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[Senate Hearing 106-948]
[From the U.S. Government Publishing Office]

                                                        S. Hrg. 106-948

   HOW SHOULD OUR FOOD SAFETY SYSTEM ADDRESS MICROBIAL CONTAMINATION?

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

                                HEARING

                               before the

                       COMMITTEE ON AGRICULTURE,
                        NUTRITION, AND FORESTRY
                          UNITED STATES SENATE

                       ONE HUNDRED SIXTH CONGRESS

                             SECOND SESSION

                                   ON

   HOW SHOULD OUR FOOD SAFETY SYSTEM ADDRESS MICROBIAL CONTAMINATION?

                               __________

                           SEPTEMBER 20, 2000

                               __________

                       Printed for the use of the
           Committee on Agriculture, Nutrition, and Forestry

                   U.S. GOVERNMENT PRINTING OFFICE
71-374                     WASHINGTON : 2001

_______________________________________________________________________
            For sale by the U.S. Government Printing Office
Superintendent of Documents, Congressional Sales Office, Washington, DC 
                                 20402

           COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY

                  RICHARD G. LUGAR, Indiana, Chairman

JESSE HELMS, North Carolina          TOM HARKIN, Iowa
THAD COCHRAN, Mississippi            PATRICK J. LEAHY, Vermont
MITCH McCONNELL, Kentucky            KENT CONRAD, North Dakota
PAT ROBERTS, Kansas                  THOMAS A. DASCHLE, South Dakota
PETER G. FITZGERALD, Illinois        MAX BAUCUS, Montana
CHARLES E. GRASSLEY, Iowa            J. ROBERT KERREY, Nebraska
LARRY E. CRAIG, Idaho                TIM JOHNSON, South Dakota
RICK SANTORUM, Pennsylvania          BLANCHE L. LINCOLN, Arkansas
GORDON SMITH, Oregon                 ZELL MILLIER, Georgia

                       Keith Luse, Staff Director

                    David L. Johnson, Chief Counsel

                      Robert E. Sturm, Chief Clerk

            Mark Halverson, Staff Director for the Minority

                                  (ii)

  
                            C O N T E N T S

                              ----------                              
                                                                   Page

Hearing:

Wednesday, September 20, 2000, How Should Our Food Safety System 
  Address Microbial Contamination?...............................     1

Appendix:
Wednesday, September 20, 2000....................................    49
Document(s) submitted for the record:
Wednesday, September 20, 2000....................................   181
Question(s) and answers submitted for the record:
Wednesday, September 20, 2000....................................   203

                              ----------                              

                     Wednesday, September 20, 2000
                    STATEMENTS PRESENTED BY SENATORS

Lugar, Hon. Richard G., a U.S. Senator from Indiana, Chairman, 
  Committee on Agriculture, Nutrition, and Forestry..............     1
Harkin, Hon. Tom, a U.S. Senator from Iowa, Ranking Member, 
  Committee on Agriculture, Nutrition, and Forestry..............    10
Daschle, Hon. Tom, a U.S. Senator from South Dakota..............     2
Kerrey, Hon. J. Robert, a U.S. Senator from Nebraska.............    13
Miller, Hon. Zell, a U.S. Senator from Georgia...................     4
                              ----------                              

                               WITNESSES

Glickman, Hon. Dan, Secretary, U.S. Department of Agriculture, 
  Washington, DC., accompanied by Catherine E. Woteki, Under 
  Secretary for Food Safety, and Thomas J. Bill, Food Safety and 
  Inspection Service Administrator...............................     5

                                PANEL I

Levitt, Joseph A. Esq., Director, center for Food Safety and 
  Applied Nutrition, Food and Drug Administration, Washington, 
  DC.............................................................    25
Ostroff, Stephen M. Dr., Associate Director for Epidemiologic 
  Science, National Center for Infectious Diseases, centers for 
  Disease Control and Prevention, Atlanta, GA....................    26

                                PANEL II

Dyckman, Lawrence, Director, Food and Agriculture Issues 
  Resources, Community, and Economic Development Division, U.S. 
  General Accounting Office, Washington, DC., accompanied by 
  Keith Oleson, Assistant Director, and Brad Dobbins, Senior 
  Analyst........................................................    44

                               PANEL III

Doyle, Michael, Dr., Director, Center for Food Safety and Quality 
  Enhancement, University of Georgia, Griffin, GA., on behalf of 
  the Council for Agricultural Science and Technology............    42
                              ----------                              

                                APPENDIX

Prepared Statements:
    Lugar, Hon. Richard G........................................    50
    Harkin, Hon. Tom.............................................    51
    Daschle, Hon. Tom............................................    53
    Roberts, Hon. Pat............................................    56
    Leahy, Hon. Patrick J........................................    57
    Bernard, Dane................................................   128
    DeWaal, Caroline Smith.......................................   153
    Doyle, Michael...............................................   124
    Dyckman, Lawrence............................................   109
    Garren, Donna................................................   134
    Glickman, Dan................................................    62
    Hollingsworth, Ann...........................................   147
    Levinson, Richard............................................   175
    Levitt, Joseph A.............................................    71
    Ostroff, Stephen M...........................................    94
    Weber, Gary..................................................   139
Document(s) submitted for the record:
    The Role of Microbiological Testing in Beef Food Safety 
      Programs, submitted by Ann Hollingsworth...................   182
    Pamphlet: Preventing Emerging Infectious Disease, submitted 
      by Richard Levinson, MD, DPA (retained in the Committee 
      files).....................................................
    Emerging Infectious Diseases: A Public Health Response, 
      submitted by Richard Levinson, MD, DPA (retained in the 
      Committee files)...........................................

 
   HOW SHOULD OUR FOOD SAFETY SYSTEM ADDRESS MICROBIAL CONTAMINATION?

                              ----------                              

                     WEDNESDAY, SEPTEMBER 20, 2000

                                       U.S. Senate,
         Committee on Agriculture, Nutrition, and Forestry,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 9:00 a.m., in 
room SR-328A, Russell Senate Office Building, Hon. Richard G. 
Lugar, (Chairman of the Committee), presiding.
    Present or submitting a statement: Senators Lugar, Smith, 
Harkin, Leahy, Daschle, Kerrey, and Miller.

OPENING STATEMENT OF HON. RICHARD G. LUGAR, A U.S. SENATOR FROM 
  INDIANA, CHAIRMAN, COMMITTEE ON AGRICULTURE, NUTRITION, AND 
                            FORESTRY

    The Chairman. This hearing of the Senate Agriculture 
Committee is called to order. Today, the Committee holds an 
important hearing to review our food safety system and how it 
addresses microbial contamination. We will hear from a number 
of scientific experts and representatives of the Federal 
Government and the consumer and public health community. We are 
hopeful today's hearing will help the Committee gather answers 
to these questions.
    Microbial contamination is the most significant threat to 
our food safety system. What are the food safety 
responsibilities of the Federal Government and the private 
sector related to microbial contamination? What is the value of 
the Hazard Analysis and Critical Control Points [HACCP], HACCP, 
approach to food safety and addressing microbial contamination? 
And what are the barriers to the development and implementation 
of the new technologies and tools to detect, prevent, and 
reduce microbial contamination? Are changes needed in the food 
safety system to aid in that detection, prevention, and 
reduction?
    Obviously, we know that all of the witnesses will not be 
able to address all of the questions, but we will be interested 
in hearing different perspectives from each of a number of 
distinguished witnesses today.
    At this hearing, we now look forward to hearing the 
testimony from our Secretary of Agriculture and officials from 
the Food and Drug Administration and the Centers for Disease 
Control and Prevention about the responsibilities of the 
Federal Government. We will also hear findings from the General 
Accounting Office about a food safety resources project that 
Senators Harkin, Hagel, and myself requested last year. And 
finally, we will learn food safety perspectives from 
representatives of academia and scientific studies, food 
processors, shippers and suppliers, growers and producers, 
consumers, and the public health organizations. I welcome all 
of our witnesses and look forward to receiving their testimony.
    [The prepared statement of Chairman Lugar can be found in 
the appendix on page 50.]
    I would like to note also the presence of the distinguished 
Democratic leader, Senator Daschle. Do you have an opening 
comment, Senator?

  STATEMENT OF HON. THOMAS DASCHLE, A U.S. SENATOR FROM SOUTH 
                             DAKOTA

    Senator Daschle. I do, Mr. Chairman, and I thank you very 
much for your recognition and for convening this hearing today 
to consider the efficacy of our food safety system.
    Food poisoning tragedies in recent years have underscored 
the importance of enforcing tough food safety standards, and I 
sincerely commend the Chairman for his continuing effort to 
make America's food supply the safest in the world. To respond 
to the challenge of making our food supply as safe as possible, 
USDA has made dramatic changes in the way it inspects meat 
products, including full implementation of HACCP. Since then, 
the Centers for Disease Control has found that foodborne 
illness has been cut in half.
    At the same time, challenges remain. USDA is struggling to 
provide sufficient inspectors to meet the demands of new 
programs. It still lacks the full complement of tools to 
respond to all the food safety issues we confront today and 
should be given mandatory recall authority. Moreover, questions 
remain about USDA's authority to set and enforce microbial 
testing standards. In fact, the recent court decision in the 
Supreme Beef v. USDA highlighted the issue of microbial 
testing, and in July, Senator Harkin offered an amendment to 
the agriculture appropriations bill to clarify Congress' intent 
that USDA have the authority to set and enforce standards for 
pathogen testing.
    The question of microbial testing encompasses a number of 
related issues. To understand how the system functions, we need 
to break it down into component parts. Considering these 
related issues separately helps clarify this debate. It becomes 
possible to assert that USDA should have the authority to set 
standards generally while challenging the standards currently 
in place. Or we can agree to support the need to provide USDA 
with sufficient enforcement authority while asserting that USDA 
should change or clarify its enforcement procedures.
    I hope we hear this morning that microbial testing of meat 
is a beneficial tool independent of plant sanitation. In other 
words, it is possible to find pathogens on meat in a plant that 
has no detectable sanitation problems. Such a plant should not 
necessarily be penalized for meat that tests positive, but 
neither should excessive levels of pathogens be disregarded 
simply because their origin is not linked to plant sanitation.
    The threat that foodborne pathogens pose to human health is 
not lessened by our inability to trace their origin. They are 
just as deadly. They are an invaluable indicator of a weak link 
in the system, and their detection should prompt USDA to work 
with the packers or slaughterhouses to identify the cause or 
source and eliminate it. Pathogen testing is very useful and is 
absolutely necessary if we are to have confidence in our food 
supply.
    The other issue I hope we can explore today is whether USDA 
should enforce standards. There are two questions embedded 
here, what a standard should be and how a standard should be 
enforced. The concerns I have heard are a blend of 
dissatisfaction with the current standards and a fear over how 
USDA might enforce standards in the future. The fact is, we 
need more data to determine whether it is most appropriate to 
set standards. While we have an abundant evidence showing that 
foodborne pathogens are a distinct threat to human health, it 
is my understanding that scientists and regulators do not have 
the data they need to precisely gauge the relationship between 
pathogen presence and the risk to human health.
    With regard to fears related to enforcement, I urge my 
colleagues to consider USDA's record in enforcing the existing 
standard. The Supreme Beef case provides a good case study. It 
illustrates that USDA does not withdraw inspectors and 
effectively shuts down plants based on micro testing 
performance. In fact, in the Supreme Beef case, USDA tried to 
work with Supreme Beef for nearly a year before withdrawing 
inspectors, and it only resorted to that step when Supreme Beef 
became completely recalcitrant, effectively disregarding the 
risk they were posing to the public. If a packing plant 
supplying the public refuses even to try to reduce pathogens in 
their product, I question the good sense of anyone who wouldn't 
want USDA to withdraw inspectors at that point.
    Moreover, I cannot understand how anyone can seriously 
argue that USDA intends to misuse the micro standard as an 
arbitrary litmus test. The agency has no record of doing so. It 
may be reasonable, however, for Congress to more clearly 
delineate the enforcement process so packers will know what to 
expect.
    Last November, I introduced S. 1988 with Senator Hatch. We 
have 22 cosponsors, Republicans and Democrats. The reason I 
mention the legislation amid remarks on food safety is that for 
the first time in 30-years, this idea is supported by consumer 
and food safety groups. The bill also enjoys a number of first-
time Senate cosponsors. Their support is due in large part to 
the fact that the uniform testing for pathogens in end products 
called for by the bill will increase the reliability of our 
overall food safety system.
    It should be noted, however, that this uniformity is also a 
trade issue. Being able to assure that all of our exported 
project is subject to uniform inspection and that USDA is 
accountable for the performance of plants in that system 
protects our producers from potential trade barriers thrown up 
by other countries. If they can argue that our exports are 
inspected in systems that they have not specifically improved, 
then they would have grounds to reject not just some but all of 
our product. Therefore, while the uniformity requirement 
attracts the support of the consumer and food safety groups, it 
is necessary to protect access to foreign markets.
    In conclusion, I want to reiterate my strong support for 
the HACCP system, my support for pathogen testing, and my 
support for the use of specific standards and enforcement 
authority employed similarly to the USDA's current practices. 
We should take this opportunity to explore ways to do even 
better. In particular, I hope we can provide USDA with 
mandatory recall authority, improve standards with better data, 
to the extent possible, correlate micro testing results with 
the public health indicators, and ensure that we never use this 
inspection system punitively.
    In the end, we need a food system that instills confidence 
in the public by achieving results. When a plant has a problem, 
USDA should work with the plant to fix the problem on an 
expedited basis and thereby protect the public health. But in 
the case of the rare bad actor, I hope we can agree that USDA 
should have the authority to withdraw inspectors as a last 
resort.
    [The prepared statement of Senator Daschle can be found in 
the appendix on page 53.]
    Again, Mr. Chairman, I thank you for holding this very 
important hearing.
    The Chairman. Thank you very much, Senator Daschle, for a 
very important statement.
    Senator Miller, do you have a comment this morning?

   STATEMENT OF HON. ZELL MILLER, A U.S. SENATOR FROM GEORGIA

    Senator Miller. Thank you, Mr. Chairman. I will be very 
brief. First of all, I want to thank you for your willingness 
to hold this important hearing on an issue of great importance 
to this country. While I am the rookie on this committee, I 
have already determined that you keep this committee focused on 
issues that in some way or another affect each of us in our 
daily life and I thank you for that.
    Food safety is obviously an issue that we all care about 
and that we all want to promote in this country. I would 
venture to say that everyone in this room is committed to doing 
all we can to protect our citizens and our domestic food 
supply. But we must approach this effort with a keen eye toward 
sound science and a commensurate regulatory system.
    For the most part, I think that we have done a good job. It 
is often said that America produces the safest food in the 
world. I believe this. But it only takes one well-publicized 
incident to damage a reputation and signal that we must be 
diligent in the monitoring of our food safety systems. I also 
believe that USDA must be a critical partner in that effort and 
I look forward to Secretary Glickman's testimony shortly.
    This issue is very, very important to my State of Georgia 
for two reasons. The first is obvious. Georgia regularly 
alternates with Arkansas as the top poultry-producing State in 
the Nation, and coming from the heart of the poultry country in 
north Georgia, I must add that I have a first-hand view of its 
importance to our agricultural economy.
    The second factor is the tremendous dedication the 
University of Georgia's College of Agriculture has to food 
safety research. We have testifying before the Committee today 
one of the Nation's leading food safety authorities in Mike 
Doyle, who works at the University of Georgia. Mike has lent 
great expertise to Congress over the years with his work on E. 
coli research and he has helped establish the Center for Food 
Safety at the University of Georgia, a tremendous resource for 
those working on these issues. We are fortunate to have Mike 
with us today and I look forward to reviewing his testimony, 
also.
    In closing, Mr. Chairman, I believe we must do all we can 
to make sure that food production and food safety never become 
competing interests. We have to do all we can on this committee 
to promote both. I would like to thank you again for your 
interest in an issue that is important to my State and our 
country. I am anxious to learn more about these important 
issues today and to work with my fellow committee members in 
addressing them. Thank you, Mr. Chairman.
    The Chairman. Thank you very much, Senator Miller.
    It is a privilege to recognize again the presence today of 
our Secretary of Agriculture, Dan Glickman. He is accompanied 
by Catherine Woteki, who is Under Secretary for Food Safety, 
and Thomas J. Billy, the Food Safety and Inspection Service 
Administrator.
    I know, Secretary Glickman, that you have a time commitment 
to another committee and will need to leave around 9:30 or 
thereabouts and will leave behind your cohorts who are here 
today. But let me take just a moment to thank you for the work 
you have done as Secretary of Agriculture. I do not know that 
this will necessarily be our last committee hearing or the last 
time we will have an opportunity to request your presence, but 
I thank you for your willingness to be so forthcoming and 
generous with your time and consultation, both here in the 
Committee room as well as at the Department. It has been a real 
pleasure to work with you. We recognize you for your testimony.

