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GERMS, VIRUSES, AND SECRETS: THE SILENT

PROLIFERATION OF BIO-LABORATORIES IN THE

UNITED STATES

HEARING

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND

INVESTIGATIONS

OF THE

COMMITTEE ON ENERGY AND

COMMERCE

HOUSE OF REPRESENTATIVES

ONE HUNDRED TENTH CONGRESS

FIRST SESSION

OCTOBER 4, 2007

Serial No. 110–70

(

Printed for the use of the Committee on Energy and Commerce

energycommerce.house.gov
COMMITTEE ON ENERGY AND COMMERCE

JOHN D. DINGELL, Michigan, Chairman

HENRY A. WAXMAN, California

EDWARD J. MARKEY, Massachusetts

RICK BOUCHER, Virginia

EDOLPHUS TOWNS, New York

FRANK PALLONE, JR., New Jersey

BART GORDON, Tennessee

BOBBY L. RUSH, Illinois

ANNA G. ESHOO, California

BART STUPAK, Michigan

ELIOT L. ENGEL, New York

ALBERT R. WYNN, Maryland

GENE GREEN, Texas

DIANA DEGETTE, Colorado

Vice Chairman

LOIS CAPPS, California

MICHAEL F. DOYLE, Pennsylvania

JANE HARMAN, California

TOM ALLEN, Maine

JAN SCHAKOWSKY, Illinois

HILDA L. SOLIS, California

CHARLES A. GONZALEZ, Texas

JAY INSLEE, Washington

TAMMY BALDWIN, Wisconsin

MIKE ROSS, Arkansas

DARLENE HOOLEY, Oregon

ANTHONY D. WEINER, New York

JIM MATHESON, Utah

G.K. BUTTERFIELD, North Carolina

CHARLIE MELANCON, Louisiana

JOHN BARROW, Georgia

BARON P. HILL, Indiana

JOE BARTON, Texas

Ranking Member

RALPH M. HALL, Texas

J. DENNIS HASTERT, Illinois

FRED UPTON, Michigan

CLIFF STEARNS, Florida

NATHAN DEAL, Georgia

ED WHITFIELD, Kentucky

BARBARA CUBIN, Wyoming

JOHN SHIMKUS, Illinois

HEATHER WILSON, New Mexico

JOHN B. SHADEGG, Arizona

CHARLES W. ‘‘CHIP’’ PICKERING,

Mississippi

VITO FOSSELLA, New York

STEVE BUYER, Indiana

GEORGE RADANOVICH, California

JOSEPH R. PITTS, Pennsylvania

MARY BONO, California

GREG WALDEN, Oregon

LEE TERRY, Nebraska

MIKE FERGUSON, New Jersey

MIKE ROGERS, Michigan

SUE WILKINS MYRICK, North Carolina

JOHN SULLIVAN, Oklahoma

TIM MURPHY, Pennsylvania

MICHAEL C. BURGESS, Texas

MARSHA BLACKBURN, Tennessee

PROFESSIONAL STAFF

DENNIS B. FITZGIBBONS, Chief of Staff

GREGG A. ROTHSCHILD, Chief Counsel

SHARON E. DAVIS, Chief Clerk

DAVID L. CAVICKE, Minority Staff Director

(II)
(III)

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

BART STUPAK, Michigan, Chairman

DIANA DeGETTE, Colorado

CHARLIE MELANCON, Louisiana

Vice Chairman

HENRY A. WAXMAN, California

GENE GREEN, Texas

MIKE DOYLE, Pennsylvania

JAN SCHAKOWSKY, Illinois

JAY INSLEE, Washington

JOHN D. DINGELL, Michigan (ex officio)

ED WHITFIELD, Kentucky

Ranking Member

GREG WALDEN, Oregon

MIKE FERGUSON, New Jersey

TIM MURPHY, Pennsylvania

MICHAEL C. BURGESS, Texas

MARSHA BLACKBURN, Tennessee

JOE BARTON, Texas (ex officio)

(V)

C O N T E N T S

Page

Hon. Bart Stupak, a Representative in Congress from the State of Michigan,

opening statement ................................................................................................ 1

Hon. Joe Barton, a Representative in Congress from the State of Texas,

opening statement ................................................................................................ 3

Hon. Gene Green, a Representative in Congress from the State of Texas,

opening statement ................................................................................................ 5

Hon. Michael C. Burgess, a Representative in Congress from the State of

Texas, opening statement .................................................................................... 6

Hon. Marsha Blackburn, a Representative in Congress from the State of

Tennessee, opening statement ............................................................................ 8

Hon. John D. Dingell, a Representative in Congress from the State of Michigan, prepared statement ...................................................................................... 49

Hon. Ed Whitfield, a Representative in Congress from the Commonwealth

of Kentucky, prepared statement ....................................................................... 50

WITNESSES

Keith Rhodes, Chief Technologist, Center for Technology and Engineering,

U.S. Government Accountability Office .............................................................. 10

Prepared statement .......................................................................................... 13

Richard Besser, M.D., Director, Coordinating Office for Terrorism, Preparedness and Emergency Response, Centers for Disease Control and Prevention 67

Prepared statement .......................................................................................... 69

Hugh Auchincloss, M.D., Deputy Director, National Institute of Allergy and

Infectious Diseases, National Institutes of Health, U.S. Department of

Health and Human Services ............................................................................... 74

Prepared statement .......................................................................................... 75

Eddie J. Davis, interim president, Texas A&M University ................................. 91

Prepared statement .......................................................................................... 92

Gigi Kwik Gronvall, senior associate, assistant professor of medicine, Center

for Biodiversity, University of Pittsburgh Medical Center ............................... 105

Prepared statement .......................................................................................... 106

Alan Pearson, director, Biological and Chemical Weapons Control Program,

Center for Arms Control and Non-Proliferation ................................................ 110

Prepared statement .......................................................................................... 112

Edward Hammond, the Sunshine Project ............................................................. 143

Prepared statement .......................................................................................... 145

SUBMITTED MATERIAL

‘‘High-Containment Biodefense Research Laboratories: Meeting Report and

Center Recommendations’’ Gigi Kwik Gronvall, et al. ...................................... 174

Subcommittee hearing exhibts ............................................................................... 185
(1)

GERMS, VIRUSES, AND SECRETS: THE SILENT

PROLIFERATION OF BIO-LABORATORIES IN

THE UNITED STATES

THURSDAY, OCTOBER 4, 2007

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS,

COMMITTEE ON ENERGY AND COMMERCE,

Washington, DC.

The subcommittee met, pursuant to call, at 10:05 a.m., in room

2123 of the Rayburn House Office Building, Hon. Bart Stupak

(chairman) presiding.

Members present: Representatives Stupak, DeGette, Green, Inslee, Burgess, Blackburn, and Barton.

Staff present: John Sopko, John Arlington, Paul Jung, Scott

Schloegel, Kyle Chapman, Kristen Carpenter, Peter Spencer, and

Alan Slobodin.

OPENING STATEMENT OF HON. BART STUPAK, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN

Mr. STUPAK. Today we have a hearing on Germs, Viruses, and

Secrets: The Silent Proliferation of Bio-Laboratories in the United

States. Each Member will be recognized for 5 minutes for an opening statement. I will begin.

This is the first of what will likely be several hearings this committee intends to hold to examine the risk associated with the recent proliferation of high-containment biological research laboratories. Today’s hearing is focused on high-contaminate bio-laboratories known as BSL–3 and BSL–4 labs in the United States. We

anticipate a future hearing will examine the proliferation of highcontainment labs outside of the United States. Another hearing

will examine the Department of Homeland Security’s plan to close

Plum Island Animal Disease Center and build a new $500 million

animal research facility elsewhere, including a new BSL–4 lab.

Our hearing today will focus on the risk associated with the recent increase of domestic BSL–3 and BSL–4 labs. These BSL–3 and

4 labs are the facilities where research is conducted on highly infectious viruses and bacteria that can cause injury or death. Some

of the world’s most exotic and most dangerous diseases are handled

at BSL–3 and 4 labs, including anthrax, foot-and-mouth disease

and Ebola fever. The accidental or deliberate release of some of the

biological agents handled at these labs could have catastrophic consequences. Yet, as we will hear from the Government Accountability Office, GAO, no single Government agency has the ultimate re-
2

sponsibility for ensuring the safety and securing of these high-containment labs. However, GAO states there is a major expansion of

the number of BSL laboratories is occurring both in United States

and abroad but the full extent of that expansion is unknown.

No one in the Federal Government even knows for sure how

many of these labs there are in the United States, much less what

research they are doing or whether they are safe and secure.

What we do know is that the Federal Government has been funding the proliferation of these labs on an unprecedented scale. For

the past 5 years, the NIH has spent more than $1 billion on the

construction of new BSL–3 and BSL–4 labs. Given the serious risk

associated with these labs, we must ask if all these new labs are

necessary. Has the NIH carefully assessed the need for these labs

before writing checks to build them? Would we be better off expanding existing facilities rather than building dozens of new ones?

When it comes to BSL–4 labs, which are the labs that deal with

the most serious diseases for which there is no cure, should we significantly limit the number of labs so there are fewer chances for

an accidental or intentional release of these most dangerous substances? Has the proliferation of these labs reached the point at

which there are so many labs doing this research that you actually

increase the chances of catastrophic release of a deadly disease?

Apart from the issue of mushroom growth of these labs, perhaps

the most important question looming over all this is, are these labs

safe? The most serious accidents so far have occurred outside the

U.S., including the death of a Russian lab worker exposed to Ebola

and the SARS infections that sickened several people and killed a

lab worker in Asia. Here in the U.S. for the past 4 years, the CDC

has received more than 100 incident reports from labs handling select agents. However, there are indications that the actual number

of incidents may be much higher.

It is also alarming to note that more than a third of the incident

reports are from 2007, which begs the question of why has there

been such a steep increase in BSL incidents.

Federal regulations require reports only for incidents involving

so called select agents, a list of highly dangerous pathogens. But

other dangerous biological pathogens are not on the select agent

list, such as hantavirus, SARS and dengue fever. It appears that

there is no Federal oversight of the possession, use or transfer of

these dreaded diseases nor is there any requirement that the theft,

loss or release of these agents will be reported to Federal officials.

Even for select agents which are regulated, there may be a significant amount of under-reporting of laboratory mishaps. A case of

point is Texas A&M University. Texas A&M recently reported to

the CDC that one of its lab researchers had been infected in 2006

with Brucella and that blood tests of three other workers indicated

two fever exposures. They reported the incidents only after one of

our witnesses, Ed Hammond, of the Sunshine Project exposed the

incidents on his Web site. The CDC’s subsequent investigation of

the Texas A&M lab revealed a number of serious violations of the

select agent rules, including lost samples, unapproved experiments,

a lack of training, safety training and lab workers without FBI

clearance, which is required for working with select agents. Unfortunately, the CDC’s August investigation revealed not only short-
3

comings at the Texas A&M University but also shortcomings on the

part of CDC’s own oversight. It turns out that the CDC had inspected the very same Texas A&M lab prior to the disclosure of

these incidents and found only minor problems. This may indicate

that the periodic lab inspections that CDC carries out may not be

as thorough as one might hope.

Other recent incidents indicate additional problems presented by

labs around the country. Problems at the CDC’s own lab in Atlanta

and recent outbreaks of foot-and-mouth disease in the UK linked

to a high-containment lab at Pirbright illustrate the importance of

proper laboratory design, construction and maintenance, in addition to workers’ safety, worker training and security.

The potential human risk involved in high-containment laboratory biological research demand that this subcommittee take a closer look at whether these labs are being designed, constructed and

operated safely. As I said, this is the first of several hearings our

Oversight and Investigations Subcommittee will conduct on germs,

viruses, and secrets.

With that I will yield back.

I will next turn to Mr. Barton.

OPENING STATEMENT OF HON. JOE BARTON, A

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS

Mr. BARTON. Thank you, Chairman Stupak, for holding this

hearing. I want to also commend Ranking Member Whitfield, who

is not yet in attendance, for his efforts.

To my knowledge, this is the first congressional hearing into the

safety and security of our Nation’s bio-laboratories. It is a matter

that deserves attention and I believe that it is timely to take it up

at this point in time.

Today we mark 6 years ago to the day that the Center for Disease Control, the director of the Center for Disease Control, learned

that lab tests confirmed that a patient dying a South Florida hospital was infected with anthrax. As it turned out, this was the first

evidence in only a few weeks after 9/11. Our Nation, including the

Nation’s Capitol, faced a series of bioterrorism attacks using weapons-grade anthrax that was delivered through the mail. Consequently, five people died. That case, to this day, remains unsolved. In the wake of the anthrax attacks, the public and the Congress were astonished to learn that the Federal Government did

not know how many U.S. labs handled anthrax nor could the Federal Government identify every laboratory in the country with access to the Ames strain of weaponized anthrax that had been used

in the attacks. Congress responded by passing the Bioterrorism Act

in 2002, which originated, if I recall correctly, in this committee.

It established a regulatory system at the Centers for Disease Control over the possession, use and transfer of select agents and toxins. We also dramatically increased spending for the building, expanding laboratories that research deadly germs and toxins.

These kinds of facilities are known as biosafety level 3 and 4 laboratories. They deal in highly infectious viruses and other biological agents. The critical part of what they do, however, must be to

protect the public and their own workers from the inherent dangers

involved in researching the very things that they research. Strict
4

safety rules and guidelines must be required to protect against

leaks, losses, are thefts of these deadly materials.

This hearing explores several questions. Has a Bioterrorism Act

helped improved Federal oversight of select agents? Are there oversight gaps? Is the expansion to research laboratories an unmitigated good or does it pose serious risk? And how well do we manage risk? There are serious reasons to be worried. Records obtained

by the committee from the CDC revealed more than 100 acts in

missing shipments in 2003. Fortunately, as far as we know, no

deaths have been reported and it does not seem that the public has

been at risk so far. A very serious biosafety incident has occurred

at my alma mater, Texas A&M University. We have the president

of Texas A&M here today to testify about what happened there and

what Texas A&M has done to make sure that that does not happen

again.

While we are examining the possible gaps in the Federal and institutional oversight of biosafety, we should also realize that the

work performed in these high-risk laboratories is critical to our Nation’s defense and health. Much has been made about the secrecy

surrounding the bio-laboratories but it hardly seems surprising

that the world of bioterrorism research is also a world steeped in

secrecy. We might need this secrecy for our own protection but it

can also let bad habits go unnoticed and unchallenged until a crisis

exposes them.

We have seen that happen over and over again at our weapons

laboratory at Los Alamos. Last year this subcommittee had to

probe to learn that at the National Institutes of Health there was

no central inventory of human tissue samples nor any systematic

collection of data about them. We learned about that particular

problem within the NIH only after the system was abused for personal gain. We also learned in the last several years how some

Government scientists have been earning outside income by consulting for drug companies. We have found that a few have operated completely outside of the NIH approval and disclosure rules.

Secrecy does not seem to nurture the truth sometimes, so the

fact that biosafety rules have been bent and lab safety breaches

have been concealed somehow should not come to us as a complete

surprise.

We are going to hear from several distinguished witnesses about

the regulatory and oversight system of these laboratories. I want

to particularly welcome the acting president of Texas A&M, Mr.

Eddie Joe Davis. He is a personal friend of mine. He has assured

me that A&M is doing everything possible to correct the problem

and make sure it does not happen again. And I will assure this

committee, as a past chairman of this subcommittee and a past

chairman of the full committee, that if we know of a problem at

Texas A&M, I will guarantee I will help correct it and I will do

whatever it takes, including calling the Governor, the chairman of

the Board of Regents, to make sure if the changes need to be made,

they will be made. Texas A&M will be a model of how to do things

right. Not that they have not been in the past but they sure will

be in the present and the future in terms of this issue. You have

my personal guarantee of that, Mr. Chairman.
5

With that I yield back to the committee and look forward to

hearing of the witnesses today.

Mr. STUPAK. I thank the ranking member. Members will be moving in and out of this hearing as we have another hearing upstairs

on Environment and Hazardous Materials. I guess that is an appropriate subcommittee for subject of today’s hearing here.

Ms. DeGette, opening statement please?

Ms. DEGETTE. Thank you, Mr. Chairman. I would like to associate myself with your opening statement and waive my opening

statement in favor of more time for questions.

Mr. STUPAK. Very good. Mr. Green?

OPENING STATEMENT OF HON. GENE GREEN, A

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS

Mr. GREEN. Thank you, Mr. Chairman, for holding the hearing.

I appreciate you mentioning our subcommittee hearing upstairs.

There are so many of us who are also members of that and so we

will be coming and going all day, along with votes on the House

floor.

But I particularly appreciate you holding this hearing on the

growth of biosafety labs and the inherent safety risks we must

work to mitigate.

For most of us here today, the dangers associated with bioagents

are all too real as we served in this capitol complex in 2001. Several of our colleagues were targets of anthrax attacks. That attack

shed tremendous light on our lack of capacity to research these

agents for their health risk and find cures for the most dangerous

of them.

Today, approximately 6 years later, we are charged with determining whether that capacity was increased too quickly without

appropriate regulatory guidelines and safeguards. We will hear a

lot today about the incidents at Texas A&M, BSL–3 lab. There is

no question that the incidents have cast a dark shadow on Texas

A&M select agent research program.

It appears that the proper procedure are either unknown or blatantly ignored and the university has taken full responsibility by

firing the individuals who acted irresponsibly and putting the full

weight of the university behind resolving the remaining issues.

I am pleased that Dr. Davis has agreed to testify before the committee today to help us learn about the A&M experience and identify any Federal oversight gaps that need to be addressed by regulation or statute.

There are several basic concerns we must address such as the

fact that we do not even know how many biosafety labs are operating in our country. We know there are currently 15 BSL–4 labs either operational or under construction, that these labs handle the

most deadly agents for which there is no treatment currently available. We know that there are 400 BSL–3 labs registered with the

Centers for Disease Control, yet the only factor that triggers the

requirement to register with the CDC seems to be the use of select

agents and the official list of select agents is not continuously updated. We seem to have no clue about how many other labs there

are working on agents that may not appear on that list yet are undeniably dangerous. I have every confidence this hearing will be ef-
6

fective in routing out many of the other regulatory issues that are

facing our biological research laboratories. In our quest to fix many

of the problems, however, I hope we will not lose sight of the need

for this research being conducted in our country.

I am proud to have much of this research being conducted in my

own backyard at UTMB, University of Texas Medical Branch in

Galveston. I recently visited the construction site of UTMB’s Galveston National Lab, which is one of only two national biocontainment laboratories in this country. The research at the Galveston

National Lab will be conducted to develop therapies and vaccines

and tests for diseases like West Nile Virus, Ebola virus and drug

resistant TB, which I’ve had legislation on.

As a nation, we need the work to be performed in our country.

During my visit to UTMB in May I learned first-hand about the

measures UTMB is taking to ensure that the lab is built with every

contingency in mind. I have also learned about the competence of

training program that UTMB has put in place. Frankly, many of

the incidents we will hear about today could have been avoided had

appropriate and thorough training of research and lab employees

taken place.

I plan to focus a good portion of my questions on the safety aspect of the issue, not only because there seems to be a universal

need facing biosafety labs but I also have a mild personal interest

in it since my daughter is currently in her second year of fellowship

in infectious disease at UTMB. It is entirely possible she will work

on some of the research conducted in select agents either in the

currently operational BSL–4 or in the Galveston National Lab

when it opens next summer. As a parent to that research, I want

to make sure that these biosafety labs adhere to the highest safety

training standards. And it is a source of personal comfort that

UTMB has placed such an emphasis on that safety training. Given

the growth of these labs nationwide, I think we need to step up our

safety training efforts nationwide and my office will begin to draft

legislation on this important issue.

And I appreciate the witnesses here today and the chairman for

calling this hearing because our Oversight and Investigation Subcommittee does the investigation, then we have to go from there to

draft legislation. And thank you, again, Mr. Chairman. I yield back

my time.

Mr. STUPAK. Thank you, Mr. Green. Mr. Burgess, opening statement please.

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS

Mr. BURGESS. Thank you, Mr. Chairman. Mr. Chairman, I want

to assure you that I do not have duties in the other subcommittee

so I will be with you all day. I did not want you to feel in danger

or abandoned.

Mr. Chairman, thank you for holding the hearing today. I am

grateful that we are investigating this. We are in the 21st century

and we have come so far from 20th century problems, 20th century

difficulties and now providing for our common defense surely includes homeland security and protecting our homeland against the

threat of biological attack.
7

Recent years we have seen Hurricane Katrina, we have seen

SARS, we have seen threats of bird flu. So natural disasters come

into that list as well. We have got to have the guidelines in place.

We have got to have guidelines in our labs, our streets to ensure

that the very situations we are trying to protect ourselves against

do not foster the environment that could be ripe for the type of biological accident or catastrophe that we all fear.

Mr. Chairman, you are right, the labs are proliferated. That is

appropriate because of the 21st century threat. Our regulation remains mired in the last century. There is a plethora of agencies but

they are beset by a lack of communication, which is typical of the

stove piping that frequently occurs within Federal agencies. And I

hope that our committee will put itself to the task of eliminating

those barriers.

The truth is, the Federal Government only regulates a specific

list of select agents but this list does not seem to be updated with

sufficient frequency and, in fact, does not include some of the most

deadly and contagious pathogens including the viruses responsible

for severe adult respiratory syndrome or SARS. I cannot help but

wonder, Mr. Chairman, if we are doing enough to keep this list updated to ensure that our scientists and our private citizens are protected.

I know this is supposed to be the first in a series of hearings on

this issue and I ask that we specifically look into whether or not

the list is updated, how it is updated and if it is done in a most

timely fashion.

Now, our committee has an important responsibility to the American public and over the years I am grateful for the active and aggressive oversight that we have had in many of our labs in the

country. As terrorism becomes more and more sophisticated and

global activities seem to make the world a smaller and smaller

place, we must continue to implement and maintain comprehensive

measures for our safety.

Today’s hearing brings further light to serious and ongoing transit laboratories across the country. When labs do not take adequate

care and caution, they literally put some of the brightest minds of

the country in danger. Part of the responsibility falls on the Federal Government due to the ambiguity regarding the regulations

and the guidelines that labs must follow.

We, as members of this committee, have a duty and responsibility to the citizens of the country, to the scientists of the country,

to resolve any ambiguities that currently exist within the Federal

regulations so that the biosafety in all labs can be assured. The sad

reality is that while the security breaches that have recently been

documented in the newspapers, while they are serious, ultimately

they could have been catastrophic had the right conditions prevailed at the time that those breaches occurred.

But having said all that, I do want to join my Texas colleagues

in welcoming the president of one of the premier research facilities

in the United States, which happens to be in one of the premier

States in the United States, the State of Texas. So Texas A&M

president, Dr. Ed Davis, welcome to our committee. Of course,

A&M has produced some of the greatest thinking minds of this century, including our ranking member, Mr. Barton. Unfortunately,
8

there has also been some controversy and today they are not going

to just be talking about the football team record.

Dr. Davis, thank you for being here today and we look forward

to hearing your discussion of exactly what happened in college station. Hopefully, you can give us some guidance on what we should

do at our level to resolve the ambiguity and allow your scientists

to have the tools in place to provide the safety that they need to

conduct their research and ultimately protect the American people.

I would also like to briefly mention, as did my colleague, Mr.

Green, the issue of training at the University of Texas Medical

Branch in Galveston. They have been a leader in this, responding

to a need and developing a formal training center for laboratory

personnel. They are receiving Federal dollars through the Department of Defense appropriations bill. Just make a note to the Majority that we do need to vote on a conference report on the Department of Defense appropriations bill with all haste and that that

should not be encumbered with other issues and I would encourage

you to talk to your leadership so that we can get that done and this

great lab in Mr. Green’s district can go forward and provide the

training that the scientists need. And they are going to work in

conjunction with the Center for Disease Control and the National

Institute of Health.

Again, Mr. Chairman, I thank you for holding this important

hearing. I know we have got a lot of issues to get to today, so I

want to be generous to you and I will yield back the balance of my

time.

Mr. STUPAK. Thank you for yielding back 35 seconds. Next, go to

Mr. Inslee for an opening statement. Please, sir?

Mr. INSLEE. I will waive my opening. Thank you, Mr. Chairman.

Mr. STUPAK. Mrs. Blackburn, opening statement?

OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TENNESSEE

Mrs. BLACKBURN. Thank you, Mr. Chairman. I appreciate the

hearing and I will also, since my late father-in-law was a Texas

Aggie, I will express my welcome to Mr. Hammond also and to any

of the other Aggies that are in the audience.

I am delighted that we are having this hearing today. The hearing focuses on facilities that conduct research on specific infectious

diseases, term-select agents. The labs that conduct the research on

these select agents are classified as either a biosafety level 3 or 4.

Now, in Tennessee, at the University of Tennessee, there are a couple of different labs. One is in Memphis and one is in Oak Ridge.

The UT Health Science Center in Memphis is currently constructing a new regional BSL–3 biocontainment lab but we are pleased

with that facility and pleased with the progress that they have

made on some of their biotechnology and the research that goes

with that. This is something when I was in the State senate in

Tennessee. I spent a good bit of time trying to help get off the

ground helping start the biotechnology association and the task

force that help feed the energy into that when I was in the State

senate. We know that these facilities are working with materials

that can potentially cause serious harm to humans and to animals
9

with some of the pathogens having no known cure. In today’s

world, the threat of terrorism, as my good colleague has mentioned,

is present. Not only could terrorists potentially use one of the

pathogens to harm the public, there is also the possibility that

those wishing America harm could genetically alter these pathogens to form a new strain with no known cure.

And while I understand that the research is clearly needed, we

must also focus on the safety of those performing the research, as

well as the communities in which these labs and facilities are located. I think we have all expressed concern with the way the

counting is done and knowing how many of these are actually

available. We know that the NIH said there was 277 in 2005 and

today the number is estimated to be around 400. I will let go also

one of the things that my colleague was mentioning. The lack of

communication between the agencies. When you look at the FDA,

the CDC and the NIH, Mr. Chairman, we continue to hear, whether it is in health sub or here, the inter-agency, as well as the intraagency communication and collaboration and share of information

seems to not be what we would like for it to be, especially when

we are looking at something as delicate and as necessary as the

type of research we are talking about and I hope that we have the

opportunity to address some of that today.

I do want to welcome our witnesses today. As I said, especially

any Aggies who are before us, I will join in welcoming them. I also

look forward to hearing and engaging in the Q and A. And, Mr.

Chairman, I yield back my time.

Mr. STUPAK. I thank the gentlelady for her opening statement.

That concludes the opening statements. Before we begin with testimony, I would like to recognize our colleague, Chet Edwards, who

is here. Chet has Texas A&M in his district and I know he has

talked to me and others about this issue. So welcome, Chet. Seeing

no other members, we will move forward to our first panel of witnesses.

We have Dr. Keith Rhodes, Chief Technologist, Government Accountability Office, Center for Technology and Engineering. And

with Dr. Rhodes is Dr. Sharma, who is GAO’s Assistant Director

of Applied Research and Methods.

It is the policy of the subcommittee to take all testimony under

oath. Please be advised that witnesses have the right under the

rules of the House to be advised by counsel during their testimony.

Do either of you gentlemen wished to be represented by counsel?

Mr. Rhodes? Dr. Sharma? No. OK. Witnesses indicated they do not,

therefore, I will ask you to rise, raise your right hand, take the

oath.

[Witnesses sworn.]

