[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]



      GERMS, VIRUSES, AND SECRETS: THE SILENT PROLIFERATION OF BIO-
                          LABORATORIES IN THE
                              UNITED STATES

=======================================================================

                                HEARING

                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             FIRST SESSION

                               __________

                            OCTOBER 4, 2007

                               __________

                           Serial No. 110-70


      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov

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                    COMMITTEE ON ENERGY AND COMMERCE

                  JOHN D. DINGELL, Michigan, Chairman

HENRY A. WAXMAN, California          JOE BARTON, Texas
EDWARD J. MARKEY, Massachusetts          Ranking Member
RICK BOUCHER, Virginia               RALPH M. HALL, Texas
EDOLPHUS TOWNS, New York             J. DENNIS HASTERT, Illinois
FRANK PALLONE, Jr., New Jersey       FRED UPTON, Michigan
BART GORDON, Tennessee               CLIFF STEARNS, Florida
BOBBY L. RUSH, Illinois              NATHAN DEAL, Georgia
ANNA G. ESHOO, California            ED WHITFIELD, Kentucky
BART STUPAK, Michigan                BARBARA CUBIN, Wyoming
ELIOT L. ENGEL, New York             JOHN SHIMKUS, Illinois
ALBERT R. WYNN, Maryland             HEATHER WILSON, New Mexico
GENE GREEN, Texas                    JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado              CHARLES W. ``CHIP'' PICKERING, 
    Vice Chairman                    Mississippi
LOIS CAPPS, California               VITO FOSSELLA, New York
MICHAEL F. DOYLE, Pennsylvania       STEVE BUYER, Indiana
JANE HARMAN, California              GEORGE RADANOVICH, California
TOM ALLEN, Maine                     JOSEPH R. PITTS, Pennsylvania
JAN SCHAKOWSKY, Illinois             MARY BONO, California
HILDA L. SOLIS, California           GREG WALDEN, Oregon
CHARLES A. GONZALEZ, Texas           LEE TERRY, Nebraska
JAY INSLEE, Washington               MIKE FERGUSON, New Jersey
TAMMY BALDWIN, Wisconsin             MIKE ROGERS, Michigan
MIKE ROSS, Arkansas                  SUE WILKINS MYRICK, North Carolina
DARLENE HOOLEY, Oregon               JOHN SULLIVAN, Oklahoma
ANTHONY D. WEINER, New York          TIM MURPHY, Pennsylvania
JIM MATHESON, Utah                   MICHAEL C. BURGESS, Texas
G.K. BUTTERFIELD, North Carolina     MARSHA BLACKBURN, Tennessee
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana

                                 ______

                           Professional Staff

                 Dennis B. Fitzgibbons, Chief of Staff

                   Gregg A. Rothschild, Chief Counsel

                      Sharon E. Davis, Chief Clerk

               David L. Cavicke, Minority Staff Director

                                  (ii)


















              Subcommittee on Oversight and Investigations

                    BART STUPAK, Michigan, Chairman
DIANA DeGETTE, Colorado              ED WHITFIELD, Kentucky
CHARLIE MELANCON, Louisiana              Ranking Member
    Vice Chairman                    GREG WALDEN, Oregon
HENRY A. WAXMAN, California          MIKE FERGUSON, New Jersey
GENE GREEN, Texas                    TIM MURPHY, Pennsylvania
MIKE DOYLE, Pennsylvania             MICHAEL C. BURGESS, Texas
JAN SCHAKOWSKY, Illinois             MARSHA BLACKBURN, Tennessee
JAY INSLEE, Washington               JOE BARTON, Texas (ex officio)
JOHN D. DINGELL, Michigan (ex 
    officio)













                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Bart Stupak, a Representative in Congress from the State of 
  Michigan, opening statement....................................     1
Hon. Joe Barton, a Representative in Congress from the State of 
  Texas, opening statement.......................................     3
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................     5
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................     6
Hon. Marsha Blackburn, a Representative in Congress from the 
  State of Tennessee, opening statement..........................     8
Hon. John D. Dingell, a Representative in Congress from the State 
  of Michigan, prepared statement................................    49
Hon. Ed Whitfield, a Representative in Congress from the 
  Commonwealth of Kentucky, prepared statement...................    50

                               Witnesses

Keith Rhodes, Chief Technologist, Center for Technology and 
  Engineering, U.S. Government Accountability Office.............    10
    Prepared statement...........................................    13
Richard Besser, M.D., Director, Coordinating Office for 
  Terrorism, Preparedness and Emergency Response, Centers for 
  Disease Control and Prevention.................................    67
    Prepared statement...........................................    69
Hugh Auchincloss, M.D., Deputy Director, National Institute of 
  Allergy and Infectious Diseases, National Institutes of Health, 
  U.S. Department of Health and Human Services...................    74
    Prepared statement...........................................    75
Eddie J. Davis, interim president, Texas A&M University..........    91
    Prepared statement...........................................    92
Gigi Kwik Gronvall, senior associate, assistant professor of 
  medicine, Center for Biodiversity, University of Pittsburgh 
  Medical Center.................................................   105
    Prepared statement...........................................   106
Alan Pearson, director, Biological and Chemical Weapons Control 
  Program, Center for Arms Control and Non-Proliferation.........   110
    Prepared statement...........................................   112
Edward Hammond, the Sunshine Project.............................   143
    Prepared statement...........................................   145

                           Submitted Material

``High-Containment Biodefense Research Laboratories: Meeting 
  Report and Center Recommendations'' Gigi Kwik Gronvall, et al..   174
Subcommittee hearing exhibts.....................................   185


















 
     GERMS, VIRUSES, AND SECRETS: THE SILENT PROLIFERATION OF BIO-
                        LABORATORIES IN THE UNITED STATES

                              ----------                              


                       THURSDAY, OCTOBER 4, 2007

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:05 a.m., in 
room 2123 of the Rayburn House Office Building, Hon. Bart 
Stupak (chairman) presiding.
    Members present: Representatives Stupak, DeGette, Green, 
Inslee, Burgess, Blackburn, and Barton.
    Staff present: John Sopko, John Arlington, Paul Jung, Scott 
Schloegel, Kyle Chapman, Kristen Carpenter, Peter Spencer, and 
Alan Slobodin.

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

    Mr. Stupak. Today we have a hearing on Germs, Viruses, and 
Secrets: The Silent Proliferation of Bio-Laboratories in the 
United States. Each Member will be recognized for 5 minutes for 
an opening statement. I will begin.
    This is the first of what will likely be several hearings 
this committee intends to hold to examine the risk associated 
with the recent proliferation of high-containment biological 
research laboratories. Today's hearing is focused on high-
contaminate bio-laboratories known as BSL-3 and BSL-4 labs in 
the United States. We anticipate a future hearing will examine 
the proliferation of high-containment labs outside of the 
United States. Another hearing will examine the Department of 
Homeland Security's plan to close Plum Island Animal Disease 
Center and build a new $500 million animal research facility 
elsewhere, including a new BSL-4 lab.
    Our hearing today will focus on the risk associated with 
the recent increase of domestic BSL-3 and BSL-4 labs. These 
BSL-3 and 4 labs are the facilities where research is conducted 
on highly infectious viruses and bacteria that can cause injury 
or death. Some of the world's most exotic and most dangerous 
diseases are handled at BSL-3 and 4 labs, including anthrax, 
foot-and-mouth disease and Ebola fever. The accidental or 
deliberate release of some of the biological agents handled at 
these labs could have catastrophic consequences. Yet, as we 
will hear from the Government Accountability Office, GAO, no 
single Government agency has the ultimate responsibility for 
ensuring the safety and securing of these high-containment 
labs. However, GAO states there is a major expansion of the 
number of BSL laboratories is occurring both in United States 
and abroad but the full extent of that expansion is unknown.
    No one in the Federal Government even knows for sure how 
many of these labs there are in the United States, much less 
what research they are doing or whether they are safe and 
secure.
    What we do know is that the Federal Government has been 
funding the proliferation of these labs on an unprecedented 
scale. For the past 5 years, the NIH has spent more than $1 
billion on the construction of new BSL-3 and BSL-4 labs. Given 
the serious risk associated with these labs, we must ask if all 
these new labs are necessary. Has the NIH carefully assessed 
the need for these labs before writing checks to build them? 
Would we be better off expanding existing facilities rather 
than building dozens of new ones? When it comes to BSL-4 labs, 
which are the labs that deal with the most serious diseases for 
which there is no cure, should we significantly limit the 
number of labs so there are fewer chances for an accidental or 
intentional release of these most dangerous substances? Has the 
proliferation of these labs reached the point at which there 
are so many labs doing this research that you actually increase 
the chances of catastrophic release of a deadly disease?
    Apart from the issue of mushroom growth of these labs, 
perhaps the most important question looming over all this is, 
are these labs safe? The most serious accidents so far have 
occurred outside the U.S., including the death of a Russian lab 
worker exposed to Ebola and the SARS infections that sickened 
several people and killed a lab worker in Asia. Here in the 
U.S. for the past 4 years, the CDC has received more than 100 
incident reports from labs handling select agents. However, 
there are indications that the actual number of incidents may 
be much higher.
    It is also alarming to note that more than a third of the 
incident reports are from 2007, which begs the question of why 
has there been such a steep increase in BSL incidents.
    Federal regulations require reports only for incidents 
involving so called select agents, a list of highly dangerous 
pathogens. But other dangerous biological pathogens are not on 
the select agent list, such as hantavirus, SARS and dengue 
fever. It appears that there is no Federal oversight of the 
possession, use or transfer of these dreaded diseases nor is 
there any requirement that the theft, loss or release of these 
agents will be reported to Federal officials.
    Even for select agents which are regulated, there may be a 
significant amount of under-reporting of laboratory mishaps. A 
case of point is Texas A&M University. Texas A&M recently 
reported to the CDC that one of its lab researchers had been 
infected in 2006 with Brucella and that blood tests of three 
other workers indicated two fever exposures. They reported the 
incidents only after one of our witnesses, Ed Hammond, of the 
Sunshine Project exposed the incidents on his Web site. The 
CDC's subsequent investigation of the Texas A&M lab revealed a 
number of serious violations of the select agent rules, 
including lost samples, unapproved experiments, a lack of 
training, safety training and lab workers without FBI 
clearance, which is required for working with select agents. 
Unfortunately, the CDC's August investigation revealed not only 
shortcomings at the Texas A&M University but also shortcomings 
on the part of CDC's own oversight. It turns out that the CDC 
had inspected the very same Texas A&M lab prior to the 
disclosure of these incidents and found only minor problems. 
This may indicate that the periodic lab inspections that CDC 
carries out may not be as thorough as one might hope.
    Other recent incidents indicate additional problems 
presented by labs around the country. Problems at the CDC's own 
lab in Atlanta and recent outbreaks of foot-and-mouth disease 
in the UK linked to a high-containment lab at Pirbright 
illustrate the importance of proper laboratory design, 
construction and maintenance, in addition to workers' safety, 
worker training and security.
    The potential human risk involved in high-containment 
laboratory biological research demand that this subcommittee 
take a closer look at whether these labs are being designed, 
constructed and operated safely. As I said, this is the first 
of several hearings our Oversight and Investigations 
Subcommittee will conduct on germs, viruses, and secrets.
    With that I will yield back.
     I will next turn to Mr. Barton.

   OPENING STATEMENT OF HON. JOE BARTON, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr. Barton. Thank you, Chairman Stupak, for holding this 
hearing. I want to also commend Ranking Member Whitfield, who 
is not yet in attendance, for his efforts.
    To my knowledge, this is the first congressional hearing 
into the safety and security of our Nation's bio-laboratories. 
It is a matter that deserves attention and I believe that it is 
timely to take it up at this point in time.
    Today we mark 6 years ago to the day that the Center for 
Disease Control, the director of the Center for Disease 
Control, learned that lab tests confirmed that a patient dying 
a South Florida hospital was infected with anthrax. As it 
turned out, this was the first evidence in only a few weeks 
after 9/11. Our Nation, including the Nation's Capitol, faced a 
series of bioterrorism attacks using weapons-grade anthrax that 
was delivered through the mail. Consequently, five people died. 
That case, to this day, remains unsolved. In the wake of the 
anthrax attacks, the public and the Congress were astonished to 
learn that the Federal Government did not know how many U.S. 
labs handled anthrax nor could the Federal Government identify 
every laboratory in the country with access to the Ames strain 
of weaponized anthrax that had been used in the attacks. 
Congress responded by passing the Bioterrorism Act in 2002, 
which originated, if I recall correctly, in this committee. It 
established a regulatory system at the Centers for Disease 
Control over the possession, use and transfer of select agents 
and toxins. We also dramatically increased spending for the 
building, expanding laboratories that research deadly germs and 
toxins.
    These kinds of facilities are known as biosafety level 3 
and 4 laboratories. They deal in highly infectious viruses and 
other biological agents. The critical part of what they do, 
however, must be to protect the public and their own workers 
from the inherent dangers involved in researching the very 
things that they research. Strict safety rules and guidelines 
must be required to protect against leaks, losses, are thefts 
of these deadly materials.
    This hearing explores several questions. Has a Bioterrorism 
Act helped improved Federal oversight of select agents? Are 
there oversight gaps? Is the expansion to research laboratories 
an unmitigated good or does it pose serious risk? And how well 
do we manage risk? There are serious reasons to be worried. 
Records obtained by the committee from the CDC revealed more 
than 100 acts in missing shipments in 2003. Fortunately, as far 
as we know, no deaths have been reported and it does not seem 
that the public has been at risk so far. A very serious 
biosafety incident has occurred at my alma mater, Texas A&M 
University. We have the president of Texas A&M here today to 
testify about what happened there and what Texas A&M has done 
to make sure that that does not happen again.
    While we are examining the possible gaps in the Federal and 
institutional oversight of biosafety, we should also realize 
that the work performed in these high-risk laboratories is 
critical to our Nation's defense and health. Much has been made 
about the secrecy surrounding the bio-laboratories but it 
hardly seems surprising that the world of bioterrorism research 
is also a world steeped in secrecy. We might need this secrecy 
for our own protection but it can also let bad habits go 
unnoticed and unchallenged until a crisis exposes them.
    We have seen that happen over and over again at our weapons 
laboratory at Los Alamos. Last year this subcommittee had to 
probe to learn that at the National Institutes of Health there 
was no central inventory of human tissue samples nor any 
systematic collection of data about them. We learned about that 
particular problem within the NIH only after the system was 
abused for personal gain. We also learned in the last several 
years how some Government scientists have been earning outside 
income by consulting for drug companies. We have found that a 
few have operated completely outside of the NIH approval and 
disclosure rules.
    Secrecy does not seem to nurture the truth sometimes, so 
the fact that biosafety rules have been bent and lab safety 
breaches have been concealed somehow should not come to us as a 
complete surprise.
    We are going to hear from several distinguished witnesses 
about the regulatory and oversight system of these 
laboratories. I want to particularly welcome the acting 
president of Texas A&M, Mr. Eddie Joe Davis. He is a personal 
friend of mine. He has assured me that A&M is doing everything 
possible to correct the problem and make sure it does not 
happen again. And I will assure this committee, as a past 
chairman of this subcommittee and a past chairman of the full 
committee, that if we know of a problem at Texas A&M, I will 
guarantee I will help correct it and I will do whatever it 
takes, including calling the Governor, the chairman of the 
Board of Regents, to make sure if the changes need to be made, 
they will be made. Texas A&M will be a model of how to do 
things right. Not that they have not been in the past but they 
sure will be in the present and the future in terms of this 
issue. You have my personal guarantee of that, Mr. Chairman.
    With that I yield back to the committee and look forward to 
hearing of the witnesses today.
    Mr. Stupak. I thank the ranking member. Members will be 
moving in and out of this hearing as we have another hearing 
upstairs on Environment and Hazardous Materials. I guess that 
is an appropriate subcommittee for subject of today's hearing 
here.
    Ms. DeGette, opening statement please?
    Ms. DeGette. Thank you, Mr. Chairman. I would like to 
associate myself with your opening statement and waive my 
opening statement in favor of more time for questions.
    Mr. Stupak. Very good. Mr. Green?

   OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr. Green. Thank you, Mr. Chairman, for holding the 
hearing. I appreciate you mentioning our subcommittee hearing 
upstairs. There are so many of us who are also members of that 
and so we will be coming and going all day, along with votes on 
the House floor.
    But I particularly appreciate you holding this hearing on 
the growth of biosafety labs and the inherent safety risks we 
must work to mitigate.
    For most of us here today, the dangers associated with 
bioagents are all too real as we served in this capitol complex 
in 2001. Several of our colleagues were targets of anthrax 
attacks. That attack shed tremendous light on our lack of 
capacity to research these agents for their health risk and 
find cures for the most dangerous of them.
    Today, approximately 6 years later, we are charged with 
determining whether that capacity was increased too quickly 
without appropriate regulatory guidelines and safeguards. We 
will hear a lot today about the incidents at Texas A&M, BSL-3 
lab. There is no question that the incidents have cast a dark 
shadow on Texas A&M select agent research program.
    It appears that the proper procedure are either unknown or 
blatantly ignored and the university has taken full 
responsibility by firing the individuals who acted 
irresponsibly and putting the full weight of the university 
behind resolving the remaining issues.
    I am pleased that Dr. Davis has agreed to testify before 
the committee today to help us learn about the A&M experience 
and identify any Federal oversight gaps that need to be 
addressed by regulation or statute.
    There are several basic concerns we must address such as 
the fact that we do not even know how many biosafety labs are 
operating in our country. We know there are currently 15 BSL-4 
labs either operational or under construction, that these labs 
handle the most deadly agents for which there is no treatment 
currently available. We know that there are 400 BSL-3 labs 
registered with the Centers for Disease Control, yet the only 
factor that triggers the requirement to register with the CDC 
seems to be the use of select agents and the official list of 
select agents is not continuously updated. We seem to have no 
clue about how many other labs there are working on agents that 
may not appear on that list yet are undeniably dangerous. I 
have every confidence this hearing will be effective in routing 
out many of the other regulatory issues that are facing our 
biological research laboratories. In our quest to fix many of 
the problems, however, I hope we will not lose sight of the 
need for this research being conducted in our country.
    I am proud to have much of this research being conducted in 
my own backyard at UTMB, University of Texas Medical Branch in 
Galveston. I recently visited the construction site of UTMB's 
Galveston National Lab, which is one of only two national 
biocontainment laboratories in this country. The research at 
the Galveston National Lab will be conducted to develop 
therapies and vaccines and tests for diseases like West Nile 
Virus, Ebola virus and drug resistant TB, which I've had 
legislation on.
    As a nation, we need the work to be performed in our 
country. During my visit to UTMB in May I learned first-hand 
about the measures UTMB is taking to ensure that the lab is 
built with every contingency in mind. I have also learned about 
the competence of training program that UTMB has put in place. 
Frankly, many of the incidents we will hear about today could 
have been avoided had appropriate and thorough training of 
research and lab employees taken place.
    I plan to focus a good portion of my questions on the 
safety aspect of the issue, not only because there seems to be 
a universal need facing biosafety labs but I also have a mild 
personal interest in it since my daughter is currently in her 
second year of fellowship in infectious disease at UTMB. It is 
entirely possible she will work on some of the research 
conducted in select agents either in the currently operational 
BSL-4 or in the Galveston National Lab when it opens next 
summer. As a parent to that research, I want to make sure that 
these biosafety labs adhere to the highest safety training 
standards. And it is a source of personal comfort that UTMB has 
placed such an emphasis on that safety training. Given the 
growth of these labs nationwide, I think we need to step up our 
safety training efforts nationwide and my office will begin to 
draft legislation on this important issue.
    And I appreciate the witnesses here today and the chairman 
for calling this hearing because our Oversight and 
Investigation Subcommittee does the investigation, then we have 
to go from there to draft legislation. And thank you, again, 
Mr. Chairman. I yield back my time.
    Mr. Stupak. Thank you, Mr. Green. Mr. Burgess, opening 
statement please.

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE 
              IN CONGRESS FROM THE STATE OF TEXAS

    Mr. Burgess. Thank you, Mr. Chairman. Mr. Chairman, I want 
to assure you that I do not have duties in the other 
subcommittee so I will be with you all day. I did not want you 
to feel in danger or abandoned.
    Mr. Chairman, thank you for holding the hearing today. I am 
grateful that we are investigating this. We are in the 21st 
century and we have come so far from 20th century problems, 
20th century difficulties and now providing for our common 
defense surely includes homeland security and protecting our 
homeland against the threat of biological attack.
    Recent years we have seen Hurricane Katrina, we have seen 
SARS, we have seen threats of bird flu. So natural disasters 
come into that list as well. We have got to have the guidelines 
in place. We have got to have guidelines in our labs, our 
streets to ensure that the very situations we are trying to 
protect ourselves against do not foster the environment that 
could be ripe for the type of biological accident or 
catastrophe that we all fear.
    Mr. Chairman, you are right, the labs are proliferated. 
That is appropriate because of the 21st century threat. Our 
regulation remains mired in the last century. There is a 
plethora of agencies but they are beset by a lack of 
communication, which is typical of the stove piping that 
frequently occurs within Federal agencies. And I hope that our 
committee will put itself to the task of eliminating those 
barriers.
    The truth is, the Federal Government only regulates a 
specific list of select agents but this list does not seem to 
be updated with sufficient frequency and, in fact, does not 
include some of the most deadly and contagious pathogens 
including the viruses responsible for severe adult respiratory 
syndrome or SARS. I cannot help but wonder, Mr. Chairman, if we 
are doing enough to keep this list updated to ensure that our 
scientists and our private citizens are protected.
    I know this is supposed to be the first in a series of 
hearings on this issue and I ask that we specifically look into 
whether or not the list is updated, how it is updated and if it 
is done in a most timely fashion.
    Now, our committee has an important responsibility to the 
American public and over the years I am grateful for the active 
and aggressive oversight that we have had in many of our labs 
in the country. As terrorism becomes more and more 
sophisticated and global activities seem to make the world a 
smaller and smaller place, we must continue to implement and 
maintain comprehensive measures for our safety.
    Today's hearing brings further light to serious and ongoing 
transit laboratories across the country. When labs do not take 
adequate care and caution, they literally put some of the 
brightest minds of the country in danger. Part of the 
responsibility falls on the Federal Government due to the 
ambiguity regarding the regulations and the guidelines that 
labs must follow.
    We, as members of this committee, have a duty and 
responsibility to the citizens of the country, to the 
scientists of the country, to resolve any ambiguities that 
currently exist within the Federal regulations so that the 
biosafety in all labs can be assured. The sad reality is that 
while the security breaches that have recently been documented 
in the newspapers, while they are serious, ultimately they 
could have been catastrophic had the right conditions prevailed 
at the time that those breaches occurred.
    But having said all that, I do want to join my Texas 
colleagues in welcoming the president of one of the premier 
research facilities in the United States, which happens to be 
in one of the premier States in the United States, the State of 
Texas. So Texas A&M president, Dr. Ed Davis, welcome to our 
committee. Of course, A&M has produced some of the greatest 
thinking minds of this century, including our ranking member, 
Mr. Barton. Unfortunately, there has also been some controversy 
and today they are not going to just be talking about the 
football team record.
    Dr. Davis, thank you for being here today and we look 
forward to hearing your discussion of exactly what happened in 
college station. Hopefully, you can give us some guidance on 
what we should do at our level to resolve the ambiguity and 
allow your scientists to have the tools in place to provide the 
safety that they need to conduct their research and ultimately 
protect the American people.
    I would also like to briefly mention, as did my colleague, 
Mr. Green, the issue of training at the University of Texas 
Medical Branch in Galveston. They have been a leader in this, 
responding to a need and developing a formal training center 
for laboratory personnel. They are receiving Federal dollars 
through the Department of Defense appropriations bill. Just 
make a note to the Majority that we do need to vote on a 
conference report on the Department of Defense appropriations 
bill with all haste and that that should not be encumbered with 
other issues and I would encourage you to talk to your 
leadership so that we can get that done and this great lab in 
Mr. Green's district can go forward and provide the training 
that the scientists need. And they are going to work in 
conjunction with the Center for Disease Control and the 
National Institute of Health.
    Again, Mr. Chairman, I thank you for holding this important 
hearing. I know we have got a lot of issues to get to today, so 
I want to be generous to you and I will yield back the balance 
of my time.
    Mr. Stupak. Thank you for yielding back 35 seconds. Next, 
go to Mr. Inslee for an opening statement. Please, sir?
    Mr. Inslee. I will waive my opening. Thank you, Mr. 
Chairman.
    Mr. Stupak. Mrs. Blackburn, opening statement?

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

    Mrs. Blackburn. Thank you, Mr. Chairman. I appreciate the 
hearing and I will also, since my late father-in-law was a 
Texas Aggie, I will express my welcome to Mr. Hammond also and 
to any of the other Aggies that are in the audience.
    I am delighted that we are having this hearing today. The 
hearing focuses on facilities that conduct research on specific 
infectious diseases, term-select agents. The labs that conduct 
the research on these select agents are classified as either a 
biosafety level 3 or 4. Now, in Tennessee, at the University of 
Tennessee, there are a couple of different labs. One is in 
Memphis and one is in Oak Ridge. The UT Health Science Center 
in Memphis is currently constructing a new regional BSL-3 
biocontainment lab but we are pleased with that facility and 
pleased with the progress that they have made on some of their 
biotechnology and the research that goes with that. This is 
something when I was in the State senate in Tennessee. I spent 
a good bit of time trying to help get off the ground helping 
start the biotechnology association and the task force that 
help feed the energy into that when I was in the State senate. 
We know that these facilities are working with materials that 
can potentially cause serious harm to humans and to animals 
with some of the pathogens having no known cure. In today's 
world, the threat of terrorism, as my good colleague has 
mentioned, is present. Not only could terrorists potentially 
use one of the pathogens to harm the public, there is also the 
possibility that those wishing America harm could genetically 
alter these pathogens to form a new strain with no known cure.
    And while I understand that the research is clearly needed, 
we must also focus on the safety of those performing the 
research, as well as the communities in which these labs and 
facilities are located. I think we have all expressed concern 
with the way the counting is done and knowing how many of these 
are actually available. We know that the NIH said there was 277 
in 2005 and today the number is estimated to be around 400. I 
will let go also one of the things that my colleague was 
mentioning. The lack of communication between the agencies. 
When you look at the FDA, the CDC and the NIH, Mr. Chairman, we 
continue to hear, whether it is in health sub or here, the 
inter-agency, as well as the intra-agency communication and 
collaboration and share of information seems to not be what we 
would like for it to be, especially when we are looking at 
something as delicate and as necessary as the type of research 
we are talking about and I hope that we have the opportunity to 
address some of that today.
    I do want to welcome our witnesses today. As I said, 
especially any Aggies who are before us, I will join in 
welcoming them. I also look forward to hearing and engaging in 
the Q and A. And, Mr. Chairman, I yield back my time.
    Mr. Stupak. I thank the gentlelady for her opening 
statement. That concludes the opening statements. Before we 
begin with testimony, I would like to recognize our colleague, 
Chet Edwards, who is here. Chet has Texas A&M in his district 
and I know he has talked to me and others about this issue. So 
welcome, Chet. Seeing no other members, we will move forward to 
our first panel of witnesses.
    We have Dr. Keith Rhodes, Chief Technologist, Government 
Accountability Office, Center for Technology and Engineering. 
And with Dr. Rhodes is Dr. Sharma, who is GAO's Assistant 
Director of Applied Research and Methods.
    It is the policy of the subcommittee to take all testimony 
under oath. Please be advised that witnesses have the right 
under the rules of the House to be advised by counsel during 
their testimony. Do either of you gentlemen wished to be 
represented by counsel? Mr. Rhodes? Dr. Sharma? No. OK. 
Witnesses indicated they do not, therefore, I will ask you to 
rise, raise your right hand, take the oath.
    [Witnesses sworn.]
    Mr. Stupak. Let the record reflect that the witnesses 
replied in the affirmative. You are now under oath. Dr. Rhodes, 
are you going to start with your opening statement please?