 STATEMENT OF HON. DAN GLICKMAN, SECRETARY, U.S. DEPARTMENT OF 
   AGRICULTURE, WASHINGTON, DC.; ACCOMPANIED BY CATHERINE E. 
 WOTEKI, UNDER SECRETARY FOR FOOD SAFETY; AND THOMAS J. BILLY, 
       ADMINISTRATOR, FOOD SAFETY AND INSPECTION SERVICE

    Secretary Glickman. Thank you, Mr. Chairman. I remember 
those days going through vetting with your staff right here, 
those very pleasant days during the process of going through 
the confirmation proceedings. But there was never any 
unpleasantness from you or this committee, and I thank you for 
your friendship. I think you have been an excellent chairman 
and focusing on a lot of very interesting and controversial 
issues affecting American agriculture, and never one to run 
from controversy, either, so I appreciate that.
    I appreciate my friend Tom Daschle and his statement and 
his dramatic interest in agricultural issues. In fact, I think 
about 80-percent of the calls into our Department are from the 
Daschle organization usually.
    [Laughter.]
    And I would welcome Senator Miller. I visited the 
governor's mansion, I remember at the Atlanta Olympics with the 
President. You talked about Dr. Doyle and the University of 
Georgia. Of course, USDA has a very fine food research/food 
safety laboratory by our Agricultural Research Service and the 
Food Safety and Inspection Service working with Dr. Doyle and 
the University of Georgia and that is a place where a lot of 
research is currently being done on pathogens and so we 
appreciate their work.
    Let me just first of all say that under the 
administration's leadership, we have made a wide range of 
improvements in our food safety system across the Government. 
Overall in the U.S., we have the safest food safety system in 
the world--I believe that very strongly--the FDA, CDC, USDA, 
and other agencies. It is not perfect, however. It is evolving 
and we are all working to make it better and nowhere is that 
more apparent than at USDA.
    Our Food Safety and Inspection Service is probably the 
largest and most effective food safety inspection force in the 
entire world. Last year, our inspectors examined approximately 
8.5-billion-carcasses and 3.4-billion-pounds-of-egg-products in 
over 6,000 plants. To ensure the safety of imported products, 
we also maintain a comprehensive system of import inspection 
and controls.
    When the Department was reorganized in 1994, we created a 
separate food safety mission area to ensure an arm's length 
regulatory system that is independent of our market promotion 
activities. The theory was, in order to keep consumer 
confidence, they had to believe that the people who were doing 
the inspection were not subject to the same people who were 
doing the selling, and that separation, I think, has been most 
effective.
    In 1996, we launched revolutionary improvements to our meat 
and poultry inspection system through our pathogen reduction 
and HACCP rulemaking. Our new system directly targets pathogens 
like salmonella and E. coli that cannot be detected with the 
naked eye. Microbiological contamination of food by pathogens 
is the most serious food-related public health threat, 
responsible for an estimated 76-million-illnesses a year, most 
mild, but some very serious and some causing death.
    By no means have we abandoned traditional physical 
inspection, the sight, touch, and smell check performed by our 
USDA inspectors. But our focus now is on reducing pathogens. 
HACCP provides the framework for our pathogen reduction 
strategy. Each meat and poultry plant is responsible for 
setting up and following a plan to prevent, reduce, and control 
food safety hazards, and by and large, industry has done a good 
job in devising their own HACCP plans that comply with these 
rules. That is not to say that there are not some bad actors, 
but the vast majority of industry has successfully risen to the 
HACCP challenge.
    It is important to recognize how significant of a step 
HACCP is. It represents nothing short of a revolutionary change 
in food safety policy, and like most revolutionary changes, it 
often causes people to perhaps want to go back to the way 
things were. But it has incorporated for the first time modern 
scientific knowledge and principles and it has replaced an 
antiquated system that I think, while it did an excellent job, 
did not keep up with nearly a century's worth of progress in 
the science area.
    But HACCP is not enough. At USDA, we believe in addition to 
HACCP, setting up the critical control points, it is imperative 
to set clear, measurable, objective performance standards that 
industry must meet. Without some kind of benchmark, we have no 
way of measuring success and progress in reducing contamination 
and foodborne illness. Without performance standards, we would 
be relying on little more than an industry honor code.
    We began by setting a performance standard for salmonella. 
It is very simple. We collected data to establish the national 
rate of contamination in raw meat and poultry products. Some 
plants were above the average, some were below the average. 
Under the performance standard, all plants must now have a 
salmonella contamination rate that is at least no worse than 
this baseline.
    Adolph Rupp, the legendary former basketball coach of the 
University of Kentucky, once said, ``If it does not matter 
whether you win or lose, then why do we keep score?'' 
Performance standards are simply our mechanism for keeping 
score, for making sure that plants are meeting their food 
safety responsibilities. And needless to say, when it comes to 
the safety of our food supply, it matters a great deal whether 
we win or lose.
    This is something of a new paradigm in food safety and not 
one that everyone agrees with. Performance standards were a 
source of great controversy when the original HACCP rule was 
being debated and drafted, and more recently, they have been 
challenged in the courts, as was referred to in Senator 
Daschle's statement. I believe these attempts to undermine 
performance standards are dangerously misguided. The fact is 
that these standards are reasonable and reachable and I do 
agree that they must be applied fairly by USDA, as well. And 
most importantly, the standards are working.
    Today, we are releasing new data that demonstrate dramatic 
salmonella reductions over the last year, that is, from July of 
1999 to July of 2000. For example, in those plants that have 
completed HACCP implementation, salmonella has been cut by more 
than half on chicken carcasses and by one-third on ground beef. 
And for every product we regulate, at least 82-percent of 
plants have met or done better than the performance standard.
    Given the success thus far, we hope in the future to be 
able to set the bar even higher, to establish even more 
stringent performance standards. We are also looking at the 
possibility of establishing performance standards for other 
pathogens beyond salmonella. Next month, we will complete a 
preliminary survey on the prevalence of another pathogen, 
Campylobacter in poultry, the first step towards possible 
performance standards there, as well.
    It is important to recognize that pathogen reduction and 
other food safety imperatives do not begin and end at the 
slaughterhouse door. Pathogens and other food safety hazards 
can be introduced on the farm, in storage, during 
transportation, or in the home or restaurant. Producers, 
packers, shippers, wholesalers, retailers, and consumers all 
share food safety responsibility. That is why we have pursued a 
seamless farm-to-table food safety strategy.
    For example, we have provided farmers with information on 
residue avoidance and helped them adopt quality assurance 
practices. We have also launched a public information campaign 
to educate consumers about safe food handling and preparation. 
Frankly, I would like to see us do more of this, perhaps by 
funding top-of-the-line public service announcements to keep 
emphasizing the food safety message. This is expensive to do. 
USDA does not have the dollars to do very much of this, but 
just for example, the mere washing of hands on a periodic basis 
can reduce food safety illness dramatically. The mere cooking 
of meat and poultry to the appropriate temperatures can reduce 
food safety contamination dramatically. It would be nice if we 
could develop some clear-cut messages on television and radio 
to communicate those simple messages very clearly and I would 
hope that we could wok with the Congress in establishing some 
budgets in the future that would do that. Of course, all of 
this is not substitute for strong regulation and sound science-
based inspection, but it is an important complement that we 
must continue to pursue.
    USDA has devised a pathogen reduction system and an overall 
food safety system in which public health trumps all other 
interests and concerns. I think the system is working. But to 
ensure our continued success, we must constantly integrate new 
technologies, adopt new research techniques, and be on the 
lookout for emerging and evolving pathogens.
    Our continued success also depends on help from the 
Congress. Congress has been very supportive of USDA's food 
safety efforts, but the Senate's fiscal year 2001 
appropriations bill is currently several million dollars below 
our request. We also need $6 million on top of our budget 
request to cover costs associated with the delay in the 
implementation of the HACCP models project. And to ensure 
effective future use of resources to address egg safety, a 
restriction on the Secretary of Agriculture's ability to 
delegate shell egg surveillance activities, we would hope 
should be removed from the appropriations language.
    I would like to just echo one point Senator Daschle made. I 
strongly believe that Congress should empower USDA with 
expanded authorities that will put more teeth in our food 
safety efforts. We must have mandatory recall and notification 
authority. The current system of voluntary industry recall is 
simply not reliable enough. And I have said this point many 
times before. The Consumer Product Safety Commission can order 
recalls of defective lamps and plugs and toys and other 
products, but we cannot do that with respect to defective food 
products. That is wrong, and that, I hope, is something that 
Congress will allow us to do in the future.
    To ensure that there is some accountability and flexibility 
in the system, we also need the authority to impose civil 
penalties against firms that violate Federal food safety rules. 
Right now, we are limited to basically either removing the USDA 
mark, which effectively is shutting a plant down totally, or 
else referring a matter to the Justice Department for 
prosecution. But most regulatory agencies have a middle ground 
approach, which is civil sanctions.
    Industry is worried about this because they worry how it 
would be applied and I understand that and I am working with 
Congress. I am sure we could come up on ways to make sure that 
those standards are fair. But it would give the enforcement 
folks at the Department more flexibility in dealing with food 
safety problems that often do not require what I call the 
atomic bomb, which is the removal of the mark and shutting a 
plant down. There has got to be some middle ground approach 
there to deal with.
    Let me just conclude by saying this. The key here is, I 
think, beyond making sure that people do not get sick and eat 
safe food, is consumer confidence. Safe food sells. If the 
public believes their food is safe, they will buy it. If they 
get hysterical about it, they will not. And we see a lot of 
hysteria around the world, not very much here in our country, 
because I think people have confidence that USDA, FDA, CDC, and 
the other food safety agencies are basically on the level, 
trying to work as hard as they can, call the shots as they see 
them and are willing to enforce the law in an independent way, 
a fair way, and an arm's length way from industry. But in other 
parts of the world, on any of these food-related issues, one 
small incident explodes into an opportunity for non-science-
based hysteria to govern and it certainly affects people's 
habits in terms of what they buy and what they eat.
    I have found that even the most outspoken skeptics of 
government activism agree that food safety regulation is 
necessary to keep our food supply safe and protect consumers 
from food-related illnesses. There are differences of opinion 
about what kind of powers and roles USDA has had, but I do not 
believe anybody wants to get rid of the mechanism that is 
there.
    We are proud of the record we have built, but we also know 
that we can do and should do better. I hope that Congress can 
work with us to help USDA and help the entire Federal 
regulatory system become even more effective in terms of 
fighting for consumers and fighting for food safety in the 
future. Thank you very much, Mr. Chairman.
    [The prepared statement of Secretary Glickman can be found 
in the appendix on page 62.]
    The Chairman. Thank you very much, Secretary Glickman.
    I am going to recognize Senator Harkin a moment for his 
opening comment, but while you are here, I just wanted to raise 
this question directly. The leaders in the meat industry who 
have met with many members of our committee state that the 
salmonella standard is scientifically flawed because it does 
not take into account the regional difficulties or seasonal 
differences in the prevalence of salmonella. Furthermore, they 
believe an advisory committee on microbiological criteria 
should have been consulted by USDA about the scientific 
validity of the performance standards.
    So they believe both on the regional and seasonal business 
and the lack of consultation with this committee that the 
standard you have talked about is flawed and, therefore, the 
results that come from it are flawed. Do you have a response to 
that?
    Secretary Glickman. I would like for both Mr. Billy and Dr. 
Woteki to respond briefly and then I will take a stab at it, as 
well.
    Ms. Woteki. I would like to respond first of all from a 
scientific standpoint. I am a scientist. I am a member also of 
the Institute of Medicine of the National Academy of Sciences, 
which recognizes scientists nationwide. So I think I can 
provide a scientific response to your question.
    I feel that the salmonella performance standard does have a 
very sound scientific base and that base is one of reducing 
pathogens through an approach that has been used widely in the 
public health community but has not been applied previously to 
food safety areas and certainly not in the meat and poultry 
inspection area. But the basis of it is, first of all, to 
establish what is the prevalence of a pathogen in the food 
supply. That was done through the baseline studies that FSIS 
performed while they were preparing the HACCP rule and prior to 
the implementation of the rule.
    Based on those baseline studies, the performance standard 
was established at the midpoint of the prevalence and the 
scientific rationale, then, is to move the distribution of the 
pathogen in products below what that average was prior to the 
implementation of HACCP. And what we have demonstrated and 
through the data that are being released today and are 
following up on data that we have released on the first year as 
well as the second year of implementation of HACCP, we have 
demonstrated that, that approach can move downward the presence 
of salmonella in meat and poultry products.
    So there is a very sound scientific rationale for it. There 
is also a history in other public health areas in using this 
approach to move downwards the distribution of, in this case, a 
pathogen in the food supply.
     Mr. Billy?
    Mr. Billy. Just to supplement what Dr. Woteki has said, we 
believe that the date, the raw data that we used to establish 
the performance standard for ground beef, which I think is the 
one you are focusing in on, is representative geographically 
and seasonally in terms of what levels of salmonella are in 
products produced by industry.
    I think what is probably the best measure of that is to 
look at the results across a large number of plants now where 
they have, in fact, been able to achieve the performance 
standard. As the Secretary said, this was established based on 
a national average in industry. We are holding all of industry 
to meet that national average, and clearly they are succeeding.
    From a public health perspective, the notion that we should 
somehow make adjustments to allow industry to have higher 
levels of salmonella in certain parts of the country because it 
is higher at certain times of the year is contrary to our 
public health interest.
    So I think we have got a good foundation. We have an 
opportunity with all of the data we have collected to look at 
revising the standard. We have got a strong database now to do 
that and would plan to forward and do that in the future, as 
the Secretary has indicated.
    The Chairman. Thank you for those responses.
    I would recognize now the distinguished Ranking Member, 
Senator Harkin, who has had, of course, a tremendous interest 
in this issue for many years.
    Senator Harkin. Thank you very much, Mr. Chairman. I 
apologize for being a little late and I thank the Secretary and 
Dr. Woteki and Mr. Billy for being here this morning. I just 
ask that my full statement be made a part of the record.
    The Chairman. That will be included in the record in full.

