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A SYSTEM RUED: INSPECTING FOOD

HEARING

BEFORE THE

SUBCOMMITTEE ON CIVIL SERVICE

AND AGENCY ORGANIZATION

OF THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED EIGHTH CONGRESS

SECOND SESSION

MARCH 30, 2004

Serial No. 108–182

Printed for the use of the Committee on Government Reform

(

Available via the World Wide Web: http://www.gpo.gov/congress/house

http://www.house.gov/reform

(II)

COMMITTEE ON GOVERNMENT REFORM

TOM DAVIS, Virginia, Chairman

DAN BURTON, Indiana

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

DOUG OSE, California

RON LEWIS, Kentucky

JO ANN DAVIS, Virginia

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

ADAM H. PUTNAM, Florida

EDWARD L. SCHROCK, Virginia

JOHN J. DUNCAN, JR., Tennessee

NATHAN DEAL, Georgia

CANDICE S. MILLER, Michigan

TIM MURPHY, Pennsylvania

MICHAEL R. TURNER, Ohio

JOHN R. CARTER, Texas

MARSHA BLACKBURN, Tennessee

PATRICK J. TIBERI, Ohio

KATHERINE HARRIS, Florida

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

C.A. ‘‘DUTCH’’ RUPPERSBERGER, Maryland

ELEANOR HOLMES NORTON, District of

Columbia

JIM COOPER, Tennessee

——— ———

———

BERNARD SANDERS, Vermont

(Independent)

MELISSA WOJCIAK, Staff Director

DAVID MARIN, Deputy Staff Director/Communications Director

ROB BORDEN, Parliamentarian

TERESA AUSTIN, Chief Clerk

PHIL BARNETT, Minority Chief of Staff/Chief Counsel

SUBCOMMITTEE ON CIVIL SERVICE AND AGENCY ORGANIZATION

JO ANN DAVIS, Virginia, Chairwoman

TIM MURPHY, Pennsylvania

JOHN L. MICA, Florida

MARK E. SOUDER, Indiana

ADAH H. PUTNAM, Florida

NATHAN DEAL, Georgia

MARSHA BLACKBURN, Tennessee

DANNY K. DAVIS, Illinois

MAJOR R. OWENS, New York

CHRIS VAN HOLLEN, Maryland

ELEANOR HOLMES NORTON, District of

Columbia

JIM COOPER, Tennessee

EX OFFICIO

TOM DAVIS, Virginia HENRY A. WAXMAN, California

RON MARTINSON, Staff Director

B. CHAD BUDGARD, Deputy Staff Director and Chief Counsel

REID VOSS, Clerk

TANIA SHAND, Minority Professional Staff Member

(III)

C O N T E N T S

Page

Hearing held on March 30, 2004 ............................................................................ 1

Statement of:

Dyckman, Lawrence J., Director, National Resources and Environment,

U.S. General Accounting Office; Robert E. Brackett, Director, Center

for Food Safety and Applied Nutrition, Food and Drug Administration;

and Merle Pierson, Deputy Under Secretary for Food Safety, U.S. Department of Agriculture ................................................................................ 8

Glickman, Dan, director, John F. Kennedy School of Government, Harvard University, and former Secretary of Agriculture; and Caroline

Smith DeWaal, director, food safety, Center for Science and Public

Interest .......................................................................................................... 106

Letters, statements, etc., submitted for the record by:

Brackett, Robert E., Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration, prepared statement of .................... 43

Davis, Hon. Danny K., a Representative in Congress from the State

of Illinois, prepared statement of ................................................................ 7

Davis, Hon. Jo Ann, a Representative in Congress from the State of

Virginia, prepared statement of ................................................................... 3

DeWaal, Caroline Smith, director, food safety, Center for Science and

Public Interest, prepared statement of ....................................................... 115

Dyckman, Lawrence J., Director, National Resources and Environment,

U.S. General Accounting Office, prepared statement of ............................ 11

Glickman, Dan, director, John F. Kennedy School of Government, Harvard University, and former Secretary of Agriculture, prepared statement of ........................................................................................................... 110

Pierson, Merle, Deputy Under Secretary for Food Safety, U.S. Department of Agriculture, prepared statement of ............................................... 75

(1)

A SYSTEM RUED: INSPECTING FOOD

TUESDAY, MARCH 30, 2004

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON CIVIL SERVICE AND AGENCY

ORGANIZATION,

COMMITTEE ON GOVERNMENT REFORM,

Washington, DC.

The subcommittee met, pursuant to notice, at 3 p.m., in room

2203, Rayburn House Office Building, Hon. Jo Ann Davis of Virginia (chairwoman of the subcommittee) presiding.

Present: Representatives Jo Ann Davis of Virginia, Davis of Illinois, Norton, Deal, Blackburn, Murphy, and Van Hollen.

Staff present: Ron Martinson, staff director; B. Chad Bungard,

deputy staff director and chief counsel; Shannon Meade, professional staff member; Reid Voss, clerk; John Landers, OPM detailee;

Michelle Ash, minority senior legislative counsel; Tania Shand, minority professional staff member; and Teresa Coufal, minority assistant clerk.

Ms. DAVIS OF VIRGINIA. We’re going to go ahead and start, and

there will be a few more Members joining us in a few moments.

The Subcommittee on Civil Service and Agency Organization will

come to order.

Two years ago, the Federal Government saw its largest reorganization since the end of World War II with the creation of the

Homeland Security Department, which involved the merger of 22

existing agencies and 180,000 employees into one mammoth Cabinet department. Today, this subcommittee begins its examination

of how the rest of the Government is structured, and whether the

existing structures need reorganization on a much smaller scale.

We begin this process by focusing on one aspect of the Federal

Government that touches our daily life, which is how the Government inspects food. Right now, there are more than a dozen Federal agencies that enforce more than 35 food safety laws, creating

such illogical situations as the Food and Drug Administration having responsibility for inspecting closed faced meat sandwiches,

while the U.S. Department of Agriculture is in charge of inspection

open faced meat sandwiches. Or if you prefer, the FDA is in charge

of cheese pizzas, while the USDA has jurisdiction over pepperoni

pizza.

And here is one more. The FDA inspects both beef soup and

chicken broth, but USDA inspects chicken soup and beef broth. In

case you didn’t get that, it’s reversed. As the old saying goes, you

can’t make this stuff up.

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This situation did not happen overnight, but it’s a result of piecemeal legislative solutions crafted over the years. It is a good example of why, every once in a while, Congress needs to take a step

back and look at the whole picture to see if there is some rearranging that should take place.

In this instance, one possible solution that some have raised is

to consolidate all the food inspection programs under a single agency. We’re going to hear testimony today on that subject, as well as

the other organizational issues facing food inspection programs. Regardless of the organizational ideas offered here today, I want to

emphasize at the outset that everyone in this room is in agreement

that we want our food supply to be safe. So that is not an issue.

I thank our witnesses and I look forward to the discussion.

We’ve been joined now by Ms. Holmes Norton and I’m going to

recognize you. Do you have an opening statement?

[The prepared statement of Hon. Jo Ann Davis follows:]

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Ms. NORTON. Thank you very much, Madam Chairwoman. I

want to especially thank you for calling this hearing on a subject

of vital importance to the American people, especially in recent

years and months. Some of us thought that mad cow would never

make its way, for example, to the United States, some of us

thought it was only a matter of time. I grew up thinking that the

food supply of the United States was impenetrable. We have

learned differently.

We have just finished a major reorganization, one of the largest

reorganizations since World War II, of the Homeland Security

agency. I’m on the Homeland Security Committee, I was on the two

main committees that considered most of the legislation that resulted in the Department.

As much as it is apparent that this set of blocks doesn’t make

much sense, about the easiest thing to do, we’ve learned, is to say

that what it takes to cure a problem is simply reorganize it. I happen to be a big fan of reorganization, because I believe in rational

structures. When I headed a Federal agency, one of the first things

we did was to reorganize the agency, reconfigure it to better do its

job and I do believe that it worked.

But we are still very much in a learning mode when it comes to

the Department of Homeland Security, huge disruptions and disquiet has resulted in some parts of the agency that we learn are

far worse off than they were before, such as processing of immigration claims. Perhaps there are other parts that are better.

I do hope before we jump in again with both feet that we learn

from that experience, I certainly hope that we learn from the experience that employees have had, where we have disrupted the way

in which employees relate to the agencies from which they came,

thrown out many of their Civil Service and collective bargaining

rights all in the name of reorganization. It does seem to me one can

reorganize without that kind of penalty and disruption.

Finally, let me say that because of the melange we see of agencies with different jurisdictions when it comes to our food supply,

of course, is the way in which Congress does business. The way in

which we do business is of course endemic to a democratic society.

When a crisis arises, and when a problem arises, we say let’s fix

that problem. And what you have if you will forgive the analogy

is some real sausage there. We just pack it in wherever we can

seem to fit, and nobody sits down and says, now, let’s do this in

some rational way, even if we reorganize our food, our approach to

food safety, we’re likely to continue to do that.

I would only caution, Madam Chairwoman, that we take a deep

breath, learn from what is happening to the Homeland Security

Department before we jump right back in with another whole, big

reorganization with all that entails for employees and management

alike.

Thank you, Madam Chairwoman.

Ms. DAVIS OF VIRGINIA. Thank you, Ms. Norton. We’ve been

joined by our ranking member, Mr. Danny Davis. I’ll yield to you

for an opening statement.

Mr. DANNY DAVIS. Thank you very much, Madam Chairwoman,

and let me apologize for being late. I was having difficulty pulling

myself away from a very interesting discussion of the effectiveness

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of drug treatment at another hearing. So I thank you for your indulgence.

Madam Chairwoman, experts and Members of Congress have

long complained that there are jurisdictional overlaps within the

executive branch. As a result, some important Federal missions slip

through the cracks. Some complaints, however, go as far back as

World War I, when calls for efficiency and economy in Government

led to efforts to strengthen the President’s management ability.

In 1932, for the purposes of reducing expenditures and increasing efficiency in Government, the President was given statutory authorization to issue Executive orders proposing reorganization

within the executive branch. A reorganization order became effective within 60 days, unless either the House of Congress adopted

a resolution of disapproval. Modification of the President’s reorganization plan authority was made necessary in 1983, when the Supreme Court in the Chattah case effectively invalidated Congress’

continued reliance upon a concurrent resolution to disapprove of a

proposed plan.

Currently in the absence of reorganization plan authority, the

President may propose executive branch reorganization through

the normal legislative process. Calls to reorganize the Federal Government have more recently come from the National Commission

on the Public Service. The Commission, also known as the Volcker

Commission, released a report in January 2003 that included the

recommendation that the Federal Government be reorganized into

a limited number of mission related executive departments.

The Federal Government’s structure for regulating for structure

is a prime example of Federal agency mission and program overlap.

Twelve different agencies administer as many as 35 laws that

make up the Federal food safety system. Two agencies account for

most Federal food safety spending and regulatory responsibilities,

the Food Safety and Inspection Service within the U.S. Department

of Agriculture and the Food and Drug Administration within the

Department of Health and Human Services.

I look forward to hearing testimony from today’s witnesses on

how the Federal food safety system should be reorganized and who

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should have the authority to effect the reorganization. So I thank

you very much, Madam Chairwoman, and yield back the balance

of my time and look forward to hearing from the witnesses.

Thank you again.

