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


 
              HOW DO WE FIX OUR AILING FOOD SAFETY SYSTEM?

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

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                               __________

                             MARCH 11, 2009

                               __________

                           Serial No. 111-12


      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov



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                    COMMITTEE ON ENERGY AND COMMERCE

                 HENRY A. WAXMAN, California, Chairman

JOHN D. DINGELL, Michigan            JOE BARTON, Texas
  Chairman Emeritus                    Ranking Member
EDWARD J. MARKEY, Massachusetts      RALPH M. HALL, Texas
RICK BOUCHER, Virginia               FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey       CLIFF STEARNS, Florida
BART GORDON, Tennessee               NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois              ED WHITFIELD, Kentucky
ANNA G. ESHOO, California            JOHN SHIMKUS, Illinois
BART STUPAK, Michigan                JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York             ROY BLUNT, Missouri
GENE GREEN, Texas                    STEVE BUYER, Indiana
DIANA DeGETTE, Colorado              GEORGE RADANOVICH, California
  Vice Chairman                      JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California               MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania       GREG WALDEN, Oregon
JANE HARMAN, California              LEE TERRY, Nebraska
TOM ALLEN, Maine                     MIKE ROGERS, Michigan
JAN SCHAKOWSKY, Illinois             SUE WILKINS MYRICK, North Carolina
HILDA L. SOLIS, California           JOHN SULLIVAN, Oklahoma
CHARLES A. GONZALEZ, Texas           TIM MURPHY, Pennsylvania
JAY INSLEE, Washington               MICHAEL C. BURGESS, Texas
TAMMY BALDWIN, Wisconsin             MARSHA BLACKBURN, Tennessee
MIKE ROSS, Arkansas                  PHIL GINGREY, Georgia
ANTHONY D. WEINER, New York          STEVE SCALISE, Louisiana
JIM MATHESON, Utah                   PARKER GRIFFITH, Alabama
G.K. BUTTERFIELD, North Carolina     ROBERT E. LATTA, Ohio
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin 
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
PETER WELCH, Vermont

                                  (ii)
                         Subcommittee on Health

                FRANK PALLONE, Jr., New Jersey, Chairman
JOHN D. DINGELL, Michigan            NATHAN DEAL, Georgia,
BART GORDON, Tennessee                   Ranking Member
ANNA G. ESHOO, California            RALPH M. HALL, Texas
ELIOT L. ENGEL, New York             BARBARA CUBIN, Wyoming
GENE GREEN, Texas                    HEATHER WILSON, New Mexico
DIANA DeGETTE, Colorado              JOHN B. SHADEGG, Arizona
LOIS CAPPS, California               STEVE BUYER, Indiana
JAN SCHAKOWSKY, Illinois             JOSEPH R. PITTS, Pennsylvania
TAMMY BALDWIN, Wisconsin             MARY BONO MACK, California
MIKE ROSS, Arkansas                  MIKE FERGUSON, New Jersey
ANTHONY D. WEINER, New York          MIKE ROGERS, Michigan
JIM MATHESON, Utah                   SUE WILKINS MYRICK, North Carolina
JANE HARMAN, California              JOHN SULLIVAN, Oklahoma
CHARLES A. GONZALEZ, Texas           TIM MURPHY, Pennsylvania
JOHN BARROW, Georgia                 MICHAEL C. BURGESS, Texas
DONNA M. CHRISTENSEN, Virgin 
    Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa


  
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     1
    Prepared statement...........................................     3
Hon. Nathan Deal, a Representative in Congress from the State of 
  Georgia, opening statement.....................................     7
Hon. Henry A. Waxman, a Representative in Congress from the State 
  of California, opening statement...............................     7
    Prepared statement...........................................    10
Hon. Joe Barton, a Representative in Congress from the State of 
  Texas, opening statement.......................................    12
Hon. Donna M. Christensen, a Representative in Congress from the 
  Virgin Islands, opening statement..............................    13
Hon. Phil Gingrey, a Representative in Congress from Georgia, 
  opening statement..............................................    13
Hon. John P. Sarbanes, a Representative in Congress from 
  Maryland, opening statement....................................    14
Hon. Joseph R. Pitts, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................    14
Hon. John D. Dingell, a Representative in Congress from the State 
  of Michigan, opening statement.................................    15
Hon. John Barrow, a Representative in Congress from the State of 
  Georgia, opening statement.....................................    17
Hon. Marsha Blackburn, a Representative in Congress from the 
  State of Tennessee, opening statement..........................    18
Hon. Diana DeGette, a Representative in Congress from the State 
  of Colorado, opening statement.................................    19
Hon. Kathy Castor, a Representative in Congress from the State of 
  Florida, opening statement.....................................    19
Hon. Betty Sutton, a Representative in Congress from the State of 
  Ohio, opening statement........................................    20
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, prepared statement......................................    21
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, prepared statement.............................    24
Hon. Eliot L. Engel, a Representative in Congress from the State 
  of New York, opening statement.................................    26
Hon. Anna G. Eshoo, a Representative in Congress from the State 
  of California, opening statement...............................    26

                               Witnesses

Caroline Smith Dewaal, Food Safety Director, Center for Science 
  in the Public Interest.........................................    27
    Prepared statement...........................................    30
William Hubbard, Advisor, Alliance for a Stronger FDA, Former 
  Associate Commissioner for Policy and Planning, Food and Drug 
  Administration.................................................    39
    Prepared statement...........................................    41
Martin Cole, Ph.D., Research Professor of Biology and Director, 
  National Center for Food Safety and Technology, Illinois 
  Institute of Technology........................................    56
    Prepared statement...........................................    59
Thomas E. Stenzel, President and CEO, United Fresh Produce 
  Association....................................................    70
    Prepared statement...........................................    73
Jim Lugg, Consultant, Chiquita Brands, Former Executive Vice 
  President, Food Safety and Quality, Fresh Express..............    89
    Prepared statement...........................................    91

                           Submitted Material

Article entitled, ``Food Problems Elude Private Inspectors,'' New 
  York Times, March 5, 2009, submitted by Ms. Eshoo..............   119


              HOW DO WE FIX OUR AILING FOOD SAFETY SYSTEM?

                              ----------                              


                       WEDNESDAY, MARCH 11, 2009

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:10 a.m., in 
Room 2123 of the Rayburn House Office Building, Hon. Frank 
Pallone Jr. (chairman) presiding.
    Members present: Representatives Pallone, Dingell, Eshoo, 
Engel, Green, DeGette, Schakowsky, Gonzalez, Barrow, 
Christensen, Castor, Sarbanes, Space, Sutton, Waxman (ex 
officio), Stupak, Deal, Shimkus, Buyer, Pitts, Murphy, 
Blackburn, Gingrey, and Barton (ex officio).
    Staff present: Phil Barnett, Staff Director; Karen Nelson, 
Deputy Staff Director for Health; Karen Lightfoot, 
Communications Director; Rachel Sher, Counsel; Steve Cha, 
Professional Staff Member; Virgil Miller, Legislative 
Assistant; Jennifer Berenholz, Deputy Clerk; Lindsay Vidal, 
Press Assistant; Alli Corr, Special Assistant; Alvin Banks, 
Special Assistant; Caitlin Sanders, Staff Assistant; Clay 
Alspach, Counsel; Ryan Long, Counsel; and Chad Grant, 
Legislative Analyst.

          OPENING STATEMENT OF HON. FRANK PALLONE, JR.

    Mr. Pallone. The subcommittee is called to order. Today the 
subcommittee is meeting to discuss the topic of food safety. 
Unfortunately, news of unsafe food products has continued to 
make front-page headlines. The outbreak of E. coli in spinach a 
few years ago, the outbreak of salmonella in peppers this past 
summer, and the most recent outbreak of salmonella in peanut 
butter all emphasize that now is the time for us to act. Nine 
people have died as a result of this most recent peanut butter 
outbreak, and hundreds more have gotten sick. And millions of 
dollars have been lost in sales due to products being recalled.
    Food safety, or perhaps more accurately the lack thereof, 
continues to be one of my top priorities. In every Congress for 
the last 12 years, I have introduced food safety legislation 
that aims to bolster the FDA's enforcement and regulatory 
authority over the food industry.
    This year, I have collaborated with my colleagues Mr. 
Dingell and Mr. Stupak to introduce a comprehensive FDA reform 
bill. Many of the food provisions within the FDA Globalization 
Act built upon concepts and provisions I have put forth in my 
previous bills, and they emphasize prevention and shifting the 
responsibility of safe food from the FDA to the manufacturers.
    What it all comes down to is that it is not the 
government's duty to make food safe. The companies, in my 
opinion, should be responsible for the products they make and 
must be held accountable for that responsibility. It is their 
job to make their food safe and to implement a plan that will 
ensure that they achieve that goal.
    It is the government's job, on the other hand, to set 
standards for food safety and hold the food industry 
accountable for meeting those standards through regulatory and 
enforcement authorities. We must empower the FDA with those 
authorities so that the agency can effectively prevent problems 
from ever occurring rather than simply reacting when something 
bad has happened. And we must also require manufacturers to put 
in place the food safety plans to ensure that their products 
and production lines are safe.
    But there are other mechanisms aside from food safety plans 
that companies can implement to ensure the safety of their 
products. And we will hear testimony this morning from industry 
experts on the various safety mechanisms companies can 
implement in order to product their product lines and keep our 
Nation's food supply safe.
    We will also hear about some of the regulatory authorities 
that the FDA needs in order to ensure that companies are 
actually implementing and following these preventative 
mechanisms.
    And finally we will hear from witnesses about the 
enforcement tools the FDA needs to fulfill its mission of 
protecting the public health and protecting Americans from 
harmful products both in the United States and abroad.
    I am looking forward to the discussion today and the 
information we will glean. We do want to pass food safety 
legislation rather quickly this year if we can, and so 
obviously today's hearing will be very helpful in that regard.
    And I do want to mention--I don't see him--but Congressman 
Stupak has done an excellent job in the O&I Subcommittee in 
bringing attention to this issue over the last, actually over 
the last 3 years. He and I and Congressman Dingell have this 
legislation, but he has repeatedly had hearings addressing some 
of the concerns that have led to the legislation.
    [The prepared statement of Mr. Pallone follows:]

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    Mr. Pallone. And I now recognize my colleague, Mr. Deal.

             OPENING STATEMENT OF HON. NATHAN DEAL

    Mr. Deal. I want to thank the Chairman Pallone for holding 
this hearing as we evaluate concepts that we as policymakers 
should consider in approaching reform of the Nation's food 
supply as a food safety issue at the Food and Drug 
Administration. I appreciate the timeliness of this hearing, 
particularly since my home state of Georgia has itself been 
under a lot of attention as a consequence of a rogue peanut 
processing operation in the state, as you indicated, 
contributed to nine deaths and several hundred Americans being 
sickened all across our country.
    But let me be clear. I support giving FDA the resources it 
needs to ensure our Nation's food supply remains safe and 
reliable for American dinner tables across the country. I 
believe a modernized approach to risk identification and 
prevention, particularly through hazard analysis and critical 
control point plans and similar prevention-minded procedures is 
a realistic and evidence-based solution to mitigating the 
hazards in the Nation's food supply chain.
    We must focus on pursuing reforms with public safety 
protection as a top priority. However, we must do so diligently 
and methodically to ensure our actions do not cripple small 
businesses in the food industry across the country.
    Our Nation's food supply needs a great deal of improvement 
in terms of the safeguards and fallback measures expected of a 
21st century food supply chain in the United States. 
Recognizing the need for a risk-based approach to food safety 
reform, I have joined Representatives Jim Costa and Adam Putnam 
in cosponsoring H.R. 1332, The Safe Food Enforcement Assessment 
Standards and Targeting Act of 2009, Safe FEAST Act as it is 
referred to. This act takes an aggressive yet realistic effort 
to improve food safety by granting FDA enhanced statutory 
authority to do its job as well as require implementation of 
safety measures to prevent food-borne problems before they even 
manifest themselves.
    It is my hope that any legislation that we pass out of this 
committee is similar to the provisions contained in H.R. 1332. 
I look forward to continuing to work with my colleagues on both 
sides of the aisle as we look at concepts that are aimed to 
improve the safety of America's food supply. Thank you for 
holding this hearing today. I look forward to the testimony of 
our witnesses, and I welcome them to this hearing today. Thank 
you. I yield back my time.
    Mr. Pallone. Thank you, Mr. Deal. Next is Chairman Waxman. 
I forgot to mention the work that you did on your previous 
committee on government oversight on the food safety issues as 
well. Thank you.

           OPENING STATEMENT OF HON. HENRY A. WAXMAN

    Mr. Waxman. Thank you very much, Mr. Chairman. America does 
not need another deadly outbreak to understand that our food 
safety system is in desperate straits. We have ample proof of 
that. This is a bad situation not just for the American public 
but for the food industry itself. We must act now to address 
the problem, and this hearing today is the first step on that 
legislative path.
    Today we will hear about some of the major concepts that 
our witnesses believe must be included in a model food safety 
bill. The FDA Globalization Act of 2009 provides an ideal 
starting point, and I commend Chairman Emeritus Dingell, 
Chairman Pallone, Chairman Stupak for their work on this bill. 
Using this bill as a foundation, this committee will work with 
the President's FDA to implement some commonsense food safety 
measures that are long overdue.
    As we move forward, we will also draw upon the work of 
Chairman Stupak and Ranking Member Walden who lead our 
subcommittee on Oversight and Investigations. It is clear we 
need to give FDA some basic authorities that will enable it to 
do its job.
    As the Oversight and Investigation hearing illustrated, FDA 
does not have the authority to routinely access records 
documenting the steps that manufacturers take to assure safety. 
FDA also lacks modern and flexible enforcement tools like 
administrative civil monetary penalties. It is our job to get 
FDA the resources and authorities it needs to get the job done 
and to do it well.
    But with over 300,000 registered food facilities throughout 
the U.S. and abroad, it is clear we can't rely on FDA alone to 
prevent food-borne illness outbreaks. Manufacturers must 
implement preventive systems to stop outbreaks before they 
occur, and we need to hold them accountable when they fail.
    Dr. Stephen Sundlof, FDA's director of food safety and 
applied nutrition, agreed at our hearing last month that each 
company in the chain of manufacturing has an obligation to 
ensure that the ingredients they are using as well as their 
final products are safe for Americans to consume.
    Related to this, I would like to announce now that next 
Thursday, on March 19, we will hold another investigative 
hearing that focuses on the companies that purchased these 
tainted peanuts and why their food safety systems failed to 
prevent these deaths and illnesses.
    We have a challenging job ahead of us, but we also have 
many reasons to be optimistic. In his budget, President Obama 
called for over $1 billion for FDA's efforts to increase and 
improve inspections, domestic surveillance, laboratory 
capacity, and domestic response to prevent and control food-
borne illnesses.
    I also know that President Obama is committed to naming an 
FDA commissioner soon, and I look forward to his announcement. 
The food safety crisis calls for strong leadership at that 
agency, and we need it now.
    Let me say a few words about the notion of a so-called 
single food agency. A lot of good points have been made about 
the need to improve our fragmented system and ensure that food 
safety is given appropriate attention by our regulatory 
agencies, but reorganizing large federal bureaucracies takes a 
great deal of time. And this is time we do not have when it 
comes to food safety. We have to act now. We have to 
concentrate the additional resources we can get at this point 
on the job at hand.
    Our first goal should be to address the problems that 
plague this program where it currently sits. After we finish 
that job, we can consider whether a reorganization is 
necessary, and if so, how to go about it.
    I look forward to hearing from our witnesses about what 
steps we can take to begin this process. Thank you, Mr. 
Chairman. Yield back my time.
    [The prepared statement of Mr. Waxman follows:]

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    Mr. Pallone. Thank you, Chairman Waxman. Our ranking member 
of the full committee, Mr. Barton.