STATEMENT OF HON. TOM HARKIN, A U.S. SENATOR FROM IOWA, RANKING 
   MEMBER, COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY

    Senator Harkin. I will make a couple of comments. I do want 
to commend you, Mr. Chairman, for your interest in food safety 
and for calling this hearing to examine how well our food 
safety system is addressing microbiological threats. As you 
said, I have had a long interest in this and I have introduced 
several bills that would help strengthen our food safety 
system.
    S. 18, the Safer Meat and Poultry Act, would give USDA the 
enforcement authority they need other than the atomic bomb of 
inspection withdrawal that you spoke about, Mr. Secretary. S. 
823, the Fruit and Vegetable Safety Act, would require that all 
fruit and vegetable processors meet existing good manufacturing 
practices, basically just have them do what they are supposed 
to be doing. S. 2760, the Microbiological Performance Standard 
Clarification Act, which would clarify USDA's authority to 
issue and enforce microbiological performance standards for 
reducing pathogens. I think all of these bills taken together 
would definitely strengthen our system.
    HACCP has gone, as you said, Dr. Woteki, has gone a long 
way towards providing a stronger and more science-based food 
safety system, particularly in meat and poultry. However, in 
the last year, USDA's legal authority to enforce its 
microbiological performance standards has been seriously 
challenged. I am talking about the Supreme Beef case. This case 
directly undercuts USDA's attempt to create a standard based on 
the logic that reducing the level of pathogens on food 
nationwide will benefit the public's health.
    We have to address this question directly. How do we ensure 
that companies nationwide are reducing pathogens? If we do not 
have some measure of a plant's performance, how do we verify 
that HACCP is really doing its job? There needs to be 
enforcement if consumers are to have confidence in this system. 
We need to find out how HACCP regulations and microbiological 
performance standards can best be enforced.
    Generally we have done, a good job--the data shows that--in 
meat and poultry regulation. That does not mean we cannot do 
better. I believe there are ways that we can plug up some of 
the holes in enforcing these standards.
    I am anticipating the testimony I read last night from the 
Center for Science in the Public Interest. I do not verify 
their data myself, But they say that nearly four times as many 
outbreaks were linked to Food and Drug Administration regulated 
foods as were linked to U.S. Department of Agriculture related 
foods. Their findings are that 682 outbreaks were linked to FDA 
regulated foods as compared to 179 outbreaks linked to USDA 
regulated foods. Lastly, they say our outbreak tracking shows 
that FDA regulated foods have been associated with many 
foodborne illness outbreaks-many more than USDA. However, FDA's 
budget for regulating foods is only about one-third of USDA's 
food inspection budget. In essence, FDA regulates more food 
with less money.
    Mr. Chairman, the more that I have studied this, the more I 
am thinking that we have got these two separate agencies out 
there, both talking about food. It seems to me we need to bring 
them together somehow. I do not want to denigrate FDA. They are 
a great organization. But I must say for the record and openly 
and as frankly as I can that the Food and Drug Administration 
is really the Drug Administration. They have focused more on 
drugs, which is fine. We need to have them focus on drugs and 
the safety of drugs and the application of drugs.
    I think the Food and Drug Administration basically has 
given food a back seat to drugs. I do not think that is true at 
USDA. So I am hoping that out of this, somehow we find some way 
of putting all of food safety together under one umbrella. I 
think that is the path we have to go. How that is going to be 
done, I do not know, but I hope we can begin to examine that 
process. Thank you very much, Mr. Chairman.
    [The prepared statement of Senator Harkin can be found in 
the appendix on page 51.]
    Secretary Glickman. Can I just make a comment on that?
    The Chairman. Yes.
    Secretary Glickman. I think your point is a useful one. 
First of all, clearly, FDA has not had the resources to do 
these things. I mean, from the beginning, you look at the 
history of food safety activities, they occurred as a result of 
the progress era and the monies came into USDA and meat and 
poultry inspection was the prime function of USDA and other 
food safety inspections were basically not relegated to 
anybody, even though we had a Pure Food and Drug Act and there 
were some things there. But FDA was largely not given the 
authority nor the personnel to do that work.
    We are working together. The President has, of course, 
created a food safety initiative that has resulted in 
attempting to get budget increases across the board and we are 
looking at what the structural role ought to be in the future 
to deal with the problems you talked about. It is probably 
going to be in the next Congress and the next administration 
before any of these decisions are going to be made, but I think 
you raise a very important point. We are going to have to 
modernize the way we handle the regulatory structure of our 
food safety system.
    Senator Harkin. We are approaching it today the same way we 
did 30-, 40-years ago, but the whole system of food production, 
distribution, consumption, has changed dramatically, and so we 
need a dramatic change in how we enhance and protect the public 
in that whole chain, from production to consumption.
    Secretary Glickman. We just, I think, need to build on the 
strengths. There are certain strengths in the system and there 
are certain talents in the system. But I agree. I think that it 
is time to really look at this question in a very open way and 
I have not prejudged it myself. I think we have got to figure 
out in the modern world how we deal with the whole litany of 
food safety issues beyond just the historical way of doing it.
    Senator Harkin. Thank you very much, Mr. Secretary. Thank 
you, Mr. Chairman.
    The Chairman. Just a quick question following up on this 
colloquy. How did we get the separation to begin with? In other 
words, why is FDA involved in this way and USDA, because 
obviously it begs the question of why we do not do something 
about it. I am grateful you are doing something, but it 
certainly highlights for this committee a very important agenda 
item, I would think, because this is totally unsatisfactory. If 
you are testifying that FDA regulated foods, people are three 
or four times more likely to get sick than the ones that you 
are doing----
    Secretary Glickman. Of course, Senator Harkin testified to 
that.
    [Laughter.]
    The Chairman. You are exempt. Give us a little bit of 
history, if you will.
    Secretary Glickman. I think Dr. Woteki----
    Ms. Woteki. I can provide you a little bit of historical 
background. In 1906, Congress enacted the two laws that have 
led to our current food safety system that----
    The Chairman. Nineteen-oh-six?
    Ms. Woteki. Nineteen-oh-six, the Federal Meat Inspection 
Act and the Pure Food and Drug Act. The Department of 
Agriculture administered both of those laws until the, I 
believe it was in the late 1930s or early 1940s when the food 
and drug responsibilities were separated out, eventually 
finding a home in Health and Human Services. At that point, 
there was a lot of concern about something that the Secretary 
alluded to in his testimony of a potential conflict of interest 
within the Department for administering the Food and Drug Act 
and it was felt that it was appropriate that, that be separated 
out.
    The Chairman. Senator Kerrey?
    Senator Kerrey. Mr. Chairman, that was before PAC 
contributions so that could not be the reason that the 
separation occurred.
    [Laughter.]

