors who are already in
    place throughout the country. FDA is exploring this option by
    evaluating how third parties might assist in providing ``boots
    on the ground'' for verification and inspection.
        Western Growers firmly believes that prevention is our
    strongest tool in efforts to reduce food-borne illness
    associated with produce. But a model program also must address
    the response to any discovery of contaminated product in the
    marketplace or outbreak of food-borne illness.
        Collaboration is equally important in efforts to respond.
    The FDA and CDC have an army of industry personnel at the
    ready. A formal recognition of this industry expertise and a
    commitment to strengthen communication with industry during an
    outbreak will both help protect the public and minimize
    economic damage to the industry.
        We believe the time has come to cease operating in silos
    and work hand-in-hand using the strengths, talents, and
    expertise of all parties to improve food safety. The program
    for leafy greens adopted in California and Arizona is moving
    the industry closer to achieving our common goal of minimizing
    the incidence of food-borne illness associated with the
    consumption of fresh product. We encourage this committee to
    assist the industry to build on and extend the success of these
    efforts.
        I appreciate the opportunity to testify today on behalf of
    Western Growers. I look forward to any questions you might have
    regarding our efforts.
        [The statement of Mr. Giclas follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Stupak. Thank you.
        Dr. Garren, your testimony please.

     STATEMENT OF DONNA GARREN, PH.D., VICE PRESIDENT, HEALTH AND
       SAFETY REGULATORY AFFAIRS, NATIONAL RESTAURANT ASSOCIATION

        Dr. Garren. Chairman Stupak and members of the
    subcommittee, thank you for this opportunity to testify before
    you today on the recent Salmonella outbreak.
        The National Restaurant Association, founded in 1919, is
    the leading business association for the restaurant industry,
    which is comprised of 945,000 restaurant and food service
    outlets and a work force of 13.1 million employees, generating
    estimated sales of $558 billion in 2008. Nationwide, the
    industry serves 133 million guests every day.
        Food safety is the utmost importance to the restaurant
    industry. Restaurants have taken the lead in assuring food
    safety within the four walls of our restaurants. The National
    Restaurant Association and our members are making multi-billion
    dollar investments in improving food safety and developing
    state of the art food safety education programs. We are
    especially proud of ServSafe, the food safety education program
    that sets the standard for our industry. More than 3 million
    food service professionals have been certified through our
    ServSafe Food Protection Manager Certification exam.
        The current Salmonella outbreak is one of the largest in
    U.S. history. Of particular concern was the over 2-month period
    of time needed to identify the source of the outbreak and the
    mid-course change in focus of the cause of the outbreak. We are
    at a critical time in food safety, and all of us have a road to
    play.
        This highlights, the outbreak highlights the need to re-
    evaluate our food safety system and implement needed
    improvements. Of particular concern is the complexity of the
    food distribution channels for fresh produce and the challenges
    presented when a finished product served to customers contains
    a number of ingredients. This complexity presents challenges to
    the public health officials leading the efforts to resolve this
    outbreak in timely manner. In moving forward, we need a better
    approach. We need a farm-to-table approach.
        We build confidence by showing people that we are always
    ready, always vigilant. For the purpose of this hearing we
    would like to focus on key areas of moving our food safety
    efforts forward. Adequate funding for FDA, improved
    collaboration and communication, stronger standards and
    practices for produce, and additional tools that include recall
    authority, traceability, improved epidemiological
    investigations, and private sector certification.
        The recent outbreak highlighted the need to provide FDA
    with adequate resources to do its job. We are encouraged by the
    Fiscal Year 2008 supplemental increase for FDA of $150 million,
    further increases recommended for Fiscal Year 2009 budget as
    well. However, this can only be a down payment on a sustained
    effort to increase the agency's appropriated base.
        This outbreak also highlights the need for increased
    collaboration and communication between industry and
    government. The fact that fresh produce is commingled and
    repacked at various steps in the chain should not present an
    insurmountable problem. There are industry experts who
    specialize in the distribution of these types of products.
    There should be a mechanism that allows the agency to tap into
    this expertise to facilitate a more meaningful investigation of
    the crisis at hand. While we recognize that conducting an
    outbreak investigation is a governmental function, we would
    urge a greater level of collaboration and communication between
    government and industry, as we all benefit from a rapid
    resolution.
