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



 
                                ------                                                                            
AMERICAN LIVES STILL AT RISK: WHEN WILL FDA'S FOOD PROTECTION PLAN BE 
                     FULLY FUNDED AND IMPLEMENTED?

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

                                HEARING

                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             SECOND SESSION

                               ----------                              

                             JUNE 12, 2008

                               ----------                              

                           Serial No. 110-126








      Printed for the use of the Committee on Energy and Commerce
                        energycommerce.house.gov

                              ----------        




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                    COMMITTEE ON ENERGY AND COMMERCE

                  JOHN D. DINGELL, Michigan, Chairman

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

                                 ______

                           Professional Staff

                 Dennis B. Fitzgibbons, Chief of Staff

                   Gregg A. Rothschild, Chief Counsel

                      Sharon E. Davis, Chief Clerk

               David L. Cavicke, Minority Staff Director

                                 _____

              Subcommittee on Oversight and Investigations

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

                                  (ii)

  
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Bart Stupak, a Representative in Congress from the State of 
  Michigan, opening statement....................................     1
Hon. John Shimkus, a Representative in Congress from the State of 
  Illinois, opening statement....................................     4
Hon. Diana DeGette, a Representative in Congress from the State 
  of Colorado, opening statement.................................     6
Hon. Greg Walden, a Representative in Congress from the State of 
  Oregon, opening statement......................................     7
Hon. John D. Dingell, a Representative in Congress from the State 
  of Michigan, opening statement.................................     8
Hon. Marsha Blackburn, a Representative in Congress from the 
  State of Tennessee, opening statement..........................    10
Hon. Mike Doyle, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................    11
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................    12
Hon. Jan Schakowsky, a Representative in Congress from the State 
  of Illinois, opening statement.................................    14
Hon. Joe Barton, a Representative in Congress from the State of 
  Texas, prepared statement......................................   108

                               Witnesses

Lisa Shames, Director, Food and Agriculture Issues, U.S. 
  Government Accountability Office...............................    15
    Prepared statement...........................................    18
Gail H. Cassell, Ph.D., Vice President, Scientific Affairs and 
  Distinguished Lilly Research Scholar for Infectious Diseases, 
  Eli Lilly and Company..........................................    35
    Prepared statement...........................................    36
J. Glenn Morris, Jr., M.D., M.P.H., T.M., Director, Emerging 
  Pathogens Institute, University of Florida.....................    38
    Prepared statement...........................................    40
Michael R. Taylor, J.D., Research Professor of Health Policy, The 
  George Washington University, School of Public Health and 
  Health Services................................................    42
    Prepared statement...........................................    44
Jeffrey Levi, Ph.D., Executive Director, Trust for America's 
  Health.........................................................    50
    Prepared statement...........................................    52
David W.K. Acheson, M.D., Assistant Commissioner for Food 
  Protection, Food and Drug Administration, Department of Health 
  and Human Services.............................................    68
    Prepared statement...........................................    71

                           Submitted Material

Letter of June 11, 2008, from Minority to Messrs. Obey and Lewis.   109
Letter of May 14, 2008, from Minority to U.S. Food and Drug 
  Administration.................................................   111
Food recall lists, 2007 to present...............................   113
News clips, dated June 12, 2008..................................   127
Power Point presentation.........................................   133
``Sen. Specter Says FDA Can't Even Ask for Money Properly,'' The 
  Wall Street Journal Online, June 11, 2008......................   113
Letter of June 10, 2008, from Sen. Specter to U.S. Department of 
  Health and Human Services......................................   138
Subcommittee exhibit binder......................................   139



















 AMERICAN LIVES STILL AT RISK: WHEN WILL FDA'S FOOD PROTECTION PLAN BE 
                     FULLY FUNDED AND IMPLEMENTED?

                              ----------                              


                        THURSDAY, JUNE 12, 2008

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                   Washington, D.C.
    The subcommittee met, pursuant to other business, at 10:04 
a.m., in room 2123 of the Rayburn House Office Building, Hon. 
Bart Stupak (chairman) presiding.
    Members present: Representatives Stupak, DeGette, Melancon, 
Doyle, Schakowsky, Dingell (ex officio), Shimkus, Whitfield, 
Walden, Burgess, and Blackburn.
    Staff present: John Sopko, Scott Schloegel, Chris Knauer, 
Keith Barstow, Calvin Webb, Kyle Chapman, Alan Slobodin, Peter 
Spencer, and Whitney Drew.

  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 ``American Lives At Risk: 
When Will FDA's Food Protection Plan Be Fully Funded and 
Implemented?'' Each member will be recognized for a 5 minute 
opening statement. I will begin.
    Today this subcommittee is holding another in a series of 
hearings examining the adequacy of the efforts of the Food and 
Drug Administration to protect Americans from unsafe food. In 
fact, today's hearing is our eighth hearing on this topic since 
January of last year. The purpose of today's hearing is to 
receive important testimony from the FDA regarding how the 
Agency plans to address its many weaknesses concerning its 
ability to protect our food supply.
    To date, our investigation and hearings have uncovered a 
multitude of problems regarding FDA's food safety efforts, 
including poor policy choices, questionable management 
decisions, and lack of resources. Collectively, FDA's failed 
regulation of domestic food producers, its ill-conceived plan 
to close laboratories and reorganize staff, and its inability 
to ensure the safety of imported foods have suggested the 
Agency's food safety system is broken.
    Outside experts have also found that the FDA's food safety 
system is in trouble. In fact, in January 2007, GAO added the 
federal oversight of food safety to its High-Risk Series and 
called for a government-wide reexamination of this country's 
food safety system. GAO found numerous concerns with the 
present food safety system including inconsistent oversight, 
ineffective coordination, and incomplete program planning. Last 
year FDA's own Science Board issued a scathing assessment of 
FDA's food protection abilities, concluding the Agency ``does 
not have the capacity to ensure the safety of food for the 
Nation.'' In April of this year, Trust for America's Health, a 
major public health watchdog organization, issued yet another 
report which also found a number of deficiencies in the ability 
of the FDA to safeguard the Nation's food supply.
    Through all of these evaluations, one common theme has 
emerged: FDA's resources are so stretched that its ability to 
protect Americans from unsafe food is seriously jeopardized. 
Perhaps the Science Board put it best in its report when it 
concluded, and I quote, ``In contrast to previous reviews that 
warned crisis would arise if funding issues were not addressed, 
recent events and our findings indicate that some of these 
crises are now realities and American lives are at risk.'' 
Indeed, the events of the last 18 months with recall after 
recall demonstrate these concerns have now become a reality.
    In response to the multitude of foodborne contamination 
outbreaks and concerns about its ability to protect Americans 
from unsafe food, in November of last year FDA released a 
document entitled ``Food Protection Plan: An Integrated 
Strategy for Protecting the Nation's Food Supply.'' The Food 
Protection Plan lays out a blueprint for addressing food safety 
and food defense for both domestic and imported foods. The plan 
attempts to prevent contamination by pursuing safety measures 
that will address risk through the life cycle of food products, 
but more importantly, to identify potential food hazards and 
counter them before they can do harm.
    The Food Protection Plan is very appealing on paper and 
appears to be a positive first step toward creating a stronger 
food safety system. Nonetheless, this subcommittee and many 
experts will testify today that they are concerned that the key 
specifics and the resources required to implement this plan 
remain elusive. As reported by GAO at our January 29th hearing, 
while acknowledging it will need additional funding, ``The FDA 
has not provided specific information on the resources it 
anticipates the Agency will need to implement this plan.'' Over 
4 months later, this committee, GAO, and others are still 
attempting to obtain basic data on what resources are needed 
and how they will be used to implement the plan.
    As of Monday, it appeared the President's budget provided 
only minimal support for making this plan a reality. The 
President's fiscal year 2009 budget originally asked for a mere 
$51 million in new budgetary authority for all programs within 
the FDA. Approximately $42 million of this would go towards 
food safety. Because of cost-of-living salary adjustments, only 
about $30 million would be available for implementing the Food 
Protection Plan.
    This is in stark contrast to the Science Board's 
recommendations. In a letter to members of this committee, it 
was recommended that an additional $375 million be provided to 
FDA across all programs in fiscal year 2009 including $128 
million for food safety and $75 million for needed IT 
enhancements. With the President's original budget offering 
only $30 million additional for food safety in fiscal year 
2009, one had to ponder how serious the Administration was in 
implementing the Food Protection Plan as experts suggested the 
Agency would need far, far more.
    Fortunately, just days before this hearing, the 
Administration apparently grasped the obvious: FDA was strapped 
for resources and $30 million was not enough to credibly 
advance the Food Protection Plan.
    On Monday evening, HHS Secretary and the FDA Commissioner 
scheduled a conference call to announce the Administration 
would amend FDA's fiscal year 2009 budget request to Congress 
and asked for an additional $275 million in new funding. 
Approximately $125 million of this would go to food safety 
efforts. I strongly applaud this request but we need to know 
far more detail about how this money will be spent.
    Despite the Administration's revised budget request, a 
major concern of the Subcommittee and others is the Agency 
lacks a meaningful strategic plan detailing what the Food 
Protection Plan will cost to implement, when key milestones 
will be achieved and what are they expected to accomplish.
    Initially, a smattering of spreadsheets and other documents 
were provided to the Subcommittee by FDA that attempted to 
detail what parts of the plan would be implemented this year. 
These plans fell short in that they did not show what the 
overall plan cost to execute nor did they prioritize which 
features were most critical in fixing existing food safety 
shortcomings. Moreover, the vague plans that were provided to 
the Subcommittee were based on earlier budget requests, not the 
new request made this week.
    To this point, FDA's strategic planning for implementing 
the Food Protection Plan appears to be almost entirely budget 
driven. Rather than articulating what really truly needs to be 
fixed, why it needs to be fixed and how fixing it would 
positively affect the current food safety system, FDA instead 
has tailored its implementation plan to match the meager 
resources offered in the President's original budget proposal 
of just $30 million for food safety.
    Because both the implementation goals and the funding for 
the Food Protection Plan remain a moving target, I will today 
seek from Dr. Acheson information on whether the Administration 
intends to submit a comprehensive strategic plan based not on 
yesterday's budget request but one based on the expected costs 
of a plan's full implementation. In short, if the FDA is going 
to be successful in getting this effort funded, it must be 
prepared to detail the plan's expected costs, strategies, 
milestones, and results on food safety. So far the plan 
proposes a number of lofty ideals but important specifics 
remain undefined.
    Today I look forward to hearing what progress has been made 
toward implementing the Administration's Food Protection Plan. 
Additionally, I want to understand what aspects of this plan 
are most critical to achieve, what they would accomplish, and 
what they are expected to cost beyond the ever-changing budget 
requests that come from the Administration. As the Agency 
stated in its Food Protection Plan, ``FDA recognizes the need 
to partner with Congress to make the changes necessary to 
transform the safety of the Nation's food supply.'' I am hoping 
today that the FDA will finally be willing to enter into this 
partnership with us and provide a credible and honest answer as 
to what is needed to realistically safeguard the Nation's food 
supply.
    Lastly, I would be remiss if I did not mention the current 
salmonella St. Paul outbreak that has led to 167 illnesses in 
17 States. This outbreak is particularly frustrating, given the 
fact that today marks the 1-year anniversary of the FDA's 
Tomato Safety Initiative, which was supposed to lead to better 
safety standards and improve notification and tracking of 
tomato outbreaks. It appears that despite 1 full year having 
passed, we are no safer today than we were a year ago. At a 
minimum, the FDA and USDA should require immediate 
implementation of country-of-origin labeling for all fruits and 
vegetables sold in the United States. Country-of-origin 
labeling has been passed by this Congress several years ago. 
Country-of-origin labeling will provide consumers with more 
information about where their food is coming from and would 
also help Federal and State officials more quickly narrow down 
source locations of contaminated fruits and vegetables.
    My time is up.
    I next turn to the gentleman from Illinois, Mr. Shimkus, 
for his opening statement, please.

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

    Mr. Shimkus. Thank you, Chairman Stupak.
    As we hold this hearing, grocers and restaurants nationwide 
have been pulling tomatoes from the shelves and menus until the 
cause of a recent salmonella outbreak in some States can be 
identified. I tried to get a BLT sandwich in the cloakroom 
yesterday and no tomato. I had a BL sandwich. There is no 
evidence that the outbreak is associated with all this produce 
but in an abundance of caution, the food industry has reacted.
    There must be a more efficient way to trace problems and 
assure safety. There must be a way to harness science and 
reduce risk from pathogens we know about and perhaps those yet 
to emerge. There must be a way to effectively deploy and 
encourage cutting-edge technologies such as irradiation and 
even gene splicing to achieve greater safety.
    As we focus on FDA's reform efforts this morning, it will 
be helpful to keep in mind the role of science and innovation 
to reduce risk and disease threats. It will be useful to 
explain what opportunities a renewed focus on science at the 
Agency will hold for encouraging innovation that truly prevents 
disease outbreaks.
    Today we will examine the Food and Drug Administration's 
Food Protection Plan, which promises to improve the Agency's 
ability to assure the safety of the food supply both domestic 
and imported. With 7 months passed since the plan's unveiling 
in November, I look forward to a progress report from the 
Agency and outside observers to examine whether this plan can 
achieve what it promised.
    During previous food safety hearings by this subcommittee, 
we have all remarked on the need for the Agency to focus on 
developing a truly risk-based food safety system that is 
oriented towards the challenges of a global marketplace. We 
have established in past hearings that we can no longer rely 
upon border operations as the primary line of defense to ensure 
imported food safety. We have established that domestic or 
foreign, there must be a systems approach to food safety which 
can more effectively prevent outbreaks than the current system 
and trace problems to the source when they are found. We have 
established the central role of modern, robust IT systems and 
the scientific know-how needed to keep the Agency on top of 
emerging health threats. We have also established that simply 
giving more money alone to FDA will not produce better public 
health protection. There need to be structural reforms and 
performance-oriented management to ensure resources are put to 
cost-effective use.
    We have called for a new regulatory model at FDA that no 
longer relies on outdated domestic-oriented posture towards the 
food supply. We have called for quicker deployment of smart 
import tracking systems at the border such as the so-called 
Predict system and the necessary restructuring for the more 
robust and effective foreign inspection program than the 
current model.
    The Food Protection Plan along with other internal efforts 
reflects a positive effort by the Administration to move in 
this direction. Another positive is Health and Human Services 
Secretary Leavitt's recent supplemental budget request for an 
additional $275 million for fiscal year 2009. This boosts the 
Administration's proposed budget to some $400 million over the 
current FDA budget with a sizable portion of this for food 
safety and cross-cutting technology improvements. How much this 
proposed funding will accelerate FDA reform is open to 
question, and Mr. Chairman, I would like to submit for the 
record a letter that the Minority sent to the appropriators in 
support of the additional request on the supplemental.
    Mr. Stupak. Without objection.
    [The information appears at the conclusion of the hearing.]
    Mr. Shimkus. The proof will be in the pudding. There are 
many bureaucratic hurdles and imperatives that can impede 
legitimate efforts to modernize a federal agency. It is 
critical today that we discuss details associated with 
implementing the risk-based Food Protection Plan and related 
technology improvements. Nobody says this is an easy or fast 
project but it is important that we see the measures and 
indicators of progress so we can be assured the promised 
improvements are implemented effectively. It is also important 
to understand what Congress should do legislatively, and soon, 
so the Agency has the necessary tools for doing its job.
    Fortunately, we have witnesses, several repeat witnesses 
today, who can assist us. As we move through the hearing today, 
I look forward to their insights into performing and planning 
as well as into what innovative and new technologies may hold 
for improving safety. Will a repostured FDA help foster the 
genetic technologies needed to inhibit foodborne pathogens? Is 
this something we should encourage to develop in the Agency? 
And Mr. Chairman, representing an ag district, I have seen what 
GMOs have done to help lower pesticide use. I have seen how it 
has helped to lower fertilizer use, and it may be a way in 
which we can move in a direction with the FDA.
    I just want to end by putting the FDA on notice of a letter 
that the Minority sent on May 14 requesting a June 6th deadline 
on questions in response to this research that we have done on 
the Office of Criminal Investigation, and I am giving them a 
heads-up on that.
    Thank you, Mr. Chairman. I yield back.
    Mr. Stupak. Did you want to enter the May 14th letter in 
from the Minority to Commissioner von Eschenbach?
    Mr. Shimkus. Yes, if that is all right.
    Mr. Stupak. Did you get a response from the Commissioner? 
Do you want to enter----
    Mr. Shimkus. We do not have a response. That is why we are 
going to enter it and ask them about it.
    Mr. Stupak. Without objection, a May 14th letter from the 
Minority to the Commissioner will be entered and made part of 
the record.
    Mr. Shimkus. Thank you, Mr. Chairman.
    [The information appears at the conclusion of the hearing.]
    Mr. Stupak. Thank you.
    Ms. DeGette for an opening statement, please.

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

    Ms. DeGette. Thank you, Mr. Chairman. I surely appreciate 
your continuing efforts to investigate the obviously broken 
food safety system in this country.
    Little did we know when we scheduled this hearing a couple 
of weeks ago that we would now be in the middle of another 
national outbreak of foodborne illness. The salmonella outbreak 
in raw tomatoes has now expanded, as we know, to at least 17 
States with 167 people sick and dozens hospitalized. Businesses 
nationwide have pulled tomatoes from their shelves, leaving 
tons of food to rot and an entire industry of farmers, 
employees and small businesses in trouble, but the FDA, hobbled 
by dwindling resources, conflicting missions, cuts in staffing 
and low morale has not been able to identify the source of this 
contamination. Sadly, we have been here before.
    This salmonella outbreak is just the latest in a steady 
stream of incidents over the past year. I was just remarking to 
staff, the longer you sit on this committee, the more depressed 
you get because the issues never get resolved and crop up again 
and again. We were glad to hear about the Food Protection Plan 
last November but there is still much desirable language in the 
document that needs to be fleshed out in its details. So I am 
hoping that the hearing will help us specify the specifics 
about what the FDA will do, how much it will cost and, 
hopefully, how it will help solve outbreaks like this most 
recent tomato outbreak.
    I would also like to know if the Agency has learned 
anything from the previous outbreaks that it is putting to use 
in the current tomato incident. To be frank, it doesn't seem to 
me like it is because we still can't trace the source of the 
salmonella contamination in the tomatoes. I am encouraged that 
the FDA submitted to Congress this week a supplemental budget 
for the Agency. I know many members of the Committee were 
dumbfounded when the Administration originally denied a need 
for additional resources but I am glad the FDA is seeking more. 
The question is, will this be sufficient to carry out its 
mission? And I hate to sound like a broken record in this 
subcommittee, but we need to create a comprehensive food 
traceability system so we don't experience delays like we are 
seeing right now in the tomato outbreak.
    The events of the last few days have once again shown that 
the FDA is incapable of quickly identifying the source of 
contamination when it occurs. What exists right now in all of 
these industries is a complicated system of going through 
records of individual companies to locate suppliers, the 
suppliers' suppliers, wholesalers, distribution centers, 
processing facilities, gathering warehouses, and farms. As we 
have learned this week, this process began in April with the 
tomato outbreak. Given the advanced technology today, this 
information should be easily accessible in an instant.
    In fact, traceability is already being done by individual 
companies and I think we should build on their successes to 
form a comprehensive national system. For example, we all know 
that UPS and FedEx can instantaneously locate a package 
anywhere in the world. In the food industry, Dole Foods and 
many beer distributors can trace their products throughout the 
supply chain. Many large and small businesses have developed 
high-tech tracing systems from bar coding, GPS, laser 
technology, and one of my companies in Colorado has even 
pioneered a process to laser numerical codes onto individual 
eggs. You can even put codes on produce like tomatoes, allowing 
consumers to trace the farm-to-fork distribution from their 
home computer. INM consulting is advising its clients that food 
traceability is a sound business investment, given the 
importance of brand preservation and risk management.
    Exciting things are happening in the field literally but 
sadly, the Federal Government has not gotten on board. Instead, 
once again, we have a food salmonella outbreak, this time with 
tomatoes, people getting sick around the country, but the FDA 
is still in its third month of trying to trace the source of 
the contamination. And what this does, it ripples around the 
industry. As I have said many a time, not only is traceability 
and mandatory recall a good thing to do for the consumer, it is 
also good for business because it avoids these massive recalls 
that really hurt production. And so obviously I think that we 
should pass my bill, H.R. 3485, the TRACE Act, but I also 
think, Mr. Chairman, that we should consider putting it in the 
draft that we are looking at in the other committee on food 
safety.
    I look forward to hearing from the witnesses this morning. 
Given the recent outbreak, I not only want to hear about 
general progress but also the progress about how we can improve 
food traceability around the country. Thank you, Mr. Chairman.
    Mr. Stupak. I thank the gentlewoman.
    Mr. Walden for opening statement, please.

  OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF OREGON

    Mr. Walden. Thank you very much, Mr. Chairman. I appreciate 
your due diligence in holding these hearings and holding the 
FDA accountable.
    Obviously there are probably few things more important to 
parents than the safety of the food that their kids ingest, and 
it is almost like a conspiracy against parents. You know how 
hard it is to get your kids to eat spinach and tomatoes to 
begin with, and it seems like we are fighting over the very 
staples of the diet you are trying to get kids to eat over 
whether or not it is even safe. Kids don't need any more 
excuses on that front.
    It is very disturbing that we are seeing more and more 
firms regulated by the FDA and fewer and fewer inspections 
occurring. It just seems backwards. At a time when our 
supplies, much like our fuel supply, is coming from other 
countries, it is imperative that we modernize and update the 
FDA to be able to deal with this new dynamic we face. There was 
a day in this country where we raised what we ate, and that day 
has sadly changed and gone. We still grow a lot of things. 
There is no doubt about it and that is important but I think if 
we are going to have security in the family and in the food 
supply, I personally believe we need country-of-origin 
labeling, and I think we need a new regulatory framework so 
that we can identify the source of an outbreak as quickly as 
possible. I have perhaps five of my fellow Oregonians who have 
fallen victim to this salmonella outbreak, three of whom are 
from Umatilla County, a rural part of my district, an 
agricultural part of my district, they believe have been 
diagnosed with this rare form of salmonella.
    So, Mr. Chairman, it strikes me that this Congress needs to 
take seriously as we do the recommendations of the science 
panel and the findings of the GAO and give the resources 
necessary to the FDA to do their job. We control the purse. It 
is up to us to get it done.
    With that, I will yield back the remainder of my time.
    Mr. Stupak. I thank the gentleman.
    Mr. Dingell for an opening statement, please.

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

    Mr. Dingell. Mr. Chairman, first, thank you for holding 
this hearing. It is important and it is the eighth in our 
series of hearings on food safety, and sadly, also upon the 
inadequacy of our food and drug laws and the inadequacy of the 
performance of the Food and Drug Administration, the Department 
of Health and Human Services, the inadequacy of their budget 
and the shoddy and shameful performance which they have so 
badly carried forward.
    A common theme of each of these hearings has been a major 
food recall or outbreak of illness linked to food and the Food 
and Drug Administration's inadequate resources and incompetent 
management. We now can look back just with regard to food and 
we can see tomatoes, spinach, grapes, mushrooms, seafood, and 
dozens of other items which have gotten on to poison and sicken 
the American consumer.
    Today's processes are no different. We face another food 
crisis. Since mid-April, there have been 145 cases of 
salmonella poisoning associated with fresh tomatoes. I am 
hearing some complaints from people who say, well, we don't 
want to pay the cost of this. I would ask how many would rather 
pay a modest increase in cost to avoid bloody diarrhea or 
something like that associated with salmonella, and do we want 
to pay a little bit more to get a competent Food and Drug 
Administration that properly carries out its responsibility and 
has the capacity to protect the American consumers? And we must 
ask, what is the point of having the best food and drug laws in 
the world if they are not enforced and if we cannot reach 
abroad to address other countries which are shipping foods, 
drugs, cosmetics, and other things into this country which 
threaten the well-being of the American consuming public.
    The outbreak that we are talking about has extended to 16 
States, 23 hospitalizations. It has sickened people. It has 
devastated an industry. It has cost consumers, producers, and 
retailers millions of dollars. Tragically, similar food crises 
have occurred in the past, as I have mentioned. Food and Drug 
cannot even identify the source of contamination or to know 
where the tomatoes which are poisoning Americans have 
originated. These continued outbreaks are unacceptable. To have 
Food and Drug come up and say they don't know what to do about 
it or how much money they need or what resources they require 
is a shame and a disgrace, and this committee, in a bipartisan 
fashion, is not going to tolerate that kind of nonsense and we 
are going to come forward with legislation which is going to do 
the job of protecting the American people and we will begin 
addressing the problem plaguing the Nation's food safety 
system.
    My colleagues and I have proposed in an April draft 
discussion legislation outlining comprehensive changes needed 
to improve the safety of domestic and imported food as well as 
drugs and medical devices. This proposal will give FDA the 
resources and the authority necessary to protect Americans, 
something which I believe that they want and something, Mr. 
Chairman, which your hearings are shining a spotlight upon so 
the people may understand the choices that are before them on 
this matter.
    Today's hearing examines the Administration's proposed Food 
Protection Plan announced last November, which illustrates the 
challenges we face in protecting this Nation from foodborne 
illnesses. On paper it looks good. It calls for preventing 
contamination by pursuing safety measures that address risks 
through the life cycles of food protects and countering food 
hazards before they do harm, admirable goals that no one will 
oppose. Unfortunately, the plan lacks the details of what is 
needed to meet these goals, including the money that is needed 
to pay for them. Since this plan first surfaced, this committee 
and the Government Accountability Office at our direction have 
made repeated requests for details about this effort but to no 
avail. If the President's initial budget for the fiscal year 
2009 allocation was any indication of how seriously the 
Administration takes this plan, I fear for the plan's success 
and I seriously question the bona fides of the makers of the 
plan. The President's original budget asked for a mere $51 
million in new budgetary authority for the FDA programs while 
requesting only $30 million in a new budget authority for 
implementing the Food Protection Plan, an amount that everyone 
who has looked at it views as inadequate.
    My concern that the Administration's plan may be smoke and 
mirrors was heightened by Tuesday night's hastily arranged 
conference call between Secretary Leavitt, Commissioner von 
Eschenbach, and select members of the press. It was only then, 
within just a few days of this hearing, that the Administration 
announced that they would seek an additional $275 million in 
new funding including $125 million specifically for food 
safety, a rather laughable process, I would observe, criticized 
by my good friend, Senator Specter, in a letter which is now 
available in the press, and in a rather excellent commentary in 
the Wall Street Journal, which says, ``Senator Specter says FDA 
can't even ask for money properly.'' What a shame.
    The Food Protection Plan may be a solid first step in how 
to protect our people and to fix a broken food safety system 
but it won't work worth a whoop if the Administration does not 
see to it that we have enough money and does not show greater 
signs about being serious about this plan. The Administration 
is going to have to work with us to provide the details and to 
assist us in drafting the legislation to fix the current 
system, including a realistic assessment of its resource 
requirements.
    I do look forward to the testimony from today's expert 
witnesses about what is really needed to protect Americans from 
unsafe food and I commend you, Mr. Chairman, for this hearing. 
We are also going to hear from the FDA's food czar, who we hope 
will not provide us with more Potemkin villages but rather will 
be candid and forthcoming in giving us and the American people 
the truth about what is needed to fix a difficult system which 
is crowned by incompetence, indifference, inadequacy, and a 
gross shortfall in funding and leadership.
    Thank you, Mr. Chairman.
    Mr. Stupak. Thank you, Mr. Dingell.
    Ms. Blackburn for an opening statement, please.

