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96–515 PDF 2004

A REVIEW OF THE USDA’S

EXPANDED BSE CATTLE

SURVEILLANCE PROGRAM

JOINT HEARING

BEFORE THE

COMMITTEE ON GOVERNMENT REFORM

AND THE

COMMITTEE ON AGRICULTURE

HOUSE OF REPRESENTATIVES

ONE HUNDRED EIGHTH CONGRESS

SECOND SESSION

JULY 14, 2004

Serial No. 108–219

(Committee on Government Reform)

Serial No. 108–39

(Committee on Agriculture)

(

Printed for the use of the Committee on Government Reform

and the Committee on Agriculture

(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

BETTY MCCOLLUM, Minnesota

———

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

(III)

COMMITTEE ON AGRICULTURE

BOB GOODLATTE, Virginia, Chairman

JOHN A. BOEHNER, Ohio

Vice Chairman

RICHARD W. POMBO, California

NICK SMITH, Michigan

TERRY EVERETT, Alabama

FRANK D. LUCAS, Oklahoma

JERRY MORAN, Kansas

WILLIAM L. JENKINS, Tennessee

GIL GUTKNECHT, Minnesota

DOUG OSE, California

ROBIN HAYES, North Carolina

CHARLES W. ‘‘CHIP’’ PICKERING,

Mississippi

TIMOTHY V. JOHNSON, Illinois

TOM OSBORNE, Nebraska

MIKE PENCE, Indiana

DENNIS R. REHBERG, Montana

SAM GRAVES, Missouri

ADAM H. PUTNAM, Florida

MAX BURNS, Georgia

JO BONNER, Alabama

MIKE ROGERS, Alabama

STEVE KING, Iowa

CHRIS CHOCOLA, Indiana

MARILYN N. MUSGRAVE, Colorado

DEVIN NUNES, California

RANDY NEUGEBAUER, Texas

——— ———

CHARLES W. STENHOLM, Texas,

Ranking Minority Member

COLLIN C. PETERSON, Minnesota

CALVIN M. DOOLEY, California

TIM HOLDEN, Pennsylvania

BENNIE G. THOMPSON, Mississippi

MIKE MCINTYRE, North Carolina

BOB ETHERIDGE, North Carolina

BARON P. HILL, Indiana

JOE BACA, California

MIKE ROSS, Arkansas

ANI ́BAL ACEVEDO-VILA ́ , Puerto Rico

ED CASE, Hawaii

RODNEY ALEXANDER, Louisiana

DENNIS A. CARDOZA, California

DAVID SCOTT, Georgia

JIM MARSHALL, Georgia

BEN CHANDLER, Kentucky

STEPHANIE HERSETH, South Dakota

EARL POMEROY, North Dakota

LEONARD L. BOSWELL, Iowa

MARK UDALL, Colorado

RICK LARSEN, Washington

LINCOLN DAVIS, Tennessee

——— ———

PROFESSIONAL STAFF

WILLIAM E. O’CONNER, JR., Staff Director

KEVIN KRAMP, Chief Counsel

STEPHEN HATERIUS, Minority Staff Director

ELYSE BAUER, Communications Director

(V)

C O N T E N T S

Page

Davis, Hon. Lincoln, a Representative in Congress from the State of Tennessee, prepared statement ................................................................................. 149

Davis, Hon. Tom, a Representative in Congress from the Commonwealth

of Virginia, prepared statement .......................................................................... 4

DeLauro, Hon. Rosa L., a Representative in Congress from the State of

Connecticut, prepared statement ........................................................................ 147

Goodlatte, Hon. Bob, a Representative in Congress from the Commonwealth

of Virginia, opening statement ............................................................................ 15

Hayes, Hon. Robin, a Representative in Congress from the State of North

Carolina, prepared statement ............................................................................. 62

Hill, Hon. Baron P., a Representative in Congress from the State of Indiana,

letter of July 26, 2004 to Chairman Davis ......................................................... 179

Kucinich, Hon. Dennis J., a Representative in Congress from the State of

Ohio, prepared statement .................................................................................... 145

Stenholm, Hon. Charles W., a Representative in Congress from the State

of Texas, opening statement ................................................................................ 16

Waxman, Hon. Henry A., a Representative in Congress from the State of

California, prepared statement ........................................................................... 10

Letter of July 16, 2004 to Tom Ellestad and Mr. Ellestad’s response ......... 177

Letter of July 16, 2004 to Ms. Fong ................................................................ 181

WITNESSES

Fong, Phyllis K., Inspector General, U.S. Department of Agriculture ................ 68

Prepared statement .......................................................................................... 71

Answers to submitted questions ...................................................................... 183

Accompanied by:

Marlene Evans, Deputy Assistant Inspector General for Audit, U.S. Department of Agriculture

Mark Woods, Assistant Inspector General for Investigations, U.S. Department of Agriculture

Gray, George M., executive director, Harvard Center for Risk Analysis, Harvard School of Public Health, Boston, MA ......................................................... 103

Prepared statement .......................................................................................... 105

Hodges, Jim, president, American Meat Institute Foundation, Arlington, VA .. 125

Prepared statement .......................................................................................... 126

Lurie, Peter G., M.D., deputy director, Public Citizen’s Health Research

Group, Washington, DC ....................................................................................... 116

Prepared statement .......................................................................................... 118

Veneman, Ann M., Secretary, U.S. Department of Agriculture .......................... 18

Prepared statement .......................................................................................... 23

Accompanied by:

Ron DeHaven, Administrator, Animal and Plant Health Inspection Service,

U.S. Department of Agriculture

Keith Collins, Chief Economist, U.S. Department of Agriculture

Weber, Gary M., executive director, Regulatory Affairs, National Cattlemen’s

Beef Association ................................................................................................... 128

Prepared statement .......................................................................................... 131

SUBMITTED MATERIAL

Bio Rad Laboratories, statement ............................................................................ 190

Page

VI

Bullard, Bill, chief executive officer, Ranchers-Cattlemen Action Legal Fund,

United Stockgrowers of America, statement ..................................................... 150

McGarity, Thomas O., president, Center for Progressive Regulation, statement ...................................................................................................................... 156

Ose, Hon. Doug, a Representative in Congress from the State of California,

submitted material ............................................................................................... 167

(1)

A REVIEW OF THE USDA’S EXPANDED BSE

CATTLE SURVEILLANCE PROGRAM

WEDNESDAY, JULY 14, 2004

HOUSE OF REPRESENTATIVES, COMMITTEE ON GOVERNMENT REFORM, JOINT WITH THE COMMITTEE ON AGRICULTURE,

Washington, DC.

The committees met, pursuant to notice, at 10:05 a.m., in room

2154, Rayburn House Office Building, Hon. Tom Davis of Virginia

(chairman of the Committee on Government Reform) presiding.

Present from the Committee on Government Reform: Representatives Tom Davis of Virginia, McHugh, Ose, Lewis, Putnam, Duncan, Murphy, Waxman, Maloney, Cummings, Kucinich, Davis of Illinois, Tierney, Van Hollen, Ruppersberger, Norton, and McCollum.

Present from the Committee on Agriculture: Goodlatte, Smith of

Michigan, Lucas of Oklahoma, Moran of Kansas, Jenkins, Gutknecht, Ose, Hayes, Osborne, Rehberg, Putnam, Burns, Rogers,

and Neugebauer.

Staff present from the Committee on Government Reform: David

Marin, deputy staff director and communications director; Jennifer

Safavian, chief counsel for oversight and investigations; Anne

Marie Turner, counsel; Robert Borden, counsel and parliamentarian; Drew Crockett, deputy director of communications; Susie

Schulte, professional staff member; Teresa Austin, chief clerk;

Sarah Dorsie, deputy clerk; Allyson Blandford, office manager;

Leneal Scott, computer systems manager; Phil Barnett, minority

staff director; Kristin Amerling, minority deputy chief counsel;

Karen Lightfoot, minority communications director and senior policy advisor; Anna Laitin, minority communications and policy assistant; Josh Sharfstein, minority professional staff member;

Earley Green, minority chief clerk; Jean Gosa, minority assistant

clerk; Cecelia Morton, minority office manager; and Naomi Seiler,

minority staff assistant.

Staff present from the Committee on Agriculture: William E.

O’Conner, Jr., majority staff director; Brent Gattis, deputy chief of

staff; John Goldberg, professional staff; Elizabeth Parker, professional staff; Pamilyn Miller, staff director, Subcommittee on Livestock and Horticulture; Pete Thomson, senior professional staff;

Callista Gingrich, chief clerk; Andy Johnson, minority professional

staff; and Lisa Kelley, minority professional staff.

Chairman TOM DAVIS. Good morning. A quorum being present,

the Committee on Government Reform will come to order. I want

to welcome the members of the Committee on Agriculture today,

2

and we look forward to today’s joint hearing on USDA’s expanded

BSE Cattle Surveillance Program

I am going to recognize Mr. Goodlatte as soon as he arrives, but

since he hasn’t arrived yet, I will go ahead with my statement, because we have the Secretary of Agriculture waiting and we want

to get down to questions.

On December 23, 2003, USDA announced for the first time that

a cow in the United States had tested positive for bovine

spongiform encephalopathy [BSE] and more commonly known as

‘‘mad cow disease.’’ Most Americans are familiar with mad cow disease as a result of the European epidemic that hit its peak in 1993.

As the committee charged with overseeing the Federal Government, Government Reform began oversight of USDA’s former mad

cow surveillance system and an investigation into USDA’s handling

of the situation surrounding the discovering of the BSE-infected

cow.

During the initial stages of this investigation, the committee was

presented with information raising significant questions about the

validity of USDA’s statements regarding its BSE surveillance system.

The committee was repeatedly told USDA’s BSE surveillance

program focused on only the high-risk cattle populations where

mad cow disease is most likely to be found. The committee was assured that only downer cattle and cattle suffering from central

nervous system symptoms were submitted to the Animal and Plant

Health Inspection Services [APHIS] and tested for mad cow disease.

Information obtained by the committee from USDA confirmed

that not only were downer and CNS symptomatic cattle tested for

BSE, but ambulatory samples were accepted by APHIS and tested

for mad cow disease. Specifically, the facility that slaughtered the

BSE-infected cow had submitted ambulatory samples for BSE surveillance with the knowledge and approval of APHIS officials working in Washington State. In addition, USDA’s Office of Inspector

General has completed an investigative report that states ambulatory samples were a part of USDA’s mad cow surveillance program.

These findings heightened the committee’s concern that USDA

lacked internal controls over its BSE surveillance program and the

agencies within USDA, as well as over communications between

USDA’s field staff and officials in Washington.

The miscommunication within USDA was highlighted in May at

Lone Star Beef Processors in Texas. Again, due to confusion over

proper protocols, a cow diagnosed with central nervous system

symptoms was not tested for mad cow disease. As a result, USDA

acknowledged a disconnect between APHIS and the Food Safety

and Inspection Services [FSIS] field staff and officials. The committee was encouraged by the renewed commitment between APHIS

and FSIS to rectify the situation and ensure the two entities develop a closer working relationship throughout the BSE surveillance system.

Seven days after the announcement of the BSE-infected cow last

December, Secretary Ann Veneman implemented additional safeguards to protect the human food supply from mad cow disease, including a ban on downer cattle, which were previously approved for

3

human consumption. USDA also prohibited the presence of specific

risk material in human food. In addition, Secretary Veneman requested the International Review Subcommittee of the Foreign Animal and Poultry Disease Advisory Committee to review USDA’s response to the BSE-infected cow and make recommendations to

USDA’s existing policy on BSE surveillance. These steps, along

with the FDA feed ban in place since 1997, illustrate the Federal

Government’s commitment to the protection of the American food

supply.

On March 15, the committee was pleased to learn that USDA

was expanding its BSE surveillance program and planning to incorporate several of the International Review Subcommittee’s recommendations, including a minimum 1-year effort to better ascertain the presence of BSE in the United States. USDA will now

sample as many adult cattle from the high-risk population as possible in the 12- to 18-month timeframe, as well as a random sampling and testing of 20,000 apparently healthy cattle aged 30

months and older.

The expanded BSE surveillance plan reached full implementation on June 1 of this year. The expanded plan is an enormous step

in assessing whether BSE is actually present in the U.S. cattle

population and, if so, at what level. We are here today to discuss

the expanded surveillance plan, its implementation, and receive

feedback as to how the initial stages are working. We expect small

hiccups, as this is a massive undertaking for the USDA. However,

given the proactive measures our Government has taken since

1997, I am confident that we will not be faced with the same mad

cow epidemic that plagued Europe.

The Committee on Government Reform will continue to conduct

oversight of USDA’s BSE surveillance program as it moves forward. I want to thank the committee’s ranking member, Henry

Waxman, for his efforts on USDA oversight, and Chairman Goodlatte of the Committee of Agriculture for holding this joint hearing,

and also the ranking member, Charlie Stenholm. I would also like

to thank our witnesses for their participation today, and look forward to their testimony. And I especially want to thank the Department of Agriculture Secretary, Ann Veneman, for her participation leading up to this hearing and for her presence here today.

I will recognize Mr. Waxman, and then we will go to Mr. Goodlatte.

[The prepared statement of Chairman Tom Davis follows:]

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Mr. WAXMAN. Thank you, Chairman Davis. And I want to thank

Chairman Goodlatte and Ranking Member Stenholm for holding

this joint oversight hearing today. Oversight is critically important

for the functioning of Government agencies, and I commend both

of you and all of you for rising to that responsibility today.

Since the first case of mad cow disease was identified last December, the administration has sought to assure and reassure the

American public and our trading partners. Numerous administration officials have promoted U.S. beef as safe and endorsed the effectiveness of steps being taken to contain the potential problem.

I am concerned, however, that the desire to reassure is trumping

the obligation to tell the truth.

In an interview on Good Morning America, just after announcing

the first detected case, USDA Secretary Ann Veneman assured the

public that ‘‘we are taking every step that we possibly can to protect the country from BSE.’’ Yet, at the time there were many steps

that USDA had not yet taken, including banning downer cattle and

high-risk materials, such as brain and spinal cord, from the food

supply.

Even now the administration is retreating from several important measures to protect against mad cow disease. Six months ago

the Associate Commissioner of the Food and Drug Administration,

Dr. Lester Crawford, testified before Congress that his agency

would act swiftly to close loopholes that allow cattle to be fed to

other cattle. Since this is the way mad cow disease is spread, closing these loopholes is important. But last week, 6 months after the

original announcement, FDA revealed that these changes are no

longer imminent. In fact, they could be delayed for years.

In another example, Secretary Veneman assured the public last

December that the detection of mad cow disease proved the surveillance system was working. She and other USDA officials have

claimed that the mad cow was a downer and had been detected

through mad cow surveillance that targeted downers. Yet, we have

learned that, contrary to the Secretary’s account, at least five eyewitnesses saw the cow walk or stand on the day of slaughter. At

least four USDA officials knew that the facility that slaughtered

the cow was testing ambulatory cattle, a departure from USDA

testing policy. What the Secretary described as evidence of the program’s success may be more accurately described as a stroke of

luck.

This hearing will focus on the Department’s new surveillance

program for mad cow disease. In the next 12 to 18 months, USDA

will attempt to test over 250,000 high-risk cattle, as well as 20,000

healthy adult cattle. The results of this survey are critically important to understanding the extent of mad cow disease in the United

States. But today we are going to hear from the Inspector General

at the U.S. Department of Agriculture about serious problems with

this program.

USDA claims the new surveillance program will be able to detect

mad cow disease even if there are as few as five infected cows in

the whole country. Yet the Inspector General found that this assurance is false. USDA relies upon the assumption that the entire risk

of mad cow disease is confined to the 1 percent of the cattle popuVerDate 11-SEP-98 11:01 Dec 16, 2004 Jkt 000000 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 F:\DOCS\10839.DOC HAGRI PsN: HAGRI
9

lation who exhibit signs of injury or illness, but mad cow disease

can occur in cows that appear to be completely healthy.

The Inspector General also found that USDA is failing to test

many animals at the highest risk for mad cow disease, those that

actually exhibit symptoms of brain disease. So far in this fiscal

year, over 100 cattle have been condemned at slaughter because

they show signs of brain disorders. But less than half of these have

been tested for mad cow disease. As many as 17 untested cattle

were adult cattle with symptoms of brain disorders, the group at

the highest risk of testing positive.

In a five-State survey of cows sent to State labs for rabies testing, only 16 percent of rabies negative samples were sent to USDA

for testing, even though this is also a high-risk group.

In addition, the Inspector General has found that mad cow data

collection is flawed with erratic reporting that often lacks key information. The inspector general has concluded that these and other

problems, if not corrected, may negatively impact the effectiveness

of USDA’s overall BSE surveillance program, impair its ability to

perform risk assessments and program evaluations, and reduce the

credibility of any assertion regarding the prevalence of BSE in the

United States.

It is essential that the administration correct these deficiencies

in its surveillance efforts. If USDA fails to act, consumer confidence

will plummet and our trading partners will not open their borders.

We all share a common objective: ensuring that our food supply

remains safe and free from any signs of mad cow disease. I look

forward to working with my colleagues and the distinguished witnesses today as we strive to attain that goal.

Thank you, Mr. Chairman.

[The prepared statement of Hon. Henry A. Waxman follows:]

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Chairman TOM DAVIS. Thank you very much.

It is now our pleasure to recognize the distinguished chairman

of the Agriculture Committee, Mr. Goodlatte.

Chairman GOODLATTE. I would like to thank the chairman and

ranking member of the Government Reform Committee for agreeing to conduct this hearing jointly with the Committee on Agriculture. The cooperation demonstrated in planning this hearing is

a testament to the professionalism of our two staffs and an acknowledgment of the importance of this topic.

As I am sure the Secretary of Agriculture can attest, the Agriculture Committee has been rigorous in our oversight of the Department’s BSE surveillance programs and determined to ensure

that we are learning what we need to know about our Nation’s cattle herd.

While our interest in the surveillance program goes back many

years, we redoubled our efforts when the first BSE-positive cow

was reported in Canada on May 20 of last year. Since that date,

we have conducted literally dozens and dozens of meetings, conference calls, and briefings with the scientific and management

personnel of the USDA’s Animal and Plant Health Inspection Service [APHIS]. This year, the committee has had a hearing and two

executive sessions with USDA. These conversations have explored

the operational details of the previous BSE surveillance program

and contributed to the development of the current expanded BSE

surveillance program. As the implementation of the program proceeds, the Agriculture Committee will continue its oversight activities with the goal of ensuring the highest quality outcome.

It is important for people to understand that the Nation’s cattle

herd is not a static, homogenous collection of animals; it is a huge

herd, at over 100 million animals, that is spread over a vast nation.

There is a broad array of operations: cow calf producers, dairymen,

replacement heifers, cattle feed lots, breeding herds, show animals,

veal calf production, and auction houses that range from a few

head to tens of thousands. This diverse herd is located in every

State of the Union. For example, there are cattle bred and born in

Hawaii that are eventually shipped to California for feeding and

slaughter.

Additionally, this herd is constantly on the move. First there is

the normal buying and selling of everything from individual animals to lots of thousands. Each year, 35 million head of cattle go

to market, which means there are 35 million animals leaving the

herd and 35 million entering the herd. Over a million live animals

are imported from Mexico each year.

The Department of Agriculture’s expanded BSE surveillance program is intended to take a snapshot of what is going on in this

herd. The surveillance is not intended or designed to be a BSE preventative. While not a direct protection measure itself, it will continue to contribute to the policy process determining our BSE defenses. The results of these tests will help shape how we maintain

or modify the protective firewalls already in place, which include

import bans on live cattle and certain ruminant products, feed bans

prohibiting the feeding of most mammalian protein to cattle and

other ruminants, and exclusion of high-risk materials and high-risk

animals in our food supply.

16

When the cow was found in Washington last December, the Department was already in the process of greatly expanding the surveillance plan. In developing the new surveillance program, USDA

asked the Harvard University Center of Risk Analysis to evaluate

their risk analysis on BSE in the United States, had an international scientific review panel review our plan for BSE, and utilized information gleaned from the international standard setting

body for animal health, the OIE. In addition, rapid screening tests

had to be evaluated and the necessary labs set up, and arrangements had to be made with many segments of the beef production

and rendering systems to ensure we could collect the large volume

of tests the program demands. Even the process of announcing suspicious results in a way that does not needlessly roil commodity

markets has to be contended with.

It has been a tremendous undertaking, and not without its ups

and downs. On June 1, the expanded program began. There is less

than 6 weeks experience with the new testing program, which is

on schedule but has not even had a chance to ramp up to a pace

that will ensure 268,500 tests in a year.

Today’s hearing is not the beginning of the Agriculture Committee’s oversight of this program, and it will not be the end. I can

assure my colleagues, the Inspector General and the Secretary,

that we will continue our close watch of the program, and we have

never been shy in suggesting how it can be improved.

Again, I would like to thank the chairman and ranking member

of the Government Reform Committee, as well as my colleague and

ranking member of my committee, Congressman Stenholm, for

working so cooperatively to put together this hearing. I look forward to today’s testimony and to hearing the questions and answers about USDA’s expanded surveillance program.

It is now my pleasure to recognize the ranking member of the

House Committee on Agriculture, the gentleman from Texas, Mr.

Stenholm.

Mr. STENHOLM. Thank you, Mr. Chairman. And I thank the

chairman and ranking member of the Government Reform Committee for joining the House Agriculture Committee today in the conduct of a very important oversight hearing.

I also want to thank Secretary Veneman for being present today,

demonstrating the seriousness with which the Department of Agriculture has been and is addressing the issue of BSE. Obviously,

this is an important and timely issue, and I am pleased we will

have an opportunity to conduct some essential oversight this morning.

The question of how best to deal with BSE surveillance has been

considered by the House Agriculture Committee for many months.

In fact, for years prior to the identification of that single BSE-positive animal in Washington State, the U.S. agriculture community,

USDA, and the House Agriculture Committee have been considering how best to protect the BSE-free status of our domestic cattle

herd. The continued safety of our beef supply is a testament to the

success of these cooperative efforts over the years.

Now, in response to the identification of BSE in a Canadian-born

cow in Washington State, USDA has further expanded their surveillance efforts. As noted, USDA has begun to expand their surVerDate 11-SEP-98 11:01 Dec 16, 2004 Jkt 000000 PO 00000 Frm 00022 Fmt 6633 Sfmt 6633 F:\DOCS\10839.DOC HAGRI PsN: HAGRI
17

veillance to sample as many as 260,000 animals in the next 12 to

18 months. It is important for us to help USDA to be successful in

this work, and I hope this is the spirit in which we will go forward

during this hearing.

There are legitimate questions, however, about the manner in

which USDA is going forward with this good work. Concerns about

risk communication, sample selection, geographic distribution, and

testing protocols have all been raised. I look forward to the testimony and discussions we will have this morning, and the light they

will shed on this important issue on how USDA is addressing these

concerns.

U.S. livestock producers are justifiably proud of the quality and

safety of our domestic beef supply. Certainly, we will continue to

maintain the ruminant feeding ban and removal of risk materials

that together protect consumers from potential BSE exposure,

should it ever occur in our domestically-produced cattle herd. In

addition, I know that we will all want to move forward working together to get the best possible information about the state of that

resource. That is what this expanded surveillance program is all

about, getting accurate information about the state of our cattle

herd with regard to BSE. So I look forward to learning more about

the ways that this hearing will advance that effort and aid USDA

in that work.

Again, I want to thank all Members and witnesses who are participating this morning. I look forward to an informative and helpful hearing.

Chairman TOM DAVIS. Thank you.

Let me ask unanimous consent that opening statements by other

Members be submitted for the record. I ask unanimous consent

that the statements by the Center for Progressive Regulation and

the Ranchers-Cattlemen Action Legal Fund, United Stockgrowers

of America be submitted for the record of this hearing. Hearing no

objection, so ordered.

We move to our first panel of witnesses. We have the Honorable

Ann Veneman, the Secretary of the U.S. Department of Agriculture. Secretary Veneman will provide the committee with an update of how the expanded BSE surveillance program is being implemented and the new written protocols that are in place for the

plan. Dr. Ron DeHaven, the Administrator of the Animal and Plant

Health Inspection Service, and Dr. Keith Collins, Chief Economist

for the USDA, accompany Secretary Veneman to answer questions.

It is our policy that we swear in all witnesses before they testify,

so if you would rise with me and raise your right hands.

[Witnesses sworn.]

Chairman TOM DAVIS. Secretary Veneman, thank you very much

for being with us. You can proceed with your statement. Your entire statement is in the record, so you can move to sum it up. We

have a light there that turns orange after 4 minutes, red after 5,

but take what time you need; this is an important program. We are

pleased to see it moving underway and appreciate your being

proactive in this area.

18

STATEMENT OF ANN M. VENEMAN, SECRETARY, U.S. DEPARTMENT OF AGRICULTURE, ACCOMPANIED BY RON DEHAVEN,

ADMINISTRATOR, ANIMAL AND PLANT INSPECTION SERVICE, AND KEITH COLLINS, CHIEF ECONOMIST

Secretary VENEMAN. Thank you, Chairman Davis and Chairman

Goodlatte, and Ranking Members Waxman and Stenholm, and

members of the committee. It is an honor to be with you today to

discuss our ongoing activities to protect public health and enhance

our food and animal safety systems against BSE.

As indicated, I am accompanied today by Dr. Ron DeHaven, our

APHIS Administrator, and Dr. Keith Collins, our Chief Economist.

You will also hear from USDA’s Inspector General today, whose office has made many recommendations to strengthen the Department’s ongoing efforts with regard to BSE.

The U.S. Department of Agriculture works to protect public

health by ensuring the safety and wholesomeness of the Nation’s

commercial supply of meat, poultry, and egg products. We take this

enormous responsibility very seriously. In addition, USDA works to

protect animal and plant health, and we take that responsibility

just as seriously.

My testimony today will focus on the implementation of our enhanced BSE surveillance plan, which we announced in March, to

collect the data needed to establish a baseline from which prevalence can be determined. However, before I begin, I would like to

provide some background as well as a brief review of the actions

the Department has taken since the December 23 find of BSE in

the United States.

BSE was discovered in England in 1986, and since then more

than 180,000 cases have been confirmed in cattle worldwide. USDA

immediately began to study the disease in order to prevent its introduction to the United States or to prevent the widespread epidemic that we have seen in Europe. USDA developed a response

plan that has been strengthened over the past 15 years as the scientific evidence and body of knowledge regarding BSE has evolved.

In 1989, the United States implemented an import ban, which

was extended in 1997 and again in 2000, on live cattle and other

ruminants and certain ruminant products from countries at high

risk of BSE. In 1997, the Food and Drug Administration banned

most mammalian proteins in the use of animal feeds given to cattle

and other ruminants to prevent spread of the disease should it

occur in the United States.

USDA began a surveillance program in 1990, and for the past 11

years has met or exceeded international standards as outlined by

the OIE, the World Organization for Animal Health, which is the

internationally recognized forum for the development and review of

standards, guidelines, and recommendations on animal health. In

fiscal years 2002 and 2003, we significantly increased BSE surveillance levels with approximately 20,000 animals tested each year.

