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



 
        THE ROLE AND PERFORMANCE OF FDA IN ENSURING FOOD SAFETY

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

                                HEARING

                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             SECOND SESSION

                               __________

                              MAY 6, 2010

                               __________

                           Serial No. 111-118


      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
JANICE D. SCHAKOWSKY, Illinois       SUE WILKINS MYRICK, North Carolina
CHARLES A. GONZALEZ, Texas           JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington               TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin             MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas                  MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York          PHIL GINGREY, Georgia
JIM MATHESON, Utah                   STEVE SCALISE, Louisiana
G.K. BUTTERFIELD, North Carolina
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 S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
PETER WELCH, Vermont
              Subcommittee on Oversight and Investigations

                    BART STUPAK, Michigan, Chairman
BRUCE L. BRALEY, Iowa                GREG WALDEN, Oregon
  Vice Chairman                        Ranking Member
EDWARD J. MARKEY, Massachusetts      ED WHITFIELD, Kentucky
DIANA DeGETTE, Colorado              MIKE FERGUSON, New Jersey
MIKE DOYLE, Pennsylvania             TIM MURPHY, Pennsylvania
JANICE D. SCHAKOWSKY, Illinois       MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas
DONNA M. CHRISTENSEN, Virgin 
    Islands
PETER WELCH, Vermont
GENE GREEN, Texas
BETTY SUTTON, Ohio
JOHN D. DINGELL, Michigan (ex 
    officio)
  

                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Bart Stupak, a Representative in Congress from the State of 
  Michigan, opening statement....................................     1
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................     3
    Prepared statement...........................................     6
Hon. Henry A. Waxman, a Representative in Congress from the State 
  of California, opening statement...............................    11
Hon. Robert E. Latta, a Representative in Congress from the State 
  of Ohio, opening statement.....................................    12
    Prepared statement...........................................    13
Hon. Joe Barton, a Representative in Congress from the State of 
  Texas, prepared statement......................................    87

                               Witnesses

Michael R. Taylor, Deputy Commissioner for Foods, Food and Drug 
  Administration; Accompanied by Steven M. Solomon, Assistant 
  Commissioner for Compliance Policy, Office of Regulatory 
  Affairs, Food and Drug Administration..........................    16
    Prepared statement...........................................    19
    Answers to submitted questions...............................    90
Lisa Shames, Director, Agriculture and Food Safety, Government 
  Accountability Office..........................................    37
    Prepared statement...........................................    39
Jodi Nudelman, Regional Inspector General for Evaluation and 
  Inspections, Region II, Health and Human Services Office of 
  Inspector General..............................................    63
    Prepared statement...........................................    65


        THE ROLE AND PERFORMANCE OF FDA IN ENSURING FOOD SAFETY

                              ----------                              


                         THURSDAY, MAY 6, 2010

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 2 p.m., in room 
2123, Rayburn House Office Building, Hon. Bart Stupak (chairman 
of the subcommittee) presiding.
    Present: Representatives Stupak, Christensen, Dingell (ex 
officio), Waxman (ex officio), Burgess, and Latta.
    Staff Present: Phil Barnett, Staff Director; Bruce Wolpe, 
Senior Advisor; Eric Flamm, FDA Detailee; Dave Leviss, Chief 
Oversight Counsel; Stacia Cardille, Counsel; Erika Smith, 
Professional Staff Member; Scott Schloegel, Investigator; Ali 
Neubauer, Special Assistant; Derrik Franklin, HHS-OIG Detailee; 
Karen Lightfoot, Communications Director, Senior Policy 
Advisor; Elizabeth Letter, Special Assistant; Mitchell Smiley, 
Special Assistant; Melissa Bartlett, Minority Counsel, Health; 
Kevin Kohl, Minority Professional Staff Member; Ruth Saunders, 
Minority Detailee; and Alan Slobodin, Chief Counsel, Oversight.

  OPENING STATEMENT OF HON. BART STUPAK, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF MICHIGAN

    Mr. Stupak. This meeting will come to order.
    Today we have a hearing entitled, ``The Role and 
Performance of FDA in Ensuring Food Safety.''
    The chairman, ranking member, and chairman emeritus will be 
recognized for a 5-minute opening statement. Other members of 
the subcommittee will be recognized for a 3-minute opening 
statement. I will begin.
    Today's hearing will mark the 12th hearing of the Oversight 
and Investigations Subcommittee since January 2007 regarding 
food safety issues. We have examined an E. coli outbreak traced 
to tainted spinach, melamine-contaminated pet food, and the 
industry practice of intentional exposure of meat and seafood 
to carbon monoxide, among other inquiries. During this 
Congress, the subcommittee has held hearings on a salmonella 
outbreak associated with peanut products manufactured by the 
Peanut Corporation of America; and actions and obligations of 
food manufacturers and retailers that purchased tainted food 
products; and the safety of bottled water.
    Today, we will continue our oversight role and performance 
in the food safety system by considering two reports. The first 
is a Government Accountability Office report entitled, ``Food 
Safety: Agencies Need to Address Gaps in Enforcement and 
Collaboration to Enhance Safety of Imported Foods.''
    GAO found that, despite the efforts and actions of the 
three Federal agencies that share jurisdiction over imported 
food--U.S. Customs and Border Protection, the U.S Department of 
Ag's Food Safety and Inspection Service, and the U.S. Food and 
Drug Administration--there are gaps in the enforcement and 
collaboration that could allow high-risk foods to enter 
domestic commerce without assurance that products are safe.
    Specifically, the GAO found: the three agencies failed to 
collaborate and to share food-related data effectively; FDA's 
authority to ensure importer compliance is limited; the 
agencies lacked the ability to assign unique identification 
numbers for importing firms; and CBP faces challenges managing 
inbound shipments.
    The second report, ``FDA Inspections of Domestic Food 
Facilities,'' was issued by the Department of Health and Human 
Services, Office of the Inspector General. The report 
identifies a number of challenges confronting FDA in 
safeguarding domestically produced food.
    OIG found that, on an average, FDA inspects only 24 percent 
of domestic food facilities annually and that the number of 
inspections declined from 2004 to 2008. The report also found 
that FDA has not inspected 56 percent of the food facilities 
under its jurisdiction during the past 5 years.
    The inspector general found that, and I quote, ``When 
violations were identified, FDA did not routinely take swift 
and effective action to ensure that these violations were 
remedied,'' end of quote. Additionally, the report found that 
some companies who had violations at their facilities 
significant enough to warrant regulatory action refused to 
grant FDA inspectors access to their official records.
    I am interested in learning more about these two reports 
and what proactive steps the GAO and inspector general believes 
FDA could be taking to ensure the safety of our Nation's food 
supply. I am also interested in hearing from FDA on the recent 
steps it has taken to reinvigorate its focus on food safety and 
to improve and enhance food safety oversight.
    The work of this subcommittee, coupled with the work of the 
Health Subcommittee and the full committee on food safety, 
culminated the introduction and passage of H.R. 2749, the Food 
Safety Enhancement Act, which passed the House of 
Representatives on July 30th, 2009.
    The provisions contained in H.R. 2749 would address several 
concerns raised by GAO. For example, Section 204 of the bill 
requires all food importers to register with FDA annually, 
comply with good importer practices, and pay a registration fee 
of $500 in order to ship food to the United States. Section 206 
requires that registered facilities have a unique facility 
identifier or they will not be allowed to import food into the 
country. I am interested in hearing from our witnesses how H.R. 
2749 could help address the concerns raised in the two reports 
before us today.
    Our witnesses today include the authors of the two reports. 
Lisa Shames is the director of the agriculture and food safety 
at the Government Accountability Office. Jodi Nudelman is the 
regional inspector general for evaluation and inspections for 
Region II at the U.S. Department of Health and Human Services, 
Office of Inspector General.
    Joining them on the panel will be Mike Taylor, FDA deputy 
commissioner for foods, and Steve Solomon, deputy assistant 
commissioner for compliance policy, from the Food and Drug 
Administration.
    The members of this subcommittee were the first to sound 
the alarm on the weaknesses of our food safety system. I look 
forward to hearing from our witnesses today about progress that 
has been made since we began pushing for reform more than 3 
years ago and about the weaknesses that remain until we have an 
effective food safety bill enacted into law.
    We are fortunate that today's hearing was prompted by the 
HHS and GAO reports rather than another widespread food 
outbreak like we saw with the spinach in 2007, peppers in 2008, 
and peanut butter in 2009. But make no mistake about it: 
Without legislative action, it is not a matter of if but when 
more lives will be put at risk by another outbreak. We cannot 
afford to put off action any longer.
    Mr. Burgess, opening statement, please?

