[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]


 
             HEARING TO REVIEW CURRENT FOOD SAFETY SYSTEMS

=======================================================================

                                HEARING

                               BEFORE THE

                        COMMITTEE ON AGRICULTURE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                               __________

                             APRIL 2, 2009

                               __________

                            Serial No. 111-8


          Printed for the use of the Committee on Agriculture
                         agriculture.house.gov


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                        COMMITTEE ON AGRICULTURE

                COLLIN C. PETERSON, Minnesota, Chairman

TIM HOLDEN, Pennsylvania,            FRANK D. LUCAS, Oklahoma, Ranking 
    Vice Chairman                    Minority Member
MIKE McINTYRE, North Carolina        BOB GOODLATTE, Virginia
LEONARD L. BOSWELL, Iowa             JERRY MORAN, Kansas
JOE BACA, California                 TIMOTHY V. JOHNSON, Illinois
DENNIS A. CARDOZA, California        SAM GRAVES, Missouri
DAVID SCOTT, Georgia                 MIKE ROGERS, Alabama
JIM MARSHALL, Georgia                STEVE KING, Iowa
STEPHANIE HERSETH SANDLIN, South     RANDY NEUGEBAUER, Texas
Dakota                               K. MICHAEL CONAWAY, Texas
HENRY CUELLAR, Texas                 JEFF FORTENBERRY, Nebraska
JIM COSTA, California                JEAN SCHMIDT, Ohio
BRAD ELLSWORTH, Indiana              ADRIAN SMITH, Nebraska
TIMOTHY J. WALZ, Minnesota           ROBERT E. LATTA, Ohio
STEVE KAGEN, Wisconsin               DAVID P. ROE, Tennessee
KURT SCHRADER, Oregon                BLAINE LUETKEMEYER, Missouri
DEBORAH L. HALVORSON, Illinois       GLENN THOMPSON, Pennsylvania
KATHLEEN A. DAHLKEMPER,              BILL CASSIDY, Louisiana
Pennsylvania                         CYNTHIA M. LUMMIS, Wyoming
ERIC J.J. MASSA, New York
BOBBY BRIGHT, Alabama
BETSY MARKEY, Colorado
FRANK KRATOVIL, Jr., Maryland
MARK H. SCHAUER, Michigan
LARRY KISSELL, North Carolina
JOHN A. BOCCIERI, Ohio
EARL POMEROY, North Dakota
TRAVIS W. CHILDERS, Mississippi
WALT MINNICK, Idaho
------

                                 ______

                           Professional Staff

                    Robert L. Larew, Chief of Staff

                     Andrew W. Baker, Chief Counsel

                 April Slayton, Communications Director

                 Nicole Scott, Minority Staff Director

                                  (ii)


                             C O N T E N T S

                              ----------                              
                                                                   Page
Lucas, Hon. Frank D., a Representative in Congress from Oklahoma, 
  opening statement..............................................     2
Peterson, Hon. Collin C., a Representative in Congress from 
  Minnesota, opening statement...................................     1
    Prepared statement...........................................     2

                               Witnesses

Keys III, Chandler, Head of Government Affairs and Industry 
  Relations, JBS USA LLC, Washington, D.C........................     4
    Prepared statement...........................................     6
Dever, David D., CEO and President, Pandol Brothers, 
  Incorporated, Delano, CA.......................................    10
    Prepared statement...........................................    12
DiMare, Anthony J., Vice President, DiMare Homestead Inc., DiMare 
  Ruskin Inc., and DiMare Johns Island Inc.; Member, Board of 
  Directors, Florida Fruit & Vegetable Association; President, 
  Florida Tomato Exchange; Member, Board of Directors, United 
  Fresh Produce Association, Ruskin, FL..........................    15
    Prepared statement...........................................    18
    Submitted report.............................................    87
Murano, Ph.D., Elsa A., President, Texas A&M University, College 
  Station, TX....................................................    38
    Prepared statement...........................................    40
Taylor, J.D., Michael R., Research Professor, Department of 
  Health Policy, George Washington University School of Public 
  Health and Health Services, Washington, D.C....................    42
    Prepared statement...........................................    44
Tucker-Foreman, Hon. Carol L., Distinguished Fellow, The Food 
  Policy Institute, Consumer Federation of America, Washington, 
  D.C............................................................    49
    Prepared statement...........................................    50
Hanlin, Ph.D., John H., Vice President Food Safety, SUPERVALU 
  INC., Eden Prairie, MN; accompanied by Michael S. Erlandson, 
  Vice President Government Affairs, SUPERVALU INC...............    73
    Prepared statement...........................................    75


             HEARING TO REVIEW CURRENT FOOD SAFETY SYSTEMS

                              ----------                              


                        THURSDAY, APRIL 2, 2009

                          House of Representatives,
                                  Committee on Agriculture,
                                                   Washington, D.C.
    The Committee met, pursuant to call, at 12:07 p.m., in Room 
1300 of the Longworth House Office Building, Hon. Collin C. 
Peterson [Chairman of the Committee] presiding.
    Members present: Representatives Peterson, Boswell, Baca, 
Scott, Costa, Kagen, Schrader, Dahlkemper, Massa, Bright, 
Markey, Kissell, Boccieri, Pomeroy, Childers, Minnick, Lucas, 
Goodlatte, Moran, Smith, and Lummis.
    Staff present: Nathan Fretz, Alejandra Gonzalez-Arias, 
Chandler Goule, Keith Jones, John Konya, Robert L. Larew, April 
Slayton, Rebekah Solem, Kristin Sosanie, Patricia Barr, John 
Goldberg, Pam Miller, Nicole Scott, Pete Thomson, and Jamie 
Mitchell.

OPENING STATEMENT OF HON. COLLIN C. PETERSON, A REPRESENTATIVE 
                   IN CONGRESS FROM MINNESOTA

    The Chairman. We will call the Committee to order. We 
apologize for the late delay or the late start here. We have 
had some other difficulties and rearranged things, so we 
appreciate everybody being patient with us. But we welcome 
everyone to today's hearing of the House Agriculture Committee.
    Food safety has been on the minds of many Americans with 
these recent recalls and foodborne illness outbreaks. At the 
beginning of this Congress our Committee adopted an aggressive 
oversight plan that makes food safety a priority. It is our 
responsibility to ensure that we have the most modern and 
effective food safety system possible, so you can expect 
rigorous oversight and action from us.
    While it is true that our current food safety system, and 
those entrusted to produce wholesome and safe food products, do 
a good job most of the time, it is clear that there are gaping 
holes in some points of the process. Modernization and reform 
are needed. During the farm bill I worked hard to ensure an 
open and transparent process that allowed for many different 
points of view, and I will use a similar process with food 
safety.
    Today's hearing, the first in a series of hearings that we 
will hold on this topic in this Congress, is just the opening 
round. The next hearing will be a joint event in April with the 
Subcommittee on Livestock, Dairy and Poultry and the 
Subcommittee on Horticulture and Organic Agriculture. Now, 
future hearings are being planned, and throughout this process, 
I expect this Committee to do its homework, to listen to all 
stakeholders, to understand the issues and consider possible 
improvements. We will use the knowledge and insight gained 
through these hearings to consider all of the alternatives that 
could be included in a food safety modernization bill developed 
by the House Committee on Agriculture.
    This is an important task, and we will work with everyone 
who shares the responsibility for safe food from the farmers 
and ranchers to the processors and handlers; the handlers to 
the retailers, and also to the consumers. As we start on this 
work, I look forward to learning from the experience of today's 
witnesses. I believe this will be a good, educational hearing 
for all of our Members, and we have a lot of work to do so let 
us get started.
    [The prepared statement of Mr. Peterson follows:]

  Prepared Statement of Hon. Collin C. Peterson, a Representative in 
                        Congress from Minnesota

    Good morning and welcome to today's hearing of the House 
Agriculture Committee. Food safety has been on the minds of many 
Americans with the recent recalls and foodborne illness outbreaks. At 
the beginning of this Congress, our Committee adopted an aggressive 
oversight plan that makes food safety a priority. It's our 
responsibility to ensure that we have the most modern and effective 
food safety system possible, so you can expect rigorous oversight and 
action from us.
    While it's true that our current food safety system and those 
entrusted to produce wholesome and safe products do a good job most of 
the time, it's clear that there are gaping holes at some points of the 
process. Modernization and reform are needed.
    During the farm bill, I worked hard to ensure an open and 
transparent process that allowed for many different points of view. I 
will use a similar process with food safety. Today's hearing is the 
first in a series of hearings that we will hold on this topic this 
Congress. The next hearing will be a joint event in April with the 
Subcommittee on Livestock, Dairy, and Poultry and the Subcommittee on 
Horticulture and Organic Agriculture. Future hearings are being 
planned. Throughout this process, I expect this Committee to do its 
homework--to listen to all stakeholders, understand the issues, and 
consider possible improvements.
    We will use the knowledge and insight gained through these hearings 
to consider all of the alternatives that could be included in a food 
safety modernization bill developed by the House Committee on 
Agriculture. This is an important task, and we will work with everyone 
who shares the responsibility for safe food--from the farmers and 
ranchers to the processors and handlers to the retailers and consumers.
    As we get started on this work, I look forward to learning from the 
experience of today's witnesses. I believe this will be a good 
educational hearing for all of our Members. We have a lot of work to 
do. Let's get started.

    The Chairman. And with that, I will recognize the gentleman 
from Oklahoma, the Ranking Member, Mr. Lucas.

 OPENING STATEMENT OF HON. FRANK D. LUCAS, A REPRESENTATIVE IN 
                     CONGRESS FROM OKLAHOMA

    Mr. Lucas. Thank you, Mr. Chairman, for calling this 
hearing which is intended to be the first in a series of 
Agriculture Committee food safety hearings this session. The 
theme of this first hearing was presented to us as educational, 
intended to lay a foundation to refresh the minds of our 
colleagues regarding the current state of the Federal food 
safety system.
    While we have many fine witnesses today, I believe it would 
have been helpful to have begun with the current 
representatives from our regulatory agencies and the many 
producers and processors who actually are subject to Federal 
food safety regulation. I am hopeful that we will hear from 
these interests fully in later hearings.
    Consumers, producers, processors and retailers I talked to 
have questions about where our food safety system is going. A 
series of foodborne illness incidents, most recently Salmonella 
illnesses and deaths associated with peanut better and peanut 
paste from a commercial supplier, have focused criticism on the 
Food and Drug Administration. It is therefore not surprising 
that most of the legislative proposals under current discussion 
have implications for FDA and the producers and processors of 
foods under their jurisdiction. It would be easy to simply 
adopt those legislative proposals, declare victory, issue our 
press releases and get on with our business. Agency 
reorganization, farm-to-table traceback, mandatory recall, 
hazard analysis plans and performance in standards, inspection 
frequency, import inspection, civil and criminal penalties, 
third-party certification and regulation of on-farm production 
practices, to name just a few of the proposals, all have 
implications for the future of our Federal food safety system.
    However, as we consider these ideas both in hearings and 
through the legislative activities, we must consider the merits 
of each proposal according to a very simple standard. We must 
judge each of these as to whether they contribute to or reduce 
the ability of our farmers and ranchers to provide our 
consumers with the safest, most affordable, the most abundant 
food supply in the history of the world.
    Again, Mr. Chairman, thank you. I look forward to the 
testimony of our witnesses and the response to our questions.
    The Chairman. I thank the gentleman for his statement, and 
I thank the other Members for their attendance. I would ask the 
other Members if they have opening statements that they will be 
made part of the record so that we can move forward. We are 
already a little over an hour behind.
    We welcome our first panel to the Committee. Mr. Chandler 
Keys, the Head of the Government Relations for JBS, LLC; Mr. 
David Dever, the CEO and President of Pandol Brothers 
Incorporated of Delano, California; and Mr. Tony DiMare, Vice 
President of DiMare Homestead, Inc., and DiMare Ruskin, Inc., 
of Ruskin, Florida.
    This was rearranged as I said from an earlier deal, but one 
of the things I wanted to do was something that has not been 
focused on enough, and that is look at the situation of 
agriculture products that are coming in from other countries. I 
want to get a better understanding of how that system works and 
find out if there are equivalent systems there as it affects 
our domestic producers.
    So we welcome the panel to the Committee. You have 5 
minutes to summarize your testimony. Your testimony will be 
made part of the record in full, and we will probably have some 
questions for you when we get done with your testimony. So 
welcome to the Committee.
    Mr. Keys, you can begin.

STATEMENT OF CHANDLER KEYS III, HEAD OF GOVERNMENT AFFAIRS AND 
                INDUSTRY RELATIONS, JBS USA LLC,
                        WASHINGTON, D.C.

    Mr. Keys. Thank you. Chairman Peterson, Ranking Member 
Lucas, and Members of the House Agriculture Committee, my name 
is Chandler Keys, and I am Head of Government Affairs for JBS 
in Washington, D.C.
    JBS is currently the world's largest beef processor with 
operations in Brazil, Argentina, Australia, Italy and the 
United States. Currently, our U.S. operations are one of the 
top three U.S. processors in both beef and pork. We also 
process lamb in Australia and the United States. Our U.S. 
operations are headquartered in Greeley, Colorado, in the 
Congressional District of the Committee's Representative Betsy 
Markey.
    Food safety is the number one priority for JBS. From the 
moment livestock enters our facilities to the time the meat is 
boxed for shipment to further processors and retailers, we are 
focused on mitigating risk and ensuring that we provide a safe 
product. We stand ready to assist Congress and the 
Administration as you look for ways to enhance meat inspection 
systems and food safety through strong science-based and risk-
based principles.
    At the request of the Chairman, I will focus my testimony 
on our Australian operations and how this division of the 
company works with Australian and U.S. regulatory officials to 
ship frozen beef trimmings into the United States.
    JBS is very familiar with the USDA regulatory regime and 
its hallmarks of continuous inspection at slaughter facilities, 
domestic plant certification, and hazard requirements. We are 
also well-versed in the system of equivalency and the 
requirement that our foreign plants must meet the same food 
safety and regulatory requirements as their U.S. counterparts 
in order to ship product into the United States. We have a 
strong professional working relationship with both Australian 
and American inspectors and regulatory bodies, and the import/
export process. It is handled by consummate professionals who 
work every day to ensure that the process runs smoothly, 
efficiently and effectively without sacrificing the tenets of 
food safety for the swift movement of product.
    As an importer, JBS' Australia division is required to 
submit all imported meat products from Australia for inspection 
by Federal agencies, including U.S. Customs, which looks for 
things requiring a duty and contraband, and the other divisions 
of the USDA that acts to stop dangerous insects and diseases 
from entering the country. USDA's Food Safety and Inspection 
Service further inspects imported meat products upon arrival 
into the U.S., determining their fitness for consumption and 
verifying that no unacceptable or illegal residues are present. 
This inspection at the port of entry is often called re-
inspection since all JBS Australian meat processing plants are 
already under an in-plant USDA inspection guidelines under the 
auspices of the Australian Quarantine and Inspection Service, 
AQIS.
    The majority of imported meat from Australia is shipped in 
containers on sea freight to points of entry in the United 
States. JBS operations are consolidated into the major ports 
across the country, Philadelphia, Long Beach, Houston, and 
these three ports are the busiest for bringing in product.
    To explain the process of importing beef into the United 
States, we must first understand the regulatory requirements of 
both the Australian and United States that an establishment 
must follow in order to ship to the United States.
    One, the Australian regulatory regime, AQIS, a regulatory 
body equivalent to the USDA, requires an establishment be 
engaged in the preparation of meat and meat products for export 
has an approved arrangement. The approved arrangement describes 
companies like JBS Australia will meet legislative 
requirements, including compliance with good hygienic practices 
and HACCP systems; product integrity including product 
identification, segregation, traceability; importing country 
requirements and animal welfare requirements.
    AQIS further requires the establishment to be listed to 
export to the United States and that all meat, meat products 
and edible offal must be slaughtered, processed and stored in 
U.S. listed establishments at all times.
    USDA regulatory requirements: in order for Australian 
product to be eligible for export, U.S. listed establishments 
must also comply with U.S. requirements. These requirements 
constitute the hallmark of USDA's regulation of foreign plants, 
equivalency.
    First, the Federal Meat Inspection Act requires foreign 
countries that export meat and poultry into the United States 
to establish and maintain an inspection system that is 
equivalent to that of the United States and to conform with 
HACCP systems. Exporting countries like Australia must undergo 
a rigorous review process before they can become eligible to 
export meat and poultry to the United States. Even after a 
country is granted eligibility, FSIS constantly reviews its 
inspection program to ensure it remains equivalent to the U.S. 
system.
    The equivalency standard is a dynamic one. Foreign 
establishments are subject to additional regulatory measures 
applied to the U.S. plants by FSIS. For example, BSE now is 
part of the process that Australian meat has to go through to 
make sure that it is equivalent to the United States.
    On an annual basis, a representative from FSIS will visit 
Australia and perform reviews, and often JBS operations are 
part of these reviews. In addition, AQIS performs verification 
activities to ensure JBS Australian establishments are 
compliant with U.S. country requirements at all times. These 
activities are performed through daily, weekly and monthly on-
plant inspections by the AQIS veterinary officers and the AQIS 
technical team managers.
    In order to comply with the U.S. requirements, U.S. listed 
establishments must have the following in place: an effective 
HACCP plan to prevent fecal, ingesta and milk contamination; 
standard operation procedures to cover all pre-operational and 
operational sanitation procedures; standard operating 
procedures for individual employee work instructions that 
describe hygiene operations establishment for each task 
performed; product monitoring records that are reviewed on at 
least a daily basis to confirm that the product has met the 
critical limits at each critical control point; and an 
effective means to segregate non-ambulatory and disabled 
animals not eligible for the U.S. market.
    Mr. Chairman, I ask that the rest of my testimony be put in 
the record to move along on time, but we look forward to 
working with this Committee in explaining the rigor of the USDA 
system as it works with the Australian system to make sure that 
the product that comes into the United States is safe and is 
equivalent.
    [The prepared statement of Mr. Keys follows:]

Prepared Statement of Chandler Keys III, Head of Government Affairs and 
           Industry Relations, JBS USA LLC, Washington, D.C.

    Chairman Peterson, Ranking Member Lucas, and Members of the House 
Agriculture Committee, I am Chandler Keys, Head of Government Affairs 
and Industry Relations for JBS USA in Washington D.C. As past Vice 
President of the National Cattlemen's Beef Association and in my more 
recent role as a government relations executive for Swift & Company and 
its successor, JBS, I have had the pleasure of working alongside many 
of you over the years. I look forward to working with this Committee 
again in the future as we strive to collaboratively address issues 
impacting the livestock sector and enhancing the safety of the U.S. 
food supply.
    JBS is currently the world's largest beef processor--with beef 
operations in Brazil, Argentina, Australia, Italy and the United 
States. Currently, our U.S. operations are one of the top three U.S. 
processors in both beef and pork. We also process lamb in both 
Australia and the United States. Our U.S. operations are headquartered 
in Greeley, Colorado, in the Congressional District of the Committee's 
own, Representative Betsy Markey.
    Food safety is the number one priority at JBS. From the moment 
livestock enter our facilities to the time meat is boxed for shipment 
to further processors and retailers, we are focused on mitigating risk 
and ensuring that we provide a safe product. We stand ready to assist 
Congress and the Administration as you look to enhance meat inspection 
and food safety through strong science-based and risk-based principles.
Importing Frozen Beef Trimmings From Australia Into the U.S.
    At the request of the Chairman, I will focus my testimony on our 
Australian operations and how this division of the company works with 
Australian and U.S. regulatory officials to ship ``fresh and frozen'' 
beef trimmings into the United States. I hope the Committee will find 
this information instructive to its deliberations on how we can enhance 
the safety of products regulated by the U.S. Department of Agriculture.
    JBS is very familiar with the USDA regulatory regime and its 
hallmarks of continuous inspection at slaughtering facilities, domestic 
plant certification, and Hazard Analysis and Critical Control Point 
(HACCP) requirements. We are also well-versed in the system of 
equivalency and the requirement that our foreign plants must meet the 
same food safety and regulatory standards as their U.S. counterparts in 
order to ship product into the U.S. We have a strong professional 
relationship with both Australian and American inspectors and 
regulatory bodies, and the import/export process is handled by 
consummate professionals who work every day to ensure that the process 
runs smoothly, efficiently, and effectively without sacrificing the 
tenets of food safety for the swift movement of product.

Overview
    As an importer, JBS' Australia division is required to submit all 
imported meat products from Australia for inspection by Federal 
agencies, including U.S. Customs and Border Protection, which looks for 
items requiring a duty and contraband, and the USDA, which acts to stop 
dangerous insects and diseases from entering the country. USDA's Food 
Safety and Inspection Service (FSIS) further inspects imported meat 
products upon arrival into the U.S., determining their fitness for 
consumption and verifying that no unacceptable or illegal residues are 
present. This inspection at the port of entry is often considered a 
``re-inspection'' since all JBS Australian meat processing plants are 
already under in-plant USDA inspection guidelines under the auspices of 
the Australian Quarantine and Inspection Service (AQIS).
    The majority of imported meat from Australia is shipped in 
containerized sea freight to ports of entry across the United States. 
JBS operations are consolidated into the major ports across the 
country; however the majority of our business goes through the ports of 
Philadelphia, PA, Long Beach, CA and Houston, TX. These three ports are 
the busiest and most adequately equipped for the importing of fresh and 
frozen meat products.

Regulatory Requirements
    To explain the process of importing beef into the U.S., we must 
first understand the regulatory requirements--both Australian and 
U.S.--that an establishment must follow in order to ship to the U.S.
Australian Quarantine and Inspection Service (AQIS)
    The Australian Quarantine and Inspection Service, a regulatory body 
equivalent to the U.S. Department of Agriculture, requires, through 
Australian Export Control (meat and meat products) Orders, that the 
occupier of an establishment engaged in the preparation of meat and 
meat products for export has an ``Approved Arrangement.''
    The purpose of the approved arrangement is to clearly describe 
those processes and practices which underpin AQIS certification of meat 
and meat products for export.
    The approved arrangement describes how companies like JBS Australia 
will meet legislative requirements, including compliance with:

   Good hygienic practices (GHP) to ensure that food is 
        wholesome;

   The application of HACCP systems for food safety;

   Product integrity through the application of product 
        identification, segregation and traceability practices ensuring 
        the product is accurately described and maintains relevant 
        importing country identification;

   Importing country requirements necessary to maintain market 
        eligibility; and

   Animal welfare requirements.

    In addition, Australian producing establishments must be registered 
by AQIS and ``listed'' as eligible to export to the U.S. and its 
territories. All meat, meat products and edible offal must be 
slaughtered, processed and stored in U.S. listed establishments at all 
times.

United States Department of Agriculture
    In order for Australian product to be eligible for export, U.S. 
listed establishments must also comply with U.S. requirements. These 
requirements constitute the hallmark of USDA's regulation of foreign 
plants: equivalency.
    The Federal Meat Inspection Act requires foreign countries that 
export meat and poultry into the United States to establish and 
maintain inspection systems that are equivalent to those of the United 
States and conform with HACCP systems. Exporting countries like 
Australia must undergo a rigorous review process before they can become 
eligible to export meat and poultry to the United States. Even after a 
country is granted eligibility, FSIS continually reviews its inspection 
program to ensure it remains equivalent to the U.S. system.
    The equivalency standard is a dynamic one. Foreign establishments 
are subject to the same additional regulatory measures applied to U.S. 
plants by FSIS. For example, when additional requirements were imposed 
on U.S. plants to mitigate the risks of Bovine Spongiform 
Encephalopathy (BSE); our JBS Australia plants had to meet those same 
standards in order to maintain eligibility to ship to the U.S.
    On an annual basis, a representative from FSIS will visit Australia 
to perform a country review to ensure the Australian systems in place 
are achieving the requirements or deliver an equivalent outcome as 
agreed upon by the two countries. JBS Australia regularly has plants 
involved in these FSIS reviews.
    In addition, AQIS performs verification activities to ensure JBS 
Australia establishments are compliant with U.S. country requirements 
at all times. These activities are performed through daily, weekly and 
monthly on-plant inspections by the On-Plant AQIS Veterinary Officer 
and the AQIS Area Technical Manager.

Understanding Equivalency
    JBS Australia establishments have systems in place that comply with 
the AQIS approved arrangement guidelines, which include importing 
country requirements such as those for the U.S.
    In order to comply with U.S. requirements, U.S. listed 
establishments must have the following in place:

   Hazard Analysis and Critical Control Points (HACCP)--An 
        effective HACCP plan that considers issues related to food 
        safety hazards (E. coli O157:H7) and includes critical control 
        points (CCPs) for all processes conducted at the establishment 
        with set critical limits that have been validated and 
        monitored. The HACCP plan is required to be reviewed annually 
        or whenever an alteration to the process has been made.

     FSIS requires zero tolerances for feces, ingesta, and 
            milk on the slaughter floor on all U.S. listed 
            establishments. U.S. listed establishments must also adopt 
            effective controls for preventing contamination of 
            carcasses with fecal, ingesta, and milk. These zero 
            tolerances must be included in the company's HACCP plans.

     Raw ground beef products destined for export to the 
            U.S. must be tested for E. coli O157:H7, utilizing a N=60 
            sampling plan for each 700 carton lot. In addition, an 
            Association of Official Analytical Chemists (AOAC) 
            accredited screening test method is required.

     U.S. listed establishments are also required to review 
            product-monitoring records on at least a daily basis to 
            confirm that the product has met the critical limits at 
            each critical control point prior to being loaded for 
            export to the U.S.

   Sanitation Standard Operating Procedures (SSOP) that relate 
        to the process controls for producing the meat product, which 
        covers procedures conducted both before (pre-operational) and 
        during (operational) operations. All corrective and preventive 
        actions undertaken to prevent product contamination need to be 
        documented.

   Standard Operating Procedures (SOP) and individual employee 
        Work Instructions (WI) that describe the hygiene operations of 
        the establishment for each process task performed including 
        corrective and preventive actions undertaken where there is 
        failure in a SOP or WI procedure.

   Non-ambulatory disabled animals ``that cannot rise from a 
        recumbent position or that cannot walk, including, but not 
        limited to, those with broken appendages, severed tendons or 
        ligaments, nerve paralysis, fractured vertebral column or 
        metabolic conditions'' are required to be segregated as they 
        are not eligible for the U.S. market.

The Export/Import Process
 Product Transfer and Loadout Requirements
    Meat and meat products from JBS Australia establishments eligible 
to export to the U.S. must adhere to strict documentation requirements 
while being transferred and loaded for shipment.

   Meat Transfer Certificates must be used to cover the 
        transfer of product from one establishment to another for 
        further processing or storage. These certificates must be 
        endorsed to prove the meat is eligible for export to the U.S.

   Shipping marks--Unique shipping marks are used for all 
        shipments of edible meat to the U.S. These shipping marks must 
        be clear and legible, and cannot be hand-written. Shipping 
        marks must be unique over a thirteen-month period and not 
        exceed 12 characters/digits. The first three characters are the 
        alpha prefix registered in the Export Documentation (EXDOC) 
        system for the purpose of monitoring shipping marks. Shipping 
        marks may be either applied as a stencil or as an adhesive 
        label. If adhesive labels are used they must be tamper evident 
        with an adhesive that ensures they remain securely attached in 
        adverse conditions such as excess moisture.

   Upon container loading, a traceable and accountable AQIS 
        high security seal is applied to the container and recorded on 
        the relevant documentation.

   Through the JBS Australia electronic export 
        documentation system and the AQIS EXDOC system, the JBS Head 
        Office and the shipping line are notified of the intention to 
        export product.

   AQIS receives a Request for Permit (RFP) from JBS 
        Australia from which a health certificate is generated for each 
        shipping mark represented within the container.

 Health Certification for meat and edible offal is accomplished 
through an E7
  health certificate. The E7 health certificate is granted when the 
following
  endorsements are made:

   All production lots of manufacturing beef exported to 
        the U.S. have been tested and cleared in accordance with the 
        AQIS E. coli O157:H7 protocol.

   The product:

       was derived from animals that have never been in;

       did not originate in and was never stored, rendered or 
            otherwise processed
              in;

       was not otherwise physically associated with a facility 
            located in; and

       has not been otherwise physically associated with or 
            exposed to, or commin-
              gled with ruminant material from:

   Any region listed in Title 9, Code of Federal 
        Regulations part 94.18(a), which governs the prohibition and or 
        restriction of the importation of products from countries with 
        rinderpest, foot and mouth disease, bovine spongiform 
        encephalopathy and other foreign animal diseases of livestock 
        and poultry.

   All health certificates for all shipments of edible 
        meat, meat products and offal must include a product 
        description as defined on the label of the product.

   The shipping line receives a pre-receivable advice (PRA) 
        from which the container is added to the vessel manifest. The 
        shipping line provides customs with the manifest, and Customs 
        contacts AQIS EXDOC to ascertain if there is health 
        certification for the container load of product.

   AQIS provides the original health certificate to JBS 
        Australia.

   JBS Australia supplies the original health certificate, 
        the bill of lading and the commercial invoice to the customer 
        prior to the arrival of the container in the U.S. port.

   A copy of all documentation for each consignment is kept 
        on file at the JBS Australia Head Office documentation 
        department.

 U.S. Customs Clearance

    When a shipment of imported meat arrives in the United States from 
Australia, JBS, via our customs broker (licensed by U.S. Customs and 
Border Protection), files entry documents with U.S. Customs.
    U.S. Customs examine the goods to determine:

    1. The value of the goods for any applicable duties, and if 
        commercial invoices are accurate;

    2. Any special markings from the country of origin that are 
        required by Federal law; and

    3. Whether the shipment contains prohibited items.

    The container may not legally enter the U.S. until the shipment has 
arrived at the port and U.S. Customs has authorized the clearance of 
the container from the pier to a USDA inspection warehouse. Upon 
delivery of the container to the warehouse, the USDA inspection process 
begins.

