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76–804 PDF 2002

S. Hrg. 107–210

FOOD SAFETY AND SECURITY: CAN OUR FRACTURED FOOD SAFETY SYSTEM RISE TO THE

CHALLENGE?

HEARING

BEFORE THE

OVERSIGHT OF GOVERNMENT MANAGEMENT,

RESTRUCTURING, AND THE DISTRICT OF COLUMBIA

SUBCOMMITTEE

OF THE

COMMITTEE ON

GOVERNMENTAL AFFAIRS

UNITED STATES SENATE

ONE HUNDRED SEVENTH CONGRESS

FIRST SESSION

OCTOBER 10, 2001

Printed for the use of the Committee on Governmental Affairs

(

(II)

COMMITTEE ON GOVERNMENTAL AFFAIRS

JOSEPH I. LIEBERMAN, Connecticut, Chairman

CARL LEVIN, Michigan

DANIEL K. AKAKA, Hawaii

RICHARD J. DURBIN, Illinois

ROBERT G. TORRICELLI, New Jersey

MAX CLELAND, Georgia

THOMAS R. CARPER, Delaware

JEAN CARNAHAN, Missouri

MARK DAYTON, Minnesota

FRED THOMPSON, Tennessee

TED STEVENS, Alaska

SUSAN M. COLLINS, Maine

GEORGE V. VOINOVICH, Ohio

PETE V. DOMENICI, New Mexico

THAD COCHRAN, Mississippi

ROBERT F. BENNETT, Utah

JIM BUNNING, Kentucky

JOYCE A. RECHTSCHAFFEN, Staff Director and Counsel

HANNAH S. SISTARE, Minority Staff Director and Counsel

DARLA D. CASSELL, Chief Clerk

SUBCOMMITTEE ON OVERSIGHT OF GOVERNMENT MANAGEMENT,

RESTRUCTURING, AND THE DISTRICT OF COLUMBIA

RICHARD J. DURBIN, Illinois, Chairman

DANIEL K. AKAKA, Hawaii

ROBERT G. TORRICELLI, New Jersey

THOMAS R. CARPER, Delaware

JEAN CARNAHAN, Missouri

MARK DAYTON, Minnesota

GEORGE V. VOINOVICH, Ohio

TED STEVENS, Alaska

SUSAN M. COLLINS, Maine

PETE V. DOMENICI, New Mexico

THAD COCHRAN, Mississippi

MARIANNE CLIFFORD UPTON, Staff Director and Chief Counsel

ANDREW RICHARDSON, Minority Staff Director

JULIE L. VINCENT, Chief Clerk

(III)

C O N T E N T S

Page

Opening statements:

Senator Durbin ................................................................................................. 1

Senator Voinovich ............................................................................................. 23

WITNESSES

WEDNESDAY, OCTOBER 10, 2001

Robert A. Robinson, Managing Director, accompanied by Keith W. Oleson,

Assistant Director, Natural Resources and the Environment, U.S. General

Accounting Office ................................................................................................. 4

Hon. Rose L. DeLauro, a Representative in Congress from the State of Connecticut .................................................................................................................. 7

Hon. Elsa Murano, Ph.D., Under Secretary of Agriculture for Food Safety,

U.S. Department of Agriculture .......................................................................... 10

Bernard Schwetz, Ph.D., D.V.M., Acting Principal Deputy Commissioner,

Food and Drug Administration, U.S. Department of Health and Human

Services, accompanied by Joseph A. Levitt, Director, Center for Food Safety

and Applied Nutrition, Food and Drug Administration, U.S. Department

of Health and Human Services ........................................................................... 13

Hon. Dan Glickman, Akin, Gump, Strauss, Hauer & Feld, L.L.P., former

Secretary of Agriculture, U.S. Department of Agriculture ............................... 15

Michael F. Jacobson, Ph.D., Executive Director, Center for Science in the

Public Interest ...................................................................................................... 27

John Cady, President and Chief Executive Officer, National Food Processors

Association ............................................................................................................ 28

Peter Chalk, Ph.D., Policy Analyst, RAND Corporation ...................................... 30

C. Manly Molpus, President and Chief Executive Officer, Grocery Manufacturers of America ................................................................................................. 31

Tim Hammonds, President and Chief Executive Officer, Food Marketing Institute ........................................................................................................................ 33

ALPHABETICAL LIST OF WITNESSES

Cady, John:

Testimony .......................................................................................................... 28

Prepared statement .......................................................................................... 108

Chalk, Peter, Ph.D.:

Testimony .......................................................................................................... 30

Prepared statement .......................................................................................... 113

DeLauro, Hon. Rose L:

Testimony .......................................................................................................... 7

Prepared statement .......................................................................................... 66

Glickman, Hon. Dan:

Testimony .......................................................................................................... 15

Prepared statement .......................................................................................... 94

Hammonds, Tim:

Testimony .......................................................................................................... 33

Prepared statement with an attachment ....................................................... 138

Jacobson, Michael F., Ph.D.:

Testimony .......................................................................................................... 27

Prepared statement .......................................................................................... 100

Molpus, C. Manly:

Testimony .......................................................................................................... 31

Prepared statement .......................................................................................... 127

Page

IV

Murano, Hon. Elsa, Ph.D.:

Testimony .......................................................................................................... 10

Prepared statement .......................................................................................... 68

Robinson, Robert A.:

Testimony .......................................................................................................... 4

Prepared statement .......................................................................................... 45

Schwetz, Bernard, Ph.D., D.V.M.:

Testimony .......................................................................................................... 13

Prepared statement .......................................................................................... 74

APPENDIX

United Food and Commercial Workers International Union (UFCW), prepared

statement .............................................................................................................. 149

(1)

FOOD SAFETY AND SECURITY: CAN OUR

FRACTURED FOOD SAFETY SYSTEM RISE

TO THE CHALLENGE?

WEDNESDAY, OCTOBER 10, 2001

U.S. SENATE,

OVERSIGHT OF GOVERNMENT MANAGEMENT,

RESTRUCTURING, AND THE DISTRICT OF COLUMBIA,

OF THE COMMITTEE ON GOVERNMENTAL AFFAIRS, Washington, DC.

The Subcommittee met, pursuant to notice, at 1 p.m., in room

SD–342, Dirksen Senate Office Building, Hon. Richard Durbin,

Chairman of the Subcommittee, presiding.

Present: Senators Durbin and Voinovich.

OPENING STATEMENT OF SENATOR DURBIN

Senator DURBIN. This hearing will come to order. I thank you all

for coming today to discuss issues of food safety and security. Some

of my colleagues are running a little bit late. This has been an unusual morning because we had a memorial service for Senator

Mike Mansfield. Most of us have just gotten off the buses and

many of my colleagues had to quickly return to their offices. They

will be joining us in a few minutes. They are running a little bit

late, but I thank you all for coming today.

The hearing will come to order and good afternoon. I am pleased

to welcome you to this hearing of the Senate Subcommittee on the

Oversight of Government Management. We are going to focus on

food safety and security and the question: Can our fractured food

safety system rise to today’s challenge? Let me say at the outset— and will say repeatedly—we have the safest food supply in the

world. That is something that bears repeating, because even

though we are raising questions about how to improve the system,

we start off with a food supply that is second to none. The question

which we are going to be asking ourselves today is whether or not

we can improve the system.

For many years now, I have worked on this issue, of food safety

focusing on questions which involve hazards in food that are naturally occurring that can be avoided with appropriate inspection and

processing. In the last several weeks this conversation has

changed. It is no longer just about food safety. It is about food security, and that is one of the aspects which we also have to take into

account. That is one of the reasons why I wanted to bring this

group together today.

2

Our government structure divides responsibility for food safety

and security between at least a dozen Federal agencies operating

under 35 different Federal statutes. It is a system of divided responsibility. It is a system of rivalry, in some aspects, when it

should be one of cooperation. It is duplicative, it is costly and it is

unduly complicated. It is impossible to explain. In an age where

our Nation’s food supply is facing tremendous pressure from emerging pathogens to an ever-growing volume of food imports, from

changing food consumption patterns to an aging population susceptible to food-related illness and even potential food security risks,

we must have a system in place to ensure the safety of our food.

Now is the time to fundamentally set the course for a food safety

system that is not only more efficient and effective, but one based

on science, with the promise of sustaining the confidence of the

consuming public. It is time for our government to have a single

food safety agency. I do not believe there is a person in this room

or in this city or this Nation that would say to us today that if they

had to invent a food safety system, they would invent what we

have in place.

Make no mistake, as I said, our country is blessed with safe and

abundant food supplies, but we can do better. Foodborne illness is

a significant problem. While food may never be completely free of

risk, we have to strive to make our food as safe as possible. Americans at every level, Federal, State and local, industry and the consuming public, share this responsibility. The Center for Disease

Control estimates that as many as 76 million Americans will suffer

food poisoning this year. Of those individuals, 325,000 will be hospitalized, and more than 5,000 will die. Children and the elderly

are especially vulnerable.

In terms of medical costs and productivity losses, foodborne illnesses cost the Nation billions of dollars annually. The situation is

not going to improve without decisive action. In fact, the Department of Health and Human Services predicts that foodborne illnesses and deaths will increase 10 to 15 percent over the next decade from natural hazards. Over the past 25 years, the GAO and

other organizations, including the National Academy of Sciences,

have issued report after report describing the problems with Federal food safety oversight and the need for a single food agency.

These organizations have made many recommendations for change.

I think it is time we make that fundamental lasting change that

GAO has asked for. We need that single food agency. I introduced

the Safe Food Act of 2001 last week. It combines the functions of

USDA’s Food Safety and Inspection Service, the FDA’s Center for

Food Safety and Applied Nutrition, FDA’s Center for Veterinary

Medicine, the Department of Commerce’s seafood inspection program, and the food safety functions of several other Federal agencies. This new agency will be funded by the combined budgets of

the consolidated agencies.

Following the events of September 11, we are more keenly focused on how varied aspects of America’s homeland security, including our Nation’s food supply, may be vulnerable to attack. Our

Federal food safety system must be able to prevent potential food

hazards from reaching the public. We must establish procedures on

the farm and during the various stages of food processing to ensure

3

that no form of deliberate contamination reaches consumers. We

also have to critically examine our import procedures to determine

if they are adequate to protect the public from food-safety threats.

A single food agency will help ensure that we have a cohesive process in place.

Last night, I met with David Byrne, who is the Health and Consumer Products Commissioner for the European Union. He is a

man I met several years ago at a St. Patrick’s Day parade in Chicago—he reminded me of that. He is trying at this point in time

to establish this type of agency for the European Union. Now is the

time for us to start that dialogue with the European Union, to continue a dialogue that may have started before, but in more earnest

and sincere terms. As we look around the world to those countries

which seek to import from the United States and export to our

country, we have to establish some meaningful, scientific, reasonable standards, so that we know the product that is moving across

the border is safe for everyone.

Overlapping jurisdictions of Federal agencies have really lessened accountability. A single agency focuses our policy and improves our enforcement. Let me just say that research could be better coordinated, as well, with a single agency. Currently Federal

funding for food safety research is spread over more than a dozen

different Federal agencies, and coordination is very limited. New

technologies to improve food safety could be approved more rapidly

with one food safety agency. Currently, food safety technologies

must go through multiple agencies for approval, often adding years

of delay.

With the incidence of food recalls on the rise, it is important to

move beyond short-term solutions. A single agency could more easily work toward long-term solutions. In this era of limited budgets,

it is our responsibility to modernize and streamline the system.

This Subcommittee has been discussing the weaknesses of the Federal food safety system for decades. I have not been here in that

discussion for decades, but it has been going on that long. It is time

to move forward. Let’s stop discussing the need and actually make

it happen. I am encouraging my colleagues on both sides of the

aisle to help me to consolidate the food safety and security functions.

At this point I was going to recognize Congresswoman Rosa

DeLauro, who I understand is on the way and may be here momentarily. When she does, I am going to invite her to come up and

speak and interrupt the panel that may be speaking at the time—

I hope everyone will understand—because of her schedule. Let me

at this point welcome our first panel then. Robert Robinson is the

Managing Director of Natural Resources and Environment with the

U.S. General Accounting Office. He is accompanied by Keith

Oleson, who is the Assistant Director of GAO’s Natural Resources

and Environment Division. Thank you for being here. We look forward to your testimony. It is customary for the Subcommittee to

swear in all of our witnesses. So, if you would not mind standing,

do you swear that the testimony you are about to give is the whole

truth, and nothing but the truth, so help you, God?

Mr. ROBINSON. Yes, sir.

Mr. OLESON. Yes, sir.

4

1The prepared statement of Mr. Robinson appears in the Appendix on page 45.

Senator DURBIN. Thank you very much. Let me note for the

record that the witnesses answered in the affirmative. Please, if

you could limit your oral statements so that we can follow up with

some questions——

Mr. Robinson.

TESTIMONY OF ROBERT ROBINSON,1 MANAGING DIRECTOR,

ACCOMPANIED BY KEITH W. OLESON, ASSISTANT DIRECTOR,

NATURAL RESOURCES AND THE ENVIRONMENT, U.S. GENERAL ACCOUNTING OFFICE

Mr. ROBINSON. Thank you, Mr. Chairman, for this opportunity to

weigh in on this matter of real national importance. As you know

and have just mentioned, GAO has long called for the establishment of a single food safety agency responsible for implementing

uniform and risk-based food safety legislation. I am here today to

renew this call.

While we believe the case for such action has been compelling for

some time, recent tragic events and the increased threats these actions portend for the future make the need for action all the more

imperative. While the American food supply is generally safe, the

5,000 deaths and millions of illnesses attributed to foodborne

pathogens each year provide ample evidence that the system needs

improvement. The current regulatory system did not emerge from

a comprehensive design, but rather was cobbled together piecemeal

over many years. The patchwork that now exists hampers efforts

to adequately address existing and emerging food safety threats,

whether those risks involved inadvertent or deliberate contamination.

It has also led to an inefficient and inflexible deployment of resources, as well as inconsistent oversight and enforcement of products with comparable risk. With respect to resources, the current

deployment is not particularly rational and certainly is not riskbased. FSIS and USDA spends about 70 percent of the Federal food

safety regulatory dollar inspecting on a daily basis about 6,000

meat, poultry and egg establishments that collectively produce

about 20 percent of federally-regulated foods. FDA, on the other

hand, has less than half of FSIS’s funding to oversee about 10

times more food production facilities and about four times more

federally-regulated foods.