In 1998, USDA asked the Harvard Center for Risk Analysis to

investigate the risk of BSE in the United States. In 2001, its report

noted that, because of the actions taken over the past 15 years, the

risk of BSE becoming a widespread epidemic in the United States

was extremely low.

19

As you know, on December 23 we announced the discovery of a

single case of BSE in Washington State in a dairy cow whose birth

predated the 1997 feed ban. On December 30, just 1 week after the

find, we announced further actions to protect public health. These

included: an immediate ban on non-ambulatory, disabled, or what

we call downer cattle from going into the food chain; a ‘‘test and

hold’’ policy, which mandates that meat from cattle tested for BSE

cannot enter into the food chain until test results have come back

negative; a requirement to remove specified risk materials, or what

is referred to as SRMs, which can carry the infectivity from the

food supply in order to protect public health; further limitations on

the use of advanced meat recovery systems; a ban on the use of mechanically separated beef from the human food supply; and a ban

on air-injection stunning.

These new food safety protections were officially released in the

form of an interim final rule less than 2 weeks later, and which

became effective immediately.

In addition, we announced the expedited implementation of a national verifiable animal identification system. Our goals are to

achieve uniformity, consistency, and efficiency across the national

ID system.

Also on December 30, I announced that an international panel of

experts would review our response and offer areas for potential enhancement. The International Review Team convened in January

and provided recommendations on specified risk material removal,

slaughter methods, surveillance design and approaches, feed restrictions, feed manufacturing and sales, traceability enhancements, and other areas that could provide meaningful additional

public or animal health benefits.

The team’s report confirmed the results of the epidemiological investigation, as well as USDA’s actions announced on December 30

to further protect human health. In briefing me on the report, Dr.

Kihm, the chairman of the team, described the SRM removal as the

single most important action to protect public health.

They recommended a strengthened surveillance program to test

cattle older than 30 months in the high-risk population, suggesting

this could be done in a 1-year program. According to the report,

surveillance systems targeting high-risk animals have been shown

to be the most efficient way to identify BSE cases. In addition, the

report said that testing of all cattle slaughtered for human consumption was unjustified in terms of protecting human and animal

health.

USDA drafted an enhanced surveillance plan designed to meet

the objectives outlined by the International Review Team. In developing the specifics of the plan, USDA worked with the OIE.

The current OIE standards provide criteria for establishing the

BSE risk status of a country or zone based on risk assessment

identifying all potential factors for BSE occurrence. For animal surveillance, the OIE recommends targeted sampling of cattle that display clinical signs compatible with BSE and cattle that have died

or been killed for reasons other than routine slaughter. According

to the OIE, surveillance should focus primarily on cattle over 30

months of age in these higher risk categories. As I mentioned, the

20

United States has met or exceeded the international guidelines for

BSE surveillance in cattle since 1993.

USDA determined that at least 268,500 samples would be collected from the high-risk population of animals. The approach assumes BSE-positive cattle would be contained in the high-risk population. Sampling efforts were therefore biased toward this population in order to test as many of these animals as possible.

The surveillance plan was reviewed by the International Review

Team and the Harvard Center for Risk Analysis. In a letter, Dr.

Kihm, the chairman of the International Team, stated, ‘‘On behalf

of the entire subcommittee, I would like to congratulate you on this

plan. All members of the subcommittee responded with positive

comments, agreeing that the plan is comprehensive, scientifically

based, and addresses the most important points regarding BSE

surveillance in animals.’’

The comments of the Harvard Center for Risk Analysis were also

supportive. ‘‘In summary,’’ wrote Joshua Cohen and George Gray,

‘‘we agree with USDA’s focus on testing high-risk cattle.’’ They

noted that USDA faces a challenge in drawing conclusions from its

testing program for the prevalence of BSE in normal cattle populations. They suggested alternative approaches for consideration.

USDA intends to continue consulting with them, as well as others,

as we collect the data.

As noted in the International Review Team’s report, experience

in Europe has shown that testing high-risk cattle is the most efficient way to identify if BSE is present in the cattle population.

USDA’s enhanced program is designed to collect the majority of

samples from the following categories: cattle exhibiting signs of a

central nervous system disorder; non-ambulatory disabled cattle;

cattle exhibiting signs of other diseases or conditions that may be

associated with BSE, such as rabies or emaciation; and older cattle

that die on the farm for unexplained reasons.

Test samples are coming from farms, slaughter facilities, rendering facilities, livestock auctions, veterinary clinics, veterinary diagnostic laboratories, and public health laboratories. Early data indicate that we are getting a representative mix of samples from these

locations, and they do suggest that we can achieve at least 268,500

samples from the targeted population.

This enhanced plan was made public and posted on the USDA

Web site on March 15. In just 21⁄2 months following that announcement, USDA undertook extensive efforts to implement what

amounts to a broad, new surveillance program. I would add that

our BSE response and surveillance plans have proceeded simultaneously with APHIS responses to other major animal and plant

disease issues. These include avian influenza, exotic Newcastle disease, soybean rust, and sudden oak death. Each one of these has

also required a substantial commitment of APHIS program staff

and management attention.

Between mid-March and June 1, APHIS took steps to build the

infrastructure for the surveillance plan. These included licensing of

rapid tests, setting up a national laboratory network, testing and

certification of laboratories, equipping the staff and holding training sessions, drafting contractual documents, compiling a field

manual, building an incident command structure, coordinating

21

with interagency partners, and collaborating with States, which are

key to the success of this program.

USDA’s enhanced BSE surveillance efforts would not be possible

without additional testing alternatives and increased laboratory capacity to handle the volume of samples submitted as part of the

program. To support this component, USDA has issued licenses or

permits for five rapid BSE test kits. In addition, 12 public laboratories strategically located across the country have been approved

by USDA to support the surveillance program. These laboratories

are all part of an existing network of State and Federal laboratories that assist APHIS with animal disease testing as needed.

Because of their geographically dispersed locations, the laboratories have reduced the distance samples needs to travel and are

thus helping ensure a rapid turnaround time between sample submission and screening. Any inconclusive results on a screening test

identified by one of these laboratories must be confirmed at

USDA’s National Veterinary Service Laboratory in Ames, IA. The

NVSL, as that laboratory is referred to, remains the national reference lab for BSE. The reporting and confirmation requirement by

USDA is also providing appropriate and timely release of information regarding the screening results. As we have throughout our response to BSE, we need to carefully balance our responsibility to

share information with the public with our responsibility to do so

in a way that does not inappropriately affect markets.

Throughout the planning and implementation of this plan, we

have continued to strengthen the program based on our own analysis, as well as suggestions received by others.

To handle day-to-day management of implementation, APHIS set

up National and Regional Command Teams based on the Incident

Command Structure, headquartered at the APHIS state-of-the-art

operations center in Riverdale, MD. These teams are charged with

making sure that all aspects of the surveillance program, sample

collection, operational activities and training, are meeting the goals

and performance standards on both a local and a national level.

To ensure interagency coordination, these teams include USDA’s

Food Safety and Inspection Service, as well as State and regional

animal health experts. In addition, we are coordinating closely with

the Food and Drug Administration and other State partners who

have been extremely helpful in providing their counsel regarding

implementation.

We have implemented new policies to ensure objectivity of sample selection. For example, under new directives, samples are being

taken from animals with signs of central nervous system [CNS]

disorders regardless of age, and all ante-mortem condemned cattle—except for veal calves that do not show signs of CNS—will be

sampled. Field staff have been instructed, when in doubt, take a

sample.

USDA is also working on a broad plan of outreach activities to

help ensure that we are receiving all possible samples. A detailed

instruction manual has been sent to the field staff involved in sample collection.

We continue activities to inform producers, slaughter facilities,

renderers, and affiliated industries about our surveillance goals,

22

and to encourage reporting of suspect or targeted cattle on the

farm or elsewhere.

Not surprisingly, given the scope of the task, our efforts continue

to evolve in order to ensure the successful implementation of such

an extensive undertaking. Our activities will include additional

work with the Office of the Inspector General.

The OIG has provided recommendations to enhance the program

and raised a number of issues that continue to merit attention,

such as assuring adequate performance measures and management

reports to monitor the effectiveness of the surveillance system and

the need for consistency across multiple labs and IT systems.

APHIS is also expediting its work with our Chief Information Officer to strengthen the system to track and report testing data.

USDA agencies are also working together to set up and conduct

a quality assurance audit system. Our Agricultural Marketing

Service will begin a nationwide evaluation of the APHIS enhanced

BSE surveillance program, beginning tomorrow, at APHIS headquarters and proceeding to regional and State offices later this

month. This assessment process will be ongoing.

In addition to our specific activities on the surveillance plan,

USDA, in partnership with other Federal agencies, is taking additional actions to strengthen our safeguards against BSE.

Last Friday USDA and the Department of Health and Human

Services issued an Advance Notice of Proposed Rulemaking to solicit public comment on the International Review Team’s recommendations, as well as other related areas that have not already

been acted upon.

On Monday of this week USDA scientists met with a group of

interagency partners to discuss prion science research needs. And,

finally, the Department continues to work with the Harvard Center

for Risk Analysis to update its risk assessment and evaluate

USDA’s BSE response.

In conclusion, we remain committed to continually addressing

ways to enhance our systems and improve implementation.

Our surveillance plan may find additional BSE-positive animals.

Notwithstanding, the United States has strong safeguards in place

to protect public health. Removal of SRMs from the food supply ensures that the highest risk materials are not entering the food

chain. By continuing the coordination between USDA and other

Federal, State and local agencies, and by enhancing our sciencebased policies and working with our employees and stakeholders,

we are confident that we can continue to provide consumers in the

United States with a safe supply of meat, poultry, and egg products.

Mr. Chairmen and ranking members, we appreciate the opportunity to inform you and the committee’s members of USDA’s ongoing BSE surveillance activities. We recognize that there are many

different ideas and different opinions about how we can achieve the

most robust system possible to guard against BSE. I look forward

to the opportunity to discuss these issues that the hearing affords

us, and I appreciate the opportunity to be here, and we are pleased

to take your questions.

[The prepared statement of Secretary Veneman follows:]

23

TESTIMONY OF ANN M. VENEMAN

Chairman Davis, Chairman Goodlatte, Mr. Waxman, Mr. Stenholm, and members

of the committees, it is an honor to be with you today to discuss the ongoing activities to protect public health and enhance our food and animal safety systems

against Bovine Spongiform Encephalopathy (BSE).

Joining me at the table today is Dr. Ron DeHaven, our point person on BSE who

until recently, served as USDA’s Chief Veterinary Officer. He currently serves as

the Administrator of the Animal and Plant Health Inspection Service (APHIS). Also

with us is Dr. Keith Collins, USDA’s Chief Economist. He has been involved with

several BSE-related issues from a policy perspective. Both are here to assist in answering any questions you may have.

Later you will hear testimony from USDA’s Inspector General, Phyllis Fong,

whose office has made many recommendations to strengthen the Department’s ongoing efforts with regard to BSE. The Office of Inspector General (OIG) has reviewed

a number of issues, and it has provided suggestions on USDA’s BSE programs.

The U.S. Department of Agriculture works to protect public health by ensuring

the safety and wholesomeness of the Nation’s commercial supply of meat, poultry

and egg products. We take this enormous responsibility very seriously. In addition,

USDA works to protect animal and plant health, and we take that responsibility

just as seriously.

As requested by the July 6 letter from Chairman Davis and Chairman Goodlatte,

my testimony today will focus on the implementation of our enhanced BSE surveillance plan, which we announced in March. The purpose of this plan is to collect the

data needed to establish a baseline from which prevalence can be determined.

However, before I begin, I would like to provide some background, as well as a

brief review of the actions the Department has taken since the December 23 find

of BSE in the United States. A more detailed background is contained in the attached materials.

BSE was discovered in England in 1986, and since then, more than 180,000 cases

have been confirmed in cattle worldwide. In 1986, USDA immediately began to

study the disease in order to prevent its introduction to the United States or to prevent the widespread epidemic that we have seen in Europe. USDA developed a response plan that has been strengthened over the past 15 years as the scientific evidence and body of knowledge regarding BSE has evolved.

In 1989, the United States implemented an import ban, which was extended in

1997 and again in 2000, on live cattle and other ruminants and certain ruminant

products from countries at high risk of BSE. In 1997, the Food and Drug Administration banned most mammalian proteins in the use of animal feeds given to cattle

and other ruminants to prevent spread of the disease should it occur in the United

States.

USDA began a surveillance program in 1990, and for the past 11 years has met

or exceeded international standards as outlined by the Office of International des

Epizootes (OIE), or the World Organization for Animal Health. The OIE is the internationally recognized forum for the development and review of standards, guidelines

and recommendations on animal health. USDA’s surveillance program has targeted

the high-risk population in accordance with the OIE recommendations. In fiscal

years 2002 and 2003, BSE surveillance levels increased significantly, with approximately 20,000 animals tested in each year. Before December 23, 2003, we had plans

to double that number for fiscal year 2004.

These actions were designed to prevent the introduction of BSE or its spread,

should it be introduced in this country. The United States has long been committed

to addressing the potential risk of BSE and these programs were strengthened over

the years as more was learned about this disease.

In 1998, USDA asked the Harvard Center for Risk Analysis to investigate the risk

of BSE in the United States. In 2001, their report was released. It noted that, because of the actions taken over the past 15 years, the risk of BSE becoming a widespread epidemic in the United States was extremely low.

As you know, on December 23, 2003, we announced the discovery of a single case

of BSE in Washington State in a dairy cow whose birth predated the 1997 feed ban.

On December 30, just 1 week after that find, we announced further actions to protect public health.

These included:

• An immediate ban on non-ambulatory disabled (downer) cattle from going into

the food chain;

• A ‘‘test and hold’’ policy, which mandates that meat from cattle tested for BSE

cannot enter into the food chain until test results come back negative;

24

1 SRMs are defined as skull, brain, spinal cord, eyes, trigeminal ganglia, vertebral column

(except the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae

and the wings of the sacrum), as well as the dorsal root ganglia of animals 30 months and older

and the tonsils and distal ileum of all animals. To ensure that the distal ileum is appropriately

removed, the removal of the entire small intestine is required.

• A requirement to remove specified risk materials (SRMs), which can carry the

infectivity, from the food supply in order to protect public health; 1

• Enhanced requirements on the use of advanced meat recovery systems. Product

produced using advanced meat recovery cannot contain spinal cord or dorsal root

ganglia; • A ban on the use of mechanically separated beef from the human food supply;

• And a ban on air-injection stunning.

These new food safety protections were officially released in the form of an interim final rule less than 2 weeks later.

In addition, we announced the expedited implementation of a national verifiable

animal identification system. Our goals are to achieve uniformity, consistency and

efficiency across the national ID system.

INTERNATIONAL GUIDANCE

Also, on December 30, I announced that an international panel of experts would

review our response actions and offer areas for potential enhancement. The International Review Team, as it came to be known, convened in January. They were

asked to evaluate the prevention and response actions taken to date and provide

recommendations on specified risk material (SRM) removal, slaughter methods, surveillance design and approaches, feed restrictions, feed manufacturing and sales,

traceability enhancements, and other areas that could provide meaningful additional public or animal health benefits.

The International Review Team’s report confirmed the epidemiological investigation as well as USDA’s actions announced on December 30 to further protect human

health. In briefing me on the report, Dr. Uhli Kihm, the chairman of the team, described the SRM removal as the single most important action to protect public

health.

The International Review Team recommended a strengthened surveillance program to test cattle older than 30 months in the high-risk population. They suggested this could be done in a ‘‘1-year program.’’ According to the report, surveillance systems targeting high-risk animals have been shown to be the most efficient

way to identify BSE cases. In addition, the report said the ‘‘testing of all cattle

slaughtered for human consumption (was) unjustified in terms of protecting human

and animal health.’’ It was also recommended that USDA strongly consider testing

a sample of healthy slaughter cattle over 30 months old to support the overall surveillance system.

ENHANCED BSE SURVEILLANCE

After receiving these recommendations, USDA drafted an enhanced surveillance

plan designed to meet the objectives outlined by the International Review Team. In

developing the specifics of the plan, USDA worked with the OIE.

The current OIE standards provide criteria for establishing the BSE risk status

of a country or zone, based on a risk assessment identifying all potential factors for

BSE occurrence. For animal surveillance, the OIE recommends targeted sampling

of cattle that display clinical signs compatible with BSE and cattle that have died

or been killed for reasons other than routine slaughter. According to the OIE, surveillance should focus primarily on cattle over 30 months of age in these highest

risk categories. As I mentioned, the United States has met or exceeded the international guidelines for BSE surveillance in cattle since 1993.

The enhanced surveillance plan focuses on testing as many high-risk cattle as possible. To develop a sampling plan with a high level of detecting BSE, USDA determined that at least 268,500 samples would be collected from the high-risk population of animals. The approach assumed BSE positive cattle would be contained in

the high-risk population. Sampling efforts are therefore biased toward this population in order to provide the most efficient method of detecting the disease. In addition to testing the high-risk cattle, USDA will also test 20,000 healthy-appearing,

older animals sent to slaughter.

The surveillance plan was reviewed by the International Review Team and the

Harvard Center for Risk Analysis. Dr. Ulrich Kihm, the chairman of the international team, stated: ‘‘On behalf of the entire subcommittee, I would like to conVerDate 11-SEP-98 11:01 Dec 16, 2004 Jkt 000000 PO 00000 Frm 00030 Fmt 6633 Sfmt 6633 F:\DOCS\10839.DOC HAGRI PsN: HAGRI
25

gratulate you on this plan. All members of the subcommittee responded with positive comments, agreeing that the plan is comprehensive, scientifically based, and

addresses the most important points regarding BSE surveillance in animals.’’

The comments of the Harvard Center for Risk Analysis also were supportive. ‘‘In

summary,’’ wrote Joshua Cohen and George Gray, ‘‘we agree with USDA’s focus on

testing high risk cattle.’’ They noted that USDA faces a challenge in drawing conclusions from its testing program for the prevalence of BSE in the normal cattle populations. They suggested alternative approaches for consideration. USDA intends to

continue consulting with them, as well as others, as we collect the data.

As noted in the International Review Team’s report, experience in Europe has

shown that testing high-risk cattle is the most efficient way to identify if BSE is

present in the cattle population. USDA’s enhanced program is designed to collect

the majority of samples from the following categories:

• Cattle exhibiting signs of a central nervous system disorder;

• Non-ambulatory disabled cattle;

• Cattle exhibiting signs of other diseases or conditions that may be associated

with BSE, such as rabies or emaciation; and • Older cattle that die on the farm for unexplained reasons.

Test samples are coming from farms, slaughter facilities, rendering facilities, livestock auctions, veterinary clinics, veterinary diagnostic laboratories, and public

health laboratories. Early data indicate that we are getting a representative mix of

samples from these locations, and suggest that we can achieve at least 268,500 samples from the targeted population.

Details of this enhanced plan were made public and posted on the USDA Web site

on March 15. In just 21⁄2 months following that announcement, USDA undertook extensive efforts to implement what amounts to a broad, new surveillance program.

I would add that our BSE response and surveillance plans have proceeded simultaneously with APHIS responses to other major animal and plant disease issues.

These include avian influenza, exotic Newcastle disease, soybean rust and sudden

oak death. Each one of these has also required a substantial commitment of APHIS

program staff and management attention.

Between mid-March and June 1, APHIS took steps to build the infrastructure for

the surveillance plan. These included licensing of rapid tests, setting up a national

laboratory network, testing and certification of labs, equipping the staff and holding

training sessions, drafting contractual documents, compiling a field manual, building an incident command structure, coordinating with interagency partners, and collaborating with states, which are key to the success of this program.

Expanding the infrastructure to test as many higher risk cattle as possible is a

difficult and complex task. The size and geographical scope of the industry presents

many challenges. The cattle populations in each state vary tremendously, as do the

industry and the concentration points for collecting samples. To address these challenges, we established sampling targets for each state and region.

USDA’s enhanced BSE surveillance effort would not be possible without additional testing alternatives and increased laboratory capacity to handle the volume

of samples submitted as part of the program. To support this component, USDA has

issued licenses or permits for five rapid BSE test kits. In addition, 12 public laboratories strategically located across the country have been approved by USDA to support the surveillance program. These laboratories are all part of an existing network

of state and Federal labs that assist APHIS with animal-disease testing as needed.

Because of their geographically dispersed locations, the laboratories have reduced

the distances samples need to travel, and are thus helping ensure a rapid turnaround time between sample submission and screening. Any inconclusive results on

a screening test identified by one of these laboratories must be confirmed at USDA’s

National Veterinary Services Laboratory in Ames, IA. NVSL remains the national

reference lab for BSE. This reporting and confirmation requirement by USDA is also

providing appropriate and timely release of information regarding screening results.

As we have throughout our response to BSE, we need to carefully balance our responsibility to share information with the public and our cooperators with our responsibility to do so in a way that does not inappropriately affect economic or international trade markets.

Throughout the planning and implementation of this plan, we have continued to

strengthen the program based on our own analysis, as well as suggestions received

by others.

To handle day-to-day management of implementation, APHIS set up National and

Regional Command Teams based on the Incident Command Structure,

headquartered at the APHIS state-of-the-art operations center in Riverdale, MD.

These teams are charged with making sure that all aspects of the surveillance proVerDate 11-SEP-98 11:01 Dec 16, 2004 Jkt 000000 PO 00000 Frm 00031 Fmt 6633 Sfmt 6633 F:\DOCS\10839.DOC HAGRI PsN: HAGRI
26

gram—sample collection, operational activities, and training—are meeting goals and

performance standards on both a local and national level.

To ensure interagency coordination, these teams include USDA’s Food Safety and

Inspection Service, as well as State and regional animal-health experts. In addition,

we are coordinating closely with the Food and Drug Administration and other state

partners, who have been extremely helpful in providing their counsel regarding implementation.

We have implemented new policies to ensure objectivity in sample selection. For

example, under new directives, samples are being taken from animals with signs

of central nervous system (CNS) disorders, regardless of age, and all ante-mortem

condemned cattle (except for veal calves that do not show signs of CNS disorders.)

Field staff have been instructed, when in doubt, take a sample.

USDA is also working on a broad plan of outreach activities to help ensure we

are receiving all possible samples. A detailed instruction manual has been sent to

field staff involved in sample collection. This guide is designed to be a ‘‘living’’ document, which will be modified as necessary, based on feedback from headquarters

and field personnel, to ensure smooth operations and continued coordination with

all involved.

We continue activities to inform producers, slaughter facilities, renderers and affiliated industries about our surveillance goals, and to encourage reporting of suspect or targeted cattle on the farm or elsewhere. These activities include public service announcements, advertisements in trade publications, and presentations to veterinary schools, agricultural colleges, and local farm organizations. In addition, materials will be available on our Web site for livestock markets, animal health technicians and veterinarians.

Not surprisingly, given the scope of the task, our efforts continue to evolve in

order to assure the successful implementation of such an extensive undertaking.

Our activities will include additional work with the Office of Inspector General.

The OIG has provided recommendations to enhance the program, and raised a

number of issues that continue to merit attention, such as assuring adequate performance measures and management reports to monitor the effectiveness of the surveillance system, and the need for consistency across multiple labs and IT systems.

We look forward to continuing to work with the OIG to appropriately implement

these recommendations.

APHIS is expediting its work with our Chief Information Officer to strengthen the

system to track and report testing data. APHIS will be field-testing new software

applications, which should improve the integrity and speed of the data collection

process.

USDA agencies are also working together to set up and conduct a quality assurance audit system. Our Agricultural Marketing Service (AMS) will begin a nationwide evaluation of the APHIS enhanced BSE surveillance program, beginning tomorrow, July 15, at APHIS headquarters and proceeding to regional and state offices later this month. Over a 4- to 6-week period, AMS will conduct onsite assessments of random locations where surveillance activities occur, with a report issued

within 4 weeks afterward. These assessments will be on-going.

In addition to our specific activities on the surveillance plan, USDA, in partnership with other Federal agencies, is taking additional actions to strengthen our safeguards against BSE.

Last Friday USDA and the Department of Health and Human Services issued an

Advance Notice of Proposed Rulemaking (ANPR) to solicit public comment on the

international review team’s recommendations as well as other related areas that

have not already been acted on.

On Monday of this week USDA scientists met with a group of interagency partners to discuss prion science research needs. And finally, the Department continues

to work with the Harvard Center for Risk Analysis to update its risk assessment

and evaluate USDA’s BSE response.

CONCLUSION

In conclusion, we remain committed to continually addressing ways to enhance

our systems and improve implementation of our efforts.

Our surveillance plan may find additional BSE-positive animals. Notwithstanding, the United States has strong safeguards in place to protect public health. Removal of SRMs from the food supply ensures that the highest-risk materials are not

entering the food chain. By continuing the coordination between USDA and other

Federal, state, and local agencies, and by enhancing our science-based policies and

working with our employees and stakeholders, we are confident that we can conVerDate 11-SEP-98 11:01 Dec 16, 2004 Jkt 000000 PO 00000 Frm 00032 Fmt 6633 Sfmt 6633 F:\DOCS\10839.DOC HAGRI PsN: HAGRI
27

tinue to provide consumers in the United States with a safe supply of meat, poultry,

and egg products.

Chairman Davis, Chairman Goodlatte, Mr. Waxman, and Mr. Stenholm, we appreciate the opportunity to inform you and the committee’s members of USDA’s ongoing BSE surveillance activities. We recognize there are many different ideas and

opinions about how we can achieve the most robust system possible to guard against

BSE. I look forward to the opportunity to discuss these issues that this hearing affords us. We would be pleased to take any questions you have at this time.

Chairman TOM DAVIS. Madam Secretary, thank you. I will start

the questions. And I know you are pleased to be here, and we are

happy to have you here, but we appreciate your proactivity in this

area and your leadership. I have a few questions.

How many cattle have been tested as of today under USDA’s expanded BSE surveillance system?

Secretary VENEMAN. Since June 1, just over 17,000.

Chairman TOM DAVIS. Now, does this put us on track with the

number you hope to test by the end of the 12 to 18 months?

Secretary VENEMAN. Keith Collins, our Chief Economist, has

done some tracking, and at the current rate we would anticipate

we could collect the 268,500 samples in the 18-month period. However, if you look at the numbers, we have continued to increase the

number of samples collected each week. Therefore, the ramping up

of the program is continuing. We are still in the early weeks of the

program. So we would anticipate that clearly we can stay at least

on the 18-month schedule, and perhaps conclude even earlier than

that.

Chairman TOM DAVIS. There have been some concerns, given the

voluntary nature of the surveillance plan, that you might not be

able to meet the goal. But you are seeing basically an upward

trend at this point and strong voluntary compliance?

Secretary VENEMAN. I would say that our early data is extremely

encouraging. When you think about the fact that we have collected

over 17,000 samples since June 1, and in the last 2 years we have

taken 20,000 samples in the entire year, I think this shows that

we have been able to implement a program very quickly, efficiently,

because we are seeing that the samples are coming in from the

whole range of sampled selection sites that I identified in my testimony: from farms, from rendering plants, from diagnostic laboratories; the whole range we are getting samples in. So I must say

we are very pleased with the preliminary numbers we have seen

in terms of the samples that are coming in. We will continue to review those numbers and to evaluate to make sure that we are staying on track.