 USDA Inspection_the ``Re-Inspection Process''
    Once at the warehouse, each container is presented to FSIS. FSIS 
enters information about the shipment into a centralized computer 
system called the Automated Import Information System (AIIS). The AIIS 
scans its memory bank to determine if the country, plant, and product 
are eligible for export to the United States. When the shipment is 
ready to be re-inspected by FSIS, the AIIS will generate an inspection 
assignment, based on the plant and country's compliance history for 
that specific product. Inspection results are later entered into the 
AIIS, helping to establish the level of re-inspection for future 
shipments from JBS Australia and for shipments from Australia in 
general.
    FSIS import inspectors first check the documents to assure the 
shipment is properly certified by the foreign country. Inspection may 
be delayed or refused if the documents contain irregularities or 
errors. If there are issues with documents, the importer is required to 
rectify the problem. Inspectors commence by examining each shipment for 
general condition and labeling.
    A recurring problem that many importers face involves inaccurate 
shipping marks (unique ID numbers stamped on each box by the exporting 
establishment that link the shipment to the government health 
certificate). The shipping marks must correspond with the Australian 
health certificate, and if they don't, a guarantee must be issued by 
the Australian Embassy. Any boxes missing shipping marks must be 
stamped by a representative of the Australian government or destroyed. 
USDA will also hold any shipment when the physical inventory count does 
not match the Australian health certificate. Overages or shortages also 
require a guarantee issued by the Australian Embassy.
    Once documentation and labeling are approved, the inspection 
continues with assignments directed by the AIIS. AIIS may designate the 
shipment as a ``skip'', and no further inspections are required. A 
plant with a good compliance history will not have as many inspections 
assigned.
    There are three levels of inspection:

    (a) ``normal'' level of inspection--all lots are re-inspected;

    (b) ``skip 1'' (S1) level--one of every four lots is re-inspected; 
        and

    (c) ``skip 2'' (S2) level--one of every 12 lots is re-inspected.

    JBS Australian plants have the highest performance record and we 
currently are on ``skip 2'' level for all beef plants.
    If the container is marked for an intensive inspection, several 
types of inspection may be assigned by the AIIS, including net weight 
checks of retail packages; examination of the container's condition; 
physical examination for product defects; and laboratory analysis for 
product composition, microbiological contamination, residues, and 
species verification. In conducting these inspections, a certain amount 
of product is randomly selected and examined by FSIS import inspectors. 
Microbiological analysis includes tests for Listeria monocytogenes, E. 
coli O157:H7, and Salmonella among others. Residue analysis testing 
targets include sulfonamides, chlorinated hydrocarbons, arsenic, 
antibiotics, carbadox and ivermectin.
    However, even with a good record, if a lot fails an intensive 
inspection, future shipments of product from the plant may be allocated 
a different inspection level. This allocation by AIIS is based on 
formulas that rate the type of defect; however, for a failed residue 
and microbiological analyses, the plant stays on ``tightened and hold'' 
until 15 consecutive lots pass within 180 days.
    When product samples are sent to FSIS laboratories for analysis, 
the shipment is usually released before test results are received. 
However, if the plant had previous violations or a problem is 
suspected, the shipment is held until the laboratory results are known. 
Even though JBS plants in Australia have the lowest possible incidence 
of problems during inspection, our internal protocols require all 
product that undergoes an intensive inspection to be withheld from 
commerce until results have been returned.
    When a shipment passes inspection, each shipping container is 
stamped with the official mark of inspection and released into U.S. 
commerce.
    If a shipment does not meet U.S. requirements, the cartons are 
stamped ``U.S. Refused Entry,'' and within 45 days must be exported, 
destroyed or converted to animal feed (with the approval of the Food 
and Drug Administration).
    JBS typically will have some boxes rejected by USDA. This is 
generally due to carton damage. Due to container moment during the 
overseas voyage, cartons may tear. Any cartons with exposed meat 
(through poly plastic liner and cardboard) are rejected. USDA will also 
reject cartons that may contain leaking chilled vacuum packages.

Conclusion
    In summary, the importation of meat and meat products from 
Australia into the U.S. is a very intensive and robust process with 
failsafe mechanisms at each step. Our products are not only subject to 
intense scrutiny and inspection in Australia; but to re-inspection at 
the U.S. port of entry. In addition, our plants must adhere to the same 
regulatory requirements and procedures as American-produced products--
ensuring that American consumers enjoy a safe, quality product 
irrespective of its origin.

    The Chairman. Thank you very much, Mr. Keys, and we 
appreciate your being with us.
    Mr. Dever, you are recognized for 5 minutes.

    STATEMENT OF DAVID D. DEVER, CEO AND PRESIDENT, PANDOL 
               BROTHERS, INCORPORATED, DELANO, CA

    Mr. Dever. Thank you very much. Good morning, Chairman 
Peterson, Ranking Member Lucas and the Members of the 
Committee. My name is David Dever and I am CEO and President of 
Pandol Brothers, Inc. Our headquarters are located in Delano, 
California, which is in the San Joaquin Valley. Today we farm 
approximately 5,000 acres, primarily of California table grapes 
in addition to importing product from Latin America.
    Pandol has led the industry with transparent forms of self-
regulation for many years. These produce-based standards work 
to identify: risks, control points, control measures, and to 
provide for independent verification. This starts with land use 
through to the transportation of our products to market. Good 
agricultural products, good manufacturing practices, food 
security, hazard analysis, and critical control point programs 
have been developed and updated annually.
    Pandol utilizes internal and external verification 
processes to provide verification of the effectiveness of these 
systems and to provide guidance for improvement. In addition, 
Pandol has introduced a Trace Recall Program and a Management 
Plan to ensure our ability to trace the product through the 
supply chain. We have complied with the U.S. Bioterrorism Act 
of 2002 which requires the ability to establish and maintain 
records, to document movement of our products both one step 
forward and one step back through the supply chain.
    Pandol is a member of the Steering Committee of the Produce 
Traceability Initiative, created and led by three leading 
industry organizations, the United Fresh Produce Association, 
Produce Marketing Association and the Canadian Produce 
Marketing Association. Adoption of these standards is now in 
motion, and complete details on this initiative can be found on 
the industry website www.producetraceability.org.
    However, with all of that that has been accomplished to 
ensure our products are safe, we acknowledge there are many 
challenges that continue to face us today in strengthening the 
safety of our food source. These include, first, the industry 
must work together at developing and improving systems and 
processes on a commodity-specific basis. Simultaneously, 
government regulation must be created to support the process, 
to provide the necessary enforcement policies to equalize the 
playing field, and to strengthen the consumer confidence in the 
overall process. We also believe these food safety standards 
must be consistent and applicable to the identified commodity, 
irrespective of its origin.
    Imported products need to meet equivalent standards as that 
required of domestic produce. Although some countries have 
sophisticated food safety operations, we encourage U.S. food 
safety officials to work together with our foreign counterparts 
to ensure and verify that equivalent policies and standards are 
in place.
    Third, the additional cost to develop and implement the 
systems along with the verification and audit process is 
costly. We must encourage, as part of this commodity-specific 
approach, that FDA develop a rule-making procedure that 
establishes risk and science-based regulations for the 
production, handling and distribution of those types of fruits 
and vegetables for which the Secretary determines such 
standards are necessary to minimize the risk of microbial 
illness.
    Fourth, time is critical when an incident occurs. A 
standardized electronic web-based record-keeping throughout the 
supply chain will provide crisis managers with the ability to 
instantaneously trace the source product, thereby allowing them 
to identify the contaminating source, limiting the threat and 
strengthening the consumers' confidence.
    Last, even with all of the proactive development of food 
safety systems, including verification processes, we continue 
to be dependent on those we do business with to apply the same 
standards to ensure the integrity of the supply chain. 
Therefore, we believe achieving consistent produce safety 
standards across the industry requires strong Federal 
Government oversight and responsibility in order to optimize 
our credibility to the consumer and to be equitable to all 
producers.
    Let me conclude with these closing thoughts. Produce safety 
must be a process of continuous improvement, not a static 
achievement. As long as there is the potential of even one 
individual getting sick, as an industry we will do all we can 
to prevent that from happening. It can be discouraging when 
events such as the jalapeno pepper, peanut, and now the 
pistachio incidents occur, and as bad as those have been, as 
producers, regulators, policy-makers and consumers, we need to 
understand that the produce industry has achieved an 
overwhelming success record in regards to food safety with the 
actual incidents of illness at an extremely low level. Please 
look at the numbers. Over one billion servings of fresh produce 
are eaten every day. More than five million bags of fresh 
salads are sold every day. Of the hundreds of fruits and 
vegetables offered in the produce section of the supermarket, 
only a handful have been implicated in illness outbreaks, and 
when they are, the incident is small in volume in comparison to 
their volume of consumption.
    But, we also know that consumers today are very concerned 
about the safety of their food. They don't care about the 
statistics or industry's effort put forth to date. They want 
improved results, and it is both the industry and government's 
obligation to restore the consumers' confidence by working 
together to develop, implement, verify and ensure the most 
thorough, state-of-the art food safety systems possible. We 
must all be able to trust the overall system of government 
insight and industry responsibility working together to produce 
the safest possible supply of fresh, healthy and nutritious 
fruits and vegetables.
    Thank you.
    [The prepared statement of Mr. Dever follows:]

    Prepared Statement of David D. Dever, CEO and President, Pandol 
                   Brothers, Incorporated, Delano, CA

    Good morning Chairman Peterson, Ranking Member Lucas and the 
Members of the Committee. My name is David Dever and I am CEO and 
President of Pandol Bros., Inc. (Pandol). Our headquarters are located 
in Delano, California which is in the San Joaquin Valley between Fresno 
and Bakersfield. The Pandol Family has been farming and bringing to 
market fresh produce for more than half a century. In 1908 Steve Pandol 
immigrated from modern day Croatia to the United States. In the early 
1940's he and his wife Margaret, also from the old country, purchased 
160 acres in the San Joaquin Valley and began farming and raising a 
family. Their three sons joined the business and together, with each 
contributing their special set of skills, they expanded the business 
into a major grower, marketer and shipper of fresh quality produce, 
primarily table grapes. Today, with the third generation in the lead 
and as the fourth generation of the Pandol Family enters the 
organization, the company continues to focus on its core competency of 
growing, shipping, importing, exporting and marketing premium quality 
table grapes and other fresh produce items. The Pandol Family farms 
approximately 5,000 acres in California. Together with sources in Latin 
America, Pandol has a supply of table grapes to bring to the 
marketplace year round. From California in the summer and fall, Mexico 
in the spring, and Chile, Peru and Brazil in late fall and winter, 
Pandol Bros, Inc. almost always has fresh table grapes available to the 
market. In addition to domestic markets Pandol has a long history of 
exporting products to the world marketplace including Canada, Europe, 
Latin American, the Middle East and especially the Pacific Rim.
    As this business has evolved over the years, so have the challenges 
over the safety of our food supply. Meeting or exceeding these 
challenges and delivering safe, quality produce to the marketplace has 
always been a primary goal of the Pandol Company. From the start of our 
company to the present day the Pandol family has been advocates of 
developing and implementing procedures that give our customers and 
consumers' confidence in the products that we grow and deliver.
    Pandol Bros. has led the industry with transparent forms of self-
regulation for many years. These produce based standards work to 
identify risks, identify control points and control measures, and to 
provide for independent verification of compliance. In fulfilling these 
produce standards Pandol evaluates and reviews:

   Land history and use.

   Adjacent land use.

   Soil amendments.

   Pesticide usage.

   Irrigation water source and quality.

   Employee hygiene and sanitation practices, including 
        training procedures.

   Employee habits and conditions, including training 
        procedures.

   Harvest procedures.

   Transportation procedures.

   Packaging materials.

   Field packing sanitation procedures.

    In each of these categories Pandol identifies any potential areas 
of hazard or exposure and develops a plan to monitor for, prevent and 
mitigate any undesirable conditions.
    Pandol utilizes verification processes which include internal 
standard operating procedures, independent experts and governmental 
agencies. We periodically perform reviews and evaluations of the 
systems and develop corrective actions as needed. Additionally, we 
utilize third party audit companies to provide verification of the 
effectiveness of the systems and to provide guidance for improvement.
    These tests or procedures are extensive but as a sample include:

   Conducting a pre-harvest pesticide residue testing program 
        which establishes that the product tested meets or exceeds U.S. 
        EPA established standards. This program is conducted and 
        monitored by an independent, third-party laboratory which 
        posts, to its website, United States tolerance levels whenever 
        residues are detected.

   We monitor microbial or physical adulteration of product by 
        participating in Good Agricultural Practices (GAP), field and 
        harvest crew audits by independent third party auditors, and 
        HACCP/GMP programs for our cold storage operation, also audited 
        by an independent third party.

   In our fields Pandol conducts independent lab testing of 
        soil and water sources, conducts fertilizer and chemical 
        monitoring and reporting programs, and assessment of adjacent 
        land uses, and other risks from surrounding activities.

   Harvest practices and employee hygiene/sanitation issues are 
        also monitored and subject to periodic third party review and 
        periodic unannounced inspection by state and Federal 
        authorities.

   Mock product recalls are periodically implemented to test 
        the traceability system.

    Pandol requires its suppliers to certify they have food safety 
programs in place that include compliance with the following 
guidelines:

   Compliance with the FDA Guide to Minimizing Microbial Food 
        Safety Hazards for Fresh Food and Vegetables.

   Good Agricultural Practices (GAP).

   Good Manufacturing Practices (GMP), if applicable.

   Third Party Audits (Field/Facility).

   Food Security Program (Field/Facility).

   Trace Recall Program.

   Multi-Residue screening of all supplied product.

   Meet all COOL regulatory requirements.

    In addition, Pandol has long been committed to the ability to trace 
its product through the supply chain, and has complied with the U.S. 
Bioterrorism Act of 2002 which requires the ability to establish and 
maintain records to document movement of its products both one step 
forward and one step back through the supply chain.
    Pandol has developed a Trace Recall Program in the event a product 
may be deemed to be potentially hazardous or defective. In addition we 
have developed a Crisis Management Plan in the unlikely event that a 
situation reaches the point of a ``disaster'' or ``crisis'' beyond the 
scope of what usual policies address. The availability of such a plan 
insures that management and employees have a clear, well thought out 
guide and plan of action if a disaster should ever arise.
    Pandol is also a member of the Steering Committee of the Produce 
Traceability Initiative, an industry wide initiative created by the 
three leading industry organizations United Fresh Produce Association, 
Produce Marketing Association and the Canadian Produce Marketing 
Association. This initiative that began in late 2007 was designed to 
assist the industry maximize the effectiveness of current traceback 
procedures, while developing a standardized industry approach to 
enhance the speed and efficiency of traceability systems for the 
future. The Steering Committee representing every segment of the 
produce supply chain; from farm to store and restaurant, and actively 
involved nine U.S. and Canadian trade associations met numerous times 
and spent countless hours in collaborative discussions and sub-groups 
to develop unparalleled standardization policies for the industry as a 
whole. Pandol, who agrees with and supports this Initiative, is working 
diligently at developing systems and procedures to be able to adhere to 
the Milestones as established by this Committee. Adoption of these 
standards is now in motion, and complete details on this initiative can 
be found on the industry website www.producetraceability.org.
    However, it is important to acknowledge and address the challenges 
that we face today in strengthening the safety of our food source:

    1. Food safety is our industry's top priority. The men and women 
        who grow, pack, prepare and deliver fresh produce are committed 
        to providing consumers with safe and wholesome foods. The 
        industry, as a whole, must work together at developing systems 
        and processes on a commodity-specific basis to enhance our food 
        safety policies. Industry needs to take the lead in assessing 
        the risks and exposure depending on the commodity, location and 
        processes involved in the production of our food. Government 
        regulation must be created to support the process, to provide 
        the necessary enforcement policies to equalize the playing 
        field and to strengthen the consumer confidence in the overall 
        process. Therefore we believe food safety standards must be 
        consistent and applicable to the identified commodity or 
        commodity sector, no matter where grown or packaged in the 
        United States, or imported into the country. Consumers must 
        have the confidence that safety standards are met no matter 
        where the commodity is grown or processed.

    2. We believe that product imported into the United States needs to 
        meet equivalent standards as that required of domestic produce. 
        U.S. food safety officials can work together with foreign food 
        safety officials to ensure and verify that equivalent policies 
        and standards are in place. Many foreign governments work 
        closely with their industries to establish and enforce food 
        safety guidance and traceability systems. We have found that 
        some of the more sophisticated food safety operations are found 
        outside of the United States. When foreign countries are 
        working congruently with U.S. standards we should acknowledge 
        their food safety programs accordingly. This approach of 
        working with and recognizing foreign regulatory systems is 
        necessary to save government and industry resources. If the 
        U.S. industry is required to police the supply chain outside of 
        the U.S., this will put U.S. companies at a competitive 
        disadvantage in the global marketplace.

    3. Within the food supply chain there are many people involved in 
        the process and many procedures that need to be complied with 
        in order to minimize risk of contaminated food. The additional 
        cost to develop and implement the systems along with the 
        verification and audit process is costly. We must encourage 
        participation of governmental agencies in providing input into 
        the ongoing development of commodity-specific science based 
        standards. In particular, as part of this commodity specific 
        approach, FDA must develop a rule-making procedure that 
        establishes risk and science-based regulations for the 
        production, handling and distribution of those types of fruits 
        and vegetables for which the Secretary determines such 
        standards are necessary to minimize the risk of microbial 
        illness.

    4. Electronic record-keeping with web based search features is the 
        next level. When an incident is reported electronic record-
        keeping will give the investigating process the ability to 
        instantaneously trace the source product in order to 
        expediently identify potential sources of the problem or to 
        eliminate possible exposures.

    5. Last, with all of the proactive development of systems in 
        addition to the independent verification processes we employ to 
        ensure that we are holding ourselves accountable for 
        compliance, we continue to be dependent on those we do business 
        with and the overall integrity of the people involved in the 
        supply chain. We do not have the systems in place or the 
        necessary personnel to monitor the compliance of non-Pandol 
        affiliated suppliers and must rely upon the honesty and 
        integrity of those we do business with. Therefore, we believe 
        achieving consistent produce safety standards across the 
        industry requires strong Federal Government oversight and 
        responsibility in order to be most credible to consumers and 
        equitable to producers.

    Let me conclude with these closing thoughts. Produce food safety 
must be a process of continuous improvement, not a static achievement. 
We are on a continuum, constantly striving toward perfection, while 
understanding scientifically that perfection--or zero risk--is not 
possible. Because our products are enjoyed by consumers in their fresh 
and natural state without cooking, we have to be right every single 
time--not one in a million, or even one in a billion. But as long as 
there is the potential of even one individual getting sick, we will do 
all we can to prevent that from happening.
    The good news is that this is happening now. For the produce 
industry we have an overwhelming success record in regards to food 
safety with actual incidence of illness extremely low. Just look at the 
numbers.

   Over a billion servings of fresh produce are eaten every 
        day.

   More than five million bags of fresh salads are sold every 
        day.

   And, out of the hundreds of fruits and vegetables offered in 
        a typical supermarket, only a very few have been implicated in 
        illness outbreaks, and then rarely as compared with their 
        volume of consumption.

    But, we also know that consumers today are walking into grocery 
stores and restaurants with new concerns, new doubts, and sometimes 
fears about produce. They don't understand those statistics; they don't 
know what farmers and processors are doing to protect the safety of 
their produce; and equally important, they do not have complete 
confidence that government is doing all it should to protect their 
health.
    Fears of food safety have no place in the fresh produce department. 
We, as an industry, must do all we can to prevent illnesses from ever 
occurring, and we will. But because science tells us there is no such 
thing as zero risk, government must also be able to assure the public 
that even if something does go horribly wrong in an isolated case, 
consumers can continue to have confidence in fresh produce. We must all 
be able to trust the overall system of government oversight and 
industry responsibility, working together to produce the safest 
possible supply of fresh, healthy and nutritious fruits and vegetables.

    The Chairman. Thank you very much for your testimony. Mr. 
DiMare?

    STATEMENT OF ANTHONY J. DiMARE, VICE PRESIDENT, DiMARE 
  HOMESTEAD INC., DiMARE RUSKIN INC., AND DiMARE JOHNS ISLAND 
                     INC.; MEMBER, BOARD OF
 DIRECTORS, FLORIDA FRUIT & VEGETABLE ASSOCIATION; PRESIDENT, 
  FLORIDA TOMATO EXCHANGE; MEMBER, BOARD OF DIRECTORS, UNITED 
                         FRESH PRODUCE
                    ASSOCIATION, RUSKIN, FL

    Mr. DiMare. Good morning, Mr. Chairman, Ranking Member 
Lucas, Committee Members, my name is Tony DiMare, and I am Vice 
President of DiMare Homestead and DiMare Ruskin, Inc.
    The DiMare Company is an 80 year old company and the 
largest vertically integrated tomato company in the United 
States. We are growers, packers, re-packers, and distributors 
of all types of fresh tomatoes. Our company has been one of the 
industry leaders and instrumental in helping form food safety 
guidelines that are in place in our industry today. The DiMare 
Company started a Food Safety and HACCP Program as early as 
1990 at our Tampa, Florida repack facility. Food safety is not 
new to the DiMare Company. We then expanded the Food Safety 
Program to the remainder of our growing and packing facilities 
in the mid-1990s.
    I would like to give the Committee an overview and sense of 
what we do as a company to ensure that the products we produce, 
pack, and distribute are handled in the safest possible manner 
by our stringent Food Safety and Food Security Programs and our 
ability to positively identify and traceback our products.
    Starting with our farms, we routinely test our irrigation 
water and the water we use for spraying our crops to ensure it 
is free from harmful pathogens. We have invested heavily in 
some areas, installing fences where animal intrusion had been a 
problem. Our field workers are trained prior to the start of 
each crop season on awareness of food safety procedures. They 
are also trained on proper personal hygiene. Proper hand-
washing after restroom use is one example of this. Our key 
personnel have been trained to identify worker illnesses and 
health issues and report them immediately to management. Our 
key personnel have also been trained for food security with 
special attention to any unusual activities and awareness of 
any unauthorized people coming onto our farms and facilities. 
Everything we do relative to food safety is documented and 
reviewed annually by one or more third-party auditors. We also 
conduct self-audits during each crop season and document those 
results. Any deficiencies are noted, and corrective actions are 
immediately addressed.
    At our packinghouses, we also have worker training sessions 
prior to the start of every season, educating workers on proper 
personal hygiene, including proper hand-washing, proper use of 
protective gloves, smocks, and hairnets. The workers are 
educated to not wear jewelry, have personal items, or food or 
drinks in the work area. There are designated eating and 
drinking areas for all employees. All of these procedures are 
in place to help minimize any possibility of contamination to 
our food products. Any machinery sprays and lubricants are of 
Food Grade quality, and MSDS records are kept for these and all 
other chemicals.
    The water we use to wash and rinse our product in our 
packinghouses is required to be of potable quality and is 
tested seasonally to ensure it is of safe quality. Our product 
at the packinghouse level typically goes through a chlorine 
bath wash procedure followed by a fresh water rinse, and then 
one final sanitizing rinse before it is quality sorted and 
sized for packaging. We very closely monitor our bath wash 
water on an hourly basis, recording chlorine levels, pH, and 
the water temperature, which are critical for ensuring proper 
kills of any bacteria or pathogens and prevention of 
infiltration of these contaminants into the tomatoes.
    The containers we harvest in are cleansed with a chlorine 
wash to rid them of any dirt and debris after they have been 
emptied of product and prior to returning to the farm for 
harvesting use again. The equipment used for all packing in all 
our operations is sanitized before the start of each packing 
day. Swab tests are conducted on the equipment twice per season 
and sent off to an independent lab for presence of total 
coliforms, E. coli O157:H7, and Salmonella.
    Pest control is another important area of our overall Food 
Safety Program. We contract with independent and licensed pest 
control companies to manage pest control in all of our packing 
operations. Traps and bait stations are placed around the 
perimeter of our properties, around the perimeter of our 
buildings, and around the inside of our packing facilities. In 
essence, we have three layers of pest control protections in 
place.
    After our product has been packed and readied for shipment, 
independent trucks used for transportation are inspected for 
cleanliness and absence of any foul odors and documented. 
Temperatures are set according to customer requests and 
temperature recorders are placed on every truck to monitor 
temperature settings during transportation. Again, everything 
we do is documented, and third-party audits are conducted 
annually to ensure we are delivering the most wholesome and 
safest products possible.
    The final process in our Food Safety Program is a Recall 
and Traceback Program. There is a Crisis Management Team in 
place at every level of our operation to act on a recall and 
quickly and timely trace our product back. I will share with 
the Committee a recent mock recall that was conducted on July 
8, 2008, by one of our repacking operations in California 
during the Salmonella saintpaul outbreak in which tomatoes were 
incorrectly named as the source. Our facility in Sacramento, 
California, was chosen to conduct the mock recall to test the 
ability of industry to effectively conduct traceback, and more 
importantly, the timeliness of a recall from an individual 
quick-serve restaurant all the way back to the individual farm 
and specific field.
    Present at the traceback were the Quality Assurance 
Director of the quick-serve restaurant, a DiMare Company 
official, industry representatives from the California Tomato 
Farmers and Western Growers Association, and four Congressional 
investigators. The recall was initiated by the QA Director of 
the quick-serve restaurant by randomly and literally selecting 
one of their individual restaurant stores from a Yellow Pages 
phone book in the Sacramento area. He proceeded to call the 
store and asked the employee to give him the identification 
numbers on the side of the DiMare Fresh tomato box. The 
information was then given to the general manager at our 
Sacramento location, who then began the traceback of the 
delivery. The individual box was tracked to an order number and 
accompanying PO number, which was tied to our internal repack 
number. From this information, we identified the packer/
shipper, who in turn identified the individual farm and the 
field from which this individual box was harvested. This entire 
process took less than 1 hour to complete.
    We strive and have achieved for tracebacks to be done in 
less than 4 hours each and every time we conduct a mock recall. 
We conduct these mock recalls twice a year in each of our 
repacking locations.
    In conclusion, I want to share the ``proactiveness'' of the 
Florida and California tomato industries with the establishment 
of mandatory food safety programs encompassing farms and 
packing operations of all tomato types. The two states 
represent approximately 80 percent of the total fresh tomatoes 
produced in the United States. The programs are audited by USDA 
and enforced by their respective state agricultural agencies. 
In the case of Florida, the growers unanimously voted in 
support of the mandatory Food Safety Program back in 2006. This 
program became law this past July 1, 2008, and is in place 
today.
    Mr. Chairman, I appreciate the opportunity to share with 
the Committee the rigorous steps and procedures we have 
implemented and practice every day at the DiMare Company. Thank 
you for your time today and the opportunity to discuss these 
issues. Thank you.
    [The prepared statement of Mr. DiMare follows:]

    Prepared Statement of Anthony J. DiMare, Vice President, DiMare
   Homestead Inc., DiMare Ruskin Inc., and DiMare Johns Island Inc.;
  Member, Board of Directors, Florida Fruit & Vegetable Association; 
President, Florida Tomato Exchange; Member, Board of Directors, United 
                 Fresh Produce Association, Ruskin, FL
    Good Morning Chairman Peterson and Committee Members.

    My name is Tony DiMare, and I am Vice President of DiMare Homestead 
and DiMare Ruskin, Inc. The DiMare Company is an 80 year old company 
and the largest vertically integrated tomato company in the United 
States. We are growers, packers, repackers, and distributors of all 
types of fresh tomatoes. Our company has been one of the industry 
leaders and instrumental in helping form Food Safety Guidelines that 
are in place in our industry today. The DiMare Company started a Food 
Safety and HACCP Program as early as 1990 at our Tampa, Florida repack 
facility. Food safety is not new to our company. We then expanded the 
Food Safety Program to the remainder of our growing and packing 
facilities in the mid-1990's.
    I would like to give the Committee an overview and sense of what we 
do as a company to ensure that the products we produce, pack, and 
distribute are handled in the safest possible manner by our stringent 
Food Safety and Food Security Programs we have in place, and our 
ability to positively identify and traceback our products.
    Starting with our farms, we routinely test our irrigation water and 
the water we use for spraying our crops to ensure it is free from 
harmful pathogens. We have invested heavily in some areas, installing 
fences where animal intrusion had been a problem. Our field workers are 
trained prior to the start of each crop season on awareness of food 
safety procedures. They are also educated on proper personal hygiene . 
. . proper hand-washing after restroom use is one example. Our key 
personnel have been educated to identify worker illnesses and health 
issues, such as tuberculosis, and report them immediately to 
management. Our key personnel have also been trained for Food Security 
with special attention to any unusual activities and awareness of any 
unauthorized people coming onto our farms. Everything we do relative to 
food safety is documented and reviewed annually by one or more third-
party auditors. We also conduct self-audits during each crop season and 
document those results; any deficiencies are noted, and corrective 
actions are immediately addressed.
    At our packinghouses, we have worker training sessions prior to the 
start of every season, educating workers on proper personal hygiene, 
including: proper hand-washing, proper use of gloves, smocks, and 
hairnets. The workers are educated to not wear jewelry, have personal 
items, or food or drinks in the work area. There are designated eating 
and drinking areas for all employees. All of these procedures are in 
place to help minimize any possibility of contamination to our food 
products. Any machinery sprays and lubricants are of Food Grade quality 
and MSDS records are kept for these and all other chemicals.
    The water we use to wash and rinse our product in our packinghouses 
is required to be of potable quality and is tested seasonally to ensure 
it is of safe quality. Our product at the packinghouse level typically 
goes through a chlorine bath wash procedure followed by a water rinse, 
and then one final sanitizing rinse before it is quality sorted and 
sized for packaging. We very closely monitor our bath wash water on an 
hourly basis, recording chlorine levels, pH, and the water temperature, 
which are critical for ensuring proper kills of any bacteria or 
pathogens, and prevention of infiltration of these contaminants into 
the tomatoes.
    The containers we harvest in are cleansed with a chlorine wash to 
rid them of any dirt and debris after they have been emptied of 
product, and prior to returning to the farm for harvesting use again. 
The equipment used for packing in all our operations is sanitized 
before the start of each packing day. Swab tests are conducted on the 
equipment twice per season and sent off to an independent lab for 
presence of total coliforms, E. coli, E. coli O157H7, and Salmonella.
    Pest control is another important part of our overall Food Safety 
Program. We have contracted an independent and licensed pest control 
company to manage pest control in all of our packing operations. Traps 
and bait stations are placed around the perimeter of our properties, 
around the perimeter of our buildings, and around the inside of our 
packing facilities. In essence, we have three layers of pest 
protections in place.
    After our product has been packed and readied for shipment, 
independent trucks used for transportation are inspected for 
cleanliness and absence of any foul odors and documented. Temperatures 
are set according to customer requests and temperature recorders are 
placed on every truck to monitor temperature settings during 
transportation. Again, everything we do is documented, and third-party 
audits are conducted annually to ensure we are delivering the most 
wholesome and safest products possible.
    The final process in our Food Safety Program is a Recall and 
Traceback Program. There is a Crisis Management Team in place at every 
level of our operation to act on a recall and quickly and timely 
traceback our product. I will share with the Committee a recent mock 
recall that was conducted July 8, 2008, by one of our repacking 
operations in California during the Salmonella saintpaul outbreak in 
which tomatoes were incorrectly named as the source. Our facility in 
Sacramento, California, was chosen to conduct the mock recall to test 
the ability of industry to effectively conduct traceback and more 
importantly, the timeliness of a recall from an individual quick-serve 
restaurant (QSR) all the way back to the individual farm and specific 
field. Present at the traceback were the Quality Assurance (QA) 
Director of the quick-serve restaurant, a DiMare Company official, 
industry representatives from the California Tomato Farmers and Western 
Growers Association, and several congressional investigators. The 
recall was initiated by the QA Director of the QSR by randomly and 
literally selecting one of their individual restaurant stores from a 
Yellow Pages phone book in the Sacramento area. He proceeded to call 
the store and asked the employee to give him the identification numbers 
on the side of the DiMare Fresh tomato box. The information was then 
given to the general manager at our Sacramento location, who then began 
the traceback of the delivery. The individual box was tracked to an 
order number and accompanying PO number, which was tied to our internal 
repack number. From this information, we identified the packer/shipper, 
who in turn identified the individual farm and field from which this 
individual box was harvested. This entire process took less than 1 hour 
to complete. We strive and have achieved for tracebacks to be done in 
less than 4 hours each and every time we conduct a mock recall. We 
conduct these mock recalls twice a year in each of our repacking 
locations.
    I appreciate the opportunity to share with the Committee the 
rigorous steps and procedures we have implemented and practice every 
day at the DiMare Company.
    Thank you for your time today and the opportunity to discuss these 
issues, Mr. Chairman and Committee Members.