In this context, the resulting oversight of food production is quite

inconsistent. Over the years, as I am sure you are aware, we have

used a number of food items, including canned soup and frozen

pizza, to put a specific face on the systems of irrationality. This

time we will use a packaged sandwich. As you can see from our

graphic, if you are producing a packaged open-faced meat or poultry sandwich, you get inspected daily by FSIS. If, on the other

hand——

Senator DURBIN. Part of the Department of Agriculture?

Mr. ROBINSON. Yes. If, on the other hand, you are producing a

closed-face sandwich with identical ingredients, you get inspected

by FDA on average once every 5 years.

5

The current fragmented structure also has implications for food

imports, an area of growing importance to our food supply. FSIS

and FDA employ vastly different approaches. On the one hand,

meat and poultry cannot be exported to the United States unless

FSIS has determined that the exporting country has an equivalent

food safety system. This allows FSIS to leverage its inspection resources. Also, until FSIS approves the release of imported products,

they generally must be kept in a registered warehouse. Unlike

FSIS, however, FDA does not have authority to require equivalency

agreements and is thereby forced to rely on widely discredited portof-entry inspections. Also, because FDA does not control imported

foods prior to its approval for release, some adulterated imports

have been released into U.S. commerce.

Now, of course, overhanging these long-standing limitations in

the current food safety system is the prospect of deliberate terrorist

contamination. The likelihood of such an attack is unknown. In a

recent report we identified only two acts of deliberate food supply

contamination over the past 15 years. However, based on the nature of our food system and the weaknesses we have already identified, we believe there is reason to doubt our system’s ability to detect and quickly respond to an orchestrated bioterrorist attack. The

U.S. food distribution system moves food from production to markets in hours. Even if contamination was detected by the extremely

limited testing that occurs, vast amounts could already be in the

hands of consumers. Furthermore, even if the current surveillance

system worked as intended, the problem would not be typically

identified until multiple illnesses were reported.

Our fragmented system would compound these inherent difficulties; for example, determining which Federal agency was responsible for responding could take precious time when speedy action

would be absolutely essential. Similarly, split responsibility could

impede timely laboratory testing and the ability to marshal the full

range of Federal resources. Mr. Chairman, as you have mentioned,

while no system can be foolproof, the fragmented system now in

place is simply not good enough. A single food safety agency is

needed now more than ever. In this regard, we are gratified to note

that consolidation of food safety activities is supported by the National Academy of Sciences, the President’s Council on Food Safety

and a large number of former food safety officials. It is also consistent with the recent actions taken by a number of other nations,

including Canada, Great Britain, Denmark, and Ireland.

Before concluding, I also want to make you aware of related work

that you may find useful. This work was performed by us in 1998

when we issued a classified report to the full Committee that laid

out the vulnerability of U.S. agriculture to a biological attack. We

have updated that work and have prepared a classified briefing.

The team is here and can present the information in a closed environment whenever called upon.

Thank you.

Senator DURBIN. Thanks, Mr. Robinson, and I will take you up

on that, which, of course, will not be today, but we will do it in a

different setting. You made reference to U.S. Department of Agriculture. Our former Secretary is here and many of us have worked

with that Department and think very highly of it. I have equally

6

high regard for the Food and Drug Administration. Many people

argue that we are dealing with two different cultures between

these agencies, in terms of the way they look at their responsibility. As the GAO took a look at food inspection, did you note any

differences in approach or application of science or different cultures?

Mr. ROBINSON. Well, differences in approach are pretty much

across the board, and a lot of it has to do with different legislative

authorities and requirements. Practically on every front, the authorities are different and, hence, the approaches almost necessarily are different. You could pretty much go down the line and

identify those differences.

Senator DURBIN. Let’s get down to basics. Some argue that the

U.S. Department of Agriculture, because it has a responsibility to

promote the products, consumption and the like, is not in a good

position to be a watchdog over the agencies and the Department—

the facilities and the businesses that it regulates through this inspection, whereas FDA takes a much different approach when it

comes to approvals for medical devices and pharmaceuticals and

the like. Did you note that in the GAO review of this process?

Mr. ROBINSON. Yes. This goes to the basic rationale that finally

led us to conclude that an independent agency was the way to go.

USDA fundamentally has the FAA problem. The same agency that

is responsible for promoting the industry is also responsible for regulating the safety of the product, obviously conflicting interests.

FDA, on the other hand, has a situation where the bulk of its resources have usually been devoted to the ‘‘D’’ part of the agency,

leaving the ‘‘F’’ part of the agency in somewhat more of a stepchild

environment when resource allocations decisions were to be made.

So there is a fundamental——

Senator DURBIN. When I took a look at this issue to try to determine how we can move from where we are today to a single food

agency, it was really tough to find a lot of parallels. The closest I

could find was the creation of the Environmental Protection Agency, where we took a lot of different agencies and brought them together under one roof with one mission, and if I am not mistaken,

it also involved a transition period before the EPA could really

open its doors and get down to business. Do you have any thoughts

on that aspect, moving from where we are today to a single food

agency? Have you seen any examples in other countries where they

have tried to accomplish this?

Mr. ROBINSON. Yes, a few years ago we did joint work with our

Canadian Office of Auditor General counterparts. We issued a joint

report with them on food import controls, and that report led the

Canadians to take action. They have moved pretty aggressively or

much more aggressively than we have to establish a single food

safety agency and although early, the signs seem to be positive. As

I mentioned in my statement, the British have moved in that direction, as have other Nations and the EU is now considering it, as

you mentioned.

I think the arguments are so compelling—the inefficiencies and

the gaps and the overlaps are so obvious it almost raises the question as to what is holding the move to rationality back. There

7

1The prepared statement of Ms. DeLauro appears in the Appendix on page 66.

seems to be growing conceptual agreement on the basic decision of

consolidation. What remains to be worked out is the details.

Senator DURBIN. There are three things holding us back. I can

tell you what they are: One is Congress, where committees have jurisdiction and do not want to give it up; the other would be the

agencies currently involved that are fearful of losing jurisdiction;

and the third are people who are regulated. They are fearful of

change. You put those three together and you can explain why for

30 or 40 years this grand idea has gone nowhere. Maybe the events

of September 11 will give us the impetus to change.

One last question before I recognize my friend, Congresswoman

DeLauro. You made a reference to the international aspect of this

and clearly that is something we have to take into account, and you

noted that the FDA, aside from random border inspection, frankly

does not do much by way of inspecting food production overseas; is

that correct?

Mr. ROBINSON. Yes. I think currently it is about 1 percent of imports under their jurisdiction are inspected. With additional resources that have been requested, that percentage could rise a few

points. But essentially you have to ask yourself if raising that inspection level from 1 percent to 3 percent—it does not move you

a lot further down the road; whereas I think leveraging resources,

like FSIS is allowed to do, to ensure that foreign nations that will

be the source of our food imports have installed systems comparable to ours and are implementing those systems based on testing, is a far more efficient way, and I think, ultimately much more

effective and a more confidence-inducing way of proceeding.

Senator DURBIN. Well, I have taken a big enough task, dealing

with trying to consolidate our domestic food safety inspection, but

I really believe, as I said at the outset, that this should be discussed in a global context. As we are talking about our allies now

who are struggling against terrorism worldwide, I think we can

find the same type of alliances when it comes to food safety and

security, so that trade can continue with peace of mind. My conversations yesterday with the European Union led me to believe

that they are ready for this, as well. It not only will help us when

it comes to food safety and security, but in trying to find some common ground and resolution to many other intractable food safety

issues between the EU and the United States. I hope that will be

part of it.

If I could ask you and Mr. Oleson to just stay where you are for

a moment, I am going to turn over the microphone to my friend,

Congresswoman DeLauro, who has been a leader on this issue in

the House. Thank you for coming.

TESTIMONY OF HON. ROSA L. DELAURO,1 A REPRESENTATIVE

IN CONGRESS FROM THE STATE OF CONNECTICUT

Ms. DELAURO. Thank you so very much, Mr. Chairman and my

good friend. I apologize to my colleagues at the table. I will try to

be brief. I would just like to say to my colleague, the Chairman,

Senator Durbin, that it has been an honor and a pleasure to work

with him. I sat on the Agricultural Appropriations Committee

8

when Senator Durbin was the chair over there. This is an issue in

which he has really taken such a leadership role, and I am pleased

that we are going to continue to work on this effort, and I am

grateful to hear about your conversations with the European Union

as to what we might be doing with our allies overseas.

Our Nation’s food safety is of critical importance, we all agree

with that. The Center for Disease Control and Prevention says that

each year 76 million people get sick and 5,000 people die from a

food-related illness. I had a personal experience with this problem.

When I was a child I contracted Salmonella. I was hospitalized for

almost 2 weeks. I was so young that I did not know why my parents had put me into this situation, away from them and so forth,

and I am told, though I do not remember, that I refused to talk

to them when I did get out of the hospital.

The numbers are staggering nationwide, of people getting sick

and people who are dying, and they do not include a vast number

of unreported illnesses. The situation is not going to improve without some decisive action. Also, in terms of what happened on September 11, we need to be concerned about the safety of our food

from a bioterrorist attack. According to Raymond Zilinskas, who is

a senior scientist with the Monterey Institute of International

Studies, the most likely scenario for a biological weapons attack

would be foodborne or beverageborne attack, using Salmonella,

Shigella, or Staphylococcal toxins.

Tommy Thompson, the Secretary of Health and Human Services,

on October 3 submitted a request to OMB for additional money for

bioterrorism programs. In addition to other priorities, he identified

food safety as a vital area that needs to be addressed. The Secretary has requested money for 200 imported food inspectors and

100 domestic food inspectors. I might add that several months ago

on the debate on this year’s agricultural appropriation, I offered an

amendment, which would have provided $90 million for 1,600 FDA

inspectors for imported food and $73 million for 630 domestic inspectors. It was defeated, but I think now more than ever we have

to go back to that effort.

Clearly, what we need is to have a comprehensive strategy, a

unified strategy. There are several agencies with different and conflicting missions that ensure our food safety. There is no standardization for inspections. Processed food facilities may see an FDA inspector once every 5 to 6 years. Meat and poultry is inspected

daily. We need to do something. Everyone here is agreeing.

In 1998 the National Academy of Sciences’ study concluded that,

‘‘A model food safety system would have a unified mission, a single

official who is responsible for food safety at the Federal level and

who has the authority and the resources to implement sciencebased policy and all Federal activities related to food safety.’’ It

makes sense in order to protect our food supply to consolidate food

safety activities into a single agency. I introduced the legislation in

the House of Representatives, like my colleague on the Senate side.

It establishes that independent agency with responsibility for all

Federal food safety activities. It would transfer food safety inspection and food labeling activities to a new agency from the several

agencies that now are engaged in that process.

9

We have 32 co-sponsors of the legislation. It is bipartisan. People

understand that this is the direction that we need to move in. This

is just plain good government, in my view. I might also add, in his

campaign President Bush publicly supported the idea of uniting all

food safety responsibility under one agency. On June 9, he said in

Philadelphia, ‘‘The Federal Government is responsible for the safety of our Nation’s food supply. The way things work now, there is

one agency that inspects cheese pizza. There is another that inspects pepperoni pizza. There is one agency that inspects food

grown outside of the United States, another for food grown here inside the United States. Apparently the revolutionary idea that

maybe these functions could be combined has not dawned on anybody yet.’’ It is time to create a 21st Century approach to our food safety

system, particularly because we have got this problem in the

United States, but globalization, aging population, faster production, distribution of food increases people being at risk. I thank you

for the opportunity to have me here today to testify. This is good

common sense. I look forward to working with my colleague on

this. I thank you again for your leadership and I thank you for letting me cut into the line.

Senator DURBIN. Congresswoman DeLauro, thank you and I

know your beeper went off, so you are going to have to make a mad

dash. I would just say that the one thing that we have to step back

and do—so many times now on Capitol Hill—is say if terrorism disappeared tomorrow and our prayers were answered, would this still

be a good idea? I think the answer is clearly yes, but terrorism has

not disappeared and we have to put it into the equation now. I

think it really adds an element of immediacy to this debate and

perhaps it will move us off dead center, where we have been too

long. Thank you for your leadership in the House. You are excused.

Thank you very much.

Mr. Robinson, I understand that some of the people who have

headed up these agencies in the past at FSIS and FDA, once liberated from government service, have announced that they always

thought this was a pretty good idea. Have you run into that?

Mr. ROBINSON. We have obviously done some exploration with individuals and touched base with eight or ten folks, and I think is

a pretty clear consensus, as I mentioned earlier, that conceptually,

consolidation makes all the sense in the world and it ought to be

pursued aggressively.

I do want to make the point, though, it is not just consolidation

of bureaucracies. You have 35 laws, as you mentioned, out there

that also need to be rationalized. The basis for a lot of action is legislative in nature, and that is going to have to be addressed to

make a single food safety agency realize the promise that so many

of us believe it can.

Senator DURBIN. Thank you.

Mr. Oleson, is there anything you would like to add?

Mr. OLESON. The individuals we contacted, former administrators of FSIS and former commissioners of FDA, former Under Secretary of Agriculture, former Secretary of Agriculture, all concur

that consolidation needs to take place and they all agree that one

thing that should be consolidated is the inspection activities, at

10

1The prepared statement of Ms. Murano appears in the Appendix on page 68.

least. There are some differences after we get past that on what

should be included, but inspection is one you can start with, as

your bill clearly recognizes, Senator.

Senator DURBIN. Good. I appreciate both of you coming today.

Thank you very much for your testimony and continued work.

Maybe before GAO does another couple dozen reports making this

recommendation, Congress will actually do something.

Mr. ROBINSON. Well, the paper on the 1992 report, our first one

on the subject, is starting to yellow. [Laughter.]

Senator DURBIN. Thanks for joining us. We appreciate it.

Mr. ROBINSON. We will be in contact with your staff relative to

the classified briefing.

Senator DURBIN. Thank you very much.

