```

[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]

 CONTINUING CONCERNS WITH THE FEDERAL SELECT AGENT PROGRAM: DEPARTMENT 
                  OF DEFENSE SHIPMENTS OF LIVE ANTHRAX

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

                                HEARING

                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED FOURTEENTH CONGRESS

                             FIRST SESSION

                               __________

                             JULY 28, 2015

                               __________

                           Serial No. 114-69

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

      Printed for the use of the Committee on Energy and Commerce
                        energycommerce.house.gov

                                ______

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                          Washington, DC 20402-0001

                    COMMITTEE ON ENERGY AND COMMERCE

                          FRED UPTON, Michigan
                                 Chairman

JOE BARTON, Texas                    FRANK PALLONE, Jr., New Jersey
  Chairman Emeritus                    Ranking Member
ED WHITFIELD, Kentucky               BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois               ANNA G. ESHOO, California
JOSEPH R. PITTS, Pennsylvania        ELIOT L. ENGEL, New York
GREG WALDEN, Oregon                  GENE GREEN, Texas
TIM MURPHY, Pennsylvania             DIANA DeGETTE, Colorado
MICHAEL C. BURGESS, Texas            LOIS CAPPS, California
MARSHA BLACKBURN, Tennessee          MICHAEL F. DOYLE, Pennsylvania
  Vice Chairman                      JANICE D. SCHAKOWSKY, Illinois
STEVE SCALISE, Louisiana             G.K. BUTTERFIELD, North Carolina
ROBERT E. LATTA, Ohio                DORIS O. MATSUI, California
CATHY McMORRIS RODGERS, Washington   KATHY CASTOR, Florida
GREGG HARPER, Mississippi            JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey            JERRY McNERNEY, California
BRETT GUTHRIE, Kentucky              PETER WELCH, Vermont
PETE OLSON, Texas                    BEN RAY LUJAN, New Mexico
DAVID B. McKINLEY, West Virginia     PAUL TONKO, New York
MIKE POMPEO, Kansas                  JOHN A. YARMUTH, Kentucky
ADAM KINZINGER, Illinois             YVETTE D. CLARKE, New York
H. MORGAN GRIFFITH, Virginia         DAVID LOEBSACK, Iowa
GUS M. BILIRAKIS, Florida            KURT SCHRADER, Oregon
BILL JOHNSON, Ohio                   JOSEPH P. KENNEDY, III, 
BILLY LONG, Missouri                 Massachusetts
RENEE L. ELLMERS, North Carolina     TONY CARDENAS, California
LARRY BUCSHON, Indiana
BILL FLORES, Texas
SUSAN W. BROOKS, Indiana
MARKWAYNE MULLIN, Oklahoma
RICHARD HUDSON, North Carolina
CHRIS COLLINS, New York
KEVIN CRAMER, North Dakota

                                 _____

              Subcommittee on Oversight and Investigations

                        TIM MURPHY, Pennsylvania
                                 Chairman
DAVID B. McKINLEY, West Virginia     DIANA DeGETTE, Colorado
  Vice Chairman                        Ranking Member
MICHAEL C. BURGESS, Texas            JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee          KATHY CASTOR, Florida
H. MORGAN GRIFFITH, Virginia         PAUL TONKO, New York
LARRY BUCSHON, Indiana               JOHN A. YARMUTH, Kentucky
BILL FLORES, Texas                   YVETTE D. CLARKE, New York
SUSAN W. BROOKS, Indiana             JOSEPH P. KENNEDY, III, 
MARKWAYNE MULLIN, Oklahoma               Massachusetts
RICHARD HUDSON, North Carolina       GENE GREEN, Texas
CHRIS COLLINS, New York              PETER WELCH, Vermont
KEVIN CRAMER, North Dakota           FRANK PALLONE, Jr., New Jersey (ex 
JOE BARTON, Texas                        officio)
FRED UPTON, Michigan (ex officio)

                                  (ii)
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Tim Murphy, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................     1
    Prepared statement...........................................     3
Hon. Diana DeGette, a Representative in Congress from the State 
  of Colorado, opening statement.................................     4
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     6
    Prepared statement...........................................     7
Hon. Fred Upton, a Representative in Congress from the State of 
  Michigan, prepared statement...................................    97

                               Witnesses

D. Christian Hassell, Ph.D., Deputy Assistant Secretary of 
  Defense for Chemical and Biological Defense, Department of 
  Defense........................................................     8
    Prepared statement...........................................    11
    Answers to submitted questions...............................   114
Daniel M. Sosin, M.D., Deputy Director and Chief Medical Officer, 
  Office of Public Health Preparedness and Response, Centers for 
  Disease Control and Prevention, Department of Health and Human 
  Services.......................................................    22
    Prepared statement...........................................    24
    Answers to submitted questions...............................   124
Gregory E. Demske, Chief Counsel to the Inspector General, Office 
  of Inspector General, Department of Health and Human Services..    37
    Prepared statement...........................................    39
    Answers to submitted questions...............................   132
Marcia Crosse, Ph.D., Director, Health Care, Government 
  Accountability Office..........................................    46
    Prepared statement...........................................    48
    Answers to submitted questions...............................   139

                           Submitted Material

Slide, ``Irradiation of  Bacillus anthracis Spores (Ames 
  Strain),'' submitted by Mr. Murphy.............................    67
Subcommittee memorandum..........................................    98
Article of July 27, 2015, ``CDC lacked key lab incident reporting 
  policy despite scrutiny, promises,'' by Alison Young, USA 
  Today, submitted by Mr. Murphy.................................   110
 
 CONTINUING CONCERNS WITH THE FEDERAL SELECT AGENT PROGRAM: DEPARTMENT 
                  OF DEFENSE SHIPMENTS OF LIVE ANTHRAX

                              ----------                              

                         TUESDAY, JULY 28, 2015

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:04 a.m., in 
room 2123 of the Rayburn House Office Building, Hon. Tim Murphy 
(chairman of the subcommittee) presiding.
    Members present: Representatives Murphy, McKinley, Burgess, 
Blackburn, Griffith, Bucshon, Flores, Brooks, Mullin, Hudson, 
Collins, DeGette, Schakowsky, Castor, Tonko, Kennedy, Green, 
Welch, and Pallone (ex officio).
    Staff present: Noelle Clemente, Press Secretary; Jessica 
Donlon, Counsel, Oversight and Investigations; Brittany Havens, 
Oversight Associate, Oversight and Investigations; Alan 
Slobodin, Deputy Chief Counsel, Oversight; Jessica Wilkerson, 
Oversight Associate, Oversight and Investigations; Christine 
Brennan, Democratic Press Secretary; Jeff Carroll, Democratic 
Staff Director; Ryan Gottschall, Democratic GAO Detailee; 
Christopher Knauer, Democratic Oversight Staff Director; Una 
Lee, Democratic Chief Oversight Counsel; and Elizabeth Letter, 
Democratic Professional Staff Member.

   OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN 
         CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

    Mr. Murphy. Good morning. Welcome to our hearing once again 
dealing with anthrax. The subcommittee today examines 
continuing concerns over the Federal Select Agent Program. This 
time our focus is on shipments of live anthrax from a 
Department of Defense laboratory at the Dugway Proving Grounds 
that occurred over a nearly 10-year period.
    And as Yogi Berra said, it is like deja vu all over again.
    Last year, we held a similar hearing on a CDC anthrax 
incident that potentially exposed dozens of CDC researchers to 
live anthrax, due to the fact that established safety 
procedures were not followed. During the hearing CDC Director 
Frieden testified, ``We will take every step possible to 
prevent any future incident that could put our laboratory 
scientists and the public at risk.'' Yet here we are again 
today.
    We also examined CDC's mistaken shipment of highly 
pathogenic avian flu and the FDA's discovery of vials of 
smallpox in an NIH building. Months after our hearing and after 
a White House-ordered safety stand-down and a laboratory sweep 
of all Federal labs, the CDC revealed there had been a transfer 
of Ebola from a CDC Level 4 lab to a CDC Level 2 lab. This is 
all deeply troubling. And despite the growing number of red 
flags, these incidents keep happening.
    Now we have learned that the Dugway Proving Grounds, an 
Army lab in Utah, has inadvertently shipped live anthrax to 
facilities across the globe. At last count, at least 192 labs 
have received shipments of live anthrax. Apparently, Dugway's 
process to inactivate anthrax spores was not fully effective. 
And the sterility testing used to validate and ensure that the 
anthrax spores were inactivated failed to detect the live 
anthrax spores. What is most troubling, however, is that Dugway 
used this potentially deadly process for years.
    As I said at last year's hearing, this is completely 
unacceptable. These dangerous safety lapses at our high-
containment labs are threatening our Nation's security and 
public health. The committee hopes to learn today what is being 
done this time to prevent future safety lapses. And will this 
be any different?
    Last week, the Department of Defense released a report 
following its internal review of the circumstances surrounding 
the live shipments of anthrax, and according to its report, the 
DoD was unable to definitively determine the root causes for 
how and why Dugway shipped live anthrax. Yet, in the report, 
the Department acknowledged that all its labs ``routinely 
operate outside validated experimental data for kill curves.''
    So in other words, it seems that Department of Defense labs 
have been irradiating larger numbers of spores than 
recommended. And the labs should have known that they could not 
guarantee inactivation of all the anthrax spores at those 
numbers, especially at the dosage of radiation given.
    This revelation begs a lot of questions, beginning with 
why? And why for so long? Who was responsible for making the 
decisions about which inactivation process to use, including 
how many spores and at what levels of radiation? Are these 
decisions evaluated and then ever re-evaluated? And what is the 
CDC's role in developing and evaluating these processes?