Chairman TOM DAVIS. Do you think the food supply and the food

chain are far safer today, as a result of what we have implemented

here, than say a year ago?

Secretary VENEMAN. I think that is a fair statement, absolutely,

because, as I mentioned in my testimony, when you remove the

specified risk materials from the food supply, as the chairman of

the International Committee said to me, that is the most important

thing that you do to protect public health. So I do believe that the

food supply is safer today.

Chairman TOM DAVIS. Now, the Inspector General has recommended in their draft audit report a number of things; they

have a number of recommendations. You have noted that they

28

merit attention. Are you planning on implementing any of these, or

have you made a decision yet as to which ones you may or may

not? Can you share any of those with the committee?

Secretary VENEMAN. As I indicated, I think that the Inspector

General has made a very good set of recommendations with regard

to where we need to place attention. There are things that we have

already implemented that they recognized as issues. For example,

in the discussion about whether or not we have tested CNS animals, we put into place a policy that says we will test all CNS animals and all ante-mortem condemned animals, taking some of the

subjectivity out of the system that the IG recognized as a problem

and that we recognized as a problem, and thereby putting clear

guidelines for those veterinarians who are out in the field as to

what will be tested and what won’t be tested.

We have also, I think, made tremendous strides in another area

of weakness, and that is that our Animal and Plant Health Inspection folks were not working closely enough with our Food Safety inspection people. We are now doing joint trainings, joint conference

calls, joint memoranda from the two administrators. It is very critical that our two agencies work closely together in this BSE surveillance program, and I think we are on track to do that.

As I indicated, we think that many of the OIG’s recommendations also relate to the importance of measuring performance. We

believe that is very important. As I indicated in my remarks, the

Agricultural Marketing Service is assisting the Animal and Plant

Health Inspection Service in reviewing the plan, the implementation, the review of the various aspects, and we are working alongside the OIG as we do that in the hope that we can be partners

in that review of how we measure the performance and the effectiveness of this plan.

Chairman TOM DAVIS. Thank you very much. My time is up.

Mr. Waxman.

Mr. WAXMAN. Thank you very much, Mr. Chairman.

Secretary Veneman, I am pleased that you are here. Assuring

the public about the safety of the food supply is a complicated matter; it involves a lot of details. But let me raise the big picture to

you, and that is the question of credibility. It is important that the

job that is being done by this Government is credible to people,

both here in the United States and abroad. Now, there have been

some warning signs that have recently come up about the administration’s efforts on mad cow disease. Six months after promising to

take important steps to protect the cattle feed, FDA retreated.

USDA also had to admit in court that we let in millions of pounds

of meat from Canada that it shouldn’t have.

But today we are hearing, and we are going to hear later from

the Inspector General about a draft report on your new surveillance program. The Inspector General found many serious flaws

across a range of issues: from the plan’s design, to its implementation, from what the plan assumes, to how the plan is portrayed to

the American public. And I want to explore some of those matters

with you.

One of the specific issues discussed by the Inspector General

speaks directly to the Department’s priorities and credibility. When

USDA announced its new surveillance plan, the Department told

29

the American public it would be able to detect one cow with mad

cow disease among 10 million cattle. This means that if there are

just five affected cows in the entire country, your testing program

will catch at least one of them. That is an impressive and reassuring claim, and one we want to make sure is going to be accurate.

One of the assumptions behind all of this is that mad cow disease is contemplated to be confirmed in high-risk target groups,

and not present in all the healthy-appearing cattle. But this assumption has been called into question by many scientists. Today

the Inspector General, as well as Professor George Gray of the Harvard Center for Risk Analysis, Dr. Peter Lurie, of Public Citizen’s

Health Research Group, have submitted testimony indicating that

in fact BSE can be found in cattle that appear to be healthy.

So what I want to ask you is your response to this challenge of

the assumption that we only need to look at downer cows and highrisk cows, and not the otherwise healthy appearing cows, in order

to detect every case of mad cow disease.

Secretary VENEMAN. Thank you, Mr. Waxman, for your question.

First let me say that as we have dealt with this issue over the past

6 months, we have done everything that we can to give as much

information as possible to the public. I think we tried to do that

from December 23 on, and to maintain our credibility. Certainly, as

you go forward, you have instances where you look at things in

greater detail, but we have tried to give the best available information that we have at the time.

Now, with regard to your questions, let me just say a bit about

how we have designed this program, and then I may ask the gentlemen on either side of me to comment as well.

Mr. WAXMAN. Secretary Veneman, I want to go into a lot of the

details of the surveillance program, but in the 5 minutes I have,

the first question I would like you to answer is whether you are

still working on the assumption that the target group of high-risk

cows are the only ones that need to be tested, not those cows that

appear to be healthy.

Secretary VENEMAN. I was about to answer that question. We

have targeted high-risk animals because we know from virtually all

of the science that is available that high-risk animals are the ones

in which we are most likely to find the disease. But we also said

in the plan that we released in March that we would test a group,

we said 20,000, of normal appearing animals over 30 months, in

other words, normal older animals, so that you would get a sampling or a group of tests that would be targeted at the normally appearing populations, as you say.

But I think it is very important to recognize that it is most likely

that we will have the disease in the high-risk populations, and that

is exactly what we have tried to target. It is what we call a biased

sample, biased to the highest risk animals.

Mr. WAXMAN. Just in conclusion, do you still think you can catch

1 cow in 10 million that might have mad cow disease? Can you

achieve that goal in the system that you have put in place?

Secretary VENEMAN. I am not a statistical expert. I might have

Dr. Collins just comment briefly on that statistical——

Mr. COLLINS. I would be happy to, Madam Secretary.

30

Mr. Waxman, that assumption that you are referring to is one

of a number of assumptions the statisticians made in designing the

sampling plan. First of all, most importantly, that we wanted to get

a random representative sample; and questions have been raised

about that the Secretary just responded to, such as the voluntary

nature of the program. Second, we made an assumption about the

prevalence of BSE in the high-risk or target population, and an assumption about the prevalence in the rest of the population. Where

do those assumptions come from? If you look at the history of the

United States, with the program that began in 1989, with a testing

program that began in 1990, with risk assessments in the mid–

1990’s, with the Harvard risk assessment in 2001 and in 2003, all

of that analysis indicated that the possibility of infectivity in the

United States was very, very low. That is in the target population.

But in the rest of the population it is extremely low.

So what APHIS did in designing this program was develop a

sample where they could detect as few as five positive animals in

the target population. If there are five positive animals in the target population, there is a very low number in the rest of the normal population; they assumed zero. It is an assumption. It is a

working assumption to get the data collection started; it is not our

estimate of the prevalence of BSE in the United States. That is the

purpose of the testing program. We are going to establish the prevalence as the testing program completes and is done.

Now, the point you raised, some people have said, OK, your analytical assumption may not be the best possible. There are questions raised about the appropriateness, I would say, of the analytical assumption. You mentioned Dr. Gray, and others have raised

it as well. We respect that. The IG has raised that issue and we

have agreed with the IG that we are going to look at this issue.

Analytically, scientifically, it is an unsettled issue because you are

talking about assumptions. So how do you determine the relationship between infectivity in the high-risk population and in the normal population? How do you do that?

Mr. WAXMAN. If your assumptions are wrong, however——

Chairman TOM DAVIS. Mr. Waxman, your time has expired.

Mr. WAXMAN [continuing]. The program is not going to be as effective as it needs to be to give people the assurance that they

need.

Chairman TOM DAVIS. Henry, I let you have a couple extra minutes. We have to move on; we have a lot of Members who have

questions.

Mr. Goodlatte.

Chairman GOODLATTE. Madam Secretary, welcome. I am delighted to have you, as well as Dr. DeHaven and Dr. Collins, with

us today to answer questions about this important issue.

As I said in my opening statement, and as you said in your statement, this is a very important issue, but also one in terms of assuring the public of the safety of the beef supply in the country, one

where the testing issue is one of indicating where there might be

problems to address. And the Department has been very proactive,

both before and after the finding of the one cow in Washington

State, which I would hasten to note was born in Canada and born

before the very significant changes in our feed rules were made

31

several years ago; nonetheless, very proactive in making sure that

additional changes and careful review of the policy has been made

to make those changes.

I wonder if you might respond to some of the criticism that the

announcement of the BSE-positive cow in December was not entirely transparent. I remember the conversations that we had, and

I remember seeing you all over America’s television networks talking about this issue and making sure that the public was aware of

the fact that this had been discovered, and what steps the Department was taking to address it. But I wonder if you might address

the criticism that the disclosures of the recent inconclusive results

needlessly roiled the commodity markets. I don’t find that to have

been the case, and I wonder if you could outline the Department’s

thinking on how it discloses the information that it discloses.

Secretary VENEMAN. Thank you very much, Mr. Goodlatte, for

the questions. First, as I indicated earlier in response to Mr. Waxman’s question, we tried very hard to get the information out as

quickly as possible, with as much information as we knew and as

it became available in the early days of the discovery of BSE. On

December 23 we had a press announcement the very afternoon that

we found out about the BSE-positive find. We tried to give as much

information as we knew to the public without unnecessarily scaring

people, but also to let people know that we did indeed have a case

of BSE in this country. We followed that up every day with a technical briefing by Dr. DeHaven, a representative of the FDA and a

representative of the Food Safety Inspection Service, so that people

would have the needed technical expertise available to them and

get updates on what was happening.

As we implemented the program for the new testing, we are

using what are called rapid tests.

Chairman GOODLATTE. Let me ask you an additional question as

part of the rapid tests. It is my understanding that the rapid test

kit manufacturer recommends running tests in duplicate to avoid

misreporting of false positives, of which we have now had two that

I am aware of. Likewise, we are informed that BSE testing protocols in Europe include similar safeguards. And I wonder if that option has been evaluated by APHIS as a part of your analysis of how

to proceed.

Secretary VENEMAN. Let me just respond to that question first.

It was determined by the scientists at APHIS that as we initially

began using this test, we ought to determine that an inconclusive

was one that was obtained after one test. As you indicate, the recommended means by which this test should be used is you repeat

the test before you determine it to be an inconclusive. But because

this was a new program, APHIS made the determination that they

should deem an inconclusive to be an inconclusive after one test.

That being said, the sample is then immediately sent to the laboratory in Ames, IA for further testing using what is called the ‘‘gold

standard.’’

Now, with regard to announcing these inconclusives we had several discussions about how and whether or not we should release

information about inconclusive. The determining factor in our discussion was the potential market impact of an inconclusive result

pending and being——

32

Chairman GOODLATTE. Madam Secretary, my time is about to expire. Let me ask one more question, then you can respond to that

and finish that one as well. I am going to try to stay within the

rules here.

In ruling against APHIS’s October 2003 and April 2004 revisions

to the list of eligible low-risk Canadian meat products, the judge

challenged the agency’s risk assessment. Regardless of the process

errors that you have already acknowledged, would importation of

products listed in the October or April revisions significantly increase risk to human or animal health?

Secretary VENEMAN. No. The products were all products from approved products and all had valid permits.

But if I might just say, about the inconclusive, we did decide to

announce those inconclusives based upon the potential market impact, if it were to leak out during that 4- to 7-day period that it

takes to retest with the gold standard test, that would have a significant market impact, and it was determined, particularly after

consultations with the CFTC, that the policy we implemented was

the appropriate one.

Chairman GOODLATTE. But you will continue to evaluate whether

or not two tests would eliminate many of the false positives and

possibly review that in the future?

Secretary VENEMAN. Yes. I think that will be something we continue to evaluate, but in the initial stages the determination was

made that we should, after one test, determine whether or not

there was an inconclusive. But we will continue to re-evaluate that.

Chairman GOODLATTE. Thank you, Madam Secretary.

It is now my pleasure to recognize the ranking member of the

Agriculture Committee, the gentleman from Texas, Mr. Stenholm.

Mr. STENHOLM. Thank you, Mr. Chairman. I want to pursue the

last questioning just a little further, because many have raised concerns about the number of false positives that may result from the

current rapid testing.

Would you or one of your staff please explain how the decision

has been made to employ this particular test and share, in your

opinion, why you believe this test has been selected over any other

test, particularly over any other test that might have a lower potential rate of false positives?

Secretary VENEMAN. I am going to ask Dr. DeHaven to answer

this question, but I will say that it has been our scientists in the

Animal and Plant Health Inspection Service that have made the

determinations about the tests.

Dr. DEHAVEN. Thank you, Madam Secretary.

I would start by pointing out that, in fact, we have run, as the

Secretary indicated, just over 17,000 samples so far and have had

two inconclusives thus far. That would suggest, even with laboratories that are somewhat inexperienced in running those samples,

that we have a very low false positive rate, recognizing, again, that

we are taking every action that we possibly can to mitigate the disruption to the markets.

At the time that we were ramping up for this surveillance program in May, at the time we had one test that was not only licensed, but also was or was very close to completing the field validation process. It is one thing to license or permit a test; it is anVerDate 11-SEP-98 11:01 Dec 16, 2004 Jkt 000000 PO 00000 Frm 00038 Fmt 6633 Sfmt 6633 F:\DOCS\10839.DOC HAGRI PsN: HAGRI
33

other to field validate it, where we are testing samples as we would

be testing field samples in an actual program. So it was the Biorad

test that we had the most experience with that had been or was

very close to being field validated.

We have, in the meantime, licensed or permitted four other tests.

We are, on an expedited basis, going through the field validation

process for those other tests so that at the end of the day we would

one, feel comfortable with any of those tests that might be used

and two, that there would be an opportunity for a fair competition

among those competitions for the testing market.

Mr. STENHOLM. Have any of these tests been field tested in Europe or other areas where they have had a greater incidence of

BSE?

Dr. DEHAVEN. Indeed, some of those tests have been used and

used extensively in Europe, to include the Biorad test that we are

currently using. We do have, not just for BSE tests, but for all of

the tests that would be used in animal disease eradication and control programs, a process where we license and then validate those

programs. So while some of these tests may in fact have been used

in Europe and elsewhere, we still go through the validation process, that quality assurance process within our own country and our

own programs.

Mr. STENHOLM. Madam Secretary, as we heard in your testimony

and we will hear in other testimonies later today, the single most

important aspect of protecting the human food supply from BSE

contamination is the removal of specified risk materials [SRMs].

Furthermore, Dr. Peter Lurie will later testify that the removal of

non-ambulatory cattle from the human food chain will not greatly

reduce the risk to humans. Having said that, is USDA reconsidering its across-the-board ban on non-ambulatory cattle? And in answering this question, with the ban on downer cattle from entering

the food chain in place, it became inherently obvious that on-farm

testing and surveillance would have to drastically improve in order

to reach these animals in the high-risk population. How many onfarm tests have you conducted thus far? And are you finding adequate cooperation to conduct on-farm surveillance?

Secretary VENEMAN. Thank you, Mr. Stenholm, for that. First of

all on the ban on downers or non-ambulatory disabled cattle that

we announced on December 30 and it was put into place with our

interim final regulation on January 12, that regulation is still in

interim final form, which means we have received comments on

that rule, and we are still reviewing those comments. I can tell you

that my agencies have told me that there were many comments received on the rule and many of those comments received were on

the issue of banning downer cattle.

With regard to the populations that we are testing, we are finding, just in our very preliminary results, which we have analyzed

in a preliminary way from the month of June, we have found that

we have obtained a significant number of samples from on-farm.

But one of the most significant things we have found is that about

nearly 69.7 percent or something like that of the samples obtained

have been from already dead animals. In other words, that would

indicate that these are on-farm animals going to rendering plants,

going to what we call 3D/4D plants, and already dead animals

34

would be the ones coming from the farms. So we believe, with this

70 percent of the samples obtained number, that we are in fact

doing very well with regard to dead animals from farms.

Chairman TOM DAVIS. Thank you very much.

Mr. Putnam.

Mr. PUTNAM. Thank you, Mr. Chairman. I just want to say, as

a cattleman as much as a Congressman in the cow calf business

in central Florida, that this disease had the potential to decimate

an entire industry, and it didn’t. In fact, the demand for beef is still

extraordinarily strong in this country; people stand in line for 2

hours to eat a steak. They won’t wait in a drive-thru for 5 minutes

to eat a chicken. The Atkins Diet obviously has had a positive influence on that, but at the end of the day this was an outbreak that

could have totally undermined not just an industry in agriculture,

but undermined all public confidence in Government and Government’s ability to deal with crises; and it did not.

And I think that is a credit to this Secretary and her Department

in the way that they actually responded to the outbreak; in the

way that they communicated their response to the public, to the

consumers, and to the press; and, frankly, it reflects very well on

generations of sound management in the Department and in Government that builds up that public confidence over time. Americans’ public confidence in their food safety system is tremendously

greater than it is in Europe, and it is a reflection of the professional science-based approach and open communications that this

Department has heralded.

And I think that all of us can Monday morning quarterback and

look for ways to improve on the next outbreak, and that is an important exercise to go through, but at the end of the day it is also

important to give credit where credit is due, and the due credit is

borne out in the fact that there is still a high level of confidence.

Beef prices are still at an above average, not necessarily an alltime high, but certainly higher than average rate, and good return

for the growers and good value for the consumer.

I just want to give the Secretary an opportunity to comment on

the decision about the Creekstone slaughterhouse and give us some

explanation of the basis for the decision not to test, and give you

an opportunity to respond to that. So I will begin with that.

Secretary VENEMAN. Thank you, Mr. Putnam, and I appreciate

your words of support for the actions of our people at the Department of Agriculture.

The Creekstone situation was one in which the slaughter company came to USDA and wanted to test all animals with BSE tests

to basically use as an assurance on food safety. And I think the

first thing that is important to recognize is that these tests will detect a BSE-infected animal only about 6 months or less from the

time that animal would show clinical signs. So from a food safety

perspective in testing younger animals, it would not give any real

food safety assurance.

Second, and I think very importantly, as I indicated in my testimony, the International Review Committee report clearly indicated

that there is no scientific justification for testing every animal. We

have discussed that additionally with the OIE, who agrees with

that, as well as other outside scientific bodies, all of whom say

35

there is not a justification. The only place in the world that this

is being done is in Japan, and it was done in response to an outbreak that was first discovered on September 10, 2001. Subsequently, I think they have had a total of 11 animals. But as a result of their outbreak, they had a strong distrust in their food safety systems and consumer confidence went way down, and Japan,

as a result, implemented a system that would test every animal.

Now, there is nobody that will say that has a scientific justification. They did that as a reassurance to the people of Japan. And

we have been in discussions with Japan to try to reopen the market, and we are hopeful that we will find a way to allow us to continue to ship beef into the Japanese market without testing every

animal, as they require currently under their domestic protocols.

I am not sure if Dr. DeHaven would like to add to that.

Dr. DEHAVEN. Thank you, Madam Secretary. I think you have

done an excellent job of summarizing the situation. I would just

add a couple of comments.

One, the focus on surveillance testing is just that, surveillance,

to determine whether or not we have the disease in this country

and, if so, at what prevalence. Food safety is taken care of, as we

have done through the Secretary’s announcement on December 30,

by removal of specified risk materials. So the purpose of testing is

for surveillance purposes. Because, in fact, it is a disease with an

incubation period of typically 5 years or more, and because the current tests that we have available, as the Secretary indicated, will

not detect an animal that is infected until just a matter of a few

months or weeks before they develop clinical signs and then

progress to death, that in fact there is no food safety value. We

would, for the most part, be testing animals under 24 months of

age, when this is a disease of animals typically 5 years of age or

more, and then again the tests would only test positive, even for

those infected animals, during a very narrow window. So there is

no food safety value, but the act of testing would certainly suggest

or at least imply a food safety value.

The OIE, the world animal health organization, recognizes for

testing that we should focus our efforts, first of all, on animals over

30 months of age for that testing program, and then target that

population, specifically those that are exhibiting CNS signs or

other clinical evidence of disease, such as non-ambulatory animals,

and that is precisely that we are doing. We would gain no surveillance value. In the international arena there would be no value

placed on the animals that we would be testing under the

Creekstone scenario in terms of determining what the prevalence

of the disease is in this country.

Mr. PUTNAM. Thank you, Mr. Chairman.

Chairman TOM DAVIS. Thank you very much.

Mr. Tierney.

Mr. TIERNEY. Thank you, Mr. Chairman.

Madam Secretary, you stated in response to Mr. Waxman’s question that you recognize the assumption that all cows with mad cow

disease will be in the high-risk population may be false. If the experts are right and it is false, doesn’t that mean that the program

may not reach the claimed effectiveness of catching 1 positive cow

in 10 million?

36

Secretary VENEMAN. I am going to ask Dr. Collins, as he discussed this previously, to discuss the statistical issue.

Mr. COLLINS. The short answer is yes, if the assumption is false.

Mr. TIERNEY. Thank you.

Mr. COLLINS. I would say, in response to that, and it is a question that Mr. Waxman asked as well, that we realize that there is

a scientific debate about that assumption, that there is no one single right answer, but that we would like to work with Harvard, we

would like to work with other experts in the field, and over the

coming months provide alternative assumptions, alternative calculations and recharacterize or amplify what we have said at this

point.

Mr. TIERNEY. Thank you.

Mr. COLLINS. And that is also, by the way, one of the recommendations of the draft IG report.

Mr. TIERNEY. Now, coming at this as a New Englander, where

we may not know as much as others may know on this subject, I

know that in January Health and Human Services Secretary

Tommy Thompson and the FDA Commissioner Mark McClellan announced new policies to reduce the chance that cattle are fed to cattle, the primary method of mad cow disease. Now, I know that direct cattle-to-cattle feed has been outlawed already, but from my

information from reading the IG report, the cow parts or the protein pellets are sometimes fed to chickens and some fall to the floor

and they are mixed in with other protein sources or the fecal matter or the feathers, and then circulated somehow back to cows. So

that use of poultry litter has been banned from cattle feed, and you

testified, I think, on January 27, in response to a question that the

ban of poultry litter for cattle feed, you said, I certainly agree with

the ban. It has been one that has certainly got a lot of attention

and a lot of questions have been raised about it. We have been

working closely with FDA on the actions that they have decided to

take and are supportive of those actions. So I assume you support

those policies because keeping cattle from being fed to cattle is critical to controlling mad cow disease. Is that fair to say, Madam Secretary?

Secretary VENEMAN. What we do know about mad cow disease is

that it is clearly spread from ruminant-to-ruminant feeding, that

means cattle-to-cattle feeding. And that has been banned in this

country since 1997.

Mr. TIERNEY. But I am talking here about—and I know it has

been banned, and I think that is obviously an excellent idea. But

we are talking now about poultry litter or other sources of protein,

where it might not come directly, but sort of the back or side door.

Secretary VENEMAN. I was getting to that.

Mr. TIERNEY. I keep saying that because we only have 5 minutes

and I would like to get to the crux of it.

Secretary VENEMAN. What FDA said was that they were going to

take additional actions to strengthen the feed ban. On Friday they

released an Advanced Notice of Proposed Rulemaking to get comments on exactly how that policy could be implemented.

Mr. TIERNEY. Let us be frank. Essentially they pulled back from

banning it, which is what they were originally going to do, and now

they have just said basically we are going to think about it some

37

more and we are going to take comments on it. How do we get to

that point, from a point where first we were going to ban it, and

I think everybody, including you, thought that was a good idea, to

all of a sudden pulling back and now we are just going to think

about it some more and take some more comments? I mean, from

the consumers’ standpoint, that is not a very comforting prospect.

Secretary VENEMAN. As I understand it, there was some re-evaluation of what exactly the FDA would request based upon the recommendations of the International Review Committee report that

came out subsequent to their initial announcement. They then

began to look at that report along with what they had previously

announced, and it was finally decided—again, FDA is not under

the jurisdiction of the U.S. Department of Agriculture——

Mr. TIERNEY. But you thought it was a good idea at one point

in time. You stood up there and said: ‘‘I certainly agree with the

ban.’’ So have you changed your mind, you no longer think the ban

is important?

Secretary VENEMAN. No, I have not changed my mind.

Mr. TIERNEY. OK. So how are consumers supposed to have any

confidence when we go from supportive of a ban to just pulling it

back? It leaves us with a concern are we more interested in protecting the industry or are we more interested in protecting the public

here? Why not implement the ban while you are thinking about

other things that you may want to do? Why not have an interim

protective rule that is reasonable, and you believe it is reasonable

and I think most of us believe it is reasonable, and then take your

comments for further action, instead of just pulling back and leaving it out there?

Secretary VENEMAN. Congressman, it is really not possible for me

to answer on behalf of the Food and Drug Administration, and I

think that question would be more appropriately directed at them.

Mr. TIERNEY. My question to you is do you think it is reasonable

to not put in the ban?

Chairman TOM DAVIS. The time of the gentleman has expired.

The Chair now is pleased to recognize the gentleman from Oklahoma, Mr. Lucas, one of our subcommittee chairmen.

Mr. LUCAS. Thank you, Mr. Chairman. And I am sure we are all

waiting with great anticipation for FDA to formulate their rule to

address the litter question.

But for just a moment let us just step back, Madam Secretary,

to the question about the statistics and how we arrived at the decision about how many animals to test, and, for that matter, whoever

probably on the panel is best prepared to answer that. But could

you give us a little discussion about how we came up with this

number of animals and what the percentage of likelihood of finding

was, and why we arrived and what we hope to accomplish by our

statistical sample?

Mr. COLLINS. Mr. Lucas, yes, I will try. Leading up to the development of the current surveillance plan, APHIS had been using as

a test standard that they were trying to detect, with 99 percent

confidence, to detect as few as 5 infected animals in the target population. That was the old plan. Under the new plan they wanted

to dramatically increase the detection level, so they went to about

one-tenth of the 45 and they said that our goal would be, with 99

38

percent confidence, to detect as few as five infected animals in the

target population. The target population has roughly been estimated at about 446,000 animals.

Now, the total adult cattle population in the United States, that

is, animals over 30 months, has been roughly estimated at 45 million animals. So if you assume all of the infectivity is concentrated

in the target animals, and not in the rest of the adult herd, which

you have just heard from Mr. DeHaven is largely undetectable,

then you would get this detection level that you could find 1 in 10

million.

So the debate here has been about whether that is a valid relationship, to say you would have 5 infected animals in the target

population and none in the rest of the adult animals coming to

slaughter. And the 45 million is not that germane an issue because

they are not presenting a threat to the feed supply or presenting

a threat to the food supply, it is the 6.2 million adult cattle that

come to slaughter every year. So the question is what is the relationship between the assumption of 5 infected in the target population and what might be in the 6.2 million coming to slaughter?

Now, APHIS assumed zero for lots of reasons. It is an analytical

assumption to determine a sampling level. Other folks, Harvard

Center for Risk Analysis, have said, there are alternative ways to

try and come up with a more realistic assumption. One way might

be to look at the European Union experience and look at the relationship between positives in the target population and positives in

the normal adult population. So what do you look at, which country

do you look at? Do you look at all countries? Do you try and find

an analog country that has an experience like ours? It is not clear,

but there is certainly some information there.