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

    Ms. Blackburn. Thank you, Mr. Chairman. I thank you for the 
hearing and for updating the Subcommittee on the 
Administration's Food Protection Plan. I am sure the public is 
very much aware of the issue that is before us with salmonella 
and the tomatoes. We are hearing about it from so many members 
on this committee this morning. I think it is worth noting that 
U.S. growers produced $1.3 billion worth of tomatoes last year 
and that this current outbreak will devastate that industry. So 
yes, indeed, it is an issue that is of concern to us for the 
health of our citizens but it also is an issue of economics for 
our agricultural community and, fortunately, our good 
Tennessee-grown tomatoes are safe and we will be able to enjoy 
those.
    We have held a lot of hearings on this, Mr. Chairman. I 
think this is our seventh or eighth hearing, and we know it is 
time for action. People are so weary of rhetoric and talk and 
saying we have a plan but nothing gets done. I was sitting here 
reading the Wall Street Journal and here we go, A4, there is 
another story about the FDA and your inability to take action. 
My goodness gracious, certainly this issue should rise to a 
level of importance to you, and you have had time. It was 
November 2007 when the FDA released its Food Protection Plan 
and how you were going to improve your food safety and 
surveillance system, and we are still waiting. The FDA needs to 
shift its focusing from reacting to food safety breaches 
following contamination and instead start looking at 
implementation and prevention policies. Your fiscal year budget 
for food safety was over $560 million. The agency would benefit 
from increased resources to meet the demands of globalization 
on the Nation's food and drug supply but we need to see some 
action from you.
    I hope that you will show that this rises to a priority for 
you and I will say, Mr. Chairman, it continues to be troubling 
to me that we continue to hear about a lack of interagency 
communication, a lack of 21st century IT systems and a lack of 
best practices to streamline safety review efforts. We have 
asked for those best practices, and I am curious if they exist 
because they tend to not be presented to us. This is an issue 
of accountability. We know you have the ability to perform 
these tasks. We would seek from you recognition of the need for 
this to be a priority and recognition that accountability is 
required.
    Mr. Chairman, I thank you for the time. I yield back the 
balance of my time and look forward to the hearing.
    Mr. Stupak. Thank you.
    Mr. Doyle for an opening statement, please.

   OPENING STATEMENT OF HON. MIKE DOYLE, A REPRESENTATIVE IN 
         CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

    Mr. Doyle. Thank you, Mr. Chairman. As you mentioned in 
your opening statement today, this marks our eighth hearing on 
food safety, and Mr. Chairman, I want to thank you for your 
tenacity and engagement into ensuring our Nation's food supply 
is as safe as possible.
    I have to say that I am pleased the Administration is 
amending its FDA funding request in this year's budget. The 
extra $275 million will be great to help ensure the safety of 
our food, drugs, cosmetics, and medical devices but it is worth 
pointing out, as others have, that it falls $100 million short 
of the amount FDA's own advisory board determined is needed.
    Mr. Chairman, as a member of the Subcommittee on 
Telecommunications and the Internet, I must say that I am 
dismayed at the many problems FDA is having updating its 
antiquated information technology infrastructure. IT is the 
backbone of an information-based workforce. It is the work you 
have to do first before you can get any other work done. When 
your computers are down, it is hard to get work done. When you 
are not giving employees the right technological tools, it is 
hard to encourage them to be entrepreneurial about their work. 
Those failures make doing the important day-to-day work 
critical to our Nation's safety extremely difficult. It is no 
wonder that the FDA performed more than double the number of 
foreign and domestic food establishment inspections in 1973 as 
they performed in 2006. It is no wonder that the folks at GAO 
have outlined dozens of suggestions and recommendations to 
improve FDA that haven't been acted upon.
    Mr. Chairman, I look forward to their testimony this 
morning as I do for all the witnesses, and hopefully with 
suggestions to improve our food supply. With that, Mr. 
Chairman, I won't take up too much more of the Subcommittee's 
time. I would rather listen to what the witnesses have to say 
and ask some questions, and I will yield back.
    Mr. Stupak. I thank the gentleman.
    Mr. Burgess for an opening statement, please.

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

    Mr. Burgess. Thank you, Mr. Chairman, and I too will try to 
be brief because most of this stuff we have heard already. It 
is our eighth Subcommittee hearing.
    The title of this hearing is interesting: ``When Will the 
FDA's Food Protection Plan be Fully Funded and Implemented.'' 
It is kind of ironic. I may only be a third-term Member but 
from my recollection of civics, funding of federal agencies is 
partly our job in Congress. So we know what the problem is. We 
have had eight hearings. We had a lot of testimony. We have 
seen the consequences. Let us start addressing them. That is 
what the American people want and what they deserve, and the 
issue of protecting people and products is not always easy.
    We live in a free society and the government is faced with 
certain challenges and tradeoffs when it comes to safeguarding 
the public and ensuring their freedom. One of the biggest is, 
how do we protect people without encroaching upon their 
freedom? It is a complex challenge but it doesn't lessen our 
obligation of keeping Americans safe. It is right there in the 
first sentence of the Constitution. It is time that this 
Congress start living up to that core responsibility.
    I hope the committee today can take some of the first steps 
to protect our food supply and protect our citizens. We are 
pretty well past the point of more finger pointing. I think 
there is enough culpability on all sides to go around but this 
committee needs to get down to work in a truly bipartisan 
manner and fill in some of the details of this FDA Food 
Protection Plan. Based on the title of this hearing, I wonder 
if both sides of the dais see great merit in this food safety 
proposal. Let us move forward in two simple steps. First is to 
legislate, and two, put the pen in the appropriators' hands and 
let them write the check.
    Yesterday, myself and several members on this side of the 
dais signed a letter supporting the inclusion of the $275 
million for the Food and Drug Administration in the 
supplemental appropriations bill that we are reportedly, 
allegedly going to vote on some time this month. This plus the 
additional requested sums in the baseline budget should meet 
the needs of the FDA, and I would just point out that the 
dollar amount requested for food protection by the science 
panel was $128 million, and with the baseline budget and the 
supplemental money, this will be $125 million, pretty close to 
what they requested. So there is no excuse. We know what the 
problem is. We know what the target funding is. Again, let us 
put the pen in the appropriators' hands and write the check.
    It is impossible to regulate the food safety system down to 
zero percent foodborne illness. We all know that. It is also 
possible to change some of our technologies so we are not 
always having to be reactive but we can be a little bit more 
proactive, but for whatever reason, we have chosen to leave 
those technologies on the shelf and not use them. Maybe we need 
to rethink some of those processes. Are there ways? We 
understand that the salmonella organism in the tomato problem 
is not just on the surface of the tomato but maybe in the 
vasculature of the tomato so washing won't always solve the 
problem. Is there another method for eradicating the salmonella 
in the tomato before it reaches the consumer? We could 
irradiate. Some people have a problem with that. Well, we have 
to have the discussion and the debate and get past that 
problem.
    This Committee should be about solutions. It should be 21st 
century results-oriented. The innovation is out there, whether 
it be irradiation, some of the activities that can be done with 
gene splicing. There are additional methods of prevention that 
we could be taking and that we just elected not to. It has been 
stated over and over again. This is the eighth oversight 
hearing. Really, it is time to stop talking. This is a 
bipartisan issue. We all agree that there needs to be a 
solution. Let us legislate, authorize and then write the check 
and get this problem solved.
    I yield back.
    Mr. Stupak. I thank the gentleman. I take it by your 
opening statement you will cosponsor Mr. Dingell's FDA 
globalization safety bill----
    Mr. Burgess. Will the gentleman yield?
    Mr. Stupak. Sure.
    Mr. Burgess. I have some problems with the legislation that 
Mr. Dingell has outlined and I prepared a letter to the 
chairman on that and so we can work on those issues. I don't 
think I am prepared to cosponsor the legislation at this point. 
There are, as I see it, some problems within the legislation. 
One of the problems is, it is a bipartisan committee. I mean, 
both sides should sit down and work on this legislative product 
before it just gets given to us. It is a whole lot easier to 
work through this process at the staff level rather than trying 
to amend the product. You know, we get the legislation and take 
it or leave it. Well, I am going to try to help as best I can 
but the reality is, it would have been far better if Mr. 
Dingell, Mr. Barton and some of us on the Subcommittee had sat 
down and worked out those problems before the legislation was 
delivered, and I yield back.
    Mr. Stupak. Well, thank you. We look forward to your letter 
because we have been working with Mr. Barton and we are making 
progress on it but we always value your input into the process. 
Thank you.
    Ms. Schakowsky for an opening statement.

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

    Ms. Schakowsky. Thank you, Mr. Chairman. I want to commend 
you for holding this hearing regarding the crucial legislation 
and for all your hard work on improving our Nation's food 
safety.
    I have been proud to participate in the seven hearings on 
food safety the Subcommittee has held this Congress which have 
revealed a number of truly shocking revelations about the major 
gaps in our food safety system. Once again, it is clear that 
the FDA is unable to ensure that the food that we serve on our 
dinner tables each night won't make us sick.
    Americans are more and more worried about the safety of the 
food they eat and rightly so. Last week's tomato salmonella 
scare sickened 167 people in 17 States, and every week another 
food recall is announced, it seems. Jars of Peter Pan peanut 
butter containing salmonella, cans of green beans containing 
botulism, spinach tainted with E. coli, poisoned pot pies, the 
largest meat recall in the history of our country, 143 million 
pounds of recalled beef of which 50 million pounds were sent to 
the school lunch program in February. Earlier this month 
salmonella was found in Puffed Rice and Puffed Wheat cereals 
produced by Malt-O-Meal. Tainted cantaloupes caused a scare in 
March. As a mother and a grandmother, I should not have to 
worry about whether I am serving my family contaminated food.
    That there are 76 million foodborne illnesses in this 
country each year is simply unacceptable. It demonstrates that 
there are real gaps in our food safety system, a system which 
doesn't come close to reflecting the technological advancements 
in the wealthiest and most powerful nation on earth, and given 
its track record and lack of resources, I am concerned about 
FDA's ability to enact the Food Protection Plan. I am 
particularly concerned about FDA's lack of willingness to share 
their plans with Congress and the public. The FDA Modernization 
Act, which we are beginning to consider in the Energy and 
Commerce Committee, has strong language which gives the FDA 
greater authority and more resources to perform their mission. 
This is especially true of food manufactured overseas, by 
giving the FDA the tools it needs to conduct inspection of 
foreign facilities. This legislation takes bold steps to 
prevent problems before they occur on U.S. soil. And by finally 
giving the FDA mandatory recall authority, we are giving the 
Agency the teeth it has been missing to stop corporations and 
companies that do not stand up to their responsibilities to 
follow the law and keep the public safe.
    So I am looking forward to working with the committee to 
strengthen that legislation. If the FDA had this authority now, 
perhaps hundreds of people would not have been exposed to 
salmonella and millions of tomatoes would still be on the store 
shelves. Consumers expect no less from their government.
    Mr. Chairman, I thank you again for convening this hearing 
and I look forward to hearing from our witnesses and yield back 
the balance of my time.
    Mr. Stupak. Thank you.
    That concludes the opening statements of all members. I 
want to thank all members for being here promptly. We did the 
business meeting and now we will start this meeting. I realize 
there is another Subcommittee meeting at this same time, the 
Environment and Hazardous Materials Subcommittee, so members 
will be moving in and out, and we welcome their participation.
    Since that concludes the opening statements by members of 
the Subcommittee, I now call our first panel of witnesses to 
come forward. On our first panel we have Dr. Gail Cassell, Vice 
President of Scientific Affairs and Distinguished Lilly 
Research Scholar for Infectious Diseases at Eli Lilly and 
Company. Dr. Cassell is also chair of the Subcommittee on 
Science and Technology of the FDA's Science Board. Dr. J. Glenn 
Morris, Jr., Director of the Emerging Pathogens Institute at 
the University of Florida. Dr. Morris is also an external 
advisor to the FDA's Science Board's Subcommittee on Science 
and Technology. Mr. Michael R. Taylor, Research Professor of 
Health Policy at the George Washington University School of 
Public Policy and Health Services. Dr. Jeffrey Levi, Executive 
Director of the Trust for America's Health, and Ms. Lisa 
Shames, Director of Food and Agricultural Issues at the 
Government Accountability Office.
    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? With the 
nodding of heads, I indicate no one wishes to be represented by 
counsel. Therefore, I am going to ask the witnesses to please 
rise and raise your right hand to take the oath.
    [Witnesses sworn.]
    Mr. Stupak. Let the record reflect that the witnesses 
replied in the affirmative. Each of you is now under oath. We 
will now hear 5 minute opening statements from our witnesses. 
You may submit a longer statement for inclusion in the record.
    Ms. Shames, we will start with you, please. We will go from 
my left to the right. We will go right across.

   STATEMENT OF LISA SHAMES, DIRECTOR, FOOD AND AGRICULTURE 
         ISSUES, U.S. GOVERNMENT ACCOUNTABILITY OFFICE

    Ms. Shames. Chairman Stupak, Ranking Member Shimkus and 
members of the Subcommittee, I am pleased to be here today to 
discuss FDA's progress in implementing its Food Protection 
Plan. As you will recall, we testified last January before the 
subcommittee that FDA's plan proposes positive first steps. 
However, we expressed concerns that it would be difficult for 
Congress to assess the likelihood of the plan's success without 
a clear description of the resources and strategies needed to 
implement it.
    I would like to make three points today. First, since 
January, FDA has added few additional details on the resources 
and strategies it needs to implement the plan. Second, FDA has 
implemented few of GAO's recommendations that could help it 
leverage resources and improve enforcement, and third, in terms 
of FDA's current resource level, its proposal to focus 
inspections based on risk has the potential to be an efficient 
and effective approach, especially since FDA's inspections have 
decreased while the number of food firms under its jurisdiction 
have increased.
    First, regarding resources and strategies, we testified 
last January that FDA had not provided specific information on 
the resources and strategies needed to implement the Food 
Protection Plan. Since then, FDA has added few details. FDA 
acknowledges that additional resources are required to 
implement the Food Protection Plan, and is directing a portion 
of its 2008 and 2009 budget to that end. However, FDA's overall 
resource needs are unclear and those resource needs could be 
significant. For example, if FDA were to inspect the over 
65,000 domestic food firms under its jurisdiction, it would 
cost approximately $524 million. This figure underscores the 
need for FDA to focus on a risk-based approach. Based on our 
review of draft internal documents, FDA appears to be refining 
its planning process. These internal documents provide some 
additional information. Nonetheless, we continue to have 
concerns about the lack of specificity. For example, we were 
told the Food Protection Plan would take an estimated 5 years. 
However, FDA has not provided us with the timelines for the 
plan's strategic actions and their associated action steps and 
deliverables. Without this type of information, we are not able 
to assess whether FDA's estimated time frame is feasible.
    We also testified in January that FDA planned to keep the 
public informed of its progress in implementing the Food 
Protection Plan. To date, FDA has not done so. While we were 
provided a list of various accomplishments, they were compiled 
from numerous public sources. Having such information in a 
consolidated document that is readily accessible reassures 
Congress and the public that actions have been taken. 
Ultimately, at a minimum, the information we are seeking is 
along the lines of a results-oriented strategic plan that 
identifies long-term and interim goals and identifies necessary 
resources including funding, human capital and information 
technology to achieve them. Publicly reporting on progress made 
against those goals facilitates congressional oversight, 
fosters accountability and promotes transparency.
    Second, regarding GAO recommendations, FDA has implemented 
few of our past food safety-related recommendations. Of the 34 
recommendations we made since 2004, FDA has fully implemented 
seven. It should be noted that FDA has started to take some 
steps on most of the remaining recommendations. Among our 
recommendations was for FDA to make it a priority to establish 
equivalence agreements with other countries. We found such 
agreements would shift some of FDA's oversight burdens to 
foreign governments. We also recommended that FDA consider an 
accreditation program for private labs and a certification 
program for third-party inspectors. None were fully 
implemented. In light of the Federal Government's long-term 
fiscal challenges, agencies including FDA need to seek out 
opportunities to better leverage their resources. The Food 
Protection Plan's proposals could help address several of these 
recommendations. For example, it requests Congress to allow FDA 
to enter into agreements with exporting countries to certify 
that foreign producers' shipments of designated high-risk 
products comply with FDA standards.
    Lastly, regarding risk-based inspections, the Food 
Protection Plan identifies the need to focus safety based on 
risk. Conducting inspections along these lines has the 
potential to be an efficient and effective approach for FDA to 
target scarce resources, which is particularly important as the 
number of food firms has increased, while inspections have 
decreased. For example, between 2001 and 2007, the number of 
domestic firms increased from about 51,000 to over 65,000 while 
the number of firms inspected declined, albeit slightly. More 
significantly, the number of foreign food firm inspections that 
FDA conducted has declined from 211 in 26 countries to 96 in 11 
countries.
    To conclude, FDA's Food Protection Plan can only be as 
effective as its implementation. Additional detail along with 
public reporting on the progress that has been made provides 
FDA a valuable opportunity to reassure Congress and the public 
that it is doing all it can to protect the Nation's food 
supply.
    Mr. Chairman, this concludes my prepared statement and I 
would be pleased to respond to any questions that you or 
members of the Subcommittee may have.
    [The prepared statement of Ms. Shames follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Stupak. Thank you for your testimony.
    Dr. Cassell, your testimony, please.


STATEMENT OF GAIL H. CASSELL, PH.D., VICE PRESIDENT, SCIENTIFIC 
AFFAIRS AND DISTINGUISHED LILLY RESEARCH SCHOLAR FOR INFECTIOUS 
                DISEASES, ELI LILLY AND COMPANY

    Ms. Cassell. Good morning, Mr. Chairman, members of the 
Committee. I appear before you today, as you have stated, as a 
member of the FDA's Science Board, the advisory committee to 
the Commissioner, and as the chair of the subcommittee of the 
Science Board that was asked in December of 2006 to assess the 
state of science and technology at the Agency for its ability 
to address their current responsibilities as it relates to the 
protection of the public's health.
    On December 3, 2007, the Science Board subcommittee 
presented the results of our findings to the full Science 
Board. The Science Board accepted the report as final and 
dissolved the subcommittee. The record of the proceedings of 
that meeting will show that due to the seriousness of the 
deficiencies found and the urgency of the situation, the 
Science Board was adamant that the report be broadly 
disseminated among the public and policymakers. The level of 
concern by all members of the subcommittee and the Science 
Board to a person was and remains very high, and thus the 
intensity of our commitment to this review and to see that in 
fact the recommendations of this committee are fully understood 
and the urgency appreciated. On behalf of our subcommittee, I 
again want to thank this committee for your interest and 
attention to the report.
    As you have heard me say before, this subcommittee review 
was unique in many respects. First, it is only the second time 
in over a century that the Agency has been reviewed by an 
external committee as a whole entity. Second, the committee was 
composed of leaders not from a single sector but industry, 
academia, other governmental agencies. I won't belabor that. 
You have heard me say that before. It is in my written 
testimony. But I would point out on this committee that we did 
have a former Assistant Secretary of Health, a former Under 
Secretary of Agriculture responsible for food safety, a former 
Chief Counsel of the FDA, and almost 50 percent of the members 
were members of the National Academy of Sciences, including one 
Nobel laureate. We worked for over a year. It was the rule, not 
the exception, that almost all members were actively engaged 
and present in our deliberations. Let me assure you one more 
time that this level of engagement by a committee is not the 
norm. Trust me. I have served on enough committees of this 
type.
    I would just say that also it is very rare that a committee 
would reach consensus so rapidly. You might ask then why were 
we able to achieve consensus and why the committee to this 
exercise, and quite simply, it was, it became readily apparent 
that FDA suffers, as you have heard this morning, from serious 
scientific deficiencies and is no way positioned to meet 
current or emerging regulatory responsibilities. It is agency-
wide. It is not limited to a single program or center. Since 
every regulatory decision must be based upon the best available 
scientific evidence in order to protect public health, we 
concluded lives were at risk and that there was an urgent need 
to address the deficiencies. Quite simply, we concluded that 
FDA can no longer fulfill its mission without substantial and 
sustained appropriations.
    Many of you this morning have suggested that you are eager 
to hear what we would tell you about the new scientific 
technologies that would be applied to the food safety system. I 
am here to tell you today that in the hearing you may remember 
that was held by your committee on January 29, that in fact Dr. 
Porter from the congressional Research Service presented a 
slide to you which showed that the resources for the FDA for 
conducting research has declined by 50 percent since 1993. For 
food safety, you should appreciate that that amount has 
declined 67 percent. It is absolutely essential if in fact the 
Agency is to have the best and most up-to-date technologies 
that they do have the resources.
    For that reason, when we were asked by this committee to 
provide our best judgment in terms of resources needed, you 
have already alluded to the fact that we requested $375 million 
in 2009. This was in great contrast, of course, to what you 
have already heard of the $50.7 million requested by the 
Administration. We are encouraged that the Administration's 
fiscal year 2009 budget amendment acknowledges the FDA's needs 
for $275 million to address serious safety issues but 
unfortunately, this amount is not sufficient to address all the 
deficiencies we found including the IT deficiencies and drug 
safety issues, and most importantly, with respect to food 
safety, it does come very close to what we recommended but 
appreciate it doesn't include the IT component in that $128 
million we recommended for food safety.
    We also wanted to point out that if it were not to become 
available until 2009, this is not in time. As we have all just 
heard about the tomato outbreak with salmonella, 23 
hospitalizations, over 145 people sickened, and plus over $51 
million lost in the space of just a few weeks. I also would 
point that in fact we also have had the 81 deaths from the 
heparin contamination. Therefore, it is urgent and we urge you 
to include the $275 million for FDA in the supplemental 
appropriations bill currently being considered by the House and 
Senate in order to get the critically needed funds flowing.
    You will hear this morning from Dr. Glenn Morris, a member 
of the subcommittee, in detail about what the specific findings 
were that relate to food safety. You will also hear our concern 
about the lack of specificity in the Agency's Food Protection 
Plan and the fact that we need a strategic implementation plan. 
We need to know what technologies are going to be utilized, how 
long this will take, and I thank you for your attention and 
conclude my comments.
    [The prepared statement of Ms. Cassell follows:]

                  Statement of Gail H. Cassell, Ph.D.

    Mr. Chairman and Members of the Subcommittee, I am Gail H. 
Cassell, Vice President for Scientific Affairs and a 
Distinguished Research Scholar for Infectious Diseases of Eli 
Lilly and Company and Professor. I am also Professor and 
Chairman Emeritus of the Department of Microbiology of the 
University of Alabama Schools of Medicine and Dentistry. I am a 
member of the Institute of Medicine of the National Academy of 
Sciences and am currently serving a second term on the 
governing board of the IOM. Of relevance to my testimony today, 
I have previously been a member of the Advisory Committees of 
the Directors of both the Centers for Disease Control and the 
National Institutes of Health. I also co-chaired the 
congressionally mandated review of the NIH intramural program. 
I appear before you today as a member of the FDA Science Board, 
Advisory Committee to the FDA Commissioner as I have done so 
twice before this year. As you know I served as Chair of the 
Subcommittee on Science and Technology of the Science Board, 
which authored the report ``FDA Science and Mission at Risk''.
    In December 2006, the Commissioner charged the Science 
Board with establishing a subcommittee to assess whether FDA's 
current science and technology can support the Agency's 
statutory mandate to protect the Nation's food and drug supply. 
The subcommittee was comprised of three Science Board members 
and 30 other experts. The subcommittee formally presented its 
report to the Science Board and FDA on December 3.
    The report was unanimously endorsed by each of the 33 
members of the subcommittee and the full Science Board. On 
December 3, the Science Board accepted the report as final and 
dissolved the subcommittee. The record of the proceedings of 
that meeting will show that due to the seriousness of the 
deficiencies found and the urgency of the situation, the 
Science Board was adamant that the report be broadly 
disseminated among the public and policy makers. The level of 
concern by all members of the subcommittee and the Science 
Board members was, and remains, high.and thus the intensity of 
their commitment to this review. On behalf of our subcommittee, 
I again want to thank you Mr. Chairman and members of your 
committee for your attention to our report.
    The subcommittee review was unique in many respects. First, 
it is only the second time in over a century that the Agency 
has been reviewed by an external committee as a whole entity. 
Second, the committee was composed of leaders, not from a 
single sector, but from industry, academia, and other 
government agencies. The expertise and level of accomplishments 
of the members are almost unprecedented in a single committee, 
especially considering their breadth and knowledge in 
regulatory science and understanding of the mission of the 
Agency.
    The subcommittee included expertise ranging from a Nobel 
laureate in pharmacology, 14 members of the National Academy of 
Sciences (including two engineers), a renowned economist and 
specialist in workforce issues, a leader in health care policy 
and technology assessment, a former CEO of a large 
pharmaceutical company, a former Assistant Secretary for Health 
and Human Services who also headed global regulatory affairs 
within a large company for over 20 years, a former Chief 
Counsel for the FDA, and the first Under Secretary for Food 
Safety at the U.S. Department of Agriculture overseeing the 
Food Safety and Inspection Service and coordinating U.S. 
Government food safety policy.
    For over a year, this group of experts worked intensively 
for thousands of hours, including many nights, weekends, and 
holidays conducting their review. It was the norm, not the 
exception, that when we met, even by teleconference, we would 
have as many as 30 members actively engaged in discussion for 
over 2 hours. Let me assure you, this level of engagement by so 
many very busy people with diverse expertise is rare in such a 
committee let alone that there would be such rapid consensus 
about its findings. How then do you explain the consensus and 
commitment to this exercise?
    It became rapidly apparent that the FDA suffers from 
serious scientific deficiencies and is not positioned to meet 
current or emerging regulatory responsibilities. It is agency-
wide, i.e. not limited to a single program or center. Since 
every regulatory decision must be based upon the best available 
scientific evidence in order to protect the public's health, we 
concluded that American lives are at risk and that there is an 
urgent need to address the deficiencies. Quite simply we 
concluded that FDA can no longer fulfill its mission without 
substantial and sustained additional appropriations.
    On February 25, in response to your request, we submitted a 
summary of the estimated resources required to implement the 
recommendations made by our Subcommittee which included $375M 
in FY 2009. This was in great contrast to the $50.7M requested 
by the Administration for FY 2009. We are encouraged that the 
Administration's FY 2009 budget amendment acknowledges the 
FDA's need for $275M to address serious safety issues. 
Unfortunately, we do not believe this amount is sufficient and 
most importantly, even if it were, it would not be available 
until March or April of 2009 at the very earliest.
    Just within the past 2 months there have been 81 deaths in 
this country from contaminated heparin. Just this past week, 
the Centers for Disease Control has reported there have been 23 
hospitalizations and 145 people sickened from salmonella 
contamination of fresh tomatoes. The later alone has cost the 
food industry over $51M in the last few days. Mr. Chairman, if 
we do not act now to address the deficiencies at FDA, we will 
see more lives lost and greater economic losses. We therefore 
urge you to include $275M for FDA in the Supplemental 
appropriations bill currently being considered by the House and 
Senate in order to get the critically needed funds flowing 
rapidly.
    You will recall in the hearing held by your committee on 
January 29, we summarized the overall findings of our 
subcommittee. In the hearing you held, April 22, findings 
concerning drug safety and foreign inspections were extensively 
discussed. However, our subcommittee found the most serious 
deficiencies to be in the area of food safety. Today you will 
hear from Dr. Glenn Morris, a member of our review group about 
our specific concerns and recommendations about food safety. In 
addition, you will hear about our concern that the Agency's 
current Food Protection Plan lacks specificity regarding the 
actions to be taken, technologies to be utilized, and 
mechanisms of implementation. I will now defer to him and the 
other panel members to discuss these issues in greater detail.
                              ----------                              

    Mr. Stupak. Thank you, Doctor.
    Dr. Morris for an opening statement, please.