              OPENING STATEMENT OF HON. JOE BARTON

    Mr. Barton. Thank you, Chairman Pallone and Chairman 
Waxman. As we all know, there are differences between the 
political parties in Congress, but there are also many 
similarities. On food safety, there is no daylight between 
Henry Waxman and Joe Barton, between the Republican minority 
and the Democratic majority. We both agree it is important. We 
both agree we need to take a look at the problem in a serious 
fashion, and we both agree that if necessary we need to work 
together to move legislation to fix that problem.
    This committee in the last Congress through the Oversight 
and Investigation Subcommittee held nine hearings on food 
safety, and just this past month, as has already been 
mentioned, we held another hearing on the most recent food 
safety outbreak, the peanut butter salmonella outbreak.
    This committee and the various subcommittees have been 
active on food safety and we are going to continue to be 
active. The food safety debate in the past few years has 
centered on funding additional money for the Food and Drug 
Administration. Unfortunately, in my opinion, instead of asking 
the appropriators to give the FDA additional funding, some have 
wanted to raise the additional money through a pay-to-play fee 
on food companies.
    Last Congress, Nathan Deal of Georgia, ranking member on 
this subcommittee, and myself wrote the appropriators and asked 
them to give the FDA additional funds through the appropriation 
process. The appropriators responded positively, increased the 
appropriation for the FDA by $150 million in last year's 
supplemental appropriation bill.
    We are the authorizing committee, and it is our job to give 
the FDA the authority to have the tools that it needs to make 
sure that our food is safe to eat. We must then get industry, 
consumers, the Food and Drug Administration, and the Congress 
together to strengthen the food safety system.
    Last week, I cosponsored the bipartisan Safe Food 
Enforcement Assessment Standards and Targeting Act. That takes 
up a page just the name of the thing. Which was introduced by 
Congressman Costa, Congressman Putnam, Congressman Deal, among 
others, because I think that it is the right approach to food 
safety. It takes a risk-based, prevention-based approach to 
fixing the problem.
    We need to focus on preventing food problems before they 
occur. One way the legislation I just enunciated does that is 
by requiring that companies create and properly execute food 
safety plans. Experts say that if the peanut corporation of 
America had had one, the salmonella outbreak never would have 
happened in the first place. The Costa Putnam bill also take a 
risk-based approach to food safety. It requires the FDA to 
focus the resources on high-risk facilities first where we get 
the most bang for our regulatory buck.
    Mr. Chairman, this is an issue that unites consumers and 
producers. Consumers want to be confident the food they eat is 
safe. Producers rely on that confidence because without it, 
their brand means nothing. In fact, it is a negative. There 
seems to also be a bipartisan and a bicameral support for 
moving food safety legislation.
    Again I say that on the Republican side, we stand united 
with our friends on the Democrat majority side. We want to 
outline the problems in hearings like the one we are having 
today. And if we need a legislative solution, we are prepared 
to cooperate in preparing that solution. Thank you, Chairman 
Pallone, again for holding this hearing.
    Mr. Pallone. Thank you. Next is the gentleman from Texas, 
Mr. Gonzalez. Thank you. The gentlewoman from the Virgin 
Islands, Ms. Christensen.

         OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN

    Ms. Christensen. Thank you, Mr. Chairman. Mr. Chairman, 
when the Subcommittee on Oversight met last month to take 
testimony on the salmonella outbreak, Chairman Pallone, you 
promised that you would hold this hearing. So I want to thank 
you and Ranking Member Deal for following up so quickly.
    In listening to the tragic stories of the families who were 
here that day and hearing the callousness of the peanut 
corporation executives from the emails that the subcommittee 
had uncovered, it was clear that there were gaping holes in the 
food safety system, which needed to be closed.
    In reviewing the testimony, several themes emerge with 
which I agree. One, the health and well being of the American 
public could not wait any longer for solutions to address our 
broken food safety system. Two, that the system must be 
completely overhauled in a manner that prioritizes 
coordination, resources, prevention, surveillance, 
accountability, transparence, and response and that empowers 
the FDA. And third, that we paid the price for our Nation's 
broken food system, and we paid in human lives and health, 
direct and indirect economic costs in the way that citizens 
both here and abroad view products coming from the U.S.
    So I look forward to the testimony of our outstanding panel 
and to working to make bills like H.R. 759 law. Thank you, Mr. 
Chairman.
    Mr. Pallone. Thank you. Mr. Gingrey.

             OPENING STATEMENT OF HON. PHIL GINGREY

    Mr. Gingrey. Thank you, Mr. Chairman. Mr. Chairman, public 
health officials estimate that each year 76 million people 
become sick, 325,000 are hospitalized, and 5,000 die from food-
borne illnesses caused by contamination. And of course, the 
most recent of these incidents in my home state of Georgia 
sickened more than 677 people in 45 states and caused at least 
nine deaths due, in part, to a breakdown at FDA Oversight.
    We therefore have an important oversight and legislative 
role in ensuring confidence in the safety of our food supply. 
And I do commend the chairman for holding these hearings. While 
I am pleased to see this committee engaged on such a critical 
issue as food safety, we must avoid sending mixed signals.
    If we are trying to build a consensus that the FDA is 
overworked and lax on food safety oversight, adding things like 
tobacco to FDA's responsibilities, I hope, will not take away 
from the very thing we are advocating here today. People 
understand the dangers of tobacco. There is no safe cigarette, 
but what they don't understand and they don't expect is a 
spinach salad or a scoop of peanut butter to kill them or their 
loved ones.
    So, Mr. Chairman, I hope that these hearings will help us 
reach a greater understanding of the breakdowns in the current 
system as well as the appropriate solutions to safeguard the 
health and the welfare of all Americans. And I do look forward 
to working with you in a bipartisan way. And I thank you, Mr. 
Chairman. I yield back.
    Mr. Pallone. Thank you. The gentleman from Maryland, Mr. 
Sarbanes.

           OPENING STATEMENT OF HON. JOHN P. SARBANES

    Mr. Sarbanes. Thank you, Mr. Chairman, for holding the 
hearing and for the work you have been doing on food safety and 
also want to salute Chairman Stupak, Chairman Waxman for their 
work as well as so many others who have been part of this 
effort.
    There are so many obvious negative consequences to not 
having good oversight of our food supply. Among them, of 
course, are when there is a severe contamination, which can 
lead to harm and to death, and we have seen that recently once 
again.
    A little less obvious is the low level contamination that 
can be broadly distributed across the food supply, but it is 
also certainly the province of those who are supposed to guard 
our food safety.
    The third that I am particularly intrigued with, and I have 
read some of the testimony and look forward to the witnesses 
today, is the effect that occurs when there is an outbreak and 
a crisis and alarm in the public that then causes people to 
turn away from healthy food, which, of course, undermines our 
overall objective of getting people to eat right in this 
country. So we have got to make sure we protect the food supply 
so that we can advance our overall goal.
    I look forward to the hearing today. Thank you. I yield 
back.
    Mr. Pallone. Thank you. Mr. Pitts.

           OPENING STATEMENT OF HON. JOSEPH R. PITTS

    Mr. Pitts. Thank you, Mr. Chairman. Like to thank you for 
convening this hearing on a topic that we read about in the 
newspapers every day, food safety. The ongoing salmonella 
outbreak linked to the consumption of products containing 
peanut ingredients from a single firm, Peanut Corporation of 
America, is only the latest in a string of high profile food 
safety related incidents.
    The U.S. food supply is widely regarded as among the safest 
in the world. Nonetheless, as we have just heard, public health 
officials estimate that each year 76 million people become 
sick, 325,000 are hospitalized, and 5,000 people die from food-
borne illnesses caused by contamination from any one of a 
number of microbial pathogens.
    Recent scares about spinach and peppers and peanut butter 
and other products, both imported and domestic, have lead to 
public confusion about which products are safe and whether the 
food items they have in their refrigerators and pantries could 
be contaminated.
    These instances have also lead to a lack of confidence 
among many Americans in the government's ability to keep them 
and their families safe from food-borne illnesses. Our 
constituents must have confidence that when they go to their 
local grocery store or convenience store, the food they buy is 
safe and it has met the highest standards and safeguards of our 
food safety system.
    The U.S. food safety system, which includes as many as 15 
different federal agencies collectively administering at least 
30 different laws related to food safety must be modernized to 
meet the conditions of the 21st century.
    I look forward to hearing from our witnesses today, 
specifically on the role FDA plays in food safety on what must 
be done to prevent or mitigate future food-borne illnesses and 
outbreaks, what changes must be made to FDA's current 
practices, and whether FDA's current resources are adequate to 
accomplish these goals.
    And I would like to thank all of our witnesses for 
testifying today. I look forward to your statements. I yield 
back my time.
    Mr. Pallone. Thank you, Chairman Dingell, and thank you for 
introducing this bill and all your efforts on this issue.

           OPENING STATEMENT OF HON. JOHN D. DINGELL

    Mr. Dingell. Thank you, Mr. Chairman, and thank you for 
holding today's hearing on the adequacy of our food safety 
system.
    I want to say that this is a most timely and necessary 
hearing because we have before us one of the finest messes in 
history. Everybody is busily blaming Food and Drug for the 
inadequacy of the protection of American consumers. The blame 
for that lies right here in the Congress and downtown in the 
executive branch because of the failure of the agencies in the 
federal government and this Congress to see to it that FDA has, 
first of all, a good and adequate basic fundamental statute on 
which they may work, and our failure to see to it that they 
have an adequate and reliable revenue stream to enable them to 
do what has to be done.
    Food safety is long a concern of mine, and today's hearing 
is very timely and necessary. You have mentioned, and it has 
been mentioned already, that we have a fine piece of 
legislation before this committee, which I will mention later. 
We do, and its enactment could do much to resolve the problems 
at Food and Drug.
    There are not only problems with regard to food, but there 
are problems with regard to pharmaceuticals and devices. And 
there are severe problems in an uncooperative food processing 
industry that has done everything it can to obfuscate the 
matters and to see to it that we don't get legislation.
    As you know, Mr. Stupak and his sister subcommittee has had 
some fine hearings, and he has brought folks in here to explain 
what is going on out there and to have Food and Drug tell us 
whether we have the resources. And we have had hell's own time 
prying the truth out of them.
    We have a major problem on our hands relating to the safety 
of the food supply. It is killing Americans. The government 
accountability offices recognize this when they designated 
federal oversight of food safety as a high risk area for the 
first time in 2007. The Congress has done nothing about this 
except to talk and to come forward with a lot of wondrous plans 
like setting up a single agency to administer the business.
    Now, we have given them some more money, and that has been 
useful, but we have a lot more that has to be done. FDA is 
responsible for 80 percent of the food supply in the United 
States, but it is receiving only 24 percent of the 
expenditures. And I repeat, as a result of this, people are 
getting sick and dying.
    Every year, 76 million people contract a food-borne illness 
in the United States. About 325,000 of these require 
hospitalization, and about 5,000 die according to the Center 
for Disease Control. So we have that on our backs and upon our 
hands.
    More specifically, in the last two years, we can cite just 
a few events which have occurred. Melamine in infant formula 
and in milk products coming in from China. Nothing done to stop 
it. Tainted peppers from Mexico, harmful seafood and harmful 
fish from China, E. coli in spinach. That is just a little, and 
every year we get new information about the Food and Drug's 
inability to protect the American people.
    Unfortunately the theme of a failed food supply system has 
not receded. We currently find ourselves in the middle of what 
is possibly the largest food recall in history, and it is 
costing billions of dollars to consumers and to innocent food 
processors because Food and Drug could not and did not do its 
job. And we have had hearings, by the way, on that which read 
like a joke book.
    We currently find ourselves with FDA wrestling with a food-
borne illness outbreak associated with salmonella which has 
been found in peanut products produced by the Peanut 
Corporation of America, PCA. And because of the outright 
negligence of this company, more than 2,100 products from ice 
cream to dog food have been recalled. And by the Department of 
Agriculture can investigate and can inspect dog food 
manufacturers every year. Food and Drug can't do the same thing 
for food processors for human beings.
    Because of the outright negligence of this company then, 
more than 680 people in 46 states have been sickened, and so 
far, we know of nine who have died from these events. And I 
think we can assume, given the way things have been going, that 
this is not yet over.
    What we have found in this instance and in many others is 
that FDA funding is woefully inadequate and their authorities 
are outdated. They have proven to be incapable of protecting 
our food supply. I commend the President for recognizing the 
inadequacy of FDA's resources and for proposing increased 
funding for food safety activities in his budget package.
    However, my experience in the Congress has shown me that 
the only way to adequately address the problem of resources is 
by ensuring a steady predictable revenue stream for FDA. I 
propose to do this by establish a registration fee for 
manufacturers so that we can look and see what is coming into 
this company.
    And I would note to you because of Food and Drug's 
inability to address this problem that we are finding 
controlled substances are coming into this country right 
alongside of other commodities uninspected by Food and Drug or 
anybody else.
    This is the only way we can make sure that Food and Drug is 
able to carry out its responsibilities. In addition to the 
shortage of resources, we must address the issue of 
authorities. It is shameful that FDA does not have authority to 
mandate recalls, to require manufacturers to identify and 
develop plans to mitigate hazards before they occur rather than 
after people are sick and die. And to identify safety questions 
by having full access to safety records without delay and to 
appropriately trace the ability and not only their own ability, 
but the origin of tainted products.
    Mr. Chairman, you and I, along with Chairman Stupak, have 
an appropriate safety solution to our food problems, H.R. 759, 
and I urge and invite our colleagues to join us in this 
particular undertaking. As a result of the failure to have Food 
and Drug given the authority it needs and the resources, 
people, I repeat, are dying.
    The Congress is working to address a mess left behind by 
another industry that has been left to self-regulate. I refer 
to the banks and the securities industry. And there, they are 
destituting people all across the United States in all kinds of 
ways from their 401(k)s to their retirements to their saving 
account and to their hopes of the future and their homes and 
their mortgages.
    I look forward to our witnesses' testimony today. I 
apologize for taking so much time, but I hope that this process 
will shake some folks up so that we will get some progress that 
we need in making the American people safe. I thank you, and I 
commend you, Mr. Chairman.
    Mr. Pallone. Thank you. The gentleman from Illinois, Mr. 
Shimkus.
    Mr. Shimkus. Thank you, Mr. Chairman, and I will be brief. 
I want to thank the Chairman Emeritus. He is passionate about 
this. I see my friend Bart Stupak here, and I got to serve on 
ONI, had numerous of these hearings. We know the need, and we 
know we need to move rapidly.
    I have always been supportive of a risk-based approach in 
making sure that the money that is needed goes to where it is 
needed. And I think we need to focus on that. There are a lot 
of preventive aspects that we can do like irradiation in a lot 
of those areas that doesn't affect food quality. I think we 
identified that, and we ought to help and incentivize movement 
in that direction. And funding is always going to be an issue. 
Make sure we fund appropriately so the money is going to where 
it is needed.
    That is why I am excited about being back on this 
committee. Mr. Chairman, I think serving with Bart has helped 
me get up to speed on this issue, and I look forward to being 
helpful. I yield back.
    Mr. Pallone. Thank you. The gentleman from Georgia, Mr. 
Barrow.