Second, Harvard University has a wonderful simulation model

where they can introduce infected feed at one point in the cattle

population and then track out how that might spread into BSE in

the animal population over a long period of time, then take a snapshot and figure out where BSE might be in the distribution of animals. That is another approach. That is a mathematical simulation

model.

These different approaches have arisen over the last several

months as the university community and others have started to

look at the APHIS assumption. So all we have said is we have assumed zero out of the 6.2 million adult cattle coming to market. If

you use the overall average European experience for the year 2002

and just assume that relationship between the infected animals in

the target population and the infected animals in the normal adult

population, you would conclude there might be as many as 2 infected animals in the 6.2 million coming to slaughter. That is just

one possible alternative scenario.

Because of the debate that this assumption has engendered, we

have agreed that we want to look at alternative assumptions, we

want to look at what the analytical experts have to say and see if

we can characterize what the alternative assumptions might mean.

But let me finish with this critical point. All of this discussion

is not germane to our sampling program. Our sampling program

does what the OIE says it should do, what the International Review Team says it should do, what the Harvard Center for Risk

39

Analysis says it should do: it focuses on the high-risk animals. And

regardless of the assumption we make about the infectivity level in

the normal adult populations, it does not change our sampling plan

one iota. It is useful information for one main purpose, and that

is, when all is said and done and we have gone through a whole

year of testing, if we find zero positive BSE animals, then we want

to be able to characterize the prevalence in the national herd, and

that is where that assumption would come into play. If we start

finding positive animals, then it is going to be the actual data that

we collect that we are going to use to establish that distribution.

So it is a very interesting analytical and academic debate, and

it will help inform us as we move forward, but it is not germane

to our sampling program, our attempt to detect BSE in the herd

today.

Chairman TOM DAVIS. The time of the gentleman has expired.

The gentleman from Minnesota, Mr. Peterson.

Mr. PETERSON. I thank the gentleman.

Madam Secretary, welcome, and I want to commend yourself and

your staff for your response to this situation, especially in December. You and I were on the phone, as I know you were with other

Members, and I think you guys really were on the ball and did a

good job. So I commend you for that.

And on the surveillance system, I am not a statistician or an actuary, so I have to assume, Mr. Collins, that what you said is correct, that you are following all the right procedures and hopefully

this will work. I think you have put a lot of time into this, and I

commend you on the effort to try to better get a handle on what

the situation is out there in the countryside.

But I want to use this time to follow up a little bit on the subject

Mr. Stenholm brought up. At a time when we have a wider audience, and maybe we are on C-Span, I don’t know, the American

public understands. I think you did too good a job, Madam Secretary, you went a little further than you should have on this

downer animal situation. And I want folks to understand what this

has done to producers, and I think maybe bring up a potential

problem. But the system we should have, and I thought we had

prior to this happening, was that we should test these animals, and

if they are not positive, that they could go into the meat supply.

That makes sense, and that is the way it ought to be done and that

is the way it should have been done. By banning these animals, a

lot of whom are just injured loading them or whatever, you have

put producers in a real problem, and I have gotten more calls about

this than any other thing that has happened out of this whole situation.

We now have a situation, and I don’t think it has been corrected

yet, where the butcher shops in Minnesota that butcher these animals for farmers and others for their personal consumption are not

butchering the animals because of this situation. So what you have

done is you have made these animals that are perfectly fine worthless. In fact, you have made it a situation where they actually have

to pay money to get rid of them. And what I think is probably happening in some cases is they are just burying these out in the back

40 or putting them in a dump or something. So I think you caused

a problem there.

40

So I think people need to understand that this whole downer animal thing, it sounds good, but I don’t think it is really getting us

any place, and it is putting a tremendous burden on producers.

And folks need to end that, and I will end that editorial with that.

And I hope that we can do something about this rule, and I know

you are considering that, and I hope we can.

The last thing, the question I want to ask is if we do find another

BSE situation in this surveillance program, or, God forbid, that we

get foot and mouth disease in this country, I am concerned about

our ability to trace back and get on top of this. How long did it take

for us to trace back the situation with this cow in Washington

State, before we finally determined where it came from?

Secretary VENEMAN. I think it took about 4 or 5 days. About 3

days.

Mr. PETERSON. Three days.

Secretary VENEMAN. Now, keep in mind—and I appreciate, Congressman Peterson, your personal interest in animal identification,

and we appreciate the fact that we have been able to work with

you as we look to try to implement a reasonable animal identification system in this country. We share the view that this needs to

be done.

What was important about the cow in Washington State is that

because it was a dairy cow, it did have an animal identification

that was pretty easily traceable. I think most of the large dairies

in this country have animal ID systems, which makes that easier

to do.

Now, as you know, we are trying to implement an animal identification system in this country. We are working through APHIS.

Dr. Collins has been involved, our general counsel has been involved, our CIO has been involved, because the technology, the

legal requirements, and how we are going to implement it are all

critical issues. So we have this team that is working with APHIS

to get this implemented. But you are absolutely correct, animal

identification is a priority. It is a priority for us in the Department,

I think it is a priority for certainly you and many other Members

of Congress, and——

Mr. PETERSON. Before my time expires, I just want to say that

I appreciate what you are doing, but I still think we are moving

too slow on this. And if we ever got foot and mouth disease in this

country, in Joplin, MO, for example, where I am told these animals

can be, within 24 hours, on both the west coast and the east coast,

I don’t think we are in a position right now to be able to trace that

stuff back quick enough.

Secretary VENEMAN. If I just might add, you are absolutely right

that the animal ID is most critical for a very contagious, fastspreading disease like foot and mouth.

Chairman TOM DAVIS. Thank you. The gentleman’s time has expired.

Mr. Murphy.

Mr. MURPHY. Thank you, Mr. Chairman, and I thank the panel

for being here.

Let me make sure I understand. In selecting animals for testing,

you randomly select, you do not do the entire population of cattle.

Do you inspect all down cattle; are all of them tested?

41

Dr. DEHAVEN. Congressman Murphy, first of all, let me explain

that our testing program is not designed to be a random sampling,

but, rather, our intent is to test as many animals as we possibly

can in that high-risk population. So it is not a matter of——

Mr. MURPHY. I am trying to get to a certain point here in 5 minutes. I understand the point you are making, and you have scientific reasons for how you do the selection, but all cattle that are

downer cattle, are they all tested?

Dr. DEHAVEN. The downer animals would be in that high-risk

population. We will test as many as we possibly can. Being realistic

about it, however, some of the animals are going to go down, they

would become non-ambulatory on the farm. We may never know

about some of those animals and may never have an opportunity

to test them.

Mr. MURPHY. What I understand from some of the farmers in my

district is if you have a downer cattle, and as long as they are not

going to the food supply, no one has to alert anybody to test them.

Is that true?

Dr. DEHAVEN. There is no requirement to report a non-ambulatory animal.

Mr. MURPHY. OK. So a non-ambulatory cattle may have BSE, but

we wouldn’t know if there is no requirement for any testing to be

done, correct?

Dr. DEHAVEN. And that goes to the statistical issues and the statistical basis for our sampling. Knowing what that overall total

population of high-risk animals is, that would include non-ambulatory, whether we catch every one of them or not, if we can test

enough of them, then we have statistical validity about what we

can say about the prevalence of the disease.

Mr. MURPHY. Do you try and do the testing before they get to

the slaughterhouse?

Dr. DEHAVEN. There is a number of collection sites that would

include animals if they become non-ambulatory at slaughter, on the

farm; some are euthanized and go to renderers.

Mr. MURPHY. Do you do some testing in a collective way of materials, for example, central nervous system materials of cattle, en

masse at a slaughterhouse? For example, if there has been 1,000

cattle there with a sample from each collected and then mix them

together and perform one test, would that be a valid test doing that

sort of assessment?

Dr. DEHAVEN. None of our testing would involve mixing of samples; they are all samples that are collected on the individual animal, identified to that individual animal and tested individually.

Mr. MURPHY. I am just asking in terms of—how much does it

cost per test to do this?

Dr. DEHAVEN. The cost of the test depends on a number of factors. One would be the cost of the actual testing itself, the test kit,

which runs in the neighborhood of $15 to $25. More substantial is

the cost of actually collecting that sample, getting it to the laboratory, and then reporting it.

Mr. MURPHY. I’m looking for the total cost. What is the total

cost?

Dr. DEHAVEN. It will vary depending on where that sample is

collected. It would be substantially less——

42

Mr. MURPHY. Give me a ball park.

Dr. DEHAVEN. I think ball park maximum would be $100.

Mr. MURPHY. OK, $100. What I am just wondering here, because

I know we all share a concern for making sure that as many are

tested. I just know it is done in some areas where you have a collection of specimens that may be mixed together, and, indeed, one

might have that if you are separating out materials in a slaughterhouse, there might be central nervous system materials. I don’t

know enough about the actual testing, if once you have a number

of things mixed, you can go through that and then say, OK, somewhere in this last 1,000 cattle that have been mixed together we

found a positive, and we have to now back-track for that. I am just

trying to think of other mechanisms that might work here in multiple levels in the food chain.

Madam Secretary, you had a comment on that?

Secretary VENEMAN. I think it is important to point out that the

only known means by which we can test for BSE right now is

through this testing from the brain. That is what the tests are sensitive to. So it is not as if you can take a lot of random material

from a slaughter plant and test that.

Mr. MURPHY. Oh, I understand that, but my assumption is that

categories of certain areas of the cow are not all heaped together.

Some categories may appear together. That is what I was just wondering, because I know in other areas of medical testing some of

these things are done as a group, for example, blood testing.

Dr. DEHAVEN. Congressman, we are focusing on animals at

slaughter, and the animals that we would test at slaughter are

going to be identified ante-mortem either because they are exhibiting central nervous system disorder, because they are non-ambulatory, or perhaps they arrived dead.

Mr. MURPHY. Yes, but they could also be asymptomatic and still

have BSE, right?

Dr. DEHAVEN. But those animals that are asymptomatic

wouldn’t be targeted for our testing program. But again, a good

point to emphasize: public health, food safety is assured not by

testing, but by removing specified risk materials from the food

chain any tissues that might be infected. So, again, the purpose of

the testing is for surveillance purposes to determine whether or not

we have the disease and, if so, at what prevalence in the national

herd. Food safety is assured by removal of SRMs.

Mr. MURPHY. I was just asking——

Chairman TOM DAVIS. The gentleman’s time has expired.

Ms. McCollum.

Ms. MCCOLLUM. Thank you, Mr. Chairman.

My questions are somewhat along the same line. And to your

point, Doctor, about the testing is to see if the food that the animals are being given is safe goes back to Representative Tierney’s

question, then why are we delaying the ban?

It is my understanding that the tests are voluntary except for the

Federal tests that are conducted where the Federal inspectors are

at the slaughterhouses. Is that correct?

Dr. DEHAVEN. Yes, ma’am, that is correct, it is a voluntary testing program.

43

Ms. MCCOLLUM. And in Minnesota, when we received the information about going forward with doing the voluntary testing, our

Animal Board of Health found that no money came along with it,

so at their own expense they sent out postcards with a 1–800 number to contact you, and along with that comes the disposal needs

and other higher costs for people who are going to be sample providers. And along the questions that the gentleman just had, have

you attempted to project these costs and determine how establishments will adequately and timely be compensated, when necessary?

Do you have any time when we can expect information like that

for our farmers?

Dr. DEHAVEN. There are several issues. One goes to the voluntary issue of the program, and APHIS has a long history of successful animal disease——

Ms. MCCOLLUM. Sir, I really don’t mean to be rude, but I have

one other question, so I am going to ask it now, because I am

afraid with your answer going into all the history, I might not.

Consumers who buy organically labeled meat products, it is my understanding that if I purchase an organically labeled meat product

today, that the cow might have ingested the brain and won’t have

been BSE tested, in other words; that there is a point—I am not

saying this very smoothly. There is a point at which an organic

label would certify to a consumer that a cow in fact would not have

received any of the products that they eat that would have had the

BSE. What is that cutoff deadline for organically labeled meat?

Dr. DEHAVEN. I would just clarify that what you are suggesting

with regard to what cattle can eat would be true for all cattle. We

have had, since August 1997, a feed ban that prohibits——

Ms. MCCOLLUM. Sir, there is an assumption when people buy

things that are organically labeled, that they have a different

meaning. An organically labeled beef is something that I have

heard consumers say, I can eat that and I don’t have to worry

about anything because it is organically fed. And that is a false assumption at this point in time, is it not?

Dr. DEHAVEN. What is important is that the current ban prohibits the feeding of ruminant proteins to ruminants, regardless of

whether it is an organic feed or not. I am not familiar enough with

the organic standards to know if it addresses specifically what animals could eat. Some animals receive feed supplements that are

typically protein supplements, but what we are saying is—and perhaps are suggesting by feeding organic feed it doesn’t include those

supplements at all. We are saying, through the feed ban, whether

animals are fed protein supplements or not, that protein cannot

have originated from other ruminants, and that is how the disease

transmission is blocked.

Ms. MCCOLLUM. So my question would be more appropriate to

the Food and Drug Administration. Who is in charge of labeling organic?

Secretary VENEMAN. We do, in our Department, oversee the organic program; it is not under Dr. DeHaven’s agency. I think it is

really important to point out that ruminant-to-ruminant feeding of

animals cannot occur in any of the livestock production in this

country, regardless of whether or not it is organic. The organic

rules prohibit any mammalian protein to be fed to animals that are

44

marketed as organic since the organic rules have been implemented, which has been in the last couple of years.

Chairman TOM DAVIS. At this time——

Ms. MCCOLLUM. Mr. Chairman, I know my time has expired, but

if they could provide to the committee the other question that he

didn’t have time to answer.

Chairman TOM DAVIS. All right, see if you can get back to us on

her follow-up question. Thank you very much.

At the conclusion we will hold the record open to give all witnesses an opportunity to respond to questions posed in writing.

At this time it is my pleasure to recognize the gentleman from

Michigan, Mr. Smith.

Mr. SMITH. Thank you, Mr. Chairman. I have been interested in

following the BSE since it was first identified in 1986 in Europe.

Oversight is appropriate, Mr. Chairman; however, there is some

danger to sending some confused signals out to consumers in the

United States. The first one is that if it is a joint committee hearing, there must be some real danger out there.

A lot of words have been said this morning about whether we can

guarantee 100 percent or do a better job of surveillance. I would

like to try to make a couple of comments, maybe getting some of

the hay out of the mow and down on the barn floor, where we can

sort out some of the chaff.

Madam Secretary, in conclusion of my four points, I would like

to see if you agree with my four points.

One, there has never been an animal raised in the United States

that has ever been identified as having BSE. What happened with

the identified animal in Washington a little over 6 months ago was

an animal that was imported from Canada that was subject to eating the kind of bone scraps and slaughter scraps that, as a footnote, have been identified as a way that BSE is transmitted from

one bovine to another. This animal came from Canada. Again, it

was raised at a time before the ban went on in 1997 of using those

particular feed scraps.

Actually, the fact that every time, Madam Secretary, that USDA

decides to announce a suspect is being sent in for further tests,

consumption, because it is sort of a scare point, goes down. So if

there is one question or maybe one suggestion, if you decide it is

the wise thing to do to announce that you are sending in a suspect

animal for a so-called gold test, that you make very clear in that

announcement that this animal has not been identified as BSE.

And I know you would do it with one sentence. I think it needs to

be more aggressive. We are disrupting an industry in the United

States because of the potential of fear.

So, No. 1, an animal has never been raised in the United States

that has ever been identified as having BSE. The one animal that

was identified in Washington actually was imported from Canada

and subject to eating the kind of scraps that have been identified

as the only way that we know of to transmit this disease.

So my suggestion is with all of the words and comments said this

morning, that somehow we need to boil it down to try to tell the

American consumer what the real risk is. And there is a lot of

media coverage. The tendency of that media is to take maybe the

most bold, scary statements.

45

So, your reaction.

Secretary VENEMAN. Thank you, Mr. Smith. I appreciate your

comments. And you are correct that the animal that was found in

Washington State was traced back to originate in Canada. It was

of an age, it was determined, that predated the feed ban. There

was also an animal discovered to have BSE in Canada in May of

last year. That animal was also found to have predated the feed

ban, which hopefully explains how these animals would have potentially gotten the disease. And that feed ban has been in effect

since 1997; it is the means by which current science shows us that

the disease is transmitted from animal to animal. So obviously the

ruminant-to-ruminant feed ban is a key component of our program

here to prevent the spread of BSE in this country; it is probably

the single most important thing in terms of preventing the spread.

Mr. SMITH. But there is one further—excuse me, go ahead.

Secretary VENEMAN. Go ahead.

Mr. SMITH. I was just going to say one further suggestion. I think

we need to refine the downer animal. The tendency is for most

farmers, to maybe limit the inspection of the kind of animals that

might be potential suspects, unless we refine some of the rules on

downer animals.

Secretary VENEMAN. As I indicated before, the downer issue is in

the rulemaking process. It was announced as an interim final rule,

and those comments are now being evaluated.

If I might just say also that in terms of the announcing of the

inconclusives, we have no evidence that has impacted consumption

in the United States. We have seen very strong consumption numbers here in the United States; we have seen some minor market

reaction on the days when those were announced, but there was a

quick bounce back as the facts became known and that they were

deemed to be negative.

Chairman TOM DAVIS. The time of the gentleman has expired.

It is now my pleasure to recognize the gentlewoman from South

Dakota, Ms. Herseth.

Ms. HERSETH. Thank you, Mr. Chairman.

Just to follow up a little bit on the testing and the samples here.

You have talked about how you are targeting the high-risk population, and you just finished describing how the case from Washington was traced back to Canada. Have there been any efforts by

the USDA to take any actions to specifically identify Canadian

born cattle in the United States for this testing program if, as you

have stated, the testing is more for surveillance actually than for

food safety?

Dr. DEHAVEN. In fact, associated with the two investigations, one

involving the Canadian cow found on May 20 in Canada, as well

as the cow found in the State of Washington on December 23, there

have been extensive epidemiological investigations ongoing on both

sides of the border. As part of that investigation, a large number

of animals were sacrificed, all of them tested and all of them tested

negative. So there certainly has been a lot of testing of Canadian

cattle as it relates to those two investigations.

We do indeed import a large number of cattle from Canada. Most

of them or many of them are going to feed lots and then to slaughter; many were, prior to May 20, when we imposed the restrictions,

46

going directly to slaughter. We also know, of course, that there is

a large number of breeding cattle and dairy cattle that have come

into the United States from Canada, and through our surveillance

program, as they have been integrated into the national herd, they

are subject to the same safeguards, firewalls, if you will, as our national herd in terms of subject to the same feed ban, subject to the

same removal of specified risk materials at slaughter, subject to

the same surveillance program.

Ms. HERSETH. OK. Over the past few days I have had a chance

to talk with a number of my constituents in South Dakota who are

producers about the handling of the reporting of the inconclusive

results, and there hasn’t necessarily been a consensus. Some feel

that it has been handled appropriately; others feel that there was

more than a minor effect on the market and they feel that perhaps,

if there is any consensus, it is if these inconclusive findings are

going to be reported, then report all the information. Where were

these two cases that resulted in false positives? Were they samples

taken at rendering facilities that had no chance of entering the

food chain? If we have 4 to 7 days from the initial screening test,

from the rapid test to the more comprehensive scientific-based test,

doesn’t that give us time then to trace that animal back, particularly if it is from a dairy herd, to determine the nation of origin

of that sample?

So I guess there is almost the sense among producers and others

in the cattle industry in South Dakota that either don’t report the

tests until you have the conclusive findings, or if you are going to

report the initial findings that are inconclusive, report more information as it relates to the origin of the animal, as it relates to the

age of the animal, and as it relates to where the sample was collected.

Do you have any thoughts? The Secretary, as you mentioned in

determining the timetable of releasing this information, that one of

the primary rationale was the potential impact on the market

based on the delay before the conclusive test and the potential

leaks that would be involved.

Mr. COLLINS. Perhaps I could start with a comment on the market and then ask Dr. DeHaven if he would amplify on the availability of further information.

This question about dealing with inconclusives, I was sitting here

as I was listening to you, the answer to that is sort of like the answer to the question of when have you stopped beating your

spouse. If we don’t put any information out and it gets leaked into

the marketplace, then we, I think, will be quite criticized for not

providing information to the market, creating uncertainty on the

part of the Government for not providing information. On the other

hand, I think if we provide too much information, we might be getting ahead of ourselves, such as identifying the location of the sample, as you mentioned.

Ms. HERSETH. But wait a minute if I could stop you there for just

a second, because it gets at some of the other questions that were

being asked as it relates to—I think it was Congressman Smith’s

questions about the consumers’ reaction to this, and perhaps there

isn’t any evidence as yet that there has been a reduction in consumer consumption. But if the public doesn’t know in the reporting

47

that the sample was collected at a facility in which the particular

animal being tested had no chance of entering the food supply,

wouldn’t that be somewhat helpful as it relates to minimizing the

market impact?

Mr. COLLINS. Let me just make one comment about the market

impact, and then I will turn it over to Dr. DeHaven to address the

rest of the question.

With regard to the market impact, you mentioned the Secretary’s

characterization of the impact being minor. What happened when

we first released the inconclusive on June 25, the next trading day

was Monday, the 28th, the market went down roughly 3 percent.

The day after that the market went up roughly 1.5 percent. And

then on Wednesday, on June 30, was the next trading day after we

announced the second inconclusive on the night of the 29th. The

market went down again roughly 1.5 to 2.5 percent that day, and

the market was mixed for quite a bit after that.

One of the notable things, I think, about that is the market we

are talking about is the futures market. During that period of time

when the market dropped, if you look at any of the trade commentary on what was happening in cash markets, producers were

not selling their animals; they were sitting, waiting to see if the inconclusive issue would be resolved. So the question of how much

money was lost by producers, the answer to that is not really clear,

the market impact, because we know that trading was very light

on the days after the inconclusive were reported.

Now, with respect to how much information we should be reporting, I will give that easy question to Dr. DeHaven.

Ms. HERSETH. OK. And if I could just make one other comment

on the flip side.

Chairman TOM DAVIS. The gentlelady’s time has expired. We will

let them answer your question, then we need to move on.

Dr. DEHAVEN. Thank you.

Chairman TOM DAVIS. Briefly.

Dr. DEHAVEN. I think it is important, first and foremost, to point

out the fact that by definition these animals are not going into the

human food supply. Whether they are animals with CNS signs,

non-ambulatory, or obviously dead animals, they are not going into

the human food supply. The only potential would be when we ramp

up our testing or normal slaughter animals, and even then we will

have a policy of holding those carcasses pending a negative test.

When we announce these inconclusives, we make it a point to

say that these animals have not entered the human food chain. So

there is no public health issue with regard to those particular animals.

I would also point out that so far, out of 17,000 plus or minus

animals that have been tested, we have only had two inconclusives.

I don’t want to minimize the impact on the markets of reporting

those, but in fact that is not a large number given the number of

animals that we have tested. And Keith does a more thorough job

than I do of explaining that the impact on the market is certainly

minimized by us reporting it as opposed to us trying to minimize

the impact of leaked information.

If we were to report the location of these inconclusive samples,

we think that there are a couple of bad precedents that we would

48

set. First of all, an inconclusive that confirms negative is simply a

negative test, it is no different than any other sample that we test

that turns out to be negative. So we don’t think it is appropriate

to handle those animals any differently, assuming that we get negative confirmatory test results. Second, if we were to report the location of those samples, then we can suggest or guess that producer or that renderer or that slaughter plant, and even the laboratory where the sample was tested, would be subject to a lot of scrutiny by the media and could in fact damage what has been up to

this point excellent cooperation from all of the industries that we

are working with. From the laboratories to the renderers to the

slaughter plants to the producers and several other industries that

I am probably failing to mention, we have had excellent cooperation. We don’t want to do anything by prematurely reporting information that could damage that excellent cooperative relationship

that we currently enjoy with the industries that we are working

with and, in fact, must have if this is going to be a successful program.

Chairman TOM DAVIS. Thank you very much.

Mr. Ose.

Mr. OSE. Thank you, Mr. Chairman. I want to examine a couple

of things, but before I do I want to get in the record some empirical

data. Mr. Chairman, on your leadership, one of the agencies over

which we have oversight is USDA, and one of the issues we have

followed most closely quietly is this issue of BSE in cattle herds.

One of the things we have dug out, which, by the way, for

everybody’s edification, one of the most informative Web sites you

can go to is the one that APHIS puts up under the USDA Web site,

where it actually tracks historically the number of tests that have

been done over the past 10 or 12 years. And if you look at that Web

site, you will find that under the BSE surveillance programs that

have been in place since May 1990, the only true focus that has

been put on this issue has been under Secretary Veneman’s leadership. And I would cite for you the numbers of tests that have actually been done, and I am going to go by year. In 1990 there were

40 tests done. I am talking in the entire herd, 40 tests for BSE

done. 1991, 175; 1992, 251; 1993, 736; 1994, 692; 1995, 744; 1996,

1,143; in 1997, concurrent with the FDA ban on the feedstock,

2,713; then in 1998 it fell to 1,080; in 1999, 1,302; in the year 2000,

2,681.

Now, when Secretary Veneman came into office, 5,272 were done

in 2001; in 2002, 19,990 were done; in 2003, 20,543; in 2004 it

tailed off a little bit, 15,513.

The point of reciting these numbers is to show that for the first

time since the early 1990’s we have in fact got somebody on the job

who is paying attention to this, trying to protect the consumer from

buying beef that is otherwise tainted with BSE.

In addition to that, one of the things that the USDA has done

is instead of relying on a single lab located in Ames, IA, they have

authorized testing to be done by now 12 newly approved labs, 7 of

which have been approved—is it 5 or 7 of which just quite recently?

The USDA has also gone and imposed under an interim rule the

removal of specified risk material, a test and hold policy for any

49

suspect carcasses, they are working on an animal ID system that

will actually be efficient.

I put this in the record for the purpose of showing that contrary

to the efforts of some that the USDA is not on the job, the facts

of the matter say that for the first time since 1992 the USDA is

on the job.

Now, my questions have to do not so much directed toward Secretary Veneman as to ask why the FDA isn’t here testifying today.

Chairman TOM DAVIS. We didn’t ask them to. We just didn’t request that they be here today. We have a full hearing, as you can

see, with three panels, and we couldn’t get everybody here.

Mr. OSE. The reason I ask the question is the only way by which

science has established that this disease is communicable from cow

to cow is by virtue of the feedstocks. Now, it is clear from the evidence, which I would have been happy to share with anybody, it

is a public record, it is on the APHIS Web site, it seems to me that

our challenge is really over at FDA, not at USDA. USDA is actually doing something for the first time in a decade. I mean, this administration actually got out of their chairs and have done something. So we ought to have a hearing about FDA, not about USDA’s

efforts.

Chairman TOM DAVIS. Let me just say to the gentleman we can

do this at a subcommittee level, but it was a joint decision between

the Agriculture Committee and this committee that we focus the

attention on the expanded surveillance system, not on the FDA

regs.

Mr. OSE. I appreciate that, Mr. Chairman. Before I yield back my

time, I just want to make sure that the facts get in the record that

the USDA has, at least on a comparative basis, done upwards of

10 times what the previous administration ever did.

I yield back.

Chairman TOM DAVIS. Thank you.

