Germs, Viruses, and Secrets - The Silent Proliferation of Bio-Laboratories in The United States
Germs, Viruses, and Secrets - The Silent Proliferation of Bio-Laboratories in The United States
HEARING
BEFORE THE
OCTOBER 4, 2007
(
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
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)
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
BART STUPAK, Michigan, Chairman
DIANA DeGETTE, Colorado ED WHITFIELD, Kentucky
CHARLIE MELANCON, Louisiana Ranking Member
Vice Chairman GREG WALDEN, Oregon
HENRY A. WAXMAN, California MIKE FERGUSON, New Jersey
GENE GREEN, Texas TIM MURPHY, Pennsylvania
MIKE DOYLE, Pennsylvania MICHAEL C. BURGESS, Texas
JAN SCHAKOWSKY, Illinois MARSHA BLACKBURN, Tennessee
JAY INSLEE, Washington JOE BARTON, Texas (ex officio)
JOHN D. DINGELL, Michigan (ex officio)
(III)
CONTENTS
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 Michi-
gan, 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, Prepared-
ness 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
(V)
GERMS, VIRUSES, AND SECRETS: THE SILENT
PROLIFERATION OF BIO-LABORATORIES IN
THE UNITED STATES
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, Ins-
lee, 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 REPRESENT-
ATIVE 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 open-
ing statement. I will begin.
This is the first of what will likely be several hearings this com-
mittee intends to hold to examine the risk associated with the re-
cent proliferation of high-containment biological research labora-
tories. Today’s hearing is focused on high-contaminate bio-labora-
tories known as BSL–3 and BSL–4 labs in the United States. We
anticipate a future hearing will examine the proliferation of high-
containment 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 re-
cent increase of domestic BSL–3 and BSL–4 labs. These BSL–3 and
4 labs are the facilities where research is conducted on highly in-
fectious 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 con-
sequences. Yet, as we will hear from the Government Accountabil-
ity Office, GAO, no single Government agency has the ultimate re-
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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 Gal-
veston National Lab, which is one of only two national biocontain-
ment 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 as-
pect 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 Sub-
committee 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 state-
ment 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 in-
cludes homeland security and protecting our homeland against the
threat of biological attack.
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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 sta-
tion. 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 Depart-
ment of Defense appropriations bill. Just make a note to the Major-
ity that we do need to vote on a conference report on the Depart-
ment 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 REP-
RESENTATIVE IN CONGRESS FROM THE STATE OF TEN-
NESSEE
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 hear-
ing 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 cou-
ple of different labs. One is in Memphis and one is in Oak Ridge.
The UT Health Science Center in Memphis is currently construct-
ing 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
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that are one, registered with the select agent program and two, fed-
erally funded, much less is known about the expansion of labs out-
side 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 mis-
sions, no agency knows how many such labs there are in the
United States or their locations. Therefore, no Federal agency is re-
sponsible 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. Impor-
tantly, 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 ex-
amine, 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-and-
mouth 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 re-
porting 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 pro-
tection. Three, developing mechanisms for informing medical pro-
viders 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 ex-
pansion 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 su-
perfluous 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 weak-
nesses 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 con-
ducted and unauthorized individuals were entering the labs. And
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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 fol-
low:]
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. More-
over, no one Federal agency has the responsibility for tracking these labs and ensur-
ing their safe operation.
Even though no one seems to know how many labs there are, the National Insti-
tutes 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 quan-
tifiable 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 labora-
tories 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, how-
ever, to learn that even though DHS is responsible for homeland security, it de-
clined 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 offi-
cials at our next hearing. That would also provide DHS with an opportunity to ex-
plain 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 dis-
eases 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-and-
mouth 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. Are they doing any hot stuff there at level 4 at Be-
thesda?
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 require-
ment 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 decentral-
ized 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
tion and the Congress have given funding to meet this require-
ment.
Ms. DEGETTE. And that is going to a wide range of types of pri-
vate 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 gov-
ernmental 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 agen-
cy 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 be-
cause 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 sup-
ported or even private. I am wondering if these non-federally fund-
ed 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. Un-
less 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 pub-
lic safety issue.
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Ms. DEGETTE. What you are saying, I think based on your expe-
rience 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 Regu-
latory Commission is not just talking about commercial power.
Ms. DEGETTE. Right.
Mr. RHODES. Talking about anyone who is handling a radio nu-
clide.
Ms. DEGETTE. Right.
Mr. RHODES. So if your transportation person who is using ce-
sium 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 op-
erate. 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 per-
mitting is local building permits?
Mr. SHARMA. Right.
60
figure out if the people are actually trustworthy. And as the num-
ber 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 an-
other accident, it is their responsibility to find out where the mate-
rial 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 intel-
ligence 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 statu-
tory 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 jurisdic-
tion 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 up-
date 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 Feb-
ruary 2006 and it was a full 13 days after an employee was ex-
posed 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 in-
spectors 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 sys-
tem of inspection relies on documentation and people honestly re-
porting 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 com-
mittees and they also must document the minutes of those meet-
ings. So it is coming from another part of the Government which
CDC, it is our understanding and in the process very labor-inten-
sive, I must say this, to review all those minutes. It was docu-
mented 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 at-
tack 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 hypoth-
esis.