             OPENING STATEMENT OF HON. JOHN BARROW

    Mr. Barrow. Thank you, Mr. Chairman, and thank you for 
keeping your promise to stay on this issue until we get 
something done about it. I can add nothing to the comprehensive 
statement of the Chairman Emeritus. But as befits my diminutive 
stature in the picture, I will focus on something smaller.
    I know that colleagues of mine are working on more 
comprehensive legislation from subjects like increasing the 
resources and increasing the amount of FDA inspections to 
creating a system of traceability to creating mandatory recall 
authority. There are a whole bunch of major elements that need 
to be put in place.
    I want to focus on something that I think ought to be a 
part of any comprehensive bill or can stand alone as a genuine 
contribution to this. And that is a measure to increase the 
effectiveness of both the sampling and the testing that is done 
of food. What we need in this country is a system that doesn't 
give manufacturers the option of knowing what they need to know 
and when they need to know it, but requires them to know what 
they need to know when they need to know it, and that provides 
real-time information, reporting that information at the very 
same time to an effective regulator of the public interest so 
that the public knows what we need to know when we need to know 
it.
    I think that would go a long way toward cleaning up what is 
broken in this system, but we cannot continue to rely on a 
system that is essentially the honor system that allows folks 
to use the American people as a population of lab rats to test 
the food on them first to find out what is wrong with it. That 
won't work. We have to be proactive about it, and that is what 
I hope the witnesses will be able to share with us about today. 
Thank you, Mr. Chairman. I yield back.
    Mr. Pallone. Thank you. The gentlewoman from Tennessee, 
Mrs. Blackburn.

           OPENING STATEMENT OF HON. MARSHA BLACKBURN

    Mrs. Blackburn. Thank you, Mr. Chairman, and welcome to our 
witnesses. We are ready to hear from you today, and I have just 
a couple of thoughts to add to the comments that have been 
made. The hearings on food safety are not new. I will also say 
that as we have worked through this process over the last 
several years, one of the things that we have repeatedly asked 
you all for is clarification on your internal communications. 
How you communicate with one agency, one division knowing what 
work is being done in another one. It seems as if you 
continually have stumbles that do harm to the work that you are 
trying to do.
    Also, best practices. You seem reticent to talk about best 
practices and how you address some of the problems that face 
you all with food safety and with other parts. We know that you 
have to change the way you deal with quality control, that that 
is something for the suppliers as well as for you all 
internally. And we know that you need a reformed review system, 
that you also need some organizational changes to take place.
    Now, with the Chairman Emeritus in his remarks, which we 
all agree with much of that. I will differ on one point. I 
think before you start spending more money, what you need to do 
is show how you are going to reorganize and how you are going 
to address the problems that are before us.
    And thank you, and I yield back.
    Mr. Pallone. Thank you. The gentlewoman from Colorado, Ms. 
DeGette.

            OPENING STATEMENT OF HON. DIANA DEGETTE

    Ms. DeGette. Thank you very much, Mr. Chairman, and I want 
to thank my compadre, Bart Stupak, for all the work we have 
been doing in ONI over the last 10 years on these food safety 
issues. I think that the bill that the chairman and the 
Chairman Emeritus and Mr. Stupak introduced is excellent, 
especially since it includes several issues I have been working 
on for many years, which is mandatory recall authority for the 
FDA and also traceability because we had the ability to do 
mandatory recall right now.
    Most people think we have it, and if we had had it, perhaps 
some of those people in this latest peanut butter outbreak 
would not have died because the FDA would have been able to 
recall that peanut butter sooner.
    Two things I will say. The first thing is I think we need 
to improve the traceability provisions in the bill, and I look 
forward to working with the chairman on that. The technology 
exists, and there is no reason we shouldn't be doing it.
    The second thing is, as well as more resources, we need to 
give the FDA more authority to obtain the information that they 
need through subpoena authority and other kinds of authority.
    And finally, I agree completely with Chairman Waxman when 
he says that we need to do all of this now, and then after we 
do it, we need to look at structural changes in the way we 
oversee our food safety in this country. Congresswoman DeLauro 
and I have worked for many years on a unity food safety agency, 
but that will take time. And time is certainly something we 
don't have right now, given what is happening with all these 
outbreaks. Thank you, Mr. Chairman.
    Mr. Pallone. Thank you. The gentlewoman from Florida, Ms. 
Castor.

             OPENING STATEMENT OF HON. KATHY CASTOR

    Ms. Castor. Thank you, Mr. Chairman, and I want to thank my 
colleague, Mr. Stupak, as well. Food safety is vital to the 
health of all Americans. And many of you know, the Government 
Accountability Office keeps a very short list of major 
government problems that require significant reform. It is 
called the high risk series, and it includes notorious 
governmental failures such as the Financial Regulatory System, 
maintenance of our roads and bridges. Food safety also is on 
this high-risk list, and reform is vital.
    Let me give you one example. Tomatoes from my home state of 
Florida last year were blamed for a nationwide salmonella 
outbreak that was eventually traced to jalapeno and Serrano 
peppers from Mexico. In the meantime, the FDA's warning not to 
consume tomatoes from Florida cost tomato producers at least 
$100 million. All of the time and effort spent warning 
consumers about Florida tomatoes only served to delay the 
solution to the real problem and allow more Americans to get 
sick.
    We have to address a lack of resources, the labyrinth 
regulatory regime, the lack of federal authority. The problems 
facing the food safety and oversight are legion, and they are 
difficult, but they are not insurmountable. So I look forward 
to the witnesses' thoughtful recommendations today. Thank you.
    Mr. Pallone. Thank you. The gentleman from Ohio, Mr. Space.
    Mr. Space. Thank you, Mr. Chairman. In yielding back, I 
would just like to thank you and Chairman Stupak and Chairman 
Dingell for your good work in this area. I look forward to the 
testimony.
    Mr. Pallone. Thank you. The gentlewoman from Ohio, Ms. 
Sutton.

             OPENING STATEMENT OF HON. BETTY SUTTON

    Ms. Sutton. Thank you, Mr. Chairman, for having this 
hearing and, you know, it was only a month ago today that under 
the tremendous leadership of Chairman Stupak that we had a 
hearing in the Oversight Subcommittee on the recent salmonella 
outbreak associated with peanut products. And at that hearing, 
I told the tragic story of an elderly woman from my district 
who died of salmonella poisoning.
    Sadly, Mr. Chairman, since then, another elderly woman from 
northeast Ohio by the name of Nellie Napier has died from 
salmonella. In fact, her death was announced that day. There 
have been over 99 cases of salmonella reported in Ohio and 680 
nationwide.
    Now, I know, Mr. Chairman, that you and others have long 
been working to fix our broken food safety system, and I thank 
you. I thank Chairman Waxman and Chairman Emeritus Dingell and 
Ms. DeGette and others.
    The bottom line, Mr. Chairman, is that Congress needs to 
act quickly and comprehensively to address the food safety in 
our country. It is clear that the FDA does not have the current 
authority or capacity to properly oversee the safety of our 
food supply. That is why I reintroduced the Protect Consumers 
Act, to give FDA mandatory recall authority. It is a very 
simple measure. Certainly should be part of a comprehensive 
overhaul, but frankly I would love to see it moved quickly in 
its own right if we cannot move the comprehensive bill as 
quickly as we would like.
    We cannot sit back and let any more people become ill from 
food they eat. I look forward to hearing from our panelists 
today and working with my colleagues to fix our broken food 
system, and I yield back.
    Mr. Pallone. Thank you. The gentleman from New York, Mr. 
Engel.
    Mr. Engel. Mr. Chairman, I would like unanimous consent to 
have Mr. Green's remarks entered into the record.
    Mr. Pallone. Without objection, so ordered.
    [The prepared statement of Mr. Green follows:]

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            OPENING STATEMENT OF HON. ELIOT L. ENGEL

    Mr. Engel. Thank you, Mr. Chairman. Thank you for holding 
this important hearing today. If there is any good that may 
come of the Peanut Corporation of America salmonella crisis, it 
is now more clearly than ever that our food safety system is 
broken and in need of critical reforms.
    An AP poll last year found that 46 percent of people were 
scared that they would get sick from tainted food, and there is 
a reason for this fear: U.S. food-borne illnesses result in 76 
million illnesses, hundreds of thousands of hospitalizations, 
and up to 5,000 deaths each year.
    As one of our witnesses astutely pointed out in his 
testimony, our Nation is sustaining deaths equivalent to those 
that perished in the World Trade Center attack in New York 
every six months. When you think about it in those terms, it 
just takes your breath away. And yet, we have set up the FDA to 
fail here. We expect the FDA to ensure the safety of our 
Nation's food supply, but we haven't given it the resources or 
authority to get the job done.
    Sure there are many food companies and facilities that are 
employing best practices to preserve their own food products, 
but unfortunately it is those that don't that cause crippling 
problems for our public health and economy. This is why it is 
so important to grant FDA the ability to mandate clear 
preventative controls, strong traceability, and mandatory 
recalls within their food safety authority.
    Mr. Chairman, the costs are clear. I look forward to 
working with you on a comprehensive food safety reform bill 
this year. I yield back.
    Mr. Pallone. Thank you. Gentlewoman from California, Ms. 
Eshoo.

            OPENING STATEMENT OF HON. ANNA G. ESHOO

    Ms. Eshoo. Thank you, Mr. Chairman, for holding this very 
important hearing on the issue of food safety, which is so 
needed. The American people should be able to trust their 
government to protect them from food-borne illnesses, and right 
now, to put it mildly, we are not even doing an adequate job.
    When people are dying or becoming seriously ill as a result 
of what they ingest in the United States of America that has 
always had the highest standards, we are really in trouble. And 
it is an area that most frankly the Congress has neglected for 
a long time.
    So I think that now is the time to address it because the 
FDA really should be the world's premier food inspection 
authority. It is an issue that affects everyone. Doesn't matter 
whether you are rich or poor, where you live in the country, 
whether you are a youngster or an oldster, God help you if you 
have ingested something that has not been reviewed.
    And we live in a global economy, and we have things pouring 
into our country, and unless it is inspected, then our citizens 
are placed at risk. I have cosponsored legislation that 
Congresswoman DeLauro has offered. I think it is a very good 
bill. I think that there are good ideas, both in this committee 
and from outside the committee. I think that the system has to 
obviously be modernized, and I really think that we should 
separate our food from the FDA.
    I think we should have a food safety administration. I, for 
one, am a little tired of running the FDA on user fees. I think 
we are doing it on the cheap, and as long as we do that, we are 
going to be plagued with the problems that we are here to 
discuss today.
    So I look forward to working with all of my colleagues on 
this issue. I don't think anyone has a corner on the market of 
wisdom on it, but I do think that the committee should take 
into consideration all of the bills that are being introduced 
on this because there are very good ideas that are contained in 
each one.
    So thanks again, Mr. Chairman, and to the witnesses that 
are going to testify today, thank you. We know that you will be 
instructive. We will learn from you, and hopefully we will pay 
close attention to you. Thank you.
    Mr. Pallone. Thank you. I think that concludes opening 
statements by the members. So we will now turn to our panel. I 
want to welcome you, and I ask you to come forward. We only 
have one panel today, but they are distinguished. And they are 
actually quite--let them sit down first.
    I will start on my left with Ms. Caroline Smith DeWaal, who 
is the food safety director for the Center for Science in the 
Public Interest, and she has been dealing and calling attention 
and been a watchdog on this issue for a number of years. Many 
of your ideas have been incorporated in my bill and then into 
the larger bill sponsored by Mr. Dingell and Mr. Stupak and 
myself.
    Mr. William Hubbard, who is former associate commissioner 
for policy and planning at the Food and Drug Administration and 
an advisor for the Alliance for a Stronger FDA. Good to see you 
again.
    Dr. Martin Cole, who is research professor of biology and 
director of the National Center for Food Safety and Technology 
at the Illinois Institute of Technology.
    Mr. Thomas Stenzel who is president and CEO of United Fresh 
Produce Association.
    And finally Jim Lugg who is former executive vice-
president, Food Safety and Quality, Fresh Express, and 
consultant for Chiquita Brands. Thank you all for being here, 
and we have 5-minute opening statements, and we will start with 
Ms. DeWaal.

  STATEMENTS OF CAROLINE SMITH DEWAAL, FOOD SAFETY DIRECTOR, 
  CENTER FOR SCIENCE IN THE PUBLIC INTEREST; WILLIAM HUBBARD, 
    ADVISOR, ALLIANCE FOR A STRONGER FDA, FORMER ASSOCIATE 
      COMMISSIONER FOR POLICY AND PLANNING, FOOD AND DRUG 
   ADMINISTRATION; MARTIN COLE, PH.D., RESEARCH PROFESSOR OF 
   BIOLOGY AND DIRECTOR, NATIONAL CENTER FOR FOOD SAFETY AND 
    TECHNOLOGY, ILLINOIS INSTITUTE OF TECHNOLOGY; THOMAS E. 
 STENZEL, PRESIDENT AND CEO, UNITED FRESH PRODUCE ASSOCIATION; 
  AND JIM LUGG, CONSULTANT, CHIQUITA BRANDS, FORMER EXECUTIVE 
     VICE PRESIDENT, FOOD SAFETY AND QUALITY, FRESH EXPRESS

               STATEMENT OF CAROLINE SMITH DEWAAL

    Ms. DeWaal. Thank you very much, Chairman Pallone and also 
Chairman Deal for having this hearing. I do want to recognize 
just the tremendous food safety leadership that is in this room 
from you, Chairman Pallone, to former Chairman Dingell, Mr. 
Stupak, and Representatives DeGette and Eshoo. You have all 
been tremendous leaders, and we are thankful to be hopefully at 
this point of having legislation poised to really address these 
problems.
    I am the director of food safety for the Center for Science 
in the Public Interest. And we represent over 900,000 consumers 
both in the U.S. and Canada. We are focused on food safety, 
nutrition and even alcohol issues. Pretty much anything you put 
in your mouth we worry about.
    The impact of the Peanut Corporation of America outbreak 
and recall are still reverberating through the food supply. It 
has caused nearly 700 confirmed illnesses and nine deaths and 
the recall of over 3,200 separate products. Despite its size 
and scope, this event is neither rare nor unexpected. Congress 
has held nearly 20 hearings in the last two years focused on 
similar failures of FDA's food program linked to everything 
from spinach tainted with E. coli, pet food containing an 
intentionally added melamine, which sickened and killed many, 
many animals, and even a previous peanut butter salmonella 
outbreak, which was thoroughly investigated in this committee.
    These events are causing steep declines in consumer 
confidence, both in the overall safety of the food supply and 
in FDA's ability to protect the public. Nearly half of those 
questioned by Consumers Union in November said their confidence 
in food safety had declined.
    Also last fall, a poll conducted by Ipsos-McClatchy 
reported that 28 percent of those polled believe food safety 
had gotten worse, and 46 gave food safety controls a failing 
grade. In July 2008, in the midst of the salmonella outbreak 
linked first to tomatoes and then to peppers, an Associated 
Press-Ipsos poll found that 46 percent of people were worried 
that they might get sick from eating tainted products. Clearly 
it is time for Congress to take action to fundamentally reform 
and fully fund our food safety system.
    I will now outline a couple of the essential elements that 
CSPI thinks need to be in any legislation moving forward to 
begin the process of reforming FDA's food safety program.
    The heart of any effective reform effort lies in 
prevention, not response. Legislation should include at least 
the following three components for preventing food safety 
problems at food processors. First, Congress should require 
every food plant regulated by FDA to have a food safety plan 
detailing that it has analyzed its operations, identified 
potential hazards, and is taking steps to minimize or prevent 
contamination. These requirements are already in place for all 
meat and poultry processors today but not in plants regulated 
by FDA.
    Legislation should set risk-based inspection frequencies 
for food plants and establish clear auditing parameters when 
states are conducting inspections on behalf of the federal 
government.
    And finally specific authority should allow the agency to 
set testing frequencies and require food processors to report 
adverse reports to government inspectors. Without these checks 
on the plants, companies can follow the practices of PCA, which 
instead of fixing its salmonella problems, it fixed the tests.
    Consumer concerns extend up and down the food chain from 
the farm to the table. So legislation also needs to provide on-
farm food safety plans that will give farmers tools to manage 
risks like raw manure, unsafe water, and worker hygiene.
    Imported foods also pose special challenges as they enter 
the U.S. from all over the world including many countries where 
they are essentially unregulated. CSPI supports the use of 
certification systems operated by foreign governments and some 
third parties if they are subject to appropriate oversight by 
FDA. Certifiers of imported product can give FDA boots on the 
ground and greatly increase the agency's capacity to enforce 
our food safety requirements among the foreign facilities from 
175 different countries that export to the U.S.
    President Barack Obama has promised a government that 
works. These new authorities, together with increased funding 
will certainly help FDA improve. But to deal with the root of 
the problem, Congress and the Obama administration will need to 
go beyond making a few improvements. Structural reforms are 
also essential.
    FDA is responsible for 80 percent of the food supply, and 
yet the commissioner's attention is frequently on drugs, 
medical devices, and cosmetics, animal feed, many other issues 
that FDA regulates. Food issues frequently unfortunately fall 
to the bottom of the pile. Today there is no single expert in 
charge of the policies budget and enforcement staff and no 
credible voice communicating to the public and the industry 
what needs to be done to prevent outbreaks.
    It is time to elevate food monitoring functions within the 
Department of Health and Human Services. With both the public 
and the regulated industries clamoring for change, we are very 
happy to be here today and to have the tremendous leadership on 
this committee. Thank you.
    [The prepared statement of Ms. DeWaal follows:]

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    Mr. Pallone. Thank you. Mr. Hubbard.

