[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
FEDERAL OVERSIGHT OF HIGH-CONTAINMENT BIOLABORATORIES
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
FIRST SESSION
__________
SEPTEMBER 22, 2009
__________
Serial No. 111-66
Printed for the use of the Committee on Energy and Commerce
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COMMITTEE ON ENERGY AND COMMERCE
HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan JOE BARTON, Texas
Chairman Emeritus Ranking Member
EDWARD J. MARKEY, Massachusetts RALPH M. HALL, Texas
RICK BOUCHER, Virginia FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida
BART GORDON, Tennessee NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky
ANNA G. ESHOO, California JOHN SHIMKUS, Illinois
BART STUPAK, Michigan JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York ROY BLUNT, Missouri
GENE GREEN, Texas STEVE BUYER, Indiana
DIANA DeGETTE, Colorado GEORGE RADANOVICH, California
Vice Chairman JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania GREG WALDEN, Oregon
JANE HARMAN, California LEE TERRY, Nebraska
TOM ALLEN, Maine MIKE ROGERS, Michigan
JANICE D. SCHAKOWSKY, Illinois SUE WILKINS MYRICK, North Carolina
CHARLES A. GONZALEZ, Texas JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York PHIL GINGREY, Georgia
JIM MATHESON, Utah STEVE SCALISE, Louisiana
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA CHRISTENSEN, Virgin Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE BRALEY, Iowa
PETER WELCH, Vermont
(ii)
Subcommittee on Oversight and Investigations
BART STUPAK, Michigan, Chairman
BRUCE L. BRALEY, Iowa GREG WALDEN, Oregon
Vice Chairman Ranking Member
EDWARD J. MARKEY, Massachusetts ED WHITFIELD, Kentucky
DIANA DeGETTE, Colorado MIKE FERGUSON, New Jersey
MICHAEL F. DOYLE, Pennsylvania TIM MURPHY, Pennsylvania
JANICE D. SCHAKOWSKY, Illinois MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas
DONNA M. CHRISTENSEN, Virgin
Islands
PETER WELCH, Vermont
GENE GREEN, Texas
BETTY SUTTON, Ohio
JOHN D. DINGELL, Michigan (ex
officio)
C O N T E N T S
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Page
Hon. Bart Stupak, a Representative in Congress from the State of
Michigan, opening statement.................................... 1
Hon. Greg Walden, a Representative in Congress from the State of
Oregon, opening statement...................................... 3
Prepared statement........................................... 6
Hon. Gene Green, a Representative in Congress from the State of
Texas, opening statement....................................... 10
Hon. John D. Dingell, a Representative in Congress from the State
of Michigan, prepared statement................................ 12
Hon. Edward J. Markey, a Representative in Congress from the
Commonwealth of Massachusetts, prepared statement.............. 13
Hon. Joe Barton, a Representative in Congress from the State of
Texas, prepared statement...................................... 15
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, prepared statement............................. 18
Witnesses
Nancy Kingsbury, Ph.D., Managing Director, accompanied by Sushil
Sharma, Assistant Director, Applied Research and Methods, U.S.
Government Accountability Office............................... 21
Prepared statement........................................... 25
Ronald M. Atlas, Ph.D., Co-Chair, Committee on Biodefense,
American Society for Microbiology.............................. 34
Prepared statement........................................... 37
FEDERAL OVERSIGHT OF HIGH-CONTAINMENT BIOLABORATORIES
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TUESDAY, SEPTEMBER 22, 2009
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 11:00 a.m., in
Room 2123, Rayburn House Office Building, Hon. Bart Stupak
[chairman of the subcommittee] presiding.
Present: Representatives Stupak, Christensen, Green,
Walden, Burgess and Gingrey.
Staff Present: Mike Gordon, Chief Investigative Counsel;
Dave Leviss, Chief Oversight Counsel; Molly Gaston, Counsel;
Scott Schloegel, Investigator; Jennifer Owens, Special
Assistant; Paul Jung, Public Health Service Detailee; Lindsay
Vidal, Special Assistant; Jen Berenholz, Deputy Clerk; Mitchell
Smiley, Special Assistant; Matt Eisenberg, Staff Assistant;
Alan Slobodin, Minority Counsel; Krista Rosenthall, Minority
Counsel; and Peter Kielty, Minority Research Assistant.
OPENING STATEMENT OF HON. BART STUPAK, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Stupak. Today, we have a hearing titled Federal
Oversight of High-Containment Biolabs. The chairman and ranking
member will be recognized for 5-minute opening statements.
Other members of the subcommittee will be recognized for 3-
minute opening statements.
Nearly 2 years ago, this subcommittee investigated some
highly troubling issues related to high-containment biolabs,
which are labs that handle some of the world's most exotic and
dangerous diseases, including anthrax, smallpox, foot and mouth
disease and Ebola virus.
On October 4, 2007, at a subcommittee hearing titled Germs
and Viruses and Secrets: The Silent Proliferation of Biolabs in
the United States, we focused on increasing the number of high-
containment biolabs, otherwise known as BSL-3 and BSL-4 labs.
The accidental or deliberate release of the dangerous
agents handled in those labs could have catastrophic
consequences. At our hearing, we examined whether the Federal
Government should be doing more to keep track of these labs and
ensure that they follow sound safety and security practices.
Since that hearing, important questions have remained
alarmingly unanswered, such as, number one, how many high-
containment labs exist in the United States and how many do we
really need; two, how many labs had serious incidents in which
lab workers or the public could have been exposed to dangerous
diseases; three, how effective are the high-containment labs'
personnel reliability measures and inventory technology? What
changes have been made to address the Department of Justice's
conclusion that a single Department of Defense employee caused
the anthrax attacks of 2001? We asked the Government
Accountability Office, GAO, to look into these issues, and
today we will learn what they found.
Unfortunately, many problems still exist such as no single
agency or office in the Federal Government keeps track of how
many high-containment labs there are in the United States,
where they are located, what types of research they are doing
and whether they are safe and secure. In short, there still
appears to be no adequate Federal plan or effort to manage,
much less coordinate, highly dangerous research. There are no
universal standards for lab design, construction, or use.
The Department of Health and Human Services publishes a
guideline, Biosafety in the Biomedical and Microbiological
Laboratories, known as the BMBL. Labs that receive NIH grants
must comply with BMBL guidelines, but private and other
nonfederally funded facilities have no similar requirement.
While labs that handle select agents must obtain Federal
registration and certification, no accreditation or
certification is required for labs working with dangerous
organisms that are not on the select agent list, such as SARS
or West Nile Virus.
There are no standards for biosafety training or the
credentialing of high-containment laboratory workers. The
Department of Health and Human Services only requires training
of workers handling organisms on the select agent list. There
are no standards or mechanisms for ensuring involuntary control
or personnel reliability.
It is essential to lab security that lab workers undergo
adequate screening and that the quantity of biological agents
in a lab is tracked carefully. Failures in personnel
reliability practices can be catastrophic. Again, the 2001
anthrax attacks, which the Department of Justice has said was
the work of one Department of Defense scientist, is a tragic
example of this risk.
Finally, the biolab community has no mechanism to catalogue
accidents and mishaps for collective analysis so lessons can be
learned and shared to improve safety and security practices.
Unfortunately, what is clear is that the Federal policy on
biosafety and security remains basically unchanged from what it
was when we had our hearing 2 years ago. There is hope that
this may change thanks to two reports that should be finalized
hopefully in the next coming weeks.
The first is the Trans-Federal Task Force on Optimizing
Biosafety and Biocontainment Oversight, which is cochaired by
HHS and USDA, which was a direct result of our hearing 2 years
ago. The task force report will make important recommendations
for improving biosafety in the United States.
Another such study by the Executive Order Working Group on
Strengthening the Biosecurity of the United States, which was
created by President Bush's executive order in January, will
make recommendations on ways to improve the select agent
program.
The committee staff has been briefed about the process for
preparing these reports. It is hoped that these reports will be
available in the next few weeks. I look forward to hearing from
the administration on this important matter at that time.
Today, we will hear testimony from the Government
Accountability Office about its findings and recommendations
concerning biolab safety and security. Their report, titled
High-Containment Laboratories: National Strategy for Oversight
Is Needed, was released yesterday. We will also hear from a
representative of the American Society of Microbiology, who can
share the perspective of those who operate and work directly
with high-containment labs. I look forward to hearing the
testimony of our witnesses regarding how we can quickly and
responsibly address this challenge and enhance our Nation's
biosafety and security.
It is our hope that this new administration will act
quickly to approve data about labs and improve lab safety and
security.
Let me also express my condolences to the families and
coworkers and friends of the University of Chicago professor,
Malcolm Casabadan, who died last week from what appears to be
an infection that he may have acquired from the lab while doing
research on the plague. This highlights the fact that even more
needs to be done to protect our scientists and the public
inside and outside the lab.
With that, I will next turn to the gentleman from Oregon,
Mr. Walden, please, for an opening statement.
OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OREGON
Mr. Walden. Thank you, Chairman Stupak. I appreciate the
opportunity to join you at this hearing today.