   STATEMENT OF KEITH RHODES, CHIEF TECHNOLOGIST, CENTER FOR 
  TECHNOLOGY AND ENGINEERING, U.S. GOVERNMENT ACCOUNTABILITY 
 OFFICE; ACCOMPANIED BY SUSHIL K. SHARMA, ASSISTANT DIRECTOR, 
 APPLIED RESEARCH AND METHODS, U.S. GOVERNMENT ACCOUNTABILITY 
                             OFFICE

    Mr. Rhodes. Thank you, Mr. Chairman. Mr. Chairman, members 
of the subcommittee, my colleague, Dr. Sharma, and I are 
pleased to be here today to discuss our preliminary findings on 
the oversight of the expansion in the United States of 
biosafety level 3 and biosafety level 4 labs, also known as 
high-containment labs. This expansion is, in part, a response 
to the global spread of emerging infectious diseases and the 
threat of bioterrorism. As you know, BSL-3 and 4 labs often 
contain the most dangerous infectious disease agents like 
Ebola, small pox and avian influenza.
    Although high-containment labs are designed to promote the 
safety of researchers and the public, accidents and security 
breaches have occurred in the past and they will occur in the 
future. Experts tell us that most accidents occur due to human 
error, which cannot be completely eliminated. In addition, 
these labs can be used by terrorists or people with malicious 
intent to acquire or develop harmful biological agents, posing 
a serious threat to our national security and public health.
    The intentional dissemination of anthrax in the U.S. mail 
highlighted major gaps in our civilian capacity to respond to a 
biological attack. One such gap noted by the National Institute 
of Allergy and Infectious Diseases was the shortage of high-
containment lab capacity available to conduct research for 
medical countermeasures. To address this concern, the 
administration and Congress responded by providing increased 
funding for biodefense research and for additional BSL 3 and 
BSL 4 labs in the private sector, especially in university 
settings.
    As a result, concerns have been raised about the adequacy 
of oversight of these labs because the deliberate or accidental 
release of biological agents can have disastrous consequences, 
such as exposing workers and the public. In addition, concerns 
have been raised about their safety, as well as operations. 
Finally, there are security concerns about the potential theft 
of the agents themselves. Accordingly, you asked us to address 
the following three questions. One: Is there an expansion going 
on? Two: Who is in charge of this expansion? And three: What 
lessons can be learned from recent incidents at three high-
containment labs? With regard to expansion, Mr. Chairman, as 
you can see on the charts, we found that a major expansion of 
BSL 3 and 4 labs is taking place in the United States. For 
example, concerning BSL-4 labs, which handle the most dangerous 
agents, the number of these labs has increased from five before 
the terrorist attacks of 2001 to 15, including at least one in 
planning. With regard to BSL-3 labs, no one knows how many 
there are but the number is surely in the thousands. In the 
past, the most dangerous of these types of labs, that is the 
BSL-4 labs, were largely in Federal hands. But since 2001, the 
expansion is taking place across many sectors, Federal, State, 
academic and private and across most of the United States. 
While information on expansion is available about high-
containment labs that are one, registered with the select agent 
program and two, federally funded, much less is known about the 
expansion of labs outside the select agent program, as well as 
the non-federally funded labs including their location, 
activities and ownership.
    With regard to who is in charge of this expansion, Mr. 
Chairman, we found no single Federal agency has the mission 
and, therefore, is accountable for tracking the number of all 
BSL-3 and 4 labs within the United States. Although several 
agencies have a need to know the number and location of these 
labs to support their missions, no agency knows how many such 
labs there are in the United States or their locations. 
Therefore, no Federal agency is responsible for determining the 
aggregate risks associated with the expansion of these labs. 
Since there is a baseline risk associated with any high-
containment lab, the aggregate risk associated with this 
expansion will increase as their numbers increase. Importantly, 
the safety and security risks will be greater for new labs with 
less experience.
    Finally, from the three recent incidents that you asked us 
to examine, one: the failure to report to CDC exposures to 
select agents by Texas A&M University, two: the power outage at 
CDC's new BSL-4 lab, and three: the most recent release of the 
foot-and-mouth disease virus at Pirbright in the United 
Kingdom. We have identified six lessons that can be learned. 
These lessons highlight the importance of one: identifying and 
overcoming barriers to reporting in order to enhance biosafety 
through shared learning from mistakes and to assure the public 
that accidents are examined and contained. Two, training lab 
staff in general biosafety, as well as in specific agents being 
used in the labs to ensure maximum protection. Three, 
developing mechanisms for informing medical providers about all 
the agents that lab staff work with to ensure quick diagnosis 
and effective treatment. Four, addressing confusion over the 
definition of exposure to aid in the consistency of reporting. 
Five, ensuring that BSL-4 lab safety and security measures are 
commensurate with the level of risk these labs present. And 
six, maintaining high-containment labs to ensure integrity of 
physical infrastructure over time.
    In summary, the expansion of BSL-3 and 4 labs is indeed 
taking place in the United States and it is proceeding in a 
decentralized fashion. While some expansion may be justified, 
unwarranted expansion without adequate oversight is 
proliferation, not expansion. Since the full extent of the 
expansion is not known, it is unclear how the Federal 
Government can ensure that sufficient but not superfluous 
capacity, bringing with it additional unnecessary risk is being 
created.
    In conclusion, Mr. Chairman, the limited Federal oversight 
that does exist for high-containment labs is fragmented among 
different Federal agencies and for the most part, relies on 
self-policing.
    As you have said in your opening statement, the inherent 
weaknesses of an oversight system based on self-policing are 
highlighted by the Texas A&M University case. While CDC 
inspected the labs at Texas A&M in February 2006, as part of 
its routine inspection, its inspectors failed to identify three 
items. One, a worker became exposed and ill. Two, unauthorized 
experiments were being conducted and unauthorized individuals 
were entering the labs. And three, both the agents and infected 
animals were missing. It was not until a public advocacy group 
learned of the Brucella incident and according to this group, 
applied pressure by demanding records about the incident, that 
the university reported this incident to the CDC. This report 
prompted the subsequent in-depth investigations by the CDC. 
This incident is raising serious concerns about, one, how well 
the agency polices select agent research being conducted in 
over 400 high-containment labs registered under the select 
agent program located at various universities around the 
country and, two, whether the safety of the public is 
compromised. Moreover, if similar safety breaches are occurring 
at other labs, they are not being reported nor is CDC finding 
them.
    I want to leave you with this thought. Since the labs are 
largely overseeing themselves at this point, it is not the 
regulators but only the operators of these labs who can tell 
you whether the three recent incidents are the tip of the 
iceberg or the iceberg itself.
    Mr. Chairman, this concludes my prepared remarks. Dr. 
Sharma and I stand ready to answer any questions you or members 
of the subcommittee may have.
    [The prepared statement of Mr. Rhodes follows:]
    

    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Stupak. Thank you, Dr. Rhodes. Dr. Sharma, you do not 
have an opening statement, sir?
    Mr. Sharma. No.
    Mr. Stupak. OK. For the record, without objection, Mr. 
Dingell's statement will be submitted for the record.
    I am sure Mr. Whitfield has one and when he comes up, it 
will be submitted for the record, as well as opening statements 
of other members of the subcommittee.
    The prepared statements of Messrs. Dingell and Whitfield 
follow:]

    Prepared Statement of Hon. John D. Dingell, a Representative in 
                  Congress from the State of Michigan

     Mr. Chairman, thank you for holding this important 
hearing. I congratulate you for shining some much-needed light 
on the hidden world of bio-research, and I look forward to 
assisting you in this investigation as we go forward.
     The central question raised by these hearings is simply 
this: Are these high-level biosafety laboratories safe?
     The fact is that we just don't know. According to the 
Government Accountability Office (GAO), no single Federal 
agency even knows how many high-level biosafety labs there are 
or where they are, much less whether they are safe and secure. 
Moreover, no one Federal agency has the responsibility for 
tracking these labs and ensuring their safe operation.
     Even though no one seems to know how many labs there are, 
the National Institutes of Health has energetically funded the 
construction of new high-containment biosafety labs all over 
the country, to the tune of more than $1 billion over the past 
5 years. It is unclear whether anyone has based these funding 
decisions on a quantifiable assessment of need. Mr. Chairman, I 
intend to ask GAO to review this spending, to provide an 
overall accounting of how much was spent, where it was spent, 
and on what basis.
     Although we don't know how many labs there are, GAO and 
other witnesses will testify that the number of high-level 
biosafety labs has increased dramatically over the last decade. 
For example, at the height of the Cold War, and as little as 10 
years ago, this country had only two Level-4 laboratories--
laboratories that handle deadly diseases that have no cure: one 
at the Centers for Disease Control and Prevention, and one 
belonging to the Army at Ft. Detrick, Maryland.
     By next year, there will be 12 such labs in operation. Do 
we really need 12 laboratories that operate at the very highest 
level of security? Is there a good reason for creating these 
labs or have we simply begun an arms race against ourselves?
     I had hoped that the Department of Homeland Security would 
be here today to assist us in answering some of these 
questions. I was surprised and displeased, however, to learn 
that even though DHS is responsible for homeland security, it 
declined our invitation to testify on the grounds that they 
were too busy and otherwise engaged.
     Perhaps we need to consider compelling the attendance of 
the proper DHS officials at our next hearing. That would also 
provide DHS with an opportunity to explain their proposal to 
close the Plum Island Animal Disease Center off the coast of 
New York and move it to the mainland.
     Plum Island is where the Department of Agriculture has for 
decades conducted research on foot-and-mouth disease. Much to 
their credit, they have done so safely and securely, and 
apparently without incident.
     The DHS proposal to close Plum Island and move foot-and-
mouth virus to the mainland U.S. is utterly baffling. Foot-and-
mouth is one of the most contagious diseases in the world. We 
know from recent incidents in the U.K. that it can escape from 
even a high-level biosafety lab. And we know that any release 
of the foot-and-mouth virus could have a devastating effect on 
the U.S. livestock industry, just as it did in the U.K. in 
2001. Why then would DHS propose to move this Level-3 biolab 
that works with the most dangerous animal diseases in the world 
from Plum Island to the heart of farm country?
     I look forward to this committee's investigation of the 
Plum Island issue as part of this series of hearings on 
biosafety laboratories.
     Mr. Chairman, I thank you for your recognition and look 
forward to the testimony of the witnesses.
                              ----------                              


    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    

    Mr. Stupak. We will begin with questioning, 5 minutes each. 
I will begin. Dr. Rhodes, you mentioned select agents, how many 
select agents are there? These select agents being done at 
these labs. Is it 72?
    Mr. Rhodes. Seventy-two.
    Mr. Stupak. OK. One of your last statements, you indicated 
that there are other labs out there. You mentioned these 400 
and some high-containment labs. But there are other labs out 
there doing other research on potentially dangerous agents and 
viruses and diseases, is that correct?
    Mr. Rhodes. Correct.
    Mr. Stupak. Do you know how many other labs that are out 
there that are not considered high-containment labs?
    Mr. Rhodes. No. That would be a larger number than the ones 
that are labeled high-containment.
    Mr. Stupak. Of these other labs, are they Government-
sponsored labs, as in research being done at the direction or 
request of the Federal Government?
    Mr. Rhodes. Not necessarily.
    Mr. Stupak. OK. But possible?
    Mr. Rhodes. Possibly.
    Mr. Stupak. So agents such as SARS, dengue fever, 
hantavirus, they are not on these select agents?
    Mr. Rhodes. Correct.
    Mr. Stupak. And that research could be done in other labs 
that we do not know about?
    Mr. Rhodes. Correct.
    Mr. Stupak. And these are just as deadly as an Ebola 
outbreak?
    Mr. Rhodes. Could be, potentially, yes.
    Mr. Stupak. OK. In your testimony you said you surveyed 12 
Federal agencies involved with these high-containment labs, is 
that correct?
    Mr. Rhodes. Yes.
    Mr. Stupak. And several of these agencies have a need to 
know within their agencies how many level 3 and how many level 
4 labs are in the United States and where they are located, is 
that correct?
    Mr. Rhodes. That is correct.
    Mr. Stupak. If I read your testimony correctly of these 12 
agencies, none of them, not Homeland Security, not the Center 
for Disease Control, not the FBI, none of the agencies actually 
know how many level 3 or level 4 labs are out there?
    Mr. Rhodes. Correct.
    Mr. Stupak. OK. The number of BSL-4 labs, those labs that 
handle the most dangerous and lethal diseases, have increased 
from two labs prior to 1990 to 15 today, is that correct?
    Mr. Rhodes. With one in planning. At least one is still in 
planning right now.
    Mr. Stupak. OK. You know, this committee also has 
jurisdiction, we have done investigations into our nuclear 
weapons research in Los Alamos and others. And it seems like in 
the field of nuclear we limit the number of labs doing 
dangerous work so we can keep the research closely regulated, 
under tight security, under Government control and consolidated 
in a few locations rather than spread across the country. With 
the BSL-4 labs, we could conceivably have an outbreak of 
something, Ebola or whatever virus spread amongst the 15 
different labs with varying levels of physical security. Should 
not Congress want these diseases in fewer hands and fewer 
locations rather than more locations and more people dealing 
with it?
    Mr. Rhodes. Well, from having come out of the nuclear 
weapons lab program--I mean, that is my background, is in 
nuclear weapons side. That was the direction that we took in 
the establishment of the labs that are authorized to work with 
nuclear weapons material, particularly special nuclear 
material. Part of that is risk. Two laboratories were 
established so that there was competition between the 
laboratories. The idea being that you come up with a better 
idea through the competitive designs. But you do not expand 
beyond two. The more BSL-4 laboratories there are, the more 
opportunities for mistakes. The more opportunities there are 
for a release. BSL-4 handles the most dangerous biological 
agents. They are the ones in some cases for which there are no 
medical countermeasures. And so narrowing the field and 
bringing the number down reduces your risk because each one of 
these laboratories does have a baseline risk to it.
    Mr. Stupak. And one of the risks that Congress was 
concerned about was terrorism, right?
    Mr. Rhodes. Absolutely.
    Mr. Stupak. So the more labs you have out there, the more 
opportunity, if you will, for something to go wrong to fall 
into the terrorists' hands.
    Mr. Rhodes. The more laboratories you have, the more staff 
you have.
    Mr. Stupak. Correct.
    Mr. Rhodes. The more staff that you have to perform 
background investigations on. The more people who are possible 
to be compromised. The more material that has to be moved in 
order to go from point A to another lab. It becomes an 
extremely complex management of material problem.
    Mr. Stupak. After the anthrax problems we had in this 
country in the fall of 2001, Congress charged the labs to 
develop medical countermeasures.
    Mr. Rhodes. Yes.
    Mr. Stupak. Could you find anything where they said to 
build more labs?
    Mr. Rhodes. I have not found anything that said, as a 
result of that, build more labs. Now, the NIAID pointed out an 
extreme gap in the laboratory structure for countermeasure 
research but from the Government's direct perspective and the 
directives out to both industry and the scientific community 
and all that, it was countermeasures, not specifically build 
laboratories.
    Mr. Stupak. Just one more and if you know the answer, maybe 
you do not. There is a level 4 lab right near here in Bethesda, 
correct?
    Mr. Rhodes. That is correct.
    Mr. Stupak. Did you check that lab?
    Mr. Rhodes. That is one of the labs that we researched.
    Mr. Stupak. Are they doing any hot stuff there at level 4 
at Bethesda?
    Mr. Rhodes. If I understand correctly, they are at level 3 
at the moment. They are only handling level 3 agents.
    Mr. Stupak. But they are licensed or not licensed but they 
are a level 4 lab?
    Mr. Rhodes. Yes, they are a level 4 containment.
    Mr. Stupak. So it is capacity not being utilized, it is 
already built?
    Mr. Rhodes. That is correct.
    Mr. Stupak. OK. Mr. Barton for questions please.
    Mr. Barton. Thank you, Mr. Chairman. The implication in the 
written report is that we have too many of these level 3 and 
level 4 biolabs. What would a good number be?
    Mr. Rhodes. I do not know what a good number would be, sir. 
The point that we are trying to stress in the report is that no 
one knows what the number is. Decomposing from capacity 
requirement to figure out what the number is. If labs are being 
built just because money is available and not necessarily to 
meet a----
    Mr. Barton. Well, based on the need as you see it today, do 
we need more or less?
    Mr. Rhodes. I do not know whether we need more or less but 
we need to know the ones that we have and we need to know what 
they are doing.
    Mr. Barton. The report does not seem to think--I mean, I 
get the implication that the report indicates we have too many. 
I do not care if you say 10 or 100 or 2.
    Mr. Rhodes. The point of the report is that there is too 
many at the moment for the level of oversight that is being 
provided. So it is stretched beyond the ability of the 
fragmented and decentralized oversight that exists now.
    Mr. Barton. So you are not worried about----
    Mr. Rhodes. If the oversight is going to stay the way it 
is, we need less labs because the oversight that is there right 
now cannot keep up with the number and the expansion that is 
going----
    Mr. Barton. When you say the oversight right now, what do 
you mean by the oversight? Do we have too many agencies? Are 
the agencies we have not doing a good job?
    Mr. Rhodes. Well, we have no single agency. We have no 
agency that actually knows what the number is and when we go 
out to the agencies, we still cannot get what the number is.
    Mr. Barton. All right. How many agencies can fund one of 
these level 3 or level 4 laboratories?
    Mr. Rhodes. Well, at the moment I think it would be 15.
    Mr. Barton. So there is 15 different Federal agencies that 
can fund these laboratories.
    Mr. Rhodes. I think so.
    Mr. Barton. Is that correct?
    Mr. Rhodes. Yes, I think so.
    Mr. Barton. How many should there be? Should we only let 
one agency fund them?
    Mr. Rhodes. No, you can let them all fund, that is fine but 
who is going to provide the oversight and make certain that 
there is cross communication between those organizations that 
are funding, as well as those organizations that are providing 
the oversight? Right now it is a very fragmented environment.
    Mr. Barton. So you do not have a problem that 15 different 
Federal agencies can fund these. Your problem is or the GAO's 
problem, not your personal problem, but is it the agencies that 
fund these labs do not coordinate between each other on 
oversight. Is that correct?
    Mr. Rhodes. That is part of it and they are not 
coordinating on the actual need for the laboratories. So a 
particular department has funding and it says it has a need and 
it goes and funds a laboratory when, for example, let us take 
Texas A&M.
    Mr. Barton. Just out of pulling a name out of a hat.
    Mr. Rhodes. Just pulling a name out of a hat. As you said 
in your opening statement, they will be the model laboratory. 
Well, why should not they be funded by multiple agencies and 
make certain that there is coordination amongst the funding so 
that the requirements are met and why should not it be that 
their oversight is coordinated as well so it is not fragmented?
    Mr. Barton. I would think, to pull a name out of a hat, 
Texas A&M would love to have multiple sources of funding.
    Mr. Rhodes. I would imagine so. I would imagine many other 
existing laboratories would like that too. The problem is that, 
as the number of labs increases, the risk increases and, as 
that risk increases, the oversight becomes more difficult. As 
the oversight becomes more difficult, the transparency of what 
is going on in the laboratory goes away and that is the major 
concern. If the United States Government decides in 
consultation with the Congress regarding funding that there 
need to be 15, 20, 50 BSL-4 labs and there are needs for it and 
there is adequate safety and security associated with it and 
there is adequate coordinated oversight and it is meeting 
adequate requirements definition, so be it.
    Mr. Barton. If you had to pick one agency today to be the 
lead coordinator for this new oversight system, which agency 
would that be?
    Mr. Rhodes. I cannot say that at this moment but we will 
report that out in the recommendations in our final report. 
These are our preliminary findings but we will report that out 
in our final report.
    Mr. Barton. Is there an existing agency that is capable of 
being the lead agency for oversight that is already in 
existence? Can you answer me that question?
    Mr. Rhodes. I do not know if I can answer that question. 
Let me give you just one point I would make about that 
oversight. The oversight has to be completely independent. The 
oversight cannot come from someone who is operating a lab. I 
will give you the example from the Pirbright incident in the 
United Kingdom. I will be very, very surprised if anyone is 
ultimately held liable for the release of Foot and Mouth virus 
from that laboratory because the operator of the lab is the 
regulator. There was a private laboratory on the Government 
facility. Funding was coming from multiple directions. Multiple 
kinds of research was being done. I do not think they will be 
able to figure out who is ultimately responsible for the leak 
and who is ultimately accountable for it. And one of the 
complicating factors is that DEFRA, which is their version of 
the Department of Agriculture, is the operator of that 
laboratory, as well as the oversight.
    Mr. Barton. I have two more questions, Mr. Chairman. I know 
that my time is expired. The first question is, should these 
type of laboratories be allowed at academic institutions 
generically?
    Mr. Rhodes. Yes, I do not see why not. I mean, that is 
the----
    Mr. Barton. So it is not a problem per se that it is at an 
academic institution?
    Mr. Rhodes. It is absolutely not an issue of where the 
laboratory is located. Obviously, people are going to have to 
have open hearings about where it should be. It is not a 
question of academia.
    Mr. Barton. Last question, Mr. Chairman. The laboratory at 
Texas A&M, was it level 3 or level 4, do you know?
    Mr. Rhodes. It is a level 3.
    Mr. Barton. Thank you. Thank you, Mr. Chairman.
    Mr. Stupak. Just a question. I mentioned about Bethesda 
being 3 and Mr. Barton mentioned about level 3. If a lab goes 
from 3 to 4, is the community around it aware or told what the 
agent or that is known?
    Mr. Rhodes. It may not be.
    Mr. Stupak. There is no requirement either way?
    Mr. Rhodes. I have not seen any documentation so far that 
there has to be a public hearing about a laboratory being 
allowed to go from 3 to 4. There may be a requirement for a 
public notice but I have not seen documentation that says that 
so far.
    Mr. Stupak. I mentioned in my opening that we intend to 
also examine level 3 and 4 labs internationally and we intend 
to examine the proposal to close Plum Island and relocate the 
foot-and-mouth disease research to the mainland. Will GAO 
continue to work with the committee on that investigation 
research?
    Mr. Rhodes. Yes.
    Mr. Stupak. OK, thank you. Ms. DeGette for questions 
please.
    Ms. DeGette. Thank you very much, Mr. Chairman, and I 
appreciate you holding these hearings which are continuations 
of hearings this committee has done for a number of years. I 
was telling staff about several years ago when I went to the 
level 3 lab, the CDC lab, up in Fort Collins, Colorado. And the 
lab at that time, they had vector-borne agents there and these 
vector-borne agents were being stored in a modular unit behind 
the building that had weeds growing up from the floor and it 
had flies flying--these are vector-borne agents and I am happy 
to report that since I visited that and with the assistance of 
my former colleague, Bob Shaffer, we succeeded in having a new 
CDC lab built there. I assume they have eliminated the weeds 
and the flies. But I was really dismayed about your testimony 
that we now have a proliferation of these level 3 and 4 labs 
since 2001. Doctor, I am wondering if you can tell us why you 
think that we have had such a proliferation of these labs?
    Mr. Rhodes. There is a perceived gap, and actually stated 
by NIAID, that there is a need post-fall of 2001 events with 
the anthrax through the mail, for a response network to a 
future terrorist event. Also a perceived need for ability to do 
research on countermeasures. And as a result of that, as I 
stated, both the administration and the Congress have given 
funding to meet this requirement.
    Ms. DeGette. And that is going to a wide range of types of 
private and public entities?
    Mr. Rhodes. Yes, ma'am.
    Ms. DeGette. So there has been no distinction made. I think 
you pointed this out. There has been no distinction made 
between governmental oversight and private or academic labs, 
correct?
    Mr. Rhodes. That is correct.
    Ms. DeGette. And is it your view--I know you told Mr. 
Barton that you did not have an opinion yet on which agency 
should be the lead agency in overseeing these labs but my 
question is, do we even want more than one agency overseeing 
level 3 and 4 labs right now? We have got the CDC, the USDA, 
the DOD and others. Do we want a coordinating lab or do we want 
just one single agency with authority over regulation of all of 
these labs?
    Mr. Rhodes. That would ultimately be the simplest answer.
    Ms. DeGette. One agency coordinating.
    Mr. Rhodes. One agency. But that said, the agency that does 
the oversight will ultimately end up being a coordinating 
agency because they will have to go to each of the departments 
and agencies that are funding and go to any of the laboratories 
and will have to coordinate with them relative to requirements 
and all that.
    Ms. DeGette. But the advantage would be you would have one 
set of standards that would be implemented, correct?
    Mr. Rhodes. That is correct.
    Ms. DeGette. Dr. Sharma is nodding in agreement. And so 
when do you think you will have your recommendation as to what 
that agency and process should be?
    Mr. Rhodes. Our schedule right now is to issue our final 
report in February.
    Ms. DeGette. February 2008?
    Mr. Rhodes. Yes, 2008.
    Ms. DeGette. Thank you.
    Mr. Rhodes. And we will have to put it out for comments, so 
I would say probably by March.
    Ms. DeGette. OK. Now, as I mentioned, not all of these 
level 3 and 4 labs are federally supported. Some of them are 
State supported or even private. I am wondering if these non-
federally funded labs have unique concerns about which we 
should be aware and which we should think about as we think 
about further regulation.
    Mr. Rhodes. A non-federally funded laboratory is, in 
effect, an information black hole, so you do not have any 
insight into it. Unless they are part of the select agent 
program or they are federally funded, the United States 
Government will not have any insight into who owns it, where it 
is, what they are doing.
    Ms. DeGette. What their protocols are.
    Mr. Rhodes. Absolutely.
    Ms. DeGette. And what can Congress do to address that 
issue?
    Mr. Rhodes. That would be part of the charter, I guess of 
the new oversight. They would have to have powers of authority 
to talk to and gain information from all BSL-3 and 4 
laboratories, not just the ones that the Government has 
oversight of because it is a public safety issue.
    Ms. DeGette. What you are saying, I think based on your 
experience with the nuclear labs, what we would have to say is, 
if a lab had in its possession a certain type of these agents, 
they would automatically be regulated federally and it is not 
happening now.
    Mr. Rhodes. Well, let us look at nuclear power for example. 
You have the Nuclear Regulatory Commission. Well, the Nuclear 
Regulatory Commission is not just talking about commercial 
power.
    Ms. DeGette. Right.
    Mr. Rhodes. Talking about anyone who is handling a radio 
nuclide.
    Ms. DeGette. Right.
    Mr. Rhodes. So if your transportation person who is using 
cesium gauges in order to figure out the depth of a freeway.
    Ms. DeGette. Right. But what----
    Mr. Rhodes. You are licensed.
    Ms. DeGette. And what I am saying is, right now we do not 
have that same authority over these biologic agents.
    Mr. Rhodes. Absolutely.
    Ms. DeGette. If someone can just set up one of these labs 
and if it is privately funded then, what you are saying is, we 
are not regulating that.
    Mr. Rhodes. Correct.
    Ms. DeGette. Yes, Dr. Sharma wants to add----
    Mr. Sharma. I would add, this is a very essential issue 
because these BSL-3 and 4 labs in the United States do not need 
any kind of permit other than building permits if they are not 
receiving any Federal funds. There is no certification 
requirements. They can operate. In addition to that, we have 
additional problems. There are these mobile labs. You can build 
it. So it is a very complex issue and right now, our system is, 
there is no way for any agency to know but we are looking at 
some other systems in other countries. There are requirements 
to see the extent of which those systems could be applied here 
and we will be reporting those as part of our report in 
February.
    Ms. DeGette. And as I said, what those systems would be is 
similar to the system that we use for nuclear material, which 
is if you are in possession of these agents and you are going 
to have a lab, then you have to meet certain requirements, 
correct?
    Mr. Rhodes. Yes.
    Ms. DeGette. And is that part of what you are developing 
for next spring?
    Mr. Rhodes. That is the direction we are looking.
    Ms. DeGette. I think the committee would all agree that is 
an extremely important set of guidelines. And I want to thank 
you both for coming today.
    Mr. Rhodes. Thank you.
    Ms. DeGette. I yield back.
    Mr. Stupak. Mr. Burgess for questions, please.
    Mr. Burgess. Thank you. Dr. Sharma, if I could just pick up 
on what you were just saying as you concluded your response to 
Ms. DeGette. So if there is no Federal funding involved, the 
only permitting is local building permits?
    Mr. Sharma. Right.
    Mr. Burgess. Did I understand that correctly? So then there 
is no one that certifies whether this is a level 3 or a level 4 
facility?
    Mr. Sharma. It is our understanding that if you are not 
receiving any Federal funds, if you are not working the select 
agents, there is nobody you have to seek permission from other 
than city or State requirements.
    Mr. Burgess. So to answer the chairman's question about who 
in the surrounding community is notified, then, obviously, no 
one would be notified in that situation, is that correct?
    Mr. Sharma. Correct.
    Mr. Burgess. Have you looked at all, and obviously other--
we have heard a little bit about the foot-and-mouth disease 
incident in Great Britain. What are the systems in other 
countries? How are they dealing with this? Because clearly this 
is something that is a process in evolution, it is a concept 
that is developing. Where are other countries on that continuum 
of development of their regulation of these types of labs?
    Mr. Sharma. We have not extensively looked at other foreign 
systems and we have plans to look at how other countries are 
handling this issue.
    Mr. Stupak. And we have asked them to do that, Mr. Burgess, 
look at other areas internationally. Not only for safety but 
you see countries like Sudan and China suddenly coming up with 
level 4 labs. I wasn't quite concerned to go to China yet but I 
was working there.
    Mr. Burgess. OK.
    Mr. Stupak. Dr. Rhodes, you had something you wanted to 
say?
    Mr. Rhodes. Let me just make one point. I was in the UK and 
was talking to the people at the Pirbright site. There is 
currently the exact same discussion that your colleague from 
Colorado was discussing. They are trying to figure out who is 
going to be the single regulator because they have the split, 
they only have two but one is for animals and one is for human 
pathogens. And then there is that area in-between, which is 
called zoonotics. Those are the agents that affect both animals 
and humans. So what is probably going to come out from that 
discussion is there will be a single regulator. There will be a 
single set of regulations. Obviously, they have to be tailored 
for working with animals versus humans. There will be no 
allowance for the regulator to be an operator. But that is the 
discussion that is going on right now in the UK as a result of 
the Pirbright outbreak.
    Mr. Burgess. Let me ask you the question, as it pertains to 
the single agency regulations with radio nuclides, zoonotics 
are a little bit different because here we have got a select 
list or select agents which is somewhat arbitrary, I would 
argue. I am by no means an expert but, I mean, SARS not being 
on that list is, well, a striking omission and I am sure there 
are good reasons why, from a research perspective, that someone 
has come up with that designation. But it just points to the 
difficulty when we talk about we want to do things to remove 
ambiguity. But there are inherent ambiguities in this system. 
Heisenberg's Uncertainty Principle probably applies here more 
so than the field of radiation sites, is that not correct?
    Mr. Rhodes. I follow your logic on that.
    Mr. Burgess. I do not think it was logic but I appreciate 
your calling it that. Let me ask you this. I mean, obviously, 
we got to this system because someone said there is a threat 
and there is value to developing a rapid response. Do I 
understand that correctly?
    Mr. Rhodes. That is correct.
    Mr. Burgess. I wasn't here in 2001. And then when I was 
here in 2003, we had the SARS kind of just crop up all at once 
and it was handled correctly. It was handled correctly from a 
lot of different levels at the CDC and the NIH and identifying 
it as a coronavirus, identifying where it came from. And really 
with no vaccine and no specific treatment, we were able to beat 
back the threat of an epidemic very, very quickly with old 
fashioned tools, epidemiology and quarantine. So, clearly there 
is value here in developing this expertise. I guess my only 
point is I hope there is some caution, in bringing down the 
regulatory hammer here, that we not cripple a system that 
delivered us from evil in the case of SARS relatively quickly, 
very competently and although 800 people did die, it could have 
been just extravagantly worse had we not been at the top of our 
game on that particular illness.
    Mr. Rhodes. And that is a very good point. I want no one to 
take our preliminary findings and think we are trying to throw 
the baby out with the bathwater. In answer to Representative 
Barton's question about academic environment, I came out of an 
academic environment. Dr. Sharma came out of an academic 
environment. We have all come out of academic environments. And 
with our scientific backgrounds, we couldn't have them without 
academic environments. So it is not saying be Draconian about 
this. It is saying let us not be Byzantine about it. The fabric 
of oversight now is so convoluted I would defy anyone--I mean, 
I have a very, very smart team and we cannot figure it out. And 
we talked to people who have regulatory authority and, as a 
matter of fact, one of them said ``that would be nice if we 
could know that, anything you can do to help us would be 
appreciated.'' Now, if somebody goes to the GAO and asks for 
help, they are in a hot spot.
    Mr. Burgess. Well, your table that you provided, page 12, 
and in your evidence book, tab 23, just comparing those two 
maps of the United States where the locations of the labs are 
strikingly different. So I think the ambiguity there speaks for 
itself that we do not even know where we are, what we got and 
what we are doing and clearly that is the thrust of this 
committee. Mr. Chairman, I thank you for your indulgence. I 
will yield back.
    Mr. Stupak. I thank the gentlemen. Dr. Rhodes, in your 
survey, did any of the Federal agencies that you looked at, did 
they indicate concern about the proliferation of these high-
containment labs?
    Mr. Rhodes. Oddly enough, the Federal Bureau of 
Investigation and the Intelligence Community were the ones who 
were most concerned about it. Obviously, they have the 
counterterrorism side and they have the national security side 
and they have the national intelligence estimate side. But the 
FBI also had another concern, which was they are the ones who 
have to clear the staff. So on one side they have the 
operational mission of trying to keep people safe and on the 
other side, they have the operational issue of trying to figure 
out if the people are actually trustworthy. And as the number 
of laboratories balloons their workload balloons, their ability 
to collect intelligence diminishes. And that was their largest 
concern.
    Mr. Sharma. I would also like to add here that if there is 
another accident, it is their responsibility to find out where 
the material came from. And if they do not know how many labs 
there are or where the potentials are, they cannot find the 
perpetrator. And in particular, I think they are in the process 
of resolving this issue, the CDC, we have been told. But up 
until now, they could not even obtain the listing of select 
agent labs that are registered with CDC and this makes their 
job very difficult. In addition, the main intelligence agency 
in general have concerns about this proliferation of labs 
especially not having a centralized Federal vision of what our 
needs are and how those needs are going to be met. Right now it 
is fragmented and they are concerned about it.
    Mr. Stupak. OK. Mr. Green for questions.
    Mr. Green. Thank you, Mr. Chairman. And Dr. Rhodes, I have 
a series of questions but I think the table on page 13 shows a 
shocking amount, that no Federal agency has the mission to 
track high-containment labs in the United States and you go 
down a number of departments and none of them have that 
ability. I am interested in the select agent program. It 
appears that the use of select agents triggers a lab's 
responsibility to register with the CDC. Would you agree?
    Mr. Rhodes. Yes.
    Mr. Sharma. Yes, sir.
    Mr. Rhodes. And USDA.
    Mr. Green. And USDA. I noticed that agents such as SARS are 
not currently on the list. It trumps me to wonder when the list 
was last updated. I know that Congress updated the list in 2002 
with the bioterrorism bill. Was that the last time there was 
any statutory change?
    Mr. Rhodes. To the best of my recollection, that is the 
last time there was a statutory requirement.
    Mr. Green. OK. I know that the CDC and USDA have 
jurisdiction over the regulation and oversight of the actual 
labs. What about the agents being studied in the labs, does any 
regulatory agency have the authority to update the list of 
these select agents?
    Mr. Rhodes. We do not know that answer.
    Mr. Green. You do not know if there is any agency who can 
update that list of the select agents? That is basically the 
question.
    Mr. Rhodes. The CDC.
    Mr. Green. The CDC?
    Mr. Rhodes. Yes.
    Mr. Green. What agency, in your views, is best poised, is 
it CDC? Do you know when they last updated that list?
    Mr. Rhodes. The last update, as I understand it, was in 
response to the 2003 requirement.
    Mr. Green. On other agents other than, for example, SARS, 
what agents do not appear on this select agent list? Is there 
any Federal regulation or inventory of the use of any of these 
agents?
    Mr. Sharma. There is a process in place. As you know, there 
are emerging threats constantly. There is a mechanism whereby 
the list can be updated but we have not specifically looked at 
the process itself, how long it takes and what is involved in 
updating the list.
    Mr. Green. OK. The CDC inspected the Texas A&M lab in 
February 2006 and it was a full 13 days after an employee was 
exposed to Brucella and was incapable of discovering the 
exposures. Is this an inherent deficiency in the inspection 
process or is this specifically an omission by the CDC in this 
instance?
    Mr. Rhodes. I think it is one of the problems in the 
ability of CDC to inspect. Let me give you a counterpart from 
the UK. The HSE, which is the Health Safety Executive, has 
inspectors. The inspectors are warranted. They have law 
enforcement authority. They can compel testimony. They can dig 
up a pipe if they want to. They can kick in a wall if they have 
cause to. They can show up with constables if they need to, if 
they think that they are in danger of personal harm because the 
Health Safety Executive looks into all kinds of public safety 
issues, not just biolabs. But the U.S. Government does not have 
a counterpart to that.
    Mr. Sharma. Let me add a few things here. I think CDC's 
system of inspection relies on documentation and people 
honestly reporting the facts. And if they are not going to, 
they are not going to find out. It is very simple. The second 
thing is, and we have shared this and there are other systems 
in place like in this case, NIH has guidelines on rDNA under 
which they require institutions that receives Federal funding 
to have institutional biosafety committees and they also must 
document the minutes of those meetings. So it is coming from 
another part of the Government which CDC, it is our 
understanding and in the process very labor-intensive, I must 
say this, to review all those minutes. It was documented that 
this person was exposed to. Now, if it wasn't for the fact that 
the Sunshine Project Group took the pain to obtain and review 
and identify this incident, there was no way. It is really the 
responsibility of the institutions to report to CDC. And if 
they are not going to, there is not much that can be done and 
not much we can find out.
    Mr. Green. OK. Mr. Chairman, I know I am out of time. I 
have another question that I would like to submit basically on 
what the GAO found was a primary source of the incidence of the 
biosafety labs and would you attribute it to majority of 
accidents to human error or engineering or design flaws of the 
system and I will submit that in writing, Mr. Chairman.
    Mr. Stupak. OK, very good.
    Mr. Rhodes. Thank you.
    Mr. Stupak. Mr. Inslee, questions please. We have six votes 
on the floor, let us get this panel in if we can and then we 
will take a break.
    Mr. Inslee. Thank you. Is there evidence that the anthrax 
attack on the Senate was essentially a way to provoke this 
inquiry we are having in this hearing? Was that the effort? Is 
there any evidence to suggest that or not?
    Mr. Rhodes. We have seen no evidence to support that 
hypothesis.
    Mr. Inslee. Well, I guess it would not make a difference. 
We have an issue and we have to deal with it, I suppose in any 
event. I've been told that there was a proposed study by NIH 
about the risks associated with proliferation of labs and the 
like that was to be completed. We have not seen it yet. Have 
you seen an NIH assessment of this issue?
    Mr. Rhodes. No, we have not seen that.
    Mr. Inslee. Is there anything forthcoming from them that 
you are aware of or not?
    Mr. Rhodes. We do not know of anything, sir.
    Mr. Inslee. OK. If we do develop some more uniform protocol 
for oversight of these labs, I assume there will be some 
concern about the military aspect of this. It is always 
difficult when you try to blend oversight of civilian and 
military operations and the military has concerns about that 
for understandable reasons.
    Mr. Rhodes. Yes.
    Mr. Inslee. How would we go about having a consistent 
oversight when we have a military operation that, I would 
assume, be part of that?
    Mr. Rhodes. Well, that is one of the models we are looking 
at in the UK because both DEFRA, as well as the Health Safety 
Executive, have oversight of both civilian and military. They 
have the Ministry of Defense laboratories under their 
oversight, so we will look into that and be able to report 
about.
    Mr. Sharma. CDC also, if the military labs are working the 
select agents, they also have to be registered with CDC and CDC 
does provide the same oversight as they provide to other 
civilian institutions.
    Mr. Inslee. OK. You mentioned that some of these existing 
requirements apply only if the facility is receiving Federal 
money. Is it likely to have more of this work done in areas 
where there is not Federal money? We have the situation with 
stem cells right. We have a proliferation of labs, some not 
taking Federal money just so they can continue the stem cell 
research because of the ridiculous restrictions we have on 
Federal funding. Are we going to see more strictly privately-
funded labs here? If we do have requirements, should it apply 
to everyone not just those who are receiving Federal money?
    Mr. Rhodes. We may. One of the problems in trying to answer 
your question is that I have to have some baseline of data. And 
because privately-funded labs, if they are not using select 
agents or are not federally funded, we do not know about them; 
then I cannot even speculate on where that would go.
    Mr. Inslee. Do you think we need some regulatory process 
for all labs, federally or non-federally funded, whether or not 
they use these specific agents? Are there risks associated with 
certain activities that we are not picking up in our system?
    Mr. Rhodes. Yes, there are. There are agents that are not 
on the select agent list and they have grave consequences as 
well. And whether regulation is direct regulation or not or 
whether it is just that we need to know where they are. I mean, 
right now, we do not even know where they are and we do not 
know what is being done and we do not know who is doing it. And 
from my standpoint and my colleague's, as well as a lot of 
safety professionals and security professionals, including our 
own Federal Bureau of Investigation and our own Intelligence 
Community, that is a worrisome subject.
    Mr. Inslee. You are not alone. We should do something. 
Thank you.
    Mr. Rhodes. Thank you.
    Mr. Stupak. Thank you, Mr. Inslee. Mr. Inslee asked the 
question: did you find any study to assess the need for more of 
these level 3 and level 4 labs and you said you did not come 
across any study?
    Mr. Rhodes. We have not come across any.
    Mr. Stupak. Did you request from NIH, CDC or U.S. 
Department of Agriculture any kind of justification of 
proliferation of these labs? Dr. Sharma?
    Mr. Sharma. NIAID in collaboration with the American 
Society of Microbiology did conduct this survey trying to 
ascertain what our lab capacity is. But this study had some 
methodological problems. Primarily one major being very low 
response rates. And we do have that study. But in addition to 
that, we do not have anything else.
    Mr. Stupak. So they tried to do a study but it was such a 
low response, you couldn't make a determination from that 
assessment?
    Mr. Sharma. Right.
    Mr. Stupak. So we still do not know what is the right 
capacity or number of labs that we need?
    Mr. Sharma. Well, if you do not know the universe of labs 
and their capabilities, you cannot obviously meet any----
    Mr. Stupak. Correct. If you do not know its abilities or 
what they are doing you cannot make the assessment.
    Mr. Sharma. Right.
    Mr. Stupak. Mr. Burgess, anything before I let this panel 
go?
    Mr. Burgess. I think Mr. Barton referenced in his opening 
statement, talking about the anthrax attack and when there was 
a Senate hearing there was a question posed to the FBI back in 
2001, the FBI was asked how many labs handle anthrax of this 
type and I guess no one knew the answer to that question.
    Mr. Rhodes. That is correct.
    Mr. Burgess. Do we know the answer today?
    Mr. Rhodes. No.
    Mr. Burgess. Well, let me ask you this. Obviously, we have 
put some time and effort into protecting the homeland with the 
proliferation of labs, is it the opinion of the two individuals 
before us from the GAO that we have moved on that continuum of 
being more secure or are we stationary or are we less secure?
    Mr. Rhodes. That fact that there is so much that is unknown 
at the moment, I would have to say we are at greater risk. 
Because as the number increases, the risk increases and it is 
not just the increase in the material, it is the increase in 
laboratories that have less experience than others.
    Mr. Burgess. So the actual risk may be generated by the 
fact that we are studying to prepare for the risk?
    Mr. Rhodes. Yes. It is a dilemma that we are in.
    Mr. Burgess. But that is one of the prices you pay for 
doing the research, correct?
    Mr. Sharma. That is correct.
    Mr. Burgess. And you'll never get to a point of relative 
security if you are not willing to invest the time and effort 
and the risk in doing the research, is that correct?
    Mr. Rhodes. That is correct but doing----
    Mr. Burgess. And we need to manage the risk.
    Mr. Rhodes. Yes. We are not----
    Mr. Burgess. So my question is, are we doing a good job of 
managing the risk. I would assume the answer to that question 
today is no.
    Mr. Rhodes. No.
    Mr. Burgess. But is it your opinion that we can get to that 
point of managed risk which now is acceptable?
    Mr. Rhodes. Yes, we can. It could be done.
    Mr. Burgess. Thank you. I yield back.
    Mr. Stupak. OK. Just along those lines though, today we are 
only talking about buildings. We have not talked about the 
quantity, quality, string of agents that are out there and who 
is doing what at what labs and things like that. We do not even 
know that.
    Mr. Rhodes. That is correct.
    Mr. Stupak. OK. Future hearing. We have six votes on the 
floor. Let us look for about 12:00, 12:15 we will be back. We 
will dismiss this panel. Thank you very much and thank you for 
your work and we will continue this investigation. So we will 
stand in recess for 45 minutes, 50 minutes.
    [Recess.]
    Mr. Stupak. It is one of those days, as I said, there is a 
hearing going on on the third floor and we have got about three 
hearings going in the Energy and Commerce Committee. So we have 
our second panel of witnesses and they are Dr. Richard Besser, 
who is the Director of the Center for Disease Control and 
Prevention, Coordinating Office of Terrorism Preparedness and 
Emergency Response. Dr. Casey Chosewood, who is director of 
CDC's Office of Health and Safety; Captain Robbin Weyant, who 
is the CDC's Director of Division of Select Agents and Toxins; 
and Dr. Hugh Auchincloss, who is the National Institutes of 
Health, Deputy Director of National Institute of Allergy and 
Infectious Diseases. It is the policy of this subcommittee to 
take all testimony under oath. Please be advised witnesses have 
the right under the rules of the House to be advised by counsel 
during your testimony. Do any of you wish to be represented by 
counsel? No one is indicating no, so therefore I will ask you 
to please rise, raise your right hand to take the oath.
    [Witnesses sworn.]
    Mr. Stupak. Let the record reflect that the witnesses have 
answered in the affirmative. You are now under oath. It is my 
understanding Dr. Besser and Dr. Auchincloss are going to be 
the only ones giving testimony, is that correct? Dr. Besser, 
you want to start with you please, sir?