[The prepared statement of Hon. Danny K. Davis follows:]

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Ms. DAVIS OF VIRGINIA. Thank you, Mr. Davis.

Are there any further opening statements?

[No response.]

Ms. DAVIS OF VIRGINIA. I ask unanimous consent that all Members have 5 legislative days to submit written statements and questions for the hearing record, and that any answers to questions provided by the witnesses also be included in the record. Without objection, it is so ordered.

I ask unanimous consent that the statement of the Grocery Manufacturers Association be included in the record. And without objection, it is so ordered.

I ask unanimous consent that all exhibits, documents and other

materials referred to by Members and the witnesses may be included in the hearing record and that all Members be permitted to

revise and extend their remarks. And without objection, it is so ordered.

On the first panel, we’re going to hear from Mr. Lawrence

Dyckman, Director of National Resources and Environment at the

General Accounting Office. Second, we will hear from Dr. Robert

Brackett, Director of the Center for Food Safety and Applied Nutrition at the Food and Drug Administration. And finally, we will

hear testimony from Dr. Merle Pierson, from the U.S. Department

of Agriculture.

It is standard practice for this committee to administer the oath

to all witnesses. If all the witnesses on both the first and second

panel will please stand, I will administer the oath to you at one

time. Anyone who is going to be testifying.

If you’ll please raise your right hands.

[Witnesses sworn.]

Ms. DAVIS OF VIRGINIA. Let the record reflect that the witnesses

have answered in the affirmative.

And if the first panel would come forward and please be seated.

We will begin with you, Mr. Dyckman, Director of National Resources and Environment at the General Accounting Office. And we

do have your complete statement in the record, so if you’d like to

summarize for 5 minutes, we would certainly appreciate it.

STATEMENTS OF LAWRENCE J. DYCKMAN, DIRECTOR, NATIONAL RESOURCES AND ENVIRONMENT, U.S. GENERAL ACCOUNTING OFFICE; ROBERT E. BRACKETT, DIRECTOR, CENTER FOR FOOd SAFETY AND APPLIED NUTRITION, FOOD

AND DRUG ADMINISTRATION; AND MERLE PIERSON, DEPUTY UNDER SECRETARY FOR FOOD SAFETY, U.S. DEPARTMENT OF AGRICULTURE

Mr. DYCKMAN. Thank you, Madam Chairwoman. Good afternoon,

Members.

I’m pleased to be here today to discuss the subcommittee’s interest in streamlining the Federal Government. Today I will highlight

our considerable body of work on the Federal food safety system

and whether its current design provides sufficient protection for

consumers while ensuring logical and effective Government resources.

In his September 2003 testimony before this subcommittee, the

Controller General stressed the importance of beginning to take

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steps to achieve fundamental reorganization of the Federal Government into a limited number of mission related executive departments. His testimony pointed out that redundant, unfocused, uncoordinated programs waste scarce resources, confuse and frustrate

program customers and limit overall program effectiveness.

As we’ve heard in the opening statement, our food supply is governed by a highly complex system, more than 30 laws administered

by 12 area agencies and various departments. Now, the system is

not a product of strategic design but rather, it emerged piecemeal

over many decades, and as was indicated, typically in response to

particular health threats or economic crisis. The result, in our opinion, is a fragmented legal and organizational structure that gives

responsibility for food commodities to different agencies and the

real problem is, it provides them with significantly different authorities and responsibilities.

As we heard in the opening statements, two principal food safety

agencies involved are FDA and USDA, but many others are involved. And we have a flip chart which shows the ever popular frozen pizza example. If you look at the chart, and you have it before

you, multiple agencies regulate both the ingredients and the processing of the pies. And to complicate matters, it was mentioned

that non-meat pizzas fall under one agency, FDA, while pizzas with

meat toppings fall under USDA. As a result, some manufacturers,

those with meat toppings, get inspected on a daily basis while others are inspected much less frequently.

The fact that the frequency of inspection is not based on risk is

really a very important but troubling distinction between the two

agencies’ enabling legislation. USDA by law must maintain continuous inspection at slaughter facilities and visit each processing

plant at least once a day while FDA generally visits plants under

its jurisdiction once every several years.

Another problem with the food safety system is that Federal resources are allocated on the basis of statutory requirements and

not based on risk. If you look at the pie charts there, you’ll see that

USDA and FDA, their funds are not proportionate to the amount

of food produced in terms of the food that they regulate. It’s not

proportionate to the level of consumption of these foods by the

American consumers or even more importantly, the frequency of

food-borne illnesses associated with these products. While USDA

regulate about 21 percent of the consumer food supply, its expenditures are about 50 percent more than FDA’s.

Our past work has chronicled these problems with the current

food safety system, but I’d like to go into, and my full statement

goes into more detail, but I’d like to touch on some highlights of

some additional problems. Let’s talk about egg safety, the overlapping responsibilities there. FDA regulates whole eggs, which are

eggs in shells. USDA regulates egg products, which are liquid eggs

or freeze-dried egg products, mostly used for manufacturing. However, over 10 years has passed since the Government is aware that

salmonella contamination from eggs poses a significant health risk,

we still don’t have a comprehensive Federal egg safety program.

Another example, with regard to health benefits that certain food

products claim. Our work shows that consumers face risks because

current Federal laws and agencies do not consistently ensure that

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these products are safe. Also, health benefits may be treated differently by different agencies. There are three agencies involved

with health claims, we have USDA, FDA and the Federal Trade

Commission. This leads consumers to face a confusing array of decisions on health claims of certain products, and particularly on the

health claims of dietary supplements.

Now, the same fragmented structure in this inconsistent approach unfortunately is being used to ensure the safety of imported

foods, which is an increasing part of the national diet. USDA must

determine that foreign suppliers of meat and poultry products have

food safety systems that are basically comparable to ours. We refer

to that as equivalency agreements.

While FDA, not having that authority, doesn’t have similar requirements, and therefore it depends largely on port of entry inspections, which we have pointed out are not as effective.

Let’s look at livestock regulation. We’ve heard about the one case

that we had in Washington on BSE, and the Canadian case. That’s

another example where you have USDA regulating the animal and

the meat it produces, but FDA regulates the safety of the feed fed

to the livestock. We believe this can compromise our ability to protect our citizens from animal diseases.

Finally, potentially an even more serious issue is that the current food safety system is further challenged by the realization that

American farms and ranches and our processed foods are in fact

vulnerable to potential attack and deliberate contamination. As we

recently reported to the Senate Committee on Governmental Affairs, bioterrorist attacks could be directed to many different targets in the farm to table continuum. This includes crops, livestock,

food products, processing foods, transportation, storage facilities

and even food and agricultural research laboratories.

While both FDA and USDA have taken steps to protect our food

supply from terrorist attack, we have to realize for the most part

it’s this antiquated system that we’re talking about that we must

depend on to prevent and respond to any such attacks.

In conclusion, given the risk posed by the existing and the new

threats that I spoke about, be they inadvertent or deliberate, we

believe we can no longer afford these inconsistent, overlapping programs and this patchwork approach to food safety. It’s time to ask

whether a system that has developed piecemeal over many decades

can efficiently and effectively respond to today’s challenges. That’s

why we believe that creating a single food safety agency to administer a uniform risk-based inspection system is the most effective

way to prevent and protect the Nation’s food supply.

Madam Chairwoman, I would be happy to answer any questions

after the panel is completed.

[The prepared statement of Mr. Dyckman follows:]

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Ms. DAVIS OF VIRGINIA. Thank you, Mr. Dyckman. Now we’ll

hear from Dr. Robert Brackett, Director of the Center for Food

Safety and Applied Nutrition at the Food and Drug Administration.

Dr. Brackett, you’re recognized for 5 minutes, and again, we have

your full statement for the record, so if you can summarize, that

would be great.

Mr. BRACKETT. Thank you and good afternoon, Chairwoman

Davis and members of the committee. I am Dr. Bob Brackett, Director of the Center for Food Safety and Applied Nutrition at the

Food and Drug Administration within the Department of Health

and Human Services. And I am pleased to be here today with my

colleague from USDA, Dr. Merle Pierson, as well as Mr. Dyckman,

to discuss the Federal food safety system. And I do want to thank

you for the opportunity to provide testimony on behalf of Health

and Human Services.

The subcommittee has expressed interest in the potential benefits of consolidating a number of food safety functions into a single

food agency. Over the years, there has been much discussion about

this. In fact, in 2002, the White House looked into this issue and

concluded that the goals of the administration are better advanced

through enhanced interagency coordination rather than through

development of legislation to create a single food agency.

Is the interagency food coordination working? Yes, the American

food supply continues to be among the safest in the world, and food

safety agencies are working more closely than ever before. Of

course, we continue to face many challenges. We face the traditional challenge of reducing the incidence of food-borne illness due

to unintentional contamination and in addition, we now face a

heightened challenge of protecting food from deliberate contamination.

To address these issues, the Department of Health and Human

Services has been implementing the most fundamental enhancements in our food safety and food defense activities in many years.

FDA is the Federal agency that regulates about 80 percent of the

Nation’s food, everything we eat except for meat, poultry and certain egg products, which are regulated by our partners at USDA.

FDA’s responsibility extends to live food animals and animal feed.

Our sister public health agency in HHS, the Centers for Disease

Control and Prevention, plays a very important and complementary

role through its surveillance of illness associated with the entire

food supply. Food supply and food defense continue to be top priorities for this administration.

In our food safety and defense efforts, FDA has many partners,

Federal and State agencies, academia, and of course industry.

We’re working closely with our Federal partners, such as USDA,

the Department of Homeland Security, the Homeland Security

Council at the White House, and the Department of State as well

as with law enforcement and intelligence gathering agencies.

I want to emphasize the close working relationship with Food

Safety and Inspection Service and the Animal and Health Plant Inspection Services at USDA, Customs and Border Protection at the

Department of Homeland Security, and with our sister public

health agencies, CDC and the National Institutes of Health. Specific examples of cooperative activities included within HHS and

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USDA and the Environmental Protection Agency and other agencies that are working with DHS, Department of Homeland Security, to achieve the objectives of Homeland Security Presidential

Directive No. 9, or HSPD–9, which has established a national policy to defend the agriculture and food system against terrorist attacks, major disasters and emergencies.

A second example is that FDA, CDC and USDA work together

on Healthy People 2010 to identify the most significant preventable

threats to health and to establish national goals to reduce these

threats. FDA, CDC and the Food Safety Inspection Service work together on food code to provide a model ordinance to local, State and

Federal Governmental bodies and tribal nations to ensure that the

food provided by retail food establishments and institutions such as

nursing homes is not a vector of communicable diseases.

To increase laboratory search capacity, FDA has worked with

CDC and FSIS to expand laboratory response network by establishing the Food Emergency Response Network to include a substantial

number of new laboratories capable of analyzing foods for agents

of concern. These are just a few of the many cooperative activities

that we participate together on.

Last July, former FDA Commissioner Mark McClelland issued a

report to Health and Human Services Secretary Tommy Thompson

entitled, ‘‘Ensuring the Safety and Security of the Nation’s Food

Supply.’’ The report outlines a comprehensive 10 point program to

protect the safety and security, now referred to as defense, of our

food supply. I’ll briefly describe three of the program areas.

A key component of the FDA’s strategic plan is to assure a high

quality professional work force. So we’re trying to create a stronger

FDA. FDA has created many new human resource policies to attract and keep high caliber employees.