    STATEMENT OF J. GLENN MORRIS, JR., M.D., M.P.H., T.M., 
 DIRECTOR, EMERGING PATHOGENS INSTITUTE, UNIVERSITY OF FLORIDA

    Dr. Morris. Mr. Chairman, members of the Committee. It is a 
pleasure to have the opportunity to speak before you today to 
review the findings of the report of the FDA's Science Board 
Subcommittee on Science and Technology on which I had the 
pleasure of being a member. In the second part of my testimony 
I would like to expand my remarks beyond the report to deal at 
a more general level with the ability of FDA to identify and 
control risks in our U.S. food supply.
    The subcommittee's report was entitled ``FDA Science and 
Mission at Risk,'' which I think correctly emphasizes the 
critical nature of the current situation at FDA. To quote from 
the report, ``FDA does not have the capacity to ensure the 
safety of food for the Nation. Crisis management at FDA's two 
food science centers, Center for Food Safety and Applied 
Nutrition and Center for Veterinary Medicine, has drawn 
attention and resources away from FDA's ability to develop a 
science base and infrastructure needed to efficiently support 
innovation in the food industry, provide effective routine 
surveillance and conduct emergency outbreak investigation 
activities to protect the food supply.'' I would say that I 
very strongly support these conclusions.
    As highlighted in the committee report, the current 
situation reflects decades of neglect of CFSAN and CVM resource 
needs, and again, this has been noted multiple times already 
this morning. Just to note one, to me, particularly insightful 
point: since 2003, CFSAN's workforce has declined from 950 FTE 
to 771 FTE, and this is at a time when there have been 
increased demands on the Agency brought on by an increasingly 
complex food supply, rapidly expanding internationalization of 
markets as well as increasing regulatory responsibility. The 
problems in CFSAN and CVM have been further exacerbated by 
major outbreaks and recalls which, of necessity, divert 
resources away from ``routine'' scientific surveillance and 
regulatory activities.
    In the absence of a clearly articulated vision for food 
safety in this country, it is difficult to come up with a 
dollar amount for what it is going to take to get everything 
working again. However, the subcommittee, in response to the 
request of this committee, developed cost estimates for 
beginning the rebuilding process in the Agency, and again, as 
has already been mentioned, the numbers that we put forth were 
approximately $128 million for fiscal 2009 with a cumulative 
increase of $775 million in annual budget by 2013. Again, I 
would strongly emphasize that that does not include the IT 
component, which is an absolutely critical component. The 
increase that is being proposed by the Agency at this point in 
time begins to move toward the number we put forward, but 
without the IT component. We are still not there yet.
    Food safety remains a critically important area of concern 
to the U.S. public as has been demonstrated by the current 
problems with tomatoes. The latest outbreak always gets the 
headlines, and is what we tend to focus on. What I would 
comment on, speaking as an epidemiologist, is that the reported 
incidence rates for the major foodborne pathogens, based on 
2007 FoodNet data, have remained relatively constant during the 
past several years with some actual increases. FoodNet was a 
system we put in place back in the mid-1990s to give us a means 
of monitoring the outcome of the new HACCP food protection plan 
at USDA. I was with USDA at the time and was instrumental in 
putting the plan in place. FoodNet showed that we had an 
initial drop in incidence of foodborne disease in this country 
after implementation of the HACCP rules, which suggests that 
there was a definite public health impact resulting from these 
landmark regulatory changes. However, this decrease has leveled 
off over the last several years, underscoring the need for new 
and innovative approaches to protect the health of the American 
people. We did a good job at USDA. We need to do something at 
FDA to really begin to address these concerns.
    There is a broad consensus that the Agency must develop a 
proactive risk-based and science-based preventive approach to 
food safety. Some of the key elements of such an approach have 
been articulated by the Agency with the announcement of their 
Food Protection Plan. However, as has already been noted, 
questions remain about implementation and the extent of the FDA 
vision. I would highlight three specific areas.
    First of all, development of a risk- and science-based 
approach to prevention requires science. To quote from the 
initial subcommittee report, ``There is a critical need to 
develop a cadre of professionals capable of applying the new 
biology, chemistry, and bioinformatics to the regulation of 
foods that exist in the manufacturing, distribution and 
consumer use environment of today's global marketplace.'' We 
need to have the scientists in place. We need to have the ideas 
and the vision to set the priorities and to be able to develop 
the risk-based system we have talked about. This is both 
laboratory science but it also a need for epidemiologic 
capabilities. It is a need for high-quality surveillance.
    This also has to be combined with a strong analytic 
capability both to guide the original data collection and to 
make sense of the data when they are collected. In this regard, 
many of the European countries such as the Netherlands and 
Denmark are well ahead of us, having in place well-designed 
surveillance systems that are used to regularly tweak the 
approaches and focus areas of the associated food safety 
regulatory agencies. Development of public health-based 
performance standards which long term are a critical element of 
a risk-based prevention system requires an even higher level of 
sophistication and surveillance and analysis. Unfortunately, 
the capacity at FDA for such analysis is limited and there is 
at best a clouded vision of what is needed for actual 
implementation of such systems.
    The second thing, no matter how good the science, the 
Agency will not be able to move forward in the absence of an 
appropriate legislative mandate. Again, I will leave that to 
the comments made by other members of this panel and others 
this morning.
    And of course, finally, the third point, there is a need 
for a substantial increase in the budgets for CFSAN and CVM. 
The estimates that we provided again are a starting point. The 
actual amounts necessary will almost certainly change depending 
on the extent of the Agency's vision and their approaches to 
implementation. In the long run, prevention is unquestionably 
cost effective. However, we have a great deal of rebuilding to 
do before we can begin to realize such cost savings.
    FDA science is at a critical juncture with the negative 
impact of declining resources being felt perhaps most strongly 
in the food safety area. I would urge the Committee to work to 
rebuild its resource base and provide the necessary underlying 
legislative mandate as part of an ongoing effort to decline and 
implement a national vision for the future of food safety.
    Thank you, Mr. Chairman.
    [The prepared statement of Dr. Morris follows:]

             Statement of J. Glenn Morris, Jr., MD, MPH \*\
---------------------------------------------------------------------------

    \*\ Dr. Morris is Director of the newly established Emerging 
Pathogens Institute (EPI) at the University of Florida, Gainesville, 
where he is also a Professor of Medicine (Infectious Diseases). From 
1994-96, Dr. Morris worked with the Food Safety Inspection Service, 
USDA, on development of the new HACCP regulations, and was instrumental 
in the establishment of FoodNet, the national surveillance system for 
foodborne illness. He has served on four National Academy of Sciences 
expert committees dealing with food safety, and currently serves on the 
Institute of Medicine's Food and Nutrition Board. Most recently, Dr. 
Morris served as a member of the FDA Science Board's Subcommittee on 
Science and Technology, which was responsible for the February, 2008 
report ``FDA Science and Mission at Risk.''
---------------------------------------------------------------------------
    Mr. Chairman, members of the Committee: it is a pleasure to 
have the opportunity to speak before you today to review the 
findings of the Report of the FDA Science Board's Subcommittee 
on Science and Technology, on which I was a member. In the 
second part of my testimony, I would like to expand my remarks 
beyond the report to deal at a more general level with the 
ability of FDA to identify and control risks in our U.S. food 
supply.
    The Subcommittee's report was entitled ``FDA Science and 
Mission at Risk,'' correctly emphasizing the critical nature of 
the current situation at FDA. In discussing food safety, the 
report concluded that ``FDA does not have the capacity to 
ensure the safety of food for the Nation. Crisis management in 
FDA's two food safety centers, Center for Food Safety and 
Applied Nutrition (CFSAN) and Center for Veterinary Medicine 
(CVM), has drawn attention and resources away from FDA's 
ability to develop the science base and infrastructure needed 
to efficiently support innovation in the food industry, provide 
effective routine surveillance, and conduct emergency outbreak 
investigation activities to protect the food supply.'' \**\ I 
would strongly support these conclusions.
---------------------------------------------------------------------------
    \**\ Report of the Subcommittee on Science and Technology, FDA 
Science and Mission at Risk, November, 2007, p.3.
---------------------------------------------------------------------------
    As highlighted in the Subcommittee report, the current 
situation reflects decades of neglect of CFSAN and CVM's 
resource needs. Since 2003, CFSAN's workforce has declined from 
950 FTE to 771 FTE, at a time when there have been increasing 
demands on the Agency. This includes demands brought on by an 
increasingly complex food supply, with rapidly expanding 
internationalization of markets, as well as increasing 
regulatory responsibilities related to new legislative 
mandates. Problems in both CFSAN and CVM have been further 
exacerbated by major outbreaks and recalls, which, of 
necessity, divert resources away from ``routine'' scientific, 
surveillance, and regulatory activities.
    In the absence of a clearly articulated vision for food 
safety in this country, it is difficult to come up with 
estimates for what it will cost to optimize the FDA food safety 
program. However, in response to a specific request of 
Representatives Dingell, Waxman, Stupak, and Pallone, our 
Subcommittee developed cost estimates for beginning the 
rebuilding process in the Agency; responses were submitted by 
Dr. Cassell on February 25 of this year. To summarize, our 
Subcommittee estimates called for an increase in the annual 
budget of food-related components of FDA of approximately $128 
million for FY2009, with a cumulative increase of $755 million 
in annual budget by 2013. This figure includes $350 million to 
strengthen imports and $100 million to strengthen work with 
nutritional supplements, animal health, and cosmetics. Separate 
from this total is an additional $450 million cumulative 5-year 
increase in annual budget for enhancement of FDA Information 
Technology, an enhancement which is critical for FDA to be able 
to deal with the massive data flows necessary for its 
activities, including appropriate surveillance and food 
protection. \***\
---------------------------------------------------------------------------
    \***\ FDA Science and Mission at Risk. Estimated Resources Required 
for Implementation. Submitted by Gail Cassell, PhD, on behalf of the 
Subc0mmittee and its Members. February 25, 2008.
---------------------------------------------------------------------------
    Food safety remains a critically important area of concern 
to the U.S. public. While attention always tends to focus on 
the latest outbreak, it is perhaps most concerning, from an 
epidemiologic standpoint, that reported incidence rates for the 
major foodborne pathogens (based on 2007 FoodNet data) have 
remained relatively constant during the past several years, 
with some actual increases. This follows initial declines in 
incidence rates seen after implementation of the USDA HACCP 
rules in 1995, suggesting that the impact of these landmark 
regulatory changes over a decade ago has ``leveled off,'' and 
underscoring the need for new and innovative approaches to 
protect the health of the American people.
    FDA, with responsibility for overseeing an estimated 80% of 
the Nation's food supply, must take the major leadership role 
in the development and implementation of such new approaches. 
There is a broad consensus that the Agency must develop a 
proactive, risk-based (and science-based) preventive approach 
to food safety. Some of the key elements of such an approach 
have been articulated by the Agency, with the announcement of 
their Food Protection Plan. However, questions remain about 
implementation, and about the extent of the FDA vision. I would 
highlight three key issues:
    1) Development of a risk- and science-based approach to 
prevention requires science. Going beyond laboratory science, 
there is a need for high quality surveillance, both 
microbiologic and epidemiologic, to clearly identify and 
delineate problem areas. This, in turn, must be combined with a 
strong analytic capacity, both to guide the original data 
collection and to ``make sense'' of the data when they are 
collected. In this regard, many of the European countries (such 
as the Netherlands and Denmark) are well ahead of us, having in 
place well-designed surveillance systems that are used to 
regularly ``tweak'' the approaches and focus areas of the 
associated food safety regulatory agencies. Development of 
public health-based performance standards, which, long-term, 
are a critical element of a risk-based prevention system, 
requires an even higher level of sophistication in surveillance 
and analysis. Unfortunately, the capacity at FDA for such 
analysis is limited, and there is at best a clouded vision of 
what is needed for actual implementation of such systems.
    2) No matter how good the science, the Agency will not be 
able to move forward in the absence of an appropriate 
legislative mandate. In particular, if we are to develop 
performance standards, there must be a regulatory structure in 
place that can make appropriate use of such standards as part 
of a flexible, risk-based performance system. The legislation 
before this committee moves in this direction, and I applaud 
these efforts.
    3) And, as previously noted, there is a need for a 
substantial increase in the budgets for CFSAN and CVM. The 
estimates provided by our subcommittee are a starting point: 
the actual amounts necessary will almost certainly change, 
dependent on the extent of the Agency's vision, and their 
approaches to implementation. In the long run, prevention is 
unquestionably cost-effective. However, we have a lot of 
rebuilding to do before we can begin to realize such cost 
savings.
    FDA science is at a critical juncture, with the negative 
impact of declining resources being felt perhaps most strongly 
in the food safety area. I would urge your committee to work to 
rebuild this resource base, and provide the necessary 
underlying legislative mandate, as part of an ongoing effort to 
define and implement a national vision for the future of food 
safety.
                              ----------                              

    Mr. Stupak. Thank you, Doctor.
    Professor Taylor, your opening statement, please.

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

    Mr. Taylor. Mr. Chairman, Mr. Shimkus, members of the 
Subcommittee, I thank you for this opportunity to testify on 
the resource challenges facing FDA in implementing its Food 
Protection Plan.
    Americans have long looked to FDA as the focal point for 
food safety leadership in the United States and internationally 
but FDA's ability to provide that leadership or even meet its 
basic food safety responsibilities is now badly impaired, in 
large part because society simply has not given FDA the tools 
it needs to do the job society expects it to do. These tools 
include adequate resources, the focus of today's hearing, but 
also a modern statutory mandate and an institutional structure 
that is capable of national and international leadership on 
food safety.
    Mr. Chairman, the time for food safety reform has come, as 
you and others today have indicated, and as the result of 
recent events surrounding tomatoes so graphically remind us 
once again. I consider FDA's new Food Protection Plan an 
important step toward the food safety reform we need. It marks 
a shift in strategic direction for FDA. The plan would move FDA 
from primarily reacting to food safety problems after they 
occur to taking an integrated systems approach that focuses on 
prevention and on the risk-based targeting of initiatives and 
resources to reduce the risk of foodborne illness. I think Dr. 
Acheson and his FDA colleagues deserve credit for this new 
direction.
    The issue now of course is implementation and substantial 
questions certainly remain. The Food Protection Plan contains 
eight broad initiatives and a total of 38 specific actions to 
strengthen FDA's food safety program. In every case, these 
initiatives and actions involve either an entirely new effort 
by FDA or significant enhancement of something FDA is doing 
now. These proposed actions are all worthy, all should be 
pursued, as should other food safety initiatives that are not 
included in the plan such as increasing the overall frequency 
of FDA inspection and establishing and enforcing mandatory on-
farm standards to ensure the safety of fresh produce. But the 
question is how. How is FDA going to do the work called for in 
its plan? FDA has issued its plan, as we have heard already 
this morning, at a time when its own Science Board has said 
that FDA lacks the resources and science base to do its food 
safety job, yet the plan itself does not address the resources 
needed to implement it or provide a timeline or priorities for 
implementation, and until earlier this week, the Administration 
had not proposed a budget for FDA that would even begin to 
address the Agency's food safety funding crisis.
    It is important to note that the total increase for food 
safety now proposed by the President for fiscal year 2009 is 
just a down payment on the more than doubling of FDA's food 
budget that the Science Board and other experts say is needed 
over a 5-year period, and under the most optimistic scenario, 
when Congress will act on the 2009 appropriations, the new 
resources would first be available to FDA almost a year after 
the Food Protection Plan was issued. I think we all agree here 
today that FDA needs resources now.
    So given this harsh budget reality, what should FDA do? One 
of the first things to do, again, as others have said, is to 
lay out for the Congress and the public an implementation plan 
for the rebuilding and reform of its food safety program. This 
should include a detailed resource plan and clear priorities 
and timelines to implement the Food Protection Plan. Now, 
making such a plan is hard for an agency like FDA to do in the 
context of an annual budget process that does not lend itself 
to long-term planning, but the food safety transformation that 
is needed and that FDA is calling for demands a long-term 
effort and plan. Congress should require such an effort and 
plan from the Administration. In addition, I think FDA should 
identify some specific actions that it can take now to begin 
the shift from reaction to prevention and address some of 
today's most pressing safety problems. In my written testimony, 
I suggest four such actions, which I will touch on briefly 
here.
    First, to begin the shift to risk-based priority setting 
and preventive risk management, FDA should identify the most 
significant food safety hazards within its jurisdiction and 
begin devising targeted strategies to reduce them. We can't 
solve food safety problems without naming them first. 
Identification of the most significant hazards in the food 
supply can not only guide FDA's actions but also inform the 
industry about risks that companies should be addressing in 
their own food safety plans whether or not those risks are 
being addressed immediately by FDA.
    Now, while we know enough to begin this kind of risk-based 
priority setting, FDA and industry alike have a pressing need 
for better and more timely information about the actual burden 
and root causes of human illness associated with foodborne 
pathogens and other hazards. FDA is dependent for this 
information, however, on the efforts of State and local health 
departments and the Centers for Disease Control and Prevention 
which have their own budget constraint, priorities, and 
limitations that have been obstacles to FDA getting the 
information it needs.
    Thus, the second immediate action I recommend is that FDA 
and the Department of Health and Human Services make it a high 
priority and take affirmative steps to improve the quantity, 
quality, and timeliness of the food safety epidemiology data 
available to FDA and others who need it to improve food safety.
    Third, I believe FDA should conduct a compliance and 
effectiveness audit of FDA's seafood HACCP program. This 
program, established in 1996, foreshadowed the approaches to 
prevention and improved oversight of imports contained in the 
Food Protection Plan and in pending food safety legislation. It 
does this by requiring all seafood processors, domestic and 
foreign, to implement a preventive control plan and requires 
importers to take affirmative steps to ensure that the seafood 
they import was produced under conditions that meet the HACCP 
requirement. Because seafood safety is an important issue in 
its own right and because preventive control plans and 
strengthened industry responsibility for prevention are 
important elements of FDA's new strategy, FDA should assess the 
overall effectiveness of the seafood HACCP role in preventing 
violations of U.S. food safety standards. It should identify 
legal, resource, and other constraints on the effectiveness of 
the rule and it should draw lessons for FDA's development of 
preventive controls for other commodities in sectors of the 
food supply. FDA should learn from that experience.
    Finally, FDA should begin rulemaking now on the safety of 
fresh produce. Over a year ago, the United Fresh Produce 
Association and the Produce Marketing Association called on FDA 
to establish produce safety standards that are, and I quote, 
``federally mandated, risk-based and allow for commodity-
specific regulation.'' I agree that FDA should establish such 
standards and I think FDA should begin the rulemaking as soon 
as possible.
    With these actions, FDA can begin down the path of reform 
but Congress needs to do its part as well. FDA needs a stable 
and adequate resource base. It needs a modern food safety 
legislative mandate and it needs an organization structure that 
unifies and elevates the food safety program within HHS. Only 
then will FDA be equipped to do the food safety job that 
Americans expect and deserve.
    I thank you again, Mr. Chairman, and I look forward to 
questions.
    [The prepared statement of Mr. Taylor follows:]

                   Statement of Michael R. Taylor \*\
---------------------------------------------------------------------------

    \*\ Mr. Taylor is Research Professor of Health Policy at The George 
Washington University School of Public Health and Health Services and 
chair of the Food Safety Research Consortium. He served formerly as 
Administrator of USDA's Food Safety and Inspection Service (1994-96) 
and as Deputy Commissioner for Policy of the Food and Drug 
Administration (1991-94).
---------------------------------------------------------------------------
    Mr. Chairman, Mr. Shimkus, members of the subcommittee, I 
appreciate this opportunity to testify on the resource 
challenges facing the Food and Drug Administration in 
implementing its Food Protection Plan. I applaud the 
subcommittee for tackling this important topic.

                              Introduction

    FDA has long been looked to as the focal point for food 
safety leadership in the United States and internationally. It 
oversees 80% of the U.S. food supply (including an even greater 
share of imported food) and is the steward of a long tradition 
of effective, science-based regulation to protect public 
health. Unfortunately, FDA's ability to provide food safety 
leadership, or even meet its basic food safety 
responsibilities, is now badly impaired, in large part because 
society simply has not given FDA the tools it needs to the job 
society expects it to do. These tools includes a modern 
statutory mandate, an adequate and stable resource base, and an 
institutional structure capable of national and international 
leadership on food safety.
    The focus of this subcommittee, and the Committee on Energy 
and Commerce as a whole, on giving FDA the tools it needs to do 
food safety right is thus timely and important. Getting food 
safety right at FDA is essential to the public's health, to the 
confidence people want to have in the food they feed themselves 
and their families, and to the economic success of the food 
system. The subcommittee's leadership will be essential to 
achieving these outcomes.
    I consider FDA's new Food Protection Plan an important step 
toward the food safety reform we need. It marks a shift in 
strategic direction for FDA, from primarily reacting to food 
safety problems after they occur to taking an integrated 
systems approach that focuses on prevention and on the risk-
based targeting of initiatives and resources to reduce the risk 
of foodborne illness. The FDA plan embodies many of the 
elements of a more effective and efficient food safety program 
that have been recommended over the last decade in a series of 
reports by the Government Accountability Office (GAO) and 
expert committees of the National Academy of Sciences (NAS).
    It is thus appropriate that Congress address FDA's 
implementation of its Food Protection Plan, including the 
resources FDA will need to put the plan into practice. In my 
testimony, I will identify some specific activities that I 
believe deserve priority management attention and funding to 
begin the shift to a prevention paradigm, as well as address 
the scale of FDA's resource needs for food safety in the long 
term.
    It is important, however, to consider the implementation of 
FDA's Food Protection Plan and resource needs in the context of 
the broader statutory and organizational problems that must be 
addressed for FDA's food safety program to succeed. I will thus 
note briefly how the obsolete food safety laws and fragmented 
organizational structure under which FDA operates stand in the 
way of full and effective implementation of the new plan and 
how these problems can be solved.

                    FDA's Food Safety Funding Crisis

    FDA's Food Protection Plan is based on four ``cross-cutting 
principles,'' all of which are sound and all of which have 
significant resource implications. These are:
    1. Focus on risk over a product's life cycle from 
production to consumption.
    2. Target resources to achieve maximum risk reduction.
    3. Address both unintentional and intentional 
contamination.
    4. Use science and modern technology.
    Building on these principles, the plan includes three core 
operational elements: (1) Preventing foodborne illness in the 
first place; (2) Intervening with risk-based FDA actions at 
critical points in the supply chain; and (3) Responding rapidly 
when contaminated food or feed is detected. Under these three 
core elements, FDA lays out eight broad new initiatives and a 
total of 38 specific actions to strengthen its food safety 
program.
    In every case, these initiatives and actions involve either 
an entirely new effort by FDA or a significant enhancement of 
something FDA is doing now. Under the critical first element of 
prevention, for example, the plan calls for FDA to, among other 
things, work with the food industry to promote corporate 
responsibility and best practices for food safety, increase 
FDA's presence overseas, generate new data and develop new 
models for prioritizing risks, and develop and implement a 
research plan on sources of contamination and methods to 
prevent it.
    These activities are all worthy, as are the 34 other 
activities called for in the plan. All should be pursued. 
Moreover, the Agency should be pursuing food safety initiatives 
that are not included in the plan, such as increasing the 
overall frequency of FDA inspection and establishing and 
enforcing mandatory on-farm standards to ensure the safety of 
fresh produce.
    And legislation being developed by Chairman Dingell and 
other leaders in Congress would give FDA responsibility for 
implementing two major and needed new programs: the first 
involves mandatory adoption of preventive controls by all food 
facilities (domestic and foreign) that produce food for the 
U.S. market; the second makes importers accountable for 
assuring that foreign produced products meet U.S. standards.
    These efforts to strengthen FDA's food safety program all 
require investment in such essential inputs to an effective 
program as increased scientific expertise and staffing levels, 
research and data collection to guide the new science- and 
risk-based preventive approach, new information management 
systems, and the operating funds needed to establish a 
leadership presence nationally and internationally. FDA has 
issued its Food Protection Plan and Congress is considering 
major new initiatives at a time, however, when the Agency lacks 
the resources to meet even its base food safety 
responsibilities, much less fund the worthy new initiatives.
    The seriousness of FDA's food safety funding crisis was 
made crystal clear by the December 2007 report of the FDA 
Science Board, which found, starkly, that ``FDA does not have 
the capacity to ensure the safety of food for the nation'' and 
that ``[t]he Nation's food supply is at risk.'' The Science 
Board report said further that FDA's food program lacks the 
resources ``to develop the science base and infrastructure 
needed to efficiently support innovation in the food industry, 
provide effective routine surveillance, and conduct emergency 
outbreak investigation activities to protect the food supply.'' 
The Science Board also noted ``an appallingly low inspection 
rate'' for FDA-regulated food facilities.
    The Science Board is not alone in its concern about the 
current state of FDA's resources for food safety. In its 
January 2008 testimony before this subcommittee, the GAO found 
that staffing levels and funding had ``not kept pace with the 
Agency's growing responsibilities.'' GAO pointed out the 
Science Board findings that the number of domestic 
establishments and food import entries for which FDA is 
responsible has grown significantly; yet, from 2003 to 2006, 
staffing levels in FDA's Center for Food Safety and Applied 
Nutrition (CFSAN) and in the field force responsible for food 
safety inspection and enforcement, actually declined, by 14 
percent and 11.5 percent, respectively. Some 200,000 overseas 
food facilities are registered with FDA, but the Agency expects 
to conduct only 125 foreign food inspections this year.
    FDA's funding constraints and downward trends provide a 
weak foundation on which to build a modern, science- and risk-
based food safety program. Recognizing the need to re-build 
FDA's scientific base and both headquarters and field capacity, 
the Science Board recommended in February 2008 substantial 
increases in FDA's budget for overseeing the food supply, to be 
phased in over a 5-year period. FDA's FY 2008 budget for 
overseeing the food supply (which includes resources for all of 
CFSAN, part of the Center for Veterinary Medicine, food-related 
field functions managed by the Office of Regulatory Affairs, 
and elements of the Office of the Commissioner and the National 
Center for Toxicological Research) is about $620 million. The 
Board recommended this be increased by $128 million in FY 2009, 
$283 million in FY 2010, $441 million in 2011, $598 million in 
2012, and $755 million in 2013.
    This would bring FDA's food-related budget in FY 2013 to 
$1.375 billion, which is not much more than the approximately 
$1.1 billion the President requested in his FY 2009 budget for 
USDA to oversee the safety of just 20 percent of the food 
supply. I agree that FDA needs resources on this scale to 
transform its food safety program from the current paradigm of 
reacting to problems to a paradigm of risk-based prevention.
    The President's original FY 2009 budget requests for FDA 
included an increase of less than $43 million over the 2008 
budget, which would just barely keep pace with FDA's core 
inflation rate of 5.8%. This would mean keeping FDA's actual 
operating capacity for food safety at essentially the same 
level that the Science Board found inadequate ``to ensure the 
safety of food for the Nation.''
    I was pleased that on June 9, 2008, HHS Secretary Leavitt 
announced that the President's FY 2009 budget request for FDA 
is being amended to add $275 million, of which $125 million 
would be available for food safety-related work, for a total FY 
2009 increase for food safety of $168 million, which exceeds 
the Science Board proposal. This is a good sign that the 
administration has recognized FDA's food safety funding crisis.
    I am concerned, however, about when these additional funds, 
if agreed to by Congress, would become available. The earliest 
possibility, of course is October 1, 2008, the beginning of FY 
2009, but that assumes Congress will pass FDA's FY 2009 budget 
on time, as opposed to a continuing resolution, which could 
extend FDA's 2008 funding level well into calendar year 2009. 
This would substantially delay implementation of the Food 
Protection Plan.
    Regardless of the prospects for the FY 2009 budget, FDA 
needs immediate budget help to get started with its prevention-
oriented food safety strategy, as today's on-going and 
widespread outbreak of illness associated with salmonella-
contaminated tomatoes so graphically demonstrates. I thus hope 
Congress will providing FDA additional food safety funds in the 
pending 2008 supplemental appropriations bill and that Congress 
will commit itself to a long-term funding plan for food safety 
at FDA, in keeping with the recommendations of the FDA Science 
Board.