    According to a recent and all-too-familiar headline, CDC 
has also announced that it will be conducting yet another 
comprehensive review of how it regulates safety and security at 
bioterror labs. I think it is important to review current 
regulations to improve processes and procedures. But past 
reviews have not brought about the change necessary to truly 
improve safety and standardize processes and procedures. 
Maybe--we hope--this review will actually bring about different 
results.
    As I said a year ago, what we have here is a pattern of 
recurring issues, of complacency, and a lax culture of safety. 
Last year, CDC Director Frieden stated that this was a wake-up 
call. However, it appears that critical Government agencies 
have hit the snooze button once again. What is it going to take 
to change things this time, and when?
    None of us want to be here again a year from now, 
discussing another set of safety lapses, and heaven forbid, a 
loss of life.
    The U.S. Government Accountability Office has conducted 
comprehensive work on the oversight of high-containment labs. 
In fact, GAO has been issuing recommendations for years calling 
for a Government-wide strategy for the requirements for high-
containment labs and the need for national standards for 
designing, constructing, commissioning, and maintaining such 
labs. Yet, these recommendations have not been implemented, 
which is one of the reasons we are here again today discussing 
another safety lapse that threatens national security and the 
public health.
    Today I would like to thank our witnesses for testifying 
here. I look forward to hearing your testimony and learning 
from you. Please be candid and straightforward with us as we 
try to find ways to improve the safety and procedures in our 
bioterrorism labs. This subcommittee will not relent in its 
oversight of Federal laboratories' compliance with select agent 
regulations, and will further explore the possibility of an 
independent agency to oversee these labs.
    [The prepared statement of Mr. Murphy follows:]

                 Prepared statement of Hon. Tim Murphy

    The subcommittee today examines continuing concerns over 
the Federal Select Agent Program. This time our focus is on 
shipments of live anthrax from a Department of Defense 
laboratory at the Dugway Proving Grounds that occurred over a 
nearly 10-year period.
    As Yogi Berra said, it's like deja vu all over again.
    Last year, we held a similar hearing-on a CDC anthrax 
incident that potentially exposed dozens of CDC researchers to 
live anthrax, due to the fact that established safety 
procedures were not followed. During the hearing CDC Director 
Frieden testified, ``we will take every step possible to 
prevent any future incident that could put our laboratory 
scientists . . . and the public at risk.'' Yet here we are 
again today. We also examined CDC's mistaken shipment of highly 
pathogenic avian flu and the FDA's discovery of vials of 
smallpox in an NIH building. Months after our hearing, and 
after a White House-ordered safety standdown and laboratory 
sweep of all Federal labs, the CDC revealed there had been a 
transfer of Ebola from a CDC Level 4 lab to a CDC Level 2 lab. 
This is deeply troubling.
    And despite the growing number of red flags, these 
incidents keep happening.
    Now, we have learned that the Dugway Proving Grounds, an 
Army lab in Utah, has ``inadvertently'' shipped live anthrax to 
facilities across the globe. At last count, at least 192 labs 
have received shipments of live anthrax. Apparently, Dugway's 
process to inactivate anthrax spores was not fully effective. 
And the sterility testing-used to validate and ensure that the 
anthrax spores were inactivated-failed to detect the live 
anthrax spores. What's most troubling, however, is that Dugway 
used this potentially deadly process for years.
    As I said at last year's hearing, this is completely 
unacceptable. These dangerous safety lapses at our high-
containment labs are threatening our Nation's security and 
public health. The committee hopes to learn today what is being 
done this time to prevent future safety lapses. Will this time 
be different? Last week, the Department of Defense released a 
report following its internal review of the circumstances 
surrounding the live shipments of anthrax. According to its 
report, the DoD was unable to definitively determine the root 
cause for how and why Dugway shipped live anthrax. Yet, in the 
report, the Department acknowledged that all its labs 
``routinely operate outside validated experimental data for 
kill curves.'' So in other words, it seems that Defense 
Department labs have been irradiating larger numbers of spores 
than recommended. And the labs should have known that they 
could not guarantee inactivation of all the anthrax spores at 
those numbers, especially at the dosage of radiation given.
    This revelation begs a lot of questions, beginning with 
why? And why for so long? Who is responsible for making the 
decisions about which inactivation process to use, including 
how many spores and at what levels of radiation? Are these 
decisions evaluated, and then, ever re-evaluated? And what is 
CDC's role in developing and evaluating these processes?
    According to a recent and all-too familiar headline, CDC 
has also announced that it will be conducting yet another 
comprehensive review of how it regulates safety and security at 
bioterror labs. I think it is important to review current 
regulations to improve processes and procedures. But past 
reviews have not brought about the change necessary to truly 
improve safety and standardize processes and procedures. Maybe 
this review will actually bring about different results.
    As I said a year ago, what we have here is a pattern of 
recurring issues, of complacency, and a lax culture of safety. 
Last year, CDC Director Frieden stated that this was a ``wake-
up'' call. However, it appears that critical Government 
agencies have hit the snooze button. What is going to change 
this time? And when? None of us want to be here again a year 
from now, discussing another set of safety lapses, that may 
have actually caused loss of life.
    The U.S Government Accountability Office has conducted 
comprehensive work on the oversight of high-containment labs. 
In fact, GAO has been issuing recommendations for years calling 
for a Government-wide strategy for the requirements for high-
containment labs and the need for national standards for 
designing, constructing, commissioning, and maintaining such 
labs. Yet, these recommendations have not been implemented, 
which is one of the reasons we are here again today discussing 
another safety lapse that threatens national security and the 
public health.
    I would like to thank the witnesses for testifying here 
today, and I look forward to hearing your testimony about what 
needs to be done to improve the safety, and procedures in our 
bioterrorism labs. This subcommittee will not relent in its 
oversight of Federal laboratories' compliance with select agent 
regulations and will further explore the possibility of an 
independent agency to oversee these labs.

    Mr. Murphy. I now recognize the ranking member, Ms. DeGette 
of Colorado, for 5 minutes.

 OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF COLORADO

    Ms. DeGette. Thank you, Mr. Chairman. Mr. Chairman, you say 
you don't want to be back here in a year like we were last 
year, but we have been here in 2007, 2009, 2014, and now 2015. 
So might as well mark your calendar now. And part of that is 
because it is really important that the Federal Government work 
on identifying and containing public health risks. But the work 
itself inherently contains risk. And that is why we do have to 
continue our oversight.
    At last year's hearing on the anthrax transfer I talked 
about the high-containment lab that we have in Fort Collins at 
which some years ago we identified terrible lapses, and I was 
able to work with my former Republican colleague, Bob Schaffer, 
from that district to get a new lab built. I am proud of that 
work, but we have to continue to be able to assure our 
constituents that similar facilities across the country provide 
no risk to workers or to the broader community.
    Now Mr. Chairman, as you said, frankly the details of the 
Dugway incident do not inspire confidence. We are talking about 
a long-term series of inadvertent shipments of live anthrax 
from the Dugway Proving Ground in Utah which is supposedly one 
of the most sophisticated facilities in the world. This 
incident only came to light in May because a private company 
contacted CDC after discovering what it thought was inactivated 
anthrax was actually live anthrax.
    Since then we have learned that 86 laboratories in 20 
States and the District of Columbia and seven foreign countries 
received live anthrax spores from Dugway over the last 12 
years. Those labs then transferred the live spores to an 
additional 106 labs. So we are talking about almost 200 labs in 
all 50 States accidentally receiving live anthrax for over a 
decade. Miraculously, nobody seems to have fallen ill as a 
result of this series of incidents. Still, like you, Mr. 
Chairman, I am concerned that this activity was going on for so 
long before one lab finally raised questions that spurred the 
Department to action.
    I am eager to hear answers from DoD about how this was 
allowed to happen in the first place and what they are doing to 
ensure it never happens again.
    I understand that the Department's review of the Dugway 
incident released last week found there is insufficient 
scientific literature to develop effective protocols for the 
inactivation of anthrax spores. The Dugway lab was therefore 
relying on procedures that did not permanently or completely 
sterilize the anthrax spores.
    Now, this is not my area of expertise, but it seems 
troubling on its face. How have we conducted research on this 
dangerous pathogen for the past decade without thoroughly 
understanding how to inactivate it? We need to conduct a 
serious examination of whether we use similarly questionable 
protocols for other select agents, and if so, I think we can 
all agree that we should immediately cease those operations to 
ensure we are not putting public health at risk.
    For now, appropriately, DoD has issued a moratorium on 
shipping inactivated anthrax from its labs. This seems like an 
important first step, but I do want to know how that affects 
the research the lab was doing. Furthermore, I want 
clarification, as how do we have 200 separate labs all across 
the country working with anthrax? Do we need to have 200 labs 
working with anthrax or is it possible that we could limit the 
number of labs and therefore limit the risk while still being 
able to do this important research?
    I also want to hear today about whether the breakdowns at 
Dugway are indicative of broader problems at this site or even 
across the high-containment lab system. The labs that handle 
these pathogens must be held to the highest standards. Yet, the 
incidents that we have seen recently raise questions about 
whether we can trust high-containment labs to safely handle 
select agents.
    Now in the last year, we have seen an anthrax exposure 
incident at CDC--this is what you said--improper shipments of 
avian flu, and even a potential Ebola exposure at a CDC lab. I 
feel really lucky that we haven't had anybody infected, but it 
could happen and I think we have just been going on borrowed 
time here.
    So I hope all of you have answers today about what we are 
really doing to make serious changes to the system and include 
recommendations that GAO has made.
    I also want to hear from our witnesses about the role 
Congress should play in making sure the program operates 
safely. And with that, Mr. Chairman, I yield back. Thank you.
    Mr. Murphy. Thank you. Does anybody else on this side wish 
to make any opening statement or comments? If not, I would 
ask--and I don't know if you have seen this yet, Ms. DeGette 
and Mr. Pallone. An article appeared in last night's USA Today. 