   STATEMENT OF RICHARD BESSER, M.D., DIRECTOR, COORDINATING 
  OFFICE FOR TERRORISM, PREPAREDNESS AND EMERGENCY RESPONSE, 
           CENTERS FOR DISEASE CONTROL AND PREVENTION

    Dr. Besser. Thank you. Good afternoon, Chairman Stupak, 
Ranking Member Whitfield, the members of the subcommittee. I am 
Dr. Richard Besser, Director of the Coordinating Office for 
Terrorism Preparedness and Emergency Response at the Centers 
for Disease Control and Prevention.
    Accompanying me today are Dr. Rob Weyant, who is the 
director of our Division of Select Agents and Toxins and Dr. 
Casey Chosewood, who is director of CDC's Office of Health and 
Safety. On behalf of CDC, I am pleased to be here today to 
discuss how CDC oversees select agents in the Nation's 
laboratories.
    To further scientific knowledge about biological agents and 
toxins and develop diagnostic tests and countermeasures against 
them, our institutions conduct research on these potentially 
harmful agents. Before undertaking any laboratory experiment, 
it is critical that one weighs the potential benefits of the 
experiment against the potential risks. We recognize that such 
research increases the risks of accidental or intentional 
release of these agents. To mitigate this risk, Congress 
authorized the Federal Government to oversee labs that work 
with select agents. The creation of this program has given our 
Nation an important tool to help minimize the inherent risks 
that accompany work with select agents. The regulation of 
select agents is a shared Federal responsibility between the 
Department of Health and Human Services, Agriculture and 
Justice. Congress gave HHS the authority to regulate the 
possession, use and transfer of biological agents and toxins 
that could pose a severe threat to public health and safety. We 
refer to these as select agents. No program for oversight of 
select agents existed in the United States prior to 1996. In 
2002, Congress significantly strengthened oversight of select 
agents with the passage of the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002. The select 
agent regulations that were established as a result of this Act 
are the ones that are currently in effect.
    It is important to note that not all laboratories work with 
select agents. Therefore, not all laboratories are regulated 
under the provisions of the select agent regulations. For 
instance, HIV and the bacteria that causes tuberculosis are not 
select agents and are not covered by the program. However, the 
Federal Government does provide biological safety guidance to 
the entire laboratory community through a document entitled, 
``Biosafety, Microbiological and Biomedical Laboratories.''
    Laboratories have multiple systems in place to ensure 
biosafety. The first line of defense is proper training of lab 
workers. Before someone can work in a lab, they should undergo 
rigorous lab safety training. People who work in labs also are 
physically protected through the use of personal protective 
equipment such as gloves, masks, goggles and for the most 
dangerous germs, biosuits. Laboratories also are engineered to 
ensure that dangerous pathogens cannot escape. Some of these 
engineering controls include negative air pressurization and 
the use of biosafety cabinets. Accidents can and will happen in 
labs. But these multiple biosafety systems can help to ensure 
that lab workers and the public are protected.
    CDC executes the select agent program through both a strong 
oversight role by evaluating and inspecting registered labs and 
by providing guidance and training to those labs. Routine 
inspections are conducted a minimum of every 3 years. 
Additional inspections are conducted any time that an entity 
requests a significant change to its select agent registration. 
An important tenant of the CDC's select agent program is that 
it treats all registered labs the same, whether that lab is a 
commercial lab, State or local public health lab or Federal 
lab, including CDC and Department of Defense labs.
    The select agent program uses standardized checklists to 
inspect all labs, has the same requirements for all labs and 
uses the same standards when referring any lab to the HHS 
Office of Inspector General for possible violations of the 
regulations.
    Public concerns and questions about the overall safety of 
our Nation's laboratory workers are understandable and 
legitimate. In the 4 years that the select agent program has 
been in place with approximately 400 organizations being 
registered and after careful investigations when a potential 
incident has been reported, there have been no confirmed losses 
or thefts of a select agent and there have been three confirmed 
releases of a select agent. After careful investigation, none 
of these releases were considered to be a public health threat.
    This does not mean, however, that such incidents cannot 
happen in the future. Even a lab that follows all biosafety 
guidelines may have accidents. But the biosafety and 
biosecurity requirements that Congress established help reduce 
the likelihood that these accidents will impact worker or 
community health.
    We have accomplished much since the program began but we 
are always looking for ways to improve. Investigations of labs 
have taught us important lessons. We have learned that we need 
to make improvements during inspection verification processes. 
In the future during our inspections, we plan to expand the 
scope of interviews and review a broader array of documents to 
identify problems that may go unreported by registered labs. In 
addition, we plan to assess the composition of our inspection 
teams and the frequency of our inspections. We also have 
learned that we need to provide additional outreach and 
training to the regulated community and create additional 
guidance documents. We will be undertaking an external review 
of the CDC's select agent program so that we can continue to 
improve our oversight of select agent work. The external group 
conducting this review will actively solicit the input of 
stakeholders and the general public. In addition to this 
review, the HHS Office of Inspector General is conducting an 
audit of CDC's management of its select agent program. We look 
forward to the findings and recommendations scheduled for 
completion in 2008 and using this work to help strengthen our 
program.
    In conclusion, the select agent programs at CDC and USDA, 
working in concert with the Department of Justice, have greatly 
enhanced the Nation's oversight of dangerous biological agents 
and toxins. The select agent regulations have helped ensure 
that research with select agents is conducted as safely and 
securely as possible. However, the possibility of accidental or 
intentional release of these agents always remains so we must 
remain vigilant and work to continuously improve our oversight. 
We will continue to enforce the regulations and provide 
technical assistance and guidance to the regulated community to 
ensure that the public's health and safety are protected.
    CDC greatly appreciates the support of this subcommittee 
and the rest of Congress in supporting its activities. We look 
forward to continuing our work with you on these important 
issues. Thank you for the opportunity to share this information 
with you and I look forward to answering questions.
    [The prepared statement of Dr. Besser follows:]

                  Statement of Richard E. Besser, M.D.

    Good morning Chairman Stupak, Ranking Member Whitfield and 
members of the Subcommittee. I am Dr. Richard Besser, Director 
of the Coordinating Office for Terrorism Preparedness and 
Emergency Response (COTPER) at the Centers for Disease Control 
and Prevention (CDC), an agency of the Department of Health and 
Human Services. Accompanying me today are Dr. Rob Weyant, 
Director of the Division of Select Agents and Toxins in COTPER, 
and Dr. Casey Chosewood, Director of the CDC Office of Health 
and Safety. On behalf of CDC, I am pleased to be here today to 
discuss how CDC oversees select agents in the Nation's 
laboratories.
    To further scientific knowledge about biological agents and 
toxins and develop countermeasures against them, our academic, 
commercial, and government institutions conduct research on 
these potentially harmful agents. We recognize that such 
research increases the risks of accidental or intentional 
release of these agents. To mitigate this risk, Congress 
authorized the Federal Government to oversee labs that work 
with select agents--which include such things as Bacillus 
anthracis (which causes anthrax), Yersinia pestis (which causes 
plague), and Variola major virus (which causes smallpox). The 
creation of this program has given our nation an important tool 
to help minimize the inherent risks that accompany work with 
select agents.
    The regulation of select agents is a shared Federal 
responsibility involving HHS, the Department of Agriculture 
(USDA), and the Department of Justice (DOJ). Congress gave HHS 
the authority to regulate the possession, use, and transfer of 
biological agents and toxins (select agents) that could pose a 
severe threat to public health and safety. The Secretary of HHS 
has delegated this authority to CDC. Congress gave USDA similar 
authority to regulate select agents that pose a severe threat 
to animal and plant health and/or animal and plant products. 
DOJ is responsible for conducting background checks, called 
security risk assessments, of any entities and individuals that 
want to work with select agents. By regulating the possession, 
use, and transfer of select agents, HHS, USDA, and DOJ 
contribute to the Nation's overall terrorism deterrence 
strategy.
    My testimony will focus on CDC's role in the regulation of 
select agents. I will describe the history of the CDC Select 
Agent Program, CDC's role in oversight of select agent 
laboratories, our collaboration with other Federal partners, 
the key components of the CDC regulatory program, key program 
accomplishments, and our future plans for enhancing the 
program.
    Establishing Oversight over Select Agents: A Brief 
HistoryNo program for oversight of select agents existed in the 
United States prior to 1996. In 1996, Congress passed the 
Antiterrorism and Effective Death Penalty Act of 1996 (P.L. 
104-132; signed April 24, 1996). With the regulations that went 
into effect in April 1997 (42 CFR 72.6), the Secretary of HHS 
established a list of biological agents that have the potential 
to pose a severe threat to public health and safety. The 
Secretary also established procedures for the transfer of these 
biological agents. The CDC Select Agent Program has been in 
place since 1996. The program was originally located within 
CDC's Office of Health and Safety and is now located within 
CDC/COTPER's Division of Select Agents and Toxins.
    In 2001, Congress expanded the scope of the program by 
restricting the shipping, possession, and receipt of select 
agents by passing the Uniting and Strengthening America by 
Providing Appropriate Tools Required to Intercept and Obstruct 
Terrorism Act of 2001 (USA PATRIOT Act); (P.L. 107-56; signed 
Oct. 26, 2001). The USA PATRIOT Act created a provision related 
to select agents requiring that no restricted person shall 
transfer (i.e., ship, possess, or receive) a select agent.
    In 2002, Congress significantly strengthened oversight of 
select agents with the passage of the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002 (the 
Bioterrorism Act); (P.L. 107-188; signed June 12, 2002). The 
Bioterrorism Act strengthened the regulatory authorities of HHS 
under Sec. 511 of the Antiterrorism and Effective Death Penalty 
Act of 1996 and granted comparable regulatory authorities to 
USDA for select agents that present a severe threat to animal 
or plant health, and/or animal or plant products. It also 
required coordination and concurrence between HHS and USDA on 
program activities (e.g., development of regulations, reporting 
forms, approval of changes to regulated laboratories--
registrations, et cetera) for select agents regulated by both 
agencies.
    The Bioterrorism Act has been implemented through a series 
of regulations. HHS published an interim final rule--the 
``Possession, Use, and Transfer of Select Agents and Toxins'' 
Interim Final Rule (42 CFR 73, 9 CFR 121, and 7 CFR 331) 
(effective on February 7, 2003) which implemented the pertinent 
provisions of the Bioterrorism Act. A subsequent Final Rule 
became effective on April 18, 2005. On October 20, 2005, HHS 
established an Interim Final Rule adding reconstructed 
replication competent forms of the 1918 pandemic influenza 
virus containing any portion of the coding regions of all eight 
gene segments to the HHS select agent list. These regulations 
are hereafter referred to as the ``select agent regulations''.

 Role of the Select Agent Program in Oversight of LaboratoriesNot All 
                   Laboratories Handle Select Agents

    Whereas HHS and USDA have authority to regulate any 
laboratories that possess, use, or transfer select agents, not 
all laboratories work with select agents. Therefore, not all 
laboratories are regulated under the provisions of the select 
agent regulations. For instance, human immunodeficiency virus 
(HIV) and Mycobacterium tuberculosis are not select agents and 
any laboratories working with these agents are not required to 
register with either HHS or USDA.
    All five currently operational Biosafety Level (BSL) 4 
laboratories in the United States are select agent registered 
entities. (Any organization that has received a certificate of 
registration through either the HHS or USDA Select Agent 
Program is referred to as a "registered entity".)

  Federal Government Guidance to Biological Laboratories and Related 
                              Requirements

    Though only a subset of laboratories is regulated by the 
Federal Government under the provisions of the select agent 
regulations, the Federal Government does provide biological 
safety guidance to the entire laboratory community. The 
Biosafety in Microbiological and Biomedical Laboratories (BMBL) 
(4th edition is available in print; 5th edition is available at 
http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm), produced 
by CDC and the National Institutes of Health (NIH), is a 
nationally and internationally recognized source that provides 
safety guidance to laboratories that work with infectious 
agents. The BMBL provides recommendations for safely working 
with a variety of human pathogens and describes standard and 
special microbiological practices, safety equipment, and 
facilities (constituting Biosafety Levels 1-4). In the BMBL, 
there are agent summary statements that provide recommendations 
for the appropriate biosafety safety level to work with these 
agents. The BMBL also is offered as a guide and reference in 
the construction of new laboratory facilities and in the 
renovation of existing facilities.
    CDC references the BMBL in the select agent regulations and 
requires select agent registered entities to comply with the 
BMBL guidelines or equivalent standards. Specifically, the 
select agent regulations state that the entity should consider 
the BMBL, NIH's Recombinant DNA Guidelines, and the 
Occupational Safety and Health Administration's regulations on 
handling toxins (29 CFR 1910.1200, 29 CFR 1910.1450) in 
developing and implementing a written biosafety plan that is 
commensurate with the risk of the select agent, given its 
intended use. If the Select Agent Program determines that the 
entity's biosafety and containment procedures are not 
sufficient to contain the select agent, then the program can 
cite the entity for non-compliance.