Mr. STUPAK. Let the record reflect that the witnesses replied in

the affirmative. You are now under oath. Dr. Rhodes, are you going

to start with your opening statement please?
10

STATEMENT OF KEITH RHODES, CHIEF TECHNOLOGIST, CENTER FOR TECHNOLOGY AND ENGINEERING, U.S. GOVERNMENT ACCOUNTABILITY OFFICE; ACCOMPANIED BY SUSHIL

K. SHARMA, ASSISTANT DIRECTOR, APPLIED RESEARCH

AND METHODS, U.S. GOVERNMENT ACCOUNTABILITY OFFICE

Mr. RHODES. Thank you, Mr. Chairman. Mr. Chairman, members

of the subcommittee, my colleague, Dr. Sharma, and I are pleased

to be here today to discuss our preliminary findings on the oversight of the expansion in the United States of biosafety level 3 and

biosafety level 4 labs, also known as high-containment labs. This

expansion is, in part, a response to the global spread of emerging

infectious diseases and the threat of bioterrorism. As you know,

BSL–3 and 4 labs often contain the most dangerous infectious disease agents like Ebola, small pox and avian influenza.

Although high-containment labs are designed to promote the

safety of researchers and the public, accidents and security

breaches have occurred in the past and they will occur in the future. Experts tell us that most accidents occur due to human error,

which cannot be completely eliminated. In addition, these labs can

be used by terrorists or people with malicious intent to acquire or

develop harmful biological agents, posing a serious threat to our

national security and public health.

The intentional dissemination of anthrax in the U.S. mail highlighted major gaps in our civilian capacity to respond to a biological

attack. One such gap noted by the National Institute of Allergy and

Infectious Diseases was the shortage of high-containment lab capacity available to conduct research for medical countermeasures.

To address this concern, the administration and Congress responded by providing increased funding for biodefense research and

for additional BSL 3 and BSL 4 labs in the private sector, especially in university settings.

As a result, concerns have been raised about the adequacy of

oversight of these labs because the deliberate or accidental release

of biological agents can have disastrous consequences, such as exposing workers and the public. In addition, concerns have been

raised about their safety, as well as operations. Finally, there are

security concerns about the potential theft of the agents themselves. Accordingly, you asked us to address the following three

questions. One: Is there an expansion going on? Two: Who is in

charge of this expansion? And three: What lessons can be learned

from recent incidents at three high-containment labs? With regard

to expansion, Mr. Chairman, as you can see on the charts, we

found that a major expansion of BSL 3 and 4 labs is taking place

in the United States. For example, concerning BSL–4 labs, which

handle the most dangerous agents, the number of these labs has

increased from five before the terrorist attacks of 2001 to 15, including at least one in planning. With regard to BSL–3 labs, no one

knows how many there are but the number is surely in the thousands. In the past, the most dangerous of these types of labs, that

is the BSL–4 labs, were largely in Federal hands. But since 2001,

the expansion is taking place across many sectors, Federal, State,

academic and private and across most of the United States. While

information on expansion is available about high-containment labs
11

that are one, registered with the select agent program and two, federally funded, much less is known about the expansion of labs outside the select agent program, as well as the non-federally funded

labs including their location, activities and ownership.

With regard to who is in charge of this expansion, Mr. Chairman,

we found no single Federal agency has the mission and, therefore,

is accountable for tracking the number of all BSL–3 and 4 labs

within the United States. Although several agencies have a need

to know the number and location of these labs to support their missions, no agency knows how many such labs there are in the

United States or their locations. Therefore, no Federal agency is responsible for determining the aggregate risks associated with the

expansion of these labs. Since there is a baseline risk associated

with any high-containment lab, the aggregate risk associated with

this expansion will increase as their numbers increase. Importantly, the safety and security risks will be greater for new labs

with less experience.

Finally, from the three recent incidents that you asked us to examine, one: the failure to report to CDC exposures to select agents

by Texas A&M University, two: the power outage at CDC’s new

BSL–4 lab, and three: the most recent release of the foot-andmouth disease virus at Pirbright in the United Kingdom. We have

identified six lessons that can be learned. These lessons highlight

the importance of one: identifying and overcoming barriers to reporting in order to enhance biosafety through shared learning from

mistakes and to assure the public that accidents are examined and

contained. Two, training lab staff in general biosafety, as well as

in specific agents being used in the labs to ensure maximum protection. Three, developing mechanisms for informing medical providers about all the agents that lab staff work with to ensure quick

diagnosis and effective treatment. Four, addressing confusion over

the definition of exposure to aid in the consistency of reporting.

Five, ensuring that BSL–4 lab safety and security measures are

commensurate with the level of risk these labs present. And six,

maintaining high-containment labs to ensure integrity of physical

infrastructure over time.

In summary, the expansion of BSL–3 and 4 labs is indeed taking

place in the United States and it is proceeding in a decentralized

fashion. While some expansion may be justified, unwarranted expansion without adequate oversight is proliferation, not expansion.

Since the full extent of the expansion is not known, it is unclear

how the Federal Government can ensure that sufficient but not superfluous capacity, bringing with it additional unnecessary risk is

being created.

In conclusion, Mr. Chairman, the limited Federal oversight that

does exist for high-containment labs is fragmented among different

Federal agencies and for the most part, relies on self-policing.

As you have said in your opening statement, the inherent weaknesses of an oversight system based on self-policing are highlighted

by the Texas A&M University case. While CDC inspected the labs

at Texas A&M in February 2006, as part of its routine inspection,

its inspectors failed to identify three items. One, a worker became

exposed and ill. Two, unauthorized experiments were being conducted and unauthorized individuals were entering the labs. And
12

three, both the agents and infected animals were missing. It was

not until a public advocacy group learned of the Brucella incident

and according to this group, applied pressure by demanding records

about the incident, that the university reported this incident to the

CDC. This report prompted the subsequent in-depth investigations

by the CDC. This incident is raising serious concerns about, one,

how well the agency polices select agent research being conducted

in over 400 high-containment labs registered under the select agent

program located at various universities around the country and,

two, whether the safety of the public is compromised. Moreover, if

similar safety breaches are occurring at other labs, they are not

being reported nor is CDC finding them.

I want to leave you with this thought. Since the labs are largely

overseeing themselves at this point, it is not the regulators but

only the operators of these labs who can tell you whether the three

recent incidents are the tip of the iceberg or the iceberg itself.

Mr. Chairman, this concludes my prepared remarks. Dr. Sharma

and I stand ready to answer any questions you or members of the

subcommittee may have.

[The prepared statement of Mr. Rhodes follows:]
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Mr. STUPAK. Thank you, Dr. Rhodes. Dr. Sharma, you do not

have an opening statement, sir?

Mr. SHARMA. No.

Mr. STUPAK. OK. For the record, without objection, Mr. Dingell’s

statement will be submitted for the record.

I am sure Mr. Whitfield has one and when he comes up, it will

be submitted for the record, as well as opening statements of other

members of the subcommittee.

The prepared statements of Messrs. Dingell and Whitfield follow:]

PREPARED STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN CONGRESS

FROM THE STATE OF MICHIGAN

Mr. Chairman, thank you for holding this important hearing. I congratulate you

for shining some much-needed light on the hidden world of bio-research, and I look

forward to assisting you in this investigation as we go forward.

The central question raised by these hearings is simply this: Are these high-level

biosafety laboratories safe?

The fact is that we just don’t know. According to the Government Accountability

Office (GAO), no single Federal agency even knows how many high-level biosafety

labs there are or where they are, much less whether they are safe and secure. Moreover, no one Federal agency has the responsibility for tracking these labs and ensuring their safe operation.

Even though no one seems to know how many labs there are, the National Institutes of Health has energetically funded the construction of new high-containment

biosafety labs all over the country, to the tune of more than $1 billion over the past

5 years. It is unclear whether anyone has based these funding decisions on a quantifiable assessment of need. Mr. Chairman, I intend to ask GAO to review this

spending, to provide an overall accounting of how much was spent, where it was

spent, and on what basis.

Although we don’t know how many labs there are, GAO and other witnesses will

testify that the number of high-level biosafety labs has increased dramatically over

the last decade. For example, at the height of the Cold War, and as little as 10 years

ago, this country had only two Level-4 laboratories—laboratories that handle deadly

diseases that have no cure: one at the Centers for Disease Control and Prevention,

and one belonging to the Army at Ft. Detrick, Maryland.

By next year, there will be 12 such labs in operation. Do we really need 12 laboratories that operate at the very highest level of security? Is there a good reason for

creating these labs or have we simply begun an arms race against ourselves?

I had hoped that the Department of Homeland Security would be here today to

assist us in answering some of these questions. I was surprised and displeased, however, to learn that even though DHS is responsible for homeland security, it declined our invitation to testify on the grounds that they were too busy and otherwise

engaged.

Perhaps we need to consider compelling the attendance of the proper DHS officials at our next hearing. That would also provide DHS with an opportunity to explain their proposal to close the Plum Island Animal Disease Center off the coast

of New York and move it to the mainland.

Plum Island is where the Department of Agriculture has for decades conducted

research on foot-and-mouth disease. Much to their credit, they have done so safely

and securely, and apparently without incident.

The DHS proposal to close Plum Island and move foot-and-mouth virus to the

mainland U.S. is utterly baffling. Foot-and-mouth is one of the most contagious diseases in the world. We know from recent incidents in the U.K. that it can escape

from even a high-level biosafety lab. And we know that any release of the foot-andmouth virus could have a devastating effect on the U.S. livestock industry, just as

it did in the U.K. in 2001. Why then would DHS propose to move this Level-3 biolab

that works with the most dangerous animal diseases in the world from Plum Island

to the heart of farm country?

I look forward to this committee’s investigation of the Plum Island issue as part

of this series of hearings on biosafety laboratories.

Mr. Chairman, I thank you for your recognition and look forward to the testimony

of the witnesses.
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Mr. STUPAK. We will begin with questioning, 5 minutes each. I

will begin. Dr. Rhodes, you mentioned select agents, how many select agents are there? These select agents being done at these labs.

Is it 72?

Mr. RHODES. Seventy-two.

Mr. STUPAK. OK. One of your last statements, you indicated that

there are other labs out there. You mentioned these 400 and some

high-containment labs. But there are other labs out there doing

other research on potentially dangerous agents and viruses and

diseases, is that correct?

Mr. RHODES. Correct.

Mr. STUPAK. Do you know how many other labs that are out

there that are not considered high-containment labs?

Mr. RHODES. No. That would be a larger number than the ones

that are labeled high-containment.

Mr. STUPAK. Of these other labs, are they Government-sponsored

labs, as in research being done at the direction or request of the

Federal Government?

Mr. RHODES. Not necessarily.

Mr. STUPAK. OK. But possible?

Mr. RHODES. Possibly.

Mr. STUPAK. So agents such as SARS, dengue fever, hantavirus,

they are not on these select agents?

Mr. RHODES. Correct.

Mr. STUPAK. And that research could be done in other labs that

we do not know about?

Mr. RHODES. Correct.

Mr. STUPAK. And these are just as deadly as an Ebola outbreak?

Mr. RHODES. Could be, potentially, yes.

Mr. STUPAK. OK. In your testimony you said you surveyed 12

Federal agencies involved with these high-containment labs, is that

correct?

Mr. RHODES. Yes.

Mr. STUPAK. And several of these agencies have a need to know

within their agencies how many level 3 and how many level 4 labs

are in the United States and where they are located, is that correct?

Mr. RHODES. That is correct.

Mr. STUPAK. If I read your testimony correctly of these 12 agencies, none of them, not Homeland Security, not the Center for Disease Control, not the FBI, none of the agencies actually know how

many level 3 or level 4 labs are out there?

Mr. RHODES. Correct.

Mr. STUPAK. OK. The number of BSL–4 labs, those labs that

handle the most dangerous and lethal diseases, have increased

from two labs prior to 1990 to 15 today, is that correct?

Mr. RHODES. With one in planning. At least one is still in planning right now.

Mr. STUPAK. OK. You know, this committee also has jurisdiction,

we have done investigations into our nuclear weapons research in

Los Alamos and others. And it seems like in the field of nuclear

we limit the number of labs doing dangerous work so we can keep

the research closely regulated, under tight security, under Government control and consolidated in a few locations rather than spread
54

across the country. With the BSL–4 labs, we could conceivably

have an outbreak of something, Ebola or whatever virus spread

amongst the 15 different labs with varying levels of physical security. Should not Congress want these diseases in fewer hands and

fewer locations rather than more locations and more people dealing

with it?

Mr. RHODES. Well, from having come out of the nuclear weapons

lab program—I mean, that is my background, is in nuclear weapons side. That was the direction that we took in the establishment

of the labs that are authorized to work with nuclear weapons material, particularly special nuclear material. Part of that is risk. Two

laboratories were established so that there was competition between the laboratories. The idea being that you come up with a

better idea through the competitive designs. But you do not expand

beyond two. The more BSL–4 laboratories there are, the more opportunities for mistakes. The more opportunities there are for a release. BSL–4 handles the most dangerous biological agents. They

are the ones in some cases for which there are no medical countermeasures. And so narrowing the field and bringing the number

down reduces your risk because each one of these laboratories does

have a baseline risk to it.

Mr. STUPAK. And one of the risks that Congress was concerned

about was terrorism, right?

Mr. RHODES. Absolutely.

Mr. STUPAK. So the more labs you have out there, the more opportunity, if you will, for something to go wrong to fall into the terrorists’ hands.

Mr. RHODES. The more laboratories you have, the more staff you

have.

Mr. STUPAK. Correct.

Mr. RHODES. The more staff that you have to perform background investigations on. The more people who are possible to be

compromised. The more material that has to be moved in order to

go from point A to another lab. It becomes an extremely complex

management of material problem.

Mr. STUPAK. After the anthrax problems we had in this country

in the fall of 2001, Congress charged the labs to develop medical

countermeasures.

Mr. RHODES. Yes.

Mr. STUPAK. Could you find anything where they said to build

more labs?

Mr. RHODES. I have not found anything that said, as a result of

that, build more labs. Now, the NIAID pointed out an extreme gap

in the laboratory structure for countermeasure research but from

the Government’s direct perspective and the directives out to both

industry and the scientific community and all that, it was countermeasures, not specifically build laboratories.

Mr. STUPAK. Just one more and if you know the answer, maybe

you do not. There is a level 4 lab right near here in Bethesda, correct?

Mr. RHODES. That is correct.

Mr. STUPAK. Did you check that lab?

Mr. RHODES. That is one of the labs that we researched.
55

Mr. STUPAK. Are they doing any hot stuff there at level 4 at Bethesda?

Mr. RHODES. If I understand correctly, they are at level 3 at the

moment. They are only handling level 3 agents.

Mr. STUPAK. But they are licensed or not licensed but they are

a level 4 lab?

Mr. RHODES. Yes, they are a level 4 containment.

Mr. STUPAK. So it is capacity not being utilized, it is already

built?

Mr. RHODES. That is correct.

Mr. STUPAK. OK. Mr. Barton for questions please.

Mr. BARTON. Thank you, Mr. Chairman. The implication in the

written report is that we have too many of these level 3 and level

4 biolabs. What would a good number be?

Mr. RHODES. I do not know what a good number would be, sir.

The point that we are trying to stress in the report is that no one

knows what the number is. Decomposing from capacity requirement to figure out what the number is. If labs are being built just

because money is available and not necessarily to meet a——

Mr. BARTON. Well, based on the need as you see it today, do we

need more or less?

Mr. RHODES. I do not know whether we need more or less but

we need to know the ones that we have and we need to know what

they are doing.

Mr. BARTON. The report does not seem to think—I mean, I get

the implication that the report indicates we have too many. I do

not care if you say 10 or 100 or 2.

Mr. RHODES. The point of the report is that there is too many

at the moment for the level of oversight that is being provided. So

it is stretched beyond the ability of the fragmented and decentralized oversight that exists now.

Mr. BARTON. So you are not worried about——

Mr. RHODES. If the oversight is going to stay the way it is, we

need less labs because the oversight that is there right now cannot

keep up with the number and the expansion that is going——

Mr. BARTON. When you say the oversight right now, what do you

mean by the oversight? Do we have too many agencies? Are the

agencies we have not doing a good job?

Mr. RHODES. Well, we have no single agency. We have no agency

that actually knows what the number is and when we go out to the

agencies, we still cannot get what the number is.

Mr. BARTON. All right. How many agencies can fund one of these

level 3 or level 4 laboratories?

Mr. RHODES. Well, at the moment I think it would be 15.

Mr. BARTON. So there is 15 different Federal agencies that can

fund these laboratories.

Mr. RHODES. I think so.

Mr. BARTON. Is that correct?

Mr. RHODES. Yes, I think so.

Mr. BARTON. How many should there be? Should we only let one

agency fund them?

Mr. RHODES. No, you can let them all fund, that is fine but who

is going to provide the oversight and make certain that there is

cross communication between those organizations that are funding,
56

as well as those organizations that are providing the oversight?

Right now it is a very fragmented environment.

Mr. BARTON. So you do not have a problem that 15 different Federal agencies can fund these. Your problem is or the GAO’s problem, not your personal problem, but is it the agencies that fund

these labs do not coordinate between each other on oversight. Is

that correct?

Mr. RHODES. That is part of it and they are not coordinating on

the actual need for the laboratories. So a particular department

has funding and it says it has a need and it goes and funds a laboratory when, for example, let us take Texas A&M.

Mr. BARTON. Just out of pulling a name out of a hat.

Mr. RHODES. Just pulling a name out of a hat. As you said in

your opening statement, they will be the model laboratory. Well,

why should not they be funded by multiple agencies and make certain that there is coordination amongst the funding so that the requirements are met and why should not it be that their oversight

is coordinated as well so it is not fragmented?

Mr. BARTON. I would think, to pull a name out of a hat, Texas

A&M would love to have multiple sources of funding.

Mr. RHODES. I would imagine so. I would imagine many other existing laboratories would like that too. The problem is that, as the

number of labs increases, the risk increases and, as that risk increases, the oversight becomes more difficult. As the oversight becomes more difficult, the transparency of what is going on in the

laboratory goes away and that is the major concern. If the United

States Government decides in consultation with the Congress regarding funding that there need to be 15, 20, 50 BSL–4 labs and

there are needs for it and there is adequate safety and security associated with it and there is adequate coordinated oversight and it

is meeting adequate requirements definition, so be it.

Mr. BARTON. If you had to pick one agency today to be the lead

coordinator for this new oversight system, which agency would that

be?

Mr. RHODES. I cannot say that at this moment but we will report

that out in the recommendations in our final report. These are our

preliminary findings but we will report that out in our final report.

Mr. BARTON. Is there an existing agency that is capable of being

the lead agency for oversight that is already in existence? Can you

answer me that question?

Mr. RHODES. I do not know if I can answer that question. Let me

give you just one point I would make about that oversight. The

oversight has to be completely independent. The oversight cannot

come from someone who is operating a lab. I will give you the example from the Pirbright incident in the United Kingdom. I will be

very, very surprised if anyone is ultimately held liable for the release of Foot and Mouth virus from that laboratory because the operator of the lab is the regulator. There was a private laboratory

on the Government facility. Funding was coming from multiple directions. Multiple kinds of research was being done. I do not think

they will be able to figure out who is ultimately responsible for the

leak and who is ultimately accountable for it. And one of the complicating factors is that DEFRA, which is their version of the De-
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partment of Agriculture, is the operator of that laboratory, as well

as the oversight.

Mr. BARTON. I have two more questions, Mr. Chairman. I know

that my time is expired. The first question is, should these type of

laboratories be allowed at academic institutions generically?

Mr. RHODES. Yes, I do not see why not. I mean, that is the——

Mr. BARTON. So it is not a problem per se that it is at an academic institution?

Mr. RHODES. It is absolutely not an issue of where the laboratory

is located. Obviously, people are going to have to have open hearings about where it should be. It is not a question of academia.

Mr. BARTON. Last question, Mr. Chairman. The laboratory at

Texas A&M, was it level 3 or level 4, do you know?

Mr. RHODES. It is a level 3.

Mr. BARTON. Thank you. Thank you, Mr. Chairman.

Mr. STUPAK. Just a question. I mentioned about Bethesda being

3 and Mr. Barton mentioned about level 3. If a lab goes from 3 to

4, is the community around it aware or told what the agent or that

is known?

Mr. RHODES. It may not be.

Mr. STUPAK. There is no requirement either way?

Mr. RHODES. I have not seen any documentation so far that there

has to be a public hearing about a laboratory being allowed to go

from 3 to 4. There may be a requirement for a public notice but

I have not seen documentation that says that so far.

Mr. STUPAK. I mentioned in my opening that we intend to also

examine level 3 and 4 labs internationally and we intend to examine the proposal to close Plum Island and relocate the foot-andmouth disease research to the mainland. Will GAO continue to

work with the committee on that investigation research?

Mr. RHODES. Yes.

Mr. STUPAK. OK, thank you. Ms. DeGette for questions please.

Ms. DEGETTE. Thank you very much, Mr. Chairman, and I appreciate you holding these hearings which are continuations of

hearings this committee has done for a number of years. I was telling staff about several years ago when I went to the level 3 lab,

the CDC lab, up in Fort Collins, Colorado. And the lab at that

time, they had vector-borne agents there and these vector-borne

agents were being stored in a modular unit behind the building

that had weeds growing up from the floor and it had flies flying—

these are vector-borne agents and I am happy to report that since

I visited that and with the assistance of my former colleague, Bob

Shaffer, we succeeded in having a new CDC lab built there. I assume they have eliminated the weeds and the flies. But I was really dismayed about your testimony that we now have a proliferation

of these level 3 and 4 labs since 2001. Doctor, I am wondering if

you can tell us why you think that we have had such a proliferation of these labs?

Mr. RHODES. There is a perceived gap, and actually stated by

NIAID, that there is a need post-fall of 2001 events with the anthrax through the mail, for a response network to a future terrorist

event. Also a perceived need for ability to do research on countermeasures. And as a result of that, as I stated, both the administra-
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tion and the Congress have given funding to meet this requirement.

Ms. DEGETTE. And that is going to a wide range of types of private and public entities?

Mr. RHODES. Yes, ma’am.

Ms. DEGETTE. So there has been no distinction made. I think you

pointed this out. There has been no distinction made between governmental oversight and private or academic labs, correct?

Mr. RHODES. That is correct.

Ms. DEGETTE. And is it your view—I know you told Mr. Barton

that you did not have an opinion yet on which agency should be

the lead agency in overseeing these labs but my question is, do we

even want more than one agency overseeing level 3 and 4 labs

right now? We have got the CDC, the USDA, the DOD and others.

Do we want a coordinating lab or do we want just one single agency with authority over regulation of all of these labs?

Mr. RHODES. That would ultimately be the simplest answer.

Ms. DEGETTE. One agency coordinating.

Mr. RHODES. One agency. But that said, the agency that does the

oversight will ultimately end up being a coordinating agency because they will have to go to each of the departments and agencies

that are funding and go to any of the laboratories and will have

to coordinate with them relative to requirements and all that.

Ms. DEGETTE. But the advantage would be you would have one

set of standards that would be implemented, correct?

Mr. RHODES. That is correct.

Ms. DEGETTE. Dr. Sharma is nodding in agreement. And so

when do you think you will have your recommendation as to what

that agency and process should be?

Mr. RHODES. Our schedule right now is to issue our final report

in February.

Ms. DEGETTE. February 2008?

Mr. RHODES. Yes, 2008.

Ms. DEGETTE. Thank you.

Mr. RHODES. And we will have to put it out for comments, so I

would say probably by March.

Ms. DEGETTE. OK. Now, as I mentioned, not all of these level 3

and 4 labs are federally supported. Some of them are State supported or even private. I am wondering if these non-federally funded labs have unique concerns about which we should be aware and

which we should think about as we think about further regulation.

Mr. RHODES. A non-federally funded laboratory is, in effect, an

information black hole, so you do not have any insight into it. Unless they are part of the select agent program or they are federally

funded, the United States Government will not have any insight

into who owns it, where it is, what they are doing.

Ms. DEGETTE. What their protocols are.

Mr. RHODES. Absolutely.

Ms. DEGETTE. And what can Congress do to address that issue?

Mr. RHODES. That would be part of the charter, I guess of the

new oversight. They would have to have powers of authority to talk

to and gain information from all BSL–3 and 4 laboratories, not just

the ones that the Government has oversight of because it is a public safety issue.
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Ms. DEGETTE. What you are saying, I think based on your experience with the nuclear labs, what we would have to say is, if a lab

had in its possession a certain type of these agents, they would

automatically be regulated federally and it is not happening now.

Mr. RHODES. Well, let us look at nuclear power for example. You

have the Nuclear Regulatory Commission. Well, the Nuclear Regulatory Commission is not just talking about commercial power.

Ms. DEGETTE. Right.

Mr. RHODES. Talking about anyone who is handling a radio nuclide.

Ms. DEGETTE. Right.

Mr. RHODES. So if your transportation person who is using cesium gauges in order to figure out the depth of a freeway.

Ms. DEGETTE. Right. But what——

Mr. RHODES. You are licensed.

Ms. DEGETTE. And what I am saying is, right now we do not

have that same authority over these biologic agents.

Mr. RHODES. Absolutely.

Ms. DEGETTE. If someone can just set up one of these labs and

if it is privately funded then, what you are saying is, we are not

regulating that.

Mr. RHODES. Correct.

Ms. DEGETTE. Yes, Dr. Sharma wants to add——

Mr. SHARMA. I would add, this is a very essential issue because

these BSL–3 and 4 labs in the United States do not need any kind

of permit other than building permits if they are not receiving any

Federal funds. There is no certification requirements. They can operate. In addition to that, we have additional problems. There are

these mobile labs. You can build it. So it is a very complex issue

and right now, our system is, there is no way for any agency to

know but we are looking at some other systems in other countries.

There are requirements to see the extent of which those systems

could be applied here and we will be reporting those as part of our

report in February.

Ms. DEGETTE. And as I said, what those systems would be is

similar to the system that we use for nuclear material, which is if

you are in possession of these agents and you are going to have a

lab, then you have to meet certain requirements, correct?

Mr. RHODES. Yes.

Ms. DEGETTE. And is that part of what you are developing for

next spring?

Mr. RHODES. That is the direction we are looking.

Ms. DEGETTE. I think the committee would all agree that is an

extremely important set of guidelines. And I want to thank you

both for coming today.

Mr. RHODES. Thank you.

Ms. DEGETTE. I yield back.

Mr. STUPAK. Mr. Burgess for questions, please.

Mr. BURGESS. Thank you. Dr. Sharma, if I could just pick up on

what you were just saying as you concluded your response to Ms.

DeGette. So if there is no Federal funding involved, the only permitting is local building permits?

Mr. SHARMA. Right.
60

Mr. BURGESS. Did I understand that correctly? So then there is

no one that certifies whether this is a level 3 or a level 4 facility?

Mr. SHARMA. It is our understanding that if you are not receiving

any Federal funds, if you are not working the select agents, there

is nobody you have to seek permission from other than city or State

requirements.

Mr. BURGESS. So to answer the chairman’s question about who

in the surrounding community is notified, then, obviously, no one

would be notified in that situation, is that correct?

Mr. SHARMA. Correct.

Mr. BURGESS. Have you looked at all, and obviously other—we

have heard a little bit about the foot-and-mouth disease incident in

Great Britain. What are the systems in other countries? How are

they dealing with this? Because clearly this is something that is a

process in evolution, it is a concept that is developing. Where are

other countries on that continuum of development of their regulation of these types of labs?

Mr. SHARMA. We have not extensively looked at other foreign

systems and we have plans to look at how other countries are handling this issue.

Mr. STUPAK. And we have asked them to do that, Mr. Burgess,

look at other areas internationally. Not only for safety but you see

countries like Sudan and China suddenly coming up with level 4

labs. I wasn’t quite concerned to go to China yet but I was working

there.

Mr. BURGESS. OK.

Mr. STUPAK. Dr. Rhodes, you had something you wanted to say?

