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






          FOOD SAFETY ENHANCEMENT ACT OF 2009 DISCUSSION DRAFT

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

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                               __________

                              JUNE 3, 2009

                               __________

                           Serial No. 111-41















      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.........................
Hon. Nathan Deal, a Representative in Congress from the State of 
  Georgia, opening statement.....................................
Hon. Henry A. Waxman, a Representative in Congress from the State 
  of California, opening statement...............................
    Prepared statement...........................................
Hon. Ed Whitfield, a Representative in Congress from the 
  Commonwealth of Kentucky, opening statement....................
Hon. John D. Dingell, a Representative in Congress from the State 
  of Michigan, opening statement.................................
Hon. John Shimkus, a Representative in Congress from the State of 
  Illinois, opening statement....................................
Hon. Diana Degette, a Representative in Congress from the State 
  of Colorado, opening statement.................................
Hon. Steve Buyer, a Representative in Congress from the State of 
  Indiana, opening statement.....................................
Hon. John Barrow, a Representative in Congress from the State of 
  Georgia, opening statement.....................................
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................
    Prepared statement...........................................
Hon. Jane Harman, a Representative in Congress from the State of 
  California, opening statement..................................
Hon. Marsha Blackburn, a Representative in Congress from the 
  State of Tennessee, opening statement..........................
    Prepared statement...........................................
Hon. Donna M. Christensen, a Representative in Congress from the 
  State of Virgin Islands, opening statement.....................
Hon. Tim Murphy, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................
Hon. Joe Barton, a Representative in Congress from the State of 
  Texas, prepared statement......................................
Hon. Betty Sutton, a Representative in Congress from the State of 
  Ohio, opening statement........................................
Hon. Mike Rogers, a Representative in Congress from the State of 
  Michigan, opening statement....................................
Hon. Tammy Baldwin, a Representative in Congress from the State 
  of Wisconsin, opening statement................................
Hon. Phil Gingrey, a Representative in Congress from the State of 
  Georgia, opening statement.....................................
Hon. Bruce L. Braley, a Representative in Congress from the State 
  of Iowa, prepared statement....................................
Hon. John P. Sarbanes, a Representative in Congress from the 
  State of Maryland, prepared statement..........................
Hon. Christopher S. Murphy, a Representative in Congress from the 
  State of Connecticut, opening statement........................
Hon. Kathy Castor, a Representative in Congress from the State of 
  Florida, opening statement.....................................
Hon. Anna G. Eshoo, a Representative in Congress from the State 
  of California, opening statement...............................
    Prepared statement...........................................
Hon. Janice D. Schakowsky, a Representative in Congress from the 
  State of Illinois, opening statement...........................

                               Witnesses

Margaret Hamburg, Commissioner, Food and Drug Administration.....
    Prepared statement...........................................
    Answers to submitted questions...............................
Michael Ambrosio, Food Marketing Institute, Vice President, 
  Quality Assurance Division, Wakefern Food Corporation..........
    Prepared statement...........................................
Pamela G. Bailey, President and Chief Executive Officer, Grocery 
  Manufacturers Association......................................
    Prepared statement...........................................
    Answers to submitted questions \1\...........................
Caroline Smith Dewaal, Safe Food Coalition, Food Safety Director, 
  Center for Science in the Public Interest......................
    Prepared statement...........................................
    Answers to submitted questions...............................
Tim F. Jones, State Epidemiologist, Tennessee Department of 
  Health.........................................................
    Prepared statement...........................................
Thomas E. Stenzel, President and CEO, United Fresh Produce 
  Association....................................................
    Prepared statement...........................................

                           Submitted Material

Statement of Wisconsin Department of Agriculture, Trade, and 
  Consumer Protection, submitted by Ms. Baldwin..................
Letter of June 3, 2009, from Commissioner Hamburg to 
  Subcommittee, submitted by Mr. Stupak..........................
Statement of the American Frozen Food Institute..................

----------
\1\ Ms. Bailey did not respond to submitted questions for the 
  record.

 
          FOOD SAFETY ENHANCEMENT ACT OF 2009 DISCUSSION DRAFT

                              ----------                              


                        WEDNESDAY, JUNE 3, 2009

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:05 a.m., in 
Room 2123 of the Rayburn House Office Building, Hon. Frank 
Pallone [Chairman od the subcommittee] presiding.
    Members present: Representatives Pallone, Dingell, Eshoo, 
Green, DeGette, Schakowsky, Baldwin, Ross, Matheson, Harman, 
Barrow, Christensen, Castor, Sarbanes, Murphy of Connecticut, 
Space, Sutton, Braley, Waxman (ex officio), Stupak, Markey, 
Deal, Whitfield, Shimkus, Buyer, Rogers, Murphy of 
Pennsylvania, Burgess, Blackburn, Gingrey and Barton (ex 
officio).
    Staff present: Karen Nelson, Staff Director/Chief Health 
Counsel; Rachel Sher, Health Counsel; Eric Flamm, FDA Detail; 
Elana Leventhal, Legislative Assistant; Virgil Miller, 
Professional Staff; Alvin Banks, Staff Assistant; Ryan Long, 
Minority Chief Health Counsel; and Chad Grant, Minority 
Legislative Assistant.

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE 
            IN CONGRESS FROM THE STATE OF NEW JERSEY

    Mr. Pallone. The meeting of the subcommittee is called to 
order, and today we are meeting to review the Food Safety 
Enhancement Act of 2009 Discussion Draft. I will recognize 
myself for an opening statement initially. This discussion 
draft was released by Chairman Waxman, Chairman Emeritus 
Dingell, Chairman Stupak, Representative DeGette, 
Representative Sutton and myself early last week. And the draft 
builds on several bills already introduced in this Congress 
including H.R. 759, a bill that I, along with Chairman Dingell 
and Stupak, introduced earlier this year.
    The Energy and Commerce Committee has done a lot of work on 
the issue of food safety. In this subcommittee alone, we have 
had four hearings on this topic in the last two years. The 
information we learned during these hearings as well as during 
the numerous conversation we had with stakeholders groups and 
the FDA has been incorporated into the draft before us today.
    And I believe this draft bill represents a strong, well 
thought out approach to improving the FDA and its food safety 
activities. We have heard time and again that our current food 
safety system is broken. It is a system that relies heavily on 
the FDA rather than placing the responsibilities on the 
manufacturers to ensure the safety of their products. It is a 
system that is geared towards responding to food outbreaks 
rather than one that is aimed at preventing them.
    And this system does not work, and recent outbreaks of 
E.coli in spinach and salmonella in peppers and peanut butter 
highlight that fact. Unfortunately, these are not isolated 
instances. Each year, 76 million Americans get sick due to 
unsafe food products. Every year, 325,000 individuals will be 
hospitalized and 5,000 will die from food borne hazards.
    It is estimated that the medical costs and lost 
productivity due to food borne diseases cost us $44 billion 
annually. And these illnesses are completely preventable.
    The good news is that there seems to be agreement that 
something must be done and that it must be done quickly. The 
President has made food safety of one his priorities. He has 
assembled a food safety working group to come up with 
principles on this issue.
    Chairman Waxman, Mr. Dingell, Mr. Stupak and I have worked 
closely with key stakeholders on this discussion draft, and as 
we move forward with the legislation, we hope to continue those 
conversations as well as conversations with our counterparts on 
this committee.
    The bill we are discussing today will modernize the food 
safety laws currently in place. It places a strong emphasis on 
prevention and shifts the responsibility for food safety onto 
those who actually make the food. It also provides the FDA with 
the necessary resources and enforcement authorities to ensure 
that all companies are in compliance with the new requirements. 
This draft bill would require all food manufacturing companies 
to register annually with the FDA so that the agency has an up-
to-date list of all facilities who sell products in the United 
States.
    It focuses on prevention by requiring companies to conduct 
thorough hazard and risk analysis of the products that they are 
making. It mandates that companies put in place preventive 
controls to mitigate and minimize those identified hazards. And 
it requires companies to document all the steps they have taken 
to implement and verify the controls to ensure they are 
effectively minimizing hazards.
    The bill also addresses the shortfalls of our current 
traceback system by requiring the FDA to establish an 
electronic interoperable record keeping system that 
manufacturers would be required to use. This measure will allow 
the agency to quickly trace the source of an outbreak back to 
its origin and prevent and minimize the number of individuals 
affected by a food borne illness.
    While shifting responsibility for food safety onto the 
manufacturers, the draft also recognizes the crucial role the 
FDA needs to play in this realm. This draft requires the agency 
to set standards for food safety and hold the food industry 
accountable for meeting those standards. It provides the FDA 
with stronger enforcement authorities, such as recall authority 
and access to records.
    The bill also increases the inspection frequency for food 
facilities, requiring that the FDA inspect facilities at an 
established minimum frequency.
    Now we are going to hear today from industry experts about 
the various provisions in this discussion draft, and I look 
forward to those conversations. I hope that we can all continue 
to work in this collaborative manner as we move to markup of 
food safety legislation in this committee.
    I am very pleased to welcome Dr. Margaret Hamburg of the 
FDA today. We had a meeting last week while we were doing the 
Energy markup. We were in the back having some conversations, 
and I was very impressed with her. This is the first time she 
will be testifying before this committee, and I thank her for 
being here.
    I also want to thank our other witnesses for appearing 
before us today. I especially want to welcome back Mike 
Ambrosio. He is, of course, from my home state. Good to see you 
again, Mike. And I will now recognize Mr. Deal for an opening 
statement.

  OPENING STATEMENT OF HON. NATHAN DEAL, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF GEORGIA

    Mr. Deal. Thank you, Chairman Pallone, for holding this 
hearing today, and thanks to our distinguished witnesses who 
have joined us to review this draft of the Food Safety 
Enhancement Act of 2009. I look forward to your testimony and 
to the questions that our committee will actually have of the 
panels.
    As a resident of the state of Georgia, which has already 
received a focal point focus of the issue of food safety, I 
know firsthand the perspective that our Nation has on the issue 
of the lack of safeguards and fallback measures that many 
people expect of a 21st century food supply chain in our 
country.
    We all agree food safety is a priority, and 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.
    Additionally implementation of preventive controls such as 
hazard analysis and critical point plans included in the draft 
under discussion is an important step forward in ensuring 
unsafe food products don't reach store shelves in the first 
place.
    As we know, preventing compromised good from entering the 
market is the best line of defense to preventing food related 
illnesses. I also believe it is important to enhance FDA's 
ability to conduct onsite inspections of food facilities. The 
inspection schedule established under the draft does recognize 
risk profiles for food in terms of how frequently facilities 
should be inspected. But the regimen set forth in the 
discussion draft fails to address the cost/benefit factor of 
conducting such frequent inspections and could possibly result 
in insufficient oversight of certain higher-risk facilities due 
to time and manpower limitations of our inspectors.
    It is my hope that our witnesses today can provide input 
with regard to an appropriate inspection schedule, which 
achieves the goal of ensuring safe food for the American people 
without placing an undue burden and strain on the FDA, which is 
already challenged under current food safety obligations.
    This legislation authorizes and annual pay-to-play 
registration fee for domestic and foreign food facilities of 
$1,000 to supplement appropriations made by Congress to FDA. In 
discussion, however, we have not been able to determine from 
the majority or the FDA exactly how much funding is necessary 
to meet the requirements of this bill.
    I believe it would be premature to impose significant fees 
on industry and in turn the American consumers without any 
reference as to how much funding is actually needed. If the 
majority remains intent on imposing such registration fees, we 
must also be certain these fees are limited to cover the 
activities such as a minimal fee paid to the FDA for an 
application to cover the cost of review and processing.
    If the goal is to improve food safety, we must ensure that 
funds are not funneled into other activities that may or may 
not have anything to do with improving food safety, a situation 
which I believe could occur under the language of the current 
proposal. Obviously these are issues, among many others, that I 
feel hopefully this committee will be able to address as we 
move this issue forward, and I look forward to the hearing 
today and the results that come out of it.
    I appreciate Chairman Pallone and Chairman Waxman's 
bipartisan efforts on this issue, and look forward to having a 
product that all the members of this committee can support. And 
thank you, Mr. Chairman, for the time.
    Mr. Pallone. Thank you, Mr. Deal. Chairman Waxman.

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    Mr. Waxman. Thank you very much, Mr. Chairman. This 
subcommittee and our full committee is beginning the process 
today of passing critically important legislation designed to 
revamp our Nation's food safety system. The Food Safety 
Enhancement Act of 2009 and this hearing marks a key milestone.
    Over the past few years, a series of food borne disease 
outbreaks in spinach, peanuts, and peppers, just to name a few, 
have laid bare some major gaps in our antiquated food safety 
laws. Oversight work by GAO and by our own Oversight Committee 
has also helped us understand where we need to focus our 
efforts to bring our food safety laws into the 21st century.
    The draft legislation that is the subject of today's 
hearing is based on the FDA Globalization Act of 2009 
introduced by Chairman Emeritus Dingell, Chairman Pallone, and 
Chairman Stupak. And I commend them for their work on that bill 
and their continued efforts in shaping this new bill.
    I also want to recognize the assistance we have received 
from the Obama administration. We have worked closely with the 
FDA to identify problems with the current food safety law and 
to find workable solutions. We will not be passing legislation 
that sets up the agency to fail. The bill requires that the 
agency set tough standards, but we have given them the 
flexibility to prioritize and address the most important risks 
first.
    The draft also incorporates helpful suggestions from 
Ranking Members Barton and Deal and Representative Shimkus. I 
believe we can reach a bipartisan agreement and look forward to 
continuing to work with all the members of this committee.
    In working with the FDA on this legislation, one thing was 
abundantly clear. The administration is absolutely committed to 
overhauling FDA's food safety program. I think we will all see 
that commitment today when we hear from Commissioner Hamburg.
    The recent food outbreaks have exposed glaring holes in 
FDA's basic food safety authorities. FDA does not have routine 
access to any records kept by the food manufacturers. FDA 
cannot require companies to conduct a recall of unsafe foods. 
The agency can only ask and hope that the company complies. FDA 
also lacks basic modern enforcement tools like administrative 
civil monetary penalties. The Food Safety Enhancement Act will 
give FDA these and other critical authorities.
    One of the most important changes that will occur under 
this bill is a focus on prevention. The legislation does not 
anticipate that FDA alone will protect us from unsafe food. The 
hallmark of any effective food safety goal must be a shared 
responsibility for food safety oversight between FDA and 
industry.
    The act will strike the right balance in this shared 
responsibility. The bill will require manufacturers to 
implement preventive systems to stop outbreaks before they 
occur and will give FDA the tools it needs to hold them 
accountable if they fail. Under the bill, FDA will also have 
clear authority to issue and require manufacturers to meet 
strong enforceable performance standards to ensure the safety 
of various types of food.
    I commend many of those in industry for recognizing the 
importance of this prevention model and coming to the table to 
support it.
    Let me turn briefly to one of the more contentious issues 
in the bill, the registration fees. I wish we did not have to 
resort to industry fees to supplement funding for FDA's work. 
However, when it comes to FDA's food program, the shortfall in 
revenues is extreme. The FDA's own science board told us that 
the FDA is so starved for resources that American lives are at 
risk. We cannot realistically expect appropriations alone to 
provide sufficient resources to close that gap.
    The recent outbreaks have also taken a major toll on the 
food industry. In the recent peanut outbreak, Kellogg's alone 
lost $70 million. Faced with such a dire situation, I think it 
is reasonable to ask the food industry to chip in. A robust 
food safety oversight system will provide a great benefit to 
industry by preventing future outbreaks and rebuilding consumer 
confidence.
    Let me be clear. We are not asking industry to cover the 
entire cost of the bill or any single part of the bill like the 
cost of inspections. The bill establishes a set fee of $1,000 
per year per facility. FDA is prohibited from increasing that 
fee in future years except to cover the cost of inflation. The 
bill simply asks industry to chip in its fair share.
    I also want to address another concern I have heard, the 
presence of FDA on farms. FDA has always had the authority of 
foods on farms, and they have generally relied on state and 
local authorities for food safety oversight on farms because 
they have a strong on-farm presence. I am confident that 
farmers have nothing to fear from this bill. The bill calls for 
FDA to set its standards through regulation, which means that 
FDA will go through a public notice and comment process.
    Our committee is busy in the middle of three months period. 
Last month, we passed a comprehensive energy and climate change 
legislation. Soon we will take up health care reform, but food 
safety is so critical that I have carved out time right in 
between to pass this legislation. Over the next few weeks, I 
intend to work with all our committee members, Democratic and 
Republican, with the FDA, with the affected industries, to 
achieve a consensus on a food safety bill that we can pass out 
of committee. We can't afford to wait any longer.
    I look forward to hearing from our witnesses today. Thank 
you, Mr. Chairman.
    [The prepared statement of Mr. Waxman 
follows:]*************** COMMITTEE INSERT ***************
    Mr. Pallone. Thank you, Chairman Waxman. The gentleman from 
Kentucky, Mr. Whitfield.

  OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN 
           CONGRESS FROM THE COMMONWEALTH OF KENTUCKY

    Mr. Whitfield. Well, thank you, Mr. Chairman, and we 
appreciate your having this hearing on this very important 
issue today. We all recognize that FDA has many very important 
responsibilities, and we have known through hearings for the 
last number of years that the resources available are always in 
question, but we recognize also that there is a definite need 
for reform of FDA. And we are delighted that Dr. Hamburg is 
here with us today to provide testimony and the other panel of 
witnesses as well.
    We look forward to working with the majority on this 
important legislation. And having said that, we do have some 
significant concerns about some provisions in this legislation, 
particularly the risk-based inspection portion, particularly 
that relating to the low-risk facilities. Also the traceability 
provisions that I understand, for example, would apply to every 
convenience store in the country. In addition to that, the 
recall provisions in this legislation, the country of origin 
provisions, particularly as it relates to the Web site 
requirements and then also, of course, the power that we give 
to FDA for subpoenas and other instruments to obtain company 
records. I think we need to look at those provisions much more 
closely.
    But obviously this is an important piece of legislation. We 
look forward to working with you and listening to the testimony 
of our witnesses today. Thank you.
    Mr. Pallone. Thank you. Next is our Chairman Emeritus, Mr. 
Dingell, and thank you for all you have done on this 
legislation.

OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF MICHIGAN

    Mr. Dingell. Mr. Chairman, thank you, and thank you for 
holding today's legislative hearing on the Food Safety 
Enhancement Act of 2009 Discussion Draft. We have worked 
together, you and I, with Chairman Stupak and others over the 
years. And I am delighted to say that this legislation is ready 
for enactment and is almost old enough to vote.
    I want to say that I am delighted that Chairman Waxman and 
my good colleagues, Ms. DeGette and Ms. Sutton, have joined us 
in our work on this bill.
    We are about to try and fund an agency which is hollow, 
which does not have either the personnel or the revenue or the 
money or the or the resources which it needs to do its job. And 
we are about for the first time since 1962, when I was a young 
member of this body, to try and see to it that it gets its 
authorities updated to deal with the real problems in the world 
of trade and in the world marketplace.
    I am pleased that we are taking the necessary steps to 
advance this legislation and address the important issue of 
food safety. I am hopeful that we will shortly be doing 
something with regard to pharmaceuticals.
    I want to thank the witnesses who have joined us today and 
look forward to hearing their testimony. And, Dr. Hamburg, 
welcome to the committee. Congratulations on your confirmation. 
I was encouraged by the administration's early recognition that 
food safety is a problem that needs to be addressed. The 
administration food safety working group is a signal to how 
serious the President considers this issue.
    And I want to thank you for the way that you and your staff 
have provided timely and helpful technical advice on the 
legislation.
    I want to note that I am hearing complaints from folks 
about the fee system. I want to make a note that the only part 
of Food and Drug that seems to be working is that which 
functions under PDUFA and that and which has the advantage of 
having industry participate in the funding. I want to note that 
the industry seems to be prospering mightily under that 
particular section and be getting service from Food and Drug in 
a proper way. And that seems to be about the only place that 
the industry is getting protection or the American consumers 
are receiving necessary safety.
    In 1938, the Congress comprehensively addressed the issue 
of food and safety. Seventy years later, Food and Drug 
Administration is still trying to protect the larger, 
increasingly global supply with outdated statutes and 
inadequate resources. As a result, the American consumer 
confidence in the Nation's food supply and the Food and Drug 
Administration and, quite frankly, in this body, the Congress, 
has declined. And American consumers are being forced to pay a 
heavy price, not only with recall after recall but also the 
fact that people are being sickened and killed by unsafe foods 
and also by pharmaceuticals.
    And again I wish to hope that we will commence work on 
pharmaceuticals as soon as this business is attended to. The 
Food Safety Enhancement Act is a measured and effective 
response to the dire situation we are faced with today 
regarding food safety.
    Mr. Chairman, the legislation is based on a bill you, 
Chairman Stupak, and I have introduced earlier this year and 
also on a bill that was introduced by me during the past 
Congress. It includes good technical advice from FDA and valued 
input from the minority and other stakeholders. And I want to 
make it clear that I am working with the minority to try and 
resolve their concerns, and that we are also working with the 
industry.
    And I want to thank my friends in the industry for the 
goodwill which they have shown in working with us. And I also 
want to thank Chairman Waxman for his leadership on this point. 
I look forward to continued deliberations in the hope of 
producing speedily a bipartisan piece of legislation that will 
pass the committee and the House, as I have indicated, both in 
a correct and a speedy fashion.
    Amongst other things, this bill will prevent safety 
problems before they occur. It will require manufacturers to 
implement food safety plans that identify and protect against 
food hazards. It will see that Food and Drug has the authority 
to see to it that good manufacturing practices are adhered to 
here in the United States and elsewhere, especially in places 
like China which is in fact the Wild West in this particular 
matter.
    It will advance the science of food safety, increase 
inspection frequency of food facilities, something which can 
happen more often on dog food manufacturers under the 
jurisdiction of the Department of Agriculture than it happens 
with regard to manufacturers who manufacture food products for 
the safety of our people.
    It will enhance FDA's ability to trace the origin of 
tainted food in the event of an outbreak or food borne illness. 
And it should be noted that the Food and Drug Administration 
and the industry are totally incapable of providing speedy 
service in this particular.
    It will enhance the safety of imported food. FDA will be 
allowed to require that certain foods be certified as meeting 
U.S. safety standards and again to trace. But also Food and 
Drug will be able to finally get enough people at the doors of 
this country to see to it that safety is properly enforced and 
that good manufacturing practices are adhered to around the 
world for the protection of our people.
    It will provide strong enforcement tools including 
mandatory food recall authority, stronger criminal and civil 
penalties for bad actors, subpoena authority, and it will 
increase and strengthen Food and Drug's detention authority.
    Finally, and I would argue more importantly, the 
legislation addresses the very important question of resources 
of the agency. We will give the agency the authorities it 
needs, and we would do them a grave disservice if we did not 
give them the resources they need.
    The legislation includes the registration fee, which will 
fund food safety activities at FDA. The revenue from this fee, 
coupled with additional appropriations which we hope we can get 
out of those skinflints at the Appropriations Committee, the 
office of managing the budget, will ensure that Food and Drug 
can do its job.
    For those who argue there is no benefit for the industry to 
pay a fee for safety activities at Food and Drug, I offer the 
following. U.S. peanut industry could lose $1 billion this year 
because of the outbreak of salmonella that forced the biggest 
food recall in history. That has just been replicated by other 
recalls in the food industry. Tomato industry lost $100 million 
in sales during the 2008 salmonella outbreak that ultimately 
was attributed to jalapeno peppers. Spinach growers took a $200 
million hit to their industry during a 2006 bagged spinach 
recall.
    And let us not forget that wonderful Chilean grape scare of 
1989, which Food and Drug had neither the authority nor the 
competence to address. I ask unanimous consent to revise and 
extend my remarks. I have a few other things I would like to 
say that I know everybody will want to read. Thank you, Mr. 
Chairman.
    Mr. Pallone. Thank you, Chairman Dingell. The gentleman 
from Illinois, Mr. Shimkus.

  OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF ILLINOIS

    Mr. Shimkus. Thank you, Mr. Chairman. Dr. Hamburg, welcome. 
I see Chairman Waxman has left the room. I appreciate his 
comments about there being some discussions. I do have to have 
admit that the discussions that we have had when we point out a 
point that is correct, they accept. When there is a debatable 
point, Mr. Chairman, there does not seem to be any movement and 
compromise. So I would encourage more discussions on some of 
these issues if we really want this to be a bipartisan bill.
    You know the other thing I have trouble with is draft 
hearings. If we are going to have a legislative hearing, let us 
have the legislation. This is the draft legislation, and if we 
had the great draft legislation hearing on climate change and 
then when the bill came before us, it had 300 additional pages 
in it. And there is fear on our part that this is a sneaky way 
to say yes, we had a legislative hearing, but you really don't 
have a legislation hearing if you don't have the legislation 
before you.
    This is the Democratic majority operandi. We claim a 
crisis. Only government can be the savior. Government must get 
bigger, and the middle class pays. And that is the issue here. 
And I was on ONI in the last Congress with Bart Stupak, readily 
accepting the premise that we have to get inspectors into these 
facilities, and we are ready to address an issue that is 
thoughtful and respectful and pays for the inspectors and 
facilities where they are not going into.
    And it is not like we haven't done anything. Congress, last 
Congress, approximately $57 million from the supplemental went 
to food safety. The House passed the 2009 omnibus appropriated 
an additional $325 million for the FDA with $140 million of the 
$325 million would go for food safety programs. In the 
President's 2010 budget, he included $1 billion additional to 
FDA for food safety.
    So there is a huge commitment already for massive federal 
funds to go to food safety. Now we have, as our concern, a 
bill, a draft that has, what, $325 million for no explanation, 
no earmarking, no direction, and that is where a lot of our 
questions will be today is why that amount? What justifies that 
amount? How are we going to ensure that it is not going to be 
used for other purposes? And the like.
    So I would ask the leadership on the other side that if 
they really want a bipartisan, let us get some bipartisan 
negotiations, sincere negotiations. I would be honored to 
yield.
    Mr. Dingell. I am very fond of the gentleman. He is very 
well noticed, and I have great respect for him. And I have been 
talking, as the gentleman well knows, to the leadership on the 
minority side both in the last Congress and this Congress. I 
want this legislation to be bipartisan. I don't want the 
gentleman to be surprised.
    I would note to my good friend that we have been having 
hearings after hearings after hearings not only here but up in 
the Oversight Subcommittee. And during that time, I have been 
continually talking to my good friends on the minority side 
because I want you to be aboard. This should not be a partisan 
issue. And when we go to the next step in this process, I will 
assure the gentleman that most of the changes that will be made 
that will be changes that will be made as a result of 
discussions with my friends on the minority side. And I say 
that with respect.
    Mr. Shimkus. And I thank my colleague, and I look forward 
to working with you. I yield back, Mr. Chairman.
    Mr. Pallone. Next is the gentlewoman from Colorado, Ms. 
DeGette.

 OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF COLORADO

    Ms. DeGette. Thank you, Mr. Chairman. Mr. Chairman, this is 
the first step towards realizing a long-held dream, not just by 
me and other members of this committee but by the millions of 
Americans who have been concerned about the safety of our food, 
especially in light of the cascading litany of food borne 
illnesses that we have heard about from other members of this 
committee.
    We have had a dozen Oversight hearings and also legislative 
hearings. We have had bills dropped by many members of Congress 
for many years, and I am so excited under your leadership and 
the leadership of Chairman Waxman and Chairman Dingell that we 
are finally on the verge of enacting comprehensive food 
legislation.
    The most important thing about this bill is it would be a 
definitive statement by this committee and this Congress that 
food safety is a priority in the United States of America.
    I want to highlight two of the sections of this bill, and I 
want to thank you and Mr. Dingell and others and Mr. Stupak for 
including the provisions of my two bills in this draft mark 
because they are critically important in the future to assuring 
safe food for everybody.
    As you know, Mr. Chairman, I have been working on these 
traceability issues for many, many years. And when I first 
started, people said it couldn't be done. But then as we 
realized with time, not only can it be done and in slightly 
different ways in every industry, but if we want to assure this 
integrity of the food system, it has to be done. What I fondly 
call the salsa scare of last year is the perfect example of 
why.
    We found people being sickened by salsa, and we couldn't 
figure out why. This destroyed pretty much the entire profit of 
the tomato crop for that whole year because everybody thought 
it was tomatoes that had the salmonella. As it turned out, 
after months and months and months of increased sickness, of 
increased scrutiny, we found out that no, it wasn't the 
tomatoes at all. It was jalapenos, and they were from Texas.
    And what I found out is that we can go to this particular 
sector of the field and find those jalapenos, and we can do it 
quickly. So traceability is going to be essential. And I look 
forward to working with my friends on the other side of the 
aisle to make sure it is not onerous. But I will say this. It 
is not just in the interest of consumers. It is in the interest 
of businesses who want to protect their profits to have 
traceability.
    Mandatory recall is a second provision of this bill that I 
have been working on for many years and I am so grateful has 
been included.
    And I want to say finally, Mr. Chairman, all of this policy 
that we talk about, it is all well and good. But I can't help 
but think about young Jacob Hurley, who you might have seen. He 
was in our last ONI committee hearing.
    Jacob is from Portland, Oregon, and he got sick from eating 
peanut butter crackers, his favorite food. When his parents 
took him to the doctor, they said they finally got him 
stabilized, and he wouldn't eat. So they told the parents have 
Jacob just eat what he loves, the peanut butter crackers, the 
very food that had made him sick in the first place.
    And the only way we found out about this was because the 
alert commissioner of Consumer Protection in Oregon showed up 
personally at his door and confiscated the peanut butter 
crackers. We need to fix this. We need to fix it now, and I am 
so grateful that we are. Thank you, Mr. Chairman.
    Mr. Pallone. Thank you, Ms. DeGette. Next is the gentleman 
from Indiana, Mr. Buyer.
    Mr. Buyer. Ma'am, welcome to the committee. Is it Hamburg 
or Hamburg?
    Dr. Hamburg. Hamburg.

  OPENING STATEMENT OF HON. STEVE BUYER, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF INDIANA

    Mr. Buyer. Hamburg. Welcome, and my first reaction to the 
discussion draft is going to lead to some questions that I will 
have for you today. It appears that Congress a lot of times 
would like to pound our chest and then show the American people 
that we are doing something well.
    But we really end up creating legislation within our own 
areas of jurisdiction, and we create problems. We create things 
that are multiplicious and redundancies. And if we really 
wanted to couple substance with the words that I have heard 
here from some of my colleagues today, we would be working with 
other committees of jurisdiction. We would have a very 
comprehensive bill. And so I am going to be asking you 
questions, ma'am, about clear lines of delineations and 
responsibilities between USDA and FDA, and who should really 
have what responsibility.
    Or should we as a Nation put all food under one agency and 
work cooperatively with the Ag Committee to do something like 
that? What we have is a discussion draft that has been cleverly 
drafted only within the jurisdiction of our own committee, and 
so what we end up doing is are we exasperating a problem? And 
so I am interested in your leadership. You are representing an 
administration, and so I am interested in your best counsel to 
us and your willingness to work with leaders of other agencies 
to truly protect the American people.
    And the other point I make is that Congress, as of late, 
has been beating up on FDA. I would say the FDA, the 
individuals that I have met and the ones that you have the 
privilege to lead are some pretty fine and capable and 
dedicated individuals.
    In the last, gosh, 16 years, 17 years that I have been 
here, whether it has been Republicans in control or Democrats, 
we continue to pass legislation that leaps more and more 
responsibilities upon your core missions. And so here is your 
challenge to maintain the gold standards, not only with regard 
to pharmaceuticals but also in food, you know, we are about to 
send you legislation for a new mission on tobacco that is 
counter to your even cultural mission.
    Yet we are going to continue to make you the whipping post, 
and so I am really concerned about the more responsibilities we 
give you, how much does that dilute your responsibilities? And 
so these are some of the questions that I am going to be posing 
to you. And with that, I yield back.
    Mr. Pallone. Thank you. Gentleman from Georgia, Mr. Barrow.

  OPENING STATEMENT OF HON. JOHN BARROW, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF GEORGIA

    Mr. Barrow. I thank the chair, and I appreciate the 
leadership you are showing on this issue. This is a matter of 
particular interest to me since, as Mr. Deal has already 
pointed out, two of the most egregious recent cases of tainted 
food in the food supply originate in my state of Georgia, and I 
think this bill represents a major step forward in trying to 
prevent this from happening again.
    One of the things that is a particular bone of contention 
with me is that in the last outbreak, we got evidence in this 
committee that the manufacturer had test results which were 
showing positive presence of salmonella. The food that was sent 
out in the marketplace was tainted, and yet they didn't report 
that to the FDA.
    Seems to me that we need to have, in addition to the good 
measures that have been incorporated in this bill, is an 
effective testing regime that has integrity in terms of 
sampling and integrity in terms of testing. And I think we have 
to make it easy for folks to be able to do this, to comply with 
this, and mandatory for them to report the results of any 
testing.
    This way I think we can pick the bad actors out very early 
on and perhaps even do a better job of arresting trends at a 
very early stage, detecting problems before they become 
serious.
    Above all, I want to make sure that we don't bring about 
the Sergeant Shultz syndrome. You know he was the comic 
characters in Hogan's Heroes, and he had a big, loud comic 
demonstration every now and then of not knowing what was 
inconvenient for him to know. So we want to make sure that 
folks don't have the option of opting out or have a 
disincentive to know what they need to know when they need to 
know it. And that we know what they know when they need to know 
it. So that is the balance I think we need to strike here. I 
look forward to working with my colleagues on this as we try 
and incorporate provisions like that in this bill. And with 
that, Mr. Chairman, I yield back. Thank you.
    Mr. Pallone. Thank you. Gentleman from Texas, Mr. Burgess.

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE 
              IN CONGRESS FROM THE STATE OF TEXAS

    Mr. Burgess. Thank the chairman. Dr. Hamburg, Dr. 
Sharpstein, good to see you again. Spent some time yesterday 
out at the FDA's facility, and I will echo the comments of Mr. 
Buyer. You have a wonderful staff that you lead out there. They 
are obviously very, very dedicated individuals, sometimes 
working under the adverse conditions that we supply. But 
certainly I know you are very proud of the organization of 
which you lead, and I believe that pride is justified.
    Mr. Chairman, I am going to stipulate to all of the 
difficulties that the Food and Drug Administration is 
encountering that have already been well-documented, and I 
would ask unanimous consent to insert my entire statement into 
the record. Let me just concentrate on the aspect that we are 
now finally, after I don't know how many hearings on this, 
getting down to somewhat of the business of acting for the FDA 
and talking about legislation that would give the Food and Drug 
Administration some tools.
    But we are also giving them a timeframe, which may prove to 
be a very difficult timeframe for implementation. And we are 
also putting some additional burden on businesses at a time 
that our economy is in some difficulty. The legislation 
proposed will mandate the largest change in food safety in at 
least two decades, and it will give the entire food industry a 
compressed time to do so. In a few short months, we will have 
to turn the current system of paper-based records into 
electronic form. Businesses will have to find the money to 
register as a food facility, and additional user fees, if we 
deem them appropriate in the future, and they will have to be 
able to fully trace the food to its place of origin.
    All those may be laudable goals, but I am not certain that 
what we are proposing as a timeframe is adequate. And then the 
Food and Drug Administration itself, in that shortened 
compressed timeframe, will have to hire enough inspectors to 
meet the new inspection standards, create unique identifier 
numbers for every food facility, be they domestic or foreign, 
set up a new administrative law position for the new criminal 
and civil penalties, and make certain that each center has a 
food safety plan, all of this instantly demanded in one piece 
of legislation.
    I would just point out when we did the Consumer Products 
Safety Improvement Act last year, H.R. 4040, we acted in good 
faith, and we acted with some dispatch. But we created some 
situations that are absolutely untenable. We have had to go 
back and try to amend some of those. We have driven some small 
businesses to the point of bankruptcy. We have created a 
situation where our resale shops, because they cannot measure 
the lead standard that we required, are in a position that they 
don't know whether they can sell the goods that have been 
donated or not.
    So I urge us to take every due caution. The law of 
unintended consequences has a very short turnaround time in our 
current globalized world, and we need to be cognizant of that.
    And then finally, let me just, you know, a word about 
bipartisanship. A bill is bipartisan if it is bipartisan at the 
beginning. And Chairman Dingell, I appreciate the courtesy that 
you showed me in the last Congress at involving me in at least 
some of the preliminary discussions of the draft that you were 
considering. But really when the draft comes to the committee 
for consideration, it really ought to have had input from both 
sides, and the fact that there are five or six Democrats on the 
bill and no Republican. Was there no Republican on this side of 
the dais with which you could sit down and talk and perhaps get 
to a point where there could be some general agreement?
    We have done this before on other pieces of legislation. We 
did it on the Food and Drug Reauthorization Act in June of 
2007. And I frankly do not understand why it is not worth the 
effort to make these pieces of legislation--we are not talking 
about points for the next election. We are talking about the 
regime that will be in place that will ensure the safety of the 
food for my grandson and Marsha's grandchildren. This is the 
legacy that we are going to be leaving, and it is too important 
to be left to partisan politics.
    And I thank you for the additional time, Mr. Chairman, I 
will yield back.
    [The prepared statement of Mr. Burgess 
follows:]*************** COMMITTEE INSERT ***************
    Mr. Pallone. Thank you. The gentlewoman from California, 
Ms. Harman.

  OPENING STATEMENT OF HON. JANE HARMAN, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    Ms. Harman. Thank you, Mr. Chairman. I would like to 
welcome Peggy Hamburg, an old friend, a brilliant physician, 
and a superbly qualified person to this committee and to her 
new role as FDA commissioner. I think you bring a lot to this 
job and will help this committee which has worked on the issue 
of food safety for years and years and years come to a 
thoughtful, careful, healthful decision on the shape of this 
legislation. So welcome.
    Mr. Chairman, I am very comfortable with the discussion 
draft, and I do know that it reflects many, many years of input 
from members. I thought that John Dingell's comment that it is 
almost old enough to vote was particularly apt. That applies to 
me too.
    And I think that coming from a state like California, which 
is the largest agricultural producer in the country, we ignore 
food safety at our peril. The vice chairman, Diana DeGette was 
chronicling some of the recent outbreaks and how important it 
is to have traceability and mandatory recall. I agree. And we 
could have saved a lot of pain, a lot of cost, and a lot of 
health problems had we had those measures in place.
    So I just want to conclude by saying that we have a able 
and willing partner facing us this morning. I think we have an 
able and willing committee on a bipartisan basis to engage with 
her, and I am very eager to see us make progress and to enact 
legislation close to the committee draft as soon as possible. 
It is in our national interest, and surely as we talk about 
grandchildren, it is in our grandchildren's interest. I yield 
back the balance of my time.
    Mr. Pallone. Thank you. Gentlewoman from Tennessee, Ms. 
Blackburn.

OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF TENNESSEE

    Ms. Blackburn. Thank you, Mr. Chairman, and I want to 
welcome Dr. Tim Jones who is going to be on our second panel. 
He is hiding over here in the back. He must be one of these 
Baptists from Tennessee. He is going to sit in the back row 
until time for him to come forward. But Dr. Jones is an 
epidemiologist with the Department of Health in our great 
state. Does a wonderful job for our state, and I am absolutely 
delighted that we are going to be able to hear from him today 
on the second panel. So, Dr. Jones, thank you for taking the 
time to come.
    While the draft legislation before us today attempts to 
improve the safety and the efficacy of the Nation's food 
supply, it appears that there is still a lot of room for 
improvement. And I am appreciative that we are having the 
hearing, and I am hopeful that we are going to be able to work 
in a bipartisan way on this issue.
    I appreciate the majority's attempt to improve the 
country's food safety system, but I think that we all know, 
especially those of us who are mothers, we know that you can't 
inspect your way to food safety. We know that this legislation 
is going to have to do more than be reactive. This legislation 
broadly increases the FDA authority to make it one of the 
largest federal agencies in the existence.
    My concern is the growth of bureaucracy, and what is going 
to happen as that bureaucracy grows. What I do think is 
necessary and I think it is necessary that our system be risk-
based, that it be preventative, and take that approach, and 
that it effectively target bad actors.
    It is imperative that resources are focused on issues of 
high risk and innovations that are most effective. However, 
this bill places undue burden on small businesses, and they 
would be harmed by burdensome and expensive provisions that are 
found in this current draft of this legislation.
    The FDA has provided no evidence that it has improved its 
internal processes in order to improve the review of the 
Nation's food supply. This is something we have talked about 
endlessly in this committee and in hearings. So we are looking 
forward to having some questions on this.
    There seems to be--and you haven't proven otherwise--that 
there are established protocols and lines of communication 
between different jurisdictions. You have not shown that there 
are best practices. Indeed, about 13 months ago, I asked for a 
list of best practices on intra-agency communication and how 
you are sharing this information, how you are working with your 
affiliates so that everyone can more easily pinpoint and get to 
the bottom of problems and bad actors and issues that are 
coming forward.
    And yesterday, the FDA announced that they are studying 
ways to make the agency more transparent. This should have been 
done before we pass a bill that would give the agency millions 
of dollars in user fees. And I am going to yield my time back 
and submit my full statement for the record and look forward to 
the questions.
    [The prepared statement of Ms. Blackburn 
follows:]*************** COMMITTEE INSERT ***************
    Mr. Pallone. Thank you. Gentlewoman from the Virgin 
Islands, Ms. Christensen.

       OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN, A 
       REPRESENTATIVE IN CONGRESS FROM THE VIRGIN ISLANDS

    Ms. Christensen. Thank you, Mr. Chairman, and welcome back, 
Dr. Hamburg. I know New York has suffered a great loss, but the 
Nation needs you more. I also think it is very fitting that as 
we have come back to Congress and begin to put the nuts and 
bolts on our health care reform legislation that the first 
hearing that this committee is having is with FDA because I 
believe we will begin that reform with an overhaul and a better 
resourcing of the Food and Drug Administration.
    From the Food Safety Enhancement Act of 2009 that we are 
looking at in draft today and the Family Smoking Prevention and 
Control Act of 2009, we are looking at a new FDA, and you have 
the challenge as well as the opportunity to remake this 
important institution in ways that it better serves the health 
of the American public while also fostering, guiding, and 
supporting the bringing of new and better treatments to us as 
well.
    I have confidence in a better resource FDA with more 
authority and one that is not overly prescriptive. I don't want 
to be overly prescriptive on what we tell the agency to do, but 
I hope that we will be able to allow the agency to do its job 
based on clear authority, adequate resources, and sound 
science.
    In the case of food safety, in this my first few months on 
this committee, I have really been alarmed to find out what has 
happened that has put the public's health in jeopardy from 
salmonella to some questions about even the IRB process and 
several other areas. So we are here to help you create a 
better, stronger FDA, and this hearing is part of that process. 
And I thank you and all of the panelists for sharing their 
experience and expertise with us this morning.
    Mr. Pallone. Thank you. Gentleman from Pennsylvania, Mr. 
Murphy.

   OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN 
         CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

    Mr. Murphy of Pennsylvania. Thank you, Mr. Chairman, and 
welcome, Dr. Hamburg. Pennsylvania's number one industry is 
agriculture, and with that comes a lot of food processing. We 
are honored to have national companies located in Pennsylvania 
like Hershey's. We have companies like Welch's grows a lot of 
grapes there. And more locally in the Pittsburgh area, regional 
distributors of groceries like Giant Eagle, national 
distributors of olive products like Delalow's, and of course 
big names like Del Monte and the corporate headquarters of 
Heinz, and small companies like Sarah's Chocolates that sells 
around the country.
    All of them have talked with us about concerns for this 
bill and certainly are very supportive of making sure we have a 
strong FDA, and we want to make sure that happens.
    A few questions were raised, and I hope I will be able to 
remain for part of this hearing; although, I have to run to the 
floor, and I apologize for that. I will miss some of this, but 
a number of issues: making sure that there is no unintended 
consequences of the bill that leads to increased price for 
consumers. Let us work on that, on the registration fee, 
particularly as it may affect some smaller businesses trying to 
work.
    Also, with regard to the traceability, need to be clear 
what exactly the obligations are for both the processed and 
fresh food industry. Are we talking about traceability of final 
product or traceability of every ingredient that went into the 
product?
    For example, if a local restaurant chain makes cookies or 
someone else makes cookies, trying to track every single 
ingredient that comes up with a specific food color dye may be 
a problem for them and would like to make sure we make that 
work for the safety of consumers but not in a way that impairs 
companies from doing their work.
    And also unintended consequences of giving the FDA copies 
of all test results could be less testing. As companies go 
through lots and lots of test for products that never make it 
to market, would it be--to test the hundreds of samples each 
day have to be available or change to the testing of products 
that are in the marketplace?
    With regard to the country of origin labeling and 
disclosure, to list every ingredient on a Web site could 
increase the costs and resources and not necessarily bring 
added value. Could there be some general labels such as some 
statement that this product may contain ingredients from one or 
more of the follow countries?
    Also how about raising the importance of making sure that 
all enforcement officers and auditors are well-trained and 
calibrated to work to define audit standard? There is also 
concern of what happens with the family farm that may sell to 
local grocery stores. To what level would they have to comply? 
And would it be that the fees for them would be so high that 
they simply could not sell any products outside of their own 
farm store? And as that impairs some smaller distributors, how 
do we help them?
    Another issue for grocery stores, what if they make 
packaged food at their stores such as some value-added ground 
beef products made in the meat departments? What happens if 
they mix in other foods at their store? How does the bill 
affect them in other ways?
    So certainly in Pennsylvania we want strong food safety 
bills. We want ones that protect consumers. We want small 
businesses to be encouraged and large businesses to be 
supported but also encourage new startups. But more than 
anything else this week we want the Penguins to win the Stanley 
Cup, and I yield back.
    Mr. Pallone. Thank you. Gentleman from Texas, Mr. Green.

   OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr. Green. Mr. Chairman, I want to thank you for holding 
the hearing today on the discussion draft of the food safety 
legislation. Over the past year or so, there have been several 
high profile food contamination incidents in the United States 
involving spinach, cantaloupes, peanut butter, and tomatoes. 
This committee has diligently investigated all of these 
incidents.
    These hearings on the FDA have clearly shown us that the 
FDA simply does not have the resources, funding, or manpower 
and technology it needs to protect the American food supply and 
fulfill its mission.
    Chairman Dingell, Chairman Pallone, and Chairman Stupak 
have worked tirelessly on this proposed legislation. I would 
like to applaud them for their dedication on this issue. I am 
hopeful for this hearing and the discussion draft will bring us 
one step closer to passing food safety legislation out of the 
House.
    I had a brief chance to review the legislation. I would 
like to briefly discuss a couple of issues that concern me. The 
discussion draft allows for food imported to be inspected by 
third-party accredited labs to conduct sample analysis. I 
support the provision, but I would like to see an investment in 
instruction in FDA labs.
    The port of Houston is the largest port in the U.S. in 
terms of foreign tonnage, and a large portion of that is 
related to our energy industry. But the port imported 606,000 
tons of imported food in 2007. The port of Houston does not 
have an FDA lab, and surprisingly there is no FDA lab in Texas 
even though we share the longest border with Mexico. I have yet 
to understand why Texas with its level of trade and southern 
border with Mexico does not have an FDA lab. In fact, there are 
over 300 ports of entry in the United States, and only 13 ports 
actually have FDA labs.
    I hope my colleague from Arkansas will forgive me, but the 
closest FDA lab to Houston and the entire state of Texas is 
located in Arkansas.
    Houston is not the only import area in Texas. Cities like 
Laredo, Texas that is one of the largest land-locked ports of 
entry in the world imports from Mexico literally thousands of 
trailers on a weekly basis. It seems unwise and frankly unsafe 
to have the FDA lab for the entire state of Texas located 100 
miles away in another state.
    The location of FDA labs throughout the U.S. needs to be 
evaluated and a report should be submitted to Congress on 
whether the FDA labs are located where they are most needed. 
The discussion draft allows FDA to assess current FDA lab 
locations and to relocate labs as necessary.
    I would like to hear from the FDA on whether they have any 
plans to evaluate current lab, FDA lab locations. Congress also 
needs allocated funds to the building of more FDA labs. I was 
pleased to see the President's budget. The allocation of funds 
was three high-volume FDA labs. If we want FDA to truly ensure 
the safety of our food supply, we need to build more FDA labs 
in areas where food imports are arriving, such as Houston, so 
the FDA can quickly and accurately test our food imports and 
ensure food safety.
    Again thank you, Mr. Chairman. Look forward to hearing our 
witnesses, and thank our new FDA director for appearing before 
the committee.
    Mr. Pallone. Thank you, Mr. Green. Our ranking member, Mr. 
Barton.

   OPENING STATEMENT OF HON. JOE BARTON, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr. Barton. Thank you, Mr. Chairman. I will be very brief. 
We support there being a legislative hearing and hearing on 
food safety. We think it is time to address this problem in a 
bipartisan fashion if at all possible. We do think it is 
important that we try to get it right if at all possible.
    We understand that it is your wish and the full committee 
chairman's wish and former Chairman Dingell's wish to move with 
legislation sometime this month. Republicans are ready to help 
if we can agree on a bill that provides the FDA with the tools 
that it needs to ensure the safety of our food supply. But we 
will not support new blanket authorities that are designed 
merely to empower the bureaucracy.
    Nearly everybody says that ``we cannot inspect our way to 
foods safety.'' We need systems that reliably prevent sickness 
by applying resources in those places that are most susceptible 
to contamination. The draft before us proposes several areas to 
strengthen prevention of food illness outbreaks such as 
requiring all manufacturers to have food safety plans and also 
the creation of appropriate produce standards.
    These ideas make sense and have near universal support. We 
are concerned however that parts of the draft add more weight 
than quality to the regulations and, in our opinion, provide 
too much discretion to the FDA without any corresponding food 
safety benefit.
    For example, country of origin labeling is not about food 
safety. AS a practical matter, it will simply increase the cost 
of groceries at the store. We know this because expert after 
expert has testified at the committee that this provision has 
absolutely no effect on safety.
    There are several other specific concerns with the draft, 
including the level and the scope of the registration fees. I 
will say that the registration fees are less in this draft than 
they have been in some previous drafts so that I can at least 
say that we are moving in the right direction.
    Having said that, it does appear that the majority simply 
wants $300 to $400 million in additional funds for the FDA, and 
we can't see that there is any clear purpose for that amount of 
funding.
    Having said that, we look forward to the hearings, and if 
we can work on some of these problems, we are prepared to be 
positively engaged in the markup that comes after the hearings. 
With that, Mr. Chairman, I will yield back.
    Mr. Pallone. Thank you, Mr. Barton. The gentlewoman from 
Ohio, Ms. Sutton.

  OPENING STATEMENT OF HON. BETTY SUTTON, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF OHIO

    Ms. Sutton. Thank you, Mr. Chairman. Thank you for holding 
this hearing on this extraordinarily important issue. I want to 
extend my appreciation to the sponsor of this bill and all of 
those who, for so long, have been fighting the fight to fix our 
food safety system and make sure that the food that is on the 
table to feed our families is safe for their consumption. And 
that which goes with them to school, they can fear not that it 
will be safe for their children to eat.
    Chairman Emeritus Dingell, I thank you very much for your 
long effort in improving our food safety network, along with 
Representative Dingell, Representative Stupak and others on 
both sides of the aisle. And look forward to working with you.
    As you may know, the very first bill that I introduced in 
the House, I believe, was a bill to call for mandatory recall 
authority for the FDA. And there is a reason for that. I mean 
we have seen these problems arise again and again and again 
within our food safety network. And the American people, I 
think, would have been shocked, as I was, to learn that our 
government did not have the authority to issue a mandatory 
recall when it became apparent that it was necessary.
    Ohio has suffered the effects of problems with our food 
safety system. Most recently, the salmonella outbreak has 
claimed lives and harmed many throughout the Buckeye State, and 
it is critical that we are moving forward with a comprehensive 
bill to finally address and ensure the safety of America's 
tables and our system. Thank you so much. I yield back.
    Mr. Pallone. Thank you. Gentleman from Michigan, Mr. 
Rogers.

  OPENING STATEMENT OF HON. MIKE ROGERS, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF MICHIGAN

    Mr. Rogers. Thank you, Mr. Chairman. Appreciate the hearing 
and congratulations, Commissioner, for your confirmation. I 
look forward to working with you. Some difficult issues ahead.
    I am glad this committee is focused on food safety. I think 
we can all agree that the FDA needs more resources to protect 
our food supply and strengthen public health. I am concerned, 
however, that this might be a ready-shoot-aim event. We just 
passed a fairly onerous bill and added a lot of authority to 
the FDA that had a huge loophole in it that allowed tobacco 
regulation to be borrowed from the general fund of the FDA.
    So you have this hole of millions and millions of dollars, 
of which you are going to have to try to apply to thousands and 
thousands of new regulators. At the same time, we are trying to 
improve food safety, and I can't think of anything more 
important than our food supply.
    My hat is off to you, Commissioner, on the challenge of 
what you have just accepted. As we all know, the FDA is 
currently unable to inspect the majority of the Nation's food 
facilities. Worse, many high-risk facilities have gone without 
inspection and oversight at all. Over the last two years, we 
have seen the impact of this failure: numerous salmonella and 
E.coli outbreaks, which have sickened thousands and even lead 
to death.
    I hope that this bill could eventually be a bipartisan 
bill. However, many of the concerns that we have expressed have 
not been addressed, and we have not had the opportunity to sit 
down and have a discussion before this bill has come before the 
committee. And I think that is horribly unfortunate when you 
are talking about food safety and food safety issues.
    The user fees in this draft are concerning to me. As 
written, the bill would require $1,000 in registration fee per 
food facility, but these funds totaling about $375 million 
which will be passed along to consumers, which are regular 
families trying to pay their bills already, there is nothing in 
there that dedicates this to new inspections.
    So we have come up with a new tax regimen that doesn't 
benefit the FDA in getting it to the place where you need it 
most, which is inspectors for food facilities and food supply. 
Makes no sense to me, and that is something we absolutely have 
to change in this bill, or, Madam Commissioner, you are going 
to be looking at a very tough hole to fill again. There is 
nothing in here that tells the appropriators where to put that 
money so that you can best use it to accomplish the mission of 
which this bill will tell you it has to do without telling you 
where the money is coming from.
    That is almost dangerous when you think about this plus the 
FDA tobacco regulation authority that allows them to take your 
money for food supply inspections and drug approval and use it 
for hiring new regulators for tobacco. That is a real problem 
that we need to fix not only in this bill, at least I hope we 
can.
    If food producers are required to pay this new tax, they 
should absolutely have the certainty that the funds are going 
to be used for food safety inspections. I think that is common 
sense. I think we can all agree on it. I would hope to work 
with the majority to get that taken care of.
    In addition, the draft's inspections schedule seems almost 
impossible to achieve. Today I hope, Commissioner, that you can 
shed some light on what a practical, risk-based inspection 
schedule should look like. And I hope you can cover that today 
in your statement and through questions.
    I also have several other concerns: the new, broad recall 
authorities. Recall authority is important, but how it is done 
is incredibly important. An expansive new civil penalty regime, 
new labeling requirements that don't seem to have anything to 
do with food safety.
    Again I think all of these issues we can address if we work 
together in a bipartisan manner and, I think, come around 
something that we all believe needs to happen. And that is more 
resources for food inspection and food safety regimes that the 
FDA has a primary responsibility for.
    I look forward to working with you and thank you, Mr. 
Chairman, for this I think all important hearing.
    Mr. Pallone. Thank you, Mr. Rogers. Gentlewoman from 
Wisconsin, Ms. Baldwin.

 OPENING STATEMENT OF HON. TAMMY BALDWIN, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF WISCONSIN

    Ms. Baldwin. Thank you, Mr. Chairman. I appreciate the fact 
that you are holding today's hearing and also want to join my 
colleagues in commending you and Chairman Stupak and Chairman 
Emeritus Dingell and Chairman Waxman for putting this very 
important discussion draft before us that addresses very 
serious challenges that we face with respect to food safety.
    Before I begin my remarks, I would like to submit for the 
record written testimony from the Secretary of the Department 
of Agriculture Trade and Consumer Protection in the state of 
Wisconsin.
    Mr. Pallone. Without objection, so ordered.
    [The information appears at the conclusion of the 
hearing.]*************** COMMITTEE INSERT ***************
    Ms. Baldwin. Thank you, Mr. Chairman. Food safety is an 
issue of great concern to me and my constituents. Approximately 
one in four people in this country are affected or sickened by 
food borne disease each year. As Americans, we rely on 
government to keep us safe, and as government, we have fallen 
down on the job.
    As we consider this draft legislation, I know that our goal 
is to empower the FDA to prevent food contamination incidents 
before they occur. I hope that we do so with appropriate and 
sufficient resources, but also with precise coordination 
between other federal agencies, the states, and the private 
sector.
    Currently with its limited resources, the FDA focuses its 
inspections on large manufacturers engaged in interstate 
commerce, and it leaves much of the front line work to the 
states. This bill creates a risk-based inspection system that 
significantly increases the frequency of inspections. I want to 
make sure that we are not duplicating efforts and that we can 
empower states to perform their work on the ground with 
logistical and financial support.
    I urge the FDA to use this legislation to create a 
stronger, more integrated food safety system that leverages 
state and local resources.
    As another result of limited resources, FDA relies on many 
private sector firms to conduct food safety testing on a 
contractual basis. I am pleased that the discussion draft 
includes a provision that would allow a laboratory 
accreditation process facilitating the FDA's use of third-party 
laboratories to perform testing.
    And I want to make sure that the conflict of interest 
language in the bill does not prevent some of the most 
experienced laboratories from maintaining their strong 
partnership with the FDA moving forward.
    I look forward to hearing your testimony, Dr. Hamburg, and 
that of the other witnesses today. And I thank you again, Mr. 
Chairman, for this hearing.
    Mr. Pallone. Thank you. Gentleman from Georgia, Mr. 
Gingrey.

  OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF GEORGIA

    Mr. Gingrey. Thank you, Mr. Chairman. Mr. Chairman, public 
health officials estimate that 76 million people become sick, 
325,000 are actually hospitalized, and 5,000 die each year from 
food borne illnesses caused by contamination. Incidents like 
those in my own home state of Georgia, where the actions of a 
few bad actors and a breakdown in effective government 
oversight sickened more than 677 people in 45 states and caused 
at least nine deaths underscores the need for action.
    I agree with my colleagues that more needs to be done to 
ensure that the food products American consumers buy are safe. 
Additionally, I support the efforts of this committee as it 
reviews ways to streamline and improve the food inspection 
system in this country.
    Mr. Chairman, I hope that these hearings will continue to 
allow us the opportunity to reflect on the breakdowns in our 
current system, as well as the appropriate solutions to 
safeguard the health and welfare of all Americans.
    Madam Commissioner, I commend you for your recent 
appointment. Look forward to hearing from you and from the next 
panel of witnesses. And with that, Mr. Chairman, I yield back 
my time.
    Mr. Pallone. Thank you. Gentleman from Iowa, Mr. Braley.

OPENING STATEMENT OF HON. BRUCE L. BRALEY, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF IOWA

    Mr. Braley. Thank you, Mr. Chairman. Welcome, Dr. Hamburg. 
I don't think anyone sitting over here has anything but good 
wishes for you and the enormous challenges you face, and we 
wish you well and look forward to many fruitful and productive 
conversations with you. As vice chairman of the Oversight and 
Investigations Subcommittee, I have been very involved in the 
hearing that we have had up to this point on this important 
subject, and I am glad to see us finally getting to the point 
of considering legislation that is so critical to the health 
and safety of Americans.
    Throughout this process, we have seen examples of both good 
and bad actors in the food industry. Some companies like Nestle 
USA set the standard with proactive food safety audits and 
showed us what can happen when companies do the right thing in 
reaching out and doing their own investigations.
    On the other hand, we heard extensively about Peanut 
Corporation of America and its unsanitary and unsafe conditions 
and about its action to misrepresent the results of audits that 
were done, which put people at risk and cost people their 
lives.
    That is why we are here today to talk about what we can do 
to improve the current state of the situation. This Food Safety 
Enhancement Act will solve many of the FDA's current 
limitations, and I am glad that it requires increased 
inspections of food facilities, tiered inspection systems that 
distinguish between high-risk facilities, low-risk facilities, 
and warehouses. And I also support the provisions to ensure the 
safety of imported foods, which is something I fought for since 
introduction of the Fresh Produce Safety Act last Congress.
    Also very importantly I am very proud that this bill has 
strong whistle-blower protections. And I believe that it will 
help keep America's food supply safe. Many might consider some 
of the provisions in this bill burdensome. However it is 
important to look at opportunity costs of failing to take 
action to improve food safety.
    In our March 19 Oversight hearing, I asked David Mackey, 
who is the CEO of Kellogg, how much the PCA Salmonella outbreak 
had cost his company, and he replied between $65 and $70 
million. The legislation before us today might have prevented 
that outbreak and saved those costs.
    Most important, however, is what we owe to the families of 
this country who have been injured or killed by unsafe foods 
and the desire to take real action to keep our food supply 
safe.
    In 2006, a graduate of Dubuque Wallard High School in my 
district, a marathon runner named Jill Cole contracted E.coli 
from a spinach salad that she ate. After 17 days in the 
hospital, she was released with just eight percent of her 
kidney function, and she now has to see a doctor twice a year 
to monitor her kidneys. Jill and all other Americans should be 
able to have faith that their food is safe, and we are here 
today to try to restore that faith. Thank you, Mr. Chairman.
    Mr. Pallone. Thank you. Gentleman from Maryland, Mr. 
Sarbanes.

OPENING STATEMENT OF HON. JOHN P. SARBANES, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF MARYLAND

    Mr. Sarbanes. Thank you, Mr. Chairman. Welcome, Dr. 
Hamburg. We are so excited to see you in this position, and we 
look forward to your testimony on the proposed legislation. The 
comment has been made a couple of times that we can't inspect 
our way to food safety, and that may be true. But we can non-
inspect our way to food danger, which I think has been 
unfortunately the hallmark of what has happened in recent past. 
And so this bill that is proposed is going to put so much more 
emphasis and inspection on the front end, which is going to 
make a tremendous difference.
    When you look at the provisions that are contained in this 
proposed legislation, so many of them go under the heading of 
no-brainers. In other words, these are things that the average 
citizen would imagine are already in place and I think would be 
surprised to learn are not in place.
    And so there is so much about this bill that represents 
some of the pent-up needs and concerns of the American public 
that we need to address. On the economics, and there has been a 
fair amount of discussion about that already just in the 
opening statements. The better we do on the front end, of 
course, with monitoring and inspection, the less cost we are 
going to have on the back end, both in terms of FDA needing to 
scramble to deal with outbreaks of food borne illness, but also 
to save cost of businesses of not having to deal with the 
effects of that.
    And I think that those save costs will far outweigh the 
investment that we put in on the front end and certainly 
justify many of the measures that are contained in this bill. 
So we look forward to your testimony, welcome, and good luck to 
you. Yield back my time.
    Mr. Pallone. Gentleman from Connecticut, Mr. Murphy.

      OPENING STATEMENT OF HON. CHRISTOPHER S. MURPHY, A 
    REPRESENTATIVE IN CONGRESS FROM THE STATE OF CONNECTICUT

    Mr. Murphy of Connecticut. Thank you, Mr. Chairman. I look 
forward to Dr. Hamburg's testimony and members of the other 
panel. I think what we are talking about here today is setting 
very high but very reasonable expectations for what we can do 
out of the FDA. And I think that if that is our goal, we can 
get a product that both parties can be proud of.
    As the former chair of Connecticut's public health 
committee, I know I speak for a lot of state policymakers in 
our feeling of helplessness over the past 5 to 10 years 
especially, and I think you are going to find, as this 
committee will find, a lot of allies in state public health 
networks. They are going to be very supportive of this 
transformation that you are undergoing to try to assist in 
their efforts, which have been very difficult over the past 
several years.
    Last thing, Mr. Chairman, I am very appreciative to you and 
to Mr. Dingell and others for including in this bill several 
aspects of the work that my colleague in Connecticut, 
chairwoman of the Agricultural Subcommittee of Appropriations 
Committee, Rosa Delaro. She has been working as a tireless 
advocate on this issue. Parts of this bill relative to the 
inspection frequency for the riskiest foods out there, 
enforceable performance standards for food borne standards are 
parts of her efforts incorporated into the underlying bill. And 
I appreciate you paying attention to her work here as well. 
Look forward to your testimony. Thank you for being here. Yield 
back.
    Mr. Pallone. Thank you. Gentlewoman from Florida, Ms. 
Castor.

  OPENING STATEMENT OF HON. KATHY CASTOR, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF FLORIDA

    Ms. Castor. Thank you, Mr. Chairman. And kudos as well to 
Rosa Delaro and Bart Stupak and John Dingell, our colleagues 
here that have worked for many years to improve food safety in 
America. And welcome to Dr. Hamburg. Based upon your 
background, obviously you enjoy a challenge, and food safety is 
an important challenge for our country.
    Of all the issues we deal with in this subcommittee, food 
is the most ubiquitous. It is relevant to all Americans. I 
wanted to remind my colleagues that the Government 
Accountability Office remember keeps that very short list of 
major government problems that require broad transformation 
before they can ever hope to be effective. The list called the 
high-risk series includes notorious government failures such as 
the financial regulatory system, which failed to prevent the 
largest financial collapse in generations. It includes the 
implementation of the Homeland Security Department, which has 
been plagued from the beginning by cost overruns. And no 
surprise, it also include federal oversight of food safety.
    And here is an example from last year that really hurt in 
my home state of Florida. Tomatoes last year from Florida were 
blamed for a nationwide salmonella outbreak that was eventually 
traced to jalapeno and Serrano peppers from Mexico. In the 
meantime, FDA intimated at the time not to consume Florida 
tomatoes, and that cost our state and agricultural producers 
and hard working folks over $100 million. All of the time and 
effort spent hinting and suggesting that Florida tomatoes were 
the problem only served to delay the solution to the real 
problem and allow more Americans to get sick.
    Our committee understands the problem. This committee has 
held several hearings, and we understand that we must act 
expeditiously. Part of the problem lies in the lack of federal 
authority to effectively respond to a crisis. When FDA does not 
have incontrovertible proof of a specific food contamination, 
it cannot today issue a mandatory recall. Instead it must rely 
on corporations to voluntarily choose to pull inventory from 
the shelves.
    The FDA does not even have the ability to assess civil 
penalties. This legislation before us gives the FDA that long 
overdue enforcement authority. The problems facing food safety 
and oversight are legion, and they are difficult. But they are 
not insurmountable, and I am confident that we will move the 
Food Safety Enhancement Act of 2009 quickly and provide 
American consumers with a safe, transparent and reliable food 
supply. I yield back my time.
    Mr. Pallone. Thank you. Gentlewoman from California, Ms. 
Eshoo.

 OPENING STATEMENT OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    Ms. Eshoo. Thank you, Mr. Chairman, for having this 
important hearing on the Food Safety Enhancement Act of 2009, 
and I want to extend the warmest welcome and congratulations to 
Dr. Hamburg. She is a woman of exceptional talent, high 
intellect, a person with great character, and someone that has 
given much to their country already and comes from one of the 
most outstanding families, I think, in our country. You can 
tell how elated I am that the President chose so wisely in 
appointing you as FDA commissioner. We all look forward to 
working with you. To the extent that you succeed, the country 
is going to succeed.
    I also think that your tenure can be and will be the mark 
where the FDA returns to being the gold standard in terms of a 
public agency. The American people believe in the FDA. They 
want the FDA to succeed because what you do they can't do for 
themselves. And the decisions that are taken can be the 
difference between life and death. That is how profound the 
decisions are.
    So I can't tell you how thrilled I am that you are the one. 
I am pleased that the legislation that we are considering is 
going to improve the traceability of food because when tainted 
food is discovered, it is critical that we know where it has 
come from, where it has gone and what stores it is sold in. If 
sales are limited to a certain area, targeted recall could take 
place, which would be more effective for consumers and 
businesses.
    And I am also pleased to see the mandatory country of 
origin labeling for food is included in the bill. I think in 
today's environment, this is really essential information for 
consumers to know where their food comes from. This is a long 
and complex bill, and I too, along with my colleague Mr. Murphy 
from Connecticut, really want to salute those that have worked 
on this issue.
    Rosa Delaro has just been tireless, and you know that she 
brings passion and intellect to what she does. And so some of 
the ideas from her legislation are embedded in this. I look 
forward to our conversation. I hope that what we are asking the 
FDA to do that you are really up to it.
    I think we have lived on fees for a long time, and I still 
have questions and would like to know directly from you whether 
you really think you are going to have the resources that are 
necessary to do this. Because if you don't, then the print of 
the legislation or law would be wonderful to read like some 
constitutions around the world that are absolutely magnificent, 
but they are not worth the paper they are written on.
    We have fallen off the edge of a cliff in terms of what is 
coming into the country and what has happened to the American 
people. We have to get this right this time. And some think 
that there should be a stand-alone food inspection agency. Can 
the FDA actually do all of this? Do you have the resources for 
it?
    I mean if there is pizza that has pepperoni on it versus 
pizza that doesn't have any meat on it, should there be a split 
jurisdiction between agriculture and the FDA in terms of 
inspection? I think the more splits there are, that there is 
more of an opportunity for things to fall between the cracks. I 
may be entirely wrong, but I still have some questions.
    I don't think this is a perfect piece of legislation, but I 
am sure glad that we are considering the issue. So I wish you 
nothing but the best. I have great, great confidence and 
respect for you, and I am very proud that the President chose 
to pick the best in the country for this job. Thank you.
    [The prepared statement of Ms. Eshoo 
follows:]*************** COMMITTEE INSERT ***************
    Mr. Pallone. Thank you. Gentlewoman from Illinois, Ms. 
Schakowsky.