I would like to have you look at it and see if you would have 
unanimous consent to submit that to the record. With no 
objection? This is titled, ``CDC lacked key lab incident 
reporting policy despite scrutiny, promises,'' and I think it 
is going to be relevant to today's hearing.
    [The information appears at the conclusion of the hearing.]
    Mr. Murphy. I now recognize Mr. Pallone for 5 minutes.

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE 
            IN CONGRESS FROM THE STATE OF NEW JERSEY

    Mr. Pallone. Thank you, Mr. Chairman. I hope today we can 
get to the bottom of what happened at Dugway Proving Ground 
that resulted in live anthrax being shipped to 192 labs in all 
50 States and at least seven foreign countries.
    Deputy Defense Secretary Robert Work described these lapses 
as a ``massive institutional failure.'' I hope Dr. Hassell can 
explain to us today how these failures could possibly have 
occurred as well as what DoD is doing to strengthen and 
standardize safety protocols across all DoD labs as we move 
forward.
    I am deeply relieved that no one has fallen ill as a result 
of these lapses, and I am hopeful that this will remain the 
case as DoD and CDC continue to track all the labs that receive 
these samples and the personnel that handle them. But this 
incident also raises broader questions about the safety of 
high-containment laboratories across the country.
    Every day hundreds of labs in the Federal Government as 
well as academic institutions and private companies handle 
dangerous pathogens and toxins under the Federal Select Agent 
Program. Make no mistake, these labs perform important work. 
High-containment labs play a critical role in biodefense by 
conducting research to improve our defenses against biological 
attacks and strengthening our public health response 
capabilities.
    Laboratories that handle select agents are required to 
abide by a set of regulations commensurate with the risk that 
these agents pose. They are required to restrict access to 
select agents to individuals who have undergone a security risk 
assessment by the FBI and implements physical security 
safeguards, lab safety measure, and incident response plans. 
They must also ensure that laboratory workers are properly 
trained on biosafety and security measures.
    Labs that participate in the program are also subject to 
registration and inspections by the CDC's Division of Select 
Agents and Toxins. There are civil penalties associated with 
lapses in safety protocols. Unauthorized possession or misuse 
of select agents is subject to severe criminal penalties. 
However, incidents in the past year involving anthrax, Ebola, 
and highly pathogenic avian flu raise questions about whether 
we need to strengthen our Federal oversight of labs that are 
working with dangerous pathogens. Is the current regulatory 
framework sufficient? Do the enforcement agencies have 
sufficient resources to ensure that oversight is robust? What 
is CDC doing to improve the Federal Select Agent program and 
prevent similar situations from occurring in the future?
    I understand that CDC and DoD have conducted reviews of 
these incidents and have promised several more. I look forward 
to hearing about the findings and recommendations from those 
reviews and how they can be used to enhance safety and security 
at all of our Nation's high-containment laboratories. I also 
want to note that GAO has an important body of work that can 
inform this discussion. I look forward to hearing from GAO 
about its recommendations to strengthen safety measures across 
high-containment labs.
    I am glad that nobody appears to have suffered any injuries 
because of this latest incident out of Dugway. The next time, 
however, the mishap may be from something more dangerous than 
liquid anthrax such as a highly infectious pathogen. So I hope 
we can all learn from this latest incident and will take 
seriously the important recommendations made by recent and 
ongoing investigations by GAO and others to make this program 
safer. Obviously we look forward to a productive discussion 
today on how we can improve oversight and what this committee 
can do to facilitate that process and again thank our chairman 
and our ranking member as we proceed. I yield back.
    [The prepared statement of Mr. Pallone follows:]

             Prepared statement of Hon. Frank Pallone, Jr.

    Thank you, Mr. Chairman, for convening this important 
hearing. I hope today we can get to the bottom of what happened 
at Dugway Proving Ground that resulted in live anthrax being 
shipped to 192 labs in all 50 States and at least seven foreign 
countries.
    Deputy Defense Secretary Robert Work described these lapses 
as a quote ``massive institutional failure.'' I hope Dr. 
Hassell can explain to us today how these failures could 
possibly have occurred, as well as what DoD is doing to 
strengthen and standardize safety protocols across all DoD labs 
moving forward.
    I am deeply relieved that no one has fallen ill as a result 
of these lapses, and I am hopeful that this will remain the 
case as DoD and CDC continue to track all of the labs that 
received these samples and the personnel that handled them. But 
this incident also raises broader questions about the safety of 
high-containment laboratories across the country.
    Every day, hundreds of laboratories in the Federal 
Government, as well as academic institutions and private 
companies, handle dangerous pathogens and toxins under the 
Federal Select Agent program.
    Make no mistake, these laboratories perform important work. 
High-containment laboratories play a critical role in 
biodefense, by conducting research to improve our defenses 
against biological attacks and strengthening our public health 
response capabilities.
    Laboratories that handle select agents are required to 
abide by a set of regulations commensurate with the risk that 
these agents pose. They are required to restrict access to 
select agents to individuals who have undergone a security risk 
assessment by the FBI, and implement physical security 
safeguards, lab safety measures, and incident response plans. 
They must also ensure that laboratory workers are properly 
trained on biosafety and security measures.
    Labs that participate in the program are also subject to 
registration and inspections by the CDC's Division of Select 
Agents and Toxins. There are civil penalties associated with 
lapses in safety protocols. Unauthorized possession or misuse 
of select agents is subject to severe criminal penalties.
    However, incidents in the past year involving anthrax, 
Ebola, and highly pathogenic avian flu raise questions about 
whether we need to strengthen our Federal oversight of labs 
that are working with dangerous pathogens. Is the current 
regulatory framework sufficient? Do the enforcement agencies 
have sufficient resources to ensure that oversight is robust? 
What is CDC doing to improve the Federal Select Agent Program 
and prevent similar situations from occurring in the future?
    I understand CDC and DoD have conducted reviews of these 
incidents and have promised several more. I look forward to 
hearing about the findings and recommendations from those 
reviews and how they can be used to enhance safety and security 
at all of our Nation's high-containment laboratories.
    I also want to note that GAO has an important body of work 
that can inform this discussion. I look forward to hearing from 
GAO about its recommendations to strengthen safety measures 
across high-containment laboratories.
    I am glad nobody appears to have suffered any injuries 
because of this latest incident out of Dugway. Next time, 
however, the mishap may be from something more dangerous than 
liquid anthrax-such as a highly infectious pathogen. So, I hope 
we can all learn from this latest incident and will take 
seriously the important recommendations made by recent and 
ongoing investigations by GAO and others to make this program 
safer.
    I look forward to a productive discussion today on how we 
can improve oversight of these labs, and what this committee 
can do to facilitate this process.
    Thank you to all of our witnesses for your testimony.

    Mr. Murphy. The gentleman yields back, and if no further 
comments from here, then we are going to go to our witnesses.
    So as you are aware, when the committee is holding an 
investigative hearing, when doing so, it has had the practice 
of taking testimony under oath. Do any of our witnesses today 
have any objections to testifying under oath? Seeing no 
objections, the Chair then advises you that under the rules of 
the House and the rules of the committee, you are entitled to 
be advised by counsel. Do any of you desire to be advised by 
counsel today? No. No one is asking for that.
    In that case, would you please rise, raise your right hand, 
and I will swear you in?
    [Witnesses sworn.]
    Mr. Murphy. All of our witnesses have answered in the 
affirmative, and so now you are under oath and subject to the 
penalties set forth in Title 18, Section 1001, of the United 
States Code.
    You may now each give a 5-minute summary of your written 
statement. Please pay attention to the lights there, and we 
will start with you, Dr. Hassell, 5 minutes.

  STATEMENTS OF D. CHRISTIAN HASSELL,PH.D., DEPUTY ASSISTANT 
   SECRETARY OF DEFENSE FOR CHEMICAL AND BIOLOGICAL DEFENSE, 
 DEPARTMENT OF DEFENSE; DANIEL M. SOSIN, M.D., DEPUTY DIRECTOR 
AND CHIEF MEDICAL OFFICER, OFFICE OF PUBLIC HEALTH PREPAREDNESS 
   AND RESPONSE, CENTERS FOR DISEASE CONTROL AND PREVENTION, 
  DEPARTMENT OF HEALTH AND HUMAN SERVICES; GREGORY E. DEMSKE, 
  CHIEF COUNSEL TO THE INSPECTOR GENERAL, OFFICE OF INSPECTOR 
 GENERAL, DEPARTMENT OF HEALTH AND HUMAN SERVICES; AND MARCIA 
CROSSE, PH.D., DIRECTOR, HEALTH CARE, GOVERNMENT ACCOUNTABILITY 
                             OFFICE

               STATEMENT OF D. CHRISTIAN HASSELL

    Dr. Hassell. Chairman Murphy, Ranking Member DeGette, and 
distinguished members of the subcommittee, I appreciate the 
opportunity to brief you today on the Department of Defense's 
inadvertent shipments of samples containing live Bacillus 
anthracis spores or anthrax. My name is David Hassell. I am the 
Deputy Assistant Secretary of Defense for Chemical and 
Biological Defense.
    The Use of inactivated or dead anthrax is an important 
element of longstanding DoD programs to develop ways to protect 
warfighters and the public from known biological threats, doing 
this with the development and testing of detection systems, 
protection equipment, diagnostics, and decontamination 
capabilities.
    We first learned of the incidents under consideration today 
on May 22 of 2015 when the Centers for Disease Control and 
Prevention was alerted by a private company regarding the 
growth of live anthrax in a sample that was inactivated by a 
laboratory at the Army's Dugway Proving Ground in Utah. The CDC 
immediately began an investigation, working with DoD 
laboratories, State officials, and the FBI.