      Near-Term Priorities To Implement FDA's Food Protection Plan

    The magnitude of the transformation that FDA's Food 
Protection Plan envisions, coupled with inevitably finite 
management capacity and budgets, means that FDA must set 
priorities for how it invests its time and money to implement 
the plan, regardless of what action Congress takes on the 2008 
supplemental and FDA's FY 2009 appropriation.
    To this end, the first thing FDA should do is determine the 
resources it needs to implement the Food Protection Plan and 
develop a detailed resource plan, including priorities, for 
their deployment. Clearly, based on the Science Board report, 
FDA needs to build its scientific base and information 
infrastructure for food safety, in addition to having the 
operating funds to take the many specific actions called for in 
the Food Protection Plan. The Plan was silent on resource needs 
but can be credible and effective only if accompanied by a 
realistic resource plan that Congress funds.
    Beyond that, I'd like to suggest four specific actions that 
FDA can pursue now. I think these deserve high priority because 
they would both begin the shift to the prevention paradigm and 
address some of today's most pressing food safety problems. 
Though all can be pursued under current law, they would also 
help lay the foundation for implementing new legislative 
mandates, such as contained in the discussion draft circulated 
by Chairman Dingell and on which Chairman Pallone held a 
hearing on April 24, 2008.

         Begin Risk-Based Priority Setting and Risk Management

    The essential starting point for a risk-based, preventive 
approach to food safety is knowing what the most important 
risks are and systematically devising affirmative strategies to 
reduce them. FDA has not taken this approach in the past, but 
the Food Protection Plan's initiatives 1.2 (Identify Food 
Vulnerabilities and Assess Risks) and 1.3 (Expand the 
Understanding and Use of Effective Mitigation Measures) signal 
FDA's intention to move in this direction.
    This is not, however, a small undertaking. It involves: (1) 
identifying the most significant hazards in the food supply, 
meaning the specific combinations of foods and microbial or 
chemical contaminants that are likely to have the greatest 
adverse impact on public health; (2) prioritizing these hazards 
based on the magnitude of the potential risks they pose and the 
availability, likely effectiveness, and cost of measures to 
reduce the risks; and (3) developing risk reduction strategies 
for the highest priority hazards, including appropriate safety 
standards for each hazard, an inspection and enforcement plan 
to ensure the standards are met, and a plan to monitor the 
effectiveness of the strategy in reducing risk to the public.
    At the outset, FDA could, for example, identify the 20 most 
significant hazards within its jurisdiction and commit 
initially to devising prevention strategies for the top five. 
As this work progresses, FDA should regularly update its 
assessment of the hazards and, as appropriate, select 
additional hazards for priority risk management attention.
    In addition to guiding FDA's priority setting and resource 
allocation, regular assessment and reporting by FDA on the most 
significant hazards in the food supply has the important 
advantage of informing the industry about risks companies 
should be addressing in their own food safety plans, whether or 
not those risks are being addressed immediately by FDA.
    Sufficient information exists today to begin risk-based 
priority setting and risk management. It is also clear that 
more complete information and better tools for analyzing and 
managing information will improve the efficiency and quality of 
the effort. FDA should, therefore, draw on its current 
knowledge and early experience with risk-based priority setting 
to map out a plan for obtaining and managing the information it 
needs. The plan should address institutional roles and 
responsibilities and resources for meeting FDA's information 
needs.

 Strengthen the Contribution of Food Safety Epidemiology to Prevention

    One of FDA's most critical information needs is better 
knowledge of the actual burden and root causes of human illness 
associated with foodborne pathogens and other hazards. Such 
information is essential to the risk-based prevention approach 
of the Food Protection Plan and to the individual efforts of 
food companies to prevent the risks arising in their 
operations. FDA should thus make it a high priority to improve 
the quantity, quality and timeliness of the food safety 
epidemiology data it receives.
    FDA is dependent for this information, however, primarily 
on the efforts of state and local health departments and the 
Centers for Disease Control and Prevention (CDC). These 
agencies operate under their own budget constraints and have 
other priorities and limitations that have been obstacles to 
FDA getting the information it needs in a timely fashion. The 
Food Protection Plan implicitly recognized this reality in 
calling for FDA to work with CDC to better attribute pathogens 
and illnesses to particular foods and identify where in ``the 
production life cycle'' the foods became contaminated.
    FDA should thus work through the Office of the Secretary of 
Health and Human Services to make the nation's food safety 
epidemiology enterprise as responsive as possible to FDA's 
information needs and the needs of other federal and state 
agencies and the food industry in their efforts to prevent 
foodborne illness. A focal point for leadership should be 
established within the Office of the Secretary to coordinate 
the efforts of FDA, USDA, CDC, and state and local health 
officials for this purpose, and FDA should have resources to 
finance specific enhancements in the way food safety 
epidemiological data are collected, analyzed and made available 
to better support implementation of the risk-based prevention 
strategy embodied in the Food Protection Plan.

  Conduct a Compliance and Effectiveness Audit of FDA's Seafood HACCP 
                                Program

    The seafood HACCP (Hazard Analysis and Critical Control 
Points) program that FDA established in 1996 foreshadowed the 
approaches to prevention and improved oversight of imports 
contained in the Food Protection Plan and pending food safety 
legislation. It requires all seafood processors, domestic and 
foreign, to prepare and implement a preventive control plan 
(specifically a HACCP plan), and it requires importers to take 
affirmative steps to ensure that the seafood they import was 
produced under conditions that meet the HACCP requirement. The 
HAACP rule's provision for imports is particularly important 
since a large majority of the seafood consumed in the United 
States is imported.
    For resource reasons, FDA's oversight of importers and 
inspection of foreign processing facilities is very limited, 
and, as seafood imports have grown, state and federal 
laboratories have documented a growing problem with chemical 
contaminants and antibiotic residues in farm-raised fish 
products, especially those coming from Asia. This raises 
questions about the reliability of the ``affirmative steps'' 
being taken by importers and the overall effectiveness of FDA 
oversight of seafood. Last year, FDA banned certain seafood 
imports from China.
    Because seafood safety is an important issue in its own 
right, and because preventive control plans and strengthened 
industry responsibility for prevention - through preventive 
control plans - are important elements of FDA's new strategy, 
FDA should conduct a compliance and effectiveness study of the 
seafood HACCP program for both domestic and imported seafood. 
The purposes should be to: (1) assess compliance rates and the 
overall effectiveness of the seafood HACCP rule in preventing 
violations of U.S. food safety standards, (2) identify legal, 
resource and other constraints on the effectiveness of the 
seafood HACCP rule, and (3) draw lessons for FDA's development 
of preventive control plans for other commodities and sectors 
of the food supply.

        Begin Targeted Rulemaking on the Safety of Fresh Produce

    Over a year ago, the United Fresh Produce Association and 
the Produce Marketing Association called on FDA to establish 
produce safety standards that are ``federally mandated, risk-
based and allow for commodity-specific regulation.'' I agree 
FDA should establish such standards, and I believe FDA should 
begin the rulemaking process as soon as possible.
    It will be a challenge for FDA to develop workable, 
science-based standards that can evolve as the science of 
produce safety evolves. I also recognize that most of the 
pending food safety legislative proposals would mandate FDA 
establishment of produce safety standards. I support such 
legislation. Nevertheless, FDA should begin the process now 
with respect to one or more specific categories of produce--
such as leafy greens and tomatoes--by gathering and analyzing 
the relevant scientific and technical information, beginning 
serious dialogue with experts in the produce industry and 
academia, and proposing regulatory options.
    In my view, the basic elements of the new standards should 
include a mandatory preventive control plan developed by each 
grower and tailored to local hazards and conditions, and, as 
appropriate and feasible, enforceable criteria or standards for 
key risk factors, such as microbial quality of irrigation, 
manure management, and control of livestock and other animal 
vectors for contamination. FDA should also evaluate the 
feasibility and reliability of utilizing state inspectors or 
private audit firms to review the sufficiency and 
implementation of these food safety plans and accompanying 
records on a regular basis and report their findings to FDA.
    By beginning the rulemaking process now, FDA will be acting 
to protect public health and will begin making the shift from 
reaction to prevention a reality for this important sector of 
the food supply.

          Modernizing FDA's Legislative Mandate and Authority

    FDA's Food Protection Plan is a good start, and solving 
FDA's food safety funding crisis is essential, but it is 
equally essential that Congress modernize the food safety laws 
under which FDA operates. The basic provisions of the Federal 
Food, Drug, and Cosmetic Act under which FDA addresses the 
central public health problem of hazardous food contaminants 
and food imports were enacted in 1938, well before today's 
understanding of the public health importance of microbial 
pathogens and the globalization of the food supply that 
continues to accelerate.
    FDA's core statutory tools consist primarily of a few broad 
definitions of ``adulteration,'' authority to inspect food 
facilities (but not, in general, food safety records), and a 
set of cumbersome-to-pursue judicial enforcement tools 
(seizure, injunction and criminal prosecution). FDA has made 
creative use of its authorities to set informal action levels 
and other de facto performance standards and adopt the seafood 
HAACP rule, but there is no mandate in the law, and thus no 
accountability for FDA to implement, a systematic science- and 
risk-based program to prevent foodborne illness.
    FDA should have such a mandate and, assuming adequate 
funding, should have clear accountability for carrying it out 
successfully. Otherwise, I question whether the new strategic 
direction presented in the Food Protection Plan will be 
sustained.

  Organizationally Unifying and Elevating the FDA Food Safety Program

    In addition to providing a modern statutory mandate and 
adequate resources, Congress should ensure that FDA has an 
organizational framework that enables the Agency to provide 
national and international leadership on food safety and to run 
a coherent, well-planned program that makes the best use of 
available resources to improve food safety. For several 
reasons, FDA lacks such a framework.
    First, within FDA, the food program has historically taken 
a back seat to the drug and medical device programs in the 
competition for management attention and resources. This is due 
in part to the intense interest that drug and device companies, 
health professionals, and patients all have in FDA's 
``gatekeeper'' role for therapeutic products and is reflected 
in the fact that most FDA commissioners come from a biomedical 
or health care background. This strong tilt toward drugs and 
devices was exacerbated by the drug and device user fee laws, 
which have further focused FDA management attention, 
accountability, and resources on the therapeutic side of the 
Agency. History has taught that the job of providing effective 
national leadership simultaneously on both therapeutic products 
and food safety is too big a job for any one person.
    Second, FDA's organizational structure for food safety is 
fragmented and lacks a clear focal point for leadership. CFSAN 
ostensibly has the lead on food safety at FDA, but CFSAN 
actually shares food safety jurisdiction with the Center for 
Veterinary Medicine, which regulates pet food and animal drug 
and feed additive residues in human food, and with the Office 
of Regulatory Affairs, which manages the majority of FDA's food 
safety resources through its field force of inspectors, 
compliance officers and laboratory personnel. The recent 
appointment in the Office of the Commissioner of an Associate 
Commissioner for Foods reflects the Agency's awareness of the 
problem but does not solve it. I have great respect for 
Associate Commissioner David Acheson, but his position lacks 
budget or line authority for programs and thus in some ways 
further clouds responsibility and accountability for food 
safety within FDA.
    Finally, food safety leadership at FDA rests at least two 
bureaucratic layers removed from the Secretary of Health and 
Human Services. As decisionmaking in the executive branch 
continues to be centralized at higher and higher levels, with 
OMB having enormous influence on regulatory policy, the full 
time leader of the Nation's premier food safety program needs 
to have the greater clout in the system that comes from being 
presidentially appointed and reporting directly to the 
Secretary.
    In my view, the solution to this structural weakness in 
FDA's food safety plan is to unify the food-related components 
of FDA into a single organization and elevate that organization 
within HHS under the leadership of a presidentially-appointed 
official reporting directly to the Secretary.

                               Conclusion

    Thank you again, Mr. Chairman, for the opportunity to 
testify on these important issues. I look forward to answering 
your questions and the questions of your colleagues on the 
committee.

                              Major Points

     I consider FDA's new Food Protection Plan, with 
its integrated and risk-based systems approach to preventing 
illness, to be moving in the right direction toward the food 
safety reform we need.
     FDA's ability to implement the Food Protection 
Plan is seriously constrained by FDA's food safety funding 
crisis.
     From 2003 to 2006, FDA's headquarters and field 
resources for food safety actually declined as the number of 
domestic establishments and food import entries grew 
significantly, leaving FDA with a weak foundation on which to 
build a modern, science- and risk-based food safety program, as 
envisioned by the Food Protection Plan.
     I support the FDA Science Board's call for a long-
term commitment to re-build FDA's science base and food safety 
oversight capacity both at headquarters and in the field, as 
well as the Science Board's specific recommendation to more 
than double the FDA food safety budget over a 5-year period 
from the current $620 million to $1.375 billion in 2013.
     FDA should move forward now, however, to begin 
implementing the Food Protection Plan by developing a detailed 
a resource plan and pursuing the following high priority 
actions:
    o Risk-based priority setting and risk management for the 
most significant hazards;
    o Strengthening the contribution of food safety 
epidemiology to prevention;
    o Conducting a compliance and effectiveness audit of FDA's 
seafood HACCP program; and
    o Targeted rulemaking on the safety of fresh produce.
     In addition to providing FDA needed resources, 
Congress should modernize FDA's food safety legislative mandate 
and direct that FDA's food safety program be unified and 
elevated organizationally with the Department of Health and 
Human Services.
                              ----------                              

    Mr. Stupak. Thank you, Professor Taylor.
    Dr. Levi, if you would, please, your opening statement.

STATEMENT OF JEFFREY LEVI, PH.D., EXECUTIVE DIRECTOR, TRUST FOR 
                        AMERICA'S HEALTH

    Mr. Levi. Thank you, Chairman Stupak, Ranking Member 
Shimkus, and members of the Subcommittee. I appreciate the 
opportunity to testify before you today.
    Trust for America's Health is a nonprofit, nonpartisan 
organization dedicated to saving lives by protecting the health 
of every community and working to make disease prevention a 
national priority. We applaud the committee for continuing its 
thorough examination of the food safety functions at the FDA.
    This hearing could not be more timely. The current outbreak 
of salmonella associated with tomatoes is a perfect 
demonstration of our need for a modernized food safety system. 
It shouldn't have taken so many people getting sick from 
salmonella poisoning for the government to start taking 
nationwide action to protect the American people, but it did. 
Not only has it taken us too long to recognize the threat, we 
are still struggling to find its source and we should have had 
systems in place to prevent it in the first place. A truly 
successful food safety system is one that we don't read about 
in the newspapers because it is working so well, but as we have 
seen over the last week, instead we have a system that places 
the lives of Americans at risk, undermines overall public 
confidence in our food supply and threatens the economic 
stability of farmers.
    At the end of April, TFAH released a report entitled 
``Fixing Food Safety: Protecting America's Food Supply from 
Farm to Fork.'' Our report finds that food safety represents a 
significant public health threat. The food safety system is 
fragmented, depending on archaic laws, and chronically 
underfunded. The current system is reactive, not preventive, 
meaning we are wasting millions of dollars on responding to 
such threats rather than building proper controls into the 
production system.
    A major investment is necessary to prepare FDA's food 
safety function for the 21st century marketplace. However, 
Congress should not provide the significant additional 
appropriations without a clear strategy of how that money will 
be spent. We believe that the FDA's Food Protection Plan is a 
good start. The plan represents a consensus document outlining 
broad concepts for modernizing the food safety system, and we 
are very pleased that the Administration has asked for an 
additional $125 million for the FDA's food safety work. But 
increased funding must be sustained over time to allow for 
effective strategic planning, and before Congress acts on this 
request, we also believe it should know how the $125 million 
request is crosswalked to the protection plan and what long-
term funding will be needed to implement each element of the 
plan.
    TFAH has long been a watchdog for responsible government 
spending. While we advocate for a stronger investment in the 
public health system, we also expect accountability and 
transparency with respect to that investment. The FDA's food 
safety system should be no different. Thus, we urge FDA to 
articulate the steps it will take to achieve each element of 
the plan including the personnel, laboratory capacity, 
information technology and research necessary to carry out each 
concept in the document. FDA should regularly report to 
Congress and the public with measurable benchmarks, data 
sharing and the resources necessary to move forward with its 
plan.
    Indeed, if the Administration is serious about modernizing 
the food safety system, each step of the implementation plan 
would carry with it a professional judgment number describing 
the appropriations necessary to achieve the goal, not just the 
legislative authority needed. We make this recommendation not 
simply for the sake of transparency but to strengthen FDA's 
argument for additional funding. There are precedents for such 
an approach. For example, the Administration released a 
national strategy for pandemic influenza along with a request 
for $7 billion to carry out the strategy 2 years ago. The 
initial strategy articulated brought concepts and principles 
for pandemic preparedness just as the Food Protection Plan 
does, but as Congress moved forward with appropriating funding 
for pandemic influenza preparedness, the strategy was followed 
by an implementation plan which contains actionable steps from 
multiple federal departments including interim milestones 
against which Congress and the public can measure progress.
    In addition, several agencies within HHS are legislatively 
mandated to provide directly to Congress so-called bypass 
budgets that reflect their professional judgment of funding 
that is needed without having to receive OMB clearance. In 
fact, Dr. von Eschenbach had that experience with this process 
during his tenure at the National Cancer Institute. Each year, 
both the National Cancer Institute and the Office of AIDS 
Research provide Congress bypass budgets which include the 
resources necessary to maintain existing research and the money 
required to achieve specific expanded or new initiatives. The 
recent dance we saw leading to the formal request for an 
additional $125 million for the FDA's food safety work was in a 
way an ad hoc version of this approach. The Subcommittee may 
want to consider enacting a regular bypass budget for the FDA 
as it embarks on its important process of modernization.
    Just as policymakers are attempting to transform America's 
healthcare system form a sick-care system to a well-care 
system, we must convert our food safety policy from reactive to 
a preventive system. The Federal Government can save money and 
lives by investing in technology, information networks and 
research. This effort will require leadership from Congress and 
the Administration to assure that both financial and human 
resources are devoted to this critical public health problem. 
The end result should be a safer food supply from farm to fork.
    I ask that my written testimony be included in the record, 
and I look forward to your questions.
    [The prepared statement of Mr. Levi follows:]

                    Statement of Jeffrey Levi, Ph.D.

                                Summary

    I am Dr. Jeffrey Levi, Executive Director of Trust for 
America's Health (TFAH), a non-profit, non-partisan 
organization dedicated to saving lives by protecting the health 
of every community and working to make disease prevention a 
national priority. At the end of April, TFAH released a report 
entitled ``Fixing Food Safety: Protecting America's Food Supply 
from Farm-to-Fork''. Our report finds the food safety system is 
fragmented, dependent on archaic laws, and chronically 
underfunded. The report can be found in its entirety at 
www.healthyamericans.org.
    Food safety represents a significant public health threat. 
According to FDA's Web site, since January of this year alone, 
FDA has issued over 80 recalls, alerts, withdrawals, and 
warnings of unsafe or mislabeled food. These numbers are far 
too high, and major gaps in our Nation's food safety system are 
to blame. The current food safety system is reactive, not 
preventive, meaning we are wasting millions of dollars on 
responding to such threats rather than building proper controls 
into the production system. Indeed, if we had a modernized food 
safety system focused on prevention, we would not need to be 
issuing this number of alerts and recalls. That said, given the 
disjointedness and underfunded nature of our food safety 
surveillance system, we cannot be sure that the alerts and 
recalls issued by FDA truly even reflect the extent of the 
problem today.
    Clearly, a profound investment is necessary to prepare 
FDA's food safety function for the 21st Century marketplace. 
However, Congress should not provide significant additional 
appropriations without a clear strategy showing how that money 
will be spent. We agree that the FDA's Food Protection Plan is 
a good start. However, the document lacks the specificity 
necessary to fund or to implement such a plan. Instead of broad 
principles, we urge FDA to articulate the steps it will take to 
achieve each element of the plan, including the personnel, 
laboratory capacity, information technology, and research 
necessary to carry out each concept in the document. FDA should 
regularly report to Congress and the public with measurable 
benchmarks, data sharing, and the resources necessary to move 
forward with its plan. This would not be unprecedented for this 
Administration: its National Strategy for Pandemic Influenza: 
Implementation Plan contains actionable steps for multiple 
federal departments to take to achieve an adequate level of 
preparedness, including interim milestones against which 
progress can be measured.
    In addition to lacking detail, the Food Protection Plan 
remains abstract because there is no budget request associated 
with it. Each step of the implementation plan should carry with 
it a professional judgment number describing the appropriations 
necessary to achieve the goal. This would be similar to the 
bypass budgets of the National Cancer Institute and the NIH 
Office of AIDS Research.
    Just as policymakers are attempting to transform America's 
healthcare system from a sick-care system to a well-care 
system, we must convert our food safety policies from a 
reactive to a preventive system. The Federal Government can 
save money and lives by investing in technology, information 
networks, and research. This effort will require leadership 
from Congress and the Administration to assure that both 
financial and human resources are devoted to this critical 
public health problem. The end result should be a safer food 
supply from farm to fork.

                               Testimony

    I am Dr. Jeffrey Levi, Executive Director of Trust for 
America's Health (TFAH). Trust for America's Health is a non-
profit, non-partisan organization dedicated to saving lives by 
protecting the health of every community and working to make 
disease prevention a national priority. We applaud the 
Committee for continuing its thorough examination of the food 
safety functions at the Food and Drug Administration (FDA). At 
the end of April, TFAH released a report entitled ``Fixing Food 
Safety: Protecting America's Food Supply from Farm-to-Fork''. 
As we know, recent tragedies have shed a light on glaring gaps 
in the Nation's federal food safety system, but we now have the 
opportunity to build a better system for the future. My 
comments today will discuss the report's findings as well as 
additional concerns we have with the current food safety 
system. The report can be found in its entirety at 
www.healthyamericans.org.
    Food safety represents a significant public health threat. 
One in four Americans is sickened by foodborne disease each 
year, and an estimated $44 billion is lost each year in medical 
and lost productivity costs. According to FDA's website, since 
January of this year alone, FDA has issued over 80 recalls, 
alerts, withdrawals, and warnings of unsafe or mislabeled food. 
These numbers are far too high, and major gaps in our Nation's 
food safety system are to blame. Indeed, if we had a modernized 
food safety system focused on prevention, we would not need to 
be issuing this number of alerts and recalls. That said, given 
the disjointedness and underfunded nature of our food safety 
surveillance system, we cannot be sure that the alerts and 
recalls issued by FDA truly even reflect the extent of the 
problem today.
    The public is deeply concerned about this issue. A 2007 
public opinion poll conducted on behalf of TFAH found that 67 
percent of Americans are worried about food safety. This number 
ranked above the threat of pandemic flu or natural disasters, 
illustrating just how strongly food safety truly touches every 
American. The food supply is vulnerable to a variety of 
pathogens, toxic metals, and other pollutants, product 
tampering, and emerging diseases. The current food safety 
system is reactive, not preventive, meaning we are wasting 
millions of dollars on responding to such threats rather than 
building proper controls into the production system.
    TFAH's report identifies several problems with the 
government's food safety system: inadequate federal leadership, 
coordination and resources; outdated laws and policies; and 
inadequate Federal, State and local collaboration.