Mr. Van Hollen.

Mr. VAN HOLLEN. Thank you, Mr. Chairman.

Thank you, Madam Secretary and gentlemen for your testimony.

And I think we all agree that our overall objective is to make sure

that the consumer has justified confidence in our food safety. I am

just trying to get a better idea of exactly how all this works, and

since I only have 5 minutes, if you could give me as brief a response as possible.

My understanding from your testimony is that there is no requirement that anybody report a downer animal. Is that right?

There is no requirement that be reported.

Dr. DEHAVEN. That is correct.

Mr. VAN HOLLEN. OK. And there is no requirement that animal

be tested, is that right?

Dr. DEHAVEN. That is correct.

Mr. VAN HOLLEN. So the testing is a voluntary program entirely.

Dr. DEHAVEN. I would just add one minor correction to what I

said before. There is a requirement to test ante-mortem condemned

animals at slaughter.

Mr. VAN HOLLEN. At slaughter. But there is no requirement to

test, obviously, every downer animal.

Dr. DEHAVEN. There is at slaughter, but not elsewhere.

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Mr. VAN HOLLEN. OK. Elsewhere, not at slaughter, but elsewhere, that is a voluntary requirement.

Dr. DEHAVEN. It is indeed. And our initial numbers would suggest that we are getting very good voluntary cooperation in support

of that program.

Mr. VAN HOLLEN. But, I mean, to the extent that it is voluntary,

it is still not a random sample, isn’t that right?

Dr. DEHAVEN. We arrive at a randomness by ensuring that we

are getting collection of samples from all of the collection sites,

whether they be animals at slaughter, renderers, salvage plants, on

the farm, diagnostic laboratories, and we ensure that we have some

randomness injected by ensuring that we are getting animals in

appropriate numbers from all the different categories of animals

that we want to test: those animals that are exhibiting central

nervous system disorders, those animals that are non-ambulatory,

those animals that are dead. And as Secretary Veneman has testified, we are encouraged by the first month’s results and with the

preliminary information. It would suggest that we are getting that

randomness inserted through good collection at all of the different

sites and of good representation of the different categories of animals that we want to test.

Mr. VAN HOLLEN. All right, let me ask you this. Is there a requirement that a downer animal be tested before it enters the noncattle animal food supply?

Dr. DEHAVEN. No, there is not. And, again, the purpose of surveillance testing is not to ensure that an infected animal doesn’t go

into the feed supply; that is why we have a feed ban in place. The

purpose of the testing is to determine prevalence of a disease.

Mr. VAN HOLLEN. Right. But getting back to Mr. Tierney’s point,

which as of now the FDA has not put into place a ban on the poultry litter issue, I want to just explore the question about whether

or not you could have the disease spread from a downer cattle into

the non-cattle food supply. So my understanding of your testimony

is that there is absolutely no requirement before that animal be

rendered and go into the non-cattle food supply that it be tested,

is that right?

Dr. DEHAVEN. Our goal is to test all non-ambulatory animals. So

to the extent that animals going into the feed supply go to renderers and salvage plants and other locations, in fact they would be

subject to testing. And, as I mentioned, we are getting good voluntary cooperation from the renderers and the salvage plants,

those locations that are producing meat and bone meal for the feed

supply. So in fact I would suggest that we are testing those animals.

Mr. VAN HOLLEN. Those that are tested, there is no requirement,

as I understand it, that you hold the animal, the results, before it

is distributed to the non-cattle food supply before you get the results of the test, is that correct?

Dr. DEHAVEN. It makes good business sense for a renderer not

to put a carcass into the feed supply until there is test results.

Mr. VAN HOLLEN. But there is no requirement that you wait for

the results of the test, is that right?

Dr. DEHAVEN. No requirement, but in fact almost all of the renderers are in fact holding them. Should any of those samples come

51

back positive and the carcass not held, there is a mechanism

through FDA to recall that feed.

Mr. VAN HOLLEN. But wouldn’t it make sense that rather than

having to trace it after the fact, wherever it may have been disseminated, that we wait and hold it until we have the results of

the test? Do you believe that would make sense as a policy?

Dr. DEHAVEN. And, in fact, that is what is happening in the majority of situations.

Chairman TOM DAVIS. The time of the gentleman has expired.

Mr. VAN HOLLEN. But why not make it a requirement?

Chairman GOODLATTE. Thank you. The time of the gentleman

has expired.

The gentleman from Kansas, Mr. Moran, another of our subcommittee chairs, is recognized for 5 minutes.

Mr. MORAN. Mr. Chairman, thank you. I thank Mr. Davis and

the ranking members as well.

Madam Secretary, if beef consumption, which I assume measures

consumer confidence, and a strong cattle market are any indications of your efforts, the Department’s efforts in regard to addressing this issue, by those standards I would like to comment that I

think the USDA has done an exceptional job in your response. We

have weathered this storm much better than I think many anticipated, and I think the USDA’s reaction, involvement, full engagement has a lot to do with that. So I thank you for those efforts.

Release of information about inconclusive tests is a significant

issue, and I would again comment upon Dr. Collins’ comments,

which I think USDA would be in a no-win position on this issue.

If you don’t release information, we will be complaining that there

is inside information and the market is being manipulated; and if

you do release the information, we are going to complain that there

are false positives. I do think that the gentlewoman from South

Dakota raises an interesting point about the amount of information

that could be helpful, and I think that is an issue that the USDA

ought to review.

False positives are important because they do affect the market,

and I think the USDA recognizes that. I remember when you announced your decision in regard to 100 percent testing. One of the

reasons that you were reluctant to support 100 percent testing was

the concern about false positives. So I think that is the issue or an

issue that I would be delighted if USDA continues to monitor, tries

to find ways to improve. And in that regard I would ask you if

there is any significant differences in the tests that are available

to test for BSE, any significant difference in the results as far as

false positives. Is there another test that is likely to have fewer

false positives but provide the same level of confidence in the results?

Secretary VENEMAN. Let me ask Dr. DeHaven to review that, because it is the APHIS scientists, as I indicated before, who are reviewing the various rapid tests, as we call them.

Dr. DEHAVEN. Thank you, Madam Secretary.

Indeed, one of the things that we look at as part of our licensing

and permitting processes for these tests, as well as the field validation, is the potential for false positive results. Again, I would point

to the statistics thus far with somewhere in the neighborhood of

52

17,000 animals that have been sampled and most of them tested

at this point, and so far two inconclusives. If my math is right, that

comes up with a false positive rate so far of 0.012 percent, a very

small percentage.

I don’t have at my disposal presently what the published data

may be with regard to false positives on some of the other tests.

I would just assure you that we would not license or permit a test,

approve it to field validation unless we felt that we were getting

acceptable results. So we do have a very rigorous quality control

process in place that ensures that we are not allowing tests to be

used that don’t have appropriate accuracy and sensitivity.

Mr. MORAN. I assume, Doctor, that you would confirm that you

have and will continue to take every effort possible to reduce the

number of false positives, even if that means a different test, different procedure.

Dr. DEHAVEN. Absolutely.

Mr. MORAN. One of the questions raised about additional information is related to Canadian cattle, and I am interested in knowing if there is any reason to believe that cattle in the United States

that originate from Canada are any more likely to test positive for

BSE than a non-Canadian cow. My question really is are the same

rules and regulations, the same criteria in place in Canada, in the

same timeframe, the same implementation, so that supply from

Canada versus a U.S. born-bred raised cow, that there is no difference?

Secretary VENEMAN. You are exactly right. I think it is important

to point out that Canada did implement the feed ban the same

year, basically the same time the United States did, that we

worked over the years very closely with Canada in terms of all of

the control measures for BSE. We have had very consistent programs. We have continued to work with them very closely as they

had their find on May 20, 2003 and we had our find on December

23, 2003. We continue to have constant dialog at our technical levels to ensure that the regulations are as close as possible in terms

of the actions that are being taken and that we share the science

that we have.

When we made the determination in December to appoint an

international review panel, that was essentially the same panel

that had looked at the Canadian situation. We thought that was

important because they had looked at the North American situation post the May 20 find. So we believe there is a very close correlation in terms of the kinds of actions that have been taken to

protect the North American beef supply between the United States

and Canada.

Chairman TOM DAVIS. The time of the gentleman has expired.

The gentleman from North Dakota, Mr. Pomeroy.

Mr. POMEROY. Madam Secretary, the last time we had a chance

to visit was regarding that May 20 Washington Post story regarding imports allowed in from Canada, at a level contrary to the position that you had earlier announced in what would be allowed.

Specifically, it took litigation against a proposed rule by R-Calf to

bring to the forefront the fact that certain imports and import certificates were allowed by the U.S. Department of Agriculture, contrary to your own stated position. This was acknowledged by you

53

in our meeting and we have a standing request for such information as you might bring us in terms of what are you doing about

it. I thought this really might be a situation where heads would

roll, because literally all of the testing, all of the things we have

been talking about regarding U.S. supply are undercut if you are

allowing imports in from Canada that are contrary to what you

said should be allowed in. What is the status of your follow-up on

the import issue?

Secretary VENEMAN. Congressman, we have, as you know, based

upon the lawsuit that you referenced, entered into an agreement

that goes back to the import permits that were permitted as of the

August announcement. I can let Dr. DeHaven explain this more

completely, but APHIS had made the decision to permit additional

products that were within the range of those products that were

announced in August. Then in April there was a decision made in

APHIS to allow, based upon some discussions with Canada, to

allow bone-in beef. That decision should not have been made. And

so as a result of the court action, all of that was pulled back.

I will tell you that no product entered the United States that did

not have a valid permit. No product entered the United States that

was not consistent with the kinds of product that was permitted

into the United States under the permits. I think there were a

number——

Mr. POMEROY. On that one, Madam Secretary—I am sorry to interrupt, but time is so short. I believe that permits were issued

specifically on items like ground beef or processed beef products,

and this was perhaps coming from plants where otherwise boxed

beef products might have been permitted, but the issue is that inspection was completely impossible. Basically without U.S. inspectors at these Canadian plants, we were just left to their good word,

which is why you didn’t allow that within the range of imports you

initially allowed. And so I am not sure that it is a correct statement that product didn’t come in under permits that were inconsistent with what you had announced would be allowed in.

What I am wondering is because you have within APHIS people

allowing decisions contrary to your decision, what have you done

about making sure that doesn’t happen again?

Secretary VENEMAN. I think that is a fair question. We have indicated with both Under Secretary Hawks, as well as Dr. DeHaven

and all his folks, that these decisions should not have been made,

particularly the bone-in decision, and Dr. DeHaven has ensured me

that he has taken actions to ensure that this type of action would

not happen again.

Mr. POMEROY. What is the status of the pending rule on live cattle imports from Canada?

Secretary VENEMAN. As you know, that rule was initially proposed last fall; it was proposed before we had the find of BSE in

our country. We initially closed the comment rule as scheduled,

then reopened it. Because of the wide range of comments that we

received in response to that rule, it is taking longer than we had

originally anticipated to finalize that rule. It is still in the review

process within USDA, reviewing the comments that came in during

both comment periods, and I can’t, at this point, give you an exact

54

time as to when we might be issuing a rule with regard to the Canadian product.

Mr. POMEROY. It is my own observation that for all of the discussion this morning about the efforts, many of them laudable, by

USDA to improve testing and surveillance of the U.S. product, allowing Canadian imports in would seem to me to undercut consumer confidence in the beef products without a conclusive determination that equivalent steps are made in Canada. In addition, as

we have discussed earlier, I believe that allowing imports in before

we have gained these vital export markets back for our ranchers

does not make good sense. It is up to the United States to gain its

export markets back based on what we have done and it is up to

Canada to gain its export markets back based on what they have

done. If we allow imports before gaining our markets back, it seems

to me that you and the trade representative will have to carry the

burden of not just our case, but making Canada’s case as we try

to win the markets back.

Thank you. I yield back.

Chairman TOM DAVIS. Thank you very much.

Mr. Duncan.

Mr. DUNCAN. Thank you, Mr. Chairman. I apologize, I have been

at other meetings.

Ms. Veneman, maybe you have already discussed this, but I was

a little surprised a while ago when I heard you testifying, you said

there had been—I don’t know as much about this as a lot of people,

as most people here, and I was surprised when you said there had

been 180,000 cases discovered since 1986. That seemed like an awfully big number to me; I didn’t know that there was that much

of it. And what I am wondering about, you mentioned in your testimony all of these things that are being done. All these things we

are doing, is that leading to the discovery of more cases or are we

seeing some progress, are the numbers of cases going down? Were

they much higher in the late 1980’s and early mid–1990’s, and now

they are going down? You may have already discussed that, but I

have had to be in and out.

Secretary VENEMAN. That is exactly the case. Let me just make

a few comments, then I can have Dr. DeHaven, who is the expert,

give you the actual numbers. It is important to recognize that is

180,000 cases worldwide. This includes all of the cases in the U.K.

The U.K., by far, I think has more than 90 percent of the cases

worldwide. So this was a concentrated disease for the most part.

And once it was discovered that ruminant-to-ruminant feeding was

the big issue, you then saw cases peak and begin to come back

down. And so I think that while we can recognize the number of

cases worldwide, the peak certainly was, as you say, during, I

think, the early 1990’s when we saw the most number of cases.

Dr. DEHAVEN. The Secretary is absolutely right. There have been

somewhere in the neighborhood of 187,000 cases worldwide. The

vast majority have been in Europe and, most notably, most of them

have been in the U.K. And that goes to the fact that while the disease may have originated there, they had unknowingly, because we

didn’t know much about the disease at that point, had a widespread problem before it was discovered how widespread and how

the disease was spread. So while they have instituted very effective

55

measures since then, they didn’t know to institute those measures

early on. Many of the measures that they took, of course, that are

now showing reward—and, in fact, the numbers of cases that they

are finding now is dramatically less than what they were finding

back in the mid–1990’s—would suggest that those measures have

been effective; and, of course, we are applying many of those same

measures here in the United States and elsewhere in North America.

So I think the danger is in terms of equating the European experience with the North American experience, and, in fact, they are

very much different; our level of exposure has been much less. We

instituted protective measures simply because we had some of the

benefit of the European experience, but we instituted some of those

safeguards much earlier on in the process, so the level of exposure

in the United States has never been what it was in many of the

European countries. So, obviously, we should have an overall BSE

program tailored to our experience and our situation, as opposed to

the European situation.

Mr. DUNCAN. What percentage of our beef do we import from

other countries, roughly?

Mr. COLLINS. We produce about 25 billion pounds; we import

about 3.5 billion pounds this year. So roughly, what is that, about

10 percent or so?

Mr. DUNCAN. OK. All right, thank you very much, and I certainly

am pleased that you are making such good progress. Thank you.

Chairman TOM DAVIS. Thank you very much.

Mr. Ruppersberger.

Mr. RUPPERSBERGER. Thank you, Mr. Chairman.

Secretary Veneman, one of the major challenges in the surveillance program is reaching cattle at the highest risk of having mad

cow disease and those cattle with signs of central nervous system

damage. Now, some of these animals are condemned at slaughter;

others are killed at the plant and sent to State labs for rabies testing. In both cases, past and current USDA policy is for all such animals to be tested for BSE. Now, the Inspector General found that

because of several operational weaknesses, cattle condemned for

slaughter for CNS symptoms were not always tested, and brain

samples from cattle testing negative or rabies were not always submitted to BSE for testing.

Those weaknesses, by the way, include insufficient monitoring of

slaughter data, the lack of effective coordination, and lack of formalized agreements with non-Federal laboratories engaged in rabies testing. The Inspector General reports that the problems testing high-risk cattle still exist under the expanded program in effect

after June 1 of this year.

Now, this spring, when a single suspect cow was not tested for

mad cow disease in Texas, there were national headlines. But the

Inspector General found that in fiscal year 2004, 17 adult cattle

with central nervous system signs were not tested. Nearly 200 such

cattle have been missed over the last 3 years, and five State laboratories visited by the Inspector General sent only 16 percent of

rabies negative samples for mad cow testing, and one State lab official told the Inspector General that he or she didn’t know it was

possible to send samples for mad cow testing.

56

Now, I have two questions. First, how can you explain USDA’s

failure to date to coordinate the testing of this group of cattle that

is so important for surveillance? And, second, would you be willing

to report a quarterly basis progress in testing these high-risk cattle, including the total number of condemned cattle and the number of those tested for mad cow disease, and the total number of

rabies negative samples and the number of these tested for mad

cow disease?

Secretary VENEMAN. Thank you, Congressman. Let me just say

that with the new surveillance program we are targeting the highest risk cattle, and I think that our initial results that we have

seen for the first month indicate that we are getting a very good

cross-sampling from the various sites, whether it is on-farm,

slaughter plants, renderers, public health labs, veterinary diagnostic labs, salvage plants, or stockyards.

Understanding the issue you talk about with CNS, I think there

are two issues. One is there are a number of cattle that weren’t

tested because they were under the age and simply APHIS did not

test them as the underage CNS cattle. After the incident in Texas

that you talked about, when this was brought to light, the USDA

changed its policy. Both FSIS and APHIS put out a directive saying that all CNS cattle, cattle with CNS signs, would be tested regardless of age. We have taken any discretion out of the system,

any subjectivity. In addition, we announced that all ante-mortem

condemned cattle at slaughter plants, except for veal calves that

don’t show CNS, would also be tested. So we have attempted to

take some of the issues that were raised, both with the Texas situation as well as in the IG report, and address that directly with

these new directives.

I think the other issues that you bring up from the IG report,

we are working very closely on the data issues; we have gotten our

CIO involved. We know that there are still data collection issues

that we need to improve upon, but we are working closely with

both the IG and with the——

Mr. RUPPERSBERGER. How about the issue of the quarterly testing? We all need accountability; we need a system. It is a system

that is in place.

Secretary VENEMAN. I couldn’t agree with you more that we need

accountability. I am not ready to commit today on a quarterly system, but we will report as much as we can on a periodic basis. We

are reporting on our Web site how many cattle are tested every

week, and that is updated on a weekly basis. I am not sure you

were here when I indicated that—as of today, since June 1, we

have tested over 17,000 animals.

Mr. RUPPERSBERGER. What is your concern about the quarterly

testing; it is just too voluminous?

Secretary VENEMAN. No. I mean, it may very well work, I just

simply——

Mr. RUPPERSBERGER. I see my red light is on. The chairman is

going to get me out.

Chairman TOM DAVIS. You can follow up with any questions; we

are going to keep the record open.

Mr. RUPPERSBERGER. That is fine.

57

Chairman GOODLATTE. I am pleased to recognize at this time the

gentleman from Georgia, Mr. Burns.

Mr. BURNS. Thank you, Mr. Chairman. I want to thank both

chairmen for holding the joint hearing; I appreciate the USDA’s response in this.

I want to first join my colleagues in saying thank you to USDA.

I think you have handled this challenge quite well. As a cattle producer, and recognizing the potential threats, we could hardly have

done better, given the challenges in December.

Certainly I want to also say I have some concerns about false

positives. We have discussed that, I think, at length. It certainly

generates market concerns and some volatility. Certainly the solution, I think, is the elimination of false positives. And I am glad

to hear your comments on that will work toward that goal.

I want to focus my question really on one issue, and that is testing versus animal ID and maybe the effectiveness and the efficiency and the efficacy of our testing program as a method of ensuring a healthy and safe beef supply vis-a-vis an animal ID system. Whether we look at testing at slaughter or whether we look

at testing on the farm, targeted population testing, give me your

input on which of these approaches is preferable. Right now there

is certainly a dual track. We are looking at both of these things,

but where are we getting the bang for our buck?

Secretary VENEMAN. Well, I think, Congressman, that these are

two elements of our overall BSE response plan that are critical.

Now, with regard to surveillance, we have had a lot of discussion

of that today. We have substantially increased our surveillance program to test at least 268,500 animals in the high-risk population,

and we are well on track to achieving that goal.

I also announced on December 30 that we would accelerate the

implementation of a national animal identification system. I think

it is important to recognize that an animal identification system is

important for a much broader purpose than just BSE. We really

began looking at the animal identification system, a national system, because of the scare that we had with foot and mouth disease

back in the early days of this administration. Fortunately for the

United States and for our cattle producers, that didn’t come to this

country, but we certainly saw the devastation that was done in Europe as a result of that disease.

One of the key elements in a disease that spreads quickly like

foot and mouth disease is the ability to quickly trace back. Because

that disease spreads so quickly, you have to know where the cattle

have been. It is also important to be able to trace back when you

have a BSE-positive cow, but it is not because the disease is going

to spread if you don’t trace it back immediately. So there are two

different kinds of tracks that you would be using animal ID for.

And so as we encountered the BSE situation, we said we have

been working on this system and it is important, to the overall

ability to monitor and to respond to animal diseases, to have a

strong animal identification system. So we have a program in

place. We are beginning to implement that program. We are working with all aspects of the industry to identify where animals are

already identified, particularly to put together a system where we

58

have a uniform system of premise identification, because you have

to have a way of identifying those premises.

So I would not see these as mutually exclusive programs. We

think they are both necessary components of, in the case of BSE,

our overall response, but in the case of the animal ID, it is an important program with regard to our overall animal disease and surveillance programs generally.

Mr. BURNS. From a resource allocation perspective, can you

share with us percentage of resources allocated to both of these important projects?

Secretary VENEMAN. We have obtained additional money for both

of these projects. We anticipate that for the surveillance program,

that this is a year to 18-month program that depending upon what

we find will determine the resources we need for the future. If we

find no additional cases, I would anticipate that we would scale

back to testing probably fewer animals. If we find additional cases,

we may change our assumptions and have more testing.

On the animal identification, there are some initial costs that we

have included in our budget. In terms of ramping up this program,

I think there will be some ongoing costs, but hopefully it will not

be long-term extensive costs to the U.S. Government.

Mr. BURNS. Thank you, Mr. Chairman. I yield back.

Chairman GOODLATTE. The gentleman from Arkansas, Mr. Ross.

Mr. ROSS. Thank you, Mr. Chairman.

And, Madam Secretary, thank you for joining us here today. As

ranking member of the Livestock and Horticulture Subcommittee

of the full Agriculture Committee, as you know, I have been very

involved in all of this business and policy dealing with BSE in

hearings not only up here, but the hearing we had in Houston as

well.

A few questions. Let me begin by mentioning this to you. In the

July 10 New York Times, there was an article entitled ‘‘U.S. Moving to New Ban for Mad Cow, Officials Say.’’ A Federal official was

quoted as saying that in an effort to eradicate mad cow disease,

they were moving toward a policy to ban the feeding of any farm

animal to other farm animals.

Madam Secretary, is this based on sound science? And to follow

up on that question, is there any hard evidence that prions are

transmittable from beef to other species such as chicken?

Secretary VENEMAN. As far as I know, there is no scientific evidence that I am aware of that would indicate that the disease is

transmissible from ruminant to poultry. I think that the article you

are referring to was referencing the recent announcement of the

Advance Notice of Proposed Rulemaking that was recently issued

by HHS and USDA, specifically requesting comment on a whole series of issues, including additional actions that may be taken with

regard to feed. And as you know, those actions would be proposed

by the Food and Drug Administration under the Department of

Health and Human Services. So I am not familiar with the exact

article you are talking about, but I believe that it would be in reference to the ANPR that was announced on Friday.

Mr. ROSS. I would simply hope that whatever policies are put in

place are based on sound science.

59

Secretary VENEMAN. We absolutely believe that science has to

control what we do with regard to animal disease and prevention

in this country. We try to follow sound scientific principles in the

decisions that we make.

Mr. ROSS. On another issue, export markets are believed to be

the only expandable market in the cattle industry, and, as we

know, they have not reopened for the most part. Currently, the

Animal Plant and Health Inspection Service lists 58 countries, 58

whose borders have been closed to the import of U.S. beef. Many

place blame on the United States’s lack of an animal ID program.

What is your position on the animal ID program? Does USDA still

want to move with a voluntary program or has USDA finally realized to get these markets opened back up it is going to have to be

a mandatory animal ID program?

Secretary VENEMAN. First let me say that I have not heard that

countries are keeping their borders closed because of lack of an animal ID system, but it is——

Mr. ROSS. There are 58 countries, Madam Secretary, so why are

they?

Secretary VENEMAN. It has been the practice of the United States

also when a country gets a case of BSE in its country, that we close

our borders to those countries. Other countries have responded to

us the same way. We have worked very hard to open up our export

markets. We have succeeded in opening up the Mexican market to

about 90 percent of the product they were previously importing. We

have had a series of meetings with the Japanese about reopening

the market; that is our No. 1 export market. We have had discussions with the Koreans.

I might go back just for a moment. With regard to the Japanese,

we are very encouraged by those discussions. We have had technical level discussions for the last 2 months. We will have another

technical discussion later this month, with a policy discussion to

follow in August, and we are hopeful that after that we can come

to some agreement under the terms by which the Japanese market

may be opened.

Likewise, we have had discussions with countries like Korea; I

have had discussions with China; the Philippines has maintained

that market open; some of the Central American countries are

opening their markets back up. So the trade issue with regard to

BSE has been a very important issue for us, and we have worked

very hard.

It was within 4 days after the announcement of the BSE cow in

December that we announced that we were sending a team to

Japan and Korea, which we did between Christmas and New

Years. That is how important we looked at our export markets.

And so we tried to ensure that has been a part of our overall BSE

program as we have moved forward, is to work with our trading

partners to explain to them what we are doing, why we are doing

it, the science behind it, and we are hopeful that we will see additional progress in opening up some of those markets soon.

Mr GOODLATTE. The time of the gentleman has expired.

The gentleman from Minnesota, Mr. Gutknecht, another of our

subcommittee chairs.

Mr. GUTKNECHT. Thank you, Mr. Chairman.

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And I want to thank the distinguished panel, clearly distinguished and very important public servants, Dr. Collins and Dr.

DeHaven. I might just say for the benefit of the Members who are

still here, Dr. DeHaven, about a week after the discovery of the incident in the State of Washington, was kind enough to go on a

radio show with me and talk to 12 radio stations at the same time

in southern Minnesota, and did a wonderful job of explaining the

disease; where it comes from, how it is spread, and what the USDA

was doing. And I think largely, and I attach myself to the remarks

by my colleague from Florida earlier; I think the very prompt response by your Department, Madam Secretary, and basically the

unstopping flow of information from people like Dr. DeHaven I

think really prevented what could have been a catastrophe in the

beef market. So my congratulations to you.

I am going to use my few minutes here in more of a comment

than a question to sort of compare how the USDA deals with these

kinds of things relative to our friends over at the FDA. And I will

be somewhat critical of the FDA because I think Members, both

those who are left here, need to understand the difference in the

safety risk.