I want to welcome our next panel: Dr. Elsa Murano, the recently

confirmed Under Secretary of Agriculture for Food Safety, thank

you very much for being with us today; Dr. Bernard Schwetz, who

is the Acting Principal Deputy Commissioner of the Food and Drug

Administration with the U.S. Department of Health and Human

Services; accompanied by Joseph Levitt, the Director for the Center

for Food Safety and Applied Nutrition from the U.S. Department

of Health and Human Services; and a good friend, former colleague

and a great public servant, Dan Glickman, former Secretary of Agriculture, who is now in private practice with Akin, Gump, Strauss,

Hauer, and Feld. I want to make sure to announce that so, when

you get back, your partners will forgive you for the time you have

given us this day.

As I said earlier, it is customary to swear in the witnesses, and

I hope you will please stand and allow me to administer the oath.

Do you swear the testimony you are about to give is the whole

truth, and nothing but the truth, so help you, God?

Ms. MURANO. I do.

Mr. SCHWETZ. I do.

Secretary GLICKMAN. I do.

Senator DURBIN. The record will indicate the witnesses answered

in the affirmative, and I would ask you to, if you would, please give

5-minute opening statements, and your whole statement will be

submitted for the record.

Dr. Murano, would you be kind enough to start?

TESTIMONY OF HON. ELSA MURANO, PH.D.,1 UNDER SECRETARY OF AGRICULTURE FOR FOOD SAFETY, U.S. DEPARTMENT OF AGRICULTURE

Ms. MURANO. Mr. Chairman and Members of the Subcommittee,

I appreciate the opportunity to appear at today’s hearing and discuss our Nation’s food safety system and structure. I am Dr. Elsa

Murano, Under Secretary for Food Safety at the U.S. Department

of Agriculture. As you know, I am a newcomer to USDA, having

just been confirmed as Under Secretary on September 26, and I

was sworn in October 2. I am honored to be serving in this important position and I am committed to the hard work ahead. I know

there are many important food safety issues before the Congress,

11

and I look forward to working closely with you to make progress

on those issues.

I have been a researcher and teacher in the field of food safety.

My research efforts have led me to investigate pathogens such as

E. coli O157:H7, Listeria Monocytogenes, and Salmonella. I believe

my experience as a scientist and educator and my perspectives as

an outsider looking in will be valuable as I begin this new position.

FSIS’s mission is to ensure that the Nation’s commercial supply of

meat, poultry and egg products is safe, wholesome and correctly labeled and packaged. FSIS’s goal is to protect the public health by

significantly reducing the prevalence of foodborne hazards in meat,

poultry and egg products. FSIS has a long, proud history of protecting the public health, dating back to 1906.

Although changes have been made over the years to the inspection program, the most dramatic change occurred when FSIS published a Pathogen Reduction/Hazard Analysis and Critical Control

Point—HACCP—systems rule in 1996. Under HACCP, industry is

accountable for producing safe food. Government is responsible for

setting appropriate food safety standards, maintaining vigorous inspections to ensure those standards are met, and maintaining a

strong enforcement program to deal with plants that do not meet

regulatory standards.

Our food safety system is being challenged by many factors. They

include emerging pathogens, an increase in international trade,

new food products in the marketplace, a growing segment of the

population at greater risk of contracting foodborne illnesses and

gaps in education all along the farm-to-table chain. On September

19 the Bush Administration published its review of the food and

agricultural system with a view toward identifying critical needs

for the next century. The report, titled ‘‘Food and Agricultural Policy, Taking Stock for the New Century,’’ details the enormous

changes that have taken place in food and agriculture. Food safety

certainly is a vital part of food and farm policy, and the report emphasizes this.

I would like to provide more details today about two key areas

of the food safety infrastructure and the importance of integrated

food safety programs. Let me begin with the USDA food safety infrastructure. Inspection of meat, poultry and egg products is an important part of that infrastructure. FSIS currently has approximately 10,000 employees, the bulk of which are stationed in the

field. More than 7,600 inspection personnel are stationed in approximately 6,000 meat, poultry, and egg plants. FSIS also certifies

foreign programs as possessing public health safeguards that are

equivalent to the U.S. program and reinspects imported product as

it enters the United States.

FSIS is also responsible for assessing State inspection programs

that regulate meat and poultry products that may be sold only

within the State in which they are produced. There are currently

27 states that have a State meat or poultry inspection program and

operate under cooperative agreements with FSIS. Another part of

the FSIS food safety program involves its three multidisciplinary

laboratories, which conduct laboratory testing for microbiological

contamination, chemical and animal drug residues, pathological

12

conditions, processed product composition, and economic adulteration.

FSIS also conducts compliance and enforcement activities to address situations where unsafe, unwholesome or inaccurately-labeled products have been produced or shipped. Surveillance is another part of the infrastructure. A strong food safety system must

have a mechanism for identifying new food safety problems rapidly.

USDA conducts surveillance of the food supply and HHS Centers

for Disease Control and Prevention, in partnership with State and

local health departments, conducts surveillance for human foodborne illness.

Outbreak responses is also key. Because coordination is essential, we have taken steps to expedite communication during large,

multistate outbreaks. One mechanism is the Foodborne Outbreak

Response Coordinating Group, FORCG, a partnership established

to better respond to interstate outbreaks of foodborne illness.

USDA, HHS and EPA formed this partnership. This interagency

group has coordinated and developed procedures for managing outbreaks, sharing information on potential sources of outbreaks and

pathogens, and coordinating interdepartmental activities.

A similar group, the Food Emergency Rapid Response and Evaluation Team, FERRET, has been established within USDA to coordinate the activities of USDA agencies. USDA participates in

PulseNET, a national network of public health laboratories supported by HHS. These laboratories aid outbreak response by performing DNA fingerprinting of foodborne bacteria and comparing

results through an electronic database maintained by CDC.

Research is another important part of the food safety infrastructure. FSIS is not a research agency, but works through the Agricultural Research Service to meet its research needs. Risk assessment

is another important part of the food safety infrastructure. You can

never completely eliminate foodborne health hazards, and resources are limited. Risk assessments help us to set priorities.

Education also figures prominently. Partnerships have been key

in education. The Fight Bac campaign is sponsored by the Partnership for Food Safety Education, a public-private partnership with

participation from USDA, HHS, and the States. I provided you

folders containing some of the outreach and educational materials

we use in the food safety education campaign. There are even a

couple of brochures in Spanish, Mr. Chairman, that you may enjoy.

Like every infrastructure, the food safety system requires periodic review, ongoing reinforcement and appropriate modernization

just to keep pace with continuously emerging and often unique

challenges. What has become very clear is that the services USDA

provides, from eliminating foodborne pathogens to protecting

against plant and animal pests and diseases to encouraging farm

practices that stress conservation—all are interrelated and must

continue to be carefully and comprehensively coordinated. We can

do more to examine whether Federal food safety agencies can improve the services they provide, but this should be done by a careful step-by-step process and by continued coordination with other

agencies involved in the food safety system.

13

1The prepared statement of Dr. Schwetz appears in the Appendix on page 74.

Mr. Chairman, thank you again for this opportunity to discuss

our Nation’s food safety system and structure, and I look forward

to any questions you may have.

Senator DURBIN. Thanks, Dr. Murano. I will have some questions. Dr. Schwetz, from the FDA.

TESTIMONY OF BERNARD SCHWETZ, PH.D., D.V.M.,1 ACTING

PRINCIPAL DEPUTY COMMISSIONER, FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN

SERVICES, ACCOMPANIED BY JOSEPH LEVITT, DIRECTOR,

CENTER FOR FOOD SAFETY AND APPLIED NUTRITION, U.S.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Dr. SCHWETZ. Good afternoon, Mr. Chairman. I am Bernard

Schwetz, the Acting Principal Deputy Commissioner of the Food

and Drug Administration. I am appearing here today on behalf of

the Department of Health and Human Services. Thank you for this

opportunity to discuss the Federal food safety system. Ensuring the

safety of the food supply is a top priority for HHS. I am pleased

to be here today with my colleague from USDA, Dr. Elsa Murano,

Under Secretary for Food Safety.

The American food supply does continue to be the strongest and

the safest in the world. Great strides have been made in recent

years that have strengthened the Federal food safety system. The

Federal food safety program includes new surveillance systems,

better prevention programs, faster outbreak response, enhanced

education and better coordinated and focused research and risk-assessment activities. Food safety agencies are working more closely

together than ever before, but our world is constantly changing and

we must continue to change with it. Indeed, we cannot rest until

we have built a strong and credible food safety system that addresses the full range of food safety issues, one that is built on scientific expertise, that is risk-based and recognizes and responds to

new risks, that provides a critical inspection presence, that has the

same level of protection to consumers from both domestic and imported foods, that efficiently stewards new technologies to the market and that effectively educates and communicates with consumers.

Within HHS, the Food and Drug Administration has jurisdiction

over 80 percent of domestic and imported foods that are marketed

in interstate commerce. This jurisdiction includes all food products

except meat, poultry, and egg products, which are regulated by

USDA. FDA seeks to ensure that foods are safe, sanitary, nutritious, wholesome, and properly labeled. HHS’s Center for Disease

Control and Prevention has an important complementary public

health role. As the lead Federal agency for conducting disease surveillance, CDC monitors the occurrence of illness in the United

States attributable to the food supply.

The disease surveillance systems coordinated by CDC are an essential information network for providing early warnings about

dangers in the food supply, for demonstrating progress in reducing

foodborne illness and for indicating new or changing patterns of

foodborne illness. Both the FDA and CDC work closely with our

14

Federal food safety partners and with State and local health food

safety officials.

While the current system is working, the system needs to be

strengthened to address the current challenges. The goal of HHS

is to work with our Federal and State partners as well as with academia, industry, consumer organizations and Congress, to build on

the current foundation, resulting in a strong and credible food safety system that addresses the full range of food safety issues. The

system has three simple steps: To identify risks, to take action, and

to measure results.

In identifying risks we must ensure a strong science base, which

is the foundation of any successful food safety system. We must

also develop, enhance, and maintain surveillance systems that can

quickly and accurately identify food safety risks in human food and

animal feed supplies and manage disease risks effectively. These

surveillance systems are the key to an effective emergency response capability.

In taking action we must start with prevention. We need strong

risk-based prevention standards to prevent contamination of all

human foods and animal feeds over the farm-to-table continuum.

As these risk-based standards are developed, we need education

and training programs so that those in the industry and the public

can effectively utilize them to reduce the risk of illness. In addition,

domestic inspections of the food industry are essential to ensure

that the appropriate preventive controls are implemented.

While FDA uses a risk-based system to prioritize its inspections

and now inspects firms that produce high-risk foods on an annual

basis, we still need to provide more frequent coverage for all the

firms. For imported food, we need a strong inspection and monitoring program to ensure that imported foods meet the same level

of protection as domestic foods. For both domestic and imported

food, we need to maintain an adequate enforcement program to be

sure the rules are followed. We also need science-based methods to

measure results so we know how we are doing. When implemented,

the framework I have just described would minimize foodborne illness and injury, maximize consumer confidence and enhance global

competitiveness.

As food may be a medium for spreading infectious diseases, let

me address the Department’s approach to the challenges of bioterrorism. The broad goals of a national response to bioterrorism are

to detect the problem, control the spread of the epidemic, and treat

the victims. Our approach to this challenge has been to strengthen

public health infrastructure to deal more effectively with epidemics

and other emergencies, and to hone our emergency health and

medical response capacities at the Federal, State and local level.

We have also worked to forge new partnerships with organizations

related to national security. Our efforts have been focused on improving the Nation’s public health surveillance network to quickly

detect and identify the biological agent that has been released,

strengthening the capacities for medical response, especially at the

local level, expanding research on disease agents that might be released, developing new and more rapid methods for identifying biological agents, and improve treatments and vaccines and improving

information and communication systems, among other activities.

15

1The prepared statement of Secretary Glickman appears in the Appendix on page 94.

Thank you for this opportunity to discuss our food safety program. HHS appreciates your continued interest and leadership in

improving food safety. I look forward to working with you and the

Subcommittee on ways to continue to improve the safety of the Nation’s food supply. I would be happy to answer questions.

Senator DURBIN. Thank you, Dr. Schwetz. Secretary Glickman.

TESTIMONY OF HON. DAN GLICKMAN, AKIN, GUMP, STRAUSS,

HAUER, AND FELD, L.L.P.1 FORMER SECRETARY OF AGRICULTURE, U.S. DEPARTMENT OF AGRICULTURE

Secretary GLICKMAN. Thank you. I am one of those liberated

souls that—speaking for myself. But it is a pleasure to be before

this Subcommittee and my senior statesman, Senator Durbin, a

great leader. Let me just say that I agree with the statement that

we have the safest food in the world, and our safety system is the

best in the world, and part of that is due to the very talented workforce at FSIS and APHIS and the Agriculture Marketing Service

people in the FDA and the other agencies, and I also would say

things are better coordinated now than they were 10 years ago

among the various agencies.

But if the current system did not exist and we started from

scratch to put it together, it would not look like it does now. We

would not design it that way. We would make some structural

changes. I believe the United States needs fundamental organizational change in the way the Federal Government handles food

safety. After working on these issues both in the House, as a House

member from Kansas, and as Secretary, during that 6-year period

when Federal food regulation underwent the most significant

changes in a century and faced some of its most severe tests, particularly in the courts, I have concluded that the basic structure is

flawed and needs rebuilding.

Senator Durbin, I commend you for doggedly pursuing this problem, and appreciate the opportunity. In my statement I start out

with a few things about Federal food safety statutes now. These

are substantive statutes. I am not going to repeat them. They are

in the statements, but things like we have called for before, for example, the ability for the government to level civil penalties, the

ability for USDA and FDA to order recalls which are not there.

There is a need for FDA and USDA to have the authority to act

against food when epidemiological evidence links it to disease, not

just in those instances when the food is infected with pathogens.

We need a lot more resources, particularly in the FDA, to do its

business, and FDA needs an adequate food manufacturing database. Currently, USDA knows where meat and poultry is processed

because of Federal recordkeeping requirements. The FDA does not

have complementary information. So all these things, many of

which continue to build on what others have said, I think need to

be mentioned, because notwithstanding what we do with organization and restructuring the Federal Government, the substantive

laws need to be strengthened to give the government appropriate

authority to do its jobs.