                  STATEMENT OF WILLIAM HUBBARD

    Mr. Hubbard. Thank you, Mr. Chairman. I have a written 
statement for the record. I will just make a few brief remarks 
if I may.
    As you know, the public is confused and even frightened by 
what is going on. Imagine a fully loaded 737 crashing every 
other week. That is the type of toll we are talking about here, 
but yet we continue to tolerate the intolerable. And the public 
health costs have been mentioned by many of the members today, 
and they are very real.
    Suffering out there is very real, and also I don't think we 
should disregard economy costs that companies and the health 
care system are being burdened by food-borne disease outbreaks 
that are largely preventable. So we are allowing things to 
happen that we can stop, and I would like to make two main 
points about the problem.
    First is the issue of FDA resources. I believe I have a 
slide if we could put it up, and I think really in a way it 
captures the problem that FDA has gone through. Do we have that 
slide? When I came to the FDA in the 1970s, there were 70,000 
food processors in the United States. FDA had the resources to 
inspect 35,000 times a year, which meant everybody could get a 
visit every other year. There were very few imports at the 
time.
    [Slide.]
    As you can see from this slide, we are now doing about 
6,000 or 7,000 a year, but if you plotted the increase in the 
industry, that has gone from the 70,000 domestic firms at that 
period to 150,000 today and another 216,000 farm firms. So we 
have gone from inspecting about 50 percent of the food supply 
at any time to five percent of the domestic processors and 
about two percent of all processors. And that has largely been 
a function of resources. FDA's budget has been cut and cut and 
cut for 30 years, and we simply need to find a way to reverse 
that.
    And you can also plot, as those numbers go the direction 
they go, recalls have gone up. FDA's adverse findings when they 
do do inspections have gone up, and you have a general lack of 
overall quality in many of these firms.
    I will say, however, as I say in my testimony, I think the 
food supply is generally safe. We have gaps though that are 
willing to cause the problem. Unless everybody does it right, 
no one can get it right.
    And then the other main point I wanted to make is 
authorities. FDA has authorities dated to 1906. It is 
essentially a relic of the 19th century. It doesn't work. It 
requires an inspector to perhaps catch a problem the day he 
happens to get there if he gets there at all. FDA needs the 
kind of preventive controls many of you have mentioned and Ms. 
DeWaal mentioned, in which they can require a firm to examine 
how they make their food and control hazards so the food never 
gets contaminated to begin with.
    And those are practices that the leading food firms use 
now, so we are not talking about imposing on the food industry 
some strange new regulatory regime. We are talking about 
adopting industry-developed preventive control technology that 
has been proven to work.
    And then lastly there are some other provisions that I 
think are very important. Trace back has been mentioned. We saw 
with the tomatoes last year and the spinach earlier how these 
outbreaks drag on for weeks or even months because FDA doesn't 
have adequate trace back authority.
    They need access to the records of these firms so they know 
where the food has come from and where it is going. They need 
mandatory recall authority. Clearly some firms simply stall for 
a few days, and during those few days while FDA is begging them 
to do a recall, the food is moving and being consumed.
    And we also need to accredit these labs that are doing a 
lot of the work because you need to know you have a high level 
of quality in the laboratories.
    There are some other things in my testimony; however, in 
the interest of time, I will stop there. But I certainly do 
urge you to act this year on food safety legislation.
    [The prepared statement of Mr. Hubbard follows:]

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    Mr. Pallone. Thank you. Dr. Cole.

                    STATEMENT OF MARTIN COLE

    Mr. Cole. Chairman Pallone, Ranking Member Deal, good 
morning. I guess what I would like to try and do, I have 
written testimony. I would like to make a few remarks to try 
and help this committee wrestle with the complexities of the 
food safety systems and what approaches they should take.
    I really do applaud the important work and the urgency and 
the opening remarks that have been made this morning. Certainly 
we have seen, I think we are all acknowledging, the complexity 
of the supply chain. The food business is global now. Go to the 
supermarket, the products can be from anywhere in the world. 
Global sourcing of ingredients.
    Look at consumer trends now. You know we want people to eat 
healthy food. There is a trend toward more natural, fresher 
products, less preserved, more convenient products, longer 
shelf life. All of those, as a food microbiologist, they go 
against traditionally what you would like to see in the 
marketplace. So we want food to be healthy, but we want it to 
be safe.
    And we certainly need to, I think as the opening remarks 
have mentioned, we have new issues, and we need a new approach, 
OK. We need to have a modern food safety system here in the 
U.S. I think really in simple terms, I look at that in terms of 
four main components to a modern food safety system.
    First of all, risk-based preventative measures. You need 
programs to monitor progress. That can be trend analysis. That 
can be testing, inspection, even Epidemiology, but you need 
programs to be able to monitor progress.
    You need appropriate government oversight. Without 
government oversight, you get the issues that we have in peanut 
butter and salmonella.
    And then lastly you need a strong research program because 
things are changing so fast. If you don't have a world class 
research program, you can't deal with issues proactively and 
deal with them swiftly.
    Dealing with microorganisms--and I am a microbiologist by 
trade--dealing with microorganisms is even more complicated 
because they are alive, OK. So bacteria have the ability to 
grow and survive and adapt throughout the food chain. So when 
we are designing food safety systems, we need to be cognizant 
of the ability of bacteria to change and to grow and adapt. So 
that adds another complexity with what we are dealing with.
    Now, in response to these issues, I mean this is not just a 
U.S. issue. Internationally, the food safety community has 
responded by developing new tools, risk-based tools, to try and 
ensure the safety of the food supply. And it now possible 
through modeling and risk assessment to be able to link the 
level of hazard or the prevalence of a hazard in the food 
supply to the likely illness that it is likely to cause. And 
that has allowed us to develop new risk management frameworks 
that will provide for scientific underpinning to the develop or 
risk-management options, the science behind the frequency of 
inspections, et cetera. So these new developments we need to be 
using.
    It is ironic that, you know, in the U.S. much of these 
developments have been led by U.S. scientists, and yet we need 
to start walking the talk here. So we have done a good job, I 
think, in tracking sporadic cases of food-borne illness through 
new tools, food safety net, Wholesfield, del electrophoresis 
fingerprinting if you like, of organisms. But we are really 
falling behind in the prevention side, and that is really where 
we need to up our game.
    A quick word about oversight testing and inspection. I 
think the short answer is you can't test and inspect safety 
into food. OK you need that oversight because without that, you 
get the PCA issue. But testing alone, think of the issue with 
salmonella where a very low infective dose can give you an 
illness. It is like looking for a needle in a haystack. The 
statistics of sampling are such that you can't test safety into 
food.
    Think also of the volume of foods that are coming into the 
U.S. now. What is it? Over 60 percent of fresh produce, fruit 
and vegetables, coming to the U.S. from overseas, over 80 
percent of seafood coming from overseas. You know we need to be 
practical about the percentage of foods we can realistically 
inspect. We need the inspection there as a deterrent, but we 
need to be smart about where we use those resources. And we 
need to use them where the highest risks are.
    Now, in industry, there are two main tools for really 
applying and implementing risk-based measures, and as was 
mentioned before, these are standards tools that have been 
adopted through Codex. The two main tools are good 
manufacturing practice, or GMP, and hazard analysis critical 
control point, or HACCP. And you can think of GMP as like the 
building blocks, the standard operating procedures for sanitary 
design, equipment, people, labeling, recall procedures, et 
cetera.
    Many of the recall issues that we see from FDA actually, if 
you look at whether GMP would deal with them or whether HACCP 
would, many of them actually would deal with GMP, and it is an 
oversight issue that we have. So we need to think about where 
we should be using GMP and also where we should be using HACCP.
    HACCP is a more systematic approach identifying, evaluating 
the food safety hazards. It is usually more quantitative in 
nature, usually defining a critical control point in the food 
chain that you must control to reduce, eliminate, and prevent 
hazards. Typically in a value chain, you would be looking at a 
performance standard for HACCP as well.
    Now, I also have one slide to share with the committee this 
morning. I could take that. I think it is a good lead in to 
some other testimony relating to fresh produce. You can go to 
slide three please. That is great. So really I think it kind of 
illustrates a good lead in to the next witness. If you look at 
the complexity of the supply chain for fresh produce, you can't 
pasteurize lettuce, OK. You would have lettuce soup if you were 
to do that.
    OK, so there isn't one kill step in the chain. So you have 
to take a through chain approach. You have to take good 
agricultural practice. You have to look at what you are doing 
in terms of washing of the produce, and you have to look at 
what you are doing in terms of the distribution.
    So I just wanted to share with you this is a complex 
business. There is research going on at the moment between 
industry and government to really try and come up with the risk 
management options that would build some robustness into the 
value chain for fresh produce. This is a category of food we 
want people to eat more of, OK. Hugely impactful in terms of 
nutrition, and yet we need to build more robustness in terms of 
safety.
    My final comment, Mr. Chairman, is around research. You 
know the U.S., I think, should be really at the forefront of 
research in terms of the safety and health of food. It is such 
an important driver of public health, but also very important 
in terms of trade for the U.S. With that, thank you very much.
    [The prepared statement of Mr. Cole follows:]

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    Mr. Pallone. Thank you, Dr. Cole. Mr. Stenzel.

                  STATEMENT OF THOMAS STENZEL

    Mr. Stenzel. Thank you very much, Mr. Chairman. I don't 
have a slide, but I will thank Dr. Cole for sharing on behalf 
of the fresh produce industry. And I will affiliate myself with 
his remarks.
    In my written testimony, I have provided a number of 
specific policy provisions that I will call to the committee's 
attention, but I would like to spend just a few minutes this 
morning talking a bit more personally about some of these 
issues.
    First, I would encourage all of you to eat more fresh 
fruits and vegetables. At a time when Congress is debating 
health care reform, all public health authorities agree that 
one of the most important things we can do to improve health is 
to eat more fruits and vegetables. But achieving that goal is 
dependent upon the main issue that we are talking about today, 
and that is the critical challenge to modernize and reform food 
safety law.
    Now, I personally am confident in my produce choices today. 
We consume over a billion servings of fresh produce every day 
in the United States, over five million bags of salad every 
day. And out of the hundreds of different produce items in the 
supermarket, a very small number, only five, have been related 
to any type of food-borne disease in recent years in quantity.
    But we also know that we have issues. Consumers know it, 
and consumers are fearful of fresh produce at the moment. And 
that is something we have to address. Now, our industry has 
been working in this area for many, many years, but the spinach 
crisis almost three years ago now was a watershed moment for 
us.
    Remember the unprecedented national response. We pulled 
spinach off of the shelves of every grocery store in America 
for weeks. In fact, we now know the only contaminated product 
came from one farm through one processing plant on one day's 
production, even one afternoon shift. It wasn't even the whole 
day. There has been no contamination from that processing plant 
or from spinach in the last two and a half years. And yet 
today, spinach consumption is still down in the United States, 
one of the healthiest vegetables that we should all be 
consuming.
    Following that outbreak, we undertook a mission. First, to 
look at a comprehensive reevaluation of all our leafy greens 
production. Mr. Lugg will talk about that, and his leadership 
in that area of our industry has been tremendous. We looked at 
every possible step and have adopted the most rigorous good 
agricultural practices with strong compliance measures and 
audits, some conducted by the California Department of Food and 
Agriculture, but also other states and private sector auditors.
    But our industry also had to address the broader question 
of federal regulation. In January of 2007, our board of 
directors adopted a series of policy principles for mandatory 
federal oversight of our business. Let me explain the three 
principles briefly.
    First, we believe produce safety standards must allow for 
commodity specific food safety practices based on the best 
available science. In a highly diverse industry that is more 
aptly described as hundreds of little industries, one size 
clearly does not fit all. For example, food safety requirements 
applicable to products grown close to the ground would be very 
different from food safety practices for fruit grown on trees.
    Secondly, we believe produce safety standards must be 
consistent for any individual commodity wherever it was grown 
or processed anywhere in the United States or imported into the 
country. Consumers must have confidence that the same safety 
standards were applied no matter whether the produce is grown 
in California, New Jersey, or Mexico.
    Finally we believe achieving consistent produce safety 
standards across the industry does require strong federal 
government oversight and responsibility. That is going to take 
credibility for consumers, and it is also going to create 
equity for producers across all of our industry. The FDA must 
determine the most appropriate nationwide safety standards in 
an open and transparent process with full input from the 
states, industry, academia, consumer groups, and all 
stakeholders.
    Most of my testimony this morning has been about 
prevention. Preventive controls are where it is at. That is 
what we have to do. As Dr. Cole said, we are not going to test 
food safety into our products. But I do have to take just one 
moment to talk about outbreak investigations as well.
    When I testified before the ONI subcommittee last summer in 
the midst of the jalapeno outbreak, I raised several issues 
that were critical, and I think the peanut paste fiasco of the 
last several months continues to reinforce those. It is clear 
that no one is in charge of these outbreak investigations. 
There is no chain of command. There is no command and control 
procedure, and American consumers and industry alike are left 
to be whipsawed back and forth from momentary change to change.
    Crisis planning is not done in advance. It seems to be 
learned on the job. The government's failure to use industry 
expertise, at least in our case, to help reduce and end the 
outbreak last summer was a tragedy.
    Now, let me say that this needs to be transparent. It has 
to be supported by consumer groups, and it has to be a squeaky 
clean system. But there is expertise in industry that can help 
reduce, moderate, and end outbreaks even in the tragic 
situations when they occur. And we have to find a way for CDC 
and FDA to take advantage of that expertise.
    Finally risk communication is critical. The principle of 
timely and rapid communication with the press and public cannot 
be underestimated. But it is also critical that any risk 
communication expert would advise precision and care in 
communicating exactly what needs to be said and not 
speculating. One single office at FDA needs to have the 
authority and accountability for public communications with one 
single officer designated as the media spokesperson.
    Let me conclude. There is a public health imperative that 
we consume more fresh produce. We as an industry are doing 
everything we possibly can to make sure that we are delivering 
safe and healthy products. But because science tells us there 
is no such thing as zero risk, government must also be able to 
assure the public that our food safety systems are based on the 
best available science and are enforced by strong and 
appropriate oversight. Thank you.
    [The prepared statement of Mr. Stenzel follows:]

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    Mr. Pallone. Thank you, Mr. Stenzel. Mr. Lugg.