Mr. RHODES. Let me just make one point. I was in the UK and

was talking to the people at the Pirbright site. There is currently

the exact same discussion that your colleague from Colorado was

discussing. They are trying to figure out who is going to be the single regulator because they have the split, they only have two but

one is for animals and one is for human pathogens. And then there

is that area in-between, which is called zoonotics. Those are the

agents that affect both animals and humans. So what is probably

going to come out from that discussion is there will be a single regulator. There will be a single set of regulations. Obviously, they

have to be tailored for working with animals versus humans. There

will be no allowance for the regulator to be an operator. But that

is the discussion that is going on right now in the UK as a result

of the Pirbright outbreak.

Mr. BURGESS. Let me ask you the question, as it pertains to the

single agency regulations with radio nuclides, zoonotics are a little

bit different because here we have got a select list or select agents

which is somewhat arbitrary, I would argue. I am by no means an

expert but, I mean, SARS not being on that list is, well, a striking

omission and I am sure there are good reasons why, from a research perspective, that someone has come up with that designation. But it just points to the difficulty when we talk about we

want to do things to remove ambiguity. But there are inherent ambiguities in this system. Heisenberg’s Uncertainty Principle probably applies here more so than the field of radiation sites, is that

not correct?

Mr. RHODES. I follow your logic on that.
61

Mr. BURGESS. I do not think it was logic but I appreciate your

calling it that. Let me ask you this. I mean, obviously, we got to

this system because someone said there is a threat and there is

value to developing a rapid response. Do I understand that correctly?

Mr. RHODES. That is correct.

Mr. BURGESS. I wasn’t here in 2001. And then when I was here

in 2003, we had the SARS kind of just crop up all at once and it

was handled correctly. It was handled correctly from a lot of different levels at the CDC and the NIH and identifying it as a

coronavirus, identifying where it came from. And really with no

vaccine and no specific treatment, we were able to beat back the

threat of an epidemic very, very quickly with old fashioned tools,

epidemiology and quarantine. So, clearly there is value here in developing this expertise. I guess my only point is I hope there is

some caution, in bringing down the regulatory hammer here, that

we not cripple a system that delivered us from evil in the case of

SARS relatively quickly, very competently and although 800 people

did die, it could have been just extravagantly worse had we not

been at the top of our game on that particular illness.

Mr. RHODES. And that is a very good point. I want no one to take

our preliminary findings and think we are trying to throw the baby

out with the bathwater. In answer to Representative Barton’s question about academic environment, I came out of an academic environment. Dr. Sharma came out of an academic environment. We

have all come out of academic environments. And with our scientific backgrounds, we couldn’t have them without academic environments. So it is not saying be Draconian about this. It is saying

let us not be Byzantine about it. The fabric of oversight now is so

convoluted I would defy anyone—I mean, I have a very, very smart

team and we cannot figure it out. And we talked to people who

have regulatory authority and, as a matter of fact, one of them said

‘‘that would be nice if we could know that, anything you can do to

help us would be appreciated.’’ Now, if somebody goes to the GAO

and asks for help, they are in a hot spot.

Mr. BURGESS. Well, your table that you provided, page 12, and

in your evidence book, tab 23, just comparing those two maps of

the United States where the locations of the labs are strikingly different. So I think the ambiguity there speaks for itself that we do

not even know where we are, what we got and what we are doing

and clearly that is the thrust of this committee. Mr. Chairman, I

thank you for your indulgence. I will yield back.

Mr. STUPAK. I thank the gentlemen. Dr. Rhodes, in your survey,

did any of the Federal agencies that you looked at, did they indicate concern about the proliferation of these high-containment

labs?

Mr. RHODES. Oddly enough, the Federal Bureau of Investigation

and the Intelligence Community were the ones who were most concerned about it. Obviously, they have the counterterrorism side and

they have the national security side and they have the national intelligence estimate side. But the FBI also had another concern,

which was they are the ones who have to clear the staff. So on one

side they have the operational mission of trying to keep people safe

and on the other side, they have the operational issue of trying to
62

figure out if the people are actually trustworthy. And as the number of laboratories balloons their workload balloons, their ability to

collect intelligence diminishes. And that was their largest concern.

Mr. SHARMA. I would also like to add here that if there is another accident, it is their responsibility to find out where the material came from. And if they do not know how many labs there are

or where the potentials are, they cannot find the perpetrator. And

in particular, I think they are in the process of resolving this issue,

the CDC, we have been told. But up until now, they could not even

obtain the listing of select agent labs that are registered with CDC

and this makes their job very difficult. In addition, the main intelligence agency in general have concerns about this proliferation of

labs especially not having a centralized Federal vision of what our

needs are and how those needs are going to be met. Right now it

is fragmented and they are concerned about it.

Mr. STUPAK. OK. Mr. Green for questions.

Mr. GREEN. Thank you, Mr. Chairman. And Dr. Rhodes, I have

a series of questions but I think the table on page 13 shows a

shocking amount, that no Federal agency has the mission to track

high-containment labs in the United States and you go down a

number of departments and none of them have that ability. I am

interested in the select agent program. It appears that the use of

select agents triggers a lab’s responsibility to register with the

CDC. Would you agree?

Mr. RHODES. Yes.

Mr. SHARMA. Yes, sir.

Mr. RHODES. And USDA.

Mr. GREEN. And USDA. I noticed that agents such as SARS are

not currently on the list. It trumps me to wonder when the list was

last updated. I know that Congress updated the list in 2002 with

the bioterrorism bill. Was that the last time there was any statutory change?

Mr. RHODES. To the best of my recollection, that is the last time

there was a statutory requirement.

Mr. GREEN. OK. I know that the CDC and USDA have jurisdiction over the regulation and oversight of the actual labs. What

about the agents being studied in the labs, does any regulatory

agency have the authority to update the list of these select agents?

Mr. RHODES. We do not know that answer.

Mr. GREEN. You do not know if there is any agency who can update that list of the select agents? That is basically the question.

Mr. RHODES. The CDC.

Mr. GREEN. The CDC?

Mr. RHODES. Yes.

Mr. GREEN. What agency, in your views, is best poised, is it

CDC? Do you know when they last updated that list?

Mr. RHODES. The last update, as I understand it, was in response

to the 2003 requirement.

Mr. GREEN. On other agents other than, for example, SARS,

what agents do not appear on this select agent list? Is there any

Federal regulation or inventory of the use of any of these agents?

Mr. SHARMA. There is a process in place. As you know, there are

emerging threats constantly. There is a mechanism whereby the

list can be updated but we have not specifically looked at the proc-
63

ess itself, how long it takes and what is involved in updating the

list.

Mr. GREEN. OK. The CDC inspected the Texas A&M lab in February 2006 and it was a full 13 days after an employee was exposed to Brucella and was incapable of discovering the exposures.

Is this an inherent deficiency in the inspection process or is this

specifically an omission by the CDC in this instance?

Mr. RHODES. I think it is one of the problems in the ability of

CDC to inspect. Let me give you a counterpart from the UK. The

HSE, which is the Health Safety Executive, has inspectors. The inspectors are warranted. They have law enforcement authority.

They can compel testimony. They can dig up a pipe if they want

to. They can kick in a wall if they have cause to. They can show

up with constables if they need to, if they think that they are in

danger of personal harm because the Health Safety Executive looks

into all kinds of public safety issues, not just biolabs. But the U.S.

Government does not have a counterpart to that.

Mr. SHARMA. Let me add a few things here. I think CDC’s system of inspection relies on documentation and people honestly reporting the facts. And if they are not going to, they are not going

to find out. It is very simple. The second thing is, and we have

shared this and there are other systems in place like in this case,

NIH has guidelines on rDNA under which they require institutions

that receives Federal funding to have institutional biosafety committees and they also must document the minutes of those meetings. So it is coming from another part of the Government which

CDC, it is our understanding and in the process very labor-intensive, I must say this, to review all those minutes. It was documented that this person was exposed to. Now, if it wasn’t for the

fact that the Sunshine Project Group took the pain to obtain and

review and identify this incident, there was no way. It is really the

responsibility of the institutions to report to CDC. And if they are

not going to, there is not much that can be done and not much we

can find out.

Mr. GREEN. OK. Mr. Chairman, I know I am out of time. I have

another question that I would like to submit basically on what the

GAO found was a primary source of the incidence of the biosafety

labs and would you attribute it to majority of accidents to human

error or engineering or design flaws of the system and I will submit

that in writing, Mr. Chairman.

Mr. STUPAK. OK, very good.

Mr. RHODES. Thank you.

Mr. STUPAK. Mr. Inslee, questions please. We have six votes on

the floor, let us get this panel in if we can and then we will take

a break.

Mr. INSLEE. Thank you. Is there evidence that the anthrax attack on the Senate was essentially a way to provoke this inquiry

we are having in this hearing? Was that the effort? Is there any

evidence to suggest that or not?

Mr. RHODES. We have seen no evidence to support that hypothesis.

Mr. INSLEE. Well, I guess it would not make a difference. We

have an issue and we have to deal with it, I suppose in any event.

I’ve been told that there was a proposed study by NIH about the
64

risks associated with proliferation of labs and the like that was to

be completed. We have not seen it yet. Have you seen an NIH assessment of this issue?

Mr. RHODES. No, we have not seen that.

Mr. INSLEE. Is there anything forthcoming from them that you

are aware of or not?

Mr. RHODES. We do not know of anything, sir.

Mr. INSLEE. OK. If we do develop some more uniform protocol for

oversight of these labs, I assume there will be some concern about

the military aspect of this. It is always difficult when you try to

blend oversight of civilian and military operations and the military

has concerns about that for understandable reasons.

Mr. RHODES. Yes.

Mr. INSLEE. How would we go about having a consistent oversight when we have a military operation that, I would assume, be

part of that?

Mr. RHODES. Well, that is one of the models we are looking at

in the UK because both DEFRA, as well as the Health Safety Executive, have oversight of both civilian and military. They have the

Ministry of Defense laboratories under their oversight, so we will

look into that and be able to report about.

Mr. SHARMA. CDC also, if the military labs are working the select agents, they also have to be registered with CDC and CDC

does provide the same oversight as they provide to other civilian

institutions.

Mr. INSLEE. OK. You mentioned that some of these existing requirements apply only if the facility is receiving Federal money. Is

it likely to have more of this work done in areas where there is not

Federal money? We have the situation with stem cells right. We

have a proliferation of labs, some not taking Federal money just so

they can continue the stem cell research because of the ridiculous

restrictions we have on Federal funding. Are we going to see more

strictly privately-funded labs here? If we do have requirements,

should it apply to everyone not just those who are receiving Federal money?

Mr. RHODES. We may. One of the problems in trying to answer

your question is that I have to have some baseline of data. And because privately-funded labs, if they are not using select agents or

are not federally funded, we do not know about them; then I cannot

even speculate on where that would go.

Mr. INSLEE. Do you think we need some regulatory process for

all labs, federally or non-federally funded, whether or not they use

these specific agents? Are there risks associated with certain activities that we are not picking up in our system?

Mr. RHODES. Yes, there are. There are agents that are not on the

select agent list and they have grave consequences as well. And

whether regulation is direct regulation or not or whether it is just

that we need to know where they are. I mean, right now, we do

not even know where they are and we do not know what is being

done and we do not know who is doing it. And from my standpoint

and my colleague’s, as well as a lot of safety professionals and security professionals, including our own Federal Bureau of Investigation and our own Intelligence Community, that is a worrisome subject.
65

Mr. INSLEE. You are not alone. We should do something. Thank

you.

Mr. RHODES. Thank you.

Mr. STUPAK. Thank you, Mr. Inslee. Mr. Inslee asked the question: did you find any study to assess the need for more of these

level 3 and level 4 labs and you said you did not come across any

study?

Mr. RHODES. We have not come across any.

Mr. STUPAK. Did you request from NIH, CDC or U.S. Department of Agriculture any kind of justification of proliferation of

these labs? Dr. Sharma?

Mr. SHARMA. NIAID in collaboration with the American Society

of Microbiology did conduct this survey trying to ascertain what

our lab capacity is. But this study had some methodological problems. Primarily one major being very low response rates. And we

do have that study. But in addition to that, we do not have anything else.

Mr. STUPAK. So they tried to do a study but it was such a low

response, you couldn’t make a determination from that assessment?

Mr. SHARMA. Right.

Mr. STUPAK. So we still do not know what is the right capacity

or number of labs that we need?

Mr. SHARMA. Well, if you do not know the universe of labs and

their capabilities, you cannot obviously meet any——

Mr. STUPAK. Correct. If you do not know its abilities or what

they are doing you cannot make the assessment.

Mr. SHARMA. Right.

Mr. STUPAK. Mr. Burgess, anything before I let this panel go?

Mr. BURGESS. I think Mr. Barton referenced in his opening statement, talking about the anthrax attack and when there was a Senate hearing there was a question posed to the FBI back in 2001,

the FBI was asked how many labs handle anthrax of this type and

I guess no one knew the answer to that question.

Mr. RHODES. That is correct.

Mr. BURGESS. Do we know the answer today?

Mr. RHODES. No.

Mr. BURGESS. Well, let me ask you this. Obviously, we have put

some time and effort into protecting the homeland with the proliferation of labs, is it the opinion of the two individuals before us

from the GAO that we have moved on that continuum of being

more secure or are we stationary or are we less secure?

Mr. RHODES. That fact that there is so much that is unknown at

the moment, I would have to say we are at greater risk. Because

as the number increases, the risk increases and it is not just the

increase in the material, it is the increase in laboratories that have

less experience than others.

Mr. BURGESS. So the actual risk may be generated by the fact

that we are studying to prepare for the risk?

Mr. RHODES. Yes. It is a dilemma that we are in.

Mr. BURGESS. But that is one of the prices you pay for doing the

research, correct?

Mr. SHARMA. That is correct.
66

Mr. BURGESS. And you’ll never get to a point of relative security

if you are not willing to invest the time and effort and the risk in

doing the research, is that correct?

Mr. RHODES. That is correct but doing——

Mr. BURGESS. And we need to manage the risk.

Mr. RHODES. Yes. We are not——

Mr. BURGESS. So my question is, are we doing a good job of managing the risk. I would assume the answer to that question today

is no.

Mr. RHODES. No.

Mr. BURGESS. But is it your opinion that we can get to that point

of managed risk which now is acceptable?

Mr. RHODES. Yes, we can. It could be done.

Mr. BURGESS. Thank you. I yield back.

Mr. STUPAK. OK. Just along those lines though, today we are

only talking about buildings. We have not talked about the quantity, quality, string of agents that are out there and who is doing

what at what labs and things like that. We do not even know that.

Mr. RHODES. That is correct.

Mr. STUPAK. OK. Future hearing. We have six votes on the floor.

Let us look for about 12:00, 12:15 we will be back. We will dismiss

this panel. Thank you very much and thank you for your work and

we will continue this investigation. So we will stand in recess for

45 minutes, 50 minutes.

[Recess.]

Mr. STUPAK. It is one of those days, as I said, there is a hearing

going on on the third floor and we have got about three hearings

going in the Energy and Commerce Committee. So we have our

second panel of witnesses and they are Dr. Richard Besser, who is

the Director of the Center for Disease Control and Prevention, Coordinating Office of Terrorism Preparedness and Emergency Response. Dr. Casey Chosewood, who is director of CDC’s Office of

Health and Safety; Captain Robbin Weyant, who is the CDC’s Director of Division of Select Agents and Toxins; and Dr. Hugh

Auchincloss, who is the National Institutes of Health, Deputy Director of National Institute of Allergy and Infectious Diseases. It is

the policy of this subcommittee to take all testimony under oath.

Please be advised witnesses have the right under the rules of the

House to be advised by counsel during your testimony. Do any of

you wish to be represented by counsel? No one is indicating no, so

therefore I will ask you to please rise, raise your right hand to take

the oath.

[Witnesses sworn.]

Mr. STUPAK. Let the record reflect that the witnesses have answered in the affirmative. You are now under oath. It is my understanding Dr. Besser and Dr. Auchincloss are going to be the only

ones giving testimony, is that correct? Dr. Besser, you want to start

with you please, sir?
67

STATEMENT OF RICHARD BESSER, M.D., DIRECTOR, COORDINATING OFFICE FOR TERRORISM, PREPAREDNESS AND

EMERGENCY RESPONSE, CENTERS FOR DISEASE CONTROL

AND PREVENTION

Dr. BESSER. Thank you. Good afternoon, Chairman Stupak,

Ranking Member Whitfield, the members of the subcommittee. I

am Dr. Richard Besser, Director of the Coordinating Office for Terrorism Preparedness and Emergency Response at the Centers for

Disease Control and Prevention.

Accompanying me today are Dr. Rob Weyant, who is the director

of our Division of Select Agents and Toxins and Dr. Casey

Chosewood, who is director of CDC’s Office of Health and Safety.

On behalf of CDC, I am pleased to be here today to discuss how

CDC oversees select agents in the Nation’s laboratories.

To further scientific knowledge about biological agents and toxins

and develop diagnostic tests and countermeasures against them,

our institutions conduct research on these potentially harmful

agents. Before undertaking any laboratory experiment, it is critical

that one weighs the potential benefits of the experiment against

the potential risks. We recognize that such research increases the

risks of accidental or intentional release of these agents. To mitigate this risk, Congress authorized the Federal Government to

oversee labs that work with select agents. The creation of this program has given our Nation an important tool to help minimize the

inherent risks that accompany work with select agents. The regulation of select agents is a shared Federal responsibility between the

Department of Health and Human Services, Agriculture and Justice. Congress gave HHS the authority to regulate the possession,

use and transfer of biological agents and toxins that could pose a

severe threat to public health and safety. We refer to these as select agents. No program for oversight of select agents existed in the

United States prior to 1996. In 2002, Congress significantly

strengthened oversight of select agents with the passage of the

Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The select agent regulations that were established as a result of this Act are the ones that are currently in effect.

It is important to note that not all laboratories work with select

agents. Therefore, not all laboratories are regulated under the provisions of the select agent regulations. For instance, HIV and the

bacteria that causes tuberculosis are not select agents and are not

covered by the program. However, the Federal Government does

provide biological safety guidance to the entire laboratory community through a document entitled, ‘‘Biosafety, Microbiological and

Biomedical Laboratories.’’

Laboratories have multiple systems in place to ensure biosafety.

The first line of defense is proper training of lab workers. Before

someone can work in a lab, they should undergo rigorous lab safety

training. People who work in labs also are physically protected

through the use of personal protective equipment such as gloves,

masks, goggles and for the most dangerous germs, biosuits. Laboratories also are engineered to ensure that dangerous pathogens cannot escape. Some of these engineering controls include negative air

pressurization and the use of biosafety cabinets. Accidents can and
68

will happen in labs. But these multiple biosafety systems can help

to ensure that lab workers and the public are protected.

CDC executes the select agent program through both a strong

oversight role by evaluating and inspecting registered labs and by

providing guidance and training to those labs. Routine inspections

are conducted a minimum of every 3 years. Additional inspections

are conducted any time that an entity requests a significant change

to its select agent registration. An important tenant of the CDC’s

select agent program is that it treats all registered labs the same,

whether that lab is a commercial lab, State or local public health

lab or Federal lab, including CDC and Department of Defense labs.

The select agent program uses standardized checklists to inspect

all labs, has the same requirements for all labs and uses the same

standards when referring any lab to the HHS Office of Inspector

General for possible violations of the regulations.

Public concerns and questions about the overall safety of our Nation’s laboratory workers are understandable and legitimate. In the

4 years that the select agent program has been in place with approximately 400 organizations being registered and after careful investigations when a potential incident has been reported, there

have been no confirmed losses or thefts of a select agent and there

have been three confirmed releases of a select agent. After careful

investigation, none of these releases were considered to be a public

health threat.

This does not mean, however, that such incidents cannot happen

in the future. Even a lab that follows all biosafety guidelines may

have accidents. But the biosafety and biosecurity requirements that

Congress established help reduce the likelihood that these accidents will impact worker or community health.

We have accomplished much since the program began but we are

always looking for ways to improve. Investigations of labs have

taught us important lessons. We have learned that we need to

make improvements during inspection verification processes. In the

future during our inspections, we plan to expand the scope of interviews and review a broader array of documents to identify problems that may go unreported by registered labs. In addition, we

plan to assess the composition of our inspection teams and the frequency of our inspections. We also have learned that we need to

provide additional outreach and training to the regulated community and create additional guidance documents. We will be undertaking an external review of the CDC’s select agent program so

that we can continue to improve our oversight of select agent work.

The external group conducting this review will actively solicit the

input of stakeholders and the general public. In addition to this review, the HHS Office of Inspector General is conducting an audit

of CDC’s management of its select agent program. We look forward

to the findings and recommendations scheduled for completion in

2008 and using this work to help strengthen our program.

In conclusion, the select agent programs at CDC and USDA,

working in concert with the Department of Justice, have greatly

enhanced the Nation’s oversight of dangerous biological agents and

toxins. The select agent regulations have helped ensure that research with select agents is conducted as safely and securely as

possible. However, the possibility of accidental or intentional re-
69

lease of these agents always remains so we must remain vigilant

and work to continuously improve our oversight. We will continue

to enforce the regulations and provide technical assistance and

guidance to the regulated community to ensure that the public’s

health and safety are protected.

CDC greatly appreciates the support of this subcommittee and

the rest of Congress in supporting its activities. We look forward

to continuing our work with you on these important issues. Thank

you for the opportunity to share this information with you and I

look forward to answering questions.

[The prepared statement of Dr. Besser follows:]

STATEMENT OF RICHARD E. BESSER, M.D.

Good morning Chairman Stupak, Ranking Member Whitfield and members of the

Subcommittee. I am Dr. Richard Besser, Director of the Coordinating Office for Terrorism Preparedness and Emergency Response (COTPER) at the Centers for Disease Control and Prevention (CDC), an agency of the Department of Health and

Human Services. Accompanying me today are Dr. Rob Weyant, Director of the Division of Select Agents and Toxins in COTPER, and Dr. Casey Chosewood, Director

of the CDC Office of Health and Safety. On behalf of CDC, I am pleased to be here

today to discuss how CDC oversees select agents in the Nation’s laboratories.

To further scientific knowledge about biological agents and toxins and develop

countermeasures against them, our academic, commercial, and government institutions conduct research on these potentially harmful agents. We recognize that such

research increases the risks of accidental or intentional release of these agents. To

mitigate this risk, Congress authorized the Federal Government to oversee labs that

work with select agents—which include such things as Bacillus anthracis (which

causes anthrax), Yersinia pestis (which causes plague), and Variola major virus

(which causes smallpox). The creation of this program has given our nation an important tool to help minimize the inherent risks that accompany work with select

agents.

The regulation of select agents is a shared Federal responsibility involving HHS,

the Department of Agriculture (USDA), and the Department of Justice (DOJ). Congress gave HHS the authority to regulate the possession, use, and transfer of biological agents and toxins (select agents) that could pose a severe threat to public

health and safety. The Secretary of HHS has delegated this authority to CDC. Congress gave USDA similar authority to regulate select agents that pose a severe

threat to animal and plant health and/or animal and plant products. DOJ is responsible for conducting background checks, called security risk assessments, of any entities and individuals that want to work with select agents. By regulating the possession, use, and transfer of select agents, HHS, USDA, and DOJ contribute to the

Nation’s overall terrorism deterrence strategy.

My testimony will focus on CDC’s role in the regulation of select agents. I will

describe the history of the CDC Select Agent Program, CDC’s role in oversight of

select agent laboratories, our collaboration with other Federal partners, the key

components of the CDC regulatory program, key program accomplishments, and our

future plans for enhancing the program.

Establishing Oversight over Select Agents: A Brief HistoryNo program for oversight of select agents existed in the United States prior to 1996. In 1996, Congress

passed the Antiterrorism and Effective Death Penalty Act of 1996 (P.L. 104–132;

signed April 24, 1996). With the regulations that went into effect in April 1997 (42

CFR 72.6), the Secretary of HHS established a list of biological agents that have

the potential to pose a severe threat to public health and safety. The Secretary also

established procedures for the transfer of these biological agents. The CDC Select

Agent Program has been in place since 1996. The program was originally located

within CDC’s Office of Health and Safety and is now located within CDC/COTPER’s

Division of Select Agents and Toxins.

In 2001, Congress expanded the scope of the program by restricting the shipping,

possession, and receipt of select agents by passing the Uniting and Strengthening

America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001 (USA PATRIOT Act); (P.L. 107–56; signed Oct. 26, 2001). The USA

PATRIOT Act created a provision related to select agents requiring that no restricted person shall transfer (i.e., ship, possess, or receive) a select agent.
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In 2002, Congress significantly strengthened oversight of select agents with the

passage of the Public Health Security and Bioterrorism Preparedness and Response

Act of 2002 (the Bioterrorism Act); (P.L. 107–188; signed June 12, 2002). The Bioterrorism Act strengthened the regulatory authorities of HHS under Sec. 511 of the

Antiterrorism and Effective Death Penalty Act of 1996 and granted comparable regulatory authorities to USDA for select agents that present a severe threat to animal

or plant health, and/or animal or plant products. It also required coordination and

concurrence between HHS and USDA on program activities (e.g., development of

regulations, reporting forms, approval of changes to regulated laboratories—registrations, et cetera) for select agents regulated by both agencies.

The Bioterrorism Act has been implemented through a series of regulations. HHS

published an interim final rule—the ‘‘Possession, Use, and Transfer of Select Agents

and Toxins’’ Interim Final Rule (42 CFR 73, 9 CFR 121, and 7 CFR 331) (effective

on February 7, 2003) which implemented the pertinent provisions of the Bioterrorism Act. A subsequent Final Rule became effective on April 18, 2005. On October

20, 2005, HHS established an Interim Final Rule adding reconstructed replication

competent forms of the 1918 pandemic influenza virus containing any portion of the

coding regions of all eight gene segments to the HHS select agent list. These regulations are hereafter referred to as the ‘‘select agent regulations’’.

ROLE OF THE SELECT AGENT PROGRAM IN OVERSIGHT OF LABORATORIESNOT ALL

LABORATORIES HANDLE SELECT AGENTS

Whereas HHS and USDA have authority to regulate any laboratories that possess, use, or transfer select agents, not all laboratories work with select agents.

Therefore, not all laboratories are regulated under the provisions of the select agent

regulations. For instance, human immunodeficiency virus (HIV) and Mycobacterium

tuberculosis are not select agents and any laboratories working with these agents

are not required to register with either HHS or USDA.

All five currently operational Biosafety Level (BSL) 4 laboratories in the United

States are select agent registered entities. (Any organization that has received a certificate of registration through either the HHS or USDA Select Agent Program is

referred to as a ′′registered entity′′.)

FEDERAL GOVERNMENT GUIDANCE TO BIOLOGICAL LABORATORIES AND RELATED

REQUIREMENTS

Though only a subset of laboratories is regulated by the Federal Government

under the provisions of the select agent regulations, the Federal Government does

provide biological safety guidance to the entire laboratory community. The Biosafety

in Microbiological and Biomedical Laboratories (BMBL) (4th edition is available in

print; 5th edition is available at http://www.cdc.gov/od/ohs/biosfty/bmbl5/

bmbl5toc.htm), produced by CDC and the National Institutes of Health (NIH), is a

nationally and internationally recognized source that provides safety guidance to

laboratories that work with infectious agents. The BMBL provides recommendations

for safely working with a variety of human pathogens and describes standard and

special microbiological practices, safety equipment, and facilities (constituting Biosafety Levels 1–4). In the BMBL, there are agent summary statements that provide

recommendations for the appropriate biosafety safety level to work with these

agents. The BMBL also is offered as a guide and reference in the construction of

new laboratory facilities and in the renovation of existing facilities.

CDC references the BMBL in the select agent regulations and requires select

agent registered entities to comply with the BMBL guidelines or equivalent standards. Specifically, the select agent regulations state that the entity should consider

the BMBL, NIH’s Recombinant DNA Guidelines, and the Occupational Safety and

Health Administration’s regulations on handling toxins (29 CFR 1910.1200, 29 CFR

1910.1450) in developing and implementing a written biosafety plan that is commensurate with the risk of the select agent, given its intended use. If the Select

Agent Program determines that the entity’s biosafety and containment procedures

are not sufficient to contain the select agent, then the program can cite the entity

for non-compliance.