I concur with your remarks and sympathies to the family of
Malcolm Casabadan, and I think it is important to note that
this was a Level 2 lab. We are dealing with Level 3 and 4 in
this hearing today.
But it does raise the issue about how far down we need to
go. And in this case, I guess they are still trying to figure
out if the bacteria, Yersinia, that persisted in his blood that
is related to the plague perhaps caused his death. And so,
clearly, we need to be investigating these safety issues in all
of our country's labs.
I also say, Mr. Chairman, that the Republican staff has
come to learn that the NIH, as part of their stimulus dollars,
now may have received upwards of a billion dollars to more
rapidly build out these labs, which I think raises the issue
about our need to do proper oversight not only of how stimulus
dollars are being spent here but elsewhere throughout the
government so the taxpayers' money is spent appropriately. So I
would hope that our subcommittee would have a hearing on
stimulus spending as it relates to the agencies under our
purview.
Yesterday, the Government Accountability Office released a
report addressing some of the issues raised at our previous
hearing regarding increased oversight and improved safety
measures at these types of laboratories; and they are here
today to discuss their findings. I appreciate that.
Just weeks after 9/11, our Nation faced a series of
bioterrorist attacks where weapons-grade anthrax was delivered
through the mail and five people died. Authorities now believe
that one scientist who worked in one of our Nation's high-
containment laboratories was responsible for those attacks. My
office was in the Longworth Building in those days, and we were
shut out of our office because of the anthrax that came into
that building.
In response to the attacks, Congress increased funding to
upgrade our Nation's biodefense program. The National
Institutes of Health, NIH, which funds much of the lab research
and construction, spent $1.7 billion in 2007, compared to $53
million on biodefense labs in 2001.
Now, that is a 32-fold increase in spending. Again, we
understand that NIH is receiving stimulus dollars to add
another billion dollars in spending for intramural/extramural
facilities, and I think it will be important to note how that
money is being spent, especially with such a steep increase in
funding and the rapid expansion of the lab network. It is time
to reexamine the Federal regulatory system to ensure safety and
efficiency.
Our hearing on October 4th of 2007 examined the results of
the Bioterrorism Act on Federal oversight of select agents. It
identified a few gaps and questioned how these labs and Federal
regulations would mitigate risks while increasing our defenses.
Now, it has been almost 2 years since our last hearing, and it
is evident both the Federal Government and the academic realm
agreed with the sense of the subcommittee's hearing that there
is a need for increased oversight and improved safety and
security measures in high-containment laboratories.
As a result of the October 2007 hearing, the Trans-Federal
Task Force on Optimizing Biosafety and Biocontainment Oversight
was created. That is cochaired by HHS and USDA, and their
report, along with recommendations to improve oversight and
safety, is scheduled to be released within the next week or
two.
In January, then-President Bush, as you mentioned, Mr.
Chairman, signed Executive Order 13486 which established the
working group to examine how to strengthen laboratory
biosecurity and safety in our Nation's high-containment labs.
Now, the working group's report was completed and sent to the
President in July; yet, to date, the administration has not
publicly commented on nor released the report nor made any
formal recommendations. The committee staff was told the
administration has begun to collect and evaluate these reports
and is in the preliminary stages of the policy process, yet a
request for a briefing or a witness for the hearing from the
White House was unanswered.
GAO's report highlights the pressing need for coordinated
national oversight of our Nation's high-containment
laboratories. GAO recommends the National Security Adviser name
a single entity charged with government-wide strategic
evaluation of high-containment laboratories including tracking
our lab capacity, evaluating our country's needs and
establishing our research priorities.
There seems to be some consensus within the scientific
community that we already have oversight infrastructures in
place within the Department of Health and Human Services and
the Department of Agriculture. I hope the administration
utilizes this existing expertise instead of creating a
centrally located biosafety--or shall I call it a Germ Czar--at
the White House.
Other reports completed by the American Association for the
Advancement of Science and the National Science Advisory Board
for Biosecurity were issued earlier this year. These reports
discussed ways to increase safety and security in our Nation's
high-containment labs, focusing on personnel reliability and
enhancing training programs. A lot of research and reports have
been completed by our government and academic associations, and
we are appreciative of those, but some of these reports have
not been finalized and made public.
In turn, only Dr. Kingsbury from the GAO is here to discuss
their report--which we appreciate--and answer our questions.
But these facts suggest to me that this committee might have
been better served by delaying this hearing for a week or two
so we could have all of the reports before us before they were
released, and various responsible Federal agencies could also
send witnesses to give us a more complete view of what we face.
The oversight of our Nation's high-containment laboratories
is an issue that is deserving of this subcommittee's attention.
However, this hearing is not inclusive, I believe, or
representative of all the work that has been done in this area,
and we need to keep that in mind as we proceed.
I do want to welcome Dr. Atlas from the American Society of
Microbiology, which has more than 40,000 members. We appreciate
your being here representing the science and health
professionals who staff these labs. Your input will be very
valuable.
He will discuss the important roles these laboratories play
in protecting our Nation, the importance of biosafety
requirements for the labs and their personnel, and
recommendations to improve biosafety training, oversight,
resources, reporting, and biosecurity.
Thank you, Mr. Chairman, for holding this hearing. I look
forward to working with you on this issue in the weeks ahead.
[The prepared statement of Mr. Walden follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Ms. Christensen, opening statement, please?
Mrs. Christensen. Thank you, Mr. Chairman, and thank you to
you and Mr. Walden. I really appreciate the opportunity to take
a second look at the lack of oversight on high-containment
biolabs.
I recall from my time on the Committee on Homeland
Security, when the National Institute of Allergy and Infectious
Disease testified that they were in the process of building the
two laboratories; and I am amazed to see how the number has
grown in the public, academic and private sectors. But I am
very concerned that--as I am sure are you, that there is no one
agency that can tell us how many of these labs there are, and
that some of the same uncertainties about what is exposure, how
best to train and certify employees still exist. Not much seems
to have changed since the 2007 report and hearing.
We all realize that we have to balance stimulating and
supporting research with providing regulatory oversight, but
the fulcrum really has to be the safety of the employees, the
surrounding communities, and our country.
I look forward to the testimony. I thank Dr. Kingsbury and
Dr. Atlas for being here today.
Mr. Stupak. 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
on the Federal oversight of the high-containment biolabs in the
U.S. This hearing is a follow-up one held by our committee in
2007. I look forward to hearing the testimony from the
witnesses on the Federal oversight of the safety systems of
these biolabs and how we can improve our evaluation and
tracking section.
In Texas, the University of Texas Medical Branch at
Galveston National Lab is one of the two national
biocontainment laboratories constructed under grants awarded by
the National Institute of Allergy and Infectious Disease, the
National Institutes of Health. And I am proud to have much of
this research being performed literally in the backyard of UTMB
at Galveston. At this BSL-4 lab, research is conducted to
develop therapies and vaccines and tests for diseases like
anthrax, avian influenza, bubonic plague, Ebola, typhus, West
Nile Virus, and tuberculosis. As a Nation, we need this work
performed.
During my visits to UTMB, I learned firsthand about the
measures that UTMB is taking to ensure that that lab is built
with every contingency in mind, and I also learned about the
comprehensive training program UTMB has in place.
I have a personal interest in the safety of biolabs because
my daughter completed her fellowship at UTMB, and she worked
some of the research conducted on the select agents at the
operational BSL-4 and in that Galveston National Lab when it
was completed. Due to the damage to the UTMB campus from
Hurricane Ike, she unfortunately left Galveston, and now she is
at the University of Nebraska working in infectious diseases.
But I also know that during Hurricane Ike that lab was the
safest place to be on the Galveston Island. There was no loss,
no exposure, and just a success on what had been done for a
number of years; and the center grew even more. It withstood a
Category 4 hurricane on a barrier island, so I think it is
built pretty well.
As a parent to a researcher, I want to make sure that these
biosafety labs adhere to higher safety training standards
wherever they may be; and it was a source of personal comfort
that UTMB had placed such an emphasis on safety training,
safety of these labs across the U.S. Given the growth of these
labs nationwide, I think we need to step up our safety training
efforts, as well as structure within the existing agency, such
as HHS or the Department of Agriculture, to track the growth of
these labs.
I appreciate the witnesses here today. And my other hat, I
serve on the Health Subcommittee, and a lot of those illnesses
that these biolabs are working on are ones that we hope to be
able--we hope they will never have to treat our constituents.
But we also know in this world they may have to, so we need
those labs here, doing their job.
Mr. Stupak. For other members--and I know Chairman Waxman
and others have submitted opening statements--their statements
will be made part of the record.
[The prepared statements of Messrs. Dingell, Markey,
Barton, and Burgess follow:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. That concludes the opening statements by
members of the committee. I now call our witnesses.
On our panel we have Dr. Nancy Kingsbury, who is the
Managing Director of Applied Research and Methods at the U.S.
Government Accountability Office; Dr. Sushil Sharma with the
GAO; and Dr. Ronald Atlas, who is the cochair of the Committee
on Biodefense at the American Society for Microbiology.