                     STATEMENT OF JIM LUGG

    Mr. Lugg. Thank you, Mr. Chairman and members of the 
subcommittee. My name is Jim Lugg. I am former executive vice-
president of food safety and quality at Fresh Express and today 
a consultant to Chiquita Brands International.
    The strategy or food safety plan is a requirement for any 
company that is in the food business. And it must be a solid 
one, and it must be adhered to. Regular reviews of that food 
safety plan are required so that we are constantly updating it 
for new risks that we have become aware of.
    In our business in Fresh Express, we have to look at really 
three areas. One is the production area. Second is harvesting, 
and third is processing. Each of those areas are unique unto 
themselves and require specialized plans. But these reviews 
that we do of these three areas are what help us identify risks 
and prevent contamination from occurring.
    More importantly, I think the overall lesson we have 
learned from these plans are that we have to do a very good job 
at focusing on preventive efforts. That means that in our case 
we have really four things that we look at: where are we 
planting the crop, what is the environment surrounding the crop 
along with its creatures, third, what kind of water will we use 
to irrigate with and then process it with, and finally, all 
along that supply chain we have the worker issue, worker 
hygiene.
    But again I stress the fact that even though we have a 
robust plan and we have been doing fresh cut lettuce since 
1978, we constantly must update that plan so as we can identify 
new risks that we didn't realize because of new science or 
whatever the case may be.
    But I can point out a simple case that you can all identify 
with, I think. If we have a lot of lettuce that we are ready to 
harvest and one of our people can identify what seems to be an 
animal incursion into that field of product, we have two 
choices. If we can clearly identify where the incursion 
occurred, we can avoid harvesting that product. If we can't 
clearly identify that risk, we abandon the field completely.
    But I emphasize that this issue of risk evaluation is a 
never ending process in the food industry. And that is true 
whether it is fresh, whether it is frozen, or whether it is 
canned. Almost without fail, these risk evaluation lead to more 
effective preventive steps, and that is the bottom line.
    And I also would emphasize that these food safety plans, at 
least at our company where we handle a number of different 
vegetables, are not transferable. Lettuce is different from 
tomato, so they must be commodity specific.
    And then I want to go on and just mention that in our 
company when we do identify a risk, we focus intently on how to 
manage that risk and how to evaluate whether our management 
practices are safe. This requires a lot of record keeping, what 
has been measured, when it was measured, and all those sorts of 
details. But the important point I want to make is that once 
the risks are identified, the preventive process controls must 
be put in place and then measured for their effectiveness.
    I also want to conclude actually by saying that we have a 
lot of tools that we can use to measure our effectiveness such 
as third party audits, testing, inspections, and so forth. And 
these tools are very effective in helping us evaluate how well 
we are doing.
    But the one thing I just want to give you a simple example 
of in closing is an acre of spinach has more or less three 
million plants in it. The typical practice for sampling a 
spinach field to measure, see if a pathogen is present, is to 
collect something less than 100 plants from that acre of three 
million plants. You can calculate for yourself how challenging 
the odds are of finding a pathogen in that sort of a regime.
    Finally and just to summarize, I believe the FDA should 
insist on every food company having a very current food safety 
plan. Secondly, the FDA should satisfy itself that regular risk 
evaluations are being done. Third, FDA should have access to 
preventive action steps that have been taken to manage the 
risk. And finally, my message is it is all about prevention. 
Thank you.
    [The prepared statement of Mr. Lugg follows:]

