[Senate Hearing 106-948]
[From the U.S. Government Publishing Office]
S. Hrg. 106-948
HOW SHOULD OUR FOOD SAFETY SYSTEM ADDRESS MICROBIAL CONTAMINATION?
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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
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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
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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
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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
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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?
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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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DOCUMENTS SUBMITTED FOR THE RECORD
September 20, 2000
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QUESTIONS AND ANSWERS SUBMITTED FOR THE RECORD
September 20, 2000
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