   A Risk Management Program and Self-Audit System are in place 
        to help reduce and eliminate potential exposures.

   Our facilities are registered with the FDA in accordance 
        with the Public Health Security and Bioterrorism Preparedness 
        and Response Act of 2002.

   We have positive lot identification and can traceback our 
        product from retail store or restaurant all the way back to our 
        farms through our internal accounting programs.

   We begin by sourcing from only approved growers and packers, 
        requiring they follow Good Agricultural Practices and that they 
        are audited by third parties.

   All products are obtained by a Purchase Order, which begins 
        the traceability--one step forward and one step back.

   Internal self-audits are conducted monthly at our repack 
        operations and seasonally at our farming and packing operations 
        to help maintain compliance.

   Customers routinely conduct unannounced audits at our 
        repacking facilities to review our Food Safety Programs and 
        verify compliance.

    The Chairman. Thank you, Mr. DiMare. I want to thank again 
the panel for being with us.
    Mr. Keys, how often are your facilities reevaluated for 
equivalency and when the FSIS visits your plants abroad, are 
they scheduled or can they come in any time? Can they just----
    Mr. Keys. Mr. Chairman, FSIS informs AQIS, which is their 
equivalent in Australia, that they are going to come for a 
review of the plants, and then AQIS will pick out of all the 
plants that are certified to export to the United States within 
Australia, they will pick a series of plants to go see. And we 
won't know at any given time when we will be inspected. It will 
be a short period of time. We will know, but we have AQIS 
officials that are in our plants every day. So they see that if 
we are doing something different to get prepared for the 
Americans, of course, they would be wise to that very quickly.
    The Chairman. But before any of these plants can ship, they 
actually get a visit from FSIS before they are certified, 
right?
    Mr. Keys. Well, they have to be certified by the 
Australians to be equivalent----
    The Chairman. Right.
    Mr. Keys.--so then we can ship. It is up to the 
Australians----
    The Chairman. But FSIS doesn't actually come to every 
plant. In some cases they will just take the word of the 
Australians?
    Mr. Keys. Yes, it is the same way when we are exporting a 
United States product to Japan or Korea. They don't certify 
each individual plant.
    The Chairman. Right.
    Mr. Keys. FSIS does that, and then you can ship.
    The Chairman. They have an agreement. Mr. Dever, is it 
Dever?
    Mr. Dever. Dever.
    The Chairman. I am sorry. In the case of the plants that 
are fruits and vegetable plants, does FDA have an equivalent 
system to FSIS in terms of going to each of these plants and 
inspecting them?
    Mr. Dever. No, they do not. We deal typically with the FDA 
who has grade inspections performed by FDA for a product being 
imported from outside the country.
    The Chairman. So FDA goes to these plants?
    Mr. Dever. No, we have FDA actually at the ports of entry 
here in the United States.
    The Chairman. And so in your case, as I understand it, you 
have some kind of agreement with your people that you are 
importing from that they meet some standards that you guys set?
    Mr. Dever. That is correct, yes. We expect equivalency from 
the standards within our organization. We require that of all 
of the----
    The Chairman. And how do you check that?
    Mr. Dever. I am sorry?
    The Chairman. How do you check that? Do you have third-
party audits, do you send your own people down there?
    Mr. Dever. No, we do not require third-party audits. We do 
have people that do go on-site from time to time and check, but 
it is not on a normal basis. It is not something that we do 
typically unless we have a concern that is brought to our 
attention.
    The Chairman. So nobody actually, necessarily, goes and 
visits that plant before they can important into the country?
    Mr. Dever. That is correct.
    The Chairman. You are comfortable with that?
    Mr. Dever. We are comfortable with the Chilean operations 
that occur today, but what we are looking for is more 
equivalency as to the Chilean operations which is where our 
product, primarily, comes from, from South America. What we are 
looking for is from some equivalency of regulations down there 
to ensure the product comes in here that equals ours.
    The Chairman. And they are not equivalent at this point in 
your opinion?
    Mr. Dever. In some cases they are even better than 
equivalent, but it is not as consistent. We are looking for 
consistency throughout----
    The Chairman. So you are talking country by country?
    Mr. Dever. Yes, correct. As an example, in Mexico, we have 
substantially much more FDA inspections done on products coming 
into the United States out of Mexico than we do from South 
America.
    The Chairman. Does FDA currently do anything to ensure that 
there are systems in place in these other countries?
    Mr. Dever. Not to my knowledge.
    The Chairman. No? Are they talking about it?
    Mr. Dever. Not to my knowledge.
    The Chairman. Mr. Keys, we understand that FSIS has a 
multi-layered system for ensuring the safety of imported 
products that determines the equivalence. What are the benefits 
of approaching inspection with a system-based approach like the 
FSIS focusing on the potential importing country and evaluating 
each system as a whole?
    Mr. Keys. We think it is important for consistency, and it 
is two governments working with one another to figure out what 
those points of equivalency are. So we as a company, we of 
course give input and try to work with each one of our 
respective governments to figure out what that equivalency is 
or if we can sustain it in plants. But at the end of the day, 
it is a negotiation and a deal between two sovereign countries 
to decide what is equivalency and then working together.
    They manage that over a continuum, and if you look how long 
Australian product has been coming into the United States, that 
history going back, two governments working together to figure 
out what equivalency means. You have that consistency and 
quality of government-to-government work that really helps 
trade flow and industry to work. And we struggle with that in 
the United States as we work with the Koreans and the Japanese 
on equivalency with their meat inspection systems, or the 
Chinese, back and forth. But it is a process that we believe 
that works well between two governments, not two industries or 
two companies.
    The Chairman. I know I am a little bit over my time, but 
Mr. DiMare and Mr. Dever, why do you think FDA has never done 
this, or why can't they do the same kind of a system that USDA 
does with these other countries? I mean, they don't have the 
resources, or they don't care?
    Mr. Dever. I don't know enough to speculate on why they 
don't. Typically we deal a lot with FDA on grade standards, but 
not a lot with USDA, and why they may be focused on other 
things other than fresh fruit and vegetables.
    The Chairman. Mr. DiMare?
    Mr. DiMare. Yes, Mr. Chairman, I would like to comment on 
that. You know, having gone through the Salmonella saintpaul 
outbreak last year and having FDA officials in both our packing 
operations and repacking operations around the country, in 
talking with some of those folks, they do wish they had more 
presence, particularly in Mexico, but a lack of resources is 
part of the issue. And I know they were a little bit frustrated 
because they don't have personnel down in Mexico to better 
monitor what was going on down there. And I know from speaking 
with some of these folks that when they did go down during this 
whole investigation and conducted inspections for tomatoes at 
the time, before peppers were named, comments were made back to 
me in the area they were investigating that this particular 
area was rich in Salmonella, although it wasn't the Salmonella 
saintpaul strain that they were trying to find.
    I think they would love to have the ability to have more 
oversight and presence, particularly in Latin American 
countries and particularly in Mexico, but, again, the lack of 
resources, from what they have conveyed to me, is part of the 
problem.
    The Chairman. Within the government, and I know I am--if it 
is all right, Mr. Lucas--is there any pressure from the people 
that want to have more trade to try to not get in the way of 
that? In other words, if we put too rigorous a test on things 
that they are going to see that as restraining trade and 
whatever. Is there pressure within the government itself not to 
do this because we are going to somehow or another restrict 
ability of Mexicans to send fruit and vegetables up here?
    Mr. DiMare. In my opinion, I am sure there is some 
sentiment to that. Yes, I am sure there are some people that 
are sensitive to over-regulating and making regulations too 
stringent to obstruct trade. And there is no doubt having again 
gone through this investigation that as soon as Mexico was 
discussed as a possibility that this Salmonella saintpaul might 
have originated from there, the political pressure in Mexico to 
our government in Washington, particularly the State 
Department, was tremendous.
    The Chairman. Yes.
    Mr. DiMare. They are extremely influential and very 
powerful in their lobby, and they put tremendous amount of 
pressure on our government to, in my opinion, to delay part of 
the process because you can't tell me an investigation could 
take 3 months like it did and all of a sudden the State of 
Minnesota Health Department, it was actually your state----
    The Chairman. We are proud of them. They are----
    Mr. DiMare.--was the actual state agency that uncovered the 
Salmonella and indeed traced it back to a distributor in Texas 
who traced it back to two farms in Mexico, for 3 months to 
investigate and looking solely at tomatoes to come to find out 
it was Serrano and jalapeno peppers from Mexico. Something is 
wrong with the system.
    The Chairman. No question about that. Thank you. The 
gentleman from Oklahoma.
    Mr. Lucas. Thank you, Mr. Chairman, and I am pursuing some 
of your thoughts there. Mr. Keys, your company has operations 
in many countries, sells products around the world. So your 
folks have experience in a wide range of food safety food 
regulatory systems.
    Based on your company's experiences, how would you rate the 
United States in comparison to many of these other countries?
    Mr. Keys. On food as it relates to meat, meat inspection, 
which is I guess what we are talking about here. It is the 
standard. People have a lot of trust in FSIS. They look to it 
for answers on how to bring equivalency, and the gold standard 
is to be able to ship fresh meat and poultry into the United 
States, and to do that you have to satisfy the USDA and you 
have to work with the USDA. I think it is important to note 
that just in the last few years, three countries, I am not 
going to name them right here, but three countries voluntarily 
pulled their certification to export to the United States to 
work with FSIS to manage some equivalency problems. And that 
was done without fanfare. It was done very professionally 
between two governments, and I think that is important. It is 
really important to have the governments working, and the 
governments to have equivalency for food safety, so companies 
know where the bright lines are, not only companies that are in 
other countries but ourselves.
    Mr. Lucas. Mr. Dever, in your testimony you state that you 
found that some of the more sophisticated food safety 
operations are found outside of the United States. Would you 
take a moment to expand on that statement and perhaps give us a 
few examples?
    Mr. Dever. There are certain companies and/or countries 
that do have sanitation requirements that I do believe exceed 
what we have here in the United States, from a regulatory 
perspective. There are certain countries that we have done 
business with in the past and continue to do business with 
today that have very detailed, not only requirements related to 
sanitation, but also inspections that are done more so than 
what we do have here.
    Mr. Lucas. Could you give me an example or two of just how 
those systems are more sophisticated?
    Mr. Dever. The requirements are such that in certain areas, 
hair nets will be required in the production of grape packing. 
All of the product will come to one facility rather than packed 
out in the field. They will have lab coats so that everything 
is covered. People will ensure that everyone's hands are washed 
and sanitized at all times, and it will continue through the 
entire packing process in order to ensure that the product 
quality is not contaminated as it is going through the process.
    Mr. Lucas. Now, you have my curiosity. I have to ask 
without naming of all of these potential places, perhaps a 
couple examples of these countries?
    Mr. Dever. I would prefer not to mention them today.
    Mr. Lucas. Okay. You advocate that FDA commencing a rule-
making program to regulate on-farm production practices. Do you 
believe that FDA has the greater expertise and resources to 
regulate farming practices than USDA?
    Mr. Dever. No, sir.
    Mr. Lucas. I am not even going to ask then how you think 
farmers and ranchers would react to such a view. Enough said. 
Thank you, Mr. Chairman.
    The Chairman. I thank the gentleman. Let me look at the 
list here. The gentleman from Georgia, Mr. Scott?
    Mr. Scott. Mr. Chairman, I am going to forego questions on 
this panel in the interest of time, and I will reserve them for 
the next panel.
    The Chairman. The gentleman from Wisconsin, Mr. Kagen.
    Mr. Kagen. Thank you for being here. I appreciate your 
testimony. I had the opportunity to read your prepared comments 
last evening. I don't have too many questions. I want to thank 
Mr. Keys for not renaming the Green Bay Packers after you 
brought the packing facility there in Green Bay. It has a lot 
to do with how we feel about ourselves.
    Is there any way that consumers, when they go to the 
grocery store, can tell where that meat is coming from? Are you 
going to comply with the country of origin labeling?
    Mr. Keys. We are complying with the country of origin 
labeling. I could say right now that the vast majority of the 
beef that we are producing and labeling, we are talking close 
to 90 percent or more, is going to be labeled with an USA 
label. And that is what consumers will see in the stores, will 
be that. That is what we use primarily, what we would call 
label number one or label A.
    Mr. Kagen. And are you inspected in your rendering 
facilities every day?
    Mr. Keys. Do we inspect our rendering----
    Mr. Kagen. You have a rendering facility, and it is being 
inspected every day. Is that true?
    Mr. Keys. Well, the rendering is separate than red meat, 
the meat part of it, but it is run professionally every day by 
our professionals, and it is regulated of course as a feed or 
however the rendered product goes out.
    Mr. Kagen. Would you have any objection, either all three 
of you, of having reports that are made by any inspector at all 
made public on the Internet? Would you have any objection to 
that at all for full transparency?
    Mr. Keys. I think you can get most of the reports that come 
out of USDA now on when we have NR's in our plants and 
noncompliance.
    Mr. Kagen. Have you ever brought to the attention of any of 
the inspectors a problem that they may not have seen that you 
have corrected yourselves?
    Mr. Keys. I don't know that answer, but I could find out 
and get back to you.
    Mr. Kagen. I appreciate it. That is all I have for this 
group. Thank you.
    The Chairman. I thank the gentleman. The gentleman from 
Kansas, Mr. Moran.
    Mr. Moran. Mr. Chairman, thank you very much. Mr. Keys, 
thank you all for your testimony today. My general inquiry is 
just about your recommendations as to what kind of the bottom 
line of what we need to do to improve food safety, and as you 
know, there is a concerted effort on this topic. I am very 
interested in knowing what the industry's kind of best 
suggestion is. It seems to me that you have described a pretty 
robust system, Mr. Keys, but based upon your area, is there 
anything that you would do to recommend improvements?
    Mr. Keys. I am just a lobbyist, not a scientist. But I will 
say I think the elephant in the room here is that there is a 
difference. There is a difference, USDA inspects meat and 
poultry, and FDA inspects everything else. I don't think the 
American public really understands that. And the robustness of 
the inspection service at USDA, it is every carcass, every day. 
It is very robust, not only domestically but as we--you go 
around the world, people look at it as a gold standard if they 
can ship fresh meat or poultry into the United States, fresh, 
frozen or whatever you want to call it, non-cooked. I think 
USDA has a long history here. I don't know enough about FDA. We 
are not regulated by FDA in our company, at any given site. But 
those are the big differences. I don't think we separate these 
things out and look at them in a way that it is meaningful to 
the public so they really understand. They just see it is 
inspected by the government. They don't know the difference 
between USDA and FDA and it never comes out, but that is 
something that maybe this hearing is trying to accomplish and 
good for you all.
    We have a robust system. A lot of people say the law on 
meat inspection developed at the turn of the last century, but 
it is a very robust law with a lot of the power given to the 
Department of Agriculture to do a lot of different things in 
working with the industry on a daily basis, if not constant 
basis, to continue to work to make the products safer and safer 
for the public. And the industry has stepped up to that 
challenge. We certainly could always do more, and we should 
always think about doing more. But we are constantly looking 
for ways to improve our systems in working with USDA to make 
sure that we are doing a better and better job.
    Mr. Moran. Thank you, Mr. Keys. Mr. Dever, you advocate 
that FDA commence a rule-making process to regulate on-farm 
production practices. Why do you believe that FDA has greater 
expertise and resources to regulate farming practices than 
USDA?
    Mr. Dever. Well, from my perspective quite honestly, I am 
looking for a regulatory body. It is more up to Congress to 
decide which is the best regulatory body to do it. So I can 
correct my testimony accordingly, but I am looking for that 
particular fact and we are looking for that kind of regulation.
    Second, is going back to your questions to Mr. Keys. From 
my perspective, the electronic record-keeping is one of the key 
things that we seriously need in this industry that is 
standardized throughout the entire supply chain. What Tony does 
in his company and what Mr. Keys is doing in their company is 
phenomenal, and I can tell you that for the most part, they can 
probably do anything within a matter of minutes and possibly an 
hour.
    But the problem is that if we don't have it through the 
entire supply chain electronically, that is where the need is. 
And a lot of things are still done manually in this industry, 
so I would suggest that.
    And last, the only thing I can say is I now, after 
listening to Mr. Keys, I am planning on having a filet mignon 
tonight for dinner.
    Mr. Moran. As a Kansan, we are delighted at your choice. 
Mr. DiMare, anything you would like to add for those specific 
suggestions?
    Mr. DiMare. I just want to clarify one thing. In the tomato 
industry, USDA's role in our industry, in our operation, is to 
inspect for quality, size, and grade. Now, as I mentioned in my 
testimony, Florida just adopted a mandatory food safety program 
this past July, and part of that program, USDA, under the 
auspices of the State Department of Agriculture in Florida, 
does the actual third-party audits which again is separate from 
quality or grade in the packing house. Same agency, two 
different roles at different times. And this is done now on an 
annual basis. It could be announced or unannounced, and that is 
for both farms and packing operations which is new, which is 
unprecedented in the produce industry. The tomato industry has 
been the leader to implement these programs which again, as I 
stated in my testimony, was unanimously supported by the 
growers. We, the growers, asked that to be mandated for food 
safety. As I said back in 2006, we actually took the vote in 
Florida, the Board of Directors, and it was unanimously passed 
to adopt this.
    So I just wanted to clarify the USDA's role from our 
perspective in the packing houses versus third-party audits as 
far as quality of grade.
    Mr. Moran. Thank you very much. Thank you, Mr. Chairman.
    The Chairman. I thank the gentleman. The gentleman from 
Oregon, Mr. Schrader.
    Mr. Schrader. Thank you, Mr. Chairman. I guess I would ask 
for the panel's comment, would enhanced regulation, as we are 
talking about here, really stop the absolute bad characters 
like we have seen in this most recent peanut butter fiasco? One 
person deliberately obstructs and has no intention of applying 
to any of the regulation. Any of the panelists? Just a real 
quick no, yes down the line.
    Mr. Keys. I would just tell you, the number one priority in 
our company, before anything, is food safety followed by worker 
safety. And our reputation is what we have to stand on. 
Regulations by and of themselves are not going to make us good 
players, so we constantly work on that. You know, we have built 
a culture in our company to work on these issues, and maybe 
some people don't have that culture, but I am not going to talk 
about them. I can only talk about us.
    Mr. Schrader. Fair enough. Mr. Dever?
    Mr. Dever. Yes, if you look from Pandol's perspective, you 
look in our written testimony, it refers to how we still have 
to count on the integrity of the people we are doing business 
with. No matter how much regulation that we instill on the 
industry, at the end of the day, if somebody intentionally goes 
to harm another human being, I don't think regulation is going 
to avoid that.
    Mr. Schrader. Thank you.
    Mr. DiMare. And I agree. You know, the liability factor, if 
you look at some of the companies that have been implicated in 
the meat industry, Cornett Foods about 6 or 7 years ago in West 
Virginia, had stores in Pennsylvania that had contaminated Roma 
tomatoes. It broke Cornett Foods. Do we as an individual 
company or industry want to take that risk because in today's 
world, all that it takes is one incident with gross negligence. 
From what I can see on the surface knowing the food industry 
and watching the news media over the peanut butter situation, 
there is no doubt there was gross negligence going on. Just 
look at the physical facility.
    Mr. Schrader. My time is running out, if I may. I 
appreciate that, and that is an important point.
    Mr. DiMare. Mr. Chairman, if I may, this is a commodity-
specific Food Safety Guidelines that we developed in the tomato 
industry, and if the Chairman wishes, I would like to submit 
it.
    The Chairman. Without objection, that will be made part of 
the record.
    [The information is located on p. 87.]
    Mr. DiMare. Thank you. And we can get one to all Committee 
Members if so----
    The Chairman. That would be good if you could make those 
available.
    Mr. Schrader. Mr. Keys has talked several times about 
USDA's process being the gold standard by which much of the 
world tries to emulate the United States' inspection process. 
Mr. Dever and Mr. DiMare, would you say that FDA standards are 
the gold standard also with produce and inspection?
    Mr. Dever. Once again, from our perspective, we deal with 
FDA inspectors most of the time, so those are the people that 
we do a lot of business with. We don't with the other party. I 
can't answer the question from that perspective.
    Mr. Schrader. All right.
    Mr. DiMare. And from our perspective, USDA does not have 
oversight of what we do on a daily basis, FDA does.
    Mr. Schrader. That is fair enough. There has been a lot of 
talk from the panel as far as equivalency being the gold 
standard, also, that really helps any company deal with at 
least a consistent set of regulations. Does the panel have any 
opinion about FDA's equivalency versus the FDA's equivalency 
procedures?
    Mr. Keys. I would just say equivalency, if you really study 
it and you look at it, how you get governments to buy in with 
other governments and work things out, that is the beauty of 
equivalency, government-to-government equivalency because it 
makes them part of the process in getting it to an end goal. If 
you don't have that, then government is in, government is out, 
and you never know where the steady line is so you can produce 
for that marketplace, and that is the important thing about 
equivalency.
    Mr. Dever. I would agree with that. We export to 24 
different countries, and we import from a number of different 
countries, and for us, if it was a global specification if you 
will, it would make it much better for the global industry from 
a food safety perspective.
    So we are looking for countries to work together within the 
government regulatory bodies because we cannot as producers, we 
can't be expected nor can we afford to go and inspect every 
facility in every country that we do business with. It is 
impossible. So we have to count on countries developing the 
right equivalent standards so that we can count on that and 
have certifications if necessary. But that is the extent of it 
from my perspective.
    Mr. Schrader. Last question. My time is actually running 
out. It has just come to my attention as a consumer and as a 
farmer, a person that spent some time in our state legislative 
situation that a lot of the problems that we are dealing with 
come from foreign countries where there is this inconsistency 
that the panel has talked about. That it is sometimes lost upon 
a great many Americans, that the fact that we catch a lot of 
the issues that we do catch in this country before they get out 
of hand is sometimes a testament to some of the inspection 
processes we already have in place that have stood the test of 
time, and in some cases are the gold standard. And while we can 
always improve them, and some of the improvements that have 
been suggested here today I am sure we will incorporate, I 
think Americans have to remember we have the safest food on the 
planet, we should feel lucky that way.
    Thank you, Mr. Chairman. I yield back.
    The Chairman. I thank the gentleman. The gentlelady from 
Wyoming, Mrs. Lummis?
    Mrs. Lummis. Thank you, Mr. Chairman. My first question is 
for Mr. Dever. What regulations are required to equalize the 
playing field? You mentioned that term in your testimony.
    Mr. Dever. We are looking for regulations for the entire 
supply chain. So that starts at the farm, goes through the 
packing houses and the transportation for the product, and how 
it is both harvested, grown, and also transported.
    Mrs. Lummis. Thank you. Mr. Keys, a question for you. Do 
you think the FSIS needs any additional funding or manpower, 
legislative authority, to make the process of importing, 
particularly Australian beef, any safer?
    Mr. Keys. Well, we think Australian beef is very safe 
because of the equivalency process that we have been going 
over. Look, I am not an FSIS employee. I am sure if I asked 
them in the back here they would certainly love more money. I 
am sure that probably wouldn't be a problem. But, more 
importantly, with the FSIS, is that the structure of their 
regulatory regime is very important, and to understand that and 
for them to work with industry to continue to modify it. I 
mean, E. coli took us from looking at every carcass every day 
to looking at the carcass basically through a microscope. And 
that whole transformation was done without new legislation. It 
was done within the guidelines of the current laws on the 
books.
    So there is a lot of flexibility there in the law to get to 
the main point which is to provide a safe and wholesome product 
for the consumer, no matter if it comes from in the United 
States or it is imported from a foreign country. It has to meet 
that standard, the same way when we ship product, our beef, to 
Japan, Korea, and our main export markets, Mexico, Canada, is 
that we have to work with those countries to get their 
equivalencies down right.
    So it is all a give and take, and if we try to do something 
a little sly or silly, we can bet that people in other 
countries that we are exporting beef to would do the same sly 
and silly thing. So what goes around comes around as my 
grandmother said.
    Mrs. Lummis. Okay. Thank you for your answer. I have 
another question for you. Now I am going to ask you to put on a 
hat that you are not currently wearing. Obviously JBS is about 
as far as you could get from the very small cow/calf operator 
or rancher/farmer in the United States, but could you talk 
about the perspective of a small rancher or processor? Do you 
think that they could continue to operate under the on-farm 
regulatory regime that has been contemplated by some of the 
proposed legislation?
    Mr. Keys. I grew up on one of those small operations, so I 
understand this. And what I think is always--to understand the 
beef industry, the cow/calf industry, is that it is 70 percent 
of our producers control 30 percent of our production in cow/
calf. So you have a lot of small, part-time guys who do this. 
And if they feel at any given point in time that it is more 
trouble to raise that animal than it is worth, based on their 
time, effort, place in the food chain, they will just quit it. 
And I think you are seeing that right now. The cow herding in 
the United States is going down at the same time that globally, 
the demand for beef is going up. And a lot of it is land cost, 
it is demographics, but it could also become heavily regulatory 
burdens on small cow/calf producers that just say enough of 
that. I am not going to do that. I am going to grow wheat or 
whatever they want to do.
    So I think that is an important balance to always watch.
    Mrs. Lummis. The last number that I was aware of is that we 
have 1.2 million ranchers. There are now less than 900,000, and 
they are declining. And if you have a specific number that is 
more current than mine, I would love to see it.
    Mr. Keys. Well, I don't have it right now, but I will get 
that to you.
    Mrs. Lummis. Thank you. Mr. DiMare, could you tell me, is 
there anything a Federal agency could do to help bolster your 
safety protocols that are already in place, or do you feel that 
they are adequate as is?
    Mr. DiMare. I don't believe there is because again, this 
document here was a creation from all stakeholders, from 
producers to users, to government regulators within FDA, 
scientists. The work has already been done in the tomato 
industry and put into this document from all these people, and 
we are currently revising and creating a new matrix for the 
tomato industry. It will be the first, again, commodity in 
produce that--I don't know when it is going to be done because 
we are right in the midst of it right now--that addresses every 
operation in the tomato chain from the farm all the way to the 
quick-serve restaurant, and the responsibilities at each one of 
those facets relative to food safety. We are doing it, we have 
been doing it.
    Mrs. Lummis. Thank you, Mr. DiMare. My time is up, but I 
want to thank you all for being here today, and I am hopeful 
that the best practices that you are instituting in the tomato 
industry will be shared among other commodities. Thank you, Mr. 
Chairman.
    The Chairman. I thank the gentlelady. The gentleman from 
New York, Mr. Massa.
    Mr. Massa. Thank you, Mr. Chairman, and thank you for the 
work you do in the private sector to secure the end product of 
what so many farmers try to get to the table. I have a lot of 
experience in supermarkets and not much on ranches. So I end up 
like most consumers seeing the end-product of their efforts. 
However, as we compare the oversight responsibilities of these 
two major government institutions, my concerns and focus are 
not necessarily about what is happening here in the United 
States but rather the food safety and jurisdiction requirements 
of our overseas imports. We have members here on the panel who 
have significant overseas interests in grapes and beef, and I 
know that countries, specifically in Latin America, still use 
pesticides that are banned by regimes in this nation and we 
still import that food. And I know there are practices overseas 
in the beef industry that frankly are not conducted here.
    And so my question to both of you today, if I might, could 
you please give us some insight as to how the United States, 
with its heavy, new importation of food, can move through these 
agencies to further secure our food safety? That really is one 
of the most critical issues we are going to be facing in the 
future. Mr. Keys?
    Mr. Keys. Thank you. The equivalency to ship fresh meat, 
fresh frozen meat, into the United States from foreign 
countries, there are only a few foreign countries that actually 
can ship here, that are certified to do so. The rigor that they 
have to go through to get that product in a container and get 
it to the United States is very robust, all the way to the 
point where USDA has a residue program to test for residues, 
chemical residues, drug residues, in all this product. And they 
do it not only for foreign product coming in but also domestic 
programs. FSIS runs a residue program. So the rigor that USDA 
has put into this system over the years on meat and poultry--
and that is by the way the only thing they do regulate on the 
food side--we believe is very robust. And they are always 
looking for ways to make it better, and we just went through a 
big reclassification on how imported countries have to test for 
E. coli. And the Australians, New Zealanders, Uruguay, 
Nicaragua, all the countries, Mexico, Canada, they all came to 
Washington, worked with the USDA, came up with a regime for 
testing for E. coli in a better, more robust way.
    And so you see those type of activities happening all the 
time at USDA because they are actively involved with their 
counterparts. That is the important link with equivalency with 
foreign countries when foreign meat and poultry comes into the 
United States.
    Mr. Massa. Thank you, sir. And with respect to grapes and 
agricultural products, this is something that we have a 
significant focus on in my district, and I would like your 
insight, specifically, for instance, Chile.
    Mr. Dever. We are looking at that all of the time because 
one of the problems that we do have in this industry is the 
equivalency portion, as we have talked about quite a bit 
throughout this hearing. Down in South America in numerous 
countries, including Chile, you have a lot of people that are 
implementing a lot of good safety regulations themselves, but 
that is by the industry, and the Chilean Fresh Fruit 
Association is doing a wonderful job, in particular, at 
spreading the word as to what is to go on down there in helping 
the people improve that aren't doing a good job. We have the 
same situation here in the United States, but from Chile's 
perspective, what we are looking for is we are trying to get as 
much assurance as possible and we want to deal with the Chilean 
Government to ensure that they understand what the requirements 
are here for safe product through the entire supply chain, and 
we are looking for that going down to the smallest grower. And 
whether it be in the United States or Chile or Argentina, I 
can't say--if anybody asked me today, can we be sure 100 
percent that everybody is complying with that, I can't say that 
today.
    Mr. Massa. But you would concur that the entire regime is 
built largely on one of trusting the foreign governments' 
certification of their systems?
    Mr. Dever. That is correct.
    Mr. Massa. With respect to beef, would you agree that we 
are relying heavily on the foreign governments' certification 
of their inspection regime?
    Mr. Keys. No, I would say it is sort of an equivalency. We 
sign off, FSIS signs off, so they can say yes, this is what we 
are going to do----
    Mr. Massa. But they are not----
    Mr. Keys.--and FSIS can say, well, no that is not good 
enough. You have to----
    Mr. Massa. But they are not American inspectors.
    Mr. Keys. But we go and audit every year. We send teams 
over there. It is a very rigorous program. There are only a few 
countries that qualify to ship beef and ship red meat to the 
United States and poultry.
    Mr. Massa. Thank you both very much. Mr. Chairman, I yield 
back. Thank you.
    The Chairman. I thank the gentleman. The gentleman from 
Nebraska is recognized. Pass? The gentleman from California, 
Mr. Costa?
    Mr. Costa. Thank you very much, Mr. Chairman, for this very 
timely hearing and for your efforts in working with myself and 
others on food safety efforts. As many of you know, I represent 
the highly diversified area in the San Joaquin Valley in which 
agriculture is the number one industry, and food safety is 
always job number one. I am also pleased that Mr. Dever from 
the Pandol family, an immigrant family from Croatia that has 
farmed in the San Joaquin Valley for generations now and is 
part of this panel, and Mr. DiMare whose family I have known 
for years as well. Good witnesses, Mr. Keys as well.
    I want to go through a quick list of questions because I 
have introduced legislation that I would invite all the Members 
to look at. Congressman Putnam and I, a bipartisan effort to 
truly try to develop, one, a gold standard and uniformity 
across the country as it relates to food safety, but first, 
when we talk about the overlapping myriad of regulations and 
issues it is important to know that--raise your hands when I 
ask you the following questions if you are doing it. Do you 
currently operate under food safety standards imposed by the 
USDA or the FDA? USDA?
    Mr. Keys. USDA.
    Mr. Costa. Okay.
    Mr. DiMare. Well, again, the Florida Tomato Industry 
developed their own food safety----
    Mr. Costa. No, I know that. I want to quickly--my time is 
limited. Yes or no.
    Mr. DiMare. No.
    Mr. Costa. No? Okay. Or is it a combination in any cases? 
Mr. Dever?
    Mr. Dever. It can be a combination, but primarily FDA.
    Mr. Costa. Okay. How many of you currently follow a 
hazardous analysis critical control plan, otherwise known as a 
HACCP? Okay. How many of you are currently following good 
agricultural practices, otherwise known as GAPs? You all follow 
which we like to refer to as a gold standard, right? How can 
you discuss differences between the HACCP and the GAPs and do 
you believe that safety on the field requires a different 
approach to those that are in the--where we do the value-added 
and the processing facilities? Yes, Mr. DiMare?
    Mr. DiMare. There are some variances between the two, 
between the farms and packaging.
    Mr. Costa. And we have to take those into account, correct?
    Mr. Dever. In most cases, we follow GAP in fields. We have 
internal GAP as well as regular, but over and above that you 
also follow good manufacturing practices when it comes to some 
of the processing of product.
    Mr. Costa. Which brings me to my next question. How many of 
you follow additional food safety requirements not required by 
law but are part of your marketing orders, part of agreements 
that you have with co-ops or farmer-collective operations? All 
of you do, which never gets taken into account when people are 
looking at the food safety issues, right?
    Mr. Dever. Correct.
    Mr. Costa. It is my understanding, and this is probably 
with Mr. Dever and Mr. DiMare--I don't know, Mr. Keys if it 
would apply to you--as we talk about our efforts to improve the 
GAPs--standards in food safety, do you support a mandatory 
commodity-specific, risk-based regulation effort and guidelines 
to fill in the holes and to create the greater confidence that 
we need among American consumers?
    Mr. Dever. Yes.
    Mr. Costa. Do you support the Safe FEAST Act? Yes?
    Mr. Dever. Yes.
    Mr. Costa. Thank you. Mr. DiMare, and I think this is 
really at the heart of the traceability program and we knew 
what happened with the tomato market last summer because of the 
scare that ended up being jalapeno peppers imported from 
Mexico. But, you mentioned your initiative in Florida and the 
guidelines of the programs that were developed in conjunction 
with the FDA, is that correct?
    Mr. DiMare. That is correct.
    Mr. Costa. And the enforcement or the audits were in 
conjunction with the FDA as well? Or the USDA? They were done 
by the USDA?
    Mr. DiMare. FDA.
    Mr. Costa. Okay. Do you think that system is effective?
    Mr. DiMare. Pardon?
    Mr. Costa. Do you think that system is effective?
    Mr. DiMare. I think it is very effective.
    Mr. Costa. Because I was wondering whether or not you can 
promulgate a system in which the FDA promulgates the 
regulations and then the USDA does the administration because a 
lot of the different food safety proposals that are out there 
want to know whether or not or how you are going to be able to 
do this as we look at developing a new food safety program.
    Mr. DiMare. Well, I just want to comment in going back to 
the investigation. I will give you a little example what 
happened with us. In our Houston facility, we had folks come in 
from FDA that came in from the drug side that had no experience 
in the produce industry in conducting these actual 
investigation, with no knowledge of produce. I think that is 
just absolutely ludicrous that in today's society with a 
regulating agency that they send in people that have no 
experience investigating something that was so serious. I think 
that is a serious problem. That needs to be looked at.
    Mr. Costa. Well, my time has expired here, but Mr. 
Chairman, can I finish this? Thank you. So you think it is 
possible then for the FDA to work on the science and then the 
USDA to work with other efforts especially when we talk about 
imported foods to in effect be the foot boots on the ground to 
provide the enforcement?
    Mr. DiMare. I think it is possible as long as both agencies 
are willing to work together.
    Mr. Costa. Under the category of not wanting to reinvent 
the wheel, I would like, at least, Mr. DiMare and Mr. Dever to 
talk about the traceability program because we have witnessed 
it just in the random sampling right now with the pistachio 
issue here in the last few days. But in the tomato industry, we 
have taken people of the Energy and Commerce Committee out to 
California, and we had a random sample that I am aware of in 
which they tried to pick five different farms. And the earliest 
they could traceback the sampling was within a \1/2\ an hour to 
the farm. The longest took 5\1/5\ hours, and that was because 
the farmer was a single operator. He was gone from the farm, 
and there was a message on his phone. When he got to his phone, 
he checked it and he called back. But the traceability factor 
is a critical part in terms of best management practices.
    Mr. Dever. I fully agree from Pandol's perspective. We are 
also on the Produce Traceability Initiative put together by the 
three industry associations that was mentioned in my testimony.
    We are very much involved in traceability, and that is one 
reason why we do believe electronic record-keeping is important 
because we do mock recalls continuously. We fortunately have 
not had the experience to date of having to use it in real life 
like Tony has. You know, grapes so far have been off of the hit 
list, and we are very fortunate for that, and I suggest 
everybody go and buy a couple pounds this afternoon. But to 
your point, traceability is extremely key to minimizing the 
damage that is caused when an incident occurs. And if you have 
the right traceability in place, it solves many of the 
problems, rather than a shotgun approach that has been used in 
other commodities that I have seen recently. Once again, we 
have not experienced that ourselves. It is just what we see in 
the industry. But from our perspective, traceability is it. And 
for the most part, the people that are in this business, if 
they don't have a good traceability program, they won't be in 
the business for very long. I mean, it is crucial to our 
industry and it is crucial to the consumer to be able to trace 
the product.
    Last, we are the ones that suffer the most if we can't do 
it because it puts us out of business. I don't know how much 
money Tony lost in the last tomato recall, but a lot of 
companies wouldn't have survived that.
    Mr. Costa. To that point, and I know all the Members of 
this Committee understand that because of their own 
representation in their own districts, but I try to explain to 
people when we are talking about food safety, the farmers first 
of all consume the products they grow. So they don't want to 
have products that potentially may be contaminated and neither 
do their neighbors and their friends. Number two, they have an 
economic interest because if you have a contamination scare, I 
mean, the bottom drops out of the market. So it is in this 
industry's interest, and a lot has changed in 20 years in our 
ability in best sciences. But, frankly, the industry really, I 
think, wants to come together. That is why we have broad 
support for our legislation and others as we try to use best 
management practices based on risk assessment and risk 
management, and how we can assure the American consuming public 
that we grow the absolute best food in the world. That those 
same standards are required for food that is imported to the 
United States, that it is not two standards but it is the same 
standard, the gold standard, which is what we are trying to 
achieve.
    Mr. Dever. And we applaud you for that.
    Mr. Costa. I have gone way past my time, and the Chairman 
has been very generous. Thank you. But just for the----
    The Chairman. I thank the gentleman. Pardon?
    Mr. Costa. I don't know if they want to comment. Both the 
other two gentlemen deal in other parts of the world, and if we 
are talking about how you establish a gold standard, at some 
point in time, I think it would be interesting for the 
Committee to know, based upon their experiences in South 
America and other places where they grow food, what lessons we 
can learn or what should be the very best standards.
    The Chairman. I think we covered that a little bit when you 
were out, but you are right on. We appreciate your leadership 
and the work that you have done on this issue, Mr. Costa. I 
look forward to working with you. The gentleman from----
    Mr. Costa. I thank the Chairman for coauthoring my bill.
    The Chairman. The gentleman from California, Mr. Baca.
    Mr. Baca. Thank you very much, Mr. Chairman. Just to follow 
up on what Mr. Costa has just said, and the question I guess 
would go for Tony DiMare. If you can elaborate a little bit 
more on how to ensure proper traceability when a crisis hits so 
that another industry does not have to go through what the 
tomato industry did, to receive false blame for the outbreak? 
Would you elaborate a little bit more on that?
    Mr. DiMare. I guess we are fortunate in the tomato industry 
we do have the ability to identify products that we ship out 
into the marketplace, which is really a tool to help, not only 
identify what your product is or where the origin is, but God 
forbid you have an issue you need to investigate and quickly 
traceback the product, you do have the ability, either through 
labeling or otherwise on the package or even the specific 
commodity to trace it back and identify where that product came 
from.
    Mr. Baca. Because now we are getting a lot of tomatoes from 
Mexico, and a lot of people don't even know that we are getting 
a lot of tomatoes. And the pesticides, the requirements, and 
the safeties are not there in comparison to those of you here 
in the United States, is that correct?
    Mr. DiMare. That is correct, and that is part of the 
challenge with country of origin labeling that has just been 
passed. You know, that is again a tool to help identify, for 
consumers, where products are coming from because there are a 
lot of products that come in from outside the United States.
    Mr. Baca. Mr. Dever, could you please give us a little bit 
more details of the Trace Recall Program?
    Mr. Dever. Specifically to Pandol's Trace Recall Program?
    Mr. Baca. Yes.
    Mr. Dever. What we do is we have a mock recall that is done 
every couple of weeks that comes through. We hire an 
independent third party facilitator to assist with that, and 
that comes into our corporate office with a phone call that 
says there is a problem. And then it goes through to the supply 
chain down to the grower that grew the product, as well as 
which ranch that product came from as well as the block that 
that product came from We typically can do that anywhere--the 
best we have been to date has been about 45 minutes, and the 
worst we have been has been about 6 hours.
    Mr. Baca. How effective is it when needed and do you think 
this is something that we can apply to the Federal level?
    Mr. Dever. Well, it is effective and I think it is 
beneficial for us to do it, so in case we do have that one 
incident where there is a problem, we are able to trace it. I 
can tell you, to give you an example, there was recently this 
season a call in to our office that was real life, that there 
was a black widow spider found in a bag of grapes. We 
identified within approximately 45 minutes that that bag did 
not come from our company. If we didn't have the ability to 
know that, that could have been a huge problem for us.
    So I think it is extremely beneficial for all corporations 
to have the ability to traceback that product, and also it 
helped the consumer know very quickly where that product came 
from and be able to deal with it.
    Mr. Baca. Thank you. In your opinion, how critical is that 
electronic record-keeping and food safety procedures?
    Mr. Dever. I think it is very critical because if it is 
done on a manual basis, it takes too much time. Time is money 
in this industry, and time is health to the consumer. Every day 
that goes by that we haven't identified the contaminated 
product and the source of that contaminated product, another 
person can have a health issue and/or more of the industry gets 
hurt from the instance. So to me it is key.
    Mr. Baca. Thank you. I yield back the balance of my time.
    Mr. Scott [presiding.] The gentlelady from Pennsylvania, 
Mrs. Dahlkemper.
    Mrs. Dahlkemper. Thank you, Mr. Chairman. Since I just came 
in and I haven't really heard all the questions, I am going to 
yield back.
    Mr. Scott. All right. The gentlelady from Colorado.
    Ms. Markey. Yes, thank you very much. I also knew I had a 
markup in another Committee, but Mr. Keys, as you mentioned in 
your testimony you are headquartered in Greeley, Colorado, 
which is in my district. I can tell you I have had an extensive 
tour of JBS' facility in Greeley and met with several USDA 
inspectors there and can attest to the vigorous control 
standards that are in place at that facility. So I look forward 
to going on another tour, that was a couple of years ago, and 
working with you.
    But I wanted to also ask the panel, how do you verify that 
your suppliers are also falling under compliance and have you 
ever dropped a supplier that you used because of noncompliance? 
And you may want to answer that Mr. Dever.
    Mr. Dever. It depends greatly on the source of the product, 
but in most cases all of our contracts with our growers--we 
don't have a lot of growers, first of all. So it is easier for 
us, but for the most part in our industry, we have contracts 
with growers that require this and also there is a lot of 
testing that is done at pre-harvest to understand the pesticide 
levels that are on the products prior to them being harvested.
    We also have independent audits that will be done from time 
to time to give us the assurance, make sure that people are 
complying. To date we have not had a grower that had to be 
eliminated from our source because of noncompliance.
    Ms. Markey. Thank you very much.
    Mr. Keys. USDA regulates right to the consumer, so if 
anybody takes our product and does something else with it, they 
have to answer to the government. We try to work with the 
people we sell our beef, pork, and lamb to, to make sure if 
they need expertise or they need help figuring out HACCP 
programs, we will work with them and we like to do that. But 
the USDA has that responsibility all the way to the consumer as 
it relates to red meat and poultry.
    Ms. Markey. Thank you, Mr. Keys. Thank you, Mr. Chairman.
    Mr. Scott. Thank you. The gentleman from North Carolina, 
Mr. Kissell.
    Mr. Kissell. Thank you, Mr. Chairman. Thank you, panel, for 
being here. I am going to pull back a little bit from some of 
the more specific questions, and I am looking for a general 
overview. And this is to each of the people on the panel if you 
could answer. In your opinions, what are the top two weakest 
points, the weakest links, in food safety? Is it the farmers, 
is it the processing, is it being able to follow the goods, is 
it imports, pesticides, regulations, lack of regulations? What 
are the top two biggest threats to food safety as you see them?
    Mr. Keys. That is 50,000 feet. I will give you what it is. 
I think it is the lack of willingness of governments around the 
world, using the WTO, the Codex, to come up with some kind of a 
standardization of sanitary, globally. I know it is tough, but 
a lot of countries, including our own, Europe, Japan, use non-
tariff trade barriers for phyto-sanitary reasons. And they do 
it for protectionist reasons, and that is a big problem because 
it confuses the public in a general term on what is science and 
what is not science and how do you cut through it when you know 
the government is using a science issue to stop trade. I think 
that really slows us down in getting to true equivalency around 
the world on trade.
    And then the number two issue would be making sure that we 
have the research dollars, infrastructure dollars going into 
critical research facilities at USDA or in the land-grant 
university to continue to look for ways to improve our food 
safety system, and then getting that technology out on the 
field and implementing it.
    Mr. Dever. Going back to the original testimony, I do think 
consistency throughout the globe is the critical thing for us. 
Food now is global. All of our sources come from around the 
world in order to be a year-round supplier of produce. As such, 
we would like to see the other countries that grow our products 
be held to the same equivalency and be consistent within the 
grower base, first of all. Second of all, I would like to see 
an electronic, as mentioned previously, traceability initiative 
that allows us to be able to trace that product to a grower, 
any country where they happen to be where that product was 
grown at any point in time. But that all costs money, and we 
are looking for support to have that happen.
    Mr. DiMare. If you again take the tomato industry as a 
model of what we have developed over years of collaboration 
between all stakeholders and the success that we have had, 
maybe it is something to consider across other commodity groups 
is to have a document such as this that addresses the whole 
food chain from farm to the end-user to make sure the best 
management practices, good agricultural practices, are adhered 
to and that there are third-party audits that are conducted to 
make sure.
    None of this is a guarantee. There is always going to be 
risk in our food chain because there are many different factors 
that play into it. But what we can do as an industry is to 
continue to address any of the gaps, try to close those gaps 
within the operation or individual company and look to prevent 
them in the future by good management practices.
    Mr. Kissell. Thank you, Mr. Chairman.
    Mr. Scott. The gentleman from Ohio, Mr. Boccieri.
    Mr. Boccieri. Thank you, Mr. Chairman. One quick question I 
just have. How often or frequent are the containers that come 
into the country from overseas inspected? Is there any data out 
there that shows the frequency?
    Mr. Keys. I can get that for you, Congressman. A lot 
depends on your track record. I mean, if you have a plant that 
is not going well and FSIS gets onto it, every container. And 
they are pretty rough on it, rough on you when you have a 
residue or you have some paperwork, literally paperwork, that 
doesn't line up, they will inspect you very hard. So there is a 
huge incentive to be a good actor and have all your ducks in a 
row.
    Mr. Boccieri. Those are the containers that are coming in 
from the ports, ships, and the like?
    Mr. Keys. Yes. Yes.
    Mr. Boccieri. Okay. Thank you, Mr. Chairman. I will yield 
back.
    Mr. Scott. Thank you very much. I believe we have 
relinquished all of our questions for this panel. I want to 
thank this panel. Thank you for your expert testimonies, it is 
very appreciated. We will now have the second panel.
    Kind of ease your conversations out into the hallway so we 
can begin our second panel. Thank you very much. We will 
introduce our second panel, which was our third panel, but we 
will make it our second panel now. First we have Dr. Elsa A. 
Murano, President of Texas A&M University, College Station, 
Texas. Thank you very much for coming, Dr. Murano. Next we have 
Mr. Michael Taylor, Research Professor, Department of Health 
Policy, George Washington University School of Public Health 
and Health Services, Washington, D.C. Thank you for being here 
with us. Then we have Ms. Carol Tucker-Foreman. Ms. Tucker-
Foreman is Distinguished Fellow, The Food Policy Institute, 
Consumer Federation of America, Chevy Chase, Maryland.
    Thank you all for coming. We are delighted to have you, and 
Dr. Murano, we will begin with you.