               Collaboration with Other Federal Partners

    The CDC Select Agent Program works closely with both USDA 
and DOJ to implement the select agent regulations. USDA's 
Animal and Plant Health Inspection Service (APHIS) is 
responsible for regulating the possession, use, and transfer of 
select agents that pose a severe threat to animal or plant 
health and/or animal or plant products. For select agents that 
pose a threat to both humans and animals or animal products, 
these select agents are regulated by both CDC and APHIS and are 
called ``overlap agents''. To limit the burden on registered 
entities, CDC and APHIS worked closely with the Office of 
Management and Budget to promulgate regulations with identical 
requirements and analogous language and to create one set of 
registration and reporting forms to be used by both agencies. 
These actions helped standardize communication and 
interpretation of the regulations among CDC, APHIS, and the 
regulated community.
    To minimize the burden on entities that possess, use, or 
transfer select agents, a single point of contact with either 
CDC or APHIS was established. This single point of contact in 
the ``lead agency'' is responsible for coordinating all 
activities and communications with respect to the entity's 
registration, including coordination with both the non-lead 
agency (APHIS or CDC) and with DOJ. CDC and APHIS collaborate 
daily on select agent activities such as the development of 
select agent policies, resolution of common issues associated 
with the entity's registration (such as reviewing the required 
plans), conducting joint inspections, developing standard 
operating procedures and entity guidance documents, and 
providing concurrences to entities' amendments. We also 
collaborate on longer-term projects to improve the 
implementation of the select agent regulations, such as the 
establishment of a national select agent Web site 
(www.selectagents.gov) and development and deployment of a 
single shared database (the National Select Agent Registry).
    CDC also works closely with DOJ's Criminal Justice 
Information Service (CJIS). CJIS conducts security risk 
assessments of all individuals and entities that request to 
possess, use, or transfer select agents. As of September 25, 
2007, 14,868 individuals have received access approval from CDC 
to work with select agents, based on the results of the CJIS 
security risk assessments. CDC also provides information to 
DOJ's Federal Bureau of Investigation (FBI) for ongoing 
criminal investigations related to select agents.

         Oversight of Select Agents: The CDC Regulatory Program

    CDC exerts a strong oversight role by evaluating and 
inspecting registered entities, in addition to providing 
guidance and training to registered entities.
    An important tenet of the CDC Select Agent Program is that 
it treats all registered entities the same--whether that lab is 
a commercial lab, state or local public health lab, or a 
Federal lab (including CDC and Department of Defense labs). The 
Select Agent Program uses standard checklists to inspect all 
labs, has the same requirements of all labs, and uses the same 
standards when referring any lab to the HHS Office of Inspector 
General (HHS-OIG) for possible violations of the regulations.

                CDC's Approach to Inspection of Entities

    Laboratory inspections are the primary means by which CDC 
confirms compliance with the select agent regulations. Routine 
inspections are conducted every three years. Additional 
inspections are conducted any time that an entity requests a 
significant change to its select agent registration. Such 
changes may include the addition of a new facility, addition of 
a new agent, or the initiation of a new procedure. Other 
inspections that are performed include follow-up inspections 
based on observations from audits performed by Federal partners 
and investigations that may have involved biosafety or security 
concerns that could affect public health and safety.
    CDC's protocol for routine inspections consists of an 
extensive review of laboratory safety and security as it 
relates to the possession, use, and transfer of select agents. 
CDC uses specific checklists to guide its inspections (the 
checklists can be found at www.selectagents.gov). These 
checklists have been developed from the select agent 
regulations and nationally recognized safety standards. The 
information entered on the checklists is derived from 
inspectors' observations of the physical safety and security 
components of the facility, an examination of the documentation 
available, and from interviews with laboratory personnel. These 
findings are conveyed to the institution in an inspection 
report. Entities must respond within a specified timeframe to 
the deficiencies noted in the inspection report and provide 
documentation of how they have resolved those deficiencies. In 
circumstances where the deficiencies are serious and CDC wants 
to confirm in person that the deficiencies have been corrected, 
a verification site visit is performed.
    When CDC identifies deficiencies and possible violations of 
the select agent regulations, several types of enforcement 
actions can occur:

      Administrative actions: CDC can decide to suspend 
or revoke a registered entity's certificate of registration (a 
suspension can be for all work at a registered entity or be 
specific to particular agents or particular types of 
experiments). Also, CDC can deny an entity's application to 
possess, use, or transfer select agents;
      Referral to HHS-OIG: CDC can refer possible 
violations of the select agent regulations to HHS-OIG. HHS-OIG 
can levy civil monetary penalties (up to $250,000 for an 
individual for each violation and up to $500,000 for an entity 
for each violation) or recommend criminal enforcement 
(imprisonment for up to five years, a fine, or both).
      Referral to FBI: CDC can refer possible 
violations involving criminal negligence or a suspicious 
activity or person to the FBI for further investigation.

    As of September 25, 2007, CDC has referred 37 entities to 
HHS-OIG for violation of the select agent regulations (such as 
for unauthorized transfers and entities that are not registered 
with the Select Agent Program in possession of select agents). 
HHS-OIG has levied $837,000 in civil monetary penalties against 
ten (10) of the entities. For further information, please see 
the HHS-OIG Web site (http://oig.hhs.gov). HHS has not referred 
to DOJ any violations of the select agent regulations for 
criminal prosecution.
    Technical Assistance and Guidance Provided to Strengthen 
the ProgramWhile enforcing the select agent regulations is the 
CDC Select Agent Program's primary responsibility, the program 
also promotes laboratory safety and security by providing 
technical assistance and guidance to registered entities. Some 
of the technical assistance that CDC provides to registered 
entities includes having a primary point of contact assigned to 
each entity, development of frequently asked questions that are 
posted on the program website, and technical presentations at 
various conferences. The CDC Select Agent Program in 
collaboration with APHIS provides assistance and guidance to 
help the entire regulated community operate as safely and 
securely as possible.
    Some examples of the assistance that the CDC and APHIS 
Select Agent Programs have recently provided to the regulated 
community include:

     As mentioned previously, CDC and APHIS released a 
security guidance document to registered entities.
      CDC and APHIS released inspection checklists to 
assist registered entities in complying with the security, 
incident response, training, and recordkeeping requirements of 
the select agent regulations.
      CDC is further educating the entities about the 
regulations and the inspection process. It recently completed 
two training videos that explain the facility inspection 
process to the regulated community.

    In addition, CDC has proactively worked with registered 
entities in advance of hurricanes to ensure that all select 
agents are properly secured. For example, prior to the landfall 
of Hurricane Katrina in 2005, CDC contacted 11 registered 
entities located in Louisiana, Mississippi, and Alabama. CDC 
collected information regarding the entities' plans to 
safeguard select agents during and after the storm and informed 
the entities that CDC stood ready to expedite the emergency 
transfer of select agents should the need arise. CDC has taken 
similar action in 2006 and 2007 in anticipation of other 
hurricanes and predictable natural disasters (such as floods) 
that could affect public health and safety, to minimize risk 
and any impact on public health and safety.

                     Program Activities and Results

    Accomplishments to Date. Since the publication of the 
select agent interim final rule in 2003 (followed by the final 
rule in 2005), CDC in collaboration with our Federal partners 
has (as of September 25, 2007):

      Conducted 607 inspections to ensure that 
appropriate security and safety measures are in place to deter 
the theft, loss, or release of select agents;
      Authorized 2,199 requests to transfer select 
agents; and
      Granted access approvals to 14,868 individuals to 
work with select agents, following a security risk assessment 
by CJIS.

                  Reports of Theft, Loss, and Release

    CDC investigates all reports of theft, loss, or release of 
select agents to ensure that the public's health and safety are 
protected. It is important for the public to know that after 
careful investigation, no incidents reported at select agent 
laboratories were considered to be a public health threat. From 
2003 until September 25, 2007, there have been one hundred five 
(105) incidents reported to CDC through the Select Agent 
Program's theft, loss, and release reporting system. As a 
result of follow-up investigations conducted by HHS, USDA, and 
the FBI regarding these reports, it was determined that there 
were:

      No confirmed losses of a select agent;
      No confirmed thefts of a select agent; and
      Three (3) confirmed releases of a select agent 
which were identified by illnesses in five (5) lab workers that 
had occurred as a result of working with these agents.

    Even in the best of laboratories, which follow all 
biosafety guidelines, accidents like a broken test tube or a 
needle stick can still occur, and we can expect that we will 
continue to receive reports of possible losses and releases of 
select agents. However, we believe we should always strive to 
eliminate all incidents. Appropriately contained and managed 
laboratories have multiple systems in place to ensure biosafety 
and have robust occupational health services in place to 
quickly mitigate the effect of any laboratory incident. We also 
believe that the security requirements put in place by the 
select agent regulations will continue to mitigate the 
possibility of a theft of a select agent.
    Moving Forward with Enhancing the Select Agent ProgramThe 
CDC Select Agent Program has accomplished much since the 
program began, but we are always looking for ways to improve. 
The Select Agent Program is a young program and it will 
continue to build upon its successes and learn from its 
challenges. CDC is committed to continuous program improvement 
to fulfill its mission.

                            Lessons Learned

    Investigations of select agent registered entities have 
taught CDC some important lessons:
      We need improvements in our inspection process. 
Some of the improvements under consideration include:
      Expand the scope of interviews to include more 
types of laboratory workers during inspections, to better 
assess the implementation of policies and the quality of 
training;
      Examine more closely the implementation of 
biosafety, security, and incident response plans;
      Review a broader array of documents during our 
inspections, such as biosafety committee meeting minutes and 
occupational health records, to identify problems that may go 
unreported by registered entities; and
      Assess the composition of our inspection teams, 
the frequency of our inspections, and whether we need to apply 
a prioritization system to how often we inspect labs.
      We need improvements in our verification process. 
Whereas before we relied primarily upon documentation from 
entities to confirm that deficiencies were corrected, we plan 
to conduct more verification site visits.
      We need to provide additional outreach and 
training to the regulated community, including additional 
outreach and training to Responsible Officials and creation of 
additional guidance documents related to biosafety, incident 
response, record-keeping, and theft, loss, and release.

    The CDC Select Agent Program also must address the 
challenge of how the select agent regulations apply to emerging 
technologies, such as synthetic genomics and nanotechnology. 
With technology advancing at a rapid pace, CDC and its Federal 
partners need to constantly review the select agent regulations 
and our implementation of the regulations to ensure that we can 
respond to new threats and vulnerabilities.

            External Review of the CDC Select Agent Program

    In the coming year, CDC will commission an external peer 
review of the CDC Select Agent Program. The external group 
conducting the review will actively solicit the input of 
stakeholders and the general public.
    In addition to this external peer review, HHS-OIG is 
conducting an audit of CDC's management of its select agent 
program. We look forward to receiving the findings from that 
audit in 2008 and plan to carefully consider and implement HHS-
OIG's recommendations.
    The select agent programs at CDC and APHIS, working in 
concert with DOJ, have greatly enhanced the nation's oversight 
of dangerous biological agents and toxins. Because of the 
efforts of the individuals in these programs, there is improved 
awareness of biosafety and biosecurity throughout the select 
agent community. The select agent regulations have helped 
ensure that research with select agents is conducted as safely 
and securely as possible. CDC and its Federal partners have 
accomplished much in the few years since the publication of the 
select agent regulations, but we must remain vigilant in 
ensuring laboratory safety and security. We will continue to 
enforce the regulations and provide technical assistance and 
guidance to the regulated community to ensure that the public's 
health and safety are protected.
    CDC greatly appreciates the support of this Subcommittee 
and the rest of the Congress in supporting its activities. We 
look forward to continuing our work with you on these important 
issues. Thank you for the opportunity to share this information 
with you. I am happy to answer any questions.
                              ----------                              

    Mr. Stupak. Thank you. Dr. Auchincloss?

STATEMENT OF HUGH AUCHINCLOSS, M.D., DEPUTY DIRECTOR, NATIONAL 
    INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL 
   INSTITUTES OF HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN 
                            SERVICES

    Dr. Auchincloss. Mr. Chairman, members of the subcommittee, 
my name is Hugh Auchincloss and I am the Deputy Director of the 
National Institute of Allergy and Infectious Diseases, one of 
the National Institutes of Health.
    I am pleased to have the opportunity to discuss the 
expansion of NIH's biodefense research infrastructure. I have 
submitted written testimony but will highlight certain portions 
in these oral remarks.
    The anthrax attacks in 2001 were a sobering reminder that 
biologic agents can be used for terrorism. In addition, defense 
against naturally-emerging infections must be a top national 
priority. In February 2002, the NIH embarked on a systematic 
planning process for biodefense. We convened a blue ribbon 
panel made up of distinguished scientists representing 
academia, private industry and the Government. And we also 
conducted extensive discussions with other Federal agencies. 
Based on this input, we developed the NIAID Strategic Plan for 
Biodefense Research and other supporting documents. That blue 
ribbon panel noted that the shortage of BSL-3 and 4 
laboratories was a major obstacle to accomplishing the 
objectives of the NIAID Biodefense Research agendas. NIAID then 
estimated the number of new facilities needed to accomplish our 
biodefense research objectives. Congress responded 
appropriating over $850 million for the construction of new 
BSL-3 and 4 facilities in four separate bills between 2002 and 
2005. As a result, 14 new BSL-3 facilities and four new BSL-4 
facilities are scheduled for completion within the next several 
years.
    During the development of our construction project, we have 
had literally hundreds of meetings in public forums to discuss 
our building program, the agents that will be studied there and 
to keep the public well informed.
    The NIH is committed to helping ensure that all biodefense 
research facilities operate safely with maximum protection of 
the public health. The safety standards for this type of 
research are best articulated in the Biosafety and 
Microbiological and Biomedical Laboratories Manual, this so-
called BMBL. However, monitoring adherence to these good 
laboratory practices is complicated because multiple agencies 
are involved. You have already heard from Dr. Besser that much 
of the research in BSL-3 and 4 facilities involves select 
agents, which are regulated by CDC and other Government 
agencies. The NIH Office of Biotechnology Activities 
administers guidelines for research involving recombinant DNA 
and requires that Institutional Biosafety Committees, or IBCs, 
oversee this work at the local level. The IBCs first came into 
existence to oversee recombinant DNA research but many 
institutions have gradually broadened IBC responsibilities to 
include oversight of research involving all pathogens studied 
at BSL-3 and 4 levels. However, at this time, there is no 
Federal body that sets national standards or policies for this 
particular function of local IBCs. To enhance the effectiveness 
of the IBCs, as their role has evolved, the NIH has worked 
intensively with the IBC community through a program of 
outreach and education. Furthermore, each of the institutions 
receiving one of the new construction grants from NIAID has an 
IBC appropriately registered with NIH and each has willingly 
accepted responsibility for adhering to the BMBL standards.
    NIH is looking at ways to strengthen local and Federal 
oversight of facilities that conduct biodefense research. 
Clearly, the issues associated with this oversight are much 
larger than the NIH or even the Department of Health and Human 
Services. Biodefense research is conducted by many Government 
agencies. For that reason, the Department of Health and Human 
Services, the United States Department of Agriculture, the 
Department of Homeland Security and the Department of Defense 
have already agreed to establish a trans-Federal task force to 
undertake, in consultation with other relevant agencies, an 
intensive analysis of the current biosafety framework and to 
develop a set of recommendations for improvement.
    Given the importance of biosafety for the country and its 
citizens, active participation from the public at large will be 
essential.
    The planned expansion of our infrastructure is needed if we 
are to fulfill our research agenda and protect the Nation from 
disease threats, be they deliberate or acts of nature. We have 
already made substantial progress in ways that I have outlined 
in my written testimony. Progress can occur more rapidly as the 
new facilities become available.
    Thank you very much and I will be happy to answer questions 
also.
    [The prepared statement of Dr. Auchincloss follows:]

                  Statement of Hugh Auchincloss, M.D.

    Mr. Chairman and members of the Subcommittee, my name is 
Hugh Auchincloss and I am the Deputy Director of the National 
Institute of Allergy and Infectious Diseases (NIAID), a 
component of the National Institutes of Health (NIH), an agency 
of the Department of Health and Human Services (HHS). I am 
pleased to have the opportunity to discuss the NIH biodefense 
research program, including the expansion of the Nation's 
biodefense research infrastructure and the need to ensure that 
biodefense research is conducted safely.
    The anthrax attacks in 2001 were a sobering reminder that 
the threat of deliberately released microbes can be used as a 
form of terrorism. Moreover, naturally occurring microbial 
outbreaks pose a serious threat to domestic and global health. 
The experience with SARS in 2003 and the ongoing outbreaks of 
H5N1 avian influenza and extensively drug-resistant 
tuberculosis have reminded us that defense against naturally 
emerging microbes must be a top national priority. Congress has 
recognized the urgency of improving our defenses against 
emerging public health threats and has supported funding for 
such research. Within the broad Federal effort against emerging 
threats to public health, the role of the NIH is to conduct and 
support basic and applied research that will lead to new 
vaccines, drugs, and diagnostic tools.

         Expanding the Nation's Biodefense Research Capability

    In February 2002, the NIH embarked on a systematic planning 
process for its biodefense research program. It first convened 
the Blue Ribbon Panel on Bioterrorism and Its Implications for 
Biomedical Research, made up of distinguished scientists 
representing academia, private industry, and government. Based 
on the panel's advice and extensive discussions with other 
Federal agencies, the NIH developed three key documents to 
guide its biodefense research program: the NIAID Strategic Plan 
for Biodefense Research, the NIAID Research Agenda for Category 
A Agents, and the NIAID Research Agenda for Category B and C 
Agents.
    As a result of the strategic planning process, a clear 
consensus emerged that meeting the goals of the biodefense 
Research Agendas would require additional research 
infrastructure, especially research laboratories built to 
modern Biosafety Level 3 (BSL-3) and Biosafety Level 4 (BSL-4) 
standards. BSL-3 laboratories are used to study contagious 
agents that can be transmitted through the air and cause 
potentially lethal infection. BSL-4 laboratories are used to 
study agents that pose a high risk of life-threatening disease 
for which no vaccine or therapy is available; they incorporate 
all BSL-3 features and occupy safe, isolated zones within a 
larger building.
    There has been considerable discussion of how best to 
assess the extent of high-containment facilities that would be 
required in the United States in the public, academic and 
private sectors and for what purposes these varied facilities 
are used. Published estimates range from as few as 200 to as 
many as 1400 BSL-3 laboratories. (Many institutions maintain 
multiple facilities.) The explanation for this wide discrepancy 
is that an assessment of laboratory capacity depends on the 
definitions and sources of information used. Estimates at the 
high end, for example, include the many hospitals that maintain 
small areas that meet BSL-3 standards that can be used for 
testing clinical samples that might contain infectious agents. 
These are not ``research laboratories.'' Some hospitals, 
pharmaceutical companies, biotechnology firms, private 
reference laboratories and State public health laboratories 
also have facilities that meet BSL-3 standards, but these are 
not generally available for NIH-sponsored research. Finally, 
many BSL-3 facilities constructed before the mid-1990's cannot 
support research on select agents and on associated animal 
models. In 2002, NIAID determined that very little usable BSL-3 
or BSL-4 research space was actually available for its academic 
scientists in the extramural research program.
    The Blue Ribbon Panel of 2002 noted the shortage of BSL-3 
and BSL-4 laboratory space as a significant rate-limiting 
obstacle in accomplishing the objectives of the NIAID 
Biodefense Research Agendas. In response, NIAID estimated the 
new BSL-3 and BSL-4 facilities that would be required to 
accomplish the Research Agenda. Congress also recognized the 
critical need for new BSL-3/4 laboratories and responded 
quickly to supply the necessary resources to fulfill this need. 
In 2002, the Department of Defense and Emergency Supplemental 
Appropriations for Recovery from and Response to Terrorist 
Attacks on the Unites States Act, Public Law (P.L.) 107-117, 
appropriated $70 million for the construction and renovation of 
NIH intramural biocontainment facilities. The Consolidated 
Appropriations Act of 2003, P.L. 108-7, provided $372.6 million 
to NIAID for construction of extramural biocontainment 
facilities and $291 million for construction of additional 
intramural biocontainment facilities. Further, the Project 
BioShield Act of 2004 (P.L. 108-276), amended the Public Health 
Service Act to provide ongoing authority to NIAID to award 
grants and contracts for construction of research facilities. 
An additional $150 million was appropriated for NIAID in the 
2005 consolidated appropriations act (P.L. 108-447) for 
extramural facilities construction grants.
    The NIH is now implementing a construction program that 
will complete 14 new BSL-3 facilities and 4 new BSL-4 
facilities within the next several years. During this process, 
the NIH or its funded institutions have participated in 
literally hundreds of public forums on the nature and safety of 
the new facilities, and have submitted reports to Congress 
annually, along with periodic updates on our strategic plans. 
In addition, NIH leadership has discussed the infrastructure 
expansion with Congress on many occasions. And because NIH does 
not fund or conduct classified research, the title and 
substance of every research project funded by the NIH is 
publicly available.
    Another important aspect of the biodefense research 
infrastructure is a network of ten NIH-funded Regional Centers 
of Excellence for Biodefense and Emerging Infectious Diseases 
Research (RCEs). Created in 2003, these multidisciplinary 
academic research programs are located at institutions across 
the country and provide the scientific expertise for a wide-
ranging biodefense research program, directed against 
deliberate and naturally-occurring threats, that will be 
pursued in the new facilities.

                      NIH Role in Ensuring Safety

    The NIH is committed to helping ensure that all biodefense 
research facilities provide maximum protection for public 
health. The NIH is committed to the highest quality in the 
design and construction of these facilities, the rigorous 
training of the personnel that operate them, and the safe 
conduct of the research undertaken within them.
    To ensure that the new laboratories are designed and 
constructed to the highest standards, the NIAID works closely 
with each grantee institution. Highly experienced NIAID staff 
architects and engineers, with extensive experience in design 
of biocontainment facilities, are assisted by a Construction 
Quality Management group of contracted consultants with 
additional expertise. Together, these teams make certain that 
the finished projects will meet the regulations of HHS's 
Centers for Disease Control and Prevention (CDC) and the 
Department of Agriculture's Animal and Plant Health Inspection 
Service (USDA/APHIS) for facilities that conduct research on 
select agents.
    The NIH also supports a vigorous biosafety and 
biocontainment training effort that has expanded substantially 
over the past five years. The National Biosafety and 
Biocontainment Training Program (NBBTP) is a partnership 
between the NIAID and the NIH Division of Occupational Health 
and Safety (DOHS), managed by a not-for-profit education and 
research foundation. The mission of this program is to prepare 
biosafety and biocontainment professionals of the highest 
caliber. The program offers two-year post-baccalaureate and 
post-doctoral fellowships at NIH's campus in Bethesda, 
Maryland, with both academic and hands-on training. The NBBTP 
has also provided training for containment laboratory operation 
and maintenance personnel across the country. In addition to 
this program, NIAID funds 28 Institutional Training Grants in 
Biodefense, and the RCEs conduct extensive training in 
biosafety and biocontainment. At the RCE at Emory University in 
Atlanta, for example, trainees from across the country 
regularly participate in BSL-3 and BSL-4 training in mock 
laboratories, constructed specifically for training purposes.
    When these new facilities are ready for operation, NIH is 
committed to ensuring that the research conducted within them 
is performed safely. The most widely used guidance on the safe 
conduct of this research is the Biosafety in Microbiological 
and Biomedical Laboratories Manual (BMBL), which was first 
produced jointly in 1984 by the NIH and CDC and which is now in 
its fifth edition and available online.
    Monitoring adherence to good laboratory practices is a 
complex process because multiple agencies are involved. Much of 
the research in BSL-3 and BSL-4 facilities involves pathogens 
that have been designated as select agents. CDC and APHIS have 
the responsibility for regulating the possession, use, and 
transfer of select agents. For research that involves 
recombinant DNA, the select agent regulations incorporate the 
NIH Guidelines for Research Involving Recombinant DNA Molecules 
(Recombinant DNA Guidelines) as a consideration in the entity's 
development of its biosafety plan. The NIH Office of 
Biotechnology Activities (OBA), with advice and guidance from 
the NIH Recombinant DNA Advisory Committee (RAC), is 
responsible for implementation of the Recombinant DNA 
Guidelines, which outlines biosafety and containment standards 
for research involving recombinant DNA. Also, the select agent 
regulations require that restricted experiments, such as the 
deliberate transfer of a drug-resistant trait to a select 
agent, must be approved by CDC or APHIS prior to initiation. 
However, some research conducted in BSL-3 facilities involves 
neither select agents nor recombinant DNA.
    Local institutional bodies play a very important role in 
oversight of many aspects of biomedical research. For example, 
oversight to protect human subjects in clinical studies is 
provided by local Institutional Review Boards (IRBs), and in 
the case of animal research, oversight to ensure humane 
treatment is provided by the Institutional Animal Care and Use 
Committees (IACUCs). The NIH Guidelines mandate that 
Institutional Biosafety Committees (IBCs) oversee recombinant 
DNA research, but many institutions have gradually broadened 
IBC responsibilities to include oversight of research involving 
all pathogens studied at BSL-3 and BSL-4 levels. At this time 
there is no Federal body that sets national standards or 
policies for this function of local IBCs, and adherence to BMBL 
guidelines for BSL-3 and BSL-4 research is voluntary; however, 
the select agents regulations require regulated entities to 
comply with the BMBL guidelines or equivalent standards.
    The NIH is deeply concerned about recent reports of 
accidents occurring in BSL-3 facilities. When these events 
involve recombinant DNA, they are reported to the OBA, and a 
root cause analysis is done so that NIH can assess the adequacy 
of the institution's response and work with the institution to 
put mechanisms in place to mitigate the chance of a 
reoccurrence. To enhance all of the functions of the IBCs, the 
NIH has worked intensively with the IBC community. These 
efforts have included an extensive program of outreach and 
education, involving frequent day-long training sessions, 
exhibits at major scientific conferences, policy guidances, 
educational resources for institutions to use in local 
training, and other means. Furthermore, each of the 
institutions receiving one of the new facilities construction 
grants from NIAID has an IBC appropriately registered with NIH 
and each has willingly accepted responsibility for adhering to 
BMBL standards.
    The NIH is examining ways to strengthen local and Federal 
oversight of facilities that conduct NIH-funded research. The 
issues associated with oversight of research in BSL-3 and BSL-4 
facilities transcend the NIH, or even the HHS. Biodefense 
research involving BSL-3 and BSL-4 facilities is conducted by 
many government agencies, including the Department of Defense 
(DoD), the Department of Homeland Security (DHS), and the USDA, 
as well as by universities and biotechnology companies. As I 
noted earlier, BSL-3 facilities exist in hospitals for routine 
handling of clinical samples. It is important to devise a 
framework that improves oversight, training, and reporting to 
enhance safety without causing unintended negative consequences 
for either patient care or the biodefense research program. For 
that reason, HHS, USDA, DHS, and DoD have already agreed to 
establish a Trans-Federal Task Force to undertake, in 
consultation with other relevant agencies, an intensive 
analysis of the current biosafety framework and to develop a 
set of recommendations for improvement. Given the critical 
importance of biosafety to protecting public health and the 
concerns that the high containment facilities engender among 
local communities, active participation in this process from 
the public at large will be essential.
    Support for infrastructure for biodefense research is 
essential if we are to fulfill our biodefense research agenda 
and protect the Nation from disease threats, be they deliberate 
or acts of nature. We have already made substantial progress 
with the facilities now available. For example, NIH-funded 
scientists have developed a safer second-generation smallpox 
vaccine called ACAM2000 and a very promising new smallpox drug 
named ST-246. Investigators have developed and tested a new 
anthrax vaccine called rPA and have achieved promising results 
with antibodies capable of neutralizing anthrax toxins. They 
have developed first- and second-generation vaccines against 
Ebola virus, and investigated a promising Ebola therapy based 
on RNA interference. These and many other advances required the 
use of containment facilities of the type that are now under 
construction. Progress should occur more rapidly as the new 
facilities become available.
    NIH-funded biodefense researchers are acutely aware of the 
threat posed by the pathogens they study. These experts 
understand the need to handle them with utmost care, the need 
for rigorous training and state-of-the-art equipment, and the 
need to scrupulously follow all required procedures. Their 
awareness also includes a deep understanding that the Nation's 
biosecurity depends on their work, which is the conduct of 
research that will lead to new tools essential to meet emerging 
and re-emerging threats to public health.Thank you for this 
opportunity to discuss this very important issue with you. I 
will be happy to answer questions.
                              ----------                              