And I don’t want to downplay the seriousness of this malady, because it is fatal; it is something we need to take very seriously, but

I think you do have to compare the differences. We know, for example, that in any given year, on average, about 6,000 Americans will

die of getting the wrong prescription drug while being kept in a

hospital here in the United States; 6,000. When you compare that

to the probability—and, in fact, I think there was a Washington

man who a couple of weeks ago said—and I am neither a statistician or particularly good in math, but I am told that there was a

man here in Washington who said recently that the likelihood of

an American getting BSE or mad cow disease is about the same as

being struck by a bolt of lightening while you are holding the winning Powerball ticket. And I think this hearing is important and

I think all of the work that you are doing at USDA is important,

but I think it is also important for us to put this in context. Because of the efforts not only of the USDA, but of the producers

themselves, I think we all believe, and I certainly am a very strong

believer, that the food supply here in the United States is very

safe, and the beef supply is the safest in the world. So I think we

need to put that into perspective, that while this hearing is important, what the USDA is doing is important, when you compare it

to the safety of virtually everything else that we put into our

mouths, it may well be that beef today is the absolute safest thing.

And I will just end parenthetically with one last comment, and

that is, frankly, you are much safer taking drugs imported from

Canada than you are just about anything else as well. So I will

continue to badger the good people over at the FDA.

With that I yield back the balance of my time.

Chairman GOODLATTE. I thank the gentleman.

The gentleman from North Carolina, Mr. Hayes, also a subcommittee chairman, is recognized.

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Mr. HAYES. Thank you, Mr. Chairman. I would like to submit my

opening statement for the record, if I might, and move on.

Chairman GOODLATTE. Without objection.

Mr. HAYES. Thank you.

[The prepared statement of Hon. Robin Hayes follows:]

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Mr. HAYES. Madam Secretary, thank you very much for being

here today, and your folks being with you. I think it is very obvious

that you all are aggressively working to deal with the issue of BSE,

and I think the fact that the IG is here is very appropriate. Questions which is her purview have been raised and you all have clearly answered them, and we appreciate that. I also appreciate the

way that you have been working with our trading partners, Japan

and others, to make sure, of course, food safety is first, but, above

that, to make sure that the markets are properly dealt with as it

relates to this, and we appreciate that as well.

I would like to identify myself with Mr. Putnam’s remarks, trying to eat at a steakhouse, and I am not going to tell you where

it is because you can’t get in anymore. It used to be you would call

for a reservation; now you call and tell them you want to come, and

they will call you back if and when you can come. So that is a very

clear indication that you all are doing a good job on the market

issue. And Mr. Ose’s raising the points of how you have aggressively pushed that forward is very important.

Thursday, July 22, at 10 a.m., we will be holding an animal ID

hearing to pick up on the issues that have been raised here today.

That is another important part of the puzzle, and we want to move

forward making sure that the industry controls that and we take

care of confidentiality, so on and so forth.

My question for you—you have answered most everything

today—is on the issue of animals on the farm, the new program

collecting on-farm samples, can you talk a little bit about it and explain what the USDA is doing to encourage producers to contact

you when they have animals that need to be tested? And the samples taken since June 1, when your program began, what percentage of these samples have come from the farm?

Secretary VENEMAN. Thank you for that question. I think it has

been a question that has been raised several times. As I indicated

earlier, we do have preliminary data, and I think the data is encouraging. First of all, what we are doing to collect from farms, we

are conducting an outreach program to reach as many producers as

we possibly can to tell them of the importance of giving the samples to us so that we can determine the prevalence of this disease.

One of the heartening things is that the gentleman whose dairy the

BSE cow was discovered on in Washington has agreed to do a public service announcement for us, telling other producers how important it is. And I think that is a very important thing that has happened in terms of our outreach; it will help tell other producers

from a personal point of view. So we are working to get as much

outreach with producers, with large animal veterinarians, with

State veterinarians, State diagnostic laboratories that deal with

producers, and to get the message out in every way that we can.

I would say that from the initial numbers that we have, that we

are getting a good representation from on-farm. The number that

has been tested on-farm, the percentage that has been tested onfarm—again, these are preliminary numbers from June—is about

7.4 percent. But that does not really indicate the number of samples we are getting from farms because many of the samples that

we are getting from rendering plants, which is about 30 percent,

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those that we are getting from salvage plants, which is about 40

percent of all samples, also come from on-farm.

My understanding from my experts is that one of the most telling

things about the samples that we are getting from on-farm is the

fact that about 70 percent of the samples we have gotten in the

first month are animals that are being presented for sampling that

are already dead. That would be an indication that most of those

are coming from on-farm. So we believe, and the experts in my Department believe that we have had a very good indication in the

first month that the kinds of samples that we are getting are exactly the kind that we are targeting, those high-risk samples, and

particularly those that are coming from farms.

Mr. HAYES. Thank you, ma’am. In addition to the hearing on the

22nd, we will be having a trade show here showing different types

of ways to track animal ID, again to encourage our producers and

ranchers to use the best and most efficient way possible.

Mr. Chairman, thank you. I yield back.

Chairman GOODLATTE. I thank the gentleman.

It is now my pleasure to recognize the gentleman from Texas,

Mr. Neugebauer.

Mr. NEUGEBAUER. Thank you, Mr. Chairman.

First of all, Madam Secretary, I want to thank you for the fact

that all through this process you have let science lead us through

this, and not politics, and I think that is very refreshing, quite honestly, in Government. I think many times when we have issues

come up in this country, we let the politics drive it, not the science.

So I commend you for letting the science drive this issue.

I have a question first for Dr. DeHaven. Are you sampling behind

the rapid test to ensure that the rapid tests are producing the appropriate results? In other words, for a kind of reliability check.

Dr. DEHAVEN. We are certainly doing that in a number of ways.

Let me clarify. First of all, we want to make sure that the 12 laboratories that we have approved to do this testing are doing a good

job, so we have a proficiency testing system where they would be

provided known samples, samples with known results, and then

having those 12 laboratories run those samples and comparing the

results. So we have a quality control system that will be in place

for those laboratories. A certain number of the samples that are

being tested at those laboratories have repeat tests at NVSL, our

national reference laboratory. So we think that we have a good

quality control system in place.

Mr. NEUGEBAUER. Thank you.

Madam Secretary, when it comes to SRM, I visited a packing

plant not too long ago, in fact, it was my second visit there, and

we were talking to some of the folks that work in those plants, and

obviously initially the policy was to go out and really identify anything that might be at-risk material. But what I think some of

them are saying is there some science that would indicate that

some of the material that is currently banned could be used in the

future. Kind of give me a feel, again talking about that concept of

letting the science lead the train here, where you are as far as reviewing SRM policy and where we see that going forward.

Secretary VENEMAN. Congressman, when we implemented the

SRM ban, which was part of the December 30 announcement and

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the January 12 Federal Register notice interim final rule, we

looked at international standards, we looked at what other countries were doing, we looked at the best available science in determining what we should include as a specified risk material. All indications are, I think by the International Review Team that

looked at the actions we had taken, is that we made the appropriate decisions with regard to SRM. All of these decisions we are

constantly looking at, primarily because in the scheme of things,

BSE is still a relatively new disease and there is a lot of science

that we don’t know. So we have to continually review the science

as we know it to make sure the actions that we are taking are appropriate with what is currently known about the science.

Mr. NEUGEBAUER. I know that we have talked about the downer

issue, but I do want to encourage you to, as you move forward, to

give producers as many options as they can for animals that would

fall under the downer category, but truly in fact have marketability

in the marketplace, and not just salvage. I think that is important

to our producers, and particularly to our smaller producers. To a

large producer, maybe that is not as big an economic blow, but to

some of our smaller producers losing an animal here or losing an

animal there that, for whatever reason, fall in that category causes

some economic problems for them.

You touched briefly on Japan, and I know that the Japanese

were in Colorado, I believe, with you last week or have been there

a couple of weeks. You said you were encouraged. We are kind of

going through a two or three step process. Could you just elaborate

briefly on that and what kind of timeline you think we might be

on with the Japanese?

Secretary VENEMAN. As I indicated, we first started meeting with

the Japanese within the first week after BSE was discovered in

this country, because it is our most important beef export market.

This has been a difficult discussion with the Japanese primarily because they had an outbreak just 2 years ago of BSE in their own

country, and they have had to deal with a huge drop in consumer

confidence in their country, something we didn’t experience, as you

know, in our own country.

We had several sets of meetings, we had the Japanese here, and

it was clear that we weren’t making progress, and so we worked

with an interagency process within the Japanese Government and

set up a series of technical meetings where a number of issues

would be discussed, and the first one of those was held in Japan

in May, was followed by this meeting you reference in Colorado in

June, followed by another one scheduled for Japan in July. That

will be followed then by a policy level meeting we believe in August, after which time we are hopeful that the policy meeting will

then come out with some parameters by which we can see some

opening of the Japanese market. Again, I can’t predict exactly what

is going to happen, but I can tell you we have been very engaged

in this process, very engaged with discussions with the Japanese,

working closely with them throughout this process, and we are

hopeful that we will see an opening of the Japanese market in the

near future.

Mr. NEUGEBAUER. Thank you.

Chairman GOODLATTE. The time of the gentleman has expired.

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The gentleman from Nebraska, Mr. Osborne, is recognized for 5

minutes.

Mr OSBORNE. Thank you.

We are winding down here. Appreciate your patience and your

endurance; it has been remarkable. Just an observation and maybe

a question at the same time. I have heard a lot from producers in

my State that are concerned about the possible you-you effect on

the markets if continued suspected positive cases being reported,

and maybe I am observing this, I hope I am, that as time goes on,

maybe the media will kind of back off on reporting, and unless we

actually get a positive case, maybe this will settle down. Do you

hope that this is what is going to happen or do you have any comment on that?

Secretary VENEMAN. I think that, Congressman, you are correct

that this is something that is not a familiar situation for our country, and so as we have introduced this new system of these rapid

tests and announced that because of market impacts we would announce the inconclusives, that would create a fair amount of media

interest. I think that if we in fact get additional inconclusives and

this becomes more routine, that you get an inconclusive and then

you send it to NVSL for testing, that people will understand that

this is the normal part of our surveillance process and it won’t generate quite so much attention. But it is hard to project because we

don’t know how many inconclusives we may get; we don’t know if

we may get additional actual positive animals. That is what this

testing program is really all about, is to measure the prevalence of

BSE that may or may not be in our cattle herd.

And I might say that we are constantly also working with the

CFTC in terms of these kinds of announcements because the market impacts are really what we are watching very closely, and the

CFTC has a very strong interest in that, and so we consult with

them regularly on these issues.

Mr. OSBORNE. Thank you. And I understand why you are reporting, and I think it is probably the right way to go, but we do hear

a lot about it.

One other question that somewhat dovetails with what Mr.

Neugebauer was asking about, and that is Japan. It is my understanding that we are going to maybe ask an independent international agency to examine our testing policy, and if they were in

agreement that we are doing a good job, that maybe this would result in a case before WTO if the borders aren’t open. Is this a

rumor that I have heard that is not correct or what?

Secretary VENEMAN. I am not exactly sure what you are referring

to, but I would say that we have had our surveillance plan, we consulted with the OIE, the world health organization. We had it reviewed before we released it by our International Review Team. We

thought that was a prudent thing to do because they had suggested

this enhanced surveillance plan. And we had it reviewed by our

Harvard Risk Assessment team that has been working with us on

the overall risk assessment for BSE. We continue to work with

international experts from all of these arenas, and I believe we will

continue to do so. I think it is very important to have that kind

of international top-notch oversight into the decisions we are making because all of these programs that we are implementing are

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brand new. We are trying to do the best possible job that we can,

and so we try to get the best expertise from a scientific perspective

that we possibly can.

So we did have some discussions with regard to Japan about

having the OIE look at our respective systems and give some advice, and that was one of the offers that we had on the table.

Mr. OSBORNE. One last thing very quickly. Another thing I hear

about a lot is opening the borders with Canada. Maybe that has

been asked previously, and I know this is related to BSE, but do

you have any comment you can make as to what process is going

to be involved here?

Secretary VENEMAN. Again, this is in the rulemaking process as

we speak. We had a proposed rule that the comment period closed

initially on January 5. We reopened the comment period on that

because of the find of BSE in this country. That comment period

closed in April. And because of the number of comments that we

have received, we are still in the process of evaluating all of those

comments. We received a lot of comments on that rule, and as you

know, you have to review all of the types of comments that you get

when you receive a rule. We are reviewing the risk assessment and

cost benefit analysis and all of those things that come along with

a rulemaking process, so at this point it is impossible for me to

project when we might see that rule completed.

Mr. OSBORNE. Thank you.

And thank you, Mr. Chairman.

Chairman GOODLATTE. I thank the gentleman for his questions.

Madam Secretary, we thank you very much for giving us 3 hours

of your time, and Dr. DeHaven and Dr. Collins too. We know that

in addition to their time here, there is a lot of time to prepare for

something like this, to handle so many diverse questions so much,

and we thank you very much. And I will tell you that, for myself,

I continue to feel that the Department is doing a good job assuring

the country that its efforts continue to make the U.S. food supply

the safest in the world.

Chairman TOM DAVIS. Thank you.

Madam Secretary, let me just say our committee, as you know,

had concerns with the old BSE surveillance system and the lack of

written protocol in place for the discovery of BSE-infected cow, but

APHIS has recently provided the committee with written protocols

for the expanded BSE surveillance program. I am encouraged that

this written guidance is a step in the right direction for the program over the next 18 months. We look forward to continue to

work with you, and you have recorded yourself well. Thank you

very much for your time.

Mr. WAXMAN. Mr. Chairman, if I might also join in thanking the

Secretary for being here today. You have been here to answer a lot

of diverse, different questions over a many-hour period. I did write

you a letter yesterday, and while the letter asked you to be prepared to discuss some of the issues that we raised in it, we really

didn’t have a full opportunity to do that, so I would like a written

response. My major concern, which is yours as well, is that we have

a system that works, but I want it to be credible. And what I don’t

want is a presentation of the issue in a way that cannot be sustained on a scientific basis given the way the whole thing is strucVerDate 11-SEP-98 11:01 Dec 16, 2004 Jkt 000000 PO 00000 Frm 00073 Fmt 6633 Sfmt 6633 F:\DOCS\10839.DOC HAGRI PsN: HAGRI
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tured and the assumptions upon which it is based. So we hope to

continue working with you on this effort.

Chairman TOM DAVIS. Thank you.

The committee will take a 2-minute recess while we bring our

next panel forward.

[Recess.]

Chairman TOM DAVIS. We now move to our next panel. Joining

us on the second panel is the Honorable Phyllis Fong, the Inspector

General for the U.S. Department of Agriculture. Ms. Fong’s testimony will address the Office of Inspector General’s audits of

USDA’s previous surveillance program and its subsequent expanded surveillance plan. Marlane Evans, the Deputy Assistant Inspector General for Audit, and Mark Woods, the Assistant Inspector General for Investigations, accompany Ms. Fong to answer

questions posed by Members.

As you know, it is our policy to swear in witnesses. If you would

rise with me and raise your right hands.

[Witnesses sworn.]

Chairman TOM DAVIS. Thank you very much.

Your entire statement is in the record and, as you know, it and

much else has been released and read by Members, so if you could

keep it to within 5 minutes, we will try to move as quickly as we

can. Thank you very much for being with us.

STATEMENT OF PHYLLIS K. FONG, INSPECTOR GENERAL, U.S.

DEPARTMENT OF AGRICULTURE, ACCOMPANIED BY

MARLANE EVANS, DEPUTY ASSISTANT INSPECTOR GENERAL, AUDIT; AND MARK WOODS, ASSISTANT INSPECTOR

GENERAL, INVESTIGATIONS

Ms. FONG. Thank you very much, Chairman Davis and Chairman Goodlatte, and Ranking Members Waxman and Stenholm, for

the opportunity to testify this morning. As you mentioned, accompanying me today are Mark Woods, who is in charge of our investigations program, and Marlane Evans, who has led the audit review for our office.

The possible presence of BSE in the American herd is a matter

of great concern and interest to all of us because of its potential

impact on animal and human health, food safety, the economy, and

international trade. We recognize that the USDA has significant

responsibilities in this area and a long history of involvement in

animal health and food safety initiatives.

With the discovery of the Canadian BSE-positive cow last year

and the Washington State cow this year, the USDA has faced an

enormous challenge to implement an effective surveillance program

to determine whether and to what degree BSE may be present in

the U.S. herd. This effort has been complicated by the size and the

geographical dispersion of the herd, the short timeframes involved,

and the complexity of the effort involving Federal, State, local, and

private entities.

Our objectives in initiating investigative and audit work have

been very simply to take an impartial look at the program as designed, as well as specific situations that have arisen, to determine

the facts and to make constructive recommendations early in the

process to assist the USDA as it moves forward in implementing

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its program. Our work, by definition, presents a snapshot of the

program at specific points in time. It is not intended to detract

from the Department’s ongoing efforts to continually refine and improve the program. On the contrary, we are encouraged by the

commitment of the Secretary and the Department to address many

of the issues that we have raised.

Much has been accomplished by the USDA since last December.

We have received excellent cooperation from numerous USDA officials and APHIS and FSIS staff. We also appreciate the oversight

and leadership that your committees are bringing to this issue, and

we look forward to working with you as we collaborate and move

forward.

I want to briefly highlight some of our key findings, particularly

on the Washington State investigation, which is of great interest

to a number of people. Our first investigation concerned the identification and status of the cow slaughtered last December in Washington State which eventually tested positive for BSE. We looked

at allegations that the cow was in fact a healthy ambulatory cow,

rather than a downer, as described publicly by USDA officials, and

we looked at allegations that the U.S. vet who examined the cow

subsequently falsified inspection records under duress.

Our investigation found no instances where the USDA personnel

knowingly conveyed false or misleading information or engaged in

intentional misconduct. We discovered no evidence that the USDA

personnel on site at the facility falsified any records pertaining to

the condition of the cow at the time of its inspection.

The VMO on site who examined the cow found that it was nonambulatory at the time it was presented for ante-mortem inspection. The plant owner also acknowledged the cow was non-ambulatory. Sworn statements provided by others who saw the cow that

day did not contradict this evidence and contained no claims that

the cow was ever ambulatory at that facility. And, finally, traceback evidence established by Canada and USDA does not support

the allegation that the cow had a white hide, as was originally alleged by the former employee of that meat processing plant.

We also did an investigation of the Texas situation, which is

summarized in my written statement, so I won’t summarize that

today.

The reason we highlight these conclusions is because they illustrate some of the difficulties USDA faces in implementing an effective program. We have also done an audit, as you are well aware,

that has been discussed in quite a lot of detail this morning, and

I just want to emphasize that our report, as you know, is in draft.

The Department has 30 days in which to respond. Our normal

process is to take the Department’s responses and to address them

and to incorporate them as appropriate within our own report,

which we will then issue in final. We pointed out a number of

areas where the Department could tighten up its surveillance plan

in a number of areas. Again, those were fully discussed this morning. And we are encouraged by the fact that the Department is

moving forward to deal with many of the issues we have raised,

and we are looking forward to getting their final response so that

we can go ahead and implement this program at the Department.

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So, in conclusion, I want to thank you again for inviting us to

testify, and we look forward to addressing your questions.

[The prepared statement of Ms. Fong follows:]

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Chairman TOM DAVIS. Thank you very much.

Let me start. How do you plan to continue oversight of the expanded BSE surveillance program over the next 12 to 18 months?

Ms. FONG. We have a number of initiatives underway. As was

referenced this morning, we have initiated a review of the situation

where beef was brought in over the Canadian border. We have that

review. We started about a week ago on that and we anticipate it

will take a little bit of time to nail that down. In addition, we have

some audit work planned to review the results of the implementation of the surveillance plan as it moves forward, and also to look

at how the Department handles SRM materials in that particular

program area.

Chairman TOM DAVIS. Your audit states that APHIS’ current IT

system is inadequate to support the expanded surveillance system.

Can you speak specifically to APHIS’ IT challenges and your recommendations?

Ms. FONG. Yes, thank you. Our audit looked at the current IT

system and concluded that it was not adequate to support the expanded surveillance program and the expanded volume of samples

that the Department expects to gather. We found that APHIS

needs to implement an integrated system that tracks samples from

collection through testing through reporting of results, and a network that integrates the network of diagnostic testing labs. Currently, APHIS uses two databases. There is some issues about

whether those two databases are compatible, whether the data is

consistent, and so we made recommendations to USDA to improve

that system.

We understand that the Office of the Chief Information Officer

has been working very closely with APHIS and FSIS on this. We

understand that they have a system in the design and implementation stage and testing, and we are actually quite encouraged by the

progress that the Department is making on that.

Chairman TOM DAVIS. Your audit states that APHIS can’t easily

identify, obtain, or test cattle in its high-risk population. Can you

elaborate on this statement and your recommendations in terms of

APHIS being able to remedy that situation?

Ms. FONG. Yes. That is a significant portion of our audit; it does

address the issue of whether the targeted population can be adequately accessed through the testing program. And we had comments in a number of areas relating to high-risk cattle condemned

for CNS symptoms, cattle who tested negative for rabies who

should then be referred over for BSE testing, confusion regarding

the whole definition of downers and the age on that. And we made

a number of recommendations to the Department that it consider

issuing more precise guidelines to deal with those issues and that

it train FSIS and APHIS staff so that they could adequately implement those new guidelines.

Chairman TOM DAVIS. And also could you elaborate on your concerns regarding the testing of rabies negative brain samples?

Ms. FONG. Basically, our concern dealt with the lack of formalized process for ensuring that tests that are sent to labs for rabies

purposes—because cattle with rabies can exhibit similar symptoms

to central nervous system disorder, it is important that a cow

whose rabies test is negative then be referred over for BSE testing

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so that can be looked at, and we were concerned because there did

not appear to be formal procedures that would ensure that those

kinds of samples were referred from the State labs to the appropriate labs for diagnostics.

Chairman TOM DAVIS. So basically they ought to be testing for

both; if it is negative on one, it just makes sense, given the symptoms on them.

Ms. FONG. Yes.

Chairman TOM DAVIS. Thank you.

Mr. Waxman.

Mr. WAXMAN. Thank you, Mr. Chairman.

Thank you very much for being here and for your report. I think

you are playing a very important role with the Department in

critiquing their proposal, and hopefully your comments will be

taken to heart by the Department and improve their surveillance

program.

But their surveillance program seems to be based on an assumption that the downer cows are the highest risk, and perhaps the

only ones that we need to be worried about. A lot of that goes back

to the first and only cow that we found with the mad cow disease,

that was the cow in Washington; and there has been a controversy

as to whether that cow was a downer cow or not.

You testified that you didn’t find any knowing or intentional misrepresentation, but you do admit that there is some controversy

over whether that cow was a downer cow or not, don’t you?

Ms. FONG. That was the allegation that was presented to us back

in January/February, that the employer of the meat processing

plant thought that the cow that was BSE positive was not a downer. So that has been one of the major issues that we have focused

on. We have, through interviews of everyone that had contact with

that cow during that time period, and interviews of that employee

and interviews of USDA employees, we have not found any evidence that would indicate that at the time the cow was presented

for inspection, that it was ambulatory. At the time that it was presented for inspection, the USDA vet who was charged with the responsibility of making the professional call, in his professional

judgment, determined that it was in fact a downer. And all the

other statements that we have obtained have not been inconsistent

with that.

Mr. WAXMAN. That highlights one particular moment in time.

Ms. FONG. Right.

Mr. WAXMAN. But there are other witnesses who said at other

times that the cow was ambulatory, that it didn’t appear to be a

downer cow. Now, if that is the reality, not perhaps at that moment when the inspector came in, then one would have to question

whether it is correct to say that the only cows that can get BSE

are downer cows, if this wasn’t in fact a downer cow.

It is important because this assumption is driving everything

else. I didn’t really get a chance to pursue this with the Secretary,

and regret it, because I was mainly questioning her about some of

your criticisms of her inspection plan itself, but do you think that

we ought to be basing all of our activities on this assumption that

the only cows that can be infected with mad cow disease are downer cows?

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Ms. FONG. I think our audit report states that is one of the concerns that we had with the surveillance plan as drafted. We understand the need to focus as a priority matter first on cows that are

in the high-risk group. We do not have a quarrel with that assumption. But we also wanted the Department to consider the fact that

the normal appearing adult population of cattle should also be

looked at, because the extrapolation from the high-risk to the normal adult cattle population is a very difficult extrapolation to

make, and so we have been involved in discussions on that issue.

Mr. WAXMAN. I am glad that you are, because it seemed like the

Department made an assumption. It might have found the cow out

of luck rather than their system working the way it was supposed

to work, but then made an assumption that this was what they

ought to base their whole policy on, and it is an assumption that

they then use to assure everyone that their system was working.

And I am not sure that it is working, and it sounds like you are

not sure if the plan is only to look at downer cows and assume that

is all we need for giving the American people and others the reassurance about the food supply, that is sufficient.

So I want to point that out, because this administration has had

problems in the past of taking an assumption, even if there is evidence to the contrary, and staying with it sometimes beyond any

point where it makes sense.

I thought your criticisms in detail were very important. One of

the points that the Secretary made to me was, well, those criticisms were not of her new plan, but the old plan. And I wanted

to just go through some of these points with you, because a lot of

what you have listed did seem to apply to her present plan, not the

old plan, isn’t that correct?

Ms. FONG. We believe that some of the lessons that we have

learned from implementation of the plan over time, old and new,

applies to the implementation of the plan as we move forward, and

so they raise legitimate issues to be discussed.

Mr. WAXMAN. Thank you very much, Mr. Chairman.

Thank you for your testimony.

Chairman TOM DAVIS. Thank you.

Chairman Goodlatte.

Chairman GOODLATTE. Ms. Fong, thank you very much for participating today and for your extensive work in this area, we very

much appreciate that, and your associates being here with you as

well.

Is it true that draft audits can be modified significantly after full

consultation with the agency involved, in this case with APHIS, as

you exchange information and find that some of your assumptions

may not be quite the same way when they have an opportunity to

respond and give you some evidence of what they are indeed doing?

Ms. FONG. The audit process does provide for that exchange of

views and viewpoints. And as I pointed out in my testimony, when

we receive the Department’s response, we will evaluate it. It is conceivable that it will or could result in some change in our audit.

Now, I just want to clarify that. In terms of our audit work and

the factual basis for the audits, the data that we actually looked

at when we went to the field establishments, it is unlikely that

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data will change unless there is data that we just weren’t aware

of during the course of the audit.

Chairman GOODLATTE. Sure. But that is an opportunity for them

to provide that before a final audit is delivered.

Ms. FONG. Exactly.

Chairman GOODLATTE. And when was your draft delivered to the

Secretary?

Ms. FONG. July 1.

Chairman GOODLATTE. And is it appropriate for a draft audit to

be considered publicly as the final conclusion of the Inspector General on an issue that is under discussion?

Ms. FONG. In our view, our final audit is our final position.

Chairman GOODLATTE. And when you made the draft available

to members of the Government Reform Committee and to members

of the Agriculture Committee, did you expect that it would be made

public?

Ms. FONG. When we transmitted it, we transmitted it to the committees with the understanding that it was essential to you in your

oversight capacities, and that you would use it in that light and

with the appropriate safeguards.

Chairman GOODLATTE. Thank you. I just wanted to make that

very clear, that while we want to be very transparent in what we

are doing, we also want to make sure that what is made public is

something that has been carefully audited and has the full availability of the evidence that might be provided by the Department

in their discussions with you.

Now, to the substance of the issue, is a cow a downer for a

month, a week, a day, or is the downer distinction drawn at the

point that the USDA veterinarian inspects the cow and makes a

professional judgment?