16

But on the regulatory structure, one of the lessons we learned

during the Clinton Administration was, short of outright organizational changes the need for much greater coordination across food

safety-related agencies was a high priority, and that led to a number of interagency entities, the President’s Council on Food Safety,

a Joint Institute for Food Safety Research, and other items. While

all of these efforts vastly improve the overall Federal response to

this problem, they suffer fundamental flaws that a consolidated

Federal regulatory agency would remedy. First and foremost is the

central control of resources.

While joint planning, communication and coordination facilitate

a united response to food safety, at the end of the day, unless control over spending is vested in a single authority, there will remain

bureaucratic and institutional obstacles to achieving the ends that

we want to achieve. A unified centralized structure brings with it

another asset, a central decisionmaking entity who is in charge,

who is accountable for the problem—an example is the Starlink

episode. The Starlink corn episode, while not probably a traditional

food safety issue, it highlights that flaw.

Most strikingly, many questioned the initial wisdom of a split

registration for this particular product, and the ability of the system to keep the corn in separate segregated marketing channels,

one for animals and one for human consumption. Regrettably,

those deficiencies were realized in what happened. Now, fortunately we have not seen that kind of problem in the magnitude on

the human side of the picture, but we have seen it in a variety of

animal-related issues, and it could have easily happened here.

I have long felt that while we went through the process in the

Clinton Administration of improving coordination and dealing with

some of the substantive issues, that we did not want to let a heated

debate over reforming the structure interfere with our primary

goal. I urged a go-slow approach to organizational revision during

the period of enormous food safety change that we went through

in the last 8 years. I did not want to either divert the attention

from the reform process, nor permit disagreements over structure

to stop that.

But the fact of the matter is that the time is now, to bring these

functions together, and I am confident a successful rationalization

of the Federal food safety regulatory structure will require bold

strokes. A piecemeal approach will leave us essentially where we

are, with a fragmented, and duplicative system.

Now, finally I might make a couple of comments about terrorism

and related threats. As we look at the threat from chemical or biological attack or other terrorist threats, too frequently agriculture

and food received scant attention. We got a wake-up call last

month, not only from the savage viciousness of the attack, but also

from the new kind of threats we face. For example, the grounding

of the Nation’s fleet of crop dusters drove that point home.

While at USDA, we launched a multiagency review of agriculture’s exposure to non-conventional threats. Without revealing

the specific threats, nor the steps we are taking to protect ourselves, let me simply state that the problem is immense, as are the

consequences and the effort we need to protect from it. Consider

again the Starlink episode, which I referred to. That is a telling

17

lesson of how quickly and pervasively an undesired product can

contaminate our food supply, or consider a few years ago when

Karnal Bunt first infested this country. To eradicate this wheat

fungus, we prevented the farmers from whose land the infected

wheat originated from planting wheat at all for 3 years.

The point these episodes illustrate is that even comparatively benign contaminants to our food supply can spread dramatically, especially given the size and concentration in much of our food distribution and processing, and may need profound and long-lasting

steps to recover. I should point out that while agents such as botulism or anthrax affecting food and water get a lot of attention,

media attention—American agriculture could also be gravely

threatened by outbreaks of more traditional problems like foot-andmouth disease and BSE.

The solution partially lies with reform structures and organizational changes. It also partly lies with good statutory authority

given to the agencies—fair statutory authority—and I am confident

that you will do that. In closing, let me repeat the three points I

want to emphasize with you: One, we need to reorganize and consolidate our Federal food safety regulators; two, we need just as urgently to make improvements to our underlying food safety statutes; and, third, an integrated food safety regulatory structure is

critical to meeting the new challenges of terrorism we face.

All of this is needed to ensure our highest priority, which is continued public confidence in the safety of our food system, which is

the linchpin of both our public health, as well as the economic

health of American agriculture.

Thank you, Mr. Chairman.

Senator DURBIN. Thank you, Secretary Glickman. Let me start

with some questions.

Dr. Schwetz, you said at one point—I do not know exactly, but

paraphrasing you—we should view food as a medium for bioterrorism. I think that is really one of the elements that underlies this

hearing today. Can you give me a description of how food could be

a medium for bioterrorism?

Dr. SCHWETZ. Well, yes, I would be happy to do that, Mr. Chairman. What I really do not want to do is talk in any detail that

would provide—— Senator DURBIN. No, I do not want you to.

Dr. SCHWETZ [continuing]. A roadmap for people to do things

that we do not want to have happen. But because we have an agricultural process that produces a lot of food, either from the United

States or imports from outside the United States that is distributed

widely, common food items that we either import and consume as

they are, or foods that are processed within the United States,

there are a relatively small number of food that represent a large

part of what we consume, and it would be possible for one of those

to become the medium of some agent that would be distributed

that would accomplish what a terrorist might want to do, is to

reach a large number of people relatively quickly through some

means that they would not necessarily expect there to be a problem.

Senator DURBIN. Dr. Murano, our lives have all changed since

September 11 at every level, governmental and personal. How have

18

things changed in the outlook of your agency at the U.S. Department of Agriculture, FSIS, and other food safety inspection since

September 11?

Ms. MURANO. Well, Mr. Chairman, I think September 11

changed everybody. Let me begin by saying that. At the agency we

took a hard look, and are right now taking a hard look at what systems we have in place and how to improve upon them. Thankfully,

we have 7,600 inspectors inspecting meat and poultry in every

plant in the United States. Having them in place as a matter of

our standard operating procedures, gives us an advantage, as a

public health agency, which is what FSIS really is.

We are about food safety, and what we do is inspect these products to try to prevent to the greatest extent possible any foodborne

outbreaks, which is one of the main goals of the agency. We can

always do better, and I assure you, again without really saying too

much as far as details, that we are looking at what other ways we

can improve our system. Certainly the entities that I mentioned in

my testimony, FORCG and FERRET, have been crucial for us to

be able to ascertain how to better coordinate activities, not only

within USDA, but also with our partner in health, HHS.

Senator DURBIN. Let me follow up on that, and just staying with

the food security aspects that we have now raised since September

11, and without asking for any detail for the same reason that Dr.

Schwetz mentioned, has there been a gathering of the various food

safety inspection agencies at the Federal level, of all the different

agencies, to sit down and to try to map out a common strategy to

protect the security of America’s food supplies since September 11?

Ms. MURANO. Let me answer that, Mr. Chairman, by saying that

as soon as I was confirmed, we had a meeting of FERRET, which

are agencies within USDA that have to do with food emergency

rapid response. We are working right now with our partners in

HHS to get FORCG to look at what its charter is, what it is doing,

the activities that it has done in the past and how we can improve

those. We have meetings scheduled very soon, and we have had

conversations with our partners at HHS to pursue these avenues.

So I assure you that we are extremely cognizant of the fact that,

now more than ever—and I agree with the words that you said at

the beginning of this session—at this time of war, we have to work

together.

Senator DURBIN. Have there been special meetings called since

September 11 of these agencies, to talk about food security?

Ms. MURANO. Yes, sir.

Senator DURBIN. Is there more evidence of cooperation among

these agencies?

Ms. MURANO. I can safely tell you yes, and perhaps one of the

reasons is a simple reason—well, two reasons. The one I just stated

is the fact that this emergency has brought us together as Americans and certainly has elevated the importance of these issues and

has made us want to work together more than ever. Second, because there are a lot of new faces, not just mine. When you have

a lot of new faces, people perhaps do not have the past histories

of animosity that might preclude reaching over and meeting each

other. So we have been able to get together very well and very

quickly.

19

Senator DURBIN. Have you talked about coordinating inspections? We know there is such a wide variety of inspection standards when it comes to food at the Federal level. Since September

11, have you addressed that possibility of coordinating these inspections?

Ms. MURANO. It is one of the issues that we are discussing.

Senator DURBIN. Dr. Schwetz, same question. Since September

11, what has happened in terms of the food security issue at FDA

and what has happened in terms of your relationship with other

agencies?

Dr. SCHWETZ. I would reinforce what has already been said, that

we have had meetings between a number of Federal agencies, even

going beyond HHS and USDA, to bring agencies together to discuss

what are the areas where we need to be communicating more effectively to deal with these kinds of issues, where are weaknesses that

we have where resources need to be put now to strengthen—— Senator DURBIN. Can you tell us any of those weaknesses that

we might address at the congressional level? Is there a need for

some funding that is readily apparent to you, in light of September

11, where we should look at it immediately?

Dr. SCHWETZ. They are matters of the proper legislation and authority to be able to do the kinds of things that we have limits to

now, and some of them have already been discussed.

Senator DURBIN. Can you give us examples?

Dr. SCHWETZ. The ability to hold product once we have a suspicion that something might be wrong, civil money penalties to a

greater extent than we have worked out these arrangements with

Customs and other agencies and with States. So there are some

legislative changes that need to be made, but primarily the vulnerability of the FDA is not having enough people to be able to man

the spots that we need to have covered, to have the inspectors, to

have the laboratory capabilities to back up the sampling that would

follow questions of terrorist action. So between resources and legislation, those are two major areas.

Senator DURBIN. Secretary Glickman raised an important point.

I want to ask him a question about it directly, but about the whole

question of the authority to withhold food product based on epidemiological concerns, as opposed to pathogens. Is that another element or another area where you see need for legislative change?

Dr. SCHWETZ. Yes, that would be.

Senator DURBIN. So at this moment in time, if we suspected or

even knew that there was a source of food in the United States

that posed a danger because of bioterrorism or epidemiological contamination, does the FDA or the USDA, have the authority to take

that product off the market?

Dr. SCHWETZ. I cannot answer that exactly, but I would assure

you that we would look between the Federal agencies, between

USDA, between Customs, whatever authorities we have collectively, we would work as hard as we could to keep that from

spreading.

Senator DURBIN. I am sure you would. Anyone in good conscience

would, but clearly Members of Congress, in good conscience, need

to give you the clear authority to do it.

Dr. SCHWETZ. Yes.

20

Senator DURBIN. Secretary Glickman, that is a point that I think

we ought to spend a moment on. But your belief now is that the

current law does not empower the agencies to do this? Though they

might find some way to do it, it is not a clear delegation of authority.

Secretary GLICKMAN. At best, it is unclear, and USDA was specifically challenged in this, in one particular instance, where we did

not have complete success, let me say. You might find some general

authority under some welfare clause provision of the Constitution

or some other agency, FEMA or somebody, but I do not believe it

is clear.

Senator DURBIN. Well, so that we understand this for the record,

should we ever—and God forbid that we do—run into a situation

of biological contamination, acts of bioterrorism on the food supply,

it is your understanding—and I believe that the other witnesses

are in agreement—that we do not have the statutory authority at

this moment to remove product from market, off the shelves, away

from consumers, absent some specific change in the law?

Secretary GLICKMAN. I do not believe so. I think that probably,

if you had a national emergency with bioterrorism, we would find

it somewhere. But I do not think we have it clearly enough to deal

with the non-terrorist problem, and therefore we would not necessarily be able to jump to the terrorist problem.

Ms. MURANO. Mr. Chairman, may I interject a little bit here?

Senator DURBIN. Sure, Dr. Murano.

Ms. MURANO. As you probably know, FSIS has the authority to

seize and detain products. So that is a very important authority

that we do have, and that certainly is one of the ways that one can

stop an outbreak from spreading any further.

Senator DURBIN. And let me ask you to follow up on that. Secretary Glickman made note of the fact that the USDA needs authority to recall food from the market. You were talking about stopping and detaining the delivery, but recalling food from the market

is not in your list of current authorities; is that right?

Dr. SCHWETZ. That is correct.

Senator DURBIN. Is that your understanding, Dr. Murano?

Ms. MURANO. That is correct. I would say food safety is the primary issue, obviously, with my colleagues at HHS and certainly

with the Food Safety and Inspection Service. When there is an outbreak situation, recalling product as rapidly as possible is extremely important. I think we all agree with that. The real question, I suppose, is who should have the responsibility to do that?

That is something worth exploring, and I think that is what the

Secretary is alluding to.

Secretary GLICKMAN. Mr. Chairman, I would just say most companies, in my experience, would voluntarily and cooperatively work

this issue, but because of mass communication and dissemination

of food, and the logistics problems, you could imagine a circumstance, even if a cooperative company would be involved in

doing it, you could not get the food fast enough back into the hands

of either the government or the company itself.

Senator DURBIN. So we have two things that have come out so

far, and one is the use of these epidemiological standards for the

monitoring of the food supply, something clearly that needs to be

21

done, and, second, the ability to recall the product clearly in the

law, where there is a national issue or urgency involved in it.

Those two things seem very clear.

Now, Secretary Glickman, you also talked about the imposition

of fines, and what are you alluding to there?

Secretary GLICKMAN. Well, right now I would say the Department of Agriculture has the ultimate penalty, the nuclear bomb, so

to speak, because what it can do—it could withdraw the mark of

inspection. It can close a factory down, which is obviously a critical

power. But, in some cases, you want to move more creatively and

quickly without having to shut a factory down, without having to

cause people to lose their jobs, and civil penalties are not within

the ambit of USDA’s authority, as they are in the Consumer Product Safety Commission and, I believe, other agencies.

Senator DURBIN. Dr. Murano, you made the point that you are

brand-new and, in that respect, have newer faces and less baggage

and less of a history. Your background is in science, I take it?

Ms. MURANO. Yes, sir. I am a scientist.

Senator DURBIN. As you take a look at the Federal laws involving food safety and inspection, do you see that common scientific

thread that weaves through these 12 different agencies and 35 different laws?

Ms. MURANO. Well, Mr. Chairman, certainly if you are asking me

common sense science, I am not going to go there.

Senator DURBIN. No one is going to go there based on common

sense.

Ms. MURANO. But let me say that I think we all recognize that

using science as the basis for what we do for food protection is the

goal that we want to achieve, and risk assessment within the risk

analysis system is one way to achieve it, as I discussed in my opening remarks. Following that thought, I would like to say again that

because food safety is our goal and what FSIS does, because it is

a public health agency, anything that would improve the safety of

our food supply is something that we are interested in doing.