A second point involves imports. Thanks to a bipartisan congressional support, a fiscal year 2002 supplemental appropriation enabled FDA to hire over 800 employees, 635 of these were hired

principally to address food safety and food defense issues, primarily

at the borders. With these additional field employees, we’ve expanded FDA’s presence at ports of entry, increased surveillance of

imported foods, increased domestic inspections and enhanced our

laboratory analysis capacity. In addition, we’re using risk management strategies to achieve the greatest food protection for our limited resources.

The Bioterrorism Act provided the Secretary of Health and

Human Services with new authorities to protect the Nation’s food

supply against the threat of intentional contamination and other

food related emergencies. These new authorities will improve our

ability to act quickly in responding to a threatened or actual terrorist attack as well as other food related emergencies. FDA has been

working hard to implement this law effectively and efficiently.

In conclusion, the Department of Health and Human Services is

making tremendous progress in its ability to ensure the safety and

defense of the Nation’s food supply. And due to the enhancements

being made by FDA, CDC and other agencies and due to the close

coordination between the Federal food safety, public health, law enforcement and intelligence gathering agencies, the U.S. food safety

and defense system is stronger than ever before.

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Thank you for this opportunity to discuss Health and Human

Services food safety and defense activities, and I would be pleased

to respond to any questions after the panel.

[The prepared statement of Dr. Brackett follows:]

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Ms. DAVIS OF VIRGINIA. Thank you, Dr. Brackett. Finally, we’ll

hear from Mr. Merle Pierson, with the USDA. Dr. Pierson, again,

your statement is in the record, if you would summarize in 5 minutes.

Mr. PIERSON. Madam Chairwoman, I appreciate the opportunity

to speak to you about the important issue of protecting the Nation’s

food supply. I’m Dr. Merle Pierson, Deputy Under Secretary for

Food Safety at USDA.

Although I served in this capacity for only the past 2 years, my

entire career, including 32 years at Virginia Tech, has been devoted

to food safety and public health. First, let me offer a brief overview

of the work and responsibilities of the Food Safety Inspection Service [FSIS]. FSIS operates under the legal and statutory authorities

of the Federal Meat Inspection Act, the Poultry Products Inspection

Act and the Egg Products Inspection Act. Under these authorities,

FSIS inspects all meat, poultry and egg products sold in interstate

commerce and reinspects imported products to ensure that they

meet U.S. food safety standards.

Ensuring the safety of meat, poultry and egg products requires

a strong, well integrated infrastructure. In order to accomplish

this, FSIS has a work force of approximately 10,000 employees,

which includes 7,600 inspection personnel stationed in over 6,000

federally inspected meat, poultry and egg products plants every

single day these plants are in operation. FSIS jurisdiction encompasses over 45 percent of all foods produced by U.S. agriculture.

The FSIS work force verifies the processing of 43.6 billion pounds

of red meat, 49.2 billion pounds of poultry, 3.7 pounds of liquid egg

products, certifies that these meet strict statutory requirements.

In addition, 3.8 billion pounds of imported meat, poultry and

processed egg products were presented for entry into the United

States from 28 of the 33 countries eligible to export in 2003. I welcome the discussion on the creation of a single food safety agency.

As you and members of the subcommittee are aware, any food safety and security system must be able to meet current and future

food safety and security challenges. In addition, I strongly believe

that any effective food safety and security system must be rooted

in public health and science.

FSIS believes and the GAO and National Academy of Sciences

has agreed that a critical component of the food safety system is

a verifiable food safety inspection system that is both risk based

and science based. A risk based system allocates resources based

on the greatest risks or hazards, while a science based system

takes these risks and hazards into account to develop science based

programs and policies.

Thanks in part to the efforts by FSIS to follow the scientific approach in administering its food safety programs, the American

public remains confident of the safety of the U.S. food supply. Additionally, our efforts are paying off, as seen by the decline in foodborne illness over the past 6 years. FSIS routinely communicates

and coordinates with its sister public health agencies. Cooperation,

communication and coordination are absolutely essential to effectively address public health issues.

I’d like to point out a few of the many examples exemplified in

these successful partnerships. FSIS works closely with the White

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House Homeland Security Council, the Department of Homeland

Security and the Department of Health and Human Services, the

USDA Homeland Security staff and other Federal, State and local

partners to develop and carry out strategies to protect the food supply from potential attack.

In December 2003 there was the discovery of a single case of

BSE in Washington State. This provides an excellent example of

the strong communication ties between USDA and its Federal and

State food safety partners. The Federal Government’s swift response to the BSE diagnosis played a vital role in maintaining high

consumer confidence.

Since 1999, FSIS and FDA have had an MOU to exchange information on an ongoing basis about establishments that fall under

both jurisdictions. Another example is the Codex Alimentarious

Commission, which is a joint WHO-FAO international standard

setting body for food safety. The USDA Under Secretary for Food

Safety has responsibility for leadership of Codex with the U.S. Government and the Codex office is managed through FSIS. Codex is

an excellent example of wide reaching coordination of food safety

activities throughout the U.S. Government.

In considering a single food safety agency, Congress must analyze the efficacy of the single food safety agency models in the

countries that have adopted such paradigms, while being mindful

of the ultimate goal, improving food safety and public health. FSIS

bases its policy decisions on science, so the single food safety agency discussion boils down to the question, will there be a measurable

benefit to public health.

As with any new food safety and security effort, we want to make

sure we maintain and continue improving on any progress that we

have made to improve public health. We must also consider the

costs associated with any major overhaul to the U.S. food safety inspection system. In addition, Congress would need to determine

how current statutory authorities would be merged into a single

food safety agency. The acts under which the food safety inspection

service operates are different than the Federal Food, Drug and Cosmetic Act administered by the Food and Drug Administration.

Under the acts FSIS administers, it must find a product not adulterated before the product can enter commerce. This is because inherent in these acts is a finding by Congress that the risks presented by meat, poultry and egg products are such that trained inspectors must affirm that these products are safe before they can

enter commerce and be distributed to consumers.

We are proud of our accomplishments, particularly the declines

in food-borne illnesses over the past few years, and we must maintain and improve on the progress that FSIS, FDA, and our food

safety partners have made thus far. Thank you for the opportunity

to provide these overview comments on our food safety and security

programs. We look forward to working with Congress to continue

to keep the Nation’s food supply safe and secure and strengthen

public health. I certainly welcome any other questions or comments. Thank you.

[The prepared statement of Mr. Pierson follows:]

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Ms. DAVIS OF VIRGINIA. Thank you, Dr. Pierson. I thank all three

of you.

We are going to move now to the question and answer period,

but I will say that we may very well be interrupted for a series of,

I believe three votes. We may have to ask for your indulgence, to

wait for us until we get back.

I will yield now to my ranking member, Danny Davis, for questions.

Mr. DANNY DAVIS. Thank you very much, Madam Chairwoman,

and I want to thank the witnesses.

Mr. Dyckman, GAO has widely reported and talked about the

high number of Federal employees that can be expected to retire

over the next few years. What impact would these retirements have

on our ability to protect the Nation’s food services and to your

knowledge, are the agencies, the U.S. Department of Agriculture

and Food and Drug Administration, taking steps to address this

probability?

Mr. DYCKMAN. Mr. Davis, we have not looked specifically at

human resource management issues in the inspection service at

USDA or at FDA. But it is my understanding that like other agencies, they face aging work forces and the stress of trying to train

their employees, to keep their skill levels up, and to transition to

a new work force. But we haven’t specifically looked at the impact

of the aging work force on the food safety agencies.

Mr. DANNY DAVIS. Drs. Brackett and Pierson both in their testimony talked about in 2002, the administration established a policy

coordinating committee to look into the possibility of creating a single food agency, and it concluded that the goals of the administration are better advanced through enhanced agency coordination,

rather than creating a single agency. Do you agree or not agree?

Mr. DYCKMAN. With all due respect, I can understand to some

extent why the administration would do that. It is difficult to bring

about change. Unfortunately, it usually takes a crisis in the food

safety system. It might unfortunately take a health crisis, a larger

outbreak of mad cow disease or foot and mouth disease or something of that nature.

Obviously, you can improve the effectiveness of any system

where you have multiple operatives of you have improved coordination. But I think the question really should be, why do we have to

rely on coordination just because we have players there? Why can’t

we reshuffle the deck and have a smaller deck, so we don’t have

to rely on one agency talking to another agency? The issue of coordination obviously is important. Over the years we have done

some work that has questioned in some cases the effectiveness of

coordination.

But I’m not here today to criticize FDA or USDA. I think I’m

here today to talk about, does it make sense to have a single food

safety agency. If we had to do it from scratch, if we just started

today and we had to do it from scratch, would we create the existing organizational structure or would we create one agency.

Obviously, the short answer to your question is, I can understand

how the administration would like to improve coordination and not

embark on a new reorganizational structure. But I think for the

long term and for the American people, it really pays to have one

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agency look at food safety, for a lot of the reasons I outlined in my

testimony.

Mr. DANNY DAVIS. Dr. Pierson, Dr. Brackett, why do you think

that there appears to be so much resistance to, I mean, we know

that agencies kind of grow up and take on roles and responsibilities

that are perhaps a little different than if we were to start something from scratch or have the opportunity to just kind of say,

we’re going to create X to take care of these needs, and so no one,

do you have any ideas about why there seems to be the reluctance

to let something go and start something new?

Mr. PIERSON. As I stated in my opening comments, the baseline

is protecting public health. That should be our main concern and

consideration. We are certainly open and willing to have consideration, discussion, opportunities looked at in terms of how can we

do what we’re doing better, and again to enhance public health. So

I don’t think it’s something that we’re closed minded about it, but

we’re open to discussion and to further doing the best job we can

possibly do. I think we’re totally devoted to doing that.

I might also further state as an example, there was a tremendous undertaking in creating the Department of Homeland Security, and the President and Congress should be applauded for that

just absolutely major undertaking and doing something very, very

well and very successfully. In doing so, we still, in USDA and other

agencies have to work in a collaborative way. And we do very, very

actively work in a collaborative way to address our issues and to

cooperate to assure that the security of the American public is protected from potential threats.

So the point I’m making is, if one creates a so-called single food

safety agency, you still have to have collaboration and cooperation

with other partners, other States, other governments, so on and so

forth, in order to make that effective.

Mr. DANNY DAVIS. Thank you.

Mr. BRACKETT. Congressman Davis, I would like to also emphasize that the current structure results from the statutes that we

must operate under. So even with the single food agency model,

you would still end up having two systems, one governing meats,

poultry and eggs, the others all the other foods. So again, the coordination, the communication between these different groups that

would oversee those sorts of foods would still be critical, and as

critical as they are right now.

Mr. DYCKMAN. Could I just add, I should have probably added

that it’s not our intent to just simply create a single food safety

agency. And I agree with Dr. Brackett that doing that by itself

wouldn’t accomplish that much. What we’re really talking about is

looking at the underlying legislation, coming up with a single food

safety model legislation that covers all food based on science or

risk.

The other thing, and then, and you can even do that before you

reorganize, and maybe you might find that it’s not necessary to reorganize, you could just have a level playing field on the regulatory

authorities of the agencies.

But I do want to add something interesting. In our full testimony

we have a chart which shows that, we interviewed senior, very senior, and one of them will testify, former executives that worked at

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USDA, even the former Secretary of Agriculture. It’s funny, when

you leave the position, frequently your ideology and your views on

the subject change. I believe that on page 18 of our full statement,

we indicate how these positions have changed. Most of the former

executives that we spoke to do favor a consolidation.