       OPENING STATEMENT OF HON. JANICE D. SCHAKOWSKY, A 
     REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS

    Ms. Schakowsky. Thank you, Mr. Chairman, and 
congratulations, Dr. Hamburg. I come to this issue with a lot 
of history and also this particular issue with a lot of 
emotion. My good friend Nancy Donnelly whose only child Alex 
was lost because of eating hamburger with E.coli and then 
dedicated her life to creating an organization, Safe Tables are 
Priority, has worked tirelessly for food safety.
    And year after year, we have people coming before us 
telling these devastating stories, and every time we say we are 
going to do something so it never happens again. And yet it 
does.
    In February, we heard testimony from Peter Hurley whose 
young son was made ill by eating Austin peanut butter crackers. 
They were found in millions of homes, and we were all shocked 
by documents presented at that hearing that showed that the 
Peanut Corporation of America knew that their products were 
tainted and yet released them into the food supply anyway.
    So the discussion draft that is before us includes 
provisions that will seriously fill many of the gaps in our 
current food system. I wanted to just mention a couple of 
things that I think ought to be considered for review. There is 
just a brief mention in the bill dealing with the issue of 
antibiotic-resistant pathogens and the extent to which 
antibiotics that are used in livestock contributes to this 
resistance. We don't always think about this as food safety, 
but I think it is a truly important issue with H1N1. I know it 
was a virus, but nonetheless everybody is waiting for that kind 
of a plague that we don't have the care for partly because of 
antibiotic resistance.
    Second, I believe the companies who have positive test 
results for possibly dangerous contaminants should be required 
to report those results to the FDA. We heard how PCA, nobody 
knew about it, and I think there are many other examples. It is 
a question on how the FDA effectively can ensure the safety of 
our food if we don't even know where there might be a problem.
    And finally I believe the collecting and disseminating of 
information about food safety and food borne illness to 
consumers is a critical component of any food safety plan. I am 
encouraged by the provisions of the bill, but I think there may 
be more that we can do to ensure that Americans are adequately 
informed. Thank you so much.
    Mr. Pallone. Thank you, and I believe that completes our 
members' opening statements. So we will now turn to our 
witness. And let me say, Dr. Hamburg, I appreciate your being 
here. I want to welcome you. We have, as you know, five-minute 
opening statements that become part of the record, and then you 
may get some questions afterwards from members of the 
committee. So thank you and if you would begin.