STATEMENTS OF NANCY KINGSBURY, Ph.D., MANAGING DIRECTOR,
ACCOMPANIED BY SUSHIL SHARMA, ASSISTANT DIRECTOR, APPLIED
RESEARCH AND METHODS, U.S. GOVERNMENT ACCOUNTABILITY OFFICE;
AND RONALD M. ATLAS, Ph.D., CO-CHAIR, COMMITTEE ON BIODEFENSE,
AMERICAN SOCIETY FOR MICROBIOLOGY
Mr. Stupak. Welcome to our witnesses.
It is the policy of this subcommittee to take all testimony
under oath. Please be advised that you have a right under the
rules of the House to be advised by counsel during your
testimony. Do you wish to be represented by counsel?
Everyone is indicating ``no.''
All right. Then I am going to ask you to please rise, raise
your right hand and take the oath.
[Witnesses sworn.]
Mr. Stupak. The witnesses replied in the affirmative.
We will hear a 5-minute opening statement from our
witnesses. You may also submit a longer statement, and it will
be in the record.
STATEMENT OF NANCY KINGSBURY, Ph.D.
Ms. Kingsbury. Mr. Chairman and members of the
subcommittee, we are very pleased to be here to discuss our
report on the national strategy for high-containment
laboratories in the United States that deal with dangerous
pathogens. Our report on those matters was released yesterday,
as you mentioned in your opening statements.
Such high-containment laboratories have proliferated in
recent years. This report focuses on the proliferation in the
West, but similar things are done in other countries.
In 2007, we reported on several issues associated with the
proliferation of these labs in the United States and some of
these risks posed by biosafety incidents that occurred in the
past. The FBI's allegation in August 2008 that a DOD scientist
was the sole perpetrator of the 2001 anthrax attacks raised
additional concerns about the possibility of insider misuse of
high-containment lab facilities, materials and technology.
Highly publicized laboratory errors and controversies about
where high-containment labs should be located had raised
questions about whether the governing framework, oversight and
standards for biosafety and biosecurity are adequate.
In this context you asked us to address the following
questions:
To what extent and in what areas has the number of high-
containment labs increased in the United States?
Which Federal agency is responsible for tracking the
expansion of high-containment laboratories in determining the
associated aggregated risks?
And what lessons can be learned from highly publicized
incidents at high-containment laboratories and actions taken by
the regulatory agencies?
We have three basic findings to report:
First, since 2001 the number of BSL-3 and BSL-4 labs in the
United States has increased, and this expansion has taken place
across Federal, State, academic and private sectors.
Information about the number, location, activities and
ownership is available for high-containment laboratories that
are registered with CDC's or USDA's select agent programs, but
not for those outside those programs.
The expansion that began after the anthrax attacks in 2001
lacked a clear, coordinated national strategy. Decisions to
fund construction of high-containment labs were made by
multiple Federal agencies in multiple budget cycles. Federal
and State agencies, academia and the private sector considered
their individual requirements, but an assessment of national
need was lacking. Even now, after more than 7 years, we were
unable to find any projections based on a government-initiated
strategic evaluation of current and future capacity
requirements linked to national public health goals. Such
information is needed, we think, to ensure that the U.S. will
have facilities in the right place with the right research
capabilities.
Second, no executive or legislative mandates directs any
single Federal agency to track the expansion of all high-
containment labs. Accordingly, no Federal agency knows how many
such labs exist in the United States and no single agency is
responsible for determining or are able to determine the
aggregate risks associated with the expansion of these labs.
Consequently, no Federal agency can determine whether high-
containment lab capacity is now less than, meets or exceeds the
national need.
Finally, four highly publicized biosafety incidents in
high-containment labs, as well as evidence in scientific
literature, demonstrate that while laboratory accidents are
rare, they do occur, primarily due to human error or systems
failures.
One of the incidents we reviewed involved the allegations
that Dr. Bruce Ivins of DOD was the source of the 2001 anthrax
attack. These allegations highlighted two lessons: First, an
ill-intentioned insider could pose a risk by removing dangerous
material from a high-containment lab; and second, it is
impossible to have 100 percent effective inventory control of
biological material with currently available technologies. Such
inventory control is possible for nuclear material and for
chemical material, but because biological material grows and
expands, there are currently no available technologies.
At Fort Detrick, USF procedures for the control of
inventories and the unrestricted use of lab facilities
allegedly allowed Dr. Ivins the opportunity to pursue his own
ends. As the number of high-containment labs increases, there
will inevitably be an increase in the pool of scientists with
expertise, and thus, the corresponding risk from insiders is
likely to increase.
Taken as a whole, these incidents we reviewed demonstrate
failure of systems and procedures meant to maintain biosafety
in high-containment labs. They reveal the failure to comply
with regulatory requirements that were not commensurate with
the level of risk to public health posed by the lab workers and
the pathogens in the lab, and the failure to fund ongoing
facility maintenance and monitor the operational effectiveness
of lab physical infrastructure.
In conclusion, I want to stress that oversight plays a
critical role in improving biosafety and ensuring that high-
containment labs comply with regulations. However, some aspects
of the current oversight programs provided by the CDC and USDA
are dependent upon entities monitoring themselves and reporting
incidents to Federal regulators.
Furthermore, personnel reliability programs have been
established by 2001 to counter insider risks, but their cost,
effectiveness and problematic impact has not been evaluated.
If an agency were tasked or a mechanism were established
with the purpose of overseeing the expansion of high-
containment labs, it could develop a strategic plan to ensure
that the number and capabilities of potentially dangerous high-
containment labs are no greater or no less than necessary. It
could balance the risks and benefits of expanding such labs and
it could determine the type of oversight needed.
To address these issues we recommended that the National
Security Adviser, in consultation with the Secretaries of
Health and Human Services, Agriculture, Defense, and Homeland
Security, and the National Intelligence Council and any other
departments and agencies that are appropriate, identify a
single entity charged with periodic strategic evaluation of
high-containment labs that will determine the number, location
and mission of laboratories needed to effectively meet national
goals to counter biothreats, the existing laboratory capacity
within the United States, the aggregate lists associated with
the expansion and the type of oversight needed.
It could also develop in consultation with the scientific
community national standards for the design, construction,
commissioning and operation of high-containment laboratories,
specifically including provisions for long-term maintenance,
which is an area that we are quite concerned about.
We also recommended that the Secretaries of Health and
Human Services and Agriculture develop a clear definition of
exposure to select agents--some of these incidents suggest that
there is some confusion in that regard--and a mechanism for
sharing lessons learned from reported laboratory accidents so
that best practices for other operators for high-containment
laboratories can be identified and distributed.
Recognizing that biological inventories cannot be
completely controlled at present, we also recommended that the
Secretaries of HHS and Agriculture review existing inventory
control systems and invest in and develop appropriate
technologies to minimize the potential for insider misuse of
biological agents.
Finally, should the Secretaries consider implementing a
more stringent personnel of liability program for high-
containment laboratories, employees to deal with insider risks,
we recommended that they evaluate and document the cost
effectiveness and programmatic impact of such a program.
We did obtain written comments on the draft of our report
from the Secretaries of Health and Human Services and
Agriculture. HHS and Agriculture concurred with our
recommendations that were directed to them. The Executive
Office of the President and the National Security Council did
not provide any comments.
Mr. Chairman, this concludes my prepared remarks, and I
will be happy to answer any questions that you or your
colleagues may have.
Mr. Stupak. Thank you.
[The prepared statement of Ms. Kingsbury follows:]
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Mr. Stupak. Dr. Atlas, opening statement, please, sir.
STATEMENT OF RONALD M. ATLAS, Ph.D.
Mr. Atlas. Thank you, Mr. Chairman, members of the
subcommittee. I want to thank you for the opportunity to
testify on behalf of the American Society for Microbiology.
When I began my career 40 years ago, we thought we had
conquered infectious diseases, but in fact that is not the
case. We have newly emerging infectious diseases every year,
whether it is SARS or multidrug and extremely drug-resistant
tuberculosis or the recurrent outbreak of the H1N1 influenza.
And these outbreaks of disease have not only public health but
also economic and political repercussions, and therefore we
need to carry out research to find the therapeutic vaccines,
diagnostics and other ways of coping with these diseases.
In other words, we must continue to perform research on
pathogenic microorganisms, and much of that research needs to
be performed in high-containment laboratories where the safety
of the scientists working on the organisms, as well as the
public, can be protected. These are not weapons laboratories;
rather, they are research laboratories where investigations are
carried out with the aim of protecting public health.
Inevitably, as we have seen in the tragic case in Chicago,
at least from the reports, there is risk to the scientists and
perhaps to the community when we work with these organisms. And
accordingly, the American Society for Microbiology has strongly
supported responsible regulation, oversight, practices and
guidelines that improve laboratory biosafety and protect
laboratory personnel, the public and the efficacious
performance of the research that leads to vaccines, therapeutic
drugs and diagnostics that we need. And over the years we have
reached a balance, at least for the moment, between the safety
practices that are carried out in the laboratory and the
ability to perform research.