Mr. DANNY DAVIS. Thank you very much, Madam Chairwoman.

Ms. DAVIS OF VIRGINIA. Thank you, Mr. Davis. We still have

about 13 minutes. Mr. Deal, do you have questions you’d like to

ask?

Mr. DEAL. Thank you, Madam Chairwoman.

Thank you, gentlemen, for being here. I think it’s interesting to

note, as you indicate in your surveys of these officials, they all

agree on consolidation. We have the two heads of the two primary

agencies here, and obviously there’s always going to be the feeling

and desire to protect what you already do, because you feel you’re

doing it well. And I notice your recommendation is not specific as

to where that consolidation should occur.

Is it inappropriate for me to ask you, Mr. Dyckman, whether or

not you have a preference from the GAO perspective as to what

agency, if any, and I notice that only two of the ones you interviewed said an independent agency should be created for that purposes, which is a minority position. I think most of us who are interested in downsizing Government would say we don’t need to create another agency.

Where would you think it would be most logically placed?

Mr. DYCKMAN. That’s obviously an interesting question, one that

I’ve given a lot of thought to. I’ve testified on this issue before and

I’ve been asked this before. I hope I’m consistent in my answer.

First let me start off by saying there are advantages and disadvantages with creating it either in USDA or FDA. Our first preference would be an independent agency, but I recognize that creating another agency in this budgetary crisis that we find ourselves

might be very difficult.

So if you don’t create an independent agency, the issue is which

of the two existing agencies. USDA has, in my opinion, more expertise, has more resources and possibly one could argue more experience. They do, however, have a downside. They promote agriculture. And one can perceive a possible conflict of interest. And

I’m not suggesting that there is a real conflict of interest, but one

can perceive that.

On the other hand, FDA, with a much smaller staff, one could

argue that it is a health agency, and that’s really what food safety

should be about. So I could see transferring assets from one agency

to another. The long answer is that I would lean, if I personally

had to choose, toward putting it in FDA because it is a health

agency and because it has, I think, more scientific knowledge and

it is not a promotion agency, as agriculture is. But obviously that

is a congressional decision.

Mr. DEAL. I would just make one further observation. One thing

that all of your interviewees agree with is that there needs to be

legislative reform, and I agree with that.

Mr. DYCKMAN. That is correct.

Mr. DEAL. I have some specifics that may be more appropriate

in the next panel we’ll get a chance to discuss some of those specifVerDate 11-MAY-2000 11:55 Nov 20, 2004 Jkt 000000 PO 00000 Frm 00099 Fmt 6633 Sfmt 6633 D:\DOCS\95290.TXT HGOVREF1 PsN: HGOVREF1
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ics. Because quite frankly, what we have done with the legislative

language in many cases is create a conflict between the agency

that’s required to certify food safety, we put barriers to their efforts

to certify because of legislative language.

The organic industry is one that comes to mind right off the top,

because we are on the one hand allowing it to be touted as safer

than everything else, yet they are excluded from many of the inspection provisions that are required of others that produce main

line products that are not labeled with a label that is giving the

impression to the public at least is safer than other products. That

I think is primarily a legislative problem that needs to be addressed.

I realize we have votes going on. Thank you, Madam Chairwoman.

Ms. DAVIS OF VIRGINIA. Thank you, Mr. Deal.

If you all will be patient with us, we have three votes. Hopefully

we’ll be back here around 4:15. But we will start the minute that

I get back in here.

Thank you. With that, the hearing is recessed.

[Recess.]

Ms. DAVIS OF VIRGINIA. Gentlemen, thank you so very much for

your patience.

Let me ask a few questions. Mr. Dyckman, let me ask you, would

the consolidation of the food inspection activities result in any savings for the taxpayers?

Mr. DYCKMAN. In the short term, probably no. There probably

will be startup costs. In the longer term, or the mid-term, particularly again if we could have one uniform risk-based legislative authority to cover food safety, I think we would be able to reduce

some inspections on foods that are not as high risk. Because inspections, particularly some of the USDA inspections, are fairly expensive on a product by product basis. So we might be able to free

up some of that inspection power and make it available for higher

risk things, or to some extent, reduce expenditures.

But there are also other savings that can be achieved. You have

regional office structures in two agencies, and some of them, I

think on average are within 10 miles of one another. You have regulatory writing, you have enforcement, you have attorneys. I think

there would be an economy of scale if you would combine.

We haven’t done specific work to look at some of the savings.

And as you know, Madam Chairwoman, we are continuing our review to look at some of these issues. Plus we’re also doing a review

for the Senate Agriculture Committee to look at the experiences of

some of the other nations that have consolidated their agencies to

see if they have tangible benefits, whether it’s cost savings or reductions in illnesses or pathogen reductions.

So it’s an appropriate question to ask. Right now I can’t assure

you that there will be cost savings. I believe I can assure you that

there will be more effective regulation and you’ll have a lot more

latitude to spend the existing dollars that we spend. But I’m hopeful that there will be eventually cost savings.

Ms. DAVIS OF VIRGINIA. If we went the route of the legislation

to make it more consistent as opposed to consolidating and making

one agency, would there be a savings then?

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Mr. DYCKMAN. There should be some savings, again, particularly

in the inspection, reduction of inspections. If inspections were purely based on risk, and not on legislative requirements, there should

be some. But obviously there are more opportunities if you can

combine functions.

Ms. DAVIS OF VIRGINIA. Let me go to you, Dr. Pierson. Based on

something that you said on there being a cost to reorganization,

some believe that the status quo is acceptable in this system because there is communication between the various agencies with

food safety responsibilities. But wouldn’t the system be better

served if you spent more time and resources on enforcement as opposed to communication?

Mr. PIERSON. No. 1, certainly we again are very open to consideration of a regulatory authority on how we carry out our responsibilities. Whether or not there would be specific cost savings relative

to——

Ms. DAVIS OF VIRGINIA. I’m not even talking cost savings now,

I’m talking, wouldn’t we be better served if one or more agencies,

depending on whether you want legislative or into one agency,

wouldn’t we be better served, the public, if we were concentrating

on enforcement instead of worrying about FDA communicating

with USDA?

Mr. PIERSON. Within our area of responsibility, of course, our

main focus is in fact enforcement. And yes, there are certain areas

where we do in fact have to specifically collaborate. I think these

collaborations in fact, even though you might be under one structure, would still have to occur. You still have the boxes and lines

and arrows to different areas, segments, etc.

So it would depend on how all this would set up. There would

still have to be collaboration between these areas. We have that

within our own structure within FSIS. Different specific areas have

to communicate with those other areas and collaborate with them,

our policy labeling staff relative to field operations, and other examples where we have to have that continuing interaction. But our

overall goal of course would be to focus on the major resources.

That’s where our major resources are, is in the inspection side of

our agency.

Ms. DAVIS OF VIRGINIA. I guess the one thing that concerns me

on the whole issue of communication, and I think you guys are

probably doing a very good job of that, please don’t misunderstand

me, I’m not attacking USDA or FDA. I’m just trying to make some

sense out of where I know Congress has gotten us, not by any fault

of yours. It’s by piecemeal legislation.

But it’s been said that when everyone’s in charge, no one’s in

charge. I guess that’s my concern, if we were to have some problem

or something and there’s no one official who’s in charge of all the

food inspection, responsibility gets scattered around to so many different agencies. How do you deal with that? How do you handle

that? And that can be to any of you.

Mr. PIERSON. I think that we, through the collaboration that does

in fact occur that responsibility is quite well relied on, and there

are many examples. Dr. Lester Crawford, Acting Commissioner of

FDA, we work with him very closely. We know who has responsibilities for different areas. Very specifically, the BSE issue that

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occurred, I think we all very well realized our area’s responsibility.

It was really, I think an excellent example of a seamless interaction to address what was a major issue and to make sure that

we maintain consumer confidence relative to the safety of this food

supply.

But that effort took interaction between Animal Plant Health Inspection Service, Food Safety Inspection Service, the Center for

Veterinary Medicine. So it was multiple mission areas. I think it

worked in, as I said, a seamless operation where we really understood those divisions of responsibilities.

Ms. DAVIS OF VIRGINIA. I may come back with some other questions, but I want to get to our other Members here. Forgive me, but

someone testified and said one of you was responsible for the dairy

and so forth, but the other is responsible for the grain. How do you

then reconcile what I said in my opening statement, one does

chicken soup and beef broth and the other does chicken broth and

beef soup? That doesn’t fall in line with anything I heard. Where’s

the area of responsibility there? I guess I’m not even sure of the

clear lines of responsibility, so I’m not sure how you all can keep

it straight.

But I want to go on to the other Members now. Mr. Deal, were

you finished before we left?

Mr. DEAL. Yes, but if you have second go-around, I’d like to ask

one quick question.

Ms. DAVIS OF VIRGINIA. OK. Mr. Murphy.

Mr. MURPHY. Thank you, Madam Chairwoman. I’m really confused. Because your statement just about one does beef soup, another one does beef broth, and one does chicken broth, the other

one does chicken soup, one does frozen cheese pizza——

Ms. DAVIS OF VIRGINIA. You didn’t even get it right.

Mr. MURPHY. No, I didn’t. [Laughter.]

The other one does frozen pizza manufacturing, meat pizza. Is

there a difference between the level of job training requirements,

education, anything between those who inspect cheese pizzas and

those who inspect pepperoni or sausage pizza?

I didn’t think so. When we talk about, how about beef broth and

beef soup? Why do we have to have two different groups inspecting

those?

Mr. PIERSON. I think in part some of this is something that has

evolved over the years, quite frankly.

Mr. MURPHY. I’m a psychologist, and we always say, one of the

definitions of insanity is doing the same thing over and over again,

expecting different results. This seems to fit in that category.

Mr. PIERSON. Yes.

Mr. MURPHY. Let me go to a statement that you made, Dr.

Brackett. You said, should a single food agency be created, there

may be a request to reallocate 635 field personnel to newly formed

agencies. Such reallocation would measurably diminish FDA’s ability and efficiency to potentially address issues involving the safety

and efficacy. Why would we have to reallocate 635 people, if they’re

needed?

Mr. BRACKETT. Congressman, I think the main reason why that

would be necessary is actually, again, and a lot of this goes to the

risk based, if you have a uniform inspection across all different

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commodities, you would be taking from areas to put them in another one, as opposed to doing it with a risk based system where

you are focusing specifically on those areas that are the highest

risk.

Mr. MURPHY. But I don’t understand why merging this into one

agency would prevent you from making the kind of adjustments

necessary to do it right. I don’t think that’s part of the discussion

here, is everybody do the same thing one way. But I would think

the discussion is still to allow enough flexibility so that you could

do the job.

Mr. BRACKETT. It would be. And again, this goes back to my earlier statement about with the assumption that if you have the current statutory structure, you have all the meat, poultry and egg

products with continuous inspection mandated as opposed to the

FDA’s laws, which require a risk based approach which is not continuous. So you still have those commodities outside of meat, poultry and egg products that do not have the requirement for a continuous inspection, together with those inspectors who must be in the

meat, poultry and egg plants under——

Mr. MURPHY. Why can’t you make that adjustment? Why can’t

we design it so—I think with some of these issues here, unless

there’s really an entirely different graduate degree required to inspect one thing versus another, can’t there be some overlap and

cross training of skills, someone could check a couple things at the

same time, beef broth, beef soup, chicken and the eggs?