   STATEMENT OF ELSA A. MURANO, Ph.D., PRESIDENT, TEXAS A&M 
                UNIVERSITY, COLLEGE STATION, TX

    Dr. Murano. Thank you, Mr. Chairman. My name is Elsa 
Murano, and I am currently the President of Texas A&M 
University, the best university in the country. From October of 
2001 to December of 2004, I had the tremendous privilege, Mr. 
Chairman, of serving the American people as Under Secretary for 
Food Safety at the U.S. Department of Agriculture. I have had a 
long career as a food microbiologist, a teacher, and as a 
research scientist working on many of the issues in the 
laboratory that I then became familiar with as a regulator 
later on while I served as Under Secretary.
    I served as the first food microbiologist to take the 
position of Under Secretary, so I felt had a special 
responsibility and certainly an opportunity to inject science 
into the policy of food safety.
    But as I began my tenure as Under Secretary, I soon learned 
that what happens in the laboratory is very different than what 
happens in the real world. You have crises that happen that 
frankly don't like to wait for laboratory results to come in.
    We had in 2002 what we later referred to as the perfect 
storm, Mr. Chairman. We had two very large outbreaks of 
foodborne illness, one involving E. coli O157:H7 in ground beef 
which resulted in a very large recall of ground beef product, 
about 19 million pounds at the time, and then very soon after 
that, there was another incident of foodborne illness due to 
listeriosis, and that was involving deli meats and that totaled 
about 28 million pounds. It was a perfect storm because it 
showed that when things go bad, a lot of things can go bad at 
the same time, and it really indicated to me that we needed to 
roll up our sleeves in a very deliberate manner and get to work 
on addressing the underlying reasons why these outbreaks and 
recalls happened. And by the way, 2002 was not the only year. 
It had been happening for about a decade, almost on an annual 
basis.
    So that situation really became an opportunity, to be 
honest with you, even though it was a trying time it was an 
opportunity to assess the case of these outbreaks and recalls. 
And what we came down to, really, is two issues, a human factor 
issue and a science issue, and let me explain. People can make 
a tremendous difference. At USDA, Food Safety and Inspection 
Service has about 8,000 inspectors at our at 6,500 meat and 
poultry processing plants every day, and as you can imagine, 
there is a lot of product that is under their jurisdiction, 
about 110 billion pounds, plus another 10 billion pounds of 
imported product every year.
    So, it became evident to me that we needed to make sure 
these people, these 8,000 strong needed to be trained in a 
different way, needed to receive the kind of training that 
would help them know the science behind food safety, behind the 
regulations that they were enforcing, behind their inspection 
practices, if you will. So, that they would know and be able to 
discern better what was going on in the plants, so that they 
could actually pick up on problems before they happened.
    So what we did is we launched a Food Safety Regulatory 
Essentials program that trained our inspectors on how to verify 
that food safety systems were working based on science.
    We also established an Office of Program Evaluation, 
Enforcement and Review, that would help supervise those 
inspectors because when you have people, you have to have 
supervision and accountability, and also we created a new class 
of inspector, the Enforcement Investigations and Analysis 
Officer. These would be super-experts, if you will, that would 
go into plants that had problems or that had a history, a track 
record of failures that we would be able to then identify the 
problems before they got to develop into an outbreak or a large 
recall.
    But the human factor, of course, also involves the plant 
operators themselves. It is not just left to the inspectors. 
And the plants had been left, frankly, in my opinion, largely 
to their own devices to implement HACCP, which is really the 
food safety prevention program FSIS had been operating under 
for several years. They were left to implement that system 
basically up to their own judgment.
    And what we found is that when we ordered reassessment of 
their HACCP plans, there was a lot of mistakes, frankly, in my 
opinion, that had been made, lack of assessing the risks 
properly. And if you think there is not a risk due to a certain 
pathogen, perhaps deeming it not likely to be present, then you 
are not going to do anything about it.
    So the first step in assessing the risk, the likelihood of 
that pathogen being in the food, is the first step that has to 
be done right. That analysis has to be done correctly.
    So to make a long story short, in ordering these 
reassessments of these plants in 2002, 62 percent of these 
operations changed their plans as a result, and 60 percent of 
them started to include E. coli O157:H7 as a hazard reasonably 
likely to occur. So that was a dramatic change in the human 
factor that was operating those plants. And of course, the 
training that we undertook, the education I should say of 
consumers, because they certainly have a role to play as well 
in terms of good, safe food handling practices, cooking 
practices and so forth which culminated in the launching of----
    Mr. Scott. Thank you, Dr. Murano. We are going to ask you 
to kind of wrap it up just a bit, please.
    Dr. Murano. Yes, sir.
    Mr. Scott. Thank you.
    Dr. Murano. I will tell you very quickly that the second 
element, that of science, became very important as well, and 
the science of risk assessment is what really made a big 
difference for us to develop policies and regulations that 
would work. So as a result, Mr. Chairman, just to tell you in a 
nutshell, we saw a tremendous decrease in the incidents of 
foodborne pathogens in foods, we saw a tremendous decrease in 
the illnesses and we achieved the Healthy People 2010 goals for 
reduction of E. coli illnesses in 2004, 6 years early.
    So it can be done, but it requires vigilance and paying 
attention to the human factor as well as to the science that 
goes into the regulations, and results can be had. USDA has a 
tremendous cadre of very dedicated----
    Mr. Scott. Dr. Murano, I am going to have to close you 
down.
    Dr. Murano. Yes, sir. I am done.
    [The prepared statement of Dr. Murano follows:]

   Prepared Statement of Elsa A. Murano, Ph.D., President, Texas A&M 
                    University, College Station, TX
    My name is Elsa Murano, and I am currently the President of Texas 
A&M University. From October of 2001 to December of 2004, I had the 
tremendous privilege of serving the American people as Under Secretary 
for Food Safety at the U.S. Department of Agriculture. Prior to my 
appointment, I had been a successful researcher and educator in the 
field of food microbiology, working on the very pathogens that have 
been the thorn on the side of regulators, the food industry, and 
consumers for many years. When I first arrived in Washington, exactly 1 
week before 9/11, I remember thinking that as the first food 
microbiologist to serve as Under Secretary for food safety, I had a 
special responsibility, as well as an opportunity, to inject science 
into the process of making our food supply as safe as possible. By this 
I meant I would use the scientific method to examine the causes and to 
arrive at solutions that would minimize food contamination and increase 
our ability to prevent foodborne illness.
    I soon learned that the most significant difference between working 
on food safety at the laboratory versus the real world is that the real 
world doesn't like waiting for results, that crises can happen while 
you are in the middle of finding solutions to problems, and so one must 
learn to balance the need to act quickly with the need to provide 
solutions that will stand the test of time. Such was the case in the 
Summer and Fall of 2002. We had been working to identify where, in the 
production of ground beef, would contamination with the pathogen E. 
coli O157:H7 be most likely to occur, as well as to determine what we 
could do to minimize it. As we were pondering this, we started to 
receive reports of several people becoming ill with this pathogen, 
resulting in one of the largest recalls of ground beef in our nation's 
history, totaling 19 million pounds. As we worked to control the 
outbreak, and to determine what went wrong so we could address the 
problem, we soon received news of several people becoming ill with 
listeriosis, resulting in one of the largest recalls of processed deli 
meats in our nation's history, totaling 28 million pounds. We referred 
to this period as ``the perfect storm'' because it showed how 
weaknesses in our system could line up in such a way as to produce the 
worst results, with multiple outbreaks by multiple pathogens in rapid 
succession.
    I've always been a believer that the worst of times can also become 
the best of times, because they can be the best teacher. So, I was 
determined that we would learn from these situations and that those 
lessons would be the basis for our strategy in order to prevent this 
from happening again. In assessing the causes, I confirmed what I had 
known before I even took the position, which is that people can make a 
tremendous difference. FSIS has almost 8,000 inspectors at over 6,500 
meat and poultry processing plants in the U.S., and these folks are 
responsible for inspecting 110 billion pounds of meat, poultry, and egg 
products, plus another 10 billion pounds of imported product each year. 
That translates to nine million inspection procedures being carried out 
every year, or a thousand procedures per inspector per year! So, it 
became evident to me that we needed to make sure that these hard-
working men and women needed to be trained in a different way, in a way 
that ensured they knew the science behind what they were doing with 
regard to food safety, so they could do a better job of anticipating 
problems, and also, that they would be supervised adequately. The 
underlying idea was to address the human factor so that errors in 
inspection would be minimized. So, we went to work to design a training 
program that would help address this, and in April of 2003, we launched 
our Food Safety Regulatory Essentials program, or FSRE, to help 
inspectors know how to verify that food safety systems implemented by 
the companies were done correctly. We also created an Office of Program 
Evaluation, Enforcement and Review, to improve our inspector 
supervision activities, and created a new class of inspector, the 
Enforcement Investigations and Analysis Officer, charged with 
conducting comprehensive food safety assessments, which could be 
targeted to specific plants based on their track-record.
    Speaking of the human factor, we also realized that over the 
previous years, meat and poultry processing plants had been left to 
their own devices to figure out how to implement food safety preventive 
programs with little oversight by FSIS. In the mid 1990s, the Hazard 
Analysis Critical Control Points system, known as HACCP, became a 
requirement of all meat and poultry processing plants, but how it would 
be implemented was left largely to each plant to determine. Let me 
explain what I mean. The very first step in implementing HACCP is to 
determine the types of hazards that are most likely to occur in a 
specific food. For ground beef, for example, plants are expected to 
determine whether in their operations, E. coli O157:H7 should be 
considered a hazard likely to be found in their product. If a plant 
answers this question with a ``no'' then they don't need to worry about 
it anymore. We found that many ground beef processing plants had in 
fact answered ``no'' and therefore, they were not taking direct steps 
to deal with this hazard. So, in October of 2002, we ordered each plant 
to reassess their HACCP plans. As a result, 62% changed their 
operations, and 60% changed their plans to include E. coli O157:H7 as a 
hazard reasonably likely to occur.
    The human factor also included consumers, for they are the ones at 
the end of the food supply chain, and what they do, or fail to do, can 
also have an impact. So, we launched a comprehensive food safety 
education campaign, designed to address three elements: a mass media 
campaign, a cluster targeting to segmented audiences, and one-on-one 
activities utilizing our brand-new ``food safety mobile'' which would 
impart the message of safe food handling practices to various locations 
throughout the country. Turns out that our mobile was also very useful 
during the aftermath of Hurricane Katrina, helping New Orleans 
residents know what to do during the storm and afterwards, and helping 
distribute safe food and water to those affected.
    Besides addressing the human factor, we also knew that we needed to 
use science to determine what else we could do to prevent contamination 
wherever possible, and how to control it, as our only other option. At 
the time of the listeriosis outbreak in the Fall of 2002, we came under 
a lot of pressure to implement regulations before our risk assessment 
on this pathogen was completed. Standing firm, we resisted the 
temptation to come up with a quick-fix solution before data was 
available, so we continued our risk assessment work. In October of 
2003, our new Listeria rule was published, based on the results of our 
risk assessment. It offered a new approach in which we created 
incentives for the industry to do more microbial testing, and to 
implement post-processing intervention technologies that would reduce, 
if not eliminate this hazard. As a result, 87% of food plants changed 
their operations, 57% started testing more for the presence of 
Listeria, 27% introduced antimicrobial treatments in their operations, 
and 17% began using technologies that would eliminate the pathogen 
after cooking. We also launched a New Technologies Office so that we 
could streamline the approval process to introduce new pathogen-
reduction methodologies as part of the arsenal available to food 
processors to control microbial contamination.
    With these two approaches, concentrating on the human factor and on 
science, at the end of my time at USDA, we achieved results beyond our 
wildest dreams. By the end of 2004, we realized a 78% reduction in the 
prevalence of E. coli O157:H7 in ground beef, and a 47% reduction in 
the prevalence of Listeria monocytogenes in deli meats compared with 
2002, which you will remember was the year of the ``perfect storm''. 
Most rewarding is the fact that by 2004 we were able to achieve the 
Healthy People 2020 goals for reduction of illnesses due to E. coli 
O157:H7 6 years ahead of schedule! Of course, all this also translated 
into decreases in other foodborne illnesses, and in breaking the yearly 
cycle of large single-event recalls of meat and poultry products down 
to zero in 2003 and 2004.
    There were two fundamental factors that contributed to our success. 
One is the culture that exists at FSIS, which has developed over many 
decades. It is a culture of commitment to prevention through continuous 
inspection and enforcement. History will attest to the fact that 
inspection is ``in the DNA'' of these incredible professionals. They 
know what to do, they know it is their responsibility to do it well, 
and they know that they are there to ensure public health. That is a 
culture of dedicated professionals which is not easy to duplicate. I 
would put FSIS inspectors against any other food inspectors in the 
world. I guarantee they are by far the best regarded among their 
colleagues, and this is due to a track record that is the envy of the 
world.
    The second factor is that FSIS is guided by legislation that 
requires daily inspection of meat and poultry products, making it 
essential for the agency to have enough personnel to accomplish this 
task, and enough funding to operate it. The laws I'm referring to are 
the Federal Meat Inspection, Poultry Inspection, and Egg Products 
Inspection Acts of 1906, 1957, and 1970. By comparison, the Food and 
Drug Administration, which is responsible for all other foods over 
which FSIS has no jurisdiction, is directed by the Food, Drug, and 
Cosmetics Act of 1938, which has no such requirements. As a result, 
most foods under FDA regulation are not inspected daily and are not 
subjected to the degree of scrutiny they should. Some don't see an 
inspector for years. This has certainly played a role in outbreaks of 
foodborne illness in foods inspected by FDA, such as tomatoes, spinach, 
and most recently, peanut butter.
    The bottom line is that in order to ensure that we are doing all we 
can to improve food safety, we need to pay attention to the human 
factor and to utilizing science, but we need to do so within a culture 
that understands how inspection works, and which is armed with the 
regulations to carry out this mission. If I could offer advice to the 
Committee, it would be to allow FSIS and FDA to play to their 
strengths. The specialty at FSIS is food policy and food inspection, 
while FDA is primarily a drug and medical device regulatory agency. 
Perhaps now is the time to consider moving all food-related activities 
from FDA to FSIS, and allow FDA to concentrate on what it does best, 
and provide FSIS the regulatory authority and funding to inspect all 
foods, not just meat and poultry. An alternative that has often been 
discussed is the creation of a single food safety agency, as a stand-
alone entity that would take over the functions of FSIS, FDA, and 
others like the National Marine Fisheries Service. Before this 
alternative is considered, I would ask the Committee to determine 
whether the formation of the Department of Homeland Security as a 
single agency right after 9/11 contributed to the problems encountered 
at FEMA in the handling of Hurricane Katrina, or whether transferring 
the import inspection from the Animal and Plant Health Inspection 
Agency at USDA to the Department of Homeland Security has reduced the 
number of illegal items introduced into commerce. My point is that 
forming a single food safety agency would disturb the operations at 
FSIS and would require the creation of a culture of inspection and 
enforcement that has taken decades to develop at a time when we need to 
enhance, not disrupt our food safety system.
    I've now been gone from Washington longer than the time I served 
there. Unfortunately, in that time we have seen some setbacks in the 
gains we made at FSIS. We have also seen more outbreaks due to 
consumption of foods regulated by FDA. It is a reminder that we need to 
be ever vigilant about making sure that the human factor, and the 
science behind food safety, are paid attention to. This requires 
leadership and I urge the President to select people to the important 
positions overseeing FSIS and FDA very carefully. We need professionals 
with the scientific expertise to understand how to improve public 
health through risk reduction, and with the decision-making skills and 
character to do what is right. Thank you so much for this opportunity 
to give you my perspective. It has been a pleasure, Mr. Chairman. I 
would be happy to answer any questions you may have.