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    Mr. Pallone. Thank you, Mr. Lugg, and thanks to all the 
panel. We will have 5 minutes questions from each member who 
desires, and I will start with myself.
    I wanted to ask Dr. Cole. You explained the difference 
between the hazard analysis and critical control points or 
HACCP and good manufacturing processes. But I am not sure I 
understand how that relates to many of the bills that are now--
you know, they are calling them preventive safety plans which 
you flashed up in your chart or preventive controls.
    Just describe to me a little better maybe the differences 
between the HACCP and many of the bills, the language in the 
bills preventive safety plans or preventive controls if you 
could a little better. I know you flashed one of those up, but 
I don't necessarily understand the difference.
    I understand that the GMPs are like the basic fundamentals 
but----
    Mr. Cole. Yes, I think the best way to think about it is 
the term preventative food safety plan is a broad term which 
could include a whole range of different preventative measures. 
The way that those preventative measures could be implemented 
within industry and then inspected are things like GMP which is 
the, as you said, are the basic kind of building blocks. You 
can't do HACCP unless you have the building blocks in place, 
unless you have the basic sanitary conditions in place.
    Mr. Pallone. But then these preventative control systems 
can vary widely. So if that is the case, is it sufficient to 
just require that all manufacturers or producers simply have a 
food safety plan in place, or do we have to--if it has to be a 
need for FDA to have ability to be more specific than that?
    Mr. Cole. I think the trick there is, because even with the 
additional resources, there is always going to be finite kind 
of resources we can bring to bear on a public health burden. So 
we have to be smart about the way that we apply these tools. 
And so we have to use either GMP or HACCP or both appropriately 
to the hazard that we are trying to control and the risk that 
we are trying to manage.
    So, you know, let us take a fresh produce example. I think 
the comments from one of the testimonies here relating the 
products--is it product specific. If we were to look at the 
safety of potatoes, OK. Potatoes usually end up being cooked 
and prepared, and we are not really that concerned about the 
safety of potatoes.
    Mr. Pallone. So it is going to vary from product to 
product?
    Mr. Cole. It is going to vary depending on the level of 
risk that we are trying to control, yes.
    Mr. Pallone. Now, let me go to Ms. DeWaal then. I mean you 
can comment on this as well, but if there was a system of 
mandatory preventive controls in place prior to the PCA 
outbreak, would that have helped to prevent it from ever 
occurring in the first place? And if you want to comment on 
what Dr. Cole mentioned.
    Ms. DeWaal. Well, thank you, and I do agree with Dr. Cole 
that the preventive control plan covers your underlying GMPs, 
sanitation plans, as well as your HACCP plan if you have one, 
and your testing.
    The key element for the PCA recall and outbreak is that the 
company, because of the absence of a plan and the records to 
support that plan, they were not compelled during the 
inspections to actually show what they knew to the inspectors, 
which meant that when the State of Georgia went in and did 
inspections, they were just doing a spot check. Conditions on 
that day were what they could inspect. If a bill passes that 
contains this kind of requirement, when an inspector arrives, 
they will not only to get to inspect the plants and the 
products that are there, they will be able to go back and look 
through the records. And hopefully in that case, they would 
have found and acted on the causative salmonella test result 
findings that PCA had.
    Mr. Pallone. Because they basically have a plan in place 
about what they have to check for is what you are saying?
    Ms. DeWaal. That is right. It gives the inspectors the 
access to the information on food safety that the plant itself 
maintains, which today FDA doesn't have it and the states don't 
have it.
    Mr. Pallone. Well, just give me a little more. Maybe, Mr. 
Stenzel, you know, talk about how a plan might be different, 
you know, like tomatoes versus spinach. And are there certain 
things that you would require, you know, for both versus things 
that would be different?
    Mr. Stenzel. There are. You are seeing the full chain here 
in this panel discussion. We actually start at the farm level 
with good agricultural practices, which are kind of the GMPs of 
the farm level I might say. That is the basics that all farms 
should be following. There are also then commodity specific 
standards and practices that we believe are appropriate, we 
have called for FDA to implement. Particularly for those 
products that have been associated with a pathogen in the past, 
even rarely. So for tomatoes, there would be different sets of 
standards and practices, commodity-specific guidelines.
    Today that exists. The industry has worked hard in 
different sectors, tomato industry, the leafy greens. In fact, 
we have done a pretty good job, but we need FDA to be the 
holder of that standard so that it is applied across the 
industry and is not left just to individuals to follow it on 
our own.
    Mr. Pallone. OK, thank you. Mr. Deal.
    Mr. Deal. I think there seems to be general agreement that 
a food safety plan needs to be in place, and they will vary 
depending on what level of production you are in. Mr. Lugg, 
though, if we do make these plans mandatory and FDA comes in to 
inspect, in your opinion, what records should be disclosed to 
the FDA inspector in terms of those safety plans?
    Mr. Lugg. We would really like to have happen is when the 
plans are being developed, we would like to have FDA input 
along with our own so that the plan has all of the steps that 
the FDA would like to see included in it so that when the 
inspector arrives, he has been a part of that architecture, and 
he can easily see what he wants to see.
    Mr. Deal. So he would, by having access to the plan, know 
what they have done from a preventive standpoint?
    Mr. Lugg. Exactly. I think the owner of the food needs to 
own the food safety plan, but certainly there are very good 
advisors within CFSAN, for example, that can assist in making 
that plan even better.
    Mr. Deal. Let us go to the next step on this in a logical 
sequence, and any of you that would like to respond, please do 
so. The next logical step is what do you do with regard to 
laboratory testing? Now, I would imagine that many firms have 
internal labs that do internal testing, and they would, of 
course, I presume, maintain records of their own internal 
testing. Others would rely on external labs to provide testing 
and test results back for them. The one big question that I 
still have is to what extent do we require those lab tests to 
be disclosed to FDA?
    And the reason I have some concern about it is that you may 
have tests being done for a variety of different reasons. One 
might be someone who is going to process a product, but they 
want to find out what the status of the raw product is. Let us 
say peanuts for example. In its raw stage, they may get a 
result that may have some salmonella contamination.
    But if they are intending to follow through with the kill 
cycle, then obviously that should eliminate that particular 
problem. My concern is that I don't think we ought to 
necessarily overburden FDA with every lab report given under 
every circumstance and for every purpose.
    So how do we differentiate what lab report should be 
disclosed? And do you have any thoughts on that?
    Mr. Hubbard. I will take a shot at that if I may. The FDA's 
concern is that if you require these lab tests to be routinely 
submitted, people may just stop doing them.
    Mr. Deal. That is right.
    Mr. Hubbard. Firms often do them as part of their quality 
control process at the end to make sure that their systems are 
working. I think the state of Georgia was considering 
legislation that would require notification. But the theory is 
if you require it and the firm just stops doing the lab 
testing, you have not improved things.
    Mr. Deal. Right.
    Mr. Hubbard. But it would be important if FDA finds a 
connected problem, say, in a PCA example, is in their 
inspection and says to them do you have any laboratory findings 
that would help us understand if you are the source of the 
problem. And if they say yes, then, of course, FDA should be 
able to access those records.
    Mr. Deal. So you are saying then that should be a part of 
the maintain records subject to inspection when the FDA 
inspector comes in, not that the lab, upon receiving a negative 
or positive, as the case may be, report that the lab has to 
directly report at that point to FDA.
    Mr. Hubbard. I understand that that is the FDA position, 
yes.
    Mr. Deal. OK. All right, anybody else want to comment on 
that? Ms. DeWaal.
    Ms. DeWaal. Thank you. I just want to note that today most 
of the bills that you are looking at do have some lab 
reporting, but the different bills are different in their 
strengths. And we really want to get, first of all, this access 
that Mr. Hubbard is talking about. Any time an inspection is 
done, the inspectors should be able to see the full range of 
what the plant is looking at.
    But there are times, for example, where, if testing is 
compulsory for an industry or where there is some kind of 
public health alert, that you might want to compel some kind of 
reporting to the agency. So I think you need to leave the door 
open in some of those circumstances for testing direct 
reporting. But the reporting really should go from the plant to 
the agency, not necessarily from the lab.
    Mr. Deal. Dr. Cole.
    Mr. Cole. Yes, I think that is a pretty good answer. Again 
it comes back to based on risk. So if we are looking at the 
testing results as part of an ongoing food safety plan, I think 
the agency should have access to those records as part of that. 
They should have access as to what follow-up actions were taken 
as a result of those results. And then for certain products, 
you might want to make it compulsory that a positive 
salmonella, for example, is a notified situation. If I am 
making infant formula, for example, and I get a positive 
salmonella, that should be a notifiable instance, and that 
should go directly to the agency.
    So again unfortunately the devil is in the detail with the 
risk, managing the risk versus the resources.
    Mr. Deal. Well, just a quick comment. That is where we need 
your help, in fleshing out the devil because we can get the 
broad principles. I think it is the fleshing out of that I 
would appreciate hearing from you if you have any further 
thoughts about how we do that. Thank you, Mr. Chairman.
    Mr. Pallone. Thank you, Mr. Deal. Mr. Gonzalez is next.
    Mr. Gonzalez. Thank you very much, Mr. Chairman. First 
question, and I need to get the pronunciation. Is it Ms. 
DeWaal? Is that correct?
    Ms. DeWaal. DeWaal, that is correct.
    Mr. Gonzalez. DeWaal. Thank you. We have DeWaals in San 
Antonio that came from Minnesota, but they spell their name a 
little different, but it is DeWaal.
    Page three of your written testimony, ``the absence of 
federal inspection, inadequate state inspection have let 
problems at PCA fester.'' No matter how much we, I guess, 
empower the FDA, it is just going to be overwhelming. We are 
never going to have all of the assets and resources truly 
because of just the expanse of the issues. And we are going to 
have to form partnerships obviously with state authorities and, 
of course, private enterprise.
    With the Peanut Corporation of America, my understanding is 
that they had an operation in Texas. You are probably very 
familiar. It may have been Georgia-based, but we had peanut 
butter, a lot of it obviously out of the state of Texas.
    Mr. Deal. Virginia-based.
    Mr. Gonzalez. It is Virginia-based? Well, then we are a 
subsidiary and happy to have been a subsidiary. But the 
question comes down to is that they did have private testing. 
And I am just wondering. I don't know what we have out there 
now as far as certification of the labs that are actually 
hired. The question always is that the closeness of the 
relationship generally will lead to whatever conclusion the 
person that is requesting the testing.
    Do you have concerns about that particular aspect going 
forward?
    Ms. DeWaal. Yes, I think it is critically important that 
the legislation should contain a lab accreditation provision. 
Now, that won't apply to every in-house lab that a company may 
have. But lab accreditation will raise the confidence that both 
inspectors at the state level, federal level, can have in the 
results of those tests.
    But getting to your question on the complexity and how will 
FDA actually manage its job, I mean they have a huge job of 
regulating both the domestic industry and the imports. And the 
reality is the agency has been starved for resources. There are 
certainly management structures that could work that would 
allow for FDA to have very consistent programs working with the 
states to do inspection, but I don't believe those programs 
have been designed at the agency.
    And unfortunately the public is really losing confidence in 
the ability of this agency to do those tasks. So it is 
important to get the funding in place, to get the new 
legislation and these new authorities in place where there is 
common agreement on so much of this.
    But I am not sure that even with those elements we are 
going to be able to restore consumer confidence in the 
functioning of this agency. So I was very glad today to hear 
Chairman Waxman say that the question of structure, which was 
also raised by Representative Eshoo, would be one that they 
would leave open for further consideration because it is very 
important that consumers trust the agency to manage this huge 
responsibility.
    Mr. Gonzalez. And I think the authors of the bills 
recognize that, and we are going to be moving forward, and 
hopefully we will do as complete a job as possible under the 
circumstances and the competing bills.
    This is going to be to Mr. Stenzel and Mr. Lugg. And that 
is what really establishes accountability? In my view, it is 
liability. Not that this may have an application, one concern I 
have is that the FDA is, in essence, not just the floor of the 
standard of care but represents the standard, which we all 
agree today is totally inadequate in form and in practice.
    And yet many people will look to that as what would govern 
the behavior of individuals out there in this particular chain 
as we say from the farm to the retailer. Do you all have any 
views on the liability of individuals out there and how 
important that aspect in this whole, what I say, the 
accountability established by liability?
    Mr. Stenzel. Mr. Gonzalez, you raise an important point. I 
think the chairman mentioned it in the beginning. It is the 
responsibility of food companies and food purveyors to ensure 
that we have safe foods. It is government's responsibility, we 
believe, to make sure that there is a system of oversight and 
integrity and set the standards that we have to comply with. 
But ultimately that liability on the individual food company is 
a pretty darn important motivator. Look at PCA, you know, for 
the example of when you do something wrong, I think they were 
called a rogue operator, Mr. Deal, look at what that penalty is 
going to be.
    I would also like to comment on your earlier question if I 
may about partnerships particularly on farm. This is very 
important. We don't anticipate a reality of FDA hiring 3,000 
inspectors to go across farms in the United States or abroad. 
The partnership there we would recommend is with USDA who knows 
agriculture in the United States, knows it abroad as well, in 
partnership with state departments of agriculture.
    FDA needs to set the public health standard. That is for 
the integrity and confidence. But then in terms of actual 
outreach education auditing on farm, a strong partnership with 
Agriculture would make sense.
    Mr. Gonzalez. And Mr. Lugg, I apologize but my time is up. 
And I yield back to the chairman.
    Mr. Pallone. Thank you. The gentleman from Illinois, Mr. 
Shimkus.
    Mr. Shimkus. Thank you, Mr. Chairman. I want to start with 
Mr. Lugg, and like the comments that were just addressed by my 
colleague from Texas, I understand that the heavy hand of a 
liability process will also punish the bad actors, and it is in 
the best interest of everyone to have a safe and efficient 
operation.
    Mr. Lugg, is it safe to say that sometimes the inspections 
conducted by you all are maybe more specific than you might get 
from an FDA inspection?
    Mr. Lugg. Yes, our inspections particularly with respect to 
good agricultural practices in the field are very detailed.
    Mr. Shimkus. Can you give us an example----
    Mr. Lugg. Sure.
    Mr. Shimkus [continuing]. Of something that you may have 
spotted that FDA may not have?
    Mr. Lugg. Yes, in the agricultural production sector, which 
the FDA really doesn't spend a lot of time with, we have our 
own staff that will go and select a piece of ground that we are 
going to plant on, and that piece of ground is chosen based on 
the environment that surrounds it, and the quality of the water 
that we could use to irrigate with. That is something that the 
FDA wouldn't normally be concerned with.
    Now, we have a new group in California called the leafy 
greens marketing agreement, and they do get concerned with the 
good agricultural practices. But the FDA folks generally come 
into our manufacturing facilities.
    Mr. Shimkus. And I think, Mr. Stenzel, I think that is kind 
of your point you were making as far as having USDA deal kind 
of with the agricultural end of this process. I think a lot of 
us, depending upon the, you know, what your life experiences 
are. I used to be in the active military, and we feared the 
inspector general coming down. And the inspector general would 
have--we knew the list, right. We knew the standards, and by 
golly, by knowing they were coming down, it made us clean up. 
Really we want to be careful. I mean we really want to go after 
the bad actors.
    I mean we want to go after the people who would take a 
report, falsify the records, inspect them, and nail them versus 
those who have a proven track record of having--or, I think you 
testified once before or when we were doing the Oversight 
Investigation, if you talk about leafy greens. And if the 
processing facility has irradiation and salmonella is--you may 
want to inspect to make sure that the irradiation machine is 
working. But if that is killing salmonella, then you have 
addressed that need versus maybe the multitude of other things 
that you might have to do.
    Ms. DeWaal, I have talked about this because I really want 
to focus, and I have talked about the risk-based approach. And 
that talked about the food safety plan, but then identifying 
for particular crops. I mean you can have a generic system, but 
you do have to identify for the specific crop. But what about 
the debate of the inspection regime? If you have a successful 
manufacturing facility, has good manufacturing process, has a 
food safety plan, has historically been graded at 100 percent, 
A plus, super duper, five star quality. Do you think it is a 
good use of our resources to be in there twice a year versus--
my issue is if they are a good actor, we ought to incentivize 
them. And we ought to take the time for the second 
investigation and go after the bad actors. Could you comment on 
that?
    Ms. DeWaal. Certainly. The question of trying to create a 
risk-based inspection system but one that also gives the agency 
the flexibility to identify the best performers and spend less 
time and less resource there is one that we have really spent a 
lot of time looking at. I wish we were dealing with legislation 
that required six-month inspections. Most of the bills actually 
are looking at, you know, maybe one year, maybe two years, 
maybe four years, depending on the type of facility. So there 
is a broad range of inspection.
    But there is one bill that actually provides strict 
inspection, a risk-based inspection system, but then gives a 
lot of flexibility to FDA to set alternative inspection 
frequencies when plants show that they deserve it. And that 
type of language is contained in Representative DeLauro's bill, 
the Food Safety Modernization Act.
    So the bills range from very general language also to very 
specific language. Her bill has more frequent inspection 
frequencies, and maybe, I don't know how the committee would 
feel about the affordability of some of the inspection 
frequencies in the bill. But it is a very good model to look at 
it because it really defines what is risk-based inspection for 
the agency and then sets these alternative inspection 
frequencies based on criteria.
    Mr. Pallone. Thank you. Ms. Christensen.
    Ms. Christensen. Thank you, Mr. Chairman, and I want to 
thank the panelists for their testimonies and particular for 
their recommendations.
    Some of you have recommended a separate agency, and I will 
ask. Anyone can answer or all can answer. For those who think 
we should have a separate agency or for those who don't, do you 
think it would be just as effective to have just a specific 
office under FDA with a single head? Would that equate well 
enough for you?
    Ms. DeWaal. I think I will start this answer. You all are 
welcome to join in. We have looked at the question of a single 
agency ranging from a unified agency with all of meat and 
poultry inspection combined with all of FDA inspection to one 
that is more narrow.
    The approach that we are looking at right now is one which 
just separates out the food functions at FDA under a separate 
food standards administration, similar to what they have done 
in many European countries and in other developed countries 
around the world.
    The food standards agency would be headed by a food safety 
expert, and we don't have that in place today at FDA. There is 
no line authority for food safety. The policy issues are 
handled at CFSAN, the Center for Food Safety and Applied 
Nutrition. The inspection force is managed by the Office of 
Regulatory Affairs. The budget comes out of the commissioner's 
office.
    There is really no line authority here, and really there is 
no risk communicator. When something bad happens, I mean who is 
going to be on the call? Right now, we hear from CFSAN. We hear 
from ORA and CDC. So I think there is a structural problem that 
needs to be addressed at FDA. It is possible that you could 
have a deputy commissioner for food issues, for example, that 
might play that role, but it is very important to us that you 
have someone with direct line authority to the secretary of 
agriculture.
    Just looking at the sister food safety agency for a moment, 
at the U.S. Department of Agriculture, they did about 10 years 
ago pass a law that required food safety to be headed by an 