Although these procedures, when properly followed, do
provide a level of safety to the workers in the community, the
ASM feels that we continuously need to review these practices
and to find new and better ways to move forward.
During the past 2 years, the ASM has met with the Trans-
Federal Task Force on Biosafety and Biocontainment Oversight
and the Executive Order Working Group on strengthening the
biosecurity of the United States and made a number of
recommendations to those groups. Clearly, there is a need to
ensure adequate training and strict compliance to provide the
levels of protection engendered in existing biosafety
procedures, as well as those that may be proposed.
The ASM has made a number of recommendations which I would
like to summarize for you.
First, the Biosafety and Microbiological and Biomedical
Laboratories Manual, or the BMBL, which contains the core
guidelines for the safe operation of all microbiological
laboratories, should be the subject of regular biennial review
and update, as needed. The BMBL, along with the NIH guidelines
for recombinant DNA research, are essential reference
documents. We need to continuously examine these, update them,
and provide more guidance for the community and to develop
specific competencies for biosafety training and recommended
procedures for incident reporting. The ASM view is that the
CDC, NIH, and USDA should take the lead for BMBL revisions, but
there should be input through from the community.
Second, the list of pathogens designated as select agents
and those requiring BSL-3 and BSL-4 containment should be
regularly updated; and again, we would urge that a scientific
community that is broadly based help to guide the development
of these lists.
Third, there should be mandated training and performance
requirements for biosafety personnel overseeing the safety of
high-containment laboratories. And again, the NIH and CDC
should make educational training programs available, and we
should continuously look to the standards that need to be
achieved.
Fourth, the select agent regulation should be revised to
change the requirements for inventory of vials and select
agents. Laboratories should be accountable for which agents
they possess and where these agents are located, but counting
of vials that are in a freezer when we are dealing with live
organisms provides a false sense of security and does not
really help in protecting the Nation.
Fifth, the NIH requirements that foreign institutions must
have comparable facilities and standards that are U.S.
Collaborative should be changed to remove hurdles for
international collaboration. We have been struck by the UTMB
experience where they no longer can get strains of hemorrhagic
fever viruses into the United States because the laboratories
overseas that, in fact, are holding those organisms may not
meet U.S. standards.
Six, the Congress should enhance funding, as needed, to
ensure the upkeep of the high-containment laboratories. Now
that many of these laboratories have been constructed, they
should be concerned that they continue to meet the high
standards to which they were built.
Seven, we need an improved system for surveillance and
reporting of laboratory-acquired illnesses. This should be done
in a way where we learn lessons from incidents which,
unfortunately, occur rather than trying to hide these incidents
for fear of recrimination.
And finally, we should be examining very carefully the
costs and benefits of potential accreditation systems. In this
regard, we see the current select agent regulations as
providing a pseudoaccreditation. There are standards, there are
inspections; as has been pointed out, this does not exist for
the nonselect agents, and I think we need to examine the
potential value of moving forward.
We would note that the American Biological Safety
Organization, ABSA, is in fact in the process of developing a
voluntary accreditation system. I think we need to look at
that. But moreover, we really need to develop the standards and
look to what we need to hold the labs accountable for and have
a system in place where we can assure this committee and the
Nation that we are complying.
In conclusion, I think we have made tremendous strides over
the past years in moving towards meeting the needs of the
Nation both in terms of the research and the safety. More needs
to be done. We need to do this carefully and in a considerate
way, so we don't upset an apple cart and put the Nation at
risk.
Thank you, Mr. Chairman, and I look forward to your
questions.
[The prepared statement of Mr. Atlas follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you both for your testimony.
One of the things we have learned from the oversight
hearings is that there is no Federal agency in charge of the
expansion of the high-containment labs. I think the average
citizen would be surprised to learn that the government doesn't
even know how many BSL-3 labs there are in the United States.
On Table 3 from the GAO report--you might want to put it up
on the monitor--we see that the number of BSL-4 labs has
increased even since 2007 when we held our first hearing. There
are now two more BLS-4 labs that are fully operational in the
United States since our 2007 hearing. There are also seven more
BSL-4 labs currently under construction.
So if we go back and we look at your Figure 1 in the GAO
report and Figure 1 on our monitor, we can see locations of the
BSL-4 labs are being built right now across the United States.
When these labs become operational, we will have double the
BSL-4 capacity in the United States without any Federal agency
analyzing whether this is appropriate needs for our country.
And if we look at Figure 2 in the GAO report, we can see
that the number of BSL-3 labs has continued to increase in the
same period of time. Table 4 shows there are about 1,400 BSL-3
labs in the United States, and these are only the BSL-3 labs
registered with the Federal Government. We can only guess how
many there are out there, because they don't have to register
unless it is handling one of those agents.
Do you have any concerns about the increase we have seen in
the number of high-containment labs?
Ms. Kingsbury. Yes, sir.
Mr. Stupak. Could you explain your concerns.
Ms. Kingsbury. Well, the concern is, there may be a need
for this number of laboratories, but nobody is looking at the
total picture. Nobody is looking at what the public health and
public safety research needs are, and linking that to where
labs are built and how many of them we need. And if you look at
the combination of Table 4 and Table 5, which are the labs that
are registered with APHIS at the Department of Agriculture, you
end up with more than 1,600 BSL-3 labs out there. That just
seems like a lot.
Mr. Stupak. You mentioned the Department of Agriculture,
and Dr. Atlas, in your report and letter that you sent after
our last hearing--were you the author of that letter or was
there a team that did that?
Mr. Atlas. We have a team.
Mr. Stupak.--you mention about--because of APHIS and the
Department of Ag there, because 75 percent of the new
infectious disease we are seeing actually comes from animals
passed to humans; is that correct?
Mr. Atlas. That is correct.
Mr. Stupak. Dr. Atlas, do you have any concerns about this
increased number of labs we are seeing?
Mr. Atlas. I don't think I have the same sort of concern
that is expressed in the GAO report because I see these labs as
safe labs. If you tell me that we are creating more safe
infrastructure within the Nation, where research can be
performed, that is something that I support.
So from that sense, no, I don't have the same concern in
terms of safety when you tell me it is a safer laboratory
structure.
Now, is it more safe than we need? I guess I don't see
things that way.
Mr. Stupak. Let me ask you this question. In your October
4th letter, and it was updated in July of this year for this
hearing, on the second page it says, ``Facilities at BSL-3 and
-4 levels of containment have been constructed because the
number and capacity of existing biocontainment facilities were
determined to be inadequate to meet the needs for biodefense
and emerging disease work.''
What is the right number then? What is the right number we
need of Level 3 and Level 4 labs?
Mr. Atlas. I don't know the right number overall. Certainly
there was an assessment done at the National Institutes of
Health that suggested we needed something on the order of 10 to
15 regional laboratories to cover the Nation that would provide
core resources for the research and potential surge capacity if
we had a major outbreak.
Beyond that, a number of institutions have seen the need or
desirability to have small laboratories where they could do
research on agents in a safe manner.
Mr. Stupak. My concern is--and I think Dr. Kingsbury
pointed out--unlike, let's say, nuclear material, with these
agents, they are always growing, expanding. And in looking at
the GAO report, and even your report or your testimony, one of
these errors we have is human error and it just comes inherent
with the job. And with nuclear, we try to contain it, we try to
have less people handling it, less chance of error.
Doesn't the same logic hold true here that the more labs
you have, the more scientists and researchers you have handling
this, the more likely a disaster, not just within the lab, but
escaping outside the labs?
Mr. Atlas. Not if we have the appropriate safety standards,
and I think that is where we would put our emphasis on
increasing the training and the resources to ensure that all of
the workers in the laboratory are performing safely. I think it
is important----
Mr. Stupak. But there really is no safety. It is on-the-job
training, isn't it? If I am a researcher, it is basically--I
don't go to some school to learn how to do it.
Mr. Atlas. There are safety courses that are offered.
Mr. Stupak. But not required.
Mr. Atlas. They are not required, and therefore you are
correct that much of the training is on the job.
I think what the ASM would propose is that we, in fact,
move to a system with national standards that would establish
minimum guidelines for the training and that we provide the
resources where we can assure this committee that anyone who is
walking into a laboratory where dangerous agents are contained
is adequately trained; and further, that we instill in the
community a culture of responsibility with a zero tolerance for
not following the procedures.
Mr. Stupak. Sure.
Let me ask you this. If you go back to Figure No. 3 that we
had up--it is in the GAO report.
It is Figure No. 2 where you went from about 400 BSL labs
in 2004 to almost 1,400 in 2008. Can you find that chart?
The question I want to ask--that is 2004, and we go up to
almost 1,400. Were these labs always in existence, and they
never reported the select agents they are dealing with? I mean,
how----
Mr. Atlas. That is probably true. What this graph
represents is the number of laboratories, I believe, registered
for work with select agents. It does not necessarily represent
the construction of new laboratories.
Mr. Stupak. No; I know that. If I have a university, I may
have many labs within my university structure.