    Mr. Scott. We have been long.
    Dr. Murano. Thank you, sir.
    Mr. Scott. We certainly will follow up that with some 
questions.
    Dr. Murano. All right.
    Mr. Scott. Five minutes is not nearly long enough----
    Dr. Murano. It is not.
    Mr. Scott.--nearly to get everything, and we appreciate 
everyone kind of keeping remarks to 5 minutes. This is indeed a 
very, very growing and urgent issue facing our country, and we 
appreciate all of your information.
    Mr. Michael Taylor.

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

    Mr. Taylor. Thank you, Mr. Chairman, Ranking Member Lucas, 
Members of the Committee, I appreciate the chance to testify 
today.
    The Committee's review of the government's food safety 
system is without question timely. The public is paying close 
attention, and food safety reform is quite properly a front-
runner issue for this Congress. Government, of course, doesn't 
make food and government cannot make it safe. But government 
has an absolutely central role on behalf of consumers in 
ensuring that food companies do their food safety job in 
keeping with what science and public expectations tell us is 
necessary, and what modern techniques show is possible.
    Unfortunately, recent illness outbreaks and problems with 
imported food demonstrate that the government's food safety 
system has fallen far behind dramatic changes in the global 
food system, and is simply not equipped to deal with today's 
food safety challenges.
    Mr. Chairman, we need a food safety system that takes a 
farm-to-table approach to preventing food safety problems, that 
uses the best available science to understand potential hazards 
and how to prevent them, and that establishes and enforces 
science-based food safety standards that hold companies 
accountable for meeting their prevention duty.
    What we have on the other hand is a food safety system that 
focuses more on reaction than prevention, under-invests in the 
science and data analysis needed for prevention, and lacks both 
modern standards and strong enforcement. It is a system that 
the National Academy of Sciences and the Government 
Accountability Office have found in numerous studies to be 
plagued by obsolete laws, inadequate and often poor use of 
resources, and fragmented organizational structures.
    I know from personal experience a lot of talented and 
committed people at USDA and FDA are working hard on food 
safety within the existing system, but today's food safety 
system is fundamentally flawed. Let me give you just a few 
examples of what I mean, first with respect to the FDA program.
    Core elements of FDA's food safety law date back to 1906. 
It is thus not surprising that the law lacks a mandate for 
companies to implement modern preventive controls, and it 
establishes little or no accountability for prevention on the 
part of the companies or on the part of FDA. FDA's current law 
takes the same weak, reactive approach to imports that it takes 
to domestic food. To have any chance of success, the reaction 
paradigm in current law depends heavily on vigorous FDA 
inspection and enforcement, yet due to chronic under-funding of 
its food safety program, FDA is unable to inspect even high-
risk domestic plants as much as once a year, or to examine more 
than about one percent of import shipments. FDA also lacks 
other basic elements of a modern enforcement toolkit such as 
traceback and mandatory recall authority.
    Finally, FDA's management structure for food safety is 
fragmented internally, and FDA lacks the management connections 
and working relationships with the CDC, Centers for Disease 
Control, which are essential both to better manage major 
outbreaks and to assemble the data and analysis needed for 
prevention.
    Mr. Chairman, FSIS and USDA have a quite different set of 
problems stemming primarily from the obsolete mandates in the 
meat and poultry inspection laws. The NAS and GAO have found, 
repeatedly, that the mandated carcass-by-carcass visual 
approach to slaughter inspection and the requirement for daily 
inspection of all processing plants without regard to relative 
risk make poor use of scarce food safety resources. Moreover, 
FSIS has no authority to address food safety at the point of 
animal production where many pathogen problems originate. Even 
within slaughter and processing plants, the authority of FSIS 
to establish and enforce pathogen reduction standards is under 
a legal cloud because the inspection laws do not expressly 
authorize them. FSIS is even precluded from conducting food 
safety research.
    Beyond FDA and FSIS, of course, there are other Federal 
agencies and literally thousands of state and local agencies 
working on food safety. They all need to be considered in 
crafting a comprehensive systems approach to food safety and 
food safety reform.
    Mr. Chairman, I am convinced that unless Congress addresses 
the problems and gaps all across the nation's food safety 
system, we will continue to fall short in fulfilling the modern 
vision of a science and risk-based system that is effective in 
preventing foodborne illness.
    So again, I commend the Committee for taking the time to 
consider these issues and look forward to your questions.
    [The prepared statement of Mr. Taylor follows:]

   Prepared Statement of Michael R. Taylor, J.D., Research Professor,
  Department of Health Policy, George Washington University School of 
        Public Health and Health Services, Washington, D.C. \1\

    Chairman Peterson, Ranking Member Lucas, Members of the Committee, 
thank you for the opportunity to testify at today's hearing to review 
the current food safety systems at the Department of Health and Human 
Services (HHS) and the U.S. Department of Agriculture (USDA). 
---------------------------------------------------------------------------
    \1\ Mr. Taylor is Research Professor of Health Policy at The George 
Washington University School of Public Health and Health Services and 
chair of the Food Safety Research Consortium. He served formerly as 
Administrator of USDA's Food Safety and Inspection Service and Acting 
Under Secretary for Food Safety (1994-1996) and as Deputy Commissioner 
for Policy of the Food and Drug Administration (1991-1994).
---------------------------------------------------------------------------
Introduction
    The Committee is right to be reviewing food safety systems at both 
HHS and USDA, which, primarily through the Food and Drug Administration 
(FDA) and the Food Safety and Inspection Service (FSIS), carry out most 
of the Federal Government's food safety regulatory activity.
    I would note, of course, that the Environmental Protection Agency 
(EPA) also plays an important role in food safety as the agency charged 
by Congress with setting tolerances for pesticide residues in food, and 
many other agencies within HHS and USDA and across the Federal 
Government perform food safety data collection, research and inspection 
activities. Moreover, literally thousands of state and local health and 
agriculture departments and laboratories play critical frontline roles 
in the nation's food safety system, with primary responsibility lodged 
at the state and local level for responding to illness outbreaks and 
regulating the food safety practices of the one million retail food 
outlets in this country.
    My testimony today will focus primarily on FDA and FSIS, but one of 
my key messages is that we need to understand food safety as a system 
problem that needs an integrated system solution, and we need a 
comprehensive food safety reform strategy that takes account of the 
severe challenges faced by both FDA and FSIS, as well as the many other 
agencies in the system, in carrying out their food safety 
responsibilities.
    FDA and FSIS both have a lot of good people working hard within the 
existing system, but today's food safety system is fundamentally 
flawed. As the National Academy of Sciences (NAS) and Government 
Accountability Office (GAO) have found in numerous studies, the Federal 
food safety system is plagued by obsolete laws and food safety 
strategies, inadequate and often poor use of resources, and fragmented 
organizational structures. Based on these problems, the GAO has placed 
the Federal Government's food safety program on the list of Federal 
programs at high risk of failure, and GAO included food safety among 
the 13 problems most in need of urgent attention by the new 
Administration and Congress.
    It is thus important that President Obama has already made food 
safety a high priority for the Administration, as has Secretary 
Vilsack, and I'm sure food safety reform will be high on the agenda of 
Governor Sebelius and Dr. Hamburg upon their confirmations by the 
Senate as Secretary of HHS and Commissioner of FDA.
    But, while there is much the food safety agencies can do on their 
own to improve their programs, transformative and sustainable food 
safety reform requires strong action by Congress, based on a 21st 
century vision of what a modern food safety system can and should do.
    In my testimony today, I will briefly outline the elements of a 
modern vision for the nation's food safety system and then analyze the 
challenges FDA and FSIS face in fulfilling the vision.

Vision
    The vision I outline here is rooted in the seminal 1998 NAS report 
Ensuring Safe Food From Production to Consumption. That report and a 
series of subsequent GAO reports have called for a science- and risk-
based food safety system that focuses on preventing food safety 
problems and that makes efficient use of all available public resources 
for that purpose. The key functional elements of such a preventive 
system include:

    1. Taking a farm-to-table approach to preventing food safety 
        problems;

    2. Using risk analysis to better understand potential hazards, 
        design interventions, and prioritize prevention efforts;

    3. Collecting necessary data to support risk analysis, through 
        monitoring of the food supply, foodborne illness surveillance, 
        and food safety research;

    4. Harnessing the primary role of food producers, processors, 
        retailers and consumers in preventing food safety problems;

    5. Implementing preventive process control, such as HACCP, 
        throughout the food industry;

    6. Establishing science-based food safety performance standards;

    7. Carrying out a modern inspection program to support the vigorous 
        enforcement of food safety standards;

    8. Integrating food safety efforts among Federal, state, and local 
        food safety agencies;

    9. Allocating government food safety efforts and resources in 
        relation to risk and opportunities to reduce risk; and

    10. Observing sound food safety practices at the final preparation 
        and consumption stage through well-informed commercial food 
        handlers and consumers.

    This system-oriented vision for the food safety system is widely 
embraced. The question for Congress is: what reforms will it take to 
implement the modern vision of an effective food safety system? My view 
is that it will take a modern legislative mandate, adequate resources 
that are better used, and effective leadership and management 
structures. These are the key ingredients for any successful government 
program, and all are lacking in the case of food safety. FDA and FSIS 
simply do not have the tools to be successful.

Gaps in the Food Safety Tool Kit
Modern Legislative Mandate
    FDA's basic food safety legislative tools date back to 1938, while 
the principles governing FSIS slaughter inspection under the meat and 
poultry inspection laws were adopted in 1906. Today's food safety laws 
were passed before foodborne pathogens emerged as a central public 
health concern and as a threat to the well-being of the food industry, 
and before globalization made the United States as dependent on food 
imports as it is today. As a result, neither FDA nor FSIS has the 
modern mandate and legal tools to deal with today's food safety 
challenges.

Food and Drug Administration
    FDA's basic, 1938-vintage statutory tools for dealing with 
Salmonella and other foodborne pathogens and chemical contaminants 
consist of authority to enter and inspect food factories, warehouses 
and other establishments; a broad definition of when a contaminant 
renders food legally ``adulterated;'' and the ability to seek judicial 
intervention to remove adulterated food from commerce. With respect to 
imports, FDA's legal authority is limited to examining shipments at the 
port of entry and blocking them if FDA inspectors can detect a problem.
    These limited tools give FDA some ability to react to problems 
after they occur, but very limited ability to ensure that food safety 
problems are prevented in the first place.
    In particular, under current law, FDA lacks:

   A legislative mandate and accountability for reducing 
        foodborne illness;

   Authority to hold the operators of all food facilities 
        accountable for implementing modern preventive controls that 
        reduce the risk of foodborne illness;

   An inspection mandate that ensures an adequate frequency of 
        inspection;

   Authority to routinely examine company records to verify 
        that proper food safety procedures have been followed;

   Authority to administratively detain products that have not 
        been produced under proper conditions;

   Authority to require that companies be able to provide 
        immediate traceback information so that major outbreaks can be 
        more promptly contained;

   Authority to order a recall of unsafe products and enforce 
        rigorous implementation of needed recalls;

   Authority to penalize violations of food safety standards 
        other than through cumbersome and time-consuming court 
        proceedings; and

   Authority to hold importers accountable for ensuring that 
        imported food is produced using modern preventive controls and 
        in a manner that meets U.S. standards.

Food Safety and Inspection Service
    The core FSIS legislative mandate is to conduct inspection in 
slaughter houses and in plants that process meat and poultry products. 
The original 1906 mandate for carcass-by-carcass slaughter inspection 
was a response to The Jungle and Upton Sinclair's documentation of 
diseased animals, gross insanitary conditions and often intentional 
commingling of bad meat with good. The visual inspection Congress 
mandated was effective in addressing those problems, but, as found by 
the NAS and other expert bodies, this mode of inspection is ineffective 
in dealing with today's food safety concerns. Pathogenic bacteria are, 
of course, invisible.
    Congress also mandates daily FSIS inspection of all plants that 
process meat and poultry products, without regard to the nature of the 
operation, which today may range from the relatively high-risk 
processing of raw ground meat products all the way to the pizza plant 
that applies pepperoni slices to a pizza that will be cooked to a very 
high temperature. In the case of the pepperoni pizza plant, FSIS will 
already have inspected the slaughter of the animals that provided the 
meat and the manufacture of the pepperoni at the processing plant.
    Slaughter plants and many meat processing plants are among the most 
sensitive and risk-prone links in the farm-to-table food safety system 
and deserve substantial government inspection. It is very clear, 
however, that the current inspection mandate and the resulting mode of 
inspection at FSIS is obsolete and wastes government resources that 
could be used more effectively in those plants and elsewhere to prevent 
foodborne illness.
    Despite its obsolete statutory mandate, important changes have 
occurred in the FSIS program in recent years. Prior to 1994, the 
official position of the Department of Agriculture was that slaughter 
houses and plants processing raw meat were not responsible or 
accountable for pathogen contamination, on the ground that consumers 
were expected to properly cook the product. We changed that when I was 
Administrator of FSIS by (1) declaring that E. coli O157:H7 is an 
adulterant in raw ground beef, (2) mandating that all slaughter and 
processing plants implement a modern preventive control system called 
HACCP (Hazard Analysis and Critical Control Points), and (3) 
establishing for the first time microbial test requirements and 
pathogen reduction performance standards.
    Since the reforms of the mid-1990s, FSIS and the industries it 
regulates have made progress in reducing pathogens, but progress has 
been constrained by the agency's obsolete statutes. On the positive 
side, minimizing pathogen contamination is now seen as a central part 
of the FSIS mission, and the professional staff at FSIS has been 
creative in using the tools they have to pursue pathogen reduction. 
Reductions in the incidence of contamination have been achieved for 
some pathogens, such as Listeria in deli meats and Salmonella in 
poultry, and many companies in the meat and poultry industry have 
substantially increased their own pathogen testing and pathogen 
reduction efforts in response to both FSIS initiatives and market 
incentives.
    On the negative side, an industry legal challenge has put a cloud 
over the enforceability of the pathogen reduction standards FSIS 
established in the 1990s, and those standards have not been updated in 
the way we originally intended. Thus, FSIS is forced to rely on 
obsolete benchmarks and indirect means in an attempt to drive pathogen 
contamination down to levels we know are achievable, when it should be 
setting and enforcing science-based performance standards to protect 
consumers. Moreover, because meeting the obsolete statutory inspection 
mandate consumes nearly all FSIS resources, it has limited capacity to 
invest in more modern approaches to enforcing every plant's duty to 
prevent food safety problems through HACCP and other means.
    There is room for more food safety progress at FSIS within the 
current statutory framework, but FSIS is unable to fulfill the vision 
of a modern, science- and risk-based food safety system because it 
lacks a modern food safety law. Most importantly, FSIS lacks:

   A legislative mandate and accountability for reducing 
        foodborne illness;

   A mandate and authority to deploy resources efficiently to 
        prevent foodborne illness;

   Authority to address food safety problems at the point of 
        animal production, where many pathogen problems originate;

   A mandate and clear authority to set and enforce science-
        based pathogen reduction performance standards;

   Authority to order a recall of unsafe products and enforce 
        rigorous implementation of needed recalls; and

   Authority to conduct food safety research.
Adequate Resources That Are Used Efficiently
    FDA regulates 80% of the food supply and the vast majority of food 
imports with a budget of about $650 million. FSIS regulates about 20% 
of the food supply with a budget of about $1 billion. The primary 
explanation for this dichotomy is that FDA has no food safety 
legislative mandate that requires a certain level of funding to 
fulfill, while FSIS has an inspection mandate that provides a strong 
anchor for FSIS resources. Slaughter plants cannot operate unless FSIS 
mans the slaughter lines, and issuance of the FSIS mark of inspection, 
which processing plants must have to ship food, depends on the daily 
inspection.
    Fulfilling the vision of a modern, science- and risk-based food 
safety system requires not only an adequate level of resources but the 
targeting of government food safety efforts and allocation of resources 
based on risk and the best opportunities to reduce risk. The 
differences in the current resource situations at FDA and FSIS mean 
they have distinct resource challenges.

Food and Drug Administration
    FDA currently has ample flexibility legally to allocate its 
resources based on risk. FDA's primary problem is that it has too few 
resources to allocate. FDA can inspect food facilities on average once 
every 10 years, and is unable to inspect all high-risk facilities even 
once per year. Moreover, as documented by the FDA Science Board, a 
group of independent experts from outside FDA, FDA's science base for 
food safety has eroded over the years; it has miniscule resources for 
applied food safety research; and it lacks the modern information 
systems that are essential to implementation of a science-based and 
preventive food safety program.
    Fortunately, Congress has recognized this funding shortfall at FDA 
and begun to correct it with increases in the last two budgets, and the 
Obama Administration has signaled plans for further significant 
increases. This is good news.
    It is essential to remember, however, that FDA will never have 
enough resources to be successful on food safety as long as it remains 
in a primarily reactive mode. That is why it is so important that 
Congress give FDA the mandate and authority to change the food safety 
paradigm to one that holds all food facilities accountable for 
implementing modern preventive controls and meeting science-based 
standards and gives FDA the tools to enforce that duty efficiently and 
effectively.

Food Safety and Inspection Service
    The resource problem at FSIS is less the level of resources and 
more the inefficient use of those resources, which is driven by the 
obsolete nature of the inspection mandate. I believe that FSIS needs a 
strong inspection mandate and that FSIS needs every one of the billion 
dollars Congress gives it to do its food safety job. But, FSIS needs a 
modern inspection mandate that is aimed at addressing today's food 
safety challenges and preventing foodborne illness and that directs and 
empowers FSIS to better allocate its resources within slaughter and 
processing plants and outside those plants, in ways most likely to 
improve food safety.

Effective Leadership and Management Structures
    One of the key findings of the 1998 NAS report Ensuring Safe Food 
From Production to Consumption was that the organizationally fragmented 
nature of the nation's food safety system is an obstacle to fulfilling 
the vision of a science- and risk-based program that is effective in 
preventing foodborne illness. With responsibilities spread across 
numerous Federal agencies and thousands of state and local agencies, it 
is often unclear which agency is responsible for what, and there is a 
fundamental lack of clearly lodged responsibility and accountability 
for mounting an integrated, systems approach to preventing foodborne 
illness. That is why the NAS recommended unifying all Federal food 
safety programs under a single, accountable leadership structure.
    I believe the creation of a single food safety agency is a worthy 
long-term goal, but consideration of that possibility should take a 
back seat to the immediate need and opportunity we have to improve the 
food safety programs of FDA and FSIS, where they sit today within HHS 
and USDA. This includes improving the leadership and management 
structures through which they implement their food safety programs.

Food and Drug Administration
    Last week, Trust for America's Health (TFAH) issued a report 
Keeping America's Food Safe: A Blueprint for Fixing the Food Safety 
System at the Department of Health and Human Services. This report 
noted the fragmentation of management responsibility for food safety 
within FDA. Two headquarters units and the FDA field force having major 
food safety responsibilities but are separately managed, with no 
official whose full-time job is food safety having management 
responsibility and accountability for the program's success. In order 
to implement a new paradigm of risk-based prevention of foodborne 
illness, FDA, HHS and Congress need to address this management problem.
    In addition, as noted in the TFAH report, the Centers for Disease 
Control and Prevention (CDC) is also a separately managed unit within 
HHS but plays a central role in investigating and thus helping to 
contain foodborne illness outbreaks. CDC also must play an even larger 
role in implementing the new prevention-oriented, risk-based food 
safety paradigm, as the agency on which the nation relies to compile 
and analyze information on foodborne illness--information that FDA and 
the food industry need to design and implement preventive measures. New 
mechanisms are required to improve management of multi-state outbreaks 
involving both FDA- and FSIS-regulated products and to ensure that CDC 
has the resources and accountability to provide the data and analysis 
on human illness that FDA and FSIS need for prevention.

Food Safety and Inspection Service
    FSIS, through the Administrator and Under Secretary for Food Safety 
has ample full-time leadership for food safety.
    The primary structural issue at USDA is that FSIS and the Under 
Secretary for Food Safety are precluded from conducting food safety 
research and must rely solely on the Agricultural Research Service 
(ARS) for the applied intramural research that FSIS needs to do its 
job. ARS has many fine researchers, and its mission includes meeting 
the research needs of operating agencies within USDA, such as FSIS, but 
ARS also has competing priorities, and its food safety research 
priorities are influenced by factors other than the FSIS program needs. 
A science-based food safety regulatory program should have the 
authority to conduct its own applied food safety research, in addition 
to collaborating with researchers in other agencies and in academia.

Conclusion
    In considering food safety reform at FDA and FSIS, it is critical 
that Congress keep its eye on the big picture and address the needs of 
these agencies comprehensively. We owe the people working on food 
safety at FDA and FSIS the legal tools, resource levels and 
flexibility, and management structures they need to meet today's 
challenges.
    Thank you again, Mr. Chairman, for the opportunity to testify 
today. I look forward to the Committee's questions.

    Mr. Boswell [presiding.] Thank you very much. Ms. Tucker-
Foreman, please?

           STATEMENT OF HON. CAROL L. TUCKER-FOREMAN,
   DISTINGUISHED FELLOW, THE FOOD POLICY INSTITUTE, CONSUMER 
            FEDERATION OF AMERICA, WASHINGTON, D.C.

    Ms. Tucker-Foreman. Thank you. Mr. Chairman, Ranking Member 
Lucas, and Members of the Committee, thank you for having me 
here today.
    I am Carol Tucker-Foreman. I was Assistant Secretary for 
Food and Consumer Services at USDA from 1977 to 1981, and in 
those days had responsibility for meat and poultry inspection, 
all the food and nutrition service programs, and the grading 
programs that are now in the agricultural marketing system. I 
was busy.
    No hearing you hold this year will be more important to 
American consumers and to food processors and to farmers. The 
continuing series of foodborne illness outbreaks, both imported 
and domestic food products, doesn't just threaten our health, 
it threatens the confidence that Americans have in our 
government food safety system and in the industry.
    The Government Accountability Office has warned that food 
safety programs are at a high risk of failure and urged 
President Obama to take steps to act quickly on them. In 2007, 
data from the Centers for Disease Control showed just how big 
the problem is. We are far from meeting the objectives of 
Healthy People 2010. There has been no reduction in E. coli 
poisoning since the agency began tracking food. Salmonella 
illnesses are double the national objective. Listeria was as 
high in 2007 as it was in 2004. The Food and Drug 
Administration, sapped of funds and leadership and saddled with 
a law that gives no mandate to prevent illness, has been unable 
to contain these illnesses that have hit people in your states 
and districts.
    Just Salmonella saintpaul from imported peppers hit people 
in 43 states including 559 Texans, 120 people in Illinois, 42 
in Georgia, and 59 in Arizona. The fresh sprout outbreak that 
occurred earlier this year, earlier last month, 27 Iowans, five 
Kansans, 84 Nebraskans, and five South Dakotans were among 
those people who got ill. So these are illnesses that hit all 
the way across the country.
    The medical costs of foodborne illness are staggering. One 
study set the annual total cost of foodborne illness in 2006, 
including medical care and lost productivity and wages, at over 
$1 trillion, $1.4 trillion in 1 year.
    Obviously, you could tell from the last panel these 
outbreaks hit businesses and they hit farmers as well. The ERS 
reported that spinach shipments dropped 17 percent and green 
onion shipments dropped ten percent after those products were 
implicated in E. coli outbreaks in 2006.
    I urge you, and my organization urges you, to act quickly 
to direct the FDA to concentrate on preventing foodborne 
illness and give it the power and the funding to do so. We also 
believe that it would be useful to give food safety a separate 
organization within HHS.
    I think that the Congress can take a look at FSIS to see 
how important that separate organizational structure can be. 
Since 1994, FSIS has come out of the dark ages. Unlike FDA, the 
FSIS system has focused on preventing illness. For imported 
products, there is a strict equivalence system. Inspectors are 
in the plant every day examining product to ensure it is safe. 
Congress has acted to give FSIS an adequate leadership 
structure, including the position of the Under Secretary for 
Food Safety, the highest ranking food safety official in the 
government .
    The agency, as Mike Taylor pointed out, is burdened by a 
seriously outmoded statute and by inadequate money to fulfill 
its obligation to have inspectors in the plant every day, and 
it doesn't have the staff of statisticians and scientists as it 
should have.
    However, I have come to think of FSIS as the Rodney 
Dangerfield of food safety. It gets no respect despite the fact 
that it has made major strides in the last 15 years to improve 
its food safety efforts. Taking food safety and putting it in a 
separate public health agency in USDA so that it is separated 
from marketing, and separated from the conflict of interest 
that arises when it has to compete with production agriculture 
issues has been very, very important.
    Now, if you would just modernize the Meat and Poultry 
Inspection Acts to let them follow through on the scientific 
basis that Mr. Taylor and Dr. Murano established, I think you 
would do the American people a great service. Thank you.
    [The prepared statement of Ms. Tucker-Foreman follows:]

   Prepared Statement of Hon. Carol L. Tucker-Foreman, Distinguished
  Fellow, The Food Policy Institute, Consumer Federation of America, 
                            Washington, D.C.