Ms. FONG. That is a very difficult question, and I am not a vet

or an APHIS employee, so I hesitate to substitute my judgment as

to animal health. I would say that it is important that the Department have a clear definition of what it means by downer or nonambulatory and ambulatory. Once that definition is established

and implemented appropriately, then it is up to the individual vet

who is charged with the responsibility of exercising his or her judgment to apply that definition in an appropriate way.

Chairman GOODLATTE. Absolutely. But if a cow has some difficulties, it may well be able to walk some of the time and may be down

some of the time as well. And if the cow is presented to the veterinarian in a downed position, that is certainly a reasonable conclusion for the veterinarian to draw when they conclude that it was

indeed a downed animal that they were examining.

Ms. FONG. That is in fact the situation that happened with the

Washington State cow. There was testimony that we had from witnesses that we interviewed that indicated the cow walked onto the

trailer that morning, but by the time the cow arrived at the slaughter facility, the cow was sternal.

Chairman GOODLATTE. Right.

Ms. FONG. Was lying down. And so the vet, at that time, called

it a downer. That is not an inconsistent statement.

Chairman GOODLATTE. Sure. Absolutely. And it is also very true

that the scientific evidence would point to animals manifesting

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symptoms of illness, either downed or ambulatory, would be the

animals for which they would pay their greatest attention to in

their testing, is that not correct? The likelihood is far greater that

is where you might find BSE. And so far in the thousands of cows

that have been tested since the change in the rules, none have

been found to have that disease, thankfully. But it is also true that

there could be some cattle in the larger population that might have

this disease that are not showing symptoms of being down, whether they are ambulatory part of the time or then downed or not,

there could be some cows out there like that. But in terms of using

the resources to find the illness that is involved here, it is true, I

would assume, and I would like your opinion on this, that the principal focus should be on those animals that are most likely to manifest the disease, with some testing, and it is indeed the case with

the new regime that some testing is taking place, for what is called

the healthy animal population.

Ms. FONG. That is the Department’s approach, and we do not

have a quarrel with that in terms of priorities. The only comment

that we would have is that the Department be very clear in what

its priorities are and its goals, and that its plan clearly communicate to the public what it is trying to accomplish.

Chairman GOODLATTE. We understand that, and they will certainly have an opportunity to respond to your draft audit in that

regard, and we certainly hope and expect that they will respond to

your points, which are well taken.

At this time, Mr. Davis, we will recognize the gentleman from

Texas, Mr. Stenholm, the ranking member of the Agriculture Committee.

Mr. STENHOLM. Thank you, Mr. Chairman.

I want to follow up on the last line. The primary purpose of all

of our food safety and inspection service, all of our activities, is to

make sure that the consumer has a wholesome, safe supply of food.

That is the purpose of this hearing. And I find it rather interesting

that in the headlines of the Washington Post in the story today, the

title says ‘‘USDA Mad Cow Detection Challenge: Report Says Animal Wasn’t A Downer.’’ That is not what your report said. Your report found no evidence of intentional falsification or failure to test

the one downer cow. That is what you said. Someone else read this;

what they wanted to see in it was that there was possibility that

it was or it wasn’t. You have testified, in answering the questions,

very specifically that based on your investigation, as came from

USDA was accurate, but there are differences of opinion, correct?

Ms. FONG. I think that is correct.

Mr. STENHOLM. And you investigated the differences of opinion

and found no evidence to corroborate those who had a different

opinion than the inspector.

Ms. FONG. Our investigation indicated that the inspector made

the call at the time, and there is no evidence that contradicted

that. I will say that investigation reports are not always easy to

understand; they can be very technical, and it is easy to be misled

by some of the terminology.

Mr. STENHOLM. And I can fully appreciate that, having dealt

with this question myself for a few years. There are those, and I

don’t question their intentions or their integrity, or anything about

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those who have differences of opinion regarding our food safety and

inspection service. But I think it is not helpful when we leak a report, whoever did, and then come to a conclusion that is not substantiated by what the report said.

Now, in your testimony you state that APHIS cannot easily identify, obtain, or test cattle in its the high-risk population. Mr. Waxman, and I think not totally incorrectly, is suggesting that we perhaps need to look at other animals other than the high-risk in

order to be as absolutely certain as we need to be, and it is my understanding, based on the current procedure, that is exactly what

we are doing now, we are looking at a pretty broad-based number

of samples so that the concerns raised by Mr. Waxman are now

being met by the procedures. Is that your finding?

Ms. FONG. The expanded surveillance plan as drafted by APHIS

provides that APHIS will sample 20,000 cows from the normal appearing adult population. And we had some concern about how that

sample was going to be handled and the statistical analysis underlying it. I think that through our conversations recently with

APHIS and the Department, that this is an issue that both sides

need to continue to talk about, because it is not an easy issue to

address. But my sense of this is that the Department understands

that we do need to do some sampling in the normal population, and

so we need to work together to figure out the best way to do that.

Mr. STENHOLM. But as someone who warned about the problem

that might be associated with banning downer animals, I am

tempted to want to agree with your assessment of the problems

that have been associated with that policy. However, given the rate

of testing among higher risk cattle that USDA seems to have

achieved, what evidence do you now have to support that original

assertion?

Ms. EVANS. Can you repeat the question, please?

Mr. STENHOLM. In your testimony you state that APHIS cannot

easily identify, obtain, or test cattle in its high-risk population. One

of the concerns that many of us had was the downer animal, I

wanted them to continue to come into the slaughter plant, have a

veterinarian determine whether or not that was a sick animal. If

it was, it is out; if it is a broken leg process, that it would continue

in. That has now been changed. You came to the same conclusion:

that because of that it was creating a problem identifying the highrisk population.

Ms. EVANS. Right.

Mr. STENHOLM. I said where I was attempting to agree with you.

That is not the point today, that is being looked at and in the interim rule being determined. The question is: given the rate of testing among the higher risk cattle that we are now achieving, or

seem to have achieved, what evidence do you have to support your

original assertion that we had a problem in that area?

Ms. EVANS. We have not done any analysis as to the testing that

has been done since June 1. That is part of what we plan to do in

the future, in looking at the effectiveness of what the Department

has done and in responding to our recommendations.

Mr. STENHOLM. Thank you.

Chairman GOODLATTE. It is my pleasure to recognize the gentleman from Kansas, Mr. Moran.

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Mr. MORAN. Mr. Chairman, thank you. Just perhaps a couple of

followup questions to questions that the IG has answered.

Let me make sure I understand the period of time which your

audit covers. And a significant part of that, I think, is that none

of that audit was conducted post the new surveillance being implemented, is that true?

Ms. FONG. We completed our field work during the spring of

2004. We initiated the audit, I believe, in February and we completed our field work through June.

Mr. MORAN. And the new surveillance was announced in March

but implemented on June 1, so the conclusions that are drawn in

your report are really based upon events and, therefore, methodology, policies that predate the new surveillance of June 1?

Ms. FONG. Our audit is based on our analysis of data that was

available prior to the June 1 implementation.

Mr. MORAN. And then in response to Mr. Stenholm’s inquiry

about the downer, part of what you are indicating is that we need

a clear definition of what a downer animal is, and perhaps a timeframe in which an animal becomes or remains a downer, is that

true?

Ms. FONG. Yes.

Mr. MORAN. But you are also indicating that if we exclude downer cattle from the food supply system, we are limiting the ability

to test the cattle that may be at most risk for BSE, is that true?

Ms. FONG. That is an issue that we have put on the table with

the Department. The question is if those animals are no longer

going to the slaughterhouses, how will we, the Department, be able

to access them for sampling; and that is something that we believe

needs to be looked at.

Mr. MORAN. Do you have any preliminary answer to that question? Is the Department doing anything to have surveillance test

those animals?

Ms. FONG. I am not aware of anything in particular. Now, that

is not to say that is not going on, it is just that we may not be

aware of it at this time.

Mr. MORAN. And I guess that is my final point, is that much may

change as you have conversations with USDA, APHIS, and you

reach your final conclusions. We ought to again look at this report

to see what your final conclusions are, is that accurate?

Ms. FONG. Right.

Mr. MORAN. That is good advice, I assume?

Ms. FONG. Yes, it is. And we do plan to, when we issue the report, to provide it to the committee for the record.

Mr. MORAN. Thank you very much, Ms. Fong. I always find you

a very impressive witness, and I thank you for your testimony.

Ms. FONG. Thank you.

Chairman TOM DAVIS. Thank you. Both committees, you will

supply it to both committees for the record?

Ms. FONG. Absolutely.

Chairman TOM DAVIS. Ms. Fong, I just want to thank you for

your testimony today and for the audit work that you have done

on the old system, and we look forward to continue to work with

you and the Department as this new system takes hold to make

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sure that we continue to have a safe food supply in this country.

Thank you.

Ms. FONG. Thank you.

Mr. WAXMAN. Mr. Chairman.

Chairman TOM DAVIS. Mr. Waxman.

Mr. WAXMAN. If I might, I would like to take another round to

clarify some issues here.

Chairman TOM DAVIS. Our problem is we are expecting votes in

a couple minutes, and I want to get the next panel on.

Mr. WAXMAN. I appreciate that, Mr. Chairman, but we don’t have

a lot of Members here.

Chairman TOM DAVIS. I know.

Chairman GOODLATTE. I think we could take questions in writing

and make sure that they are answered.

Mr. WAXMAN. Mr. Chairman, I would like to pursue less than 5

minutes of questions, if I might.

Chairman TOM DAVIS. Mr. Waxman, we have tried to indulge everybody today, and this hearing started at 10. What I would like

to do at this point is have you submit the questions in writing.

And, Ms. Fong, will you try to respond to them and get back to

him on that? I think that is appropriate.

I would like to move to the last panel and get them in before the

vote if we can; otherwise, they can be stuck here for a much longer

period of time.

Mr. WAXMAN. Mr. Chairman, I regret that I can’t have the opportunity to ask more questions, but I will submit them in writing.

Chairman TOM DAVIS. That would be fine. If we had Members

here, we could have had them yield, but I just want to move this

along.

Mr. WAXMAN. I didn’t think I would have to call some Member

to give me the courtesy of asking a few more questions, but next

time we will do that, Mr. Chairman.

Chairman TOM DAVIS. All right, thank you.

Now you are dismissed.

In fact, this looks like a time, with the vote coming on, maybe

we ought to recess.

Mr. WAXMAN. Mr. Chairman, since we are not going to have a

chance to put on the next panel, may I have a few minutes to ask

some questions of Ms. Fong?

[Recess.]

Chairman TOM DAVIS. We now move to our next panel.

I want to thank our witnesses for appearing today. Joining us in

our third panel will be Dr. George Gray, the executive director of

the Harvard Center for Risk Analysis; Dr. Peter Lurie, the deputy

director of the Public Citizen’s Health Research Group; Mr. Jim

Hodges, president of the American Meat Institute; and Dr. Gary

Weber, who is the executive director of the National Cattlemen’s

Beef Association.

Again, gentlemen, it is our policy that we swear everybody in, so

if you would rise with me and raise your right hands.

[Witnesses sworn.]

Chairman TOM DAVIS. Thank you all for being with us and for

your patience. It has been a long day for those of you sitting out

there.

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Dr. Gray, why don’t we start with you and we will move straight

on down. If you can keep it to 5 minutes, your entire testimony is

in the record, and then we will go ahead to questions.

STATEMENT OF GEORGE M. GRAY, EXECUTIVE DIRECTOR,

HARVARD CENTER FOR RISK ANALYSIS

Mr. GRAY. Thank you, Mr. Davis, Mr. Goodlatte, and Mr. Waxman. As I have just been introduced, I am George Gray from the

Harvard Center for Risk Analysis. You can learn more about our

group by looking at our Web site, our mission, our research, and

our funding.

My comments today are based on my research and experience as

a scientist, a risk analyst, and a public health professional. They

shouldn’t be attributed to anybody else, including the Center for

Risk Analysis or the Harvard Center of Public Health.

I do want to recognize publicly the contribution of my colleague,

Dr. Joshua T. Cohen, to work the work upon which this testimony

is based. Part of this testimony is based on a review of USDA’s enhanced surveillance plan that we did for the Department at the request of the Department in March 2004, and that is attached to my

testimony.

I really want to make three main points today, and I will try and

do them very quickly. The first one is surveillance that provides us

information that helps us to manage risk. It helps us to do this by

understanding whether BSE is present in the U.S. cattle herd and

how extensively it might have spread. We have to remember that

it is not a public health measure. The U.S. Government has already taken many steps to help reduce the risk of BSE to animals,

primarily there through the feed controls that the FDA put in place

in 1997, and to humans; and some of the most important things

have already been discussed today, the removal of high-risk materials from human food. So surveillance helps us determine if those

measures have been successful, and they will help us decide whether additional or even fewer measures are needed going forward.

My second point is that USDA’s focus on testing high-risk animals is the best way to monitor the population. Of course, the most

accurate estimate of the number of animals with BSE in the

United States could be developed if we tested every single animal,

but much of the energy there would not be productively spent. And

I do want to touch on some knowledge that we know from what has

happened in the rest of the world about how high-risk this highrisk group is that we are talking about.

Data from Europe—and here I am going to talk about combining

information across all of the European Union and the data from

their testing in 2002 and 2003. But there it tells us that the prevalence of BSE in the high-risk animals, virtually the same definition

that the USDA is using, the rate in those animals is about 25

times higher than the prevalence in apparently healthy animals

over 30 months of age. So there is the potential for BSE in apparently healthy animals, and that is an important thing we have to

recognize. However, in testing, this tells us that in Europe they

have to test, on average, about 1,300 high-risk animals to find 1

BSE case. They have to test over 33,000 apparently healthy aniVerDate 11-SEP-98 11:01 Dec 16, 2004 Jkt 000000 PO 00000 Frm 00109 Fmt 6633 Sfmt 6633 F:\DOCS\10839.DOC HAGRI PsN: HAGRI
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mals. So if we want to find the cases, we should look where we

know they are, and that is in the high-risk group.

Now, Dr. Cohen and I have some concerns about the assumptions

underlying the estimates of the sensitivity of the USDA plan, and

we discuss those in some detail in our memo that you can read. So

I think that it is important to say that we are going to have to go

back and reevaluate exactly what we learn from this system, but

this surveillance plan is the best way to get a handle on what is

happening in the United States with BSE.

So to summarize, I think that the USDA expanded surveillance

plan will provide us useful knowledge for BSE risk management,

it will help us to make better decisions. However, it is important

to remember that protecting human and animal health depends on

other measures, which have already been taken or, in some cases,

they have been proposed by Government agencies. The expanded

surveillance plan as designed, it is targeted and it is efficient, and

it will provide us useful information. There will be challenges in interpreting and in communicating the results, but I am confident

that these challenges can be met.

Thanks for the opportunity to address you, and I would be happy

to answer any questions.

[The prepared statement of Mr. Gray follows:]

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Mr. GOODLATTE. Thank you, Dr. Gray.

Dr. Lurie, welcome.

STATEMENT OF PETER G. LURIE, DEPUTY DIRECTOR, PUBLIC

CITIZEN’S HEALTH RESEARCH GROUP

Dr. LURIE. Thank you. Like Dr. Gray, I too am going to make

three points.

The first is that the previous and, indeed, the now proposed surveillance system has never been able to detect BSE at the level

claimed; it was never able to detect BSE at the level of one in a

million adult cattle. And the now proposed one will not be able to

do so at the level of 1 in 10 million cattle, as claimed.

The second is that although important to remove downer cattle

and other high-risk cattle from human consumption, the contribution in terms of reducing the overall risk of BSE exposure to

human beings is quite limited and not as high, I think, as has been

implied by USDA.

And, finally, as the IG has very well documented, the system has

been characterized by inconsistent sampling of downer cattle and

still more risky CNS cattle, as well, as we now learn, the rabies

negative cattle, and we don’t think there has been adequate geographical distribution, either.

On the first point, the USDA has claimed on its surveillance Web

site in the past that it could detect the disease at a level of 1 or

more cases per million in the adult population, and they now reiterate that with respect to 1 in 10 million at the 95 percent confidence interval for the new expanded program. Both claims, it has

been very clear today, rest on the false assumption that there are

literally no cows likely to turn up positive in the normal appearing

animal population. Dr. Gray has just said that is not the case, the

IG has said that is not the case, and, indeed, from what I can understand, Secretary Veneman herself is now backing off from the

claim of 1 in 10 million, and it is none too soon.

It is certainly true that the risk for BSE is higher in the downer

than in the non-downer cattle; there is no question about that. The

question, though is if literally all of the risk is located among the

downer or other high-risk animals. In fact, 287 normal appearing

cattle tested positive for BSE in Europe in 2002. So although Dr.

Collins, I believe his name was, says there is debate about the extent of the risk among the lower risk animals, one thing that there

is no debate about is that the USDA’s assumption is absolutely

false, i.e., that it is zero risk. Nobody endorses that position, yet

that is precisely the assumption upon which the 1 in 10 million and

1 in 1 million, previously, estimates have been based.

Let me draw your attention quickly to a graph that I have attached to my testimony and try to walk you through it. The way

this works is along what I would call the X axis, the bottom part,

you learn that if the risk of downer and high-risk animals is 500

times higher than that among normal appearing animals, most of

the risk for BSE does in fact appear in the high-risk category,

about 83 percent of all risk. However, as you move to the left, lower

and lower fractions of the total BSE risk are among the downer

and high-risk animals. We based our estimates on the data from

Europe, where there is a 31-fold increased risk among the high-risk

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animals compared to the lower risk ones, something similar to

what Dr. Gray has done. In fact, if anything, we have been conservative in so doing. And what that arrow shows, using the European

data, which, after all, are the only data we can use because there

are no comparable American data, is that only 24 percent of the

total risk is among the higher risk animals.

There are two implications to this. The first I have already stated repeatedly, which is that the 1 in 10 million assurance is false.

The second is that by removing downer cattle from consumption,

again, a good move, you have only had a limited impact upon the

overall risk of U.S. humans for contracting BSE.

I almost don’t need to say much about the problems that have

been portrayed by the IG with respect to the implementation of

this program because I think that she has done a very good job of

them, but we ourselves have done a study back in 2001 in which

we showed a 600-fold difference in the rates of testing among dairy

cattle for BSE, from the highest state compared to the lowest state

in terms of rates, so a truly massive variation in terms of the rates

of testing by state, when they should be approximately equal.

Much has been said about the case in Texas, I don’t think I need

to reiterate that. The case in Washington, all of these indicate that

there are questions about the implementation of the program, in

addition to the way risk communication has occurred.

In sum, then, there is much about the design of USDA’s expanded surveillance program that is praiseworthy. The focus on

high-risk animals, not the exclusive focus, but the general focus on

high-risk animals is a good thing, as is the greatly increased number of tests, the expansion of testing to include 20,000 normal appearing animals, and the approval of more rapid testing technologies. But the program has also been riddled with deficiencies

in the risk communication and implementation fields. After all, this

is a program, we have heard, that is not random, has incorrectly

estimated a 1 in 10 million risk, by removing the downer cattle has

only removed about 24 percent of the risk in the targeted population, has missed 55 percent of cattle with CNS symptoms, has

missed 84 percent of those that are negative for rabies, and appears not to be geographically distributed. If the public and potential importers of U.S. cattle and cow products are to be reassured,

it can only be on the basis of accurate scientific information, rather

than the false or misleading information that has represented a

significant portion of the USDA response to date.

Thank you.

[The prepared statement of Dr. Lurie follows:]

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Chairman GOODLATTE. Thank you, Dr. Lurie.

Mr. Hodges, welcome.

STATEMENT OF JIM HODGES, PRESIDENT, AMERICAN MEAT

INSTITUTE FOUNDATION

Mr. HODGES. Thank you, Mr. Chairman.

A review of some basic facts is necessary in order to understand

the purpose and adequacy of any BSE surveillance program. Erroneous comparisons have been drawn between the United States

and Europe with respect to the risk of BSE and its animal health

consequences. The facts show that the U.S. risk is many orders of

magnitude lower than Europe’s. More than 180,000 cases of BSE

have been diagnosed in cattle since the disease was first discovered

in the U.K. in 1986. At the height of the epidemic, in 1992, more

than 1,000 cases per week were being diagnosed, and that is only

the diagnosed cases. Experts have estimated that between 3 and 4

million cases of BSE actually occurred, and that is compared to 2

cases of BSE in North America, both of which were determined to

be of Canadian origin.

Potential human exposure to the BSE infective agent in the

United States is exceedingly small. The United States is not Europe. We will not experience the animal disease epidemic or the

number of human illnesses that occurred in the U.K. because we

took preventative steps to protect both human and animal health.

Considerable debate has ensued regarding how best to protect

the public. The first objective is to prevent the introduction and

spread of the disease in the cattle population. To that end, firewalls

have been constructed, as you have heard earlier today, to protect

the U.S. cattle herd. Import restrictions on countries that have

BSE were first put in place in 1989. In 1990, the United States was

the first country in the world to implement an animal disease surveillance program when the disease was not known to exist in this

country. A precautionary ruminant-to-ruminant feed ban was implemented in 1997 to prevent the amplification and spread of the

disease in our cattle herds.

Those firewalls have been significantly strengthened in recent

months. All slaughter facilities must now remove potentially infectious material, or the so-called specified risk material. Experts

from around the world agree that removing SRM from the food

supply is the most effective means to protect public health.

An effective surveillance program is a necessary component of an

effective animal disease prevention program, but it is not a food

safety program. Testing cannot guarantee that BSE is not present

in the animal, nor can testing protect public health. All of the laboratory methods currently used can only detect the disease a maximum of 6 months prior to the clinical onset of the disease where

visible signs of the disease can be observed. Testing young animals

under 30 months of age is scientifically indefensible. In fact, one

leading BSE expert said that testing young animals constitutes veterinary malpractice.

Given the average age of clinical onset of the disease is 4 to 7

years, and the limits of testing methods, the U.S. surveillance program is appropriately focused on the cattle population that is most

likely to exhibit the disease. To illustrate, as Dr. Gray did earlier,

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data from Europe show that approximately 1 in 4 animals that

show clinical signs of a central nervous system disorder test positive; in the emergency slaughter and fallen stock, or what we

would term dead or downers, it is approximately 1,000; and for the

older, normal appearing animals, approximately 1 in 30,000 test

positive. Let me make clear, however, that the industry supports

a robust animal disease surveillance program. If the disease is

present in the United States, we want to know it. It is a very important way that we can effectively determine if our BSE prevention measures are working properly.

The appropriate level of animal disease surveillance is a matter

of how much confidence you need or want in the data, or stated differently, how much sampling error are you willing to tolerate. At

the projected sampling rate of approximately 270,000 animals in

the high-risk population, we would be able to detect the disease if

it exists in more than 1 in 10 million animals in the target population with a 99 percent confidence level. That is a high degree of

statistical confidence that greatly exceeds world animal health

standards.

Critics of the USDA’s surveillance program have focused on a

lack of random sampling, poor geographical distribution, and an inability to determine an accurate prevalence rate. These criticisms

might be justified if the USDA were collecting data for a peer-reviewed scientific journal article, but this is not an academic exercise; it is an ongoing animal disease surveillance program. The objective is to sample as many animals as possible in the cattle population that is most likely to exhibit the disease. The dead and

downer category is estimated at approximately 440,000. USDA

plans to sample in excess of 200,000 head, or about one-half of this

high-risk population. If BSE exists in our domestic herd, we will

find it.

Thank you, Mr. Chairman.

[The prepared statement of Mr. Hodges follows:]

TESTIMONY OF JAMES HODGES

Thank you for inviting me to testify at this joint hearing on the U.S. Department

of Agriculture’s Bovine Spongiform Encephalopathy (BSE) Surveillance Program. I

am honored to be a part of this distinguished panel.

BSE has garnered considerable attention since the first indigenous cases of BSE

in North America were diagnosed in Alberta, Canada on May 20, 2003 and Washington State on December 23, 2003. A review of some basic facts is necessary in

order to understand the purpose and adequacy of any BSE surveillance program.

Comparisons have been drawn between the U.S. and Europe with respect to the

risk of BSE and its animal and human health consequences. The U.S. remains a

very low risk country in comparison to many countries around the world. Despite

speculation to the contrary, the facts show that our risk level is many orders of

magnitude lower than Europe’s.

More than 180,000 cases of BSE have been diagnosed in cattle since the disease

was first discovered in the United Kingdom in 1986. And more than 95 percent of

the cases worldwide have occurred in the U.K. At the height of the epidemic in 1992

more than a 1,000 cases per week were being diagnosed. In 1992 alone, more than

36,000 cases were diagnosed. And that’s only the diagnosed cases. Experts have estimated that between 3 and 4 million cases of BSE actually occurred. That’s compared

to two cases of BSE in North America, both of which were determined to be of Canadian origin.

Fortunately, the number of BSE cases in the U.K. has declined every year since

1992. The epidemic appears to be drawing to a close with approximately 1,200 BSE

cases being diagnosed worldwide last year.

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Unfortunately, British citizens were exposed to massive doses of the infective

agent during the early years of the epidemic. Even given this massive exposure,

slightly more than 150 human illnesses in the world have been attributed to the

BSE agent. The number of variant Creutzfeldt-Jakob disease (vCJD) illnesses has

declined for four consecutive years and only one case of vCJD was reported last

year.

Bottom line: Potential human exposure to the BSE infective agent in the U.S. is

exceedingly small compared to the massive human exposure that occurred in the

U.K. The U.S. is not Europe. We will not experience the animal disease epidemic

or the number of human illnesses that occurred in the U.K. because we took preventive steps to protect both human and animal health. For more than 15 years, we

have learned and adopted interventions based on the U.K.’s experience.

Even though the public health risk from BSE in the U.S. is exceedingly small,

considerable debate has ensued regarding how best to protect the public. The first

objective is to prevent the introduction and spread of the disease in the cattle population. If the disease does not enter and reside in the cattle population, then a significant level of human health protection is achieved.

To that end, firewalls have been constructed to protect the U.S. cattle herds. Import restrictions on countries that have BSE were first put in place in 1989. In 1990,

the U.S. was the first country in the world to implement an animal disease surveillance program when the disease was not known to exist in this country. And a precautionary ruminant-to-ruminant feed ban was implemented in 1997 to prevent the

amplification and spread of the disease in our cattle herds. Those firewalls have

been significantly strengthened since December 23, 2003 when a case of BSE was

diagnosed in Washington State.

Most importantly, for consumer health protection, all slaughter facilities in the

U.S. must now remove potentially infectious material, the so-called specified risk

materials or SRMs, from the food supply. Experts from around the world agree that

removing SRM from the food supply is the most effective means to protect public

health.

Only SRMs have been shown to be vectors of the infective agent, beef muscle has

not. In the event additional BSE cases are diagnosed in North America, effective

SRM removal prevents human exposure to the infective agent. Without exposure

there is no human illness.

As an added precaution, animals most likely to harbor the disease—clinical suspects and non-ambulatory or downer animals—are prevented from entering the food

supply.

I provide this background to highlight the point that an effective surveillance program is a necessary component of an effective animal disease prevention program,

but it is not a food safety program. Testing cannot guarantee that BSE is not

present in the animal, nor can testing protect public health. Removal of SRM protects public health.