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

    Mr. Burgess. I thank the chairman for the recognition.
    And I am pleased to join you and the other members on the 
committee as we convene this hearing on the role of the Food 
and Drug Administration to ensure food safety for the American 
public. Food safety reform is relatively controversial, yet a 
critical issue, competing for attention with a long list of 
domestic priorities.
    Last July, in a bipartisan fashion, the House passed food 
safety legislation. I supported the legislation because, while 
historically the performance of the FDA has been questioned, I 
felt this was partly a result of inadequate tools.
    But the enduring role of the Food and Drug Administration 
today still remains a very complex question. The House 
legislation did not address the future progress of future 
inspection and whether or not it is the proper role of both the 
Food and Drug Administration and the United States Department 
of Agriculture to continue their bifurcated jurisdiction over 
food. We heard, for instance, that a food such as pizza if it 
has only cheese on it is wholly the province of the Food and 
Drug Administration, whereas if it has pepperoni as well, it is 
in the province of the U.S. Department of Agriculture.
    One thing is crystal-clear without controversy: The future 
of the FDA should not be as a reactive body dictated by the 
events of yesterday, but rather an effective and efficient, 
proactive agency preventing the emergencies of tomorrow.
    And I agree wholeheartedly with the chairman of this 
subcommittee when he says it is not a question of if but when. 
Because, as we were coming into the room for this hearing 
today, across the newswire from the Columbus Dispatch, Federal 
health officials will come to Columbus this weekend to help 
determine what is responsible for a three-State E. coli 
outbreak that has sickened at least seven people there. So, as 
we see, even tomorrow's headlines today are being covered in 
this committee.
    It is important for the Food and Drug Administration as 
well as the industry to work cooperatively to reduce the number 
of and help prevent food-borne illnesses and contamination 
before the tainted products are able to enter the markets.
    The Food and Drug Administration should make maximum use of 
information technologies for risk assessment, but it has come 
to my attention and the attention of the committee that the 
Food and Drug Administration has delayed the rollout of the 
promising new system, PREDICT. PREDICT uses a variety of 
assessments to rank food import shipments according to risk. 
The system is currently in use in New York and Los Angeles, but 
the nationwide deployment was recently postponed indefinitely 
because of technical problems.
    And this is not the first time that we have heard of the 
failure of the Food and Drug Administration to keep pace with 
changes in technology. From the failures of the 510(k) medical 
device process to the backlog of new drug applications to the 
entire portfolio of food issues, the Food and Drug 
Administration regulates fully 25 percent of all government 
activity, yet the Food and Drug Administration remains 
technologically in the 1990s. This is why scientific innovation 
and information technology must play a central role in the 
prevention and the strategic analysis that is essential to a 
successfully functioning Food and Drug Administration.
    We are going to hear from four witnesses today, including 
two from the agency itself. And although much has been said 
about the past limitations of the agency and the uptick in 
funding shortfalls from a year ago, I do not believe that it is 
simply a resource question and that simply increasing the 
resources of the Food and Drug Administration will solve the 
problems outlined before us today. After numerous hearings, we 
have learned that simply providing more money to FDA will not, 
by itself, result in a safer food supply.
    From our agricultural imports to domestic manufacturing, 
the Food and Drug Administration must streamline the process 
and internal controls to identify high-risk products and 
manufacturers before tainted goods are able to enter the food 
supply. While continuing to collaborate with their counterparts 
at the USDA and the Customs and Border Protection, the Food and 
Drug Administration internal communications between Washington 
and their regional offices at home and abroad must be 
increased. Communication may not create the perfect system, but 
it will create a more reliable and a more efficient one.
    I am also interested in an update of the issues that still 
hinder work of the FDA and any new ideas you may have to foster 
innovation to improve the agency as a whole. As Commissioner 
Hamburg recently said, it is simply not possible for FDA to 
inspect our way to safety.
    Congress must advocate for an all-of-the-above approach in 
addressing food safety solutions. We must support and advocate 
for the FDA to continue to advocate for risk-based approaches 
to the inspection and testing processes, as well as support 
improvements to modernize scientific standards, safety 
controls, and information technology.
    While these update reports from the Government 
Accountability Office and from Health and Human Services 
Inspector General are helpful, their reports do not change the 
conversation regarding this domestic priority. Food safety is 
important. Food safety legislation has passed the House. Food 
safety is now awaiting Senate action.
    So I hope today's hearing is not just to continue to put 
pressure on the Senate to act for food safety. It is my 
understanding that the Senate is already planning to vote on 
this issue as soon as the Financial Services bill is finished. 
I hope, instead, we also ask questions about whether the 
progress and the evolution of food safety requires more 
advancements than red-tape bureaucracy than the government will 
logically allow.
    I would like to thank the chairman again, and I look 
forward to the testimony of our witnesses and to our questions.
    I will yield back.
    [The prepared statement of Mr. Burgess follows:]

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    Mr. Stupak. Thank you, Mr. Burgess.
    Mr. Waxman, full committee chairman, opening statement 
please, sir?

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

    Mr. Waxman. Thank you very much, Mr. Chairman. I want to 
commend you for calling this important hearing and to examine 
the role of FDA in protecting the Nation's food supply.
    Today we are going to hear from two reports, one from GAO, 
the other from HHS Inspector General, about the FDA 
performance. These two reports tell a story of an agency that 
is trying to keep the food supply safe but needs new 
authorities, more effective tools, and increased funding to 
meet its obligation.
    In GAO's report, it found that FDA needs to coordinate its 
enforcement efforts better with other agencies. For example, 
FDA and Customs and Border Protection should be able to work 
together to assign a unique identification number to firms that 
import our food. This is currently not the case. In fact, there 
are some that have more than three identifiers, and GAO found 
one firm had 75. These multiple identifiers make it more 
difficult for FDA to track foods that are imported.
    GAO also questioned whether FDA's current penalties are 
sufficient to keep an importer from violating FDA requirements.
    The OIG report focused on FDA's inspection of domestic food 
facilities. They found that FDA inspected only 24 percent of 
food facilities each year between 2004 and 2008. The number of 
FDA inspections declined during that time, even as the number 
of facilities increased. Over the course of 5 years, FDA failed 
to inspect 56 percent of facilities that were subject to its 
authority and only inspected an additional 14 percent.
    These two reports are very disturbing. It is a similar 
story to what we heard last year. We were told in the two 
hearings on salmonella outbreak in peanut butter that sickened 
over 700 people--and the investigators revealed executives at 
the Peanut Corporation of America knew their peanuts were 
testing positive for salmonella, but they chose to ship the 
tainted food anyway.
    Many of the concerns raised in these two reports and in the 
wake of the salmonella outbreak are addressed by the Food 
Safety Enhancement Act of 2009, which the House passed on a 
bipartisan basis. The legislation contains critical fixes. I am 
pleased that we are holding this important hearing. I hope the 
Senate will act soon and we will have this new legislation in 
place. And I hope we will see, through the efforts of 
legislation and oversight, a more comprehensive food safety 
regimen at FDA.
    Thank you for holding the hearing. I yield back my time.
    Mr. Stupak. Thank you, Mr. Chairman.
    Mr. Latta for 3 minutes?
    We will try to get them in.

OPENING STATEMENT OF HON. ROBERT E. LATTA, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF OHIO

    Mr. Latta. Well, thank you very much, Mr. Chairman and 
Ranking Member Burgess.
    First of all, thanks for holding this subcommittee hearing 
on the Food and Drug Administration ensuring food safety. And 
it is also an honor being recently appointed on the Energy and 
Commerce Committee, and I look forward to working with you on 
the important issues that come before the Oversight and 
Investigations Subcommittee.
    Instances of contaminated food products are a serious 
concern for the public. Just last week, the FDA announced that 
contaminated materials were used in production of several lots 
of pediatric Tylenol products. About 1,500 lots of the bottled 
products are currently being recalled. Furthermore, as the 
percentage of U.S. food supply imported from foreign countries 
increases and bioterrorism continues to be a threat, food 
safety is a critically important issue.
    Last summer, the House debated H.R. 2749, the Food Safety 
Enhancement Act, and it is expected that the Senate will soon 
take action on the legislation.
    I represent the largest agricultural district in the State 
of Ohio and am a member of the House Agriculture Committee. I 
believe that H.R. 2749 did not adequately address the concerns 
of the agricultural community, nor was it referred to the 
Agriculture Committee at that time for any hearings. 
Additionally, the Congressional Budget Office estimates that 
H.R. 2749 will authorize $2.314 billion over fiscal years 2010 
through 2014 and that it will take $3.5 billion for the FDA to 
administer the new regulatory activities under the legislation 
at that time.
    The spending level authorized by H.R. 2749 is of grave 
concern, especially when the September 2009 GAO report found 
that gaps in enforcement and collaboration currently undermine 
food safety efforts among Customs and Border Patrol, the FDA, 
and USDA's Food and Safety Inspection Service. Furthermore, the 
same report indicates there is a lack of information sharing 
between the FDA and States during a recall, which impedes 
States' efforts to quickly remove contaminated food.
    The safety and security of the Nation's food supply is of 
utmost importance; however, with 15 Federal agencies already 
administering at least 30 Federal laws concerning food safety, 
I am concerned of the prospect of an increased size in the 
bureaucracy, budget, and statutory authority for the FDA when 
improvements in communication, collaboration, and technology 
have been recommended by the GAO.
    Mr. Chairman, I thank you for this opportunity. I look 
forward to hearing the testimony from the witnesses on the 
panel today. And I yield back.
    [The prepared statement of Mr. Latta follows:]

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    [GRAPHIC] [TIFF OMITTED] T6573A.007
    