Mr. BRACKETT. Congressman, there are also cases where this is

being done now. A good example might be a plant that produces

a cheese pizza and a meat pepperoni pizza, in which we have an

MOU with the FDA so that their inspectors are looking at everything. If they happen to see something related to the cheese pizzas,

they have the authority to call us, we come in there, so they are

eyes and ears——

Mr. MURPHY. Call you into what?

Mr. BRACKETT. To act upon the observations that they have

made.

Mr. MURPHY. But they don’t have the authority to take other actions, they can’t simply say, there’s something wrong with the

cheese here?

Mr. BRACKETT. Or perhaps that it was produced under unsanitary conditions. But now with the new Bioterrorism Act, that will

allow us to actually give them that authority, and we are looking

into that possibility of doing that.

Mr. MURPHY. So they wouldn’t have to call in another layer of

bureaucracy. Yes, Mr. Dyckman.

Mr. DYCKMAN. Again, I want to emphasize that we’re not calling

for reorganization or consolidation first, without looking at the

basic underlying statutes. I think your assumptions are correct,

that it would make no sense to just reorganize with the same statutory legislation requirements, because that would tie up the flexibility that you would gain by a reorganization. So I think what

we’re talking about is looking at the enabling legislation, coming

up with a uniform food safety piece of legislation, and then considering how best to reorganize.

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Mr. MURPHY. Do we know what the level of administrative costs

are of having these multiple agencies?

Mr. DYCKMAN. We have issued a report, it’s several years old,

that documents the costs of each agency. What we have not done

is try to estimate what would be saved by consolidation. That’s a

little more difficult.

I might add that one of the countries that we will be looking at

that did consolidate, they originally estimated, I think, a 7 percent

initial startup cost, but they hope to save 13 percent in the midterm. So those are the types of things we will look at when we look

at the foreign country experiences, so we might have some additional information on other countries’ experiences with this issue.

Mr. MURPHY. That would be helpful. Thank you.

Ms. DAVIS OF VIRGINIA. If the gentleman would yield to me for

just 1 second, let me just be clear on the cheese and meat pizzas.

I think you said it depends, sometimes there’s overlap if they did

both at the factory. Do I take it to mean that you inspect it at the

manufacturer, and if that’s the case, I wouldn’t think DiGiorno has

a cheese manufacturing plant and a meat manufacturing plant, do

they?

Mr. BRACKETT. No, they don’t.

Ms. DAVIS OF VIRGINIA. Don’t most of the frozen pizzas, don’t

they do them all in one place?

Mr. BRACKETT. Yes, Madam Chairwoman, they do that. But what

I’m saying is those products that have a certain level of meat, that

is, such as pepperoni pizzas, must be produced under continuous

inspection. That is not the case with the cheese pizzas, which are

under FDA authority.

The other point that I omitted to say about the FDA inspectors

is they often do have multiple responsibilities, that they also may

do drugs, devices, other FDA regulated products, in which case

they would have to have significantly more education.

Ms. DAVIS OF VIRGINIA. I think you make the argument yourself

for having one set of inspections. Because it bothers me a little bit

that the cheese wouldn’t be inspected very often but the meat is.

You can do something to cheese as well as you could to meat, right?

Mr. BRACKETT. You could do something, and if it’s intentional,

that’s a different story. But one of the reasons that we look at it

this way, too, is risk based inspection. Cheese pizzas are typically

not considered one of the higher risk foods, so it would not necessarily get the same scrutiny that another high risk product will.

Whereas in the case of USDA, and I’ll let Dr. Pierson talk, their

product, they don’t have a choice, it must be done under continuous

inspection.

Mr. MURPHY. I feel better already.

Ms. DAVIS OF VIRGINIA. I’m glad you do, Mr. Murphy, because I

don’t.

Mr. MURPHY. I actually don’t feel better.

Ms. DAVIS OF VIRGINIA. I thought you were being a little facetious over there.

Mr. MURPHY. I did get sick off a cheese pizza once.

Mr. PIERSON. That’s correct, for meat and poultry topped pizzas,

the type of thing that Bob is talking about, they would come under

our authority, that’s our statutory authority for inspection on that

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particular case when our inspector has to be there at least one time

during the shift, during the day at those operations. Slaughter operations, our inspectors have to be there continuously. So there’s

differences on that. But it’s a presence each day in those operations.

Ms. DAVIS OF VIRGINIA. I’ve gone way over my time, but Mr.

Dyckman’s dying to say something.

Mr. DYCKMAN. Yes, I really don’t want to pick on the frozen pizza

industry, I love pizza.

Ms. DAVIS OF VIRGINIA. It’s the easiest one to talk about.

Mr. DYCKMAN. Right. But I think their most substantive issues

in terms of the whole issue of whether meat has continuous inspection or should it have continuous inspection or not. But another

issue, you asked about overlap and duplication in general. Let me

give you an example. Both USDA and FDA did risk assessments

because of bioterrorism and the like. And they did them independently. Both agencies issued guidelines to the industries that they

regulate in terms of how to protect for security issues. And they did

those independently.

And those are the types of issues that I think we’re also talking

about in terms of a scale of efficiency that would be appropriate

and would be achievable if you had one agency.

Ms. DAVIS OF VIRGINIA. I started something here. Dr. Brackett.

Mr. BRACKETT. Thank you, Madam Chairwoman. The point I’d

like to make, or correction for the record, which is that the vulnerability assessments at USDA and FDA were done collaboratively,

sitting down together, going through the whole thing. The guidance

documents were done separately, because again of our constituencies and our knowledge of the particular commodities. So USDA

had one set for meat and poultry and FDA had some for our commodities. But that was mainly a means of communicating to our

regulated constituency.

Ms. DAVIS OF VIRGINIA. Thank you. Mr. Van Hollen, I will yield

to you for questions.

Mr. VAN HOLLEN. Thank you, I’ll just wait to hear the next

round of testimony.

Ms. DAVIS OF VIRGINIA. Mr. Davis, do you have any other questions?

Mr. DANNY DAVIS. Well, I do indeed, thank you, Madam Chairwoman.

Dr. Pierson, I know that Mr. Glickman, former Secretary of Agriculture, is going to testify on the next panel that due to a lack of

resources, products in FDA’s regulatory system do not undergo as

thorough an inspection process as products under the U.S. Department of Agriculture’s jurisdiction. My question is how would coordination efforts address these concerns? And would Mr. Glickman’s

concerns be better addressed if one entity had the resources and responsibilities for all the inspections?

Mr. PIERSON. I think it all boils down to, again, the issue of statutory authorities. What Congress has passed is the acts under

which we operate. Those provide that basic difference, basic differences between what FDA does and how they carry out their

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damental requirements there for our continuous inspection and our

continuous presence.

Mr. DANNY DAVIS. But would not the products require as much

review or as much inspection? What we say is, because of their

statutory authority——

Mr. PIERSON. I think what you’re driving to is what you would

call a risk based inspection system. That’s something that we’re

working on very hard, how to prioritize those risks and where do

we best place the resources in that food system. And so we were

of course identifying what are the risks, and at what point should

these risks be best controlled. So we want to redeploy the inspection force such that we do address those priority issues. Certainly

we need to collaborate as the laws now exist with FDA in those priorities.

I’ll give you an example, the risk ranking that was done in collaboration with FDA for listeria monocytogenes. And we addressed

those areas with the highest risk, and for instance on our part specifically passed a regulation that addressed listeria monocytogenes

and its control in ready to eat meat and poultry. As a matter of

fact, our regulatory compliance sampling as a result of that has

shown significant reduction in terms of positive ready to eat samples for listeria monocytogenes.

So it’s an example of where yes, there’s collaboration and we did

our risk ranking and identified where the greatest risks are and

placed resources in that area. The type of model I believe you’re

driving at is the same thing or the same direction we should be

going to. That’s where we’re headed.

Mr. DANNY DAVIS. Thank you very much, Madam Chairwoman.

I have no further questions.

Ms. DAVIS OF VIRGINIA. Thank you, Mr. Davis. Mr. Deal.

Mr. DEAL. Thank you, ma’am.

Mr. Dyckman, in your report you talk about the area of claims

of health benefits. And you point out that both FDA, USDA and the

Federal Trade Commission all have that certifying responsibility to

varying degrees. I assume that’s a function that you would also recommend be consolidated, and if so, do you have a preference as to

where that consolidation should occur?

Mr. DYCKMAN. I think it would follow the same lines as where

the inspection activities would be consolidated. The issue there is

again, different legislative responsibility, different legislative authorities. When we did our report on functional foods and dietary

supplements, we found again big differences between the legislative

authorities that each agency has, and that accounts for the differences in the quality of or the types of claims that different products can make, whether it’s a dietary supplement, whether it’s a

food, whether it’s a functional food.

So I would say that it would still follow wherever the inspection

activities would go, that agency should have the lead on that as

well.

Mr. DEAL. The reason I think that is a little more difficult question is that there are certain certifications both at the production

level and at the processing level. If you’re only at the tail end of

the system, it’s pretty hard to verify the claims that are inherent

in the production phase of it.

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Mr. DYCKMAN. No question about that. And the inconsistencies

that we found relate to the testing evidence that has to be presented by the manufacturer depending on the type of product that’s

involved.

Mr. DEAL. Let me go to the border situation. We do have the border agency now that has that responsibility, I believe USDA still

continues, and I presume FDA has some responsibilities there, too.

Is that a function of border inspection that could be consolidated?

It appears to me that there could be some consolidation. Does it

make a difference whether the product that is coming across the

border is in the process stage versus the unprocessed stage, and

how would that kind of consolidation end, under what agency

would it take place?

Mr. DYCKMAN. Representative Deal, you’re getting into a line of

questioning that is appropriate, but we haven’t done the work to

look at all the different factors. Obviously border inspections are

different than food inspections at a plant. It could very well be

that, and Homeland Security has responsibilities as well. So there’s

another agency involved.

I don’t have the short answer for that question in terms of which

is the most appropriate agency. It could be that the responsibilities,

if you only take the inspection in food processing facilities and consolidate that, it could very well be that we might decide to leave

some other responsibilities with the current agencies.

Mr. DEAL. This is my final point. The difference between standards of production and standards at the processing stages, we have

some legislative problems there, and I’ve used the organic industry

as an example. And I think it’s a classic example where we,

through the Organic Standards Board, have given them authority

to set certain standards. But they are basically self-certifying, no

pesticides, no commercial fertilizers, no GMOs, etc. But they have

their own certifying agencies.

We found, as I was looking into it, a dairy farmer whose wife was

his certifying agent, that he had complied. And if there is no testing at the processing stage to verify the things that are inherent

in the production requirements, there is a huge inconsistency and

I think quite frankly a misleading of the public and perhaps even

some safety factors that ought to be considered.

So it’s not a simple issue, and I think it does require a comprehensive review of everything that we have out there. Once

again, a piecemeal approach may not produce us any better results

than our piecemeal approach we currently have.

Mr. DYCKMAN. I agree with you. What I would hope though is

that at some point, and it might occur next month, next year or in

5 years, that the Congress decides, well, the current system is not

the best system, so let’s begin. We have to begin somewhere. Let’s

put together a panel that is not going to decide whether or not we

will consolidate, but how do we go about consolidating, what is the

best way to revise and to restructure the current system, which is

clearly a patchwork system.