If you are supposed to be registered before, is there that
much more interest in these 80 select agents; or have they
always been doing the work, and we never knew about it? Which
once again shows no coordination or no one is in charge here.
Mr. Atlas. In post-2002, the Nation has made a significant
investment in bioterrorist-related or potentially related
organisms. That has brought a great deal--as pointed out, we
went from a very small budget to a $1.7 billion sort of
investment in research that was largely in the research to be
conducted rather than construction of new laboratories. And
that has led to a number of individuals joining in the effort
to develop vaccines against Ebola and anthrax and the other
diseases, to protect the Nation about what is now seen as a new
threat from the misuse of biological weapons.
Mr. Stupak. It is sort of like what Mr. Walden said: We put
the money out there and suddenly everyone became BSL-3 labs
that do research. They follow the money and not necessarily the
threat?
Mr. Walden. I didn't say that.
Mr. Stupak. I know you didn't say that. I'm summarizing.
It almost seems like if we throw money out there, suddenly
we are all BSL-3 and BSL-4 labs.
Mr. Atlas. Certainly, when I testified before the Congress
in the 2002 era, there was a perception that we had a
tremendous threat facing us, and we had to combat that threat
by racing to develop stockpiles of vaccines and therapeutics
that could be moved across the Nation.
We needed better vaccines; when we looked at some of the
ones we had, we decided they weren't safe enough. Smallpox
vaccine that you and I once used, we weren't going to give to
our children; we wanted something safer than that.
We called upon the National Institute of Allergy and
Infectious Disease to move forward with that. And, in fact, it
has been a tremendous investment, that has been brought forth
with congressional support and fervor, because the Congress was
very worried about this disease. The community has responded by
trying to perform the needed research, and that has led to an
expansion.
Mr. Stupak. Mr. Walden.
Mr. Walden. Thank you, Mr. Chairman.
I have the dubious honor of representing the area with the
largest biological attack on U.S. soil. The Bhagwan Shree
Rajneesh set up encampment in southern Wasco County outside the
town of Antelope. They concocted a little mixture that they
then spread in the salad bars in the city and poisoned hundreds
of people. It took the Federal Government more than a year to
admit that it was actually a biological attack, this Salmonella
strain that they spread.
So I take this issue real seriously and realize there is a
threat that if the folks in that encampment could pull it off,
it could happen by a serious terrorist somewhere.
Do you think there is still a pretty good threat against
the country?
Mr. Atlas. We understand that there is a threat of criminal
activity and terrorism and that we need to be vigilant.
From the community's perspective, we need to develop a true
taboo against the use of biological weapons. It is a zero
tolerance--nowhere, no-how, no one--which also suggests that
the community must be your eyes and ears and that we need a
system whereby the community can responsibly report any
suspicious activities that might represent misuse, and that the
community has zero tolerance for a lack of adherence to
biosafety procedures.
Mr. Walden. So, Dr. Atlas, I think that is a very salient
point.
Is there such a system in place where scientists who
observe something they believe to be inappropriate can
effectively communicate that to somebody who can do something
about it, at least check?
Mr. Atlas. I don't think we have an adequate coordinated
system of knowing who to call, other than your local FBI
office, which may not have the ability to adequately understand
the information.
Certainly, the American Society for Microbiology has put
forth and is putting forth every day to our members a code of
ethics that calls upon them to only use the science for the
betterment of humankind and to report to appropriate
authorities any potential misuse of the science.
Mr. Walden. Dr. Kingsbury, I haven't had a chance to
thoroughly go through your report, but did you look at those
issues at the GAO?
Ms. Kingsbury. The issues you are talking about, the
outbreak in Oregon?
Mr. Walden. No. I am sorry. I moved off that into what Dr.
Atlas is suggesting, that there isn't a really good reporting
mechanism for scientists to feed in observances of misuse of
some of these agents.
Ms. Kingsbury. There is really not, in any of the programs
that we see.
Mr. Walden. Did you review that in the course of your
investigation, though, that issue?
Mr. Sharma. We looked at it in context of the Department of
Defense and the Department of Energy, which do have a personnel
reliability program. Even in those highly intrusive programs,
there is no mechanism whereby a coworker can report on his
coworker.
Mr. Walden. Do you make recommendations in your report
about such a system?
Mr. Sharma. We made a recommendation that the Secretary of
HHS and Agriculture--if they decide to implement this as a way
to mitigate the inside risk, that they should consider the cost
and impact of this program.
Now, let me just say within the Department of Defense we
talked to a number of scientists who are working in BSL-3 and
BSL-4 labs and they all unanimously said that a determined
scientist, despite the intrusive nature of the PR people, as
they are called, can easily take the material out. There is
nothing there that can stop a determined scientist.
Mr. Walden. So, in other words, there is nothing we can do
to stop a mad scientist from taking the pathogens out and doing
whatever they want to do with them.
Ms. Kingsbury. We already have laws against doing what some
people might do to harm people.
Mr. Walden. Is there a way to do some presecurity
clearance? I don't want to bog down our whole research system.
Ms. Kingsbury. That is what a personnel--a more stringent
personnel security program would probably require. There is a
cost to that. And the whole basis for our concern about the
growth in the number of laboratories is grounded in the fact
that this Federal Government needs to make some hard choices
about costs.
So you can't do that if you are not doing an evaluation of
what things cost and what you are getting from them.
Mr. Walden. And what the risk is.
Ms. Kingsbury. What the risk is, exactly right.
Mr. Walden. We have heard these four incidents and then the
latest, which was actually the Level 2 lab. How many are there?
If you had 1,600 labs--by the way, that doesn't mean 1,600
separate buildings; is that right? As the chairman said, you
have got multiple labs that are in the same center.
Ms. Kingsbury. Can be, but nobody knows how many there are.
Mr. Walden. Does each agency that has labs know how many
labs that they have? Does HHS know how many labs they have?
Does USDA know how many labs they have?
Ms. Kingsbury. The Federal agencies probably do, yes.
Mr. Walden. So somebody knows, silo by silo, agency by
agency, what labs they have?
Ms. Kingsbury. Which ones have been built by the Federal
Government. But these labs are being built by the State
government, they are being built in the private sector, they
are being built by other than the Federal----
Mr. Walden. If I wanted to go out and build a lab and deal
with these agents at Level 3 or 4, can I do that and not tell
anybody?
Ms. Kingsbury. You can't do it and not tell anybody if they
are on the select agent list.
If they are not on the select agent list, then, yes, you
can. All you have to do is get the money for it.
Mr. Walden. And the select agent list is the one that has
the worst of the worst?
Ms. Kingsbury. Most of the worst of the worst.
Mr. Walden. So that raises the issue, should other agents
be put--who gathers up the select agent list?
Ms. Kingsbury. CDC and the Department of Agriculture,
separately for human pathogens and plant and animal pathogens.
Mr. Walden. All right. You said you thought there were too
many labs at 1,600.
Ms. Kingsbury. We said we don't know whether there are too
many, whether there are too few.
Mr. Walden. I thought you said earlier today that you
thought there were too many.
Ms. Kingsbury. I very carefully said, we need to find out
how many are really out there, we need to look at the national
strategy, the current consideration of the biothreat and decide
whether that amount of capacity is less than we need, the same
of what we need--and so we have got it right by guess--or more
than what we need.
And if I were a betting person, my bet would be on more.
Mr. Walden. We have more labs than we need?
Ms. Kingsbury. There is a very, very large capacity to do
this kind of work, and without looking again at the threat,
without looking again at how much we really need, in
comparison, at least at the Federal level, to the other needs
facing our Nation today, I think that is a very important
analysis that should be done.
Mr. Walden. But you haven't done that analysis, so that
would be a personal opinion?
Ms. Kingsbury. It is our view that the analysis should be
done. It would not be appropriate for GAO to do it. GAO would
argue that the executive branch has the responsibility for
doing that.
Mr. Walden. And would it be helpful--I assume when these
other reports come out or are finalized by the Obama
administration that you all will take a look at those before
going forward.
Ms. Kingsbury. We will be very interested in looking at
them in the context of some of our other ongoing work. Or if
this subcommittee would like to ask us to do that, we can do
that as well.
Mr. Walden. Wouldn't that round out your report?
Ms. Kingsbury. It might.
Mr. Walden. Thank you. My time has expired.
Mr. Stupak. Mr. Green for questions.
Mr. Green. Thank you, Mr. Chairman.
You and the ranking member asked some of the best
questions. And why don't we have some type of mandatory
certification, whether it is filled by State government or
private entity.
Dr. Atlas, is there any reason you can think of of not
having some registration between these Federal agencies that
oversee it?
Mr. Atlas. I think the only issue from the community is the
question of overregulation. A registration per se without
requirements for performance doesn't get you very far. When you
begin to impose inspections and other performance requirements,
the question is, are they really helping you in terms of
improving safety or security or are they paperwork.
Mr. Green. When you are talking about BSL-3 or BSL-4 lab
regulation and inspected on an annual basis, it doesn't seem
like--and some standards, I would hope, whether they are State-
owned or privately owned, they would have their own safety
standards, it would be common between these companies and State
governments or even the Federal government.