    Mr. Stupak. Thank you, Mr. Latta. Good to have you on 
board. Look forward to working with you.
    Mrs. Christensen for 3 minutes, please?
    Mrs. Christensen. Thank you. I will try to be shorter than 
that.
    Every year, 300,000 people in this country are hospitalized 
and 5,000 die after consuming contaminated food or beverages. 
So thank you, Chairman Stupak and Ranking Member Burgess, for 
following up on this issue.
    It is very important that we explore the weaknesses in the 
food safety network and the coordination, or lack of it, 
between CBP, FSIS, and FDA, as well as any new authorities 
these agencies might need. So I just look forward to hearing 
the testimony of our witnesses and to working with the 
subcommittee and the larger committee to address the gaps in 
our food safety system.
    And thank you, Chairman Stupak, once again, for holding 
this hearing on this issue that is really vital to the safety 
and health of everyone who lives in this country.
    Mr. Stupak. Well, thank you.
    And we have 2 minutes left to vote. We have a series of 
votes. There are four votes, plus a motion to recommit. So we 
are going to stand in recess until 3:15.
    So this committee will be in recess until 3:15.
    [Recess.]
    Mr. Stupak. The committee will come to order.
    Mr. Dingell, do you have an opening statement, sir?
    Mr. Dingell. Mr. Chairman, I will dispense with my opening 
statement. I thank you.
    Mr. Stupak. Very good.
    Then that concludes the opening statements by members of 
the subcommittee. I call our first panel.
    On our first panel we have Mr. Michael Taylor, deputy 
commissioner for foods with the Food and Drug Administration; 
accompanying him is Mr. Steven Solomon, assistant commissioner 
for compliance policy at the Food and Drug Administration; Lisa 
Shames, director of agriculture and food safety at the 
Government Accountability Office; and Ms. Jodi Nudelman, 
regional inspector general for evaluation and inspections for 
the Health and Human Services Office of Inspector General.
    We welcome you all.
    It is the policy of this subcommittee to take all testimony 
under oath. Please be advised that you have the right, under 
the rules of the House, to be advised by counsel during your 
testimony. Do you wish to be represented by counsel?
    Everyone is shaking their head ``no,'' so I will take it as 
no.
    Please then rise, raise your right hand, and take the oath.
    [Witnesses sworn.]
    Mr. Stupak. Let the record reflect the witnesses replied in 
the affirmative.
    You are now under oath.
    We are going to begin with your opening statement of 5 
minutes, please. If you would like to submit a longer statement 
for the record, it would be accepted.
    Mr. Taylor, shall we start with you?

TESTIMONY OF MICHAEL R. TAYLOR, DEPUTY COMMISSIONER FOR FOODS, 
FOOD AND DRUG ADMINISTRATION, ACCOMPANIED BY STEVEN M. SOLOMON, 
    ASSISTANT COMMISSIONER FOR COMPLIANCE POLICY, OFFICE OF 
REGULATORY AFFAIRS, FOOD AND DRUG ADMINISTRATION; LISA SHAMES, 
       DIRECTOR, AGRICULTURE AND FOOD SAFETY, GOVERNMENT 
   ACCOUNTABILITY OFFICE; JODI NUDELMAN, REGIONAL INSPECTOR 
 GENERAL FOR EVALUATION AND INSPECTIONS, REGION II, HEALTH AND 
           HUMAN SERVICES OFFICE OF INSPECTOR GENERAL

                 TESTIMONY OF MICHAEL R. TAYLOR

    Mr. Taylor. Yes, sir.
    Good afternoon, Mr. Chairman, Ranking Member Burgess, and 
members of the subcommittee. I am pleased to be here today with 
my colleague, Dr. Steven Solomon, and to have this chance to 
talk with the committee about FDA's food safety program.
    I also want to really thank you, Mr. Chairman, as well as 
Chairman Dingell, Chairman Waxman, and all the members of the 
committee, for your leadership in passing the Food Safety 
Enhancement Act, which we do hope will soon go to conference 
with the bill now pending in the Senate.
    As you know, food safety is an important priority for the 
Obama administration. Soon after taking office, the President 
established a Food Safety Working Group which brought together 
experts from all Federal agencies with responsibilities related 
to food safety.
    In its July 2009 report, the working group recognized the 
challenges posed by a rapidly changing and globalized food 
supply and the need to shift our focus to preventing food 
safety problems throughout the system. The working group also 
recognized the importance of inspections, recommending that the 
government prioritize crucial inspection and enforcement 
activity, build on and enhance State and local food safety 
efforts, and utilize better data to guide these efforts and 
evaluate their outcomes.
    In August of 2009, Commissioner Margaret Hamburg created my 
office, the Office of Foods, to lead a unified FDA foods 
program and to enhance FDA's ability to meet today's challenges 
in food safety. We recently launched the One Mission, One 
Program initiative, which involves over 100 experts from 
throughout FDA who are addressing topics crucial to the future 
success of the foods program and the implementation of the 
anticipated new legislation. This includes an inspection and 
compliance strategy group that is looking hard at the way we 
conduct inspections.
    FDA's food safety inspections have focused traditionally on 
identifying sanitation, manufacturing, and product 
contamination problems in food facilities and gathering 
evidence of regulatory violations for use in possible 
enforcement cases. These efforts have contributed significantly 
to food safety over the years, but the preventive control 
requirements and other new tools provided by H.R. 2749 would 
greatly enhance the ability of FDA investigators and FDA 
inspections to protect public health.
    We will, of course, continue to act to remove contaminated 
food from commerce, but our focus will shift from collecting 
evidence of food safety problems after they have occurred to 
ensuring that food companies are doing what is necessary to 
prevent problems in the first place.
    Our goal needs to be high rates of compliance with the 
prevention-oriented standards envisioned by H.R. 2749. And to 
achieve this, we envision our investigators conducting a wider 
array of inspection activities than is common today and 
targeting those activities in ways that get the maximum 
compliance and public health bang for the buck.
    The recent Office of Inspector General report on domestic 
inspections is a useful snapshot of FDA's food safety system as 
it has existed in recent years. OIG has identified areas of 
opportunity for enhancing FDA's enforcement authority, and FDA 
has already addressed many of the issues noted in the report.
    For instance, improving the speed and predictability of 
follow-up to inspections and strengthening the agency's 
enforcement program are top agency goals. Last August, 
Commissioner Hamburg announced six initiatives to ensure that 
enforcement actions taken by the agency are swift, aggressive, 
and will have a positive impact on public health.
    FDA appreciates OIG's recognition of the gaps in the 
agency's inspection authority, and we support their legislative 
recommendations. These include the use of civil monetary 
penalties for FD&C Act violations related to food and the 
authority provided in Section 106 of H.R. 2749 for routine 
access to all records bearing on whether a food may be in 
violation of the act.
    The GAO report of September 2009 raised some important 
issues relating to the safety of imported food. The agency 
agrees with many of GAO's recommendations, and we are working 
to incorporate them into both short-term and long-term 
initiatives.
    The report looked at FDA's new PREDICT system for targeting 
import shipments. This technology, which is deployed in Los 
Angeles and New York, will improve import screening and 
targeting to better prevent the entry of unsafe foods and 
expedite the entry of non-violative foods. A pilot test of the 
prototype system showed that PREDICT works to target shipments 
that are more likely to be found violative when examined by 
FDA.
    FDA has encountered problems with rolling out PREDICT 
nationwide due to difficulties with incorporating it into the 
agency's outdated IT infrastructure, which is now undergoing 
major upgrades. These problems have delayed the full deployment 
of PREDICT, but we will continue to move forward as 
expeditiously as possible, with full roll-out anticipated by 
the end of the year. And we will continue to evaluate and 
strengthen PREDICT as the project progresses.
    FDA was encouraged that GAO recognized the importance of 
new legislative authorities as a key to strengthening FDA's 
oversight of imported foods. In accordance with GAO's 
recommendations, FDA is working with Congress to obtain 
authority for civil money penalties and to acquire the use of a 
unique identifier by food facilities, both of which are 
provided by H.R. 2749.
    The House bill will provide other valuable tools for 
ensuring that importers reliably verify--and this is really 
important--reliably verify that the foods they import are 
produced in accordance and compliance with the same prevention-
oriented standards that we would make applicable to foods 
produced in the United States. We all know that for our food 
safety system to be effective, prevention must begin at the 
point of production, not at the port of entry.
    Mr. Chairman, protecting our Nation's food supply remains a 
top priority for FDA and the administration. We really are at a 
historic moment for food safety in the United States. As we 
work collaboratively to improve our authorities, our practices, 
and our policies, it will enable us to meet the food safety 
challenges of the 21st century. And we appreciate the support 
of this committee and look forward to working with you in the 
future.
    Thank you.
    [The prepared statement of Mr. Taylor follows:]

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    Mr. Stupak. Thank you.
    Mr. Solomon, do you have anything to add?
    Mr. Solomon. No, thank you.
    Mr. Stupak. Ms. Shames, would you like to do an opening 
statement?