COLLABORATION WITH OTHER FEDERAL PARTNERS

The CDC Select Agent Program works closely with both USDA and DOJ to implement the select agent regulations. USDA’s Animal and Plant Health Inspection

Service (APHIS) is responsible for regulating the possession, use, and transfer of select agents that pose a severe threat to animal or plant health and/or animal or

plant products. For select agents that pose a threat to both humans and animals
71

or animal products, these select agents are regulated by both CDC and APHIS and

are called ‘‘overlap agents’’. To limit the burden on registered entities, CDC and

APHIS worked closely with the Office of Management and Budget to promulgate

regulations with identical requirements and analogous language and to create one

set of registration and reporting forms to be used by both agencies. These actions

helped standardize communication and interpretation of the regulations among

CDC, APHIS, and the regulated community.

To minimize the burden on entities that possess, use, or transfer select agents,

a single point of contact with either CDC or APHIS was established. This single

point of contact in the ‘‘lead agency’’ is responsible for coordinating all activities and

communications with respect to the entity’s registration, including coordination with

both the non-lead agency (APHIS or CDC) and with DOJ. CDC and APHIS collaborate daily on select agent activities such as the development of select agent policies,

resolution of common issues associated with the entity’s registration (such as reviewing the required plans), conducting joint inspections, developing standard operating procedures and entity guidance documents, and providing concurrences to entities’ amendments. We also collaborate on longer-term projects to improve the implementation of the select agent regulations, such as the establishment of a national

select agent Web site (www.selectagents.gov) and development and deployment of a

single shared database (the National Select Agent Registry).

CDC also works closely with DOJ’s Criminal Justice Information Service (CJIS).

CJIS conducts security risk assessments of all individuals and entities that request

to possess, use, or transfer select agents. As of September 25, 2007, 14,868 individuals have received access approval from CDC to work with select agents, based on

the results of the CJIS security risk assessments. CDC also provides information

to DOJ’s Federal Bureau of Investigation (FBI) for ongoing criminal investigations

related to select agents.

OVERSIGHT OF SELECT AGENTS: THE CDC REGULATORY PROGRAM

CDC exerts a strong oversight role by evaluating and inspecting registered entities, in addition to providing guidance and training to registered entities.

An important tenet of the CDC Select Agent Program is that it treats all registered entities the same—whether that lab is a commercial lab, state or local public

health lab, or a Federal lab (including CDC and Department of Defense labs). The

Select Agent Program uses standard checklists to inspect all labs, has the same requirements of all labs, and uses the same standards when referring any lab to the

HHS Office of Inspector General (HHS-OIG) for possible violations of the regulations.

CDC’S APPROACH TO INSPECTION OF ENTITIES

Laboratory inspections are the primary means by which CDC confirms compliance

with the select agent regulations. Routine inspections are conducted every three

years. Additional inspections are conducted any time that an entity requests a significant change to its select agent registration. Such changes may include the addition of a new facility, addition of a new agent, or the initiation of a new procedure.

Other inspections that are performed include follow-up inspections based on observations from audits performed by Federal partners and investigations that may

have involved biosafety or security concerns that could affect public health and safety.

CDC’s protocol for routine inspections consists of an extensive review of laboratory

safety and security as it relates to the possession, use, and transfer of select agents.

CDC uses specific checklists to guide its inspections (the checklists can be found at

www.selectagents.gov). These checklists have been developed from the select agent

regulations and nationally recognized safety standards. The information entered on

the checklists is derived from inspectors’ observations of the physical safety and security components of the facility, an examination of the documentation available,

and from interviews with laboratory personnel. These findings are conveyed to the

institution in an inspection report. Entities must respond within a specified timeframe to the deficiencies noted in the inspection report and provide documentation

of how they have resolved those deficiencies. In circumstances where the deficiencies

are serious and CDC wants to confirm in person that the deficiencies have been corrected, a verification site visit is performed.

When CDC identifies deficiencies and possible violations of the select agent regulations, several types of enforcement actions can occur:

• Administrative actions: CDC can decide to suspend or revoke a registered entity’s certificate of registration (a suspension can be for all work at a registered entity
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or be specific to particular agents or particular types of experiments). Also, CDC can

deny an entity’s application to possess, use, or transfer select agents;

• Referral to HHS-OIG: CDC can refer possible violations of the select agent regulations to HHS-OIG. HHS-OIG can levy civil monetary penalties (up to $250,000 for

an individual for each violation and up to $500,000 for an entity for each violation)

or recommend criminal enforcement (imprisonment for up to five years, a fine, or

both).

• Referral to FBI: CDC can refer possible violations involving criminal negligence

or a suspicious activity or person to the FBI for further investigation.

As of September 25, 2007, CDC has referred 37 entities to HHS-OIG for violation

of the select agent regulations (such as for unauthorized transfers and entities that

are not registered with the Select Agent Program in possession of select agents).

HHS-OIG has levied $837,000 in civil monetary penalties against ten (10) of the entities. For further information, please see the HHS-OIG Web site (http://

oig.hhs.gov). HHS has not referred to DOJ any violations of the select agent regulations for criminal prosecution.

Technical Assistance and Guidance Provided to Strengthen the ProgramWhile enforcing the select agent regulations is the CDC Select Agent Program’s primary responsibility, the program also promotes laboratory safety and security by providing

technical assistance and guidance to registered entities. Some of the technical assistance that CDC provides to registered entities includes having a primary point

of contact assigned to each entity, development of frequently asked questions that

are posted on the program website, and technical presentations at various conferences. The CDC Select Agent Program in collaboration with APHIS provides assistance and guidance to help the entire regulated community operate as safely and

securely as possible.

Some examples of the assistance that the CDC and APHIS Select Agent Programs

have recently provided to the regulated community include:

• As mentioned previously, CDC and APHIS released a security guidance document to registered entities.

• CDC and APHIS released inspection checklists to assist registered entities in

complying with the security, incident response, training, and recordkeeping requirements of the select agent regulations.

• CDC is further educating the entities about the regulations and the inspection

process. It recently completed two training videos that explain the facility inspection

process to the regulated community.

In addition, CDC has proactively worked with registered entities in advance of

hurricanes to ensure that all select agents are properly secured. For example, prior

to the landfall of Hurricane Katrina in 2005, CDC contacted 11 registered entities

located in Louisiana, Mississippi, and Alabama. CDC collected information regarding the entities’ plans to safeguard select agents during and after the storm and informed the entities that CDC stood ready to expedite the emergency transfer of select agents should the need arise. CDC has taken similar action in 2006 and 2007

in anticipation of other hurricanes and predictable natural disasters (such as floods)

that could affect public health and safety, to minimize risk and any impact on public

health and safety.

PROGRAM ACTIVITIES AND RESULTS

Accomplishments to Date. Since the publication of the select agent interim final

rule in 2003 (followed by the final rule in 2005), CDC in collaboration with our Federal partners has (as of September 25, 2007):

• Conducted 607 inspections to ensure that appropriate security and safety measures are in place to deter the theft, loss, or release of select agents;

• Authorized 2,199 requests to transfer select agents; and

• Granted access approvals to 14,868 individuals to work with select agents, following a security risk assessment by CJIS.

REPORTS OF THEFT, LOSS, AND RELEASE

CDC investigates all reports of theft, loss, or release of select agents to ensure

that the public’s health and safety are protected. It is important for the public to

know that after careful investigation, no incidents reported at select agent laboratories were considered to be a public health threat. From 2003 until September 25,

2007, there have been one hundred five (105) incidents reported to CDC through

the Select Agent Program’s theft, loss, and release reporting system. As a result of
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follow-up investigations conducted by HHS, USDA, and the FBI regarding these reports, it was determined that there were:

• No confirmed losses of a select agent;

• No confirmed thefts of a select agent; and

• Three (3) confirmed releases of a select agent which were identified by illnesses

in five (5) lab workers that had occurred as a result of working with these agents.

Even in the best of laboratories, which follow all biosafety guidelines, accidents

like a broken test tube or a needle stick can still occur, and we can expect that we

will continue to receive reports of possible losses and releases of select agents. However, we believe we should always strive to eliminate all incidents. Appropriately

contained and managed laboratories have multiple systems in place to ensure biosafety and have robust occupational health services in place to quickly mitigate the

effect of any laboratory incident. We also believe that the security requirements put

in place by the select agent regulations will continue to mitigate the possibility of

a theft of a select agent.

Moving Forward with Enhancing the Select Agent ProgramThe CDC Select Agent

Program has accomplished much since the program began, but we are always looking for ways to improve. The Select Agent Program is a young program and it will

continue to build upon its successes and learn from its challenges. CDC is committed to continuous program improvement to fulfill its mission.

LESSONS LEARNED

Investigations of select agent registered entities have taught CDC some important

lessons:

• We need improvements in our inspection process. Some of the improvements

under consideration include:

• Expand the scope of interviews to include more types of laboratory workers during inspections, to better assess the implementation of policies and the quality of

training;

• Examine more closely the implementation of biosafety, security, and incident response plans;

• Review a broader array of documents during our inspections, such as biosafety

committee meeting minutes and occupational health records, to identify problems

that may go unreported by registered entities; and

• Assess the composition of our inspection teams, the frequency of our inspections,

and whether we need to apply a prioritization system to how often we inspect labs.

• We need improvements in our verification process. Whereas before we relied primarily upon documentation from entities to confirm that deficiencies were corrected,

we plan to conduct more verification site visits.

• We need to provide additional outreach and training to the regulated community, including additional outreach and training to Responsible Officials and creation of additional guidance documents related to biosafety, incident response,

record-keeping, and theft, loss, and release.

The CDC Select Agent Program also must address the challenge of how the select

agent regulations apply to emerging technologies, such as synthetic genomics and

nanotechnology. With technology advancing at a rapid pace, CDC and its Federal

partners need to constantly review the select agent regulations and our implementation of the regulations to ensure that we can respond to new threats and

vulnerabilities.

EXTERNAL REVIEW OF THE CDC SELECT AGENT PROGRAM

In the coming year, CDC will commission an external peer review of the CDC Select Agent Program. The external group conducting the review will actively solicit

the input of stakeholders and the general public.

In addition to this external peer review, HHS-OIG is conducting an audit of

CDC’s management of its select agent program. We look forward to receiving the

findings from that audit in 2008 and plan to carefully consider and implement HHSOIG’s recommendations.

The select agent programs at CDC and APHIS, working in concert with DOJ,

have greatly enhanced the nation’s oversight of dangerous biological agents and toxins. Because of the efforts of the individuals in these programs, there is improved

awareness of biosafety and biosecurity throughout the select agent community. The

select agent regulations have helped ensure that research with select agents is conducted as safely and securely as possible. CDC and its Federal partners have accomplished much in the few years since the publication of the select agent regulations,
74

but we must remain vigilant in ensuring laboratory safety and security. We will

continue to enforce the regulations and provide technical assistance and guidance

to the regulated community to ensure that the public’s health and safety are protected.

CDC greatly appreciates the support of this Subcommittee and the rest of the

Congress in supporting its activities. We look forward to continuing our work with

you on these important issues. Thank you for the opportunity to share this information with you. I am happy to answer any questions.

Mr. STUPAK. Thank you. Dr. Auchincloss?

STATEMENT OF HUGH AUCHINCLOSS, M.D., DEPUTY DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS

DISEASES, NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Dr. AUCHINCLOSS. Mr. Chairman, members of the subcommittee,

my name is Hugh Auchincloss and I am the Deputy Director of the

National Institute of Allergy and Infectious Diseases, one of the

National Institutes of Health.

I am pleased to have the opportunity to discuss the expansion of

NIH’s biodefense research infrastructure. I have submitted written

testimony but will highlight certain portions in these oral remarks.

The anthrax attacks in 2001 were a sobering reminder that biologic agents can be used for terrorism. In addition, defense against

naturally-emerging infections must be a top national priority. In

February 2002, the NIH embarked on a systematic planning process for biodefense. We convened a blue ribbon panel made up of

distinguished scientists representing academia, private industry

and the Government. And we also conducted extensive discussions

with other Federal agencies. Based on this input, we developed the

NIAID Strategic Plan for Biodefense Research and other supporting documents. That blue ribbon panel noted that the shortage of

BSL–3 and 4 laboratories was a major obstacle to accomplishing

the objectives of the NIAID Biodefense Research agendas. NIAID

then estimated the number of new facilities needed to accomplish

our biodefense research objectives. Congress responded appropriating over $850 million for the construction of new BSL–3 and 4 facilities in four separate bills between 2002 and 2005. As a result,

14 new BSL–3 facilities and four new BSL–4 facilities are scheduled for completion within the next several years.

During the development of our construction project, we have had

literally hundreds of meetings in public forums to discuss our

building program, the agents that will be studied there and to keep

the public well informed.

The NIH is committed to helping ensure that all biodefense research facilities operate safely with maximum protection of the

public health. The safety standards for this type of research are

best articulated in the Biosafety and Microbiological and Biomedical Laboratories Manual, this so-called BMBL. However, monitoring adherence to these good laboratory practices is complicated

because multiple agencies are involved. You have already heard

from Dr. Besser that much of the research in BSL–3 and 4 facilities involves select agents, which are regulated by CDC and other

Government agencies. The NIH Office of Biotechnology Activities

administers guidelines for research involving recombinant DNA
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and requires that Institutional Biosafety Committees, or IBCs,

oversee this work at the local level. The IBCs first came into existence to oversee recombinant DNA research but many institutions

have gradually broadened IBC responsibilities to include oversight

of research involving all pathogens studied at BSL–3 and 4 levels.

However, at this time, there is no Federal body that sets national

standards or policies for this particular function of local IBCs. To

enhance the effectiveness of the IBCs, as their role has evolved, the

NIH has worked intensively with the IBC community through a

program of outreach and education. Furthermore, each of the institutions receiving one of the new construction grants from NIAID

has an IBC appropriately registered with NIH and each has willingly accepted responsibility for adhering to the BMBL standards.

NIH is looking at ways to strengthen local and Federal oversight

of facilities that conduct biodefense research. Clearly, the issues associated with this oversight are much larger than the NIH or even

the Department of Health and Human Services. Biodefense research is conducted by many Government agencies. For that reason, the Department of Health and Human Services, the United

States Department of Agriculture, the Department of Homeland

Security and the Department of Defense have already agreed to establish a trans-Federal task force to undertake, in consultation

with other relevant agencies, an intensive analysis of the current

biosafety framework and to develop a set of recommendations for

improvement.

Given the importance of biosafety for the country and its citizens,

active participation from the public at large will be essential.

The planned expansion of our infrastructure is needed if we are

to fulfill our research agenda and protect the Nation from disease

threats, be they deliberate or acts of nature. We have already made

substantial progress in ways that I have outlined in my written

testimony. Progress can occur more rapidly as the new facilities become available.

Thank you very much and I will be happy to answer questions

also.

[The prepared statement of Dr. Auchincloss follows:]

STATEMENT OF HUGH AUCHINCLOSS, M.D.

Mr. Chairman and members of the Subcommittee, my name is Hugh Auchincloss

and I am the Deputy Director of the National Institute of Allergy and Infectious

Diseases (NIAID), a component of the National Institutes of Health (NIH), an agency of the Department of Health and Human Services (HHS). I am pleased to have

the opportunity to discuss the NIH biodefense research program, including the expansion of the Nation’s biodefense research infrastructure and the need to ensure

that biodefense research is conducted safely.

The anthrax attacks in 2001 were a sobering reminder that the threat of deliberately released microbes can be used as a form of terrorism. Moreover, naturally

occurring microbial outbreaks pose a serious threat to domestic and global health.

The experience with SARS in 2003 and the ongoing outbreaks of H5N1 avian influenza and extensively drug-resistant tuberculosis have reminded us that defense

against naturally emerging microbes must be a top national priority. Congress has

recognized the urgency of improving our defenses against emerging public health

threats and has supported funding for such research. Within the broad Federal effort against emerging threats to public health, the role of the NIH is to conduct and

support basic and applied research that will lead to new vaccines, drugs, and diagnostic tools.
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EXPANDING THE NATION’S BIODEFENSE RESEARCH CAPABILITY

In February 2002, the NIH embarked on a systematic planning process for its biodefense research program. It first convened the Blue Ribbon Panel on Bioterrorism

and Its Implications for Biomedical Research, made up of distinguished scientists

representing academia, private industry, and government. Based on the panel’s advice and extensive discussions with other Federal agencies, the NIH developed three

key documents to guide its biodefense research program: the NIAID Strategic Plan

for Biodefense Research, the NIAID Research Agenda for Category A Agents, and

the NIAID Research Agenda for Category B and C Agents.

As a result of the strategic planning process, a clear consensus emerged that

meeting the goals of the biodefense Research Agendas would require additional research infrastructure, especially research laboratories built to modern Biosafety

Level 3 (BSL–3) and Biosafety Level 4 (BSL–4) standards. BSL–3 laboratories are

used to study contagious agents that can be transmitted through the air and cause

potentially lethal infection. BSL–4 laboratories are used to study agents that pose

a high risk of life-threatening disease for which no vaccine or therapy is available;

they incorporate all BSL–3 features and occupy safe, isolated zones within a larger

building.

There has been considerable discussion of how best to assess the extent of highcontainment facilities that would be required in the United States in the public, academic and private sectors and for what purposes these varied facilities are used.

Published estimates range from as few as 200 to as many as 1400 BSL–3 laboratories. (Many institutions maintain multiple facilities.) The explanation for this wide

discrepancy is that an assessment of laboratory capacity depends on the definitions

and sources of information used. Estimates at the high end, for example, include

the many hospitals that maintain small areas that meet BSL–3 standards that can

be used for testing clinical samples that might contain infectious agents. These are

not ‘‘research laboratories.’’ Some hospitals, pharmaceutical companies, biotechnology firms, private reference laboratories and State public health laboratories

also have facilities that meet BSL–3 standards, but these are not generally available

for NIH-sponsored research. Finally, many BSL–3 facilities constructed before the

mid–1990’s cannot support research on select agents and on associated animal models. In 2002, NIAID determined that very little usable BSL–3 or BSL–4 research

space was actually available for its academic scientists in the extramural research

program.

The Blue Ribbon Panel of 2002 noted the shortage of BSL–3 and BSL–4 laboratory space as a significant rate-limiting obstacle in accomplishing the objectives of

the NIAID Biodefense Research Agendas. In response, NIAID estimated the new

BSL–3 and BSL–4 facilities that would be required to accomplish the Research

Agenda. Congress also recognized the critical need for new BSL–3/4 laboratories and

responded quickly to supply the necessary resources to fulfill this need. In 2002, the

Department of Defense and Emergency Supplemental Appropriations for Recovery

from and Response to Terrorist Attacks on the Unites States Act, Public Law (P.L.)

107–117, appropriated $70 million for the construction and renovation of NIH intramural biocontainment facilities. The Consolidated Appropriations Act of 2003, P.L.

108–7, provided $372.6 million to NIAID for construction of extramural biocontainment facilities and $291 million for construction of additional intramural biocontainment facilities. Further, the Project BioShield Act of 2004 (P.L. 108–276), amended

the Public Health Service Act to provide ongoing authority to NIAID to award

grants and contracts for construction of research facilities. An additional $150 million was appropriated for NIAID in the 2005 consolidated appropriations act (P.L.

108–447) for extramural facilities construction grants.

The NIH is now implementing a construction program that will complete 14 new

BSL–3 facilities and 4 new BSL–4 facilities within the next several years. During

this process, the NIH or its funded institutions have participated in literally hundreds of public forums on the nature and safety of the new facilities, and have submitted reports to Congress annually, along with periodic updates on our strategic

plans. In addition, NIH leadership has discussed the infrastructure expansion with

Congress on many occasions. And because NIH does not fund or conduct classified

research, the title and substance of every research project funded by the NIH is

publicly available.

Another important aspect of the biodefense research infrastructure is a network

of ten NIH-funded Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCEs). Created in 2003, these multidisciplinary academic research programs are located at institutions across the country and provide

the scientific expertise for a wide-ranging biodefense research program, directed
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against deliberate and naturally-occurring threats, that will be pursued in the new

facilities.

NIH ROLE IN ENSURING SAFETY

The NIH is committed to helping ensure that all biodefense research facilities provide maximum protection for public health. The NIH is committed to the highest

quality in the design and construction of these facilities, the rigorous training of the

personnel that operate them, and the safe conduct of the research undertaken within them.

To ensure that the new laboratories are designed and constructed to the highest

standards, the NIAID works closely with each grantee institution. Highly experienced NIAID staff architects and engineers, with extensive experience in design of

biocontainment facilities, are assisted by a Construction Quality Management group

of contracted consultants with additional expertise. Together, these teams make certain that the finished projects will meet the regulations of HHS’s Centers for Disease Control and Prevention (CDC) and the Department of Agriculture’s Animal and

Plant Health Inspection Service (USDA/APHIS) for facilities that conduct research

on select agents.

The NIH also supports a vigorous biosafety and biocontainment training effort

that has expanded substantially over the past five years. The National Biosafety

and Biocontainment Training Program (NBBTP) is a partnership between the

NIAID and the NIH Division of Occupational Health and Safety (DOHS), managed

by a not-for-profit education and research foundation. The mission of this program

is to prepare biosafety and biocontainment professionals of the highest caliber. The

program offers two-year post-baccalaureate and post-doctoral fellowships at NIH’s

campus in Bethesda, Maryland, with both academic and hands-on training. The

NBBTP has also provided training for containment laboratory operation and maintenance personnel across the country. In addition to this program, NIAID funds 28

Institutional Training Grants in Biodefense, and the RCEs conduct extensive training in biosafety and biocontainment. At the RCE at Emory University in Atlanta,

for example, trainees from across the country regularly participate in BSL–3 and

BSL–4 training in mock laboratories, constructed specifically for training purposes.

When these new facilities are ready for operation, NIH is committed to ensuring

that the research conducted within them is performed safely. The most widely used

guidance on the safe conduct of this research is the Biosafety in Microbiological and

Biomedical Laboratories Manual (BMBL), which was first produced jointly in 1984

by the NIH and CDC and which is now in its fifth edition and available online.

Monitoring adherence to good laboratory practices is a complex process because

multiple agencies are involved. Much of the research in BSL–3 and BSL–4 facilities

involves pathogens that have been designated as select agents. CDC and APHIS

have the responsibility for regulating the possession, use, and transfer of select

agents. For research that involves recombinant DNA, the select agent regulations

incorporate the NIH Guidelines for Research Involving Recombinant DNA Molecules

(Recombinant DNA Guidelines) as a consideration in the entity’s development of its

biosafety plan. The NIH Office of Biotechnology Activities (OBA), with advice and

guidance from the NIH Recombinant DNA Advisory Committee (RAC), is responsible for implementation of the Recombinant DNA Guidelines, which outlines biosafety and containment standards for research involving recombinant DNA. Also,

the select agent regulations require that restricted experiments, such as the deliberate transfer of a drug-resistant trait to a select agent, must be approved by CDC

or APHIS prior to initiation. However, some research conducted in BSL–3 facilities

involves neither select agents nor recombinant DNA.

Local institutional bodies play a very important role in oversight of many aspects

of biomedical research. For example, oversight to protect human subjects in clinical

studies is provided by local Institutional Review Boards (IRBs), and in the case of

animal research, oversight to ensure humane treatment is provided by the Institutional Animal Care and Use Committees (IACUCs). The NIH Guidelines mandate

that Institutional Biosafety Committees (IBCs) oversee recombinant DNA research,

but many institutions have gradually broadened IBC responsibilities to include oversight of research involving all pathogens studied at BSL–3 and BSL–4 levels. At

this time there is no Federal body that sets national standards or policies for this

function of local IBCs, and adherence to BMBL guidelines for BSL–3 and BSL–4 research is voluntary; however, the select agents regulations require regulated entities

to comply with the BMBL guidelines or equivalent standards.

The NIH is deeply concerned about recent reports of accidents occurring in BSL–

3 facilities. When these events involve recombinant DNA, they are reported to the

OBA, and a root cause analysis is done so that NIH can assess the adequacy of the
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institution’s response and work with the institution to put mechanisms in place to

mitigate the chance of a reoccurrence. To enhance all of the functions of the IBCs,

the NIH has worked intensively with the IBC community. These efforts have included an extensive program of outreach and education, involving frequent day-long

training sessions, exhibits at major scientific conferences, policy guidances, educational resources for institutions to use in local training, and other means. Furthermore, each of the institutions receiving one of the new facilities construction grants

from NIAID has an IBC appropriately registered with NIH and each has willingly

accepted responsibility for adhering to BMBL standards.

The NIH is examining ways to strengthen local and Federal oversight of facilities

that conduct NIH-funded research. The issues associated with oversight of research

in BSL–3 and BSL–4 facilities transcend the NIH, or even the HHS. Biodefense research involving BSL–3 and BSL–4 facilities is conducted by many government

agencies, including the Department of Defense (DoD), the Department of Homeland

Security (DHS), and the USDA, as well as by universities and biotechnology companies. As I noted earlier, BSL–3 facilities exist in hospitals for routine handling of

clinical samples. It is important to devise a framework that improves oversight,

training, and reporting to enhance safety without causing unintended negative consequences for either patient care or the biodefense research program. For that reason, HHS, USDA, DHS, and DoD have already agreed to establish a Trans-Federal

Task Force to undertake, in consultation with other relevant agencies, an intensive

analysis of the current biosafety framework and to develop a set of recommendations for improvement. Given the critical importance of biosafety to protecting public

health and the concerns that the high containment facilities engender among local

communities, active participation in this process from the public at large will be essential.

Support for infrastructure for biodefense research is essential if we are to fulfill

our biodefense research agenda and protect the Nation from disease threats, be they

deliberate or acts of nature. We have already made substantial progress with the

facilities now available. For example, NIH-funded scientists have developed a safer

second-generation smallpox vaccine called ACAM2000 and a very promising new

smallpox drug named ST–246. Investigators have developed and tested a new anthrax vaccine called rPA and have achieved promising results with antibodies capable of neutralizing anthrax toxins. They have developed first- and second-generation

vaccines against Ebola virus, and investigated a promising Ebola therapy based on

RNA interference. These and many other advances required the use of containment

facilities of the type that are now under construction. Progress should occur more

rapidly as the new facilities become available.

NIH-funded biodefense researchers are acutely aware of the threat posed by the

pathogens they study. These experts understand the need to handle them with utmost care, the need for rigorous training and state-of-the-art equipment, and the

need to scrupulously follow all required procedures. Their awareness also includes

a deep understanding that the Nation’s biosecurity depends on their work, which

is the conduct of research that will lead to new tools essential to meet emerging and

re-emerging threats to public health.Thank you for this opportunity to discuss this

very important issue with you. I will be happy to answer questions.

Mr. STUPAK. Thank you. Captain or Dr. Chosewood, an opening?

Dr. CHOSEWOOD. No.

Mr. STUPAK. OK. We will go to questions.

Dr. Besser, if we can start with you please. There is a thing

called restricted experiments, right, which pose extraordinary

risks?

Dr. BESSER. Yes, sir.

Mr. STUPAK. And you have to apply for a permit to do these restricted experiments?

Dr. BESSER. That is correct.

Mr. STUPAK. Where are these restricted experiments carried out,

at level 3 labs or level 4 labs?

Dr. BESSER. Yes, they are conducted in select agent laboratories,

primarily at level 3 and 4.

Mr. STUPAK. OK. And how many applications do you receive for

these restricted experiments on an average each year?
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Dr. BESSER. Approximately five or six.

Mr. STUPAK. Five or six. If these are restricted experiments or

the ones that impose extraordinary risk and if you only get five or

six of these, why would we want to increase all these labs then?