        Effective communication guides the public, the news media,
    healthcare providers, and industry in responding appropriately
    to outbreak situations. There are certain challenges and
    hurdles inherent in developing materials to inform and educate
    the public about potential health and safety risks in an
    accurate and timely manner. We must overcome these obstacles
    and improve how we communicate health and safety information.
        It would be a serious error to underestimate the importance
    of developing, by consensus among stakeholders, the final
    version of risk communication strategy and plan. Communications
    professionals in the public and private sectors need to ensure
    strong and well-integrated working relationships that will help
    sustain communications resources as an outbreak evolves. The
    planning, preparation, and practice must begin now.
        Over the past several----
        [Bells.]
        Mr. Stupak. Stop. Soon as we start again.
        Go ahead.
        Dr. Garren. OK. Over the past several years, there have
    been repeated calls for stronger safety standards for fresh
    produce. This outbreak reinforces the importance and urgency of
    that task. The produce industry has taken positive, proactive
    steps to establish standards. Now it is time for the FDA to
    take the next step.
        The first goal of any food safety system must be
    prevention. FDA's good agriculture practices, developed a
    decade ago, should be updated and made mandatory. The National
    Restaurant Association supports the FDA in setting mandatory
    general standards for produce as well as commodity-specific
    standards for commodities the FDA deems as posing a higher
    risk.
        Prevention alone cannot guarantee safety and so emphasis
    must be placed on rapid response when an outbreak does occur.
    This leads directly to the issue of traceability. The produce
    industry has made important strides in recent years to improve
    traceability, yet more can be done. We must apply our best
    collective knowledge, expertise, and emerging technology so
    that finding the source of contaminated produce is a matter of
    hours or days, not weeks or months.
        Traceability systems may need to be developed commodity by
    commodity to address varying supply chains. A one-size-fits-all
    strategy may not work for all sectors and stakeholders. In
    addition, any credible traceability system should be effective
    for all stakeholders and routinely tested to determine
    potential flaws prior to a crisis event.
        The National Restaurant Association supports granting the
    FDA the authority to recall a food product that poses serious
    adverse public health risk and the company refuses to complete
    a voluntary recall. Enhanced and coordinated recall
    notification should be developed to better inform the consumer
    so that the FDA is communicating these notices to the public in
    a consistent manner.
        We also believe that there should be better resources for
    investigating outbreaks at the State level. The epidemiology of
    food-borne illness is sophisticated and always changing. Many
    States lack the manpower and resources to do it well. Poorly
    managed investigations can be catastrophic, as we most recently
    demonstrated by this particular outbreak.
        We must ensure States have the necessary funding available
    to access this information and implement better investigations
    related to food.
        Increasingly, our members are relying on private sector to
    ensure compliance by suppliers with food safety standards. This
    approach provides consistency of standards and quality across b
    orders, cost efficiency in the supply chain, and less
    duplication of certification processes, and simpler buying. We
    believe the FDA should support the use of third party
    certification as a way to leverage the agency's limited
    resources.
        In conclusion, the ongoing Salmonella outbreak has been
    long, costly and frustrating for all concerned. We must do
    better. This means taking a new look at our food safety system
    to ensure we have a comprehensive farm-to-table strategy. We
    must look for ways for government at all levels to collaborate
    more closely with industry experts during the course of an
    outbreak investigation. And we must establish stronger
    standards and practices that move us towards continuous
    improvement in produce safety.
        Thank you for this opportunity to testify.
        [The statement of Dr. Garren follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Stupak. Thank you, Dr. Garren.
        Dr. Brackett, your testimony please, sir.

     STATEMENT OF ROBERT E. BRACKETT, PH.D., SENIOR VICE PRESIDENT
       AND CHIEF SCIENCE AND REGULATORY AFFAIRS OFFICER, GROCERY
                       MANUFACTURERS ASSOCIATION

        Mr. Brackett. Thank you, Chairman Stupak and other member
    of the subcommittee.
        The Grocery Manufacturers Association represents the
    world's leading food, beverage and consumer product companies,
    and the members of GMA share your commitment to ensuring the
    safety of our nation's food supply. Product safety is the
    foundation of that consumer trust.