    Mr. Stupak. Thank you. Captain or Dr. Chosewood, an 
opening?
    Dr. Chosewood. No.
    Mr. Stupak. OK. We will go to questions.
     Dr. Besser, if we can start with you please. There is a 
thing called restricted experiments, right, which pose 
extraordinary risks?
    Dr. Besser. Yes, sir.
    Mr. Stupak. And you have to apply for a permit to do these 
restricted experiments?
    Dr. Besser. That is correct.
    Mr. Stupak. Where are these restricted experiments carried 
out, at level 3 labs or level 4 labs?
    Dr. Besser. Yes, they are conducted in select agent 
laboratories, primarily at level 3 and 4.
    Mr. Stupak. OK. And how many applications do you receive 
for these restricted experiments on an average each year?
    Dr. Besser. Approximately five or six.
    Mr. Stupak. Five or six. If these are restricted 
experiments or the ones that impose extraordinary risk and if 
you only get five or six of these, why would we want to 
increase all these labs then?
    Dr. Besser. When you look at the breadth of work that takes 
place in select agent laboratories, it is a very small part of 
that work that would be classified as a restricted experiment. 
The vast majority of the work does not fall within the category 
of restricted experimentation.
    Mr. Stupak. OK. Well, before 2001, we had three of these 
labs, level 4 labs, we are now up to 15. How many labs do we 
need at level 4?
    Dr. Besser. We are at the anniversary of that anthrax 
attack and at that time I was in Boca Raton working with the 
FBI investigating that outbreak. I spent 2 weeks in the 
Winnebago with them. And during that time, I can tell you that 
we were pretty scared about our ability to deliver 
countermeasures to people who might need them.
    Mr. Stupak. OK. But how many labs do we need, or do we need 
more Winnebagos?
    Dr. Besser. I can tell you based on my experience in that 
event and my experience previously as head of the branch at CDC 
that does anthrax work, that there was a limitation on our 
ability to develop countermeasures based on the number of labs. 
I cannot tell you though how many labs we need.
    Mr. Stupak. But to develop countermeasure does not mean 
necessarily more labs, right?
    Dr. Besser. Well, when you look at what it takes to develop 
a countermeasure, these measures need to be tested and much of 
that work, in terms of testing, requires animal testing. That 
type of work does require high-containment laboratories.
    Mr. Stupak. OK. Dr. Auchincloss, let me ask you then 
because you said you have the distinguished panel. There was 
strategic planning of the three or four level labs and you 
indicated there were not enough labs.
    Dr. Auchincloss. That is correct, sir.
    Mr. Stupak. So did the panel recommend how many labs we 
needed then?
    Dr. Auchincloss. The panel recommended a research agenda. 
It did not recommend, specifically, the number of new 
facilities that would be needed.
    Mr. Stupak. Would the research agenda then dictate the 
number of labs we need in this country?
    Dr. Auchincloss. The research agenda was what we used to 
determine the number of new facilities needed in the country.
    Mr. Stupak. OK. So you used the research agenda to 
determine the number of labs we need in this country. Is that 
what you said?
    Dr. Auchincloss. That is what I said.
    Mr. Stupak. So how many level 3 labs do we need in this 
country?
    Dr. Auchincloss. We determined, on the basis of that 
research agenda, that between 10 and 15 BSL-3 facilities were 
needed for the extramural community.
    Mr. Stupak. Ten to 15.
    Dr. Auchincloss. And at least two level 4 facilities for 
the extramural community.
    Mr. Stupak. OK. We had three. We are now up to 15. So it 
should be five, so we got 10 too many level 4 labs?
    Dr. Auchincloss. Sir, the estimates that the NIH has put 
together refer to the needs for the scientists that the NIH 
funds.
    Mr. Stupak. Sure.
    Dr. Auchincloss. And we are not trying to claim that our 
planning applies to other Government agencies or other funding 
agencies.
    Mr. Stupak. So you only want five labs total then to do 
what NIH wants to do?
    Dr. Auchincloss. NIH determined that it needed between 10 
and 15 BSL-3 facilities.
    Mr. Stupak. Right. And two more level 4.
    Dr. Auchincloss. And two level 4 for the extramural 
community.
    Mr. Stupak. Correct.
    Dr. Auchincloss. And then we actually determined that we 
have two additional level 4 facilities for the intramural 
program that can be worked.
    Mr. Stupak. So your scientific panel only looked at what 
NIH's needs were.
    Dr. Auchincloss. Our scientific panel only looked at what 
the NIH research agenda would be.
    Mr. Stupak. Did CDC do the same things, take a look at what 
you thought was necessary?
    Dr. Besser. No, sir. CDC looked at its own needs in terms 
of the work that we do in diagnostics and that lead to the 
expansion at CDC in our level 4 capabilities.
    Mr. Stupak. OK. So the CDC then determined you needed so 
many level 4 for your work you do in this area?
    Dr. Besser. That is correct.
    Mr. Stupak. And how many is that, level 4 labs?
    Dr. Besser. Four additional laboratories at CDC.
    Mr. Stupak. Four more additional labs at CDC. So it looks 
like every agency is making their own assessment and doing 
their own thing basically, right?
    Dr. Besser. I think that there is room for a more 
comprehensive look at our national needs in both of these 
areas.
    Mr. Stupak. Well, if you got 15 different agencies, was 
your other testimony, you are up to four. If we did five, four 
at each one, four times 15 is 60. We would need 60 more level 4 
labs if every agency did their own assessment. Is anyone in 
control ball? Who should be in control? It sounds like CDC, in 
your testimony, Dr. Besser, are the ones who do the protocol; 
you are the ones that do the inspections. Should you be in 
charge of all the labs of all the agencies?
    Dr. Besser. I think that the process that Dr. Auchincloss 
referred to in his oral statement of pulling together an intra-
governmental group, pulling together a blue ribbon panel to 
look at the activities in BSL-3 and BSL-4 facilities will help 
to address that issue. I think that CDC is effectively 
executing its mission around the select agent program. But as 
we have heard, that does not cover all of the organisms that 
need to be handled safely and securely in laboratories.
    Mr. Stupak. Well, let me ask this. It seems like from where 
I am sitting, over a billion dollars have been spent on labs 
that we know of. No one can tell me how many labs that we have, 
the quantity of stuff we are looking at, the quality of stuff 
we are looking at that could be a threat to this country. It 
seems like if we put the money out there then germs will come, 
so we will build these labs. I mean, what has really changed 
since the fall, other than anthrax, OK? Other than that, what 
has really changed that would require this proliferation of 
labs that agencies double and triple in labs they have. Is 
there a greater threat to us? If so, should we not be putting 
the money into research as to most all labs? So what has 
changed in the last 5 years, other than more money available? 
Can someone answer that?
    Dr. Besser. I will start and you can follow. I think 2001 
was a wake up call; and it was a wake up call in terms of 
anthrax. But it was a wake up call beyond that and it forced a 
look at what are the potential agents that could be used 
deliberately and what are our abilities to respond with either 
vaccines or treatments for those conditions. That lead to issue 
of legislation and a push to develop countermeasures.
    Mr. Stupak. True.
    Dr. Besser. But as part of that, there was a move to expand 
the laboratory capability to be able to address those needs. In 
addition to that, if we look at our overall preparedness 
efforts around the country, there has been developed something 
called the Laboratory Response Network, which is not doing 
research but it does have BSL-3 capabilities in order to be 
able to rapidly diagnose these type of serious infections we 
are talking about to allow communities to respond faster. We 
are now at a point where 90 percent of the U.S. population 
lives within 100 miles of one of these facilities and it has 
created, I think, a laboratory infrastructure that is critical 
to our preparedness and response.
    Mr. Stupak. But preparedness would be a countermeasure, a 
medical countermeasure to like anthrax. Have we seen any 
counterterrorism, medical counterterrorism measures to defeat 
anthrax. We still have not determined the strain from 2001, 
according to the last panel, as the one that killed five people 
and sickened 20 others.
    Dr. Besser. There has been a lot of work done in the area 
of anthrax, vaccine work and countermeasures. CDC has 
undertaken a study looking at the existing anthrax vaccine to 
try and reduce the number of doses that are required to confirm 
protection. In addition, NIH has supported extensive work in 
developing vaccines for anthrax that might be much safer.
    Mr. Stupak. When was the last time you updated the selected 
list, the selected agents?
    Dr. Besser. The last time was August 28 of this year. We 
published in the Federal Register and it is still open for 
comment, the latest revisions to the select agent list.
    Mr. Stupak. Is SARS going to be one of these select agents?
    Dr. Besser. SARS was considered by the committee. If I 
could explain the process by which agents are considered? There 
is an intergovernmental committee called the ISATTAG. That is 
the Intergovernmental Select Agent and Toxin Technical Advisory 
Group. It contains representation from all the Federal agencies 
that do work with select agents: CDC, NIH, FDA.
    Mr. Stupak. This group met in August this year. When did it 
meet before August of this year?
    Dr. Besser. Well, the notice went out in August.
    Mr. Stupak. OK. They met this year. When did they meet 
before this year?
    Dr. Besser. The ISATTAG not only reviews the select agent 
list for our program, but they also review proposals for 
restricted experiments, as was discussed earlier. And the 
ISATTAG meets on an ad hoc basis, typically four or five times 
a year as needed when issues come up.
    Mr. Stupak. OK. Now, getting to the issue asked about SARS.
    Dr. Besser. No, select agents.
    Mr. Stupak. OK. You met four to five times. SARS is a 
select agent. The hantavirus is not a select agent. And there 
is one other, dengue fever. These are all we have no cure for. 
If they break out, people can die.
    Dr. Besser. Right.
    Mr. Stupak. It seems like you are building the labs but no 
one is doing anything about getting a list and trying to 
restrict the research of the most dangerous things that could 
cause most harm to us and spend, what, 5, 6 years.
    Dr. Besser. Each of those agents has been considered and 
was not included on the list. There are 14 criteria that are 
looked at when considering an agent for the select agent list. 
When the SARS epidemic first occurred and we knew very little 
about that virus, it was being handled in BSL-4 facilities. 
When the ISATTAG looks at the science around an agent and 
whether it should be considered a select agent, we look at the 
degree of pathogenicity, how bad an infection does it cause, 
how easy is it to transmit person-to-person, how easy is it to 
spread within a community, what is the route of exposure, how 
stable is it in the environment, how easy would it be for 
somebody to produce that agent, can it be genetically 
manipulated or altered because there are long term----
    Mr. Stupak. SARS does not make it then?
    Dr. Besser. Well, SARS did not make it to that list and if 
you----
    Mr. Stupak. Since the fall of 2001, have you added any more 
agents to this select list? Select list first came out, what, 
in 1996?
    Dr. Besser. Yes. In October 2005.
    Mr. Stupak. How many have you added since the fall of 2001?
    Dr. Besser. The 1918 influenza virus was added in October 
2005.
    Mr. Stupak. OK. We had flu. Did you add anything else? I am 
trying to justify all this money and all these labs. If we have 
a select agent list in 1996 at 72 and we add one, we get up to 
73 maybe; how do we justify a proliferation of all these labs?
    Dr. Besser. Well, the work being done in those laboratories 
is not necessarily being done just on the new agent, 1918 flu. 
But it is acknowledging the lack of work or the need for work 
with some of the existing agents.
    Mr. Stupak. Correct. And Congress' charge was to develop 
countermeasures to make America safe. And if the list has not 
grown more agents that we should be concerned about but yet we 
have probably 10 times more labs than we had before then. 
Again, it goes back to look like we are building labs and 
hoping the germs will come. That is my concern. Mr. Green for 
questions.
    Mr. Green. Thank you, Mr. Chairman. When you let off by 
asking how many Winnebagos we need, our colleague, Mike Ross on 
our committee keeps talking about all those FEMA trailers we 
have in some field in Arkansas. Maybe we can put wheels on them 
and get them. I thank our panel for being here and appreciate 
your work. Coming from Texas, we certainly have been following 
the news accounts on instances in the Texas biosafety labs. One 
of the news articles quotes a laboratory expert who compared 
lab settings to hospital settings and noted that infections are 
not entirely unexpected. Generally, where are the risks in this 
line of work and would you say that they are primary to the lab 
worker or would it be to the broader community?
    Dr. Chosewood. Obviously, we are concerned about infections 
or releases in any setting because safety is a vital component 
of all laboratory work for certain. The vast majority of 
incidents that have occurred and given the vast amount of work 
that has gone on, we believe that the actual number of events 
is very small. But when those events have occurred, they have 
affected primarily the laboratory workers. The select agents 
folks can give you some specific numbers on the amount of 
workers who have acquired infection. But the risk to the 
environment, in all of those cases, has been non-existent in 
our opinion.
    Mr. Green. OK. Another course of questions of safety are of 
utmost concern, but I also want to make sure that we have a 
measured and thoughtful reaction to the incidents we hear 
about. Of course, we want 100 percent safety but based on the 
incidents to date, the expert indicated that he was not certain 
the problems reached the level of a crisis. Can you share your 
thoughts on that issue, and would you agree or disagree with 
that statement whether it had reached that level of crisis?
    Dr. Besser. I think it is critically important that we move 
forward very quickly to convene an intergovernmental group and 
look at a process for reviewing how lab safety oversight is now 
provided and we are committed to doing that. I think that the 
work of this committee in shedding light on issues about safety 
will help move the entire field forward and we welcome an 
opportunity to see the GAO report and the preliminary report 
and their recommendations because I think that as a young 
program, there is a lot we can learn and there is a lot we can 
do to improve our oversight.
    Mr. Green. Well, I know our Oversight and Investigation 
Subcommittee, we do not do legislation but typically will refer 
to our the committee's Health Subcommittee, for example, and I 
look forward to working with you and I know our full committee 
does. Based on the incident reports received by the CDC, what 
is the primary source of the incidents in the biosafety labs? 
Can you attribute it to accidents, the human or engineering 
design flaws?
    Dr. Besser. The vast majority of events involve human 
error. That is why it is so important that individuals, like 
your daughter, are well trained if they are going to be working 
in a laboratory; that they have the right equipment for the 
type of experiment that they are doing; that that experiment 
has been designed to minimize the amount of risk; and that 
their engineering controls, in case that individual makes an 
error, it does not get outside of the laboratory.
    Mr. Green. OK. Our GAO witness mentioned the CDC biosafety 
microbiological and the biomedical laboratories guide, as well 
as the importance of training lab staff. Specifically, Dr. Rose 
mentioned that BMBL's guidelines that personnel must receive 
training on potential hazard and precautions. Can you elaborate 
on that training guideline? Is there a mandate for that 
guideline for level 3 and 4 or is it to all the levels of these 
labs?
    Dr. Besser. You want to comment on that, Dr. Weyant?
    Dr. Weyant. With respect to the regulated select agent 
community, select agent laboratories are required to have a 
biosafety plan, along with a security plan and an incident 
response plan. They are required to train their staff in 
accordance with these plans and they are also required to 
perform drills on an annual basis. As part of our inspection 
regime through the CDC select agent program, we review training 
records when we inspect entities.
    Mr. Green. OK. I would like to carry forward and since I am 
almost out of time, Dr. Weyant, I am interested in clarifying 
the type of agents that are being researched in the BSL-3 and 
BSL-4 labs. Our witness on our fourth panel has referred to 
these agents as biological weapons agents. A term that 
certainly elicits strong reaction from the public. My 
understanding, however, is that these are not actually weapons 
agents by definition, rather they are infections agents 
occurring naturally in nature. Is it fair to assume that the 
BSL-4 labs are necessarily working on biological weapons agents 
and can you clarify the distinction of the two?
    Dr. Weyant. Well, it depends on usage. An agent such as 
bacillus anthracis, the agent that causes anthrax, exists in 
the environment. It exists in soil in many parts of the world. 
However, the agent can be grown up and purified and weaponized 
as was demonstrated in the events beginning October 4, so it is 
difficult to take a single organism on this list and say it is 
absolutely a weapons agent or it is absolutely a naturally-
occurring agent. I would say it is fair to say that for the 
agents listed on this list, it is possible that they could be 
both.
    Dr. Besser. If I could add to that.
    Mr. Green. Please.
    Dr. Besser. Currently CDC is assisting States on 
investigation of cases of anthrax in Connecticut, cases of 
botulism in the Southeast, cases of tularemia in the Southwest. 
These are all agents that are select agents and it is important 
that they have laboratories that can diagnose those. But in 
their naturally-occurring form, they are not something that 
could readily be used in a biological attack. But in these 
laboratories we can learn about those agents and we can work to 
improve our diagnosis, which is critical, and help to develop 
treatments.
    Mr. Green. OK. Thank you, Mr. Chairman.
    Mr. Stupak. But in response to that last question, 
especially on botulism, the FDA's response was that it closed 
down six of their 13 labs.
    Mr. Green. I think those make sense, which was just said.
    Mr. Stupak. Botulism. If we are going to find it, FDA has 
responsibility but they want to close six of the 13 labs. 
Should not we add food safety to CDC then?
    Dr. Besser. There are different roles in FDA. We have a 
primary role in terms of investigating outbreaks related to 
botulism and distributing the botulism antitoxin. And to 
succeed in that mission, we have to ensure that we have rapid 
diagnostics. Currently, our laboratories at CDC are working on 
a new ELISA test, which is rapid test for diagnosing botulism 
that will have natural applications, as well as applications if 
there were deliberant events.
    Mr. Stupak. Right. I do not disagree with you with that 
last statement but if the FDA, who is responsible for it, is 
closing the labs and you guys are opening more labs, it seems 
like the agencies--no one is in charge here. Everyone is doing 
their own thing. With that, let me turn it over to Mr. Burgess 
for questions please.
    Mr. Burgess. Thank you, Mr. Chairman. I apologize for being 
out of the room for a while. I know I pledged to you earlier 
today that I would not desert you through this hearing and my 
State delegation called and they actually rank a little higher 
than you, Mr. Chairman. Let me just follow up and listening to 
the chairman's questions, Dr. Besser, in the room outside, on 
the select list, the select agent list, that is developed, SARS 
is not on that list. Is there a downside to having an agent on 
that list? Does it in any way inhibit research, inhibit the 
evaluation of the agent? Is there a research-oriented reason 
not to put an agent on that list? Is it going to make it more 
difficult for the scientists to do their job? And actually, 
whoever feels that they can answer the question. Dr. Weyant, 
that is fine.
    Dr. Weyant. Thank you, sir. Yes, there is a downside to 
doing work in a highly-regulated environment. There are 
extensive record keeping requirements that we have for select 
agent laboratories. There are extensive security requirements. 
As was discussed earlier this morning, individuals who apply to 
work with select agents have to undergo a Department of Justice 
security clearance procedure, whereas individuals that would 
not work on a select agent, do not have to undergo that. So 
there is a downside to working in a highly-regulated 
environment. There is a lot more paperwork and it is more 
resource intensive.
    Mr. Burgess. I referenced SARS earlier because of the 
rapidity with which you guys, all of you at the table, made the 
designation of a coronavirus previously reported and causing 
human disease, came from a remote area in China, spread on 
planes from people coming over here. Really relatively 
unsophisticated tools that beat back the threat of this 
epidemic and I do not want to see us, Mr. Chairman, do anything 
on this committee that would rob us of that ability and I 
cannot say that anyone new going into that epidemic that we are 
going to be able to beat this with epidemiology and quarantine. 
But at the same time, because of the work that you do, the 
scientific ground work that you did early on in that 
investigation, lead you to the conclusion that we have tools on 
a shelf that we can beat this with and they, in fact, are the 
same tools that were available in 1918 and let us get busy and 
do them.
    In fact, I was really concerned, not to pick on the CDC but 
you guys had a scientist get sick over in China; and he got put 
on a Lear jet and brought back over to this country and I think 
refueled two or three times coming back over here. I called the 
CDC back in 2003 very concerned about is this the best way to 
be handling a suspected case of SARS, putting them on an 
airplane with the recirculating air that is present on an 
airplane, worrying about the exposure to people, perhaps the 
ground based operators who would be involved in refueling that 
plane and doing it for service that was required at the various 
stops it made back to this country. It turned out the scientist 
did not have SARS.
    While I appreciate your dedication to bringing one of your 
own back who was ill, I must admit I was terribly concerned. 
Turns out that that concern was misplaced. Again, I just do not 
want us to do anything that undermines your ability to do your 
job because often times you do not know what it is you are 
going up against and you are literally walking across a bridge 
as you are building it. And we just have to be very careful 
that we do not stymie that creativity and that ability to 
respond. But that does lead me to the question that I asked the 
previous panel before and if you wanted to place us on a 
continuum of exposure to safety, obviously we were at one place 
in 2001 when the anthrax attacks on the Senate occurred, have 
we moved on that continuum forward or back in the 6 years that 
have passed since that time?
    Dr. Weyant. I think we have moved forward and I think we 
have moved forward because we now have a program in place that 
is really requiring a lot of laboratories that are working on 
select agents. The area of select agents, as has been said, 
does not cover the full spectrum of germs that can be harmful. 
But we did not have in place a program that required a detailed 
background check for individuals who work with these agents. We 
did not have a program that required approval and required 
inspections, that required documentation of safety, as well as 
security methods. So that is an improvement. There is a lot 
more that can be done and this process of this committee is 
raising really important issues that we need to address. I can 
tell you about the CDC's ability to move people who are 
potentially infectious has improved. By early spring, we will 
have a self-contained biocontainment unit that we will fit in 
the CDC plane that will allow for transport of a passenger 
safely. Again, it is critical, especially when we do not know 
what we are dealing with, like the beginning of the SARS 
epidemic, that we are able to use engineering controls to 
protect the public.
    Mr. Burgess. True. Well, that is very reassuring to hear 
that. Mr. Chairman, I just also have to mention, last year when 
I was taking a trip to Iraq, I think it was one trip with Mr. 
Green and I took a side trip to Geneva to visit what was going 
on with the World Health Organization. At that time, we were 
all real concerned about the bird flu. And CDC had their people 
on the ground in Geneva, in the, I do not know what you call 
it, the whatever it is, the biologic room, and it is an 
impressive amount of work. And that is impressive protection 
provided by American scientists on loan to the World Health 
Organization. Not the World Health Organization, directive of 
the CDC but American scientists on loan. And they went through 
the day's reports with me. It was absolutely astounding the 
breath, the scope, the danger that people were in having to go 
to remote areas and ferret out the symptoms that had come to 
their attention that might be indicative of something much more 
serious. So, Mr. Chairman, unless we get too complacent or smug 
up here that these are not real illnesses, real issues, I mean, 
these guys are on the front line and I believe they are 
committed to doing a good job. I just want us to be able to 
give the tools, deliver the tools to them that they need.
    Mr. Stupak. Dr. Besser, on your page four of your testimony 
the statement is made that the NIAID estimated the new BSL-3 
and BSL-4 facilities would be required to accomplish the 
research agenda. Our committee has asked for a copy of that 
assessment. When will you provide that copy of the assessment?
    Dr. Besser. We will work with your committee to provide 
that as soon as we can.
    Mr. Stupak. Yes, but we would have liked it before the 
hearing, that is why I am asking, so get it to us, OK?
    Dr. Besser. Yes, sir.
    Mr. Stupak. All right. Second, let me ask you this 
question. When you are working with SARS, as has been brought 
up, bird flu to plague or Ebola, safety should be paramount. Do 
you feel that the community where these labs are located and 
first responders in these communities should be notified of 
what agents are being studied at those labs?
    Dr. Besser. I think that is an important question and I 
think it is critically important that communities are aware 
that laboratories are in their community, that they have been 
engaged as part of the decision as to whether a laboratory is 
being placed. When it comes to specifics about what agents are 
in the laboratory, I think that is a difficult question and one 
that is hard to answer. There is the importance of transparency 
but there is also the issue of letting individuals who may want 
to do harm know where certain agents are located and both of 
those have to be weighed.
    Mr. Stupak. OK. So you said, well, they should know about 
the lab but not necessarily the agents being studied there. But 
should the public then be made aware or notified of the shift 
of a lab from a level 3 to a level 4, like you may be doing 
down in Bethesda? Should that community be made known that it 
is going to go from a level 3 to a level 4?
    Dr. Besser. I think that is an important question. I am 
looking forward to guidance on some of these issues from our 
review process. I think that we have to weigh the issue of 
sharing information that could do harm to a community versus 
being open about what is going on. And I think that the more 
trust that the community has that the labs are being run 
safely, the less that is an issue. But I do not think that we 
are where we need to be in terms of that level of trust.
    Mr. Stupak. You think we are there at the level of safety?
    Dr. Besser. I think that the laboratories that are being 
built, these state of the art laboratories, are extremely safe. 
That does not mean that an error will not occur.
    Mr. Stupak. Yes, your own CDC lab in Atlanta was supposed 
to have redundancy in the electricity event when the lightening 
stuck. Everything shut down in a level 4 lab. You did not have 
the redundancy that was required and that is a brand new lab.
    Dr. Besser. Dr. Chosewood?
    Dr. Chosewood. Sure. I would love to comment on that. In 
fact, we believe that the GAO findings about the lack of 
redundant power is absolutely incorrect.
    Mr. Stupak. It is incorrect?
    Dr. Chosewood. Yes, sir.
    Mr. Stupak. You should have just one power source at a 
level 4 lab, is that what you are saying?
    Dr. Chosewood. No, but in fact, that is not the case. The 
power outage in our building 18 laboratory occurred as a result 
of an error.
    Mr. Stupak. A lightning strike, right?
    Dr. Chosewood. A lightning strike to the building.
    Mr. Stupak. Yes.
    Dr. Chosewood. And unfortunately, the lightning protection 
system in that building had been interrupted by ongoing 
construction nearby. And so the power failure in that instance 
was completely appropriate. It was as if you were having a 
power surge in your own home.
    Mr. Stupak. So you think----
    Dr. Chosewood. And if that were the case----
    Mr. Stupak. Power outages at level 4 labs are certainly 
appropriate?
    Dr. Chosewood. No, I did not say that. One of the things 
that I think is important is to imagine a power surge in your 
own home and you have a breaker that trips appropriately. That 
is exactly what occurred in this situation. And that is what 
you would want.
    Mr. Stupak. The backup system cable was cut, was not it?
    Dr. Chosewood. This was an interruption of the lightning 
protection system but not the backup cable for power.
    Mr. Stupak. So then why did not the back up one come on 
then?
    Dr. Chosewood. Because it was not supposed to in an 
overload situation like a lightning strike. So basically at the 
time of the lab--we should tell you that we had no active work 
going on. The maximum containment labs in building 18 are 
actually not functional at this point. But even if they had 
been functional, there are multiple systems of safety in place 
to avoid escape of any dangerous pathogens.
    Mr. Stupak. But if you do not have any power, those backup 
systems are not going to work.
    Dr. Chosewood. No, I would disagree because the facilities 
are designed to withstand higher levels of containment than the 
typical space. These are pressurized areas. If you have a power 
loss in a maximum containment laboratory, the actual air flow 
goes neutral, it does not become positive. You do not have the 
escape of that air in the lab to the outside.
    Mr. Stupak. OK.
    Dr. Chosewood. Backup power is important. It is a critical 
thing but that was not the case here and our laboratories do 
have backup power.
    Mr. Stupak. Well, GOA tends to disagree with all you said 
but that is the information we have to work with, to share 
information with us and then maybe we can get some of this 
squared away. You mention audits. Let me just ask about an 
audit. Do you do any surprise inspections of these labs? Do 
they know when you are coming to inspect the labs?
    Dr. Weyant. The select agent regulations give us the 
authority to do surprise inspections.
    Mr. Stupak. Yes, but you do it?
    Dr. Weyant. As a rule, we do not do surprise inspections.
    Mr. Stupak. Well, if they know when you are coming, it is 
pretty easy to pass inspection. Is that what happened at A&M? 
You guys were right there, you guys approved everything, some 
minor things were out of hand and if it wasn't for this 
Sunshine Project, we never would have found out about the 
instance there, right?
    Dr. Weyant. Yes, I think the issue of unannounced 
inspections is something we need to consider as we look at 
improvements in our program. I would rather not get into the 
details of Texas A&M given that they have been referred to the 
Inspector General to assess whether civil or criminal penalties 
may----
    Mr. Stupak. I am not here to dump on A&M but I am just 
trying to say, without any kind of surprise inspection system, 
how are you going to know? I mean, you said documentation. How 
do you know if the documentation is valid? I mean, this 
Sunshine Project went through a Freedom of Information, went to 
the State agencies and found the information you should have 
been looking for and you were just there. So, I mean, if 
Sunshine can do it, why cannot you who are responsible for 
inspections figure out a way to double check, to truly audit, 
to be truly independent what we are all doing.
    Dr. Weyant. With each one of these events, we learn and we 
look to make improvements. And from our experience with Texas 
A&M and other institutions, there are additional documents, 
employee health records and such, that we will be looking at.
    Mr. Stupak. OK.
    Dr. Weyant. We will be looking to expand the pool of people 
that we interview and we look for, again----
    Mr. Stupak. Let me go to Mr. Burgess to see if he has 
anything further. We have got 5 minutes before we have to run 
down for two votes. We should be able to get right back and we 
can----
    Mr. Burgess. I know they will hold the votes for you, Mr. 
Chairman, so we will take the 5 minutes.
    Mr. Stupak. Sure.
    Mr. Burgess. Can I just ask a question for really anyone on 
the CDC side? If we find a problem, as was encountered at Texas 
A&M, should we not encourage a system that would promote 
voluntary reporting? You've got an issue, confess your sin, 
work on correcting it rather than a system that truly punitive. 
Design the system more like NASA, more like what we see with 
the nuclear submarine program that has such a proactive safety 
record.
    Dr. Besser. I think that is a very creative idea and 
something we need to explore. We do not want to have a system 
in place that actually leads to less transparency in reporting 
because of fear of penalties. We want a system where 
laboratories can learn from each other to prevent these from 
happening in the future.
    Mr. Burgess. Dr. Auchincloss, if I could ask you just in 
regard to NIH and funding for the NIH. Of course, you know this 
committee went through a rather lengthy and involved 
reauthorization process that culminated last year in December 
and finally just sent it to--work and we got a bill passed that 
reauthorized the NIH for the next 5 years, funding at about $30 
billion a year to increase by 5 percent a year. We took a lot 
of grief for only increasing your budget by 5 percent every 
year and yet this year the House passed labor NIH's budget is 
about a 2.3 percent increase, if my arithmetic is correct. Is 
that your understanding as well?
    Dr. Auchincloss. That is my understanding.
    Mr. Burgess. So why have you all not been more outspoken 
about not receiving your full authorized funding increase at 
NIH? Clearly, we are at a time in our Nation's history where if 
anyone needs a funding, you guys need the funding. We 
authorized a 5 percent increase. Again, we were criticized for 
it not being a 7 or 9 or 10 percent increase and we only 
managed to come up with 2.3 this year.
    Dr. Auchincloss. We have research agendas for extreme drug-
resistant tuberculosis, further work on influenza, such where 
we could spend the money.
    Mr. Burgess. Well, no question you can spend the money but 
really it is a question of planning too. How can you obligate 
or ask a young scientist to obligate their life to you when you 
are not sure that your funding stream is going to be steady? 
That was the whole purpose in reauthorizing the NIH budget last 
year. That is why we went through that long laborious process. 
I would just ask the NIH to help us make certain that your 
funding requirements receive no less the attention than every 
other thing that we deal with on this committee, whether it be 
the FDA regulation of tobacco or the lyrics of rap songs. Your 
work is every bit as important as that work and I want to hear 
from you. When we are not doing our job at the funding level, 
goodness knows, I heard from everyone last year, where were all 
your groups this year? Where was the NIH when your funding was 
cut by half, by over 50 percent, your funding increase was cut 
by over 50 percent, where was the involvement of the NIH?
    Dr. Auchincloss. I got your point, Congressman, I do.
    Mr. Burgess. Very well. And you'll deliver that to Dr. 
Zerning? Thank you.
    Mr. Stupak. Less construction, more research. With that 
said, we will be at recess for about 10 minutes. We have two 
votes. This panel is dismissed. Thank you.
    [Recess.]
    Mr. Stupak. Witness to come forward. That is Dr. Ed Davis, 
president of Texas A&M University. Dr. Davis, it is the policy 
of this subcommittee to take all testimony under oath. Please 
be advised witnesses have a right under the rules of the House 
to have counsel present and to be represented by counsel at 
this time. Do you have counsel with you, sir?
    Mr. Davis. No.
    Mr. Stupak. OK. Witness indicates no. So then I would ask 
you to please rise, raise your right hand.
    [Witness sworn.]
    Mr. Stupak. Thank you, sir. Let the record reflect that the 
witness has replied in the affirmative. He is now under oath. 
Dr. Davis, you'll have 5 minutes for an opening statement. You 
may submit a longer statement for the record if you wish. Dr. 
Davis, we'd like to have your opening statement please, sir.