    By May 25, all known laboratories that received inactivated 
anthrax samples from that same batch had been notified and 
instructed to stop working with the samples. Also on May 25th 
the four DoD laboratories that produce inactivated anthrax were 
directed to stop producing, shipping, and working with any 
inactivated anthrax other than for purposes related to this 
current matter.
    Subsequent tests by Dugway identified other batches of 
inactivated anthrax as containing live spores, and on June 2nd 
the Department of Defense notified all known recipients of 
inactivated anthrax from Dugway to stop working with the 
material, whether it was confirmed to contain live anthrax or 
not.
    There's no known or suspected cases of anthrax infection 
among workers at any of the laboratories that produced or 
received inactivated anthrax, and there is no known risk to the 
general health and very little risk to laboratory workers 
themselves. However, as a precaution, 31 U.S. citizens, 8 non-
DoD, 23 DoD, were placed on postexposure prophylaxis treatment, 
and this was completed yesterday.
    Returning to the subject of the four DoD Laboratories that 
produce inactivated anthrax, on May 29th the Deputy Secretary 
directed that those four DoD laboratories test all previously 
inactivated anthrax that was in their inventory to identify the 
presence of any live spores. That testing is now complete, and 
the results are as follows: Since 2003, the four DoD 
laboratories irradiated a total of 149 batches of live anthrax 
spores. Of the 96 samples that were available to test, 17 
tested positive for the presence of live anthrax. All of these 
originated from Dugway.
    We now know that over the past 12 years, 86 laboratories in 
20 States, DC, and seven foreign countries received directly 
from Dugway inactivated samples that contained live spores. In 
addition, the CDC has informed us that an additional 106 labs 
received secondary transfers from some of the original 86 
direct recipient labs. This brings the total to 192 labs in all 
50 States, DC, and the three Territories of Guam, Puerto Rico, 
the U.S. Virgin Islands.
    A recently completed Comprehensive Review of the root 
causes of the incident resulted in several key findings 
including that the primary systemic issue is the lack of 
specific validated standards to guide the development of 
protocols, processes, and quality assurance measures, and the 
resulting recommendations are grouped into three broad 
categories being enhance quality control programs, establish 
testing protocols that are based on relevant scientific data, 
and improve program management.
    The Department is committed to ensuring that this doesn't 
occur again and will implement the recommendations that were in 
the report and the further directives outlined by Deputy 
Secretary Work on 23rd of July. In the interim, the 
aforementioned moratorium will continue. Our top priority is 
the safety of all involved, and we remain committed to complete 
transparency of information as we go forward. Thank you for the 
opportunity to testify today, and I'll welcome your questions.
    [The prepared statement of Dr. Hassell follows:]
    
    
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    Mr. Murphy. Thank you, Dr. Hassell. Dr. Sosin, before you 
speak, I just want to note that we haven't really had the 
chance to review a lot of your testimony because it wasn't in 
until 9:00 last night, and the committee rules, we ask for 48 
hours. So we really didn't have time to review that. So when we 
get the testimony at the last minute, it is difficult for us to 
review it. I don't want to think that CDC is trying to 
frustrate our purposes here, but I do want to indicate to you 
and if you could pass the word onto CDC department that for 
future testimony, we want that 48-hour limit adhered to.
    So at this point, we would like to hear from you for 5 
minutes. Thank you.

                  STATEMENT OF DANIEL M. SOSIN

    Dr. Sosin. Thank you. Chairman Murphy, Ranking Member 
DeGette, distinguished members of the subcommittee, I want to 
thank you for this opportunity to testify before you today. I 
would like to share with you what CDC has done to respond to 
the inadvertent release of live Bacillus anthracis spores, or 
anthrax, from Dugway Proving Ground and to provide perspective 
on the Select Agent Program that CDC supports.
    CDC works 24/7 to save lives and protect people. We 
activated our emergency operation center in face of uncertainty 
about the scope and severity of this release. We understand how 
concerning this incident has been, and our primary focus 
continues to be making certain people are safe and that anthrax 
materials are secured and ultimately disposed of.
    This incident raises serious and challenging issues. It is 
important to note, however, that scientific research in 
laboratories is a vital component of our Nation's defense 
against naturally occurring diseases and bioterrorism. This 
research is complex and sometimes dangerous. While it is not 
possible to eliminate all risk, those of us working in this 
field across the country and around the world must do all we 
can to minimize risk.
    Here's what we know about today about the Dugway incident. 
There have been no suspected or confirmed cases of anthrax 
infection associated with these samples. Persons that CDC has 
assessed is at some risk and who have accepted treatment will 
have completed antibiotic and vaccine prophylaxis yesterday, 
and no complications have been reported.
    The facilities that received these samples have 
appropriately secured or destroyed them, and those needing 
decontamination have completed the procedures or are well under 
way.
    Highlighting this positive news is not meant to downplay 
the seriousness of the situation. On multiple occasions over 
more than a decade the production methods at Dugway failed to 
inactive anthrax spores. The failure of inactivation was 
evident because growth was being detected on multiple 
production runs. These runs were routinely sent back for 
additional irradiation. This should have been seen for what it 
was, an indication that the margin of safety with the method 
was not sufficient. Additionally, sterility testing at Dugway 
to confirm the inactivation was successful at killing the 
organism failed to detect live spores.
    We have looked and found no evidence of a similar problem 
at other facilities that inactivate anthrax spores. The 
existing rules and regulations on anthrax spore inactivation 
are under review.
    Here's what we don't know. The Federal Select Agent Program 
relies primarily on sterility testing to assure that a select 
agent can no longer grow. We remain unsure whether there was a 
problem with the execution of this testing at Dugway or if the 
biology of spores was not sufficiently understood to make the 
procedure reliable.
    And here's what we are doing moving forward. We are 
maintaining a moratorium on the use and transfer of inactivated 
anthrax spores until we have an acceptable and credible 
approach to increasing safety and security. And we are 
developing a research agenda on spore biology to answer 
questions about inactivation and sterility, and we will help to 
conduct some of that research.
    At Dr. Frieden's direction, we are initiating a review of 
the CDC Federal Select Agent Program. The review will 
complement ongoing work to improve laboratory safety at CDC 
this past year. The time is right with new leadership over the 
CDC Federal Select Agent Program for a thorough review of our 
program to ensure it's meeting its mandate, especially in light 
of recent lab incidents.
    The world benefits from discoveries made working with 
dangerous pathogens, and the scientists who work with these 
organisms also have a commitment to protecting public health 
and safety. We must achieve a balance to protect workers and 
the communities around them while encouraging and supporting 
scientific advancement. But safety comes first.
    One characteristic of CDC's stewardship of the Federal 
Select Agent Program is a commitment to improvement. The 
regulations have been refined with advice from many including 
numerous Federal advisory and review bodies and the public. 
This input has led to revisions to the select agent regulations 
concerning personnel reliability, incident reporting, 
coordination of inspections with Federal partners, and tracking 
shipments of select agents.
    Although much work has been done to enhance the 
effectiveness of CDC's regulatory oversight of select agents 
and toxins, more work remains to be done. Where improvements 
can be made to better the program, we will make them. Whether 
there is disagreement on the best path forward, we will 
contribute our scientific and programmatic expertise to the 
debate. We will work diligently and thoughtfully with anyone 
sharing our commitment to protect Americans from biological 
threats. Thank you.
    [The prepared statement of Mr. Sosin follows:]
    
    
    
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    Mr. Murphy. Thank you. Dr. Demske, you are recognized for 5 
minutes.

                 STATEMENT OF GREGORY E. DEMSKE

    Mr. Demske. Good morning, Chairman Murphy, Ranking Member 
DeGette, members of the subcommittee, I'm Greg Demske, Chief 
Counsel to the Inspector General at the Department of Health 
and Human Services. I appreciate the opportunity to appear 
before you today to discuss the Federal Select Agent Program.
    While CDC administers the Select Agent Program with the 
Department of Agriculture, OIG is authorized to impose civil 
money penalties for violations of the regulations. We also 
audit, evaluate, and offer suggestions for program improvement. 
CDC reviews all potential select agent violations and 
immediately refers urgent or criminal matters to the FBI. In 
other matters, CDC further investigates and determines whether 
to exercise its authority to suspend or revoke registration or 
require remedial actions. If CDC concludes a civil violation 
may have occurred, it refers the case for OIG for potential 
enforcement.
    OIG carefully evaluates every referral and decides whether 
to pursue the case and what penalty to seek based on the facts 
and circumstances of the particular case. In our experience, 
violations of the regulations pose varying risks to public 
health and safety. To date, OIG has imposed 20 CMPs totaling 
$2.4 million for select agent violations. Two of our cases have 
involved Dugway.
    In April 2007, Dugway shipped anthrax to a research 
facility. The shipment included a certification that the 
anthrax was non-viable. The research facility tested the 
material and found the presence of a low concentration of 
viable anthrax. We found that Dugway ignored the results of its 
postinactivation viability test which showed viable anthrax was 
present. Later, in November 2010, a Government laboratory 
received a shipment from Dugway that included a vial of 
Botulinum neurotoxin. Small amounts of this select agent are 
exempt from the regulations. The packing slip indicated that 
the vial contained an exempt amount, but in fact, the shipment 
included a regulated amount. Dugway then self-reported two 
other unauthorized shipments of this select agent.
    As a Federal entity, Dugway presents an enforcement 
challenge for OIG. Any CMP on a Federal entity would simply 
shift money within the Government at a net cost to taxpayers 
and may not promote better compliance. Consistent with our 
approach to date with other Federal entities, OIG issued Notice 
of Violation letters to Dugway for both cases. Both letters 
stated that OIG had determined Dugway had violated the select 
agent regulations and it should examine its current policies 
and practices, take corrective action, and monitor its 
safeguards on an ongoing basis. Yesterday OIG received another 
referral from CDC on Dugway. We are reviewing the matter now.