Dr. BESSER. When you look at the breadth of work that takes

place in select agent laboratories, it is a very small part of that

work that would be classified as a restricted experiment. The vast

majority of the work does not fall within the category of restricted

experimentation.

Mr. STUPAK. OK. Well, before 2001, we had three of these labs,

level 4 labs, we are now up to 15. How many labs do we need at

level 4?

Dr. BESSER. We are at the anniversary of that anthrax attack

and at that time I was in Boca Raton working with the FBI investigating that outbreak. I spent 2 weeks in the Winnebago with

them. And during that time, I can tell you that we were pretty

scared about our ability to deliver countermeasures to people who

might need them.

Mr. STUPAK. OK. But how many labs do we need, or do we need

more Winnebagos?

Dr. BESSER. I can tell you based on my experience in that event

and my experience previously as head of the branch at CDC that

does anthrax work, that there was a limitation on our ability to develop countermeasures based on the number of labs. I cannot tell

you though how many labs we need.

Mr. STUPAK. But to develop countermeasure does not mean necessarily more labs, right?

Dr. BESSER. Well, when you look at what it takes to develop a

countermeasure, these measures need to be tested and much of

that work, in terms of testing, requires animal testing. That type

of work does require high-containment laboratories.

Mr. STUPAK. OK. Dr. Auchincloss, let me ask you then because

you said you have the distinguished panel. There was strategic

planning of the three or four level labs and you indicated there

were not enough labs.

Dr. AUCHINCLOSS. That is correct, sir.

Mr. STUPAK. So did the panel recommend how many labs we

needed then?

Dr. AUCHINCLOSS. The panel recommended a research agenda. It

did not recommend, specifically, the number of new facilities that

would be needed.

Mr. STUPAK. Would the research agenda then dictate the number

of labs we need in this country?

Dr. AUCHINCLOSS. The research agenda was what we used to determine the number of new facilities needed in the country.

Mr. STUPAK. OK. So you used the research agenda to determine

the number of labs we need in this country. Is that what you said?

Dr. AUCHINCLOSS. That is what I said.

Mr. STUPAK. So how many level 3 labs do we need in this country?

Dr. AUCHINCLOSS. We determined, on the basis of that research

agenda, that between 10 and 15 BSL–3 facilities were needed for

the extramural community.

Mr. STUPAK. Ten to 15.
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Dr. AUCHINCLOSS. And at least two level 4 facilities for the extramural community.

Mr. STUPAK. OK. We had three. We are now up to 15. So it

should be five, so we got 10 too many level 4 labs?

Dr. AUCHINCLOSS. Sir, the estimates that the NIH has put together refer to the needs for the scientists that the NIH funds.

Mr. STUPAK. Sure.

Dr. AUCHINCLOSS. And we are not trying to claim that our planning applies to other Government agencies or other funding agencies.

Mr. STUPAK. So you only want five labs total then to do what

NIH wants to do?

Dr. AUCHINCLOSS. NIH determined that it needed between 10

and 15 BSL–3 facilities.

Mr. STUPAK. Right. And two more level 4.

Dr. AUCHINCLOSS. And two level 4 for the extramural community.

Mr. STUPAK. Correct.

Dr. AUCHINCLOSS. And then we actually determined that we

have two additional level 4 facilities for the intramural program

that can be worked.

Mr. STUPAK. So your scientific panel only looked at what NIH’s

needs were.

Dr. AUCHINCLOSS. Our scientific panel only looked at what the

NIH research agenda would be.

Mr. STUPAK. Did CDC do the same things, take a look at what

you thought was necessary?

Dr. BESSER. No, sir. CDC looked at its own needs in terms of the

work that we do in diagnostics and that lead to the expansion at

CDC in our level 4 capabilities.

Mr. STUPAK. OK. So the CDC then determined you needed so

many level 4 for your work you do in this area?

Dr. BESSER. That is correct.

Mr. STUPAK. And how many is that, level 4 labs?

Dr. BESSER. Four additional laboratories at CDC.

Mr. STUPAK. Four more additional labs at CDC. So it looks like

every agency is making their own assessment and doing their own

thing basically, right?

Dr. BESSER. I think that there is room for a more comprehensive

look at our national needs in both of these areas.

Mr. STUPAK. Well, if you got 15 different agencies, was your

other testimony, you are up to four. If we did five, four at each one,

four times 15 is 60. We would need 60 more level 4 labs if every

agency did their own assessment. Is anyone in control ball? Who

should be in control? It sounds like CDC, in your testimony, Dr.

Besser, are the ones who do the protocol; you are the ones that do

the inspections. Should you be in charge of all the labs of all the

agencies?

Dr. BESSER. I think that the process that Dr. Auchincloss referred to in his oral statement of pulling together an intra-governmental group, pulling together a blue ribbon panel to look at the

activities in BSL–3 and BSL–4 facilities will help to address that

issue. I think that CDC is effectively executing its mission around

the select agent program. But as we have heard, that does not
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cover all of the organisms that need to be handled safely and securely in laboratories.

Mr. STUPAK. Well, let me ask this. It seems like from where I

am sitting, over a billion dollars have been spent on labs that we

know of. No one can tell me how many labs that we have, the

quantity of stuff we are looking at, the quality of stuff we are looking at that could be a threat to this country. It seems like if we

put the money out there then germs will come, so we will build

these labs. I mean, what has really changed since the fall, other

than anthrax, OK? Other than that, what has really changed that

would require this proliferation of labs that agencies double and

triple in labs they have. Is there a greater threat to us? If so,

should we not be putting the money into research as to most all

labs? So what has changed in the last 5 years, other than more

money available? Can someone answer that?

Dr. BESSER. I will start and you can follow. I think 2001 was a

wake up call; and it was a wake up call in terms of anthrax. But

it was a wake up call beyond that and it forced a look at what are

the potential agents that could be used deliberately and what are

our abilities to respond with either vaccines or treatments for those

conditions. That lead to issue of legislation and a push to develop

countermeasures.

Mr. STUPAK. True.

Dr. BESSER. But as part of that, there was a move to expand the

laboratory capability to be able to address those needs. In addition

to that, if we look at our overall preparedness efforts around the

country, there has been developed something called the Laboratory

Response Network, which is not doing research but it does have

BSL–3 capabilities in order to be able to rapidly diagnose these

type of serious infections we are talking about to allow communities to respond faster. We are now at a point where 90 percent

of the U.S. population lives within 100 miles of one of these facilities and it has created, I think, a laboratory infrastructure that is

critical to our preparedness and response.

Mr. STUPAK. But preparedness would be a countermeasure, a

medical countermeasure to like anthrax. Have we seen any

counterterrorism, medical counterterrorism measures to defeat anthrax. We still have not determined the strain from 2001, according

to the last panel, as the one that killed five people and sickened

20 others.

Dr. BESSER. There has been a lot of work done in the area of anthrax, vaccine work and countermeasures. CDC has undertaken a

study looking at the existing anthrax vaccine to try and reduce the

number of doses that are required to confirm protection. In addition, NIH has supported extensive work in developing vaccines for

anthrax that might be much safer.

Mr. STUPAK. When was the last time you updated the selected

list, the selected agents?

Dr. BESSER. The last time was August 28 of this year. We published in the Federal Register and it is still open for comment, the

latest revisions to the select agent list.

Mr. STUPAK. Is SARS going to be one of these select agents?

Dr. BESSER. SARS was considered by the committee. If I could

explain the process by which agents are considered? There is an
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intergovernmental committee called the ISATTAG. That is the

Intergovernmental Select Agent and Toxin Technical Advisory

Group. It contains representation from all the Federal agencies

that do work with select agents: CDC, NIH, FDA.

Mr. STUPAK. This group met in August this year. When did it

meet before August of this year?

Dr. BESSER. Well, the notice went out in August.

Mr. STUPAK. OK. They met this year. When did they meet before

this year?

Dr. BESSER. The ISATTAG not only reviews the select agent list

for our program, but they also review proposals for restricted experiments, as was discussed earlier. And the ISATTAG meets on

an ad hoc basis, typically four or five times a year as needed when

issues come up.

Mr. STUPAK. OK. Now, getting to the issue asked about SARS.

Dr. BESSER. No, select agents.

Mr. STUPAK. OK. You met four to five times. SARS is a select

agent. The hantavirus is not a select agent. And there is one other,

dengue fever. These are all we have no cure for. If they break out,

people can die.

Dr. BESSER. Right.

Mr. STUPAK. It seems like you are building the labs but no one

is doing anything about getting a list and trying to restrict the research of the most dangerous things that could cause most harm

to us and spend, what, 5, 6 years.

Dr. BESSER. Each of those agents has been considered and was

not included on the list. There are 14 criteria that are looked at

when considering an agent for the select agent list. When the

SARS epidemic first occurred and we knew very little about that

virus, it was being handled in BSL–4 facilities. When the ISATTAG

looks at the science around an agent and whether it should be considered a select agent, we look at the degree of pathogenicity, how

bad an infection does it cause, how easy is it to transmit personto-person, how easy is it to spread within a community, what is the

route of exposure, how stable is it in the environment, how easy

would it be for somebody to produce that agent, can it be genetically manipulated or altered because there are long term——

Mr. STUPAK. SARS does not make it then?

Dr. BESSER. Well, SARS did not make it to that list and if

you——

Mr. STUPAK. Since the fall of 2001, have you added any more

agents to this select list? Select list first came out, what, in 1996?

Dr. BESSER. Yes. In October 2005.

Mr. STUPAK. How many have you added since the fall of 2001?

Dr. BESSER. The 1918 influenza virus was added in October

2005.

Mr. STUPAK. OK. We had flu. Did you add anything else? I am

trying to justify all this money and all these labs. If we have a select agent list in 1996 at 72 and we add one, we get up to 73

maybe; how do we justify a proliferation of all these labs?

Dr. BESSER. Well, the work being done in those laboratories is

not necessarily being done just on the new agent, 1918 flu. But it

is acknowledging the lack of work or the need for work with some

of the existing agents.
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Mr. STUPAK. Correct. And Congress’ charge was to develop countermeasures to make America safe. And if the list has not grown

more agents that we should be concerned about but yet we have

probably 10 times more labs than we had before then. Again, it

goes back to look like we are building labs and hoping the germs

will come. That is my concern. Mr. Green for questions.

Mr. GREEN. Thank you, Mr. Chairman. When you let off by asking how many Winnebagos we need, our colleague, Mike Ross on

our committee keeps talking about all those FEMA trailers we

have in some field in Arkansas. Maybe we can put wheels on them

and get them. I thank our panel for being here and appreciate your

work. Coming from Texas, we certainly have been following the

news accounts on instances in the Texas biosafety labs. One of the

news articles quotes a laboratory expert who compared lab settings

to hospital settings and noted that infections are not entirely unexpected. Generally, where are the risks in this line of work and

would you say that they are primary to the lab worker or would

it be to the broader community?

Dr. CHOSEWOOD. Obviously, we are concerned about infections or

releases in any setting because safety is a vital component of all

laboratory work for certain. The vast majority of incidents that

have occurred and given the vast amount of work that has gone on,

we believe that the actual number of events is very small. But

when those events have occurred, they have affected primarily the

laboratory workers. The select agents folks can give you some specific numbers on the amount of workers who have acquired infection. But the risk to the environment, in all of those cases, has

been non-existent in our opinion.

Mr. GREEN. OK. Another course of questions of safety are of utmost concern, but I also want to make sure that we have a measured and thoughtful reaction to the incidents we hear about. Of

course, we want 100 percent safety but based on the incidents to

date, the expert indicated that he was not certain the problems

reached the level of a crisis. Can you share your thoughts on that

issue, and would you agree or disagree with that statement whether it had reached that level of crisis?

Dr. BESSER. I think it is critically important that we move forward very quickly to convene an intergovernmental group and look

at a process for reviewing how lab safety oversight is now provided

and we are committed to doing that. I think that the work of this

committee in shedding light on issues about safety will help move

the entire field forward and we welcome an opportunity to see the

GAO report and the preliminary report and their recommendations

because I think that as a young program, there is a lot we can

learn and there is a lot we can do to improve our oversight.

Mr. GREEN. Well, I know our Oversight and Investigation Subcommittee, we do not do legislation but typically will refer to our

the committee’s Health Subcommittee, for example, and I look forward to working with you and I know our full committee does.

Based on the incident reports received by the CDC, what is the primary source of the incidents in the biosafety labs? Can you attribute it to accidents, the human or engineering design flaws?

Dr. BESSER. The vast majority of events involve human error.

That is why it is so important that individuals, like your daughter,
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are well trained if they are going to be working in a laboratory;

that they have the right equipment for the type of experiment that

they are doing; that that experiment has been designed to minimize the amount of risk; and that their engineering controls, in

case that individual makes an error, it does not get outside of the

laboratory.

Mr. GREEN. OK. Our GAO witness mentioned the CDC biosafety

microbiological and the biomedical laboratories guide, as well as

the importance of training lab staff. Specifically, Dr. Rose mentioned that BMBL’s guidelines that personnel must receive training

on potential hazard and precautions. Can you elaborate on that

training guideline? Is there a mandate for that guideline for level

3 and 4 or is it to all the levels of these labs?

Dr. BESSER. You want to comment on that, Dr. Weyant?

Dr. WEYANT. With respect to the regulated select agent community, select agent laboratories are required to have a biosafety plan,

along with a security plan and an incident response plan. They are

required to train their staff in accordance with these plans and

they are also required to perform drills on an annual basis. As part

of our inspection regime through the CDC select agent program, we

review training records when we inspect entities.

Mr. GREEN. OK. I would like to carry forward and since I am almost out of time, Dr. Weyant, I am interested in clarifying the type

of agents that are being researched in the BSL–3 and BSL–4 labs.

Our witness on our fourth panel has referred to these agents as biological weapons agents. A term that certainly elicits strong reaction from the public. My understanding, however, is that these are

not actually weapons agents by definition, rather they are infections agents occurring naturally in nature. Is it fair to assume that

the BSL–4 labs are necessarily working on biological weapons

agents and can you clarify the distinction of the two?

Dr. WEYANT. Well, it depends on usage. An agent such as bacillus anthracis, the agent that causes anthrax, exists in the environment. It exists in soil in many parts of the world. However, the

agent can be grown up and purified and weaponized as was demonstrated in the events beginning October 4, so it is difficult to

take a single organism on this list and say it is absolutely a weapons agent or it is absolutely a naturally-occurring agent. I would

say it is fair to say that for the agents listed on this list, it is possible that they could be both.

Dr. BESSER. If I could add to that.

Mr. GREEN. Please.

Dr. BESSER. Currently CDC is assisting States on investigation

of cases of anthrax in Connecticut, cases of botulism in the Southeast, cases of tularemia in the Southwest. These are all agents that

are select agents and it is important that they have laboratories

that can diagnose those. But in their naturally-occurring form, they

are not something that could readily be used in a biological attack.

But in these laboratories we can learn about those agents and we

can work to improve our diagnosis, which is critical, and help to

develop treatments.

Mr. GREEN. OK. Thank you, Mr. Chairman.
85

Mr. STUPAK. But in response to that last question, especially on

botulism, the FDA’s response was that it closed down six of their

13 labs.

Mr. GREEN. I think those make sense, which was just said.

Mr. STUPAK. Botulism. If we are going to find it, FDA has responsibility but they want to close six of the 13 labs. Should not

we add food safety to CDC then?

Dr. BESSER. There are different roles in FDA. We have a primary

role in terms of investigating outbreaks related to botulism and

distributing the botulism antitoxin. And to succeed in that mission,

we have to ensure that we have rapid diagnostics. Currently, our

laboratories at CDC are working on a new ELISA test, which is

rapid test for diagnosing botulism that will have natural applications, as well as applications if there were deliberant events.

Mr. STUPAK. Right. I do not disagree with you with that last

statement but if the FDA, who is responsible for it, is closing the

labs and you guys are opening more labs, it seems like the agencies—no one is in charge here. Everyone is doing their own thing.

With that, let me turn it over to Mr. Burgess for questions please.

Mr. BURGESS. Thank you, Mr. Chairman. I apologize for being

out of the room for a while. I know I pledged to you earlier today

that I would not desert you through this hearing and my State delegation called and they actually rank a little higher than you, Mr.

Chairman. Let me just follow up and listening to the chairman’s

questions, Dr. Besser, in the room outside, on the select list, the

select agent list, that is developed, SARS is not on that list. Is

there a downside to having an agent on that list? Does it in any

way inhibit research, inhibit the evaluation of the agent? Is there

a research-oriented reason not to put an agent on that list? Is it

going to make it more difficult for the scientists to do their job?

And actually, whoever feels that they can answer the question. Dr.

Weyant, that is fine.

Dr. WEYANT. Thank you, sir. Yes, there is a downside to doing

work in a highly-regulated environment. There are extensive record

keeping requirements that we have for select agent laboratories.

There are extensive security requirements. As was discussed earlier this morning, individuals who apply to work with select agents

have to undergo a Department of Justice security clearance procedure, whereas individuals that would not work on a select agent,

do not have to undergo that. So there is a downside to working in

a highly-regulated environment. There is a lot more paperwork and

it is more resource intensive.

Mr. BURGESS. I referenced SARS earlier because of the rapidity

with which you guys, all of you at the table, made the designation

of a coronavirus previously reported and causing human disease,

came from a remote area in China, spread on planes from people

coming over here. Really relatively unsophisticated tools that beat

back the threat of this epidemic and I do not want to see us, Mr.

Chairman, do anything on this committee that would rob us of that

ability and I cannot say that anyone new going into that epidemic

that we are going to be able to beat this with epidemiology and

quarantine. But at the same time, because of the work that you do,

the scientific ground work that you did early on in that investigation, lead you to the conclusion that we have tools on a shelf that
86

we can beat this with and they, in fact, are the same tools that

were available in 1918 and let us get busy and do them.

In fact, I was really concerned, not to pick on the CDC but you

guys had a scientist get sick over in China; and he got put on a

Lear jet and brought back over to this country and I think refueled

two or three times coming back over here. I called the CDC back

in 2003 very concerned about is this the best way to be handling

a suspected case of SARS, putting them on an airplane with the

recirculating air that is present on an airplane, worrying about the

exposure to people, perhaps the ground based operators who would

be involved in refueling that plane and doing it for service that was

required at the various stops it made back to this country. It

turned out the scientist did not have SARS.

While I appreciate your dedication to bringing one of your own

back who was ill, I must admit I was terribly concerned. Turns out

that that concern was misplaced. Again, I just do not want us to

do anything that undermines your ability to do your job because

often times you do not know what it is you are going up against

and you are literally walking across a bridge as you are building

it. And we just have to be very careful that we do not stymie that

creativity and that ability to respond. But that does lead me to the

question that I asked the previous panel before and if you wanted

to place us on a continuum of exposure to safety, obviously we were

at one place in 2001 when the anthrax attacks on the Senate occurred, have we moved on that continuum forward or back in the

6 years that have passed since that time?

Dr. WEYANT. I think we have moved forward and I think we

have moved forward because we now have a program in place that

is really requiring a lot of laboratories that are working on select

agents. The area of select agents, as has been said, does not cover

the full spectrum of germs that can be harmful. But we did not

have in place a program that required a detailed background check

for individuals who work with these agents. We did not have a program that required approval and required inspections, that required documentation of safety, as well as security methods. So

that is an improvement. There is a lot more that can be done and

this process of this committee is raising really important issues

that we need to address. I can tell you about the CDC’s ability to

move people who are potentially infectious has improved. By early

spring, we will have a self-contained biocontainment unit that we

will fit in the CDC plane that will allow for transport of a passenger safely. Again, it is critical, especially when we do not know

what we are dealing with, like the beginning of the SARS epidemic,

that we are able to use engineering controls to protect the public.

Mr. BURGESS. True. Well, that is very reassuring to hear that.

Mr. Chairman, I just also have to mention, last year when I was

taking a trip to Iraq, I think it was one trip with Mr. Green and

I took a side trip to Geneva to visit what was going on with the

World Health Organization. At that time, we were all real concerned about the bird flu. And CDC had their people on the ground

in Geneva, in the, I do not know what you call it, the whatever it

is, the biologic room, and it is an impressive amount of work. And

that is impressive protection provided by American scientists on

loan to the World Health Organization. Not the World Health Or-
87

ganization, directive of the CDC but American scientists on loan.

And they went through the day’s reports with me. It was absolutely

astounding the breath, the scope, the danger that people were in

having to go to remote areas and ferret out the symptoms that had

come to their attention that might be indicative of something much

more serious. So, Mr. Chairman, unless we get too complacent or

smug up here that these are not real illnesses, real issues, I mean,

these guys are on the front line and I believe they are committed

to doing a good job. I just want us to be able to give the tools, deliver the tools to them that they need.

Mr. STUPAK. Dr. Besser, on your page four of your testimony the

statement is made that the NIAID estimated the new BSL–3 and

BSL–4 facilities would be required to accomplish the research

agenda. Our committee has asked for a copy of that assessment.

When will you provide that copy of the assessment?

Dr. BESSER. We will work with your committee to provide that

as soon as we can.

Mr. STUPAK. Yes, but we would have liked it before the hearing,

that is why I am asking, so get it to us, OK?

Dr. BESSER. Yes, sir.

Mr. STUPAK. All right. Second, let me ask you this question.

When you are working with SARS, as has been brought up, bird

flu to plague or Ebola, safety should be paramount. Do you feel

that the community where these labs are located and first responders in these communities should be notified of what agents are

being studied at those labs?

Dr. BESSER. I think that is an important question and I think it

is critically important that communities are aware that laboratories are in their community, that they have been engaged as part

of the decision as to whether a laboratory is being placed. When

it comes to specifics about what agents are in the laboratory, I

think that is a difficult question and one that is hard to answer.

There is the importance of transparency but there is also the issue

of letting individuals who may want to do harm know where certain agents are located and both of those have to be weighed.

Mr. STUPAK. OK. So you said, well, they should know about the

lab but not necessarily the agents being studied there. But should

the public then be made aware or notified of the shift of a lab from

a level 3 to a level 4, like you may be doing down in Bethesda?

Should that community be made known that it is going to go from

a level 3 to a level 4?

Dr. BESSER. I think that is an important question. I am looking

forward to guidance on some of these issues from our review process. I think that we have to weigh the issue of sharing information

that could do harm to a community versus being open about what

is going on. And I think that the more trust that the community

has that the labs are being run safely, the less that is an issue.

But I do not think that we are where we need to be in terms of

that level of trust.

Mr. STUPAK. You think we are there at the level of safety?

Dr. BESSER. I think that the laboratories that are being built,

these state of the art laboratories, are extremely safe. That does

not mean that an error will not occur.
88

Mr. STUPAK. Yes, your own CDC lab in Atlanta was supposed to

have redundancy in the electricity event when the lightening stuck.

Everything shut down in a level 4 lab. You did not have the redundancy that was required and that is a brand new lab.

Dr. BESSER. Dr. Chosewood?

Dr. CHOSEWOOD. Sure. I would love to comment on that. In fact,

we believe that the GAO findings about the lack of redundant

power is absolutely incorrect.

Mr. STUPAK. It is incorrect?

Dr. CHOSEWOOD. Yes, sir.

Mr. STUPAK. You should have just one power source at a level

4 lab, is that what you are saying?

Dr. CHOSEWOOD. No, but in fact, that is not the case. The power

outage in our building 18 laboratory occurred as a result of an

error.

Mr. STUPAK. A lightning strike, right?

Dr. CHOSEWOOD. A lightning strike to the building.

Mr. STUPAK. Yes.

Dr. CHOSEWOOD. And unfortunately, the lightning protection system in that building had been interrupted by ongoing construction

nearby. And so the power failure in that instance was completely

appropriate. It was as if you were having a power surge in your

own home.

Mr. STUPAK. So you think——

Dr. CHOSEWOOD. And if that were the case——

Mr. STUPAK. Power outages at level 4 labs are certainly appropriate?

Dr. CHOSEWOOD. No, I did not say that. One of the things that

I think is important is to imagine a power surge in your own home

and you have a breaker that trips appropriately. That is exactly

what occurred in this situation. And that is what you would want.

Mr. STUPAK. The backup system cable was cut, was not it?

Dr. CHOSEWOOD. This was an interruption of the lightning protection system but not the backup cable for power.

Mr. STUPAK. So then why did not the back up one come on then?

Dr. CHOSEWOOD. Because it was not supposed to in an overload

situation like a lightning strike. So basically at the time of the

lab—we should tell you that we had no active work going on. The

maximum containment labs in building 18 are actually not functional at this point. But even if they had been functional, there are

multiple systems of safety in place to avoid escape of any dangerous pathogens.

Mr. STUPAK. But if you do not have any power, those backup systems are not going to work.

Dr. CHOSEWOOD. No, I would disagree because the facilities are

designed to withstand higher levels of containment than the typical

space. These are pressurized areas. If you have a power loss in a

maximum containment laboratory, the actual air flow goes neutral,

it does not become positive. You do not have the escape of that air

in the lab to the outside.

Mr. STUPAK. OK.

Dr. CHOSEWOOD. Backup power is important. It is a critical thing

but that was not the case here and our laboratories do have backup

power.
89

Mr. STUPAK. Well, GOA tends to disagree with all you said but

that is the information we have to work with, to share information

with us and then maybe we can get some of this squared away.

You mention audits. Let me just ask about an audit. Do you do any

surprise inspections of these labs? Do they know when you are

coming to inspect the labs?

Dr. WEYANT. The select agent regulations give us the authority

to do surprise inspections.

Mr. STUPAK. Yes, but you do it?

Dr. WEYANT. As a rule, we do not do surprise inspections.

Mr. STUPAK. Well, if they know when you are coming, it is pretty

easy to pass inspection. Is that what happened at A&M? You guys

were right there, you guys approved everything, some minor things

were out of hand and if it wasn’t for this Sunshine Project, we

never would have found out about the instance there, right?

Dr. WEYANT. Yes, I think the issue of unannounced inspections

is something we need to consider as we look at improvements in

our program. I would rather not get into the details of Texas A&M

given that they have been referred to the Inspector General to assess whether civil or criminal penalties may——

Mr. STUPAK. I am not here to dump on A&M but I am just trying

to say, without any kind of surprise inspection system, how are you

going to know? I mean, you said documentation. How do you know

if the documentation is valid? I mean, this Sunshine Project went

through a Freedom of Information, went to the State agencies and

found the information you should have been looking for and you

were just there. So, I mean, if Sunshine can do it, why cannot you

who are responsible for inspections figure out a way to double

check, to truly audit, to be truly independent what we are all

doing.

Dr. WEYANT. With each one of these events, we learn and we

look to make improvements. And from our experience with Texas

A&M and other institutions, there are additional documents, employee health records and such, that we will be looking at.

Mr. STUPAK. OK.

Dr. WEYANT. We will be looking to expand the pool of people that

we interview and we look for, again——

Mr. STUPAK. Let me go to Mr. Burgess to see if he has anything

further. We have got 5 minutes before we have to run down for two

votes. We should be able to get right back and we can——

Mr. BURGESS. I know they will hold the votes for you, Mr. Chairman, so we will take the 5 minutes.

Mr. STUPAK. Sure.

Mr. BURGESS. Can I just ask a question for really anyone on the

CDC side? If we find a problem, as was encountered at Texas

A&M, should we not encourage a system that would promote voluntary reporting? You’ve got an issue, confess your sin, work on

correcting it rather than a system that truly punitive. Design the

system more like NASA, more like what we see with the nuclear

submarine program that has such a proactive safety record.

Dr. BESSER. I think that is a very creative idea and something

we need to explore. We do not want to have a system in place that

actually leads to less transparency in reporting because of fear of
90

penalties. We want a system where laboratories can learn from

each other to prevent these from happening in the future.