Mr. DEAL. Thank you, Madam Chairwoman.

Ms. DAVIS OF VIRGINIA. Mr. Murphy, do you have any other

questions?

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Mr. MURPHY. Yes, I just want to followup on an area that has

to do with how information is shared between all the agencies. For

example, are there alerts or communications and training that

takes place between the agencies, so people are going through the

same training processes, or does everybody have their own, with

training on how to do inspections? Any crossover there?

Mr. DYCKMAN. I’ll let FDA and USDA respond.

Mr. BRACKETT. Thank you. Well, as I mentioned earlier, because

our inspectors do have multiple authority, they do get specialized

training. And it may be different than that for USDA, and I’ll let

Dr. Pierson talk about that. Because each of these commodities

takes a special knowledge.

But we do communicate directly, calling each other, we know

each other, when we have issues, we share them. We also serve on

committees together to look at the scientific basis and the risk

rankings for the different foods. And in fact, Dr. Pierson and I, Dr.

Pierson is chair and I’m vice chair of the microbiological criteria for

foods, in which we both use the scientific knowledge and share the

scientific knowledge and issues with each other in deciding on what

we’re going to do.

Mr. PIERSON. The training that we provide for our inspection

force is of course very specifically designed to inspect relative to the

meat and poultry as well as egg product inspection acts and the

regulations that we promulgate based relative to those acts. Those

would be fundamentally different, of course, than under the Federal Food, Drug and Cosmetic Act. So you have to train according

to those requirements, that’s one.

There are some basic principles, quite frankly, that are similar,

such as in the hazard analysis critical control point concept that’s

used for food safety management.

Mr. MURPHY. Is that training done together, between agencies, or

is that separate?

Mr. PIERSON. No, because they are under the USDA, FSIS, all

meat and poultry plants must have developed and implemented

HACCP systems. And these HACCP systems, this rule as promulgated is of course relative to our authorities, too. Whereas FDA,

Bob could speak to it relative to seafood, for example. So there are

some differences relative to the basic approach to inspection. There

are commonalities.

Let me mention if I could briefly, where you have this dual jurisdiction issue that our inspectors are trained on those overlap areas.

Mr. MURPHY. That’s important to know, that they’re capable of

doing that. Also, is there any sharing of computer information files,

data back and forth between agencies? Are the computers compatible in communicating that information back and forth between all

these agencies?

Mr. PIERSON. As far as our inspection activities, because of the

different approach, I think we don’t have systems we share such

as that. But we do in fact, when we work, for example, on risk assessments, collaboration on risk assessments, we would share back

and forth.

Mr. MURPHY. But you have to share then in terms of producing

a report, and that has to then, or I’m thinking, when you’re dealing

with, whether it’s the feed or beef and poultry and also with the

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grains and etc., whether it’s in the early stages or it’s in the processing, that if there’s information that comes across in terms of

risk alerts or management or training issues, that those would be

shared across all agencies. Does that happen or does that not

occur?

Mr. PIERSON. Certainly in issues, we definitely notify one another. I was thinking of an example, for instance, in the school

lunch programs. If in fact there is an issue that might occur,

there’s a Food and Nutrition service under which there’s a responsibility. We work very closely with Food and Nutrition Service if in

fact there’s an unfortunate event of a food-borne disease outbreak.

In fact, we then will work in collaboration with FDA when those

involve potential FDA products. So there has to be a seamless operation to immediately share that information such that FDA is well

aware of what’s happening. As a matter of fact, we end up doing

that, too, very closely in working with States.

Mr. MURPHY. Given that, it just seems to me to solidify the idea

that if everybody’s on the same mission and you begin to at least

have some ways of communicating between folks, I still don’t understand why we need different agencies to do it. Dr. Brackett.

Mr. BRACKETT. Thank you, Congressman Murphy. We do have,

and are looking toward actually sharing real time data. For instance, in the President’s budget there is a laboratory reporting

network system known as E-Lexnet that is going to serve as the

platform for both USDA as well as FDA and State laboratories. So

we are cognizant of that, we are working toward that end.

Mr. MURPHY. Thank you, Madam Chairwoman.

Ms. DAVIS OF VIRGINIA. We’re going to move on to the second

panel, but I just want to leave Dr. Brackett and Dr. Pierson with

this last question. If you were to design our food inspection agency

today, would you use the system that we have today? If not, why

not?

Mr. PIERSON. Coming from an academic background, that’s like

a prelim question.

Ms. DAVIS OF VIRGINIA. Yes, it’s sort of a loaded question.

Mr. PIERSON. Thank you very much.

Before I came to USDA, I thought, gee, wouldn’t that be nice to

consolidate it into a single agency. But after experiencing the Federal Government and the Federal Government process and the

agency, I’m not trying to avoid you, Madam Chairwoman——

Ms. DAVIS OF VIRGINIA. Sure you are, but it’s OK.

Mr. PIERSON. But anyway, what I come out with is that before

we just jump into such a thing, before we consider such a thing,

we have to make darned sure what we’re doing is the right thing,

that we’re protecting public health. And whatever that system

might be, I think we have to build it upon assurance of public

health and the outcome, if it’s a single agency, if it’s such as we

have now, if it’s redoing the acts, let’s go one of those directions,

let’s pursue one of those. But let’s not just jump into it without giving very careful thought and attention.

Ms. DAVIS OF VIRGINIA. I don’t think you’ll have any argument

from me. I’m not one to want to jump into anything.

Mr. BRACKETT. Madam Chairwoman, I agree with Dr. Pierson.

The critical thing is to maintain public health and to continue havVerDate 11-MAY-2000 11:55 Nov 20, 2004 Jkt 000000 PO 00000 Frm 00109 Fmt 6633 Sfmt 6633 D:\DOCS\95290.TXT HGOVREF1 PsN: HGOVREF1
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ing the safest food system in the world that we do have now and

we do enjoy. A single food safety system or one involving several

different agencies or a number of different agencies are two different models that one could use. I think it would take a complete

fore-thinking of what we would be losing with the current system

versus what would we be gaining, the underlying statutes as we

mentioned earlier, to be sure that we don’t lose public health, that

we don’t lose public trust.

Even though we have a number of different agencies involved

now, I prefer to think of it less as a fragmented system and more

as a tapestry.

Ms. DAVIS OF VIRGINIA. With that, gentlemen, I want to thank

you all for your patience and your understanding, for being here

today, and I hope we didn’t grill you too much. I’m sure we’ll have

other questions as time goes on.

I’d now like to invite our second panel of witnesses to please

come forward to the witness table. First, we will open with a statement from the Honorable Dan Glickman, former Secretary of Agriculture and Member of Congress. Then we will hear from Carolina

Smith DeWaal, Director of Food Safety at the Center for Science

and Public Interest. I want to thank you two, as well, for being so

patient.

STATEMENTS OF DAN GLICKMAN, DIRECTOR, JOHN F. KENNEDY SCHOOL OF GOVERNMENT, HARVARD UNIVERSITY,

AND FORMER SECRETARY OF AGRICULTURE; AND CAROLINE SMITH DEWAAL, DIRECTOR, FOOD SAFETY, CENTER

FOR SCIENCE AND PUBLIC INTEREST

Mr. GLICKMAN. Thank you, Madam Chairwoman. Let me say

that I spent 18 years in this body——

Ms. DAVIS OF VIRGINIA. So you understand.

Mr. GLICKMAN. And I also spent many times in this room, many

hours in this room, which the Judiciary Committee has some of

their subcommittees operating under at times. So to all of you here,

Mr. Murphy who I don’t know, Mr. Deal, who I did serve with, Mr.

Davis, Mr. Van Hollen, it’s a pleasure to be here.

As you know, now I’m at Harvard, not because I could get in, because Mr. Van Hollen was a good predecessor of mine, but I run

a program there at the Kennedy School. I’m a little bit probably

less partisan than I used to be. But this has been a terrific hearing.

I think everybody has asked amazing questions. One of the best

hearings I’ve ever heard on food safety, and it’s a pleasure to be

here with my friend, Caroline Smith DeWaal.

Let me just make a couple of comments. One of the big issues

here is resources. USDA has all the resources. FDA has a pittance

of resources. The truth of the matter is, one of the problems is that

they have probably, USDA has probably more resources per problem than FDA does. So we have a mis-allocation of resources in

terms of these issues.

One of the first things I would recommend to you is that should

be a, the allocation of resources in food safety should be done on

the basis of a comprehensive, qualitative and quantitative risk assessment. Mr. Murphy talked about this. To my knowledge, that

has never been done. Who does what in the Federal Government

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on food safety? What kinds of resources do they get, and what

kinds of public safety protection is there in there?

Until you get to that question, you can’t really decide how you

want to reorganize this stuff. We can talk about pizza and chicken

broth until we’re blue in the face. But quite honestly, the real issue

is the threat to the American people from contaminated and infected food. We have never done that kind of assessment to figure

out where the threats are, where the resources are. Maybe we have

mis-allocated them dramatically. I suspect that we have. And that’s

one of the things that maybe, I think that will take some legislation to do that. But that’s something I would recommend to you.

The second thing is, I believe that we need to consolidate desperately. I was Secretary at a time when we went through the

HACCP program, we had a lot of food safety problems, it was after

the Jack in the Box situation, it was before the BSE issue, which

by the way I think my successor has handled very, very well in

quelling any kind of fears out there.

But you know, H.L. Mencken once said, for every complicated

problem there is a simple and a wrong solution. I would like to tell

you that this problem is simply solved by just creating a single food

safety agency. But what happens to issues like GMOs which may

be safety related or may be trade related? Sanitary and

phytosanitary barriers of other countries, hormones, antibiotics.

There are a whole litany of problems there that I suspect while we

might be able to get a consensus in this room that are food safety

related, out in the country side and among the constituency groups,

I don’t think you could do that.

On the other hand, if we were to start the system up today as

I think Mr. Davis and you, Congresswoman, suggested, it would

never look like the system we have today. So let me tell you where

I think we ought to start. We ought to start with the inspection

functions. We have 10,000 or so inspectors in the USDA or FSIS

employees and about 10 percent of that at the FDA. We have a

mis-allocation of inspectors.

One of the things I recommend you do is you look at this inspection force of food and we try to consolidate that inspection force.

Mr. Murphy talked about cross training. We don’t do any cross

training to speak of, really quite honestly it’s very nominal. And we

could, as a first step toward consolidation, we could begin the process to cross train and cross deputize food safety employees so that

they could do the various functions either at the border or at the

meat and poultry plant or at an egg plant, or at a pizza plant or

wherever else it is.

I suspect what you’re going to find is that people are not necessarily, and the resources are not necessarily always where the

threats are.

Now, to do what even I’m talking about is no simple task. There

are an awful lot of people who have a stake in the status quo, and

don’t want any changes in the system whatsoever. Some employees, some companies, there are people who think the system is just

fine the way it is.

But we are bound to face more serious food safety threats in the

future. Where I think you need to go down the road is to allocate

and focus your attention on what are the most serious food safety

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threats, which are both naturally occurring, whether it’s salmonella, e coli, listeria, campylobacter, all of the basic threats that

we know people get, whether it’s the unnaturally occurring, terrorist type or insidious type of activities, both in terms of internal

processing plants and at our borders. And then focus on what resources are there necessary to employ enough inspectors at every

one of these places of high vulnerability and cross train them, cross

deputize them, and they’re probably going to have to ultimately be

subject to one agency or a lead agency in that process. Whether

that’s USDA or FDA or somebody else, I think that’s the main

road.

