U.S. GOVERNMENT PRINTING OFFICE

71–374 CC WASHINGTON : 2001

S. HRG. 106–948

HOW SHOULD OUR FOOD SAFETY SYSTEM

ADDRESS MICROBIAL CONTAMINATION?

HEARING

BEFORE THE

COMMITTEE ON AGRICULTURE,

NUTRITION, AND FORESTRY

UNITED STATES SENATE

ONE HUNDRED SIXTH CONGRESS

SECOND SESSION

ON

HOW SHOULD OUR FOOD SAFETY SYSTEM ADDRESS MICROBIAL

CONTAMINATION?

SEPTEMBER 20, 2000

Printed for the use of the

Committee on Agriculture, Nutrition, and Forestry

(

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

THAD COCHRAN, Mississippi

MITCH MCCONNELL, Kentucky

PAT ROBERTS, Kansas

PETER G. FITZGERALD, Illinois

CHARLES E. GRASSLEY, Iowa

LARRY E. CRAIG, Idaho

RICK SANTORUM, Pennsylvania

GORDON SMITH, Oregon

TOM HARKIN, Iowa

PATRICK J. LEAHY, Vermont

KENT CONRAD, North Dakota

THOMAS A. DASCHLE, South Dakota

MAX BAUCUS, Montana

J. ROBERT KERREY, Nebraska

TIM JOHNSON, South Dakota

BLANCHE L. LINCOLN, Arkansas

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)
(III)

C O N T E N T S

Page

HEARING:

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

APPENDIX:

Wednesday, September 20, 2000 ............................................................................ 49

DOCUMENT(S) SUBMITTED FOR THE RECORD:

Wednesday, September 20, 2000 ............................................................................ 181

QUESTION(S) AND ANSWERS SUBMITTED FOR THE RECORD:

Wednesday, September 20, 2000 ............................................................................ 203

Wednesday, September 20, 2000

STATEMENTS PRESENTED BY SENATORS

Lugar, Hon. Richard G., a U.S. Senator from Indiana, Chairman, Committee

on Agriculture, Nutrition, and Forestry ............................................................. 1

Harkin, Hon. Tom, a U.S. Senator from Iowa, Ranking Member, Committee

on Agriculture, Nutrition, and Forestry ............................................................. 10

Daschle, Hon. Tom, a U.S. Senator from South Dakota ...................................... 2

Kerrey, Hon. J. Robert, a U.S. Senator from Nebraska ....................................... 13

Miller, Hon. Zell, a U.S. Senator from Georgia ..................................................... 4

WITNESSES

Glickman, Hon. Dan, Secretary, U.S. Department of Agriculture, Washington,

DC., accompanied by Catherine E. Woteki, Under Secretary for Food Safety,

and Thomas J. Bill, Food Safety and Inspection Service Administrator ......... 5

PANEL I

Levitt, Joseph A. Esq., Director, center for Food Safety and Applied Nutrition,

Food and Drug Administration, Washington, DC. ............................................ 25

Ostroff, Stephen M. Dr., Associate Director for Epidemiologic Science, National Center for Infectious Diseases, centers for Disease Control and Prevention, Atlanta, GA. ........................................................................................... 26

PANEL II

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

and Brad Dobbins, Senior Analyst ..................................................................... 44
Page

IV

PANEL III

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

Agricultural Science and Technology ................................................................. 42

APPENDIX

PREPARED STATEMENTS:

Lugar, Hon. Richard G. .................................................................................... 50

Harkin, Hon. Tom ............................................................................................ 51

Daschle, Hon. Tom ........................................................................................... 53

Roberts, Hon. Pat ............................................................................................. 56

Leahy, Hon. Patrick J. ..................................................................................... 57

Bernard, Dane .................................................................................................. 128

DeWaal, Caroline Smith .................................................................................. 153

Doyle, Michael .................................................................................................. 124

Dyckman, Lawrence ......................................................................................... 109

Garren, Donna .................................................................................................. 134

Glickman, Dan .................................................................................................. 62

Hollingsworth, Ann .......................................................................................... 147

Levinson, Richard ............................................................................................. 175

Levitt, Joseph A. ............................................................................................... 71

Ostroff, Stephen M. .......................................................................................... 94

Weber, Gary ...................................................................................................... 139

DOCUMENT(S) SUBMITTED FOR THE RECORD:

The Role of Microbiological Testing in Beef Food Safety Programs, submitted by Ann Hollingsworth ...................................................................... 182

Pamphlet: Preventing Emerging Infectious Disease, submitted by Richard

Levinson, MD, DPA (retained in the Committee files) ..............................

Emerging Infectious Diseases: A Public Health Response, submitted by

Richard Levinson, MD, DPA (retained in the Committee files) ................
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HOW SHOULD OUR FOOD SAFETY SYSTEM

ADDRESS MICROBIAL CONTAMINATION?

WEDNESDAY, SEPTEMBER 20, 2000

U.S. SENATE, COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY, Washington, DC.

The Committee met, pursuant to notice, at 9:00 a.m., in room

SR–328A, Russell Senate Office Building, Hon. Richard G. Lugar,

(Chairman of the Committee), presiding.

Present or submitting a statement: Senators Lugar, Smith, Harkin, Leahy, Daschle, Kerrey, and Miller.

OPENING STATEMENT OF HON. RICHARD G. LUGAR, A U.S.

SENATOR FROM INDIANA, CHAIRMAN, COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY

The CHAIRMAN. This hearing of the Senate Agriculture Committee is called to order. Today, the Committee holds an important

hearing to review our food safety system and how it addresses microbial contamination. We will hear from a number of scientific experts and representatives of the Federal Government and the consumer and public health community. We are hopeful today’s hearing will help the Committee gather answers to these questions.

Microbial contamination is the most significant threat to our food

safety system. What are the food safety responsibilities of the Federal Government and the private sector related to microbial contamination? What is the value of the Hazard Analysis and Critical

Control Points [HACCP], HACCP, approach to food safety and addressing microbial contamination? And what are the barriers to the

development and implementation of the new technologies and tools

to detect, prevent, and reduce microbial contamination? Are

changes needed in the food safety system to aid in that detection,

prevention, and reduction?

Obviously, we know that all of the witnesses will not be able to

address all of the questions, but we will be interested in hearing

different perspectives from each of a number of distinguished witnesses today.

At this hearing, we now look forward to hearing the testimony

from our Secretary of Agriculture and officials from the Food and

Drug Administration and the Centers for Disease Control and Prevention about the responsibilities of the Federal Government. We

will also hear findings from the General Accounting Office about a

food safety resources project that Senators Harkin, Hagel, and myself requested last year. And finally, we will learn food safety perspectives from representatives of academia and scientific studies,
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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
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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
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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,
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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
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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
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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-theline 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
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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
9

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 base-
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line 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
11

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
12

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——
13

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.
14

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
15

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 require-
16

ments 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
17

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.
18

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.
19

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
20

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——
21

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
22

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.
23

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
24

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.
25

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
26

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
27

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.
28

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
29

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?
30

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
31

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.
32

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
33

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 con-
34

cerns 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.
35

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?
36

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
37

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.
38

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
39

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?
40

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.
41

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——
42

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.
43

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 strate-
44

gies 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 HACCPbased 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 Ag-
45

riculture’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.
46

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.
47

[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

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DOCUMENTS SUBMITTED FOR THE RECORD

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QUESTIONS AND ANSWERS SUBMITTED FOR THE

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