                    TESTIMONY OF LISA SHAMES

    Ms. Shames. Yes, thank you.
    Chairman Stupak, Ranking Member Burgess, and members of the 
subcommittee, I am pleased to be here today to discuss FDA's 
oversight of imported food.
    Effective FDA oversight is critical to public health. About 
60 percent of fresh fruits and vegetables and 80 percent of 
seafood are imported.
    My testimony today will focus on three key issues: FDA's 
overseas inspections of imported food; gaps in import 
enforcement; and statutory authorities that could further help 
FDA.
    First, regarding the inspections: The number of FDA's 
overseas inspections has fluctuated since 2001. As shown in 
Table 1, annual inspections ranged from 95 to 153 out of an 
estimated 189,000 foreign firms. These inspections were 
conducted in 56 countries, mostly in Mexico. FDA conducted 46 
inspections in China during this time frame.
    To augment these inspections, FDA has opened offices in 
China, Costa Rica, and India and plans to open more in Mexico, 
Chile, the Middle East, along with the European Union.
    In addition, PREDICT, a risk-based computer program is to 
assist FDA inspectors flag higher-risk food shipments. As Mr. 
Taylor said, a pilot test of PREDICT was promising. PREDICT 
nearly doubled the percentage of field examinations that 
resulted in violations. However, FDA told us that PREDICT's 
nationwide roll-out has been delayed, primarily because of 
technical problems.
    Second, we identified several gaps in enforcement that 
could allow food with safety violations to enter U.S. commerce.
    One gap is that FDA has limited authority to assess civil 
penalties on violators. Importers post a monetary bond for 
shipments to provide assurance that they meet U.S. 
requirements. However, even though the bond may be up to three 
times the value of the shipment, this sum may be negligible for 
a large importer. An unscrupulous importer may consider 
forfeiting the bond as a part of the cost of doing business. 
FDA agreed with our recommendation that it seek authority to 
assess penalties. We note that H.R. 2749 provides for assessing 
penalties.
    A second gap is the lack of unique identification numbers. 
Importers get computer-generated ID numbers from FDA. Because 
importers may provide their names and addresses slightly 
differently for each shipment, multiple identifiers are 
generated. FDA officials told us that firms have, on average, 
three unique identifiers, and one firm had 75. In addition, 
foreign firms are to register with FDA and are assigned a 
registration number, as well. FDA told us that there may be 
duplicate registration numbers, as well. FDA agreed with our 
recommendation to pursue the use of specific identifiers. H.R. 
2749 also provides for such a unique identifier system.
    A third gap is that FDA does not share product distribution 
lists with States during a food recall because the information 
is considered commercially confidential. State officials told 
us that, without this information, they lose time removing 
recalled food from grocery shelves. FDA agreed with our 
recommendation to find ways to share information to the States.
    On a positive note, one gap we found appears to be 
resolved. We were told that FDA now receives the arrival time 
of imported food shipments. This can help FDA coordinate any 
further review for high-risk imports.
    Finally, we have made several recommendations that would 
help FDA improve food safety oversight. GAO has called for 
mandatory food recall authority. Currently, food recalls are 
voluntary, and FDA has no authority to compel companies to 
recall contaminated foods except for infant formula. Other 
government agencies that regulate other products, such as toys 
or car tires, have recall authority and have had to use it when 
companies did not cooperate.
    FDA should also strengthen its oversight of food 
ingredients determined to be generally recognized as safe, or 
GRAS. Companies may conclude a substance is GRAS without FDA's 
approval and even without its knowledge because companies are 
not required to inform FDA. FDA generally agreed with our 
recommendation that it develop a strategy to require companies 
to provide basic information about their GRAS determinations 
and, in view of emerging science, to conduct reconsiderations 
of GRAS ingredients.
    We also recommended that FDA seek any statutory authority 
that the agency determines it needs to implement our 
recommendations.
    And, lastly, FDA agreed with our recommendation that it 
seek authority to issue regulations for preventive controls for 
high-risk food. As Mr. Taylor said, FDA already has regulations 
for preventive controls for seafood and juice which require 
firms to analyze safety hazards and implement plans to address 
those hazards. FDA officials told us that issuing regulations 
for preventive controls might be one of the most important 
things that they can do to enhance the oversight of fresh 
produce.
    We note that H.R. 2749 contains provisions that address 
mandatory recall, GRAS ingredients, and preventive controls.
    In conclusion, a substantial volume of our food supply is 
imported. Our work has shown that FDA could strengthen its 
oversight of imported food and close gaps in its enforcement by 
assessing penalties, developing unique identifiers, and sharing 
information with State agencies. Additional statutory 
authorities to conduct a mandatory recall and to establish 
preventive controls could further help FDA's food safety.
    Mr. Chairman, this concludes my prepared statement, and I 
would be happy to answer any questions that you or other 
members of the subcommittee may have. Thank you.
    [The prepared statement of Ms. Shames follows:]

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    Mr. Stupak. Thank you.
    Ms. Nudelman, your opening.

                   TESTIMONY OF JODI NUDELMAN

    Ms. Nudelman. Good afternoon, Chairman Stupak, Ranking 
Member Burgess, and other members of the subcommittee. I am 
Jodi Nudelman, regional inspector general in New York for the 
U.S. Department of Health and Human Services Office of 
Inspector General. I appreciate the opportunity to appear 
before you today to discuss our most recent review of FDA's 
food inspections program.
    FDA's inspections are an important tool for ensuring food 
safety. Recent outbreaks, however, such as the salmonella 
outbreak caused by peanuts in 2009, have raised questions about 
FDA's inspection process and its ability to protect the 
Nation's food supply.
    Our most recent review focused on FDA's inspections of 
domestic food facilities. In brief, our review found that more 
than half of food facilities went 5 or more years without an 
inspection. We also found that the number of FDA inspections is 
going down, even as the number of food facilities is going up. 
In 2004, FDA inspected over 17,000 facilities. In 2008, this 
number dropped to fewer than 15,000. The number of high-risk 
facilities inspected also declined during this time. If FDA 
does not routinely inspect food facilities, it cannot be sure 
that these facilities are complying with the law and that the 
food they handle is safe.
    Our review also found that FDA's inspectors are identifying 
fewer violations in food facilities. During an inspection, an 
inspector may find violations of FDA's regulations or laws. 
Based on the nature of the violations, he or she may assign the 
facility a classification. In the most severe cases, the 
inspector will assign the facility an OAI classification, which 
means ``official action is indicated.'' Between 2004 and 2008, 
the number of facilities that received OAI classifications 
dropped from about 600 to less than 300.
    Most commonly, facilities received OAI classifications for 
unsafe practices and unsanitary conditions in the facility. 
These classifications resulted from violations such as food not 
being adequately refrigerated or evidence of rodent 
infestation. We also found that nearly three-quarters of the 
facilities that received OAI classifications had a history of 
violations. Even more concerning, half of these facilities had 
been cited for the exact same violation in a prior inspection.
    Further, our report found that FDA did not always take 
swift and effective action to remedy the violations. When a 
facility receives an OAI, FDA should consider taking some type 
of regulatory action. In the year that we studied, FDA took 
regulatory action against 46 percent of the facilities that 
received OAIs. For the remaining, FDA either lowered the 
classification or took no regulatory action.
    Moreover, for a third of the facilities with OAIs, FDA did 
not take additional steps to ensure that the violations were 
corrected. This means that FDA did not reinspect these 
facilities in a timely manner or review any other evidence to 
determine whether the violations were corrected.
    Based on these findings, we made six recommendations to 
FDA. We recommended that FDA increase the frequency of its 
inspections, especially its high-risk inspections; provide 
additional guidance about when to lower OAIs; take appropriate 
action against facilities with OAIs; ensure that violations are 
corrected; seek the authority to access facilities' records 
during an inspection; and, finally, consider seeking the 
authority to impose civil penalties through administrative 
proceedings.
    In conclusion, our report identified significant weaknesses 
in FDA's inspections program. We found that many food 
facilities go without routine inspections. We also found that, 
when FDA finds violations, it does not always take swift and 
effective action to ensure that the violations are remedied. 
Taken together, our findings demonstrate that more needs to be 
done to protect public health and to ensure that FDA has the 
necessary tools to keep food safe.
    This concludes my testimony, and I welcome your questions.
    [The prepared statement of Ms. Nudelman follows:]