    Good morning Chairman Peterson, Ranking Member Lucas and Members of 
the Committee. My name is Carol Tucker-Foreman. I am Distinguished 
Fellow in the Food Policy Institute at Consumer Federation of America. 
CFA is a nonprofit association of over 300 local, state and national 
organizations, representing a combined membership of over 50 million 
American consumers. Since 1968 we have conducted research, provided 
educational materials and engaged in advocacy on behalf of consumers on 
a range of issues including banking and financial services, food and 
agriculture, and product safety. Our positions and priorities are set 
by vote of representatives of our member groups.
    From 1977-1981 I served as Assistant Secretary of Agriculture. My 
responsibilities included oversight of the nation's meat, poultry and 
egg inspection and food assistance programs. In 1986 I founded the Safe 
Food Coalition which includes foodborne illness victims, consumer and 
public health organizations and a trade union to seek improvements in 
U.S. Government food safety programs, especially meat and poultry 
inspection. I am a member of the Food and Drug Administration Food 
Advisory Committee, the National Advisory Committee on Meat and Poultry 
Inspection and USDA's Advisory Committee on Agricultural Biotechnology.
    No hearing you hold this year will be more important to American 
consumers, to the food industry, or to the people who produce our food. 
Americans are acutely aware of the crisis in our food safety system. We 
have experienced recurring outbreaks over the past few years, including 
a new one involving pistachio nuts this week.
    Consumers are not the only ones who fear our food safety system is 
failing. In January 2007, the Government Accountability Office declared 
the Federal food safety programs at ``high risk'' of failure. In 
November 2008, the GAO named food safety as one of 13 topics most in 
need of urgent action by the new Administration and the new Congress.
    Each spring the Centers of Disease Control and Prevention (CDC) 
reports on levels of foodborne illness. The April 2007 report was 
sobering. The agency announced that there has been almost no reduction 
in foodborne illness in recent years. In 2007, the Salmonella illness 
rate was more than double the national goal. There has been no real 
decline in the rate of E. coli illness since the FoodNet tracking 
began. There has been no decline in Campylobacter illnesses since 2002 
and the Listeria rate was as high in 2007 as it was in 2004.\1\ Unless 
something changes quickly and radically, the nation will not meet the 
Healthy People 2010 national objectives for reducing foodborne illness.
---------------------------------------------------------------------------
    \1\ Centers for Disease Control and Prevention, ``Preliminary 
FoodNet Data on the Incidence of Infection with Pathogens Transmitted 
Commonly Through Food--10 States, 2007.'' MMWR 57(14): 366-370, April 
11, 2008.
---------------------------------------------------------------------------
    At a time when everyone is feeling the pinch of severe recession, 
the economic costs of foodborne illness continue to rise. Dr. Tanya 
Roberts, formerly of USDA's Economic Research Service, estimates that 
illnesses caused by all foodborne pathogens cost the nation $1.4 
trillion each year in medical expenses, lost productivity and wages.\2\
---------------------------------------------------------------------------
    \2\ Roberts T, ``Estimates of the Societal Costs of U.S. Food-Borne 
Illness.'' American Journal of Agricultural Economics, Vol. 89, Issue 
5, pp. 1183-1188, December 2007.
---------------------------------------------------------------------------
    Numbers as large as these have a certain unreality about them. They 
may seem unconnected to what goes on in our daily lives. It is 
important to remember the personal suffering and loss that are involved 
but not factored into the trillion dollar loss. There is no calculation 
for physical suffering or the pain when a family loses a young child or 
beloved grandparent to a foodborne disease.
    I urge you to remember that we are talking about individual lives. 
Over the past 5 years, thousands of people have, literally, been 
poisoned by common, everyday foods that we serve at the family dinner 
table--spinach, lettuce, tomatoes, peppers and peanut products.
    In addition, we have been threatened by high levels of drug 
residues and toxic chemicals in fish and dairy products imported from 
China.
    The largest foodborne disease outbreak was the most recent. Almost 
700 people got sick and nine deaths have been tied to consumption of a 
variety of foods that contained peanut products contaminated with 
Salmonella typhimurium. Starting early this year, 2,100 products from 
more than 200 companies were recalled.
    This was the second major Salmonella contamination, outbreak and 
recall of peanut butter products in 2 years. Previously, FDA had viewed 
peanut butter and related products as ``low-risk'' foods, not 
particularly susceptible to contamination. That illusion should have 
ended with the outbreak of Salmonella illnesses traced to peanut 
products produced by Con-Agra at a plant a short distance away from the 
one involved in the most recent outbreak. However, FDA made no 
substantive changes in order to effectively prevent another peanut 
related outbreak.
    That next outbreak wasn't long in coming. Between April and June 
2008, more than 1,300 people in 43 states, the District of Columbia and 
Canada were infected by Salmonella saintpaul, an unusual strain of the 
bacterium. The outbreak, originally thought to have been caused by 
tomatoes, was ultimately traced to Serrano and jalapeno peppers 
imported from Mexico.
    Foodborne illness is not something that happens just to other 
people. Citizens of 46 states were hit by the Peanut Corporation of 
America outbreak. The victims included 100 Ohioans; 76 Californians; 43 
Minnesotans. The 2008 Salmonella saintpaul outbreak traced to 
contaminated Serrano and jalapeno peppers hit 559 Texans, 120 people in 
Illinois, 42 in Georgia, 59 in Arizona. This month 84 Nebraskans, 27 
Iowans, and five Kansans and South Dakotans were among the victims of a 
Salmonella saintpaul outbreak traced to eating contaminated fresh 
sprouts.
    These people are your friends, neighbors and constituents. They and 
all the rest of us need your help and your leadership to rewrite the 
archaic laws and organizational structure that govern our food safety 
system.
    The outbreaks I've discussed were the result of poor sanitation or 
mishandling at some point in the food chain. None resulted from 
consumer mishandling, although a great deal of foodborne illness can be 
traced to consumers' failure to handle foods carefully.
    Thankfully, Americans have not been subjected to illnesses caused 
by intentional efforts to poison our food. We cannot assume, however, 
that that will never happen. Former Secretary of HHS Tommy Thompson, as 
he left office, noted that we are unprepared to address attacks on our 
food supply and urged that the nation begin to address this.
    The continuing series of foodborne illness outbreaks have seriously 
shaken consumer confidence in the safety of our food supply.

   After the Peanut Corporation of America outbreak, the 
        University of Minnesota's Food Industry Center reported that 
        only 22.5% of consumers were confident the food supply is safer 
        today than it was a year ago.\3\
---------------------------------------------------------------------------
    \3\ Consumer Confidence in Food Safety Plunges in Wake of Peanut 
Butter Contamination, University of MN Study Finds, UMN News, Feb. 23, 
2009).

   A Consumers Union study conducted last November, found that 
        48 percent of those polled said their confidence in the food 
        supply had declined.\4\
---------------------------------------------------------------------------
    \4\ Food-Labeling Poll 2008, Consumer Reports National Research 
Center, NRC #2008. 18, Nov. 11, 2008.

   Last spring, the United Fresh Produce Association conducted 
        a survey of consumer attitudes toward produce safety. In April 
        46% of consumers were concerned about produce safety. Four 
        months later, the tomato/pepper Salmonella saintpaul outbreak 
        had occurred and the number of people concerned about produce 
        safety had risen substantially. 54% were concerned about 
---------------------------------------------------------------------------
        produce safety and 56% were concerned about salad mix.

    That lack of confidence is bad for the food business and for food 
producers. The CEO of Kellogg's told the House Energy & Commerce 
Committee that the PCA recall cost the company $65-$70 million.\5\ 
Although no major brands of peanut butter sold at retail were involved 
in the PCA outbreak, sales of those products plunged after the outbreak 
became known.
---------------------------------------------------------------------------
    \5\ Statement of David Mackay, President & CEO, Kellogg Company, 
before the House Committee on Oversight and Investigations, ``The 
Salmonella Outbreak: The Role of Industry in Protecting the Nation's 
Food Supply.'' U.S. House of Representatives, March 19, 2009.
---------------------------------------------------------------------------
    Foodborne illness outbreaks are also bad for farmers who grow the 
crops implicated. Florida tomato farmers were devastated by the 
connection of their product to the Salmonella saintpaul outbreak that 
came at the height of their growing season. Spinach and lettuce farmers 
experienced a drop in demand after their products were implicated in 
outbreaks. USDA recently announced that farmers will likely cut their 
production of peanuts by about 27 percent this year as a result of 
smaller contracts from buyers.\6\ It is true that these markets often 
come back but the lost sales and lost income are not recoverable.
---------------------------------------------------------------------------
    \6\ Rampton R., ``U.S. peanut plantings to drop 27 percent after 
peanut scare.'' Reuters, March 31, 2009.
---------------------------------------------------------------------------
    We can expect that outbreaks like these will continue, threatening 
the health of consumers and the businesses of food processors and 
farmers until Congress acts to address the archaic laws, confused 
organizational structure and under-funded food safety system.
The Source of the Problem
    The U.S. food safety system is broken. The Government 
Accountability Office (GAO) has identified 15 agencies involved in 
administering 30 different Federal laws that touch on food safety.
    The two agencies with primary responsibility for protecting our 
food are the Food Safety and Inspection Service (FSIS), located in the 
Department of Agriculture (USDA) and the Food and Drug Administration 
(FDA) located in the Department of Health and Human Services (HHS). The 
primary laws governing food safety were written over 100 years ago.\7\ 
The most recent major food amendments to the Food Drug and Cosmetic Act 
were passed 70 years ago. The last rewrite of the Meat Inspection Act 
was over 50 years ago. The world we live in and the way we produce, 
process and consume food have all changed radically but the laws remain 
the same.
---------------------------------------------------------------------------
    \7\ The primary legal authorities for the FDA are the Federal Food 
Drug and Cosmetic Act, as amended (21 U.S.C. 301 et seq.); the Public 
Health Service Act, as amended (42 U.S.C., et seq.) and the Egg 
Products Inspection Act, as amended (21 U.S.C., 1031 et seq.) Governing 
authorities for FSIS are the Federal Meat Inspection Act of 1906, as 
amended (21 U.S.C. 601 et seq.) the Poultry Products Inspection Act of 
1957, as amended (21 U.S.C. 451 et seq. and the Egg Products Inspection 
Act, as amended (21 U.S.C. 1031 et seq.).
---------------------------------------------------------------------------
We Need A 21st Century Food Safety System
    Consumer Federation of America and other consumer and public health 
organizations have called on Congress and the President for over 20 
years to undertake a comprehensive revision and modernization of food 
safety laws and to combine all food safety activities in an independent 
food safety agency.
    Both the GAO and a number of expert committees have examined the 
problems with the food safety system. The GAO has produced a number of 
studies, beginning in the mid-1990s, documenting the pressing need to 
modernize food safety laws and organization.\8\
---------------------------------------------------------------------------
    \8\ Numerous reports available at U.S. Government Accountability 
Office website, http://gao.gov/.
---------------------------------------------------------------------------
    In 1998, the National Academy of Sciences recommended that Congress 
modernize food safety laws and overhaul the Federal Government's food 
safety structure to meet current needs.\9\ My colleague Mike Taylor 
served on that committee and has taken a lead role in updating some of 
its recommendations. In 2003 another NAS committee recommended that 
Congress give the agencies the authority to set and enforce 
microbiological criteria.\10\
---------------------------------------------------------------------------
    \9\ Institute of Medicine, National Research Council Ensuring Safe 
Food from Production to Consumption, 1998.
    \10\ Institute of Medicine, National Research Council Scientific 
Criteria to Ensure Safe Food, 2003.
---------------------------------------------------------------------------
    Starting in the 1990s, Senator Richard Durbin and Representatives 
Rosa DeLauro, Frank Pallone and John Dingell introduced bills that gave 
FDA enhanced authority to prevent foodborne illness. Senator Durbin and 
Representative DeLauro also introduced legislation to create an 
independent single food safety agency.
    In the 111th Congress, nearly a dozen bills have been introduced so 
far, including H.R. 1332, The Safe FEAST Act sponsored by Rep. Costa 
and several Members of this Committee. All the bills embrace at least 
some of the elements identified by the NAS and GAO as necessary for 
securing the safety of both domestic and imported foods.
    Some key elements of what is required for an effective modern food 
safety system appear in the recommendations of almost all of the 
outside panels and most are reflected to some degree in all the bills 
introduced in Congress this year.
Frequently Noted Elements of An Adequate Food Safety System

    1. Create a system that addresses risks of foodborne illness that 
        may arise anywhere along the food chain, from farm to fork and 
        into the consumer's mouth. Microbiological pathogens can enter 
        food at any point.

    2. Make prevention the focal point of the new system.

    3. Require food companies to develop and implement controls to 
        assure that the food they sell is safe.

    4. Require food safety agencies to establish and enforce microbial 
        performance standards that will reduce pathogens to a minimum 
        and assure an acceptable level of public health protection.

    5. Protect the integrity of the system and the food supply by 
        providing for comprehensive enforcement. This should include: 
        regular oversight (inspection) conducted by public officials 
        and based on the risk presented by the product; require 
        sampling and testing for pathogens and reporting; assure food 
        safety officials have access to company food safety records; 
        and authorize agencies to require recalls of contaminated food.

    6. Ensure that the food we import is as safe as that produced and 
        processed here.

    7. Provide for research capacity to develop the best means to 
        address current and emerging pathogens.

    8. Assure adequate financial and staff resources in an 
        institutional setting that provides the leadership, visibility, 
        and status needed to support the program.

Comparison of How Existing Food Safety Authorities and Organizations 
        Address the Elements of a Modern Food Safety Program
    As a starting point for thinking about what kind of statutory 
changes may be necessary to build the kind of system envisioned in 
these elements, it is useful to examine the basic legal mandates of the 
two agencies and compare how they address the elements under current 
law.
    The Food and Drug Administration has responsibility for ensuring 
that all domestic and imported foods except meat, poultry, processed 
eggs and, since passage of the 2008 Farm Bill, farm-raised catfish, are 
safe, nutritious, wholesome and accurately labeled. Domestically, FDA 
has responsibility for some 44,000 food processors, 114,000 food 
retailers and 935,000 restaurants.
    The Food Safety and Inspection Service is responsible for the 
safety, wholesomeness and proper labeling of most domestic and imported 
meat and poultry and their products sold for human consumption. It 
regulates over 6,000 domestic meat, poultry plants and egg plants.

1. System Authority Should Extend From Farm to Fork
    FDA--has some ability to regulate on-farm activities. However, this 
ability is limited and according to the Congressional Research Service, 
FDA's general approach has been not to impose mandatory on-farm safety 
standards or inspections of agricultural facilities but to rely on 
farmers' adoption of good agricultural practices to reduce hazards 
prior to harvest. FDA issues good agricultural practices as guidance, 
not regulations; they are advisory and not legally enforceable.\11\
---------------------------------------------------------------------------
    \11\ Congressional Research Service, RS22600, The Federal Food 
Safety System: A Primer, Geoffrey S. Becker, March 3, 2009.
---------------------------------------------------------------------------
    FSIS--authority begins at the door of the slaughterhouse. Has no 
on-farm authority.

2. System Designed to Prevent Contamination and Foodborne Illness
    Prevention is a core public health value. It is always better to 
prevent a problem than try to resolve it. The language in the FFDCA and 
the FMIA and PPIA is quite similar but the results are quite different.
    FDA--system is reactive. The FFDCA contains no specific direction 
to the agency to prevent food contamination or foodborne illness. FDA's 
primary food safety authority is the power to seize adulterated or 
misbranded food. The burden is on FDA to prove a product is adulterated 
or mislabeled before it can act. To justify a product seizure FDA must 
have laboratory tests to show that the product is adulterated or 
misbranded before it acts. As a result, FDA often doesn't act at all 
until there are confirmed reports of illness or death.
    FSIS--system is preventive. Meat and poultry processors must, in 
effect, prove to a USDA inspector that the plant's product is safe and 
accurately labeled. Products can't be entered into commerce until a 
USDA inspector applies the ``mark of inspection.'' This means that 
trained Federal inspectors paid by public funds must take an 
affirmative action before food products can leave the plant.

3. System Requires Companies to Take Responsibility for Safety of Their 
        Products
    FDA--The FFDCA does not give FDA specific authority to require 
companies to establish or follow preventive controls. FDA's primary 
method of operation is to rely on each company's self-interest in 
producing safe products, and to work with the industry to encourage 
improved production practices.\12\ FDA has required HACCP systems in 
seafood and fresh juices. A HACCP plan for shell eggs has been in 
process for several years.
---------------------------------------------------------------------------
    \12\ Ibid.
---------------------------------------------------------------------------
    Virtually all large processors have some form of process control, 
many with higher standards than the government would require. Majority 
of other facilities do not have formal process controls. Very few farms 
have adopted formal systems for avoiding food safety problems.
    FDA's failure to require food companies to institute preventive 
process controls was partially responsible for the Peanut Corporation 
of America's ability to hide their activity. Since PCA wasn't required 
to show the FDA or Georgia State inspectors their plans, inspection was 
just a quick visual review of what the plant looked like at a given 
moment.
    FSIS--Since 2000, FSIS has required all meat and poultry companies 
to adopt HACCP systems and sanitary operating plans. A dozen years into 
HACCP, many companies still have not identified any critical control 
points or adopted meaningful HACCP programs. Lack of specific statutory 
authorization for HACCP and sanitation procedures prevents full 
benefits of HACCP. The agency cannot permanently withdraw inspection 
from a plant that fails to follow its HACCP and sanitation plans.
    One of the most glaring weaknesses of the FSIS system is that, 
unable to withdraw inspection from plants that fail to adopt effective 
HACCP plans, FSIS then tries to ``help'' them comply, contrary to the 
notion that this is the ``company's'' plan. This requires additional 
agency resources to assist a company that is unable or unwilling to 
develop an effective HACCP plan. It also means that FSIS is caught 
between the old inspection system in which it often was the only 
quality control in the plant, and the new system where companies are 
supposed to take ownership of their food safety plans.

4. System Requires Agencies to Establish and Enforce Pathogen Reduction 
        Performance Standards
    FDA--has no specific mandate or authority to establish pathogen 
reduction performance standards that companies must meet. FDA has 
adopted some performance criteria and standards. Government needs to 
establish a minimum acceptable level of public health protection. If 
food companies know what the standard is most will immediately set 
their own systems to meet or exceed the standard.
    FSIS--has no specific authority to establish or apply performance 
standards, nor to withdraw inspection from companies that fail to meet 
them. But agency has instituted standards for generic E. coli and 
Salmonella on animal and poultry carcasses. Lack of specific authority 
to set and enforce these standards limits effectiveness. Enforcement of 
performance standards is a key public health element but courts have 
limited FSIS's enforcement. The agency does have authority to set a 
zero tolerance standard for E. coli O157:H7 in ground beef and trim, 
and zero tolerance for Listeria and Salmonella in ready-to-eat 
products.

5. System Provides for Adequate Enforcement, applied according to the 
        risk presented by the product. Must include regular oversight 
        (inspection) by public officials to assure companies are 
        complying with standards; microbial testing and reporting; 
        access to records; mandatory recall. Food safety system 
        integrity depends upon adequate enforcement authority.
    FDA--
    Inspection--Consistent with its reactive approach to food safety, 
FDA makes little investment in preventive inspections to assure a 
company is complying with the law. FDA contracts with state governments 
to conduct inspection of some facilities and works with states to set 
safety standards for food establishments.\13\ Common practice is to 
rely on non-FDA sources for information that a particular facility may 
be in need of additional inspection or to act after having cause to 
believe a facility is connected to an outbreak of foodborne 
illness.\14\
---------------------------------------------------------------------------
    \13\ Much of the information on the basic information about FDA and 
FSIS authorities, jurisdiction and funding is from Congressional 
Research Service paper, 7-5700. The Federal Food Safety System: A 
Primer, by Geoffrey S. Becker, March 3, 2009.
    \14\ Food Safety Primer.
---------------------------------------------------------------------------
    Risk-Based Inspection--Current effort to devise mechanism to assign 
inspector based on risk. Work plan and budget say FDA inspects ``high-
risk'' facilities more often. Many plants are inspected only once in a 
decade. FDA has no organized system for determining level of risk and 
applying resources accordingly but has begun analysis of relative risk, 
working with outside groups, including the Institute of Food 
Technologists.
    Government Access to Company Records--FDA does not have authority 
to require access to plant records; does not require companies to keep 
records and provide FDA information on source of material or 
destination of products.
    Traceback--no authority or capacity to track products back to 
source.
    Recall--no authority to require recall. Recalls are voluntary but 
FDA, with a court order, can seize a product that is adulterated.
    FSIS--
    Inspection--law requires continuous inspection in slaughter and 
processing of animals and birds. For animals, FSIS must inspect before 
slaughter; individual post-mortem carcass inspection for red meat 
animals and poultry. At least daily visit to every processing plant.
    Risk-Based Inspection--Inspection resources not applied according 
to risk. Agency has been trying to devise a risk-ranking system but has 
been unable to produce one that meets scientific criteria. Statutory 
requirement to inspect every poultry carcass is not risk-based, but 
FSIS has no alternative given law and lack of data to support another 
system.
    Consumer groups oppose attempts to alter system without rewriting 
underlying law to include better enforcement tools and more science. 
Requirement to visit every processing plant daily is also not risk-
based but agency has failed to offer a valid alternative or to persuade 
Congress to change the law. FSIS has trouble meeting responsibility to 
visit every processing plant at least daily. In addition, many high 
risk meat grinding operations are visited only once daily when a more 
intensive regime would offer more protection for consumers. Plants that 
are not high risk often have same level of inspection.
    Government Access to Company Records--most records must be made 
available on request of inspector.
    Traceback--each inspected plant is identified by a plant number 
which follows product making it easier to identify products and recall 
them. Products packaged for final sale in a USDA inspected plant will 
have the plant number on the final package so that consumers can 
identify a recalled product. FSIS has no authority to track product 
back to the farm of origin. No way to determine if some ranches and 
feed lots have cattle that consistently turns up with high levels of E. 
coli contamination.
    Recall--no authority to require plant to recall products. Recalls 
are voluntary on part of plant.

6. System Ensures Safety of Imported Foods
    FDA--countries wishing to export to the U.S. may do so after filing 
registration forms with the agency as required by the Bioterrorism Act.
    As of Jan. 2009, 367,600 facilities in 180 foreign countries were 
registered to export to the U.S.\15\ The exporting country is not 
required to demonstrate its food safety system is equivalent to the 
U.S. system.
---------------------------------------------------------------------------
    \15\ http://www.cfsan.fda.gov/furls/ffregsum.html, Accessed March 
30, 2009.
---------------------------------------------------------------------------
    FDA inspects less than one percent of all the food that enters the 
country. Imported foods are responsible for a large proportion of 
foodborne illnesses that arise from FDA-regulated products. In 2006 the 
FDA stated, ``to the best of our knowledge, approximately half of the 
foods that have been associated with foodborne illness have been 
imported.'' \16\
---------------------------------------------------------------------------
    \16\ FDA Office of Regulatory Affairs. ``FY 2007 ORA Field 
Workplan,'' October 1, 2006, p. 03-20.
---------------------------------------------------------------------------
    In June 2007, FDA detained imports of farm-raised seafood from 
China because of the possibility they were contaminated with unapproved 
drug residues. In late 2008, FDA held up further imports of dairy 
products from China until importers could prove they were not 
contaminated with melamine, a toxic chemical intentionally added to 
milk to increased measured protein levels. The same chemical was 
implicated in the recall of large amounts of pet food and in infant 
formula in China.
    FSIS--no country can export meat or poultry to the U.S. until FSIS 
has certified that the exporting country has an inspection system that 
is equivalent to the U.S. In addition, each foreign plant that wants to 
export to the U.S. must be found to be operating in a manner that is 
equivalent to that required of U.S. plants.
    FSIS inspectors are present at all points of import into the 
country to carry out statistical sampling and testing to assure the 
safety of imported products. The agency inspects approximately 10% of 
all meat and poultry imports at port.

7. System Provides for Research Capacity
    FDA--little research capacity.
    FSIS--USDA does most of the government's food safety research but 
it is done at ARS and FSIS has virtually no influence over focus of 
efforts.

8. System Has Appropriate Organizational Structure and Accountability
    FDA--new paper from George Washington University's School of Public 
Health reports that no single official at FDA has a full time job 
directing food safety as well as budget and line authority over all the 
food elements of the FDA.\17\ Within FDA, food safety is dispersed 
among three organizational units, the Center for Food Safety and 
Applied Nutrition, the Center for Veterinary Medicine and the Office of 
Regulatory Affairs. Directors of each unit report to the Commissioner 
but coordination responsibility rests with Associate Commissioner for 
Foods who is housed in the Office of FDA's Deputy Commissioner for 
Operations. The Associate Commissioner for Foods, sometimes called the 
FDA's food ``czar'' has no line authority and no control over the food 
safety budget. The FDA Commissioner reports directly to the Secretary 
of HHS but historically the Commissioner has given little time to 
oversight of food safety functions.
---------------------------------------------------------------------------
    \17\ Taylor, Michael R. & David, Stephanie, 2009 Unifying and 
Elevating Food Safety Leadership at HHS, George Washington University 
Medical Center, School of Public and Health Services.
---------------------------------------------------------------------------
    FSIS--The USDA Reorganization Act of 1994 removed food safety 
activities from USDA marketing and animal health activities and created 
a separate entity to protect public health program from undue 
influence.
    The Act also created the Under Secretary for Food Safety, the 
highest ranking food safety official in government and gave this Level 
III official direct and specific responsibility for oversight and 
administration of the USDA's meat, poultry and egg inspection programs. 
Act requires that Under Secretary be someone qualified by training or 
experience to address food safety issues. Under Secretary is under 
direction of the USDA Secretary and therefore not entirely free from 
influence driven by agricultural interests. However, both Democratic 
and Republican Administrations have, since 1994, sought to appoint 
individuals with food safety or public health credentials. Industry 
continues to apply pressure to appoint someone with ties to the 
industry.

System Has Adequate Budget and Staff Resources
    FDA--the FDA's food budget for FY 2009 is $648.7 million ($210 
million for the Center for Food Safety and $438.2 million for food 
related activities of the Office of Regulatory Affairs). In FY 2008, 
there were 2,800 food related staff, 1,900 in the field and 900 
headquarters staff. FDA inspection (compliance) staff have science 
education and training.
    For most of the last 25 years, until recently, the FDA budget has 
been either reduced or flat. The food portion of the FDA budget 
suffered during part of that period because money was directed to the 
drug program in order to assure that appropriated funds were sufficient 
to keep drug user fees in place.
    FSIS--2008 budget of $930 million in appropriated funds in FY 2008, 
and $140 million in fees paid by companies that want to operate 
additional shifts beyond those covered by Federal inspection. FSIS has 
9,400 staff. Approximately 8,000 of the staff are present in meat and 
poultry plants on a daily basis. The FSIS staff includes 1,000 doctors 
of veterinary medicine. Since HACCP, FSIS has created a compliance 
staff with 300 Enforcement, Investigations and Analysis Officers (EIAO) 
and program investigators in addition to the inspection staff. A risk-
based system will require FSIS to upgrade GS level and training of 
inspectors to handle new tasks.

Conclusion
    There has been extensive discussion of reorganizing inspection 
functions. CFA supports creation of a single independent food safety 
agency that would combine all Federal food safety functions.
    As an interim step we support the approach Representative DeLauro 
has taken in H.R. 875 to divide FDA into a Federal Drug Administration 
and a Food Safety Administration within HHS, providing separate budget 
authority and leadership for food.
    CFA does not support moving meat and poultry inspection to the 
Department of HHS. Addressing the very serious problems that now plague 
FDA's food safety programs and possibly creating a new Food Safety 
Administration within HHS will be a major undertaking, not leaving 
resources for integrating a much larger program.
    In addition, as the FDA has slipped into dysfunction, the food 
safety functions of the USDA have made some progress toward a more 
modern and science-based program. Little more can be done without 
rewriting the authorizing statutes. We urge this Committee, in 
cooperation with the Obama Administration, to take the lead in 
developing new authority embracing the elements discussed here.
    Occasionally, it is proposed that FDA's food safety functions be 
moved to a new Department of Food and Agriculture. I'm not sure how 
Consumer Federation of America would feel about that. However, with or 
without food safety functions, creating a Department of Food and 
Agriculture that acknowledges and embraces all the people of the U.S. 
as its constituency is an idea whose time I hope will come.

