[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]




                               BEFORE THE


                                 OF THE

                        HOUSE OF REPRESENTATIVES


                             FIRST SESSION


                           SEPTEMBER 22, 2009


                           Serial No. 111-66

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                    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
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
BARON P. HILL, Indiana
DORIS O. MATSUI, California
JERRY McNERNEY, California
PETER WELCH, Vermont    

              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
MIKE ROSS, Arkansas
JOHN D. DINGELL, Michigan (ex 

                             C O N T E N T S

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


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



                      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.


    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 
    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 
    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.


    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 
    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 
    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 
    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 
    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:]

    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 
    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.


    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 
    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:]


    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.


    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.


    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 
    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 
    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 
    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:]

    Mr. Stupak. Dr. Atlas, opening statement, please, sir.


    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 
    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 
    Thank you, Mr. Chairman, and I look forward to your 
    [The prepared statement of Mr. Atlas follows:]

    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 
    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, 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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, 
    Mr. Burgess. Thank you, Mr. Chairman. I apologize for being 
    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 
    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 
    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 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 
    Mr. Burgess. And the fact that that has to go through our 
annual appropriations process makes for some additional 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    Mr. Stupak. We have done it earlier but fine. It will be 
    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 
    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 
    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 
    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 
    [Whereupon, at 12:30 p.m., the subcommittee was adjourned.]