Existing BSE testing methods have limitations. All of the laboratory methods currently used can only detect the disease a maximum of six months prior to clinical

onset of the disease where visible signs of the disease can be observed.

BSE has an extremely long incubation period before clinical signs can be observed. The youngest case diagnosed last year in Europe occurred in an animal that

was 50 months of age. The disease could not have been detected with existing testing methods until the animal was almost four years old. Testing young animals is

scientifically indefensible. In fact, one leading BSE expert said that testing young

animals constitutes veterinary malpractice.

Given the average age of clinical onset is 4 to 7 years and the limits of testing

methods, you can readily see why the USDA surveillance program is appropriately

focused on the cattle population that is most likely to exhibit the disease. To illustrate, 2002 data from the European Union shows that approximately 1 in 4 animals

that show clinical signs of a central nervous system disorder, test positive. In the

emergency slaughter and fallen stock category, or what we would term dead and

downer, approximately 1 in 1,000 tested positive. For older, normal appearing animals, approximately 1 in 30,000 tested positive.

It should be noted that a higher level of infectivity is present in the European

cattle population when compared to the U.S. herds. We would expect cattle in Europe to be diagnosed at a younger average age than in the U.S. since the age of

clinical onset is inversely proportional to the infective dose So you can see that testing young animals under 30 months of age—which make up more than 80 percent

of our domestic slaughter—provides no reliable information for determining the

prevalence of BSE in the cattle population or for enhancing our animal disease surveillance program.

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Let me make clear, however, that the industry supports a robust animal disease

surveillance program. If the disease is present in the U.S. we want to know it and

we want to know its prevalence. That’s a very important way we can effectively determine if our BSE prevention measures are working properly.

You might ask, ‘‘Why don’t we test all older animals over 30 months of age as

is done in most of Europe?’’ The answer is very simple. Europe’s decision was not

made based solely on the scientific evidence. Europe, and even more so Japan, over

reacted to a severe loss of consumer confidence in its government institutions to protect them from harm. Large scale testing was implemented to regain consumer’s

confidence and to provide cover for the politicians. In contrast, U.S. consumers have

maintained a high level of confidence in U.S. beef safety.

From a scientific perspective, the appropriate level of animal disease surveillance

is a matter of how much confidence you need or want in the data. Or stated differently, how much sampling error are you willing to tolerate. At the projected sampling rate of approximately 270,000 animals in the high-risk cattle populations, we

would be able to detect the disease if it exists in more than 1 in 10 million animals

in the target population with a 99 percent confidence level. That’s a high degree of

statistical confidence that greatly exceeds recommended world animal health standards.

In closing, I would like to emphasize three points. First, the risk of BSE in U.S.

cattle is very low and the risk to human health from BSE is even lower. This fact

has been confirmed by numerous risk assessments. Second, sound scientific principles and reliable data must underpin all of our preventive control measures. To

do otherwise endangers the credibility of all our institutions. Finally, a robust animal disease surveillance program is an integral part of our BSE preventative control

measures but it is not a food safety program.

Thank you for inviting me to present the meat industry’s views on BSE testing

and surveillance.

Chairman GOODLATTE. Thank you, Mr. Hodges.

Dr. Weber, welcome.

STATEMENT OF GARY M. WEBER, EXECUTIVE DIRECTOR, REGULATORY AFFAIRS, NATIONAL CATTLEMEN’S BEEF ASSOCIATION

Mr. WEBER. Thank you. It is a pleasure to be here, and we appreciate this opportunity to share our perspectives with this organization, this committee, this process, as we have engaged in it many

times in the past.

And I think just to reiterate, rather than go through a redundancy, all of the things the United States has done since 1989, it

is important, though, to reference that these steps were taken before we have ever had the disease, and we are the first country in

the world to take that kind of an aggressive approach.

I have enclosed a timeline in my testimony which clearly illustrates how different the United States has been, how proactive we

have been in preventing BSE. And so from that perspective we

enter this discussion about surveillance from a position of being

proactive.

This program, as I said, began in 1989, and it has been supported and expanded and analyzed by both democratic and republican administrations, and so we are in this mode now of analyzing

a surveillance program that is built upon a long history of being

aggressive and proactive. This expanded BSE surveillance program

represents one recommended by an International Review Team,

supported by the international animal health scientific community,

supported by risk analysis experts, and we support it being developed and implemented fully.

Obviously, we had a case of BSE, it was of Canadian origin, and

the International Review Team, in recognizing this, still suggested

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that we expand the surveillance program to confirm our assumptions that have been made in previous risk assessments that the

disease prevalence in the United States is very low. And, indeed,

as experts have determined, if it is present, we believe that the

current feed restrictions, as they are being fully enforced, are in

the process of eradicating the disease if it were present. So as others have said, we support this expanded testing program.

There has been a lot of discussion about whether it is absolutely

capable of determining this level of 1 in 10 million, but in the animal health arena it is important to recognize that we are estimating the prevalence of a disease. That estimate will work its way

into other risk assessments and analysis of whether additional

measures need to be taken. It is just an estimate, it is not meant

to be an absolute, and we support a process that can reach a desired level of surveillance that we can feel confident in, and we believe this program will do that.

Under the current surveillance program, the USDA has established an outstanding network of approved laboratories that will

contribute to the national BSE surveillance effort. It is important

to review that it is our understanding that these laboratories are

using a rapid test that is used in many countries. It is an automated system, the ones that are currently in place in the seven

laboratories, and that it does have very high sensitivity that can

produce a fairly high level of inconclusive test results that have to

be proven by the gold standard, whether or not they are actually

BSE or not, and that is the immunohistochemistry method. And

we, again, support this process of looking at inconclusives. All of

these samples are sent to our National Veterinary Services Laboratory in Ames, IA, and, again, we support the transparent process

that is underway here.

The only issue we have with USDA and the laboratories is that

we want to make sure that the laboratories are using the best

quality assurance program possible to ensure the quality of test results. We don’t want to miss any true inconclusives, but we also do

not want to have a high number of such results that are reported

simply on the fact that normal variations of operation in the lab

systems, because this does have an effect on our markets and on

consumers. To date, consumers remain completely confident in our

system, as evidenced by beef demand, and we want to continue

that, and we believe we are building on a foundation that USDA

has helped establish of that confidence; we want to continue doing

that.

The NCBA has offered our support in ensuring that USDA has

access to as many animals in the targeted risk population as possible. Data from this expanded surveillance program will be important for many reasons. These estimates will provide data to our

longstanding programs, the analysis of those, and I think it will

show that staying on the course that we have established since

1989 will continue to protect animal health. And it is important to

note that public health is protected by the SRM removal practices.

The removal of animals from the downer/dead/disease population

from the human food supply is an appropriate additional safeguard. The NCBA will continue to analyze the situation as the surVerDate 11-SEP-98 11:01 Dec 16, 2004 Jkt 000000 PO 00000 Frm 00135 Fmt 6633 Sfmt 6633 F:\DOCS\10839.DOC HAGRI PsN: HAGRI
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veillance program works forward and determine what, if any, additional science risk-based measures are necessary.

Thank you again for this opportunity to share our views with

you, and I look forward to your questions.

[The prepared statement of Mr. Weber follows:]

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Chairman GOODLATTE. Thank you, Dr. Weber.

Thank you all.

We will now start with questions, and I am pleased to recognize

the gentleman from California, Mr Waxman.

Mr. WAXMAN. There has been some confusion about whether the

cow in Washington State was a downer cow, and I tried to clarify

this issue with the Inspector General from the Department of Agriculture, but I was not given the time to do so. And I wondered, Dr.

Lurie, maybe you could help set the record straight. The Inspector

General testified the USDA inspector noted that the cow was lying

down when it arrived at the slaughter facility. This isn’t a surprise

to me; I have noticed this fact in every letter I have noted on the

subject. But isn’t the veterinarian’s assessment of whether the cow

was lying down the very definition of a downer? It is that one moment in time when the cow was lying down that makes it a downer

cow or not?

Dr. LURIE. It seems clear that there is at least the potential for

misunderstanding based on differing definitions that seem to be

floating around, but I think probably the way to consider this is

through a directive from the FSIS, 6900.1, revision No. 1 from November 1998. And in that the definition of a downer cow, and let

me read this into the record, is:

Livestock that cannot rise from a recumbent position (downer) or that cannot

walk, including, but not limited to, those with broken appendages, severed tendons

or ligaments, nerve paralysis, fractured vertebral column, or metabolic conditions.

So the definition, then, is an animal that cannot rise.

Mr. WAXMAN. Now, Chairman Davis and I received a sworn

statement from the owner of the slaughter facility that the cow did

get up after its examination by the veterinarian. Moreover, the veterinarian told congressional staff that he believed the cow’s standing up after his exam was a distinct possibility. Is your view that

this cow was unquestionably a downer?

Dr. LURIE. The definition, based on what I have just read to the

record, does not appear to be based on a momentary assessment.

If it is an animal that cannot rise I read at any moment in time.

In fact, you appear to have, from what I am reading from your letter from yesterday, there are now a total of five people who have

said that there was a moment at which it rose, maybe even most

of its moments, and by that definition it seems reasonable to conclude that it wasn’t a downer.

Mr. WAXMAN. Now, this is a matter I would have liked to pursue

with the Inspector General. I am going to send written questions

to her, and I appreciate your view on it. Let me ask you one other

question. Senior USDA officials have said that the discovery of mad

cow disease is proof that our surveillance system worked as intended, but the Inspector General found that several USDA employees knew that the slaughter facility had a special contract to

test non-downers and in fact did test cows that were ambulatory

by everybody’s definition. Without this contract, which violated

USDA policy, the owner says there would have been no cows tested

at the slaughter facility at all.

Do you think the system worked or did we just get lucky in finding this cow with mad cow disease?

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Dr. LURIE. Clearly the practice at the plant appears to have been

inconsistent with USDA directives, so it is hard to say that the system worked as intended. Moreover, any claim of the effectiveness

of the surveillance system as being demonstrated by the detection

of a cow is inconsistent with the way that USDA has, at least at

times, presented the purpose of its surveillance system and, indeed,

the way I think everybody on this panel has put forth. The purpose

of the surveillance system is in fact not to protect the supply, the

purpose is to be able to estimate the prevalence.

Mr. WAXMAN. Now, if we are estimating the prevalence, do you

think that we can say, as the Secretary has, that there is a 1 in

a million or 1 in 10 million—that we are going to be able to detect

cows in that kind of scenario?

Dr. LURIE. Absolutely not, and for exactly the reasons that I have

said, that Dr. Gray has said, and now that the USDA appears to

be acknowledging, that there is a non-zero risk among the lower

risk animals. In fact, the IG report makes the estimate, based on

assumptions different than ours, but in general of the same order,

that 15 per 10 million, not 1 per 10 million, but 15 per 10 million

is the limit on the detection at 268,000 animals.

Mr. WAXMAN. I appreciate that. I see the yellow light is on, and

I know I am going to be gaveled as soon as it is red, but had there

been a more honest assessment of the status of the cow, perhaps

USDA would have avoided a mistaken assumption, which Secretary Veneman backed away from today, that all cows with mad

cow disease would be downers or other high-risk cattle. This would

have prevented misleading statements to the public about what the

testing program can accomplish. Do you agree with that?

Dr. LURIE. I do.

Mr. WAXMAN. Thank you.

Chairman TOM DAVIS. Dr. Lurie, let me start with you. Do you

feel that with the new BSE surveillance program, that at least the

meat supply is safer today than it was a year ago?

Dr. LURIE. I don’t particularly think that because I don’t think

that the surveillance program is really about that. The surveillance

program is about estimating the extent of the disease. So in that

sense I don’t think it makes much difference in that sense. As has

been repeatedly pointed out, what protects us against BSE in this

country is the import ban, the feed ban, and the SRM ban. The surveillance system is about measurement, not really about protection.

Chairman TOM DAVIS. Dr. Gray, I will ask you to comment on

that, but also you were tasked by the Government to assess all aspects of USDA’s BSE surveillance program. In Dr. Lurie’s testimony, which I heard in the back, he challenges many aspects of

this program. Having reviewed this program as part of your work,

do you have any comments?

Mr. GRAY. Sure. First of all, we were asked if we would review

this, and it was something that we sort of did nights and weekends, and a little extra time to help out. When we looked at this,

I think that if you look at our testimony, we fundamentally agree

with the approach of looking at high-risk animals. Again, if we are

going to look for BSE, let us look where we know the disease is,

and all the data from countries that have much worse problems

than we do suggests that the rate is much, much higher in the aniVerDate 11-SEP-98 11:01 Dec 16, 2004 Jkt 000000 PO 00000 Frm 00144 Fmt 6633 Sfmt 6633 F:\DOCS\10839.DOC HAGRI PsN: HAGRI
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mals that—Europe somehow has a definition of downers that they

use too, their down stock, their fallen stock, their high-risk animals. That is the place to look.

The question of estimating prevalence—the difficult thing here is

going to be what if we don’t see any cases. What do we tell the

American people about what we could have found if it was really

there? That is what this 1 in 10 million fight is about. One in 10

million, that prevalence can be estimated in a variety of different

ways, and we suggest in our memo a couple of different ways of

doing it. I think the important point here is not exactly what that

number is; and I think there will be quibbles. I think that the Department has learned, we have learned, others have learned, as

time has gone by, how to do a better job of estimating that. But

at the end of the day we will be able to tell people that the rate

in this country is probably very low. We can calculate it. We have

time to work on the data when it comes in. I think we will do a

good job of that.

And then the third point is that we know what to do without surveillance. And this goes back to the point that surveillance is not

our public health measure. We know what to do, and those steps

have already been taken. Surveillance is going to be something

that is going to help us figure out how well things are going.

Chairman TOM DAVIS. Let me ask over here for Dr. Weber and

Mr. Hodges, what effect does the disclosure of inconclusive rapid

test results have on the cattle markets, in your opinions?

Mr. WEBER. I think the prevailing opinion is that early on in this

process it will create significant volatility. The way these tests have

been designed and operated, according to the manufacturer and

other countries in Europe, in those settings, if they come up with

an inconclusive, the odds are fairly high that it will be determined

to be positive by the immunohistochemistry test. The way the test

is being operated now is any one of these positive reactors is sent

to Ames and declared an inconclusive. I think that the industry,

the markets I don’t think will ever be desensitized by the number

of these; they can’t afford to. And so, consequently, we want to try

to minimize the extent to which we have inconclusives, but not

jeopardize the sensitivity of the testing system; that is not our objective. But we do want to make sure that good laboratory practice

is in place, good procedures are in place, that we do not have an

inordinate number of these, because it will affect the market I

think throughout the process.

Mr. HODGES. Mr. Chairman, it is AMI’s belief that no results

should be released until the results are confirmed, using the most

sensitive assays. Releasing test results before they are confirmed

may falsely suggest to consumers that there is a public health urgency. The BSE agency is not contained in beef and therefore carcasses will be held or destroyed pending test results. Therefore we

see no compelling need to communicate such preliminary and, as

the name would suggest, inconclusive information.

Chairman TOM DAVIS. Finally, my last question to all of you, and

I will start with you, Dr. Gray, is as of December 30 non-ambulatory are prohibited from entering the human food supply regardless

if they are exhibiting signs of CNS diseases or not. Do you agree

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with the ban on downer cattle, and how effective do you think the

ban is?

Mr. GRAY. I am not dodging this, but we have studied BSE extensively; we have done analysis. We haven’t looked at this whole

problem. Everything that happens when we make a decision is

going to have consequences. If we ban downers, they are going to

go somewhere, and that could potentially create problems. I don’t

know if we have thought through this question all the way. I personally haven’t, so this is not something I have a strong feeling on.

Dr. LURIE. I am not going to dodge the question. I think that the

decision to remove downer animals from the human consumption

is the correct decision, and in terms of effectiveness, I think it will

remove 24 percent, by my estimate, of the overall risk to American

consumers. I think that the policy is in place; I think it deserves

a chance to work. I am encouraged by the data from the Secretary

that they are doing a good job of getting animals that are dead on

the farm, and that suggests to me that there is at least a good

chance that this downer animal ban will not result in the hiding

of animals that someone would prefer not to see tested.

Chairman TOM DAVIS. My time is up, but I would just opine so

then the food supply is safer than a year ago because of that downer, if for no other reason.

Dr. LURIE. No, I thought the question had to do with surveillance, and I said with respect to the surveillance program. That is

not about surveillance. The downer animals are safer because they

can’t be eaten, not because they are tested.

Chairman TOM DAVIS. If you have answers, you don’t have to answer my question in terms of the ban on downer cattle.

Mr. HODGES. Mr. Chairman, AMI supports the condemnation of

cattle that exhibit clinical signs consistent with CNS disorders. We

are also supportive of an inspection system that identifies and condemns cattle that fit certain scientifically based measures indicative of clinical BSE. However, AMI does not support wholesale

condemnation of cattle based upon a broad definition of non-ambulatory disabled status. Cattle may become non-ambulatory for a variety of reasons, both chronic and acute, and we believe that the

Department should carefully consider whether some of these animals would be acceptable for slaughter.

Mr. WEBER. I guess to add to that, it is similar to the policy that

Jim Hodges has espoused. We have had concerns about denying access to the market for these animals because we wanted to make

sure we had them available for the surveillance program. I think

that the success this first month of surveillance, with over 17,000

samples, indicates that USDA is effectively gathering many of

those, and that is going to continue. We do feel that many animals

go to market in a humane manner, which could be processed, especially by individuals, who, if it is their own animals, for their own

consumption. And I think in contrast to some of the information

that has been shared here today, it is my understanding, if you

look at BSE and the risk in this dead/down/diseased/disabled population, and, in fact, if you look at it from a disease perspective and

what is called the LD–50’s, the doses of infectivity, in Europe that

is over 96 percent of the potential risk of the BSE agent is in that

population. So indeed we dramatically are reducing risk when we

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remove animals over 30 months that may be non-ambulatory from

the human food supply.

Chairman GOODLATTE. Dr. Lurie, in his written testimony, states

that the removal of non-ambulatory or downer cattle from the

human food supply will not greatly reduce the risk to humans, and

that is because, as he and many others have correctly noted, the

testing system for BSE is a surveillance system, it is a system designed to determine whether the problem exists. And if cattle don’t

get to the places where they are tested, then you are not getting

full access to that information. So we point that out for the record.

However, Dr. Lurie has also testified that the way you do present

BSE from occurring are all things that the Department is doing,

and I think have increased those things that they are doing in

terms of determining what parts of cattle are allowed into the beef

supply and how cattle can be fed.

Dr. Weber, Mr. Hodges, I wonder if you want to respond, as Dr.

Gray had the opportunity to respond to Dr. Lurie’s main contention, which seems to me to be that the old system—most of his

quarrel seems to be with the old system in terms of statistics. I

think he has some disagreement with the current system as well,

but I would like you to give us your view of whether we are doing

the necessary things to determine whether BSE exists in our food

supply and to what prevalence.

Mr. WEBER. Clearly, as you have said and others have reiterated,

the beef supply is safe because of the actions that have been taken.

That is not a question. It seems as if we are debating what the absolute prevalence number will be through the surveillance program. But it is, I think, quite honestly the case we will have an

estimate from this, and that number will help us evaluate future

BSE prevention measures in the United States.

Chairman GOODLATTE. Mr. Hodges.

Mr. HODGES. The industry is concerned about whether BSE exists in this country to give us an indication of whether our preventative measures should be reviewed and adjusted. It is less important to have the absolute prevalence rate, because we can calculate

that rate. It is simply a matter of the confidence intervals that we

have around that rate. But we believe that the Department of Agriculture’s aggressive sampling program, is extraordinary. If you

compare it to other major exporting countries around the world,

where they test in hundreds or a few thousand, compared to the

hundreds of thousands that USDA now is projected to test. So we

believe that this is a very good program. Obviously it will require

some refinements over the course of time, but fundamentally it is

in the industry’s best interest as afforded.

Chairman GOODLATTE. Both of your organizations and the hundreds of thousands, if not millions, of people that you represent in

the cattle business and in the meat processing business have a

great deal at stake here in terms of making sure that the confidence of the American consumer is high. I would take it that you

believe the best way to do that is to have a transparent system

that assures the public that full testing is being done.

Mr. HODGES. Absolutely.

Chairman GOODLATTE. Now let me address this issue briefly

about the cattle in Washington State. That was detected under the

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old system, not the new one, but there seems to be still some suggestion that this was not a down cattle. The testimony is very direct. The Office of Inspector General has conducted two investigations of this question, and their reports clearly establish that the

BSE-positive cow sampled was a downer. Quoting from one of the

investigations: ‘‘Ultimately, the owner of Vern’s acknowledged that

the animal identified as the BSE index cow was lying down in the

trailer when it was presented to the USDA veterinarian for antemortem inspection.’’ In fact, Tom Ellestad, the co-owner of Vern’s,

made numerous public statements refuting whether or not the cow

was a downer; however, when interviewed by the Office of the Inspector General Ellestad advised,

At the time animal tag No. 6810 was presented to the Veterinarian Medical Officer Thompson, it was lying down.

Further, Ellestad explained that the cow was a downer at the

time of slaughter and said,

If she had been prodded with a lot of effort, she probably could have gotten up.

Ellestad said, however, that they were careful not to prod the

downer animal due to humane handling purposes and, instead,

stunned her while down.

We will make that statement and several others of other witnesses a part of the record.

Mr. WAXMAN. Will the gentleman yield?

Chairman GOODLATTE. I would be happy to yield.

Mr. WAXMAN. I just want to point out that I think you are not

quoting Mr. Ellestad, but quoting somebody else who seems to be

citing Mr. Ellestad. Perhaps we could leave the record open and

have further information on what Mr. Ellestad did or did not say.

Chairman GOODLATTE. We would certainly welcome the record to

remain open for clarification.

Mr. WAXMAN. Thank you.

Chairman GOODLATTE. The gentleman from Kansas, Mr. Moran,

is recognized.

Mr. MORAN. Mr. Chairman, having just arrived, I don’t have any

questions. Thank you very much.

Chairman GOODLATTE. Thank you. You are bringing us to a

rapid conclusion.

Gentlemen, we thank you all for your participation in this hearing today, and I have some remarks I would like to share to bring

this to a close.

I would like to close by saying that prior to today’s hearing a

great many things have been said, either out of ignorance or malice, about the previous BSE surveillance program and the current

expanded surveillance program that do great harm to our ability to

shape a sound public policy. Anyone of clear mind who has reviewed the totality of the testimony presented today could only

come to two obvious conclusions: first, that the cow tested in December was from the appropriate sampling population and, second,

that while the BSE surveillance program in the past has had certain administrative failings, USDA is currently in the process of

implementing a much improved, much expanded program and remains committed to ongoing improvements.

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As I observed in my opening statement, the Department of Agriculture’s expanded BSE surveillance program is intended to take a

snapshot of what is going on in this herd, this herd of 100 million

head of cattle. The surveillance is not intended or designed to prevent BSE. While not a direct protection measure itself, it will continue to contribute to the policy process determining our BSE defenses. The result of these tests will help shape how we maintain

or modify the protective firewalls already in place, which include

important bans on live cattle and certain ruminant products, feed

bans prohibiting the feeding of most mammalian protein to

ruminants, and exclusion of high-risk materials and high-risk animals in our food supply.

As a result, I remain confident that our food supply in this country, and most particularly our beef supply in this country, is of the

highest quality, and I commend those in the Department and those

in the industry who have taken this matter very seriously. It is a

serious matter, but it is also very important that we look at fact

and, in doing so, allow the American public to look at the facts that

assure them that their food supply is very safe.

The gentleman from California.

Mr. WAXMAN. Thank you, Mr. Chairman. I wouldn’t have objected for your additional time, even though you had taken up your

5 minutes in questions.

I just want to say that we all support the idea that we do the

most effective job of protecting the consumers in this country from

any unhealthy or unsafe food product. I think that as we look at

the situation of that so-called downer cow, I think the question is

a lot more open than my colleague from Virginia would indicate.

From what we have seen from many instances of evidence of testimony from people that were involved, I think we got lucky, rather

than did the right thing, and that our system was well tailored to

meet the situation.

What strikes me as the most important matter is that we be

credible. We do what is necessary, and if we can’t get a zero risk

or a 1 in 10 million, or even a 1 in 1 million kind of reduction of

risk, then we be honest about it. And I don’t think that representations are to be made citing Harvard or citing anyone else when the

evidence does not support those representations.

I hope that the result of this hearing will be very constructive.

I want the Secretary to succeed in the efforts of the Department.

I think she should take to mind all the points raised by the Inspector General. I think the Inspector General found, as if she were

looking for whether there was a criminal violation, she found there

was no intentional misrepresentation, no wrongdoing, no one wanted to misrepresent the situation, but I think that was a very carefully phrased response to what was a broader issue of whether that

cow was a downer cow or not. The issue is one under the USDA

definition, and if that cow had the potential to get up and walk,

it was not officially a downer cow, might not otherwise have been

tested, and we might not have known what is going on in this

issue.

I think we shouldn’t make wrong assumptions and then follow

through with policies that are based on wrong assumptions, and I

think we ought to be honest with the American people about what

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we can and cannot do. We need to do the best we can do, but not

mislead people into thinking that we have solutions and then close

their minds to additional evidence that shows that our assumptions

may have been incorrect to start with.

Chairman GOODLATTE. I thank the gentleman for his comments.

This debate will continue, and, in fact, I will ask unanimous consent that the record remain open for 10 additional days for the submission of answers to any questions raised by members of the committee and for other documentary information. And we will make

a notation that we want to see that final audit from the Office of

the Inspector General, and that will probably take longer than

that, so for that one item we will hold the opportunity to submit

that later.

Mr. WAXMAN. Mr. Chairman, I know you have asked consent of

this, and I won’t disagree, but I do want to point out that to get

those final audits from inspectors general can be a year or more.

We are waiting for some of the reports that they were supposed to

have done on listeria and other matters. That is why it is important not to wait until the final audit, but to make use of interim

reports so that we can learn from and let the public know about

those interim reports. But if the final report comes in, I think it

ought to be part of the record.

Chairman GOODLATTE. We are advised that it will be much

shorter than that, but we will make sure that is made a part of

the record. And, again, I would point out that taking an audit that

is incomplete is inappropriate when the party being audited has

not had an opportunity to respond. It would be like a bank examiner taking an audit and publishing it before the party that is

being examined has an opportunity to produce whether they have

a receipt to demonstrate this or that or the other activity took

place.

Mr. WAXMAN. I am going to disagree with you, Mr. Chairman,

but it don’t know if we want to prolong the debate.

Chairman GOODLATTE. I am not going to prolong the debate. You

have had two cracks at it, and I think we will call it there. We will

wait for that final audit and we will also continue to work with you

and everybody who has been involved with this to make sure that

we do have a safe food supply in this country.

With that, the hearing will be adjourned.

[Whereupon, the committees were adjourned, to reconvene at the

call of their respective Chairs.]

[The prepared statements of Hon. Dennis J. Kucinich, Hon. Rosa

DeLauro, and Hon. Lincoln Davis and additional information submitted for the hearing record follow:]

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