    The Chairman [presiding.] Thank you very much. I want to 
thank all of the witnesses for being here and putting up with 
us with all this stuff going on. We didn't know the budget was 
going to be up today when we set this up.
    Dr. Murano and Mr. Taylor, the industry values the USDA 
mark of inspection. Can you tell me what the USDA mark of 
inspection means and does FDA provide an equivalent to the USDA 
mark, and if so, what level of inspection backs up the 
inspection mark?
    Dr. Murano. Let me address that a little bit, and Mr. 
Taylor can follow up as well, obviously. Mr. Chairman, the mark 
of inspection at its most basic level means that there has been 
an inspector who has actually been at the plant who has looked 
at that carcass. But it is not only that, it is also backed up 
by an entire system that was developed and implemented in the 
early 1990s as a result of some foodborne illness outbreaks. It 
is called HACCP, Hazard Analysis Critical Control Points, which 
the USDA requires every meat and poultry plant to have. And 
that program, that system, involves microbial testing, involves 
monitoring every step that is critical to control the hazards 
that may be present in that product. So it is a whole array of 
different things that are involved in ensuring to the greatest 
extent that one can that that product has been inspected, by 
not only an actual inspector being there, but an inspector that 
is looking at the entire process; not only at the carcasses 
what you can see with the naked eye, which is insufficient 
clearly because microorganisms are not seen with the naked eye. 
And this comes out of these laws that are pretty old, 
hearkening back to 1906, and so forth, that require that there 
be carcass-by-carcass inspection. And that is why there has to 
be an inspector in every plant every day from the USDA 
perspective.
    FDA is under no such laws, and therefore plants sometimes 
don't see an FDA inspector for a year or longer. And so it is a 
huge difference. You do not see a mark of inspection by FDA 
that is in the same vein, and I don't know that the public 
realizes that, the robustness and the rigor with which meat and 
poultry is inspected in this country. It is not perfect 
because, obviously, we continue to have outbreaks of meat and 
poultry products, but I would agree with Ms. Tucker-Foreman 
that there has been tremendous improvements at USDA. It is the 
Rodney Dangerfield. I will tell you that when I was at USDA as 
Under Secretary, one of the things that bothered me a lot is 
that there was not the same expectation of product that was 
inspected by FDA in terms of if there was an outbreak, FDA 
would put out the Food Safety Alerts and things like that. And 
I always said, boy, if something happened at USDA with a USDA 
product, if all we did was put out a Food Safety Alert it would 
be chaotic. We were expected to stop the outbreak. We were 
expected, rightfully so, to find out the source of the 
outbreak, to get at who and what caused the outbreak. And that 
fundamental difference between the two agencies is really 
rooted in regulations, the lack of robustness in the 
regulations that FDA operates under, but also, frankly, a 
culture, a culture of inspection that exists at USDA borne out 
of decades, and that culture is really not at FDA from my point 
of view.
    The Chairman. Mr. Taylor?
    Mr. Taylor. Since your having served at both USDA and FDA, 
I may turn out to be the designated FDA defender at the hearing 
here today, but I do want to answer your question about the 
mark of inspection and Dr. Murano's reference to the history of 
it is germane. The concept of carcass-by-carcass inspection and 
the issuance of a mark came about in the aftermath, as you 
know, of The Jungle, 1906, when gross sanitation conditions, 
diseased animals were common in the food supply. And the 
judgment, correctly, at the time was that a carcass-by-carcass 
visual inspection could solve that problem, could eliminate 
those animals from the food supply. And the mark of inspection 
and the inspection program that is in place stems from the fact 
that you have done a good job of dealing with those visible 
problems.
    The reason why the National Academy of Sciences and GAO 
have criticized that approach to inspection and said that it is 
not really contributing significantly to today's food safety 
problems is because today we are concerned about invisible, 
microbial pathogens, and the visual inspection program simply 
doesn't address those. I referred to the lack of standards in 
my testimony. One of the limitations in terms of what that mark 
stands for is that because there are not enforceable standards 
for microbial pathogens that make people sick, there is very 
wide variability across slaughter plants with respect to 
control of pathogens. Many have made enormous progress, and 
they are doing a terrific job, others less so. But the mark of 
inspection doesn't reflect in any way directly the degree of 
control over the pathogens that make people sick.
    The Chairman. Thank you. Carol, you want to comment on 
this, too? And my time is out, but we appreciate you being with 
us and the work that we did together during the farm bill, we 
very much appreciated that.
    Ms. Tucker-Foreman. Thank you. I thought it came out very 
well. Now, if we can just get the regulations out.
    I am going to agree just a little bit with both of the 
other panelists. The mark of inspection doesn't represent today 
what it did in the beginning, but it is still important. It 
does say to the American people a government official who has 
pledged to protect public health has been present and looked at 
this product. And it is not just looking anymore. Under HACCP, 
we have developed and Mr. Taylor started it, an intensive 
system of microbial testing to determine that meat and poultry 
are not adulterated. There were performance standards that were 
established when he was at USDA, and it is an important point 
to make that USDA continues to have a number of recalls every 
year. I just took a quick look at the recalls for 2008 which 
was a pretty good year for USDA; over half of the recalls that 
occurred at USDA occurred because USDA inspectors tested the 
product, found that it had E. coli or in the case of ready-to-
eat products, Salmonella or Campylobacter or Listeria and 
recalled the products before they got into retail commerce. 
This is prevention, and FDA because it is not oriented to 
prevention, the product is out there and it has been eaten and 
people get sick and then someone says, uh-oh, I guess we better 
call the FDA. That is too late in the system.
    Now, Consumer Federation and other consumer groups and the 
National Academy of Sciences have urged that Congress give USDA 
and FDA specific authority to enforce those microbial 
standards. Right now if a plant does not comply, the only thing 
USDA can do is go in and say, Hey guys, you didn't comply. And 
if they still don't comply, ultimately they send in an 
assessment team, and the assessment team sits there until the 
company finally does it right. That is not a very good use of 
public resources. There ought to be the ability to say you 
failed the test, there is the penalty, fix the problem and we 
will go on. Thank you.
    The Chairman. Thank you, and all of the panel. I just want 
to make the point which has kind of been made but to make it 
clear that you know, one of the problems here is that USDA 
actually has a law, and FDA doesn't, basically. I mean, that is 
what it boils down to. I mean, they don't have to do this 
stuff. And, like in the case of the previous panel, they don't 
have to go in and have an equivalency on the plants and so 
forth.
    You know, I still don't quite understand why they don't, 
you know. If it is pressure from the industry, that they don't 
want this stuff inspected overseas or exactly what is going on 
there, but, we are again part of the problem, the Congress. We 
haven't given these agencies the tools to do what they should 
be doing. And hopefully out of this process that we are 
starting here, we can be helpful along with the other 
committees to get these people the tools and the resources to 
do what has to be done. That is what we intend to do.
    So I recognize the gentleman from Oklahoma, the Ranking 
Member, for his questions.
    Mr. Lucas. Thank you, Mr. Chairman. Dr. Murano, some 
advocates have proposed the creation of a single food safety 
agency. Let us discuss for a moment the nature of risk profiles 
for different food products. Do they lend themselves to a one-
size-fits-all model of food inspection?
    Dr. Murano. Well, the simple answer is no, and it is 
because it is tied to risk. Some products are very highly 
processed, meaning that they have steps in the preparation of 
those products that kills microbial contaminants, for example. 
So those products are relatively safe. You know, nothing is 
absolutely safe unless it is sterilized completely which a 
canned food product is.
    So there is a degree of risk. The fresher products, the 
products that are not processed are more likely to be 
contaminated, the highly processed products, less likely to be 
contaminated after processing. And so there is a whole family 
of products that fall into many of these categories. One of the 
things that needs to happen is for there to be a recognition 
that the products that are more risky need to be subjected to 
more inspection, more monitoring, more testing. The products 
that are less risky, there can be less of that oversight.
    I will say that from my perspective on the issue of single 
food safety agency or what should we do, if we just kind of 
take all those words out of the discussion and just look at 
what makes sense, what does common sense dictate. When I worked 
at USDA and now of course I have been away for even longer than 
I served as Under Secretary, I certainly got an opportunity to 
see what USDA does, got an opportunity to see what my 
colleagues at FDA were doing and the differences in the laws 
and so forth, as the Chairman just mentioned. And it is clear 
to me that at FSIS, because of the laws, there has been as I 
said earlier a culture of inspection, an expectation that 
things would be done a certain way which I don't believe is as 
prevalent at FDA. Plus FDA, frankly, has jurisdiction over 
medical devices and drugs and other kinds of products. So they 
are spread pretty thin at FDA.
    So I would offer the suggestion that maybe what we need to 
do is play to these agencies' strengths. In other words, if 
FSIS as I believe is where the strength is in terms of food 
inspection, as one of the gentlemen from the last panel talked 
about, he even uses USDA personnel as third-party auditors of 
his fruit and vegetable operation. Perhaps all food inspection, 
not just meat and poultry, needs to reside at FSIS because 
these people have that culture over decades of being able to do 
that, and then FDA has some other activities related to food.
    One thing the Chairman mentioned or maybe somebody else 
did, I guess it was Mike Taylor, that FSIS does not have the 
ability to conduct research, and that is something that 
frankly, as a scientist, troubled me when I was at USDA. There 
are research agencies within USDA, and we tried to work as well 
as we could with them and we did. But a more direct line for 
FSIS to participate in research funding would have been 
helpful, when I was there.
    So I will just finish by telling you, sir, that to me, 
putting everything under one umbrella, even though it may sound 
good, we need to study that very carefully. What makes most 
sense to me is look at the agencies we have now, play to their 
strengths, and frankly the laws need to be changed. But FSIS is 
more adept to conduct inspections, I believe, at this point 
than any other agency in the government .
    Mr. Lucas. Thank you, Doctor. Ms. Tucker-Foreman, do you 
think FDA authority should be extended to regulate on-farm 
production practices?
    Ms. Tucker-Foreman. Yes, sir, in some cases I do. We have 
supported that legislation.
    Mr. Lucas. I guess one of the concerns I have always had, 
from my understanding they have something like 1,900 field 
personnel, and they are already charged with the responsibility 
with 44,000 food processors to look at and 114,000 retail 
establishments, 900,000+ restaurants. I just have always been 
concerned about how we then expand that out to cover probably 
two million-plus farms across the country. Tell me with the 
time remaining that I have how you envision how we would be 
able to do that.
    Ms. Tucker-Foreman. Let me answer you very quickly since 
your time is up, and I can talk to you about it in more detail 
later.
    Mr. Lucas. Of course.
    Ms. Tucker-Foreman. First of all, under Congresswoman 
DeLauro's bill, H.R. 875, there are categories of risk 
established so that some plants, those with the highest risk, 
would be inspected most frequently, and those with lower risk 
would be inspected less frequently. In addition, there is a 
provision that you have the assistance of state governments and 
even some third-party certifiers for on-farm work. There is no 
way you are ever going to give FDA enough inspectors to do that 
job, so you are absolutely right.
    Mr. Lucas. Mr. Chairman, would you indulge me with one more 
question? If FDA issues regulations regarding on-farm 
production practices in the United States, do you believe that 
these identical regulations should be enforced on foreign farms 
producing products that are then imported into the United 
States?
    Ms. Tucker-Foreman. Oh, I can certainly agree with you on 
that because again, to my mind, the greatest strength of the 
Meat and Poultry Inspection Program is the equivalence. Now, 
the trade folks just don't like that equivalence. They say, we 
are only getting meat and poultry from 34 countries. All you 
have to do to export FDA-regulated products to the United 
States of America is register under the Bioterrorism Act.
    Mr. Lucas. To flesh up in the way that would be necessary 
for FDA to be able to do this, you know how challenging 
appropriations are in this place. So from your perspective, 
would you envision a user-fee system that would generate the 
revenue to provide the enforcement?
    Ms. Tucker-Foreman. No, registration fee yes, and we have 
urged the adoption of registration fee on food processing 
companies. I really think that the on-farm program, the place 
that it is needed most, is with regard to produce, fresh 
produce, that is being shipped as fresh produce. And we think 
that Senator Durbin and Congresswoman DeLauro have developed 
mechanisms that would ease the demands on FDA for inspection 
resources to do that.
    Mr. Lucas. Mr. Chairman, I appreciate the Committee's 
indulgence on extra time.
    The Chairman. I thank the gentleman. The gentleman from 
Georgia, Mr. Scott.
    Mr. Scott. Thank you very much, Mr. Chairman. As you may 
know, I am Chairman of our Subcommittee on Livestock, Dairy, 
Poultry, Seafood, and Food Safety and Inspection for those 
areas come under us. I am very concerned about the fact we are 
not moving even fast enough. But let me first start with you, 
Mr. Taylor. In your testimony, you mentioned that FDA lacks the 
resources to adequately inspect food facilities. Would you 
please clarify for us exactly what constitutes an inspection by 
the FDA? My understanding is that such inspections are actually 
just audits of food establishments, and the agency never 
actually inspects the food itself. Does the FDA notify food 
establishments in advance that they will be coming to inspect?
    Mr. Taylor. First of all, there is no one type of FDA 
inspection. There are different kinds of inspections based on 
the facility and based on the reason for the inspection. And 
those inspections are unannounced, and they do include more 
than just auditing. In fact, FDA, one of the problems it has 
got with its statute, it does not have routine access to the 
records that relate to a company's food safety system. They 
need that access. In fact, the typical inspection includes 
visually observing and taking samples from the production line 
of the food itself, samples from the equipment to see if it is 
contaminated. So it is a direct inspection, hands-on 
inspection, of the facilities and the food there.
    Mr. Scott. But I mean, are you adamant on your point that 
the FDA lacks the resources to adequately inspect food 
facilities?
    Mr. Taylor. The inspection frequency that they are able to 
achieve, if you average out the number of inspections they are 
able to do annually, and the number of plants, averages out to 
about one every 10 years. I consider that inadequate resources. 
There is a critical point here though which comes up, and it is 
a comparison between USDA and FDA. The gap in inspection 
intensity is obviously enormous, and that reflects a lot of the 
history of why we do what we do on meat and poultry, why we do 
carcass-by-carcass. And you can debate whether that makes 
sense. You don't want to aspire, I would argue, to a system at 
FDA for all the rest of the food supply and all of its 
diversity that emulates the USDA approach, which is all about 
inspection in a very constant way.
    FDA inspection will be sufficient and effective when it is 
with respect to enforcing a company's duty to have modern, 
preventive controls. If the company is not obligated to have 
modern, preventive controls, then FDA is in the position of 
looking around for the problem as opposed to being able to yes, 
audit the company's system but also take the verification 
samples, do the microbial testing and so forth to really, in an 
efficient way, determine whether that company is operating an 
effective system.
    Mr. Scott. Dr. Murano, let me ask you as a follow-up on 
that, how does what Mr. Taylor is saying compare to how FSIS 
conducts its inspections?
    Dr. Murano. Well, sir, as I alluded to, because FSIS is in 
the plants every day, they have access to the records that are 
the food safety records that the plant has. If they have an 
operation where they are processing, say, hot dogs, they look 
at the records that the plant is keeping of the temperature 
controls, for example, for the oven, their sanitation operating 
procedures and records of the percent chlorine in a solution 
that sanitizes equipment, things of that nature, all the time. 
They are able to look at that as well as take samples, and that 
is the essence of the difference. I agree with Mr. Taylor that 
not every product requires that kind of oversight, but 
certainly on a regular basis, on a frequent basis being able to 
look at the complete process is extremely important. And it is 
the basis for why USDA has done so well. Again, not perfect 
because we are dealing with human beings, and human beings make 
mistakes, but it is a fundamental difference that has enabled 
USDA to be much more proactive, much more preventive.
    Mr. Scott. Let me ask you one other thing as my time is 
running out, I listened intently to your testimony, and it 
seems to me that I picked up that you were saying that the weak 
link is in plant operators. Is that an accurate assessment?
    Dr. Murano. Well, let me put it to you this way. There are 
several links in this food safety chain, and just like 
inspectors are an important link, another important link, if 
not the most important link, are the plant operators 
themselves. They are the ones that are making the food, that 
are producing the products. So just as we went about training 
our inspection personnel, we knew that if they had been making 
mistakes based on lack of adequate scientific training and so 
forth, that the plant personnel maybe needed some looking into. 
And so we, as a regulatory agency, what we could do is mandate 
reassessments to make sure that those operators looked at their 
process, explained and justified why they did what they did 
based on science, and that had not happened very well before. 
That made a difference.
    Mr. Scott. By plant operator, you are distinguishing a 
plant operator from regular plant worker, food processor, 
somewhere down the line. Is that plant operator a supervisory 
designation?
    Dr. Murano. Yes, sir, that is what I mean. A supervisor 
that would be accountable for monitoring the various steps in 
the process and for supervising their own line people.
    Mr. Scott. Okay. Thank you very much, Mr. Chairman.
    The Chairman. I thank the gentleman. I think we are going 
to recess. We have one vote. If the panel would stay if you 
have time to do that, I know the Members have some more 
questions. Mr. Boswell will be recognized as soon as we get 
back, and we appreciate your patience and being with us. It is 
very helpful, and it is just how things go around here. You 
guys know about that.
    Dr. Murano. I understand.
    The Chairman. The Committee will be in recess until the 
call of the chair.
    [Recess]
    The Chairman. The Committee will come back to order. Is Mr. 
Taylor in the vicinity? All right. We appreciate the panel 
sticking around. I now recognize the gentleman from Iowa, a 
Subcommittee Chairman for such time as he may consume.
    Mr. Boswell. You got by Mr. Taylor. Is he, Chandler----
    The Chairman. You want to ask Mr. Taylor?
    Mr. Boswell. Well, I kind of want to go with him in a 
minute anyway.
    The Chairman. We will find him.
    Ms. Tucker-Foreman. They sent out a party.
    Mr. Boswell. Okay. Before we get started, I will just say 
this. First off, it is a great panel, Mr. Chairman, and they 
bring the expertise that we have been looking for. So we are 
certainly glad to have you here, and what you have done in the 
past that certainly makes you eminently qualified to be with us 
and help us out. I want to talk about some of the things we are 
importing here. We will give Chandler just a second here and we 
will go on without Mr. Taylor.
    The Chairman. Here he comes.
    Mr. Boswell. Mr. Taylor has arrived. What I want to do, to 
include you in, Mr. Taylor, and of course the whole panel, is 
with a recent CODEL we went to Japan and Vietnam and Korea and 
so on, and some concerns were brought back from that visit, 
particularly Vietnam. I want to ask some questions to you, but 
can you tell me, Mr. Taylor and the rest of you jump in, can 
you tell me how our fish and seafood are categorized with 
respect to risk? And we are all hearing very troubling things 
about the fish and seafood that is currently being imported 
into the United States. In the recent past FDA has issued 
import alerts of imported farm-raised fish and seafood, 
particularly from China. However, I was surprised to learn that 
domestic fish are only inspected by the Department of Commerce 
on a voluntary basis, and I wonder if that should be mandatory. 
And I would like for you to comment on this. There are about 
two or three items in there and I got more to follow.
    Mr. Taylor. Thank you. If I may, let me just correct the 
facts on the domestic inspection. There is as voluntary 
Department of Commerce National Marine Fisheries Seafood 
Inspection Program, but it is a voluntary fee-for-service thing 
that is done by Commerce to support the trade, essentially. 
That is not the regulatory inspection program. FDA has a 
regulatory seafood HACCP inspection program, and they do 
inspect domestic seafood facilities. And in fact, they are 
typically considered, particularly ones processing raw seafood, 
high-risk facilities in terms of the frequency of inspection 
they get by FDA. So, FDA strives, I would have to check to be 
sure, but currently strives for at least annual inspection of 
high-risk domestic seafood establishments.
    Mr. Boswell. So to put it in the right categorization, to 
categorize this, how is that done?
    Mr. Taylor. Again, it has been a while since I have been at 
the agency.
    Mr. Boswell. Okay.
    Mr. Taylor. I haven't looked at this. I can certainly 
provide that for the record. Seafood is inherently a higher, 
particularly when it is being processed for sale in raw form, 
an inherently high-risk food. It promotes microbial growth. 
There are a lot of hazards that can come in. That is the one 
area in which FDA uses current authority to mandate modern 
preventative controls as HACCP systems mandated by FDA for 
seafood. The issue of the Chinese imports and those import 
alerts had to do with animal drug residues and chemical 
residues from just the practices that go on in fish farming in 
some situations in China and even elsewhere in Asia. And so 
this is based on testing of the product, detecting illegal 
residues that don't meet our U.S. standards for such residues 
in food.
    Mr. Boswell. That is a concern. To continue, where does 
Commerce's authority end and FDA begin and how do they work 
together?
    Mr. Taylor. Again, FDA is the food safety regulatory agency 
with respect to seafood, other than catfish if I may note.
    Mr. Boswell. I was going to get to that in just a minute.
    Mr. Taylor. Yes, sir. Department of Commerce has no food 
safety regulatory authority. Again, they are conducting a 
voluntary service, basically, for the industry. They look to 
FDA standards as the template for their inspection, so they are 
borrowing FDA standards. They are providing a level of 
inspection that, frankly, FDA is unable to provide and that 
some companies want to have for their business purposes.
    Mr. Boswell. So if we are not mandating domestic inspection 
at face, how can we guarantee the imports are safe? And you 
have just answered that, even if the importers meet the 
equivalent standards.
    Now that we are giving FSIS the authority to inspect 
catfish, what exactly will change when the authority is 
transferred from FDA to FSIS?
    Mr. Taylor. I think, Congressman, that remains to be seen 
based on how USDA chooses to implement that, and the nature of 
the program that they design. I hope that it will be a HACCP-
based approach, and I hope they will find a way to make 
efficient use of inspection resources. There are a lot of 
catfish out there.
    Mr. Boswell. Well, I hope you are right as well. What 
specifically will change, with regard to inspection presence at 
catfish farms and slaughter and processing facilities, and how 
will importers be affected? You may want to note that I would 
like for Dr. Murano to jump in, too, but would you like to 
finish up on anything you want to say, Mr. Taylor?
    Mr. Taylor. No, I hope I have answered your question.
    Mr. Boswell. Well, you might want to pursue it a little 
more.
    Dr. Murano. Sir, I would agree, and certainly based on my 
experience at USDA, I would expect that USDA would apply the 
same principles as they do to meat and poultry to the catfish. 
It is muscle food, after all. So the same kinds of things 
happen, in the harvesting would be akin to the slaughter part 
of things, the processing in terms of cleaning and packaging 
and all of that, all of those things would apply, and 
therefore, the same system, the HACCP preventive system I would 
expect is what would be implemented with inspection that is, I 
believe, not required for it to be carcass-by-carcass with 
catfish. I don't think that is the case. So I am sure it will 
be a modification. But I would expect that they would do it 
with more rigor than has been done in the past.
    Mr. Boswell. This is my last question, Mr. Chairman, but 
would you feel, any comment from anybody, that as you check 
this out and food safety being the concern, we have certainly 
got to look at the processing and the packaging all that. I 
would like to know your thoughts about going out for catfish, 
for example, the spawning, the environment they are raised in, 
how concerned would you be about that?
    Dr. Murano. Certainly. I think that is very important. In 
fact, when it comes to cattle, there is a lot of contamination 
that happens when the animal is still alive. So some oversight 
over the production side of things of the live animal is 
required and is something that, frankly, needs to be applied to 
cattle as well. It is more difficult because you have an open 
environment that is a lot more difficult to control what goes 
on, but there are certain practices, best practices, sir, that 
can be identified that producers can adhere to that would 
minimize, never eliminate, but minimize contamination.
    Mr. Boswell. I appreciate that. It seems to me like I have 
always heard that, for example, fish or catfish in particular 
pick up about everything in the environment. And if they are 
spawned and raised in unsanitary conditions, I won't quite go 
to farm language here, and there would be some concern. Would 
that be correct?
    Dr. Murano. That is correct. I am no fish expert, but I 
understand that certainly when you decontaminate fish by a 
process called purification where you put the fish in a tank 
with water that is clean and you process that for a while. So 
you can remove the contamination. But you are right, the place 
where it is raised certainly can have an impact on the 
colonization of microorganisms in that product.
    Ms. Tucker-Foreman. If I could add one thing about a the 
law that was passed last year, it applies only to farm-raised 
catfish, and the inspection is of processing plants. It applies 
only to domestic, farm-raised catfish and the inspection is of 
processing plants. And it is required to be continuous, which 
means that somebody will have to be in the plant once a day. It 
remains to be seen whether the Department will require that 
HACCP principles be attached, since it is required, as Dr. 
Murano said, for all the other products regulated by FSIS. I 
assume that that will be the case, but we haven't seen the 
regulations yet.
    As for wild catfish, I grew up on them. They ate 
everything. That is what made them taste good.
    Mr. Boswell. Okay. But would you share the concern that Dr. 
Murano said about the environment where they are spawned and 
raised in, though, in the fish farm operations?
    Ms. Tucker-Foreman. I think it is an interesting question, 
who will have that jurisdiction now because I am sorry, I can't 
remember exactly the legislation addressed, the ponds. These 
are all farm raised, so they have a very controlled 
environment.
    In terms of on-farm food safety, we have advocated at 
Consumer Federation for years that on-farm food safety 
regulations of some sort be applied in order to use process 
controls, have people set standards, have the government set 
the standards. And then have companies have process controls 
that will assure that animals are not unduly contaminated all 
the way from birth to the point where they are slaughtered, 
because meat inspection now starts at the slaughterhouse, just 
a little late.
    Mr. Boswell. I appreciate that very much, particularly 
since the trip. And I guess equivalency is the word I may have 
left out. We are talking about catfish. We understand that, but 
they are fish that are very similar as you well know. There is 
some debate whether they are or they aren't. I guess I am also 
concerned about that as I am about a fish farm you just 
described. I think about a plot if you will, a tank if you 
will, earthen tank or whatever, but also some of them are put 
in rivers and considered fish farms, and there is not too much 
care about what goes into the river. That is a concern. So 
thank you very much, Mr. Chairman. Thank you, panel.
    The Chairman. Mr. Kissell?
    Mr. Kissell. Thank you, Mr. Chairman. Thank you, panel. I 
had asked the first panel this question, and I want to ask you 
all the same thing. Of all the concerns about food safety, 
whether it be in the fields, processing, imports, pesticides, 
regulation, lack of regulation, whatever, what are your top two 
concerns about food safety and why?
    Dr. Murano. I can start. I will mention one, for example, 
that bothered me when I was at USDA as Under Secretary. What 
happens when you consider meat and poultry, once it is in the 
retail store and a butcher can grind product, co-mingle it, 
there are certain jurisdictions that end right there at the 
retail level, and you have the local health department that 
takes over. And I will tell you just from the experience that 
we had that there would be times that there would be outbreaks 
for example, foodborne illness, that it would have been a lot 
better to have prevented than if we had had some control, some 
way to control things at the retail level. Things can kind of 
get out of control at that point in terms of co-mingling of 
products. When we tried to identify, for example, from where 
was the outbreak originating, what product, we would find many 
times that a product was ground at the retail store from many 
different suppliers. That is what made the recalls as large as 
they were because we could never pinpoint it necessarily to one 
plant, in some cases. So that is one area that I think it would 
be nice to have more oversight, whether it is FDA or somebody 
else, have a little bit more oversight.
    And I will just end by saying the fruit and vegetable arena 
is one that is always a challenge because you have products 
that are grown outside, out of doors, with birds flying 
overhead and contaminating product that is so closely tied to 
the soil. Anything that we can do to try to put interventions 
that will decontaminate those products before they get to the 
consumer, we can go a long way because so many people want to 
have fresh produce, salads, and healthy foods like that. 
Without the processing that can eliminate those microorganisms, 
the risk is always going to be there, be it tomatoes, peppers, 
whatever it may be.
    Mr. Taylor. From my standpoint by far the highest priority 
food safety reform issue is FDA, and it is shifting FDA's 
paradigm from a reaction paradigm to prevention paradigm. That 
means very specifically a statutory mandate for FDA to require 
that all companies producing food for the commercial 
marketplace use modern preventive controls suitable to their 
operations, and that FDA have the mandated authority to set and 
enforce standards to ensure the adequacy of those controls. It 
sort of boils down to that.
    If you look at the various bills pending, most of them 
embody those and have a lot of the provisions that are 
necessary to make that happen, whether it is enforcement tools 
or inspection mandates or whatever. But that is the core as it 
shifts from a reactive paradigm to a preventive one and the 
ability to set standards and hold companies accountable for 
prevention.
    Ms. Tucker-Foreman. I agree with Mike Taylor on that, and 
second to that would be to modernize the Meat and Poultry 
Inspection Acts to have the same kind of authority to have 
enforceable standards as recommended by the National Academy of 
Sciences in 2003.
    Mr. Kissell. Thank you, panel. Thank you, Mr. Chairman.
    The Chairman. I thank the gentleman. The gentleman from 
California.
    Mr. Costa. Thank you very much, Mr. Chairman. Ms. Tucker-
Foreman, you have, I believe, made the statement and others 
that additional information is needed under the FSIS effort to 
fully implement what I refer to as a risk-based, risk 
assessment effort that uses FSIS. In your view, what data do we 
need to continue to pull through, especially as we are looking 
at the area of fresh fruits and vegetables?
    Ms. Tucker-Foreman. Congressman, you have asked me about 
FSIS. I think you meant to ask me about FDA. FSIS doesn't 
regulate----
    Mr. Costa. Yes, but under the FDA, what data would they 
require? I am sorry, I misspoke.
    Ms. Tucker-Foreman. I am not sure I have said it about FDA. 
At FSIS, we are very concerned that there is not adequate data 
to move ahead with a public health-based poultry slaughter 
system which they have proposed. With regard to fresh fruits 
and vegetables, what we think is appropriate is to require 
operations to set up process controls similar to HACCP. They 
can be HACCP. Those process controls can be as simple as the 
product and the operation underway at a particular location, or 
as complicated as those are to show that there is a mechanism 
for assuring food safety. Then, those need to be based on 
Federal health standards, public health standards. Does that 
answer your question? I am not sure that I----
    Mr. Costa. The pay-for would be the same methodology that 
you spoke in a response to my colleague who asked whether it 
would be a fee, I think. I am trying to remember the response 
you gave to him in terms of how you pay for this additional 
inspection program.
    Ms. Tucker-Foreman. And I am glad Mr. Lucas is here because 
in responding to his question, I did not factor in the most 
important element I believe which is that if each company is 
required to establish a process control system, then you can 
allocate your resources according to the adequacy of process 
control. I am assuming that nobody would be inspected on a 
daily basis under such a system.
    Mr. Costa. What are best science practices? And we had the 
analogy earlier going back to the book, The Jungle, and the 
inspection under USDA of each carcass on beef. But don't you 
think the scientific progress that has been made over almost 
now a century, in terms of best management practices, best 
science, that a random methodology can really reduce the--so 
you can ensure the detection effort?
    Ms. Tucker-Foreman. I believe we are talking here about 
what I am calling process controls, but companies establish 
HACCP plans to identify all the places in their operation where 
something might go wrong, and then identify the steps that they 
need to take to prevent that from happening. But----
    Mr. Costa. Go ahead. I just want to get my time.
    Ms. Tucker-Foreman.--that has to be in our view calibrated 
to what Federal public health standards are. Otherwise, every 
company would set up their----
    Mr. Costa. Yes, I understand a national standard, a uniform 
standard.
    Ms. Tucker-Foreman. Yes, sir.
    Mr. Costa. My bill has that.
    Ms. Tucker-Foreman. Yes, it does.
    Mr. Costa. That is not the discussion. That is not my 
question anyway.
    Ms. Tucker-Foreman. Okay.
    Mr. Costa. The point I am trying to raise is at some point, 
I mean, the standards for clean water, for example, what is 
detectable. And it was every part per million, and that is what 
was detectable. Now every parts per billion and that is what is 
detectable. Now, we are able to determine every parts per 
trillion, and when you have the limited dollars for health 
safety and health protection to get your best bang for your 
buck, I don't think because the threshold because of the 
amazing ability of science to continue to improve our ability, 
in this case for detection. That when you are doing risk 
assessment versus risk management that we ought to be going out 
trying to trace very trillionth level of element that might be 
a carcinogen, for example.
    Ms. Tucker-Foreman. I think there is a difference between 
pathogens and chemical contamination.
    Mr. Costa. No, I know there is.
    Ms. Tucker-Foreman. They don't grow those chemicals.
    Mr. Costa. Correct, but the concept is the same in terms of 
trying to get the best bang for your dollar in terms of risk 
assessment versus risk management.
    Ms. Tucker-Foreman. We call that a risk-based system where 
you allocate your resources where there is the greatest risk, 
yes, sir.
    Mr. Costa. And you support that?
    Ms. Tucker-Foreman. I do.
    Mr. Costa. Mr. Taylor, you are anxious to--my time is out. 
I don't know how you want to----
    Mr. Taylor. Just real briefly. In thinking about produce 
safety standards and what science is needed, we do need to get 
very specifically to the level of, for example, what is the 
appropriate microbial quality of the water that you use for 
irrigation in a tomato-growing operation.
    Mr. Costa. Right.
    Mr. Taylor. And you are right. I mean, you have to look at 
that from the standpoint of its contribution to a system, all 
the controls that are in place, and what the finished result 
is. It is not a matter of chasing zero in terms of microbial 
content of the water, it is looking at it in a system way.
    The point I want to make though is that one of the 
weaknesses in our system is that FDA, which is the agency 
responsible for developing those standards, has never been 
given among the mandates they have, they are not precluded from 
research but they have no mandate to do research and provide 
leadership to get that practical applied research. So again, 
this whole shift to a risk-based system does require equipping 
our regulatory agencies with the scientific tools to get this 
right from a public health standpoint.
    Mr. Costa. Dr. Murano, did you want to comment?
    Dr. Murano. Just very briefly, sir. As a microbiologist, I 
will tell you that the best way to control contaminates, 
hopefully even eliminate them, is to first know what the risk 
is. What are the contaminants likely to be found, where are 
they introduced along the line, and then you can start to 
intervene and put steps in the process to intervene. So risk 
assessment, you are absolutely right. That is exactly at the 
crux of the matter but not to have a zero risk because I think 
we all----
    Mr. Costa. That is impossible.
    Dr. Murano. That is impossible.
    Mr. Costa. You will never achieve it.
    Dr. Murano. And risk assessment ties, not only the 
likelihood of the presence but the likelihood of someone 
getting ill and with all of the----
    Mr. Costa. It is the difference of preventive health 
maintenance versus the FDA which I would liken to the emergency 
room physician.
    Dr. Murano. Exactly.
    Mr. Costa. I mean, the way the FDA works today----
    Dr. Murano. It is a little late.
    Mr. Costa.--I mean, the car wreck has happened already----
    Dr. Murano. Yes, sir.
    Mr. Costa.--or the person is already very sick and they may 
be in ICU and they are there. They are in the emergency room.
    Dr. Murano. Correct. I agree.
    Mr. Costa. There is a whole lot of stuff you could have 
done before they ever got there.
    Dr. Murano. This is correct, and they do have good 
agricultural practices, GAPs, as guidelines for farmers to use, 
but they are really not enforced to be honest with you. It is 
up to each producer as we saw with the panelists who testified 
before us.
    Mr. Costa. Well, if there is a second round there are a 
couple other questions I would like in this line, but thank you 
very much, Mr. Chairman.
    The Chairman. I thank the gentleman. I recognize the 
gentleman from Iowa.
    Mr. Boswell. Just a comment, Mr. Chairman. I want to 
compliment you for assembling this panel of expertise today. 
The trip we went on, Pete was there, Mr. Lucas, from your staff 
and made a great contribution, Chandler. I see Mr. Goule in the 
back of the room. I won't call him out because he was on FSIS, 
and we know some things that we probably ought to talk about. 
And with the expertise of these folks to work for this, we may 
want to huddle and talk some. And if everything is okay, we 
will leave it alone. If it is not, maybe we ought to do 
something about it. Thank you.
    The Chairman. I agree with you and we need to get some of 
these trade people in here and straighten them out. That is 
part of the problem with all this stuff in my opinion. I just 
wanted to, if I could, ask a question.
    You know, it seems to me that these companies that are in 
this business that have developed brand names, they have put a 
lot of money into developing brands and so forth--and I may be 
getting off field here--they seem to me to be more focused or 
concerned on this than people that don't have that situation 
because if they have a problem, it really hurts them. So they 
have a very good motivating influence to make sure that 
whatever they are doing is not a problem. And it seems like 
with a lot of these things that crop up, it is some little 
company that doesn't have a brand name that is in the middle of 
all of this that nobody ever heard of. Is that something that 
is taken into consideration when you are looking at risk in 
terms of--not scientific, but it does have a big influence or 
at least in my mind--and I would like to know what you think 
about that.
    Dr. Murano. If I may, Mr. Chairman, very quickly I will 
give you a very good example of that being so true. The 
companies, the small companies, that don't have a recognizable 
brand that supply to bigger meat and poultry companies, 
sometimes, were the cause of the problems in meat 
contamination. And so when we order the reassessments of HACCP 
plans, one of the things that we required is that these plants 
would have to verify from their suppliers that things were done 
right. So, when you start to put the burden on the companies 
that want to protect their brand, it is in their best interest 
for many reasons, public health reasons, their bottom line as 
well, to do the right thing. It kind of goes downstream and 
they start requiring it of their suppliers that may not be as 
accountable as those big companies are.
    The Chairman. But we as a government, do you think we 
should inspect those people more?
    Dr. Murano. And we do, and that is exactly right. At FSIS, 
that is what we started to discover is that we needed to go to 
those companies that maybe were falling through the cracks, if 
you will, that were not being monitored as robustly as they 
should have been, that they themselves maybe didn't have the 
expertise. We found that out with Listeria. That was a big 
problem because a lot of mom and pop operations producing deli 
meats were the cause of outbreaks. And so we started to target 
those companies more through our new cadre of inspectors that 
were doing the more thorough analysis.
    The Chairman. Mr. Taylor, it looks like you wanted to----
    Mr. Taylor. Yes, I guess I hesitate to make it a big 
company/small company issue. I think the fact is that there are 
different business incentives for companies to put extra effort 
into food safety, and brands are very much one of those 
factors. A lot of small businesses do fantastic job on food 
safety as well. I think there is a much bigger point here, 
though, suggested by your question is that innovation on food 
safety has typically come from the private sector, from leaders 
in the industry who have incentives to do more. Certainly when 
we were trying to put the HACCP system in place following the 
Jack in the Box outbreak in the early 1990s, McDonald's was 
driving progress, Jack in the Box was driving progress through 
their systems way faster than we were able to do it. And there 
are big retailers today who have specifications, supply chain 
management techniques, traceability systems that really 
represent best practices, and government needs to learn from 
those. To figure out how you set--create a level playing field 
that is workable across an industry that elevates all of the 
players to a level that meets public expectations with those 
industry best practices leadership really providing a lot of 
input into where standards should go.
    Ms. Tucker-Foreman. If I could add just one thing to that, 
I absolutely agree that the brand name is desperately important 
and people protect it, but they have to have some help. The 
Chief Executive Officer at Kellogg testified that it cost his 
company $65 to $70 million to recall the peanut products that 
were contaminated by peanuts from Peanut Corporation of 
America. And they had supply chain management. They paid a 
certifier to go in and certify that plant, but the certifier 
kind of went in and looked around, didn't check it very well, 
and the company was able to hide records because there was no 
food/drug law that said you can't do that and you have to 
provide them to inspectors from Georgia and FDA.
    So there is always going to be somebody who tries to get 
around the best system, but systems get set up assuming, just 
like the cop on the beat, that somebody will not play by the 
rules and you want to reduce their window for not playing by 
the rules to the smallest one that is possible. Thank you.
    The Chairman. Thank you. I don't know, we have one more 
panel. Everybody is not completed. I guess we will dismiss this 
panel. Dr. Murano, Mr. Ralph Hall is waiting back there for 
you. He has been patient. Welcome to the Committee, Ralph.
    So thank you very much to this panel, and thank you for 
being with us and being so patient. It was very helpful.
    We will call the next panel, which we apologize to for 
making you sit through this whole ordeal here today, but I 
would encourage the Members that are here to stay and listen to 
this. They have done some good thinking, and they have some 
ideas that should be considered by the Committee. And from my 
home State of Minnesota, which has been one of the leaders in 
ferreting out a lot of these issues, we are very proud of our 
people there that have done some outstanding work in some of 
these food safety issues. So we welcome to the Committee from 
the SUPERVALU Corporation in Minnesota, Dr. Hanlin who is their 
food safety person. I don't know exactly what your title is, he 
has been at a number of other companies and he is accompanied 
by Mike Erlandson who a lot of you may know used to be Mr. 
Sabo's Chief of Staff. So welcome to the Committee, and thank 
you for your patience and sitting through all of this until we 
got here. You are recognized, Dr. Hanlin.