Mr. BURGESS. Dr. Auchincloss, if I could ask you just in regard

to NIH and funding for the NIH. Of course, you know this committee went through a rather lengthy and involved reauthorization

process that culminated last year in December and finally just sent

it to—work and we got a bill passed that reauthorized the NIH for

the next 5 years, funding at about $30 billion a year to increase

by 5 percent a year. We took a lot of grief for only increasing your

budget by 5 percent every year and yet this year the House passed

labor NIH’s budget is about a 2.3 percent increase, if my arithmetic

is correct. Is that your understanding as well?

Dr. AUCHINCLOSS. That is my understanding.

Mr. BURGESS. So why have you all not been more outspoken

about not receiving your full authorized funding increase at NIH?

Clearly, we are at a time in our Nation’s history where if anyone

needs a funding, you guys need the funding. We authorized a 5

percent increase. Again, we were criticized for it not being a 7 or

9 or 10 percent increase and we only managed to come up with 2.3

this year.

Dr. AUCHINCLOSS. We have research agendas for extreme drugresistant tuberculosis, further work on influenza, such where we

could spend the money.

Mr. BURGESS. Well, no question you can spend the money but

really it is a question of planning too. How can you obligate or ask

a young scientist to obligate their life to you when you are not sure

that your funding stream is going to be steady? That was the whole

purpose in reauthorizing the NIH budget last year. That is why we

went through that long laborious process. I would just ask the NIH

to help us make certain that your funding requirements receive no

less the attention than every other thing that we deal with on this

committee, whether it be the FDA regulation of tobacco or the

lyrics of rap songs. Your work is every bit as important as that

work and I want to hear from you. When we are not doing our job

at the funding level, goodness knows, I heard from everyone last

year, where were all your groups this year? Where was the NIH

when your funding was cut by half, by over 50 percent, your funding increase was cut by over 50 percent, where was the involvement of the NIH?

Dr. AUCHINCLOSS. I got your point, Congressman, I do.

Mr. BURGESS. Very well. And you’ll deliver that to Dr. Zerning?

Thank you.

Mr. STUPAK. Less construction, more research. With that said,

we will be at recess for about 10 minutes. We have two votes. This

panel is dismissed. Thank you.

[Recess.]

Mr. STUPAK. Witness to come forward. That is Dr. Ed Davis,

president of Texas A&M University. Dr. Davis, it is the policy of

this subcommittee to take all testimony under oath. Please be advised witnesses have a right under the rules of the House to have

counsel present and to be represented by counsel at this time. Do

you have counsel with you, sir?

Mr. DAVIS. No.
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Mr. STUPAK. OK. Witness indicates no. So then I would ask you

to please rise, raise your right hand.

[Witness sworn.]

Mr. STUPAK. Thank you, sir. Let the record reflect that the witness has replied in the affirmative. He is now under oath. Dr.

Davis, you’ll have 5 minutes for an opening statement. You may

submit a longer statement for the record if you wish. Dr. Davis,

we’d like to have your opening statement please, sir.

STATEMENT OF ED DAVIS, INTERIM PRESIDENT, TEXAS A&M

UNIVERSITY

Mr. DAVIS. Mr. Chairman and Ranking Member Barton, subcommittee members, my name is Ed Davis. I am president of Texas

A&M University. As a brief point of personal privilege, I would like

to acknowledge Mr. Barton’s long service to the State of Texas, his

district and to his alma mater, Texas A&M, as well as Mr. Chet

Edwards, who accompanied me this morning here, who is our 17th

Congressional District Congressman.

You might legitimately ask why the president of Texas A&M is

here. I am not a microbiologist. I am not a doctor. I am not even

a lawyer. But the answer is really pretty simple. Texas A&M has

a proud heritage of scientific research. In fact, our 131st birthday

is today and we have had a long history of providing service to our

country. More importantly, however, is we have a history of being

an honest, high-integrity and forthright institution in doing everything that is right.

I am here today as president to make four important points for

the record. Number 1, we made a mistake. We failed to report an

exposure to a select agent, Brucella, in a timely manner. The details of the incident are contained in my written testimony and I

am pleased to give any additional details that you may wish. I am

satisfied through our internal review that this was due to human

error. It was compounded by a failure to have adequate protocols

and redundant controls in place to ensure it could not happen.

Number 2, we take this issue very seriously. I, as president, have

become personally involved in this situation. I have devoted time

and resources to assess what happened, to analyze appropriate corrective steps, and to move to implementation to return our program

to doing the scientific work, the very important scientific work that

benefits the public health system and the security of our country.

Number 3, we are taking corrective actions to fix the problem. We

want to rescue our research, revise the select agent registration

with the CDC as our regulatory partner, hire and properly organize

the best talent to lead our safety, security and compliance activity

and re-establish the trust with the CDC, with you and with our research funding partners.

Finally, Mr. Chairman and members, we intend as a learning

outcome of this episode, to develop in conjunction with you and the

CDC a model program for select agent research and compliance to

be in place across the country. In summary, we are committed to

getting it right. We will use CDC’s comprehensive review that has

been provided as our road map to compliance and we will move forward from there. But we will leave nothing undone in moving our

program to one of a model of documented excellence. This research
92

is important, as I said, to our country’s public health system and

to our national security.

I think from the hearing today I have observed three protocols

and partnerships that make sense and I think the hearing has

been valuable for that. One is that we need to have good science.

That is our job in conjunction with our funding partners. We need

to have absolute compliance. That is our job with our regulator, the

CDC. And we need regulatory oversight and coordination, which is

the task of the hearing of this committee today. I think it provides

value. We appreciate the opportunity to be here. I am here to answer any questions or provide further details. Mr. Chairman.

[The prepared statement of Mr. Davis follows:]

TESTIMONY OF EDDIE J. DAVIS

Mr. Chairman, Ranking Member Barton and members of the subcommittee, my

name is Eddie Joe Davis, interim president of Texas A&M University at College

Station. I have held this position since December 2006. The College Station campus

is the largest of the 10 campuses that fall within the Texas A&M University System. I am appearing here today at the Subcommittee’s request.

Texas A&M’s College Station campus is home to approximately 38,000 undergraduate students at 10 colleges and approximately 7,000 graduate students. The

University takes great pride in its reputation as a top tier research institution. I

am here today to provide testimony regarding our select agent research laboratories.

As you may be aware, these laboratories have recently been the subject of investigation by the Centers for Disease Control & Prevention or ‘‘CDC’’ and, as of June of

this year, our select agent research work has been suspended pursuant to CDC’s

orders.

My comments today will first focus on some background information regarding the

University’s research program, internal compliance program and the select agent

labs. I will then move on to the recent matters leading to the CDC’s suspension of

the University’s select agent research and our commitment to run a model program

to which others compare themselves. Finally, I will provide observations regarding

the application of recent Federal regulations governing the possession and use of select agents in the laboratories that have emerged over the past few years.

I want to make it absolutely clear that Texas A&M University is, first and foremost, fully committed to both the safety and protection of our employees, students

and community, and to following the guidelines and rules on safely and securely operating our laboratories that handle select biological agents and toxins. Only then,

will we seek inspection and approval from the CDC to resume the research in these

labs.

TEXAS A&M SELECT AGENT RESEARCH AND COMPLIANCE

Organizational Structure. The University’s research organization falls under the

Division of Research and Graduate Studies which carries out its mission through

several internal units and a variety of external units and centers that are focused

on important new fields of scientific inquiry. The work of the Division’s units and

centers spans the full range of scholarly endeavors and disciplines, securing Texas

A&M University’s place among the world’s leading research institutions.

The Office of Research Compliance, which is a key unit of the University’s Division of Research and Graduate Studies, is responsible for providing training and

support to faculty, students and staff in regulatory requirements for scientific research. Through key committees and related programs and activities, the Office of

Research Compliance develops, implements and oversees compliance with university

policies and any applicable research requirements or regulations related to the following areas, among others:

• Research involving humans;

• Research involving animals; and

• Research involving hazardous materials, select agents or recombinant DNA.

Research projects involving infectious/biohazardous agents are subject to approval

by the University’s Institutional Biosafety Committee or ‘‘IBC.’’ The IBC serves as

the University’s primary interface between the research institution, the Biological

Safety Officer (BSO), and principal investigators (PIs) concerning lab review, secu-
93

rity, safety, emergency plans, and other activities. In addition to the BSO, the University has also designated a responsible official or ‘‘RO’’ as required by the March

2005 Federal regulations promulgated by the Department of Health & Human Services for select agents and toxins. The RO is the University’s designated individual

who has the authority and control to ensure compliance with the regulations governing our select agent labs.

We presently employ an RO and a BSO, but in an effort to assure full compliance

and seamless communications, we will combine these responsibilities into a single

person who will report directly to high-level University management. At present, we

have an on-going nation-wide search for a new RO/BSO and we expect to have this

position filled by the end of the month. With the promulgation of the select agents

and toxins rule, the roles of the RO and BSO have evolved and taken on additional

responsibilities, which require unique skill sets and experience.

Select Agent Research Laboratories. Texas A&M University has a long history of

applied and basic research involving Shiga toxin-producing E. coli, Brucella and

Coxiella species with the goal of advancing the understanding of mechanisms of infection and disease, gene function, and vaccine development. The research efforts of

our investigators have resulted in a better understanding of mechanisms of infection, which have yielded significant and relevant results with respect to

immunogens for vaccine development, detection of the infectious agent and modes

of delivery for achieving the highest probability for success in immunization against

disease organisms. The collective contributions and over-arching theme of our research with Shiga toxin-producing E. coli, Brucella and Coxiella bacteria are in understanding host-pathogen interactions as the basis for prevention of disease. While

these are zoonotic agents (i.e., agents that are transferable from animals to humans)

and prevalent in the surrounding environment, most of the research focuses on diseases in animals and the economic impact of the resulting animal losses, as well

as development of better human and animal vaccines. The recognition of the bioweapons potential of these particular agents has only served to make the ongoing

research at Texas A&M more relevant and important. The four BSL–3 research laboratories at the University that are registered with the CDC as handling select

agents are led by principal investigators Dr. Garry Adams, Dr. Thomas Ficht, Dr.

Jim Samuel and Dr. Vernon Tesch.

Dr. Adams is a Professor and Associate Dean for Research and Graduate Studies

in the College of Veterinary Medicine. Dr. Adams’ research involves studies of the

genetic basis of natural disease resistance, molecular pathogenesis of intracellular

bacterial pathogens, and the development of vaccines and diagnostic tests against

zoonotic diseases. For almost two decades, he has been actively involved in improving the scientific basis of the two largest animal health regulatory issues in the

U.S.—brucellosis and tuberculosis. Recently, he has been very active in developing

and implementing biodefense and emerging diseases research initiatives.

Dr. Ficht is a professor in the Department of Veterinary Pathobiology at the University’s College of Veterinary Medicine. Dr. Ficht’s research involves Brucella, an

animal pathogen, which invades or persists in the phagosomal compartment of an

animal’s eucaryotic cells including professional phagocytes. His research explores

host-agent interaction between monocyte-derived macrophages and Brucella with

the aim of identifying the bacterial factors that subvert intracellular killing and the

host factors responsible for protecting the host from infection.

Both Dr. Samuel and Dr. Tesch are Associate Professors in the Department of Microbial and Molecular Pathogenesis in the College of Medicine at the Texas A&M

University System Health Science Center. Dr. Samuel’s research involves identifying recombinant vaccine strategies to elicit protective immunity to the obligate

intracellular bacterial pathogen, Coxiella burnetii, the etiologic agent of Q fever and

a biothreat agent. Dr. Tesch’s research involves a family of bacterial toxins called

Shiga toxins known to cause disease in humans. Shiga toxins are produced by

Shigella dysenteriae and E. coli. These microorganisms have been in the news lately, as the ingestion of undercooked hamburgers or other foods contaminated with

Shiga toxin-producing E. coli may lead to widespread outbreaks of bloody diarrhea.

A fraction of patients, mostly children, go on to develop life-threatening complications involving acute renal failure and neurological abnormalities.

Texas A&M University has been conducting research involving the propagation of

Brucella since the late 1970’s and has performed research using BSL–3 facilities

since the mid 1990’s. Research in the other BSL–3 laboratories has similarly been

on-going for some time. In addition to the four research laboratories, two BSL–3 diagnostic laboratories are operated by the Texas Veterinary Medical Diagnostic Lab

(TVMDL) located at the College Station campus. From its inception, the TVMDL

has occasionally received tissue or blood samples from animals which contain bio-
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logical agents and toxins (e.g., rabies, e-coli, and Brucella) and, therefore, it must

be equipped to handle these samples in a high containment laboratory.

CDC’S INVESTIGATION OF TEXAS A&M’S SELECT AGENT RESEARCH LABS

I now would like to turn our attention to the reported exposure of a University

lab worker to the select agent Brucella and the resulting CDC investigation of the

University’s select agent labs. I will first address the details of the exposure and

follow that up with comments regarding the CDC’s investigations earlier this year.

2006 Brucella Exposure. In February 2006, a post-doctoral research associate in

Dr. Thomas Ficht’s lab was conducting an experiment involving brucellosis using a

Madison Chamber. A ‘‘Madison Chamber’’ is an aerosol infection chamber that is

used to infect test animals with various pathogens. The use of the chamber for this

experiment was loaned to Dr. Ficht’s research associate by another researcher at the

University’s Health and Science Center, who used the chamber for tuberculosis research. A Ph.D. research assistant involved in the tuberculosis research which uses

the Madison chamber was present during the burcellosis experiment conducted by

Dr. Ficht’s research associate. The research assistant is proficient in the operation

of the Madison Chamber from her use in research concerning tuberculosis. At the

time of the experiment, she was present in Dr. Ficht’s lab to observe the proper use

of the chamber by the research associate who was working with Brucella. After the

experiment had concluded and the test animals removed, she cleaned the chamber

as she would if the pathogen had been tuberculosis.

About 2 months later, the research assistant notified Dr. Ficht that she was ill

with flu-like symptoms and inquired as to whether or not anyone else was ill. On

that same day, Dr. Ficht had all other lab employees who were present during the

experiment in February tested and notified the BSO. Within the next two weeks,

the research assistant was diagnosed with Brucellosis and, through blood testing,

it was confirmed that no other employees had contracted it. The research assistant’s

positive test for Brucella was entered into the public health database by the Brazos

County Health Department, which was automatically transmitted to the Texas Department of Health and CDC. The research assistant returned to work, was given

follow up blood testing and has continued to be monitored pursuant to the institution’s occupational health program.

In October 2006, the University received a request for public documents involving

incident reports for risk group 2 and higher pathogens from Mr. Edward Hammond

of the Sunshine Project, one of the witnesses at today’s hearing. In November 2006,

the University produced a document showing that there had been a single incident

relating to brucellosis. The University continued to inquire internally as to whether

there were any additional documents. In April 2007, additional documents were

identified regarding the Brucella exposure. At that time, the University immediately

notified CDC and provided the documents to Mr. Hammond.

CDC’s 2007 Investigation. Following the notification to CDC, the University received a notice of suspension of select agent research in Dr. Ficht’s lab. Inspectors

from CDC then visited the University to follow-up on the notification of exposure

and conducted an inspection of the University’s four BSL–3 laboratories. A few

weeks later, the University submitted information to CDC regarding elevated titers

for Q fever—a term of measurement of antibodies in the blood—for three employees

who worked in Dr. Jim Samuel’s lab. Although it was not clear whether notification

was required for these elevated titers, the University elected to report these levels

to CDC out of an abundance of caution. While these elevated titers were cause for

concern, none of the individuals became ill. Following this disclosure by the University, the CDC issued an order suspending all select agent research at the University. The University immediately complied.

On July 23, 2007, an 18-member team from the CDC conducted a comprehensive

site review of the University’s select agent research activities which ultimately led

to the CDC’s August 31st site visit report. Though the CDC’s report acknowledged

the efforts of the University in curing the deficiencies noted by the CDC inspectors,

we acknowledge that several additional steps need to be accomplished in order to

be re-certified for select agent research. Our No. 1 goal is to ensure that our laboratories are operated in a safe and secure manner, in compliance with all applicable

laws and regulations.

We are using CDC’s August 31st site report as our roadmap to full compliance.

In fact, we have already begun to take corrective action to cure many of the deficiencies cited in the report and have engaged outside experts—some of who were

recommended by the CDC—to assist in this process. This will continue full speed

ahead. Only after we have satisfied ourselves in the areas of biosafety, security,

training, recordkeeping and incident response, we will ask the CDC to allow us to
95

re-start the laboratories. We desire to get back to the important business of vaccine

research, with the CDC as our partner, as soon as possible.

MARCH 2005 CDC REGULATIONS COULD USE SOME CLARIFICATION

I would now like to turn our attention to the Select Agent and Toxins regulations

that were promulgated in March 2005. These regulations are found at 42 C.F.R. §

73.1 et seq. and were developed pursuant to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. These Federal regulations pertain specifically to the possession, use and transfer of select agents and toxins and

I will refer to them as the ‘‘SAT Regulations.’’

Like many labs in the U.S. handling select agents and toxins, we have grappled

with compliance with these regulations. Over the past two and one-half years since

their promulgation, several areas have emerged which we believe need further clarification or improvement. I address a few of these areas below:

Definitions—perhaps the most challenging aspect of the SAT Regulations pertain

to definitional interpretations of key terms. The possession, use and transfer of select agents and toxins in biomedical laboratories is a highly complex scientific endeavor. Added to that is the need to operate the laboratories in a safe and secure

manner. Given these complexities, the application of definitional terms in the regulations can take on different meanings given different operating scenarios. Terms

that are broadly defined can take on different meanings to different people, which

can result in differential application and enforcement of the regulations. The following terms in the SAT Regulations have led to a good deal of confusion:

‘‘Access’ to select agents or toxins. 42 C.F.R. § 73.10(a) restricts access to select

agents and toxins to only those individuals that have been approved by the HHS

Secretary or Administrator, following a security risk assessment by the Attorney

General. Whether someone has access or not depends on ‘‘if the individual has possession of a select agent or toxin (e.g., ability to carry, use, or manipulate) or the

ability to gain possession of a select agent or toxin.’’ 42 C.F.R. § 73.10(b) (emphasis

added). While the former condition (has possession) is straightforward, it is the latter condition that creates the bulk of the confusion (has the ability to gain possession). For example, does someone who has not been pre-approved and observes an

experiment in a select agent lab have the ability to gain possession of the select

agent? Or, if the select agent or toxin is in an animal that is locked in cage within

the lab, does that change the analysis? Presently, the definition of access to select

agents or toxins is interpreted to be extremely broad. Some degree of reason needs

to be applied to the rule in order to facilitate good laboratory practices and the advancement of scientific research. The effect of the broad application of the definition

is that any person who enters a SAT lab could arguably have access to the select

agent and, therefore, must be pre-approved.

‘‘Routine cleaning, maintenance, repairs, or other activities not related to select

agents or toxins’’ 42 C.F.R. § 73.11(d)(2) provides for certain exceptions to the rule

requiring that individuals entering a SAT lab be pre-approved. The exception in

(d)(2) specifies that an individual who conducts routine cleaning, maintenance, repairs, or other activities may gain access to the lab so long as (1) his or her activity

is ‘‘not related to select agents or toxins’’ and (2) he or she is accompanied by an

approved individual. The exception is often confused with the requirement set forth

in a 73.10(b) as described above. Furthermore, it is unclear what is meant by an

activity that is ‘‘not related to select agents or toxins.’’ Does the maintenance or repair of a vent hood that is used for the handling of select agents or toxins fall within

this exception? It could be argued that any activity within a select agent or toxin

laboratory is ‘‘related’’ to the agent or toxin handled in that laboratory.

‘‘Occupational exposure or release’’ of a selection agent or toxin. 42 C.F.R. §

73.19(b) specifies the notification requirements in the event of a release of a select

agent or toxin. The trigger for the notification is based upon whether there is an

‘‘occupational exposure or release of a select agent or toxin outside the primary barriers of the biocontainment area.’’ The SAT Regulations do not define the terms ‘‘occupational exposure’’ or ‘‘release,’’ leaving both the regulator and the regulated without clear direction as to what is expected. In terms of select agents and toxins, there

is little guidance as to what constitutes an occupational exposure (e.g., mode of the

exposure or acceptable limits or levels?).

‘‘Restricted experiments.’’ 42 C.F.R. § 73.13(a) establishes a requirement that an

individual or entity may not conduct certain ‘‘restricted experiments’’ unless approved by the HHS Secretary. Subsection (b) sets forth two types of restricted experiments—experiments using recombinant DNA that involve the deliberate transfer of a drug resistance trait to select agents and experiments that involve the deliberate formation of recombinant DNA containing genes for the biosynthesis of select
96

agents. While there are likely strong public policy reasons for restricting these types

of experiments (based upon the ultimate end use) without express approval from

HHS, these two types of restricted experiments are very broadly defined and may

unintentionally limit legitimate experiments involving similar approaches but result

in completely different outcomes (and end uses).

Authorization of Access to Select Agents and Toxins—another area of confusion

involves the authorization of an individual’s access to a select agent or toxin. 42

C.F.R. § 73.10(a) states that ‘‘[a]n individual or entity—may not provide an individual access to a select agent or toxin, and an individual may not access a select agent

or toxin, unless the individual is approved by the HHS Secretary or Administrator,

following a security risk assessment Attorney General.’’ The confusion arises as to

whether the authorization of an individual is (a) as to a specific select agent, wherever that select agent might be handled, or (b) as to a specific select agent handled

at a specific location. If the latter interpretation is correct, the authorization requirement becomes a bureaucratic paperwork mess. For example, a research scientist and his/her staff who work with Rickettsia prowasekii (a select agent) may,

from time to time, visit the labs of or work with other research scientists who handle the same agent. Requiring that scientist and his/her staff who are already authorized to access this select agent at their home lab to obtain authorization anytime they visit another lab or location where the select agent is handled serves no

purpose, nor does it achieve any public policy. The regulation should be clarified

such that the authorization applies to the specific agent in question, not the specific

agent and location. The focus of the authorization should be, first, on the individual

(which is why there is a security risk assessment on the individual) and, second,

on the handling of the select agent.

In closing, I want to express my appreciation to the CDC for providing a comprehensive review of the steps necessary to rebuild the compliance model for our

select agent and toxin research program at Texas A&M. As I mentioned previously,

we are using it as our road map to full compliance.

The University has made significant progress in implementing corrective actions

that cure the deficiencies noted by CDC in its findings and has brought in outside

experts, including several recommended to us by CDC, who have aided us greatly

in the process. Our efforts will continue at full speed ahead until we have satisfied

the CDC and ourselves. Our goal is for the University’s select agent labs to be the

model to which others compare themselves.

Mr. STUPAK. Thank you, Dr. Davis. We will begin questioning.

We will see if Mr. Barton would like to start.

Mr. BARTON. Mr. Chairman, I am willing to go first but I am also

willing to let the Chair exercise its prerogative to question first.

Mr. STUPAK. You are the graduate Texas A&M. Why do not you

go first?

Mr. BARTON. All right. I will be happy to. I think in full disclosure, Mr. Chairman, I need to say, not only did I attend Texas

A&M, my father attended Texas A&M, my three children attended

Texas A&M, numerous aunts, uncles, nephews, nieces and cousins

have attended Texas A&M. If you added up all the relatives who

have had the privilege to go to that institution, it would be in the

neighborhood of 30. So I am a biased questioner in favor of Texas

A&M. But having said that, as a Member of Congress and this subcommittee and the past chairman, I am absolutely committed to

getting to the bottom of what went wrong and making sure that

it does not happen again. Mr. Davis, as acting president of Texas

A&M, when were you first made aware of the Brucella exposure

and how was it reported to you?

Mr. DAVIS. In April 2007, Congressman Barton and I was notified that we had discovered that there was an error and a failure

to report within the timeframe required by the select agent regulations. This did come about through a request from the Sunshine

Project for us to produce documents related to our select agent program. And as we did review those documents and discovered that
97

this incident was not reported, as soon as we discovered it, we did

report the incident and at the same time, provided that information

to the Sunshine Project. The reason the incident was not reported

is fairly and lengthy and detailed but I think it is important that

I give you some summary of what happened. A laboratory worker

was actually an authorized person in a lab observing the use of an

aerosol piece of equipment, which she was using for tuberculosis research. This chamber was then used in a Brucellas experiment in

a different laboratory. After she had completed that work, the other

researcher, the person that was actually providing the machine,

cleaned the machine unbeknownst to the laboratory technician that

was conducting the research. As a result, her exposure to the Madison Chamber, we believe is where the infection came about. A few

weeks later she became ill with flu-like symptoms. She went to her

doctor. She was diagnosed with the flu and, ultimately, through a

couple of trips back to an infectious disease doctor, found that she

had, indeed, been exposed to Brucellas. At that time, she went back

to the principle investigator, informed him of this. He immediately

informed our biological safety officer, where the failure to report to

the CDC occurred. He did have the rest of his lab workers tested.

No one else revealed any indication of Brucellas or brucellosis and

the individual that was infected was treated and has been cleared

and has been routinely tested since that time, with no adverse effects.

Mr. BARTON. The individual that was infected was infected in

doing a procedure which she did voluntarily and was not instructed

to do so against protocol, is that correct?

Mr. DAVIS. That is correct.

Mr. BARTON. But in spite of that, this employee is currently

cured and, so far as you know, has no complaint against the university, is that correct?

Mr. DAVIS. That is correct.

Mr. BARTON. OK. Now you mentioned that there was an exposure incident of Brucella, we have talked about that. It is my understanding that there was also a Q fever exposure that went unreported. Can you comment on that?

Mr. DAVIS. I think it is helpful to clarify that. After our Brucella

report and a visit by the CDC, after the CDC had come in in April

to review this incident with us, after their departure, we were reviewing documents and discovered that we had elevated titers in

three employees who were actually involved in Q fever research.

We do titer testing, obviously, to determine from a public health

standpoint, if anyone has had exposure, it allows us to understand

if they should be referred to a physician for possible treatment. In

these cases, it was not clear that we were required to report the

titers. We did it out of an absolute abundance of caution because

we had just not reported Brucellas.

Mr. BARTON. This was after the Brucella.

Mr. DAVIS. This was after the Brucellas incident and after their

visit. We felt it was important that we absolutely reveal anything

that was of any concern. Unfortunately, after we did report the Q

fever incident, shortly after that, the CDC suspended our select

agent research.
98

Mr. BARTON. Now currently, is the Texas A&M University system fully cooperating with the CDC in their investigation or re-examination of the facilities and procedures at Texas A&M?

Mr. DAVIS. Yes, we are. We have, of course, received their August

31 report. We have had a team of individuals, including outside experts, helping us with the response to that report, as well as the

reconstruction of a total re-registration of our select agent program.

Mr. BARTON. And so long as you are the acting president of

Texas A&M, are you committed to doing everything within your

power to make sure that A&M fully complies with the CDC directives and cooperates in every way to ensure the safety of these

agents if this type of research is allowed to be commenced again?

Mr. DAVIS. Mr. Barton, we are absolutely committed to the research, to the safety, to the compliance of this research. Absolutely.

Mr. BARTON. Mr. Chairman, before I yield back, I want to recognize, I think, the chairman of the board of regents at the Texas

A&M University system is in the audience, Mr. John White, and

I think that shows the seriousness with which the university takes

this matter. With that I yield back, Mr. Chairman.

Mr. STUPAK. Well, thank you, Mr. Barton. All the people went to

Texas A&M in your family, I thought you would end up by saying

they named a lab after you.

Mr. BARTON. Well, there is an Olin E. ‘‘Tiger’’ Teague Research

Center at Texas A&M, who was my predecessor and who Congressman Edwards worked for as a district aid. So there is Aggie sixth

district congressman facility on campus but it is not named after

Joe Barton.

Mr. STUPAK. You’ll have to do a Chet Edwards, right? Dr. Davis,

this is a level 3 lab at Texas A&M, right?

Mr. DAVIS. Yes, sir.