Mr. Atlas. For the most part, I think that is true, and
certainly when we are dealing with the select agents, there are
regular and sometimes multiple inspections by different
agencies.
And for those labs, going back to the earlier question, the
government knows exactly where they are, they know which agents
are there, they know their performance requirements, and they
have copies of all of their manuals of operating procedures.
It is the other naturally recurring agents, whether it be
the current influenza virus that is circulating or SARS when it
broke out, that that was put into a laboratory, where we are
not seeing the same oversight that we see for the select
agents.
Mr. Green. And I agree with you we don't want to stop the
research because I agree with H1N1, that we couldn't be on
where we are at now in the development without lots of
different folks looking at it and different not only government
agencies but nongovernment. But it just seems like between the
Department of Agriculture and NIH or FDA we could have a
Memorandum of Understanding so they would have the same
standards and they would split up the requirements, that they
would have common standards to the benefit of the labs.
Mr. Atlas. To some extent there is certainly coordination
between agriculture and HHS on many of these issues. I think
what the ASM has proposed is that we have a full study of cost
and benefit of moving towards standards, figure out what those
standards would be and then see whether or not it is
appropriate to institute an accreditation system across all the
high containment labs. We are not ready to sort of jump off the
bridge and say ``mandate that'' until we understand the cost
benefits and what we would be looking at, but we think that
that sort of study and examination ought to be done and done
now.
We have made that recommendation before both the Executive
Order Working Group and the Trans Federal Task Force. I don't
know whether or not that has been accepted and whether that
will move forward.
Mr. Green. Dr. Kingsbury, in your testimony you talked
about the decreasing budgets particularly for the agencies. And
yet with a proliferation of the number of BSL3 labs, the
doubling the BSL4, and nearly increase of 1,400, are we not
seeing these agencies respond because they don't have the funds
to develop this coordinated effort?
Ms. Kingsbury. That is part of the issue I suspect. It is
also behind our concern about if you are going to have this
many laboratories you really need to think ahead about how you
are going to fund them from a maintenance perspective. So it is
all tied up in the same thing. I think what agency officials
that we met with told us about this issue of interagency
coordination is no one agency currently believes that it has
the authority to direct another agency to do anything about the
labs it funds. And so each agency may know what they have, but
nobody, and one of the reasons we directed some of our
recommendations to the National Security Council and the
National Intelligence Council is that it would take something
at that level, at the White House level, to figure out what
needs to be done to give a single entity sufficient authority
to do the kinds of things we are talking about here.
Mr. Green. So you don't think you would need legislation,
it could actually be done under current regulations?
Ms. Kingsbury. I am not sure whether we need legislation or
not frankly. I am looking forward to these reports that we have
been talking about because we have some expectation that that
issue maybe taken up.
Mr. Green. Thank you, Mr. Chairman. I am all out of time.
Mr. Stupak. Mr. Gingrey, questions, please.
Mr. Gingrey. Mr. Chairman, thank you and, Mr. Chairman, I
apologize to our witnesses, Dr. Kingsbury and Dr. Atlas, for
being late. I had a press conference, but I am glad I didn't
miss this. I know it is a very important hearing, Mr. Chairman,
and I appreciate your holding it.
Dr. Atlas, let me ask you this. You reference the need for
careful consideration of recommendations regarding new
requirements for biosafety and biosecurity in laboratories in
light of the very careful equilibrium that currently exists to
oversee and manage research activities, and you also state that
excessive policy changes could upset the delicate balance.
Dr. Atlas, what could be the impact on our scientific
community if we were to pursue a policy, certain changes that
did upset that delicate balance, what would be the consequences
of that?
Mr. Atlas. The consequence is that the Nation would be less
safe. If we don't carry out the research that we need on
infectious disease, if we have scientists abandoning work on
pathogens to work in other areas, then, in fact, we are not
going to have the vaccines we need. We are not going to have
the therapeutic drugs, and we are going to see that we cannot
contain outbreaks of disease. If you went to an extreme, you
just wouldn't have a vaccine for H1N1 coming in a few weeks.
So we need to ensure that we are not having a burden on the
community that causes scientists to say, I am going to go work
elsewhere. That is the call for careful evaluation. It is not a
call for no regulation, no oversight. Quite the opposite. It is
a call for carefully considered, appropriate regulation and
oversight. What one doesn't want is a knee-jerk reaction that
says, oh, my God, we have to do something, let's do it today
without thinking through the consequences, but once you have
broad input from the community with leadership of HHS and USDA,
the ASM thinks we can move ahead and continuously improving the
system and that we need to have that done on a regular basis.
It is not a one-time affair.
Mr. Gingrey. Dr. Atlas, thank you, and I appreciate it. I
want to use my remaining time to also ask Dr. Kingsbury a very
important question as well. To my knowledge, Dr. Kingsbury, two
government reports were recently completed that deal with the
subject of strengthening oversight of biosecurity in the United
States, one completed by the Executive Working Group and, in
fact, sent to the President in July, the other I understand
just completed by the Trans-Federal Task Force on Optimizing
Biosafety and Biocontainment Oversight, which is chaired by HHS
and USDA, as you know. Given the subject matter of these yet to
be released reports, I am wondering whether you think this
hearing might have been better served or could be better served
with these reports available for us to consider?
Ms. Kingsbury. ``Might'' may be a good word, but we don't
substitute our judgment for the committee chairmen about when
they want to have a hearing.
Mr. Gingrey. I am not really asking you to second guess the
chairman. I am just asking you your opinion in regard to these
reports.
Ms. Kingsbury. I am here to report to our work, sir, not my
personal opinions.
Mr. Gingrey. Thank you very much. I will ask Dr. Atlas the
same question in my remaining time.
Mr. Atlas. I think the answer is we would be happy to meet
with your staff or your committee again once those reports are
issued to continue our dialogue.
Ms. Kingsbury. We just talked recently, a few minutes ago,
about the possibility of the chairman asking us to look at
those reports and give him our views.
Mr. Gingrey. Certainly. Well, again let me just say I think
it is important that we, Mr. Chairman, maybe I would suggest
that you strongly consider having a hearing, another hearing
once those reports are released in light of this hearing today,
and with that, Mr. Chairman, I will yield back my time, and I
thank both witnesses for their response.
Mr. Stupak. Thanks, Mr. Gingrey. Mr. Burgess for questions,
please.
Mr. Burgess. Thank you, Mr. Chairman. I apologize for being
late.
Mr. Chairman, I guess the question may have already been
asked to you and we can discuss this afterwards, I don't
understand why we don't have someone from the Department of
Homeland Security here on the panel.
Now the Department of Homeland Security recently selected
Kansas as the site for the new foot and mouth disease facility.
Are level 4 labs, and I will ask this to both of our witnesses,
are level 4 labs appropriate for inland research diseases such
as foot and mouth disease? Wouldn't it have been better to hold
the hearing before we held the vote? You don't have to answer
the second part.
But is an inland facility appropriate for this monitoring
and research on a very contagious illness? Because 40 percent,
45 percent of the Nation's cattle traverse the State of Kansas
at some time in their lives.
Ms. Kingsbury. It was a very large number in a recent
resolution discussion in the House about that. We issued a
report recently that looked at the question not asking our
opinion per se about whether it is appropriate to put a
facility on the mainland as opposed to an island, but rather
looking at the evidence that the Department of Homeland
Security put forth in making that decision and concluding, as
they clearly did conclude, that there is no risk of doing foot
and mouth disease research on the mainland, or essentially no
risk. Then the facility that is being talked about is going to
do more than foot and mouth disease, but the thing that has
continued to concern us is that, A, foot and mouth disease is
the most infectious virus on the planet, and, B, the research
on that requires research with a lot of very large animals. And
so the whole design and operational structure of that facility
on the mainland where cows are in the neighborhood has not yet
been laid out in a way that we would conclude, and our experts
would conclude, has demonstrated that it is safe to do foot and
mouth disease research in particular in that facility.
Mr. Burgess. When do you expect that we will have the
availability of that information, or will this just be
information that is gained along the way after the facility
opens?
Ms. Kingsbury. Well, the Kansas State University folks and
the people who are putting that facility where they have
selected to put it in the Department of Homeland Security will
have to develop a design for the building, they will have to
develop operating protocols, they will have to develop all of
the things about how you would contain an outbreak if it did
get out, and so forth. And those are the things that aren't
developed yet but hopefully would be developed before any of
that virus actually enters the building.
Mr. Burgess. ``Hopefully'' may be a good word there as
well.
Dr. Atlas, do you have anything to add to that.
Mr. Atlas. I think that one can design and operate a BSL4
agricultural facility safely. As to the exact location, the
risks, I will leave that to the DHS and the community. But
clearly the Kansas community wanted that facility there for
that, in that location. It was not a matter of their saying,
the Federal Government is putting something where we don't want
it.