    Over the years OIG has audited Government and private 
entities for select agent compliance. For example, OIG audited 
six Federal laboratories and provided audit results to the 
heads of the relevant Federal agencies, putting them on notice 
of deficiencies. OIG is expanding our audits and evaluations of 
select agent management. We will focus on CDC's oversight of 
the Select Agent Program and on the operation of HHS 
laboratories that handle select agents.
    Through our enforcement work, OIG has also identified 
several opportunities to improve program compliance, oversight, 
and enforcement. As reflected in my written testimony, these 
opportunities focus on enhanced documentation requirements and 
increased authority for CDC inspectors. We stand ready to work 
with CDC and others in HHS to continue to improve the Select 
Agent Program and use our enforcement tools to promote 
compliance with these regulations that protect the health and 
safety of the American people.
    Thank you again for inviting me to speak. I'd be happy to 
answer questions.
    [The prepared statement of Mr. Demske follows:]
    
    
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    Mr. Murphy. Thank you, Mr. Demske. Dr. Crosse, you are 
recognized for 5 minutes.

                   STATEMENT OF MARCIA CROSSE

    Dr. Crosse. Chairman Murphy, Ranking Member DeGette, and 
members of the subcommittee, I'm pleased to be here today to 
discuss GAO's work on high-containment laboratories. The 
biosafety and biosecurity practices in these laboratories are 
intended to reduce the exposure to biological agents and 
prevent their loss, theft, or misuse.
    The recent shipments of live anthrax bacteria from DoD to 
U.S. and international laboratories, similar to last year's 
potential exposures of CDC personnel to live anthrax bacteria, 
shows multiple breakdowns in compliance with established 
policies and inadequate oversight of Federal high-containment 
laboratories. This is another example in an ongoing series of 
safety lapses which continue to occur, often with the same root 
cause as for prior incidents.
    We've been lucky so far. Researchers in these labs work 
with high-risk biological agents that may result in serious or 
lethal infections and, in some instances, have the potential to 
be used in biological weapons. These labs do important work 
with pathogens to develop vaccines and countermeasures and to 
understand emerging infectious diseases. However, the pathogens 
handled by these laboratories also have the potential for high-
consequence accidents. If the types of mistakes we've seen were 
to occur with a particularly transmissible pathogen like 
certain strains of influenza, not only would the laboratory 
workers or their close contacts be at risk but an epidemic 
could be triggered with consequences far beyond what we've seen 
to date.
    GAO is currently conducting work for this committee to 
examine these issues, and the preliminary findings from our 
work show that DoD and CDC have begun to address weaknesses in 
the management of their high-containment laboratories but have 
not yet fully implemented these activities. The steps these 
agencies are taking are intended to address fundamental flaws 
in the oversight structure, reporting, and tracking of 
biosafety and biosecurity incidents after they have occurred. 
For example, DoD officials said that the Dugway incident is the 
first incident that DoD has tracked at the senior department 
level. Since 2012 DoD has been revising its policies and 
procedures including reporting requirements and expects to 
finalize these changes by this fall. But these changes will 
only cover a subset of DoD's high-containment laboratories.
    Our ongoing work will also examine if DoD is implementing 
steps intended to improve the culture of safety at its 
laboratories so that future events are reduced or prevented.
    Similarly, CDC began taking steps to address weaknesses 
identified in assessments of the June 2014 anthrax incident and 
other safety incidents in its own laboratories, but the agency 
has not yet completed implementing recommendations intended to 
improve its laboratory oversight. For example, an internal work 
group recommended that CDC develop agency-wide policies to 
provide clear and consistent requirements for biosafety for all 
agency laboratories. In response, CDC developed a Specimen 
Transport Policy but has not developed other agency-wide 
policies, such as requirements for laboratory documentation and 
emergency protocols.
    As I stated at the outset, the incidents you are examining 
today are part of a long series of safety lapses. Since 2007, 
GAO has reported on these issues and has made multiple 
recommendations to improve Federal oversight of high-
containment laboratories. The Federal departments agreed with 
our recommendations and have conducted some activities to 
respond but have not implemented our key recommendation to 
establish a single Federal entity with responsibility for 
oversight of all high-containment laboratories.
    We recommended the establishment of a single Federal entity 
to, one, conduct Government-wide strategic planning for 
requirements for high-containment laboratories, including 
assessments of their risks; and two, develop national standards 
for designing, constructing, commissioning, operating, and 
maintaining such laboratories.
    We continue to believe that such an entity or some other 
mechanism to ensure higher-level oversight is needed in the 
face of the continuing proliferation of high-containment 
laboratories and the ongoing failures by agencies to fix their 
problems on their own.
    In closing, the lapses we've seen are indicative of 
failures in a system that is supposed to have multiple levels 
of control, including cross-checks, inspections, training, 
procedures, and validated protocols that should prevent such 
accidents from occurring and certainly should prevent such 
incidents from recurring.
    Mr. Chairman, this completes my remarks. I'd be happy to 
answer questions you or other members of the subcommittee may 
have.
    [The prepared statement of Ms. Crosse follows:]
   
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    Mr. Murphy. Thank you, Doctor. I will now recognize myself 
for 5 minutes of questioning of the witnesses. Dr. Sosin, at 
the end of your testimony you said we will work diligently and 
thoughtfully with all of our Federal partners and anyone 
sharing our commitment to protect Americans from biological 
threats. Please let the CDC know, I don't believe them anymore.
    The USA Today article I referenced earlier said that the 
CDC refused to actually produce a policy to USA Today regarding 
the lab incident reports in this newly required lab safety 
office. When was that report actually written? Do you have any 
idea?
    Dr. Sosin. Thank you, Chairman. I was asked to appear here 
today, and I apologize for the lateness of testimony. I 
apologize that----
    Mr. Murphy. But do you know anything about this report that 
they are referring to in USA Today?
    Dr. Sosin. I know that an article came out last night. I 
did not know about that report and----
    Mr. Murphy. OK.
    Dr. Sosin [continuing]. And if----
    Mr. Murphy. Well, could you----
    Dr. Sosin. We would be happy to assure that after this 
hearing we provide you answers to----
    Mr. Murphy. Well, this committee would like that report. I 
would like to know when it was written. If we could have that, 
that would be valuable. Thank you.
    Dr. Hassell, I am trying to dumb this down. Now, if I put a 
cup of coffee in a microwave oven and turn it on, it gets hot 
in a certain amount of time. If I put a dozen cups of coffee in 
that same microwave, same amount of time, they are not going to 
all be heated, right? OK. Because we know that about radiation 
and mass, some physics principles.
    [Slide follows.]
    
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    When I look here, and I believe this is from a report here, 
and it is on the graph there as well, is that--on the screen--
that on the very upper left dot where it says the Dugway 
irradiation levels here, it is saying it is operating way out 
of the realm of the acceptable processes here. And the report 
states that the DoD routinely operates outside of validated 
experimental data for kill curves.
    So based upon that finding, it sounds like validated 
experimental data does exist and all the DoD labs whose mission 
involved inactivation of anthrax were operating outside of it. 
Is that correct?
    Dr. Hassell. Yes, sir.
    Mr. Murphy. So is there--who is responsible for setting the 
number of spores and dosage of radiation? And are the protocols 
reevaluated routinely to determine that?
    Dr. Hassell. That is one of the next steps we are looking 
into. This original review was mainly focused on compliance to 
make sure that people were following the protocols they had and 
not shown there was the willful disregard for the protocols or 
nefarious intent.
    Mr. Murphy. You said it was willful?
    Dr. Hassell. It was not willful, nor was it nefarious. But 
what the graph shows, though, is they were working outside of 
that gray box that sort of shows experimental parameters that 
should have been the foundation for this work.
    The next step in this is we are looking at the very 
accountability issue. How was that decision made to move 
outside of that realm? And as you noted, it wasn't just Dugway. 
All the labs were outside of that area.
    Mr. Murphy. Because somebody did make the decision. That is 
something that is important. We need to know because we like to 
think that there is a scientific rule set up that they are 
following and that all the labs are following that, too. So let 
me ask Dr. Hassell and Dr. Sosin: In response to these most 
recent shipments of live anthrax, have either of your agencies 
made any personnel changes or refer to anyone for their civil 
penalties or criminal prosecutions for these actions? Have 
either one of your agencies done that?
    Dr. Hassell. For DoD, that is that second part of the 
investigation that will kick off now looking at the 
accountability issue to determine that. And if I may, one of 
the issues is not only the individual that made that decision, 
if that was an individual that made that decision, but what was 
the process? Was there an overall systemic process that led 
people to perhaps gradually get outside of that experimental 
box? We are looking at both of those, but the accountability is 
taken very seriously by all seniors in the Department.
    Mr. Murphy. Dr. Sosin?
    Dr. Sosin. I would also like to acknowledge that we 
understand your concern and take it seriously. No disciplinary 
actions have been taken at CDC with respect to the DoD sample 
incident. In fact, CDC staff responded in a remarkable way to 
assure that all these samples were secured and destroyed and 
that the people that might have been exposed were protected.
    Regarding the Select Agent Program, we continue to consider 
and take advice and input on how to change the nature of the 
program----
    Mr. Murphy. Do you work with the DoD? I mean, does the CDC 
work with other labs in terms of setting and reviewing 
standards on any regular basis or at all?
    Dr. Sosin. CDC works with DoD in a variety of ways.
    Mr. Murphy. With regard to this? So I am trying to find 
out--
    Dr. Sosin. Not with respect to setting standards----
    Mr. Murphy. OK.
    Dr. Sosin [continuing]. On anthrax.