    STATEMENT OF HON. J. ROBERT KERREY, A U.S. SENATOR FROM 
                            NEBRASKA

    Senator Kerrey. I am sure it probably had something to do 
with Congressional oversight. I am not sure exactly what.
    First of all, let me thank both you and Senator Harkin for 
holding these hearings. I think it is extremely important. We 
pay tribute to the United States Department of Agriculture 
insufficiently for making certain that we have the safest food 
supply in the world. Our consumer confidence is good as a 
consequence. We cannot be vigilant enough, in my view, given 
the new situation that we have in the marketplace, which is 
that it is a world market, not just world market in theory, it 
is a world market in practice, so that my consumers, no matter 
if I am manufacturing product in some little town in Ohio or 
some little town in Nebraska, they know worldwide. If there is 
a problem with my food product, they know it worldwide 
immediately and the market will put a substantial penalty.
    This is the exchange, Mr. Secretary, you and I had before 
on the comparison with consumer products. It is a much 
different environment. If I put salmonella out to my customers, 
my customers will quit coming into my restaurant. I do not care 
what you do. FDA does not have to do anything. You do not have 
to do anything. The State Department of Health does not have to 
do anything. If there is a story in the Omaha World Herald that 
my customers have gotten sick from eating salmonella--and by 
the way, they are much more apt to get sick as a consequence of 
mishandling of dairy products than they are of meat products--
if they get sick as a consequence of my serving them 
salmonella, I am out of business and I am going to have trouble 
in any other part of the country where I am operating as a 
consequence of that having occurred.
    So everybody understands that in the food business that 
wants to stay in the food business and they are training their 
employees and working with their employees to make certain that 
does not happen. Now, occasionally you have got people, as in 
any economic environment, who do not care, and they are always 
running at the margin. They are always pressing the envelope 
and they are always trying to cut corners and they put 
everybody at risk as a consequence.
    Therefore, it is very important that we give you the 
authority, in my view, to get the bad people out and keep the 
good people in the business, and that was really the underlying 
principle of HACCP. Not only are we going to use good science 
to go to the critical control points, and I was very much 
involved in trying to make HACCP a reality, but one of the 
things that I am also very much aware of is that there has been 
significant resistance inside of the meat inspectors' union to 
this new system and I would like to talk about that a bit.
    One of the things I have privately talked about to my 
staff, and it is the first time I have said it out loud, 
perhaps because I am not running for reelection, but----
    [Laughter.]
    Senator Kerrey.--that maybe in statute we should abolish 
this union and rewrite the law and create a real health-
oriented organization, because they still are thinking like 
inspectors. They are still thinking in the old world, and a lot 
of them do not like this new system. They do not like it at all 
and they have oftentimes been reluctant to follow your 
instructions.
    You are nodding. I wonder if you are willing to say, yes, 
that you have had some difficulty----
    [Laughter.]
    Secretary Glickman. Well, I am not running for reelection, 
either, Senator.
    [Laughter.]
    But I am going to let Mr. Billy answer that.
    Senator Kerrey. Mr. Billy was nodding in the affirmative. 
Has there not been resistance inside the meat inspectors' union 
to making this change?
    Mr. Billy. Yes, there has been resistance and----
    Senator Kerrey. Why not at least change the name of it so 
they are not called meat inspectors anymore, so they are called 
food safety, even health specialists and require them to 
establish real liaisons with epidemiological people in the 
Departments of Health and so forth so that we can make these 
kinds of discoveries and track down where the problems are. Why 
not just change the name of the union, or the name of the job 
and just aggressively go in there and say, look, if you are 
willing to do a system which is health-based, which is 
basically saying there is a new sheriff in town--it is like 
``48 Hours,'' you know. It is Eddie Murphy walking in the bar 
and saying, ``There is a new sheriff in town here.''
    [Laughter.]
    If you are willing to help us figure out how to reduce 
pathogens at the levels that we have set, we will be your best 
friend. And if you are not, we are your worst enemy. We are 
your worst nightmare. I mean, why not that kind of an approach? 
Is it going to take Congress to impose in the statute what it 
seems to me there has been great difficulty in doing 
administratively?
    Mr. Billy. I am intending to stay in my position----
    [Laughter.]
    and I do face certain requirements under labor-management 
law, so I am not going to comment on the union. But let me say 
this. We certainly agree that we need a different kind of 
person looking to the future that carries out our 
responsibilities in food safety and it is for that very reason 
that we have embarked upon the establishment of a new kind of 
position called the consumer safety officer that is college-
educated, comes to us properly trained in the sciences, and 
then with additional training with respect to their job can 
play an entirely different role than the one we have looked to 
our inspectors to play traditionally.
    Senator Kerrey. Do not give the colleges more power than 
they need. They do not necessarily have to be college educated, 
do they, to understand the----
    Mr. Billy. I think in this day and age, they do. Otherwise, 
it will force us to do a great deal of additional training at 
our expense and it would shorten that process if we could 
acquire people that have the basic training in the sciences, 
math, and so forth to carry out the kind of thinking and 
decision making that is required under a HACCP-type approach.
    We have asked for and forwarded to Congress proposals to 
implement this shift to consumer safety officers. 
Unfortunately, we have not gotten support from Congress in 
terms of moving forward and we are sort of wallowing----
    Senator Kerrey. You are talking about an add-on. You are 
talking about----
    Mr. Billy. No, we have----
    Senator Kerrey. Would you still have people in GS positions 
that would be called meat inspectors?
    Mr. Billy. We would through an interim period as we 
complete filling out what we consider to be our workforce of 
the future.
    Senator Kerrey. How long is the interim period?
    Mr. Billy. Probably several years, Sir.
    Senator Kerrey. What is several?
    Mr. Billy. Probably about 5-years it would take us to go 
through a transition like I have described, and that is with 
full support for it.
    Senator Kerrey. Just one person's opinion on this thing, I 
think this is one where you have just got to cut the cord. I 
think you start right now and say it is food safety specialist. 
Let us train them up. I mean, the market is demanding it. And, 
by the way, we are finding ourselves, those of us who supported 
HACCP, we are on the defensive. HACCP is not working. HACCP 
does not provide the intensity of regulation. It is a pro-
industry champ. You are shaking your head no, but those of us 
who supported HACCP are answering press calls from people who 
are saying, this is not working, that HACCP is not a good 
system.
    And I think my view is it is in part related to this old 
system of saying I am a meat inspector. I was trained as a meat 
inspector. I am a meat inspector and I am going to go out to 
that plant and act like a meat inspector. Fine. Give me your 
pathogen requirements and pathogen standards, but I am going to 
go out there as a meat inspector, and I think it creates a real 
problem in the field.
    Senator Harkin. I just might add, Bob, I think Senator 
Kerrey is absolutely right. HACCP works. If you have got a 
conscientious, good company that really wants to do it, HACCP 
works. But if you have got someone like you said that is--you 
know, there is always somebody cutting the edge, trying to be 
on the edge--then it does not work.
    Senator Kerrey. But I am skeptical about you needing 
additional authority. If you have got somebody out there who is 
a bad operator, shut them down. Just shut them down. I mean, 
you have got the authority to do that. Shut them down. Why do 
you need, what is it----
    Secretary Glickman. Mandatory recall, which I think we 
ought to have, and we also have asked for the same authorities 
that the FAA has, that the banking regulators have, and that is 
civil authority, civil fines. In some cases, it is more 
effective to levy a $100,000 fine a day than it is to shut them 
down. In some cases it is not. I am just saying that 
flexibility is there in most regulatory----
    Senator Kerrey. I see a discontinuity, I must say, Mr. 
Secretary. On the one hand, you talk about the consumer 
confidence they have in the food supply in the United States. I 
do not want to, because we have other panelists coming up here, 
I would love to explore the salmonella issue a bit because I do 
understand it fairly well from serving food product on a 
regular basis. But when you say we need more authority and you 
make the case for more authority, oftentimes when you make the 
case, you leave the impression that there are great gaps in our 
capacity to regulate and I do not see it.
    Secretary Glickman. I guess one parallel I would say was 
the airline industry. The FAA could always shut an airline down 
and remove its certification to fly, but they found that it was 
also useful when there were perhaps less serious things than 
massive safety problems, that civil fines, and that is a big 
deal now with the airlines and they publicize those fines and 
it has had an impact. I am just saying there are perhaps 
parallels.
    Let me just mention one other thing. That is, there is a 
spectrum of viewpoints within the employees' sector on the 
HACCP program. There are a lot of our employees who think this 
is the right way to go. I want you to know that. Now, I think 
they----
    Senator Kerrey. I must say, that is not comforting. The 
word ``lot'' is not comforting.
    Secretary Glickman. No, no, no. In fact, in my judgment, it 
is the majority of employees feel that way.
    Senator Kerrey. That is not comforting.
    [Laughter.]
    Secretary Glickman. When you have traditional labor-
management relationships, this is always going to be a problem 
area. Now----
    Senator Kerrey. I think Mr. Billy's answer said it all. He 
cannot tell us what his opinion is. So I think we need to 
change the law. I think unless we change the law that gives you 
the authority to do what you have to do, you are not going to 
be able to it. Your answer, which is I cannot answer your 
question, Senator, because of--what was it, labor something or 
other----
    Mr. Billy. Labor-management law.
    Senator Kerrey.--labor-management law. The labor-management 
law does not allow you to tell me whether or not you can do the 
job. I mean, I think you made the case by not being able to 
answer the question, even though I saw the head going this way 
[nodding] when I was asking.
    [Laughter.]
    Anyway, thank you, Mr. Chairman.
    The Chairman. Thank you. I need to get Secretary Glickman 
out of the hearing as gracefully as possible because he has 
made a commitment really to be somewhere else at 9:30 and he 
has been most generous.
    Secretary Glickman. Thank you.
    The Chairman. All right, one more.
    Senator Harkin. Just before he leaves, again, the 
salmonella performance standards have not been revised since 
they were issued in 1996, yet there have been plans to revise 
them. Do you know where you are in that process?
    Secretary Glickman. Mr. Billy?
    Mr. Billy. Yes. We made a commitment that after the very 
small plants had implemented HACCP and we had a measure of 
their ability to meet the initial performance standards, we 
would then review all them and move forward to make revisions. 
The very small plants implemented in January of this year. We 
are now collecting data from them. So about the end of this 
calendar year, we will be in a position to make decisions about 
revisions to the various performance standards. Obviously----
    Senator Harkin. So we could expect those early next year 
maybe?
    Mr. Billy. Early next year, yes, Sir.
    Senator Harkin. By March, April?
    Mr. Billy. Yes, we will be in a position to do it by March.
    Senator Harkin. Thank you.
    The Chairman. Thank you very much. Thank you, Mr. 
Secretary. Will the other witnesses remain so that we can 
continue to visit with Mr. Billy and Dr. Woteki.
    In the chart that is presented here, essentially, you have 
said or used the words ``salmonella prevalence.'' What does 
that mean? What odes it mean, the prevalence of salmonella? Is 
this a standard all by itself or----
    Ms. Woteki. It is a rate, the percentage of products that 
test positive for the pathogen.
    The Chairman. Would some product not have any salmonella? I 
mean, is there a situation where there is none?
    Ms. Woteki. Correct.
    The Chairman. You move from zero to prevalence. What is 
that range?
    Ms. Woteki. OK. In the testing that the Agency does, there 
are, for different products, a certain number of samples that 
are taken----
    The Chairman. Yes.
    Ms. Woteki.--and each one of those samples is tested for 
salmonella. So the percents that you see there are the percents 
out of that set of tests that were done that were positive.
    The Chairman. By positive, you mean they had at least one 
unit of salmonella as opposed to zero?
    Ms. Woteki. Well, there was a detectable level of the 
salmonella.
    The Chairman. A detectable level of salmonella.
    Ms. Woteki. Right.
    The Chairman. So prevalence means detectable level as 
opposed to none at all?
    Ms. Woteki. It is the percent of products tested that had a 
detectable level.
    The Chairman. Let us try it again. Let us say that you have 
15 different kinds of hot dogs and you get one kind of hot dog 
and a majority of the hot dogs in that category had salmonella.
    Ms. Woteki. So that would be over 50-percent.
    The Chairman. OK, of that particular item.
    Ms. Woteki. Of that particular hot dog.
    The Chairman. There could be many, many things this plant 
is doing, but that particular one had a majority of the pieces 
of hot dogs had salmonella. Now, in the chart that you have, 
for example, with broilers, prior to the HACCP baseline 
studies, you point out 25-percent of these lines had a 
prevalence of salmonella, and this is down ought of 9.9-
percent----
    Ms. Woteki. Correct.
    The Chairman.--following the standard you have imposed. 
Will the standard be a floating standard? In other words, you 
talk about improvement. Is the improvement in the standard or 
the improvement in the number of times that you have a line 
that has prevalence?
    Ms. Woteki. Well, the concept is that after HACCP 
implementation, after this last year when the very smallest of 
the plants came on line and we had experience from them from 
their performance with respect to the performance standard, 
that the Agency would then evaluate the overall performance of 
the industry and consider whether they would move downward the 
performance standard. And so far, the data are indicating for 
broilers, as you were pointing out, that the baseline studies 
that were conducted before HACCP implementation, 20-percent of 
broilers, that was kind of the mid-point of that distribution--
tested positive for salmonella. Now it is just under 10-
percent. So that whole distribution of product prevalence for 
salmonella has shifted downward. So it would make an argument, 
I think, for reexamining whether we should establish a new 
performance standard that will be lower than 20-percent for 
broilers.
    The Chairman. Yes, Sir?
    Mr. Billy. And for the other performance standards for the 
various market or product categories. We would do this through 
notice and comment rulemaking. We have the data from all of our 
analyses, so we have a data set to use. We would pursue 
changing the existing performance standard and tighten them 
based on industry performance. In response to Senator Harkin's 
question, what I indicated was we would be prepared to move 
forward on that early next year.
    The Chairman. Well, obviously, progress has been made, but 
getting back to the logic of Senator Kerrey's reasoning, is 
this comforting that 9.9-percent of broiler samples have a 
prevalence of salmonella? In other words, granted, you have 
gotten from 20 to roughly ten. Maybe next time you will try for 
five or so forth. But what does this mean in terms of the food 
supply of the country----
    Ms. Woteki. It is comforting----
    The Chairman.--that in this case, 9-percent of the poultry 
out there have a prevalence of salmonella?
    Ms. Woteki. It is comforting from the perspective that the 
direction that it is going is downward. We are certainly not 
happy with that level of salmonella prevalence in the food 
supply and in this particular product class. But the direction 
that it is going is downward and that has a public health 
benefit.
    The Chairman. Well, of course, but I am still trying to 
drive at what it is that we are finally about. Is it zero 
salmonella? Why should there be any salmonella? Or will 
somebody argue today, and we will find out, that we are being 
far too rigorous? In other words, if you have some evidence of 
salmonella, it does not make that much difference in terms of 
public health, a certain toleration level. In other words, we 
are talking about an impossible situation in which you knock 
out a good part of the food supply. What does any salmonella 
mean with regard to the safety of somebody ingesting food in 
America?
    Ms. Woteki. Well, any salmonella poses a potential risk 
because it is an organism that can grow and multiply. So a raw 
food product with salmonella present within it, if it is not 
properly handled, not kept refrigerated, not cooked properly, 
has the potential for causing illnesses in people who consume 
that product.
    The Chairman. When the meat industry, and you are correct, 
Mr. Billy, they were talking about the ground beef case 
essentially, say that an advisory committee was set up and it 
was going to look at this in a scientific way and they feel 
that has been ignored, that essentially over at USDA you sort 
of hit a standard and now you are going to lower it some more. 
As you find that people are complying, you may lower it some 
more, driving, from my question, it still not to zero, so now I 
am worrying about the public as a whole ingesting anything 
here.
    How do you meet these arguments that people are actually 
producing this meat in the South in this particular case, the 
regional argument that was made, and you point out, well, after 
all, people in the South ought to be protected the same as 
people in the North. The fact that the weather changed should 
not make a difference, but it probably does make a difference 
if you are a producer, apparently, of ground beef.
    So with all of these things floating around, how are we 
going to come to some equity that a court of law that heard all 
this case and sort of ruled USDA out of the picture for the 
moment is going to come to a reasonable conclusion?
    Mr. Billy. We knew from the outset that progress on 
reducing pathogens would come incrementally based on the 
availability of science, the understanding of where the 
pathogens are coming from and why, and the technology that is 
available. It is for that reason that we set a course that we 
described as farm-to-table, that you cannot solve this in one 
location, one place.
    If we can find better ways to produce the animals that 
minimize the presence of salmonella, we ought to figure that 
out and do it. If we can introduce new technology, which 
industry has done--steam pasteurization, steam vacuum, hot 
water washes, things like that, that can impact the presence of 
salmonella on a carcass, we should do that. There is a new 
technology, irradiation, available, that is available for 
products. Then we need to focus on the food service sector and 
the retail sector and training and the things that they need to 
do, and then finally the consumer in the home.
    If we do all those things, our knowledge base and the 
technology that is available will allow us to minimize the risk 
of foodborne illness from salmonella. That is our goal. We do 
not know the answer of where the end point is. I think we need 
to be driven by our knowledge and by the technology that is 
available. As we see progress, ratchet down the standards and 
then that will force those that are marginal to do even better, 
and those that have resisted some of this new technology to put 
it in their plans or to follow different production practices.
    So I think it is an incremental progress that we can expect 
here and we are seeing it and I expect it to continue. It is 
the beauty, I believe, of the performance standards, because it 
allows the calibration of HACCP, how effective it needs to be, 
and we are seeing that, in fact, the vast majority of industry 
can achieve the levels that we have set initially and I believe 
even if we tighten them up some.
    The Chairman. Senator Kerrey?
    Senator Kerrey. I need to stipulate one more time at the 
beginning of my questions a couple things. One is that I want, 
whether it is USDA or FDA, I want you to shut down anybody that 
is putting the consumer at risk because they put me at risk, as 
well, and not just in my private businesses but also I have 
100,000 people in Nebraska that work in the meat industry. They 
put them all at risk. Shut them down. So I am not going to 
shill for anybody out there that is putting somebody at risk.
    Second, I think you guys are doing the best job that you 
can, so I am complimentary of you, but I am going to get into 
some stuff that may sound like it is not, because I challenge, 
along the lines that the Chairman is going, this idea of 
prevalence.
    First of all, you say, Dr. Woteki, detectable. I presume 
you mean detectable with a given set of scientific tools, 
because if you want to, you can detect down to one. You could--
no?
    Ms. Woteki. Well, not necessarily.
    Senator Kerrey. You are saying that there are not 
scientific tools that could tell you whether or not there is 
salmonella in my coffee?
    Ms. Woteki. We have at this point very good microbiological 
tests, but as with other types of scientific tests, as well, 
chemical as well as microbiological tests, there is a range as 
you get down to fewer and fewer organisms and fewer and fewer 
molecules, approaching zero, where you will come up with a 
negative test. You will have a non-detect. But there still 
might be an organism there----
    Senator Kerrey. All right. So you do not want to say to the 
consumer, when we say detectable, we do not mean that the 
product necessarily is completely free of salmonella. There 
still may be--you may have one organism.
    Ms. Woteki. Yes.
    Senator Kerrey. You may have ten organisms on the product. 
You may still have some. On that basis, if you came in and let 
us say you tested 535 members of Congress to find out whether 
or not we had washed our hands. Is it possible there is 
salmonella on my fingers right now?
    Ms. Woteki. Yes.
    Senator Kerrey. Then it is possible that you could come in 
and say that there is a 50-percent presence of salmonella in 
Congress as a consequence of us not understanding how to wash 
our hands properly, is that not true?
    Ms. Woteki. Possible.
    Senator Kerrey. I could acquire salmonella poisoning, I 
could produce the gastroenterological, whatever the impact is. 
I forget why it makes you sick. Why does it make you sick, by 
the way? I have lots of organisms in me that are not making me 
sick. Why does that one make me sick?
    Ms. Woteki. Well, some of these microorganisms, when they 
are in a food, produce a toxin, and so when you consume that 
toxin, it makes you sick. Others, when you eat the organism----
    Senator Kerrey. Or I might get used to the toxin. I mean, 
if I travel from one country to another or one region of the 
country to another----
    Ms. Woteki. You may develop a resistance to the organism. 
But for those organisms like salmonella, when you ingest it, it 
can then produce a toxin inside your body that makes you sick.
    Senator Kerrey. I am just saying that the prevalence rate 
of salmonella on the hands of members of Congress could be 
higher than it is, let us say, in steers and heifers, could it 
not?
    Ms. Woteki. A better comparison would be your GI tract with 
their GI tract.
    [Laughter.]
    Senator Kerrey. Do we have to?
    [Laughter.]
    But it follows on what the Chairman is asking. I mean, what 
level of confidence do we acquire? Again, as I understand 
HACCP, not only do we do critical control points inside of the 
plant, we go after those things that produce the greatest 
chance of making consumers sick, and there you are talking 
about human beings with lower resistance. It will be children 
because of their lower body weight. It could be elderly people 
as a consequence of perhaps lower resistance, as well. Should 
we not be targeting in that fashion? It could come as a 
consequence of the consumers just simply not knowing what they 
used to know.
    I mean, if I go to a picnic in the summertime, I do not eat 
deviled eggs. I think that is because my mom told me to be 
careful about eating deviled eggs. Well, I am not sure I told 
my kids that. And increasingly, consumers are not preparing 
their food as much. Somebody else is preparing it for them. You 
are talking about farm to table. Should we not be targeting 
inside of that chain in aggressive fashions in an objective way 
to try to reduce illness?
    Ms. Woteki. That is----
    Senator Kerrey. I mean, trying to reduce pathogens does not 
tell us anything. We should be trying to reduce the illnesses 
that are associated with the consumption.
    Ms. Woteki. And the way that you do that is exactly right, 
Senator, in taking a farm-to-table approach.
    Senator Kerrey. But it could lead you back to washrooms in 
the Senate dining room. It could take you other places than 
just out to somebody that is processing steers and heifers.
    Ms. Woteki. And that is why we have an active education 
program. That is why the Secretary was asking for some 
additional assistance to get out messages to consumers. And 
that is also why we have a very active research program.
    Senator Kerrey. But with great respect to the requests that 
are coming from the Secretary, the impression is being left, I 
believe, with the consumers that the number one problem is the 
bacteria, the pathogens--which is itself a rather provocative 
word--the prevalence of pathogens, in this case salmonella, 
that exists inside of processing plants. And in my view, in 
many ways, it is the least of our problems.
    Ms. Woteki. Well, our overall message in our farm-to-table 
strategy to consumers has been that everybody has a 
responsibility for food safety, everybody who is involved----
    Senator Kerrey. If you get the prevalence down----
    Ms. Woteki.--from production through to the final point 
where you do the preparation and serving to your family.
    Senator Kerrey. What is your----
    Ms. Woteki. We have provided educational messages through a 
partnership with the industry and with consumer groups, the 
``Fight BAC'' campaign that has gotten a lot of visibility but 
not as much as we would like to get those messages out about 
the things that consumers can do to help protect themselves. 
And the role of regulation and the role of HACCP in this is 
part of an overall strategy.
    Mr. Billy. Can I add something here?
    Senator Kerrey. Sure.
    Mr. Billy. You have a witness about to come up that is an 
expert in this area in terms of salmonella from CDC. I think 
their testimony is right on point in terms of your questions 
and I would suggest that you hear them out and then come back 
to your questions based on their views about this approach and 
what it is achieving and the overall problem----
    Senator Kerrey. Mr. Billy, what the Chairman is saying, and 
I will just say it directly, I do not have any confidence of 
going from 49-percent in ground turkey down to 30-percent is 
going to reduce the number of illnesses in America, and that is 
the objective.
    Mr. Billy. OK.
    Senator Kerrey. You can go from 30-percent down to five 
percent. One out of 20 is not great odds. If you go down to 
five percent, have you got the problem solved? The answer is 
no. We do not know that 30-percent is producing illnesses, that 
there is an epidemiological connection between that 30-percent 
and illnesses.
    Ms. Woteki. We know that it is going in the right direction 
to reduce illnesses.
    Senator Kerrey. Tell me how you know that.
    Ms. Woteki. Because if you have fewer people exposed, then 
you are reducing the likelihood that there will be illnesses.
    Senator Kerrey. Reducing the people that are exposed 
reduces the likelihood is not a scientific-based statement. I 
mean, that----
    Ms. Woteki. Yes, it is, Sir.
    Senator Kerrey. No, ma'am, it is not. If I----
    Ms. Woteki. We use statistics.
    Senator Kerrey. It lacks the precision necessary. You are 
establishing, it seems to me, a principle under HACCP that we 
are going to go at critical control points to reduce illnesses. 
So why not back this thing off and say, here is the number of 
illnesses that are occurring in America today. Here is where 
the illnesses are occurring and we are going to try to reduce 
the illnesses.
    Ms. Woteki. That is----
    Senator Kerrey. That seems to me to be a scientific 
approach.
    Ms. Woteki. And that----
    Senator Kerrey. But you start off by saying, we are going 
to just try to reduce the likelihood as a consequence of this 
effort. I do not necessarily think there is going to be a cause 
and effect relationship between the regulatory cost to the 
consumer and the benefits that the consumer receives.
    Ms. Woteki. I think I would refer you to Mr. Billy's 
comment. You are going to hear from an expert that is 
monitoring the occurrence of illnesses in the U.S. population.
    Senator Kerrey. You underestimate both of your abilities. 
Both of you are experts, as well, and I am just saying I do not 
think you can give the consumers a great deal of confidence 
going from 50-percent down to 30-percent because you do not 
necessarily----
    Ms. Woteki. I think it is a remarkable accomplishment, both 
by the industry as well as by the Food Safety and Inspection 
Service. It is moving us in the right direction. It is moving 
us towards lower levels of pathogens overall as well as 
reducing the occurrence of pathogens in products. That reduces 
exposure and that is going to lead to fewer illnesses.
    Senator Kerrey. It does not necessarily reduce exposure. It 
reduces----
    Ms. Woteki. Yes, it does.
    Senator Kerrey. No, it does not necessarily reduce exposure 
based upon the statement that you made earlier, because you do 
not know what is happening in the rest of the food chain. You 
could have increased exposure in all the rest of the food chain 
and as a consequence you do not get reduced illnesses as a 
result of this reduction.
    Ms. Woteki. Well, the data are showing that there are an 
overall reduction in foodborne illnesses. That reduction has 
occurred at the same point in time that----
    Senator Kerrey. Well, that is like saying I just had four 
sunspots in a row and George Bush dropped 20 points in the 
polls and that is why. You are establishing a cause and effect 
relationship because one thing happened right after another and 
it does not necessarily--you know this--it does not necessarily 
mean that one thing caused the other.
    Ms. Woteki. Epidemiologically, we also deal with 
associations. What I have described is an association in time. 
It has a biologically plausible base and it is, therefore, a 
scientifically sound inference to draw from our current 
program.
    Senator Kerrey. I sat for a long time on the floor of the 
Senate listening to arguments about asking for increased 
authority for USDA and the arguments that were used for asking 
for increased authority, I believe, set off unnecessary fears 
in consumers that they have got problems in processing plants 
in America and that there is great danger out there associated 
with consuming American food.
    I have supported your programs. I like what you are trying 
to get done. I am just saying that I think there is a flaw in 
the thinking here. I do not necessarily disagree that it has 
been an accomplishment to go from 49- to 30-percent in ground 
turkey, but what does it tell us?
    Mr. Chairman, I will wait for the additional witnesses. I 
think the horse is dead and I am continuing to feed it.
    [Laughter.]
    Senator Kerrey. I appreciate the exchange.
    The Chairman. This is a characteristic of our Agriculture 
Committee hearings, that we have a spirited exchange and 
illumination, hopefully. I appreciate both of you coming and 
staying with the Secretary.
    I want to make a comment that Senator Roberts has submitted 
a statement for the record, which we will include.
    [The prepared statement of Senator Roberts can be found in 
the appendix on page 56.]
    Senator Roberts has submitted, as well, a question that he 
would like an answer to and it has to do with the shortage in 
many of the packing plants in Western Kansas of inspectors. Of 
course, that is a problem all by itself in terms of the 
mechanics of making all this work, and if you would respond 
promptly to Senator Roberts' question, I would appreciate it.
    We thank you both and you have heralded our next witnesses 
that we look forward to now with great anticipation. Thank you.
    The next witnesses are Mr. Joseph A. Levitt, Director of 
the Center for Food Safety and Applied Nutrition of the Food 
and Drug Administration, and Dr. Stephen Ostroff, Associate 
Director for Epidemiologic Science, National Center for 
Infectious Diseases, Centers for Disease Control and Prevention 
in Atlanta, Georgia.
    Gentlemen, we welcome you. I will ask you to testify in the 
order that I have introduced you, which will be Mr. Levitt 
first. To the extent that you are able to summarize your full 
testimony, we would appreciate it. The full testimony will be 
made a part of the record for both of you, and for that matter 
for all of our witnesses today. Mr. Levitt, would you proceed.