  STATEMENT OF MARGARET HAMBURG, COMMISSIONER, FOOD AND DRUG 
                         ADMINISTRATION

    Dr. Hamburg. Chairman Pallone and members of the 
subcommittee, I am Dr. Margaret Hamburg, commissioner of the 
Food and Drug Administration. Thank you for the opportunity to 
appear before you today to discuss the urgent need for reform 
of our Nation's food safety system. I commend you, Chairman 
Waxman, Chairman Stupak, Chairman Emeritus Dingell, and other 
members of the committee and your staffs for your leadership 
and hard work in developing this draft legislation.
    The food safety bill under consideration represents 
significant reforms needed to modernize our food safety system. 
I am honored to have been chosen by President Obama to lead 
this great agency, and I am inspired by the President's 
personal commitment to improving food safety, including the 
progress being made by his food safety working group.
    The President has backed up his commitment with resources, 
proposing historic increases in funding for FDA's food safety 
efforts. I also appreciate the support of Secretary Kathleen 
Sebelius and the Department of Health and Human Services and of 
Secretary Tom Vilsac and the U.S. Department of Agriculture for 
major progress on food safety.
    In addition, a coalition of consumer groups is fighting for 
improvement in the food safety system so that more families do 
not have to suffer tragic consequences from food borne disease. 
Major sectors in the food industry also support and are 
advocating for fundamental change, but even with all this 
support and momentum, our efforts will fall short unless 
Congress modernizes food safety laws to deal with the 
challenges of the 21st century. That is why this hearing is so 
important.
    From the perspective of FDA, there are three key questions 
to ask about food safety legislation. First, does the 
legislation support a new system focused on prevention? Second, 
does the legislation provide FDA the legal tools necessary to 
match its existing and new food safety responsibilities? And 
third, does the legislation provide or anticipate resources for 
the agency to match its responsibilities?
    To comment on the discussion draft, let me address each of 
these issues in turn. The first, does the legislation support a 
new food safety system focused on prevention? The draft 
legislation would indeed transform our Nation's approach to 
food safety from responding to outbreaks to preventing them. It 
would do so by requiring and then holding companies accountable 
for understanding the risks to the food supply under their 
control and then implementing effective measures to prevent 
contamination.
    Does the legislation provide FDA the legal tools necessary 
to match its existing and new responsibilities? In a new food 
safety system, FDA has the fundamental responsibility of 
overseeing and verifying the implementation of preventive 
measures by hundreds of thousands of companies. The agency also 
retains the existing critical role of protecting the public 
during an outbreak. FDA needs new legal authorities to be able 
to succeed in these roles and protect the public health. This 
legislation would provide these critical tools.
    My written testimony provides several examples, but I would 
like to highlight one of the most important new authorities 
now. Section 106 provides FDA with explicit authority to access 
food records during routine inspections, thereby addressing one 
of the most significant gaps in FDA's existing authority. The 
authority provided in this provision is essential to enable FDA 
to identify problems and require corrections before people 
become ill.
    It also enables the agency to verify, during routine 
inspections, that firms are maintaining proper distribution 
records. Records access and record keeping by all persons in 
the distribution chain are the key mechanisms of providing 
regulators with information on plant operations, product 
safety, and product distribution. Such information is necessary 
to verify compliance and to identify problems.
    Lastly, does the legislation provide or anticipate 
resources for the agency to match its existing and new 
responsibilities? The draft legislation makes an important 
investment in the resources needed for major progress. After 
all, FDA must have the resources necessary to meet its 
responsibilities. Otherwise, the public will not benefit from 
the promise of a modern food safety system, and the agency will 
fail to meet the expectations of the President, Congress, and 
the public.
    The bill authorizes three fees that are also requested in 
the President's fiscal year 2010 budget. One of these is in 
Section 101, which provides for a registration fee. This fee is 
of critical importance to enable the agency to improve and 
expand its food safety activities, including to increase its 
inspection coverage of the approximately 378,000 registered 
facilities and to enhance its other food safety activities.
    Section 105 proposes a rigorous inspection schedule for 
food facilities. These requirements start 18 months after the 
enactment. To meet these requirements, Section 105 allows the 
agency to use inspections conducted by inspectors from 
recognized state, local, other federal agencies, and foreign 
government officials.
    FDA would like to raise three issues about Section 105. 
First, the amount of resources required to achieve these 
inspection goals would far exceed even the historic increases 
in the President's fiscal year 2010 budget. Moreover, it would 
be difficult, if not impossible, for FDA to hire and train 
thousands of additional staff so quickly, even while relying on 
inspections by state, local and other federal and foreign 
government officials.
    As a result, FDA encourages the committee to modify this 
section to take into account the operational and resource 
challenges involved.
    Second, as we develop a new food safety system, FDA will 
gain better information to guide the agency's approach to 
inspection and oversight. We will understand where we must 
inspect more frequently because of the high risk of certain 
foods, facilities, and processes, and understand where we can 
protect public health without conducting inspections as 
frequently.
    As a result, FDA would support flexibility to modify the 
inspection requirements based on the best available data on 
risk.
    Third, Section 105 could do more to provide flexibility to 
FDA in meeting the inspection challenge. The draft legislation 
allows the agency to rely on inspections by other federal 
agencies as well as by state, local, and foreign governments. 
An additional promising mechanism for international inspections 
is certification by accredited third parties. FDA would like 
the flexibility to explore the use of such an accreditation 
system and audit the performance of accredited third parties. 
With strong standards and robust oversight by FDA, this 
approach could help address the oversight challenge posed by 
the more than 220,000 registered foreign facilities exporting 
to the United States.
    This is a historic moment for food safety in the United 
States, a moment for FDA and its sister agencies in the federal 
government to rise to the challenge of the 21st century. 
Success means fewer hospitalizations and deaths, fewer 
devastating recalls, and greater health for the American 
people.
    The draft legislation is a major step in the right 
direction. I commend the committee for its leadership, and on 
behalf of the hundreds of dedicated staff devoted to food 
safety at FDA, I look forward to assisting with the legislative 
process. I welcome any questions you may have.
    [The prepared statement of Dr. Hamburg 
follows:]*************** INSERT 1 ***************
    Mr. Pallone. Thank you, Dr. Hamburg. We will have a series 
of questions now from the members. Each of them gets five 
minutes, and I will start with myself. Under the bill, all 
facilities, both domestic and foreign, seeking to market food 
in the U.S. must register each year and provide certain 
information about the facility to the FDA. If the facility is 
not registered, it is illegal to market food from that facility 
in the U.S. And in order to register, each facility would be 
required to pay $1,000 per year as a registration fee.
    Now, my understanding is in 2002, there was bioterrorism 
legislation, and under that legislation, food facilities were 
required to register, but there was no requirement to update 
that registration. So my questions reference that registration 
under the 2002 bill. Has that system resulted in problems in 
terms of FDA's ability to accurately account for all facilities 
selling food in the U.S. And maybe you can tell us what 
problems exist.
    And then the second part is do you believe that linking a 
fee to the requirement to register would help address whatever 
problems exist under this system that dates back to that 2002 
bioterrorism legislation.
    Dr. Hamburg. Thank you. I think it is clear, based on the 
experience since the bioterrorism act in 2002, that we do need 
the extended authorities that would be offered in this bill. We 
know that when a facility registers once but doesn't have to 
register again, that it does create problems in terms of our 
ability to fully understand the nature of the food-related 
activities in that facility.
    The Peanut Corporation of America, I think, is one good 
example. When they first registered, they weren't actually 
making peanut butter, and then they added that to their 
activities. With annual registration, we would have a much 
better record and understanding of the activities. And it would 
provide us with the tools to be more responsible in our 
oversight and in our inspections.
    With respect to the issue of fees, I think it is a very 
important component of any food safety plan that Congress would 
enact. We absolutely need to have the resources to do our job. 
I understand that fees represent a burden on companies, and I 
wish that we were not dependent on that mechanism in all cases. 
But I do think that that fee is an investment in a robust and 
effective food safety system. That fee will go to enable the 
FDA to provide certain specific services and put in place the 
board and modernized food safety system that American consumers 
expect and need.
    Mr. Pallone. All right, let me go back to this fee because 
in the President's budget, he asked $75 million in registration 
and re-inspection fees. So obviously the administration has 
already shown support for the concept of a registration fee for 
food facilities in the budget.
    However in our bill, with its $1,000 per facility fee, we 
would generate much more than the $75 million that is in the 
President's budget. So I want you to explain, if you could, 
what was contemplated in the President's budget request of the 
$75 million. Did that request seek to address the new 
authorities provided in this bill?
    Dr. Hamburg. Well, the President's budget request was, of 
course, put together before the specifics of this proposed 
legislation was put forward. So it wasn't addressing all of the 
specific requirements laid out in this bill, importantly 
including the inspection schedule.
    In my written testimony, there is an appendix that actually 
lays out some of the food safety highlights in the President's 
bill and some of the targeted areas for that $75 million 
increase in the budget.
    It was to include many elements that are a part of this 
legislation, increased inspections but not to the degree that 
this legislation would call for, the implementation of 
preventive controls, strengthened laboratory testing, a 
stronger integration of FDA and federal food safety efforts 
with the state and local activities which is ultimately very, 
very essential to the----
    Mr. Pallone. Well, I know that the bill allows these fees 
to be applied towards a broad array of FDA's food safety 
activities. You know, in other words, it allows the fees to be 
used to boost FDA's ability to develop standards like 
performance standards and preventive controls. Do you agree 
that the fees should be applied towards all these activities 
that we mention in the bill?
    Dr. Hamburg. I think we want a robust, comprehensive 
program, and those fees should be applied to putting in place 
that suite of activities. The preventive controls are directly 
related to what companies must do under the new legislation, 
and I think it is very appropriate that the fees cover that 
aspect. For example, the inspections obviously are directly 
related. Very important that the fees cover that aspect and 
many other aspects of the portfolio of activities outlined in 
the legislation really are essential to what needs to be done 
to protect consumers and ultimately to protect the food 
industry. So that the public and consumers can be assured that 
the products are safe.
    Mr. Pallone. Thank you. Thank you very much. Mr. Deal. I am 
sorry. Mr. Whitfield.
    Mr. Whitfield. Thank you. Mr. Deal had to leave. Dr. 
Hamburg, as you probably know, Senator Kennedy and Durban and 
Burr and Greg have introduced a food safety bill on the Senate 
side. And has the administration endorsed that bill, or has it 
endorsed this bill, or has it endorsed any bill?
    Dr. Hamburg. You know I have to be honest that I have not--
I have only been on the job seven days, and I have been focused 
on your piece of legislation.
    Mr. Whitfield. OK.
    Dr. Hamburg. And so I would be happy at a later time to 
discuss in more detail the bill on the Senate side.
    Mr. Whitfield. But as far as you know, the administration 
has not endorsed either bill?
    Dr. Hamburg. I don't believe so.
    Mr. Whitfield. OK. Well, the reason I brought that up, 
there are some significant differences in this Senate bill and 
the House bill. And one area of difference relates to recall 
authority of the FDA. And under this bill, the FDA would have 
the authority for recall if an article of food may cause 
adverse health consequences. That would be the legal standard, 
may cause. But in the Senate bill, it says that there must be a 
reasonable probability of serious adverse health consequences 
or death. So those standards are significantly different, and I 
would just ask you, since you are now going to be responsible 
for this. That first standard that is in this bill seems so 
general and so nebulous in a way. Does that bother you? Don't 
you think it would be better to have a more precise identified 
standard for recall?
    Dr. Hamburg. Well, I certainly understand the concern that 
you are raising, and I think there may be some opportunities 
for some wordsmithing. Certainly we would never seek to recall 
a product without, you know, some reasonable expectation that 
there was serious adverse consequences and harm related to that 
product. A recall is no small issue both in terms of resources 
and efforts on the part of the FDA and also its implications on 
industry and consumers who want access to those products.
    So I think it is an area that we would like to work with 
you on for language. We wouldn't want it to be too 
overwhelmingly prescriptive because you want to have the 
flexibility in that kind of potentially emergency situation to 
move forward.
    Mr. Whitfield. Well, I agree. I mean I think this is an 
area that we should look at because we know the ramifications 
of a recall, the expense involved, and certainly we want to 
have a balancing of protecting the public versus preventing 
undue expenses to companies as well. So I am glad to see that 
that is at least an area that you would be willing to talk 
about.
    I might also say the same thing would apply to these access 
of records. There really is no standard at all in this bill, 
but in the Senate bill, it says that if FDA has a reasonable 
belief that an article of food presents a threat of serious 
adverse health consequences or death, FDA would have access to 
and be able to copy all records and so forth and so forth. But 
under this bill, it appears that FDA would just have blanket 
authority to request any records at any time without any sort 
of standard being met.
    Dr. Hamburg. Well, here I would like to stress that I think 
access to routine records is extremely important to assuring a 
safe food supply. It is very important that when inspectors go 
into a facility, they can examine certain aspects of what have 
been the procedure during a preceding period of time and not 
just inspect what is happening at that moment. Had we been able 
to better access to routine records in the case of PCA, which 
has been talked about already this morning, we would have been 
able to see that there was documentation of contamination 
several years earlier, which had not been adequately addressed.
    Mr. Whitfield. My time has about expired, but I would like 
to ask just one additional question. It relates to Jan 
Schakowsky's comment in her opening statement about the use of 
antibiotics in the agricultural community and the fact that 
more and more people seem to be establishing immunity to 
certain antibiotics. Is that a concern of yours?
    Dr. Hamburg. It is a huge concern of mine in terms of the 
growing problem of antibiotic resistance in this country and 
around the world and the implications that it has for our 
armamentarium of antibiotics to address serious and life-
threatening diseases. I think it is an area that merits a lot 
of attention by the FDA, working in partnership with others. It 
is a topic I would be happy to come back and discuss in more 
detail with you. And it is very high priority for me in terms 
of overall goals to improve public health.
    Mr. Pallone. Thank you. Chairman Dingell.
    Mr. Dingell. Mr. Chairman, thank you. Welcome again, Dr. 
Hamburg. Congratulations. My first question, it will be a yes 
or no--well, inspections are an important part of finding and 
addressing food safety problems. Isn't this correct?
    Dr. Hamburg. Yes.
    Mr. Dingell. Your agency does not have a good record when 
it comes to inspecting food facilities. Last year, you 
inspected 6,562 food facilities in the United States, 152 
foreign facilities in the same time. Was that enough 
inspections? How many should you have? And what resources would 
you need to do the job?
    Dr. Hamburg. I think we can do better. With respect to the 
question of exactly how many, you know, I cannot tell you that 
now. But----
    Mr. Dingell. I will submit you a letter asking these 
questions in greater detail.
    Dr. Hamburg. I was warned that you would do that.
    Mr. Dingell. And I ask unanimous consent that the record 
remain open to include both my letter and the response of the 
administrator.
    Mr. Pallone. So ordered.
    Mr. Dingell. Would you support an increased frequency 
requirement?
    Dr. Hamburg. We clearly need to do more frequent 
inspections. We also need to do smarter inspections, and we 
need not to rely simply on inspections as our tool for a safer 
food supply.
    Mr. Dingell. We agree on that. I am keenly aware that there 
is a substantial cost associated with conducting foreign and 
domestic facility inspections. How much do you need to do this 
properly in terms of personnel and money? If you can't give it 
now, I will ask the record be kept open to receive that.
    Dr. Hamburg. All right, well it is a complicated answer, 
and there are some unknowables, but we need a lot more money.
    Mr. Dingell. Mr. Chairman, I ask unanimous consent that the 
record remain open so that this can be inserted at the 
appropriate time.
    Mr. Pallone. Mr. Chairman, the record will remain open. You 
don't have to keep saying it.
    Mr. Dingell. Thank you. And it is clear with new inspection 
requirements, FDA is going to need new additional resources to 
meet that requirement. Is it not?
    Dr. Hamburg. That is absolutely true.
    Mr. Dingell. The President has asked additional resources 
for food safety activities at the agency. He requested, I am 
told, about $259 million in additional money. Is that correct?
    Dr. Hamburg. Yes.
    Mr. Dingell. It was the President's intent that these 
additional dollars, amounting to $164.8 million in new budget 
authority and $94.4 million in new fees, registrations, re-
inspection and export certification would be used for 
increasing the number of food facility inspections conducted by 
your agency. Is that not correct?
    Dr. Hamburg. It would be used for that as well as other 
components of a more comprehensive modernized food safety 
system.
    Mr. Dingell. Thank you. It is correct that the President's 
budget request for food safety's activity did not include any 
new requirements that may come with the food safety legislation 
that we are considering here. Is that correct?
    Dr. Hamburg. I am sorry, but could you repeat the question?
    Mr. Dingell. The President's request for new monies did not 
include monies to address the questions that you will be 
compelled to face under the new legislation. Is that correct?
    Dr. Hamburg. It addressed some components but not the 
full----
    Mr. Dingell. But not all?
    Dr. Hamburg. --panoply of requirements that are outlined in 
this legislation.
    Mr. Dingell. There are many who have resisted new money for 
improving food inspection frequency by the agency. They ask 
that the use of these dollars for such activity be prohibited. 
Would you agree with that or disagree?
    Dr. Hamburg. I hate to do this, but this style of 
questioning----
    Mr. Dingell. I am sorry. I have limited time.
    Dr. Hamburg. I know.
    Mr. Dingell. I have 12 seconds left.
    Dr. Hamburg. Could you just repeat the question?
    Mr. Dingell. Question: do you agree with the idea that we 
should prohibit the use of registration fees for inspection?
    Dr. Hamburg. I think we need registration fees to enable 
the agency to do its inspectional activities and other 
components of a food safety plan.
    Mr. Dingell. As a matter of fact, one of the few successful 
activities of Food and Drug at this particular time is what you 
do under PDUFA, which is supported by fees. Is that not 
correct?
    Dr. Hamburg. That is correct.
    Mr. Dingell. And you are starving in almost every other 
place. Isn't that so?
    Dr. Hamburg. Correct.
    Mr. Dingell. Can you state with any certainty the number of 
people, importers, customs brokers, filers, who import products 
under FDA's jurisdiction to the United States in any year? I 
believe the answer to that question is no.
    Dr. Hamburg. Is no, and this legislation would enable us to 
get a much better handle on who is out there producing and 
distributing food for U.S. consumption.
    Mr. Dingell. And the reason is that they are not currently 
required to register with FDA. Isn't that the reason?
    Dr. Hamburg. That is a large part of the reason, yes.
    Mr. Dingell. Isn't it important to FDA to have an accurate, 
up-to-date accounting of who these people are?
    Dr. Hamburg. Very important.
    Mr. Dingell. Now, these individuals are not required to 
comply with certain requirements to ensure the safety of these 
products that they import. They can handle any type of FDA-
related products and are not required to have any specific 
training so do to. Is that not correct?
    Dr. Hamburg. That is correct. We would like to make sure 
that individuals importing food into the United States followed 
standards and guidelines that we expect with domestic food 
production.
    Mr. Dingell. Good. The discussion draft establishes a 
program to require importers, U.S. custom brokers of foods, 
drugs, and devices and others to register with the FDA and 
require that good importer practices are maintained as a 
condition for maintaining registration. Do you agree with that 
requirement?
    Dr. Hamburg. We would like importers to be registered.
    Mr. Dingell. Now, one more question, and then--well, I tell 
you what. I note my time is up. Madam Administrator, I will be 
submitting you a letter. Mr. Chairman, thank you for your 
patience, and I would thank my colleagues. I would note that 
the changes in the draft that we have before us today are those 
which have been largely done in consultation with FDA and in 
consultation with my minority colleagues. The next changes that 
you see will originate in about the same way. Thank you, Mr. 
Chairman.
    Mr. Pallone. Thank you, Chairman Dingell. Next is the 
gentleman from Indiana, Mr. Buyer.
    Mr. Buyer. Thank you. In your statement, you support the 
FDA's ability to trace foods more quickly during an outbreak, 
so you would support a track and trace system with regard to 
food. Is that correct?
    Dr. Hamburg. I would. I think it is very important to our 
ability to respond quickly to outbreaks of concern.
    Mr. Buyer. And since you appear to be endorsing the bill, 
this draft discussion bill in front of us, you also support 
then the FDA's ability to increase inspections of food 
processing facilities. Is that correct?
    Dr. Hamburg. I think we need to do more inspections, but as 
I said earlier, I think we also need to recognize that it isn't 
simply increasing the number of inspections that will get us to 
the food safety system that we need. But it is also instituting 
the preventive controls and really shifting the way we think 
about food safety and also, you know, stronger partnerships 
with the locals and foreign government.
    Mr. Buyer. Ma'am, when you discover a contaminated food, 
you believe it is your responsibility then to prevent the 
distribution of that contaminated food into the marketplace. Am 
I correct?
    Dr. Hamburg. Yes.
    Mr. Buyer. So you are asking for that ability to do a 
recall. Would that be correct?
    Dr. Hamburg. Yes.
    Mr. Buyer. And that once that contaminated food has been 
discovered, do you believe that you should have the ability to 
order the destruction of the contaminated food?
    Dr. Hamburg. It depends on the specific circumstance. 
Sometimes with a contaminated food, it might be possible to 
reprocess it and make it available in a safe way. But it is 
contaminated and putting consumers at risk and such an option 
does not exist, then that food should not be allowed to be 
provided to consumers.
    Mr. Buyer. Since you support a federal tracking system for 
food, would you also be willing to support a electronic 
pedigree system for an interoperable tracking system for 
pharmaceuticals?
    Dr. Hamburg. You know I think that in both realms, it is 
very important to know where things came from----
    Mr. Buyer. Is this yes?
    Dr. Hamburg. --and where they are going.
    Mr. Buyer. Is this a yes?
    Dr. Hamburg. Well, you know, I am reluctant to----
    Mr. Buyer. You are going to choose contaminated lettuce 
over adulterated drugs? I don't think so.
    Dr. Hamburg. No, I am not. I didn't think your question was 
either/or. I thought it was----
    Mr. Buyer. My question is if you are going to support a 
pedigree system for the tracking and tracing of contaminated 
food, don't you also believe that it is important for us to 
have an electronic pedigree for the tracking and tracing of 
pharmaceuticals?
    Dr. Hamburg. In concept, I think, as I said, that 
traceability is very important to assure that what consumers 
get is----
    Mr. Buyer. All right, let me get to this. We have 11 
international mail facilities. Add three other mail facilities, 
DHL, UPS, and FedEx, of which 30,000 to 35,000 pharmaceutical 
packages come into those mail facilities every day. So do the 
math. When you do your inspections about 80 percent of them are 
either adulterated or they are counterfeit knockoffs. Yet FDA 
claims they do not have the ability to destroy.
    So you are sitting here before this committee today saying 
that you know believe that you should have increased ability to 
inspect and to go after this contaminated food. I want to make 
sure that you also believe that you should have the ability to 
destroy these counterfeit, knockoff drugs. Because if you just 
do the math, that has got to be in excess of 350,000 
counterfeit adulterate, knockoff drug packages per day. That is 
millions of packages per year that are harming people. So let 
me go right to you. Do you believe that FDA should have the 
authority, equal authority, to destroy these counterfeit 
adulterated drugs?
    Dr. Hamburg. As I indicated earlier, this is my seventh day 
on the job, and I haven't been briefed in full on all these 
issues. The problem of counterfeit drugs is huge concern, and I 
am eager to work with you since you clearly care very much 
about it.
    Mr. Buyer. All right, you know what is happening right now? 
Here is customs, and right over here is FDA. There is not even 
a wall, yet customs has the ability to destroy. But you claim 
you don't have the ability to destroy. Please don't come before 
this committee and tell our country that you think we ought to 
be able to protect you with regard to food, but with regard to 
drugs, I can't believe as a doctor you would say----
    Dr. Hamburg. And I am not telling you that, sir, but I am--
--
    Mr. Buyer. Well, then be clear.
    Dr. Hamburg. --telling you that these are issues that are 
at the heart of the FDA mission and as a physician, extremely 
important to me. They are issues that I am determined to work 
on, determined to work with members of Congress to find 
appropriate solutions. But I am not comfortable at this time 
discussing the specifics of that program which I haven't been 
fully briefed on.
    Mr. Buyer. All right, ma'am, I will be willing to work with 
you because I can't believe that this would be an issue that 
you would equivocate on. I yield back.
    Mr. Pallone. Gentlewoman from Colorado, Ms. DeGette.
    Ms. DeGette. Thank you very much, Mr. Chairman and Dr. 
Hamburg. I want to add my welcome to that of my colleagues to 
your appointment. I know you are going to be working with this 
committee on a lot of different issues.
    I want to talk to you about the trace back system because 
we have worked very closely over the years and most 
particularly on this latest iteration of the legislation on 
setting forth mandatory characteristics that would be contained 
in the tracing system that the FDA sets up through the 
regulatory process.
    For example, the bill requires that the origin and previous 
distribution history of food must be maintained, and that 
history must be linked with the subsequent distribution history 
of the food. And it also requires--to me this is a really key 
component--that the system be interoperable. So for different 
types of food, they can figure it out.
    Some people question whether it will ever be feasible to 
implement this type of system, and I am wondering if you can 
give your opinion on the feasibility of this type of a trace 
back provision.
    Dr. Hamburg. Well, as you indicated, it is very, very 
important and key to our success in being able to respond 
swiftly to outbreaks and make the appropriate interventions to 
protect the American public. Interoperability is absolutely key 
because it involves a whole range of different players along 
the full life cycle of the product, and that is one of the 
great challenges.
    I think as we move forward in developing and implementing a 
traceability program, we need to work very carefully with 
industry and with the different components of the food 
production system. We need to do it in the context of public 
meetings and open exchange, but that should be our goal 
absolutely.
    Ms. DeGette. And in the draft legislation, that is exactly 
what we do is we give the FDA the authority to work with 
industry and consumer groups to develop both the specific types 
of traceability technology and also the interoperability, 
correct?
    Dr. Hamburg. Yes.
    Ms. DeGette. In other words, we are not saying--different 
sectors of the food industry have different types of 
traceability requirements, and we are not saying that we have a 
one-size-fits-all, correct?
    Dr. Hamburg. Correct.
    Ms. DeGette. Do you think that there is an economic case to 
be made to the industry for better traceability?
    Dr. Hamburg. I think absolutely because with the 
opportunity to really do adequate trace back, we can really 
target what are the components of a food or the specific food 
products that are causing the problem and remove those or put 
in place the interventions to decrease the risk to that 
particular component of the food life cycle. In that way, we 
can both save lives and reduce illness.
    But I think also reduce the cost to companies who, as we 
have heard about this morning, you know, have occasionally been 
inappropriately targeted when the trace back was inadequate and 
we didn't identify the correct product. And also when there is 
a whole industry, but there is only one processor or 
manufacturer that is the problem, then we can protect the rest 
of the industry by really honing in on the particular product 
at risk.
    Ms. DeGette. And once we develop this system, it should 
also make identification and removal of the specific 
contaminated food much more speedy than it has been----
    Dr. Hamburg. Absolutely.
    Ms. DeGette. --which again benefits consumer health, and it 
benefits the economic interests of that sector. Just one last 
question. The draft legislation that we have prepared exempts 
farms that sell directly to consumers or to restaurants from 
the traceability requirements, the farmers markets and so on. 
Do you think that that is an appropriate carveout for them?
    Dr. Hamburg. I think that we have to recognize the burdens 
on smaller businesses, but we also, from a public health point 
of view, have to assure that when there is a problem we can get 
access to the information that is needed to identify the source 
of a contaminated food. So we need to work very closely with--
--
    Ms. DeGette. You know one thing is that these farmers 
markets, for example, they are not broadly distributing their 
food. It is just local. So if someone did get sick, the state 
health department could easily trace it back.
    Dr. Hamburg. It certainly makes it easier to do the 
outbreak investigation.
    Ms. DeGette. Right. Thank you very much.
    Mr. Pallone. Thank you. Gentleman from Illinois is ready?
    Mr. Shimkus. Thank you, Mr. Chairman. Mr. Chairman, can I 
ask you a process question first?
    Mr. Pallone. Sure.
    Mr. Shimkus. Is there a possibility that the subcommittee 
may consider this legislation next week?
    Mr. Pallone. Yes.
    Mr. Shimkus. And if so, I would ask then if members who 
could submit questions for the record by the close of business 
tomorrow, could we have witnesses respond to those questions by 
the close of business Monday?
    Mr. Pallone. Sounds like a good idea to me since we are 
likely to mark up next week. You have no problem with that?
    Dr. Hamburg. I think that is very appropriate approach.
    Mr. Pallone. OK.
    Mr. Shimkus. And we do know----
    Mr. Pallone. Without objection, that is what we will do.
    Mr. Shimkus. We know that is challenging, but, of course, 
this is a draft as I said in the opening statement. So we 
appreciate that. And again we do appreciate your testimony and 
welcome on board and we are all working for really on the same 
team trying to get responsible legislation that protects human 
health while ensuring that fees go to where fees need to go. So 
I just have two.
    One, and this goes back in history. Two decades ago when 
Congress was deliberating on how to improve the state clinical 
laboratory testing--and I have been in the lab tech issue a 
lot--this committee under the leadership of now Chairman 
Emeritus Mr. Dingell, Mr. Waxman, and my own former colleague 
Mr. Madigan issued a conference report stating that proficiency 
testing is considered one of the best measures of laboratory 
performance and arguably the most important measure since it 
reviews actual test results rather than merely gauging the 
potential for good results.
    As we examine the discussion draft and its call for 
accreditation standards for laboratories to perform analytical 
testing on food, in your opinion, should proficiency testing be 
explicitly included here too?
    Dr. Hamburg. I think that we would only want to work with 
accredited labs, and the accreditation process addresses those 
kinds of concerns. The accuracy of the testing is key to making 
the right decisions, and, you know, I think that as we move 
forward, laboratory testing needs to be a strong component of 
what we do. And so efforts to ensure the accuracy of testing 
results is absolutely key to protect businesses and to provide 
the public health system with the information it needs to take 
action on.
    Mr. Shimkus. And I would agree with that. I think that is 
as close to a yes as I will get, and that is fine. But I think 
that is a critical component if we are going to do this, that 
the proficiency test be a process by which we, you know, test 
the tester so we have some certainty.
    Let me go back, and I know we have talked about this $75 
million in the President's budget and $375 million in revenue. 
I mentioned this in my opening statement before some of the 
discussion, and I understand that, you know, this legislation 
offers more authority. And so that is why there may be a 
differing number than what the President proposed.
    But I think a lot of us are going to be challenged by the 
fact--and what would be helpful before we move to markup is, 
you know, show us the money. Show us where we came up with this 
amount. As I have said also, there has already been millions of 
dollars put into food safety over the past six months.
    A lot of us are trying to understand where $375 million 
came out. We understand that there was $1,000 per facility, and 
you add up the facilities, you get $375 million. But that 
doesn't answer the question as to where is that money? Is that 
money going to go to an inspection regime? And what does it 
cost to do an inspection regime?
    I have been really a strong spokesperson for a risk-based 
system. Now, the risk-based system promoted in this draft 
legislation in nowhere near what I believe a risk-based system 
should be. I think you should go after risky individuals. And 
facilities that in essence offer no risk, you ought to 
incentivize them, and this has been statements that I have made 
for a long time. So I think even this risk-based approach that 
we are saying can be modified somewhat.
    So is there a way to get up a better handle, or do you have 
better numbers that support this discussion draft that $375 
million actually means $374 million more dollars worth of 
ability to inspect?
    Dr. Hamburg. Well, regrettably, I don't believe that the 
$375 million will cover the costs of inspecting on the schedule 
outlined in the bill. We actually would need considerably more 
resources to do that. We know, you know, based on--estimates 
vary, but that domestic inspections cost a little over $9,000. 
International inspections are probably threefold higher, and 
the number of facilities requiring inspection are very, very 
large, numbering in the hundreds of thousands. The numbers add 
up quickly.
    Mr. Shimkus. And my time has expired, and I apologize. I 
would just say that there is going to be skeptics that say oK, 
we have $375 million on a fee schedule, and it is not going to 
go for inspection.
    Dr. Hamburg. It will go for inspection.
    Mr. Shimkus. It will go to other aspects of the FDA, and it 
would help provide some clarity. And, Mr. Chairman, if I could 
just end on this because the chairman emeritus mentioned this 
once again that there has been negotiation with his Republican 
colleagues. I would call them information positions of the 
answer of no. Not really negotiations on addresses of the bill, 
and I would encourage, maybe this is going to be a member-
member discussion. But if we want a bipartisan bill, we ought 
to have some just not dictates, this is what we are going to 
do, but this is where we need to work together. And I yield 
back my time.
    Mr. Pallone. Thank you. Let me just reiterate again what 
Mr. Shimkus suggested in terms of the questions. We are going 
to ask the witnesses, including you in the next panel, and I 
will not remind the next panel that they submit their 
questions--the members submit question by the end of tomorrow 
night, which would be Thursday night and that we have responses 
by the end of business day on Monday, oK. I will mention that 
again. I mean I don't know. It may be difficult to meet that 
schedule.
    Mr. Shimkus. Yes, would the chairman yield? And we 
understand that is a lot to ask, but for us to move, I think 
it----
    Mr. Pallone. Yes, that is fine and----
    Dr. Hamburg. No, we are happy to comply with that. We 
appreciate that you are taking this----
    Mr. Pallone. OK.
    Dr. Hamburg. --so seriously and wanting to move it forward 
swiftly.
    Mr. Pallone. All right, thank you. Gentlewoman from 
California, Ms. Harman.
    Ms. Harman. Thank you, Mr. Chairman. I have sat here for a 
few hours listening to this hearing, and I think the content is 
very important. And I do think this committee has developed an 
enormous record on this subject. This is not new information 
for members of this committee, and I do think we will be able 
to move legislation next week. And I hope it will be 
bipartisan, and I agree with Mr. Shimkus that there should be 
opportunity for the other side to participate.
    I wanted to acknowledge a comment that Mr. Buyer made 
before he left the hearing room. He was in some fashion 
implying that Dr. Hamburg is not focused on drug safety. My 
response to that is of course she is. She has been here for 10 
minutes and the first topic up is food safety, so let us give 
her and this committee time to focus on that subject in the 
near future and not be accusing each other in some way of 
perhaps inadequate attention.
    On the subject of food safety, which is what we are talking 
about, there is a section in the legislation about testing by 
accredited labs. Last year, I recall a huge worry about whether 
the prior administration was going to cut back on the number of 
accredited labs and the impact that that would have on major 
ports of entry like the ports of Los Angeles and Long Beach. My 
district happens to be there. That are the place where enormous 
amounts of imported food enter the country.
    So I just want to give you a chance, Dr. Hamburg, not in 
terms of a yes-and-no answer session, but could you assure us 
that lab capacity is a priority of yours and assure us that 
there will be adequate lab capacity for the anticipated 
importation of food and for the standards in this legislation 
to work?
    Dr. Hamburg. Absolutely. Laboratory testing is an essential 
component of a strong, science-based food safety system. And we 
do not have any plans to restrict our laboratory capacity. And 
I think, you know, as we move forward, we will want to make 
sure that we are applying the best possible science, including 
laboratory science, to our testing and screening activities. I 
hope that there will be advances in laboratory science and 
technology that will enable us to do our inspections in a more 
efficient and cost-effective way. But it is a pillar of what we 
do, and we will continue to support it. And we may, as 
resources become available and needs suggest, actually expand 
our capacity.
    Ms. Harman. Well, I appreciate that, and I am not 
suggesting that our current lab structure be frozen in time. 
Obviously if there are improvements either in location or in 
function, we ought to embrace that.
    But another one of the concerns that has been expressed is 
the ability to get the results from the lab to the FDA in a 
timely manner. Do you think the current system is adequate in 
that respect, and are you thinking about improvements to that?
    Dr. Hamburg. Well, we are eager to implement a system for 
reportable foods that will include laboratories reporting 
positive tests to FDA, and I think that will be a very 
important additional element to our activities.
    Ms. Harman. Good. Well, I appreciate that too. Obviously in 
light of some of the recent outbreaks and their devastating 
impact on human life and health, it is important to get that 
information out and accurate as soon as possible.
    Mr. Chairman, I don't have further questions of the 
witness. I am just thrilled that she is here. I yield back.
    Mr. Pallone. Thank you. Gentlewoman from the Virgin 
Islands, Ms. Christensen.
    Ms. Christensen. Thank you, Mr. Chairman, and I think your 
time is almost up. Thank you for your patience with all of the 
questions and listening to all of our opening statements.
    In your testimony, you reference Section 106 that provides 
the more explicit authority for FDA to access food records 
during inspections. Do you think that that is enough, or should 
we go further in the legislation to mandate that those records 
be forwarded to FDA?
    Dr. Hamburg. You know I think what is outlined in the 
legislation is certainly a very good starting point. We don't 
want to be inundated with information. We don't want to put too 
much of a burden on industry, but we do need that access to 
records. We need companies to keep appropriate records, and we 
need to be able to have it to be able to inform our routine 
inspectional activities, to be able to work with the companies 
to make sure that they have adequate preventive controls in 
place. And we need it certainly in the event of a serious 
outbreak of public health concern to enable us to swiftly get 
the information we need for action.
    Ms. Christensen. So you think that requiring them to have 
their plans and to have their plans audited in conjunction with 
your authority to have access to the records should be 
sufficient?
    Dr. Hamburg. You know I think we would want this to be a 
dynamic process as we learn more, putting in place the programs 
and policies and then learning from experience. But I think the 
bill lays out a very sensible and doable approach.
    Ms. Christensen. OK, and you also talk about the huge task 
of hiring and training inspectors. And if I understand 
correctly, you are asking for some more flexibility in the 
legislation to be able to do that. Are you asking for general 
flexibility, or would a transitional timetable with times 
certain in the legislation work just as well?
    Dr. Hamburg. Well, I think we just have to recognize that 
this would be an enormous scale-up of activity and that we need 
the timeframe to enable us to do it right, to recruit the 
people and train the people to work with industry to develop 
the systems that work. So we like flexibility in that way, and 
we would like more general flexibility so that we can learn as 
we go in terms of the inspection schedule and some of the 
requirements in that regard.
    Ms. Christensen. OK, my last question is kind of a general 
one. I don't think it was asked before, but even as late as 
yesterday, someone asked the secretary the question about one 
single entity to secure food safety with the authority over the 
food safety program for the country.
    I don't think the secretary supported it. I am sure you 
don't support it, but what can you say about, if you have had a 
chance to look at how FDA and USDA work together or don't work 
as well together as they should? What can you say about 
addressing the concerns that give rise to the legislation that 
would put it in a single entity?
    Dr. Hamburg. Well, a couple of responses to your important 
question. One is that clearly as the new FDA commissioner, I 
have a first and urgent priority to strengthen food safety 
within the FDA and I think that there are many things that we 
can do to strengthen our program to improve accountability, to 
raise the issue as high priority. Part of strengthening food 
safety within FDA is strengthening coordination with critical 
partners as well, and that certainly means with USDA, and I 
look forward to a working relationship with them.
    It also means strengthening the working partnerships with 
state and local public health organizations, and it very 
importantly also involves working with other international 
agencies and foreign governments because I think we are going 
to see the percentage of food coming in from overseas 
increasing in the years to come. And the globalization has a 
profound impact on the work of the FDA.
    And I also do think that the authorities and tools that 
this new draft legislation could potentially provide to the FDA 
will be extremely important in moving the federal government 
and the FDA in the direction that we need to for robust and 
modernized food safety system.
    Ms. Christensen. Thank you for your answers. Thank you, Mr. 
Chairman.
    Mr. Pallone. Thank you. Gentlewoman from Ohio, Ms. Sutton.
    Ms. Sutton. Thank you, Mr. Chairman, and thank you very 
much, Dr. Hamburg, for your service and for all that I am 
confident you are going to do to improve food safety in this 
country.
    As I mentioned in my opening statement, Ohio has been hit 
hard by issues arising from food safety. In the past year, 
there have been 105 cases of salmonella reported in Ohio and 
sadly three deaths resulting from the most recent peanut-based 
strain.
    Nellie Napier was a constituent of mine who unfortunately 
died from salmonella poisoning that she contracted in a nursing 
facility, and just in April of this year, in Cuyahoga County 
there were three incidences of illness from E.coli and another 
death, this time a seven-year-old girl. So this is an urgent 
issue for the people tht I am so honored to represent.
    I mentioned that I introduced the Protect Consumers Act, 
which was a bill that would give the FDA mandatory recall 
authority, and I am happy to see that it is a part of this 
comprehensive bill. And I would just like to get a little bit 
more of your opinion about the need for recall authority. And 
this bill, of course, seeks to remedy the situation of the FDA 
not having the mandatory recall authority by laying out two 
different types of recall authorities.
    First if the FDA believes that a certain food may cause 
adverse health consequences or death, the FDA can require a 
recall. But in that scenario, FDA must first give the company 
an opportunity to voluntarily recall its own products. And if 
that doesn't work, then the FDA can order a mandatory recall.
    And then, of course, the second type of recall is an 
emergency recall if the FDA finds that a certain food presents 
a threat of serious adverse health consequences or death. You 
may do that immediately.
    Can you just tell me about whether you think that the need 
and the approach, the two-tiered approach, is addressed in a 
good way in this bill and why it makes sense?
    Dr. Hamburg. Well, I think the history is that voluntary 
recall is often effective in getting those potentially harmful 
products off the shelves and protecting consumers but that you 
do need that emergency mandatory recall function as a backup. 
There certainly have been cases where the mandatory recall of a 
dangerous product has been delayed because of a reluctance on 
the part of the company to pull that product, and there has 
been a back-and-forth and lawyers involved and delays of weeks, 
putting consumers at risk.
    So I think that to have the mandatory recall as a emergency 
measure is very, very important. And sadly in a world where we 
might also need to address intentional contamination of food, 
that emergency mandatory recall becomes a very, very important 
tool. You know I think the reality is that having that as an 
enforcement tool probably makes it easier to also work with 
companies on the voluntary recall.
    So I think it is a continuum that we need. We need both.
    Mr. Shimkus. Will the gentlelady yield just on this same 
point, just a follow up on this?
    Ms. Sutton. I have very little time, but I will yield.
    Mr. Shimkus. Yes, just to follow up. One of the issues 
would be may cause. That is kind of a low standard. I think 
there is going to be concern about the may cause language in 
here and how do you define that.
    Dr. Hamburg. Yes, well we discussed that earlier, and I 
think perhaps there is some wordsmithing that could be done on 
that point.
    Mr. Shimkus. Thank you. I thank my colleague.
    Ms. Sutton. Sure, and if I could just follow up on the 
suggestion that has been made and some have argued that because 
mandatory recall is such a strong tool that only the 
commissioner should be able to exercise the authority to order 
a recall with no further delegation. And I just wanted to know 
about your thoughts on the approach of having only the 
commissioner order a recall and how that would work for the 
FDA. And frankly, while I am at it, would such an approach work 
with regard to suspensions and subpoenas, and what are your 
thoughts about those subjects?
    Dr. Hamburg. Well, these are important and powerful 
authorities that shouldn't be used lightly. However, I think 
that experience shows that senior level officials can be 
entrusted with these authorities along with the commissioner, 
but it is certainly something that we would want to work with 
Congress on in order to put in place the system that people 
have the most confidence in.
    Ms. Sutton. I thank you, and I am certain that we share 
concerns about expediency and making sure things happen in a 
quick time. And I think that your answer on the way that the 
recall authority would work, you having the mandatory authority 
would give you an opportunity to encourage even more strongly--
or they would be necessarily encouraged, the companies, to 
comply on their own as well. So thank you very much.
    Mr. Pallone. Thank you. Mr. Green.
    Mr. Green. Thank you, Mr. Chairman, and again, Dr. Hamburg, 
appreciate your patience today in--but if you think this is 
tough, you have FDA to work on, which is--and I laugh because 
in '07 we spent a great deal of our time, both in the 
subcommittee and the full committee, in reforming FDA. And then 
last year with all the food safety issues that came up, it 
seemed like we are back at it again, and I am glad you are 
there.
    In my opening statement, I mentioned my concerns about the 
location and number of FDA labs, and I know my colleague from 
southern California, Congressman Harman, mentioned the same 
thing. Texas does have the longest running border with Mexico, 
and the port of Houston is right behind the port of LA/Long 
Beach in imported tons of food, yet we don't have an FDA lab. 
And I have had the honor of meeting my FDA inspectors on the 
docks of the port of Houston, but they are detailed out of 
Laredo, Texas.
    And I guess because it is such a large state and the need 
for a lab somewhere, I am glad the bill does include the 
ability to contract with labs because we want the inspections 
done as quick as possible. Does the FDA tend to evaluate the 
current locations of the 13 labs and whether these locations 
are meeting the inspections demands? But also in the 
President's budget, talks about three high-volume FDA labs, and 
how would the FDA decide where to place these labs? And what 
consideration would be placing in a place like Texas or even 
southern California? I didn't know southern California didn't 
have a lab with LA/Long Beach. And that is my only question. So 
thank you, Mr. Chairman.
    Dr. Hamburg. Well, you know, I am fascinated that the 
laboratory issue comes up so much here because it is such a key 
issue. And in my past experience as a public health official, 
it is often the laboratory that is the underappreciated 
component of public health needs. So this is very encouraging 
to me.
    At the present time, we don't have any plans to expand that 
basic, you know, network----
    Mr. Green. Thirteen labs.
    Dr. Hamburg. --of laboratories that you mentioned. 
Although, as I said to Congresswoman Harman, you know, with 
additional resources and expanding need, that might be a 
possibility. We will be creating some additional high 
throughput laboratories. And in all honesty, I am not certain 
about the process by which those laboratories are being 
developed and cited. It is something I need to go back as a 
very new FDA commissioner and learn more about. But the 
laboratory issue is one that is essential as we have discussed.
    Mr. Green. I guess the reason it comes up so often is it, 
over the last three years actually, our committee has spent so 
much time on, you know, pharmaceutical safety, food safety, and 
the concern is that we are importing so much of our food. Like 
I said, Laredo, Texas is probably the biggest land-based port 
in the world. And so much food comes from Mexico we need the 
inspections as timely as possible to move the produce or 
whatever the products, the foodstuffs particularly. But we also 
need to make sure that it is--and the problem is it is not paid 
for. But with this fee that is going to be assessed, hopefully 
that will generate the resources, both for the personnel and 
also for the facilities.
    And I guess if you are having to contract with private 
labs, that may be great, but there are times that a public lab 
would be faster and ultimately cheaper to the folks who pay the 
bills. And so that is why I just ask FDA to look at that. I am 
glad we are going to contract because we want the commerce to 
flow. But if there is a need to have a lab that would be more 
economical and just as fast to contract with the private labs, 
then I would hope this funding source--I guess over the last 
three years, our hearings have said FDA is--the staff, we don't 
have the staff, we don't have the resources. Well, we are going 
to try to give you the resources in this bill and hopefully to 
hire the staff and to have the facilities.
    Dr. Hamburg. And let me just assure you that your 
constituents are not being compromised in terms of the 
laboratory testing that is needed to protect their food supply 
because samples can be shipped to labs. In the modern era, it 
can be done in a timely and safe way. So the coverage in terms 
of laboratory testing is still available, but I hear and 
understand your concern about the gap in terms of an onsite 
facility in your region.
    Mr. Green. Well, and I think the fear that some of us had 
is that we don't want to play favorites. These ports compete 
for cargo, and we don't want it to be based on that there is 
not an FDA lab or it is slower to get this through one port as 
compared to the other port. And I know I have run out of time 
but appreciate the responsibility you are taking on. And 
hopefully we will provide you with the tools that you need. 
Thank you, Mr. Chairman.
    Mr. Pallone. Thank you, Mr. Green. Mr. Stupak.
    Mr. Stupak. Thank you, Mr. Chairman, and thank you, 
Commissioner, for being here. As chair of Oversight and 
Investigations and one of the authors of the Food Safety 
Enhancement Act, I have done about nine hearings in the last 
two years just on food safety and certainly is a major problem. 
One of the problems I found every time we had a hearing, there 
is always lack of information that the FDA did not have from 
either the manufacturer of the food or the producer of that 
food. And it was always difficult to get information.
    In the Safety Enhancement Act authorizes the FDA to issue 
subpoenas for records and other things relevant to any hearing 
investigation or proceeding or relative to any other matter 
within the FDA's jurisdiction, including matters under the 
Public Health Service Act and the Federal Anti-Tampering Act.
    Do you believe subpoena power would be beneficial to the 
FDA?
    Dr. Hamburg. It is very important for us to get access in a 
timely way to the information that we need, and I think that 
that authority will enable us to act more swiftly and 
effectively, yes.
    Mr. Stupak. Well, I hope you would because I think we are 
still waiting for information from the 2007 salmonella outbreak 
and peanut butter and from the Georgia plant, Blakely, Georgia. 
I don't think we got all that information yet.
    Some in the food industry though appear to be concerned 
that the FDA will abuse its subpoena power. Their concerns 
center around the subpoena provision that authorizes the FDA to 
issue subpoenas in matters under FDA's jurisdiction that are 
not part of a particular hearing or investigation of a specific 
violation of the act.
    There seems to be a fear that FDA will go on fishing 
expeditions, constantly sending out burdensome unnecessary 
requests for documents. How would you address these concerns?
    Dr. Hamburg. Well, I think that we have enough work to do 
without going on fishing expeditions. We would be seeking 
information that would be of vital importance to addressing the 
tasks at hand. It would be of great value to have the ability 
to access critical information, to inform the inspection 
process as well as to inform outbreak investigations. And I 
think that if we are going to be able to really move forward to 
ensure the safety of the food supply, this is one of a number 
of tools that will enable us to really do what needs to be 
done.
    Mr. Stupak. That is refreshing to hear because I have been 
pushing subpoena power for the FDA for 10 years, and get a 
witness to agree from the FDA. But by the time I got back to my 
office, the FDA had called me and say that is not the official 
position of the FDA. We are against subpoenas. So it is 
refreshing to hear that, and I am sure you won't use it for a 
fishing expedition.
    Let me ask you this. Chairman Waxman and I wrote to you to 
review this phenyl A BPA. While previous FDA commissioner found 
no problem with it, FDA's own science review found says there 
was room for concern. And we wrote to you, and you wrote back 
indicating that you have agreed to review the safety of BPA. So 
let me just say thank you on that point.
    I think it is important that we look at all the documents 
and all the evidence and all the studies, not just two studies 
when there are over 100 other studies that raise concern on 
this phenyl A.
    Also on food safety, on the lab situation, it has been my 
concern the last FDA commissioner thought food safety was to 
close six or seven of the 13 field labs, which I thought was 
the wrong idea. So we have always fought reorganization or 
closing of these labs. And we actually had to put in 
legislation to make sure these field people, critical work for 
the FDA and for the safety of the American people, stay on 
their jobs.
    And you recently wrote back to me, myself and Chairman 
Waxman, indicating that there are no current or future plans to 
close or consolidate any of these 13 field laboratories. And 
you also went on and said that you are actually hoping you will 
be able to hire at least 70 new analysts for the 13 labs to 
replace staff losses over the last few fiscal years. So thank 
you for that, and without objection, I would like to place the 
record from the commissioner in the record, this letter in the 
record.
    Mr. Pallone. Without objection, so ordered.
    [The information appears at the conclusion of the 
hearing.]*************** COMMITTEE INSERT ***************
    Mr. Stupak. Let me ask you one more question if I may. 
Risk-based inspection schedule. One of the important new 
requirements in the new food safety bill will be to put in 
place is a risk-based inspection schedule for food facilities. 
Under current law, even risky facilities can go years between 
FDA inspections, but our legislation has strict requirements to 
make sure FDA inspectors actually get into the riskiest 
facilities as frequently as possible. The riskiest facilities 
must be inspected at least every 6 to 18 months. No food 
production or storage facility will go more than four years 
between inspections.
    Under current law, there is not any requirement regarding 
how frequently these facilities must be inspected, is there?
    Dr. Hamburg. There is not, and I think that your desire to 
see a risk-based strategy be put in place is absolutely key so 
that we can target resources on the highest risk.
    Mr. Stupak. Does this bill give you the flexibility you 
need to modify the inspection goals based on available 
resources and the best available evidence on risk?
    Dr. Hamburg. Well, as I said in my testimony, I am 
concerned about the requirements for inspection outstripping 
available resources, and that has been a chronic problem for 
the FDA in terms of being able to fulfill its important 
mission.
    I think that the inspectional strategy outlined in the 
draft legislation is a wonderful aspirational goal. I would 
love to be able to sit here and say that FDA could take it on 
and fully achieve it, but there is a reality of limited 
resources, both dollar and human. And I think that is where we 
need some flexibility to really look at the numbers and really 
also begin to move swiftly in the direction outlined in this 
bill but also try to learn as we go so that we can find ways to 
do our inspections in a more efficient targeted way and really 
focus on the highest risk and really try to leverage other 
resources to achieve the goals as well through partnership with 
state and locals, partnership with foreign governments and 
potentially with third parties that are certified and overseen 
by the FDA to help us particularly with respect to the 
burgeoning number of foreign sites for inspection.
    Mr. Stupak. Well, the----
    Mr. Pallone. I am sorry, Mr. Stupak, but we are----
    Mr. Stupak. I just want to mention about the registration 
fee for----
    Mr. Pallone. I am sorry. No more questions though. We are 
done with questions. Go ahead. You had a comment?
    Mr. Stupak. Yes, I was just going to say hopefully the 
registration fee that we would be putting in place with up to 
400,000 facilities would provide enough resources to do the 
inspection and other work that the FDA sorely needs to the 
resources and the personnel to do it. We understand that. 
Hopefully that will be part of the bill.
    And thank you, Mr. Chairman, and thanks for your help on 
this bill.
    Mr. Pallone. Thank you. Mr. Deal.
    Mr. Deal. Yield briefly to Mr. Shimkus for a follow up.
    Mr. Shimkus. And I thank my ranking member, and I am glad 
my colleagues here because I want to follow up on this 
wordsmithing that we talked about on the may cause. That is why 
we still have the same problem on the subpoena power issue 
because in the subsection three, it says ``any other matter 
relative to the commissioner's jurisdiction under this act.'' I 
would like there to be a ``may cause.''
    I have a problem with the ``may cause'' in the other part 
of the bill or the draft. We should at least have a ``may 
cause'' for offering a subpoena to someone. And so I would hope 
that that would be something else we would look at. So I think 
there is some issues.
    We want subpoena power, but we want it for a reason. We 
just don't want it to be at the whim, with all due respect, Dr. 
Hamburg. And I will yield back to the ranking member.
    Mr. Deal. Let me ask you a question with regard to another 
area, and that is the registration and fees collected from 
commercial importers, and there has been a change in this draft 
from previous drafts that we have seen. Specifically, why 
should drug and device manufacturers who currently already pay 
an annual establishment fee be required to pay a duplicative 
fee? And what entities are really encompassed within this 
commercial importation fee schedule?
    Dr. Hamburg. Well, the importer fee refers to fees on the 
individuals or the companies that are serving as the link 
between foods that are grown, processed, manufactured overseas 
and being brought into the United States to be distributed to 
consumers here. And so they are not necessarily representing a 
given manufacturer, but it is a very important function because 
it is that bridge between what is happening on the 
international scene and what is coming into this country for 
use.
    Mr. Deal. Specifically with regard to the drug and device 
manufacturers who currently already register and already pay a 
fee, would you envision that they are going to have to pay an 
additional registration fee in addition to what FDA already 
collects from? And if so, why?
    Dr. Hamburg. In terms of the importer function, I need to 
go back and look at this issue with respect to devices because 
I don't know how that system is set up, whether it is the 
manufacturer that is serving in that role or not. So I will go 
back and learn more about that.
    Mr. Deal. Would you take a look at that? I think that is 
one that we really seriously need to look at. I don't think we 
ought to be duplicating what you are already doing because you 
have jurisdiction there. I think that would be unfair.
    Let me ask you also quickly with regard to the tracing of 
food, the tracing system that is put in place for you to issue 
regulations. It appears that that would include the restaurants 
to be able to have traceability, and I am told that 7 out of 
every 10 eating establishments are not part of chain 
operations. They are just independent, separate food 
operations. I am just curious as to whether or not you think 
that this would have a serious impact on these small business 
owners. And do you think we ought to do a cost/benefit analysis 
before we impose that kind of cost on these individuals?
    Dr. Hamburg. Well, I think clearly we want to work with 
restaurant owners and small businesses in order to make sure 
that the systems are not too cumbersome, but it is very 
important that they keep records because if there is a tainted 
food that is in their facility, the implications for the health 
of their business as well as for the health of their consumers 
is very significant indeed. And I think that they would want to 
be able to assist in sharing their information about where the 
foods came from so that the traceback can occur and we can 
identify the source of an outbreak and control it.
    So I think they are a very important link in the food 
supply chain and, you know, protecting health really depends on 
them keeping records.
    Mr. Deal. Let me ask you what has FDA done to implement the 
current, what I think is called the one-up-one-back 
traceability requirements? What has been done to implement 
that?
    Dr. Hamburg. Well, the one-up-one-back has been in place, 
as I understand it, for a while now. But it has proven not to 
be adequate to really capture the full lifecycle of a product 
and that we really need, as we mentioned earlier, the full 
supply chain to be documented and integrated. Interoperability, 
not just fragments, you know, is really key to a successful and 
swift investigation of outbreaks and the ability to control a 
problem and prevent future exposures to a contaminated food 
product.
    Mr. Pallone. Thank you. Just the way we are proceeding, Mr. 
Markey is going to go now, and he is our last----
    Dr. Hamburg. OK.
    Mr. Pallone. --questioner for you, Dr. Hamburg. We have one 
vote, but we will be right back after that. And then we will 
start with the second panel. So, Mr. Markey.
    Mr. Markey. Thank you, Mr. Chairman, very much. 
Congratulations, Dr. Hamburg.
    Dr. Hamburg. Thank you.
    Mr. Markey. You may know that I have a bill that calls for 
BPA to be banned from being used in food and beverage 
containers because of the risks that have been identified. We 
have also recently learned the food and chemical industries 
have launched a public relations campaign opposing any efforts 
to deal with this issue.
    Is the FDA concerned about BPA? And what does the FDA plan 
to do about those concerns?
    Dr. Hamburg. Well, we are concerned. Certainly I am aware 
of, you know, some of the studies that have raised issues in 
animal populations and some of the information about BPA. In 
many components of the food supply, we are starting to see 
activities at the local and the state level in terms of action 
with respect to BPA. And I would hope that FDA could really be 
providing leadership on some of these issues of assessing and 
analyzing risk.
    We are taking another look at the BPA issue. The acting 
chief scientist at the FDA has been asked to take the lead on 
this because, of course, this is a decision where we have to 
bring the best available scientific data to bear. We need to 
look at all of the studies and examine them. But it is an issue 
of great consequence for Americans. As a mother as well as a 
physician, it is an issue that I think we need to look at 
seriously.
    And I look forward to being able to come back with some 
report from this serious look that is being taken. And we 
expect that it is going to be task for him over the summer to 
lead this review, and by the end of the summer, beginning of 
fall, we hope to be able to put forward a fresh look at the BPA 
issue.
    Mr. Markey. Do you have any advice for parents who are 
concerned about their children ingesting this chemical?
    Dr. Hamburg. Well, I think of course parents that are 
concerned can find alternatives that don't have BPA, and I 
think that for the most part, I think that those alternatives 
are pretty clearly labeled and pretty available. And I think 
anyone with concerns, you know, should do so.
    Mr. Markey. OK, thank you for your work on this. If you 
could keep us posted on the progress you are making on----
    Dr. Hamburg. Absolutely.
    Mr. Markey. --the evaluation of it. Thank you so much. 
Thank you, Mr. Chairman.
    Mr. Pallone. Thank you, and thank you very much, Dr. 
Hamburg. As we have said, you know, we do intend to move 
forward on this bill next week, and we appreciate your input 
and whatever else comments you may give us by next Monday. We 
have one vote. We will come back, and then we will hear from 
our second panel. Thank you.
    Dr. Hamburg. Thank you. Thank you for your leadership on 
this important issue.
    [Recess.]
    Mr. Pallone. The subcommittee will reconvene, and I see our 
second panel is already seated. Let me introduce each of you. 
On my left is Mr. Michael Ambrosio, who is representing the 
Food Marketing Institute, and he is the vice president for 
Quality Assurance Division at Wakefern Food Corporation. Next 
we have Ms. Pamela G. Bailey, who is president and chief 
executive officer of the Grocery Manufacturers Association. And 
then we have Ms. Caroline Smith DeWaal, who is the Safe Food 
Coalition food safety director of the Center for Science in the 
Public Interest. Dr. Tim F. Jones, who is a state 
epidemiologist from the Tennessee Department of Health. And 
last is Mr. Thomas E. Stenzel who is president and CEO of 
United Fresh Produce Association.
    Welcome. You know it is five minutes, and obviously your 
statements become part of the record if you want to include 
material more than the five minutes. And we all heard before--I 
know some of you are wondering if you can meet the deadline, 
but since we do intend to go to markup next week, I agreed with 
what Mr. Shimkus said about we will give you any additional 
written questions by the end of business tomorrow, and we would 
like them back by Monday at the end of business.
    So we will start with Mike Ambrosio. Thank you for being 
here again.