    Mr. Murphy. And the reason is this: When we had our 
hearings for General Motors and someone made the decision of 
either making a spring this big or this big, and it cost a 
number of lives. And they refer to that as the GM shrug. People 
said, ``Eh. Well, some engineer decided, on we go.'' And it is 
that area when we know when people adhere to scientific 
standards, I have the highest respect for them. When things 
begin to slip out--and I would agree, we are not looking at 
something nefarious or deliberate here, but to let anything 
slip by over time, that is the problem. And as Mr. Pallone 
pointed out, luckily no one has died yet from this, but we 
really have dodged the bullet for a long time.
    But I see I am out of time. I recognize Ms. DeGette for 5 
minutes.
    Ms. DeGette. Now Dr. Crosse, you talked in your testimony 
about how people could be infected and even some kind of 
epidemic could be started if you got a particularly virulent 
agent that got released, correct?
    Dr. Crosse. Correct.
    Ms. DeGette. In addition, we have got national security 
implications relating to the mishandling of these agents. Is 
that also correct?
    Dr. Crosse. That is also a concern.
    Ms. DeGette. And that is if these agents, these active 
agents got into the wrong hands, right?
    Dr. Crosse. That is right.
    Ms. DeGette. Now, you had a lot of recommendations that 
have not been fully implemented yet, is that right?
    Dr. Crosse. Yes, although--I mean, many of the 
recommendations they have taken at least some actions. The 
primary one where there has been no movement is to have some 
type of more centralized oversight.
    Ms. DeGette. So to have a single Federal entity that could 
set the standards for all of the agencies, is that right?
    Dr. Crosse. That is right.
    Ms. DeGette. Now Dr. Hassell, what is your agency's opinion 
about that recommendation of a single Federal entity?
    Dr. Hassell. It makes sense in many ways. I will say that 
within the Department itself, we are going to do that 
internally because it is so----
    Ms. DeGette. OK. So if it makes sense in many ways, why 
haven't we done that? Why haven't you guys implemented that in 
cooperation with your fellow agencies?
    Dr. Hassell. Like I said, we are going to do that 
internally. We are in discussions now on these issues.
    Ms. DeGette. But you don't disagree with the idea?
    Dr. Hassell. No, ma'am.
    Ms. DeGette. And what about you, Dr. Sosin? What is your 
agency's view of this?
    Dr. Sosin. CDC works with APHIS at USDA as if we are one 
program. We work very closely. We do joint inspections on 
overlap agents. Whenever a change is proposed or considered in 
one program, it is discussed with the other program.
    Ms. DeGette. Well, that is nice, but what about DoD?
    Dr. Sosin. So the oversight function of the lab--I am 
trying to understand your question. I believe----
    Ms. DeGette. Well, OK.
    Dr. Sosin [continuing]. It is about oversight function, 
correct?
    Ms. DeGette. What Dr. Crosse's agency is recommending is 
one single oversight agency that would set forth the protocols 
for the dispensing of these agents. And so I am asking each of 
your agencies if you would object to that kind of--it would 
make sense to me to get one protocol no matter which lab is 
dispensing it or whatever. What is your view on that?
    Dr. Sosin. Thank you. My view is that it is a complex 
decision, that there are constraints to having one standard for 
all procedures. Anthrax for example----
    Ms. DeGette. What constraints would those be?
    Dr. Sosin. For example, with anthrax, there are many 
different uses of the products, DNA preps for developing 
vaccines----
    Ms. DeGette. But in any case if you are sending it around, 
you don't want it to be live.
    Dr. Sosin. That is absolutely----
    Ms. DeGette. That is not something that is--
    Dr. Sosin. No question.
    Ms. DeGette [continuing]. Subject to debate. So if you can 
have one agency that could come up with the protocols about 
oversight on how you are going to make that not be live and how 
you are going to dispense it, you wouldn't object to that, 
would you?
    Dr. Sosin. We wouldn't object, and we believe that the 
Select Agent Program, the Federal Select Agent Program, would 
be the appropriate body to do that. It will take----
    Ms. DeGette. OK. Could that have oversight over the DoD, 
too?
    Dr. Sosin. Absolutely.
    Ms. DeGette. So do you think that you might cooperate to 
make that happen?
    Dr. Sosin. We will cooperate in any way to----
    Ms. DeGette. OK. Let us know what we can do to help you 
because it seems to me that is an excellent recommendation, OK? 
And you are nodding, Dr. Hassell. Can you work with Dr. Sosin 
on that and his other colleagues?
    Dr. Hassell. Yes, ma'am, and that was----
    Ms. DeGette. Thank you.
    Dr. Hassell [continuing]. Stated in the statement. We 
definitely are working together.
    Ms. DeGette. OK. Now here is something else, having been on 
this committee for a long time. I have noticed this at all the 
Federal labs, not just the ones dealing with anthrax and other 
select agents but also our nuclear labs have the same problem 
of a culture of safety, and we have really struggled in this 
committee to get people to understand how important it is to 
have a culture of safety. So Dr. Hassell, can you think of 
anything we can do to systematize some kind of culture of 
safety?
    Dr. Hassell. That is a question I have myself, ma'am. I 
have spent 10 years at the DuPont Company, which goes back 200 
years making gunpowder for Thomas Jefferson. And that safety 
culture is there. So one of the things I plan to do is go out 
and see those industry best practices for doing this that the 
Government----
    Ms. DeGette. How long----
    Ms. Hassell [continuing]. Perhaps could adopt.
    Ms. DeGette. How long have you been there?
    Dr. Hassell. At the----
    Ms. DeGette. At DoD.
    Dr. Hassell. Just about a year today.
    Ms. DeGette. OK. And Dr. Sosin, do you have some ideas 
about how we can increase the culture of safety at these labs?
    Dr. Sosin. I personally do not. I know that the CDC and 
CDC's Director take this issue incredibly seriously and have 
developed a series of ideas that will evolve.
    Ms. DeGette. OK. I think we need you guys to supplement 
your testimony about this because this is really important. And 
I have one other question. I don't have time, but I would like 
a written answer for this. I would like to know why all of the 
problems in this particular incident seem to have come out of 
this one lab. Was it a problem with how they were handling this 
anthrax, how they were trying to treat it or is it a problem 
with the procedure itself? And maybe that is what you are 
investigating right now, but that seems like the crux of the 
problem.
    Thank you, Mr. Chairman.
    Mr. Murphy. The gentlelady's time has expired. I will now 
recognize the vice chairman of the subcommittee, Mr. McKinley, 
for 5 minutes.
    Mr. McKinley. Thank you, Mr. Chairman. This is a subject I 
acknowledge is foreign to me. So I was delighted to try to hear 
and learn from some of your testimony on this. But I am just 
curious before I have got a list of six questions. I am trying 
to go back to the fundamentals. Why would we ship inactive 
cells to laboratories? What would you gain by shipping 
something that is dead?
    Dr. Hassell. Maybe we could----
    Mr. McKinley. You have to use the microphone.
    Dr. Hassell. So one of the aspects of this inactivated 
anthrax is that it maintains the shell that is around the 
original live spore. The physical structure is still there. 
That is important because that is the basis for the detection 
systems and the diagnostic systems that are developed.
    Mr. McKinley. OK. That----
    Dr. Hassell. So the closer we can get to that the better we 
are.
    Mr. McKinley. That helps a little bit to explain. Let's go 
back to something that the gentlelady from Colorado mentioned 
earlier that I didn't pick up in the reading. We are doing this 
in 200 laboratories around the country? Is that an accurate 
statement? We are studying that in 200 laboratories? We have 
live anthrax in 200 laboratories?
    Dr. Sosin. The statement there, though, is 192 labs that 
receive this material were not intended to receive live 
anthrax. There are 181 registered entities within the Federal 
Select Agent Program registered to possess, use, or transfer 
Bacillus anthracis.
    Mr. McKinley. OK. So apparently there is some--I would 
struggle with that to understand why we have to have 300 or 200 
looking at some of--I would really, especially given the 
circumstances of this. Dr. Crosse, before I get to--again, I am 
going to run out of time here I think--how would you grade the 
DoD's handling of this matter? Would you give them an A on how 
they handled it? An F? Give me a----
    Dr. Crosse. Well, since the incident was reported, they 
have moved pretty quickly to identify where the samples were 
sent, although that was still developing over the last few days 
and they have----
    Mr. McKinley. How would you grade it? Would you grade it 
passing? Acceptable? A B? A C?
    Dr. Crosse. I think their response, once it was discovered, 
has probably been a B. I think the activities leading up to it 
and the fact that this went on for so long is definitely a 
failure.
    Mr. McKinley. Well, I understand it has been going on for 
10 years?
    Dr. Crosse. Yes. That is a failure and the fact that they 
have four different laboratories inactivating anthrax with four 
different methods and with four different chains of command 
that don't talk to one another.
    Mr. McKinley. Go back to Dr. Hassell. Since anthrax is 
probably the most dangerous agent that we can handle, I suppose 
it is more dangerous than Ebola. But getting it, getting that, 
is probably the biggest threat that we have in national 
security that someone doesn't get this agent. So in this case, 
has anyone tried to grow this live anthrax after they have 
received these products, with 200 laboratories? Have they tried 
to reactivate it?
    Dr. Hassell. It was grown to show the presence of the live 
spores. I may not be understanding your question. I apologize.
    Mr. McKinley. OK. Well, let me move on because I only have 
1 minute left. And so is this the same type of anthrax that was 
used in 2001?
    Dr. Sosin. This is absolutely not the same type of anthrax 
used in 2001. This is a wild type anthrax. It was in a liquid 
formulation with extremely small numbers of spores in a 1 Ml 
sample. Very different situation, nonetheless, taken extremely 
serious.
    Mr. McKinley. So this is something that different--do you 
feel that our national security is more at risk because of the 
process we have been handling this for the last 10 years?
    Dr. Sosin. The CDC----
    Mr. McKinley. It is a yes or a no, isn't it?