       Inadequate Federal Leadership, Coordination and Resources

    The Federal food safety system is fragmented. According to 
the 2007 GAO report, there are 15 agencies collectively 
administering over 30 laws. Even among lead agencies, the 
government's ability to prevent illness is undermined by the 
segmented responsibilities among many agencies, which often use 
differing regulatory approaches. No agency has statutory 
authority to forge an integrated strategy, and no agency or 
person has final authority over food safety. This results in 
overlapping inspections by FDA and USDA's Food Safety and 
Inspection Service (FSIS) and food companies having to follow 
different regulations from each agency within the same plant. 
Clearly, FDA could use its resources better through increased 
collaboration and coordination with USDA.
    The current system is not just fragmented, but also 
experiences misaligned priorities and resources. FDA regulates 
80 percent of the U.S. food supply, and an estimated 85 percent 
of known foodborne outbreaks are associated with FDA-regulated 
food. However, FDA receives less than 40 percent of the overall 
federal dollars devoted to food safety programs. In addition, 
funding for food safety programs at FDA and FSIS has barely 
kept pace with inflation. Even as these agencies must take on 
new challenges, such as those laid out in the FDA Food 
Protection Plan, they are barely able to pay for their existing 
food safety system.
    Furthermore, within both FDA and USDA, food safety is not 
the top priority. At FDA, pharmaceuticals and medical devices--
the ``drug'' part of the Food and Drug Administration--receive 
priority attention. At USDA the focus is on promoting U.S. farm 
commodities abroad and helping farmers and agribusiness at 
home.
    We agree with the Science Board's assessment that 
weaknesses in the FDA's food safety function are directly 
related to its inadequate resources. Trust for America's Health 
recommends at least doubling FDA's food budget in real terms 
over the next 5 years. The need for additional appropriations 
has been echoed by the National Academy of Sciences Institute 
of Medicine, the Government Accountability Office, and the 
Health and Human Services Inspector General. TFAH believes FDA 
needs a consistent source of funding to keep up with its 
mandate. We were pleased to see additional food safety money in 
the Senate's supplemental, but appropriators should bear in 
mind that increased funding should be rolled into baseline 
appropriations in FY 2010, rather than returning to previous 
funding levels. It is nearly impossible for the Agency to 
adequately plan and hire full-time staff if it is unclear 
whether money will be stable from year to year.
    In addition to funding, FDA needs to ramp up its personnel 
levels. According to former FDA Commissioner Mark McClellan, 
the President's FY 2009 budget ``does little to make up for the 
steady loss of staffing that the Agency has endured for the 
past decade.'' We were pleased that FDA recently announced 
plans to hire 1,300 science and medical staff, including 600 
new positions, and we are eager to see how they are used to 
implement the FDA's Food Protection Plan. However, given the 
broad consensus among experts who doubt the FDA's ability to 
fulfill even its existing food safety mandate given current 
funding levels, we are reluctant to view this announcement as 
an end to the Agency's problems.

                       Outdated Laws and Policies

    Increased funding for food safety is a start. But our 
report notes that the Federal Government is spending existing 
funds on outdated, inefficient practices. TFAH has long been an 
advocate for accountability within the public health system, 
and the federal food safety system is an example of 
misallocated funds due to adherence to an archaic framework. 
The USDA's FSIS spends most of its resources visually 
inspecting every beef, pork, and poultry carcass in ways not 
too different from practices used 100 years ago, although the 
health of animals has greatly improved and most foodborne 
illnesses cannot be detected visually. Likewise, FDA's food 
safety statutes date to 1906 and 1938. FDA's law developed a 
system that is reactive to problems prevalent in early 20th 
Century food system, such as adulteration and misbranding. It 
empowers FDA primarily to act only after food safety problems 
occur.
    Our report finds that Congress has not provided the Agency 
with a modern, public health mandate to prevent foodborne 
illness; has not updated the Agency's legal tools to meet the 
challenges of a high-tech, globalized food supply; nor has it 
provided the funding stream necessary to carry out research and 
inspection.
    America's food supply faces new threats, and the safety 
system needs to reflect changes in the market. A 21st Century 
production and distribution system means that instead of a 
single contaminated head of lettuce affecting one family, that 
lettuce may be divided among a dozen prepackaged bags of salad 
shipped across the country. The centralization of agribusiness 
means there is significant contact between livestock and crops, 
which can lead to a single infected product causing pervasive 
damage.
    Deliberate contamination of the food supply for economic or 
terroristic reasons could also have a widespread, devastating 
impact on the Nation before the Federal Government even has 
time to react. We saw this in 2007 when imported pet food 
killed thousands of cats and dogs in the United States after 
being deliberately contaminated with melamine for economic 
profits. It is not science fiction to believe such action could 
occur again, with malicious intent. The Administration's 
Homeland Security Presidential Directive 9 called for a 
coordinated national approach to deliberate threats to the food 
supply. HSPD-9 tasked the Department of Homeland Security to 
work with USDA, HHS, and EPA to coordinate a national response, 
but FDA has not received additional funding and USDA has 
received only additional $150 million. FDA needs more authority 
to implement measures against agroterrorism, including 
increased surveillance.

           Inadequate Federal, State, and Local Collaboration

    The existing governmental food safety system is 
decentralized, so state and local departments have authority 
that extends beyond federal jurisdiction. State and local 
health departments are the frontlines in the fight against 
unsafe food, as they investigate outbreaks, inspect 
restaurants, and coordinate communication up the chain. The 
vast majority of foodborne diseases are detected and 
investigated at the local level. Yet, the capacity of states to 
conduct appropriate safety surveillance and communicate that 
back to the Federal Government varies dramatically. Federal 
support (through the CDC) for such critical state activities is 
minimal. In a 21st Century food economy, outbreaks are not 
limited to one state; early detection of what could become a 
national problem is dependent on the capacity of the state with 
the weakest surveillance system.
    The relationship between Federal and State regulators is 
also not well defined, so jurisdiction and communication may be 
hindered. In addition to a lack of resources to quickly respond 
to outbreaks, there are no mandatory national standards for 
state and local governments to adopt in their communities. 
Instead, most states adhere to voluntary standards such as the 
FDA's Food Code, a model to assist governments in regulating 
the retail and food service industry. Although these standards 
are updated every other year, the vast majority of states have 
not adopted the most recent guidelines. The Voluntary National 
Retail Food Regulatory Program is another voluntary guideline 
for states to develop science-based measures of performance 
that will lead to more effective and uniform regulation of the 
food industry. Only 12 states have fully enrolled and achieved 
verification by external evaluators of the program. TFAH 
recommends creating uniform standards and practices across the 
federal, state, and local levels. States should be encouraged 
and incentivized to adopt and comply with uniform standards of 
the most recent FDA Food Code and the National Retail Food 
Regulatory Program.
    The systems used to monitor food disease outbreaks are also 
a patchwork of various government agencies at the federal, 
state, and local level working largely independently with 
limited coordination. Government surveillance, or detection of 
foodborne diseases, exists alongside food safety practitioners 
from the private sector, public interest groups, and academia. 
As Michael Taylor, former FDA Deputy Commissioner for Policy, 
addressed in his recent report on the Food Safety Information 
Infrastructure, these data sources remain isolated, without the 
legal, logistical, or cultural means to share information. At a 
recent congressional briefing hosted by TFAH, Dr. Tim Jones, 
state epidemiologist for Tennessee, noted that communication of 
hazards is highly variable among states, which often lack the 
personnel, technology, and data sharing systems to react 
quickly to detected outbreaks. TFAH contends that a person's 
protection from disease should not depend on where he or she 
lives, and the fragmented food surveillance system is an 
example of such disparity.

                    Opportunities for Modernization

    TFAH believes that we need a comprehensive approach to 
update and strengthen the Federal food safety system. The 
institution of Hazard Analysis and Critical Control Points 
(HACCP) is a good example of a promising approach to 
modernization within FDA and FSIS. Such a system first requires 
companies to identify potential hazards and critical control 
points throughout the production process, and then establish 
preventive procedures to monitor and ensure those hazards are 
avoided. However, FDA has not implemented HACCP across the food 
production chain, and where it exists in many cases it is only 
on a voluntary basis. Widespread implementation of HACCP and 
other preventive systems could save money in the long run by 
identifying potential problems before they occur.
    Imported food presents a new, troubling frontier for food 
safety. Fifteen percent of the food we eat is imported, 
including 60 percent of produce and 75 percent of seafood. Yet, 
only 1 percent of shipments are inspected by the FDA each year. 
The Administration released the Import Safety Action Plan and 
the Food Protection Plan in November. These plans called for 
working with foreign governments to ensure compliance with U.S. 
safety standards, but as Mr. Taylor notes in our report, the 
FDA does not have the resources to ensure the safety of imports 
without harnessing the expertise and resources of the private 
sector. In addition to providing resources for implementing the 
Import Safety Action Plan and the Food Protection Plan, 
Congress should require food importers to be legally 
accountable for assuring that foreign producers are shipping 
goods to the U.S. that meet U.S. food safety standards.
    As mentioned earlier, surveillance is a key component to 
identifying foodborne outbreaks. Congress can support this 
mission through removing legal restrictions on data sharing, 
mandating coordinated data collection among government 
agencies, and improving the collection of and accessibility to 
data. Data collection and improving networks among all actors, 
including private sector and academia, is critical to mitigate 
the effects of unsafe food. TFAH recommends government food 
safety officials and food companies should be given the tools 
to keep track of information about disease outbreaks in humans, 
plants, and animals and results of food inspections so they can 
quickly detect and contain problems. CDC's surveillance program 
should also be able to function in a way that not only monitors 
outbreaks and investigates preventive strategies, but also 
provides accountability to gauge how well U.S. food safety 
systems are working.
    In order to develop a dynamic, evolving food safety system, 
greater investment in research is a prerequisite. Ongoing 
research is needed to identify emerging threats and up-to-date 
ways to contain them, as well as to rank relative risks and the 
health impacts of those hazards. The FDA Food Protection Plan 
echoes the need to strengthen the Agency's research capacity, 
but the document does not clarify how it will implement the 
mission or how it will work with other federal agencies to 
coordinate a research agenda. As the Science Board report tells 
us, FDA does not have the funding to conduct its existing 
research requirements and lacks a clear vision of new areas of 
research needed. Funding and planning are vital to carrying out 
a modern research program, which should serve as a basis for 
FDA's regulatory framework.

                         Planning and Resources

    Clearly, a profound investment is necessary to prepare 
FDA's food safety function for the 21st Century marketplace. 
However, Congress should not provide significant additional 
appropriations without a clear strategy of how that money will 
be spent. We agree that the Food Protection Plan is a good 
start. The Plan represents a consensus document, outlining 
broad concepts for modernizing the food safety system. However, 
it lacks the specificity necessary to fund or to implement such 
a plan. TFAH has long been a watchdog for responsible 
government spending. While we advocate for a stronger 
investment in the public health system, all of our reports 
insist on accountability and transparency with respect to that 
investment. FDA's food safety system should be no different. 
Before Congress appropriates significant funds to modernize the 
food regulatory system, FDA must demonstrate exactly how it 
intends to spend those funds. Instead of broad principles, we 
urge FDA to articulate the steps it will take to achieve each 
element of the plan, including the personnel, laboratory 
capacity, information technology, and research necessary to 
carry out each concept in the document. FDA should regularly 
report to Congress and the public with measurable benchmarks, 
data sharing, and the resources necessary to move forward with 
its plan.
    In addition to lacking detail, the Food Protection Plan 
remains abstract because there is no budget request associated 
with it. If the Administration is serious about modernizing the 
food safety system, each step of the implementation plan should 
carry with it a professional judgment number describing the 
appropriations necessary to achieve the goal. We make this 
recommendation not simply for the sake of transparency, but to 
strengthen FDA's argument for additional funding. As an 
example, the Administration released a National Strategy for 
Pandemic Influenza along with a request for $7 billion to carry 
out the strategy. The initial strategy articulated broad 
concepts and principles for pandemic preparedness, just as the 
Food Protection Plan does. But as Congress moved forward with 
appropriating funding for pandemic influenza preparedness, the 
strategy was followed by an Implementation Plan, which contains 
actionable steps for multiple federal departments to take to 
achieve an adequate level of preparedness, including interim 
milestones against which Congress and the public could measure 
progress. The implementation plan gave credence to the 
President's funding request.
    Developing a comprehensive strategic plan with a 
corresponding budget request is not a novel concept. Several 
agencies within HHS are legislatively mandated to provide 
Congress with so-called by-pass budgets that reflect their 
professional judgment of funding that is needed without having 
to receive OMB clearance. In fact, Dr. von Eschenbach had 
experience with this process during his tenure with National 
Cancer Institute. Each year, both the National Cancer Institute 
and the Office of AIDS Research provide Congress and the 
President with their annual budgets, which include the 
resources necessary to maintain existing research and the money 
required to achieve specific expanded or new initiatives. The 
Subcommittee may want to consider enacting a similar mandate 
for the FDA as it embarks on this important process of 
modernization.

                               Conclusion

    Just as policymakers are attempting to transform America's 
healthcare system from a sick-care system to a well-care 
system, we must convert our food safety policies from a 
reactive to a preventive system. The Federal Government can 
save money and lives by investing in technology, information 
networks, and research. This effort will require leadership 
from Congress and the Administration to assure that both 
financial and human resources are devoted to this critical 
public health problem. The end result should be a safer food 
supply from farm to fork.
                              ----------                              