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    Mr. Stupak. Thank you.
    And thank you to all the witnesses for your testimony.
    And let me just apologize. We got tied up on the floor. I 
thought we would be back by 3:15. It was about a half-hour 
later. You never know what happens when you get to the floor.
    We will now move to questions.
    Mr. Taylor, let me ask you this. The FDA announced a 
lettuce recall today. Freshway Foods is doing a voluntary 
recall of shredded romaine lettuce with a use on date by May 
12th--or use on or before May 12th. I guess three people have 
been hospitalized.
    In the trace-back, do we have any idea of where that 
romaine is originating from?
    Mr. Taylor. Our understanding of the investigation so far 
is it came from a production site in Arizona, in Yuma, Arizona, 
where this company had its growing operations. We don't know 
the cause of contamination, but we do know that there was 
product contaminated, people got sick. And so this recall is 
highly appropriate to protect the public health.
    Mr. Stupak. Is the lettuce strictly grown in Arizona, or is 
it mixed with lettuce from Mexico, as we have seen in the past?
    Mr. Taylor. Well, this is romaine that is grown just in 
Arizona. And it is sold to institutions in a bulk sort of form, 
is the general way in which this product is distributed.
    Mr. Stupak. If I remember correctly, when we were out in 
California, you were there with us, and we were doing some of 
the farming there. And I thought Arizona and California had a 
very good trace-back method. You could almost tell from what 
field it came from. Would you care to comment on this in the 
matter of this case?
    Mr. Taylor. Well, in this case, once we had the company 
identified, there was not a problem getting back to the source 
of production.
    Mr. Stupak. OK. So the production field produced right 
there, and you don't know if it is in machinery or whether it 
was the growing site.
    Mr. Taylor. We don't know--yes, we are investigating, we 
are back at the farm investigating the cause, so that 
investigation goes on. But, as you know, there can be multiple 
vectors, avenues for getting this kind of contamination into an 
open field where product is growing.
    Mr. Stupak. Right. It was for romaine that was used by the 
May 12th. Today is May 6th. How long has this investigation 
been going on?
    Mr. Taylor. The first cases go back to--the first onset of 
illness goes back to April 6th. But it has been only in the 
last week or 10 days that we became aware of this. There is 
that lag factor between people first becoming ill and it 
getting reported.
    Mr. Stupak. Right.
    Mr. Taylor. And we found yesterday a positive sample of 
lettuce, which really confirmed the epidemiological hypothesis 
that this product was responsible for the problem. So there was 
actually a very swift recall response once the evidence fell 
into place.
    Mr. Stupak. And I take it Freshway Foods has been 
cooperative, no problems there?
    Mr. Taylor. They have worked closely and responded very 
quickly when the evidence came into place.
    Mr. Stupak. OK.
    Ms. Nudelman, let me ask you this. I am looking at page 10 
of your report. That is where you start with Table 1, food 
facilities inspected by the FDA, fiscal year 2004 through 2008. 
And I think you testified the average of the inspections were 
about 24 percent of all the places inspected. Correct?
    Ms. Nudelman. Yes.
    Mr. Stupak. Now, the one that struck me was, in 2004 you 
had 59,305 facilities should be inspected; by 2008, it has 
grown to 67,819. If my math is correct, that is about 8,514 new 
facilities in less than 5 years.
    How is the FDA going to keep up with more and more 
facilities without the resources?
    Ms. Nudelman. I think that is a good question. I mean, 
clearly we document the number of facilities has grown and, at 
the same time, the number of inspections has declined.
    I think the other important factor in this is the number of 
high-risk inspections that are completed. And that is one way 
to target resources and target----
    Mr. Stupak. Right. Well, if we jump to the next table, that 
is Table 2, which is the high-risk facilities inspected by the 
FDA and, again, through the same years, 2004 to 2008. You have 
had, again, more high-risk facilities come online, about 565, 
if my math is correct here. The number of inspections has 
actually dropped from 77 percent to 63 percent.
    Any correlation during that period of time from 2004 to 
2008, how many inspectors did the FDA have? Did the number of 
inspectors go down?
    Ms. Nudelman. That is correct. And this is one of the 
things that FDA talked about in terms of the reason why there 
was a decline in the number of high-risk inspections as well as 
the number of overall inspections.
    Mr. Stupak. Let me go to your next chart on page 12, again, 
number of inspections per facility between 2004 and 2008. I 
take it facilities inspected more than three times, there is 21 
percent of them, were probably the greater or high-risk foods.
    Ms. Nudelman. I am not positive about that. That makes 
sense to me, but I am not--I can look at that in a little bit 
more detail for you.
    Mr. Stupak. All right.
    Let me go to the bottom of page 14. In your report, you 
were talking about the FDA OAI classifications--refused to 
grant FDA officials access to their records. Most of the 
facilities had a history of violations. Then you say the FDA 
does not have statutory authority to require food facilities to 
provide access to these records.
    Do you know if the FDA ever received those records in these 
four or five cases?
    Ms. Nudelman. In the reports that we looked at, that was 
for 2008, and it just documented clearly the types of records 
that they did not receive. I don't know. And maybe FDA has a 
better sense of that.
    Mr. Stupak. Yes, I was going to ask Mr. Taylor.
    Any comment on that? Do you know if they ever received 
those records?
    Mr. Taylor. We got what we felt was a satisfactory 
resolution. Dr. Solomon can walk you through the details of 
each one. It varied from case to case. But, in some cases, we 
went ahead and got injunctions to solve the problem or took 
other forms of enforcement action. And if you would like, we 
can put----
    Mr. Stupak. Sure. Just quickly, if you could just tell us 
what would happen on those.
    Mr. Solomon. In one of those cases, we actually used the 
authority under the Bioterrorism Act, 414, to meet that 
threshold to have to request those records. Obviously, that 
delayed us.
    In two of the other cases, we conducted an injunction in 
order to try and get those records and requesting others for--
--
    Mr. Stupak. Injunction would stop them from doing what, 
shipping their product?
    Mr. Solomon. We were able to stop them from shipping 
product, and, at the same time, we used that consent decree 
that was signed to go to the suppliers there and get the 
information that we needed to control the product.
    Mr. Stupak. OK. So you went to the supplier to find out 
what the facility was doing?
    Mr. Solomon. Correct.
    Mr. Stupak. OK.
    Mr. Solomon. So these were longer processes that took us to 
try and get the records that were needed.
    Mr. Stupak. Sure. OK.
    My time is up. Mr. Burgess for questions?
    Mr. Burgess. Just staying with that concept for a minute, 
Mr. Taylor and Mr. Solomon, on the food safety bill that we 
passed out of this committee that is now awaiting activity over 
in the Senate, there is a provision for emergency recall, which 
I think you referenced, Mr. Solomon, as part of the 
bioterrorism defense. But, still, it is a voluntary recall 
under the bill that we passed.
    Is that your understanding, as well?
    Mr. Solomon. We don't currently have mandatory recall 
authority, which is part of the Food Safety Enhancement Act.
    Mr. Burgess. And after the passage of this legislation, is 
that a deficiency that you feel will be corrected? Or will you 
still be relying on the emergency provisions of the 
Bioterrorism Act to have that emergency provision?
    Mr. Solomon. We could use all the tools available, and we 
would use that mandatory recall authority if that was necessary 
in order to effectuate getting product removed from the market.
    Mr. Taylor. If I may add, the bill, 2749, would also give 
us routine records access, so the company would be obligated to 
provide the records we need to conduct an investigation and to 
find and discover the problems and solve the problems.
    Mr. Burgess. Mr. Taylor, congratulations on your new post--
--
    Mr. Taylor. Thank you, sir.
    Mr. Burgess [continuing]. I think, I hope, for you.
    How many people currently work in your office?
    Mr. Taylor. Well, in my immediate Office of Foods, it is a 
very small staff of about 15 people. But we really work within 
the overall foods program. There is the Center for Food Safety 
and Applied Nutrition, the Center for Veterinary Medicine, and 
then the large field force. So, you know, there are upwards of 
5,000 people in the foods program.
    But this new office that the commissioner created is a 
small leadership office, essentially.
    Mr. Burgess. OK. Do you plan on expanding it?
    Mr. Taylor. The immediate office will grow slightly, but 
the last thing we want to do is to try to manage the program 
from the Office of Foods. We have great management teams and 
people throughout the foods program and these organizations, 
and our job is to lead and to unify and elevate their work 
within the FDA.
    Mr. Burgess. So, you just referenced the Center for 
Veterinary Medicine. Those directors report to you, as well?
    Mr. Taylor. Yes, sir. The director of the Center for 
Veterinary Medicine reports to me, as does the director of the 
Center for Food Safety and Applied Nutrition.
    Mr. Burgess. At this point, are you considering merging the 
Center for Food Safety as well as the Center for Veterinary 
Medicine?
    Mr. Taylor. We have no plans to merge the organizations. We 
are looking at how we manage this program in a unified way and 
how we can be sure that we are really able to empower the 
people in these organizations to accomplish the things they are 
setting out to accomplish. And so we are looking at how we 
manage the program, but we have no plan for mergers at this 
point.
    Mr. Burgess. Let me just ask you a couple of questions 
about PREDICT since that has come up in your testimony as well 
as the testimony of the GAO. It holds promise, correct?
    Mr. Taylor. Yes, sir.
    Mr. Burgess. But there were problems.
    Mr. Taylor. Yes.
    Mr. Burgess. And those problems were related to the status 
of the IT systems that are surrounding it?
    Mr. Taylor. Yes, sir. Really--and I am not the IT expert on 
the case, but it is really a function of the aging IT 
infrastructure, the servers, the basic equipment that supports 
the IT system.
    And so what happened, in lay terms, is a combination of 
things. You put this whole new application onto the system, 
which put extra demand on the system. And it was happening at 
about the time that we have grown our field workforce. We have 
been able, with resources Congress has provided over the last 
couple of years, to hire additional inspectors and other people 
in our field force.
    So that combination of extra demands on an aging IT 
infrastructure resulted in slowdowns and some, you know, 
servers going down. And the IT people realized that that aging 
infrastructure could not support the new system.
    But, again, with resources Congress has provided, we are 
making the investments to upgrade that infrastructure. So, you 
know, that upgrade and the imperative to test that carefully 
and be sure that when we do implement--you know, that is 
pushing back implementation. But we hope to roll out PREDICT 
nationwide by the end of the year. That is our goal.
    Mr. Burgess. You anticipated my question. But I was going 
to ask you, you have developed a strategic plan for dealing 