    Dr. Sosin. I don't believe that these samples created such 
a risk. I believe that they were secured quickly and destroyed, 
that there are very small numbers of spores in this material 
and that it is naturally occurring type of anthrax.
    Mr. McKinley. Let me ask in the last--well, my thought 
process initially--why we were shipping this to seven foreign 
nations? Does someone have a written authorization? Is there 
one of those proverbial emails that someone was requesting 
this? And then who authorizes the shipment of that and under 
what process do they explain how they want to get it? Why would 
we ship to seven foreign nations?
    Dr. Hassell. So in several cases, those were actually DoD 
facilities that were located in those foreign nations, and 
other cases they were allies that----
    Mr. McKinley. We don't have enough DoD facilities in 
America that we have to go overseas? I am running out of time.
    Mr. Murphy. OK. I now recognize Mr. Green for 5 minutes.
    Mr. Green. Thank you, Mr. Chairman. Unfortunately, the 
incident that led to today's hearing is not the first instance 
of issues of handling and shipment of bioagents at Dugway 
Proving Grounds. CDC and the Office of Inspector General 
examined safety lapses at Dugway in 2007. The result? The same 
kinds of problems we are hearing about today, failing to 
properly inactivate anthrax specimens. Is that correct, Dr. 
Hassell?
    Dr. Hassell. Yes, sir.
    Mr. Green. Based on the previous problem, should Dugway 
have made a better effort to check its procedures and double-
check the samples to see if the process worked?
    Dr. Hassell. That is my initial impression. We are going to 
be looking at that much more because there were some serious 
implications there, and we are going to be following up on that 
much more. So we can report back.
    Mr. Green. Similarly when the CDC announced last year that 
it had inadvertently transferred live anthrax, did DoD as a 
precautionary measure direct its lab to check their own 
processes for ensuring that anthrax was inactivated properly?
    Dr. Hassell. No, sir.
    Mr. Green. Why not?
    Dr. Hassell. I am not sure. That is a good question. We are 
going back and trying to figure out what were the steps leading 
up to this. It should have been better indicators that we could 
have taken action and detected this earlier.
    Mr. Green. Well, again, I think the reason for the hearing 
is it seems kind of strange that, you know, CDC made a mistake 
and we had a problem with a DoD facility, and somebody in 
management authority didn't say let's check to make sure the 
DoD is doing it right because of what happened at the CDC, 
particularly because of the problem at Dugway. Nobody decided 
to do that?
    Dr. Hassell. It doesn't appear so, sir.
    Mr. Green. Beyond the particulars of this anthrax incident, 
it is a fact that such shipments of live anthrax can 
accidentally occur raises serious questions about the handling 
of select agents at both Dugway and other DoD labs.
    Dr. Hassell, based on the continuing problems we did find 
at Dugway, what assurance can you give the subcommittee that 
there is no long-standing safety problems at Dugway or at other 
DoD facilities that handle high-risk biological agents?
    Dr. Hassell. So that is a good question. We are trying to 
look and see if there are some general lessons we can learn 
from this and use it to ask some of the questions such as your 
previous question. Just internally, are there indicators here 
that would indicate we need to be asking other questions about 
other operations across the whole complex.
    Mr. Green. What is DoD doing to look across all of its 
facilities and check their biosafety and biosecurity policies 
and procedure are adequate?
    Dr. Hassell. We are undertaking an effort now to look at 
that, as was pointed out earlier, the chain of command is 
disparate right now. So we are trying to tighten that up. We 
are going to make sure that the standards, for example, for the 
inactivated anthrax, we will ensure internally that that's 
standardized across all the laboratories. And then we can use 
that as the basis and see if there are other operations that we 
need to take some more actions on.
    All four of those facilities do different activities. 
Dugway is largely a production facility. The other ones are 
more research facilities. So one size may not fit all, but 
there are definite lessons we could learn from this, and 
whenever possible, we will standardize.
    Mr. Green. How is DoD ensuring a serious issue such as 
potential exposures or concerns about misuse are communicated 
from the laboratories to the senior leadership?
    Dr. Hassell. Some of the recommendations have been made 
previously we are going to be more vigorous on. The DoD 
instruction that was mentioned earlier that has been in 
process, that will include aspects that will bring all of the 
reporting forward to a higher level. So for example, the 2007 
incident, that will not just remain--if that had happened 
today, that wouldn't just remain at Dugway or that immediate 
command. It would come all the way up to a central office 
within the Department. We would review all of those. We're in 
the process now of pulling in all of the Inspector General 
reports, CDC reports from all of the laboratories up to my 
office, and we're reviewing all of those to see if there are 
indicators and lessons to be learned.
    Mr. Green. Well, following my colleague from West Virginia, 
so far we have been extremely fortunate these incidents at 
Dugway have not led to broader public health or security 
problems, and I hope today's hearing and other ongoing 
oversight of this incident serves as a call to action to 
tighten up these processes, not just for anthrax and at Dugway 
but other select agents and at all facilities. We don't want to 
have to have somebody here again, and I hope the Armed Services 
Committee is also looking at it and seeing that the issues are 
being corrected.
    Mr. Chairman, I yield back my time.
    Mr. Murphy. The gentleman yields back. I now recognize Dr. 
Burgess for 5 minutes.
    Mr. Burgess. Thank you, Mr. Chairman. Thanks to our 
witnesses for being here today.
    Dr. Sosin, let me just ask you a couple of questions 
basically about what we are doing to harden our public health 
infrastructure in locations where these agents may be under 
study because we have heard sort of a recurrent theme. I 
certainly appreciate what Ranking Member DeGette has said 
earlier. I mean, I have been on this committee for a number of 
years as well, and it seems like there is a recurrent theme 
here. We want everything to be perfect, but there are human 
beings involved and sometimes they aren't perfect. So I 
remember reading--I was just a regular guy in private practice 
when the anthrax attack happened in 2001. I remember reading 
with just absolute horror what happened when those five 
individuals were infected and subsequently died, reading about 
their emergency room doctor's experience that here was a guy 
that didn't look that sick. He looked like the last 700 people 
that just walked in the door, but as we found out with anthrax, 
you can be a lot sicker than what you look. And by the time 
clinical deterioration begins, you are almost too late on the 
curve to rescue someone, although rescue is possible if you 
start early. Because unlike Ebola, anthrax is treatable with 
relatively common antibiotics.
    So bearing in mind that Ebola experience from not quite a 
year ago, CDC was telling us last July, August, September, we 
got everybody up to speed about Ebola. We don't have to worry 
about Ebola coming to this country. The President made a 
statement that we don't have to worry about Ebola coming to 
this country. The CDC has done what it needs to do to get 
everybody prepared. And then it didn't happen.
    So this is not quite the same thing, but you know you have 
got sites where this is under study. You know that 
unfortunately lapses can occur. So do you have like a 35- or 
50-mile radius around these sites where you are at least 
notifying the people on the front lines, the emergency rooms, 
the emergency room doctors, that ``this is something we are 
working on in your community''?
    Dr. Sosin. Thank you for that question. First with respect 
to hardening infrastructure, yes, there are support programs at 
the State and local level to address anthrax and other 
bioterrorism threats. As you pointed out, there are not only 
the routine treatments, there are some advanced medical 
countermeasures that have been developed such as antitoxin to 
help treat later stages of anthrax and vaccine. Those were 
actually brought to bear, the vaccine and antibiotics and 
prophylaxis in this incident.
    The State authorities are informed of the institutions and 
their jurisdiction and the agents that are there as a part of 
their public health preparedness programs. There is no active 
outreach to the medical community in the absence of an 
incident, but we are quick to respond as we did in this 
instance with the information about how to diagnose, how to 
watch for, monitor, and how to treat.
    Mr. Burgess. Let me just interrupt you because my time is 
going to drift away from me. Could you provide the committee 
those materials that you provided----
    Dr. Sosin. Absolutely.
    Mr. Burgess [continuing]. To the emergency rooms and what 
radius around where the breach occurred, what the geographic 
radius was?
    Dr. Sosin. I will say that these materials were not sent to 
emergency departments, although we did consider it. We were 
monitoring the workers in the laboratories closely, and these 
materials were sent to the laboratories and to the State health 
departments.
    Mr. Burgess. But Dr. Sosin, that is the point.
    Dr. Sosin. Yes.
    Mr. Burgess. These people thought they were getting 
inactivated strains, and they were active. So somebody leaves 
work for a weekend and Sunday afternoon has got a low-grade 
temperature, just doesn't feel right. A family member says go 
down to the Care Now facility, and again, they will look well 
until they get deathly ill.
    Dr. Sosin. Absolutely.
    Mr. Burgess. That is the problem.
    Dr. Sosin. That is why these were isolated to laboratories, 
and we were working directly with the laboratories, the 
workers, and the health departments to monitor them.
    Mr. Burgess. Well, forgive me if I am unmollified, but the 
problem was you didn't know what you didn't know at that point. 
And certainly the people in the community who may have been the 
doctors and nurses and the caregivers who were seeing patients 
wouldn't have known that this was what they were up against.
    I guess my concern is how do we get that information out 
there? How do we make people aware? Once you know that anthrax 
is in the consideration, OK. Fair enough. But before you know 
it, they look like the last 1,500 patients that have come 
through the door with a viral syndrome.
    I do have a question that I need to ask Mr. Demske, and if 
we don't have time to get through all of it, maybe you can 
provide me an answer in writing. But when you look at the 
referrals for violations of the Federal Select Agent Program, 
CDC, NIH, United States Army Medical Research Institute of 
Infectious Diseases seem to be the top three. So you have an 
enforcement policy where you can actually fine, but you don't 
fine Federal agencies. Is that correct?
    Mr. Demske. To date we have not fined any Federal agencies. 
That's correct.