    Mr. Stupak. Thank you, Doctor. Your written statement, as 
all written statements, will be part of the record.
    I will begin with questions. We will go 5 minutes so we can 
move the rounds along here. Let me ask you this question. We 
have all touched on it today, the tomato, salmonella in the 
tomatoes. If you take a look at the timeline, mid-April, people 
started getting sick from tomatoes. On June 3, the FDA issued 
its first warning in the States of New Mexico and Florida for 
certain types of tomatoes. On June 7, the FDA put out its 
warning nationwide for certain types of tomatoes. And we know 
it is the first year anniversary of the FDA's Tomato Safety 
Initiative. Why hasn't this initiative worked to stop the 
salmonella in tomatoes if we knew it was a problem, we 
implemented a plan a year ago, but here we are, a year later, 
having nationwide warning? Anyone care to tackle that? 
Professor Taylor.
    Mr. Taylor. Well, I will put the answer to that question in 
an even broader context. We knew 10 years ago that there was a 
significant increase in outbreaks associated with fresh 
produce. FDA put in place a so-called guidance for good 
agricultural practices, which was a worthy thing to do at the 
time. It reflected what was known at the time but it was very 
broad guidance. It said pay attention to microbial quality of 
the water but there were no standards or criteria for what is 
appropriate microbial quality of the water that is used in 
irrigation and other risk factors were addressed only in these 
very broad sort of terms. A properly funded and mandated FDA 
would have had a leadership responsibility and the resources 
behind it to drive the research and develop the criteria, to 
set the standards that should have been in place long ago to 
ensure the safe production of tomatoes and other fresh produce 
on the farm. So I think the tomato safety plan was another 
effort with the best information available but it was not 
linked with the focused research base and the scientific 
knowledge needed, coupled with an actual regulatory 
intervention to create accountability for implementing these 
control measures.
    Mr. Stupak. But this safety initiative would also have to 
be initiated not just here in this country but also like Mexico 
and other places where we import tomatoes, would it not? It 
doesn't make any sense to have a tomato initiative just 
confined to the domestically produced crop but would have to be 
for imports too, would it not?
    Mr. Taylor. Absolutely. I think there is wide agreement 
that as we put in preventive control requirements and measure 
domestically, we have to make importers accountable for 
ensuring that the imported product meets those standards. It 
should be a condition of entry into the United States because 
it demonstrated compliance with the same preventive control 
measures in foreign fields as we would expect to have in U.S. 
fields.
    Mr. Stupak. Dr. Morris?
    Dr. Morris. Just to add, again, I think what the tomato 
outbreak points out is the difficulty of being purely in a 
reactive mode, and I am highly sympathetic with FDA, having 
been in similar positions in government. It is extremely 
difficult to do these trace-backs, but having said that, the 
whole point of this is to put in place a system where we don't 
have to do the trace-backs.
    Mr. Stupak. Sure. Wouldn't the year-ago tomato initiative 
make us proactive or preventive, not reactive? I mean, 
reactive, we still don't even know where the tomatoes are 
coming from.
    Dr. Morris. Exactly.
    Mr. Stupak. Let me ask you this. This is the report we have 
all referred to, the Food Protection Plan, put forth by the FDA 
last November, and then the request for $50 million to 
implement it. Dr. Levi, I take it that the newest request that 
came Monday, which was $125 million, you would not give even 
the $125 million based on this report. What else would you look 
for before Congress would just throw money at a situation?
    Mr. Levi. Well, I would be loathe to say don't give them 
the money. I would say that there is enough opportunity in the 
appropriations process to do a back-and-forth to get a lot more 
specificity associated with the spending of this money but----
    Mr. Stupak. What specificity would you like to see in that 
report?
    Mr. Levi. I would want to see dollar figures associated 
with each element of the report, and I think we have heard from 
others here that even that money, the $125 million, may not be 
sufficient, but we can't really judge what is missing and what 
we are going to get for that $125 million until that request is 
crosswalked to the protection plan. If the Administration says 
this money is to implement the plan, they should at least be 
able to tell us what parts of the plan we are buying with $125 
million.
    Mr. Stupak. Professor Taylor, we will go right down the 
line.
    Mr. Taylor. I just want to add that it is a matter of 
priorities and sequence of activities. Those 38 very 
significant actions can't all be done at once. They shouldn't 
all be done at once. FDA should identify what are the priority 
things needed to get this process going. I suggested a few in 
my testimony. There may be better ones that that but it is a 
matter of priorities and sequence.
    Mr. Stupak. Dr. Morris?
    Dr. Morris. And I would also, as I noted in my testimony, 
the $128 estimate from the Science Board subcommittee is a very 
loose estimate. I mean, essentially it is a starting point and 
a ballpark figure, and there is clearly a need to link this 
with specifics because that is going to drive what the real 
costs are.
    Mr. Stupak. Dr. Cassell?
    Ms. Cassell. I don't have anything to add. I like Glenn 
said it----
    Mr. Stupak. OK. Now, on that $125 million they asked for on 
Monday night, that does not include any IT, which would 
certainly help us try to figure out where tomatoes are coming 
from. Ms. Shames, would you like to comment on that? What would 
you like to see? And GAO has been very critical of it. What 
would you like to see in that Food Protection Plan?
    Ms. Shames. The Food Protection Plan really is the 
rudiments of a strategic plan, and there is a statutory 
precedent for the sort of information that Congress has asked 
for from executive agencies to do the oversight that is needed. 
Information should include the long-term goals, which are laid 
out in terms of the core elements in the Food Protection Plan. 
But then beyond that, we would want those long-term goals to be 
segmented into interim goals and with those interim goals to 
know exactly what the associated resources are in terms of 
dollars, in terms of people, in terms of technology.
    Mr. Stupak. You said long-term goals. This report, I get 
the impression there is no limit, no time. What kind of plan--
--
    Ms. Shames. There is no----
    Mr. Stupak. A 1-year, 3-year, 5-year plan? What should it 
be?
    Ms. Shames. There is no stated time frame to the plan. You 
are right about that. We have been told that it is envisioned 
to be a 5-year plan.
    Mr. Stupak. My time is up. I will turn to Mr. Shimkus.
    Mr. Shimkus. Thank you.
    Mr. Stupak. Wait a minute. Dr. Cassell had her hand up. If 
it is a 5-year plan, we should at least have 5 years worth of 
data, should we not, and budget requests, Dr. Cassell?
    Ms. Cassell. I personally would like to know more about the 
technologies that will be applied and the plan to ensure that 
in fact there is professional development of those individuals 
responsible for food safety, getting back to our original 
report, so that we can always be sure they are on the cutting 
edge and are aware of emerging new technologies.
    Mr. Stupak. Thank you.
    Mr. Shimkus, please.
    Mr. Shimkus. Thank you, Mr. Chairman. Reforming a federal 
bureaucracy is a difficult challenge. It doesn't have the 
market forces of bankruptcy and so that is an inherent 
challenge.
    I want to focus on some broad issues. You know, this is 
really a lot of specificity that to the layman is touch. That 
is why you are here and I appreciate it. All you mentioned a 
focus on risk-based approach. I think everyone mentioned the 
importance of doing that. We are in discussions on an FDA 
authorization bill, and there is still not acceptance that a 
risk-based approach is an appropriate way to go because I think 
there are feelings from some of my friends on the other side 
that this means going soft on industry. Can some of you chime 
in on that? I don't believe it is true. I think it is a cost-
benefit way of identifying problems, but just respond to that 
concern. Go ahead, sir.
    Mr. Taylor. I think it is very important to distinguish 
between the industry role in food safety and the government 
role, and when we talk about a risk-based approach, it is not 
about going soft on industry's duty to ensure that every 
product that they market meets safety standards. And in fact, 
the proposals to require every food facility to have a 
preventive control plan stands for the idea that every company 
should be sure that they have got a plan in place to meet 
standards. Regardless of whether it is a high-risk product or a 
low-risk product, everybody should have a preventive food 
safety plan. When we use the term risk-based effort by the 
government, we are really talking about how the government can 
then deploy its resources, whether they are inspection 
resources or research or new rulemaking, standard setting. ow 
does the government deploy its inherently finite resources to 
address the most significant hazards in the food supply and 
mount the preventive initiative that do often require 
government initiatives. So it is risk based in terms of 
priority setting and use of government resources and targeting 
those significant hazards that are out there that we know about 
and that require a concerted effort to address through 
research, technological innovation, standard setting, 
education, whatever the appropriate tool might be.
    Mr. Shimkus. Anyone else want to--Ms. Shames.
    Ms. Shames. The government and FDA in particular can only 
afford a risk-based approach to its inspections. For example, 
if FDA were to inspect every single domestic facility dealing 
with food, it would come to over $500 million. That figure is 
astounding. If FDA were to inspect every foreign facility, it 
would come to over $3 billion.
    Mr. Shimkus. I have tried to raise this in some of my 
discussions. If you have good actors who have zero defects 
across their whole product line, it doesn't make sense to be in 
there twice a year and focus those resources and maybe go to 
once a year but that is kind of--Dr. Morris, do you want to add 
something?
    Dr. Morris. Just to further expand on this idea, one cannot 
inspect safety into a product, and you can't inspect every 
single thing that goes by, every single apple. Again, the 
concept is to create a preventive system that minimizes the 
risk, puts in place multiple hurdles to minimize risk. But 
again, you come back to, what is the government's role, and the 
government needs to target its role so that it hits the areas 
where there is the greatest risk of occurrence of human 
disease. And again, this is where some of the difficulties 
arise and that ultimately our goal is to keep people from 
getting sick, but to figure out how to put in place a plan that 
minimizes the risk for human disease is difficult and it 
requires some science, it requires some work, and it requires 
some resources to be able to do that, and that is where the 
vision gets cloudy. To be able to really do what needs to be 
done to appropriately prioritize resources, government 
resources, to maximize the impact of government to be able, you 
know, to get the safest possible product.
    Mr. Shimkus. Because we are a reactive body, especially 
even on a 1-year spending budgetary cycle, would a 2-year 
budgetary cycle be helpful in this whole reform debate? I will 
just allow anybody that wants to--Dr. Taylor.
    Mr. Taylor. Anything that can be done to extend the 
planning horizon and planning of use of resources is to the 
good, so----
    Mr. Shimkus. Yes, the idea is, you pass a budget for 2 
years, and the second year you use to do oversight and 
investigation and do evaluation. If you are every year fighting 
on just the spending end--because I look at this. You look at, 
this is a chicken and the egg debate. We have a plan, then we 
have to fund, then we have to execute, then we have to evaluate 
through the execution process and then we have to revise, and 
you can't do that if you are limited by a 1-year budgetary 
cycle.
    Mr. Levi. I also think it is important to keep in mind that 
a lot of the problem at FDA is personnel, that they need more 
scientists to do the work, and if there is not predictability 
for funding, then it is very hard to recruit scientists to come 
and work there because they don't know whether they are going 
to have a job from one year to the next, and I think that is 
also the challenge with focusing on a supplemental. We should 
get as much money as we can into the supplemental but that is 
even more unpredictable, especially if for fiscal 2009 we are 
at least starting probably all predictions are for a continuing 
resolution and that creates even more instability and 
uncertainty and makes the hiring process that much more 
difficult.
    Mr. Shimkus. And I appreciate that comment, because I did 
have a question on this whole staffing issue and where it is 
good to get the additional money but there is uncertainty 
there, and Mr. Chairman, that is all I have because you 
answered the question, Dr. Levi. Thank you.
    Mr. Stupak. Thank you, Mr. Shimkus.
    Ms. DeGette for questions, please.
    Ms. DeGette. Thank you very much, Mr. Chairman.
    Well, I have been looking at this plan, and it has happened 
before when I have looked at agency plans, it seems to me to be 
more of an idea than a plan, because in reading it, principles 
of the plan focus on risk, target resources, address both 
unintentional and deliberate contamination and use science. 
Well, I think this is what most of you are saying. We all 
support those hortatory goals but my question is, how do we get 
from point A to point B? So I am wondering if very briefly, 
starting with Ms. Shames, you could maybe give us two or three 
ideas, and one of them you have already testified, many of you, 
about, is put specific price tags on specific portions of the 
so-called plan. I am wondering if there are a couple of other 
specific suggestions you can make as to what we can do to make 
this dream a real plan. Ms. Shames?
    Ms. Shames. We testified in January that many of their 
proposals were consistent with the recommendations that GAO had 
made, so I would say that that would be a starting point in 
terms of FDA's priorities to take.
    Ms. DeGette. The GAO recommendations?
    Ms. Shames. Exactly.
    Ms. DeGette. Thanks.
    Dr. Cassell?
    Ms. Cassell. It all goes back to having the right people 
with the right skills, and quite honestly, I believe that the 
CFSAN and CVM have been so underfunded in the area of research, 
as I pointed out, now for over a decade as well as their 
overall funding. Personally, I don't think they have the right 
set of people with the right skills to maybe----
    Ms. DeGette. And what could we do to help that to happen?
    Ms. Cassell. I think to immediately request the 
supplemental funding and then hold the feet to the fire in 
terms of getting more specificity around the plan and to also 
guard against the possibility that you wouldn't have recurring 
funding so that you will have difficulty recruiting the 
individuals.
    Ms. DeGette. Dr. Morris?
    Dr. Morris. I would strongly concur with Dr. Cassell's 
statement. I would also add though that one also needs the 
expertise at the top levels of management to really understand 
how to approach these problems. If you really want to get 
concrete with some of this, to my mind the top priority is to 
identify what the problem areas are. We have to have good 
surveillance. Right at the moment, FDA surveillance is woefully 
inadequate. We don't even know what our problems are out there. 
We can't really identify what the major products are that are 
creating problems, where the pathogens are. There is just--
there is a significant lack of knowledge, and in particular 
when we compare our knowledge base with the knowledge base of 
what is present in Europe, for example----
    Ms. DeGette. Dr. Morris, I am sorry to cut you off. I have 
a very limited amount of time.
    Dr. Morris. Certainly.
    Ms. DeGette. And now we have a vote on the Floor.
    Professor Taylor?
    Mr. Taylor. I can be quick because I agree on the capacity 
points and also very much agree on the need for information, to 
know what the problems are and to know what the preventive 
solutions are, but then it is a matter of acting, and again, I 
think there are hazards out there, whether it is imported 
seafood or produce, where it is time to act to put in place 
preventive controls. Congress can legislate to make that 
easier. FDA has some authority. We should get action on that 
front.
    Ms. DeGette. Thank you.
    Doctor, is it Levi or Levi?
    Mr. Levi. Levi.
    Ms. DeGette. Levi.
    Mr. Levi. And I will be brief as well. I agree with my 
colleagues. Long-term funding for people, for technology, and 
give the FDA the authority that we want them to have so that 
they can really create a modernized system.
    Ms. DeGette. Now, Dr. Levi, one of the things that the FDA 
has said is they can't talk about a multi-year plan because of 
statutory limitations, but in your testimony, you noted that in 
your oral and written testimony you said that we did exactly 
that with the pandemic flu plan. Do you see any barriers in 
doing it with food safety as well?
    Mr. Levi. Absolutely not. I mean, it is a policy choice on 
the part of the Administration to project out into the future. 
They were able to do it for pandemic flu, and Congress actually 
did it in a way that provided almost $7 billion so that it 
could be carried out as milestones were reached. It is a very 
similar scientific challenge that you can only move just so 
fast because you have certain milestones that need to be 
reached before you can take the next step and invest the next 
set of money.
    Ms. DeGette. OK. I have one last question and 18 seconds. 
My question is, maybe for you and also Professor Taylor, do we 
have the technology right now in private industry to start 
exploring a food traceability system?
    Mr. Levi. I am not an expert on that.
    Ms. DeGette. Maybe Professor Taylor?
    Mr. Taylor. Yes. I mean, when the market creates an 
incentive, industry has plenty of technology available to 
implement traceability. There are economic issues but again, 
that picture is changing as well see the impact of some of the 
problems where we don't have traceability and the ability to--
--
    Ms. DeGette. It costs money to do traceability but it costs 
a lot more money not to have any tomatoes being distributed, 
correct?
    Mr. Taylor. Absolutely. The market can compel it or you can 
compel it, you know. It could go either way if the capacity is 
there.
    Dr. Morris. If I could make the point again that perhaps 
rather than investing large sums in traceability, if we put the 
money in prevention.
    Ms. DeGette. Well, I actually think----
    Dr. Morris. Both are important.
    Ms. DeGette. I actually think both are important. I 
completely agree with you that you are. That is why I also 
support mandatory recall because I don't really want to have to 
do mandatory recall, but I think it holds a hammer over the 
head and----
    Dr. Morris. We need both.
    Ms. DeGette. They both work hand in hand. Dr. Cassell?
    Ms. Cassell. I don't want to frighten you but I do want you 
to appreciate that I believe we have the technologies today to 
apply to be able to detect parasitic and viral infections that 
are foodborne that we are not yet even screening for, and this 
is something that the new technologies, the new expertise would 
bring to bear, but I am quite honestly not convinced we are 
doing it, and that is what frightens me the most.
    Ms. DeGette. Dr. Cassell, if you are in this job long 
enough, nothing frightens you anymore. You just expect the 
worst. Thank you very much.
    Mr. Stupak. Well, thank you. We have five votes on the 
Floor. We are going to recess until 12:30. I am going to ask 
this panel if they can stay. I know Mr. Doyle and others were 
here and wanted to ask questions. I know we may go another 
round because it is a very good panel.
    Thank you. We are in recess until 12:30.
    [Recess.]
    Mr. Stupak. I call the Subcommittee back to order. A couple 
of members are going to come back for questions. I have a few 
more and then we will go back and forth, see who shows up.
    Let me ask Ms. Shames, let me ask you, if I may, you say 
on, I believe it is page 10 of your report, since 2004, 4 
years, the GAO has been asking or made specific recommendations 
back in 2004 for the FDA to implement a strategy for food 
safety and 7 of those 34 have been implemented, and part of it 
was improving monitoring, enforcement processes. And there were 
21 recommendations you made with three of them being 
implemented or about 14 percent. If you take the 34 and seven 
of them have been implemented, that is about 20 percent. It has 
been 4 years. Why haven't the other 80 been implemented, or 80 
percent of them, I should say, the other 27. Any idea?
    Ms. Shames. Most of them FDA has started to take some 
initial steps but I think that is a very good question. I don't 
have an answer for you.
    Mr. Stupak. Back in 1998, the GAO also recommended, highly 
recommended, in fact, very forcefully recommended that the IT 
at FDA be improved upon. Have any recommendations from 1998, 10 
years ago, been implemented to bring the IT into compliance?
    Ms. Shames. There are others back at GAO who can talk more 
knowledgably about FDA's IT system. I do know, of course, that 
if they are going to undertake a risk-based approach, data is 
absolutely important. Data are underpinnings to be able to make 
those priority decisions, and of course, IT systems would be 
absolutely necessary for that.
    Mr. Stupak. And I think we established this earlier, but 
the extra money that Secretary Leavitt and Commissioner von 
Eschenbach asked for Monday night did not include any money for 
IT, for information technology. Is that correct?
    Ms. Shames. That is the way we understand it, yes.
    Ms. Stupak. You also note in your testimony that while 
FDA's Food Protection Plan recognizes the need to partner with 
Congress to obtain 10 additional statutory authorities to 
transform the safety of the Nation's food supply, you say, 
``FDA's congressional outreach strategy is general.'' What do 
you mean when you say that their outreach strategy is general?
    Ms. Shames. What we mean is that we would expect that FDA 
would know best the impediments that it has to conduct its 
regulatory authority. It would be presumptive on FDA to 
outreach to the Hill, to be able to provide draft legislation, 
to provide other technical assistance, to more proactively 
undertake to get the tools that FDA needs to be able to meet 
its mission.
    Mr. Stupak. In other words, they need the legislative 
language to implement part of this?
    Ms. Shames. I would say that that would be one thing that 
they would do, yes.
    Mr. Stupak. Professor Taylor, if I may, on page 13 of your 
testimony you say, ``Over a year ago, the United Fresh Produce 
Association and Produce Marketing Association called on the FDA 
to establish produce safety standards that are federally 
mandated, risk-based and allow for commodity-specific 
regulation.'' Did the FDA ever work with the produce 
associations to put forth this risk-based alternative?
    Mr. Taylor. My understanding is that there was work done 
within FDA to develop ideas for beginning that rulemaking, and 
I must say, I rely on press reports for my knowledge of the 
process but that effort was rebuffed in the Office of the 
Secretary so that a decision was made that at a level above FDA 
within the department not to proceed with that rulemaking.
    Mr. Stupak. So the fresh produce producers said let us do 
something and it is your understanding they went to the FDA, 
the FDA thought it was a good idea but the Secretary, that 
would be the Secretary of HHS then, rebuffed the idea?
    Mr. Taylor. That is my understanding.
    Mr. Stupak. On page 16, you say on the bottom of page 16, 
``I have great respect for Associate Commissioner David 
Acheson, but his position lacks budget or line authority for 
programs and thus in some way further clouds responsibility and 
accountability for food safety within FDA.'' Is that your 
assessment of the food czar situation now?
    Mr. Taylor. Well, yes, I think that creating that position 
was an effort to recognize that food safety and responsibility 
for it is lodged in multiple components of FDA. There is a 
Center for Food Safety and Applied Nutrition, which people 
think is the lead agency. There is also the Center for 
Veterinary Medicine, which has significant food safety 
responsibilities. And then the Office of Regulatory Affairs at 
FDA, which manages the field functions, all the inspectors, and 
the laboratories, and actually consumes the majority of 
resources that are labeled food safety resources at FDA. All 
three of those major components are managed separately. They 
report to the Commissioner but the Commissioner has more than 
one full-time job looking after the drug supply and the medical 
product side of the Agency, and so we have got a institution 
where food safety leadership is fragmented internally, and I 
think the effort to coordinate out of the Commissioner's 
office, which Dr. Acheson has been asked to do, is a worthy 
step, but anyone who has run a government program knows that if 
you don't have line authority and resource allocation authority 
over the programs you are expected to coordinate; coordination 
is a very difficult thing. Management is what is necessary and 
the leadership that comes with the actual tools of leadership 
and management.
    Mr. Stupak. So the food czar should really have direct 
authority, budgetary and line authority over veterinary and the 
Office of Regulatory Affairs?
    Mr. Taylor. I mean, my view is that these elements of FDA 
ought to be unified into a single functioning entity that is 
responsible for the food side of FDA's jurisdiction, and with 
direct accountability to a single person who is in charge of 
food safety at FDA and has that as their full-time 
responsibility and can manage all the resources of FDA to do 
food safety.
    Mr. Stupak. I see a lot of nodding of heads. Does anybody 
else want to comment on that? Dr. Cassell, Dr. Morris, Dr. 
Levi, Ms. Shames?
    Dr. Morris. I would just strongly second the need for this 
type of authority. From a scientific standpoint, one of the 
major problems that arises is the lack of coordination among 
the agencies, and having a single line authority is absolutely 
critical. We are just not getting anywhere because there isn't 
that. I will say there is a larger problem and that there is 
further dissemination of responsibility in USDA and CDC, but 
that goes beyond what we are talking about today.
    Mr. Stupak. Dr. Cassell, would you care to comment?
    Ms. Cassell. I was actually just going to refer back to one 
of the other comments that you asked. I don't want to be 
misleading. It is possible that maybe FDA in their request and 
the Secretary in his request, in their $275 million, were 
thinking that they would apply monies from that for IT. What we 
estimated is that $128 million would be needed for food safety, 
an additional $75 million for IT and an additional $172 million 
for drug safety and also to address the emerging science issue 
and the management issues. So I just didn't want to mislead 
anybody. I don't know what their intentions were but clearly, 
in our opinion, it would not address all of the needs that are 
as critical that need to be addressed.
    Mr. Stupak. Right. In the June 9th request for the 
additional money, it was $125 million protecting America's food 
supply, $100 million safer drugs, devices, and biologics, and 
$50 million, modernizing FDA's science and workforce. I didn't 
see any breakdown for IT so that is why I was asking the 
question. Thank you.
    Mr. Shimkus for questions.
    Mr. Shimkus. Thank you, Mr. Chairman.
    Ms. Shames, there is a briefing binder. Dr. Morris, I think 
it is in front of you, not the Science Board one but--because I 
want to refer to tab 11 to begin with, and tab 11 has the 
business case paper for the Food Protection Plan. Have you seen 
this or reviewed this?
    Ms. Shames. Yes.
    Mr. Shimkus. What information do you feel is lacking in 
this document that Congress would need to evaluate FDA's 
justification for spending this money?
    Ms. Shames. This is the information that was released with 
the President's budget in February of this year, and it does 
describe what FDA intends to do with the $42 million for this 
fiscal year, but beyond that, what we are looking for--and 
there is a statutory model for it--is to lay out over, let us 
say, a 5-year period, just what the long-term goals are for 
food safety, break those long-term goals down into interim 
goals, and to be able then to discuss the associated resource 
needs for both the interim goals and the long-term goals. And 
resource needs should be considered very broadly--dollars, 
people, technology, in other words, everything that is brought 
to bear to be able to accomplish that. That really is the 
minimum information, but under the Government Performance and 
Results Act, departments are to provide more information. What 
are the external factors, for example, that they identify that 
could somehow impede accomplishing their goals. And likewise, 
there is call for evaluations. If you haven't achieved your 
goals, why not? Conduct some sort of formal evaluation to show 
that.
    Mr. Shimkus. And Dr. Levi, in the pandemic influenza thing, 
is that similar to the approach that we did with that, and that 
is--does that sound----
    Mr. Levi. The pandemic strategic plan, implementation plan 
actually does agency across the government agency by agency 6-
month, 12-month, 18-month, 2-year, 3-year goals for a variety 
of activities.
    Mr. Shimkus. So we are saying that is a good model to move 
in this direction?
    Mr. Levi. Yes.
    Mr. Shimkus. Let us go back to the briefing binder, Ms. 
Shames, on tab 10, 5 pages in, which is number 2, there is a 
quote, ``Use enhanced modeling capability, scientific data and 
technical expertise to evaluate and prioritize relative risk.'' 
From your information, do you know what this will cost to 
achieve or when the Agency will accomplish this task?
    Ms. Shames. Certainly not from this information. Now, we 
have received some internal documents that provide a little 
more detail on some of the deliverables associated with the 
strategic components, but there is nothing more publicly 
available.
    Mr. Shimkus. Should this be public?
    Ms. Shames. Yes, we believe that this sort of public 
reporting is useful for congressional oversight, reassures the 
public, especially at a time like this when there is a food 
outbreak. Public reporting, I think is a very healthy thing.
    Mr. Shimkus. It is transparent. People can evaluate and 
hold people accountable based upon the standards established, 
and I would agree with that. I am going backwards, sorry, but 
tab 7 now, which is a letter from Commissioner von Eschenbach 
to Senator Arlen Specter. We kind of talked about it today in 
some opening statements. He stated in his professional judgment 
that FDA needs the $275 million immediately to accelerate its 
reforms. You have reviewed that, I am sure.
    Ms. Shames. We are familiar with this as well. The 
progression that you are presenting obviously gets more and 
more detailed so we do see some associated dollars here with 
the activities. I think what is interesting here is that this 
was the Commissioner's professional judgment. We didn't see 
this accompanying information with the amendment that the 
Administration just asked for. So I think it is reasonable to 
assume that this would be applicable but that is only because 
we have evaluators who are doing a side-by-side comparison.
    Mr. Shimkus. And we are legislators and we deal in public 
policy. We are always schizophrenic because on one hand, you 
know, we are--I think most of us understand FDA more money but 
we want to it to be accountable. We want it to be directed in 
the right ways. But of course, I am a fiscal conservative that 
doesn't want to spend any more money, doesn't want to raise any 
more taxes, and so it is a dilemma but it is easier for us to 
go to our constituents if there is a credible plan, if we can 
have goals and objectives that are attainable and then 
especially with all these problems that we have had. I mean, 
there is public awareness of the need to move more 
aggressively.
    Tab 13, this will be my last, at least in the binder, shows 
a menu of IT programs associated with different levels of 
funding, page 11 in tab 13. Have you seen this information in 
the Food Protection Plan?
    Ms. Shames. I can't say offhand. It certainly is aligned by 
the core elements that is in the Food Protection Plan.
    Mr. Shimkus. But this is the kind of stuff that we would 
hope to see in budgetary information that we are all kind of 
addressing.
    Ms. Shames. Absolutely. It lays out the dollars going 
forward and just what some of the activities are.
    Mr. Shimkus. Great. And while we go, you all are welcome to 
page through this in those tabs, but my time is expired. I will 
turn back to the chairman.
    Mr. Stupak. Seeing no other members available for 
questioning, I would like to thank this panel again for your 
expertise and your input into this process, and I will dismiss 
this panel. Thank you again, and thank you for bearing with us. 
I said that we had five votes. We ended up having six so we 
went a little longer than what we thought, but thank you again 
for being here and thanks for your help.
    Ms. Cassell. Mr. Chairman, as we are leaving, can I just 
make one statement?
    Mr. Stupak. Yes.
    Ms. Cassell. And that is that our committee certainly 
struggled with the issue, Mr. Shimkus, that you just described, 
i.e., the need for the plan and wanting the Agency to be 
accountable, and what we concluded was, in the absence of 
additional resources and significant resources, even if you had 
a plan, I think that there would be no hope and so I think that 
we concluded that the first thing that had to happen was to get 
those resources to the Agency and then to begin to help address 
the issues and to perhaps solidify the plan.
    Mr. Shimkus. Mr. Chairman, if I can follow up, and when I 
talk about the schizophrenia of public policy folks, that is 
why I focus on this risk-based approach also because we are 
always going to have--we are never going to have enough money, 
but the question is, directing it into the area that we need, 
and really I like to incentivize the good actors. I really want 
the good actors to get patted on the back. Some will fall 
through the cracks somewhere down the line, we understand that, 
but if you can incentivize the good actors, go after the bad 
actors, I think that is a better application of our resources, 
and I appreciate those comments, Dr. Cassell.
    Mr. Stupak. Thank you again.
    I now call our second panel of witnesses to come forward. 
On our second panel, we have Dr. David W.K. Acheson, Assistant 
Commissioner for Food Protection at the Food and Drug 
Administration, also known as the drug czar--food czar. Sorry. 
I gave you a promotion, drug czar. I just want to make sure you 
are paying attention.
    It is the policy of this subcommittee to take all testimony 
under oath. Please be advised that witnesses have the right 
under the rules of the House to be advised by counsel during 
their testimony. Doctor, do you wish to be represented by 
counsel?
    Dr. Acheson. No.
    Mr. Stupak. The witness indicated no. Then I will ask you 
to please rise and raise your right hand to take the oath.
    [Witness sworn.]
    Mr. Stupak. Let the record reflect that the witness replied 
in the affirmative. You are now under oath, Doctor. We will now 
hear your opening statement. You may submit a longer statement 
for inclusion in the record. Please begin, sir.