with the deficiencies in the IT architecture?
    Mr. Taylor. Yes, sir. We have the--you know, upgrades are 
being made; it is being tested. You know, we will test the 
PREDICT system before we make it operational. But the IT folks 
are confident that we will have the infrastructure to support 
this and, you know, make it serve the function that we know it 
can, which will really be much better targeting of imports.
    Mr. Burgess. So when we have this hearing a year from now, 
you will be able to report to me----
    Mr. Taylor. I will be here, yes----
    Mr. Burgess [continuing]. Satisfactorily that it has been 
up and running for 6 months and it is targeted and in the right 
place?
    Mr. Taylor. That is our absolute aspiration and goal. We 
are working hard to achieve it. And we welcome coming back and 
giving that answer.
    Mr. Burgess. You can understand the frustration of people 
who--you know, we are requiring every physician's office across 
the country to make great investments in information 
technology, and our own FDA, which is our premiere Federal 
agency that handles 25 cents out of every Federal dollar, at 
least domestically, has been unable to meet its own challenge.
    Clearly, we have to get our own house in order before we 
can be too critical of other people who have been slow in that 
regard, as well.
    Mr. Taylor. I understand.
    Mr. Burgess. I am going to yield back to the chairwoman.
    Mrs. Christensen [presiding]. Thank you, Mr. Burgess.
    The chair is now really honored to recognize our chairman 
emeritus, Mr. Dingell, for questions.
    Mr. Dingell. Thank you, Madam Chairman. I commend you for 
the way you are presiding, and I thank you for being 
recognized.
    I want to begin by commending Chairman Stupak and the 
committee for this hearing. And I want to observe that this 
committee has completed a rather remarkable piece of 
legislation with regard to food safety that rests comfortably 
in the arms of the United States Senate. As my old daddy used 
to say, that is the place where good legislation goes to die.
    Regrettably, the points made by the witness on behalf of 
the GAO are very much on point. Her observation of the two 
statutory methods that need to be added to the arsenal of FDA 
are included in that legislation.
    I know this is going to sound a little hostile to the 
panel, but I want to begin by commending--and I want you to 
understand, there is nothing hostile in these questions. But I 
want to lay the framework of understanding how the events about 
which we are surrounded affect what it is we are doing.
    And I will start by observing that FDA, in 2008, inspected 
153 foreign food facilities out of 189,000 such facilities 
registered with FDA. That is, of course, only a small fraction 
of the, in fact, number of worldwide sources of foods imported 
to the United States. But we were able, in each of those years, 
according to GAO, to investigate only a very small number of 
the massive numbers of exporters into the United States.
    I noted, with regard to China, FDA conducted 46 inspections 
to China. China is one of the biggest exporters of food to the 
United States. I observe that that is a country which sends us 
melamine in milk products, mushrooms, vegetables, fish, 
shellfish, and other food products that are contaminated, 
dirty, filthy, or adulterated.
    And, frankly, again, the legislation to which we address 
ourselves sits over there in the Senate. That is a remarkable 
piece of legislation which came out of this committee 
unanimously with the full support of every single Member. And 
the leadership of this subcommittee made it possible for that 
legislation to move because of the way Mr. Stupak and the 
members of the committee, including my colleagues on the 
minority side, worked very hard to see to it that this 
legislation had not only a proper flooring and support but also 
a full justification.
    Now, having said these things, I would like to make a quick 
observation and then a question.
    Since 2007, FDA has had two major outbreaks linked to 
peanut butter, involving hundreds of illnesses and nine deaths. 
That is out of about the 5,000 deaths that exist in this 
country.
    And now I would like to address the types of enforcement 
action that have been taken against the companies. I would note 
that the GAO asserts that additional authority to routinely 
inspect records, detain food, subject violators to civil 
penalties, subpoena witnesses to help stepped-up enforcement 
efforts would be significantly helpful.
    Am I correct in that, to my witnesses down there, 
particularly you, Commissioner, and you, ma'am, from the GAO?
    Mr. Taylor. Yes, sir. Those new authorities are crucial to 
our doing our job.
    Mr. Dingell. Now, I note FDA's budget anticipates hiring 
129 new food and safety inspectors based on revenue from the 
registration and reinspection fees in H.R. 2749.
    What will happen, if you please, to its plans to hire these 
129 new inspectors if these fees are not included in the bill 
that the President signs as they are in the budget?
    Mr. Taylor. We won't be able to hire those inspectors. And, 
you know, we need more inspections to ensure the safety of 
food.
    Mr. Dingell. That means that the ongoing record of dismal 
ability to investigate or to inspect food processors will 
continue unabated.
    Mr. Taylor. Yes, sir.
    Mr. Dingell. Now, I note that the Peanut Corporation of 
America recall, while it was still ongoing, one of the 
companies that received the PCA product, Westco Fruit and Nut 
Company, refused FDA access to important safety records and 
refused to conduct a voluntary recall, and FDA seized the 
product of the company.
    Now, I note that we should address--in that instance, Food 
and Drug would be able, had the legislation been passed, to use 
the mandatory recall authority to remove products that are 
already on the market. Is that not so?
    Mr. Taylor. Yes, sir, that is correct.
    Mr. Dingell. Now, how would such mandatory recall authority 
result in a different outcome in the Westco case?
    Mr. Taylor. Well, we could have directed that firm to 
recall that product, to stop distribution, withdraw the product 
from the market. We wouldn't have to have been in a lengthy 
discussion and then have to go to court and get a judicial 
intervention. We could have acted swiftly with those----
    Mr. Dingell. In other words, all of this sawing of the air 
would have to go on while people were dying of bad peanut 
butter.
    Mr. Taylor. Again, if we are delayed in removing product 
from the market, people are at risk.
    Mr. Dingell. Now, following the outbreak in the recall 
first linked to tomatoes and later to jalapeno and serrano 
peppers, the inspector general identified weaknesses in the 
current one-up/one-down traceability system, including bad 
record-keeping, lack of access to records, and firms that 
didn't know about the requirements.
    Has FDA's experience in other outbreaks confirmed flaws in 
the one-up/one-down traceability?
    Mr. Taylor. Yes, sir. I mean, that requires a lot of shoe 
leather by FDA. It is an old-fashioned paper system, 
essentially, when we have electronic alternatives, systems that 
the industry itself is developing, that can get us this 
information much more quickly.
    Mr. Dingell. Now, how important is trace-back in containing 
food-borne illness outbreaks?
    Mr. Taylor. Trace-back is crucial. Once CDC identifies the 
food vehicle, we then need to be able to go back to the source 
of production so we can get to the root of the problem and 
contain it. So it is really crucial to public health, as well 
as to protecting the industry, to contain a problem so that the 
industry, its own business, won't be disrupted any more than 
need be.
    Mr. Dingell. You can protect honest men and women in the 
industry from unfair competition by scoundrels and rascals, but 
you would also protect them against unsafe materials that could 
enter into the products that they distribute. Isn't that right?
    Mr. Taylor. Yes, sir. That is exactly it.
    Mr. Dingell. Now, in your report--this is to Ms. Shames. In 
your report, you state CBP's computer system does not notify 
FDA when imported food shipments arrive at U.S. ports. It is 
extremely important that these two agencies coordinate when it 
comes to imported food. Do you agree with that?
    Ms. Shames. We agree. We have been able to update that 
information, and CBP has told us that now it does give FDA the 
time of arrival. And this should help FDA in terms of 
coordinating its inspections.
    Mr. Dingell. What additional steps need to be taken by the 
administration to fully address this concern?
    Ms. Shames. We feel that CBP should continue to work 
towards this effort to share time-of-arrival information with 
USDA. That part of our recommendation has not yet been 
implemented.
    Mr. Dingell. Thank you.
    Madam Chairman, you have been most kind to me with regard 
to the time. I yield back the balance.
    Mrs. Christensen. Thank you, Mr. Chairman.
    I now recognize myself for 5 minutes of questions. And I 
want to ask a question about information sharing, as well.
    Ms. Shames, I would like to ask you about GAO's finding 
that FDA does not always share product distribution information 
with State regulators during a recall. If food needs to be 
removed, FDA may not give State regulators important 
information like which grocery stores and warehouses received 
the recalled product.
    FDA's inadequate coordination with States means that States 
must duplicate FDA's efforts and track down the same 
information. You found that public health--and I guess this is 
a quote--may be at risk during the time it takes for the States 
to independently track distribution information when a product 
is found to be contaminated.
    So my question, Ms. Shames: FDA's limited provision of 
information to States during an outbreak seems illogical, so 
what is the agency's rationale for withholding that 
information?
    Ms. Shames. FDA says that this information is commercially 
confidential. And while we recognize that, we still recognize 
the public need that the State agencies are often the ones that 
are actually going into the grocery stores and removing the 
contaminated product off of the shelf. What we recommended to 
FDA and what FDA agreed to is that they would explore ways to 
try to get comparable information to the State agencies.
    I should note that USDA, the Food Safety and Inspection 
Service, does give product name information to the States as a 
way of trying to expedite any recall.
    Mrs. Christensen. OK.
    So, Mr. Taylor, so you have agreed, and you have the 
authority to share that information with the States?
    Mr. Taylor. We are able to share this information with 
State officers who are commissioned by FDA. And to some extent 
around the country we have actually commissioned State 
officials to function as FDA officials, so we are able to do it 
to that extent. But we do have legal constraints under the laws 
that govern disclosure of information.
    This is a strong feature of the legislation, H.R. 2749, 
that this committee has passed, that the House has passed, 
because it would explicitly authorize us to share information 
with State officials, with other organizations, when necessary 
to protect public health, and still protecting the confidences 
of companies but getting the information in the hands of people 
who need it to protect public health. And we enthusiastically 
embrace that. We need that clear authority from Congress.
    Mrs. Christensen. OK. Thank you. You answered the rest of 
my question.
    My next question is on monetary bonds and civil penalties. 
I am concerned that FDA may not have sufficient authority to 
keep an importer from violating food safety requirements. Under 
our current system, the importing company maintains control 
over their food shipments but is not allowed to release them 