undersecretary of food safety, and that person does have direct 
line authority to the secretary of agriculture.
    So our concern about some kind of deputy commissioner model 
is that you would still have everything going through the 
commissioner who has just an incredibly large job for consumer 
protection today.
    Mr. Hubbard. I will give it a shot too. I have spent some 
time over the years thinking about that. It may be necessary to 
do that at some point, but if we could wave a magic wand right 
now and create a single food agency, tomorrow nothing would be 
any different because you would still have an under-resourced, 
under-authorized agency that couldn't solve these problems. So 
I think you are doing the right way which is fix the underlying 
problem. Then go back and see if the structure can work with 
that and be effective. And if it is not, then I think the next 
step would be to look at a single agency.
    Mr. Stenzel. If I may, I think I am going to agree with 
Caroline on this, that I do think that there is a fundamental 
problem in the lack of direct food authority within the agency 
at this point. So I would urge you to think about at least that 
narrow issue in the current food safety legislation.
    Whether is the equivalent of undersecretary of FSIS at USDA 
I think is a good one. We have to untangle food authority from 
everything else within FDA.
    Ms. Christensen. Thank you. I came from the Committee on 
Homeland Security, and, of course, there as well, food security 
is also a major concern. And the way the system is today, I 
don't have any degree of comfort that if the terrorists wanted 
to do something to our food system that they would have any 
problem. I was noting that then Secretary Tommy Thompson had 
raised that concern, and he remarked that he couldn't 
understand why terrorists had not attacked our food supply 
because it was so easy to do.
    But your recommendations talks about preventing 
contamination at the production, at the storage and 
transportation lines. Do you feel that the recommendations that 
you are giving us around the food safety system now are 
adequate also for protecting from an attack either from a 
homegrown or outside terrorist?
    Mr. Hubbard. Well, the principles are the same because you 
would analyze the risk and how easy it would be, say, to 
introduce a microbial agent into food and then have it, you 
know, be shipped around to a lot of different places and injure 
a lot of different people. So you still would be looking at 
well, how accessible is my facility? Might be as simple as 
making sure there is a security guard every night and the doors 
are locked. And of course, in other areas, it might need to be 
more sophisticated than that.
    Mr. Pallone. Mr. Gingrey.
    Mr. Gingrey. Thank you, Mr. Chairman. A couple of weeks ago 
when we were having a hearing about the salmonella outbreak, 
unfortunately from the processing plant in my home state of 
Georgia down in southwest Georgia. The testimony told us that 
the labs, these private labs that the processing plant 
contracted with to check for salmonella, apparently there were 
several positive results, and then finally one negative. And 
you know the rest of that story.
    But the question I want to ask of the entire panel is what 
came up during that hearing. The fact that the labs were not 
required, maybe even prohibited, as I understood it, from 
sending that positive information to anybody else except from 
whence it came, from who they were contracted with to do the 
laboratory testing, and it just seemed to me that it would be 
fairly easy to get that information to the FDA. Computers allow 
us to do that.
    I would like to ask the entire panel in fact what your 
thoughts are in regard to these positive results from the 
private labs actually being required to submit those to the 
FDA. And we will start from my left, your right.
    Ms. DeWaal. Thank you. The facts situation that was 
outlined in that committee hearing was just tragic, and I think 
the committee did a tremendous service to get those facts out. 
The mandatory requirement for labs to report would--it looks 
like an appealing solution because they are the ones doing the 
test. But we have real concerns that if you don't couple any 
mandatory testing reporting with a requirement to test, then 
the result will be, as Mr. Hubbard said, that companies just 
won't test.
    So you need to have in the legislation the ability for FDA 
to say for peanut processors, you might have to test for this 
pathogen or that indicator organism, and then determine when 
those test results would be appropriate. I do think that there 
are some pathogens--botulism is an example--where mandatory 
reporting by a lab might be appropriate.
    But I think the legislation should be clear that FDA has 
the authority to require companies to test. They should be able 
to test their test records when they inspect the plants, and 
that means anybody, the Agricultural Department of Georgia or 
the FDA. And then on certain pathogen combinations that, in 
fact, it would be open to mandatory testing either by the plant 
or by the lab.
    Mr. Hubbard. Mr. Deal touched upon that earlier. Certainly 
it would be important if FDA went to a facility like PCA and 
was doing an inspection and identified PCA as a source of a 
problem, that they should be able to say as part of their 
inspection process have you done any lab testing? And if the 
answer is yes, could we see that so we could see what you knew 
and when you knew it?
    But to require all labs to automatically send information 
to the FDA could actually cause people to stop doing the 
testing, which would not be an outcome that I think most people 
would want. I think Ms. DeWaal sort of----
    Mr. Gingrey. But as Ms. DeWaal said, FDA certainly could 
require in certain commodities at----
    Mr. Hubbard. In certain commodities.
    Mr. Gingrey [continuing]. Certain steps in the process----
    Mr. Hubbard. Yes.
    Mr. Gingrey [continuing]. That the testing be done for 
particular pathogens, and that could be a requirement.
    Mr. Hubbard. And that might be necessary in some cases. 
That is right.
    Mr. Cole. I would agree with those comments. I think this 
is a situation where given, you know, this is not the first 
outbreak we have had with peanut butter. We had one two years 
ago. There have been outbreaks overseas. I think we should be 
viewing this product as a high-risk product. We should have a 
requirement to test and a requirement to report those tests. I 
think also we need to have preventative controls in place to 
prevent contamination. Once salmonella is in that product, it 
is very resistant, oK, to heat processing et cetera. So we need 
suppliers or companies buying that product too should have, you 
know, really done a better job in supplier assurance of that 
product rather than just looking at test results as well.
    Mr. Stenzel. I think we share a pretty common view on the 
panel, particularly the access to those test records is the 
most critical aspect. I share the same concern in terms of 
required every single test to be automatically forwarded to 
FDA. I am not sure that that is the most effective answer for a 
company that deliberately retested and retested until they 
found something they wanted.
    That is criminal behavior, and no matter what standard we 
would put in place, I am not sure we are going to prevent 
someone who does that. They would not send the results----
    Mr. Gingrey. Yes, agreed. In that situation, it wouldn't 
have made a difference.
    Mr. Stenzel. But the access to the records I think is 
absolutely critical.
    Mr. Gingrey. Thank you, Mr. Stenzel. Mr. Lugg? Your 
microphone is not on.
    Mr. Lugg. I am sorry. Because we are in the fresh business, 
and the difficulty we have in collecting a representative 
sample, we rely so heavily on prevention that we just have a 
lot of lab results from our agricultural fields. We do have a 
program of what we call intelligent testing, and we do share 
those results routinely with researchers and our California 
Department of Public Health.
    As far as a requirement to furnish test results, I think 
that might discourage people from actually getting tests done 
and might in the end result in not the result that you would 
like.
    Mr. Pallone. We have to move on. Mr. Waxman.
    Mr. Waxman. Thank you, Mr. Chairman. I want to elaborate on 
some of the points Mr. Gonzalez raised. We have learned at 
numerous hearings the foods program at FDA has been starved for 
resources over the years and, Mr. Hubbard, in your testimony, 
you state there are currently 150,000 registered facilities in 
the U.S. And the charts you provided us today on the plummeting 
numbers of inspections in the U.S. paint a stark picture of the 
effects of this loss of resources, and that has a real impact 
on food safety.
    But the problem doesn't stop there. We are all acutely 
aware of the fact that we now have an increasingly globalized 
food market. We import foods from all over the world, 
apparently more than 200,000 registered foreign food 
facilities. How much does each inspection cost? Do you have any 
kind of estimate you can give?
    Mr. Hubbard. Domestic inspection or HACCP inspection can be 
around $3,000 and regular sanitation GMP inspection can be 
around $2,000. So they are not cheap.
    Mr. Waxman. Well, if we are talking about having FDA 
inspect over 360,000 facilities with some regularity, that is 
an overwhelming task in terms of the workload, and it will 
obviously cost a great deal.
    I have heard many suggest that the answers to extend FDA's 
workforce by supplementing it with private inspectors working 
on behalf of FDA, but I want to raise some concerns about that. 
There was a recent article in ``The New York Times'' that 
raised problems with these private inspectors. They say that 
food company being inspected often hires and pays for its own 
private inspector creating a conflict of interest, how those 
private inspectors frequently did not catch the problems at 
plants, whose products later sickened consumers.
    And some of those companies who later were found to have 
contaminated products were even given excellent or superior or 
ratings. That was the case with both PCA peanut outbreak and 
with the children's snack Veggie Booty in 2007.
    So in some ways, I am even more concerned about the notion 
of relying on private inspectors in foreign countries. 
Obviously the primary reason domestic companies want to import 
from other countries is that these products are less expensive. 
And the reason they are less expensive is usually that they are 
not produced under strong food safety protection. So relying on 
third parties in those countries raises some serious questions.
    My fundamental concern with a third-party system for 
imported foods governed by FDA is that it still puts a huge 
burden and responsibility on FDA. I think that a company 
benefiting from the importation of cheaper products and 
ingredients should have a duty to check up on these foreign 
companies and be held accountable when there are failures.
    Indeed, some companies are already doing very thorough 
inspections of their foreign suppliers on their own. Do you 
agree that a company should have a responsibility to check on 
its own suppliers? And if we are forced to rely on third-party 
private inspectors, what sort of protections do you think can 
be put into place to address some of these concerns?
    Mr. Hubbard. Yes, Mr. Chairman. You have touched upon a 
very important issue, and it may be your single hardest policy 
choice in this debate because you are absolutely right. The 
third-party system has not proven itself to be working properly 
now. It clearly is not working. FDA does believe that there are 
ways of beefing up that system----
    Mr. Waxman. Don't pay attention to that.
    Mr. Hubbard [continuing]. With prohibitions against 
conflict of interest, with better training, with FDA audits 
behind them. The fundamental dilemma is you can never have 
enough inspectors to go to 316,000 facilities of FDA 
inspectors. But on the other hand, these third-party folks need 
to be under a very serious regimen of oversight, and I do think 
that your question about having the importers, the U.S. 
importer bear more responsibility for the quality of the 
product they are buying from, say, China is an important piece 
of it.
    And, in fact, the major food companies are beginning to 
acknowledge that they need to do that, that they need to know 
who they are buying from and what their quality is. And if they 
don't know that, they should not be buying from that foreign 
firm.
    Ms. DeWaal. Thank you.
    Mr. Waxman. Do you want to add anything to that?
    Ms. DeWaal. I do. The concept you have laid out in terms of 
having the company take more responsibility works well when you 
are dealing with ingredients. But, sir, it doesn't work so well 
when you are dealing with whole foods. There are a lot of foods 
that come in a port of entry and go directly into retail. And 
who is going to be that importer of record becomes a real issue 
because it is defined today in regulations. But it could give 
rise to some fly-by-night situations.
    Mr. Waxman. Well, we have to look at these concepts 
carefully because we can't afford all the inspectors that we 
think we are going to need, and I don't know that we can rely 
on all those third-party inspectors either to feel that we are 
being protected.
    I see my time has expired, and other members are waiting 
for their turn. So I will yield back the time I have overdone.
    Mr. Pallone. Thank you, Chairman Waxman. I am going to ask 
Mr. Sarbanes to ask questions, and then that will be it before 
the votes. We have three votes, a 15, a 5, and a 5. So we will 
ask you to stay so we can continue with questions. So we will 
do Mr. Sarbanes, and then we will come back for the rest of the 
members.
    Mr. Sarbanes. Thank you very much, Mr. Chairman. Thank you 
all for your testimony. I was particularly interested in the 
discussion about consumer confidence and how difficult it is 
going to be to restore consumer confidence. And I take it that, 
if I am hearing the discussion properly, even with the best 
food safety regime in place, there is still going to be 
outbreaks, right? So if you link your bid to boost consumer 
confidence to the notion that you would prevent outbreaks, that 
is sort of a dead-end aspiration.
    So it really comes then, I would imagine, the thing that is 
going to bolster consumer confidence the most effectively is a 
rapid response when there is--because that is the high profile 
incidences, right, that occur? Otherwise it is like oxygen. You 
are not going to notice it, right, if things are working well. 
So it is when there is an outbreak that you have a rapid 
response, that you have the traceability opportunities and so 
forth. And you show the public that you can quickly isolate it, 
you know, within hours, within days, whatever is feasible to do 
with a good safety regime. And then they come away from the 
experience saying, you know, the cop is on the beat. This is 
being handled, and, you know, we are protected.
    And I would just like to get your reaction to that. And 
maybe there is other leverage points to help with this consumer 
confidence question, but it seems to me that is probably one of 
the most obvious. Yes, Ms. DeWaal.
    Ms. DeWaal. Thank you. You are right that we are always 
going to have outbreaks. The issue is how many and how big are 
they. The bills that you are considering address both ends. If 
we can prevent the problems from occurring, then the number of 
outbreaks will be reduced. If we can increase the traceability, 
the ability to find the contaminated product, then we are going 
to reduce the size of those outbreaks.
    So I think there are components that address both of those 
issues, but I think they are both essential.
    Mr. Sarbanes. Any other comments? Yes?
    Mr. Hubbard. I would like to make the point, Mr. Sarbanes, 
most of my career at the FDA, Roper and Washington Post and 
Harris polls showed FDA with the second highest consumer 
confidence in the entire--among all civilian agencies, next to 
the National Park Service. But since, 2000, that has reversed.
    Mr. Sarbanes. Um-hum.
    Mr. Hubbard. It used to be around 70 percent confidence 
level. Now it is around 30 percent. That is a tremendous 
reversal that I think reflects the kind of concern you are 
talking about because when FDA can't find the source of these 
things quickly and then stamp them out, get the food out of the 
commerce, then I think the public just feels their government 
is not serving them well.
    So the speed at which outbreaks can be responded to and 
stopped is absolutely important. But that will require more 
than FDA.
    Mr. Sarbanes. Right.
    Mr. Hubbard. You have the CDC component, and then the state 
health departments are a big piece of that.
    Mr. Sarbanes. Let me ask a question about the deterrent 
effect because you all have alluded to this. And I am just 
curious now where the number of inspections relative to the 
number of facilities and so forth is so low. I mean is there an 
operative deterrent effect at the current time, or not really?
    Mr. Hubbard. I actually tracked that a few years back. As 
the inspections went down, the recalls went up. And the adverse 
findings from the FDA inspections that did get done went up. So 
in other words, as inspectors disappeared, the vigilance in the 
firms disappeared with them.
    Mr. Sarbanes. Right.
    Mr. Hubbard. So I think the fact that they think FDA might 
come helps, and the fact that, you know, FDA won't come now is 
clearly not helpful.
    Mr. Sarbanes. Well, and I imagine there is a sort of 
tipping point that you have to get past to create an effective 
deterrent in this process. I have no further questions. Thank 
you, Mr. Chairman. I yield back.
    Mr. Pallone. Thank you. So we are going to break. We have 
three votes. Should be back in about half an hour, but we will 
come right back and finish with the rest of the members. 
Committee stands in recess.
    [Recess.]
    Mr. Pallone. If I could ask the panel to take their seats 
again, and thank you. And our next member for questions is the 
gentlewoman from Florida, Ms. Castor.
    Ms. Castor. Thank you, Mr. Chairman. To the panel, just as 
folks all across the country would be surprised that FDA does 
not have mandatory recall authority, I think they would also be 
quite surprised that the FDA does not have the authority to 
fine bad actors.
    Has this always been the case? Compare that to other 
agencies that have that authority to institute civil monetary 
penalties and then if you would provide a recommendation on 
what you think an FDA reform food safety bill should contain.
    Mr. Hubbard. I will give that a shot if I may. If you line 
up the various authorities of agencies all across government, 
the newer agencies tend to have a much broader range of 
authorities, such as civil money penalty and subpoena 
authority.
    FDA is one of the oldest agencies, and it was created in 
1906. And at the time, it was believed that the way to enforce 
the law is to put the owner in jail if he sold a bad food. But, 
you know, you are not going to put the Kraft CEO in jail 
because one of his firms made a little mistake. And to enjoin 
the company that is making the food, which is a good thing, and 
seize the food if it was considered adulterated.
    But it did not give FDA these more modern tools that 
provide them more leverage. So, for instance, civil money 
penalties, the industry won't like, but it is a nice 
intermediate tool to say OK, tomorrow it is going to cost you 
$1,000. And if you don't fix it, it might cost you $2,000. And 
finally they will fix it.
    And those kind of flexible tools have been shown to be very 
helpful for FDA in other contexts such as medical devices where 
it does have that authority.
    So I absolutely encourage you to look at the modern toolbox 
that regulatory agencies have and consider giving FDA those 
tools as well.
    Ms. DeWaal. We strongly agree. There are a whole set of 
tools, including things like even citizen sue provisions which 
are used in statutes that have been developed in the last 20 or 
30 years. FDA doesn't have any of this capacity. So I think the 
bill should include updating both the criminal penalty section 
but also giving this new authority for civil monetary 
penalties, traceability, and mandatory recall. Thank you.
    Mr. Stenzel. Honestly, Ms. Castor, I really don't have the 
experience to answer the question historically or related to 
other agencies. I do think some of the civil penalty areas can 
make sense in this area as well.
    Ms. Castor. Anyone else? Are any states that you know of, 
have they adopted their own civil penalties under their state 
inspection regulatory authority? Do you know? OK, thank you 
very much, and I will yield back.
    Mr. Pallone. Thank you. The gentlewoman from Ohio, Ms. 
Sutton.
    Ms. Sutton. Thank you, Mr. Chairman, and thank you for the 
witnesses for waiting for us. A couple of things very quickly. 
Mr. Lugg, you made an observation that has been made here in 
the past in our oversight hearing in which when discussing the 
concept of required reporting of test results to the FDA, you 
indicated that that may result in the failure to test and have 
an opposite effect.
    But I have to tell you that after we heard that sort of 
proffered at the last hearing, I received a lot of feedback, 
and it was certainly running through my mind, from my 
constituents who all well, we will fix that. We will just make 
them test. And so I mean I just have to tell you that in the 
realm of America, people are like that seems ridiculous to this 
congresswoman and to the people at least who I heard back from.
    So I think we can correct that problem if we need to by 
mandating the test. And I just appreciate having the 
opportunity though to address that. The other questions that I 
have, a lot of you have talked about imports and the complex 
sort of questions that it creates in ensuring the safety of the 
process and the food that results on our dinner tables.
    Ms. DeWaal and I think, Dr. Cole, you also addressed this 
issue. And, Dr. Cole, I think, if I am not mistaken--let us see 
if I can find it--you explained the way that this works under 
the WTO. And I think that that is really, really helpful 
because I am not sure that people out and about really 
understand our limitations on ensuring the safety of imports 
into this country. That in many ways--and perhaps this is a 
simplification, and I certainly ask you to explain in more 
detail--but in summary, when I read your statement about this, 
in essence we rely on the standards of other countries. Is that 
sort of an accurate assessment, or would you like to expand on 
that?
    Mr. Cole. I think through WTO, appropriate level of 
protection is defined by the member, in this case a country, 
and the regulations are set up to provide a shield, not a 
sword. So if a country can decide that it is going to have a 
more stringent standard than the default CODEX standard, it 
needs to have evidence that its own safety system can meet that 