STATEMENTS OF MICHAEL AMBROSIO, FOOD MARKETING INSTITUTE, VICE 
     PRESIDENT, QUALITY ASSURANCE DIVISION, WAKEFERN FOOD 
 CORPORATION; PAMELA G. BAILEY, PRESIDENT AND CHIEF EXECUTIVE 
  OFFICER, GROCERY MANUFACTURERS ASSOCIATION; CAROLINE SMITH 
 DEWAAL, SAFE FOOD COALITION, FOOD SAFETY DIRECTOR, CENTER FOR 
      SCIENCE IN THE PUBLIC INTEREST; TIM F. JONES, STATE 
 EPIDEMIOLOGIST, TENNESSEE DEPARTMENT OF HEALTH; AND THOMAS E. 
  STENZEL, PRESIDENT AND CEO, UNITED FRESH PRODUCE ASSOCIATION

                 STATEMENT OF MICHAEL AMBROSIO

    Mr. Ambrosio. Thank you. Chairman Pallone, Ranking Member 
Deal, and members of the Health Subcommittee, I am honored to 
appear before you today on behalf of the Food Marketing 
Institute to present our views and suggestions on the Food 
Safety Enhancement Act Discussion Draft.
    FMI and its member company share the common goal of 
enacting legislation this year that would genuinely improve the 
safety of the food supply. Steps that actually prevent the 
presence of adulterance in the food supply are the only true 
way to improve the safety of our food.
    I am Mike Ambrosio, vice president of quality assurance, 
Wakefern Food Corporation. I have been in charge of food safety 
programs at Wakefern for 30 years. Founded in 1946, Wakefern 
has grown from a small struggling cooperative into the Nation's 
largest retailer-owned, non-farm cooperative in the United 
States. We are headquartered in Keasbey, New Jersey. Wakefern, 
along with its Shop Rite Stores, employs over 47,000 
individuals in New Jersey, New York, Pennsylvania, Delaware, 
Connecticut, Massachusetts, Rhode Island, and Maryland.
    Today I am also representing FMI, a national trade 
association that has 1,500 member companies made up of food 
retailers and wholesalers in the United States and around the 
world.
    FMI members operate approximately 26,000 retail food stores 
with combined annual sales of roughly $400 billion representing 
three-quarters of all retain food store sales in the United 
States. FMI's retail membership is composed of national and 
regional chains as well as independent grocery stores.
    This morning I will present several of FMI's 
recommendations for revising the bill, but I ask that my entire 
statement be included in the record.
    In April of 2008, I testified before this subcommittee on 
legislation that would have modernized and overhauled the food 
safety systems at the Food and Drug Administration. Since that 
time, high-profile food safety outbreaks and recalls involving 
tomatoes, jalapenos, peanuts, and pistachios have not only made 
headlines but regrettably have caused illness and in some cases 
even death.
    Many of the themes and ideas that I share today will be 
similar to those that I shared in 2008, but there are 
differences that reflect lessons learned and new weaknesses in 
the existing food safety system identified from these latest 
recalls.
    As the purchasing agent for the consumer and the final link 
in the supply chain, our industry understands that it is vital 
to ensure that the FDA has the necessary authority, 
credibility, and resources to meet the challenges of today's 
global marketplace.
    Consumer confidence remains an essential factor in this 
debate. Food safety issues can be extremely complex and 
consumer vary greatly in their knowledge of the science and 
other issues affecting the safety of our food supply. However 
as food safety issues draw national headlines, consumer 
awareness has a well concern about the safety of commercially 
prepared food and products purchased at the supermarket 
heightens.
    Mr. Chairman, I applaud you, Mr. Dingell, Chairman Waxman, 
and all members of the committee for your efforts to address 
changes that are needed to improve our food safety system. We 
support many of the proposals in the draft by emphasizing the 
need to have preventative measures be the foundation on which 
the food safety system should be built. The draft also 
recognizes that we need to focus on the majority of resources 
on facilities and products that pose the greatest risk of 
contamination that could result in food borne illness or 
injury. We must continue to be sure that any changes meet 
certain criteria, be supported by science, have measurable 
benefits, be affordable, be realistic and be implemented 
without unintended consequences.
    First we applaud you for not only designating an entire 
section of the bill solely to prevention, but also putting this 
first in the most extensive section of the bill. From our 
perspective, this is the appropriate emphasis.
    In addition, I would like to specifically comment on 
certain sections of the draft. FMI recognizes that a strong 
public/private partnership is needed to help ensure safety of 
the food supply. Although every penny counts in this tough 
economic times, there is nothing more important than improving 
and ensuring the safety of our food supply. We are willing to 
support a fair registration or user fee provided that it is 
utilized by the FDA in a transparent and accountable manner to 
improve the safety of our food supply through means such as 
conducting research and consumer education programs.
    We look forward to working with the committee to address 
our concerns about how the FDA may utilize any fees collected. 
We support the requirement that every registered food facility 
conduct a risk assessment and implement and maintain a 
validated food safety plan and identify potential resources of 
contamination and appropriate food safety controls and document 
those controls that would prevent, eliminate, and reduce 
potential hazards.
    Adherence to food safety plans goes a long towards 
developing a culture within a company that is critical to 
ensuring food safety. Mr. Chairman, thank you for the 
opportunity to testify. We appreciate the work that has gone 
into the development of the Food Safety Enhancement Act 
discussion draft with the goal of improving food safety and the 
food supply and helping to restore consumer confidence in the 
food safety system. I look forward to your questions and remain 
available to the subcommittee. Thank you.
    [The prepared statement of Mr. Ambrosio 
follows:]*************** INSERT 2 ***************
    Mr. Pallone. Thank you. Ms. Bailey.