until FDA approves. Importers post a monetary bond with Customs 
and Border Protection to guarantee the product will meet all 
U.S. Requirements, including those of FDA.
    At least, that is how the system is supposed to work. But 
the GAO investigation found that FDA and Customs and Border 
Protection officials do not believe that the bonding system 
stops import firms from releasing their goods prior to FDA 
approval. GAO found that many brokers and importers expect that 
they will occasionally have to forfeit the monetary bond as 
part of the cost of doing business.
    So, again, my question to you, Ms. Shames, is: Why is the 
current system of monetary bonds not a sufficient deterrent?
    Ms. Shames. What we are seeking is for FDA to be able to 
assess the civil penalties, to make it more of a deterrent for 
unscrupulous importers who try to do that.
    Mrs. Christensen. Is the amount of the bond adequate as a 
deterrent, or does it need to----
    Ms. Shames. FDA and CBP officials told us that they thought 
that the amount of the bond really was insufficient.
    And this is something that we reported in an earlier report 
back in 1998. So, well over a decade ago, we were hearing this 
information from those agencies.
    Mrs. Christensen. And your testimony stated that GAO 
recommends that the FDA commissioner seek authority from 
Congress to assess civil penalties. Can you elaborate? Why does 
FDA need authority to assess the civil penalties?
    Ms. Shames. Now it cannot do that; it relies on CBP for any 
enforcement actions. And giving FDA this authority, again, we 
feel, would be a deterrent for any unscrupulous importers.
    Mrs. Christensen. So, Mr. Taylor, if FDA could impose civil 
monetary penalties for violations of food safety requirements, 
would that assist FDA in its mission?
    Mr. Taylor. That would be a big help, to create more 
accountability for importers.
    There is another very important feature of the legislation, 
though, that would require importers to register with us and to 
meet requirements for their own practices in order to stay 
registered, to stay in business as importers. So we would have 
also the authority to de-register an importer.
    So, again, it is critical that we enhance the 
accountability of importers to play by the rules, essentially.
    Mrs. Christensen. Is there authority needed to increase the 
amount of the bond--well, that would be CBP.
    Mr. Taylor. Right.
    Mrs. Christensen. Yes. Thank you.
    OK, I am out of time. So are we going to have a second--oh, 
you are back.
    I will recognize Mr. Burgess, Dr. Burgess, for a second 
round of questioning.
    Mr. Burgess. Thank you.
    Mr. Taylor, approximately 13 million shipments of food 
arrive in the U.S. Every year from foreign producers. And, of 
course, the number is growing, as we have seen from all the 
graphs.
    There are numerous examples of foods that have been 
problematic. We have heard about the melamine in the milk and 
the problems with gluten and some of our pet food contamination 
of a few years ago.
    You have opened some stations overseas, the FDA has opened 
some stations overseas. In addition to that--and the first 
question is, have we opened enough? Have we done enough in that 
regard?
    And what other measures are we employing to increase or 
enforce lax safety standards in other countries?
    Mr. Taylor. Yes. You know, I think it is going to take a 
combination of tools and efforts to ensure the safety of 
imports.
    Those foreign offices are--they are not inspection posts, 
but they are critical posts for gathering intelligence about 
what is happening in other countries, to explain our 
requirements to foreign governments and to foreign firms.
    But that is just one small piece of the toolkit. We do need 
to do more inspections overseas, but we also need to hold the 
importer accountable and see that they are policing their own 
supply chain and being able to provide real assurances to us, 
documented assurances, that they are producing products 
overseas or sourcing their product from facilities that meet 
our standards.
    So it is going to take a combination of things. But it is 
all about building more accountability into the supply chain, 
all the way back to the point of production.
    Mr. Burgess. And it would seem intuitive that the importer 
would want that accountability in the supply chain, because, 
after all, if their products are felt to be unsafe when they 
get over here, their market share is going to suffer.
    But is the FDA working with the importers directly in a 
collaborative fashion, educational fashion, to try to get more 
accountability on that end?
    Mr. Taylor. We do work with the importer community. We have 
issued guidance to the importer community on good importer 
practices that we think they should observe to meet that 
responsibility, to offer food only that meets our standards.
    You know, some importers feel the accountability. They are 
part of a supply chain. The major processor in this country 
might be the importer, in some cases. But, in other cases, 
importers don't have a stake in what happens to the food after 
it passes from them, and so they lack accountability.
    And so there is a real gap in the system, you know, if we 
don't have systematic accountability on importers as a critical 
part of the safety assurance system.
    Mr. Burgess. So what can you do to impose that degree of 
accountability if it may not exist naturally as part of the 
marketplace?
    Mr. Taylor. We need the passage of H.R. 2749. That is one 
of the most critical elements of the legislation, to define 
that accountability, to give us the authority to set the rules 
that the importers need to play by in order to provide an 
adequate assurance that the food that they are offering is 
meeting our standards; again, backed up by our own ability to 
go inspect, backed up by what foreign governments are doing, 
backed up by a host of other checks.
    But that importer accountability is really a linchpin of 
the system. And it is lacking now as a really enforceable 
matter. It is something we urge on the industry, but there is 
no legal requirement for the importer to really take that 
responsibility. They only run the risk that we will send the 
food back. Or, you know, they may get it into the country under 
a bond, and, as a cost of doing business, you know, some of 
them, unscrupulous, will make a decision to let the product go.
    So there is a lack of accountability in that part of the 
system that H.R. 2749 would directly address.
    Mr. Burgess. I have always felt that it really is necessary 
to have some sort of a stop button that you guys can push in a 
hurry if you need to, if we find that we have something coming 
in that we really shouldn't.
    Ms. Nudelman, let me just ask you a question. And I 
apologize if Chairman Stupak has already covered this. But, in 
the report, it found in fiscal year 2007 the FDA took no 
regulatory action for 25 percent of facilities who received the 
OAI classification.
    Why would the FDA classify a facility as ``official action 
indicated'' rather than one of the lesser classifications and 
then take no action? What would be a possible--that seems 
counterintuitive to me. What would be a possible rationale for 
doing that?
    Ms. Nudelman. Well, in some cases, if the facility agreed 
to take action or promised to take action, then they did not 
issue--they did not take any further regulatory action. That 
was the most common response that we heard.
    Mr. Burgess. And then how is the follow-up for that 
overseen to ensure that, indeed, the voluntary action was taken 
and the problem was corrected?
    Ms. Nudelman. Well, that is one of the things we found. In 
about 36 percent of the facilities, FDA didn't take any--didn't 
reinspect to ensure that the correction was made or look at any 
other evidence. So there is not always the follow-up.
    Mr. Burgess. So that is still inherently a weak spot that 
needs to be fixed.
    Ms. Nudelman. Correct.
    Mr. Burgess. Thank you, Mr. Chairman. I will yield back.
    Mr. Stupak [presiding]. Mr. Dingell, did you have a 
question or two on this second round here, please?
    Mr. Dingell. Mr. Chairman, I will impose again briefly upon 
your patience. And I want to thank for your courtesy to me. And 
I also want to commend you for the series of hearings you have 
held on these matters, because they have made it possible for 
us to move forward in a very significant fashion to protect 
people and to see that Food and Drug finally has the law and 
the resources it needs to do its business.
    Now, these questions are for Ms. Nudelman. There are 
226,373 foreign food facilities registered with FDA. When the 
inspector general looked at the domestic facilities registered 
in 2009, it found 48 percent provide inaccurate information; 7 
percent either fail to register or failed to cancel their 
registrations; and 5 percent created multiple registrations.
    Now, if domestic registrations are this prone to errors, in 
your opinion, how reliable is the list of foreign facility 
registrations?
    Ms. Nudelman. The numbers that you cite are right on, and 
it would make--I think it is even more challenging for foreign 
facilities to have accurate information in the registry.
    Mr. Dingell. Now, what can be done to help FDA improve the 
accuracy of its registration lists? Obviously, more people; 
obviously, more money; obviously, more inspections; obviously, 
a better computer system.
    Do they need, in addition to that, additional authority 
under law to do the things that need to be done, to induce 
better cooperation from the people who are supposed to 
register? What has to be done, in your expert opinion?
    Ms. Nudelman. I think there is a number of ways FDA can 
improve the accuracy and the completeness of the information in 
the registry. We make a recommendation to FDA to consider 
seeking the authority to have facilities register on a more 
routine basis. And that would allow the facilities to provide 
updated information about the foods they handle and about 
contact information.
    Mr. Dingell. Thank you.
    Now, Mr. Taylor, do you have a comment you would like to 
make?
    Mr. Taylor. Well, I think that suggestion that Ms. Nudelman 
made is an excellent one. I think the requirement to have a 
unique identifier is important. And I think the requirement for 
the importer, as part of good importer practices, to be able to 
vouch for the accuracy of the information, identifying the 
foreign sources of supply, the foreign facilities from which 
they are sourcing products for import--all of those, I think, 
would really improve the reliability of the registration list. 
And those are all addressed in the Food Safety Enhancement Act.
    Mr. Dingell. Now, Ms. Shames, you have talked about the 
ability to inspect. And, in your very excellent study, you 
talked about the need for FDA to be able to do a better job of 
getting the cooperation of Homeland Security and other 
government agencies.
    How could that best be done? Could that best be done by 
having a memorandum of agreement between the agencies, a 
memorandum of agreement required by congressional action, or by 
some other mechanism whereby we could see to it that these two 
very important agencies, or several very important agencies, 
talk to each other so that they are able to use the advantages 
that comes with having several different agencies enforcing 
different laws but able to work together to address the 
problems that concern us?
    Now, what is your comment, please?
    Ms. Shames. It will be a multifaceted solution to a very 
complicated problem, and I wish I could tell you that there 
will be a single step that could correct that. We found that at 
the working level that the relationships between FDA and CBP 
were oftentimes very cordial, that they were able to work 
around, for example, not getting the time of arrival 
information.
    Mr. Dingell. Of course, that is a structural failure, is it 
not?