 STATEMENT OF ED DAVIS, INTERIM PRESIDENT, TEXAS A&M UNIVERSITY

    Mr. Davis. Mr. Chairman and Ranking Member Barton, 
subcommittee members, my name is Ed Davis. I am president of 
Texas A&M University. As a brief point of personal privilege, I 
would like to acknowledge Mr. Barton's long service to the 
State of Texas, his district and to his alma mater, Texas A&M, 
as well as Mr. Chet Edwards, who accompanied me this morning 
here, who is our 17th Congressional District Congressman.
    You might legitimately ask why the president of Texas A&M 
is here. I am not a microbiologist. I am not a doctor. I am not 
even a lawyer. But the answer is really pretty simple. Texas 
A&M has a proud heritage of scientific research. In fact, our 
131st birthday is today and we have had a long history of 
providing service to our country. More importantly, however, is 
we have a history of being an honest, high-integrity and 
forthright institution in doing everything that is right.
    I am here today as president to make four important points 
for the record. Number 1, we made a mistake. We failed to 
report an exposure to a select agent, Brucella, in a timely 
manner. The details of the incident are contained in my written 
testimony and I am pleased to give any additional details that 
you may wish. I am satisfied through our internal review that 
this was due to human error. It was compounded by a failure to 
have adequate protocols and redundant controls in place to 
ensure it could not happen. Number 2, we take this issue very 
seriously. I, as president, have become personally involved in 
this situation. I have devoted time and resources to assess 
what happened, to analyze appropriate corrective steps, and to 
move to implementation to return our program to doing the 
scientific work, the very important scientific work that 
benefits the public health system and the security of our 
country. Number 3, we are taking corrective actions to fix the 
problem. We want to rescue our research, revise the select 
agent registration with the CDC as our regulatory partner, hire 
and properly organize the best talent to lead our safety, 
security and compliance activity and re-establish the trust 
with the CDC, with you and with our research funding partners.
    Finally, Mr. Chairman and members, we intend as a learning 
outcome of this episode, to develop in conjunction with you and 
the CDC a model program for select agent research and 
compliance to be in place across the country. In summary, we 
are committed to getting it right. We will use CDC's 
comprehensive review that has been provided as our road map to 
compliance and we will move forward from there. But we will 
leave nothing undone in moving our program to one of a model of 
documented excellence. This research is important, as I said, 
to our country's public health system and to our national 
security.
    I think from the hearing today I have observed three 
protocols and partnerships that make sense and I think the 
hearing has been valuable for that. One is that we need to have 
good science. That is our job in conjunction with our funding 
partners. We need to have absolute compliance. That is our job 
with our regulator, the CDC. And we need regulatory oversight 
and coordination, which is the task of the hearing of this 
committee today. I think it provides value. We appreciate the 
opportunity to be here. I am here to answer any questions or 
provide further details. Mr. Chairman.
    [The prepared statement of Mr. Davis follows:]

                      Testimony of Eddie J. Davis

     Mr. Chairman, Ranking Member Barton and members of the 
subcommittee, my name is Eddie Joe Davis, interim president of 
Texas A&M University at College Station. I have held this 
position since December 2006. The College Station campus is the 
largest of the 10 campuses that fall within the Texas A&M 
University System. I am appearing here today at the 
Subcommittee's request.
     Texas A&M's College Station campus is home to 
approximately 38,000 undergraduate students at 10 colleges and 
approximately 7,000 graduate students. The University takes 
great pride in its reputation as a top tier research 
institution. I am here today to provide testimony regarding our 
select agent research laboratories. As you may be aware, these 
laboratories have recently been the subject of investigation by 
the Centers for Disease Control & Prevention or ``CDC'' and, as 
of June of this year, our select agent research work has been 
suspended pursuant to CDC's orders.
     My comments today will first focus on some background 
information regarding the University's research program, 
internal compliance program and the select agent labs. I will 
then move on to the recent matters leading to the CDC's 
suspension of the University's select agent research and our 
commitment to run a model program to which others compare 
themselves. Finally, I will provide observations regarding the 
application of recent Federal regulations governing the 
possession and use of select agents in the laboratories that 
have emerged over the past few years.
     I want to make it absolutely clear that Texas A&M 
University is, first and foremost, fully committed to both the 
safety and protection of our employees, students and community, 
and to following the guidelines and rules on safely and 
securely operating our laboratories that handle select 
biological agents and toxins. Only then, will we seek 
inspection and approval from the CDC to resume the research in 
these labs.

             Texas A&M Select Agent Research and Compliance

     Organizational Structure. The University's research 
organization falls under the Division of Research and Graduate 
Studies which carries out its mission through several internal 
units and a variety of external units and centers that are 
focused on important new fields of scientific inquiry. The work 
of the Division's units and centers spans the full range of 
scholarly endeavors and disciplines, securing Texas A&M 
University's place among the world's leading research 
institutions.
     The Office of Research Compliance, which is a key unit of 
the University's Division of Research and Graduate Studies, is 
responsible for providing training and support to faculty, 
students and staff in regulatory requirements for scientific 
research. Through key committees and related programs and 
activities, the Office of Research Compliance develops, 
implements and oversees compliance with university policies and 
any applicable research requirements or regulations related to 
the following areas, among others:

     Research involving humans;
     Research involving animals; and
     Research involving hazardous materials, select 
agents or recombinant DNA.

     Research projects involving infectious/biohazardous agents 
are subject to approval by the University's Institutional 
Biosafety Committee or ``IBC.'' The IBC serves as the 
University's primary interface between the research 
institution, the Biological Safety Officer (BSO), and principal 
investigators (PIs) concerning lab review, security, safety, 
emergency plans, and other activities. In addition to the BSO, 
the University has also designated a responsible official or 
``RO'' as required by the March 2005 Federal regulations 
promulgated by the Department of Health & Human Services for 
select agents and toxins. The RO is the University's designated 
individual who has the authority and control to ensure 
compliance with the regulations governing our select agent 
labs.
     We presently employ an RO and a BSO, but in an effort to 
assure full compliance and seamless communications, we will 
combine these responsibilities into a single person who will 
report directly to high-level University management. At 
present, we have an on-going nation-wide search for a new RO/
BSO and we expect to have this position filled by the end of 
the month. With the promulgation of the select agents and 
toxins rule, the roles of the RO and BSO have evolved and taken 
on additional responsibilities, which require unique skill sets 
and experience.
     Select Agent Research Laboratories. Texas A&M University 
has a long history of applied and basic research involving 
Shiga toxin-producing E. coli, Brucella and Coxiella species 
with the goal of advancing the understanding of mechanisms of 
infection and disease, gene function, and vaccine development. 
The research efforts of our investigators have resulted in a 
better understanding of mechanisms of infection, which have 
yielded significant and relevant results with respect to 
immunogens for vaccine development, detection of the infectious 
agent and modes of delivery for achieving the highest 
probability for success in immunization against disease 
organisms. The collective contributions and over-arching theme 
of our research with Shiga toxin-producing E. coli, Brucella 
and Coxiella bacteria are in understanding host-pathogen 
interactions as the basis for prevention of disease. While 
these are zoonotic agents (i.e., agents that are transferable 
from animals to humans) and prevalent in the surrounding 
environment, most of the research focuses on diseases in 
animals and the economic impact of the resulting animal losses, 
as well as development of better human and animal vaccines. The 
recognition of the bioweapons potential of these particular 
agents has only served to make the ongoing research at Texas 
A&M more relevant and important. The four BSL-3 research 
laboratories at the University that are registered with the CDC 
as handling select agents are led by principal investigators 
Dr. Garry Adams, Dr. Thomas Ficht, Dr. Jim Samuel and Dr. 
Vernon Tesch.
     Dr. Adams is a Professor and Associate Dean for Research 
and Graduate Studies in the College of Veterinary Medicine. Dr. 
Adams' research involves studies of the genetic basis of 
natural disease resistance, molecular pathogenesis of 
intracellular bacterial pathogens, and the development of 
vaccines and diagnostic tests against zoonotic diseases. For 
almost two decades, he has been actively involved in improving 
the scientific basis of the two largest animal health 
regulatory issues in the U.S.--brucellosis and tuberculosis. 
Recently, he has been very active in developing and 
implementing biodefense and emerging diseases research 
initiatives.
     Dr. Ficht is a professor in the Department of Veterinary 
Pathobiology at the University's College of Veterinary 
Medicine. Dr. Ficht's research involves Brucella, an animal 
pathogen, which invades or persists in the phagosomal 
compartment of an animal's eucaryotic cells including 
professional phagocytes. His research explores host-agent 
interaction between monocyte-derived macrophages and Brucella 
with the aim of identifying the bacterial factors that subvert 
intracellular killing and the host factors responsible for 
protecting the host from infection.
     Both Dr. Samuel and Dr. Tesch are Associate Professors in 
the Department of Microbial and Molecular Pathogenesis in the 
College of Medicine at the Texas A&M University System Health 
Science Center. Dr. Samuel's research involves identifying 
recombinant vaccine strategies to elicit protective immunity to 
the obligate intracellular bacterial pathogen, Coxiella 
burnetii, the etiologic agent of Q fever and a biothreat agent. 
Dr. Tesch's research involves a family of bacterial toxins 
called Shiga toxins known to cause disease in humans. Shiga 
toxins are produced by Shigella dysenteriae and E. coli. These 
microorganisms have been in the news lately, as the ingestion 
of undercooked hamburgers or other foods contaminated with 
Shiga toxin-producing E. coli may lead to widespread outbreaks 
of bloody diarrhea. A fraction of patients, mostly children, go 
on to develop life-threatening complications involving acute 
renal failure and neurological abnormalities.
     Texas A&M University has been conducting research 
involving the propagation of Brucella since the late 1970's and 
has performed research using BSL-3 facilities since the mid 
1990's. Research in the other BSL-3 laboratories has similarly 
been on-going for some time. In addition to the four research 
laboratories, two BSL-3 diagnostic laboratories are operated by 
the Texas Veterinary Medical Diagnostic Lab (TVMDL) located at 
the College Station campus. From its inception, the TVMDL has 
occasionally received tissue or blood samples from animals 
which contain biological agents and toxins (e.g., rabies, e-
coli, and Brucella) and, therefore, it must be equipped to 
handle these samples in a high containment laboratory.

     CDC's Investigation of Texas A&M's Select Agent Research Labs

     I now would like to turn our attention to the reported 
exposure of a University lab worker to the select agent 
Brucella and the resulting CDC investigation of the 
University's select agent labs. I will first address the 
details of the exposure and follow that up with comments 
regarding the CDC's investigations earlier this year.
     2006 Brucella Exposure. In February 2006, a post-doctoral 
research associate in Dr. Thomas Ficht's lab was conducting an 
experiment involving brucellosis using a Madison Chamber. A 
``Madison Chamber'' is an aerosol infection chamber that is 
used to infect test animals with various pathogens. The use of 
the chamber for this experiment was loaned to Dr. Ficht's 
research associate by another researcher at the University's 
Health and Science Center, who used the chamber for 
tuberculosis research. A Ph.D. research assistant involved in 
the tuberculosis research which uses the Madison chamber was 
present during the burcellosis experiment conducted by Dr. 
Ficht's research associate. The research assistant is 
proficient in the operation of the Madison Chamber from her use 
in research concerning tuberculosis. At the time of the 
experiment, she was present in Dr. Ficht's lab to observe the 
proper use of the chamber by the research associate who was 
working with Brucella. After the experiment had concluded and 
the test animals removed, she cleaned the chamber as she would 
if the pathogen had been tuberculosis.
     About 2 months later, the research assistant notified Dr. 
Ficht that she was ill with flu-like symptoms and inquired as 
to whether or not anyone else was ill. On that same day, Dr. 
Ficht had all other lab employees who were present during the 
experiment in February tested and notified the BSO. Within the 
next two weeks, the research assistant was diagnosed with 
Brucellosis and, through blood testing, it was confirmed that 
no other employees had contracted it. The research assistant's 
positive test for Brucella was entered into the public health 
database by the Brazos County Health Department, which was 
automatically transmitted to the Texas Department of Health and 
CDC. The research assistant returned to work, was given follow 
up blood testing and has continued to be monitored pursuant to 
the institution's occupational health program.
     In October 2006, the University received a request for 
public documents involving incident reports for risk group 2 
and higher pathogens from Mr. Edward Hammond of the Sunshine 
Project, one of the witnesses at today's hearing. In November 
2006, the University produced a document showing that there had 
been a single incident relating to brucellosis. The University 
continued to inquire internally as to whether there were any 
additional documents. In April 2007, additional documents were 
identified regarding the Brucella exposure. At that time, the 
University immediately notified CDC and provided the documents 
to Mr. Hammond.
     CDC's 2007 Investigation. Following the notification to 
CDC, the University received a notice of suspension of select 
agent research in Dr. Ficht's lab. Inspectors from CDC then 
visited the University to follow-up on the notification of 
exposure and conducted an inspection of the University's four 
BSL-3 laboratories. A few weeks later, the University submitted 
information to CDC regarding elevated titers for Q fever--a 
term of measurement of antibodies in the blood--for three 
employees who worked in Dr. Jim Samuel's lab. Although it was 
not clear whether notification was required for these elevated 
titers, the University elected to report these levels to CDC 
out of an abundance of caution. While these elevated titers 
were cause for concern, none of the individuals became ill. 
Following this disclosure by the University, the CDC issued an 
order suspending all select agent research at the University. 
The University immediately complied.
     On July 23, 2007, an 18-member team from the CDC conducted 
a comprehensive site review of the University's select agent 
research activities which ultimately led to the CDC's August 
31st site visit report. Though the CDC's report acknowledged 
the efforts of the University in curing the deficiencies noted 
by the CDC inspectors, we acknowledge that several additional 
steps need to be accomplished in order to be re-certified for 
select agent research. Our No. 1 goal is to ensure that our 
laboratories are operated in a safe and secure manner, in 
compliance with all applicable laws and regulations.
     We are using CDC's August 31st site report as our roadmap 
to full compliance. In fact, we have already begun to take 
corrective action to cure many of the deficiencies cited in the 
report and have engaged outside experts--some of who were 
recommended by the CDC--to assist in this process. This will 
continue full speed ahead. Only after we have satisfied 
ourselves in the areas of biosafety, security, training, 
recordkeeping and incident response, we will ask the CDC to 
allow us to re-start the laboratories. We desire to get back to 
the important business of vaccine research, with the CDC as our 
partner, as soon as possible.

        March 2005 CDC Regulations Could Use Some Clarification

     I would now like to turn our attention to the Select Agent 
and Toxins regulations that were promulgated in March 2005. 
These regulations are found at 42 C.F.R. Sec.  73.1 et seq. and 
were developed pursuant to the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002. These 
Federal regulations pertain specifically to the possession, use 
and transfer of select agents and toxins and I will refer to 
them as the ``SAT Regulations.''
     Like many labs in the U.S. handling select agents and 
toxins, we have grappled with compliance with these 
regulations. Over the past two and one-half years since their 
promulgation, several areas have emerged which we believe need 
further clarification or improvement. I address a few of these 
areas below:
     Definitions--perhaps the most challenging aspect of the 
SAT Regulations pertain to definitional interpretations of key 
terms. The possession, use and transfer of select agents and 
toxins in biomedical laboratories is a highly complex 
scientific endeavor. Added to that is the need to operate the 
laboratories in a safe and secure manner. Given these 
complexities, the application of definitional terms in the 
regulations can take on different meanings given different 
operating scenarios. Terms that are broadly defined can take on 
different meanings to different people, which can result in 
differential application and enforcement of the regulations. 
The following terms in the SAT Regulations have led to a good 
deal of confusion:
     ``Access' to select agents or toxins. 42 C.F.R. Sec.  
73.10(a) restricts access to select agents and toxins to only 
those individuals that have been approved by the HHS Secretary 
or Administrator, following a security risk assessment by the 
Attorney General. Whether someone has access or not depends on 
``if the individual has possession of a select agent or toxin 
(e.g., ability to carry, use, or manipulate) or the ability to 
gain possession of a select agent or toxin.'' 42 C.F.R. Sec.  
73.10(b) (emphasis added). While the former condition (has 
possession) is straightforward, it is the latter condition that 
creates the bulk of the confusion (has the ability to gain 
possession). For example, does someone who has not been pre-
approved and observes an experiment in a select agent lab have 
the ability to gain possession of the select agent? Or, if the 
select agent or toxin is in an animal that is locked in cage 
within the lab, does that change the analysis? Presently, the 
definition of access to select agents or toxins is interpreted 
to be extremely broad. Some degree of reason needs to be 
applied to the rule in order to facilitate good laboratory 
practices and the advancement of scientific research. The 
effect of the broad application of the definition is that any 
person who enters a SAT lab could arguably have access to the 
select agent and, therefore, must be pre-approved.
     ``Routine cleaning, maintenance, repairs, or other 
activities not related to select agents or toxins'' 42 C.F.R. 
Sec.  73.11(d)(2) provides for certain exceptions to the rule 
requiring that individuals entering a SAT lab be pre-approved. 
The exception in (d)(2) specifies that an individual who 
conducts routine cleaning, maintenance, repairs, or other 
activities may gain access to the lab so long as (1) his or her 
activity is ``not related to select agents or toxins'' and (2) 
he or she is accompanied by an approved individual. The 
exception is often confused with the requirement set forth in 
 73.10(b) as described above. Furthermore, it is 
unclear what is meant by an activity that is ``not related to 
select agents or toxins.'' Does the maintenance or repair of a 
vent hood that is used for the handling of select agents or 
toxins fall within this exception? It could be argued that any 
activity within a select agent or toxin laboratory is 
``related'' to the agent or toxin handled in that laboratory.
     ``Occupational exposure or release'' of a selection agent 
or toxin. 42 C.F.R. Sec.  73.19(b) specifies the notification 
requirements in the event of a release of a select agent or 
toxin. The trigger for the notification is based upon whether 
there is an ``occupational exposure or release of a select 
agent or toxin outside the primary barriers of the 
biocontainment area.'' The SAT Regulations do not define the 
terms ``occupational exposure'' or ``release,'' leaving both 
the regulator and the regulated without clear direction as to 
what is expected. In terms of select agents and toxins, there 
is little guidance as to what constitutes an occupational 
exposure (e.g., mode of the exposure or acceptable limits or 
levels?).
     ``Restricted experiments.'' 42 C.F.R. Sec.  73.13(a) 
establishes a requirement that an individual or entity may not 
conduct certain ``restricted experiments'' unless approved by 
the HHS Secretary. Subsection (b) sets forth two types of 
restricted experiments--experiments using recombinant DNA that 
involve the deliberate transfer of a drug resistance trait to 
select agents and experiments that involve the deliberate 
formation of recombinant DNA containing genes for the 
biosynthesis of select agents. While there are likely strong 
public policy reasons for restricting these types of 
experiments (based upon the ultimate end use) without express 
approval from HHS, these two types of restricted experiments 
are very broadly defined and may unintentionally limit 
legitimate experiments involving similar approaches but result 
in completely different outcomes (and end uses).
     Authorization of Access to Select Agents and Toxins--
another area of confusion involves the authorization of an 
individual's access to a select agent or toxin. 42 C.F.R. Sec.  
73.10(a) states that ``[a]n individual or entity--may not 
provide an individual access to a select agent or toxin, and an 
individual may not access a select agent or toxin, unless the 
individual is approved by the HHS Secretary or Administrator, 
following a security risk assessment Attorney General.'' The 
confusion arises as to whether the authorization of an 
individual is (a) as to a specific select agent, wherever that 
select agent might be handled, or (b) as to a specific select 
agent handled at a specific location. If the latter 
interpretation is correct, the authorization requirement 
becomes a bureaucratic paperwork mess. For example, a research 
scientist and his/her staff who work with Rickettsia prowasekii 
(a select agent) may, from time to time, visit the labs of or 
work with other research scientists who handle the same agent. 
Requiring that scientist and his/her staff who are already 
authorized to access this select agent at their home lab to 
obtain authorization anytime they visit another lab or location 
where the select agent is handled serves no purpose, nor does 
it achieve any public policy. The regulation should be 
clarified such that the authorization applies to the specific 
agent in question, not the specific agent and location. The 
focus of the authorization should be, first, on the individual 
(which is why there is a security risk assessment on the 
individual) and, second, on the handling of the select agent.
     In closing, I want to express my appreciation to the CDC 
for providing a comprehensive review of the steps necessary to 
rebuild the compliance model for our select agent and toxin 
research program at Texas A&M. As I mentioned previously, we 
are using it as our road map to full compliance.
     The University has made significant progress in 
implementing corrective actions that cure the deficiencies 
noted by CDC in its findings and has brought in outside 
experts, including several recommended to us by CDC, who have 
aided us greatly in the process. Our efforts will continue at 
full speed ahead until we have satisfied the CDC and ourselves. 
Our goal is for the University's select agent labs to be the 
model to which others compare themselves.
                              ----------                              