 STATEMENT OF JOSEPH A. LEVITT, ESQ. DIRECTOR, CENTER FOR FOOD 
  SAFETY AND APPLIED NUTRITION, FOOD AND DRUG ADMINISTRATION, 
                        WASHINGTON, DC.

    Mr. Levitt. Thank you very much. Mr. Chairman, it is a 
pleasure to be here today. My name is Joseph A. Levitt. I am 
the Director of FDA's Center for Food Safety and Applied 
Nutrition. As you know, Dr. Henney, the FDA Commissioner, is 
concurrently testifying at another hearing at the same time.
    The Chairman. Dr. Henney called me--I will mention this for 
the record--and indicated that she would be in another hearing 
and very much missed being here today, and we miss her but we 
are delighted that you are here.
    Mr. Levitt. Thank you very much. Food safety is clearly a 
top priority at the FDA and I would summarize my testimony by 
making five main points with one small introduction, which I 
have here, in addition to the glass I am drinking from, a glass 
of water which is halfway down, and a lot of the questions I 
think that came up in the last panel that will continue to come 
up, is whether or not this glass is half empty or half full. 
What I think all of us in the Federal agencies believe is that 
it is halfway but moving in the right direction, and that as we 
continue to have these hearings into the future, we will 
continue to show clear progress.
    Five points that I would like to make. Number one, food 
safety is clearly a compelling public health problem. The CDC 
estimates, and that everyone has repeated, 76-million-
illnesses, 300,000 hospitalizations, 5,000 deaths annually, 
means that we must do all we possibly can to reduce the 
incidence of foodborne illness, and Senator Kerrey, you are 
right. We need to focus ultimately on reducing the illnesses, 
that is what our ultimate goal needs to be. The focus is 
clearly on microbial contamination, but we cannot let it be 
exclusively that. There are important issues of chemical 
contamination and physical hazards and these vary according to 
the different products that we regulate. So we cannot do one at 
the exclusion of the other, but microbial contamination is 
clearly of a paramount concern to all of us.
    Point number two, again, a point that has been made 
already, we need science-based solutions to address this 
problem and address that all the way from the farm to the 
table. FDA has a strong tradition of being a science-based 
regulatory agency. The science enables us first to try and 
understand truly what the problem is and then to be able to 
devise solutions that could be scientifically shown to be 
effective. FDA has initiated a number of food safety programs, 
and I have a chart over here, that we have ongoing. While I 
list them there as accomplishments, the accomplishment is 
really at this point in the initiation and the approach in the 
issue. We have more work to do.
    We have programs, you can see, through HACCP. Seafood HAACP 
was the first HACCP program put into place several years ago, 
about the same time as the meat and poultry program. We have a 
new program in good agricultural practices that we are 
addressing both domestically and internationally. We have a 
program on juice safety which started with warnings but is 
proceeding to preventive controls to be sure that all the juice 
is safe. We have devised with the Department of Agriculture an 
egg safety action plan to reduce the risk from salmonella 
enteritidis in eggs.
    We are working with the Customs Service on an imported 
foods action plan. We do have a world economy. Imports are 
skyrocketing in the foods area. We have to be able to address 
those both at the border but also with an increased overseas 
presence.
    We are focusing our domestic inspections on those firms 
that produce foods at highest risk and have our goal with a 
budget that Congress is providing to get to those firms 
annually. We know that prevention is the key, but we cannot 
prevent everything, and so an effective outbreak response in 
conjunction with CDC, in conjunction with the State and local 
authorities, in conjunction with the Department of Agriculture 
is key and we have been putting in place systems that are more 
rapidly detecting and containing illnesses. Those are supported 
by research, risk assessment, and education.
    Point number three, we have not done this alone and we 
could not do this alone. The Nation is focused this week on the 
Olympics. We are all familiar with the five Olympic rings 
linking the five continents of the world. So, too, in food 
safety. We have the Federal agencies. We have the State and 
local agencies. We have the industries, the consumers, and the 
health professionals. We are all interlinked and must remain 
so. The system is only as strong, as we know, as its weakest 
link.
    Point number four, these programs are already showing what 
we believe are clear and undeniable results. The CDC data that 
you are about to see does show actual reductions in foodborne 
illness, not everywhere, but clearly in areas where we have 
applied attention and we are gratified on that. We believe the 
investment to date has been well spent.
    But point number five, this is just a down payment. We must 
do more. These programs are working, but they are just 
starting. We must continue our resolve and go the distance to 
benefit American consumers, and the strategic plan to be 
unveiled by the administration this fall by the President's 
council that Secretary Glickman referenced, we believe will set 
a blueprint for the future.
    In conclusion, in just 3-years, we that are involved 
believe that we have fundamentally improved the Nation's food 
safety system. There is no turning back, but there is much more 
work to be done.
    I am very proud to be working here at the FDA at this 
critical time and I am especially proud of the hundreds of 
dedicated men and women at the FDA as well as the many more at 
all the other agencies who are working tirelessly to make our 
nation's food supply as safe as it can possibly be. Thank you 
very much.
    [The prepared statement of Mr. Levitt can be found in the 
appendix on page 71.]
    The Chairman. Thank you very much, Mr. Levitt.
    Dr. Ostroff.

  STATEMENT OF STEPHEN M. OSTROFF, MD, ASSOCIATE DIRECTOR FOR 
EPIDEMIOLOGIC SCIENCE, NATIONAL CENTER FOR INFECTIOUS DISEASES, 
    CENTERS FOR DISEASE CONTROL AND PREVENTION, ATLANTA, GA