Mr. STUPAK. OK. Are you in the process of expanding that lab

at all?

Mr. DAVIS. We are not. In our revised registration documents,

Mr. Chairman, we are actually recommending to the CDC that we

re-activate two of our laboratories. The two other laboratories, or

four in total, we have some physical corrections to make to that but

we are not seeking immediate re-registration of those other two.

Not until we have them fully in compliance will we ask the registration to include them

Mr. STUPAK. Were you here when the last panel testified?

Mr. DAVIS. I was.

Mr. STUPAK. OK. I asked about unannounced inspections. Do you

think CDC should do unannounced inspections?

Mr. DAVIS. I think we should have a program that can endure

any kind of inspection, Mr. Chairman, announced or unannounced.

I also believe, and this goes back to another question I believe you

asked and it is related to Mr. Barton’s question, the idea of no fault

reporting, it seems to us, is a very valid concept and should be pursued. We should be encouraged to report any kind of occupational

exposure or loss. And there needs to be greater definition of those

things.

Mr. STUPAK. Congressman Edwards explained to me a couple

times that the person who is in charge of safety of your labs there

has been terminated from employment and you are going about
99

correcting it. Any suggestions on how we do this? I heard a lot from

the CDC saying, well, we got documentations, we will be questioning this and looking at this. And in the Texas A&M case, the people who were in charge of certain things within the lab had all that

documentation. Maybe not to the level it was supposed to be but

they had that documentation and CDC passes you through and

then because of the Sunshine Project, we find there were greater

concerns. They come back in with their team and they find serious

violations. Any suggestions on how we can make sure CDC, or whoever is going to do it, do these inspections for independent verification so we do not have this situation again? As the president of

Texas A&M, I am sure you got the report from CDC saying everything is fine and then boom, we find things are not so good.

Mr. DAVIS. Certainly it is something that I would not be expecting on a daily basis to be involved in but I am involved in it now

and I do have some thought about how we go forward. Frankly, I

think this hearing is a positive view of what needs to be done.

You’ve revealed some issues, some lapses in the overall integration

of the select agent program and the biological research program. I

think it is more complex than just inspections. I think what we

have to have, it is very interesting as I analyzed the exit interview

from the CDC, this was in an oral exit interview, one of the things

that became very clear to me was that there was a gap between

the understanding at the research compliance office and what was

going on in the labs. And part of that misunderstanding was the

fact, if you do not document it, you have not done it. It is a bit like

Sarbanes-Oxley issues. So what we actually did is employed an expert in the scientific compliance area, Dr. Claudia Mickelson, from

MIT with an expert in accounting in Sarbanes-Oxley compliance

because we thought we needed to be much better at transaction

process documentation. You need to know when people are entering

the lab. You need to know who is on the registration. You need to

be sure those things are protected. It is a very complex environment which this is all about. But let me give you one other example of why it is so complex. Our re-registration document now is

900 pages, going toward 1,000. We are not finished. That is for four

labs that would fit inside this hearing room. There is a huge

amount of work that has to be done on not just writing the regulations and implementing them but having the time to make those

regulations work together so that everybody understands what the

expectations are and the expectation has to be safety, security and

good science.

Mr. STUPAK. I understand that and also you have to have the

people in there who are trained to do it. Like your biosafety person

who was the biosafety officer at A&M. Had no training in biosafety

but was an industrial hygienist by education, experienced and he

was asked to take on these extra duties. Who would have made

that decision, the head of the lab, your safety officer?

Mr. DAVIS. Of the person that was there before?

Mr. STUPAK. Right, who was assigned these extra duties, who

wasn’t qualified to do it.

Mr. DAVIS. Well, I do not know who made that decision. I wasn’t

there at the time. I will tell you this, we are currently advertising

and seeking a new biological safety officer that will also be our re-
100

sponsible official in interacting with the CDC. We are looking for

a much greater level of expertise. That is, we want someone who

is an accomplished scientist with experience in the area of biological compliance. And we have two good candidates and we hope to

have that filled within just a very short period of time.

Mr. STUPAK. Do you think the communities have a right to know

what is going on at these labs?

Mr. DAVIS. Absolutely.

Mr. STUPAK. There was some reluctance from the last panel to

let them know what agents or what we are doing at these labs but

that can be part of the checks and balance, can it not?

Mr. DAVIS. It does. One of the recommendations of the GAO that

I heard this morning I think is very sound is that we need to work

with the community health providers to be sure they know what

we are working on in the laboratories, so if there is an exposure,

accidental or otherwise, they recognize the symptoms if it comes

from someone who is working in one of these labs.

Mr. STUPAK. It is Mr. Green’s. I will turn to him for questions

just in a second. Let me ask you this and hopefully we can all learn

from the Texas A&M situation. You are telling me your re-license

is up to almost 1,000 pages now. I am sure as you talk with other

university presidents and others who have labs on their academic

facilities, you must have heard from others saying, boy, they are

putting you guys through a wringer. We got to tighten up ourselves. Is that pretty common? I am not asking you to blow the

whistle on anybody but I am just saying, it seems like this has

been pretty shoddy the way we have been doing it throughout this

country, even with the proliferation. We really need to look at this

in more detail. Not that we are trying to tie up research but, at

the same time, it just seems like this has been sort of an area we

never paid much attention to until we really—and unfortunately,

your sort of institution that sort of got looked at closer.

Mr. DAVIS. This is not the type of role model we would like to

be, Mr. Chairman. However, I think our episode and the revelations of this hearing will probably cause others to awaken to the

need to be very vigilant about these issues and to really focus on

both the regulations and their interactions with the regulating

agency.

Mr. STUPAK. Well, my time is up and as you can see, Texas A&M

has a lot of support on this committee. I am the only one here not

representing Texas A&M. So with that, let me turn it to Mr. Green

for questions or do you want to go, Mr. Burgess? Go ahead, Mr.

Green, you would have been next anyway.

Mr. GREEN. Dr. Davis, thank you for being here and I can imagine under uncomfortable circumstances because those of us who are

familiar with Texas A&M and high institutions are not found when

something bad happens. But the good thing about it is when something bad happens you also want to fix it and that is what I am

proud of that we are problem solvers. I wish I could tell you I always voted right but if I find out it was wrong, then I will fix it

somehow. And I hope you know your testimony before us today providing us with the lessons it learned, which can make sure that our

regulatory gaps are filled. And my last series of questions from

CDC, I mentioned the need for rigorous training of lab workers and
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the CDC mentioned that labs should have a biosafety plan, emergency response plan, a security plan among others. And its investigations in the incidents at A&M, GAO noted that the infected researcher had a wealth of experience in BSL–2 labs in particularly

tuberculosis. She was then called in to a BSL–3 lab to work on

Brucella despite not receiving training on that specific agent. Did

any biosafety plan speak to the specific protocols when alternating

between BSL–2 and BSL–3 labs?

Mr. DAVIS. Yes, Congressman Green, it did. Unfortunately, a

modest change in that and that is the worker actually volunteered

to participate in the experiment because she was familiar with the

Madison Chamber, which was used in tuberculosis experimentation

and was being loaned in the lab that was doing Brucellas experiments. So that is not an excuse, it is simply a statement that it

is quite different then that she was urged to do it or asked to do

it. It was a voluntary activity.

Mr. GREEN. The GAO office spoke to laboratory experts who

highlight inherent safety risk when researchers switch from BSL–

2 to BSL–3. And the GAO noted that the procedures, protocols are

different among labs and the researchers really need to make sure

that their safety protocols become part of their routine. From the

university research program perspective, is this a point made clear

to select agent programs either through the CDC or other safety

guidelines? Do you know if that was made plain to A&M?

Mr. DAVIS. Well, clearly from the interactions we have had with

the CDC and the GAO, we are very engaged in improving and upgrading our safety plans, our training plans. Actually, during the

time that our laboratories are not in operation, we are taking advantage of that time, in addition to getting our documentation completed. We are also having training sessions with the individuals

that are assigned to the laboratories, including specific training on

the select agents in which they are working. So indeed, we are taking advantage of this time to improve our safety, security and capacity to do the research.

Mr. GREEN. When the CDC visited A&M in February 2006, days

after the unknown exposure occurred, was there any mention from

the CDC about the need to implement training protocols for researchers specific to the agents they were handling?

Mr. DAVIS. I cannot answer that, Mr. Green. I do not know what

was contained in the report in their February 2006 visit. I was not

in place at the time.

Mr. GREEN. OK. Well, I guess from the testimony from our earlier panels and seems like there is enormous lack of clarity in the

system and when it comes to authorities and the responsibilities

and protocols on the part of the Federal agency and also individual

research institutions and given the nature of these agents, I think

the questions need to be crystal clear to both the agency but also

to our institutions. And I look forward to working with you, of

course, the CDC, NIH and other schools to see if we can get that

so we do not have a repeat of what happened at Texas A&M and

maybe happen somewhere else that we do not know about as we

sit here today. Thank you, Mr. Chairman.
102

Mr. DAVIS. One of the positive outcomes of this is we do have an

opportunity to get better, all of us do and that is what we intend

to do.

Mr. GREEN. Thank you.

Mr. STUPAK. Thank you, Mr. Green. Mr. Burgess, questions

please.

Mr. BURGESS. Thank you, Mr. Chairman, Dr. Davis. Thank you

for being here with us and ensure your commitment to making

sure we get it better and my responsibility being on this committee

is being sure that we give you the tools that you need, give your

researchers the tools that they need so they are protected and in

turn they protect us. Let me just ask you briefly, the individual

that was involved with the brucellosis incident, was that an experienced lab worker, was that a student, what was that person’s role

in the lab?

Mr. DAVIS. She was a research associate. She was a Ph.D. scientist. She was experienced in laboratory activities and safety protocols.

Mr. BURGESS. Did the extent that you are able to disclose it with

all of the Federal regulations regarding HIPAA, can you tell us the

condition of that individual today, what their health status is?

Mr. DAVIS. Her health is fine and we continue to monitor her for

any reoccurrence.

Mr. BURGESS. OK. So she was treated and responded to—OK.

Well, that is good news. Let me ask you this because I mean, A&M,

most people may not know this but you are the only school of veterinary medicine in our State and probably in the region. The Brucellosis is not really a new infective agent. Brucellosis has been

around for a long time. Has your university been involved with the

study or work of Brucellosis in the past?

Mr. DAVIS. Yes, sir, for quite a long time. Actually before we

knew what a select agent was, we were working on Brucellosis research. My guess is probably as early as the early part of the 20th

century because Bangs Disease or Brucellosis in cattle has been a

major issue and problem in the State of Texas. So Texas A&M has

actually lead in that. We have had laboratories in place, the BSL–

3 type laboratories, since the middle ’80’s, prior to the select agent

program, implementation working on Brucellosis research.

Mr. BURGESS. So even going back into the early part of last century, even though you were not able to or your predecessors were

not able to intuit, that this agent would be a select agent in the

21st century, you had ongoing procedures and protocols to protect

from contamination and protect your laboratory workers?

Mr. DAVIS. Yes, sir, we did. This research was primarily in animal-borne diseases and zoonotic diseases related to those pathogens.

Mr. BURGESS. Well, before we were called for this hearing today,

have you expressed concerns to the CDC about the ambiguities regarding the CDC’s handling of the select agents, the rules for handling select agents? Do you feel like those have been delivered to

you a timely fashion with the appropriate clarity to allow your researchers and your lab personnel to make the correct choices and

assignments?
103

Mr. DAVIS. As we mentioned a while ago, I think there are some

areas that still remain unresolved, such as the definition of an occupational exposure, so that there is clarity and there is also a promotion of open reporting of incidents. There are probably a few

other areas that are related to the security issues with select

agents where you have to have the Department of Justice approval

for individuals participating in particular laboratories. Currently,

the approval is related directly to the laboratory that the individual

might work in. So if you have a visiting faculty member going to

another lab using the same type of pathogen, they are not eligible

unless they are cleared again. And we think there are some improvements there but these are modest and we are certainly working with the CDC to try to find ways to reach agreement on all of

those.

Mr. BURGESS. And do you collaborate with any labs that are from

outside the country? I will respond going forward and making sure

that we write the correct protocols or will write the correct legislation that allows you to write the correct protocols for the protection

of your community and protection of your workers. I mentioned at

the previous panel that was up here the concept of rather than

having a punitive system, to have a no fault system similar to

NASA, similar to commercial aviation, similar to, again referencing

the nuclear submarine program in this country that has a remarkable safety record. A culture of not tolerating any security lapses

or any safety lapses but at the same time, rather than coming

down with extremely punitive measures, suspending a license or

suspending your ability to do the work you are trying to do, to

work in a collaborative fashion to learn from the mistake and go

on and make sure we are going forward, that we have the correct

procedures in place. Is that something that you are exploring internally in the university right now?

Mr. DAVIS. We are very much in favor of that and would love to

see that and implement it.

Mr. BURGESS. But are you working toward that specific goal?

Mr. DAVIS. Our position is we will report anything that we suspect falls under the rules as an occupational exposure, although we

are currently still trying to get absolute definition of what that is.

Mr. BURGESS. Again, I thank you for your generous contribution

of time today for this committee. I think you have been very helpful with providing insight and Mr. Chairman, how we can craft the

appropriate legislation that will not stymie this research but, ultimately, we all have the same goal in mind and that is protecting

our country. So with that, I will yield back.

Mr. STUPAK. Mr. Barton and I were talking about my series of

votes when I walked back here, some things we should or could be

doing. I am a little confused here, maybe you can help me out. This

Sunshine Project, right, that reported the stuff. Sunshine Project?

Sunshine Project. They foiled the information from Texas A&M,

right, and received the information from Texas A&M?

Mr. DAVIS. Well, in our case it is open records but the same——

Mr. STUPAK. But they got your records?

Mr. DAVIS. Yes.
104

Mr. STUPAK. Then why did not the CDC notice those problems

when they were there with their inspection, when they said everything was fine?

Mr. DAVIS. I cannot answer that, Mr. Chairman.

Mr. STUPAK. And they would have access to it, right?

Mr. DAVIS. Absolutely. I will tell you, however, that when we received the request from the Sunshine Project——

Mr. STUPAK. OK.

Mr. DAVIS. We do not have a system that accumulates everything

that is going on in laboratories without going through keyword

search.

Mr. STUPAK. Sure.

Mr. DAVIS. And so it did take us some time to actually locate and

dig out the documents which gave us the alert that this exposure

occurred.

Mr. STUPAK. Right.

Mr. DAVIS. And so I think it is fair to say that the CDC probably

did not do that same level of inquiry and that is why we discovered

it and passed the information onto both them and the project.

Mr. STUPAK. But in order to get it into Texas A&M archives or

your stuff.

Mr. DAVIS. Electronic.

Mr. STUPAK. Yes. Someone reported it electronically?

Mr. DAVIS. Yes, sir.

Mr. STUPAK. And then when the Sunshine Project put forth, did

the keyword search, that is when it popped up.

Mr. DAVIS. We did the keyword search based on their request.

Mr. STUPAK. And you actually provided them with the information.

Mr. DAVIS. That is correct.

Mr. STUPAK. So CDC should have at least, knowing its electronic,

could have done an electronic search or then but where would your

lab person be?

Mr. DAVIS. They could have asked us to do the electronic search.

Mr. STUPAK. Sure. They could have asked you. Even if—inspection team, they just could ask you to do a key search and you

would have.

Mr. DAVIS. Right.

Mr. STUPAK. But this report then, would not the lab director

know? Your lab director know about this?

Mr. DAVIS. He did and as soon as he detected it, it was reported

to the biological safety officer.

Mr. STUPAK. Right.

Mr. DAVIS. Which reported through——

Mr. STUPAK. This is the public health.

Mr. DAVIS. Yes.

Mr. STUPAK. OK. That had the right training.

Mr. DAVIS. That is correct.

Mr. STUPAK. OK.

Mr. DAVIS. I know it sounds Byzantine but, indeed, it was and

that is the reason we failed to report it.

Mr. STUPAK. OK. Did the Government Accountability Office come

down and do an inspection at Texas A&M?
105

Mr. DAVIS. They came and visited with individuals at our university. I do not know if I would characterize it as a review or inspection.

Mr. STUPAK. OK. Was that after this incident was made public

about the Sunshine Project, do you know?

Mr. DAVIS. They were here this August, which was after.

Mr. STUPAK. It was after.

Mr. DAVIS. And then they were here in November 2006, which

would have been, I guess, also after the incident occurred but not

after it was reported. It was reported actually in April of 2007.

Mr. STUPAK. I know GAO’s been, in all fairness, Chris Shays had

a position in a different committee, Homeland Security, and started

this whole GAO and that was in 2005. And I thought it was a good

idea, so we picked up on it and so I know it has been going on for

some time, that is why I asked that question. My question base

prompt any other questions, Mr. Barton, Mr. Burgess, Mr. Green?

If not, Dr. Davis, thank you and we will call for our next panel,

our last panel of the day.

Mr. DAVIS. Thank you.

Mr. STUPAK. The last panel is Dr. Gigi Kwik Gronvall, senior associate and assistant professor of medicine at the University of

Pittsburgh Medical Center, Center for Biosecurity. Dr. Alan Pearson, who is the director of the Biological and Chemical Weapons

Control Program at the Center for Arms Control and Non-Proliferation. And Mr. Edward Hammond of the Sunshine Project. If you

would come forward please.

It is the policy of the subcommittee to take all testimony under

oath. Please be advised witnesses have the right under rules of

House to be advised by counsel during your testimony. Do any you

wished to be represented by counsel? Everyone shook their head no

so I will take it for a no. Then I am going to ask you to please rise

and raise your right hand to take the oath.

[Witnesses sworn.]

Mr. STUPAK. Let the record reflect the witnesses have replied in

the affirmative. You are now under oath. We have 5-minute opening statements. You can submit longer ones for the record. We ask

Dr. Gronvall, do you want to go first here?

STATEMENT OF GIGI KWIK GRONVALL, SENIOR ASSOCIATE,

ASSISTANT PROFESSOR OF MEDICINE, CENTER FOR BIOSECURITY, UNIVERSITY OF PITTSBURGH MEDICAL CENTER

Ms. GRONVALL. Thank you, Mr. Chairman, distinguished members of the committee. I have submitted written testimony but I

will summarize those in my oral remarks. First, I would like to

make it clear that it is urgent that the Nation finds ways to protect

itself against large scale epidemics. In fact, it was the recognition

that there needed to be research to form those methods of protection, the medicines and vaccines that are needed that led to the expansion of the high-containment laboratories in the first place.

Without these high-containment laboratories, critical research cannot be performed. However, these labs need to be safe otherwise

they cannot operate. And so I will highlight several actions which

could be taken to help ensure that these new labs are both safe and

productive in the future.
106

The first action that could be taken is to increase biosafety training. The way that people learn biosafety and high containment, the

way that I learned biosafety, was to apprentice to a more senior,

knowledgeable person. However, with the expansion of laboratories,

there may not be enough senior knowledgeable people to go around.

And so one solution is to standardize the training and require certification for high-containment work.

You can also increase the number of biosafety officers who are

credentialed for high-containment work, so they can provide training and they can provide guidance as research is being conducted.

The second action which could be taken is to develop a reporting

system so that all mistakes, near misses are captured, learned

from, and the results disseminated across high-containment laboratories. One model that may be useful is that used for aviation safety reporting. It was set up because it was found that most aviation

incidents and accidents had common root causes. But because these

incidents were not being reported, they were not being learned

from and so the new accidents were not being prevented. So that

is one potential model where people are encouraged to report.

The third action which could be taken is to share lessons and

operational experience across the high-containment laboratories. In

particular, it should be easier for a more senior, knowledgeable person to conduct training in multiple high-containment laboratories.

The fourth action which could be taken is to make public engagement a priority. Public engagement is essential to the success of

these laboratories. The community has a right to know that the

people who are working in these high-containment laboratories are

well trained, that if there is an accident, that it is being dealt with

appropriately. Some labs have done a better job of this than others.

And so the successes of some of these labs should be taken as lessons learned and disseminated across the high-containment laboratories and emulated.

So finally I just want to point out that this is not a domestic

issue. This is a global issue and these labs are expanding all over

the world because these countries recognize that these are important for not only work on SARS and avian influenza and diseases

like this, but that it could be a major part of economic growth in

the 21st century. Thank you.

[The prepared statement of Ms. Gronvall follows:]

TESTIMONY OF GIGI KWIK GRONVALL

Mr. Chairman, distinguished members of the committee:

Thank you for the opportunity to speak to you today. My name is Gigi Kwik

Gronvall. I am a Senior Associate at the Center for Biosecurity of the University

of Pittsburgh Medical Center (UPMC) and an Assistant Professor at the University

of Pittsburgh School of Medicine. The Center for Biosecurity is a nonprofit, multidisciplinary organization located in Baltimore that includes physicians, public

health professionals, and biological and social scientists. I am a biological scientist,

trained in laboratories at Johns Hopkins University and the United States Army

Medical Research Institute for Infectious Diseases (USAMRIID). My colleagues and

I at the Center for Biosecurity are committed to the development of policies and

practices that help prevent bioterrorist attacks or destabilizing natural epidemics

and, should prevention fail, that mitigate the destructive consequences of such

events.

It is a privilege to come before you today to discuss the expansion of high-containment BSL–3 and –4 laboratories. Protecting the Nation against destabilizing largescale epidemics, whether natural or man-made, is an urgent priority. The anthrax
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attacks in 2001, the SARS epidemic in 2003, and the current threat of avian influenza all are important reasons why we must conduct research to determine how microbes work and how to defeat them with medicines and vaccines. These new highcontainment biological laboratories are needed to provide the safe, protective environment necessary to do this research. In high-containment laboratories, potential

bioterrorism agents such as Ebola or Marburg, as well as emerging diseases such

as SARS and avian influenza, can be safely studied and understood. The labs can

also be used to develop animal models essential to developing and testing vaccines,

drugs, and other needed medical countermeasures.

The high-containment laboratories are necessary if we are to produce the scientific advances needed to develop medical countermeasures against bioweapons

and emerging diseases. However, recent highly publicized laboratory errors and

siting controversies have raised questions about whether the governing framework

and standards for biosafety and biosecurity measures are adequate. Since 2005, my

colleagues and I at the Center for Biosecurity have been concerned that the expanding number of high-containment laboratories may strain current systems for personnel training in biosafety and biosecurity. We held a meeting at the Center on July

11, 2006, to discuss these issues, the report from which we would like to submit

into the record. At this meeting, we heard from distinguished scientists and experts

in biosafety, biosecurity, and public health—both proponents of the laboratories, as

well as those who oppose the recent expansion. Based on those conversations, we

believe that there are several things that can be done to ensure that these new

high-containment laboratories are productive and safe and operate with due consideration for their neighboring communities. These actions include expanding biosafety training for researchers and workers coming into high-containment research

from less dangerous areas of research; monitoring the safety performance and operational experience of the high-containment facilities; increasing communication between the high-containment laboratories to share operational experiences; and initiating a public engagement effort at the Federal level that clarifies the need for highcontainment laboratories.

Currently, operational BSL–4 facilities can be found in Frederick, Maryland; Richmond, Virginia; Atlanta, Georgia; Galveston, Texas; and San Antonio, Texas. There

are additional BSL–4 facilities under construction in Hamilton, Montana; Boston,

Massachusetts; Frederick, Maryland; and Galveston, Texas. The exact number of

BSL–3 laboratories in the United States is not known, however an NIH-sponsored

survey estimates that there are 277 distinct facilities with BSL–3, with about 600

individual laboratories, and a 2007 report from DHS and HHS states that 633 highcontainment laboratories are registered in the Select Agent Program. In addition,

13 BSL–3 laboratories are being built specifically for biodefense research, principally funded by the National Institute of Allergy and Infectious Diseases (NIAID).

It should be noted, however, that high-containment laboratories are being built

all over the world at a rapid pace. For example, there were 16 BSL–3 laboratories

brought on-line in India in 2006 alone. This expansion is due in part to concerns

about SARS and avian influenza, but also because of a recognition that bioscience

is a key economic driver for the 21st century: in the US, the biopharma industry

produced $188 billion in revenue and 400,000 jobs in 2004 alone. The model that

the U.S. sets in operating these high-containment laboratories productively yet safely should provide leadership to other countries heavily investing in biotechnology

and pathogen research.

Promoting safety, security, and scientific innovation in the biological sciences has

been a challenge undertaken by the government and the bioscience community since

2001. It has led editors of scientific journals to come together in 2003, with the goal

of reducing the likelihood that legitimate bioscientific research could be used for malevolent ends. It has led to the forming of the National Science Advisory Board for

Biosecurity, chartered in 2004 within NIH. Government and university researchers

have also participated in fora intended to diminish the risks and maximize the benefits of new areas of bioscience, such as synthetic genomics. While bioscience promises great strides in enhancing quality of life through the development of medicines

and vaccines, it is a powerful technology that must be used safely if we are to enjoy

its benefits.

Biosafety protection is designed to be flexible. In the U.S., biological laboratory

research can be categorized by its safety level; Biosafety Levels (BSL) 1 through 4.

In this testimony, we use the term high-containment to refer to work performed in

the two highest levels, BSL–3 and BSL–4. BSL–3 laboratories are used to study biological agents that are potentially lethal and transmissible by the aerosol route and

that require special safety design features, such as sealed windows and specialized

ventilation systems. BSL–4 laboratories are typically used to study lethal agents for

which no vaccine or therapy is available. They incorporate the BSL–3 laboratory
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safety features, plus additional safety features such as full-body suits ventilated by

life-support systems.

In general, the biosafety requirements needed to protect researchers are dictated

by the specifics of a biological experiment and are designed to be flexible. For example, an experiment that could normally be safely performed at a low biocontainment

level may need additional biosafety protections if the researcher must handle a large

volume of infectious material. This flexible system for applying biosafety protections

requires researchers to weigh risks as they work. This is a necessity for bioscience

research; hard-and-fast regulations for every situation are difficult to develop, as

these researchers are not working on one repetitive process that can be fine-tuned

but are constantly exploring new scientific ground. The researchers need to use informed judgment.

Biosafety guidelines, such as the Biosafety in Microbiological and Biomedical Laboratories Manual published by the CDC and NIH are thus intended to inform the

judgment of researchers, biosafety officers, and others who advise on biosafety, so

that biosafety protections can be applied where they are needed. However, some biological organisms are more typically worked on in one safety level versus another:

infectious Ebola and Marburg viruses are researched in the highest level of containment, BSL–4; SARS is typically worked on in BSL–3; and Bacillus anthracis, the

causative agent of anthrax, is typically safely worked on in BSL–2.

Biosafety training program expansion for researchers entering high-containment.

As the new high-containment laboratories become operational in the coming years,

additional qualified staff will also be needed. As indicated in our report last year,

we have concerns that the usual methods of biosafety training for high-containment

research—that is, intensive one-on-one training within a mentor-apprentice relationship—will not be sufficient to handle the influx of researchers and technicians into

the field. Developing core competencies and standards for new staff could be a useful and important way to train new staff on safety practices. It could also conserve

the experienced mentors’ valuable time and abilities and shorten the time it takes

for the labs to become productive.

To develop the workforce, NIH could assess how many people will require training

for their work in the high-containment laboratories, and develop and fund programs

that can supplement on-the-job training. An assessment may be necessary, as not

all of the new hires for a laboratory will work in high-containment conditions. For

example, it is estimated that the Boston University National Biocontainment Laboratory will create 600 jobs, but not all of those new employees will work in highcontainment conditions.

Biosafety officers, already required at every high-containment facility, will also be

needed in greater numbers. Biosafety professionals can help researchers determine

the best biosafety procedures and practices for laboratory-specific, experiment-specific containment decisions, so that the researchers can be productive and safe. Biosafety officers can also provide on-the-job biosafety training. NIH could work with

the American Biological Safety Association, the biosafety professional organization,

to determine credentialing standards required for work in high-containment laboratories. This may help to ensure that biosafety officers are knowledgeable resources

for the researchers in these labs.