I would like to say one more thing regarding recalls. In exploring

this issue, we have to obviously think about whose responsibility

it should be for our food supply. Should it be the responsibility of

the people who make it, or should it be the government’s responsibility? There are some extremely complex issues that are embedded

within that question. So it is something that we have to look at

very carefully.

Senator DURBIN. I am going to ask one semi-scientific question,

and forgive me, as a liberal arts lawyer, if I do not state it very

artfully, but, Dr. Schwetz, is there any mechanism in place now

where you can monitor contamination beyond the obvious Salmonella, E. coli, to those new threats that we are considering, the

bioterrorist threats? Are there ways to monitor these things?

Dr. SCHWETZ. Yes. The bacteriological and the other detection

procedures for being able to identify viruses and bacteria and other

organisms that might be included, those procedures are, for the

most part, available. Many of them have been used clinically for

many years. So the methods to identify those organisms are available for our use. We have adapted those so we can identify those

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22

tact with food. So the methods are available to identify the organisms.

Senator DURBIN. The last question I will ask of the three principals on the panel goes to this culture between the FDA and the

USDA. This is a battle I have been witnessing for 20 years. Sometimes it is a friendly relationship and sometimes not so friendly,

but it appears that the two agencies really view their missions in

different terms, and one of the reasons we do not have a single food

agency is because there are those who just love the USDA and

every part of it and do not want to give up anything, on Capitol

Hill and the population at-large, and others who feel the same

about the FDA. But many argue that they really are two different

philosophies, two different cultures that come to this business of

food inspection. I would like to first ask Secretary Glickman, what

is your thought on that?

Secretary GLICKMAN. Well, Senator, I really do not think that is

as big a factor. I will tell you, after the Congress reorganized the

Department of Agriculture in 1994, you created a separate Food

Safety and Inspection Service and pulled it out of the marketing

and regulatory programs, basically—I must tell you my experience

with those folks at FSIS led me to believe that they were among

the toughest government regulators that I saw, and people of high

integrity.

Now, the fact of the matter is they were officed in the same

building and basically were in the same venue with people who had

promotion functions, as well. I do not really think that is the critical problem here, because I think the system can kind of trudge

along probably all right with coordination the best you can. I just

do not think, given the modern world of pathogens and threats,

that you cannot do it very well without some sort of central accountability there, and that is why I think this needs to be done.

I think in the old days, this may have been a problem. I really

do not think it is as much of a problem anymore.

Senator DURBIN. Dr. Schwetz, you have been at FDA for awhile.

What is your observation?

Dr. SCHWETZ. Yes, I have been with the FDA for a little over 8

years now, and my observation is that the working relationship is

far different today than it was 8 years ago. There are a number of

things that have happened in the past few years that have forced

us to work together more effectively than we ever did before, and

I think for the most part we have come to realize that we do have

partners in other agencies that we have to depend on, we have to

work with, for example, to keep things like BSE out of the country,

and foot-and-mouth disease. So the readiness plans that we have

developed, the science that we have shared, the people that we

have kind of moved back and forth to tap the intelligence that we

have between the agencies, there is a lot more of that today than

there ever has been.

Senator DURBIN. Dr. Murano, you are the new person in town,

but do you see a difference in the mission between the FDA and

your food safety responsibilities at USDA?

Ms. MURANO. Mr. Chairman, when I talk to my colleagues in

FDA who are scientists like myself, we are scientists and we have

the same view in terms of what we want to do to achieve a safer

23

food supply. So, at that level, certainly I know that we have kindred spirits. What we have to do is forget what the relationships

have been in the past. I know that probably sounds extremely

naive of me to say that, but I am going to give it my best and I

know my colleagues at HHS will, as well, because we are in a new

day. We are facing threats that we never imagined we would have

to be facing and we are committed to working together.

We are Americans. We have an incredible challenge ahead of us,

and we have to meet that challenge. This is the time to do it.

Senator DURBIN. Thank you very much. Senator Voinovich.

OPENING STATEMENT OF SENATOR VOINOVICH

Senator VOINOVICH. Thank you, Mr. Chairman, for holding this

hearing. This is the third hearing that I have participated in on

this subject of oversight of food safety, and I commend the Chairman for his long-standing interest in this area. I am not going to

go into my full opening statement, but I would like to say to you,

as a follow-up to this hearing—I would like to request that the administration witnesses submit for the record a comprehensive list

of all the Federal agencies involved in food safety, from the Animal

and Plant Health Inspection Service at the Department of Agriculture to the U.S. Customs Service, along with a description of the

function the agency serves, the current personnel levels at the

agency, the personnel needs of the agency in terms of both numbers and skills. I know that is not new information, because I know

from talking to Sean O’Keefe allegedly that request has gone out

to various agencies about where they stand in terms of their personnel.

Senator VOINOVICH. It is my understanding the Food Safety Inspection Service at the Department of Agriculture is working to attract health inspectors with a stronger service background to improve the agency’s oversight. I think this kind of information would

be very useful to this Subcommittee in our deliberations.

In terms of questions, in the governmentwide high-risk area of

human capital management, GAO says the following about the Department of Agriculture: ‘‘Organizational cultural problems, including resistance from the affected USDA agencies and employees,

have hampered department-wide reorganization and modernization

efforts. Further, the Nation’s food safety system, in which USDA

plays a major role, continues to suffer from inconsistent oversight,

poor coordination and inefficient deployment of services.’’ Do you feel—and I am asking this of the administration witness—do you feel that the human capital management as it relates

to food safety oversight is an issue only at the Department of Agriculture, or does it span across various departments and agencies

involved in our Federal food safety oversight system? If the problem does include the entire food safety system, would a consolidation—that is what this is all about—would a consolidation of food

safety oversight into one central agency improve this organization

culture that is resistant to change?

Ms. MURANO. I would like to answer that by saying I think we

all know that managing people is always a challenge, no matter

what organization you are talking about, whether it deals with food

safety or it does not deal with food safety. I am aware of great efVerDate 11-MAY-2000 08:18 Aug 22, 2002 Jkt 000000 PO 00000 Frm 00027 Fmt 6633 Sfmt 6633 76804.TXT SAFFAIRS PsN: SAFFAIRS
24

forts that are taking place right now to modernize the workforce

of the Food Safety and Inspection Service. I have been very impressed with the effort that these folks have begun already with

their new consumer safety officers, to bring a highly technicallytrained individual to inspection plants.

There are also efforts to—and, in fact, right now there are epidemiologists on staff, as well, who are dispatched in cases where

there might be a foodborne illness outbreak suspected. So it is not,

I do not think, any more the perhaps-stereotypical view that people

have held over what inspectors are. We have extremely highlytrained people and have worked really hard in that last few years

to modernize the workforce. There has been a reorganization at

FSIS to better serve or better accomplish the services that FSIS is

supposed to provide.

Is there room for improvement? Absolutely, there always is room

for improvement, and that is what I am here for, and that is what

the administrator at FSIS has as a top priority, because that is one

of the two things that FSIS does and does very well—inspect our

food supply in a way that is effective and in a way that is done

in a transparent way, and that is accountable. That is the key feature of any activity that one conducts. You must be accountable to

the people that you serve and to your superiors.

The second activity, of course, has to do with regulations, and to

base those on science is a key feature of FSIS as an agency. So I

think we need to start looking at what the agency has accomplished in the last few years under Secretary Glickman, who certainly has been witness to some of those planning activities, and

I am happy to tell you that those are being realized right now, even

as we speak.

Would better cooperation and some consolidation be a way to go?

We are very open to discussing any way that will improve the safety of our food supply, because that is our commitment.

Senator VOINOVICH. Well, the fact of the matter is that we have

been talking about this—the Chairman of the Subcommittee, what,

you have been working on this for 20 years? We keep talking about

something is going to happen, and even though there are some

really good things that each agency is doing and we have a fine

system, I do not think it is where it ought to be. From a governmental point of view, as I look at this organization, speaking as a

former mayor and governor, it is a crazy patchwork that does not

make sense and, to me, needs to be reorganized to get the job done,

to eliminate the duplication, take advantage of the strengths that

we have in the various departments and get the job for the public.

I know some of the industrial people are worried about it because

we will have some kind of a super-czar agency that might harass

them or whatever the case may be. But I would like you to tell me

if you have seen any better coordination in the last couple of years.

I think it has gotten to the point where you need to reorganize this

operation.

Mr. Schwetz, I would like your opinion. What do you think?

Dr. SCHWETZ. Our feeling is that reorganization by itself, Senator, is not going to make our food safety system a lot better than

it is today. We have already gained a lot of benefit in the last few

years by virtue of better funding, to be able to do the work which

25

represents the underpinnings for a safer food supply. So there has

been a lot of progress made, and we think that even within the existing system more progress can continue to be made.

If the decision is made that there would be a single food agency,

it is not a matter of reorganization. The legislative underpinnings

to determine the authorities have to be redetermined. The right

kind of budget support has to be there to deal with the risks that

we would identify are the primary risks to deal with in the food

supply. So we have to have the right funding, we have to have the

right laws, we have to have the right kinds of expertise within that

agency or within our existing agencies to be able to deal with the

risks that we have.

One of the concerns that we have, also, is that even within a

large organization where you have an office of this and you have

an office of that, you still have different cultures between various

components of a large organization. So we would have to work awfully hard to be sure that we do not have those same kinds of differences between components of a new organization that we all cite

today as those examples at the margins of our organizations now

that make it look like we have two different approaches or two different people looking at the same problem. So reorganization by

itself is not going to be a simple thing and it will not be enough

to really—— Senator VOINOVICH. Reorganization is never simple. I have been

through it several times in both capacities, but the issue is, have

we gotten to the point now where we need to do that? What do you

think of Chairman Durbin’s bill?

Senator DURBIN. Put him on the spot.

Senator VOINOVICH. What do you think about it? Is the administration at all interested? Of course, they have got their hands full

right now. I am sure they are not thinking about this problem, but

where are we?

Dr. SCHWETZ. The new bills do address some of the problem, but

one of the difficulties that we recognize, for example, within the

Food and Drug Administration itself, is that we have certain components of the agency that are specifically assigned to food safety,

but the way we are organized there are also parts of each one of

our components of the agency, that even though they might be assigned to drugs or to veterinary drugs or to other statutory authorities, that still involves food safety. So it is very difficult to say that

this is the part of the FDA that deals with food safety, because

there is a large part of it that also deals with drugs, deals with devices, and deals with biologics. They also have people who deal

with food safety issues. So that makes it very difficult to think

about how the Food and Drug Administration would work if the

food part of it was taken out and took out the research capabilities,

took out the field capabilities, all of which are shared between food

questions and questions of other products that we regulate. The

same question exists if you expand it between agencies.

Ms. MURANO. The administration has not taken a position on

this issue, but I would like to say again that my office is open to

discussion on this subject.

Senator VOINOVICH. Mr. Glickman, you have been there. What do

you have to say about it?

26

Secretary GLICKMAN. I agree with you. I would say that, at a

minimum, budgets, planning and accountability for food safety

ought to be in one place. Now, the devil is always in the details.

I was just thinking as you were talking, the inspection functions— those of you who know the difficulties in the relationships between

inspectors and FSIS at USDA, and that has got a long history and

culture, know that that is a significantly different relationship than

certainly you have at FDA, where you hardly have any inspectors

at all. So, as you say, this has to be done very intelligently. It has

to be very inclusive in order to not create a revolution in the process, but that should be no reason not to try to do it.

I think that is why I think somebody suggested—I think the

GAO suggested you start at the inspection, try to bring them together, because that is where the rubber hits the road in terms of

finding problem product. But I go back to this thing, there has got

to be some central budgeting and central accountability in this

process, as well. If you do not have it, then it is not worth anything.

Senator DURBIN. Thank you very much. Let me ask one last

question of Dr. Murano and Dr. Schwetz. Since September 11,

there has been a heightened awareness of national security and a

lot of efforts to coordinate the U.S. response, and I am one who applauds Governor Ridge joining the administration in his new capacity with the Homeland Defense Agency. But can you tell me whether or not either of your agencies, USDA and the FDA, have been

included in these national security briefings and discussions since

September 11?

Ms. MURANO. I can tell you, Mr. Chairman, that we are very

much included, and that is all I will say.

Senator DURBIN. OK. Dr. Schwetz.

Dr. SCHWETZ. Yes, we are also very much included with a lot of

the discussions that are going on between agencies and with the

National Security Council.

Senator DURBIN. Thank you. Thank you very much. I want to

thank this panel for the contribution they made today. We appreciate you coming by.

I am now pleased to welcome the next panel and invite them to

come forward: Dr. Michael Jacobson, Executive Director of the Center for Science in the Public Interest; John Cady, President and

Chief Executive Officer of the National Food Processors Association; Dr. Peter Chalk, Policy Analyst with RAND Corporation;

Manly Molpus, President and Chief Executive Officer, Grocery

Manufacturers of America; and Tim Hammonds, President and

Chief Executive Officer, Food Marketing Institute.

Thank you all for coming. If you will remain standing behind

your appropriate name places, I will swear you in, as custom of the

Subcommittee. Please raise your right hand. Do you solemnly

swear to tell the truth, the whole truth, and nothing but the truth,

so help you, God?

Mr. CADY. Yes.

Mr. CHALK. Yes.

Mr. HAMMONDS. Yes.

Mr. JACOBSON. Yes.

Mr. MOLPUS. Yes.

27

1The prepared statement of Mr. Jacobson appears in the Appendix on page 100.

Senator DURBIN. Thank you very much. Let the record indicate

that the witnesses have answered in the affirmative.

Dr. Jacobson, would you be kind enough to begin?

TESTIMONY OF MICHAEL F. JACOBSON, PH.D.,1 EXECUTIVE

DIRECTOR, CENTER FOR SCIENCE IN THE PUBLIC INTEREST

Mr. JACOBSON. Thank you very much Senator Durbin. My name

is Michael Jacobson. I am the Executive Director of the Center for

Science in the Public Interest. CSPI is an education and advocacy

organization based in Washington that focuses on food safety and

nutrition. We are supported largely by the 800,000 subscribers to

our Nutrition Action Healthletter and by foundation grants.

