[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]
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
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COMMITTEE ON ENERGY AND COMMERCE
JOHN D. DINGELL, Michigan, Chairman
HENRY A. WAXMAN, California JOE BARTON, Texas
EDWARD J. MARKEY, Massachusetts Ranking Member
RICK BOUCHER, Virginia RALPH M. HALL, Texas
EDOLPHUS TOWNS, New York J. DENNIS HASTERT, Illinois
FRANK PALLONE, Jr., New Jersey FRED UPTON, Michigan
BART GORDON, Tennessee CLIFF STEARNS, Florida
BOBBY L. RUSH, Illinois NATHAN DEAL, Georgia
ANNA G. ESHOO, California ED WHITFIELD, Kentucky
BART STUPAK, Michigan BARBARA CUBIN, Wyoming
ELIOT L. ENGEL, New York JOHN SHIMKUS, Illinois
ALBERT R. WYNN, Maryland HEATHER WILSON, New Mexico
GENE GREEN, Texas JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado CHARLES W. ``CHIP'' PICKERING,
Vice Chairman Mississippi
LOIS CAPPS, California VITO FOSSELLA, New York
MICHAEL F. DOYLE, Pennsylvania STEVE BUYER, Indiana
JANE HARMAN, California GEORGE RADANOVICH, California
TOM ALLEN, Maine JOSEPH R. PITTS, Pennsylvania
JAN SCHAKOWSKY, Illinois MARY BONO, California
HILDA L. SOLIS, California GREG WALDEN, Oregon
CHARLES A. GONZALEZ, Texas LEE TERRY, Nebraska
JAY INSLEE, Washington MIKE FERGUSON, New Jersey
TAMMY BALDWIN, Wisconsin MIKE ROGERS, Michigan
MIKE ROSS, Arkansas SUE WILKINS MYRICK, North Carolina
DARLENE HOOLEY, Oregon JOHN SULLIVAN, Oklahoma
ANTHONY D. WEINER, New York TIM MURPHY, Pennsylvania
JIM MATHESON, Utah MICHAEL C. BURGESS, Texas
G.K. BUTTERFIELD, North Carolina MARSHA BLACKBURN, Tennessee
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
______
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)
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
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 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 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 responsibility 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
shortcomings 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 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.
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 effective 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.
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, 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
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 intra-agency 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?
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 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-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 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 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:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
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-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.
----------
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
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 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.
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, 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 Department 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-and-mouth 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 administration 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.
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.
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.
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 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 process 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 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.
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.
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?
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 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 release 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.
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 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 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 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 HHS-
OIG'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, 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
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.
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 high-containment 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 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 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?
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.
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 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 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 person-to-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.
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, 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.
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 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 Organization, 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.
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.
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 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 drug-
resistant 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.
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 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, security, 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 biological 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 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. Sec. 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. Sec.
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. Sec.
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.
Sec. 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
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. Sec. 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. Sec. 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 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. Sec.
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 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.
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 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 responsible 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 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.
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?
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.
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?
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.
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 large-scale
epidemics, whether natural or man-made, is an urgent priority.
The anthrax 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 high-
containment 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 high-containment 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 high-containment 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
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 high-
containment 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
research-acquired 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 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 high-containment 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 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 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 2\1/4\ 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 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:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
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.
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 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 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 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 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.]
[Material submitted for inclusion in the record follows:]
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