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 as-
sessment 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 over-
sight 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 Exec-
utive, 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 se-
lect 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 re-
quirements 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 Fed-
eral 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 be-
cause 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 activi-
ties 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 secu-
rity professionals, including our own Federal Bureau of Investiga-
tion and our own Intelligence Community, that is a worrisome sub-
ject.
65
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 Na-
tion’s laboratory workers are understandable and legitimate. In the
4 years that the select agent program has been in place with ap-
proximately 400 organizations being registered and after careful in-
vestigations 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 acci-
dents 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 inter-
views and review a broader array of documents to identify prob-
lems that may go unreported by registered labs. In addition, we
plan to assess the composition of our inspection teams and the fre-
quency of our inspections. We also have learned that we need to
provide additional outreach and training to the regulated commu-
nity and create additional guidance documents. We will be under-
taking 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 re-
view, 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 re-
search with select agents is conducted as safely and securely as
possible. However, the possibility of accidental or intentional re-
69
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 dur-
ing inspections, to better assess the implementation of policies and the quality of
training;
• Examine more closely the implementation of biosafety, security, and incident re-
sponse 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 pri-
marily 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 commu-
nity, including additional outreach and training to Responsible Officials and cre-
ation 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 implementa-
tion of the regulations to ensure that we can respond to new threats and
vulnerabilities.
Dr. AUCHINCLOSS. And at least two level 4 facilities for the extra-
mural 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 to-
gether 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 plan-
ning applies to other Government agencies or other funding agen-
cies.
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 commu-
nity.
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 re-
ferred to in his oral statement of pulling together an intra-govern-
mental 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
81
cover all of the organisms that need to be handled safely and se-
curely 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 look-
ing 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 commu-
nities 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 facili-
ties 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 an-
thrax. 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 an-
thrax, 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 addi-
tion, 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 pub-
lished 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
82
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 oc-
curred, 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 pro-
gram that required approval and required inspections, that re-
quired 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 pas-
senger 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 con-
cerned 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
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 redun-
dancy 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 sys-
tem 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 appro-
priate?
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 pro-
tection 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 func-
tional at this point. But even if they had been functional, there are
multiple systems of safety in place to avoid escape of any dan-
gerous pathogens.
Mr. STUPAK. But if you do not have any power, those backup sys-
tems 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 as-
sess 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, em-
ployee 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. Chair-
man, 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 vol-
untary 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
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 wit-
ness 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, sub-
committee 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 every-
thing 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 de-
tails 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 cor-
rective 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 re-
search 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 for-
ward from there. But we will leave nothing undone in moving our
program to one of a model of documented excellence. This research
92
the CDC mentioned that labs should have a biosafety plan, emer-
gency response plan, a security plan among others. And its inves-
tigations in the incidents at A&M, GAO noted that the infected re-
searcher 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 experi-
ments. 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 up-
grading our safety plans, our training plans. Actually, during the
time that our laboratories are not in operation, we are taking ad-
vantage of that time, in addition to getting our documentation com-
pleted. 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 tak-
ing advantage of this time to improve our safety, security and ca-
pacity 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 re-
searchers 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 ear-
lier 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. STUPAK. Then why did not the CDC notice those problems
when they were there with their inspection, when they said every-
thing 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 re-
ceived 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 informa-
tion.
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—inspec-
tion 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 univer-
sity. I do not know if I would characterize it as a review or inspec-
tion.
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 as-
sociate and assistant professor of medicine at the University of
Pittsburgh Medical Center, Center for Biosecurity. Dr. Alan Pear-
son, who is the director of the Biological and Chemical Weapons
Control Program at the Center for Arms Control and Non-Prolifera-
tion. 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 open-
ing 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 BIO-
SECURITY, UNIVERSITY OF PITTSBURGH MEDICAL CENTER
Ms. GRONVALL. Thank you, Mr. Chairman, distinguished mem-
bers 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 protec-
tion, the medicines and vaccines that are needed that led to the ex-
pansion of the high-containment laboratories in the first place.
Without these high-containment laboratories, critical research can-
not 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
Mr. STUPAK. Thank you. Thank you all for your testimony. We
will begin questioning, Dr. Gronvall. You indicated that your train-
ing 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 appren-
tice relationship.
Mr. STUPAK. OK. In your testimony, you described the prolifera-
tion 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 opin-
ion?
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 informa-
tion 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 assess-
ment?
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 report-
ing 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 some-
thing 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 assess-
ment 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.
169
Mr. STUPAK. OK. Mr. Hammond, you indicated there were two
other Texas universities that came forward since Texas A&M be-
came 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 com-
mittee 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 nec-
essary.’’ What is your estimate then of what is prudent and nec-
essary 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, logi-
cally, there should have been additional labs built to deal with revi-
talizing 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. Ham-
mond, 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 pri-
vate lab?
Mr. HAMMOND. One of the things that my organization has done
in the past several years to look at the institutional biosafety com-
mittee 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 compli-
ance 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 com-
pliance with the BMBL and that should be applied to all labora-
tories, 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
170
else today, this may be one of those things that we ought to try
to immediately correct because it does sound like a significant de-
fect. 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 peo-
ple 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. Ham-
mond, 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 organiza-
tions do. I receive contributions from individuals and I raise fund-
ing 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 com-
mittee to make that generally available to members of the commit-
tee. 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 Sun-
shine 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 Govern-
ment, 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 or-
ganization, 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
172
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 proce-
dure 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 con-
cludes 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 objec-
tion, 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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