As we have heard earlier, CDC estimates that contaminated food

causes 76 million illnesses and 5,000 deaths every year. Over the

past decade several notorious outbreaks of foodborne illness, named

after such companies as Jack-in-the-Box, Schwan’s, and Sara Lee,

have demonstrated that unintentionally-contaminated food is all

too common, all too deadly. More recently, the terrorist attack has

spurred widespread concern about intentional contamination of our

food supply and the government’s ability to minimize that risk.

Those concerns are not unfounded. Last year, a CDC committee

warned that terrorists might try to contaminate our food supply

with such pathogens as clostridium botulinum, and E. coli

O157:H7.

The recent National Academy of Sciences report agreed, explaining that biological agents could be produced quickly and inexpensively. We saw how easily bacteria can be used as a weapon when

in 1984 members of a religious commune in Oregon contaminated

10 salad bars with Salmonella, sickening 751 people. Be it bioterrorism or sloppy manufacturers, we are relying on old laws to regulate new hazards. The Safe Food Act of 2001, introduced by Senator Durbin, offers a much-needed corrective to one of the major

defects in our Nation’s food safety system.

Food safety oversight is balkcanized among at least nine Federal

agencies, from the Department of Agriculture to the Bureau of Alcohol, Tobacco and Firearms. That fragmented responsibility, compounded by inflexible statutory restrictions, results in many gaps,

inconsistencies and inefficiencies in government oversight. For example, as we have heard many times over the past 5 or 10 years,

makers of pepperoni pizzas get inspected every day, while makers

of cheese pizzas get inspected only once every few years, even

though both kinds of pizzas pose similar risks, I had not learned

until today about open-faced versus closed-faced sandwiches, which

takes this issue to ludicrous heights.

Currently, the FDA, which has just 150 inspectors to ensure the

safety of four million shipments of imported food, inspects less than

1 percent of those shipments. Eggs, depending on whether they are

in the shell or processed, are overseen by either FDA or FSIS, and

a third agency grades them for quality. Meanwhile, no agency is

trying to prevent Salmonella contamination from ever happening

back on the farm.

28

1The prepared statement of Mr. Cady appears in the Appendix on page 108.

For crops that are genetically engineered to produce a pesticide,

the EPA evaluates the safety of the pesticidal chemical while the

FDA reviews the safety of the whole plant except for the pesticide.

EPA’s process is open and mandatory, while the FDA’s process is

secret and voluntary. Frankly, that kind of jury-rigged system is

nuts. Professor John Bailar of the University of Chicago, who authored a paper published by the National Academy of Sciences,

concluded, ‘‘Our country needs a single independent food safety

agency. When bioterrorism is added to the mix, the case for prompt

and sweeping change becomes compelling.’’ A sensible system, food safety system, would allow officials to deploy resources when and where they are needed most. For instance,

judging from CSPI’s database of foodborne-illness outbreaks, foods

regulated by the FDA caused four times as many outbreaks as do

foods regulated by USDA. However, the FDA has only about onetenth as many inspection personnel, and there is no way to transfer inspectors from factories producing lower-risk canned beef stew

to packers distributing higher-risk fresh alfalfa sprouts. That mismatch between risk and resources has led CSPI and other consumer groups to call on Congress and the President to develop a

single coherent food safety statute that would be implemented by

a single independent food safety agency.

CSPI strongly supports the Safe Food Act of 2001, which, if

passed, would result in a major and long-needed upgrading of our

food safety system. We also would strongly support a parallel and

equally-essential effort to develop a unified food safety statute.

Thank you very much, Senator, both Senators, for your continuing leadership to improve food safety and for giving me the opportunity to offer CSPI’s views.

Senator DURBIN. Thanks, Dr. Jacobson. Mr. Cady.

TESTIMONY OF JOHN CADY,1 PRESIDENT AND CHIEF EXECUTIVE OFFICER, NATIONAL FOOD PROCESSORS ASSOCIATION

Mr. CADY. Thank you, Mr. Chairman, for this opportunity to testify about our ability to ensure food security within the framework

of our current regulatory system. My written testimony, which I

will not read, outlines in greater detail our thoughts, not just on

this subject, but also on the broader issue of whether we need a

single food safety agency. I will make a few opening comments and

look forward to your questions, sir.

First, Mr. Chairman, I want to salute both you and the Ranking

Member and former Chairman of the Subcommittee, Senator

Voinovich, for your leadership on food safety issues. You have my

commitment to continue to work with you and the Subcommittee

on how we can best improve the management of our food safety

regulatory systems.

Mr. Chairman, the National Food Processors Association is the

Nation’s largest food-only trade association and its voice on scientific, technical and regulatory issues involving food safety. There

are a lot of food-trade associations, as you know, which reflect the

great diversity and reach of our industry, but NFPA’s focus has

long been on research, science, food safety, manufacturing practices

29

and emergency situations for our 350-member food companies. We

have special expertise in the area of food security, which has long

been a top priority of our industry, specifically in the area of tampering and contamination.

Mr. Chairman, we have great confidence in our food safety regulatory system for protecting the integrity of our food supply, both

for domestic and imported foods. We believe both Secretary

Veneman and Secretary Thompson and their respective agencies

have done an outstanding job of responding to the tragic events of

September 11. We are confident that they have worked closely with

their regulated industries to ensure that the systems are in place

to adequately address threats to our food supply. Through our association the industry has also created an alliance for food security,

which is coordinating the industry’s efforts and communications

with Federal agencies.

We recognize that the food safety system is not perfect. We have

long advocated for more resources for the Food and Drug Administration to ensure it can perform its core mission. In particular,

FDA’s information tracking system for imported foods, called Oasis,

needs to be updated. More research to develop better sampling and

testing techniques are needed to get a more rapid response. We understand that the Bush Administration is advocating more inspectors at our borders and ports to make sure that nothing slips

through, and I have been told that Governor Ridge will focus on

food safety and food security as part of the new Office of Homeland

Defense, where he will be looking at budgets and the need for new

legislative authorities.

Given the vast powers that FDA already has over imported foods,

we do not believe, however, that additional authorities at this time

are necessary, and any emergency regulatory actions taken during

this period of crisis should have sunset provisions considered. It is

also very important that we do nothing that has the unintended

consequence of lessening consumer confidence in our Nation’s food

supply. Our Nation’s outstanding food safety record has led to a

high and justified level of consumer confidence in our food supply.

It would do a serious disservice to consumers to send a message

that our food supply is unsafe, especially in light of the tragic

events of September 11 and the war in which we are now engaged.

We must all watch what we say, how we say it, and understand

that our words greatly impact the public.

On your proposal for a single food safety agency, Mr. Chairman,

we commend you for your thoughtful approach to a very difficult

issue, NFPA, however, is not yet prepared to endorse this proposal.

In fact, as I noted in our written statement, we believe all the objectives that you outlined in the bill can be achieved by better utilizing existing authorities, starting with the Cabinet Secretaries, to

both coordinate and allocate resources and streamline overlaps in

jurisdiction before seeking any kind of new legislation. A new management layer, which I see a single food agency to be, is simply not

necessary at this time. Rather, we endorse a single food safety policy that would be implemented on a unified basis across the existing agencies.

Thank you, Mr. Chairman and Senator Voinovich, and I look forward to your questions.

30

1The prepared statement of Mr. Chalk appears in the Appendix on page 113.

Senator DURBIN. Thanks, Mr. Cady. Mr. Chalk.

TESTIMONY OF PETER CHALK, PH.D.,1 POLICY ANALYST, RAND

CORPORATION

Mr. CHALK. Mr. Chairman, and Members of the Subcommittee,

thank you very much for this opportunity to provide testimony on

this very important subject. I am a policy analyst at RAND who

has spent most of the last 10 years studying terrorism. The views

I will be presenting are my own and should in no way be reflected

as representing RAND or of any of the sponsors of its research.

Over the last 7 years considerable investments have been made

in infrastructure protection within the United States, and this has

led to an increasingly well protected infrastructure that now spans

the ambit from conventional bombings right through to more exotic

acts of biological terrorism. Agriculture, however, is one area where

not too much attention has been paid in this regard, and I would

suggest that this is problematic for two main reasons.

Agriculture is absolutely critical to the economic, social and political stability of the United States. Certainly, in economic terms it

is of utmost importance. It is the country’s largest single employer,

$50 billion is raised every year through agricultural exports. Cattle

farmers and milk producers alone earn between $50 billion and $54

billion through meat and milk sales. The disruption of this highly

critical sector would cause a tidal economic wave effect that would

impact, not only on the sector itself, but also on the individual and

the consumer.

For a number of reasons, agriculture does remain vulnerable to

either deliberate acts of sabotage or indeed, to naturally occurring

outbreaks.

First, the disease susceptibility of animals in general has risen

as a result of biotechnic modifications that have served to lower the

natural disease resistance of animals to pathogens.

Second, there are many more diseases that are both highly contagious and infectious to animals than is the case with human

beings. We know of at least 22 that currently exist. Most of these

are also environmentally hardy and many livestock are not routinely vaccinated against them.

Third, diseases tend to spread very quickly amongst animal populations simply because of the intensive and concentrated nature

by which they are housed, bread and transported within the United

States. A typical dairy can be expected to have at least 1,500 lactating cows, with some of the larger facilities having between 5,000

and 10,000 animals. Stopping an outbreak of a highly infectious

disease at any one of those facilities would be very difficult.

We also have a proliferation of food processors—particularly at

the lower end or the smaller end of the scale—that lack adequate

internal quality control, may not have very viable product recall

plans; and also, largely do not undertake effective screening of seasonal employees, which exacerbates the potential of insiders getting

in. I should have stress that this problem exists at the medium and

lower end of the scale. And finally, the increased production of genetically modified foods has also increased the possibility of exVerDate 11-MAY-2000 08:18 Aug 22, 2002 Jkt 000000 PO 00000 Frm 00034 Fmt 6633 Sfmt 6633 76804.TXT SAFFAIRS PsN: SAFFAIRS
31

1The prepared statement of Mr. Molpus appears in the Appendix on page 127.

tremists and radicals carrying out acts of violence against GM

foods, and we have certainly seen aspects of that in Europe.

The impact of a major agricultural disaster in this country would

be enormous. Economically, we would have effects that could cross

at least three levels: Direct economic impacts resulting from containment procedures and eradication procedures; indirect economic

effects resulting from compensation paid to farmers who were affected by the loss of their products—in the UK, the recent foot-andmouth disease outbreak has resulted in over $1 billion in compensation costs alone being paid; and finally, international costs in

the form of protective trade embargos that are imposed by major

trade partners against the affected country, in this case, the United

States.

Beyond that we would also probably get a loss of political support

and confidence in government. A major agricultural disaster would

undoubtedly cause people to lose confidence in the food supply, and

it could also cause them to question the effectiveness of existing

WMD preparedness in general. In addition, the actual mechanics

of instituting a viable response to a major agricultural disaster

could elicit public criticism in the form of reaction to mass culling

and disposal operations.

Finally, we could have social instability as a result if an act led

to a major public health scare, and here we are talking about a

foodborne disease outbreak or the introduction of an animal disease

outbreak that is also zoonotic in its implications.

A number of areas do need to be substantially increased and enhanced in preparation for public infrastructure protection of agriculture. We need more diagnostic training. We need an overhaul of

the veterinarian curriculum with more emphasis given on largescale husbandry, better standardized links between the criminal

justice communities, intelligence communities and the USDA.

I do support your own suggestion here of instituting a single

agency to stream line and rationalize the oversight for food safety

within this country. Thank you very much.

Senator DURBIN. Thank you, Mr. Chalk. Mr. Molpus.

TESTIMONY OF C. MANLY MOLPUS,1 PRESIDENT AND CHIEF

EXECUTIVE OFFICER, GROCERY MANUFACTURERS OF

AMERICA

Mr. MOLPUS. Thank you, Mr. Chairman and Members of the

Subcommittee. I appreciate the opportunity to appear before you

this afternoon and compliment the Chairman and Members of the

Subcommittee for giving us this opportunity for an exchange of

views on the important issue of food safety. The testimony I am

providing this afternoon is endorsed by a number of additional food

trade organizations, specifically, the American Frozen Food Institute, the American Bakers Association, International Dairy Foods

Association, and the Snack Food Association.

GMA-member companies make and market the world’s best

known brands of foods and beverages around the world. Our members represent approximately 90 percent of the branded food and

32

beverage products sold in the United States. So nothing is more

fundamental or has a higher priority for us than food safety.

The United States, as the Chairman indicated in his opening remarks, has the safest, most abundant and varied food supply in the

world. We have achieved this enviable position, not by luck or accident, but through the commitment of the food and agriculture industries and generations of dedicated public servants. The achievements of this partnership are reflected in the high confidence that

American consumers have in the safety of their food supply. According to the Gallup organization, 82 percent of consumers have

confidence that the Federal Government adequately ensures the

safety of food. That consumer confidence is not misplaced. We do,

in fact, have a remarkably good food safety record.

The system we have is not perfect however, and it can be enhanced, but before we embark on a radical restructuring of the food

safety regulatory system, we believe we should be absolutely convinced that there is no better way to address the issues of concern.

During the Clinton Administration, the President’s Council on Food

Safety studied this issue and concluded that, ‘‘Reorganization by

itself will not significantly change the food safety system’s capability to assure public health protection,’’ and that, ‘‘No single

structure for the food safety system provides a perfect solution.’’

Today’s food safety system has evolved into a sophisticated

science-based system that appropriately allocates responsibility

among several Federal agencies. The allocation of responsibility

among multiple agencies is not inherently wrong or misguided.

Rather, it reflects the informed judgment of lawmakers and government food safety officials over many decades that different sectors

of the food supply present different challenges and, thus, call for

different inspection expertise and different focus of regulatory resources. When fundamentally different regulatory systems are

called for, dividing responsibility among agencies represents a logical approach. In short, food safety regulation is not a one-size-fitsall situation.

We should not underestimate the challenges that would be faced

in combining all food safety regulatory activities. From the experience of many of our member companies, it is difficult and disruptive to implement a merger. Combining organizations inherently

means a period of uncertainty, distraction, loss of focus and efficiency. Now, perhaps more than any time in our history, we need

to stay focused on the job at hand. Having said that, this does not

mean that we seek to maintain the status quo. There is room for

improvement of our current system and we have four recommendations.