If you wanted to really start out, if you really wanted to protect

the public interest, that’s where I think you have to protect the

public interest. Because if you have an inspection problem in south

Florida, or on the border in North Dakota or some place else, and

you don’t have any FDA inspectors there or far too few USDA or

some Homeland Security inspectors, and you want to get some others who are more in surplus positions, we can’t do that right now.

We can’t cross deputize.

Now, the States and the Federal Government have some memorandum of agreement, but I must disagree a little bit with both

speakers who were here today. The truth of the matter is, there is

no seamless structure between the agencies. Everybody does their

job the best they can. And by the way, most do a good job. Most

of the employees are really hard working and doing their best. But

there is not seamlessness there.

Let’s look at the recent BSE crisis, which was handled very, very

well. When there is a crisis at a national level, the agencies can

usually get together pretty well. But on the day to day threats that

occur, those are the problems that really worry me very, very

much. So I would suggest that you look at the inspectors, focus on

trying to consolidate their functions and if necessary, make the

statutory changes to do that, to give them the authority to, and

this is going to take a few years, this is nothing that’s going to happen overnight.

And probably not get too hung up on one single food safety agency that you’re going to end up with every trade problem in the history of the world, every export-import problem, all sorts of things

that are perhaps not classic trade problems that we’re going to find

in that category because of turf battles here in the Congress, because of problems with industry and employee groups are really

never going to get solved.

One final point I would say is this, and again, I would say, I

think there have been better questions raised here in this hearing

than I have heard in all the years that I was in USDA on this particular point. I would encourage you as members to be, one thing

that always struck me about FAA is the oversight over FAA and

the airline industry was impeccable in this country. Because one

accident occurs and it’s absolutely catastrophic usually. Not to

mean that it’s not perfect, and the accidents have produced what

I call a better Federal oversight over safety issues. Even with airlines that are in problem areas financially, you don’t really worry

about the fact that they’re not doing the work that needs to be

done.

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And I would encourage you in the Congress, and I encourage the

White House to give this matter of food safety oversight continuing

attention and not just when there’s a BSE crisis. Because I’m telling you, that’s what happens here.

I don’t know if they kept it up, during the Clinton administration, we had the President’s Council on Food Safety, which had all

the various agencies that would meet periodically. I don’t know

whether that has continued to meet or not. It should. And it ultimately may be that the President is going to have to designate an

agency to kind of be in charge, at least on paper, of all these kinds

of situations.

But I would also encourage the White House to have this constant level of engagement. These people are trying to do the best

job that they can. Unfortunately, they couldn’t answer your last

question because it was a political question. If I were them, I would

be scared to death to answer that kind of question as well.

Ms. DAVIS OF VIRGINIA. I didn’t expect them to answer it.

Mr. GLICKMAN. But what you’ve done is you’ve raised very, very

good questions. This is a complicated issue. The science is evolving,

the threats are evolving, the pathogens are evolving. They’re even

becoming more virulent all the time. And what you need is an inspection force, at least initially, it’s a little bit like the armed services, we need an inspection force that’s ready on the ground to protect the American people against the most basic threats there are.

Then you move out after that to try to deal with perhaps some of

the more comprehensive type problems.

Thank you.

[The prepared statement of Mr. Glickman follows:]

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Ms. DAVIS OF VIRGINIA. Thank you very much. We appreciate all

your insight and all the years that you were here to learn.

Mr. GLICKMAN. Sometimes those years don’t give you insight.

But I got the chance to say it anyway.

Ms. DAVIS OF VIRGINIA. When you get outside, you get the insight. [Laughter.]

Ms. DeWaal, thank you for your patience and you’re now recognized for 5 minutes.

Ms. DEWAAL. Thank you so much, and it’s so hard to follow

former Secretary Glickman.

I’m director of food safety at the Center for Science in the Public

Interest. I’m also a constituent of Representative Van Hollen, and

I really appreciate the opportunity to testify today.

CSPI is supported by 850,000 subscribers, and we have no either

Government or industry money, which means our views can be

very independent. I’ve been monitoring this issue since 1997 and

have been involved in the issues of food safety for well over a decade.

Nearly 100 years ago, Congress passed the food safety laws that

form the basis of Government food inspection. Today, two Government agencies inspect the food supply. USDA checks meat and

poultry processors daily, including inspecting each individual carcass, meat or poultry carcass, individually. FDA meanwhile has authority for all other food products, including many other high risk

products, like seafood, fresh fruits and vegetables and raw eggs,

but manages this mandate on a shoestring budget.

In 1997, the huge resource imbalance between FDA and USDA

led CSPI to call on Congress to cerate a single, independent food

safety agency, so that the Government could apply resources more

equitably to all the foods that pose the greatest risk to the public.

In 1998, the National Academy of Sciences published a report that

also called for consolidation of food safety responsibilities under a

single statute with a single budget and a single leader. This report,

entitled, ‘‘Ensuring Safe Food from Production to Consumption,’’

concluded that, ‘‘The current fragmented regulatory structure is not

well equipped to meet current challenges.’’

Here are just a few examples. Food safety problems that start on

the farm often fall through the cracks completely of agency jurisdiction. The same food processing plant may get two entirely different

food inspections as we have seen with the pizza example. Quality

inspections sometimes occur more frequently than safety inspections, as happens in the egg industry. New food safety programs

like HACCP are implemented completely differently at USDA versus FDA. And multiple agencies may prolong the time that it takes

to bring the benefits of new technologies to the consumer.

Let me highlight a few other examples. One is that the coordination with the State agencies that handle food safety is literally a

nightmare. State laboratories that analyze food samples for chemical or microbiological contamination, which are critical in our fight

against bioterrorism, for example, these labs have complained

about the lack of uniform testing methods and about inconsistent

reporting requirements with the Federal agencies. They have to

provide samples to USDA, FDA, CDC and EPA.

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And under the current structure, imported products are treated

completely differently if they’re regulated by FDA, which just does

a border inspection and USDA, which actually goes to the country,

they approve the program, they approve each individual plant and

they check 20 percent of the meat or poultry that’s crossing the

border.

In a global marketplace, other countries are moving quickly to

modernize their food safety programs. And the United States is

falling behind, literally, when it comes to having a modern food

safety statute and mandate. Numerous countries have already created unified food safety agencies that cover the entire food supply.

And in Europe, especially, this effort was driven by the BSE crisis.

It’s clearly not news to anyone that statutes designed when the

model Ts were being driven are not suited to address modern hazards. But make no mistake, if the terrorists were to strike the U.S.

food supply, consumer confidence in the Government’s fractured

food safety programs would plummet as far as confidence in airport

security did following September 11th. Even Dr. John Bailar, the

chairman of the National Academy of Sciences Committee calling

for a more unified food safety structure, said ‘‘When bioterrorism

is added to the mix, the case for prompt and sweeping change becomes compelling. While additional tinkering with the details of

our food safety system might be helpful, the consolidation of responsibilities, authorities and resources for food safety into a single

high level agency is critical.’’

Today, a unified agency operating under a modern food safety

statute is truly an issue of national security. Thank you.

[The prepared statement of Ms. DeWaal follows:]

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Ms. DAVIS OF VIRGINIA. Thank you so much, Ms. DeWaal and

Secretary Glickman.

We’ll now go to the question and answer period, and I’ll call on

Mr. Davis, our ranking member, for questions.

Mr. DANNY DAVIS. Thank you very much, and I too want to

thank the witnesses especially for their patience. Mr. Glickman,

Dr. Brackett testified that the Department of Homeland Security

has taken the lead in establishing national policy to defend the agriculture and food systems against terrorism. However, you testified that the creation of DHS creates a disincentive for the Congress to make fundamental changes in the short term.

DHS appears to be working collaboratively with the Department

of Agriculture and the Food and Drug Administration to address

food safety concerns as it pertains to terrorism. If DHS is actively

involved in the process, do you still believe that Congress needs to

act in the short or the long term?

Mr. GLICKMAN. First of all, I think that, my judgment is that the

jury is still out on DHS and what they’re doing in the bioterrorism

areas that affect food and agriculture. I think they’re trying their

best, and I’m not privy to the systems that are going on there. But

there has been an enormous amount of reorganization in the Government as a result of DHS. For example, Animal Plant Health Inspection Service at USDA, which is the lead agency for basically inspecting imports of animal products, other food products, has seen

its mission further divided as a result of the Department of Homeland Security. Some of their mission is now in DHS, some of the

mission remains in USDA.

So in effect, what we have done as part of that statute is further

complexify it, as opposed to consolidating, we basically divided.

What it’s done, I suspect if you talk to people in USDA, and maybe

this is just temporary, is that it’s created morale problems and is

has not enhanced a lot of the feeling that USDA is out there largely promoting its own food safety functions. That’s to be, I assume

that’s to be expected because of what happened after September 11.

I guess my point is that the Department of Homeland Security

is still feeling its own oats, and I’m not sure that is not going to

interfere to some degree with the possibility of consolidating food

safety functions. Because my guess is they’re going to want to have

more and more jurisdiction over these issues, not less and less.

Mr. DAVIS. Ms. DeWaal, how would you rate our system and the

safeness of our system with that of other countries?

Ms. DEWAAL. I appreciate your question. I think we’re blessed

with a very safe food supply compared to many other regions of the

world. That said, there is a lot we can improve. And unfortunately,

our system, our fractured Federal system actually stands in the

way of us correcting some well known food safety problems.

Our representative from GAO today mentioned the egg issue.

We’ve known for almost 10 years that you could solve, you could

virtually eliminate illnesses from eggs by instituting on-farm controls. We’ve known that. We’ve had pilot studies. USDA ran them.

They were very, very effective. Yet we don’t have a regulation in

place that actually implements them, because it took them a bunch

of years actually under the Clinton administration to just figure

out who was in charge of eggs.

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One agency today regulates chickens, another regulates eggs and

a third regulates the meat from the chickens. In almost every problem we end up with that kind of division where almost three agencies are involved. So I think that we have some areas of the food

supply that are very safe but other areas that desperately need improvement.

Mr. GLICKMAN. I just want to add one thing. One of the positive

notes in all this is large sectors of private food industry have actually moved ahead of the Government in doing food inspection and

setting up systems that are actually more stringent than what either the FDA or USDA requires. That’s a trend we have to continue to encourage.

Mr. DANNY DAVIS. Ms. DeWaal, can I infer then that you’re saying that it’s really time to bite the bullet and go ahead and put in

place an agency that has this responsibility?

Ms. DEWAAL. Exactly right. The rest of the world is really moving ahead of us in this area. You know, we’re the United States,

we don’t want to be behind in anything. So I really think it is time

to bite the bullet and move forward.

Mr. DANNY DAVIS. Thank you very much. I have no further questions.

Ms. DAVIS OF VIRGINIA. Thank you, Mr. Davis. Mr. Murphy.

Mr. MURPHY. Thank you, Madam Chairwoman, and welcome

here.

I’m from Pennsylvania, so your comments about the hepatitis A

outbreak are particularly a concern to me. I just want to followup

with regard to this. In your written testimony you talk about meat

that’s imported is inspected by the USDA at two points, once onsite

at the farm and once at a processing plant, then maybe inspected

again somewhere after that. But plants that come in, vegetables

that come in are only inspected once they reach this country and

then only 1 to 2 percent?