It was also clear that Plum Island either needed massive
renovation or the facility needed to be relocated to a location
where the scientific community would join in the critical
research that is needed as was pointed out not only on foot and
mouth disease but on many of the other agriculturally relevant
agents that would be worked on there.
So something had to be done to provide an adequate
facility, and my contention is that you can build an adequate
facility and locate it in an appropriate place.
Mr. Burgess. An observation from Galveston a year ago of
course Hurricane Ike ravaged the island as even today had some
difficulty recovering but a brand new biodefense laboratory
that at that point was not occupied but certainly came through
what I would regard as a very serious stress test came through
with pretty much flying colors. These labs are expensive to
build. They are expensive to maintain. Is the funding level for
both the building and the maintenance, are those funding levels
adequate? Is that something that is receiving the appropriate
amount of scrutiny and the appropriate amount of monitoring?
Ms. Kingsbury. We didn't directly look at what the funding
level would be. There is an initial funding being discussed in
current appropriations discussion, but what the entire facility
will end up costing I think I would argue we don't know yet.
Mr. Burgess. What about the maintenance dollars?
Ms. Kingsbury. We are very worried about the maintenance
issue. The outbreak of foot and mouth disease in Great Britain
was directly tieable to a maintenance issue in a relatively
older facility. So as these facilities age, it will be very
important to continue to pay attention to how much maintenance
is going to be necessary and to provide the support for doing
that.
Mr. Burgess. And the fact that that has to go through our
annual appropriations process makes for some additional
uncertainty.
Ms. Kingsbury. In a time of very high budget constraints.
Mr. Burgess. Sure. And again, Mr. Chairman, I think that is
something this committee needs to pay particular attention to
as we go through the next several years because as we have seen
from our appropriators before, and I understand the difference
between an authorizer and an appropriator. If you go up to the
NIH, all the buildings were named for an appropriator, there is
none named for an authorizer. I do understand the difference
between an authorizer and appropriator, but it is certainly our
job to keep up the oversight on that and when, as correctly Dr.
Kingsbury pointed out, as those budgetary dollars are squeezed,
we need to make certain that areas where legitimate functions
of government are not compromised.
I will yield back the balance of my time. Thank you.
Mr. Stupak. Thank you, Mr. Burgess.
A couple of questions if I may. On page 32 you have table
Number 10 which shows the 12 Federal agencies that have the
BSL3 and BSL4 labs, but none of them outside their own agency
know how many labs that really exist BSL3 or BSL4, correct?
Ms. Kingsbury. That is correct.
Mr. Stupak. You indicated in your testimony, how many of
these 12 agencies, I think people would be surprised even the
Department of the Interior has these labs, how many of them
have personnel reliability measurements or protections of the
12 agencies? The Department of Defense you said, does anybody
else?
Ms. Kingsbury. We don't think so. Do we?
Mr. Sharma. Department of Energy.
Mr. Stupak. Because of nuclear labs?
Mr. Sharma. Within the last year they have begun to
implement a personnel reliability program.
Mr. Stupak. Just last year?
Mr. Sharma. Yes.
Mr. Stupak. So of the 12 agencies, the only robust one
would be Department of Defense, Energy is starting, so we have
10 more without any kind of measurement. OK.
Dr. Atlas, do you think academic and private institutions,
do you think they should be registered labs level 4 and level
3? Do you think they should be registered with the government?
Mr. Atlas. And I think the question is what comes with the
registration? If you just mean someone should send you a note
that says we have a laboratory and it doesn't bring anything
else about, I don't see much value. But there is also very
little burden, so you are not going to get resistance to that.
I think the Census, if you are going to register the labs you
ought to be asking additional questions, and that is where the
devil will be in the details about what it means to register
and potentially be accredited at the end of the day. So I do
see a value in a system that ensures increased biosafety, that
reassures this committee and the public at large that what is
going on in the laboratories is being appropriately done.
Mr. Stupak. We don't know what is going on in laboratories
unless they tell us, right? And if you are one of these select
agents, you are level 3 or you are level 4, so why would there
be a reluctance to register with the government the labs?
Mr. Atlas. I think first of all for the select agents, they
are registered. Everybody has to go through a clearance
process. The government knows exactly where those laboratories
are and everything that is going on in those laboratories. If
you talk about laboratories which might be isolating a new and
emerging infectious disease organism, there are questions about
how quickly and who you would tell and what you are doing
particularly if you in the private sector.
Mr. Stupak. Let's say I am at a level 3 lab and I am not
doing a non-select agency. Shouldn't I still register with the
government? One of the questions that has been going around
here this morning is how many labs do we need. If we have 2,600
level 3 labs do we need 2,600?
Mr. Atlas. I think it would go back to the question how
many of these are coming from government funding? That is how
much is the government investing versus someone sees an
opportunity to develop a vaccine, is willing to invest in that
vaccine or therapeutic drug development of which we have a real
problem getting people to invest, but if companies see that and
they build a laboratory to safely perform the work to develop a
new vaccine against influenza virus, they ought to be able to
do that I would argue, that that is part of the
entrepreneurship of this country. Now should they have to do it
safely? Absolutely.
Mr. Stupak. Sure, but one of the criticisms has been we
have thrown a lot of money at this issue since 2002. If there
is a lot of BSL3 labs out there that could do the work, why
would the government build more BSL3 labs because we don't know
if they are going to exist if we are not registered. I guess
that is the part I am trying to get at.
Mr. Atlas. I am not convinced that the government is
spending a lot on building new laboratories. That was not as I
saw it part of the GAO report was actually the dollars going
into the labs. It was charts that showed an increase in the
number of registered laboratories which may represent academic
and private sector as well as the public sector.
Mr. Stupak. And we don't know, we don't know how many there
are. Even you point out in your testimony that the real expense
is not just building but the maintaining because of the high
level of sophistication you need to maintain a level 3 or level
4.
Mr. Atlas. I think going back to the earlier question, that
is where the ASM would also register our concern, is that we
have to be vigilant about ensuring maintenance.
Mr. Stupak. You make a number of recommendations about
seven I heard here today and in the letter you sent in 2007 you
had a number of them, and a lot of them probably would not
require Federal rules or laws such as increased training or
reporting of incidents but has ASM membership, have you taken
it upon yourself to do this without government regulation or
government lead here and reporting incidents and doing
training, you mentioned training? Why doesn't the organization
do it instead of having government mandates?
Mr. Atlas. I think we look to the CDC and NIH to impact,
take the leadership role in guiding the community in this
regard. They are the primary authors along with USDA of the
BMBL, and the ASM is seeking increased input into that process.
But in terms of developing a responsible culture of reporting
incidents, that I think needs to be within a government
function.
Mr. Stupak. I am just a little surprised. You are a
scientist. I would think you would want to take the lead here
in the development without government intervention or telling
you how do it.
Mr. Atlas. Where ASM comes from would be working with the
government to in fact see that a system is implemented, not
trying to undermine or circumvent what properly would be a role
of public health.
Mr. Stupak. Mr. Walden.
Mr. Walden. Thank you, Mr. Chairman. Dr. Atlas, I sure
appreciate your testimony and comments today. I especially when
you said that you wouldn't necessarily want the government
deciding somebody couldn't open the lab to go figure out the
new and latest vaccine, I don't want a government complete
takeover of this whole process. What I want is to make sure
those labs are safe and secure. And I think it makes sense that
we kind of know what is out there, where they are, and I
appreciate your testimony too and you talk about just sending
in a note saying I am a lab and I am here doesn't really
accomplish the goals of safety and security. And so I
appreciate what you have had to say today.
You also had some really I thought good recommendations
that you shared with us and I understand also shared with the
Trans-Federal Task Force and the Executive Working Group.
How were those recommendations received by those two
organizations?
Mr. Atlas. Well, we are waiting to see the report which we
have not seen. They certainly had broad input not only from ASM
but many other organizations shared viewpoints with both of
those groups. They held public hearings. We attended those.
There was broad input, and now we, like you, wait for the
outcomes of that.
Mr. Walden. And I appreciate that and we look forward to
their response. My understanding is there are 242 entities
doing this type of research that are registered, which then
among those entities constitute the 1,362 laboratories. So in a
given university setting we can be sending Federal tax dollars
in to do this research toward H1N1 vaccine or toward anthrax
vaccine or whatever we have decided as priorities, that goes
into those 242 entities and within wherever they do their
research they are multiple lab, right?
Mr. Atlas. Yes. And how they decide to define a lab which
may be that the animal facility may be one laboratory and then
the room where you actually do research outside of the animals
could be a second lab. One of the issues pointed out in the GAO
report is that we do not have a standard definition for what
constitutes a laboratory. We do have a definition of what an
entity is that has to report that they have a select agent, but
it has to be a contiguous property.
Mr. Walden. So let me switch gears for a second. If you
were the National Security Council and you were advising the
President, who would you pick as the lead agency to oversee
this national lab network?
Mr. Atlas. I would see it from a safety perspective and a
public health perspective and in turn to HHS, so the ASM as
consistently sought the leadership of HHS and USDA and not
supported in prior testimony a DHS oversight of that because we
have seen it as a broad public health issue which then does
combat pathogens which potentially are misused, but we are
looking at the broad emergence of infectious diseases.