        The recent investigation into the food-borne illnesses
    outbreaks due to Salmonella Saintpaul is the latest event to
    challenge our whole food safety system. The inability of the
    current food safety system to rapidly and accurately determine
    the source of Salmonella Saintpaul in this outbreak is a major
    contributor to the erosion of consumer confidence in the safety
    of the nation's food supply.
        The topic of this hearing is what we have learned as a
    result of the Salmonella outbreak. And we have learned three
    things. Clearly, the first thing we have learned is that FDA is
    in dire need of additional resources to carry out its mission
    of protecting the public from food-borne hazards, and not just
    money but in terms of scientific expertise and IT
    infrastructure. And all of that goes along with protecting the
    food supply.
        Secondly, we have learned that the ability to trace a
    product is meaningless if the epidemiological data implicates
    the wrong product. This highlights the need for more resources
    at the State and local levels as well so that we can more
    rapidly and thoroughly investigate these food-borne illnesses
    if they occur.
        Third, we have learned the need to do more to prevent food
    safety incidents in the first place.
        The GMA has led the effort to provide current guidance to
    the food industry, both domestically and abroad, by issuing the
    GMA Food Safety Chain Supply Handbook this past April in 2008.
    And I have a copy of that here for you. This reference manual
    represents a tool chest for companies in search of examples of
    successful management practices for suppliers to consider. The
    GMA Handbook clearly states that at a minimum, suppliers and
    transporters should consider their ability to trace back and
    trace forward the movement of ingredients and finished goods
    through the whole supply chain.
        But traceability was not the real issue in the Salmonella
    Saintpaul outbreak that we are discussing today. We really need
    to modernize our entire food safety system. GMA continues to
    propose that Congress modernize our food safety system by
    making risk and prevention of contamination the focus of our
    food safety strategies going forward. GMA CEO Cal Dooley and I
    have testified many times before Congress on the issue of
    improving food safety. We have consistently proposed the
    following reforms, many of which are included in legislation
    already introduced in both the House and the Senate. These
    include first:
        One, that we urge you to give FDA the power to establish
    mandatory safety standards for fruits and vegetables. In
    particular, give FDA the power to establish food safety
    standards for those fruits and vegetables that have repeatedly
    been involved in food safety incidents.
        Two, we urge you to require food companies to have a food
    safety plan. In particular, every food company selling food in
    the U.S. should conduct a food safety risk evaluation that
    identifies potential sources of contamination, identifies
    appropriate food safety controls, and verifies that those
    controls are effective, and then documents those controls in
    the food safety plan subject to FDA review.
        Now, with respect to trace-backs, Congress and the FDA
    should evaluate the trace-back requirements in the Bioterrorism
    Act to determine whether it should be extended to farms, given
    these recent developments.
        In addition, there is also one inadvertent outcome from the
    Bioterrorism Act. The law clearly requires food companies to
    keep the ``one up-one down'' records that have been discussed
    so far. However, there appears to be some ambiguity as to
    whether the law gives FDA the express authority to check during
    a routine investigation to see if a company is, in fact,
    keeping such records. We believe Congress should clarify FDA's
    authority. By expressly granting FDA such authority, FDA can
    better assess whether companies are properly prepared to trace
    product when a food-borne incident does occur.
        Third, require every food importer to police their foreign
    suppliers. In particular, Congress should require that all food
    importers document the food safety measures and controls being
    implemented by their foreign suppliers and should require food
    importers to make their foreign supplier food safety plan
    available to FDA.
        And, four, build the capacity of foreign governments and
    enlist the help of the private sector. In particular, Congress
    should direct FDA to develop a plan to help build the
    scientific and regulatory capacity of major exporters to the
    U.S. and should create a registry of private laboratories that
    meet FDA standards.
        Mr. Chairman, we are grateful for the opportunity to work
    with you and promote a risk-based approach to food safety
    regulation and to allow FDA the flexibility to respond to
    emerging risks in the manner that most efficiently uses the
    agency's precious resources. We look forward to working with
    you to develop and implement improvements that will make risk
    and prevention the focus of our nation's food systems.
        This concludes my oral testimony. And my written
    testimonies have been submitted for the record.
        [The statement of Dr. Brackett follows:]
        [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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