    Dr. Ostroff. Thank you, Mr. Chairman, members of the 
Committee, for the opportunity for us to be here today and to 
discuss the CDC's role in addressing the challenges posed by 
foodborne diseases.
    Much of this country's public health system was built 
around the control and prevention of food and waterborne 
illnesses, and I believe that all of us would agree that the 
century which just ended was largely one of success. Diseases 
which were common a century ago, like typhoid fever and 
botulism, have mostly faded from memory and our food supply is 
nutritious, varied, abundant, and among the safest in the 
world.
    However, we also live in a time of rapid change and this 
has an impact on our ability to deal with foodborne illness. In 
an era of emerging infectious diseases, probably no area has 
seen more change than foodborne illness. Let me give some 
examples.
    Twenty-five-years-ago, we did not recognize Campylobacter 
as a foodborne pathogen, yet now we know it is the most common 
of the major bacterial foodborne threats. Twenty-years-ago, E. 
coli O157:H7, which today strikes fear in parents throughout 
the country and is the most common cause of acute kidney 
failure in children, was unknown. Ten-year- ago, Cyclospora, 
the parasite which caused large outbreaks linked to Guatemalan 
raspberries, had not even been identified. And only 5-years-
ago, no one knew that bovine spongiform encephalopathy, or 
``mad cow disease,'' posed a threat of fatal human illness.
    Such a situation occurs because our food supply and 
production system is highly dynamic. Today's consumers have 
different preferences and demands than their predecessors and 
the food supply must keep pace. While today's diversified 
global food supply brings many benefits, it also brings with it 
an array of real and potential pathogens. Large-scale food 
production and distribution brings efficiency and economy of 
scale, but also creates opportunities for outbreaks of similar 
size and distribution. New prepared and prepackaged products 
make life easier in the kitchen, but they also produce new and 
different risks.
    Last year, CDC published our first estimates of the burden 
of foodborne illness in the United States in a number of years. 
Our findings suggest that there are approximately 76-million-
episodes of foodborne illness every year. While most of these 
episodes are mild and self-limited, others are more serious and 
result in 325,000 annual hospitalizations and 5,200 deaths.
    Of these 76-million-illnesses, only 18-percent are caused 
by pathogens that we currently recognize. While some proportion 
of the remainder of the illnesses may not be due to infectious 
agents, many probably result from viruses, bacteria, and 
parasites still waiting to be discovered. With today's 
technologies, in the next 25-years we will probably find even 
more disease-causing agents than we did over the last 25-years.
    Despite our 20th century successes, our estimates of 
foodborne disease demonstrate that we still have work to do. 
CDC's major role is to monitor trends in foodborne illness and 
the factors responsible for these trends. In response, we have 
worked with our partners at USDA and FDA and in State and local 
health departments to improve our ability to recognize, 
monitor, and respond to foodborne illnesses.
    Among the more significant enhancements are the FoodNet and 
the PulseNet system. FoodNet is a network of nine sites around 
the country, as you see on the map, which actively and 
systematically monitors for the major bacterial, viral, and 
parasitic causes of foodborne illness, conducts surveys for 
unreported illnesses, and conduct risk factor studies. The 
combined population being monitored is 29-million-persons, or 
11-percent of the U.S. population.
    PulseNet is the Innovations in Government award-winning 
system of local, State, USDA, and FDA laboratories which does 
molecular fingerprinting of bacterial foodborne pathogens, 
allowing prompt recognition of large and small foodborne 
outbreaks so that interventions can occur earlier and disease 
prevented. Currently, 48 public health laboratories in 46 
States take part.
    FoodNet and PulseNet are powerful tools which harness 21st 
century technology to give us insights into patterns of 
foodborne disease not previously available. Because the FoodNet 
data are systematically collected, for the first time, we can 
actually evaluate trends over time and across sites, helping to 
prioritize interventions such as HACCP and then see their 
impact on disease occurrence.
    Since FoodNet was started in 1997, we have seen some very 
positive trends. Among all the bacterial pathogens being 
monitored, we have seen approximately a 20-percent decline in 
the incidence of disease caused by these organisms, which 
translates into 855,000 fewer illnesses in 1999 compared with 
only 2-years earlier. Encompassed in these declines is a 22 
percent drop in E. coli O157, a 26-percent decline in 
Campylobacter, a 44-percent decline in shigellosis, and a 48-
percent decline in Salmonella enteritidis, the type of 
salmonella which is associated with eggs. Cases of Cyclospora 
have essentially dropped to zero since FDA took actions related 
to Guatemalan raspberries.
    Since these trends are consistent across FoodNet sites, we 
believe they are real and strongly suggest that the food safety 
interventions taken over the last few years have had a 
positive, measurable impact.
    One trend which is not improving is antibiotic resistance 
among foodborne bacterial pathogens. CDC and FDA monitor such 
resistance through the National Antibiotic Resistance 
Monitoring System. Between 1980 and 1999, the percentage of 
Salmonella strains resistant to at least one antibiotic has 
increased from 15-percent to 26-percent, while the proportion 
which were multi-drug resistant increased from 12- to 21-
percent. Clearly, more needs to be done in this area, which has 
a direct impact on our ability to take care of patients with 
these diseases. Of note, as we meet, another hearing chaired by 
Senator Cochran is taking place in the Labor-HHS Subcommittee 
of the Senate Appropriations Committee to see what can be done 
to address this serious problem.
    CDC is committed to work with our partners in government, 
industry, and the consuming public to continue to improve our 
ability to monitor, control, and prevent foodborne illness. We 
have defined core capacities at the State level to address 
foodborne illness and will soon make our outbreak data more 
readily available on the Internet to our partners and to the 
public. We will also periodically update the foodborne illness 
burden estimates as we hopefully expand the scope and breadth 
of our monitoring systems.
    The recent FoodNet data suggests efforts to improve food 
safety are bearing fruit even with the challenges of a changing 
food supply. We hope to be able to report continued improvement 
to you in the future as we work together to improve food 
safety. I thank you and will answer any questions that you may 
have.
    [The prepared statement of Dr. Ostroff can be found in the 
appendix on page 94.]
    The Chairman. Thank you both. The testimony you have 
presented, I think, is fascinating in implications for those of 
us who are semi-amateurs looking in at your work.
    To begin with, the figure you have used, as did the 
previous panel, 76-million Americans having a problem here is a 
very significant number. It is one of every four of us in this 
room, on average, each year. But then beyond that, as you say, 
some of this is temporary, but 325,000 hospitalizations. So the 
health care costs associated with this situation is a profound 
figure. Have any of you come to that idea of what we are 
talking about in terms of the incidence of health care costs?
    Dr. Ostroff. We are in the process of doing economic 
analyses, both looking at the costs of the illnesses as well as 
the relative efficacy of interventions from an economic point 
of view.
    The Chairman. If we were in a different committee at a 
different time, we would be talking about Medicaid and 
Medicare, health insurance. Obviously, this is not----
    Dr. Ostroff. But this is a substantial cost, there is no 
question about it.
    The Chairman. I would think so. So one of the cost-benefit 
ratios of all this has to be what kinds of investments can be 
made in the kinds of work that you are doing and USDA and what 
kind of payoff there is going to be. Now, in addition to 
limiting human suffering, the incidence with regard to our 
medical costs and our health care costs could be significant.
    Dr. Ostroff. Right, and there is no question, if you look 
at these data, that suggests that there are probably close to a 
million fewer illnesses than there were 2-years ago, and 
especially since what we are monitoring here is among the more 
severe of the bacterial pathogens, that impact has also been 
significant in terms of cost saving.
    The Chairman. Sobering in all of this, though, is the 
figure then that modifies the 76 in which you said that maybe 
only 18-million of these cases out of the 76, less than one out 
of four, actually can be traced to the pathogens that we know 
about now.
    Dr. Ostroff. That is correct. Actually, it is 14-million. 
It is 18-percent.
    The Chairman. Oh, I see, 18-percent. So is daunting because 
out there somewhere, the other 50-some million people may have 
had something we do not know about. You sort of charted the 
times of discovery of the various things we do know about so 
that we have those on the radar screen at least, and we can 
argue as to how well we are proceeding with that, but the 
unknown, we do not know. How much time and money is being spent 
trying to discover the rest of it, how the other 50-some 
million Americans become ill?
    Dr. Ostroff. I think all of the agencies are looking to 
identify additional agents that may be responsible for 
foodborne illnesses. We see disease outbreaks very often, and 
some of it is due to technological limitations where we cannot 
identify what the causative agent is. We have a condition, one 
that comes to mind is something called Brainard diarrhea, which 
causes a chronic diarrheal illness, and we have had outbreaks 
caused by this over the years and we have looked and we have 
looked and we have looked and we cannot quite identify what the 
pathogen is.
    It is a dynamic era. We see this all the time, not only in 
the foodborne disease arena but in all the other areas that we 
deal with, emerging infectious diseases, that there are lots of 
other agents out there yet waiting to be found and it is a 
challenge for anyone that deals with food safety, whether it is 
at the Federal level, at the State level, in the academic 
setting, etc., I think that over the coming years, we will 
clearly identify additional pathogens that we just simply have 
not had the technology to be able to find yet.
    The Chairman. You have identified a network of people in 
your agency or allied with that are monitoring all the time the 
situation, but do they monitor situations--for instance, we had 
in the Committee a while back Senator Abraham of Michigan and 
he was here along with some parents who were aggrieved about 
strawberries.
    Dr. Ostroff. I remember that one well.
    The Chairman. For instance, from things like that, do you 
see patterns or do you see an incident bobbing up and do you 
immediately go to the source, I suppose, to try to find is it 
something new, is it something different----
    Dr. Ostroff. Oh, absolutely. Absolutely.
    The Chairman. Is that a way of discovery, then, of----
    Dr. Ostroff. Outbreaks are always unfortunate. I mean, I 
would love to be put out of business, to never see an outbreak 
of any disease. But in point of fact, they are very valuable to 
us. They very often are the sentinel event that tells us that 
something new and different is occurring. Whether that new and 
different thing may be a new pathogen that we have not seen 
before or may represent a new risk factor, because again, the 
food supply itself is dynamic and changing, so over time you 
recognize patterns of disease outbreaks that have different 
causes and different reasons for occurring.
    So from our perspective, it is very important to 
investigate as thoroughly as possible every outbreak that we 
see because you just never know when you are going to recognize 
some new and different threat that----
    The Chairman. But back there at central headquarters, when 
something bobs up at all in America, you go after it.
    Dr. Ostroff. Well, you know, the responsibility for doing 
so rests at the State level. We are a non-regulatory agency and 
we do not have authority to go out and actually investigate. We 
do so at the invitation of the appropriate State health 
department.
    The Chairman. I see. So until a State health department 
calls you, you are sort of mute back there?
    Dr. Ostroff. Well, we can offer assistance even if they do 
not call us to come out into the field such as, accepting 
specimens to do advanced diagnostics to find the causative 
agents, assisting them with their investigations, etc..
    The Chairman. Are these State groups usually pretty quick 
in calling you, or----
    Dr. Ostroff. They are very cooperative and it has been very 
helpful to us. We have used many of the resources that we have 
gotten through the food safety initiative to channel them to 
the State health departments and even to the local health 
departments, so they can do their job better, and that creates 
a network, a network not only within our traditional partners 
in the State health departments, but also in the Department of 
Agriculture, etc., so that we can actually work better to 
respond to these problems.
    The Chairman. Earlier, we were discussing the salmonella 
with regard to ground beef, but the salmonella you have here is 
with regard to eggs. There has been a 48-percent reduction in 
terms of illness over the course of this period of time you are 
graphing here. How important is the salmonella situation? 
Clearly, that has come to the fore because of the court case 
and one of the impetus of this hearing, but give us some 
perspective as to how important it is.
    Dr. Ostroff. It is important for several reasons. One is 
that it is among the most common of the bacterial foodborne 
causes of disease. It usually runs neck and neck with 
Campylobacter, being the more recent one. Campylobacter, 
generally, in most of the surveys, you find the incidences 
higher than Salmonella, but the severity of illness is 
significant. We do know that in terms of fatalities, that it is 
among the big three.
    The Chairman. What are the other two?
    Dr. Ostroff. One is a parasite called toxoplasmosis, 
something that has not been discussed, and the third one is 
Listeria. Those, among the known pathogens, account for about 
75-percent of all of the foodborne-related deaths. So it is a 
very significant pathogen. You are talking about millions of 
cases of illness every year and those are the ones that 
basically we know about. So ability to deal with and control 
the occurrence of Salmonella would have a significant impact on 
the burden of foodborne illness.
    The Chairman. What would be your comment--as you recall in 
the court case last December, there was a separation between 
the idea of a sanitary plant and the idea of a specific 
standard for salmonella. These were two different things, at 
least the court apparently found that they were. What sort of 
comment would you have about that?
    Dr. Ostroff. Well, the only thing that I would say is that 
it is hard for us as a non-regulatory agency to comment on 
regulatory issues, but we are also an agency that likes to 
measure. That is what we do. We measure incidence and 
occurrence of many things and I think that the more we can 
define objective, measurable standards, the more likely we are 
to have something that we can hold ourselves against and seek 
to achieve.
    The Chairman. Well, that is probably true. Now, looking at 
it from our standpoint in Congress, should we have written the 
law in a different way? In other words, is it possible that 
someone could say, well, the law as it is written says the 
plant must be sanitary. It does not say the salmonella 
prevalence must be such or that you cannot have any.
    Dr. Ostroff. Right.
    The Chairman. In other words, as legislators, should we 
sort of go down this chart and say, in essence, in your plant, 
our tolerance is zero for salmonella, that is the law, so it is 
unambiguous? Granted, I understand what you do, but I am asking 
you for advice as a witness on what the law of the land should 
be.
    Dr. Ostroff. My personal belief, and again, this is not an 
agency position, my personal belief is similar to what Senator 
Kerrey said. It is not that you can just focus on one 
particular thing. I do not think that it should be an either/or 
situation, to say that either it ought to be sanitary or you 
ought to have this standard. Quite frankly, I think that both 
are important. I think the more opportunities that we have to 
limit the burden of pathogens in the food supply, the more 
likely it is--and I hate to use that term ``more likely,'' but 
Senator Kerrey is right, it is associations--the more likely it 
is that we will reduce the incidence of disease.
    The Chairman. Mr. Levitt, you heard earlier some discussion 
by Senators as well as witnesses about the role of FDA and the 
role of USDA in all of this and whether we need to clarify who 
does what. What is your own view? You are here for the FDA and 
obviously proud of the work that you and your associates are 
doing, but it does appear that there is some confusion as to 
the history of this, starting with the laws in 1906 and 
progressing through the history we heard in the 1930s and 1940s 
that may have come from enthusiasm of the Agency, a President, 
the Congress, whoever initiated these situations. But what 
would be your own recommendation as to how we get this back 
under control where we have some unity of effort?
    Mr. Levitt. I think, number one, the FDA does regulate 
about 80-percent of the food supply.
    The Chairman. Eighty percent?
    Mr. Levitt. Yes. I think the number in testimony is 78.
    The Chairman. I see.
    Mr. Levitt. And so when somebody suggests that the majority 
of outbreaks are on products that are under our purview, well, 
most of the products are under our purview. To the extent that 
people thought originally because of some of the early episodes 
that the real problem on food safety was ground beef simply, 
that is wrong. We have found problems throughout, and to the 
extent that these organisms are in the environment, they get 
into different products. And so that is why we have this long 
litany of programs addressing the different kinds of product 
areas--a program for eggs, a program for fresh fruits and 
vegetables, a program for seafood. We need to look at each of 
these on their merits and I think we have tried to go in a 
risk-based way on how to apply and get that cup a little more 
full with each successive year. So I think point one is, we do 
have a lot of responsibility in this area.
    Two is that we feel that a strong part of our history--I 
think each agency, we have our strengths. FDA's strength is 
strong science and know how and bang for your buck. One of the 
large food safety scares back in the 1970s was a concern about 
botulism. It was not a concern, it was a reality of botulism in 
canned food and FDA very quickly--this is all clearly before my 
time--brought to the fore the science, what do you need to do, 
and came forward with the low-acid canned food regulations 
which are the predecessor to today's HACCP regulations. So it 
is an agency that has traditionally risen to the occasion.
    What these kind of issues do is they raise the issue of 
coverage, of resources. We have over the last 3-years within 
the FDA under the food safety initiative, most of the increased 
funding has gone to the food part of the FDA, and I think we 
all feel that is needed and we all anticipate probably a lot 
more will be needed and GAO will have words to say, I am sure, 
on the resource front.
    But I think the critical issue is, do we have, if you will, 
our eye on the ball? Are we addressing these problems in a way 
that is achieving real results? And if we are, then we need to, 
a combination of stay the course and accelerate the course. We 
have a program that is getting the job done. We are all 
impatient. Impatience here is good. We want it to go faster 
than maybe it does. There were some other discussions about how 
long things take. Change takes time. We wish it would take less 
time.
    We have a conundrum of one of the safest food supplies in 
the world, and yet looking at these numbers, we want to make it 
even safer. And so I think we need to continue to approach it 
in a way that is getting us somewhere, that is cost effective, 
that is receiving real results, and that we have to also 
realize we have to change a little with time.
    I see Senator Harkin has rejoined us. I had the 
opportunity, Senator, earlier this week at a conference of--not 
a food safety conference but a different conference where you 
were not able to come in person but you were able to send a 
video and you talked there about the difference between the 
torch bearers that are moving into the future and the 
pallbearers that are trying to return to the past. I think in 
this setting we feel very much that we are the torch bearers. 
All of us are the torch bearers moving ahead on food safety.
    We have a system that has been in place for a long period 
of time. We have changes that are going on all around us--the 
global economy, the changes in the demographics of the 
population with a greater number of elderly and immune-
compromised in the population, more people eating outside the 
home.
    We have not talked much about retail. One thing FDA has is 
while the States have the primary responsibility for retail, 
the FDA has put out and established what we call the food code, 
which is a set of model recommendations to States and States 
are adopting it more and more. We wish it were faster, but we 
are proceeding.
    So we have in place a system that while imperfect is 
filling up that glass, and we have very much benefitted by 
Congress' support in the area of funding, and as I said, in the 
administration's plan, we are trying to lay out what we think 
we need over the long haul.
    The Chairman. Let me, while Senator Harkin is getting his 
breath, ask Senator Kerrey to continue the questioning.
    Senator Kerrey. Thank you very much, Mr. Chairman.
    First of all, I appreciate both the witnesses' testimony 
and obviously successful efforts in making our food supply 
safer. What concerns me still is that we talk about regulating 
using science but we oftentimes do not.
    For example, Dr. Ostroff, I do not think there is really 
any scientific basis for this chart that you put up here. I 
mean, there is no question there has been declines in foodborne 
illnesses of a million. I do not question that. But as to 
whether that was caused by CDC's program, which was at least 
inferred in the testimony, that CDC's program produced that 
reduction. My guess is you do not have a scientific basis for 
that evaluation. It may have occurred as a consequence of 
parents and other consumers watching television and learning in 
the process of the 0157:H7 debate that they have got to cook at 
180 degrees and you could see the reduction occurring just 
because people are not ordering rare hamburger anymore, medium-
rare product as a consequence of acquiring some understanding 
that came as a result of now being more afraid of eating the 
product than they were before.
    I presume that you have not done a scientific evaluation in 
order to produce that chart, although I would say it is likely 
that the chart will be reused in arguments, that there have 
been a million fewer illnesses, etc.. That there is a cause and 
effect relationship may not be quite as obvious as the chart at 
least implies that there is.
    Dr. Ostroff. Well, first of all, it is not CDC's program. 
We again are not taking the regulatory actions. We obviously 