standard as well. That is kind of how it works in a nutshell.
    So there are frameworks there from CODEX that we can borrow 
from. There are default criteria that we can use. It doesn't 
stop us setting our own standard, but we need to be able to 
show actually that we are meeting that standard for our own 
public health benefit, if you know what I mean.
    Ms. Sutton. But with respect to the WTO and as things 
currently exist, you mentioned that the idea of what is 
considered ``reasonable'' differs from country to country, and 
acceptable risk is culturally defined.
    And I think that those are important things for the 
American people to understand when we talk about certainly 
another subject that is related to this, and that is the way 
our trade system is working and what kind of exposures we have 
as a result of some of the policies that we follow. So I 
appreciate that assessment.
    Now, there are so many things that I would to explore more. 
But, Ms. DeWaal, as you noted in your testimony and we have 
heard some conversation here today about, the ability to access 
records from food manufacturers is now currently found in the 
Bioterrorism Act of 2002. And, of course, the FDA cannot demand 
access to food company's records unless they believe that an 
article of food is adulterated and presents a threat of serious 
adverse health consequences or death to humans or animals.
    And if you could just take this moment to explain how the 
limitations of working under that framework have resulted in 
adverse results.
    Ms. DeWaal. Thank you for the question. Probably one of the 
best examples of the failing of records access when it was 
needed by FDA was in an inspection of another peanut butter 
processor. That company, and it was disclosed actually in this 
committee's investigations, that company found that they had an 
inspection going on, and the inspector wanted to see the 
salmonella testing records. But the company itself said well, 
you have to submit the request in writing. FDA never circled 
back with that written request, and the company never disclosed 
those records. Another major multistate recall resulted from 
peanut butter linked to that company.
    It is clear that FDA does not have the record access that 
it needs under the Bioterrorism Act. So I think it is essential 
that in any legislation that should emerge from this process 
that that be fixed. And records access should be tied into this 
food safety plant. It should be broad. It should go to testing. 
It should go to processing records and corrective actions. 
Thank you.
    Mr. Pallone. Thank you. Ms. Eshoo.
    Ms. Eshoo. Thanks again, Mr. Chairman, and thank you to the 
witnesses for your patience and waiting and for the testimony 
that you have given.
    I wanted to highlight something that appeared in the ``New 
York Times'' last week, and Chairman Waxman made reference to 
it. But I want to read this, and with your permission, Mr. 
Chairman, I would like to place the full article in the record 
of the hearing.
    Mr. Pallone. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Ms. Eshoo. Thank you. The story starts out ``when food 
industry giants like Kellogg want to ensure that American 
consumers are being protected from contaminated products, they 
rely on private inspectors like Eugene A. Hatfield. So last 
spring, Mr. Hatfield headed to the Peanut Corporation of 
America plant in southwest Georgia to make sure its chopped 
nuts, paste, and peanut butter were safe to use in things as 
diverse as granola bars and ice cream. The peanut company 
though knew in advance that Mr. Hatfield was coming.
    He had less than a day to check the entire plant, which 
processed several million pounds of peanuts a month. Mr. 
Hatfield, 66, an expert in fresh produce, was not aware that 
peanuts were readily susceptible to salmonella, which he was 
not required to test for anyway. And while he was inspecting 
the plant to reassure Kellogg and other food companies of its 
suitability as a supplier, the Peanut Corporation was paying 
for his efforts.''
    You can tell where I am going with this. Now, here is a 
quote. ``The overall food safety level of this facility was 
considered to be SUPERIOR''--that is in capital letters--``he 
concluded in his March 27, 2008 report for his employer, the 
American Institute of Baking, which performs audits for major 
food companies. A copy of the audit was obtained by the ``New 
York Times.''
    Now, it seems to me we have a big problem here. We know, 
according to your testimony, what it costs to do inspections. 
It is not cheap, but it seems to me that outside of national 
security, there are two major functions the government has--and 
I have always kept this with me, from local government to the 
Congress--public health and public safety.
    And this issue bears both responsibilities. We are now not 
only talking about preventing. We are talking about life and 
death in our system, the American system, that should be the 
gold standard of the world. So for the record, what I would 
like to know is do you think that this third-party, these 
private inspectors are really the best way to go? I mean it 
said in this article that the contributions of third-party 
audits to food safety are the same as the contribution of mail 
order diploma mills to education.
    Why don't we start over here? I heard your comments 
earlier. Why don't we start over here with Mr. Lugg?
    Mr. Lugg. Thank you for the question. That is a very good 
subject that you raise, and that is----
    Ms. Eshoo. I know it is, but I want to know what you think 
of these private inspectors. Do you think they should be 
retained? Do you think they have a place in the system? Do you 
think that we can reform it so that private inspectors have to 
exercise more responsibility? Tell me what you think 
representing you--who are you representing?
    Mr. Lugg. Chiquita Brands----
    Ms. Eshoo. Chiquita.
    Mr. Lugg [continuing]. International.
    Ms. Eshoo. Right.
    Mr. Lugg. Our philosophy has been from day one we cannot 
rely on third-party inspectors.
    Ms. Eshoo. Um-hum.
    Mr. Lugg. We do believe that there should be in place a 
system for licensing third-party inspectors, and they should be 
regularly brought in to keep their licenses in force. And----
    Ms. Eshoo. So they are not paid by the very people that 
they are inspecting? Is that what you are saying?
    Mr. Lugg. Whoever pays, I didn't address the payment issue.
    Ms. Eshoo. I see.
    Mr. Lugg. But I just am----
    Ms. Eshoo. Well, how is what you just said, how does it 
differ from what we have today?
    Mr. Lugg. Well, we are very concerned that standards are 
different depending on the audit firms that do the audit.
    Ms. Eshoo. I see.
    Mr. Lugg. And if we always go back to the CODEX 
Almuntarius, which is a fundamental document and auditors are 
licensed based on their knowledge and so forth of how to 
conduct inspections, there should be an improvement in the 
third-party audit, regardless of who pays for it.
    Ms. Eshoo. Good. Mr. Stenzel.
    Mr. Stenzel. Congresswoman, I would say that private 
inspectors are an essential and important part of our food 
safety system today.
    Ms. Eshoo. But what I just read----
    Mr. Stenzel. Because we have one example where it didn't 
work----
    Ms. Eshoo. But this is--so you think it is the only one?
    Mr. Stenzel. I didn't say it is the only one, nor that it 
is the end of the solution. But private inspection is one way 
that private sector companies do audit each other, and that is 
an important part. No one is more concerned than Kellogg in 
that story that the people they hired to do inspections didn't 
do an adequate job.
    Ms. Eshoo. But where is the safety valve in this, in what 
you are saying?
    Mr. Stenzel. But here is where I think is important when we 
get to this legislation. Should FDA incorporate third-party 
private inspectors? And if that becomes the case, then there 
has to be much more rigorous certification of inspectors.
    Ms. Eshoo. So you are acknowledging that there are holes in 
what the system does now?
    Mr. Stenzel. Absolutely.
    Ms. Eshoo. Good. All right. Well, at least you are doing 
that. I am glad. And, Mr. Chairman, I think that when we do a 
bill, we have to pay a lot of attention to this area. And I 
think that it is important to have a stand-alone NHHS.
    I worry a great deal that what Congress is going to fall 
back on is what we have done with so many other areas of FDA 
and fund it through some kind of user fee. And I don't think 
that is the way to approach this. I think we are skating on 
very, very thin ice.
    I also think that Congress should be taking a look at an 
overlapping term for the FDA commissioner so that it is never 
politicized. I think it should be a six-year term and not be 
subject to the whims of politics that we have seen. That hasn't 
come up today, but I think there is a lot of work to be done 
relative to the FDA.
    And if we come up with all kinds of reforms but we don't 
fund what needs to be funded, we are going to be right back 
here with these good people hearing testimony all over again. 
So thank you. I was glad to return from the floor. I did want 
to ask the questions, and I thank the witnesses and the 
chairman. This is a big issue for us in the country.
    Mr. Pallone. Thank you. Ms. DeGette.
    Ms. DeGette. Thank you very much, Mr. Chairman. Mr. 
Stenzel, I wanted to ask you. With produce in particular, the 
industry now has the ability to trace produce not just from the 
field but from the exact part of the field it was planted all 
the way to the end wherever it is, the grocery store or the 
restaurant. Correct?
    Mr. Stenzel. That possibility exists. It is certainly not 
in place across the whole industry.
    Ms. DeGette. But it is done in parts of the industry?
    Mr. Stenzel. In some cases, yes.
    Ms. DeGette. Some companies have instituted voluntary 
traceability within their companies, correct?
    Mr. Stenzel. Absolutely. Many companies are doing that.
    Ms. DeGette. And, in fact, California has enacted standards 
that involve traceability, correct?
    Mr. Stenzel. Yes, ma'am.
    Ms. DeGette. And so I guess I am wondering what your 
industry's view would be if we enacted traceability laws as 
part of comprehensive food safety legislation?
    Mr. Stenzel. I would comment on the whole area. 
Traceability is an essential part of food safety. I think it is 
something that we have to look at. I would first ask in the 
Bioterrorism Act in the one up, one down, I am not aware of any 
case where FDA has ever cited a company for failure to produce 
records in an adequate time. So a lot of what we talk about in 
produce traceability, even last summer's episode was chasing 
the wrong commodity.
    Ms. DeGette. Right.
    Mr. Stenzel. Not the fact they couldn't trace the tomatoes.
    Ms. DeGette. Right. Well, we need to fix the one up one 
down too.
    Mr. Stenzel. Right.
    Ms. DeGette. I think everybody agrees with that. But if we 
did fix that, we could do traceability.
    Mr. Stenzel. On traceability for produce, about 18 months 
ago, our industry launched an industry-wide initiative to 
handle bulk produce. If it is in a bag or if it is in a 
package, you have a UPC code, and it is much more easily 
tracked. But for bulk produce in cartons----
    Ms. DeGette. I hope you don't mind if I interrupt you.
    Mr. Stenzel. Please.
    Ms. DeGette. I only have 5 minutes, and the question I 
asked you was does your industry support traceability?
    Mr. Stenzel. We are doing everything we can to implement 
traceability across the----
    Ms. DeGette. And would you support it as part of a 
comprehensive----
    Mr. Stenzel. Certainly as part of comprehensive food 
safety.
    Ms. DeGette [continuing]. Legislation. Thank you very much. 
And, Mr. Lugg, what is your view on traceability? Would you be 
supportive as well?
    Mr. Lugg. We certainly are 100 percent supportive, and if 
you look at any of our packaged salads, you can trace them 
immediately.
    Ms. DeGette. Now, Mr. Hubbard, I want to ask you a question 
about traceability because, as you know, we have discussed this 
in my legislation. And I have also talked about it with Ms. 
DeWaal. So you might actually have some input too.
    What my traceability legislation says is that the FDA shall 
develop guidelines for each different industry. Do we have the 
technology to do that in the different parts of the food 
industry?
    Mr. Hubbard. I think we do, and in fact, I think the tomato 
folks showed some of that technology to you last summer. And 
clearly there is bar code and radio frequency identification 
technology and others that allow you to track a product all the 
way back to its origin. And the Defense Department is using it 
for everything from tanks to nuts and bolts. And so it is 
becoming widely used anyway. And I would hope that that might 
be one avenue for a solution here.
    Ms. DeGette. This is an issue we started talking about some 
years ago. And people in the industry didn't think that they 
could do it. And so they opposed it, but now I call it the 
salsa fiasco of last year where first we thought it was 
tomatoes, then jalapenos. And it took months and months. It not 
only hurt the consumers, it devastated the tomato industry. I 
think people are now realizing not just the health benefits but 
the commercial benefits.
    Ms. DeWaal, I wanted to ask you a question. I think you 
talked about this before, and I just wanted to put a little 
fine point on it. With the peanut problems we have had this 
year, it seems to me that the types of records production, you 
would both need to have mandatory inspections of some kind in 
every industry. And you would also have to have mandatory 
production of those documents because if you just had mandatory 
production of the documents without the mandatory inspections, 
then people might not do the inspections. Is that what you were 
saying?
    Ms. DeWaal. That is correct. The inspections are an 
essential part of the enforcement program. This is to prevent 
outbreaks from occurring. The records production should be part 
of that, and also mandatory testing for certain pathogens that 
might be linked to those products. So all of this goes into a 
preventive approach.
    Ms. DeGette. Right, because you don't want people to get 
sick in the first place if possible. I just have one last 
question for all the witnesses if you can just answer yes or 
no. Would you support mandatory recall authority for the FDA as 
part of comprehensive food safety legislation?
    Ms. DeWaal. Yes.
    Mr. Hubbard. Yes.
    Mr. Cole. Yes.
    Mr. Stenzel. Yes.
    Mr. Lugg. And yes.
    Ms. DeGette. Thank you very much, Mr. Chairman.
    Mr. Pallone. Thank you. Mr. Stupak.
    Mr. Stupak. Thank you, Mr. Chairman, and thanks for 
allowing me to sit in even though I am not part of the 
subcommittee. You know my interest in this and in our 
legislation. The hearing focused today a lot on inspection 
fees, certifications, even brought up the 6-year term for the 
FDA commissioner. But no matter what we do in this field, 
whether it is inspection fees or whatever we are doing, we 
still have to change the culture of the FDA.
    You can have all the laws and all the money in the world, 
but if we don't have a culture at the FDA that is willing to be 
aggressive in this area, we are still going to have food-borne 
illnesses. For instance, we talked a lot about the tomato 
industry. The tomato industry and members of our Committee on 
Oversight Investigations repeatedly told the FDA because of the 
time of the outbreak, the only place that tomatoes could have 
possibly affected it were from south Florida. South Florida has 
a very good trace back and certification of their product. So 
it couldn't have come from the United States.
    But what did the FDA do? They still--and if you go to their 
Web site today--still insist it is tomatoes. They have killed 
the tomato industry. Last year, $125 million they lost because 
the FDA wouldn't listen to anybody. And we find out it is 
jalapenos out of Mexico. But go to Web site, the tomato 
industry is still being associated with this outbreak. So I 
think we need leadership at the FDA, and we haven't had that.
    Mr. Hubbard, you said that we can never make food 100 
percent safe, and I guess I would tend to agree with you 
somewhat. And then you said that there are gaps in our food 
safety system. What are those gaps?
    Mr. Hubbard. Well, principally, it is that the system 
relies upon this infrequent inspection process and forces FDA 
to pay got-you or state inspectors, instead of putting the 
burden on the producer to demonstrate at all times that they 
are producing a safe food. That is the paradigm shift that 
needs to occur.
    Mr. Stupak. OK, let me ask you this. Our committee's 
research has found that more than 10 years ago, recommendations 
to develop a national food protection training center have been 
repeated made, yet no action has been taken to date.
    More than 8 years ago, the Department of Health and Human 
Services office of inspector general concluded that an 
effective food safety system depends on the collective effort 
and coordination among federal, state, and local levels on 
government. Yet that same report noted the FDA provides limited 
training for state food protection professionals, and that 
states themselves cannot afford the cost of such training.
    Nearly 2 years ago, the FDA issued program standards, which 
requires states to have training plans that ensure all 
inspectors receive training required to adequately perform 
their work assignments. Still only a few states have done it. 
So let me ask do we need a national food protection training 
center to train state and local inspectors to federal 
standards, and maybe even these private inspectors we have 
heard so much about today?
    Mr. Hubbard. I think we do, and in fact, I would urge you 
to consider in your legislation authorizing or mandating that 
FDA creates such a thing. I think the Georgia example showed 
that states were not perhaps up to snuff, and these third-party 
inspectors, as several members have raised, clearly are not up 
to snuff either. So that sort of a training academy would, in 
my view, raise standards for everyone.
    Mr. Stupak. OK, there is some limited training, I know, 
through University of Maryland, but it is very limited. You 
don't have to go through it, so we are almost looking like a 
college curriculum. That is being developed through some 
legislation. That is why I wanted to ask you that question.
    But let me ask you this, and if you know this. What is the 
current practice? Like take the PCA, Peanut Corporation of 
America. Georgia and Texas state inspectors inspected it. What 
happened to those reports? Do they go to the FDA and sit on a 
shelf or in someone's computer program? Is there an internal 
audit about what is being done in these inspections?
    We heard about Mr. Hatfield from Ms. Eshoo about never 
inspecting or gave a superior rating. The one in Texas received 
a very good rating. Is there an internal audit conducted by the 
FDA then of these reports that come in? Or do they just sit 
until something happens? Do you know?
    Mr. Hubbard. Well, there is the paper process that says how 
it should work, and there is a way it apparently really works. 
What should have happened in that case is that state inspector 
should have been trained to an FDA standard, which I gathered 
didn't happen.
    Mr. Stupak. Right.
    Mr. Hubbard. Then they should have presented the FDA with 
the findings, but, of course as you know, the state inspector 
didn't find any problems. So, you know, I suppose you could 
argue there was nothing for FDA to follow up on.
    Mr. Stupak. But wouldn't the FDA at least have some 
standards like especially since you had the 97 ConAgra peanut 
butter outbreak? Wouldn't they at least inspect for salmonella?
    Mr. Hubbard. They did do guidance after that ConAgra 
example, and the way it works is the FDA actually commissions 
state officials. So when they go in, they carry two badges, the 
Georgia badge and the FDA badge. And they are supposed to do 
the equivalent of an FDA inspection, but that apparently did 
not happen in this case.
    Mr. Stupak. Correct, because a true FDA inspection takes a 
little bit of time. I think you indicated $2,000 up to $5,000 
for an inspection and more than 8 hours.
    Mr. Hubbard. Yes, on average, an FDA inspection of that 
nature would take a day to a day and a half, whereas state 
inspections are often done in a couple of hours.
    Mr. Stupak. So even if these inspectors are trained, 
certified, everything, you still need an internal audit of what 
they are doing, or someone at the FDA looking at this to make 
sure it is being done properly, do we not?
    Mr. Hubbard. I think you are right.
    Mr. Stupak. OK, was there ever internal audits like that of 
state inspectors on foods? Do you know in your time there?
    Mr. Hubbard. You know, I am sorry. I don't know, but I 
would hope so.
    Mr. Stupak. Well, I think that is one of the questions in 
our follow up period that we are having next week is, you know, 
were there internal audits and what was going on with these 
things? One more if I may, Mr. Chairman.
    Mr. Lugg, you indicated that I think your first priority, 
you said, when you come to work on food is you select the land 
and then you watch the water and that. Is that in this country 
or other countries too? Chiquita bananas come from all over, 
right? Costa Rica, everywhere?
    Mr. Lugg. Yes, our company operates in approximately 70 
countries around the world, but particularly in the Fresh 
Express packaged salads, whether the product is coming from 
Guatemala, which we have to get our snow peas from in winter 
months, or down in Chile where get in the winter months. We 
send our own inspecting staff down to locate the land, and then 
we use special, global, geospacial technology to make sure that 
those lots are actually being harvested when they say they 
were.
    Mr. Stupak. OK, what about the chemicals that they use 
during the process? Is that all approved by your company?
    Mr. Lugg. Those are chemicals that we approve, and then 
there are samples taken to make sure that they are within the 
residue limits.
    Mr. Stupak. Thank you, Mr. Chairman.
    Mr. Pallone. Thank you, Mr. Stupak. Let me thank the whole 
panel. I mean we are done with our questions, but, you know, we 
really do appreciate your input not only today but throughout 
the process. Mr. Stupak has had hearings and hearings in the 
full Government Reform Committee with Mr. Waxman. We do intend 
to move a bill. You know, I this subcommittee, probably our 
next hearing will be a legislative hearing on legislation that 
we would move. We are still waiting for the new FDA. I mean 
there isn't a commissioner. So we would still like to get that 
input. But, you know, it is our intention to move fairly 
quickly.
    So thank you very much. We appreciate all your input. 
Without objection, this meeting of the subcommittee is 
adjourned.
    [Whereupon, at 1:25 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

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