First, consumers in the food industry are best served by strong

food safety agencies which develop policy based on sound science.

I would like to focus particularly on FDA. Although the responsibilities of the FDA have increased dramatically over the last several

decades, the funds appropriated to FDA for its food safety-related

functions have failed to keep pace. GMA has already taken a leadership role in this area. For some time we have provided leadership

to a food industry coalition whose objective is to increase the

awareness of more resources at FDA.

33

1The prepared statement of Mr. Hammonds with an attachment appears in the Appendix on

page 138.

We have at GMA a board-led task force of CEOs committed to

helping assure that the case for additional FDA resources is made.

For the past several years GMA has urged Congress to fully fund

increases in FDA’s budget for food safety, and I think it is worthwhile mentioning today that the Congress, with the help of several

appropriators on the Subcommittee, including the Chairman, is

about to, for the first time, approve the FDA’s full budget request.

Second, our food safety system must emphasize science and research. We must identify and fight the true causes of foodborne illness with the right scientific weapons. Good science has always

been a critical component of sound food safety regulation, and it is

incumbent, therefore, on all of us with the shared commitment to

effective food safety regulations to think creatively about ways to

bring more science to FDA, and better scientists. We might do this

through a fellowship program, such as what doctors go through at

NIH and come out of NIH. We might have a fellowship program

bringing young scientists to FDA.

Third, collaboration, coordination and consultation should be a

full-time commitment for all our Federal and State regulators. The

Secretaries should make it absolutely clear as they carry out their

shared missions that their job is to eliminate duplications and inefficiencies. A good example has been the joint agency work on foodsafety research.

Fourth and finally, one of the most dramatic changes that occurred with regard to our food-safety supplies is the extent to

which we now have a global marketplace. FDA regulated products

enter the United States from more than 100 countries. We must

ensure that our regulatory agencies have more resources and tools

to effectively regulate imported products.

In conclusion, GMA and its member companies are firmly committed to the continued integrity and effectiveness of our food safety regulatory system. No one has a greater stake in the credibility

of the system than our member companies. We are open to considering a wide range of ideas and proposals to improve our current

systems. But before we scrap a system that is regarded as the best

in the world, we should fully explore strategies to enhance the system through adequate funding, better coordination, the best

science, and continued innovation.

Thank you, Mr. Chairman.

Senator DURBIN. Thank you, Mr. Molpus. Mr. Hammonds.

TESTIMONY OF TIM HAMMONDS,1 PRESIDENT AND CHIEF

EXECUTIVE OFFICER, FOOD MARKETING INSTITUTE

Mr. HAMMONDS. Chairman Durbin and Senator Voinovich, thank

you for inviting me here today. My name is Tim Hammonds and

I am the president and CEO of the Food Marketing Institute. FMI

is the national trade association representing the retail supermarkets and food distribution industry. I will summarize here

today, but with your permission, will submit my full statement

along with FMI’s board-adopted policy in support of designating a

single food agency for your record.

34

In our view, this hearing is especially timely because our current

Federal food safety system is ill-equipped to deal with today’s challenges. Clearly, no one now designing a regulatory system to maintain the wholesomeness and integrity of our food would ever design

anything remotely resembling what we have today. The case for

designating a single food agency, then centralizing resources and

responsibility, was compelling in May of the year 2001 when FMI’s

board of directors adopted that position. The need for such a system now is imperative.

We believe this could be accomplished without disturbing the

oversight authority of the current committees of jurisdiction in the

House and the Senate. You will note that we are on record in support of designating a single food agency, not in support of creating

an entirely new agency. We believe too much expertise would be

lost, too much of our existing credibility would be squandered, and

too much time would be wasted if we attempt to create an entirely

new agency from scratch. In our view, the best course of action

would be to centralize resources, responsibility and authority within one of the existing agencies, then elevate the status of this group

to a level appropriate to our new challenges.

In the wake of the attacks on America on September 11, we have

begun to look for vulnerable areas in our society. The safety of our

food supply is a legitimate subject for inquiry, but under that microscope, it is clear that now when additional funds are needed to

ensure food security, we can ill afford the current system’s lack of

coordination and the resulting waste of resources. Should a crisis

arise, either real or manufactured as a hoax, the deficiencies of our

current system would become glaringly obvious. For example, let’s

assume a tampering hoax is staged. The public needs rapid reassurance from a credible source. Under current policy that could

easily involve multiple government agencies.

Since it is rare that a single agency has complete jurisdiction

over the entire scope of a major food safety problem, it has been

our experience that none of the agencies step forward in times of

crisis. It becomes impossible to find a spokesperson who can rapidly clarify the facts and reassure the public. Far more typically,

the public is faced with a lengthy delay while our overlapping bureaucracies creep into some sort of action, culminating eventually

in a message of reassurance to the public.

To the issue of whether a coordinator would be enough to oversee

the existing agencies, we have an open mind on that, but we are

doubtful. Although some improvements could certainly be made,

there would still be overlapping jurisdictions and gaps.

Let me emphasize that none of this is due to the lack of skill or

dedication of those working within our various food safety agencies.

Quoting from the 1998 report of the commission to ensure safe food

from production to consumption, ‘‘These are dedicated, capable people, but they operate within an institutional framework that is out

of date and poorly designed to accomplish the critical goals that

food safety regulation in this field must achieve. The increasing

complexity of food production and delivery and the exploding internationalization of the U.S. food supply impose added pressures on

the Federal regulatory apparatus which was constructed in similar

times.’’

35

Our FMI board of directors is open to other solutions that would

improve food safety oversight; however, we find it difficult to come

up with a simpler or more direct approach than designating a single food safety agency. Thank you, Mr. Chairman and Members of

your Subcommittee, for the opportunity to speak with you today on

behalf of the members of the Food Marketing Institute.

Senator DURBIN. Thanks, Mr. Hammonds.

I would like to ask Mr. Cady and Mr. Molpus a question, because

from your testimony you appear to be skeptical of this notion—I

guess that is a kind way of putting it, but let me just ask you this,

Mr. Cady, first: Do you agree that what ever food safety inspection

standard we have, it should be based on science?

Mr. CADY. Well, coming from a science organization, sir, the answer is obviously yes. It needs to be based on science. It needs to

be risk-based. It needs to be properly budgeted for, which we have

not done over the years, especially in the FDA arena. It also needs

to be one that has a policy that emanates from science and risk assessment, that is permeated throughout a unified food safety system.

Senator DURBIN. Do you think our current system is based on

science?

Mr. CADY. I believe that the majority of our system is currently

based on science, but I caution that I do not believe we have gotten

far enough into the risk-assessment arena, where we can make better use of the resources that we do have available. But I think the

science that is done by the agencies has improved tremendously

over the years and I think that the agencies coordinating activities

are making it even better.

Senator DURBIN. Can you then tell me the scientific basis for

daily inspections at the U.S. Department of Agriculture and quadrennial inspections through the Food and Drug Administration?

Mr. CADY. Well, I think, again, if you look at the risk involved

in the Department of Agriculture inspections—and there are historic issues, sir, that I am not saying we cannot take care of and

that the department could not make better—but there are historic

issues based on animals that are being processed. Eighty percent

of my members’ food, however, is not regulated by FSIS, and so you

look at—Mr. Jacobson even mentioned—somebody who is making

a high-acid tomato product in Ohio, as an example. Is that the

same as some other product that perhaps has more risk than that

does? I think we have not made good use of that particular tool in

the risk-assessment area.

Senator DURBIN. You have made several points and I do not

want to blend them together. I am trying to keep them separate.

The point about funding, adequate inspection and the like is certainly one that no one argues with, I do not believe. But I do believe that Dr. Jacobson’s initial point is the important one here.

The current system is not based on science. The current system is

so disparate in terms of the application of inspection, for example,

that it is hard for me to rationalize why daily inspection of agriculture through the Department of Agriculture, Poultry, and Meat

makes sense, but inspection once every 4 or 5 years through the

Food and Drug Administration still makes sense.

36

I have to tell you that I think what drove the USDA into daily

inspection was not the wisdom Mr. Molpus refers to, but Upton

Sinclair scared Americans into finally initiating some sort of a Federal responsibility for inspecting meat. If you ever read it, as most

of us have, you can understand why. Chicago has changed a lot,

incidentally, since the book was published. But, there just is not

any consistent science here.

Mr. CADY. I disagree, of course, with Mr. Jacobson on that. I

think the science is there. I am not sure when you get into the inspection system—what I understand you are saying is—I think the

science is there, how it is carried to the inspection system, throughout the inspection system, I guess is what your question is. Again,

if you have limited dollars and you have limited inspectors, you

have to go to a risk-based system, and that makes better use of

your resources, and we have not done that fully.

Senator DURBIN. You said in your testimony no additional authority is necessary. Now, that is a very broad statement in light

of what we just heard from former Secretary Glickman——

Mr. CADY. No, I was talking about over the ports and that particular area. I do not believe—again the lawyers have to argue this

out and I am not a lawyer, but from what our discussions have

been on this with lawyers, we believe that they can do what they

need to do today at the ports in order to beef up security.

Senator DURBIN. Let’s go to a specific point then, so I can have

your testimony on the record. Former Secretary Glickman has

noted the fact that the agencies, USDA and FDA, do not have authority today to deal with products that have been subject to epidemiological contamination as opposed to pathogen. Do you believe

that the law should be changed so that they have that authority?

Mr. CADY. I think we have to look at those authorities and we

have to decide whether or not that is good for the system and good

for the whole food safety system. Please remember that the industry spends millions and millions of dollars a year on food safety

systems of their own and we get into these situations such as civil

and monetary penalties, and criminal penalties, which exist today

for adulterated food. The question I have always had is that when

somebody goes out—and this has happened—and makes a bad decision on shutting down a plant under a mandatory system, let’s say,

what recourse does that particular plant or company have if the decision is not correct? Essentially they are out of business. So, my

point is, it needs to be looked at. If they need authority in that particular area, then I am not against opening it up and talking about

it at all.

Senator DURBIN. Well, I would like to ask Mr. Molpus. You said

something in your testimony—it is part of the record now—and it

says that the current system—you were referring to the current

system—reflects the informed judgment of law makers and government officials over many decades, that different sectors of the food

supply present different challenges and thus, call for a different inspection and regulatory system. That seems to suggest that there

is some sort of divine plan here behind our food and safety inspection, or at least a coordinated—let’s use that, a coordinated thinking and ‘‘wisdom’’—you used the word wisdom—behind our current

37

system. Do you find wisdom in a system that treats an openedfaced sandwich different than a closed sandwich?

Mr. MOLPUS. Well, with all due respect, Mr. Chairman, the Congress must find that to have some wisdom. What I think has been

said here numerous times today—and I think it bears repeating— many of these issues flow from the fact that the Congress, in passing the statutes that created the inspection systems for food in

total, created different statutes with different laws that affect different segments of the industry. Congress created, as you eloquently alluded to, the Meat Inspection Act after Upton Sinclair’s

in ‘‘The Jungle.’’ As you may remember, I was president of the

American Meat Institute in the first life where we met, and that

is a different statute than the one that is dealing with other foods.

And to your point with the questioning of Mr. Cady, the intensity

that we want in a meat plant every day, intensive inspection that

is mandated by law—that can be changed by the Congress. It will

not be changed by bringing all the agencies together. We have a

lot of fun poking fun at pizza. Pizza has been one of the most successful products in the history of the American food industry. It

has managed to survive this quagmire of government inspection. It

has been a tremendous success with consumers and in the industry, and combining the agencies, putting all the agencies in one

house, would not solve that pizza problem. It would not solve, I do

not think, the open-faced sandwich problem. If there is any point

that needs to be made here today, it is underlying statutes—and

that is what I was trying to make in my testimony—it is underlying statutes separately passed by the Congress that drive different types of approaches to inspection.

Senator DURBIN. That is why we are here today, those underlying statutes and that so-called wisdom that brings us to this

point where we are so embarrassed today by what we have. Let me

ask you, as I have asked Mr. Cady, Secretary Glickman makes the

point about epidemiological contamination. Do you think the FDA

and USDA should have authority when it comes to epidemiological

contamination as it does for pathogens?

Mr. MOLPUS. Well, essentially we are not regulated by USDA. I

have seen nothing that makes me think FDA needs that authority

or I did not hear them say they desired that authority. I do not

think we have had those kind of issues with the type of foods that

FDA regulates.

Senator DURBIN. Mr. Molpus, based on Dr. Schwetz’s testimony,

I do not see how we can take that position. He has said in his testimony that food is a medium for bioterrorism. I do not want to create panic, but I want to be realistic. I do not want something to

happen tomorrow and hear, ‘‘Why didn’t you even talk about it in

Congress the day before?’’ That is why I think that what the Secretary has suggested is a reasonable suggestion, to give these agencies the authority to deal with bioterrorism. God forbid we ever

need it, but they should have that authority. Should they not?

Mr. MOLPUS. Well, I will tell you this, Senator, they have never

talked to us about needing that authority that I am aware of. It

has never been an issue in the regulation of the foods that I represent. If it is an issue, then we are willing in these particular

times to sit down with the agency and rediscuss and reevaluate

38

some of these legislative needs. They may be on an emergency

basis, some things we need to do. Whether that is one of them or

not, I could not tell you today.

Senator DURBIN. I think that is a reasonable position. Dr.

Jacobson, could you comment on that suggestion from Secretary

Glickman about the epidemiological protection?

Mr. JACOBSON. I am not sure what the underlying laws here are,

but my sense was that Secretary Glickman was saying if a food is

linked to health problems without proof of a particular organism,

then the government should be able to take action. And I think

that it is patently obvious that government should be able to take

action, because it might take weeks or months to track down a particular organism—like we saw with mad cow disease. It is a new

organism in our experience.

I would like to step back, if you do not mind. I am very disappointed that the industry is not supporting the best possible

food-safety system. Yes, we need changes in the statutes and we

need reorganization, and I think former Secretary Glickman was

very clear about this. Neither by itself will work. We need to do the

two things sequentially or at the same time, but move in that direction. If there were a tragedy where you have FDA and FSIS

fighting over whether the beef broth was 1 percent or 3 percent

beef, and so we do not know who is going to regulate it, it would

be a crying shame that actions were not taken because we had this

crazy statutory patchwork and bureaucratic mess. And if we did

have that tragedy, I think the food industry and opponents of action in Congress would feel extraordinarily embarrassed.