STATEMENT OF JOHN H. HANLIN, Ph.D., VICE PRESIDENT FOOD SAFETY, 
               SUPERVALU INC., EDEN PRAIRIE, MN;
           ACCOMPANIED BY MICHAEL S. ERLANDSON, VICE
          PRESIDENT GOVERNMENT AFFAIRS, SUPERVALU INC.

    Dr. Hanlin. Good afternoon, Chairman Peterson, Ranking 
Member Lucas, Committee Members, ladies and gentlemen. My name 
is John Hanlin, I am the Vice President of Food Safety at 
SUPERVALU. We are one of the largest grocery chains in the 
United States, and I refer you to figure 1 of the packet that I 
hope you have in front of you that will tell you a little bit 
more about who we are.
    We are based in Minnesota. We operate over 2,500 retail 
stores, 35 distribution centers and employ over 190,000 people. 
Many of you may know us better by the banners under which we 
operate, and these include ACME and Shaw's in the Northeast, 
Jewel/Osco, Cub Foods, Albertson's on the West Coast, and 
others.
    I am joined this afternoon by Mike Erlandson. Mike is 
SUPERVALU's Vice President for Government Affairs, and we bring 
a unique perspective to the national discussion on improving 
the safety of our nation's food supply. I have almost 25 years' 
experience working in the food safety area on both the 
manufacturing and the retail aspects of the business. And prior 
to joining SUPERVALU, I worked for companies that included 
Campbell Soup, The Pillsbury Company and General Mills. Mr. 
Erlandson spent 20 years working here in the nation's Capitol 
as Chief of Staff to former U.S. Congressman Martin Sabo from 
Minnesota.
    As one of the largest grocery store chains, we find 
ourselves removing products from our shelves and our DCs almost 
daily due to food safety issues reported to us by the USDA, FDA 
and food manufacturers. Consumers are losing confidence in the 
food supply. Equally important is the fact we have entered a 
new age of food safety. The same bacteria that were 
traditionally associated with beef, poultry, eggs and pork are 
contaminating raw agricultural commodities, and people are 
getting sick.
    Several of the largest outbreaks of E. coli O157:H7 and 
Salmonella in recent memory have been associated with fruits 
and vegetables. For example, the spinach out break of 2006, 
last summer's Salmonella outbreak due to jalapeno peppers and 
possibly tomatoes and most recently peanut butter.
    If you refer to figure 2 in your handouts, as you well 
know, both USDA, on the right hand of the slide, and FDA lead 
our food safety inspections systems. USDA has primary 
responsibility for meat, poultry and eggs products, while FDA 
has jurisdictional responsibility over everything else.
    In the past, this made sense given the historical 
association of foodborne illness with animals and poultry, a 
diet different than today's and a simpler supply chain. But 
currently inspection of meat and poultry and its products is 
not always clear-cut. On figure 2 about halfway down you will 
notice several arrows going from right to left. Under some 
circumstances, meat, poultry and egg products move from USDA 
inspection to FDA jurisdiction depending upon how the item is 
manipulated further down the manufacturing or the supply chain.
    For example, in figure 3 we show a frozen breakfast entree 
comprising a sandwich with two side items. This product is 
under inspection of the USDA, and you will see that mark of 
inspection on left-hand side. However, a breakfast sandwich-
only product, as shown in figure 4, is not under the inspection 
of the USDA. Similarly, in figure 5 you see a steak Panini-
style product. This product is fully enrobed by bread and is 
under USDA inspection; however in figure 6 a similar steak 
Panini-style sandwich that looks more like a sandwich is not 
under USDA inspection. And finally, in figure 7, these 
cheeseburger sandwiches are not required to be inspected by the 
USDA nor do they bear the USDA mark of inspection.
    We show these slides to highlight the fact that all of 
these products generally carry the same relatively low food 
safety risk, yet the inspection requirements vary differently. 
I will come back to this notion of risk-based inspections in a 
moment as we offer some ideas on new approaches to risk-based 
inspections and a re-deployment of resources that we have 
today.
    We need to modernize our food safety inspection and 
enforcement system. Consumers are changing their dietary 
habits. They are listening to the messages about the importance 
of increased consumption of fruit and produce. And as I said, 
organisms traditionally associated with animals and birds can 
contaminate fruit and produce and make people sick.
    Our supply chain grows in complexity. A few lots of a raw 
agricultural commodities when used as an ingredient in other 
products can contaminate hundreds of products representing 
millions of pounds of food. Given all of these converging 
factors, we propose a refocus and re-alignment of the current 
Federal food safety inspection systems. Specifically we propose 
taking the successful risk-based USDA surveillance, inspection 
and enforcement model that has helped reduce the incidence of 
Salmonella in poultry, and has highlighted the challenges with 
reducing E. coli in ground beef, and expanding that risk-based 
inspection model to other agricultural commodities like spinach 
and other leafy greens, tomatoes, fresh fruits, peanuts, grains 
and other raw agricultural commodities. This is shown in figure 
8. In other words expand USDA's risk-based inspection system to 
include commodities that today receive minimal inspection due 
to budget challenges at FDA.
    What we propose in figure 8 is to focus USDA risk-based 
efforts against improving the safety of all commodities, 
particularly those commodities that are consumed in the raw 
state, or those that are cooked or pasteurized and eaten 
without a further microbial step. We believe an approach like 
this--pushing food safety upstream in the supply chain, that 
will help all of us. It will do three things. It will reduce 
overall public exposure to pathogens, thereby improving food 
safety; it will provide greatest synergies in the 
implementation of good agricultural practices; and we believe 
it will strengthen international competitiveness of U.S. 
agriculture.
    As I close here, I would like to go back for a minute and 
talk about redeployment of resources. This type of model would 
enable the agency to deploy resources against the greatest food 
safety risks. Imagine for a moment being able to redeploy the 
FTE resource currently inspecting a facility making frozen 
sandwiches as an entree and re-training that inspector to 
inspect and be in a peanut facility every day, or perhaps 
inspecting and surveilling and sampling a spinach farm just 
prior to harvest. We believe the proposed model would work if 
we, as a nation, create a single food agency or whether we 
maintain dual jurisdictional responsibilities within USDA and 
FDA.
    In a dual role we would envision FDA providing the food 
safety leadership further down the supply chain, for example, 
in the manufacture of frozen pizza, entrees, canned soup, 
broths, sauces, snacks, and other packaged products.
    In closing we understand where our food safety risks are. 
We must look beyond the current meat and poultry divide and 
focus on food safety systems across all categories of 
commodities using a risk-based approach. There is nothing more 
important than safe food to those of us in the food business 
and all of us as consumers.
    Mr. Erlandson and I look forward to further discussions, 
and all of us at SUPERVALU look forward to working with you to 
ensure that we prevent foodborne illness. Thank you.
    [The prepared statement of Dr. Hanlin follows:]

   Prepared Statement of John H. Hanlin, Ph.D., Vice President Food 
                Safety, SUPERVALU INC., Eden Prairie, MN

John H. Hanlin, Ph.D.--Vice President Food Safety, SUPERVALU INC.

Michael S. Erlandson--Vice President Government Affairs, SUPERVALU INC.

    Good morning Chairman Peterson, Committee Members, ladies and 
gentlemen,

    My name is John Hanlin, I am the Vice President of Food Safety at 
SUPERVALU. We are one of the largest grocery chains in the United 
States. I refer you to figure 1 of your packet. We are headquartered in 
Minnesota and operate over 2,500 retail stores, 35 distributions 
centers and employ over 190,000 people. Many of you may know us better 
by the banners under which we operate. These include ACME and Shaw's in 
the Northeast, Jewel/Osco in the Chicago area, Cub Foods in Minnesota, 
Albertson on the West Coast, Save-A-Lot nationally and several others.
    I am joined this morning by Mike Erlandson, SUPERVALU's Vice 
President for Government Affairs. We bring a unique perspective to the 
national discussion on improving the safety of our nation's food 
supply. I have almost 25 years experience working in the food safety 
area on both the manufacturing and retail aspects of the business. 
Prior to joining SUPERVALU, I worked for companies that included, 
Campbell Soup Company, The Pillsbury Company and General Mills. Mr. 
Erlandson spent 20 years working here in the nation's Capitol as Chief 
of Staff to former U.S. Congressman Martin Sabo from Minnesota.
    As one of the largest grocery store chains, we must remove products 
from our shelves and our DC's almost daily due to food safety issues 
reported to us by USDA, FDA and food manufacturers. Consumers are 
losing confidence in our food supply and this has been highlighted in 
several public opinion surveys of recent.
    We have entered a new age of food safety. Scientific advances in 
the fields of epidemiology, DNA fingerprinting of pathogens and good 
laboratory practices, are showing that the same bacteria that were 
traditionally associated with beef, poultry, eggs and pork are 
contaminating raw agricultural commodities. Several of the largest 
outbreaks of E. coli O157:H7 and salmonellosis in recent memory have 
been associated with fruits and vegetables, e.g., spinach, last 
summer's outbreak due to jalapeno peppers and possibly tomatoes and 
most recently peanut butter.
    If you refer to figure 2, as you well know, both USDA (right hand 
side) and FDA (left hand side) lead our food safety inspections 
systems. USDA has primary responsibility for meat, poultry and eggs 
products, while FDA has jurisdictional responsibility over everything 
else we eat.
    In the past, this made sense given the historical association of 
foodborne illness with animals and poultry, a diet different than 
today's and a simpler supply chain. Currently inspection of meat and 
poultry is not always clear cut and sometimes a meat and poultry 
containing product is under FDA jurisdiction, not USDA inspection.
    On figure 2, you'll notice several arrows going from right to left. 
Under some circumstances, meat, poultry and egg products move from USDA 
inspection to FDA jurisdiction depending on how the item is manipulated 
further down the manufacturing chain.
    Figure 3 shows a frozen breakfast entree comprising a sandwich with 
two side items. This product is under inspection of the USDA (mark of 
inspection on left hand side). However, a breakfast sandwich-only 
product (figure 4) is not under the inspection of the USDA. In figure 5 
you see a steak Panini-style product. This product is fully enrobed by 
bread and is under USDA inspection; however in Figure 6 a similar steak 
Panini-style product more in line with a sandwich is not under USDA 
inspection.
    Similarly in Figure 7, these cheeseburger sandwiches are not 
required to be inspected by the USDA nor bear the USDA mark of 
inspection. We show these slides to highlight the fact that all of 
these products generally carry the same (relatively low) food safety 
risk yet the inspection requirements vary differently. I'll come back 
to this notion of risk-based inspections in a moment as we offer some 
ideas on new approaches to risk-based inspection and a re-deployment of 
resources.
    We need to modernize our food safety inspection and enforcement 
system. Consumers are changing their dietary habits--they're listening 
to the messages about the importance of increased consumption of fresh 
fruit and produce. Our scientists in government, at Universities, in 
industry and those working for consumer groups understand how organisms 
traditionally associated with animals and birds can contaminate fruit 
and produce and make people sick.
    Our supply chain grows in complexity--a few lots of a raw 
agricultural commodity when used as an ingredient in other products can 
contaminate hundreds of products representing millions of pounds of 
food.
    Given all of these converging factors, we propose a refocus and re-
alignment of our current food safety inspection systems. Specifically 
we propose taking the successful risk-based USDA surveillance, 
inspection and enforcement model that has helped reduce the incidence 
salmonella in poultry and has highlighted the challenges associated 
with reducing E. coli O157:H7 in ground beef and expanding to other 
agricultural commodities like spinach, and other leafy greens, 
tomatoes, fresh fruits, peanuts, pistachios, grains and other raw 
agricultural commodities. This is shown in figure 8.  In other words 
expand USDA's risk-based inspection system to include commodities that 
today receive minimal inspection due to budget challenges at FDA.
    What we propose in Figure 8 is to focus USDA risk-based efforts 
against improving the safety of all food commodities, particularly 
those commodities that are consumed in the raw state or those that are 
cooked or pasteurized and eaten without a further microbial 
inactivation step, e.g., peanuts, almonds, cooked chicken. We believe 
an approach like this--pushing food safety upstream in the supply chain 
will:

    1. reduce overall public exposure to pathogens and thereby improve 
        food safety.

    2. provide greatest synergies in the implementation of good 
        agricultural practices.

    3. strengthen international competitiveness of U.S. agriculture.

    I'd like to go back for a minute and talk about redeployment of 
resources. This type of model would enable the agency to deploy 
resource against the greatest food safety risks. Imagine for a moment 
being able to redeploy the FTE resource currently inspecting a facility 
making a frozen, fully cooked, cheeseburger sandwich (figure 8) and re-
training the Inspector to inspect a peanut facility or a spinach farm 
just prior to the harvest.
    We believe this proposed model would work if we, as a nation, 
create a single food agency or maintain dual jurisdictional 
responsibilities within USDA and FDA. In a dual role we would envision 
FDA providing the food safety leadership further down the supply chain, 
e.g., the manufacture of frozen pizza, entrees, canned soup, broths, 
sauces, snacks, seasonings, etc.
    In closing we understand where our food safety risks are. We must 
look beyond the meat and poultry divide and focus on food safety 
systems across all categories of commodities using a risk-based 
approach. There is nothing more important than safe food to those of us 
in the food business and all of us as consumers.
    Mr. Erlandson and I look forward to further discussions and all of 
us at SUPERVALU look forward to working with you to ensure that we 
prevent foodborne illness.
    Thank you.

                               Attachment

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    The Chairman. Thank you very much for your testimony. I 
have tried to explain this to a couple other Members, and I 
found out that I didn't know as much about this as I needed to. 
So what you are proposing is that we would extend what FSIS 
does across all the commodities at the farm level, and then 
through the processing plant. So that would be like a slaughter 
plant or in the case of produce where they wash the lettuce and 
put them into bags and so forth, is that where the cutoff would 
be with USDA? I guess I am not as familiar with fruits and 
vegetables.
    Dr. Hanlin. Yes, Chairman Peterson, that is fundamentally 
the concept that we are bringing to the Committee today as to 
where the bright light or the dividing line is. We believe that 
experts in government and academia and industry could really 
help flesh that out for different commodity groups. For 
example, perhaps USDA might have inspectional jurisdiction to 
the point where milk is pasteurized but then as milk goes to 
manufacturers who are making sour cream, cottage cheese, yogurt 
and other, more complex diary products, one could imagine 
perhaps that being a convenient split.
    With respect to bagged salad, we would suggest that if the 
product is being field cored and immediately packaged that that 
would stay with USDA. However, if the spinach or the lettuce or 
the leafy greens are being brought into a facility, they are 
being sliced, diced, chopped, shredded, and put into bags where 
the raw commodities are being significantly transformed, we 
feel that would be again another breakpoint.
    So it is really, where does that commodity substantially 
change its form?
    The Chairman. Then in the case of that, why would FDA be 
better at regulating that plant that cuts this lettuce up or 
whatever as opposed to USDA? What is the logic behind that?
    Dr. Hanlin. Well, sir, what we are trying to do is really 
try to provide a food safety framework that would work 
regardless of whether we, as a nation, go to a single agency or 
whether we feel that there is a role for both FSIS which really 
is the single agency within USDA or SFAN, if you will, the 
single food agency within FDA. So we wanted to try to provide a 
model that would work regardless of whether it is going to be a 
single agency or perhaps dual jurisdictions.
    The Chairman. Well, I have been in a couple of these, I 
guess you would call, processing plants for lettuce, and I 
would compare that kind of to a slaughter plant. I mean, they 
come in and they wash them and they run them through these 
lines, and it is kind of like what we do in a slaughter 
facility. So I don't know why you wouldn't have USDA. You know, 
there probably should be inspectors on the line there like they 
are on a meat inspection. I don't know.
    But anyway, what you are saying to us is that you are not 
locked into this, you are just making some suggestions about 
how to----
    Dr. Hanlin. Correct. We are not locking in to say this must 
be the bright light for fruit, this must be the bright light or 
the line if you will for produce. What we are offering up 
today, sir, is just the concept of taking the very successful 
programs that have occurred within USDA, FSIS, and rather than 
cutting the pie this way with the dividing line being meat and 
poultry, can we cut it another way and use the risk-based 
inspection, enforcement and surveillance programs that have 
worked for meat and poultry, and try to bring them over to 
other commodities that today are not inspected by the USDA for 
food safety.
    Mr. Erlandson. In the case of your example, Chairman 
Peterson, I think that processing plant for fruits and 
vegetables or lettuce would probably fall under FSIS or the 
single food agency that would be housed under the USDA. Again, 
you are expanding both the USDA and the FDA in food safety, and 
you have a logical dividing line where products are clearly 
closer to the farm and closer to that process versus packaged 
goods, so to speak, which falls into a different area. And, 
that you also get USDA focused on what it does best, and you 
add I would think a new level of educating the farmers in this 
country as our world becomes more complicated with foodborne 
illnesses, things growing up from the ground, et cetera. Do 
this with more of a focus on addressing all of the commodities 
at that level instead of having only some of the commodities as 
it is today.
    The Chairman. Thank you. The gentleman from Oklahoma.
    Mr. Lucas. Thank you, Mr. Chairman. Gentlemen, would you, 
for a little background reinforcement educational process 
because of the magnitude of your operation, remind me of when 
FDA or USDA requests a recall? Take me quickly through the 
steps that are involved for you at the retail level.
    Dr. Hanlin. We would be happy to. We are only as good in 
terms of our recall function as the quality of the information 
that we receive through USDA, through FDA, and from the food 
manufacturers. We monitor all of the websites, we monitor all 
of the blogs, we have a good idea of what is happening out 
there, but once we get a formal communication from USDA, FDA or 
the manufacturer directly, they are calling us to say there is 
an issue, we then active our recall team.
    Our recall team then works directly with the supplier to 
understand what DCs or distribution centers did that product go 
into. So we need to know which DCs was the product shipped to 
and what is or are the UPC codes, the barcode numbers, for that 
product. And then once we have that information, which 
typically we can gather in a matter of minutes, 30, 40 minutes, 
we are then able to electronically execute a recall. And for a 
health hazard recall, we require that the product be removed 
from the shelves within a 3 hour window. For a non-health 
hazard recall, we let it go longer But our focus is to get the 
product off of our shelves, out of our back rooms, out of our 
DCs quickly. What we also do is we also make sure that we are 
auditing our own shelves to determine that we have indeed 
removed the product from the shelves.
    Mr. Lucas. In your experiences in dealing with recalls, I 
know there is no such thing as typical, but could you tell me, 
based on your experiences, how much product usually comes back 
from the customers? Because more often than not a certain 
amount of whatever it is has made its way out the door.
    Dr. Hanlin. Yes, sir. I can provide good information on 
what we are destroying at store level and at DC level. We would 
be very happy to follow up with you to try to understand how 
much product is actually being returned by our shoppers. I 
don't have that information in front of me, but we can follow 
up with you on that.
    Mr. Erlandson. And Congressman, I would add, on the 
recalls, in the case of just the pistachio situation, the 
retailers are pulling the product that is being targeted off 
the shelves as fast as they can because as many people have 
said today, there is nothing more important than food safety to 
those of us in the food business. And what becomes so important 
there is that as the investigation goes forward, that the 
people investigating the product, whether that be the 
manufacturers or the government do so efficiently and quickly 
so that you don't have products like in the case of tomatoes 
rotting on the shelves in the back or being destroyed when they 
certainly didn't need to be destroyed.
    Mr. Lucas. Exactly. Thank you for those insights. Thank 
you, Mr. Chairman.
    The Chairman. The gentleman, from North Carolina, Mr. 
Kissell.
    Mr. Kissell. Thank you, Mr. Chairman. I apologize. I was 
enjoying some of these peanuts.
    In the model that you are proposing, and the cutoff between 
FSIS and FDA, you talked about the bright light of where the 
divide should be, is any consideration given in your 
experiences to which side of those two agencies does a better 
job in terms of food safety?
    Dr. Hanlin. Well, the previous panel articulated the 
fundamental differences between the jurisdictional powers that 
USDA and FDA have. Our concept here is that with respect to the 
USDA regulations, that we have a model that is working. We have 
a model whereby the USDA, their programs, have really helped 
drive down the Salmonella rate in poultry. We respect that 
there are huge challenges, and they haven't achieved the same 
quality of results with respect to E. coli O157:H7 in ground 
beef, but the methodology, the inspection, the surveillance, 
the enforcement, the training that USDA provides, the risk-
based approach, which really has helped improve the safety of 
the meat and poultry products. And so our concept here is how 
do we take the ideas, the concepts, the risk-based method and 
try to apply it to categories that currently don't see the same 
level of inspection.
    It is not a one-size-fits-all, and clearly the type of 
inspection for spinach and leafy greens, the way that they are 
processed and handled may be different for tomatoes, it may be 
different for apples. But again, that concept of reducing, 
eliminating, and preventing hazards using a risk-based approach 
we think is very powerful.
    Mr. Kissell. You were also talking about when there is an 
alert that goes out, and the inspections that have to take 
place with what you have in the stores or in the supply chain 
or what is brought back to you. Is it consistent that the 
product is checked quickly or you might have insinuated, or 
maybe I just understood that perhaps there is a length of time 
there that we just don't get the inspections done as quickly as 
we should.
    Dr. Hanlin. Could you describe what you mean by----
    Mr. Kissell. Well, once something has been defined as----
    Mr. Erlandson. A recall?
    Mr. Kissell. A recall, yes. And you halt the product, 
whatever it is in the supply chain stores, warehouses, and it 
comes back in maybe from customers, is that inspected quickly? 
I just got the insinuation perhaps that you thought that 
perhaps it didn't get inspected as quickly as it should, and 
perhaps we didn't get on top of it as quickly as we could. I 
mean, it may have just been something I picked up.
    Dr. Hanlin. At SUPERVALU, we execute recalls as quickly as 
we can with the best available information. It is all about 
protecting the consumer. And so we will execute recalls and 
pull product perhaps before we have all the information that we 
need. Sometimes we know if it is just going to be a couple more 
minutes while the supplier gives us the UPC, we will wait a 
couple more minutes. But again, we are ready to hit that recall 
button, but we want to make sure that we have accurate 
information. But it is very time-sensitive. As soon as we 
execute that recall for products that are frozen or 
refrigerated, we will dump and destroy. We want to get them out 
of our system as quickly as possible and make sure they are 
unavailable to anyone in our shops or DCs.
    Mr. Kissell. Thank you very much. Thank you, Mr. Chairman.
    The Chairman. I thank the gentleman. Well, we have been 
called to vote, and the Members, like everybody else, have had 
about enough. But, you have brought some very interesting 
perspective to this debate, and it is a new way of thinking 
about how to approach this that has some merit. And I want to 
not only the Committee Members but others to be exposed to this 
as we go. I don't know how many Members you have had a chance 
to talk to yet of the other Members but----
    Mr. Erlandson. We have been working our way around, and it 
is quite well-received. It just takes a little while for people 
to wrap their arms around. So we appreciate that.
    The Chairman. Yes, I had a meeting yesterday with Ms. 
DeLauro for some time. Apparently you haven't got to her yet, I 
guess.
    Mr. Erlandson. We have talked to her staff, but apparently 
they haven't gotten to her yet.
    The Chairman. Okay. She wants to, if you get a chance, she 
would like to talk to you guys directly, too. So the more we 
can get all the different players that are involved in this, 
get as much information as we can, I think the better chance we 
have in coming up with the right solution. Clearly there is 
improvement that can be made in food safety, and that is what 
our Committee is about here. We are trying to do our part to 
make sure we get a safer food system and protect people as much 
as possible. And we appreciate very much your involvement and 
your addition to this process. Thank you for being with us, 
being so patient, and we will probably as we get down the line 
here, we will probably have you involved again in whatever we 
end up doing.
    Mr. Erlandson. We appreciate it.
    The Chairman. And the Committee stands adjourned.
    [Whereupon, at 3:40 p.m., the Committee was adjourned.]
    [Material submitted for inclusion in the record follows:]

Submitted Report By Anthony J. DiMare, Vice President, DiMare Homestead 
 Inc., DiMare Ruskin Inc., and DiMare Johns Island Inc.; Member, Board 
of Directors, Florida Fruit & Vegetable Association; President, Florida
   Tomato Exchange; Member, Board of Directors, United Fresh Produce
                              Association

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