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

    Dr. Acheson. Good afternoon, Chairman Stupak and members of 
the subcommittee. I am Dr. David Acheson, Associate 
Commissioner for Foods at the Food and Drug Administration, 
which is part of the Department of Health and Human Services. I 
would like to thank you for the opportunity to discuss our 
ongoing activities to implement the Food Protection Plan to 
enhance food safety.
    As we all know, food can become contaminated at many 
different steps along the path from farm to fork. In recent 
years, FDA has done a great deal to prevent both deliberate and 
unintentional contamination of food at each of these steps. 
However, changes in consumer preferences, changes in industry 
practices, and the rising volume of imports have posed 
challenges that required us to adapt our current food 
protection strategies.
    To address these challenges, last November Secretary 
Leavitt presented to the President an Action Plan for Import 
Safety, or Action Plan, to enhance the safety of imported 
products. In conjunction with the Action Plan, FDA released the 
Food Protection Plan, which provides a framework to identify 
and counter potential hazards. Together, these Plans provide an 
updated and comprehensive approach to assure that the U.S. food 
supply remains one of the safest in the world. The plans 
encompass three core elements: prevention, intervention, and 
response. The prevention element means promoting increased 
corporate responsibility to build safety in from the start so 
that food problems do not occur. The intervention element 
focuses on risk-based inspections, sampling, and surveillance 
at all points in the food supply chain to verify that the 
preventive measures are being implemented. The response element 
bolsters FDA's emergency response efforts by allowing for 
better communication and increased speed and efficiency.
    To expedite implementation of both Plans, the 
Administration has amended its budget request for fiscal year 
2009 to include an additional $275 million for FDA. This 
increase includes an additional $125 million to intensity 
efforts to implement the Food Protection Plan. This adds to the 
increase of $42.2 million proposed in the fiscal year 2009 
budget announced in February. The $275 million increase also 
includes $65 million to modernize FDA's information technology 
infrastructure, $25 million of which will specifically support 
our food safety and food defense programs.
    With the funding requested in the President's amended 
fiscal year 2009 budget, we will hire an additional 353 FTEs to 
accelerate our Food Protection Plan implementation activities. 
These resources will allow FDA to achieve priorities, such as 
identifying and targeting the greatest risks for intentional 
and unintentional contamination; conducting essential research 
on mechanisms of food contamination and deploying new rapid 
screening technologies to detect microbial and chemical 
contaminants; conducting more risk-based inspections and 
strengthening our emergency response; establishing more rapid 
response teams; expanding FDA's international presence to 
include offices in China, India, Latin America, Europe, and the 
Middle East; establishing IT systems to support interoperable 
databases that will enhance research, threat assessment, and 
surveillance; and improving our ability to conduct trace-backs.
    We are moving forward to work with partners to develop the 
necessary scientific foundation. FDA has established a number 
of cross-cutting implementation teams and is working with our 
external food safety partners to focus on key areas to support 
our implementation efforts. I would like to take a couple of 
moments to describe five of these key cross-cutting areas of 
focus that are current priorities.
    First, the risk-based approach. FDA has been using a risk-
based approach for setting priorities for many years. However, 
there are new models relating to risk assessments and new 
mechanisms that could improve our risk-based approach. FDA has 
developed an internal steering committee and is working on 
defining appropriate models, examining product/hazard 
combinations, and ranking foods by their risk to public health. 
These will enhance our ability to maximize effectiveness of our 
resources by focusing on food products that pose the greatest 
risk.
    Secondly, outreach. FDA has undertaken a number of specific 
outreach activities. For example, we have met with 
representatives of many foreign governments, state, and local 
partners, industry and consumer groups. The agency recently 
opened a docket to collect comments from all stakeholders on 
implementation of the Food Protection Plan. To provide a forum 
for local, State and Federal partners to exchange information 
and ideas about implementing the Plan, FDA will host a meeting 
on August 12-14, 2008, in St. Louis, Missouri, with officials 
from the departments of health and agriculture from all 50 
States.
    Thirdly, traceability. FDA is currently reaching out to 
various organizations to gain a better understanding of best 
practices for traceability and the use of electronic track-and-
trace technologies to more rapidly and precisely track the 
origin and destination of contaminated foods, feed, and 
ingredients. FDA will use this information to develop key 
attributes for a successful track-and-trace system. In 
addition, FDA plans to issue a request for applications to 
providing funding to six states to establish rapid response 
teams to investigate multi-state outbreaks of foodborne 
illness.
    Fourthly, FDA Beyond Our Borders. Consistent with the goals 
of the Action Plan and the Food Protection Plan, HHS and the 
People's Republic of China signed an agreement to enhance the 
safety of food and feed exported from China to the United 
States. The agreement establishes a bilateral mechanism to 
provide greater information to ensure products exported from 
China to the United States meet U.S. safety standards. As part 
of its Beyond Our Borders Initiative, FDA has also made a 
commitment to station agency representatives in China. We are 
considering similar endeavors in other countries, as I 
mentioned earlier.
    Finally, voluntary third-party certification programs. In 
April, FDA published a notice in the Federal Register to 
solicit public comments on the use of voluntary third-party 
certification programs for foods and feeds including pet foods. 
Third-party certification could provide FDA with additional 
assurances of safety and with valuable compliance information 
that would allow FDA to allocate inspection resources more 
effectively. The public comments will assist FDA in the design 
and development of such programs.
    These are just a few of our current high-priority areas of 
focus as we implement the Food Protection Plan. In my written 
statement, I also provided numerous examples of specific 
implementation activities.
    In closing, FDA remains committed to working closely with 
all of its partners to implement the Plan's measures to protect 
the Nation's food supply. The degree of progress and the 
overall success are dependent on both resources and new 
legislation. As you know, the Food Protection Plan identifies 
legislative authorities that are necessary for achieving full 
implementation. We commend this committee for its work on 
drafting legislation and look forward to working with you on 
this important legislation as we move forward. We also urge 
Congress to provide the funding requested in the amended fiscal 
year 2009 budget.
    Thank you for the opportunity to discuss FDA's activities 
to implement the Food Protection Plan. I would be happy to 
answer any questions.
    [The prepared statement of Dr. Acheson follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    
    Mr. Stupak. Thank you, Doctor. Let me begin.
    In the President's proposal for fiscal year 2009, you 
received $30 million for food safety. What made the FDA realize 
that you need another $125 million for food safety here in the 
last 6 months? What made the light go on that you needed more 
funds for food safety?
    Dr. Acheson. I think as we were beginning to address the 
implementation of the Food Protection Plan, based, as you 
pointed out earlier in this hearing, in November we published 
the strategy, a high-level document, and as we have driven that 
down to specific implementation and what it is going to cost in 
the 2008-2009 time frame, it was very clear that more money was 
going to be needed, and that helped drive it.
    Mr. Stupak. So in November you said you put forth your Food 
Protection Plan and as you began to implement it, you realized 
you needed more money. Do I understand that right?
    Dr. Acheson. Not exactly. When we put the Food Protection 
Plan out, it was clear, we stated publicly at the time that we 
would need more resources in order to specifically implement 
the full components of the Food Protection Plan. You asked 
specifically what drove us to come up with that number and that 
was as we were defining what we could accomplish in the 2008-
2009 time frame. That helped drive where did that specific $125 
million come from.
    Mr. Stupak. OK. Because I am a little confused now, because 
when Commissioner von Eschenbach sat where you sat at our April 
22nd hearing I asked him about implementing this and if the 
total budget, the $59 million that was requested in 2009, was 
enough, and he thought that would be fine to implement this 
program. What happened between April 22nd and June 10th that 
you put forth the plan?
    Dr. Acheson. I think as we moved forward and had further 
internal discussions, the Commissioner recognized that there 
were other areas where we could usefully use additional 
resources.
    Mr. Stupak. Do you have any idea then what would it cost to 
implement the Food Protection Plan as written in November of 
2007?
    Dr. Acheson. In its totality?
    Mr. Stupak. Yes.
    Dr. Acheson. We have thought this through over a period of 
2008, 2009 in a fair degree of specificity. Beyond that, it 
gets a little difficult to actually determine what resources it 
will take because so much of what you would do in the second 
and third year of the plan is dependent on the progress you 
make in the first year. To give you a specific example, if 
legislative proposals are enacted to require preventive 
controls, which is one of the things that is in the plan, to be 
able to enact that and make it happen and increase the levels 
of inspection and guidance required, that is going to require 
resources, and at this point I don't know what those would be.
    Mr. Stupak. All right, but how would you put forth a plan 
for food safety for the Nation but have no idea what it is 
going to cost after the first year of implementation and you 
are only off by $30 million for food safety and you come back 
and you ask for $120 some, so you are only off by four times. 
So if your initial assessment was you only need $30 million for 
this when you submit the budget on April 22 besides our hearing 
to make you run up those numbers, Commissioner von Eschenbach 
says you only need $30 million. Six weeks later you are coming 
up and saying no, we need $125 million, but after that, you 
don't know what else you need. So how can you put forth a 
proposal to protect the American people and not even know what 
it is going to cost 1 year, 2 years, 3 years, 4 years, or 5 
years out? Do you have any ideas what it is going to cost 5 
years out?
    Dr. Acheson. At this stage, I couldn't tell you what it is 
going to cost 5 years out. The key part here is to develop a 
strategy, a vision, lay out the plan, and as the hearings 
illustrated earlier, put more granularity and specificity into 
it.
    Mr. Stupak. I agree, but you must have some guesstimation 
what it is going to cost. I mean, you would have to know it 
took 4 or 5 years to do it, right? When you were doing this, 
you had to come up with some guesstimation. The Science Board, 
there is their binder right there, they gave estimations for 5 
years out. Did you even look at their numbers and say they are 
probably in the right ballpark?
    Dr. Acheson. I did look at their numbers and I don't have 
any argument with them.
    Mr. Stupak. So we should take the Science Board's number 
then to help you implement this Food Protection Plan for the 
country?
    Dr. Acheson. Well, as we both understand, there is a budget 
process that is followed in terms of FDA seeking funding.
    Mr. Stupak. Correct.
    Dr. Acheson. And in that context, we only take it out in 
terms of the money that we ask as far as the budget process 
allows. If you choose to take the Science Board's numbers----
    Mr. Stupak. You were so wrong with your first request. It 
was only $30 million for food safety and 7 months later, now it 
is $125 million for food safety. But yet the Science Board came 
up with $128 million for food in 2009, $283 million in 2010, 
$441 in 2011, $598 million in 2012, $755 million in 2013. As I 
think we heard Mr. Shimkus and others, we are willing to help 
out but we are not just going to throw money at a problem but 
we need some concrete estimates of what it is going to cost, 
where are we going with this whole process. If we go to the 
appropriators and say here is $128 million, that is what we 
want next year, they are going to say what are we going to have 
for the following year and thereafter. I mean, it is a sizable 
amount of money. We are not even talking about information 
technology which everyone says you are very lacking in that 
area too. So I guess I am just trying to get some kind of sense 
of where we are going with it.
    Dr. Acheson. Well, let me try to provide a little clarity. 
Certainly the number that is in the Science Board proposal for 
2009 is absolutely on track with where we now are for 2009 for 
food safety. It is essentially the same number. There is a 
couple million difference but it is the same number.
    Mr. Stupak. Sure, that is just for food, but the Science 
Board for IT had $75 million. You don't even bring that into 
play.
    Dr. Acheson. No. As I said in my oral statement, there is 
new money in the 2009 request for IT, $25 million specifically 
for food safety. So there is $125 million for food safety and 
on top of there that there is an additional $25 million for 
food safety-related IT in the 2009 request. So there is an IT 
component built on top of that $125 million for food safety in 
that 2009 additional request.
    Mr. Stupak. My time is up, but let me ask you this. We got 
the Food Protection Plan, which I have said earlier was tailor-
made to the President's budget, original budget, and I have 
asked about a couple years out. So as the Agency's food czar, 
do you plan to submit to Congress an implementation plan which 
shows milestones, costs for the period that it would roughly 
take to implement this Food Protection Plan roughly 5 years? 
Will you do that? Will you submit that to the Congress so we 
have some idea on where we are going with this process?
    Dr. Acheson. I have the ability to submit to you milestones 
and an implementation plan and a more specific set of timelines 
as we have heard. In terms of what I can provide in resource 
requests around that, what I can tell you is that I will work 
within our Administration to provide you the maximum amount of 
information that we can provide you around the resources. I can 
only commit to provide you with details of how we will 
implement this plan.
    Mr. Stupak. But you are the czar, you put together this 
plan. Why can't you tell Congress, the American people what it 
is going to cost for the next 5 years, what milestones are 
going to be achieved? How are we going to address that, and if 
you could do that for us? Why do you have to stay within the 
Administration's constraints? Why not do the job as food czar 
and say here is what we need, here is what it is going to take, 
here is my request for the Congress? Isn't that sort of your 
authority as the food czar?
    Dr. Acheson. Well, if you are asking me to go outside of my 
authority within the Administration, then that might put me in 
a bit of a bad place.
    Mr. Stupak. But isn't it really what we need to do to get 
at food safety? Whatever the next Administration, shouldn't 
they submit a plan for 4 or 5 years so we know where we are 
going with this whole process?
    Dr. Acheson. There needs to be a realistic assessment of 
what is this going to take, both in terms of an implementation 
strategy, FTEs, and obviously you are right, ultimate cost, but 
working within the constraints of the process----
    Mr. Stupak. But here is our problem. We heard the same 
thing in 1998 from the GAO. In 2004, GAO laid out 34 
recommendations to be implemented, hasn't been done. Then we 
had this food plan in November of 2007. You had the Science 
Board plan right there. We have so many plans floating around 
that never get implemented because no one ever has the courage 
to step forward and ask what needs to be done; here is what 
needs to be done, here is what it is going to cost us, and I 
think the American people would really like to say someone is 
finally addressing the issue. As Mr. Dingell said in his 
opening statement, they are tired of being sick, but if it is 
going to cost us a few pennies more if we can see results, we 
could probably implement it.
    Dr. Acheson. Let me commit to giving you at least greater 
specificity on timelines, plans, short- and medium-term goals, 
longer-term goals that I will commit to do, and I will also 
commit to work with the Administration to provide you whatever 
I can within my authority as associate commissioner in terms of 
resources. I can't go beyond that.
    Mr. Stupak. When can we expect that detailed plan?
    Dr. Acheson. It is going to evolve. I think we can provide 
you a detailed plan over the next--for the next year to 18 
months, probably within 6 to 8 weeks. We have gotten most of 
it. Part of the strategy here is trying to apply the logic. As 
you are building this plan, you have a lot of complex issues 
going on with a lot of activities, and we have captured much of 
that, but what you have got to do is, if you are going to set 
up a risk-based approach, you have to determine what is the 
logic flow through that, what do you have to do first, and we 
made a lot of progress there, so I would hope that within 6 to 
8 weeks we can provide you something for at least the first 2 
years, and then looking out beyond that in a----
    Mr. Stupak. Six to 8 weeks or a year to 18 months you are 
going to provide that to us?
    Dr. Acheson. I hope within 6 to 8 weeks to be able to 
provide----
    Mr. Stupak. Because you gave us one year's worth. This is 
the first year. This is your 2009 request, which had some 
details, but it is only--and that was the $42 million plan. We 
would like to see a full plan for a couple of years out.
    Dr. Acheson. I would like to go into greater detail than 
what you are holding in your hand there for the next year.
    Mr. Stupak. We would appreciate that. Should your budget, 
if you reach a milestone, should you get the money, I think 
Professor Morris said that we should tie it into a process 
where you do not receive the money unless you reach a 
milestone. Would you be in favor of that?
    Dr. Acheson. I think you need to look at--there is always a 
danger that you won't reach a milestone for some unspecified or 
unpredicted reason. Part of this process is transparent and 
exploratory. You can't map out 5 years of how do we fix the 
food supply. This is the eighth hearing that you personally 
have held on this.
    Mr. Stupak. Right.
    Dr. Acheson. It is really complicated, as illustrated by 
the number of hearings, and the problems that we have got to 
address are multiple: they are domestic, they are 
international, and I am not going to commit to saying we will 
set a milestone 2 years out. We may or may not make that. That 
is just reality. That is life.
    Mr. Stupak. Well, the Science Board right there, they have 
it all laid out right there for you, all you have to do. That 
is from A to Z, how best to do it. It is already laid out for 
you if you care to try it.
    Mr. Shimkus for questions.
    Mr. Shimkus. Thank you, Mr. Chairman.
    I am going to page back here because I would--well, before 
I do that, I need to ask you to take back to Dr. von 
Eschenbach, I said in my opening statement, response to this 
Office of Criminal Investigations letter, and if you would see 
that you relay that request from me. I think Ranking Member 
Barton would appreciate it and it would help us with our good 
friends in the Majority who might think we have to go to other 
extremes to get the information versus just a nice, polite 
letter.
    Dr. Acheson. I apologize that you don't have that I will 
most certainly take that back.
    Mr. Shimkus. Great. I always keep going back to this--have 
you looked at this national strategy for pandemic influenza and 
their implementation plan and looked at how the perception of 
the plan at least, the first panel seemed to think it did a 
couple things. It set out goals. It set out milestones. It set 
out funding. Have you all looked at that to look at a way in 
which--when corporate America wants to build hopefully a lot 
more coal-fired power plants in this country, they have to plan 
10 years out to get through all the permitting, to get the land 
acquisition, to fight the environmental groups, hopefully win, 
and then build the project, buy the coal. Everybody has long-
term plans. That is our frustration. So, one, have you looked 
at that as a guide, and then if so, what have you determined 
and there is legislative action that we need to do to help you 
do that? When we do our budget, and I have problems with our 
budgetary process. Like I said, I like to have really the cost 
structure be a 2-year cycle but we do a 5-year. Ours is a 5-
year budget plan. Now, we know we are not going to achieve it. 
We know there are going to be different areas that are going to 
be skewed, but at least we have an idea of what is going to 
happen, where tax cuts may be required to expire or other 
things. So talk to me about the influenza analysis and then 
again the whole budgetary cycle.
    Dr. Acheson. In terms of your question about the pandemic 
plan, I personally have not looked at that for quite some time. 
I was certainly interested in following it when it was being 
developed. The discussion earlier today has illustrated that I 
need to go back and have a look at that specifically in terms 
of the way it was laid out and structured and see if it applies 
to the Food Protection Plan or at least if elements of it can 
be applied to the Food Protection Plan. It is clearly a model 
that you all feel works and is successful and we should pay 
attention to that and go and look but at this point I need to 
make that assessment. In terms of the budget process, 
essentially it is what it is and what we do----
    Mr. Shimkus. But the submission by the Administration is 
not--I mean, we don't pass that and it doesn't go back to the 
President. It is not signed into law. When we pass out budget, 
it is not--we don't send it back up to the President to get 
signed into law. It is a guide that directs our appropriators 
to spend money a certain way and they have to do the 
allocations and that is how the process kind of begins. It is 
very frustrating.
    Dr. Acheson. Well, we are under constraints within FDA in 
terms of the budget process and we have to follow that. That is 
the way the law is written and that is what we have to do. So 
within that, we certainly operate within those constraints and 
clearly if you were to change those, then we would respond 
accordingly.
    Mr. Shimkus. We have a lot of million-dollar numbers 
floating around here, trying to get a handle on. The request, 
the Administration has added a $275 million request to the 2009 
budget with $125 million of that for food protection. Is that 
your understanding?
    Dr. Acheson. Yes.
    Mr. Shimkus. And that is on top of the $42 million and then 
the--so there is $42 million and $125 million of the $275 
million that is food protection addition dollars?
    Dr. Acheson. Correct.
    Mr. Shimkus. How are you going to use that money to 
accelerate the plan's implementation?
    Dr. Acheson. Probably the easiest way for me to answer that 
is I think in the book that you had here, you have a copy of 
the professional judgment from our Commissioner which lays out 
in some detail how it would fall under prevention and 
intervention and response. But within that, we have got 
essentially money and FTEs allocated to increasing FDA's 
presence beyond the borders, as an example, setting up the 
office in China, trying to set up, establish the offices in 
India and Central and South America, those sorts of things. 
Also, increasing our ability to provide technical assistance to 
foreign countries that need it, that requires resources and 
people. And developing the tools, IT tools and others for 
international information exchange to help inform the risk-
based process. There is a lot ofyou probably don't want me go 
through----
    Mr. Shimkus. Let me then add to, now we also have the 
additional $275 million in new resources through the proposal 
of the budget supplemental, correct? The emergency 
supplemental. That is--
    Dr. Acheson. Through the fiscal year 2009 addition, $125 
million added in the fiscal year 2009 change.
    Mr. Shimkus. Yes, but the response to Senator Specter on 
the 2008, in this emergency supplemental requested an addition 
of $275 million?
    Dr. Acheson. Well, are we talking about a supplemental or 
are we talking about the----
    Mr. Shimkus. I am talking about both, and that is the 
problem, because the basic--if the emergency supplemental of 
$275 million gets approved, can you deal with that money?
    Dr. Acheson. Absolutely, no question.
    Mr. Shimkus. And what will you do with it?
    Dr. Acheson. We will do exactly what we will do with it if 
we got it in 2009. We would just do it sooner.
    Mr. Shimkus. Mr. Chairman, my time is expired. Thank you.
    Mr. Stupak. Thank you, Mr. Shimkus.
    Ms. DeGette for questions, please.
    Ms. DeGette. Thank you, Mr. Chairman.
    Dr. Acheson, when Commissioner von Eschenbach appeared in 
front of this committee almost a year ago, Tuesday, July 17, 
2007, and announced your appointment as the new czar, he said, 
``This plan will enable FDA to be engaged in quality assurance 
through the total life cycle of food from its very production 
all the way to consumption. If you will, FDA's commitment is to 
be engaged from farm to fork, and to do that in the context of 
a comprehensive, well-developed plan that includes prevention 
so we can eliminate food safety problems by building quality 
into our very production of food.'' Would you agree that is the 
general purpose of what you are supposed to be doing with this 
new plan?
    Dr. Acheson. It is heavily focused on prevention but with 
intervention and response built in as well.
    Ms. DeGette. OK. So this plan now that came in out in 
November 2007, would you say that this is a comprehensive, 
well-developed plan?
    Dr. Acheson. It is a comprehensive, well-developed 
strategic vision of where to take food safety.
    Ms. DeGette. Correct. As I said when I talked to the 
previous panel, there is nothing really very specific in here. 
It is general goals, right?
    Dr. Acheson. It is a strategic vision.
    Ms. DeGette. OK. Now, we also have under tab 10 of your 
notebook the Food Protection Operations Plan. I am sure you are 
familiar with that as well, correct?
    Dr. Acheson. Yes.
    Ms. DeGette. So my question is, would you say that is a 
comprehensive, well-developed plan?
    Dr. Acheson. It does not give specific timelines and 
metrics.
    Ms. DeGette. It doesn't give specific timelines, metrics, 
or price tags, does it?
    Dr. Acheson. No.
    Ms. DeGette. So you wouldn't say that is a comprehensive, 
well-developed plan, would you?
    Dr. Acheson. I have already committed to provide that.
    Ms. DeGette. OK. And you have committed to provide that 
within 6 to 8 weeks from now, you say?
    Dr. Acheson. For the next----
    Ms. DeGette. For the next 2 years?
    Dr. Acheson. Yes.
    Ms. DeGette. For the next how long a period? Because first 
you said 18 months, then you said 2 years.
    Dr. Acheson. No, I said 18 months to 2 years.
    Ms. DeGette. OK. Great. So my question to you is it has now 
been 7 months since we received this whatever you called it and 
we haven't had a specific detailed plan. Now you are saying 
another 6 to 8 weeks before a detailed plan. Is that going to 
have the breakdown with the metrics, and the price tags and so 
on and so forth?
    Dr. Acheson. To the greatest of our ability, yes, it will 
have the breakdown of the metrics.
    Ms. DeGette. What does that mean?
    Dr. Acheson. Pardon?
    Ms. DeGette. What does that mean and what do you need to 
get the ability to put metrics and price tags to all of the 
specific items in both of your Food Protection Plan and your 
Operations Plan?
    Dr. Acheson. Well, the first point is what are the 
priorities over the next 18 months to 2 years?
    Ms. DeGette. Well, I would think the priorities would be to 
stop food outbreaks like the new outbreak that we have got with 
the tomatoes right now.
    Dr. Acheson. That is the ultimate priority, to improve the 
safety of food.
    Ms. DeGette. Well, how long is it going to take for the 
ultimate priority to be achieved?
    Dr. Acheson. To rule out outbreaks?
    Ms. DeGette. Well, to prevent outbreaks.
    Dr. Acheson. We will never completely prevent outbreaks. 
The goal is to minimize----
    Ms. DeGette. OK, that is not productive. Let me ask you 
another question. In your Food Protection Plan, there are many 
sections that talk about additional legislative authority 
needed, correct?
    Dr. Acheson. Yes.
    Ms. DeGette. Has the FDA come to Congress with any draft 
language for legislation needed to implement the plan?
    Dr. Acheson. In the Food Protection Plan itself, the 
document you have there, there is a fair degree of detail in 
terms of what the specific legislative proposals would be.
    Ms. DeGette. OK. But has the FDA actually developed 
language to support those proposals?
    Dr. Acheson. We have not provided legislative language----
    Ms. DeGette. Does the FDA intend to develop language to 
support those proposals?
    Dr. Acheson. At this stage, there is a great deal of 
language already developed by many members of Congress that we 
are providing technical assistance and look forward to doing 
more of that as we go on.
    Ms. DeGette. Which specific legislation are you referring 
to, sir?
    Dr. Acheson. Yours, for one.
    Ms. DeGette. OK.
    Dr. Acheson. There are many that are out there.
    Ms. DeGette. Now, isn't it the case that the Administration 
did submit accompanying language with a number of recent 
legislative efforts including the Medical Device User Fee Act, 
the Animal Drug User Fee Act, the Generic Animal Drug User Fee 
Act, and the reauthorization of PADUFA?
    Dr. Acheson. I was not familiar with any of those, but if 
you say that, I have no reason to----
    Ms. DeGette. All right. But as far as you know, the FDA's 
intent for these recommendations in your plan is to simply 
provide technical support to Congress but not to provide 
language. Is that correct?
    Dr. Acheson. At this stage, there is no intent to provide 
specific legislative language.
    Ms. DeGette. Now, you had told Mr. Stupak that you cannot 
exceed the authority given by the Administration in terms of 
the budget. Is that correct?
    Dr. Acheson. That is my understanding of my role, yes.
    Ms. DeGette. And what specifically are the parameters of 
that authority that you have been given by the Administration?
    Dr. Acheson. My understanding of that is that during the 
development of a budget for 2009 or 2010 or wherever we are 
going, there is internal discussion that I take a major role in 
in terms of determining what are we going to need to move 
forward on whatever it is we are working on in the next stage 
of the Food Protection Plan. That is turned into a specific 
budget document, which is forwarded up through the departments, 
subsequently OMB, the President, and finally to Congress.
    Ms. DeGette. And it is your understanding then that your 
authority does not include projecting out over 5 years or even 
2 years budget numbers?
    Dr. Acheson. My understanding of our ability, our authority 
is that if I was to do that, it would be for internal use only 
and I would not be allowed to share it.
    Ms. DeGette. And who told you that?
    Dr. Acheson. That is my understanding of the law, and if I 
am incorrect, please correct me.
    Ms. DeGette. You believe that is according to the statutes?
    Dr. Acheson. That is my understanding.
    Ms. DeGette. OK. And so how is it that you think you are 
going to be able to do a detailed plan for the next 18 months 
to 2 years if you are limited statutorily to only providing a 
budget for the coming fiscal year?
    Dr. Acheson. What I committed to provide was a detailed 
implementation plan in terms of timelines and short- and long-
term goals and I said I would work within the Administration to 
the best of my ability to provide maximum information on the 
resources required to achieve those goals. I cannot promise 
that.
    Ms. DeGette. Well, the problem we have is, if it is going 
to take a 5-year plan to fully implement the food safety 
regulations in this country, then we need to know how much it 
is going to cost and what we are going to need to do to do it. 
If in 6 to 8 weeks we receive more of this exhibit 10 or this 
other plan with sort of hortatory goals, that is not going to 
help us in feeling like we are developing legislation that is 
going to protect our constituents. You can see our frustration, 
Dr. Acheson.
    Dr. Acheson. I understand. You want to know how much is it 
going to cost to implement----
    Ms. DeGette. We want to know. We are not asking for a 
budget. What we are asking for is cost estimates, and we 
believe that is in your statutory authority, and furthermore, 
we don't see how we can really do legislation. We don't see how 
the FDA can implement a plan if it doesn't have cost estimates 
that go out over the life of the plan.
    Dr. Acheson. I understand your frustration. Will you allow 
me to explore that and see what I can provide?
    Ms. DeGette. Absolutely. When can you get back to us with 
an answer? Because part of my other frustration with FDA, 
although not with you personally, is that over the years I have 
asked for reams of information from the FDA on many, many 
topics and never received a response. So I know you won't be 
that way, so when are you going to respond on that?
    Dr. Acheson. I will. Until I explore the ramifications, I 
am loathe to commit to how long it will take but I will begin. 
I just don't know.
    Ms. DeGette. Are you willing to meet with the chairman and 
ranking member of the Subcommittee next week to discuss this?
    Dr. Acheson. I would be very willing to do that.
    Ms. DeGette. Thank you very much.
    Thank you, Mr. Chairman.
    Mr. Stupak. Thank you.
    Dr. Acheson, if I may, if you take a look at the 
frustration of what we are trying to ask you, if you go to page 
5 of your plan, the Food Protection Plan, item 2, it states the 
following: ``Use enhanced modeling capability, scientific data 
and technical expertise to evaluate and prioritize the relative 
risk of specific food and animal agents that may be harmful.'' 
That is a very admirable goal but there is no spreadsheet. It 
doesn't show how you intend to do this; how do you intend to 
accomplish this or what is the expected cost? So where would we 
find that information? I mean, this is a bunch of laudatory 
goals but it doesn't say how you are going to do it. What do 
you expect to do? How are you going to achieve that goal of 
prioritizing the relative risk? What is the biggest risk we 
have in food right now? What is the biggest risk to this 
country's health in food? I am not talking about tomatoes. What 
is the biggest risk?
    Dr. Acheson. Probably meat and poultry.
    Mr. Stupak. Meat and poultry, so that would be USDA. Give 
me one that is under your jurisdiction. What is the greatest 
risk under FDA jurisdiction?
    Dr. Acheson. Fresh produce.
    Mr. Stupak. Fresh produce, like spinach. How many outbreaks 
have we had of that? We have had----
    Dr. Acheson. Two.
    Mr. Stupak. Man, the last 10 years I think there have been 
eight----
    Dr. Acheson. No, two with spinach. There has been eight or 
nine with other leafy greens.
    Mr. Stupak. No, Salinas Valley, there has been at least 20 
in 10 years.
    Dr. Acheson. Excuse me. I think you are confusing spinach 
with other leafy greens like lettuce, romaine lettuce.
    Mr. Stupak. Right.
    Dr. Acheson. Two spinach outbreaks, and you are correct; 
there has been seven or eight other leafy green outbreaks like 
lettuce and the like.
    Mr. Stupak. In the Salinas Valley?
    Dr. Acheson. Yes.
    Mr. Stupak. So wouldn't one of your priorities on the risk, 
if you are taking a look at Salinas Valley, which is the salad 
bowl of America and you have had 20 outbreaks of leafy greens 
in 10 years. Wouldn't that be a priority to try to crack down 
on that and get an epidemiology study to determine what is 
going on? Wouldn't that be a priority?
    Dr. Acheson. Absolutely. It is a priority, and that is why 
there was a leafy green initiative started, which is still 
underway.
    Mr. Stupak. Right, and we have this Tomato Safety 
Initiative that has been going on for a year, so why is it the 
FDA is having a difficult time determining the source of the 
current salmonella tomato outbreak?
    Dr. Acheson. There are two answers to that question. One is 
related to the complexities of a trace-back, particularly when 
it is linked to something like tomatoes where not every tomato 
has a code on it. The second part to your question is, how does 
that tie in with the tomato initiative that is currently 
underway in Florida and in Virginia? That is essentially a 
collaborative effort to understand what is going on at the 
grower level, at the farms, that could help prevent future 
outbreaks.
    Mr. Stupak. But you can't determine that unless you know 
where the tomatoes are coming from.
    Dr. Acheson. Well----
    Mr. Stupak. If the tomatoes are coming from Mexico, as some 
people suspect, then you have to know what the growing process 
is in Mexico and what the water they are using, what is the 
handling, what is the processing, what is the shipping. Would 
you not?
    Dr. Acheson. I beg to differ.
    Mr. Stupak. Really?
    Dr. Acheson. Yes. Preventative controls to prevent 
salmonella getting on a tomato are going to work in Florida 
just as well as they are going to work in Mexico. The key thing 
is, what is the science behind the correct preventative control 
and then you apply it in Florida and you apply it in Mexico.
    Mr. Stupak. Absolutely, if Mexico is doing the same as we 
do in Florida or Virginia or wherever we are growing tomatoes, 
right?
    Dr. Acheson. You know, there are not a million different 
ways to grow tomatoes.
    Mr. Stupak. Oh, I agree, but if your water isn't clean in 
Mexico, I don't care the way you grow it, you are probably 
going to have salmonella poisoning in the tomatoes, right?
    Dr. Acheson. Having a water supply that is not heavily 
contaminated with salmonella is going to be important but that 
is true wherever you are growing them.
    Mr. Stupak. Let me ask you this. The Food Protection Plan 
and what you have laid out here, how would that specifically 
have prevented the salmonella outbreak in tomatoes? If this was 
implemented, how would this have prevented it?
    Dr. Acheson. If that is fully implemented, number 1, you 
would have done more research to understand the preventative 
controls and what actually works. To your point, is it the 
water supply that you have really got to control? What is the 
science behind that? What is the risk associated with water 
versus frogs that happen to be living in the field, so you 
would get to that point. And through the legislative proposals, 
you would have required the preventative controls to be put in 
place at the various points.
    Mr. Stupak. OK, legislative proposals. Why haven't you 
submitted any legislative proposals then to help us because you 
need legislators, us, to implement your plan? So why haven't 
you submitted any legislative proposals to us?
    Dr. Acheson. There is a fair degree of detail in terms of 
what those would look like in our plan and we have certainly 
met multiple times with staff on the Hill to discuss specifics 
around these and are now providing and want to provide more 
technical assistance and other discussions based on the 
language that has already been put out by a number of 
Congressmen.
    Mr. Stupak. Tell me one Congressman who has a legislative 
proposal to implement this.
    Dr. Acheson. Senator Durbin.
    Mr. Stupak. OK. That is the other body. We can't talk about 
them. I am talking about in the House.
    Dr. Acheson. There are many aspects in your bill that 
address----
    Mr. Stupak. But see, we are the committee that has sort of 
been looking at this and if we don't know what those 
legislative proposals are; how is anyone else going to know? I 
would think if you are going to do legislative proposals to 
implement a food safety plan, you at least start with the 
Energy and Commerce Committee, who has jurisdiction over it.
    Dr. Acheson. We have had many conversations with the Energy 
and Commerce Committee and I look forward to having more about 
the specifics of this, but the draft language that your 
committee came up with essentially used much of the proposals 
and thinking that were in the plan.
    Mr. Stupak. So you support Mr. Dingell's bill, the 
Globalization Food and Drug Act of 2008?
    Dr. Acheson. There are many aspects in that which are 
synchronized with----
    Mr. Stupak. Would you please put in writing what you would 
agree with and not agree with in the globalization bill of Mr. 
Dingell so we have some idea where you agree and you don't 
agree so we can work it out? Because we have nothing like that 
yet.
    Dr. Acheson. We are certainly committed to providing the 
appropriate technical assistance along those lines, yes.
    Mr. Stupak. You indicated when we were talking about 
Mexico, we were talking about the tomatoes, but you also 
indicated in your statement the FDA Beyond Our Borders and you 
specifically mentioned China. When we had our hearings on 
heparin, the agreement with China really didn't help us any. 
When they tried to go into certain plants, they were not 
allowed to look for heparin. When they wanted to take a look at 
the labs, they were not allowed to. So how do these agreements, 
if the FDA inspectors cannot really get into the nitty-gritty 
to make the determination if the water is clean that is used to 
grow tomatoes, if it is not working in China, what is going to 
be different to make sure it is going to work in Mexico or 
China, whether it is food or drugs?
    Dr. Acheson. With regard to the agreement in China, on the 
food side, that is, with AQSIQ, the regulatory body in China 
that controls exports, the process that we are undergoing there 
is that they have a registration and certification system in 
place. The question we have is, what comprises that? Does it 
meet our standards? That is the first question, at least on 
paper. Second question, when we go out and audit that process, 
which the intent is to do that sometime later in 2008, early 
2009, are they actually doing what they say they are doing. 
Then the third part is assuming that they are, there needs to 
be an ongoing audit of the process, and if we start to receive 
certified product based on that process, we have got to do 
checks in the United States, and to your point, if we find that 
it doesn't meet those standards, then clearly the agreement is 
not being met.
    Mr. Stupak. Well, to my point then, if you don't find that 
they are meeting the standards, if we take a look at drugs 
alone and there are many more hectares growing food for export 
to the United States than there are plants producing drugs in 
China and you are inspecting them, FDA is inspecting them every 
30 to 40 years, that is not going to be very efficient. Now, I 
know you need more people, but would you commit to supporting 
the COOL, the country-of-origin labeling, so we can help 
understand where some of this food comes from so if you do have 
the outbreak like you do with tomatoes, if they came from China 
or from Mexico, which might narrow your focus on the salmonella 
in tomatoes, would it not? So would you commit to supporting 
the COOL program?
    Dr. Acheson. Well, to answer the first part of your 
question, this is not all about having an FDA inspector going 
and visiting every foreign food manufacturing facility in 
China. This is about leveraging through the Chinese government, 
and if our voluntary certification program moves forward, 
through third-party voluntary inspections.
    Mr. Stupak. The leveraging hasn't worked; that we saw with 
heparin. We had this agreement. We were supposed to go into the 
plants when we wanted to go into certain plants, and Dr. 
Woodcock and Dr. Brown, they said they were denied access to 
plants and the labs to make sure, to see if that detail that we 
were supposed to do that and that the Chinese were following to 
certify these labs and the process. It was denied, so----
    Dr. Acheson. If access is denied and there is a problem, 
then clearly the agreement isn't operating in the way the 
agreement was agreed, so that is a different issue.
    Mr. Stupak. What about COOL? Do you support that, country-
of-origin labeling? Will you implement it?
    Dr. Acheson. Country-of-origin labeling is under the 
jurisdiction of USDA.
    Mr. Stupak. But also you have responsibility for 80 percent 
of the food, most of our food, especially the fruits and 
vegetables and tomatoes that we are talking about come 
underneath your jurisdiction when they come from other 
countries, especially this time of the year, in the winter, 
so----
    Dr. Acheson. Country-of-origin labeling is no guarantee of 
the safety or lack thereof of a food.
    Mr. Stupak. I agree, but it----
    Dr. Acheson. It is a piece of information for consumers.
    Mr. Stupak. And it would also narrow your focus in trying 
to find out where this tomato outbreak is. If we knew those 
tomatoes were coming from Mexico because they were marked 
because they don't have a bar code, as you said. But at least 
if they were marked, we could at least narrow our focus; could 
we not?
    Dr. Acheson. Probably not, in fact, in practicality for 
tomatoes, simply because most people when they consume a tomato 
just know they have consumed a tomato. They don't know where it 
came from. And by the time somebody----
    Mr. Stupak. You think consumers don't know where food comes 
from if it is labeled?
    Dr. Acheson. Well, let me ask you a question, if I may?
    Mr. Stupak. Sure.
    Dr. Acheson. If you have eaten a tomato in the last week, 
do you know where it came from?
    Mr. Stupak. No, because you won't implement country-of-
origin labeling. If you had country-of-origin labeling, I would 
know where the tomato came from and you could focus your 
resources on Mexico, if that is where we believe the same is 
coming from, as opposed to New Mexico and Texas and the other 
States that you are sort of spinning the wheels on.
    Ms. DeGette. Will the chairman yield? Or if we had 
traceability?
    Mr. Stupak. Right.
    Dr. Acheson. I would support that, absolutely. I think 
traceability is a far more powerful tool than country-of-origin 
labeling in terms of food safety.
    Mr. Stupak. So you don't support country-of-origin 
labeling?
    Dr. Acheson. I don't go either way on it. My point is that 
it is not a food safety tool. It is an information for 
consumers tool.
    Mr. Stupak. I agree, but it would help narrow your focus 
when you are doing investigations; would it not?
    Dr. Acheson. It certainly wouldn't hurt.
    Mr. Stupak. If you had the address--when I did criminal 
investigations, if I had addresses, it would certainly help me 
out when I did mine. Let me ask you one more.
    Dr. Acheson. Traceability would help you a whole lot more. 
That is what the address is giving you. It is giving you the 
traceability.
    Mr. Stupak. That is right. Let me ask you one more 
question. The Office of Regulatory Affairs manages the majority 
of the FDA's food safety resources through its field force of 
inspectors, compliance officers and laboratory personnel. 
Shouldn't that be more consolidated underneath your position as 
Associate Director of Food Safety?
    Dr. Acheson. The way that the Commissioner has chosen to 
set up my position is to give me the mandate of integration and 
coordination across the Agency. This is essentially the 
structure that he has established. I achieve that through 
providing essentially the leadership and the vision with ORA 
and CFSAN and CVM and the National Center for Toxicological 
Research and others working on implementing the Food Protection 
Plan. As you well know, the current structure is set up that 
way and that is the way that the Commissioner has decided to do 
it.
    Mr. Stupak. All right. Our committee staff was at the Port 
of Baltimore to learn about the FDA's entry reviewers inspect 
food imports using the IT platform called Oasis. As you know, 
current methods are often labor-intensive, are not 
interoperable with other existing databases and provide almost 
no risk analysis to inbound food commodities. So under the Food 
Protection Plan, how will the system change and when can we 
expect results?
    Dr. Acheson. There are many components to answer your 
question. First of all, you need to be addressing what is the 
level of risk associated with certain foods, and it is not just 
the food product, the food hazard combination. It is where does 
that food come from, what do we know about the foreign 
manufacturer, many components that feed into this. The model 
that we have developed to begin to address this is Predict. 
Predict is run through a pilot program in the Port of Los 
Angeles looking at seafood. The evaluation of that program 
looked like it was successful. So the question is, how do we 
expand that, where do we go, and part of the Food Protection 
Plan includes the expansion of Predict. Some of the new monies 
in the 2009 budget will go toward doing that. Are you going to 
ask a question?
    Mr. Stupak. When will Predict then be validated if that is 
the new model? When will that be validated? It has been going 
on for some time for Los Angeles. I mean, in order to expand it 
other places, you have to validate its accuracy and--
    Dr. Acheson. Yes.
    Mr. Stupak. So when will that be done?
    Dr. Acheson. The components of Predict are currently going 
out for peer review from FDA to see whether through peer review 
there is a sense that this works. We believe that we are now at 
a point where we need to do two or three things on Predict. One 
is to expand it on seafood to some other ports, see if it is 
applicable to other places. The second is to rank the food 
items under a series of priorities in terms of what is the next 
food that we would want to load into Predict and then to begin 
the process of risk ranking that food, because one of the 
powers of Predict is; it doesn't just give you a yes-no answer. 
It gives you levels of risk depending on a variety of factors. 
And then the third component is to look at what is the IT 
interoperability, applying Predict across the whole system. 
Those three things will begin all in parallel, and the peer 
review process that is underway will help tweak, if necessary, 
the scientific approach and the data handling approach to make 
the system better.
    Mr. Stupak. I appreciate your patience.
    Next to Mr. Shimkus for questions, please.
    Mr. Shimkus. Thank you, Mr. Chairman.
    I think they are going to call votes around 2:00. You will 
be spared from too much more harassment. I have three quick 
questions. They really do follow up on Predict. I am hopeful, 
and I think a lot of us are hopeful this will be rolled out to 
a larger venue. You made a statement already--some of my 
question was dealing with that and also if new monies come in, 
some would be directed--I think you have kind of mentioned that 
would happen.
    Dr. Acheson. Yes.
    Mr. Shimkus. Can you--can the FDA provide a copy of the 
contract with New Mexico State University that pertains to 
Predict? Is that doable?
    Dr. Acheson. Can we provide you with the contract?
    Mr. Shimkus. Yes, a copy of the contract.
    Dr. Acheson. I can certainly see if we can provide you with 
that, yes.
    Mr. Shimkus. Good. I want to now jump to China real quick 
and these agreements that we have, not just with China but 
other countries. What insights are we gaining in our 
negotiations with other countries and in particular with China? 
Is there--in our negotiations with them, I think one of our 
concerns is the inspection and quarantine, address preservation 
of evidence, and access to personnel beyond just faster access 
to production facilities. Can you talk about that?
    Dr. Acheson. Yes, this isn't all about faster access to 
production facilities. It is about gaining a level of 
confidence in their registration and certification process. 
When they say that a shipment of shrimp is certified to be safe 
and meets FDA standards, we have to be sure that that is true. 
That means getting an understanding of their systems, how do 
they inspect, not only the processing facility but the farm 
where these shrimp are grown, the control over use of 
inappropriate antibiotics----
    Mr. Shimkus. Right, and that keys into the whole heparin 
debate that we were talking about because the ability of the 
Chinese government to go back to the hog confinement facility 
obviously is questionable, in fact, did not happen, and so 
these negotiations I think we are going to be--and how you all 
conduct those in the whole chain is going to be very, very 
important.
    Dr. Acheson. I agree. We are at the point of laying out 
what the expectation is. There is an audit built into this. 
This is where we go and say--when you say that you are checking 
up on not only the processor but also the farm where these 
shrimp are grown, are they doing that and to what level and----
    Mr. Shimkus. That is the accessibility part, though.
    Dr. Acheson. Yes, and----
    Mr. Shimkus. We have to have someone to be able, if there 
is a question mark, to be able to have those folks onsite that 
will get quick access to these facilities.
    Dr. Acheson. Yes, it is a matter of gaining confidence in 
their system, and we have to do that by understanding the 
system and physically getting over there and looking at it and 
watching what they are doing and then continuing the audit 
process.
    Mr. Shimkus. Part of this whole FDA reform debate and 
legislation will be how do we fund, how do we bring more 
resources to you so we can effectively have the arrangement so 
that we have the people in these facilities, and there are a 
lot of us--what I want is, I want the people who want to 
provide, who want to sell into our market to help pay for us to 
make sure that those goods that people are trying to get access 
to our market is funding for your ability to make sure that 
they are safe. That is why it is timely. That is why this 
Oversight and Investigation Subcommittee is great because it 
really sets the building blocks for legislative response.
    The last time I want to tie in with this debate is using 
science. We had one of our hearings, we talked about 
irradiation, and of leafy greens. In fact, I double-dog dared 
the chairman to eat a leafy green that was irradiated. We found 
it was tasty. He wouldn't eat the mushroom. But there is also 
gene splicing and other technologies that we will need your 
help to push forward as we--to hopefully overcome this concern. 
We would rather be proactive versus reactive. When we are 
reactive, then it is going to be costly, both in money, in 
human suffering and frustration, and these tomato folks, there 
is going to be a lot of people that are going to take a big 
loss and they are not going to be culpable or responsible, and 
so can you just talk briefly about technology real quick.
    Dr. Acheson. Technology is critical. Utilizing modern 
technology, that is part of the Food Protection Plan. That is a 
high-level vision. And it gets down to detection technology: 
what can you develop in terms of handheld rapid detection 
technology. What is the prevention technology that works. I 
mean, you mentioned irradiation. Is that a reasonable approach 
that you could take that is actually economically effective and 
protects public health? You talked about genetic tools. Are 
there some components there that could help us? I think part of 
what we are going to use this new money for is to build up the 
scientific cadre within the Center for Food Safety and Applied 
Nutrition and the Center for Veterinary Medicine, and that will 
help address some of those questions, figuring out what is the 
new technology. We don't have to develop all of that ourselves 
but what we have got to do is make the connectivity with 
academia and others and industry who have that technology and 
say well, that is interesting, we could apply that in a 
preventative mechanism for an FDA-regulated product. That only 
happens if you have enough people to get out there and have 
that dialogue, so it is all built in to that. I couldn't agree 
more that modern technology is key here.
    Mr. Shimkus. And that will help us as we talk about what is 
the plan, what are the costs and that is that long-range debate 
and the milestones. That ties into the whole thing, and I am 
done, Mr. Chairman. I yield back.
    Mr. Stupak. Thank you.
    Ms. DeGette for questions, please.
    Ms. DeGette. Thank you, Mr. Chairman.
    Dr. Acheson, I want to talk to you for a few minutes about 
the tomato situation. Has the FDA been able to trace the 
location of the original contamination of the tomatoes?
    Dr. Acheson. Not yet.
    Ms. DeGette. And what is the process currently for trying 
to trace the source?
    Dr. Acheson. I would like to first of all correct a mis-
comment earlier in terms of this trace-back that has been going 
on since mid-April. It hasn't. The first case from CDC was 
reported on April 16. It wasn't until May 31 that the link with 
tomatoes was officially made by CDC and the State and the local 
officials and FDA began its trace-back, so that was 12 days 
ago.
    Ms. DeGette. So what you are saying is that the first case 
of salmonella was reported in April but the CDC didn't know 
what was causing the salmonella?
    Dr. Acheson. What I am saying is, is that the first case, 
yes, was April 16. Now, you have to remember that you are 
talking here not just about CDC, you are talking here about the 
State and local public health infrastructure.
    Ms. DeGette. Right. I understand that, but what you are 
saying is the first cases of salmonella were reported in mid-
April?
    Dr. Acheson. Yes.
    Ms. DeGette. But the cause of the salmonella was not 
pinpointed until late May?
    Dr. Acheson. May 31.
    Ms. DeGette. OK. And that is because--and I know how these 
public health issues are. They have these cases of salmonella, 
it took them a while to link that it was from tomatoes, right?
    Dr. Acheson. That is right.
    Ms. DeGette. So what you are saying is, the trace-back 
efforts started May 31?
    Dr. Acheson. Right.
    Ms. DeGette. So what is that process?
    Dr. Acheson. OK. That process is when you know that you 
have got a patient who has consumed a tomato, you want to then 
find out where did you buy it and when did you buy it. That 
will take you to the local supermarket. You then say to the 
supermarket, where do you get your tomatoes from in this time 
frame when the patient got sick, and it may be from two or 
three suppliers. You go back to each one of those suppliers and 
say where did you get your tomatoes from, and it may be from 
two or three distributors and the legs expand as you go out and 
you are chasing every one down.
    Ms. DeGette. Right.
    Dr. Acheson. One of the legs that we are doing right now, 
beginning with a single case, it has led down five different 
sets of distribution, of which there is anything from two to 
nine different distributors or suppliers. The other complexity 
with tomatoes specifically is when a crate of tomatoes arrives 
at a distributing facility, they may handpick them because 
somebody says I only want small, unripe ones; somebody says I 
only want large, ripe ones.
    Ms. DeGette. Right.
    Dr. Acheson. So they are pulling them out and mixing them 
up, and that has to be figured out. We have to get the invoices 
to show that it is tracking back. We have--as you know, we have 
excluded many areas of the country that either were not 
harvesting at the time----
    Ms. DeGette. They weren't harvesting?
    Dr. Acheson. They weren't harvesting or they were 
harvesting and where they were distributing was not where we 
were seeing illness so somebody who is distributing to the 
State it is grown in and the neighboring State, you see illness 
in 17 States, it is not them.
    Ms. DeGette. But it is sort of an inexact science the way 
we do traceability right now for produce and a lot of other 
food items too.
    Dr. Acheson. It is actually very exact but it is very 
cumbersome. It needs to be exact to be legally binding.
    Ms. DeGette. Well, we had some hearings on the spinach 
issue and it took them a long time to trace that and they were 
never 100 percent sure what the source of the contaminated 
spinach was. They thought they isolated it to a farm in 
California but they could never be 100 percent sure. I was 
actually encouraged when I heard you tell Mr. Stupak that you 
support trace-back provisions. First of all, we have the 
technology right now to do traceability for produce, correct?
    Dr. Acheson. There is a lot of technology that is out 
there. It is not necessarily interoperable at this point.
    Ms. DeGette. And Dole, for example, is using trace-back 
process, correct?
    Dr. Acheson. I don't know.
    Ms. DeGette. If we could get interoperability with trace-
back systems, that would expedite the traceability 
dramatically, correct?
    Dr. Acheson. Interoperability is critical, yes.
    Ms. DeGette. But if we had interoperability, it would----
    Dr. Acheson. It would help.
    Ms. DeGette [continuing]. Greatly increase the response 
because it would be a lot more easy to pinpoint where that 
produce came from once you realized that the outbreak was 
caused by that produce, correct?
    Dr. Acheson. Assuming that the produce we are talking about 
had some marker on it that allowed you to----
    Ms. DeGette. Well, right now when you go to the store, and 
I am amazed, frankly, when I go to the grocery store, 
everything you buy has now a little label on it. A tomato has a 
little sticky label on it. Each banana has a sticky label on 
it. So you can do that, correct?
    Dr. Acheson. Yes, and often the labels have the country of 
origin on them, just as a point.
    Ms. DeGette. Well, right now I am focusing on traceability.
    Dr. Acheson. I apologize.
    Ms. DeGette. And has the FDA investigated what it would 
take to make the traceability systems interoperable?
    Dr. Acheson. We are actively doing that right now. We have 
met with a number of trade associations who are using 
traceability systems and they are a little different, and we 
are trying to right now understand what is the universe of 
traceability systems to begin to understand what might an 
interoperable system look like.
    Ms. DeGette. And what is your time frame for making those 
assessments?
    Dr. Acheson. Well, I think clearly this tomato outbreak has 
accelerated those. There is no question.
    Ms. DeGette. So are you thinking again the 6- to 8-week 
time period, 3 to 6 months, a year?
    Dr. Acheson. For what? For an understanding of what an 
interoperable system----
    Ms. DeGette. For an understanding of what we would need to 
do nationally to implement a traceability system.
    Dr. Acheson. I sincerely hope we would be there within a 
year, if not sooner.
    Ms. DeGette. OK. I am wondering if you have someone over at 
the FDA who is an expert in traceability that we might meet 
with as we develop our food safety legislation.
    Dr. Acheson. We have many people who do this.
    Ms. DeGette. If you wouldn't mind having those people get 
in touch with my staff, I would say next week also, that would 
be extremely helpful.
    Dr. Acheson. Sure.
    Ms. DeGette. I have one last question, if I can find it. I 
don't know if you are familiar with the letter that Senator 
Specter sent to Secretary Leavitt on June 10, 2008, about his 
concern about the budget amendment for the FDA for food safety. 
Are you familiar with that letter?
    Dr. Acheson. I am familiar with some of the press around 
it. I haven't seen the letter itself.
    Ms. DeGette. Well, in the letter--and I will have someone 
give you a copy of it--Senator Specter says, ``The submission 
of your budget amendment at this time undermines the work that 
we have been doing to obtain these additional dollars on an 
expedited basis. The facts are that if these funds are not 
provided in the supplemental, no additional dollars will be 
available until March or April of 2009 at the earliest. 
Supporting additional dollars in fiscal year 2009 sends a 
signal that there is no urgency in providing these funds.'' It 
is in the third paragraph of that letter. I would ask you if 
the department supports the providing of the funds in the 
supplemental appropriations bill so we can begin to get some 
funding for these food safety issues right now rather than 
waiting for an entire another year by going through the regular 
budget process?
    Dr. Acheson. My understanding is that there is an active 
discussion between Congress and the White House right now, and 
that essentially all I know about that component is that it is 
under active discussion.
    Ms. DeGette. Well, let me ask you this. Would the Agency 
support--well, let me just strike that and ask you, if we could 
begin to provide the money to fund the Food Safety Plan right 
now, would that enable the Agency to start expediting some of 
the planning and some of the implementation that we all agree 
needs to happen right away?
    Dr. Acheson. The sooner we get the money, the sooner we 
will be able to move and the faster we will be able to go.
    Ms. DeGette. Thank you very much.
    Mr. Stupak. Let me ask just to wrap things up; the 
traceability now, are you saying that you support Ms. DeGette's 
idea of traceability or will the Administration support it?
    Dr. Acheson. I am saying that I am supporting the 
importance of traceability.
    Mr. Stupak. So it is possible what happened with the United 
Fresh Produce Association and Produce Marketing Association 
when they worked with the FDA to establish safety standards, 
could get swatted down as one farther up the totem pole, right?
    Dr. Acheson. Let me just back up a little bit. I haven't 
read Ms. DeGette's bill for a little while and I don't remember 
the specifics in it, but what I can tell you is that 
traceability is critical in terms of response, and whether the 
Administration may ultimately take what Ms. DeGette's draft 
language is, I couldn't say. But the concept of traceability 
certainly is important.
    Mr. Stupak. Well, you said all day today your hands have 
been tied with OMB as far as budget money. Testimony earlier 
was that the federally-mandated risk base that allow for 
commodity-specific regulation that the fresh produce 
association and the FDA started to swat it down by Secretary of 
HHS; so traceability, that I think we all agree would be 
helpful. It could get swatted down as it went farther up the 
chain, right?
    Dr. Acheson. I can't predict what farther up the chain may 
do to anything. All I can say is, is that from my role as 
associate commissioner for foods, traceability is important and 
I would advocate for it.
    Mr. Stupak. You would advocate for it. Well, let me ask you 
this. So you advocate. Since we have had outbreaks of 
salmonella, E. coli, botulism over the past 12 months and in 
our last hearing on heparin, Dr. Woodcock agreed that subpoena 
power would be helpful. As food czar, will you also agree that 
subpoena power would be helpful to address the food-related 
outbreaks?
    Dr. Acheson. Subpoena power for what?
    Mr. Stupak. For records. Take ConAgra, the salmonella and 
peanut, we are still waiting for those records, and you have no 
subpoena power, FDA has no subpoena power to get those records. 
Would you support subpoena power to get records of the 
producers?
    Dr. Acheson. Well, through the Bioterrorism Act, we do have 
the authority to require records through section 414. If 
somebody has got--and we have done that a number of times in 
relation to foodborne outbreaks where----
    Mr. Stupak. Well, will you use it then to get the records 
from ConAgra for peanut butter?
    Dr. Acheson. I don't think we have used it for that.
    Mr. Stupak. But will you?
    Dr. Acheson. You are talking about old records.
    Mr. Stupak. We are talking about past records.
    Dr. Acheson. Yes. Records that are linked to a current 
ongoing situation, we use section 414 of the Bioterrorism Act 
and have used that to get records.
    Mr. Stupak. So do you support subpoena power or not?
    Dr. Acheson. I would have to get back to you on that to try 
to understand more specifically subpoena power, whether it is 
additive to what we already have or whether we would need it.
    Mr. Stupak. How about mandatory recall? Would you support 
mandatory recall?
    Dr. Acheson. Yes, that is in the Food Protection Plan.
    Mr. Stupak. OK. And last but not least, we talked about Mr. 
Dingell's legislation, the Food and Drug Administration 
Globalization Act of 2008. Will you get back, make a commitment 
to get back with us with specific technical assistance on the 
Dingell legislation?
    Dr. Acheson. I certainly will promise to get back to you 
and probably the most constructive way is to have a direct 
dialogue over that.
    Mr. Stupak. OK, but that does that mean you are going to 
provide the technical assistance? The Dingell draft has been 
around for some time and we have got nothing from the FDA. We 
have asked for it.
    Dr. Acheson. I will--yes, the FDA will provide technical 
assistance.
    Mr. Stupak. When? This year, next year?
    Dr. Acheson. This year.
    Mr. Stupak. How about next week?
    Dr. Acheson. That may be a bit quick.
    Mr. Stupak. All right. Six days then. I am not going up any 
further.
    Dr. Acheson. Six days.
    Mr. Stupak. All right.
    Dr. Acheson. I will do my best.
    Mr. Stupak. I will look for it in 6 days. Any questions?
    I want to thank you, Dr. Acheson, for your testimony and 
thank you for your time. That concludes all of our questioning. 
I want to thank all the witnesses for coming here today and for 
your testimony. I ask for unanimous consent that the hearing 
record remain open for 30 days for additional questions for the 
record. Without objection, the record will remain open. I ask 
unanimous consent that the contents of our document binder be 
entered into the record. Without objection, the documents will 
be entered into the record.
    That concludes our hearing. Without objection, this meeting 
of the subcommittee is adjourned.
    [Whereupon, at 2:14 p.m., the Subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