    Mr. Stupak. Thank you, Dr. Davis. We will begin 
questioning. We will see if Mr. Barton would like to start.
    Mr. Barton. Mr. Chairman, I am willing to go first but I am 
also willing to let the Chair exercise its prerogative to 
question first.
    Mr. Stupak. You are the graduate Texas A&M. Why do not you 
go first?
    Mr. Barton. All right. I will be happy to. I think in full 
disclosure, Mr. Chairman, I need to say, not only did I attend 
Texas A&M, my father attended Texas A&M, my three children 
attended Texas A&M, numerous aunts, uncles, nephews, nieces and 
cousins have attended Texas A&M. If you added up all the 
relatives who have had the privilege to go to that institution, 
it would be in the neighborhood of 30. So I am a biased 
questioner in favor of Texas A&M. But having said that, as a 
Member of Congress and this subcommittee and the past chairman, 
I am absolutely committed to getting to the bottom of what went 
wrong and making sure that it does not happen again. Mr. Davis, 
as acting president of Texas A&M, when were you first made 
aware of the Brucella exposure and how was it reported to you?
    Mr. Davis. In April 2007, Congressman Barton and I was 
notified that we had discovered that there was an error and a 
failure to report within the timeframe required by the select 
agent regulations. This did come about through a request from 
the Sunshine Project for us to produce documents related to our 
select agent program. And as we did review those documents and 
discovered that this incident was not reported, as soon as we 
discovered it, we did report the incident and at the same time, 
provided that information to the Sunshine Project. The reason 
the incident was not reported is fairly and lengthy and 
detailed but I think it is important that I give you some 
summary of what happened. A laboratory worker was actually an 
authorized person in a lab observing the use of an aerosol 
piece of equipment, which she was using for tuberculosis 
research. This chamber was then used in a Brucellas experiment 
in a different laboratory. After she had completed that work, 
the other researcher, the person that was actually providing 
the machine, cleaned the machine unbeknownst to the laboratory 
technician that was conducting the research. As a result, her 
exposure to the Madison Chamber, we believe is where the 
infection came about. A few weeks later she became ill with 
flu-like symptoms. She went to her doctor. She was diagnosed 
with the flu and, ultimately, through a couple of trips back to 
an infectious disease doctor, found that she had, indeed, been 
exposed to Brucellas. At that time, she went back to the 
principle investigator, informed him of this. He immediately 
informed our biological safety officer, where the failure to 
report to the CDC occurred. He did have the rest of his lab 
workers tested. No one else revealed any indication of 
Brucellas or brucellosis and the individual that was infected 
was treated and has been cleared and has been routinely tested 
since that time, with no adverse effects.
    Mr. Barton. The individual that was infected was infected 
in doing a procedure which she did voluntarily and was not 
instructed to do so against protocol, is that correct?
    Mr. Davis. That is correct.
    Mr. Barton. But in spite of that, this employee is 
currently cured and, so far as you know, has no complaint 
against the university, is that correct?
    Mr. Davis. That is correct.
    Mr. Barton. OK. Now you mentioned that there was an 
exposure incident of Brucella, we have talked about that. It is 
my understanding that there was also a Q fever exposure that 
went unreported. Can you comment on that?
    Mr. Davis. I think it is helpful to clarify that. After our 
Brucella report and a visit by the CDC, after the CDC had come 
in in April to review this incident with us, after their 
departure, we were reviewing documents and discovered that we 
had elevated titers in three employees who were actually 
involved in Q fever research. We do titer testing, obviously, 
to determine from a public health standpoint, if anyone has had 
exposure, it allows us to understand if they should be referred 
to a physician for possible treatment. In these cases, it was 
not clear that we were required to report the titers. We did it 
out of an absolute abundance of caution because we had just not 
reported Brucellas.
    Mr. Barton. This was after the Brucella.
    Mr. Davis. This was after the Brucellas incident and after 
their visit. We felt it was important that we absolutely reveal 
anything that was of any concern. Unfortunately, after we did 
report the Q fever incident, shortly after that, the CDC 
suspended our select agent research.
    Mr. Barton. Now currently, is the Texas A&M University 
system fully cooperating with the CDC in their investigation or 
re-examination of the facilities and procedures at Texas A&M?
    Mr. Davis. Yes, we are. We have, of course, received their 
August 31 report. We have had a team of individuals, including 
outside experts, helping us with the response to that report, 
as well as the reconstruction of a total re-registration of our 
select agent program.
    Mr. Barton. And so long as you are the acting president of 
Texas A&M, are you committed to doing everything within your 
power to make sure that A&M fully complies with the CDC 
directives and cooperates in every way to ensure the safety of 
these agents if this type of research is allowed to be 
commenced again?
    Mr. Davis. Mr. Barton, we are absolutely committed to the 
research, to the safety, to the compliance of this research. 
Absolutely.
    Mr. Barton. Mr. Chairman, before I yield back, I want to 
recognize, I think, the chairman of the board of regents at the 
Texas A&M University system is in the audience, Mr. John White, 
and I think that shows the seriousness with which the 
university takes this matter. With that I yield back, Mr. 
Chairman.
    Mr. Stupak. Well, thank you, Mr. Barton. All the people 
went to Texas A&M in your family, I thought you would end up by 
saying they named a lab after you.
    Mr. Barton. Well, there is an Olin E. ``Tiger'' Teague 
Research Center at Texas A&M, who was my predecessor and who 
Congressman Edwards worked for as a district aid. So there is 
Aggie sixth district congressman facility on campus but it is 
not named after Joe Barton.
    Mr. Stupak. You'll have to do a Chet Edwards, right? Dr. 
Davis, this is a level 3 lab at Texas A&M, right?
    Mr. Davis. Yes, sir.
    Mr. Stupak. OK. Are you in the process of expanding that 
lab at all?
    Mr. Davis. We are not. In our revised registration 
documents, Mr. Chairman, we are actually recommending to the 
CDC that we re-activate two of our laboratories. The two other 
laboratories, or four in total, we have some physical 
corrections to make to that but we are not seeking immediate 
re-registration of those other two. Not until we have them 
fully in compliance will we ask the registration to include 
them
    Mr. Stupak. Were you here when the last panel testified?
    Mr. Davis. I was.
    Mr. Stupak. OK. I asked about unannounced inspections. Do 
you think CDC should do unannounced inspections?
    Mr. Davis. I think we should have a program that can endure 
any kind of inspection, Mr. Chairman, announced or unannounced. 
I also believe, and this goes back to another question I 
believe you asked and it is related to Mr. Barton's question, 
the idea of no fault reporting, it seems to us, is a very valid 
concept and should be pursued. We should be encouraged to 
report any kind of occupational exposure or loss. And there 
needs to be greater definition of those things.
    Mr. Stupak. Congressman Edwards explained to me a couple 
times that the person who is in charge of safety of your labs 
there has been terminated from employment and you are going 
about correcting it. Any suggestions on how we do this? I heard 
a lot from the CDC saying, well, we got documentations, we will 
be questioning this and looking at this. And in the Texas A&M 
case, the people who were in charge of certain things within 
the lab had all that documentation. Maybe not to the level it 
was supposed to be but they had that documentation and CDC 
passes you through and then because of the Sunshine Project, we 
find there were greater concerns. They come back in with their 
team and they find serious violations. Any suggestions on how 
we can make sure CDC, or whoever is going to do it, do these 
inspections for independent verification so we do not have this 
situation again? As the president of Texas A&M, I am sure you 
got the report from CDC saying everything is fine and then 
boom, we find things are not so good.
    Mr. Davis. Certainly it is something that I would not be 
expecting on a daily basis to be involved in but I am involved 
in it now and I do have some thought about how we go forward. 
Frankly, I think this hearing is a positive view of what needs 
to be done. You've revealed some issues, some lapses in the 
overall integration of the select agent program and the 
biological research program. I think it is more complex than 
just inspections. I think what we have to have, it is very 
interesting as I analyzed the exit interview from the CDC, this 
was in an oral exit interview, one of the things that became 
very clear to me was that there was a gap between the 
understanding at the research compliance office and what was 
going on in the labs. And part of that misunderstanding was the 
fact, if you do not document it, you have not done it. It is a 
bit like Sarbanes-Oxley issues. So what we actually did is 
employed an expert in the scientific compliance area, Dr. 
Claudia Mickelson, from MIT with an expert in accounting in 
Sarbanes-Oxley compliance because we thought we needed to be 
much better at transaction process documentation. You need to 
know when people are entering the lab. You need to know who is 
on the registration. You need to be sure those things are 
protected. It is a very complex environment which this is all 
about. But let me give you one other example of why it is so 
complex. Our re-registration document now is 900 pages, going 
toward 1,000. We are not finished. That is for four labs that 
would fit inside this hearing room. There is a huge amount of 
work that has to be done on not just writing the regulations 
and implementing them but having the time to make those 
regulations work together so that everybody understands what 
the expectations are and the expectation has to be safety, 
security and good science.
    Mr. Stupak. I understand that and also you have to have the 
people in there who are trained to do it. Like your biosafety 
person who was the biosafety officer at A&M. Had no training in 
biosafety but was an industrial hygienist by education, 
experienced and he was asked to take on these extra duties. Who 
would have made that decision, the head of the lab, your safety 
officer?
    Mr. Davis. Of the person that was there before?
    Mr. Stupak. Right, who was assigned these extra duties, who 
wasn't qualified to do it.
    Mr. Davis. Well, I do not know who made that decision. I 
wasn't there at the time. I will tell you this, we are 
currently advertising and seeking a new biological safety 
officer that will also be our responsible official in 
interacting with the CDC. We are looking for a much greater 
level of expertise. That is, we want someone who is an 
accomplished scientist with experience in the area of 
biological compliance. And we have two good candidates and we 
hope to have that filled within just a very short period of 
time.
    Mr. Stupak. Do you think the communities have a right to 
know what is going on at these labs?
    Mr. Davis. Absolutely.
    Mr. Stupak. There was some reluctance from the last panel 
to let them know what agents or what we are doing at these labs 
but that can be part of the checks and balance, can it not?
    Mr. Davis. It does. One of the recommendations of the GAO 
that I heard this morning I think is very sound is that we need 
to work with the community health providers to be sure they 
know what we are working on in the laboratories, so if there is 
an exposure, accidental or otherwise, they recognize the 
symptoms if it comes from someone who is working in one of 
these labs.
    Mr. Stupak. It is Mr. Green's. I will turn to him for 
questions just in a second. Let me ask you this and hopefully 
we can all learn from the Texas A&M situation. You are telling 
me your re-license is up to almost 1,000 pages now. I am sure 
as you talk with other university presidents and others who 
have labs on their academic facilities, you must have heard 
from others saying, boy, they are putting you guys through a 
wringer. We got to tighten up ourselves. Is that pretty common? 
I am not asking you to blow the whistle on anybody but I am 
just saying, it seems like this has been pretty shoddy the way 
we have been doing it throughout this country, even with the 
proliferation. We really need to look at this in more detail. 
Not that we are trying to tie up research but, at the same 
time, it just seems like this has been sort of an area we never 
paid much attention to until we really--and unfortunately, your 
sort of institution that sort of got looked at closer.
    Mr. Davis. This is not the type of role model we would like 
to be, Mr. Chairman. However, I think our episode and the 
revelations of this hearing will probably cause others to 
awaken to the need to be very vigilant about these issues and 
to really focus on both the regulations and their interactions 
with the regulating agency.
    Mr. Stupak. Well, my time is up and as you can see, Texas 
A&M has a lot of support on this committee. I am the only one 
here not representing Texas A&M. So with that, let me turn it 
to Mr. Green for questions or do you want to go, Mr. Burgess? 
Go ahead, Mr. Green, you would have been next anyway.
    Mr. Green. Dr. Davis, thank you for being here and I can 
imagine under uncomfortable circumstances because those of us 
who are familiar with Texas A&M and high institutions are not 
found when something bad happens. But the good thing about it 
is when something bad happens you also want to fix it and that 
is what I am proud of that we are problem solvers. I wish I 
could tell you I always voted right but if I find out it was 
wrong, then I will fix it somehow. And I hope you know your 
testimony before us today providing us with the lessons it 
learned, which can make sure that our regulatory gaps are 
filled. And my last series of questions from CDC, I mentioned 
the need for rigorous training of lab workers and the CDC 
mentioned that labs should have a biosafety plan, emergency 
response plan, a security plan among others. And its 
investigations in the incidents at A&M, GAO noted that the 
infected researcher had a wealth of experience in BSL-2 labs in 
particularly tuberculosis. She was then called in to a BSL-3 
lab to work on Brucella despite not receiving training on that 
specific agent. Did any biosafety plan speak to the specific 
protocols when alternating between BSL-2 and BSL-3 labs?
    Mr. Davis. Yes, Congressman Green, it did. Unfortunately, a 
modest change in that and that is the worker actually 
volunteered to participate in the experiment because she was 
familiar with the Madison Chamber, which was used in 
tuberculosis experimentation and was being loaned in the lab 
that was doing Brucellas experiments. So that is not an excuse, 
it is simply a statement that it is quite different then that 
she was urged to do it or asked to do it. It was a voluntary 
activity.
    Mr. Green. The GAO office spoke to laboratory experts who 
highlight inherent safety risk when researchers switch from 
BSL-2 to BSL-3. And the GAO noted that the procedures, 
protocols are different among labs and the researchers really 
need to make sure that their safety protocols become part of 
their routine. From the university research program 
perspective, is this a point made clear to select agent 
programs either through the CDC or other safety guidelines? Do 
you know if that was made plain to A&M?
    Mr. Davis. Well, clearly from the interactions we have had 
with the CDC and the GAO, we are very engaged in improving and 
upgrading our safety plans, our training plans. Actually, 
during the time that our laboratories are not in operation, we 
are taking advantage of that time, in addition to getting our 
documentation completed. We are also having training sessions 
with the individuals that are assigned to the laboratories, 
including specific training on the select agents in which they 
are working. So indeed, we are taking advantage of this time to 
improve our safety, security and capacity to do the research.
    Mr. Green. When the CDC visited A&M in February 2006, days 
after the unknown exposure occurred, was there any mention from 
the CDC about the need to implement training protocols for 
researchers specific to the agents they were handling?
    Mr. Davis. I cannot answer that, Mr. Green. I do not know 
what was contained in the report in their February 2006 visit. 
I was not in place at the time.
    Mr. Green. OK. Well, I guess from the testimony from our 
earlier panels and seems like there is enormous lack of clarity 
in the system and when it comes to authorities and the 
responsibilities and protocols on the part of the Federal 
agency and also individual research institutions and given the 
nature of these agents, I think the questions need to be 
crystal clear to both the agency but also to our institutions. 
And I look forward to working with you, of course, the CDC, NIH 
and other schools to see if we can get that so we do not have a 
repeat of what happened at Texas A&M and maybe happen somewhere 
else that we do not know about as we sit here today. Thank you, 
Mr. Chairman.
    Mr. Davis. One of the positive outcomes of this is we do 
have an opportunity to get better, all of us do and that is 
what we intend to do.
    Mr. Green. Thank you.
    Mr. Stupak. Thank you, Mr. Green. Mr. Burgess, questions 
please.
    Mr. Burgess. Thank you, Mr. Chairman, Dr. Davis. Thank you 
for being here with us and ensure your commitment to making 
sure we get it better and my responsibility being on this 
committee is being sure that we give you the tools that you 
need, give your researchers the tools that they need so they 
are protected and in turn they protect us. Let me just ask you 
briefly, the individual that was involved with the brucellosis 
incident, was that an experienced lab worker, was that a 
student, what was that person's role in the lab?
    Mr. Davis. She was a research associate. She was a Ph.D. 
scientist. She was experienced in laboratory activities and 
safety protocols.
    Mr. Burgess. Did the extent that you are able to disclose 
it with all of the Federal regulations regarding HIPAA, can you 
tell us the condition of that individual today, what their 
health status is?
    Mr. Davis. Her health is fine and we continue to monitor 
her for any reoccurrence.
    Mr. Burgess. OK. So she was treated and responded to--OK. 
Well, that is good news. Let me ask you this because I mean, 
A&M, most people may not know this but you are the only school 
of veterinary medicine in our State and probably in the region. 
The Brucellosis is not really a new infective agent. 
Brucellosis has been around for a long time. Has your 
university been involved with the study or work of Brucellosis 
in the past?
    Mr. Davis. Yes, sir, for quite a long time. Actually before 
we knew what a select agent was, we were working on Brucellosis 
research. My guess is probably as early as the early part of 
the 20th century because Bangs Disease or Brucellosis in cattle 
has been a major issue and problem in the State of Texas. So 
Texas A&M has actually lead in that. We have had laboratories 
in place, the BSL-3 type laboratories, since the middle '80's, 
prior to the select agent program, implementation working on 
Brucellosis research.
    Mr. Burgess. So even going back into the early part of last 
century, even though you were not able to or your predecessors 
were not able to intuit, that this agent would be a select 
agent in the 21st century, you had ongoing procedures and 
protocols to protect from contamination and protect your 
laboratory workers?
    Mr. Davis. Yes, sir, we did. This research was primarily in 
animal-borne diseases and zoonotic diseases related to those 
pathogens.
    Mr. Burgess. Well, before we were called for this hearing 
today, have you expressed concerns to the CDC about the 
ambiguities regarding the CDC's handling of the select agents, 
the rules for handling select agents? Do you feel like those 
have been delivered to you a timely fashion with the 
appropriate clarity to allow your researchers and your lab 
personnel to make the correct choices and assignments?
    Mr. Davis. As we mentioned a while ago, I think there are 
some areas that still remain unresolved, such as the definition 
of an occupational exposure, so that there is clarity and there 
is also a promotion of open reporting of incidents. There are 
probably a few other areas that are related to the security 
issues with select agents where you have to have the Department 
of Justice approval for individuals participating in particular 
laboratories. Currently, the approval is related directly to 
the laboratory that the individual might work in. So if you 
have a visiting faculty member going to another lab using the 
same type of pathogen, they are not eligible unless they are 
cleared again. And we think there are some improvements there 
but these are modest and we are certainly working with the CDC 
to try to find ways to reach agreement on all of those.
    Mr. Burgess. And do you collaborate with any labs that are 
from outside the country? I will respond going forward and 
making sure that we write the correct protocols or will write 
the correct legislation that allows you to write the correct 
protocols for the protection of your community and protection 
of your workers. I mentioned at the previous panel that was up 
here the concept of rather than having a punitive system, to 
have a no fault system similar to NASA, similar to commercial 
aviation, similar to, again referencing the nuclear submarine 
program in this country that has a remarkable safety record. A 
culture of not tolerating any security lapses or any safety 
lapses but at the same time, rather than coming down with 
extremely punitive measures, suspending a license or suspending 
your ability to do the work you are trying to do, to work in a 
collaborative fashion to learn from the mistake and go on and 
make sure we are going forward, that we have the correct 
procedures in place. Is that something that you are exploring 
internally in the university right now?
    Mr. Davis. We are very much in favor of that and would love 
to see that and implement it.
    Mr. Burgess. But are you working toward that specific goal?
    Mr. Davis. Our position is we will report anything that we 
suspect falls under the rules as an occupational exposure, 
although we are currently still trying to get absolute 
definition of what that is.
    Mr. Burgess. Again, I thank you for your generous 
contribution of time today for this committee. I think you have 
been very helpful with providing insight and Mr. Chairman, how 
we can craft the appropriate legislation that will not stymie 
this research but, ultimately, we all have the same goal in 
mind and that is protecting our country. So with that, I will 
yield back.
    Mr. Stupak. Mr. Barton and I were talking about my series 
of votes when I walked back here, some things we should or 
could be doing. I am a little confused here, maybe you can help 
me out. This Sunshine Project, right, that reported the stuff. 
Sunshine Project? Sunshine Project. They foiled the information 
from Texas A&M, right, and received the information from Texas 
A&M?
    Mr. Davis. Well, in our case it is open records but the 
same----
    Mr. Stupak. But they got your records?
    Mr. Davis. Yes.
    Mr. Stupak. Then why did not the CDC notice those problems 
when they were there with their inspection, when they said 
everything was fine?
    Mr. Davis. I cannot answer that, Mr. Chairman.
    Mr. Stupak. And they would have access to it, right?
    Mr. Davis. Absolutely. I will tell you, however, that when 
we received the request from the Sunshine Project----
    Mr. Stupak. OK.
    Mr. Davis. We do not have a system that accumulates 
everything that is going on in laboratories without going 
through keyword search.
    Mr. Stupak. Sure.
    Mr. Davis. And so it did take us some time to actually 
locate and dig out the documents which gave us the alert that 
this exposure occurred.
    Mr. Stupak. Right.
    Mr. Davis. And so I think it is fair to say that the CDC 
probably did not do that same level of inquiry and that is why 
we discovered it and passed the information onto both them and 
the project.
    Mr. Stupak. But in order to get it into Texas A&M archives 
or your stuff.
    Mr. Davis. Electronic.
    Mr. Stupak. Yes. Someone reported it electronically?
    Mr. Davis. Yes, sir.
    Mr. Stupak. And then when the Sunshine Project put forth, 
did the keyword search, that is when it popped up.
    Mr. Davis. We did the keyword search based on their 
request.
    Mr. Stupak. And you actually provided them with the 
information.
    Mr. Davis. That is correct.
    Mr. Stupak. So CDC should have at least, knowing its 
electronic, could have done an electronic search or then but 
where would your lab person be?
    Mr. Davis. They could have asked us to do the electronic 
search.
    Mr. Stupak. Sure. They could have asked you. Even if--
inspection team, they just could ask you to do a key search and 
you would have.
    Mr. Davis. Right.
    Mr. Stupak. But this report then, would not the lab 
director know? Your lab director know about this?
    Mr. Davis. He did and as soon as he detected it, it was 
reported to the biological safety officer.
    Mr. Stupak. Right.
    Mr. Davis. Which reported through----
    Mr. Stupak. This is the public health.
    Mr. Davis. Yes.
    Mr. Stupak. OK. That had the right training.
    Mr. Davis. That is correct.
    Mr. Stupak. OK.
    Mr. Davis. I know it sounds Byzantine but, indeed, it was 
and that is the reason we failed to report it.
    Mr. Stupak. OK. Did the Government Accountability Office 
come down and do an inspection at Texas A&M?
    Mr. Davis. They came and visited with individuals at our 
university. I do not know if I would characterize it as a 
review or inspection.
    Mr. Stupak. OK. Was that after this incident was made 
public about the Sunshine Project, do you know?
    Mr. Davis. They were here this August, which was after.
    Mr. Stupak. It was after.
    Mr. Davis. And then they were here in November 2006, which 
would have been, I guess, also after the incident occurred but 
not after it was reported. It was reported actually in April of 
2007.
    Mr. Stupak. I know GAO's been, in all fairness, Chris Shays 
had a position in a different committee, Homeland Security, and 
started this whole GAO and that was in 2005. And I thought it 
was a good idea, so we picked up on it and so I know it has 
been going on for some time, that is why I asked that question. 
My question base prompt any other questions, Mr. Barton, Mr. 
Burgess, Mr. Green? If not, Dr. Davis, thank you and we will 
call for our next panel, our last panel of the day.
    Mr. Davis. Thank you.
    Mr. Stupak. The last panel is Dr. Gigi Kwik Gronvall, 
senior associate and assistant professor of medicine at the 
University of Pittsburgh Medical Center, Center for 
Biosecurity. Dr. Alan Pearson, who is the director of the 
Biological and Chemical Weapons Control Program at the Center 
for Arms Control and Non-Proliferation. And Mr. Edward Hammond 
of the Sunshine Project. If you would come forward please.
    It is the policy of the subcommittee to take all testimony 
under oath. Please be advised witnesses have the right under 
rules of House to be advised by counsel during your testimony. 
Do any you wished to be represented by counsel? Everyone shook 
their head no so I will take it for a no. Then I am going to 
ask you to please rise and raise your right hand to take the 
oath.
    [Witnesses sworn.]
    Mr. Stupak. Let the record reflect the witnesses have 
replied in the affirmative. You are now under oath. We have 5-
minute opening statements. You can submit longer ones for the 
record. We ask Dr. Gronvall, do you want to go first here?

 STATEMENT OF GIGI KWIK GRONVALL, SENIOR ASSOCIATE, ASSISTANT 
 PROFESSOR OF MEDICINE, CENTER FOR BIOSECURITY, UNIVERSITY OF 
                   PITTSBURGH MEDICAL CENTER

    Ms. Gronvall. Thank you, Mr. Chairman, distinguished 
members of the committee. I have submitted written testimony 
but I will summarize those in my oral remarks. First, I would 
like to make it clear that it is urgent that the Nation finds 
ways to protect itself against large scale epidemics. In fact, 
it was the recognition that there needed to be research to form 
those methods of protection, the medicines and vaccines that 
are needed that led to the expansion of the high-containment 
laboratories in the first place. Without these high-containment 
laboratories, critical research cannot be performed. However, 
these labs need to be safe otherwise they cannot operate. And 
so I will highlight several actions which could be taken to 
help ensure that these new labs are both safe and productive in 
the future.
    The first action that could be taken is to increase 
biosafety training. The way that people learn biosafety and 
high containment, the way that I learned biosafety, was to 
apprentice to a more senior, knowledgeable person. However, 
with the expansion of laboratories, there may not be enough 
senior knowledgeable people to go around. And so one solution 
is to standardize the training and require certification for 
high-containment work.
    You can also increase the number of biosafety officers who 
are credentialed for high-containment work, so they can provide 
training and they can provide guidance as research is being 
conducted.
    The second action which could be taken is to develop a 
reporting system so that all mistakes, near misses are 
captured, learned from, and the results disseminated across 
high-containment laboratories. One model that may be useful is 
that used for aviation safety reporting. It was set up because 
it was found that most aviation incidents and accidents had 
common root causes. But because these incidents were not being 
reported, they were not being learned from and so the new 
accidents were not being prevented. So that is one potential 
model where people are encouraged to report.
    The third action which could be taken is to share lessons 
and operational experience across the high-containment 
laboratories. In particular, it should be easier for a more 
senior, knowledgeable person to conduct training in multiple 
high-containment laboratories.
    The fourth action which could be taken is to make public 
engagement a priority. Public engagement is essential to the 
success of these laboratories. The community has a right to 
know that the people who are working in these high-containment 
laboratories are well trained, that if there is an accident, 
that it is being dealt with appropriately. Some labs have done 
a better job of this than others. And so the successes of some 
of these labs should be taken as lessons learned and 
disseminated across the high-containment laboratories and 
emulated.
    So finally I just want to point out that this is not a 
domestic issue. This is a global issue and these labs are 
expanding all over the world because these countries recognize 
that these are important for not only work on SARS and avian 
influenza and diseases like this, but that it could be a major 
part of economic growth in the 21st century. Thank you.
    [The prepared statement of Ms. Gronvall follows:]

                    Testimony of Gigi Kwik Gronvall

    Mr. Chairman, distinguished members of the committee:
     Thank you for the opportunity to speak to you today. My 
name is Gigi Kwik Gronvall. I am a Senior Associate at the 
Center for Biosecurity of the University of Pittsburgh Medical 
Center (UPMC) and an Assistant Professor at the University of 
Pittsburgh School of Medicine. The Center for Biosecurity is a 
nonprofit, multidisciplinary organization located in Baltimore 
that includes physicians, public health professionals, and 
biological and social scientists. I am a biological scientist, 
trained in laboratories at Johns Hopkins University and the 
United States Army Medical Research Institute for Infectious 
Diseases (USAMRIID). My colleagues and I at the Center for 
Biosecurity are committed to the development of policies and 
practices that help prevent bioterrorist attacks or 
destabilizing natural epidemics and, should prevention fail, 
that mitigate the destructive consequences of such events.
     It is a privilege to come before you today to discuss the 
expansion of high-containment BSL-3 and -4 laboratories. 
Protecting the Nation against destabilizing large-scale 
epidemics, whether natural or man-made, is an urgent priority. 
The anthrax attacks in 2001, the SARS epidemic in 2003, and the 
current threat of avian influenza all are important reasons why 
we must conduct research to determine how microbes work and how 
to defeat them with medicines and vaccines. These new high-
containment biological laboratories are needed to provide the 
safe, protective environment necessary to do this research. In 
high-containment laboratories, potential bioterrorism agents 
such as Ebola or Marburg, as well as emerging diseases such as 
SARS and avian influenza, can be safely studied and understood. 
The labs can also be used to develop animal models essential to 
developing and testing vaccines, drugs, and other needed 
medical countermeasures.
     The high-containment laboratories are necessary if we are 
to produce the scientific advances needed to develop medical 
countermeasures against bioweapons and emerging diseases. 
However, recent highly publicized laboratory errors and siting 
controversies have raised questions about whether the governing 
framework and standards for biosafety and biosecurity measures 
are adequate. Since 2005, my colleagues and I at the Center for 
Biosecurity have been concerned that the expanding number of 
high-containment laboratories may strain current systems for 
personnel training in biosafety and biosecurity. We held a 
meeting at the Center on July 11, 2006, to discuss these 
issues, the report from which we would like to submit into the 
record. At this meeting, we heard from distinguished scientists 
and experts in biosafety, biosecurity, and public health--both 
proponents of the laboratories, as well as those who oppose the 
recent expansion. Based on those conversations, we believe that 
there are several things that can be done to ensure that these 
new high-containment laboratories are productive and safe and 
operate with due consideration for their neighboring 
communities. These actions include expanding biosafety training 
for researchers and workers coming into high-containment 
research from less dangerous areas of research; monitoring the 
safety performance and operational experience of the high-
containment facilities; increasing communication between the 
high-containment laboratories to share operational experiences; 
and initiating a public engagement effort at the Federal level 
that clarifies the need for high-containment laboratories.
     Currently, operational BSL-4 facilities can be found in 
Frederick, Maryland; Richmond, Virginia; Atlanta, Georgia; 
Galveston, Texas; and San Antonio, Texas. There are additional 
BSL-4 facilities under construction in Hamilton, Montana; 
Boston, Massachusetts; Frederick, Maryland; and Galveston, 
Texas. The exact number of BSL-3 laboratories in the United 
States is not known, however an NIH-sponsored survey estimates 
that there are 277 distinct facilities with BSL-3, with about 
600 individual laboratories, and a 2007 report from DHS and HHS 
states that 633 high-containment laboratories are registered in 
the Select Agent Program. In addition, 13 BSL-3 laboratories 
are being built specifically for biodefense research, 
principally funded by the National Institute of Allergy and 
Infectious Diseases (NIAID).
     It should be noted, however, that high-containment 
laboratories are being built all over the world at a rapid 
pace. For example, there were 16 BSL-3 laboratories brought on-
line in India in 2006 alone. This expansion is due in part to 
concerns about SARS and avian influenza, but also because of a 
recognition that bioscience is a key economic driver for the 
21st century: in the US, the biopharma industry produced $188 
billion in revenue and 400,000 jobs in 2004 alone. The model 
that the U.S. sets in operating these high-containment 
laboratories productively yet safely should provide leadership 
to other countries heavily investing in biotechnology and 
pathogen research.
     Promoting safety, security, and scientific innovation in 
the biological sciences has been a challenge undertaken by the 
government and the bioscience community since 2001. It has led 
editors of scientific journals to come together in 2003, with 
the goal of reducing the likelihood that legitimate 
bioscientific research could be used for malevolent ends. It 
has led to the forming of the National Science Advisory Board 
for Biosecurity, chartered in 2004 within NIH. Government and 
university researchers have also participated in fora intended 
to diminish the risks and maximize the benefits of new areas of 
bioscience, such as synthetic genomics. While bioscience 
promises great strides in enhancing quality of life through the 
development of medicines and vaccines, it is a powerful 
technology that must be used safely if we are to enjoy its 
benefits.
    Biosafety protection is designed to be flexible. In the 
U.S., biological laboratory research can be categorized by its 
safety level; Biosafety Levels (BSL) 1 through 4. In this 
testimony, we use the term high-containment to refer to work 
performed in the two highest levels, BSL-3 and BSL-4. BSL-3 
laboratories are used to study biological agents that are 
potentially lethal and transmissible by the aerosol route and 
that require special safety design features, such as sealed 
windows and specialized ventilation systems. BSL-4 laboratories 
are typically used to study lethal agents for which no vaccine 
or therapy is available. They incorporate the BSL-3 laboratory 
safety features, plus additional safety features such as full-
body suits ventilated by life-support systems.
     In general, the biosafety requirements needed to protect 
researchers are dictated by the specifics of a biological 
experiment and are designed to be flexible. For example, an 
experiment that could normally be safely performed at a low 
biocontainment level may need additional biosafety protections 
if the researcher must handle a large volume of infectious 
material. This flexible system for applying biosafety 
protections requires researchers to weigh risks as they work. 
This is a necessity for bioscience research; hard-and-fast 
regulations for every situation are difficult to develop, as 
these researchers are not working on one repetitive process 
that can be fine-tuned but are constantly exploring new 
scientific ground. The researchers need to use informed 
judgment.
     Biosafety guidelines, such as the Biosafety in 
Microbiological and Biomedical Laboratories Manual published by 
the CDC and NIH are thus intended to inform the judgment of 
researchers, biosafety officers, and others who advise on 
biosafety, so that biosafety protections can be applied where 
they are needed. However, some biological organisms are more 
typically worked on in one safety level versus another: 
infectious Ebola and Marburg viruses are researched in the 
highest level of containment, BSL-4; SARS is typically worked 
on in BSL-3; and Bacillus anthracis, the causative agent of 
anthrax, is typically safely worked on in BSL-2.
    Biosafety training program expansion for researchers 
entering high-containment. As the new high-containment 
laboratories become operational in the coming years, additional 
qualified staff will also be needed. As indicated in our report 
last year, we have concerns that the usual methods of biosafety 
training for high-containment research--that is, intensive one-
on-one training within a mentor-apprentice relationship--will 
not be sufficient to handle the influx of researchers and 
technicians into the field. Developing core competencies and 
standards for new staff could be a useful and important way to 
train new staff on safety practices. It could also conserve the 
experienced mentors' valuable time and abilities and shorten 
the time it takes for the labs to become productive.
     To develop the workforce, NIH could assess how many people 
will require training for their work in the high-containment 
laboratories, and develop and fund programs that can supplement 
on-the-job training. An assessment may be necessary, as not all 
of the new hires for a laboratory will work in high-containment 
conditions. For example, it is estimated that the Boston 
University National Biocontainment Laboratory will create 600 
jobs, but not all of those new employees will work in high-
containment conditions.
     Biosafety officers, already required at every high-
containment facility, will also be needed in greater numbers. 
Biosafety professionals can help researchers determine the best 
biosafety procedures and practices for laboratory-specific, 
experiment-specific containment decisions, so that the 
researchers can be productive and safe. Biosafety officers can 
also provide on-the-job biosafety training. NIH could work with 
the American Biological Safety Association, the biosafety 
professional organization, to determine credentialing standards 
required for work in high-containment laboratories. This may 
help to ensure that biosafety officers are knowledgeable 
resources for the researchers in these labs.
    Monitoring safety performance of high-containment 
laboratories. With the laboratory expansion, a systematic 
analysis of safety issues and operational problems in high-
containment laboratories can help to ensure that the 
laboratories are operating safely. Currently, reporting of 
laboratory-acquired infections is required for all select 
agents, those pathogens that require clearance to possess under 
the Select Agent Rule as defined by 45 CFR 72, whether they 
occur at BSL-2, -3, or -4 laboratories. NIH grants also 
stipulate that institutions report any serious accidents or 
research-acquired infections. However, many of the experts we 
consulted thought nonlethal infections were underreported, and 
operational problems or ``near misses'' were generally not 
reported.
     Without reporting, and without analysis of these 
incidents, lessons cannot be learned from the experience. 
Laboratory procedures cannot be analyzed in light of the 
accidents, so that future accidents can potentially be avoided. 
To correct this situation, disincentives to reporting should be 
removed, to encourage researchers and their institutions to 
report and take corrective action.
     Generally, there is a disincentive to report acquired 
infections and other mishaps at research institutions. 
Infections lead to negative publicity and scrutiny from the 
granting agency, adversely affecting future research funding. 
In addition, after a scientist acquires an infection in the 
laboratory, neither the scientist nor the laboratory wishes to 
advertise the mistake. These barriers need to be cleared so 
biosafety can be enhanced through shared learning from 
operational experiences, and also so the public may be 
reassured that accidents are being thoroughly examined and 
contained.
     One possible model for high-containment laboratories to 
emulate is the reporting mechanism used for aviation incidents, 
wherein airlines can contribute operational experience without 
fear of regulatory action. Mistakes are analyzed and learned 
from, but they are not attributed to individuals (except when 
mistakes result from criminal actions, such as drunkenness). 
Institutional anonymity may also be required in order to get 
robust reporting from research institutions. Procedures would 
need to define thresholds and mechanisms for reporting if an 
accident poses a danger to the community surrounding the 
laboratory, however.
     There are other potential models for the high-containment 
labs from the nuclear and chemical industries. The Institute of 
Nuclear Power Operations (INPO), formed after the Three Mile 
Island accident, emphasizes personnel training, safety 
management, and lessons learned; and Responsible Care, formed 
after the Bhopal tragedy, is a voluntary initiative of the 
chemical industry to share lessons learned. These models are 
from for-profit enterprises, underlining that any reporting 
system will be expensive. Another possibility could be a 
reporting clearinghouse, where operational experiences would be 
posted and available for outside analysis.
     Ultimately, it is the laboratory director's responsibility 
to ensure that all laboratory personnel are properly trained to 
do research safely in high-containment. Yet, the institution 
where the research takes place may be responsible for ensuring 
that the head of the laboratory, the staff, and the lab 
environment conforms with biosafety requirements and accepted 
practices. The CDC or NIH could monitor proactively whether 
biosafety is being managed at those institutions where Federal 
money pays for the research and infrastructure.
    High-containment laboratories and sharing lessons learned. 
Mechanisms to enable and encourage inter-laboratory training 
and information exchange will be important for these 
laboratories. Currently, the Select Agent Rule and concerns 
about legal liability may have inadvertently become barriers to 
learning across high-containment research facilities. Under the 
Select Agent Rule, as defined by 45 CFR 72, HHS and USDA keep 
lists of pathogens that require select agent clearance. The 
rule regulates the possession, use, and transfer of those 
agents; imposes security requirements for the facility in which 
the work will be performed; requires inspections; and can 
impose criminal and civil penalties on those who do not adhere 
to the Rule. In addition, security risk assessments are 
administered to individuals who work with select agents by the 
Department of Justice, a process that is renewed every five 
years. Once cleared, an individual is allowed to work with a 
specific biological agent, but only within a specific 
laboratory. The specificity of this clearance procedure 
inhibits the practical exchange of safety-related information 
and techniques between high-containment laboratory researchers, 
by preventing, for example, a technician in one laboratory from 
demonstrating techniques in another laboratory without going 
through a separate lengthy clearance process.
     In addition to clearance barriers, the perception that 
laboratories will be liable for accidents that occur to 
scientists visiting for training purposes may have prevented 
some training opportunities from taking place. This should be 
addressed so that experienced scientists and technicians can 
more easily demonstrate techniques and safety procedures 
developed in one laboratory to another. This could speed up the 
process for new laboratories to become productive; it could 
maximize the use of specialized facilities of some 
laboratories; and it could result in increased safety of the 
research.
    Public engagement as a Federal priority for high-
containment labs. NIAID has a great deal of information about 
the new high-containment laboratories on its website, but 
direct engagement with the communities where the laboratories 
are being built is handled by the institution proposing the 
laboratory. Thus, the strategies and outcomes of public 
engagement, as well as the transparency of laboratory 
operations to the public, have varied considerably. This has 
undoubtedly exacerbated the controversy surrounding the siting 
and operation of these laboratories, particularly in the face 
of highly publicized laboratory errors. While individual 
facilities bear final responsibility for their relationships 
with their neighbors, NIAID could have a clearer mechanism to 
engage with the public about the siting and operation of these 
laboratories, beyond the NEPA process. It may help if there is 
a more aggressive and proactive Federal effort to standardize 
public engagement and transparency of operations for high-
containment laboratories and to direct funds to this purpose.
     A public engagement program could address the concerns 
that have surfaced in siting high-containment laboratories. 
Often, proponents of the labs interpret protests against the 
laboratories as a lack of understanding of science: however, 
the concerns about the labs are varied. For example, there have 
been concerns that the labs would become a terrorist target, or 
that the laboratory would not provide jobs to the community. 
The communites' concerns could be actively addressed both by 
HHS and NIAID and by the institution sponsoring the laboratory.
     These high-containment laboratories should be a critical 
part of the research infrastructure for understanding the 
mechanisms of pathogenicity, as well as developing and testing 
medical countermeasures. However, as these labs come online, so 
should new systems for training of personnel, monitoring safety 
performance, and engaging the public. Experience has shown that 
proactive steps such as these can lead to more effective and 
cost-efficient safety management than burdensome requirements 
imposed following a serious accident. A new governance 
framework could enable the laboratories to operate more safely, 
with consideration for their communities, and it could help the 
laboratories fulfill their intended purpose of protecting the 
Nation against natural and man-made biological threats.
                              ----------                              