    Ms. Shames. Well, yes, in this case it was.
    Mr. Dingell. And whose fault is that, the other agency or 
is that the importer or the food broker or who?
    Ms. Shames. Well, there are many players that are involved 
in the oversight of food safety. FDA is one, and, as you noted, 
CBP really is the first face for an importer. So one of the 
challenges that we identified is CBP's own computer system, 
that that system----
    Mr. Dingell. And that's probably hopelessly out of date, as 
is the Social Security computer system.
    Ms. Shames. Well, there are hardware changes that would 
have to be made, for example, for getting a unique identifier. 
This is something that FDA feels it needs. We have certainly 
identified that it's something that is very important, but CBP 
told us that it would be difficult for its current system to do 
it, and they really could not offer any sort of timeline of 
when that might be done.
    So it's structural in terms of the many agencies that are 
involved, but it also gets to the resources in terms of, you 
know, the computer systems that it has in place as well as the 
people.
    Mr. Dingell. Thank you. Mr. Chairman, again, thank you for 
your courtesy to me, and I want to remind everybody that you 
and this subcommittee have had tremendous leadership in this 
matter. I want to remind everybody that this committee, working 
unanimously, together in a bipartisan fashion, has set out 
legislation that would address the problems we now discuss 
today, which reside comfortably in the United States Senate.
    Thank you, Mr. Chairman.
    Mr. Stupak. Well, hopefully the Senate will move that 
legislation, get it to conference, and we can go from there.
    Let me ask, Ms. Shames, about the unique identifier. How 
can one firm have 75 different identifiers?
    Ms. Shames. It can happen very inadvertently, when a 
company registers for an import shipment, it may identify 
itself one time as White, Incorporated. The second time the 
company might identify itself as White Company. So it is 
something that is done most of the time, very innocently, but 
it means that there needs to be some sort of scrubbing of the 
list to make sure that each company has a single----
    Mr. Stupak. So the company enters its information on a 
computer Web site so it is really the company that enters it, 
which would then give it a number----
    Ms. Shames. That's right.
    Mr. Stupak [continuing]. Which could be unique on something 
as simple as an address, a different address.
    Ms. Shames. Yes.
    Mr. Stupak. Does Customs and Border Patrol use unique 
identifiers?
    Ms. Shames. They do not, no. They also----
    Mr. Stupak. Shouldn't they actually have access to it at 
the same time? Shouldn't that company give it to Customs and 
Border?
    Ms. Shames. Ideally FDA and CBP and would have the same 
unique identifier.
    Mr. Stupak. Ideally, but reality is they don't, right?
    Ms. Shames. Right.
    Mr. Stupak. If we would limit the number of ports that food 
could be imported into this country, would that help?
    Ms. Shames. Well, that is an approach that USDA takes.
    Mr. Stupak. Right, on meat products.
    Ms. Shames. Well, that only USDA regulated imports come 
from food systems that have or are equivalent to ours, only 
through designated ports. USDA also goes and audits those 
countries to make sure that their systems are comparable or 
equivalent.
    Mr. Stupak. Well, is that something we should look at? I 
was going back to your chart number one that you had in here, 
you know, you said 80 percent of our seafood comes from foreign 
sources, I think she said 60 percent of our fruits and 
vegetables. And they can come into basically any airport or any 
trucking location on our border,correct?
    Ms. Shames. That's true, yes. Stakeholders that we have 
spoken to said that it would be difficult for FDA to really 
replicate the same system that USDA has, because----
    Mr. Stupak. I am not saying replicate it, but shouldn't you 
limit the ports of entry? I mean, how can you control anything 
if every airport and every truck crossing is basically a port 
of entry for food or seafood?
    Ms. Shames. Well, it's an approach that the European Union 
has taken to limit the ports for its risk-based foods, so it 
is--there are precedents for it.
    Mr. Stupak. Any comments on that, Mr. Taylor, on either 
unique identifiers or limit the number of ports?
    Mr. Taylor. Yes. Again, from a consistent--an ease of 
implementation by the regulatory agency, that's certainly 
advantages to that. I think the challenge we face that is 
different from the USDA is that, you know, we are dealing with 
a much larger array of commodities coming from a much larger 
volume of countries, there's a huge volume of trade.
    And so I think there would be, you know, big practical 
questions you would have to work through. I don't think anyone 
wants to disrupt the trade in food, but we need to be sure it's 
safe. And how do you do that? It's a really important question.
    Mr. Stupak. Let me ask you this then, Mr. Taylor, you 
mentioned the shipper's bond. What is the usual amount of a 
bond? Does it depend on the product and the value?
    Mr. Taylor. Typically three times the value of the 
shipment.
    Mr. Stupak. OK. You said many times the shipper will just 
forego the bond.
    Mr. Taylor. Again, our understanding is that some shippers, 
you know, who have a large volume of business are willing to 
just take that chance of letting a product go out into 
commerce, even though it's still under bond, because, you know, 
in the whole course of their business they don't get caught 
very often or they aren't--there's not a problem that requires 
that that product be brought back. And so, again, it's the cost 
of doing business for some of these firms.
    Mr. Stupak. Well, should we make it higher?
    Mr. Taylor. I think you could try a higher bond. I mean, I 
think the civil penalty approach is one part of it. I think the 
importer accountability and the fact that an importer could 
lose its registration under the Food Safety Enhancement Act 
would be perhaps even stronger tools, you know, to make them 
have really something really at stake for playing by the rules. 
That's what we need to do.
    Mr. Stupak. You know, Mr. Dingell pointed out, and I think 
we have all pointed out that, you know, it's expensive to keep 
our food supply safe and the agency needs inspectors, and I 
think GAO report says, what, $16,000 per inspection at a food 
facility. And the IG said that, and I am quoting now, The 
decline in inspection is largely due to the significant decline 
in staffing level that resulted from cuts.
    And in the legislation that we have pending in the Senate, 
the Food Safety Enhancement Act, we have an annual registration 
fee of $500. These fees would be devoted towards funding a 
variety of food safety activities. Any idea and what percentage 
would go towards inspectors?
    Mr. Taylor. Well, we would envision the fee revenue being 
used to a significant degree to meet the inspection mandates, 
or to at least contribute to meeting the inspection mandates in 
the legislation. But we also have to invest those resources in 
the tools for the inspectors and the scientific basis for what 
they are doing, so it would be a mix of activities. And you 
could also contribute to the import oversight.
    So we would distribute it across a mix of activities to 
meet the objectives of the statute.
    Mr. Stupak. Well, under the Obama administration, did you 
not receive a substantial increase in money for food safety in 
the last year?
    Mr. Taylor. The 2010 budget is, yes, is an increase over 
2009, and there's an increase requested in 2011.
    Mr. Stupak. Well, have you hired more inspectors?
    Mr. Taylor. Yes, sir, the last 2 or 3 years of funding has 
enabled our field force to add 6- or 700 inspectors, who are 
completing their training, and we are going to be able to 
increase our inspections because of that in the coming years. 
So there has been that step up, you know, through the increases 
we have gotten. It's not sufficient to meet the inspection 
mandate in the legislation, but it's a step in the right 
direction, which we appreciate.
    Mr. Stupak. OK. Mr. Burgess, any questions?
    Mr. Burgess. Yes. Just following up on that last line from 
Mr. Stupak about the budget, did you, did the FDA receive any 
money from the stimulus bill or the big health care bill that 
we just passed?
    Mr. Taylor. No--there was some money that went into HHS for 
management matters related to FDA like comparative 
effectiveness of pharmaceuticals, but there was not money that 
directly affects the food program.
    Mr. Burgess. Did the Obama administration seek funding for 
the FDA in either one of these laws?
    Mr. Taylor. Well, again, the stimulus money was about 
immediate projects that could stimulate economic activity in 
the near term and so that we----
    Mr. Burgess. Mr. Taylor, we gave $10 billion to NIH. Are 
you any less deserving than they are?
    Mr. Taylor. We would never say----
    Mr. Burgess. $10 billion to NIH. Now I love the guys at 
NIH, but you are important too.
    Mr. Taylor. Yes, sir, we agree with you.
    Mr. Burgess. Well, do you know why the administration 
didn't ask for additional funding for the FDA in either of 
these laws?
    Mr. Taylor. I would have to get back to you on that. I 
don't personally--I wasn't involved in that.
    Mr. Burgess. Well, and it's all well and good, just like 
the Obama budget, and what great things are going to happen as 
a result of it, but we are not going to pass a budget on the 
floor of this House I don't think, unless Mr. Stupak knows 
something that I don't know----
    Mr. Stupak. It wouldn't be first time getting me wrong on 
legislation.
    Mr. Burgess. And certainly, we are not going to do any 
appropriations bills before election day, so your level of 
funding till some omnibus in the lame duck session, so are you 
oK with that level of funding at this point?
    Mr. Taylor. Well, again, we are going to need additional 
resources to carry out the expectations of the Food Safety 
Enhancement Act. Again, that's why the fee provision and that--
the registration fee provision in that law, that bill is very 
important to us. We do need a stable, predictable and adequate 
level of resources to meet the mandates in the legislation.
    Mr. Burgess. Well, and I couldn't agree with you more and 
that a stable, predictable source of funds is not just true for 
you but true other agencies as well, but so far we seem to be 
doing things in fits and starts. And you, in fact, got left out 
of the fits and starts, unfortunately.
    Mr. Chairman, you have been very indulgent. It has been a 
long day. I am going to yield back the balance of my time.
    Mr. Stupak. Thanks, Mr. Burgess. And as Mr. Dingell has 
pointed out, you know, the Food Safety Act went through this 
committee 51-0, and we appreciate our colleagues on the 
Republican side of the aisle to help us provide a stable 
funding source for that FDA through that $500 per facility 
registration fee. That will provide the stable funding so we do 
have the resources to get to it.
    It's not just resources it's, information sharing. And 
hopefully we can do that whether it's Customs and Border Patrol 
or we get the PREDICT program worked out a little more so the 
high risk foods we can identify.
    Well, thank you and thank you to all of our witnesses. 
Sorry about the delay there on the floor for a while. We 
appreciate you staying with us and being here today.
    That concludes all questioning. I want to thank all of our 
witnesses for coming today and thank you for your testimony. 
The rules of the committee provide that members have 10 days to 
submit additional questions for the record. That concludes our 
hearing. This meeting of the subcommittee is adjourned.
    [Whereupon, at 4:58 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

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