have participated in trying to get the prevention messages out, 
to conducting the investigations to identify the risk factors, 
etc..
    Senator Kerrey. I was less under the impression that you 
were making the case that FoodNet had produced substantial 
successes and that----
    Dr. Ostroff. No. Before we had such a system which 
systematically and methodically uses the same exact technique 
year after year after year to accumulate the data, when we saw 
changes, either up or down, we were never confident that those 
were true changes, that they could simply be artifact. The 
State of Nebraska may have changed the way that they do 
monitoring of foodborne illnesses, and so from 1-year to the 
next they all of a sudden see more disease.
    We have had many instances where we have had what we refer 
to as pseudo outbreaks, where all of a sudden we have 
laboratories that start testing for a pathogen and you see a 
tremendous upsurge in the number of cases of E. coli or 
something like that and it is not real. It is simply because 
there was a change in the practices of the monitoring.
    But because we have the FoodNet and we have the sites doing 
the same thing exactly the same way from 1-year to the next, we 
are in a position now to say that these trends do actually 
represent reductions. But what I cannot say, and you are 
absolutely correct, is that it may be true, but unrelated. I 
mean, it could be both.
    Senator Kerrey. You say there are 5,200, approximately, 
deaths a year----
    Dr. Ostroff. Correct.
    Senator Kerrey.--that occur as a consequence of food 
illnesses----
    Dr. Ostroff. Correct.
    Senator Kerrey.--and 360,000 hospitalizations that occur as 
a consequence of food----
    Dr. Ostroff. Correct.
    Senator Kerrey. Do you have data that allows us as policy 
makers to try to figure out how much money to put in education, 
how much and how to regulate? Do you have data that allows us 
to know what it is that is killing American people, what is 
producing the deaths?
    Dr. Ostroff. Well, again, as was pointed out before, for a 
substantial proportion of those deaths, the pathogen is not 
identified. However----
    Senator Kerrey. Does that mean you are not certain that it 
was a foodborne illness?
    Dr. Ostroff. No, we are not certain. We know that it was 
food associated, but we do not exactly know what the causative 
pathogenic agent was. In other words, the microbe has not been 
identified.
    Senator Kerrey. Does that mean you are not certain--I mean, 
you have 5,200 deaths a year. Do you have data for each one of 
those deaths or is that an extrapolation from a smaller set?
    Dr. Ostroff. No, it is an extrapolation.
    Senator Kerrey. An extrapolation from a smaller sample?
    Dr. Ostroff. Right.
    Senator Kerrey. You have deaths that are occurring, and are 
you able then to break that down to guide us? I mean, I take 
Mr. Levitt, and I presume you agree with Mr. Levitt's five 
things, that the first order of business has got to be 
scientific based, and we should have both our regulation and an 
education effort be scientific based. And part of our purpose 
on this committee is trying to decide what the regulation ought 
to be. We heard USDA earlier making an appeal for increased 
authority to regulate.
    Mr. Levitt. Right.
    Senator Kerrey. And we are trying to figure out, should we 
give increased authority. Will that increased authority reduce 
the number of deaths, reduce the number of hospitalizations, 
reduce the number of foodborne illnesses? So it seems to me 
that from you, we need to be able to track this in a more 
precise fashion.
    Dr. Ostroff. Right. You know, there are many thins that are 
occurring at the same time--consumer education, the HACCP 
regulation, changes on the farm, changes in handling after 
product leaves the plant. It is difficult for us to say what 
the relative contribution of each of those changes is to the 
reductions that we see. All we can say to you is that based on 
the monitoring systems that we have in place, we do see 
reductions in the number of illnesses. We have to believe that 
the reasons behind those reductions----
    Senator Kerrey. Let me give you an example, Dr. Ostroff. 
Let us say Congress passes a law and says that the United 
States of America will not accept any food imports whatsoever. 
We will guard our borders. No more food from outside the United 
States is going to come in. Consumers of America are going to 
have to eat only those things that are grown and processed 
here. Will that reduce the number of deaths in America as a 
consequence of foodborne illnesses?
    Dr. Ostroff. We have always maintained that we do not have 
data that suggests that food that comes into the country from 
overseas is any riskier than food which is produced 
domestically. All we know is that the patterns of the----
    Senator Kerrey. Does that apply to all countries, Dr. 
Ostroff, or just to----
    Dr. Ostroff. All I know is that we have no data right now 
that shows we see more foodborne disease associated with 
imported products on a relative basis than we----
    Senator Kerrey. Do you have sufficient data to reach that 
conclusion, do you think, or----
    Dr. Ostroff. We do not have data that tells us that one is 
riskier than the other. All we do know is that the patterns of 
pathogens that we see in foods that come into the country 
versus foods that are produced domestically are different.
    Senator Kerrey. My own view is that we would be on sounder 
ground, especially on the regulation side, to track these 
deaths from foodborne illnesses back into regulatory responses. 
Whatever the regulatory response is, let the science and let 
whatever is happening out there with consumers guide our 
decisions both on regulation and on education, because I think 
what is happening is not that, and I acknowledge that in 
politics it is rare that we use science to evaluate what it is 
that we are doing.
    Dr. Ostroff. Right.
    Senator Kerrey. But it seems to me that when you are 
dealing with something like the food supply of this country, 
that it should, and it seems to me the most important indicator 
is the ones that you provided. Even though you have 
extrapolated it from smaller samples and you are not 100-
percent certain, it seems to me that the beginning point ought 
to be people that you think that have died as a consequence of 
consuming food in the United States or who were ill as a 
consequence of consuming food and we ought to track that back 
and produce a regulatory response that tries to reduce those 
numbers.
    Dr. Ostroff. What I can say is that at the same time that 
we have noticed these reductions in the incidence of foodborne 
disease caused by these pathogens, we have also seen reductions 
in, and I hate to use the term ``prevalence'' again, in the 
prevalence of organisms in the various products that are being 
assessed. While it is possible that those are completely 
unrelated to each other, that it is a chance coincidence, you 
have to believe that since it is biologically plausible that 
there is a cause and effect there.
    Senator Kerrey. What I am suggesting is that our response, 
our regulatory response needs to begin with the thing that 
provokes the most concern. The most concern amongst consumers 
is, and indeed, I drink this water comfortably as a consequence 
of presuming that the Washington, D.C., water supply is safe. 
You are drinking a glass of water there. Have you checked out 
our ice machine?
    Dr. Ostroff. Not today.
    Senator Kerrey. Perhaps you should before you drink it. I 
do not know. So I am consuming based upon believing that I can 
drink this glass of water without either getting sick or dying, 
because I prefer not to have either one of those two things 
happen. So it seems to me that our regulatory response should 
begin with that concern, and I am not sure it does. I am not 
sure it does at all. We have a HACCP system that is supposed to 
be paying attention to critical control points, but I see less 
science than I would like when it comes to trying to evaluate 
what our regulatory response ought to be in our food 
industries, and I thank you.
    The Chairman. Thank you very much, Senator Kerrey.
    Senator Harkin.
    Senator Harkin. Thank you very much, Mr. Chairman. Again, I 
am sorry I had to leave. We had to report some bills out of 
another committee, so I had to leave for a little bit.
    Mr. Levitt, first, I just want to say that I am happy to 
see that FDA is making progress in picking up review of new 
food safety technologies, especially in the area of--we had to 
deal with packaging materials for electron beam irradiation.
    Mr. Levitt. I remember that.
    Senator Harkin. I am glad we got that through. I often 
wonder, why did it take so long? I mean, we had packaging 
materials that were safe for gamma ray radiation which any 
scientist will tell you, if it is safe for that, it has got to 
be perfectly safe for electron beam irradiation, yet it just 
took months and months. It just drug on and on, and finally we 
got it, but I wonder why it just took so long to do that. I am 
happy we finally got it done.
    I am also concerned about FDA's labeling on electron beam 
irradiation. Processors and manufacturers still have to put 
that symbol on there and I am wondering why. Why do you have to 
put that symbol on there? Why don't you allow alternatives? Why 
do we have to continue with this, what do they call it--I 
forget the name of it, that symbol you put----
    Mr. Levitt. The radura symbol.
    Senator Harkin. Yes, the radura symbol, that is right. Why?
    Mr. Levitt. The background on the labeling for food 
irradiation is that FDA's labeling regulations and laws are 
based on has something changed about the food that we would 
consider a material fact for consumers to know. And in the case 
of food irradiation, when the safety determinations were made, 
with which we have very high confidence, there was also a 
conclusion made that the irradiation process can make some 
changes, if you will, in kind of the texture or the quality of 
the food in terms of how it feels, not how safe it is. And so 
the conclusion was made that we needed to put that on the label 
as a material fact.
    Now, we have received a lot of comment on that point from 
opposing sides. We have consumers that are saying we must know. 
It is very important for us to know if this is used. We have 
others from the industry that have argued forcefully it is 
scaring people. It is, if irradiation is going to help, we have 
to be able to use it in a way that is consumer friendly, if you 
will.
    Senator Harkin. Well, I like to call it electron beam 
pasteurization because it is closer to a pasteurization process 
than it is to a radiation process. We are not using any kind of 
nuclear materials or anything like that for gamma rays. This is 
only electron beams. It is similar to the electron beams in a 
microwave, not quite the same, but similar. So to use that 
terminology is a holdover from the past when, in fact, it was a 
gamma ray radiation.
    Mr. Levitt. We did issue an advanced notice of proposed 
rulemaking and we will be proceeding ahead to kind of relook at 
the issue.
    Senator Harkin. Well, I hope so, because I think you----
    Mr. Levitt. I cannot say how that relook will come out, but 
I know there is a lot of interest, certainly from you, from a 
number of other members of the Congress. In our appropriations, 
I believe we are being directed to pursue vigorously ahead on 
that, and so we will be relooking at that issue.
    Senator Harkin. Do you not agree that, that is a 
significant step that can be used to significantly reduce 
pathogens in food and food products?
    Mr. Levitt. I would certainly agree. We have----
    Senator Harkin. That does not absolutely ensure it. 
Obviously, when it gets into consumers' hands, if they 
mishandle it, obviously, you cannot prevent that.
    Mr. Levitt. But again, you look at the numbers of and the 
scope of the problem. If we have a tool, whether it is food 
irradiation or other technologies, we need to be able to use 
those tools effectively to make the food supply as safe as 
possible--we are in 100-percent agreement on that.
    Senator Harkin. Well, this is just in the beginning and 
obviously there are storage, transportation, consumer 
information, ``Fight BAC,'' all the other things you and USDA 
are doing, which are good.
    Mr. Levitt. Right.
    Senator Harkin. But I am glad to hear you are moving ahead 
on that.
    On another topic, seafood--I am told that a large part of 
the seafood industry still fails to comply with the seafood 
HACCP rule that you have had for a couple of years now. In 
addition FDA still has not addressed concerns with mercury in 
seafood that Senator Leahy and I have repeatedly asked you to 
address.
    Two questions. Why is it taking so long to get seafood 
processors compliant with HACCP and what are your plans for 
addressing mercury in seafood?
    Mr. Levitt. Let me begin with seafood HACCP. Again, it is a 
little bit of a half empty, half full story. We believe that we 
are and the industry is making truly significant progress. We 
are dealing with an industry that prior to this regulation in 
December of 1997 was very much, if you will, in the old school 
of how to produce food, and we have worked through what we call 
a seafood HACCP alliance with training with the industry. We 
have produced something called the Fish and Fishery Products 
Hazards and Control Guide, which is an over 200-page manual 
addressing how to do seafood HACCP right.
    Now, we are dealing with over 150 species of fish and we 
are dealing with, for the most part, an industry with small 
businesses throughout. We recognize that and try to put into 
place, if you will, a progressive program, where year one we 
went out and inspected and the good news was out of the 4,000 
domestic processors, 1,000 got it right the first time, and we 
have a very rigorous rating system. We grade these plants on 11 
different types of hazards that could apply there, and if the 
company passes on ten and does not pass on the eleventh, they 
do not get an overall passing grade. So the overall grade is 
designed to encourage comprehensiveness in approach.
    The second year, we have got a lot of progress. The third 
year, we are seeing more. We are also losing patience. We also 
took our first enforcement action just a short time ago and we 
have entered into a consent decree of injunction with one 
company that simply was not getting it at all. And so there is 
a limit, that we feel if it is raising a public health issue, 
the company has had time, then we need to take the next step.
    But we feel that if you look at it as a whole, each year we 
are making clear progression. The industry is seeing it. There 
was an interesting survey done or study done--we did not even 
know anything about it--by a sea grant college up in 
Stonybrook, New York, which did their own survey of the 
industry. And what they found and documented was that, that 
industry is going through an entire thought change on what it 
means for food safety. They are looking and identifying their 
hazards. They are putting in, what are the control points that 
are critical? What are the limits that I have to meet? What is 
the verification? What is the monitoring? What is my built-in 
corrective action? This is an entirely new way of doing 
business.
    Based on what limited baseline data we had, we are 
progressing ahead. The reality is, we are probably on a 5-year 
plan to get to where everybody would like to be. But I think 
that we feel so long as we are seeing progress and that we 
should continue in this direction.
    At the same time, we have to realize maybe we need to make 
some mid-course corrections. We are doing that in two ways. 
Number one, we are looking and evaluating to say where are most 
of the problems we are seeing and really channel the next 
degree of training and inspections focusing on where the 
biggest problems are.
    Second, our program, seafood HACCP, has been cited for an 
inadequate amount of testing that is done, and beginning in 
this coming fiscal year--we actually started last year partway 
through the year to increase the testing, but we will be 
increasing our verification testing that FDA will be doing when 
we go out and inspect in the 2001 cycle. So we are trying to be 
responsive but also realize that if we are moving ahead, again, 
let us continue to press. We do not mind being tough graders. 
We think that is important. So again, we think the cup is half 
full and getting fuller, but we know it is a work in progress. 
We know we are not all the way there.
    Senator Harkin. I appreciate that. I think in your 
testimony you said that your HACCP requirement requires all 
4,100 seafood processors and 150 species of fish to complete 
HACCP systems.
    Mr. Levitt. Right.
    Senator Harkin. Beginning in 1998, your goal has been to 
inspect domestic seafood processors annually. Is that still 
your goal, just once a year?
    Mr. Levitt. Yes, and within our, if you will, world, that 
is----
    Senator Harkin. How would you feel if we just had meat and 
poultry inspections once a year, that someone came by a plant 
once a year?
    Mr. Levitt. That is really not my area.
    Senator Harkin. Well, I know it is not your area, but 
people eat seafood like they eat meat and poultry. Again, I am 
not taking you to task. What I am trying to do is to make a 
point. In your testimony, you said you cover 78-percent of all 
domestic and imported food. That means Agriculture does the 
other 22-percent.
    Mr. Levitt. Right.
    Senator Harkin. Yet their budget for food safety and 
inspection is, what, three times yours? So you are covering 
three times as much food with one-third as much money.
    Mr. Levitt. That is correct.
    Senator Harkin. Well, I am saying there is a problem there.
    Mr. Levitt. Right, and that is why we have been requesting 
increases, and I know you are a member of the Appropriations 
Committee and you have been supporting those.
    Senator Harkin. I sure have.
    Mr. Levitt. And as I said, I think that the investment is 
paying off.
    Senator Harkin. Let me ask you another pointed question, 
Mr. Levitt. How good is your tracing ability? If there is an 
outbreak of illness due to seafood, how good do you think your 
tracing ability is to trace it back to the source and to find 
out where other elements of that seafood may have been 
distributed?
    Mr. Levitt. I think in terms of ability--I will get to 
authority, but let us start with ability.
    Senator Harkin. Ability, yes.
    Mr. Levitt. Ability to do it is improving. We all think we 
need to continue to get better at it. That is both FDA in 
conjunction with CDC and the----
    Senator Harkin. Well, CDC obviously has a part of this, 
too.
    Mr. Levitt. Right, and the State and local health officials 
do, also. We are working hard at it and getting better at it, 
but it is difficult.
    Senator Harkin. It is my information--again, I could be 
corrected, and I ask Dr. Ostroff if he wants to chime in on 
this--that when it comes to meat and poultry, that the tracing 
ability, both of FSIS and CDC in conjunction with them, is 
pretty darn good. They can trace an outbreak back pretty well. 
But in terms of seafood, it is not that good. That is just my 
information and that is why I asked you the question.
    Mr. Levitt. Yes. Well, I mean, it kind of goes back to one 
of the initial perceptions----
    Senator Harkin. OK.
    Mr. Levitt.--which was probably true at the beginning of 
the century when the laws were set up, which is that the meat 
by its nature poses a greater hazard than the other products 
which are now regulated by FDA. And so different statutory 
systems were set up that were felt to be appropriate with each.
    What we are seeing today is that the hazards have changed, 
the foods implicated have changed, and we are needing to keep 
up and being sure all our programs are modernized, and I think 
you are speaking directly to the need for that.
    Senator Harkin. Exactly.
    Mr. Levitt. So I think we would agree.
    Senator Harkin. Thank you. I appreciate that. Thank you 
very much, Mr. Chairman. I know you have to move on. We could 
go on with this panel for a long time.
    The Chairman. Well, thank you. We could, indeed, and we 
really appreciate your working with us, really, throughout what 
has been an hour or more of testimony.
    Mr. Levitt. It was our pleasure. Thank you very much.
    The Chairman. Thank you for coming and for your 
achievements.
    Dr. Ostroff. And thank you for your attention to this 
matter. We appreciate it very much, Mr. Chairman.
    Mr. Levitt. Thank you.
    The Chairman. The Chair would like to call now a panel that 
will include Mr. Lawrence Dyckman, Director of the Food and 
Agriculture Issues at the U.S. General Accounting Office; Dr. 
Michael Doyle, Director of the Center for Food Safety and 
Quality Enhancement, University of Georgia, Griffin, Georgia, 
on behalf of the Council for Agricultural Science and 
Technology; Mr. Dane Bernard, Vice President, Food Safety 
Programs, National Food Processors Association, Washington, 
DC.; Dr. Donna Garren, Vice President of Scientific and 
Technical Affairs, United Fresh Fruit and Vegetable 
Association, Alexandria, Virginia; Dr. Gary Weber, Executive 
Director, Regulatory Affairs, National Cattlemen's Beef 
Association, Washington, DC.; Dr. Ann Hollingsworth, President 
of the American Meat Science Association, Carrollton, Georgia, 
on behalf of the American Meat Science Association and the 
American Meat Institute; Ms. Caroline Smith DeWaal, Director of 
Food Safety, Center for Science in the Public Interest, 
Washington, DC.; and Mohammad Akhter, MD, Executive Director of 
the American Public Health Association in Washington, DC.
    Senator Harkin. While these witnesses are taking their 
seats, I wonder if I might just ask Mr. Billy a question here. 
I am sorry I had to leave early. Mr. Billy, I am going to put 
this in the record but there is a report, and let me just read 
it to you. ``Using fluorescent spectroscopy, the ARS 
researchers and Iowa State University chemist Jacob W. Petrich 
built a detector that illuminates unseen fecal contamination on 
meat. Petrich says the device is adaptable to any size packing 
plant. As a hand-held unit, similar to a metal detectors used 
in airports, the instrument could alert meat packers to fecal 
contamination within seconds. The contaminated carcass could 
then be sanitized before the contamination spreads.'' Do you 
know about that and do you know if that technology is being 
utilized or what is being done with it?
    Mr. Billy. I am aware of the research that is going on and 
I think it is very promising, and I think it offers the 
potential to see changes in how we examine carcasses using that 
kind of technology. We are planning to hold another technology 
conference and feature that kind of new development. We think 
it is a terrific new development.
    Senator Harkin. Would you work with my staff on this? I 
want to see, if this technology really works, why are we not 
implementing this? This seems to me another device or another 
way we could use to really cut down on fecal contamination.
    Mr. Billy. Oh, I agree----
    Senator Harkin. I just wondered if you were aware of it.
    Mr. Billy.--and that is the source of a lot of pathogens, 
so it is a real--very vital area to what we are trying to do.
    Senator Harkin. Thank you, Mr. Billy. Thank you, Mr. 
Chairman, for indulging me.
    The Chairman. Thank you, Senator Harkin. Thank you again, 
Mr. Billy.
    I will ask you to testify in the order that I introduced 
you, and let me mention that, in fact, testifying on behalf of 
the American Public Health Association will be Dr. Richard 
Levinson.
    First of all, let me state that all of your testimony will 
be placed in the record in full and you need not ask or request 
that. It will be done. second, we will ask that you confine 
your initial comments to 5-minutes so that all can be heard and 
we can then get into a free-flowing comment here, as you 
witnessed with the previous panel.
    First of all, Dr. Doyle.