Mr. Stupak. And that would also bring in CDC and their
experts into that process.
Mr. Atlas. Certainly CDS, NIH within the HHS context is
there. Now ASM did support within the oversight system the
involvement of the Department of Justice and the FBI clearance
process for who could enter select agent labs, it wasn't just
saying put public health in charge where there are security
concerns, but it did say if at the end of the day we are really
concerned with protecting public health and animal health then
the agencies that have experience in those areas ought to be
the lead agencies.
Mr. Walden. Dr. Kingsbury said there are long-term
maintenance issues and they are quite concerned about them.
Can you, representing those working in these labs, can you
talk to us briefly, I know I have a minute left, in terms of
those maintenance issues that are out there?
Mr. Atlas. What we what we saw in the foot and mouth
incident in England does raise the issue of maintenance, and
certainly what we see in the academic community is you get the
money up front for something and they will let the facilities
run down, you never see them in any university I have been
associated with, to have an adequate maintenance budget. So you
keep deferring your maintenance. And in these facilities you
can't afford to do that. There really does need to be adequacy
and oversight of maintenance.
Mr. Walden. Thank you. I appreciate your testimony, both of
you, today. Thank you, Mr. Chairman.
Mr. Stupak. Mr. Gingrey, questions?
Mr. Gingrey. No, Mr. Chairman.
Mr. Stupak. Mr. Burgess, any follow-up?
Mr. Burgess. Yes, Mr. Chairman, if I could just ask a
general question. I guess Dr. Kingsbury, but Dr. Atlas, please
feel free to weigh in as well. With regards to Plum Island, do
we have a ballpark estimate as to what it would cost to do
those upgrades that you alluded to that might be quite costly?
Dr. Kingsbury. First of all, we would have to recognize
that Plum Island has done already spent a lot of money
upgrading their current facility. And when they made an
application, if you will, to be considered in this recent
decision process, they identified another part of their island
where they could build the kind of facility that would need to
be built to do the broader range of research. That is
relatively costly compared to exactly the same building on the
mainland because all the materials have to be shipped onto the
island. So the DHS has always made that point as one of the
reasons that they don't find the Plum Island solution
attractive.
But you could build almost the same kind of building there.
It is just a matter of whether the additional cost is
prohibitive. There have been expressed concerns about
recruiting scientists to work on an island. It is a fairly
pleasant 45-minute ferry trip to get there. We have done it. It
hasn't seemed to be a big deal with respect to recruiting
enough scientists. That remains to be seen if we were going to
try to do that. But we recognize in our report that Plum Island
has already invested a great deal in upgrading their current
facility and for a 50-year-old building, it is in pretty good
shape.
Mr. Burgess. So in a dollar-to-dollar comparison, Plum
Island versus an inland facility the cost is about the same but
there are logistic issues that would make the building easier?
Ms. Kingsbury. It would cost a lot of money.
Mr. Burgess. But there are also security issues that will
cost money at an inland facility that are perhaps not
calculated in this equation?
Ms. Kingsbury. That is correct, and DHS did not take that
cost and those designs into account in making their decision.
Mr. Burgess. Just going back to Mr. Walden's point for a
moment about the HHS ultimate being the one who has the
supervisory role, does there need to be an entity that oversees
HHS on that because of the security concerns that exist that
Mr. Walden was bringing up? I hesitate to use the word
``czar,'' but does there need to be a bio czar that is looking
at this from more of a security standpoint?
Mr. Walden. No more czars.
Ms. Kingsbury. We focused most of our work on the biosafety
side of these issues, not the biosecurity side. Some of our
colleagues testified this morning on a physical security
examination that they did of several of the BSL4 laboratories.
The problem there is what is the actual threat and what is the
experience that has happened over the past years of anybody
breaking into a lab, and we are not aware of any incidents.
That would suggest that physical security upgrades may or may
not be needed.
Mr. Burgess. On visiting the new lab in Galveston, I was
impressed with the security. Always of course you do have to
ask yourself what is the threat from an internal disruption or
an Earth, someone who is working in the facility that decides
to take a different approach to their employment. So what do we
have available to help us with that?
Ms. Kingsbury. Well, that is what a personnel reliability
program would help with, but again even in that case there has
been only one alleged case of an insider doing illegal things
in the way that we all worry about. And so I think to study it
and to think about how you are going to invest the taxpayers'
money, looking at the question from a somewhat broader context
really is important, including how much of this research
capacity do we need? We have built a lot of it as we have been
talking about through this whole hearing there is a lot of
young scientists out there getting very interested in these
kinds of jobs. What happens if the funding for supporting that
research dries up? Where are those scientists going to go with
the skills that could make them insider threats if they were to
get upset?
So those are the kinds of issues that we think need to be
studied in evaluating the national need here in comparison to
other national needs.
Mr. Burgess. Thank you. Thank you, Dr. Kingsbury.
Mr. Chairman, I will yield back the balance of my time.
Mr. Stupak. Thank you. Let me just ask a question here. Mr.
Burgess and Mr. Gingrey brought up Plum Island. Both you and
Dr. Sharma did the report, the GAO report on moving the foot
and mouth disease off Plum Island to the mainland, right?
Ms. Kingsbury. That is correct.
Mr. Stupak. And if I remember correctly GAO did not
conclude that the DHS study showed that foot and mouth disease
can be done safely on the mainland?
Ms. Kingsbury. That is correct. I am not going to take a
case, Dr. Atlas's belief that it could be done, but the
evidence that we were given in the environmental impact
statements, and so forth, do not demonstrate that point.
Mr. Stupak. Very good. Any other questions?
Mr. Burgess. Mr. Chairman, I would just ask unanimous
consent that my opening statement can be inserted in the
record.
Mr. Stupak. We have done it earlier but fine. It will be
entered.
I want to thank the witnesses for their testimony.
I want to be sure that GAO continues its oversight of the
domestic and international lab proliferation. Dr. Kingsbury,
your team has done good work, and I would ask that the GAO
review the two reports which will hopefully be out in the next
few weeks. Around here they always say a few weeks always means
a few months, the one being Trans-Federal Task Force for
Optimizing Biosafety and Biocontainment Oversight and the
Executive Order Working Group on Strengthening the Biosecurity
of the United States. This subcommittee would be interested in
the proposals set forth in these two reports. We are asking
that GAO assess any recommendations set forth in those reports
and report back to us with your assessment. Will you do that
for us?
Ms. Kingsbury. Yes, sir.
Mr. Stupak. Thank you, and that concludes our hearing.
Members will have----
Mr. Walden. Can I ask while we are together here just two
questions? One we had asked you and Chairman Waxman about the
opportunity to do an oversight hearing and invite up the auto
czar from the White House. We haven't gotten a response to that
letter from the end of June.
Mr. Stupak. There have been a number of conversations going
back and forth. I think the 28th is the end of the program, and
speaking with some of the interest groups they said wait until
we get the program done and we will see what went wrong and
what went right with it. So there is still some interest in
doing one. Yes.
Mr. Walden. And the other issue involves insurance. I know
that you and Mr. Waxman sent a letter to 52 heads of insurance
companies asking for their financial information. I am
wondering if we are any closer in knowing when we might have a
hearing involving that issue.
Mr. Stupak. We are kicking around some calendar dates. As
you know, the majority leader has just given us some dates
back, if you will, some Fridays, there has been some
discussions if we are here on Thursday can we do a Friday
morning hearing to get some of them done. We would like to have
some hearings, not just on the insurance industry but also what
is the effect on small businesses and the cost of health
insurance. I look forward to spending the next month and doing
some hearings on insurance. I know we all have an interest in
that.
Mr. Walden. So within the next 30 days we may have multiple
hearings on these issues?
Mr. Stupak. We would like to assess how does the
information come in and where we are going with it.
Mr. Walden. Will we be looking at other contributors to
that cost equation other than just the executive comp on
insurance companies?
Mr. Stupak. What is the cost on small businesses, if you
have some examples, we would be happy to hear it. I just
received one yesterday, about 30 percent increase for a small
business.
Mr. Walden. I was a small business owner for 22 years. I
never throw the dart high enough on the budget planning board.
Mr. Stupak. Is the 33 percent increase going into health
care or is it going into other objects? That is what we want to
know.
Mr. Walden. Thank you very much.
Mr. Stupak. Thank you.
Mr. Burgess. Mr. Chairman, along that same line, if I could
ask you or the ranking member, has that information that was
gathered from those companies, has that been, has the majority
staff shared that with the minority staff?
Mr. Stupak. Everything we have, we haven't even received
everything from every request we have made but the information
wee received, minority class--staff--and they are class, has
had access to it, and then it will continue, continue to have
access to it.
OK, committee will provide and members have 10 days to
submit additional questions for the record. So if there are any
more questions we will get them to the appropriate party. That
concludes our hearing. The meeting of the subcommittee is
adjourned.
[Whereupon, at 12:30 p.m., the subcommittee was adjourned.]