                   STATEMENT OF PAMELA BAILEY

    Ms. Bailey. Thank you, Mr. Chairman. Good afternoon.
    Mr. Pallone. I don't know if that is on, the mike. You 
don't have a mike.
    Ms. Bailey. Thank you. I am Pam Bailey, and I am president 
and CEO of the Grocery Manufacturers Association which 
represents more than 300 food, beverage, and consumer products 
companies.
    Americans enjoy one of the safest food supplies in the 
world, but we recognize that steps can and must be taken to 
make our food supplies even safer. We applaud Chairman Waxman, 
Chairman Emeritus Dingell, Chairman Stupak, and Chairman 
Pallone for developing the discussion draft of the Food Safety 
Enhancement Act of 2009.
    Product safety is the foundation of consumer trust. We look 
forward to working with the committee to quickly enact food 
safety reforms that will restore consumer confidence and will 
continually improve the safety of our food supply.
    Although the food industry is ultimately responsible for 
the safety of our products, strong government oversight is a 
critical part of our foods safety system. That is why GMA 
supports much in the discussion draft, including your proposal 
to set safety standards for fruit and vegetables, your 
proposals to improve the safety of imported food and food 
ingredients and your proposals to give FDA strong enforcement 
powers to deal with bad actors, including mandatory recall 
authority.
    In particular, we strongly support proposals to require all 
food manufacturers to conduct a hazard analysis to identify 
potential sources of contamination, identify appropriate 
preventive controls and to document those preventive controls 
in a food safety plan.
    We believe that food safety plans are the cornerstone of 
prevention and that they will help ensure that safety is built 
in from the very beginning. We have proposed certain 
modifications to some of these provisions to your staff, and we 
look forward to working with you.
    In particular, we look forward to working with you to 
address your concerns about traceability. We recognize that the 
discussion draft instructs FDA to assess the costs, benefits, 
and feasibility of traceability technologies and gives FDA the 
power to exempt certain foods. Furthermore, we recognize that 
the discussion draft instructs FDA to conduct pilot projects 
and public meetings. However, we believe these studies, 
meetings, and pilot projects should be completed before FDA 
decides whether and how to assign the food industry the 
responsibility for tracking a food product and which coding and 
identification systems may be best suited to this task.
    As you anticipate in the draft, the cost and feasibility of 
requiring every manufacturer to maintain the full pedigree of 
every ingredient in every food may outweigh the public health 
benefits. To address concerns raised during the peanut product 
recall, we urge you to consider whether intermediate 
distributors and brokers should include on the labeling of 
their bulk ingredients the identity of the ingredient supplier.
    In general, we support proposals to give FDA stronger 
enforcement powers, including the power to order a recall. We 
believe that certain enforcement provisions of the discussion 
draft, such as mandatory recall and suspension of registration, 
should only be exercised by senior agency officials when there 
is a risk of serious adverse health consequences and should 
ensure that companies are afforded certain due process 
protections, such as an administrative hearing.
    As we saw during the recent recalls of tomatoes and 
jalapeno peppers, recalls can have a devastating financial 
impact, and they need to reflect the best science and wisest 
agency judgment.
    Finally, we strongly support efforts to provide FDA with 
additional resources. GMA helped create the alliance for a 
stronger FDA, and we have worked with other consumer and 
industry groups to increase FDA spending. If Congress enacts 
the FY 2010 request of the FDA and the Obama administration, we 
will have seen food safety spending at FDA increase by nearly 
80 percent since F& 2006.
    More funding is needed. We look forward to working with the 
committee to identifying appropriate role for industry. Our 
industry is significantly increasing our own investments in 
food safety, and we are prepared to make additional investments 
to continually improve the safety of our food supply and to 
comply with many of the new mandates that are envisioned in the 
discussion draft. We are not opposed to all fees, and I am 
confident that the committee can reach a bipartisan consensus 
on the agency's resource needs and an appropriate role for 
industry.
    Let me close by saying again that the food and beverage 
industry is committed to working with you to quickly enact food 
safety legislation which makes the prevention of contamination 
the foundation of our food safety system. Thank you.
    [The prepared statement of Ms. Bailey 
follows:]*************** INSERT 3 ***************
    Mr. Pallone. Thank you. Ms. DeWaal.

               STATEMENT OF CAROLINE SMITH DeWAAL

    Ms. DeWaal. Thank you very much. Thank you for your 
leadership, Chairman Pallone, and also the leadership from many 
other members of this subcommittee and committee. And also 
thank you to you, Ranking Member Deal, for the many hearings 
that we have sat through. We have listened to the witnesses. 
This work has been going on before this committee for a long 
time, and I think hopefully we are nearing an end.
    My name is Caroline Smith DeWaal, director of food safety 
for the Center for Science in the Public Interest, but today I 
am representing 10 consumer, public health, and victims' 
advocacy organizations that are members of the Safe Food 
Coalition.
    Let me begin by saying that we believe this is a strong 
bill that will improve food safety. It requires food companies 
to build into their processes the conduct of regular hazard 
analysis, and they have the institute preventive controls to 
prevent problems from occurring. It provides a modern framework 
for food safety oversight to replace the antiquated food safety 
laws that have hamstrung the Food and Drug Administration. It 
gives FDA essential new authority to carry out the mission of 
preventing illnesses and outbreaks and to inspect food plants 
much more frequently, and it addresses the funding issues 
urgently needed to institute the program improvements, doing 
this with a modest registration fee.
    The heart of any effective reform effort lies in 
prevention, which is in the bill's hazard analysis and 
preventive control section. The bill provides FDA with new 
tools like written plans and access to processing records that 
will allow government inspectors to review the conditions in 
plants over time, not just when inspectors are in the facility.
    We recommend additional strengthening of the bill by 
requiring companies or labs to report pathogen on final product 
samples to FDA whenever they are encountered in a facility. 
This would give FDA an early warning of problems and might 
prevent another tragedy, like the outbreak linked to the Peanut 
Corporation of America.
    It is a common adage that you cannot detect what you don't 
inspect. Random and frequent inspection by public officials is 
a necessary component of an effective food safety system. This 
legislation divides food companies into three categories based 
on risk and directs FDA to inspect the facilities every six 
months to four years.
    While this is a vast improvement over FDA's existing 
program, we continue to believe that more frequent inspections 
are needed, particularly of high risk facilities. Risk-based 
inspection is a concept that expands across the entire spectrum 
of food products not just those regulated by FDA.
    The registration fee, as proposed, is quite modest. And at 
$1,000 per facility, it should provide somewhere between $300 
and $400 million in new revenue for food safety activities. Let 
us put this fee into context. In the Peter Pan outbreak, the 
average cost per victim reporting an illness was $2,650. And 
this is based on an estimate using the Economic Research 
Service Cost calculator. So when there is an outbreak, 
consumers who are affected may pay over $2,500 or more. These 
are individuals. So clearly $1,000 fee on each facility to 
avoid these problems is more than reasonable, especially when 
compared to the cost of individuals and families that you have 
had here before this committee, testifying on the severe impact 
of food borne illness.
    In addition, I would just like to note that companies 
themselves can run advertising campaigns to promote their 
products that run into the tens and even hundreds of millions 
of dollars.
    To conclude, I just want to say that polling has shown that 
the public has lost confidence in the safety of food. The 
percentage of consumers confident in food safety fell to about 
22 percent according to the University of Minnesota's Food 
Industry Center. This legislation provides a modern framework 
for FDA's regulation of the food supply that will deliver many 
benefits to consumers though it does stop short of structural 
reforms that we also think are essential.
    We appreciate your leadership, and we believe that these 
new authorities that you are proposing will over time prevent 
the outbreaks and illnesses and help restore consumer 
confidence.
    Earlier this year, members of the Energy and Commerce 
Committee made commitments to the victims of the Peanut 
Corporation of America outbreak that change would come to FDA. 
President Obama said at a bare minimum, we should be able to 
count on our government, keeping our kids safe when they eat 
peanut butter.
    We urge you, Chairman, to act swiftly to finalize this 
legislation and to enact it. Thank you.
    [The prepared statement of Ms. DeWaal 
follows:]*************** INSERT 4 ***************
    Mr. Pallone. Thank you. Dr. Jones.

                   STATEMENT OF TIM F. JONES

    Dr. Jones. Mr. Chairman, members of the subcommittee, thank 
you for the opportunity to be here today. Recent high profile 
outbreaks demonstrate the huge challenges and opportunities for 
improvement in the Nation's food supply and food safety 
infrastructure. Laws, policies, and, to be frank, philosophies 
developed decades ago no longer suffice to successfully meet 
these new demands.
    The legislation we are discussing today is therefore a 
critical step in reviving the food safety capacities of the 
FDA. I work in a state health department as a epidemiologist 
responsible for investigating food borne diseases and in effect 
cleaning up the mess left when things go awry in the food 
safety chain.
    I am excited to see that this proposed legislation 
addresses many of the problems that I experience firsthand in 
my role both investigating and helping prevent food borne 
disease.
    Improving the traceability of food as called for in this 
legislation is fundamental to successfully achieving many of 
the other tasks described. If traceback information had been 
more promptly available and shared faster, I think that many of 
the problems associated with the recent tomato/jalapeno 
incident could have been mitigated. And likewise tracing peanut 
butter from one plant to 4,000 different commercial products 
would have been utterly impossible with many other types of 
foods.
    Ensuring that all foods are traceable efficiently and 
accurately is critical to maintaining food safety. 
Contamination of produce and foods which are eaten uncooked are 
of particular concern because consumers have less control over 
the safety of those foods in their own kitchens. Setting 
standards for pre-harvest food production starts to close a 
major current gap in the Nation's food safety system.
    Suspected produce-associated illnesses are particularly 
difficult to investigate from both the public health and 
regulatory perspectives. While large food service corporations 
and the suppliers often have excellent quality control programs 
with impeccable records, many other companies don't.
    The portions of this bill requiring country of origin 
labeling, improved distribution records, and plans to regulate 
the safe production and harvesting of fruits and vegetables are 
important to help address these problems.
    I am pleased to see that the agency is being encouraged to 
markedly increase the scrutiny of food-handling entities. I 
would like to emphasize the importance of basing inspections 
and product testing and any other interventions by the agency 
on sound science. The bill does have important directives to 
improve testing in the science base of the agency's activities.
    It is critical that from top to bottom activities are more 
efficient and effective and not just more frequent. This bill's 
requirement that the agency's activities are risk-based is 
particularly critical. It is likely that as technology 
improves, the value of traditionally defined inspections will 
change dramatically. And I urge that the agency retain 
sufficient flexibility and authority to adapt to changes 
rapidly and with as few barriers as possible.
    I think it is important that in any discussion of the food 
safety system to emphasize the importance of interaction 
between FDA and CDC along with state and local partners and 
meeting the directive to enhance the science of food safety and 
develop risk-based approaches. Data from CDC and its partners 
on things like outbreaks, disease surveillance, and attribution 
of human disease to specific foods will be critical. It is 
imperative that such data are developed and shared 
cooperatively to meet the needs of all the partners involved in 
the system.
    In every discussion that I have been in pertaining to food 
safety, the importance and current inadequacy of effective 
information sharing is probably the most common single topic 
that is raised. I am pleased to see that issue addressed in 
this bill. Improving the technological capacity to share 
information will be important in accomplishing this, but 
perhaps even more important is changing the engrained policies 
of not sharing information among partner agencies far beyond 
any logical limit, even when the failure to do so threatens the 
public health.
    To meet the mandates of this bill, FDA will have to 
increase interaction and coordination with state and local 
agencies, which will require funding and focused attention. 
Federal regulatory agencies frequently are prohibited from 
sharing proprietary information obtained during investigations. 
The flow of information in both directions between FDA and CDC 
as well as state public health partners is critical.
    Examples of this include such things as distribution lists 
during recalls, information on suspected products or producers, 
and information on potentially exposed people.
    The FDA, CDC, and other partner agencies must have both the 
authority and expectation to share actionable information with 
the public health partners to the extent necessary to protect 
the public's health.
    And I will conclude with a final comment about the 
importance of ensuring FDA and its state and local partners 
have adequate resources to meet the responsibilities with which 
they are charged in this bill. No one would argue that the FDA 
is currently underfunded, overworked and essentially 
overwhelmed. State and local food safety capacity must also be 
robust in order to maintain an effective food safety system.
    Adequate and consistent funding and resources must be 
dedicated explicitly to sustain the food safety programs at FDA 
as well as the state and local partners who work with them to 
keep the food supply safe. Americans will eat a billion meals 
today, and I can't think of a better investment than one that 
will keep every one of those meals safe.
    [The prepared statement of Dr. Jones 
follows:]*************** INSERT 5 ***************
    Mr. Pallone. Thank you, Dr. Jones. Mr. Stenzel.