STATEMENT OF MICHAEL P. DOYLE, DIRECTOR, CENTER FOR FOOD SAFETY 
   AND QUALITY ENHANCEMENT, UNIVERSITY OF GEORGIA, GRIFFIN, 
GEORGIA; ON BEHALF OF THE COUNCIL FOR AGRICULTURAL SCIENCE AND 
                           TECHNOLOGY

    Mr. Doyle. Good morning and thank you, Mr. Chairman and 
members of the Committee. I appreciate the invitation to 
present testimony before the Senate Committee, especially as 
related to approaches to increase the microbiological safety of 
foods. I hope my testimony will be helpful in understanding the 
value of the HACCP approach to increasing the safety of foods 
and in identifying changes needed in the food safety system to 
aid in the reduction of microbial contamination.
    I am Michael Doyle, the Director of the Center for Food 
Safety and Quality Enhancement at the University of Georgia and 
my primary professional experience has been focused on research 
and developing methods to detect and control foodborne 
pathogens at all levels of the food continuum, from farm to 
table.
    My primary involvement in the topics of interest to this 
committee include membership on the Institute of Medicine 
Committee to ensure safe food from production to consumption 
and on the Council of Agriculture, Science, and Technology, 
task force on foodborne pathogens, risk, and consequences.
    I am testifying on behalf of CAST, which is a nonprofit 
consortium of 38 scientific societies representing more than 
180,000 scientists and many individual student, company, 
nonprofit, and associate society members. The mission of CAST 
is to identify food and fiber, environmental and other 
environmental issues, and to interpret related scientific 
research information for legislators, regulators, and the media 
for use in public policy decision making.
    Now the information I shall provide you largely has been 
extracted from three sources, and these include a CAST report 
on foodborne pathogens entitled ``A Review of 
Recommendations;'' a second CAST report which addresses 
foodborne pathogens, risks, and consequences; and a third 
report which deals with an Institute of Medicine report 
addressing ensuring safe food from production to consumption.
    A large variety of microorganisms having varied growth 
characteristics, unique niches in animals and processing 
facilities, and differing tolerances or sensitivities to food 
preservatives and processing treatments are responsible for an 
estimated 76-million-cases of foodborne illness annually in the 
United States. Considering the wide diversity of sources, 
tolerances, and growth properties of foodborne pathogens, there 
is no single process that can assure absolute safety of all 
foods and still retain desirable eating characteristics.
    For this reason, a science-based systematic approach that 
identifies and assesses the microbiological hazards and risks 
associated with food and incorporates effective treatments for 
their control was needed to effectively reduce the risk of 
foodborne illness. Hence, the HACCP system subsequently was 
developed to meet this need, largely through the efforts of the 
International Commission on Microbiological Specifications for 
Foods and through the USDA and FDA National Advisory Committee 
on Microbiological Criteria for Food.
    Many refinements and improvements of HACCP have been made 
since the HACCP concept was first introduced. However, the 
HACCP system is believed by the food safety community to be the 
best approach available both nationally and internationally for 
reducing the risk of foodborne illness. CAST recommends that 
HACCP principles be applied from farm or other production 
sources all the way through consumption.
    It should be recognized that HACCP is not a panacea. For 
example, not detect emerging hazards and no minimum level of 
safety is guaranteed. Furthermore, the HACCP approach is a 
dynamic process and refinements and adjustments will 
continually need to be made as new foodborne hazards are 
detected and processes are modified. A major limitation to the 
adoption of HACCP by food processors is that small firms have 
minimal resources to develop, implement, and maintain effective 
HACCP programs. Progress is being made at this level, but more 
resources may be needed to assist small processors in adopting 
the HACCP system.
    Under the current statutory and budgetary constraints, the 
benefits of HACCP systems cannot be fully realized. For 
example, current resources are inadequate to continue 
traditional inspection and to implement HACCP systems fully. A 
glaring defect in the present USDA meat and poultry inspection 
is that substantial resources are directed to problems that do 
not have the greatest health impact, for example, carcass-by-
carcass organoleptic visual or water detection, which is 
involved in the inspection of meat and poultry.
    The elimination of continuing inspection of meat and 
poultry would not necessarily end all anti-and postmortem 
inspections of carcasses if HACCP programs were appropriately 
developed and implemented. Such programs would have to include 
appropriate methods to identify diseased animals which might 
require some level of carcass inspection as identified by 
hazard analysis.
    An additional impediment to the application of HACCP to 
reduce the risk of foodborne illness is the failure of many 
segments of food production to adopt effective intervention 
strategies that can be used on the farm. When practical and 
effective intervention strategies on the farm and on-site 
preharvest levels are made available, food producers should be 
provided resources where needed and should be required to use 
such strategies in the interest of enhancing public health.
    An overarching impediment to improving efficient and 
effective regulatory attention to microbiological food safety 
issues is the major statutory shortfall that exists for our 
current system. Specifically, they are inconsistent, uneven, 
and at times archaic food statutes that inhibit the use of 
science-based decision making in activities related to food 
safety.
    Also, these statutes can be inconsistently interpreted and 
enforced among agencies. For example, the current directive 
embedded in statute requires that each meat and poultry carcass 
be subjected to physical inspection. Although physical 
inspection may have been appropriate for hazards present 70-
years-ago, the process impedes the FSIS efforts to allocate its 
substantial regulatory resources in ways that correspond to the 
health hazards presented by contemporary sources of food or 
modern means of food production and processing, specifically 
the implementation of HACCP-based inspection.
    In short, the hazards of greatest concern today are 
microbiological contamination and they are not readily 
detectable with the traditional inspection methods of sight, 
sound, odor, and touch. This regulatory statute impedes 
coherent risk-based regulation to enable implementation of a 
more science-based inspection system now available to 
regulatory agencies.
    Again, I thank you, Mr. Chairman, for this opportunity to 
comment on this very important issue and I would be happy to 
answer any questions.
    [The prepared statement of Mr. Doyle can be found in the 
appendix on page 124.]
    The Chairman. Thank you very much, Dr. Doyle.
    Let me mention that in introducing all of the witnesses, I 
neglected to mention that the Director of Food and Agriculture 
Issues at the U.S. General Accounting Office, Mr. Dyckman, is 
here, and he has two helpers with him, Mr. Oleson and Mr. 
Dobbins. I would like to hear now from you, Mr. Dyckman, and 
then we will proceed with the remainder of the panel of which 
Dr. Doyle was the first in line. Would you proceed with your 
testimony?

     STATEMENT OF LAWRENCE J. DYCKMAN, DIRECTOR, FOOD AND 
    AGRICULTURE ISSUES, RESOURCES, COMMUNITY, AND ECONOMIC 
     DEVELOPMENT DIVISION, U.S. GENERAL ACCOUNTING OFFICE, 
    WASHINGTON, DC.; ACCOMPANIED BY KEITH OLESON, ASSISTANT 
           DIRECTOR; AND BRAD DOBBINS, SENIOR ANALYST

    Mr. Dyckman. I am with distinguished company, so I am not 
at all offended, Senator.
    Mr. Oleson, to my left, is the Assistant Director who has 
done much of the food safety work over the last several years, 
and Mr. Dobbins from San Francisco also heads the effort that 
we are doing for you today.
    Mr. Chairman, we are pleased to be here today to provide an 
overview of the food safety expenditures by the Department of 
Agriculture's Food Safety and Inspection Service and the Food 
and Drug Administration. FSIS is responsible for ensuring the 
safety of meat, poultry, and processed egg products moving in 
interstate and foreign commerce and FDA oversees all other 
foods and animal drugs and feeds.
    As this committee and Senator Hagel requested, we are 
conducting a review to determine for fiscal years 1998 and 1999 
the amount of resources available to both of these agencies, 
how these resources were spent, and how much States are 
spending on food safety themselves.
    My testimony today presents an overview of our work to date 
on Federal agencies' expenditures. We have not finished our 
surveys of the States and will be reporting that to you in our 
final report.
    You have heard a lot of background about foodborne 
illnesses, so I will not bore you with the details or Senator 
Harkin. But I just want to repeat that the CDC estimates that 
there are 76-million illnesses. We took those estimates and we, 
from a much smaller number of illnesses reported to CDC for 
which the source of the illness was confirmed, we computed that 
85-percent, were associated with food products that FDA 
regulates and 15-percent with products under FSIS jurisdiction, 
and I think this has some relevance to the budgets that we will 
be talking about right now.
    FSIS spent about $678 million in 1998 and $712 million in 
1999 on food safety activities. Figure 1 in my full statement, 
and it is on page five, shows that about 84-percent of FSIS's 
1999 expenditures were for field activities. Inspections at 
slaughter, processing, and import establishments accounted for 
$486 million, or 68-percent of the total agency's expenditures. 
Field office administration, supervision, and compliance 
activities accounted for another $34 million. Also, the Office 
of Field Operations in Washington, DC., the office that manages 
field activities, spent another $80 million, of which $44 
million was in support of State inspections.
    FSIS headquarters-based activities accounted for $112 
million in 1999 or 16-percent of that agency's dollars. Four 
offices conduct these activities. There is the Office of 
Management, which spent about $62 million. Next comes the 
Office of Public Health and Science, spent about $25 million. 
The Office of Policy Program Development and Evaluation, about 
$19 million. And finally, the Office of the Administrator, and 
they spent about $6 million.
    Moving on to FDA's food expenditures, in 1998 and 1999, 
they spent about $231 and $260 million, respectively, obviously 
much less than FSIS. As shown in Figure 2, which is on page 
eight of my full statement, about $146 million, or 56-percent 
of fiscal year 1999 money, went to field activities. About 44-
percent went to headquarters activities involving three 
centers.
    The Office of Regulatory Affairs conducted field activities 
for FDA centers. Its staff conducts inspections and enforcement 
activities as well as criminal investigations, education, and 
outreach activities. For 1999, the office's work for the Center 
for Food Safety and Applied Nutrition totaled $134 million and 
work for the Center for Veterinary Medicine totalled about $12 
million.
    In aggregate, FDA's headquarters' based activities totaled 
$114 million and the vast majority went to the two centers I 
just mentioned.
    Now, Mr. Chairman, I would like to end with a perspective 
on some of the reasons for the relative size of FSIS and FDA's 
food safety budgets. Prior witnesses have touched upon this, 
but by legislation, FSIS must preapprove products under its 
jurisdiction before they can be marketed. It operates under a 
mandated inspection frequency that marks all inspected and 
approved meat, poultry, and egg products with a USDA inspection 
stamp so that they can be legally sold.
    In contrast, by law, FDA generally allows the food products 
it regulates to enter the market without preapproval. It has no 
mandated inspection frequency. As such, FDA inspects food 
establishments under its jurisdiction about once every 5-years 
and inspects only 1-percent of the almost 4-million annual 
imported food entries.
    Mr. Chairman, we plan to issue you and Senator Hagel a 
report in early 2001. We will include information on States and 
more analysis of these figures.
    This completes my prepared statement. My colleagues and I 
will be happy to answer any questions you or Senator Harkin 
have.
    [The prepared statement of Mr. Dyckman can be found in the 
appendix on page 109.]
    The Chairman. Thank you very much for your oral testimony, 
likewise for your very full statement. This is made a part of 
the record.
    Let me mention a procedural problem at this point. I am 
told, due to objections from Senator Murray and other Democrats 
on the Senate floor, there has been an objection to committees 
continuing past the hour of 11:30, which gives us 1-minute. Let 
me consult with my colleague, Senator Harkin. My idea would be, 
Tom, to proceed in this way, that we have already put into the 
record the full statement of all of our witnesses and at 11:30 
we will ask the stenographer and court reporter to cease 
operations, but the two of us might then continue to hear the 
witnesses and engage in colloquy with them because we 
appreciate your coming, taking time to come here. Your 
statements are going to be a part of our record and made 
available to everybody in a public manner. But at the same 
time, there may be some benefit to Senator Harkin and to myself 
from visiting with you informally, as we would be doing. Is 
that a satisfactory procedure?
    Senator Harkin. As long as we do not get hauled into court 
someplace.
    [Laughter.]
    The Chairman. I think this will suffice. The Committee has 
faced this problem before and we have usually overcome in about 
this manner.
    We will at this point bring the official hearing to a 
conclusion. The official hearing is adjourned.
    Senator Smith. Mr. Chairman?
    The Chairman. Yes?
    Senator Smith. Before we adjourn, may I include in the 
record my opening statement and perhaps a few questions I had 
for earlier witnesses?
    The Chairman. Yes, we will include that in the official 
record, Senator Smith's statement and his questions and ask 
witnesses to respond as rapidly as possible.
    [The prepared statement of Mr. Bernard can be found in the 
appendix on page 128.]
    [The prepared statement of Dr. Garren can be found in the 
appendix on page 134.]
    [The prepared statement of Dr. Weber can be found in the 
appendix on page 139.]
    [The prepared statement of Dr. Hollingsworth can be found 
in the appendix on page 147.]
    [The prepared statement of Ms. DeWaal can be found in the 
appendix on page 153.]
    [The prepared statement of Dr. Levinson can be found in the 
appendix on page 175.]
    The Chairman. Having said that, now we are officially 
adjourned and we move into an informal session.
    [Whereupon, at 11:30 a.m., the Committee was adjourned.]
      
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                            A P P E N D I X

                           September 20, 2000

      
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                           September 20, 2000

      
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             QUESTIONS AND ANSWERS SUBMITTED FOR THE RECORD

                           September 20, 2000

      
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