                      Statement of Hon. Joe Barton

    Thank you Chairman Stupak and Ranking Member Shimkus, for 
holding this hearing today to examine FDA's food protection 
plan.
    We are again reminded about how important food safety is 
with this week's salmonella outbreak in raw tomatoes. Each year 
in the U.S. there are 76 million cases of food poisoning and 
5,000 deaths, according to the Centers for Disease Control. 
What can we do to reduce the number of outbreaks?
    First, we can't forget that in America, it isn't the 
government that feeds the people. That system mostly collapsed 
along with the Berlin Wall. The government does have a role, 
though, and I think our first job is to examine policies that 
help promote innovation among the industries that produce the 
food we eat. For example, this subcommittee has already 
received testimony on the increased safety levels that can be 
achieved with more food irradiation. According to Dr. Michael 
Osterholm of the University of Minnesota, if 50% of meat and 
poultry were irradiated, 900,000 fewer people would get sick 
and 300 fewer would die.
    Irradiation isn't the only food safety technology 
available, however. There are new gene-splicing technologies 
that go beyond irradiation and could kill bacterial toxins 
before these microorganisms could grow within the plant cells. 
Unfortunately, the Luddites who insist on scaring consumers 
about the value of science and technology are hard at work, 
too, and I realize that winning broad acceptance of these new 
techniques is going to be a slow and difficult business.
    Second, we must bring FDA into the 21st century on matters 
of food safety. Today we will examine the FDA's Food Protection 
Plan. We should look closely at the details and keep on top of 
this agency to make sure it can make the sustained effort 
necessary to implement its proposed reforms.
    This subcommittee's work has helped the Agency and 
Administration respond to our findings--and the Administration 
really has responded. Just 2 days ago, Health and Human 
Services Secretary Michael Leavitt announced an amendment to 
the FY 2009 FDA budget request that adds $275 million for food 
and drug safety. I think the President and Secretary Leavitt 
got it right, and I am in favor of this additional funding 
because I think it will go a long way to allowing FDA to 
correct the deficiencies that this subcommittee's good work has 
highlighted over the past year.
    This is serious money, for a serious purpose. After eight 
oversight hearings and one legislative hearing on food safety, 
it's time for us to join the Administration and start acting. 
We don't have much time because as everybody in this room 
knows, the legislative window for this Congress is closing. 
Oversight functions can't stop, but the legislating needs to 
start in earnest.
    I have made clear throughout these Oversight hearings that 
I support working with the Majority to craft effective 
legislation to authorize resources and reform this agency. We 
seem to agree on a lot of the same things, and I'm convinced 
that we have a real chance to create effective, bipartisan 
legislation that will help make people's food safer.
    That brings me to my third point--bipartisanship. I've 
spent nearly a quarter of a century on this committee, and what 
I've learned tells me that major pieces of FDA legislation pass 
through this committee most easily and most effectively when we 
figure out how to work together. There just should not be any 
light between Republicans and Democrats on this issue, but the 
Majority's a latest sweeping food and drug safety draft bill 
was written and made public with no input from the Republican 
side.
    I'm happy to report, however, that our staffs have been 
regularly meeting to overcome a poor start. I appreciate your 
efforts, Chairman Stupak. I hope we can see more bipartisan 
interaction on the legislation, especially now that the 
Administration has given us something to work with.

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