Ms. DEWAAL. That’s right.

Mr. MURPHY. Now, of that 1 to 2 percent, if you have several

hundred bushels coming from the same farm, does that mean that,

maybe green onions or something, 1 or 2 percent of that particular

farm is inspected, or it’s just 1 to 2 percent of anything? So a whole

farm could go by with no inspection at all?

Ms. DEWAAL. In most cases, whole farms are going by and never

being inspected. At FDA, they don’t have authority to go to the foreign country to check.

Mr. MURPHY. But USDA does?

Ms. DEWAAL. USDA does.

Mr. MURPHY. Why not?

Ms. DEWAAL. It goes back to these hundred year old statutes

that were just designed differently.

Mr. MURPHY. So even when there is an outbreak, it’s tough to

get authority to go back and inspect the farm in Mexico or wherever that might be?

Ms. DEWAAL. They can’t go unless they’re invited by the country.

But USDA can go any time they want.

Mr. MURPHY. Clearly there’s an arcane rule that needs to change

to allow us to do that.

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Also, you were here before when I asked the question about communicating between agencies. Mr. Secretary, I’m wondering, with

your experience, if you can comment on that because part of my

sense is if Congress wants to answer a question, we have to go to

each agency and ask the same question. Hopefully then they’ll give

it to us. But then we have to fit the pieces together after that. Is

that your understanding?

Mr. GLICKMAN. That’s correct. It’s absolutely correct. In a crisis,

the agencies communicate rather well. Because usually the political

pressures from the Congress are very great and the White House

to get people together at the table at the same time. That’s how

this President’s Council on Food Safety was ultimately created.

But these processes don’t seem to have any sustained life to

them. So right after the BSE epidemic, which thank God was only

one case in this country, is over, or the e coli epidemic is over, we

kind of go back to the way we were, everybody doing their own

thing.

Mr. MURPHY. Let me add another layer to that. Then you have

the State departments, whether it’s a department of agriculture or

a department of health, also trying to coordinate it. My assumption

is they also face the same dilemma. So in Pennsylvania, we have

the other issues with poultry and concerns about flu there. So they

also then have to begin to talk to different agencies and coordinate

that. But that’s a day to day issue for them.

Mr. GLICKMAN. Yes, actually, FDA does have some agreement

with States, they have these collaborative agreements. One thing

I would tell you is, you may want to consider looking at the statutes to see if in fact the agencies are really authorized to have collaborative or joint operating agreements. And I’m not sure they

necessarily are. For example, USDA’s Forest Service and the Department of Interior now operate under joint operating agreements

with respect to some park and forest facilities. I’m not sure, as a

matter of fact, if there’s different statutory formulas and bases,

whether they can do that under current law.

Mr. MURPHY. Do you have anything to add to that, Ms. DeWaal?

Ms. DEWAAL. FDA does have agreements, cooperative agreements, for the inspections by the States. In fact, what we’ve seen

over the years is more and more of the food safety inspections are

actually being done at the State level. So Pennsylvania probably

has a very active inspection program at the State level. Pennsylvania also was where the pilot study was run which showed the onfarm controls for salmonella in eggs was very effective.

So the States are very effective in this area, but they have trouble coordinating with the Federal Government.

Mr. MURPHY. Does that information then go up to the Federal

level and the Federal people disseminate that to other States, or

is that up to the States to figure that out between themselves?

Ms. DEWAAL. It’s up to States to figure out. And again, during

a couple of years during the 1990’s there was an effort to bring the

States together with the Federal Government. But in recent years,

that effort has fallen apart. I know the States are anxious to get

it going again, because they just need standards like consistent laboratory standards, and they need a way to interact with a Federal

Government that is much more streamlined.

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Mr. GLICKMAN. If there is a public health or an imminent disease

problem, the Center for Disease Control is basically the agency of

Government that tries to coordinate all this. Therefore, you’ve got

another player in this game, which is CDC, which once there’s an

outbreak or once there’s an epidemic, then they handle all the epidemiological data, all the transfer of information, a lot of the communications. And they are very engaged, by the way. I don’t know

what the resource needs are. But you can’t really probably even

consolidate a lot of these functions without considering what CDC’s

role is, because it’s the disease prevention agency.

Ms. DEWAAL. But CDC then can’t engage one of the Federal

agencies until they know what food it is. So you have an outbreak

going on, but they don’t know which Federal agency to engage, because they don’t know whether the food is regulated by USDA or

FDA.

Mr. MURPHY. I appreciate the candor the two of you have

brought to this situation, where it seems like there’s a number of

ongoing mistakes that have been made for decades. It reminds me

of a Will Rogers quote where he says, good judgment comes from

experience and lot of that experience comes from bad judgment.

Mr. GLICKMAN. My father used to tell me that all the time.

Mr. MURPHY. You learned well. [Laughter.]

Thank you, Madam Chairwoman.

Ms. DAVIS OF VIRGINIA. Thank you, Mr. Murphy. Mr. Van

Hollen.

Mr. VAN HOLLEN. Thank you, Madam Chairwoman, and I want

to thank both of you for being here today. Secretary Glickman,

thank you for your service, and you’re doing a good job from all reports up at the Kennedy School. Caroline, thank you for all you’ve

done in this area over many, many years. I appreciate all your

work in this area.

I’m just struck by the fact, Mr. Secretary, you started out by

pointing out that we have this huge resource imbalance between

USDA and FDA. Then I turned to Ms. DeWaal’s testimony where

she says in 1997, the huge resource imbalance between FDA and

USDA led CSPI and other consumer organizations to call on Congress to create a single independent food safety agency, and it goes

on to cite a 1998 National Academy of Sciences report.

It does remind me of the other point you raised, which is that

so often, we respond to emergencies and there’s a flurry of activity,

and very quickly the political momentum behind any change gets

lost. I think if there’s one lesson coming out of the 9/11 Commission

that can be generalized to all sorts of issues, which is where you

have very credible evidence of a threat, it’s important that we respond quickly and seriously to it. So I hope that we will not wait

for another food type of emergency before we act on this issue.

With respect to consolidation, there’s one question that sort of,

dealing with all these budgets and resources that comes to mind,

which is, are we talking about consolidating existing resources and

better utilizing them, or in order to get the safety results that we

need, are we going to at the same time we consolidate, we’re going

to have to add resources and manpower to this issue? And if it’s

going to be a question of actually not just reorganizing, but adding

people, inspectors to the process, has anybody, I haven’t had a

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chance to look at the GAO report, has anyone taken a look at what

additional manpower is required and what the cost would be to get

the kind of system that we want that would really provide for food

safety?

Mr. GLICKMAN. I think it’s an excellent question. I do not believe

there has been in recent years an independent, qualitative and

quantitative risk assessment of food safety threats. So it’s hard to

really know how many inspectors we need.

My judgment is we need more than we have overall. Although on

the USDA’s side, in terms of meat and poultry inspection, because

of all the new HACCP systems, in the future we may not need

quite as many there as we have in the past. That’s controversial

and a lot of people in the inspection community might disagree

with me.

But I suspect we need way more on the FDA side of the picture,

then you need to make the law somewhat compatible in the process. But until you do that kind of assessment, you’ll never really

know.

Ms. DEWAAL. We are actually working with several Members,

Representatives DeLauro and Latham on this side, and then Senator Durbin on the other side, on looking at this question of how

to develop a risk based inspection system. So I hope that this committee would work with those Members or tackle your own issue

of how to create this risk review, so that we can get inspection

that’s risk based today.

We have more inspectors inspecting chickens at a rate of 30 birds

per minute than we have invested in any other area of food safety.

And literally, we have Government employees who sit at one point

on a line and watch birds, chickens plucked, broiler chickens fly by

them. I’ve seen it in action, it’s quite amazing. But it’s amazing

they can stay awake, too, because it’s not an effective situation.

Mr. GLICKMAN. If I may add, just quickly, on the other hand, the

new HACCP systems that are employed in many of the plants actually reduce that need, because they’re a more science based system and they work very well. A lot of the pathogens you can’t physically see as they go by, you’ve got to test these products to see

what’s in there.

But one other thing I would warn you about, especially at USDA,

the relationship between the inspectors and the management of the

Food Safety Inspection Service is, shall I say, historically very unstable. And to go down this road, there are a whole lot of labormanagement issues that are going to have to be addressed that are

not going to be easy to tackle.

Mr. VAN HOLLEN. One quick followup. You talked about chicken

being one of the most inspected items. Seafood, on the other hand,

I gather, is one of the least inspected items, and that comes under

FDA, I understand. I think the HACCP standards for USDA with

respect to poultry are very different and uneven compared to the

fish. Can you just talk about seafood for a moment?

Ms. DEWAAL. Seafood has been a fascinating issue, and actually

when Secretary Glickman was a member of the House of Representatives he worked on a seafood inspection bill back in the

early 1990’s. Basically, while meat and poultry are inspected every

single day, regardless of whether it’s pepperoni being chopped onto

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a pizza or meat slaughter plant, seafood, they’ve actually improved

now, they’re up to once a year for the highest risk seafood plant.

So the bottom line is, we have like products that pose a comparable risk but are inspected entirely differently. The HACCP systems are also entirely different, because the agencies just don’t

have the same kind of legislative authority.

Ms. DAVIS OF VIRGINIA. Thank you, Mr. Van Hollen.

I guess you heard, we have bells and whistles going off, because

we have three more votes. I’m just going to ask you one question,

to you, Secretary Glickman.

Why do you think, this is an issue that has been studied for a

long time, from what I’m gathering, why do you think any efforts

to correct these deficiencies have pretty much gone by the way side

and not brought any greater changes?

Mr. GLICKMAN. I think for several reasons. It’s a fundamental

question. One, the system is generally safe. It could be made safer,

but it’s generally safe. Second, American people have confidence in

the safety of the system.

Ms. DAVIS OF VIRGINIA. Keep in mind that the purview of this

committee is reorganization. So we’re looking for efficiency.

Mr. GLICKMAN. Right. But you asked why hasn’t anything been

done. And I think one of the reasons it hasn’t been done is the public hasn’t been clamoring for this, with the exception of when there

is a food safety crisis. Then you tend to gin up, there tends to be

more interest, then it tends to come back down again.

My own experience after serving in the Congress, frankly, is the

turf divisions between various congressional committees has a lot

to do with this issue. I don’t know if they are still as profound as

they once were, but I suspect they are.

Ms. DAVIS OF VIRGINIA. Every bit.

Mr. GLICKMAN. Fourth, by and large the White House, previous

White Houses, have not viewed food safety in the same general,

same area as they have viewed, let’s say homeland security in recent years, or terrorism or those kinds of issues. I suspect you can

do some consolidation and save some money. But I’ll tell you, my

judgment is ultimately we’re going to have to spend more money

on this issue, not less. It’s just you’d like to have it spent on the

inspectors out there in the field who are actually protecting the

public interest.

Ms. DAVIS OF VIRGINIA. Thank you both very much, and we will

have some questions for the record that we will submit to you in

writing. Rather than have you wait, we have three votes, it could

be 45 minutes or so. So we will adjourn the hearing, and thank you

both very much.

Hearing is adjourned.

[Whereupon, at 5:32 p.m., the subcommittee was adjourned, to

reconvene at the call of the Chair.]

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