Monitoring safety performance of high-containment laboratories. With the laboratory expansion, a systematic analysis of safety issues and operational problems in

high-containment laboratories can help to ensure that the laboratories are operating

safely. Currently, reporting of laboratory-acquired infections is required for all select

agents, those pathogens that require clearance to possess under the Select Agent

Rule as defined by 45 CFR 72, whether they occur at BSL–2, –3, or –4 laboratories.

NIH grants also stipulate that institutions report any serious accidents or researchacquired infections. However, many of the experts we consulted thought nonlethal

infections were underreported, and operational problems or ‘‘near misses’’ were generally not reported.

Without reporting, and without analysis of these incidents, lessons cannot be

learned from the experience. Laboratory procedures cannot be analyzed in light of

the accidents, so that future accidents can potentially be avoided. To correct this situation, disincentives to reporting should be removed, to encourage researchers and

their institutions to report and take corrective action.

Generally, there is a disincentive to report acquired infections and other mishaps

at research institutions. Infections lead to negative publicity and scrutiny from the

granting agency, adversely affecting future research funding. In addition, after a scientist acquires an infection in the laboratory, neither the scientist nor the laboratory wishes to advertise the mistake. These barriers need to be cleared so biosafety

can be enhanced through shared learning from operational experiences, and also so
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the public may be reassured that accidents are being thoroughly examined and contained.

One possible model for high-containment laboratories to emulate is the reporting

mechanism used for aviation incidents, wherein airlines can contribute operational

experience without fear of regulatory action. Mistakes are analyzed and learned

from, but they are not attributed to individuals (except when mistakes result from

criminal actions, such as drunkenness). Institutional anonymity may also be required in order to get robust reporting from research institutions. Procedures would

need to define thresholds and mechanisms for reporting if an accident poses a danger to the community surrounding the laboratory, however.

There are other potential models for the high-containment labs from the nuclear

and chemical industries. The Institute of Nuclear Power Operations (INPO), formed

after the Three Mile Island accident, emphasizes personnel training, safety management, and lessons learned; and Responsible Care, formed after the Bhopal tragedy,

is a voluntary initiative of the chemical industry to share lessons learned. These

models are from for-profit enterprises, underlining that any reporting system will

be expensive. Another possibility could be a reporting clearinghouse, where operational experiences would be posted and available for outside analysis.

Ultimately, it is the laboratory director’s responsibility to ensure that all laboratory personnel are properly trained to do research safely in high-containment. Yet,

the institution where the research takes place may be responsible for ensuring that

the head of the laboratory, the staff, and the lab environment conforms with biosafety requirements and accepted practices. The CDC or NIH could monitor

proactively whether biosafety is being managed at those institutions where Federal

money pays for the research and infrastructure.

High-containment laboratories and sharing lessons learned. Mechanisms to enable

and encourage inter-laboratory training and information exchange will be important

for these laboratories. Currently, the Select Agent Rule and concerns about legal liability may have inadvertently become barriers to learning across high-containment

research facilities. Under the Select Agent Rule, as defined by 45 CFR 72, HHS and

USDA keep lists of pathogens that require select agent clearance. The rule regulates

the possession, use, and transfer of those agents; imposes security requirements for

the facility in which the work will be performed; requires inspections; and can impose criminal and civil penalties on those who do not adhere to the Rule. In addition, security risk assessments are administered to individuals who work with select

agents by the Department of Justice, a process that is renewed every five years.

Once cleared, an individual is allowed to work with a specific biological agent, but

only within a specific laboratory. The specificity of this clearance procedure inhibits

the practical exchange of safety-related information and techniques between highcontainment laboratory researchers, by preventing, for example, a technician in one

laboratory from demonstrating techniques in another laboratory without going

through a separate lengthy clearance process.

In addition to clearance barriers, the perception that laboratories will be liable for

accidents that occur to scientists visiting for training purposes may have prevented

some training opportunities from taking place. This should be addressed so that experienced scientists and technicians can more easily demonstrate techniques and

safety procedures developed in one laboratory to another. This could speed up the

process for new laboratories to become productive; it could maximize the use of specialized facilities of some laboratories; and it could result in increased safety of the

research.

Public engagement as a Federal priority for high-containment labs. NIAID has a

great deal of information about the new high-containment laboratories on its

website, but direct engagement with the communities where the laboratories are

being built is handled by the institution proposing the laboratory. Thus, the strategies and outcomes of public engagement, as well as the transparency of laboratory

operations to the public, have varied considerably. This has undoubtedly exacerbated the controversy surrounding the siting and operation of these laboratories,

particularly in the face of highly publicized laboratory errors. While individual facilities bear final responsibility for their relationships with their neighbors, NIAID

could have a clearer mechanism to engage with the public about the siting and operation of these laboratories, beyond the NEPA process. It may help if there is a more

aggressive and proactive Federal effort to standardize public engagement and transparency of operations for high-containment laboratories and to direct funds to this

purpose.

A public engagement program could address the concerns that have surfaced in

siting high-containment laboratories. Often, proponents of the labs interpret protests against the laboratories as a lack of understanding of science: however, the

concerns about the labs are varied. For example, there have been concerns that the
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labs would become a terrorist target, or that the laboratory would not provide jobs

to the community. The communites’ concerns could be actively addressed both by

HHS and NIAID and by the institution sponsoring the laboratory.

These high-containment laboratories should be a critical part of the research infrastructure for understanding the mechanisms of pathogenicity, as well as developing and testing medical countermeasures. However, as these labs come online, so

should new systems for training of personnel, monitoring safety performance, and

engaging the public. Experience has shown that proactive steps such as these can

lead to more effective and cost-efficient safety management than burdensome requirements imposed following a serious accident. A new governance framework

could enable the laboratories to operate more safely, with consideration for their

communities, and it could help the laboratories fulfill their intended purpose of protecting the Nation against natural and man-made biological threats.

Mr. STUPAK. Thank you. Dr. Pearson.

STATEMENT OF ALAN PEARSON, DIRECTOR, BIOLOGICAL AND

CHEMICAL WEAPONS CONTROL PROGRAM, CENTER FOR

ARMS CONTROL AND NON-PROLIFERATION

Mr. PEARSON. Well, thank you for inviting me to testify today on

behalf of the Center for Arms Control and Non-Proliferation. Since

1980, the Center has been working to protect the American people

from the threat of nuclear, chemical and biological weapons and we

see the issues being considered here today as integrals to achieving

that goal.

Over the last 6 years, the Federal Government has dramatically

increased U.S. research and development activity and infrastructure focused on biological agents that could be used as biological

weapons.

The data are clear. Annual R&D funding is up six-fold since

2001. More than two dozen new high-containment facilities, which

we have heard about, funded specifically to work with such agents.

Over 15,000 individuals approved to work with such agents. This

expansion recognizes our need for a national biodefense program

but it is not necessarily an unalloyed good. It also creates risks to

laboratory personnel, public health and national security. Basically,

and we have heard this already today, when more dangerous research is performed by more people in more locations, there are

simply more opportunities for significant biosafety or biosecurity

breaches to occur.

I would like to just make one point clear. The risk is not limited

to the BSL–4 labs, although that is usually the focus of the attention. There is actually good reason for concern that the risk may

be even greater at some of the BSL–3 labs. The most obvious risk

is that of the lab accident. A second particularly acute risk that I

would like to bring to your attention is that the very labs designed

to protect us against biological weapons could become a source for

them. The easiest way for a sub-state enemy, such as Al-Qaida, to

obtain a bioweapons capability will be for it to penetrate an existing research project that uses these agents. Nor should we ignore

the possibility that a U.S. biologist working in one of these labs

could become disgruntled or even turn rogue.

Some types of contemporary pathogen research taking place in

these labs increase risk further still. For instance, efforts to deliberately enhance the virulence or transmissibility of pathogens, to

understand how they cause disease, are inherently more risky than
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experiments of the past. They are also dual-use in nature, the

knowledge and materials generated by the experiments can be used

for either hostile or peaceful purposes. And a particular concern in

this regard is threat assessment research, which is typically classified research that involves the exploration of offensive aspects of biological weapons agents and delivery mechanisms for defensive

purposes.

Looking internationally for just a moment, each of these concerns

that you are hearing about becomes amplified. Our actions here,

taken for the best of intentions of protecting our Nation, also provide a plausible justification for others to do the same. So there is

a critical need for rigorous oversight and maximal transparency of

these facilities and activities.

What I would like to highlight here then are just a few of the

tools that our Federal Government needs in order to ensure that

oversight is stronger. First, Congress should mandate the establishment of a universally mandatory and transparent incident reporting system. Second, Congress should mandate a national licensing system and registry for all level 3 and level 4 facilities in

the United States, including an integrated and effective auditing

process. Licensing and registration are key to both effective oversight and comprehensive strategic planning. Third, Congress

should mandate institutional biosafety committee review of all research projects involving bioweapons agents and other high-risk

pathogens and activities. Fourth, Congress should make these requirements legally mandatory for all institutions, government, academic and private, not just those receiving funds from NIH and

they should apply also to all relevant research, whether that research is classified or not. Fifth, compliance requires effective monitoring and enforcement. A law not monitored and enforced may be

little better than a voluntary guideline. Congress should seriously

consider consolidating all CDC and NIH, responsibilities and authorities relevant to monitoring and enforcing the suggestions I

just made into a single office located within the Office of the Secretary of Health and Human Services. Sixth, Congress should mandate comprehensive inter-agency needs and risk assessments to determine our current and anticipated U.S. needs for high-containment facilities and the potential risks associated with them. Until

such assessments are completed and reviewed, there should be no

funding for any additional facilities. Last, Congress should modify

section 351(a)()h of the Public Health Service Act to more narrowly

and accurately define necessary and appropriate requirements for

withholding information about activities involving these agents. As

currently written, that section is hurting biosafety, biosecurity and

national security by impeding public accountability of our institutions and Federal agencies and by reducing our ability to reassure

others that our R&D activities comply with our obligations under

international law. Thank you.

[The prepared statement of Mr. Pearson follows:]
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Mr. STUPAK. Thank you. Mr. Hammond, opening statement, 5

minutes, sir.

STATEMENT OF EDWARD HAMMOND, THE SUNSHINE

PROJECT

Mr. HAMMOND. Thank you, Mr. Chairman. It is the Sunshine

Project and to explain what it is, it is a very small, non-governmental organization. We are based in Texas in the U.S. and Austin

and also have an office in Hamburg, Germany and we are dedicated to biological weapons control.

I have submitted lengthy written comments and addressing

many of the issues that the prior panelists have addressed. I am

not going to go back over them but I have presented some additional thoughts about where Congress might go on some these

issues that have been raised. So to minimize duplication, I really

just want to highlight a few of the things that I brought up in my

written comments.

The first thing that I would like to do is just to give a little bit

of shape and talk a little bit about some data on the lab expansion

that my organization has put together with Margaret Race from

the SETI Institute. If you look at page two and three of my written

testimony, we have tried to bring together a table that has data on

the most important new labs that exists or are under construction.

This table excludes a lot of laboratories that we know of. But if you

look at just those labs that are there, you are talking about a construction spree that is going on right now that is approximately 4

million gross square feet. That is 90 acres of laboratory space that

is either under construction or is going to be under construction

shortly. In terms of BSL–4 space, the historic amount, in fact, the

amount up until mid–2004 in the United States was about 14,000

net square feet. With the projects that are on the books right now,

we are looking at approximately 165,000 square feet just with what

is already either under construction or planned. That is a 12-fold

increase approximately. We do not know the final finished square

footage of some of the labs that are under construction but that is

the best estimate that we can make. The four million square feet,

to put that in terms that I think are more readily understandable,

that is the size of about 36 big box stores. That is how much lab

space we are going—if you stretch them end to end, it would a

chain that is 21⁄4 miles long.

The second issue that I want to bring up which has not been directly addressed is that of transparency of the Centers for Disease

Control. I filed numerous Freedom of Information Act requests

with the Centers for Disease Control, spoken to many journalists

and other non-governmental organizations that have done the

same. It is the apparent policy of the Centers for Disease Control

to not even attempt to locate records regarding select agents. They

deny absolutely all requests for anything. So the level of transparency with respect to the Centers for Disease Control on its oversight of select agents is, well, non-existent. There is none. And I

think that if I lived near a biological facility I would frankly find

that to be offensive.

Moving on, and I think this is an important point because it is

emerging now, I believe that there is a positive correlation between
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the transparency of these laboratories and compliance and accident

reporting. We saw in the case of Texas A&M that the revelation

of one accident caused them to report several additional reportable

incidents that occurred at the university. In my own research since

then, I have found that two other institutions in Texas have reported select agent accidents, both of which occurred after Texas

A&M became public. Those institutions did not report anything

prior. And if the data that is coming out in the press now and the

Associated Press and in other sources in the last few days is correct, there has been a tremendous spike in reports to the Centers

for Disease Control of accidents involving select agents since April

2007. And I believe that that spike is, at least in part, attributable

to—first of all, it is attributable to the expansion of our laboratories

to begin with. But second of all, it is attributable to the transparency at Texas A&M. So there is a positive correlation between

the two.

Finally, to wrap up, with respect to the expansion of laboratories,

I believe that our country does not need 400 laboratories and

15,000 people handling biological weapons agents. Our system cannot absorb all the new laboratories that are coming on line. Even

with explicit training, we still do not need 400 laboratories and

15,000 people handling biological weapons agents. We do not have

the people to absorb a 12-fold increase in biosafety level 4 capacity.

I believe that Congress should act to impose a moratorium. It

should not authorize construction of any new biodefense facilities

and it should consider killing some projects that are underway.

Among those, the National Bio and Agro-Defense Facility, the very

unpopular lab at Boston University and the Regional Biocontainment lab at Hawaii, which is late and over budget. Even if we kill

those projects, we are still going to be increasing our biosafety level

4 space by approximately seven-fold. And we should do that and

step back and perform the national needs assessment and then we

can move forward if we need to move forward with any new labs.

Thank you.

[The prepared statement of Mr. Hammond follows:]
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Mr. STUPAK. Thank you. Thank you all for your testimony. We

will begin questioning, Dr. Gronvall. You indicated that your training was through an apprenticeship?

Ms. GRONVALL. Yes.

Mr. STUPAK. And you got to answer yes or no. I am sorry.

Ms. GRONVALL. Yes.

Mr. STUPAK. OK. With the proliferation of labs then, if you have

to go through an apprenticeship, where are they getting the people

to work in these labs?

Ms. GRONVALL. Well, I mean by working in laboratories as you

are training to be a biological scientist, you work in a lab, you

learn from the people who have worked there for more years and

have more experience. So that is what I mean by mentor apprentice relationship.

Mr. STUPAK. OK. In your testimony, you described the proliferation of these level 3 and level 4 labs in U.S. and around the world.

Are there too many high-containment labs in the U.S. in your opinion?

Ms. GRONVALL. I would say that we have so much research that

needs to be accomplished, but that I really would have to know

what is going on in the laboratories. I do not have enough information to answer that.

Mr. STUPAK. So in other words, needs assessment?

Msr. GRONVALL. I would like to know more to answer.

Mr. STUPAK. Are you aware of anyone ever doing a needs assessment?

Ms. GRONVALL. No.

Mr. STUPAK. OK. You make the point that no blame reporting

may be a method of improving voluntary reporting and our ability

to learn from mistakes. Is this the same type of systems that is in

place for the nuclear industry? You mentioned airline industry but

is that the model you are looking at?

Ms. GRONVALL. I think the main points of any model for reporting would just be to encourage reporting and to not punish people

for reporting to make sure that there are incentives to report and

that you are capturing as much experience as possible. So there are

a number of industries, I think the chemical industry also has a

reporting system like that.

Mr. STUPAK. But if they do not report, you have no problem with

a punishment system then?

Ms. GRONVALL. I think where you want to go is that you want

to make reporting to be the norm and not reporting to be something that you do not want to do.

Mr. STUPAK. OK. Dr. Pearson, let me ask you the same question.

Are there too many high-containment labs in the United States?

Mr. PEARSON. I do not think without having a good needs assessment that you can answer that question.

Mr. STUPAK. And you are not aware of——

Mr. PEARSON. I have seen no evidence that there has been a good

needs assessment done.

Mr. STUPAK. OK. What was that section you wanted us to look

at, 351(a)(h)—the withholding?

Mr. PEARSON. Yes, it was passed in the Bioterrorism and Public

Health Emergency Response Act of 2002.
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Mr. STUPAK. OK. Mr. Hammond, you indicated there were two

other Texas universities that came forward since Texas A&M became public. Do you know if the CDC has done anything with those

two other universities?

Mr. HAMMOND. No, sir. In part, that is why I drew attention to

CDC’s policy to immediately reject all Freedom of Information Act

requests. In the past, in addition to the two universities in Texas

that reported, we have uncovered numerous additional incidents in

other States that required reporting or appear to require reporting

and we cannot obtain any documentation to determine whether or

not they were, in fact, reported and whether or not CDC acted on

the reports.

Mr. STUPAK. Have you then turned that information over to

CDC, your Sunshine Project?

Mr. HAMMOND. I’ve made the information public in forums where

CDC personnel—that are involved in the select agent program.

Mr. STUPAK. OK. After I want you to share that with the committee staff if you would. Those are the two universities, we will

get to the bottom of it. You state in your testimony that the BSL

lab expansion has gone ‘‘far beyond what is prudent and necessary.’’ What is your estimate then of what is prudent and necessary here in the United States?

Mr. HAMMOND. I believe that a certain answer requires the needs

assessment, however, my judgment based upon my experience is

that we would be safer and could accomplish our national needs in

biodefense if our program were perhaps a fifth or even smaller

than what we have right now. That would imply a much smaller

number of new labs. I believe that following the history of offensive

biological weapons programs, following what happened in 2001 and

expansion of our biodefense program was merited and that, logically, there should have been additional labs built to deal with revitalizing our biodefense program but we went considerably too far.

So something on the order of a fifth is my estimation.

Mr. STUPAK. This committee has asked for a needs assessment

too from CDC and they claim there is one out there but no one has

ever seen it.

Mr. HAMMOND. I believe that.

Mr. STUPAK. You mentioned private corporate labs, Mr. Hammond, as being unaccounted for in the Government’s oversight of

the labs 3 and 4. What would you like to see done there on the private lab?

Mr. HAMMOND. One of the things that my organization has done

in the past several years to look at the institutional biosafety committee system that is managed by the NIH Office of Biotechnology

Activities. And compliance there is only required for institutions

that are presently receiving NIH funding for recombinant DNA for

genetic engineering research. I took a look at private sector compliance and found that out of the top 20 biotech companies, only

about two are in compliance. I think that clearly the guidelines for

recombinant DNA should be made a matter of law as should compliance with the BMBL and that should be applied to all laboratories, not simply those that are currently federally funded.

Mr. STUPAK. Thanks. My time is up but as I indicated in my

opening statement, we will be sending our staff to look at some of
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these overseas labs. We are just as concerned. We want to get a

hold of you or have you get a hold of us on what—because you are

connected with Europe too you said. There is a Sunshine Project

there?

Mr. HAMMOND. Yes, sir.

Mr. STUPAK. OK. We may want to get some suggestions on what

labs you think we ought to look at, both secure and not so secure.

Mr. Burgess for questions.

Mr. BURGESS. Thank you. Mr. Hammond, just let me be sure

that I understand correctly. You are advocating 80 percent reduction on available laboratory capacity from where we are right now?

Mr. HAMMOND. No, sir. What I said was that I believe that a biodefense program that is approximately a fifth or perhaps even less

of our present size would be able to adequately address our national security needs. And because there would be fewer people

handling these agents and fewer laboratories, it would make us

safer in the sense that there would be less opportunity for diversion of select agents. I am not advocating for any of the existing

infrastructure, major infrastructure, to disappear. Rather this is

with respect to the expansion.

Mr. BURGESS. So the expansion should be reduced by 80 percent.

Are these expansion plans that currently exist? I guess what I am

asking is—conducted the needs assessment that Chairman Stupak

has asked CDC for. Do you have data that you can share with this

committee about how you have arrived at those figures?

Mr. HAMMOND. My statement was with respect to the program

as a whole, not with respect to a laboratory, the fifth comment. Not

with respect to laboratories in particular. With laboratories, I believe that do need the needs assessment. But it is my judgment,

having spent now a number of years in very intense interaction

with practically every laboratory that handles these agents in the

US, particularly outside of the Government sector, that that scale

reduction would be appropriate and would make us, in fact, safer.

Mr. BURGESS. Let me ask you this because you raise a point in

your written testimony that is significant about the building of an

infectious agent out of its component parts, the nucleic acid issue.

And if I understand your writing correctly, the CDC, in fact, has

a loophole that would allow such a constructive infectious agent,

say if someone was building the 1918 flu, had one nucleic acid

change, that then is no longer an agent that falls on the select list,

is that correct?

Mr. HAMMOND. That is correct, sir, in effect. The select agent

rule in the plain language of the rule would appear to encompass

these complimentary DNAs or these types of genetic constructs

that you refer to. However, it appears that CDC has chosen to only

consider those that are themselves infectious to be covered by the

rule. And what this enables is for a person to possess, basically, all

of the components that are needed to produce a select agent, even

in a period of a few hours without being registered under the rule.

Mr. BURGESS. Mr. Chairman, I would like for it to be clarified

to the committee, is this a rule that is been developed within the

agency? Do they need legislative help to close the loophole? I would

like for the committee staff to explore this so we know. This does

not sound like a good idea and I think if we have learned nothing
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else today, this may be one of those things that we ought to try

to immediately correct because it does sound like a significant defect. But I think I would also argue that we may need more lab

space rather than less. But I do agree with you that the more people you have involved in a project, particularly when it is new and

you are finding your way, the more people that are involved in a

project, there is the greater potential for human error. Mr. Hammond, I got to tell you, I am from Texas. I have never heard of your

group before. Where do you get your funding?

Mr. HAMMOND. In the way that most non-governmental organizations do. I receive contributions from individuals and I raise funding from foundations.

Mr. BURGESS. Can you supply to this committee a list of your

major donors?

Mr. HAMMOND. I would be happy to, sir, but certainly I have a

policy. I mean, the Sunshine Project engages in criticizing others

on transparency issues, so certainly I would be more than happy

to answer any question you have with respect to my organization.

Mr. BURGESS. You anticipated my question. I would ask the committee to make that generally available to members of the committee. And then I just have to ask you this. At the bottom, just before

the table at the bottom of the first page, you reference the Sunshine Project, the Margaret Race of the SETI Institute. What does

that acronym stand for?

Mr. HAMMOND. It is a NASA-funded institute that has to——

Mr. BURGESS. Is that the Search for Extra Terrestrial——

Mr. HAMMOND. Yes, Extra Terrestrial Intelligence.

Mr. BURGESS. OK.

Mr. HAMMOND. If I may, the interest there is that—and it can

be corrected if I misspeak but the interest there is that the Government, NASA, has a long-term interest in potentially constructing a

level 4 laboratory in the event that they return samples from Mars

and so, therefore, NASA is interested in—it has funded work at the

SETI Institution to keep track of issues related to biosafety level

4 labs.

Mr. BURGESS. As I recall, this group out of Berkeley was the one

that connected personal computers across the country to evaluate

whether there were meaningful signals coming from outer space.

Do I remember that correctly?

Mr. HAMMOND. Sir, I honestly do not know but I do not believe

so.

Mr. BURGESS. OK, I just had to ask. Mr. Chairman, if I may just

ask Dr. Pearson a question. Your concept of the large oversight organization, is that generally accepted by other scientists who work

in this area? If we were to take a poll of scientists who work on

these problems, they would be enthusiastically supportive of you,

moderately supportive of you or recoil in horror? Where would they

fall on that metaphysical scale?

Mr. PEARSON. I think that you are asking a very good question.

Certainly, it’s a concept that has raised a lot of controversy and

concern in the science community. We have an advisory board right

now that is trying to look exactly at this question of what kind of

oversight should be implemented on a national level. It is certainly

an ongoing discussion. I think the question here is not whether or
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not we should have national oversight. The debate is over what

that oversight should look like.

Mr. BURGESS. Mr. Chairman, I would just reference tab 22 in the

binder you provided for us. There is some concern that too much

movement too quickly in this arena will, in fact, stymie safety and

have the adverse affect on safety that we all seek. So again, I do

urge a little bit of caution when we get to the business of writing

legislation. I do hope you will let the minority participate in whatever legislative comes out of these hearings and I will yield back

the balance of my time.

Mr. STUPAK. Thank you, gentlemen. You mention national security. We invited the Department of Homeland Security to assist us

in answering some of these questions and I was surprised and displeased, to say at the least, that they refused to show up, even

though they are responsible for Homeland Security. So they declined our invitation but there will be more work to be done. Concludes questions. We got votes on the floor, so I am going to excuse

this panel. I thank them for coming. Before you leave, one more

question. Plum Island up in New York, we have a level 4 lab there,

level 3, and they want to shut that one down and move it to the

mainland. I think they do mostly foot-and-mouth disease there.

Good idea, bad idea? Any comments. EHS does, that is why we are

still to answer the question but go ahead. Mr. Hammond, I will go

right down the line.

Mr. HAMMOND. My comment would be that it is not entirely clear

to me at all that, in fact, Plum Island will be closed if the National

Bio and Agro-Defense Facility is constructed. Among my recommendations was that Congress consider terminating the project

to construct the National Bio and Agro-Defense Facility.

Mr. STUPAK. Right.

Mr. HAMMOND. Which would possibly imply that Plum Island

would remain open, which is, I believe, may happen anyway.

Mr. STUPAK. Plum Island is one of the few places where no one

lives there, it is just the lab is the only thing on Plum Island. That

is why it makes sense I think. Dr. Pearson, anything on Plum Island or no opinion?

Mr. PEARSON. I am sorry, say that again.

Mr. STUPAK. Plum Island, should they close it?

Mr. PEARSON. Sure.

Mr. STUPAK. Move it to the mainland?

Mr. PEARSON. I think that with the case of Plum Island you have

a 50-year old facility that clearly either needs to be replaced on

Plum Island or replaced somewhere else. The issue with moving it

to the mainland, I think the primary issue given the agents it is

going to work with is, again, one of what happens if an agent gets

out. If it is working with FMD and you plunk it down in the middle

of cattle territory, is that a significant concern. So that is one

thing. That is why it has been on Plum Island. It is simply an issue

of do we have the oversight levels safe enough at that. The only

other issue that I would raise and this, again, gets back to the

needs assessment, I do believe that there is a need for a facility

like Plum Island or NBAF. The issue is the new NBAF facility is

going to be three times the size of Plum Island. So the question is,

is it being scoped out in the right way. And that is where the needs
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assessment needs to come in. I believe DHS has at least done some

needs assessment on that. I have not seen it and the committee

might want to look at that.

Mr. STUPAK. Thank you. Dr. Gronvall?

Ms. GRONVALL. I think as far as Plum Island goes, the issue is

really there are pluses and minuses for keeping it there or moving

it. But the agents that they are going to be working with are select

agents, the people who are involved go through the security procedure but there is no safety procedure and I think that is something

that would need to be considered if you are going to keep it there

or move it to make sure that the people are trained that are in the

laboratory.

Mr. STUPAK. OK. Thank you and I will dismiss this panel and

thank you for sharing your testimony with us today. That concludes all questioning. I want to thank the witnesses for coming

today. I ask unanimous consent that the hearing will remain open

for 30 days for additional questions for the record. With no objection, the record will remain open. I ask unanimous consent that the

contents of our document binder be entered in the record and the

staff have the chance to edit any sensitive documents prior to

printing. No objection, the documents will be entered in the record.

That concludes our hearing. This meeting of the subcommittee is

adjourned.

[Whereupon, at 2:55 p.m., the subcommittee was adjourned.]

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