                 STATEMENT OF THOMAS E. STENZEL

    Mr. Stenzel. Good afternoon, Chairman Pallone, Ranking 
Member Deal, and members of the subcommittee. I am pleased to 
be with you. As you know, the fresh produce industry has been a 
leading proponent of strong federal government oversight of 
food safety. My name is Tom Stenzel. I am president and CEO of 
the United Fresh Produce Association. Our organization has been 
privileged to testify 10 times in the last two years before 
this committee or other members of Congress, perhaps only 
runner up to Caroline on this panel.
    Our board of directors in January of 2007 adopted a series 
of policy principles calling for mandatory, science-based 
regulation by the federal government. Today we congratulate you 
and the leadership of the full committee in presenting the 
draft of the Food Safety Enhancement Act of 2009 for 
consideration.
    While my written statement contains a number of suggestions 
for strengthening the bill, I will focus just now on three key 
areas of concern. Let me start by repeating those policy 
principles I mentioned. To protect public health and ensure 
consumer confidence, produce safety standards must allow for a 
commodity-specific approach based on the best available 
science, must be consistent and applicable to the identified 
commodity, no matter whether it was grown in the United States 
or imported, and it must be federally mandated with sufficient 
federal oversight of compliance in order to be credible to 
consumers.
    We are pleased that these principles are recognized in the 
draft Food Safety Enhancement Act. In looking specifically at 
the draft, we strongly support the bill's intent in Section 104 
for FDA to focus on maximizing public health by implementing 
regulatory standards for those specific raw agricultural 
commodities that it believes are most critical. The FDA has 
estimated that only five commodities have been associated with 
80 percent of all produce-related food borne disease outbreaks 
in the past 10 years, and that is where we must direct our 
resources.
    In a highly diverse industry that is more aptly described 
as hundreds of different commodity industries, one size does 
not fit all. We support Congress specifying that FDA have broad 
authority to regulate any produce commodities it determines 
necessary. But with a clear mandate to develop rule making that 
focuses resources for maximum public health benefit on those 
specific types of commodities for which the secretary 
determines that such standards are necessary to minimize the 
risk of serious adverse health consequences.
    We also recommend that Section 104 strengthen the support 
for collaboration between HHS and the U.S. Department of 
Agriculture and all state agencies in all areas of education, 
research, and enforcement with regard to produce. It is 
important that we bring the broadest knowledge and resource 
base possible to assist all stakeholders in understanding and 
complying with FDA set public health standards.
    Dealing with Section 107 on traceability, I want to assure 
the committee that fresh produce industry is committed to farm 
to fork traceability of our products. As I presented in 
detailed testimony before the House Committee on 
Appropriations, Chairwoman Delaro's Ag Subcommittee earlier 
this year, we have underway a produce traceability initiative 
to provide electronic traceability for 6 billion cases of fresh 
produce that move annually within the United States. This is a 
massive and extremely expensive long-term undertaking, but it 
is a commitment that we have made.
    However we are concerned that the prescriptive nature of 
Section 107 could actually derail these important efforts to 
bring the most cost efficient and cost effective technology to 
bear on this challenge. As you weigh various traceability 
provisions, we urge that Congress set the goal to mandate for 
food traceability but not overly prescriptive requirements such 
as those in this bill.
    Rather we believe Congress would be more effective in 
mandating an intensive evaluation of technologies, systems, and 
pilot tests that will truly lead to the end result we all 
desire. To that point, this legislation should set a goal for 
total supply chain traceability across the food industry, not 
single out individual food categories for traceability.
    Finally on the question of imports, I believe the committee 
should carefully examine all of the provisions regulating 
imported foods to assure equal treatment and fair standards for 
imported and domestically produced foods. This should be a 
principle maintained throughout all provisions.
    In Section 201, we support the bill's intent to require 
importers to register with FDA and comply with good importer 
practices. The committee should make clear that this is the 
standard protocol for importing foods, and that the limitations 
and restrictions envisioned in Section 109 provide very extreme 
authorities to be used by FDA only in worst case scenarios when 
required to minimize the risk of severe adverse health 
consequences.
    With regard to imports, we also strongly support the 
concept of the safe and secure food importation program in 
Section 113 and urge that the bill require FDA to implement 
such a program with clear direction that it shall be 
implemented rather than may be implemented.
    Finally, let me mention 143 and country of origin labeling. 
The fresh produce industry is already required under the 2008 
Farm Bill to provide mandatory country of origin labeling at 
retail point of sale. Our industry has moved rapidly to ensure 
compliance with this law and urges that those products which 
are already covered be specifically exempted from any new 
duplicative coverage under the FDNC Act.
    Let me conclude with a comment about public health. The 
very Department of Health and Human Services that regulates our 
safety has the dual responsibility to promote public health but 
consider the fact that we need, as Americans, to double our 
consumption of fruits and vegetables to meet the very simply 
U.S. dietary guidelines.
    With that public health imperative, fears of food safety 
have no place in the fresh produce department. Thank you for 
your leadership on this effort.
    [The prepared statement of Mr. Stenzel 
follows:]*************** INSERT 6 ***************
    Mr. Pallone. Thank you, and thank all of you. We will now 
take questions from the panel, five minutes each, and I will 
start.
    I wanted to start with Ms. DeWaal. Many in the industry 
have called for prevention, or I should say a stronger emphasis 
on prevention. And many feel that we need to share the 
responsibility for making food safe. The FDA obviously does an 
important job, but manufacturers must also be responsible for 
the foods that they make.
    Now, one of the ways that the draft before us proposes to 
do this is through a new emphasis on prevention. It requires 
companies to conduct hazard analysis to identify potential 
safety risks for the food they handle. It then requires that 
the facility owner adopt preventive measures to reduce or 
eliminate these risks.
    So, Ms. DeWaal, can you elaborate on how preventive 
controls, such as those put forth by the bill, will help make 
food safer? And could you give us some examples of preventive 
controls and how they might be implemented or applied?
    Ms. DeWaal. Thank you, Chairman Pallone. The systems that 
are going to be applied in this bill are well tested. We have 
watched the implementation of what are called HACCP or hazard 
analysis critical control point systems in the seafood 
industry, in the beef and poultry industries, and in the--also 
in fresh juice and several other industries.
    The problem would be the approach that FDA has been taking 
up until now and the solution that your bill will bring to the 
agency is that they have been trying to apply these systems one 
by one, industry by industry. And I think what you see here is 
a unitary view, among industry and consumer organizations, that 
these systems are needed across the board. They are developed 
by the industry. They are driven by the industry. They design 
the programs, but the government can use them to actually go in 
and conduct inspections, which are much more meaningful than 
the ones they do today.
    Mr. Pallone. Well, let me ask each of you. I will ask Ms. 
Bailey and then go to the others quickly if you would respond, 
whether you support these preventive approaches to food safety.
    Ms. Bailey. Absolutely. Yes, sir.
    Mr. Pallone. OK, Mike?
    Mr. Ambrosio. Yes.
    Mr. Pallone. Dr. Jones?
    Dr. Jones. Yes, sir, we do.
    Mr. Pallone. All right, great. I mean obviously a consensus 
on the preventive approach being the critical part of the bill. 
I wanted to ask about access to records though too. One of the 
new requirements in the bill references access to records. 
Section 106 requires that food manufacturers and producers 
retain records relating to the foods they produce, and upon 
request, provide these records to the FDA. FDA would, in the 
event of a food borne disease outbreak or during an inspection, 
have access to information on how foods were produced, 
manufactured, transported or stored. And I will initially ask 
Dr. Jones. Can you describe for us how this type of records 
access would be helpful to the FDA in the event of a food borne 
disease outbreak?
    Dr. Jones. Well, I mean I think access to those records are 
critical in order for them to sort of pinpoint their 
interventions, but I also think the ability for FDA to share 
that data with other agencies that assist them in those 
investigations is critical. And that has been a huge barrier 
for us. I mean I worked on outbreaks where FDA had the names 
and phone numbers of people that had consumed contaminated 
product and would not or thought that they could not share that 
information with public health departments that are responsible 
for calling those people and telling them not to eat the stuff. 
And that is just mind-boggling to me. I mean I think it is 
subtle, but there is some addressing that issue in this bill.
    Mr. Pallone. You want to comment also, Ms. DeWaal on 
whether you believe that this access to records provision will 
help protect public health?
    Ms. DeWaal. The access to records provision gives the 
agency the ability to look at plants. When they visit them, 
they can look at them as they are operating over time. Today 
when an FDA inspector goes into a plant, they just see the four 
walls of the plant. They may not even get access to any records 
in that facility. They can look at production practices as they 
are happening on that day.
    But with the access to records provision together with this 
preventive control system and this written food safety plan, 
the inspector will be able to go and look back and where the 
company has faced perhaps challenges in its operation and how 
they have addressed them.
    Mr. Pallone. OK, thank you. I mean I don't know if anybody 
else wanted to address that, but I think that is fine. Thank 
you. Mr. Deal.
    Mr. Deal. Thank you. Mr. Stenzel, I guess I am going to 
start with you from the producer side of it. First of all, in a 
general context, do you see any problem or potential of this 
legislation creating overlaps with FDA jurisdiction and 
requirements to do things versus current USDA requirements to 
do things in our food supply?
    Mr. Stenzel. We don't see any jurisdictional issues in 
public health in that sense. FDA has the statutory authority 
now to regulate the fresh produce industry. We do suggest 
strongly that there be a good coordination with the U.S. 
Department of Agriculture in education, enforcement. Certainly 
one of the keys to implementing this bill is going to be an 
effective structure with FDA working with USDA and state and 
local agencies in compliance, enforcement, inspections. That 
needs to be strengthened, but there is not a jurisdictional 
issue of competing authorities.
    Mr. Deal. My understanding is that at the production level 
that good agricultural practices are the primary preventive 
tool and mechanism for dealing with it at the production level. 
Do you see perhaps that an updating or improvement on those 
agricultural practices standards as they apply to fruits and 
vegetables is important? And is there anything here that would 
prevent that from taking place?
    Mr. Stenzel. Yes, sir, Mr. Deal, that is an extremely 
important part. The FDA's good agricultural practices are 
called to be updated in this draft legislation. We strongly 
support that as the baseline guidance for all fruit and 
vegetables. For those specific commodities in which FDA has 
determined a significant level of risk, then you move into the 
rule making procedure. But that is one of the key things. It is 
the way we can best focus our public health resources on the 
greatest risk.
    I said in my testimony that 80 percent of all the outbreaks 
have been associated with just five commodities. So the basic 
good agricultural practices are very appropriate for all fruits 
and vegetables, but let us focus the rule making on those 
specific commodities that require it.
    Mr. Deal. And, Ms. Bailey, I believe you made the point 
that since we have mandated studies and pilot projects, et 
cetera, that those be completed before we start trying to write 
the rules and regulations. Is that one of the points you were 
making?
    Ms. Bailey. On traceability, yes.
    Mr. Deal. Yes. It seems to me that if we are going to do 
the studies and the pilot projects, we ought to do that before 
we write the regulations because presumably they will give us 
the information to guide us in the rule making process. So I 
think your point is well made. In that regard, Mr. Stenzel, 
your industry has already put in place some traceability 
standards. How do you see your current efforts in traceability? 
How do they correspond with what is in this legislation?
    Mr. Stenzel. I tell you this is proving to be a massive, 
massive undertaking, and, you know, we are committed to doing 
it even on a voluntary basis before any type of requirement. 
But extremely complex system of creating that interoperable 
system that can see the life cycle all the way through of our 
products. But some of the specific language in this bill, the 
full pedigree of each product, gives us great cause for 
concern.
    Even though we are moving down a path of hundreds of 
millions of dollars being invested in interoperable 
traceability systems, we don't think they might meet exactly 
the terms of this bill. So we would also strongly advise that 
FDA be mandated to get involved in the technology, in the pilot 
test, learn about each industry, and then write the regulation.
    It is premature to tell every industry exactly how it 
should be done until we have this greater learning.
    Mr. Deal. One of the scares that we have alluded to here 
was the Mexican pepper scare that adversely impacted the tomato 
industry. And I guess I would ask you again how do we ensure 
that foreign producers meet the kind of standards that we would 
need? Would it require, in your opinion, some kind of foreign 
producer verification system of some sort?
    Mr. Stenzel. Well, I think the requirements in the import 
section are appropriate. That importers will now be required to 
register with the FDA, and as part of good importer practices, 
they will have to assure that their products have been grown in 
accordance with these standards. We believe that is an 
appropriate step to be taken.
    I don't think anyone envisions going, searching around on 
every farm around the world, nor every farm in America to be 
honest with that. That is simply not going to be the case. The 
authority should be there for FDA if they need to investigate 
an issue, but the basic responsibility is going to lie with the 
importer or the food manufacturer.
    Mr. Deal. Does your organization represent the organics 
producers?
    Mr. Stenzel. Yes, sir, we have a number of organic 
suppliers in our group.
    Mr. Deal. Thank you. I have a statement, and I think we 
have cleared it with your staff from the Frozen Food Institute 
to be inserted in the record?
    Mr. Pallone. Without objection, so ordered. Chairman 
Dingell.
    [The information appears at the conclusion of the hearing.]
    Mr. Dingell. Mr. Chairman, thank you. I would like to 
commend the panel for their very helpful testimony and thank 
you all. I would particularly like to address my questions, 
however, to Ms. Bailey from GMA. I would like to first begin by 
welcoming you. I would like to follow up by thanking you for 
the cooperative way in which you and GMA have been working with 
the staff to try and resolve the difficulties which we 
confront. And I would like to also express my particular thanks 
to you for the most helpful way in which you have behaved and 
the remarkable change that has occurred under your leadership. 
So I thank you.
    First of all, am I fair in stating that FDA has been so 
underfunded that they have not been able to provide the 
necessary services to protect either the industry or the 
consumers for a number of years?
    Ms. Bailey. That is right.
    Mr. Dingell. And as a result, they have been unable to 
adequately fulfill their role in ensuring the safety of the 
Nation's food supply?
    Ms. Bailey. Yes, we would agree.
    Mr. Dingell. Unfortunately our reporter doesn't have a nod. 
You have to say yes or no.
    Ms. Bailey. I am sorry. I said yes, and if I could give an 
example, FDA has not been able to update good manufacturing 
practices since 1986, and that is just one example of something 
they have not been able to do without adequate resources.
    Mr. Dingell. That sounds like a very serious matter. Tell 
us what that means.
    Ms. Bailey. Well, good manufacturing practices serve the 
basis----
    Mr. Dingell. Those are required both in food and drugs, 
cosmetics and also----
    Ms. Bailey. That is right.
    Mr. Dingell. --in pharmaceuticals.
    Ms. Bailey. That is right, and so the preventive controls 
that we are talking about, in HACCP for example, are one step 
up from good manufacturing practices. You want to have them 
updated, and as we all know, there have been enormous advances 
in manufacturing and food processing since 1986 relating to 
pathogen control, environmental testing, all of the 
advancements. And FDA has not been able to incorporate them 
into updated good manufacturing practices guidance for 
industry.
    Mr. Dingell. Would you also agree that FDA's science base 
has eroded?
    Ms. Bailey. Absolutely yes.
    Mr. Dingell. And that the FDA's information technology 
systems are inadequate?
    Ms. Bailey. Yes.
    Mr. Dingell. And that FDA has not been doing an acceptable 
level of surveillance and research?
    Ms. Bailey. That is right.
    Mr. Dingell. Would you agree that they have not conducted a 
satisfactory number of inspections over the years? This figure 
I got, which seems interesting. FDA conducted 6,562 domestic 
food facility inspections in 2008, 152 foreign food facility 
inspections in 2008. The total number of registered facilities 
is 378,000, but there are many more out there in the world who 
are shipping stuff to us. Is that a fair statement?
    Ms. Bailey. That is an accurate statement, yes.
    Mr. Dingell. Thank you. And I am sure that you agree, as 
you have said in your statement, that FDA needs additional 
resources to do their job?
    Ms. Bailey. Yes.
    Mr. Dingell. And I want to commend you very much for the 
way that you have been working with us on the registration and 
the fee question. And I want you to know that we are going to 
try very hard to see to it that we come up with something that 
enables industry to work, prosper, have a satisfactory Food and 
Drug Administration, one which protects the consumers but also 
which doesn't overburden the industry. And we look forward to 
continuing our efforts on that, and I hope that you will 
continue to give us those assistances.
    And again the reporter has no nod but----
    Ms. Bailey. Yes, we look forward to that. I thought that 
Dr. Hamburg this morning laid a good basis for those 
discussions going forward.
    Mr. Dingell. I am troubled about foreign people who deliver 
food into the United States. Food and Drug doesn't have the 
right number of inspections and inspectors at the border, do 
they?
    Ms. Bailey. No, that is right. They do not.
    Mr. Dingell. I am told they only inspect about one percent 
of foods coming into the United States. And the games are 
played oftentimes where they are turned back, rather where food 
shipments are turned with the result that they go out and come 
in another port. Are you troubled about that?
    Ms. Bailey. Yes, we need strong inspections at the border.
    Mr. Dingell. Now, I am also troubled about the fact that 
Food and Drug has no understandings with their sister agencies, 
with customs, with immigration. So as a result a lot of times, 
their inspectors will be at the ports, and there is no Food and 
Drug folk. We ought to see to it that there is a cooperative 
agreement there to make that possible so that they would work 
together instead of ignoring each other's business. Isn't that 
right?
    Ms. Bailey. I think that sounds like a good idea, yes.
    Mr. Dingell. Now, I note that I am three seconds overtime. 
Pleasure to have you before us. Thank you. Thank you, Mr. 
Chairman.
    Ms. Bailey. Thank you, Mr. Dingell.
    Mr. Pallone. Thank you, Chairman Dingell. Mr. Shimkus.
    Mr. Shimkus. Thank you, Mr. Chairman. I have a lot of 
questions. I am going to try to be quick. You all sat in the 
first testimony. Can any of you tell me what ``may cause'' 
means? Mr. Ambrosio, do you know what ``may cause'' means?
    Mr. Ambrosio. It is a very vague term.
    Mr. Shimkus. OK, Ms. Bailey, ``may cause''?
    Ms. Bailey. I am not certain, no.
    Mr. Shimkus. OK, Ms. DeWaal?
    Ms. DeWaal. Thank you. The actual subsection says ``if the 
secretary has reason to believe that the use or consumption of 
or exposure to an article of food may cause adverse health 
consequences.'' So the actual standard, sir, is ``reason to 
believe'' and the ``may cause'' is in there, but it really is a 
standard which is very protective of public health. Thank you.
    Mr. Shimkus. Dr. Jones?
    Dr. Jones. I agree with those comments.
    Mr. Shimkus. And Mr. Stenzel?
    Mr. Stenzel. I believe that it is a much more vague 
standard than that.
    Mr. Shimkus. And I hope we can work to clean up that 
language, and I think there is an opportunity to do that. Let 
me ask this subpoena question again to those who may want to 
talk about that. There are three criteria in Section 311 which 
I didn't allude to the first. First, ``does any hearing, 
investigation, and other proceeding, respecting a violation of 
the act''? I think most people agree subpoena.
    ``Any hearing, investigation or other proceeding to 
determine if a person is in violation of a specific provision 
of this act''? I think an average person would say oK, subpoena 
these babies.
    The third one, ``any other matter relative to the 
commissioner's jurisdiction under this act, the Public Health 
Service Act, and the Federal Anti-Tampering Act.'' Any other 
matter, vague or not? Mr. Ambrosio?
    Mr. Ambrosio. It is vague.
    Mr. Shimkus. Thank you. Ms. Bailey?
    Ms. Bailey. Yes, that--it is vague.
    Mr. Shimkus. Ms. DeWaal?
    Ms. DeWaal. Actually these acts are important to protect us 
against swine flu, against bioterrorism. So in fact, these 
acts, if you understand the relationship between the Food, 
Drug, and Cosmetic Act, and these other legal statutes, I think 
the language may be appropriate but----
    Mr. Shimkus. It may be. It may not be. It may be.
    Ms. DeWaal. --we will go back and look at it.
    Mr. Shimkus. OK, thanks. Dr. Jones?
    Dr. Jones. I am a physician, not a lawyer.
    Mr. Shimkus. OK, either am I, but I pretend to be one here.
    Dr. Jones. You know, so my tendency is to err on the side 
of protecting the public's health, but I agree it is somewhat 
vague.
    Mr. Shimkus. My tendency is to question the legal language 
of the law that may harm folks by the--I found the language of 
the law is very important. And interesting things can be done 
as this gets crafted. Mr. Stenzel, I think it is also quit a 
general standard and do suggest it is an area to look at 
throughout the bill. Thank you.
    Mr. Stenzel, I want to ask specifically on Section 104, 
which calls for the secretary to issue regulation on produce 
safety standards. The language in the bill says the standard 
may include minimum standards for safety. This is a lot of the 
language stuff that I have been focusing on today. Why would we 
want the agency to issue minimum standards instead of the 
appropriate standards for safety?
    Mr. Stenzel. Mr. Shimkus, thank you for raising that. That 
is actually a subject I addressed in my written testimony. I 
don't think we should be using such terms as minimum or 
expecting minimum standards. We should have the agency write 
the standards that are most appropriate that all producers 
should follow. I can tell you this: that as soon as we have 
minimum standards, the first thing that is going to happen is 
someone is going to say that is not good enough.
    So if we are going to go down this path, let us make sure 
the agency writes the most appropriate standards.
    Mr. Shimkus. And that is that whole debate that we always 
have appear about some certainty. Industry needs certainty. If 
we have vague language, there is uncertainty, and with 
uncertainty comes higher risk because of trying to comply. I 
appreciate that. Ms. Bailey, what was surprising in the draft 
is--and I was on the ONI last Congress. I can't talk about what 
was the hearings in previous Congresses or what is going on 
this time.
    But baby formula has popped into this debate, and I know of 
no hearings on baby formula in the last Congress when I was 
ranking on ONI. Have there been any reported problems that 
would suggest that there needs to be a reason to change the way 
infant formula is regulated? In the premises, it is highly 
regulated already. Do you want to comment on that?
    Ms. Bailey. Yes, we are not familiar either with the origin 
of that provision. We noticed it in this draft, and we are, of 
course, aware of how high the regulated baby formula is. And we 
are interested in receiving further information, but it 
obviously is very important, as is the safety of the product 
and the availability to mothers and children.
    Mr. Shimkus. And thank you, Chairman. My time expired. I 
would have gone on with a pilot program. I think that has been 
discussed a little bit. I know Mr. Ambrosio has some comments, 
and I think a pilot program might be important. And I yield 
back.
    Mr. Pallone. The problem that we have is there is an 
important vote on our other subcommittee. So I would like to 
adjourn for just five minutes so that the members can go and 
vote in the other subcommittee, and we will come right back. So 
the subcommittee, if you bear with us, is just in recess for 
five minutes.
    [Recess.]
    Mr. Pallone. Ms. DeGette.
    Ms. DeGette. Thank you very much, Mr. Chairman. I want to 
echo Mr. Dingell's thanks to every single witness here for 
working with us on this legislation. All of your input has been 
very, very important, and none of you will be surprised to know 
I want to talk about the mandatory recall provisions of the 
bill, and I want to start with Ms. DeWaal.
    First of all, do you think, Ms. DeWaal, that the current 
provisions of the Bioterrorism Act are sufficient to give us 
the mandatory recall that we need in a robust food safety 
system?
    Ms. DeWaal. No, I don't.
    Ms. DeGette. And why is that?
    Ms. DeWaal. Well, the Bioterrorism Act actually didn't 
really give them mandatory recall, but it does give them the 
authority to take certain actions like administrative detention 
and some other actions when they meet a very high----
    Ms. DeGette. But to interrupt you, it really has the one 
step back and one step up. Is that sufficient to give us the 
whole traceability?
    Ms. DeWaal. I am sorry.
    Ms. DeGette. I said mandatory recall, and I meant 
traceability.
    Ms. DeWaal. OK, I am sorry. Traceability----
    Ms. DeGette. That is what happens when you break my train 
of thought.
    Ms. DeWaal. Thank you for that clarification. The one step 
up and one step back traceability was a good first step into 
this area, but I think the provisions in this bill are much 
improved on that. What we have seen over the years, since that 
law was passed, is that the FDA itself has had trouble with 
identifying food products involved in major recalls and 
outbreaks.
    Ms. DeGette. Because it just doesn't go far enough forward 
or backward, correct?
    Ms. DeWaal. Right.
    Ms. DeGette. And, Dr. Jones, you are nodding your head yes 
as well.
    Dr. Jones. Yes, I mean I think there is such a huge food 
production chain that if there is one point in the chain where 
records aren't good----
    Ms. DeGette. You lose the whole thing.
    Dr. Jones. I mean if Bruno's produce doesn't know where it 
came from, you could have the rest of the industry known, and 
you can't get anywhere.
    Ms. DeGette. Right, thank you. Now, I want to ask you, Mr. 
Amobrosio, Ms. Bailey, and Mr. Stenzel, I have read all of your 
testimony and listened to you here today. You don't object in 
general to the concept of traceability, do you, Mr. Ambrosio?
    Mr. Ambrosio. No.
    Ms. DeGette. Ms. Bailey?
    Ms. Bailey. No.
    Ms. DeGette. And Mr. Stenzel?
    Mr. Stenzel. No, ma'am.
    Ms. DeGette. And in fact, Mr. Ambrosio, in your testimony, 
you recommended that the secretary be allowed to design systems 
based on information gathered and not be mandated to develop a 
specific type of system prior to those efforts, correct? And, 
Ms. Bailey, in your testimony, your written testimony, you 
talked about the concept of including intermediate distributors 
and brokers in the labeling of bulk ingredients to the supplier 
so that we could get that traceability, correct?
    Ms. Bailey. That is right, yes.
    Ms. DeGette. And, Mr. Stenzel, I have to say the produce 
industry in this country was really--maybe I shouldn't say this 
in front of everybody else, but you folks were the ones that 
gave me courage to believe that we could do traceability 
because you are doing such a great job. So I want to commend 
you. I guess the issue, as I heard in all of your testimony 
today, is some concerns with the specific language of Section 7 
of the committee draft. Would that be accurate to say, Ms. 
Bailey?
    Ms. Bailey. That is right.
    Ms. DeGette. And I just want to--you know you talk in your 
verbal testimony today about the tomato recall, and you were 
talking about mandatory versus voluntary recalls. But that made 
me think about traceability too because it doesn't really 
matter if the recall is mandatory or voluntary. If it is 
overbroad, it is still--I guess I should ask you, Mr. Stenzel, 
since it is produce. If it is overbroad, it still devastates 
the entire market, correct?
    Mr. Stenzel. Yes, that is absolutely correct.
    Ms. DeGette. So really what you want to have is the ability 
to quickly trace where contamination came from foods, correct? 
And, you know, what we have been seeing lately, I was thinking 
about the latest, the pistachios, where they were saying just 
don't eat any pistachios. Then I thought well, what if you had 
pistachios that were incorporated in granola or something like 
that that went a long way. You could really devastate a food 
agency. Ms. Bailey, I wonder if you want to comment on that.
    Ms. Bailey. I think first of all we are absolutely 
sympathetic with your goal and the importance of improving our 
traceability systems. I think it is a matter of prioritizing 
how we go about it. That is why we recommended--first of all, 
there is a difference between a single product like a 
strawberry that is ready to eat versus ingredients that may be 
co-mingled and----
    Ms. DeGette. Right.
    Ms. Bailey. --and put into additional products.
    Ms. DeGette. Exactly, right.
    Ms. Bailey. And we saw in the peanut paste problem that 
when there are brokers involved, PCA would sell the paste to a 
broker who would then sell it to an end manufacturer. And that 
is why we included the recommendation that the distributor 
label it.
    Now, going forward, what we have learned working with our 
member companies and other areas of the food industry, it can 
be enormously expensive when you start to deal with co-mingled 
ingredient commodity products, and that is where we caution. 
And we think the legislation has it absolutely right. Let us 
ask FDA to first identify cost/benefit because in the end 
resources are finite.
    Ms. DeGette. Right, let me just say, because my time has 
expired, that I really hope all of you will come in and work 
with us on this particular traceability language because from 
the very early days of my working on this issue, what you are 
saying is exactly my view, which is we need to have 
traceability throughout the industry but that we can't have a 
one-size-fits-all traceability system or technology. The key is 
those things be interoperable.
    So if you have tomatoes and peppers mixed in a salsa, that 
is one level of complexity. If you have that salsa incorporated 
in a processed food, that is another layer of complexity. And 
then if you have that put into something at a restaurant or any 
place, that is another layer. So we have to really work on 
that.
    What I am amazed about though is that we do have the 
technology, and we just need to work on it. So I hope you will 
all work with us in the next week to improve this language. 
Thank you for your indulgence, Mr. Chairman.
    Mr. Pallone. Mr. Buyer.
    Mr. Buyer. I had to take a deep breath because Mr. Matheson 
and I and I guess now Chairman Dingell and Gene Green, you 
know, we have taken this trying to educate the committee here 
on electronic pedigree with regard to drugs. Yet now all of a 
sudden, there is this great interest to do something expansive 
on pedigree with food.
    So I just want you to stop and ponder and think about this, 
Mr. Chairman, because as we move to the Drug Safety Bill, it is 
the reason I went right at the FDA Commissioner. You can't say 
I have this level of interest in making sure that they go after 
tainted food but with regard to drugs well, maybe that is a 
little bit different. We are not going to send this message to 
the country that tainted food, bad lettuce, that is really 
awful, but we can have a different standard when it comes to 
bad Lipitor. I am uncomfortable.
    Let me ask some questions because I don't think I 
completely understand. When I look at Section 106 and Section 
107, we have sort of an all-in, and then under traceability, we 
have some exemptions. So you know I come from a very small 
town. I grew up on the Tippecanoe River, Buffalo, Indiana. We 
have two stops signs on either side of a bridge. That is the 
size of the town I come from. So I think about small 
businesses, and I worry.
    So when we think about access to records, and we are going 
to say requirement with regard to restaurants. Are we going to 
include concessionaires? Does anybody anticipate that, that we 
would include concessionaires? So that when you go to MCI 
Arena, how about when you go to the college football game? How 
about high school? How about little league? You know we make 
deer chili at our little league games. I mean what all is going 
to be included?
    How about convenience stores? How about when you pull into 
that mom-and-pop gas station and they have created something? 
You can get elk sausage. I mean what kind of requirements are 
we going to be placing, and where do we stop? Has anybody 
thought about do we as a committee need to have better 
definition as to who is in and who is out? Total silence. Yes?
    Mr. Stenzel. Congressman, at the risk of your wrath, I just 
don't think that food safety is something that is determined by 
scale or size of company. I run a trade association that has 
many very small members who are going to be extremely 
challenged to comply with this regulation. We also have very 
many big members, but in last summer's outbreak, we also found 
that some of the issues and some of the issues where people 
were getting sick were the very smallest restaurants. And we 
have to be able to have a system that takes care of----
    Mr. Buyer. Well, there is food handling. There is a 
different between food processing and food handling, right?
    Mr. Stenzel. Yes, sir.
    Mr. Buyer. So the people up here on this dais love to talk 
about all these food borne pathogens and all these sicknesses 
that everybody comes down to predominantly deals with the 
handling of food, right, not so much always the processing of 
food at a manufactured facility? I almost feel like they are 
being used as a scapegoat when, in fact, it is other handling. 
And probably everybody here in the audience and around the 
country, we have all gotten sick because somebody left the 
mayonnaise out overnight or something.
    Well, when I look at the traceability requirement, we 
decide, I guess, farms, for example, they got to keep their 
records or, I guess, little league has to keep their records or 
everybody that is going to be involved with food is going to 
have to keep their records, but we are going to exempt now 
restaurants and farms would be required to maintain the safety 
records. But direct sales by farms are exempt.
    What about seafood? So if we are going to exempt on the 
farm, are we going to exempt seafood? How about that trawler 
that goes right out there, gets the seafood and he owns the 
restaurant and the trawler and processes the food? Should they 
be exempted just like we are going to exempt on the farm? Total 
silence. See those are the same kind of questions I have. When 
we start picking and choosing where we draw the line. Ms. 
Bailey?
    Ms. Bailey. If I could, the language in that section at the 
end is very important and I think goes to the heart of our 
concerns. There are a number of questions. There has to be a 
sense of what is feasible technologically, what the cost/
benefit is, and what the relation is to food safety.
    Mr. Buyer. If we are going to exempt farms, should we 
exempt trout farms, catfish farms? How about fish caught on the 
Great Lakes? What about seafood?
    Ms. Bailey. I think those are all questions that need to be 
answered, and if I could offer, the analogy might be--this is 
very similar to electronic medical records in that it is a 
concept that makes good sense. But it is not easy to achieve 
and there are many reasons why it is not easy to achieve both 
technologically and----
    Mr. Buyer. Well, see it is easier for me to be able to 
achieve electronic pedigree in the drug industry when I have 
specific companies, yet I can't get cooperation here to do 
this. But they say that what I am trying to do is too complex? 
What the heck is this? This is a decentralized model of the 
umpteenth degree. I would love to work with you, Mr. Chairman. 
I yield back.
    Mr. Pallone. Thank you. OK, we are done with our 
questioning, and just a reminder again. You heard us earlier 
about that you may get written questions by the close of 
business tomorrow, and we would like you to answer them by the 
close of business on Monday. And again I want to thank you all. 
This was very helpful. I can't emphasis enough that even 
though, you know, our plan is to go to markup next week, that 
we would very much like and we intend to, you know, consider a 
lot of the statements that were made today as we move forward 
over the next week. And several members have commented on how 
valuable, you know, your testimony is going to be as we move 
forward.
    Without objection, the meeting of the subcommittee is 
adjourned. Thank you.
    [Whereupon, at 2:30 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

                                 
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