    Mr. Stupak. Thank you. Dr. Pearson.

 STATEMENT OF ALAN PEARSON, DIRECTOR, BIOLOGICAL AND CHEMICAL 
   WEAPONS CONTROL PROGRAM, CENTER FOR ARMS CONTROL AND NON-
                         PROLIFERATION

    Mr. Pearson. Well, thank you for inviting me to testify 
today on behalf of the Center for Arms Control and Non-
Proliferation. Since 1980, the Center has been working to 
protect the American people from the threat of nuclear, 
chemical and biological weapons and we see the issues being 
considered here today as integrals to achieving that goal.
    Over the last 6 years, the Federal Government has 
dramatically increased U.S. research and development activity 
and infrastructure focused on biological agents that could be 
used as biological weapons.
    The data are clear. Annual R&D funding is up six-fold since 
2001. More than two dozen new high-containment facilities, 
which we have heard about, funded specifically to work with 
such agents. Over 15,000 individuals approved to work with such 
agents. This expansion recognizes our need for a national 
biodefense program but it is not necessarily an unalloyed good. 
It also creates risks to laboratory personnel, public health 
and national security. Basically, and we have heard this 
already today, when more dangerous research is performed by 
more people in more locations, there are simply more 
opportunities for significant biosafety or biosecurity breaches 
to occur.
    I would like to just make one point clear. The risk is not 
limited to the BSL-4 labs, although that is usually the focus 
of the attention. There is actually good reason for concern 
that the risk may be even greater at some of the BSL-3 labs. 
The most obvious risk is that of the lab accident. A second 
particularly acute risk that I would like to bring to your 
attention is that the very labs designed to protect us against 
biological weapons could become a source for them. The easiest 
way for a sub-state enemy, such as Al-Qaida, to obtain a 
bioweapons capability will be for it to penetrate an existing 
research project that uses these agents. Nor should we ignore 
the possibility that a U.S. biologist working in one of these 
labs could become disgruntled or even turn rogue.
    Some types of contemporary pathogen research taking place 
in these labs increase risk further still. For instance, 
efforts to deliberately enhance the virulence or 
transmissibility of pathogens, to understand how they cause 
disease, are inherently more risky than experiments of the 
past. They are also dual-use in nature, the knowledge and 
materials generated by the experiments can be used for either 
hostile or peaceful purposes. And a particular concern in this 
regard is threat assessment research, which is typically 
classified research that involves the exploration of offensive 
aspects of biological weapons agents and delivery mechanisms 
for defensive purposes.
    Looking internationally for just a moment, each of these 
concerns that you are hearing about becomes amplified. Our 
actions here, taken for the best of intentions of protecting 
our Nation, also provide a plausible justification for others 
to do the same. So there is a critical need for rigorous 
oversight and maximal transparency of these facilities and 
activities.
    What I would like to highlight here then are just a few of 
the tools that our Federal Government needs in order to ensure 
that oversight is stronger. First, Congress should mandate the 
establishment of a universally mandatory and transparent 
incident reporting system. Second, Congress should mandate a 
national licensing system and registry for all level 3 and 
level 4 facilities in the United States, including an 
integrated and effective auditing process. Licensing and 
registration are key to both effective oversight and 
comprehensive strategic planning. Third, Congress should 
mandate institutional biosafety committee review of all 
research projects involving bioweapons agents and other high-
risk pathogens and activities. Fourth, Congress should make 
these requirements legally mandatory for all institutions, 
government, academic and private, not just those receiving 
funds from NIH and they should apply also to all relevant 
research, whether that research is classified or not. Fifth, 
compliance requires effective monitoring and enforcement. A law 
not monitored and enforced may be little better than a 
voluntary guideline. Congress should seriously consider 
consolidating all CDC and NIH, responsibilities and authorities 
relevant to monitoring and enforcing the suggestions I just 
made into a single office located within the Office of the 
Secretary of Health and Human Services. Sixth, Congress should 
mandate comprehensive inter-agency needs and risk assessments 
to determine our current and anticipated U.S. needs for high-
containment facilities and the potential risks associated with 
them. Until such assessments are completed and reviewed, there 
should be no funding for any additional facilities. Last, 
Congress should modify section 351(a)()h of the Public Health 
Service Act to more narrowly and accurately define necessary 
and appropriate requirements for withholding information about 
activities involving these agents. As currently written, that 
section is hurting biosafety, biosecurity and national security 
by impeding public accountability of our institutions and 
Federal agencies and by reducing our ability to reassure others 
that our R&D activities comply with our obligations under 
international law. Thank you.
    [The prepared statement of Mr. Pearson follows:]

    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    
    Mr. Stupak. Thank you. Mr. Hammond, opening statement, 5 
minutes, sir.

       STATEMENT OF EDWARD HAMMOND, THE SUNSHINE PROJECT

    Mr. Hammond. Thank you, Mr. Chairman. It is the Sunshine 
Project and to explain what it is, it is a very small, non-
governmental organization. We are based in Texas in the U.S. 
and Austin and also have an office in Hamburg, Germany and we 
are dedicated to biological weapons control.
    I have submitted lengthy written comments and addressing 
many of the issues that the prior panelists have addressed. I 
am not going to go back over them but I have presented some 
additional thoughts about where Congress might go on some these 
issues that have been raised. So to minimize duplication, I 
really just want to highlight a few of the things that I 
brought up in my written comments.
    The first thing that I would like to do is just to give a 
little bit of shape and talk a little bit about some data on 
the lab expansion that my organization has put together with 
Margaret Race from the SETI Institute. If you look at page two 
and three of my written testimony, we have tried to bring 
together a table that has data on the most important new labs 
that exists or are under construction. This table excludes a 
lot of laboratories that we know of. But if you look at just 
those labs that are there, you are talking about a construction 
spree that is going on right now that is approximately 4 
million gross square feet. That is 90 acres of laboratory space 
that is either under construction or is going to be under 
construction shortly. In terms of BSL-4 space, the historic 
amount, in fact, the amount up until mid-2004 in the United 
States was about 14,000 net square feet. With the projects that 
are on the books right now, we are looking at approximately 
165,000 square feet just with what is already either under 
construction or planned. That is a 12-fold increase 
approximately. We do not know the final finished square footage 
of some of the labs that are under construction but that is the 
best estimate that we can make. The four million square feet, 
to put that in terms that I think are more readily 
understandable, that is the size of about 36 big box stores. 
That is how much lab space we are going--if you stretch them 
end to end, it would a chain that is 2\1/4\ miles long.
    The second issue that I want to bring up which has not been 
directly addressed is that of transparency of the Centers for 
Disease Control. I filed numerous Freedom of Information Act 
requests with the Centers for Disease Control, spoken to many 
journalists and other non-governmental organizations that have 
done the same. It is the apparent policy of the Centers for 
Disease Control to not even attempt to locate records regarding 
select agents. They deny absolutely all requests for anything. 
So the level of transparency with respect to the Centers for 
Disease Control on its oversight of select agents is, well, 
non-existent. There is none. And I think that if I lived near a 
biological facility I would frankly find that to be offensive.
    Moving on, and I think this is an important point because 
it is emerging now, I believe that there is a positive 
correlation between the transparency of these laboratories and 
compliance and accident reporting. We saw in the case of Texas 
A&M that the revelation of one accident caused them to report 
several additional reportable incidents that occurred at the 
university. In my own research since then, I have found that 
two other institutions in Texas have reported select agent 
accidents, both of which occurred after Texas A&M became 
public. Those institutions did not report anything prior. And 
if the data that is coming out in the press now and the 
Associated Press and in other sources in the last few days is 
correct, there has been a tremendous spike in reports to the 
Centers for Disease Control of accidents involving select 
agents since April 2007. And I believe that that spike is, at 
least in part, attributable to--first of all, it is 
attributable to the expansion of our laboratories to begin 
with. But second of all, it is attributable to the transparency 
at Texas A&M. So there is a positive correlation between the 
two.
    Finally, to wrap up, with respect to the expansion of 
laboratories, I believe that our country does not need 400 
laboratories and 15,000 people handling biological weapons 
agents. Our system cannot absorb all the new laboratories that 
are coming on line. Even with explicit training, we still do 
not need 400 laboratories and 15,000 people handling biological 
weapons agents. We do not have the people to absorb a 12-fold 
increase in biosafety level 4 capacity. I believe that Congress 
should act to impose a moratorium. It should not authorize 
construction of any new biodefense facilities and it should 
consider killing some projects that are underway. Among those, 
the National Bio and Agro-Defense Facility, the very unpopular 
lab at Boston University and the Regional Biocontainment lab at 
Hawaii, which is late and over budget. Even if we kill those 
projects, we are still going to be increasing our biosafety 
level 4 space by approximately seven-fold. And we should do 
that and step back and perform the national needs assessment 
and then we can move forward if we need to move forward with 
any new labs. Thank you.
    [The prepared statement of Mr. Hammond follows:]

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    Mr. Stupak. Thank you. Thank you all for your testimony. We 
will begin questioning, Dr. Gronvall. You indicated that your 
training was through an apprenticeship?
    Ms. Gronvall. Yes.
    Mr. Stupak. And you got to answer yes or no. I am sorry.
    Ms. Gronvall. Yes.
    Mr. Stupak. OK. With the proliferation of labs then, if you 
have to go through an apprenticeship, where are they getting 
the people to work in these labs?
    Ms. Gronvall. Well, I mean by working in laboratories as 
you are training to be a biological scientist, you work in a 
lab, you learn from the people who have worked there for more 
years and have more experience. So that is what I mean by 
mentor apprentice relationship.
    Mr. Stupak. OK. In your testimony, you described the 
proliferation of these level 3 and level 4 labs in U.S. and 
around the world. Are there too many high-containment labs in 
the U.S. in your opinion?
    Ms. Gronvall. I would say that we have so much research 
that needs to be accomplished, but that I really would have to 
know what is going on in the laboratories. I do not have enough 
information to answer that.
    Mr. Stupak. So in other words, needs assessment?
    Msr. Gronvall. I would like to know more to answer.
    Mr. Stupak. Are you aware of anyone ever doing a needs 
assessment?
    Ms. Gronvall. No.
    Mr. Stupak. OK. You make the point that no blame reporting 
may be a method of improving voluntary reporting and our 
ability to learn from mistakes. Is this the same type of 
systems that is in place for the nuclear industry? You 
mentioned airline industry but is that the model you are 
looking at?
    Ms. Gronvall. I think the main points of any model for 
reporting would just be to encourage reporting and to not 
punish people for reporting to make sure that there are 
incentives to report and that you are capturing as much 
experience as possible. So there are a number of industries, I 
think the chemical industry also has a reporting system like 
that.
    Mr. Stupak. But if they do not report, you have no problem 
with a punishment system then?
    Ms. Gronvall. I think where you want to go is that you want 
to make reporting to be the norm and not reporting to be 
something that you do not want to do.
    Mr. Stupak. OK. Dr. Pearson, let me ask you the same 
question. Are there too many high-containment labs in the 
United States?
    Mr. Pearson. I do not think without having a good needs 
assessment that you can answer that question.
    Mr. Stupak. And you are not aware of----
    Mr. Pearson. I have seen no evidence that there has been a 
good needs assessment done.
    Mr. Stupak. OK. What was that section you wanted us to look 
at, 351(a)(h)--the withholding?
    Mr. Pearson. Yes, it was passed in the Bioterrorism and 
Public Health Emergency Response Act of 2002.
    Mr. Stupak. OK. Mr. Hammond, you indicated there were two 
other Texas universities that came forward since Texas A&M 
became public. Do you know if the CDC has done anything with 
those two other universities?
    Mr. Hammond. No, sir. In part, that is why I drew attention 
to CDC's policy to immediately reject all Freedom of 
Information Act requests. In the past, in addition to the two 
universities in Texas that reported, we have uncovered numerous 
additional incidents in other States that required reporting or 
appear to require reporting and we cannot obtain any 
documentation to determine whether or not they were, in fact, 
reported and whether or not CDC acted on the reports.
    Mr. Stupak. Have you then turned that information over to 
CDC, your Sunshine Project?
    Mr. Hammond. I've made the information public in forums 
where CDC personnel--that are involved in the select agent 
program.
    Mr. Stupak. OK. After I want you to share that with the 
committee staff if you would. Those are the two universities, 
we will get to the bottom of it. You state in your testimony 
that the BSL lab expansion has gone ``far beyond what is 
prudent and necessary.'' What is your estimate then of what is 
prudent and necessary here in the United States?
    Mr. Hammond. I believe that a certain answer requires the 
needs assessment, however, my judgment based upon my experience 
is that we would be safer and could accomplish our national 
needs in biodefense if our program were perhaps a fifth or even 
smaller than what we have right now. That would imply a much 
smaller number of new labs. I believe that following the 
history of offensive biological weapons programs, following 
what happened in 2001 and expansion of our biodefense program 
was merited and that, logically, there should have been 
additional labs built to deal with revitalizing our biodefense 
program but we went considerably too far. So something on the 
order of a fifth is my estimation.
    Mr. Stupak. This committee has asked for a needs assessment 
too from CDC and they claim there is one out there but no one 
has ever seen it.
    Mr. Hammond. I believe that.
    Mr. Stupak. You mentioned private corporate labs, Mr. 
Hammond, as being unaccounted for in the Government's oversight 
of the labs 3 and 4. What would you like to see done there on 
the private lab?
    Mr. Hammond. One of the things that my organization has 
done in the past several years to look at the institutional 
biosafety committee system that is managed by the NIH Office of 
Biotechnology Activities. And compliance there is only required 
for institutions that are presently receiving NIH funding for 
recombinant DNA for genetic engineering research. I took a look 
at private sector compliance and found that out of the top 20 
biotech companies, only about two are in compliance. I think 
that clearly the guidelines for recombinant DNA should be made 
a matter of law as should compliance with the BMBL and that 
should be applied to all laboratories, not simply those that 
are currently federally funded.
    Mr. Stupak. Thanks. My time is up but as I indicated in my 
opening statement, we will be sending our staff to look at some 
of these overseas labs. We are just as concerned. We want to 
get a hold of you or have you get a hold of us on what--because 
you are connected with Europe too you said. There is a Sunshine 
Project there?
    Mr. Hammond. Yes, sir.
    Mr. Stupak. OK. We may want to get some suggestions on what 
labs you think we ought to look at, both secure and not so 
secure. Mr. Burgess for questions.
    Mr. Burgess. Thank you. Mr. Hammond, just let me be sure 
that I understand correctly. You are advocating 80 percent 
reduction on available laboratory capacity from where we are 
right now?
    Mr. Hammond. No, sir. What I said was that I believe that a 
biodefense program that is approximately a fifth or perhaps 
even less of our present size would be able to adequately 
address our national security needs. And because there would be 
fewer people handling these agents and fewer laboratories, it 
would make us safer in the sense that there would be less 
opportunity for diversion of select agents. I am not advocating 
for any of the existing infrastructure, major infrastructure, 
to disappear. Rather this is with respect to the expansion.
    Mr. Burgess. So the expansion should be reduced by 80 
percent. Are these expansion plans that currently exist? I 
guess what I am asking is--conducted the needs assessment that 
Chairman Stupak has asked CDC for. Do you have data that you 
can share with this committee about how you have arrived at 
those figures?
    Mr. Hammond. My statement was with respect to the program 
as a whole, not with respect to a laboratory, the fifth 
comment. Not with respect to laboratories in particular. With 
laboratories, I believe that do need the needs assessment. But 
it is my judgment, having spent now a number of years in very 
intense interaction with practically every laboratory that 
handles these agents in the US, particularly outside of the 
Government sector, that that scale reduction would be 
appropriate and would make us, in fact, safer.
    Mr. Burgess. Let me ask you this because you raise a point 
in your written testimony that is significant about the 
building of an infectious agent out of its component parts, the 
nucleic acid issue. And if I understand your writing correctly, 
the CDC, in fact, has a loophole that would allow such a 
constructive infectious agent, say if someone was building the 
1918 flu, had one nucleic acid change, that then is no longer 
an agent that falls on the select list, is that correct?
    Mr. Hammond. That is correct, sir, in effect. The select 
agent rule in the plain language of the rule would appear to 
encompass these complimentary DNAs or these types of genetic 
constructs that you refer to. However, it appears that CDC has 
chosen to only consider those that are themselves infectious to 
be covered by the rule. And what this enables is for a person 
to possess, basically, all of the components that are needed to 
produce a select agent, even in a period of a few hours without 
being registered under the rule.
    Mr. Burgess. Mr. Chairman, I would like for it to be 
clarified to the committee, is this a rule that is been 
developed within the agency? Do they need legislative help to 
close the loophole? I would like for the committee staff to 
explore this so we know. This does not sound like a good idea 
and I think if we have learned nothing else today, this may be 
one of those things that we ought to try to immediately correct 
because it does sound like a significant defect. But I think I 
would also argue that we may need more lab space rather than 
less. But I do agree with you that the more people you have 
involved in a project, particularly when it is new and you are 
finding your way, the more people that are involved in a 
project, there is the greater potential for human error. Mr. 
Hammond, I got to tell you, I am from Texas. I have never heard 
of your group before. Where do you get your funding?
    Mr. Hammond. In the way that most non-governmental 
organizations do. I receive contributions from individuals and 
I raise funding from foundations.
    Mr. Burgess. Can you supply to this committee a list of 
your major donors?
    Mr. Hammond. I would be happy to, sir, but certainly I have 
a policy. I mean, the Sunshine Project engages in criticizing 
others on transparency issues, so certainly I would be more 
than happy to answer any question you have with respect to my 
organization.
    Mr. Burgess. You anticipated my question. I would ask the 
committee to make that generally available to members of the 
committee. And then I just have to ask you this. At the bottom, 
just before the table at the bottom of the first page, you 
reference the Sunshine Project, the Margaret Race of the SETI 
Institute. What does that acronym stand for?
    Mr. Hammond. It is a NASA-funded institute that has to----
    Mr. Burgess. Is that the Search for Extra Terrestrial----
    Mr. Hammond. Yes, Extra Terrestrial Intelligence.
    Mr. Burgess. OK.
    Mr. Hammond. If I may, the interest there is that--and it 
can be corrected if I misspeak but the interest there is that 
the Government, NASA, has a long-term interest in potentially 
constructing a level 4 laboratory in the event that they return 
samples from Mars and so, therefore, NASA is interested in--it 
has funded work at the SETI Institution to keep track of issues 
related to biosafety level 4 labs.
    Mr. Burgess. As I recall, this group out of Berkeley was 
the one that connected personal computers across the country to 
evaluate whether there were meaningful signals coming from 
outer space. Do I remember that correctly?
    Mr. Hammond. Sir, I honestly do not know but I do not 
believe so.
    Mr. Burgess. OK, I just had to ask. Mr. Chairman, if I may 
just ask Dr. Pearson a question. Your concept of the large 
oversight organization, is that generally accepted by other 
scientists who work in this area? If we were to take a poll of 
scientists who work on these problems, they would be 
enthusiastically supportive of you, moderately supportive of 
you or recoil in horror? Where would they fall on that 
metaphysical scale?
    Mr. Pearson. I think that you are asking a very good 
question. Certainly, it's a concept that has raised a lot of 
controversy and concern in the science community. We have an 
advisory board right now that is trying to look exactly at this 
question of what kind of oversight should be implemented on a 
national level. It is certainly an ongoing discussion. I think 
the question here is not whether or not we should have national 
oversight. The debate is over what that oversight should look 
like.
    Mr. Burgess. Mr. Chairman, I would just reference tab 22 in 
the binder you provided for us. There is some concern that too 
much movement too quickly in this arena will, in fact, stymie 
safety and have the adverse affect on safety that we all seek. 
So again, I do urge a little bit of caution when we get to the 
business of writing legislation. I do hope you will let the 
minority participate in whatever legislative comes out of these 
hearings and I will yield back the balance of my time.
    Mr. Stupak. Thank you, gentlemen. You mention national 
security. We invited the Department of Homeland Security to 
assist us in answering some of these questions and I was 
surprised and displeased, to say at the least, that they 
refused to show up, even though they are responsible for 
Homeland Security. So they declined our invitation but there 
will be more work to be done. Concludes questions. We got votes 
on the floor, so I am going to excuse this panel. I thank them 
for coming. Before you leave, one more question. Plum Island up 
in New York, we have a level 4 lab there, level 3, and they 
want to shut that one down and move it to the mainland. I think 
they do mostly foot-and-mouth disease there. Good idea, bad 
idea? Any comments. EHS does, that is why we are still to 
answer the question but go ahead. Mr. Hammond, I will go right 
down the line.
    Mr. Hammond. My comment would be that it is not entirely 
clear to me at all that, in fact, Plum Island will be closed if 
the National Bio and Agro-Defense Facility is constructed. 
Among my recommendations was that Congress consider terminating 
the project to construct the National Bio and Agro-Defense 
Facility.
    Mr. Stupak. Right.
    Mr. Hammond. Which would possibly imply that Plum Island 
would remain open, which is, I believe, may happen anyway.
    Mr. Stupak. Plum Island is one of the few places where no 
one lives there, it is just the lab is the only thing on Plum 
Island. That is why it makes sense I think. Dr. Pearson, 
anything on Plum Island or no opinion?
    Mr. Pearson. I am sorry, say that again.
    Mr. Stupak. Plum Island, should they close it?
    Mr. Pearson. Sure.
    Mr. Stupak. Move it to the mainland?
    Mr. Pearson. I think that with the case of Plum Island you 
have a 50-year old facility that clearly either needs to be 
replaced on Plum Island or replaced somewhere else. The issue 
with moving it to the mainland, I think the primary issue given 
the agents it is going to work with is, again, one of what 
happens if an agent gets out. If it is working with FMD and you 
plunk it down in the middle of cattle territory, is that a 
significant concern. So that is one thing. That is why it has 
been on Plum Island. It is simply an issue of do we have the 
oversight levels safe enough at that. The only other issue that 
I would raise and this, again, gets back to the needs 
assessment, I do believe that there is a need for a facility 
like Plum Island or NBAF. The issue is the new NBAF facility is 
going to be three times the size of Plum Island. So the 
question is, is it being scoped out in the right way. And that 
is where the needs assessment needs to come in. I believe DHS 
has at least done some needs assessment on that. I have not 
seen it and the committee might want to look at that.
    Mr. Stupak. Thank you. Dr. Gronvall?
    Ms. Gronvall. I think as far as Plum Island goes, the issue 
is really there are pluses and minuses for keeping it there or 
moving it. But the agents that they are going to be working 
with are select agents, the people who are involved go through 
the security procedure but there is no safety procedure and I 
think that is something that would need to be considered if you 
are going to keep it there or move it to make sure that the 
people are trained that are in the laboratory.
    Mr. Stupak. OK. Thank you and I will dismiss this panel and 
thank you for sharing your testimony with us today. That 
concludes all questioning. I want to thank the witnesses for 
coming today. I ask unanimous consent that the hearing will 
remain open for 30 days for additional questions for the 
record. With no objection, the record will remain open. I ask 
unanimous consent that the contents of our document binder be 
entered in the record and the staff have the chance to edit any 
sensitive documents prior to printing. No objection, the 
documents will be entered in the record. That concludes our 
hearing. This meeting of the subcommittee is adjourned.
    [Whereupon, at 2:55 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

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