Senator DURBIN. I think you are right. I am going to turn it over

to my colleague here, Senator Voinovich, and I will just make one

comment. I find that there is a resistance in some areas to the

changes which we are discussing. When it comes to government

agencies, there is only one thing that can bring someone who is involved in this area around to my point of view and that is leaving

civil service. Once they are out of the private sector, they seem to

think that this is nothing but the best idea in the world.

Senator Voinovich.

Senator VOINOVICH. In the high-risk series update published

January 2001 by the General Accounting Office—and by the way,

they put human capital as a new high-risk area—they cite the Department of Agriculture’s organizational culture, especially in its

role of overseeing food safety, as an example of an agency that

faces human capital challenges. Although food safety is not deemed

a high-risk issue, GAO has listed food safety oversight as one of the

major management challenges facing the Department of Agriculture.

GAO has explained that they feel the problem is not isolated to

the Department of Agriculture, but rather than identifying it as a

governmentwide problem, they chose to focus on the USDA. Now,

these problems have been around a long, long time. I would be interested, Mr. Cady, and Mr. Molpus, what suggestions have your

organizations made over the years to these agencies, and what kind

of response have you received? I know you mentioned, finally, that

they funded the budget.

Senator DURBIN. This year.

39

Senator VOINOVICH. This year—but what recommendations have

you made and what kind of response have you gotten back over the

years, and what makes you think that now that we have an additional challenge that things are going to be different in terms of coordination between the agencies and the commitment of resources

that need to be made? You mentioned—I think Mr. Molpus, you

talked about consumer—more resources; science and research coordination; regulated, updated products and so forth. They are all

out there, and what is really being done? And how do you respond

to the fact that it has not been done and it does not require some

new way of accomplishing this issue?

Mr. MOLPUS. Senator, I think the FDA has made some considerable progress. I think over the last 4 years there has been a significant or a noticeable decrease in the diagnosed cases of Salmonella

and Listeria. They have set forth some targets for 2005, which, in

reduction of these foodborne illnesses, they have almost reached

those targets already. There is continual innovation and progress.

I think what we are saying from industry is, it could be faster.

There could be more resources. They have been a resource-starved

agency, and with additional resources and the application of better

and improved science and technology, and given that we all say

that they are best in the world, I think they can get the job done

without going through the distraction of a structural reorganization.

Senator VOINOVICH. But the fact is, they have not gotten the job

done. It is an issue of priority in terms of somebody coordinating

it and saying that this is a national problem.

I was interested in Mr. Hammond’s testimony. You are saying

that we have had outbreaks. Why don’t you share with me an example of a couple of them where you could not get somebody to

step up to the table and clarify it? If we had something like this

right now, how would we deal with it in a way that the public

would feel confident that something was happening, Mr. Hammonds?

Mr. HAMMONDS. Well, almost any of the outbreaks would serve

as an example. Perhaps the clearest was our Chilean grape situation, which in hindsight turned out not to be a huge problem, but

at the time it was impossible for us to find someone from the government willing to step forward and reassure the public. But retailers and T.V. news cameras can always find a supermarket. Retailers turned out to be the ones out front on that, and the ones doing

as best we can to give the public reassurance.

I would point out that in the middle of the food distribution system, groups tend to be regulated by single agencies or have very

clear lines of authority. When you arrive closer to the consumer

and you get into the supermarket, one way or another we are regulated by everyone. So we see the kinds of overlaps, the kinds of

gaps and therefore, the kinds of time we waste trying to get a credible analysis of the situation and a reassuring statement out of the

government. So, perhaps we deal with a more difficult problem

than those earlier in the distribution system, but it is a problem.

Senator VOINOVICH. The manufacturers are saying the system is

OK, and those of you that are out there, retailers, say this system

is not working, and you’re concerned that you get the wrong inforVerDate 11-MAY-2000 08:18 Aug 22, 2002 Jkt 000000 PO 00000 Frm 00043 Fmt 6633 Sfmt 6633 76804.TXT SAFFAIRS PsN: SAFFAIRS
40

mation out there and you cannot move in on it and this will have

a devastating impact on your businesses. People stop buying whatever the case may be, and it just ratchets down. It is interesting

with the airlines, the enormous cascading that has gone on in this

country in other areas. Everyone is saying now, if you really want

to do something about the economy, get the planes flying and get

them up in the air and make people feel secure. One or two items

like this just have—it was the egg thing at one time and it just ripples across. So, there seems to be a difference of opinion here between Mr. Molpus, Mr. Cady and you, Mr. Hammonds, and you are

all on the private sector side of this thing.

Mr. MOLPUS. It is rare that we disagree. The point that it goes

to we have a different relationship with the agencies than the supermarket industry and a lot of this goes to the view and experience that we have had with the agency versus someone else’s experience. We have not had the experience of having indecisiveness

about who is in charge during the time of any sort of a food safety

crisis that we have dealt with. We are looking at throwing out

some atypical examples and coming to conclusions, rather than

looking at the vast majority of incidents. It is fairly clear. You can

talk about the pizza issue, but it is fairly clear that the products

are at USDA and that they deal with them through the system and

the products that are at FDA and that they deal with them.

Mr. JACOBSON. Do not forget the $100 billion worth of products

whose labeling and safety is overseen by the Bureau of Alcohol, Tobacco and Firearms. The Treasury Department does not put this at

the top of its list when you are asking the Secretary for what the

issues are. We have seen cases where beer was contaminated with

nitrosamines, which are cancer-causing substances. Wine and liquors were contaminated with urethane, another cancer-causing

substance, and these substances developed during the manufacturing processes. Wine contains sulfites, which is deadly to a small

percentage of the population. It causes acute reactions.

When we went to the Bureau of Alcohol, Tobacco and Firearms,

they did not have the foggiest idea of what to do about these

things. It took a fair length of time before they learned how to coordinate with the FDA. That may be at the extremes, but we are

talking about a lot of product being consumed that falls largely outside the ambit of FDA or USDA. That is something I think should

be expressed in your bill. But, I think Mr. Molpus is right. Usually

things work out fine and we do have a pretty safe food supply in

this country. Most people do not die of food poisoning, just 5,000

a year. Is that OK? We need to be concerned about where the problems are and maybe it is one-tenth of 1 percent of all the food or

decisions that are being made, but that is where the problems are

going to occur. That is what we should anticipate and prevent.

Mr. CADY. I would like to make a couple of comments, if I could.

One, my association is responsible for working with our companies

relative to recalls when they occur, and in the 14 years that I have

been associated with this, I have never had a problem determining

or having the agencies determine as to who is responsible or in

charge of that particular recall. So, I can just say that I have not

seen that fall through the crack in terms of responsibility.

41

You made a couple of statements earlier, both of the Senators

did, relative to why doesn’t this thing work then, if we think it is

such a great system. I think it is like anything else. If you have

two companies that merge, there is a CEO that drives the issue in

terms of bringing those two companies together, not only in terms

of their culture, but also in terms of their production issues, marketing issues. What has not occurred in the government aspect of

managing this system, in terms of coordination and communication, is the accountability taken over by, and I start at the Secretary level, to make sure that the coordination and the communication exists. What we really do is, we usually talk about it at

these type of hearings and the Secretaries may talk about it, but

it gets pushed down to the working level agencies that actually do

it, and it is harder to do that.

I think that we need my suggestion, in terms of trying to clear

up some of this pizza issue, which I love to hear about—I do not

think it is a food safety issue. I think it is a department issue, in

terms of who should be responsible for pizza, which is a great product, but it is not a food safety issue. But, I think from that you can

get a lot more out of this system. Are there some legislative things

that need to change? Probably. Are there some department responsibilities that could be put together? Probably. Are there better

ways we can do risk assessment? Certainly. But, I think people

have to focus on it and carry it through, and I do not believe in

my tenure in this town that that has occurred.

Senator VOINOVICH. Well, the question I have is, and I challenge

you today, is to come up with those recommendations about the

things that you think need to be done in terms of coordination, in

terms of resources and some of the things that you have talked

about now and in your testimony.

Mr. CADY. We will do that.

Senator VOINOVICH. And, to see if you can get that kind of attention given to it—I have, and I have been here a short time—but,

getting agencies to coordinate their activity around here is very,

very difficult.

Mr. CADY. Well, let me add that we brought up the EPA a little

while ago. One of the concerns I have with going to a single food

agency from a government bureaucracy perspective is that I look

at the EPA, and after 30 years—and you go back to see what it was

supposed to do and how much was supposed to be encompassed in

that—and I can tell you that in my relationships with the EPA as

a new agency now of 30 years, the coordination and communication

amongst and between is not particularly good—I am not sure how

it was before then. I was not here at that time—but it has not been

that terrific because we have a new agency.

I also think we need to talk about food safety from a political

perspective, Mr. Chairman. Food safety cannot be politicized and I

am concerned about what a single food agency, at the end of the

day, headed by a politically appointed administrator, would amount

to, and I think that——

Senator VOINOVICH. If your analogizing it to EPA, I agree.

Mr. CADY. That is my point, sir. That is how I feel about it.

Senator DURBIN. I might just say in defense of the EPA——

Mr. CADY. OK, Senator.

42

Senator DURBIN. The standards for air and water quality over

the last 30 years dramatically improved. We focused our resources

on a mission and we really achieved a lot. There is more to achieve

and you will find, I think, some bureaucratic tangles in virtually

every single agency.

Mr. Cady, you talk about a CEO driving this kind of combination. We may have that in place. As quoted earlier, Presidential

candidate George W. Bush was in favor of this concept that we are

talking about today and I have spoken to him about it. He understands it then and now, and I think in the context of September

11, understands there is a new dimension to it. I might also add,

as I did earlier, I think Governor Ridge is going to have some voice

in this, as he should, to talk about whether or not this is part of

the security of our Nation. I trust Tom Ridge a lot, because I have

known him for so long, and I hope as soon as he can get his head

above water that I can talk to him about this, too.

Mr. CADY. I think you will see that happen, and food security

and food safety, I think, is going to be a large part of his focus once

he gets organized.

Senator DURBIN. Dr. Chalk, before we break here, let me go back

to some of the points you have made, and one of them I felt was

particularly important when it came to our agricultural exports

being such a large part of American food processing in agriculture.

I think the point you made here is the share of products sold overseas is more than double that of other U.S. industries. So one of

the points I made early on was the hope that this is not just a

monologue in the United States, but becomes a dialogue with other

countries, so that we can start establishing standards one to the

other, with some hope that we can harmonize the way we produce

food so that it is safe and secure as it crosses borders. I do not

know if that is the point that you are alluding to as well.

Mr. CHALK. Absolutely, and I think that any initiatives that are

taken on that basis are overdue and only to the good. One only has

to look at the numerous examples of countries that have been affected by major animal disease outbreaks: Taiwan, the United

Kingdom recently, Argentina this year, to catalog the enormous

economic destruction that can be wrought on those countries, not

only in the term of immediate protective embargoes, but the ripple

effect that can go on for many years. Taiwan is still suffering from

the 1990–1997 outbreak, and actually has not recovered. So, I

think that any institution of cross-border standardization has to be

part of the overall solution, particularly in a globalized world.

We are no longer dealing with countries that can view what occurs within their own borders stopping at that border. We are in

an international system. Where the trading of commodities is more

global and rapid than ever. Therefore, it is incumbent that we do

have some sort of globalized or at least regionalized standardization across borders.

Senator DURBIN. Can you imagine that first meeting with the EU

when we sit down and say, in our wisdom, based on our view of

science, we think that a whole egg should be inspected perhaps

once every day and that a broken egg inspected once every 4 years?

When you get down to it, there is no way we can say that with a

straight face and that reflects the current system in America.

43

The last question I have for you, Dr. Chalk, is you make a point

here about confidence in government, and I think what has happened in Europe is instructive of where we are today. I think there

are some parallels here, because in Europe, government did not respond to a very serious concern of consumers, whether it was BSE

or antibiotics in animal feed or some of these other concerns that

people had, GMOs for that matter, and as a result the stage was

taken over by people who did not bring science to the party. They

brought a lot of fear to the party. As a result, I think, many of

these government agencies were discredited in Great Britain and

in the European Union. Now they are struggling to re-establish

their credibility.

Well, we have a new world, too. We have a new challenge where

I think consumers are going to look to us. What have we learned

from September 11 based on some of the things we have heard in

the testimony at the hearing today? What are we going to do, as

a government, to respond to what people are legitimately concerned

about? Sadly, bioterrorism is one of those that is back on the stage.

I hope we have a credible governmental response so that people believe they can have confidence, not only in their government, but

equally important, or more important, in the safety of our food supply.

I will just close as I started. We have the safest food supply in

the world. It bears repeating. We can do better and what we have

heard today are, I think, some suggestions and examples of ways

that we can improve it. I want to thank all those who attended. I

want to announce that the record of the hearing will remain open

for 1 week for Subcommittee Members to submit statements or additional questions for witnesses.

I thank my colleague, Senator Voinovich, for joining me.

Senator VOINOVICH. Can I just make one last comment?

Senator DURBIN. Certainly.

Senator VOINOVICH. I was quite pleased to hear that the Department of Agriculture and the Food and Drug Administration are

working together with the administration. That was very comforting to me. I would hope that those of you who represent the industry would be making your recommendations also about things

that you see that are out there that we ought to be concerned

about, because you are actually out on the front lines dealing with

these problems. I think your input would be very, very important

and I am sure well-received.

Mr. CADY. We have a process going now just doing that in terms

of the alliance that are running, in terms of information, working

with the government, working with both agencies, so that the communication is flowing both ways. And I think it is going to work

well, sir.

Mr. MOLPUS. The conversations with FDA are daily.

Senator VOINOVICH. Good. Thank you.

Senator DURBIN. Thank you, witnesses. I thank you, Senator

Voinovich. The Subcommittee stands adjourned.

[Whereupon, at 3:20 p.m., the Subcommittee was adjourned.]

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