    Mr. Burgess. But that seemed--you know, that is what Willie 
Sutton would say. You robbed banks because that is where the 
money is. Right now, the violations, the multiple violators 
seem to be coming from those three groups. So can you get back 
to me in writing and discuss what you are doing to consider 
providing the same civil money penalties at any other lab, any 
other lab in the country would have to face if they had breach 
of these agents.
    Mr. Demske. Just to be clear, most of the referrals and 
most of the labs, incidents that have been referred to us, have 
not involved Federal entities but certainly there have been 
repeat instances at Federal entities, and we would be happy to 
provide you an answer.
    Mr. Burgess. The multiple offenders at CDC, NIH, and the 
United States Military. That is the problem.
    Mr. Murphy. It is the civil penalties and other penalties 
we need to know about from there. Thank you.
    Mr. Tonko, you are recognized for 5 minutes.
    Mr. Tonko. Thank you, Mr. Chair. We have heard about the 
importance of keeping labs safe and secure. Thus I would like 
to explore how labs both private and public that fail to meet 
critical safety standards and regulations are held accountable. 
Both CDC and HHS, through their Offices of Inspector General 
have roles and enforcement. CDC's division of select agents and 
toxins can refer entities, the Office of Inspector, for civil 
money penalties or certainly notices of violation. CDC could 
deny, revoke, or suspend a lab's registration or require a lab 
to enter into a performance improvement plan. Criminal charges 
can also be made in cases of misuse, unauthorized possession, 
or unauthorized transfer. So Dr. Sosin and Mr. Demske, could 
you briefly walk us through the different enforcement options 
and how you determine the appropriate response for a given 
violation?
    Dr. Sosin. Thank you for your question. You have correctly 
pointed out options, the administrative options the CDC has to 
suspend, deny, or revoke registration. The registration process 
itself is intended to screen and assure that there is good 
laboratory practice, good laboratory leadership and an 
appropriate use for the select agent materials.
    So that process and a variety of other steps in the program 
are intended to assure that the entity itself is taking the 
appropriate steps that it needs to take. The decision to 
suspend or revoke is one taken very seriously on the importance 
of balance, particularly for facilities of the nature that you 
all are talking about here. These are important biodefense 
facilities doing important work, and the history of the program 
has been to work collaboratively with these programs to 
identify the specific problems and address them. But those are 
options, and the referral to FBI if there is a concern about 
suspicious activity or referral to OIG.
    Mr. Tonko. Thank you. Mr. Demske?
    Mr. Demske. Yes. When we receive a referral from the CDC, 
one of our attorneys or multiple attorneys will review the 
allegations and the findings of the CDC, will often consult 
with the scientists and expert at CDC so that we make sure we 
understand those facts. If we believe that there has been a 
violation, it is our policy to them contact the entity that is 
the subject of the matter and give them the opportunity to 
provide us with information or arguments about why the penalty 
would not be appropriate. We take that into account, often 
again in consultation with CDC and decide whether to go forward 
with the case and we use our--looking across the experience of 
the cases that we have had, make a judgment about what we think 
the case should be valued at if we do seek a civil money 
penalty.
    Mr. Tonko. Now, do your offices routinely work together to 
take action against those who are in violation?
    Mr. Demske. We certainly communicate and work together from 
our perspective to make sure that we understand the facts and 
the science in these matters for us to determine whether to go 
forward.
    Mr. Tonko. And Dr. Sosin, what types of violations would 
result in a lab losing its registration?
    Dr. Sosin. I can tell you that the process of revoking a 
registration is one that is undertaken through careful efforts 
to help the laboratory address the concerns and improve its 
practices and that revocation would come only after the 
inability of that facility to make those changes or their 
decision to no longer be interested in doing that work. I can 
get further clarification of the specific measures if you'd 
like.
    Mr. Tonko. And in your opinion, how often has that 
happened?
    Dr. Sosin. I believe that it has happened two times. I can 
get you the exact number.
    Mr. Tonko. OK. I would also like to get a sense of the 
frequency of violations and actions to address them. Dr. Sosin, 
are you seeing any trends at the CDC in terms of enforcement 
actions, any trends in referrals to the Office of Inspector 
General for instance or performance improvement plans or lab 
registration actions?
    Dr. Sosin. The Federal Select Agent Program is constantly 
evolving in its approaches and tools such as the corrective 
action plan process are relatively new and evolving. So trends 
are hard to evaluate in that context. I know that at the 
request of this subcommittee, specific enforcement actions have 
been laid out in a response and should have the kind of 
information you would be looking for.
    Mr. Tonko. OK, and I am out of time, but if Mr. Demske, if 
you could perhaps feed the panel with that same trend that you 
cite, any trends that you cite, that would be helpful.
    Mr. Demske. Yes.
    Mr. Tonko. Thank you.
    Mr. Murphy. Thank you. I now recognize Mrs. Blackburn for 5 
minutes.
    Mrs. Blackburn. Thank you, Mr. Chairman, and thank you to 
our witnesses for your patience. We appreciate this. As you 
know, we have got another hearing going on this morning.
    Dr. Sosin, I want to come to you if I may. I have got a 
copy of Dr. Frieden's testimony from this committee last year, 
and he was testifying about the June 2014 anthrax incident. He 
said, and I am going to read from the testimony, and I am 
quoting. ``These incidents should never have happened. The lack 
of adequate procedures and oversight that allowed them to 
happen was totally unacceptable. We will explore the broader 
implications of these incidents and incorporate the lessons 
learned from them to proactively prevent future incidents at 
laboratories across the Nation that work with pathogens.''
    So I want to know, can you explain why we didn't seem to 
learn the lessons? Can you talk about why there is another 
comprehensive review of safety and security of the bioterror 
labs? Why was not Congress notified? Why is another review 
necessary? Were the problems at the CDC not corrected? And then 
who is going to conduct the new review? And ultimately, who do 
we hold responsible for this?
    Dr. Sosin. Thank you for your questions. Pardon me if I 
need refreshing on some of them.
    Mrs. Blackburn. I will be happy to refresh.
    Dr. Sosin. I am sure you will. I think it is important to 
recognize that the oversight program is not a CDC laboratory 
itself. It functions separately. Nonetheless, in hindsight, 
there has been reason to look more closely at anthrax 
inactivation. There is no question that that is necessary, and 
before a moratorium on the use and transfer of these materials 
will be lifted, we will have a policy about how to validate----
    Mrs. Blackburn. Whoa, whoa, whoa. Wait a minute. That was 
supposed to be done. So why was it not done? Who is responsible 
that it did not get tended to last year?
    Dr. Sosin. The work of a complex laboratory, 
microbiological laboratory, has thousands of procedures and 
potential vulnerabilities.
    Mrs. Blackburn. So you are saying no one person is in 
charge, that it is done by committee?
    Dr. Sosin. No. I am saying that the nature, the current 
nature of the Federal Select Agent Program is one of setting 
broad standards to achieve high laboratory performance but does 
not review each individual specific procedure at each entity. 
There will need to be----
    Mrs. Blackburn. Well, did the procedures call for notifying 
Congress?
    Dr. Sosin. I am sorry?
    Mrs. Blackburn. Did the procedures call for notifying 
Congress if you need to do a review, if you have another 
incident?
    Dr. Sosin. So----
    Mrs. Blackburn. So that is not a part of your best business 
processes?
    Dr. Sosin. I apologize if Congress was not notified 
regarding the review that Dr. Frieden requested we take 
internally of the Federal Select Agent Program at CDC. That 
review is not a review of CDC labs and procedures. That is a 
review of what opportunities we have----
    Mrs. Blackburn. OK. Well, let me ask you this----
    Dr. Sosin [continuing]. To improve the oversight program.
    Mrs. Blackburn [continuing]. This way. Going back to his 
testimony where he says that it never should have happened, 
lack of adequate procedures, totally unacceptable, going to put 
the processes in place, and incorporate the lessons learned. 
Was this not done last year?
    Dr. Sosin. Many things were done. This was not addressed.
    Mrs. Blackburn. So, OK. So it was not addressed? That is 
the answer that I wanted a yes or no. Either it was done or it 
was not done, and that is what we want to know.
    And see this is what is part of is so frustrating to the 
taxpayers who are footing the bill for this because you all 
feel like you have immunity if you will, and you don't have to 
move forward and do the job because you have a continuing 
appropriation. You just don't do the job until it is 
convenient.
    Dr. Sosin. Congressman, I don't believe that----
    Mrs. Blackburn. So you mess up once. You mess up twice. You 
mess up 86 times, and it is no skin off your back because 
nobody is responsible, because you operate by committee, 
because we ask you to do something and report back to us. What 
do you do, sit around and go, well, we will get around to it 
later? Maybe we need to give you around to it and have you go 
get the job done.
    Dr. Sosin. Perhaps I am misunderstanding----
    Mrs. Blackburn. The fact that we are having to have another 
hearing and look at this is something that is frustrating. You 
should realize that there was a mistake and immediately move 
forward to correct the procedures and the policies and then 
should change the way that things are done. And I know I am 
running out of time, and I will yield back the balance of my 
time.
    Dr. Sosin. I do think it is important to clarify that the 
CDC error with anthrax was addressed. It was a different 
situation. What I did acknowledge is that as the Federal Select 
Agent Program, with anthrax, with inactivation, in hindsight we 
should have and we will address inactivation procedures before 
that is used again.
    Mr. Murphy. I am sure you can understand----
    Dr. Sosin. Absolutely.
    Mr. Murphy [continuing]. We have heard that before.
    Dr. Sosin. I understand.
    Mr. Murphy. Ms. Castor, you are recognized for 5 minutes.
    Ms. Castor. Thank you, Mr. Chairman. Regarding the DoD 
review of the Dugway incident and the science surrounding 
inactivation protocols, the DoD review concluded that one of 
the root causes of the Dugway incident was scientific 
uncertainty about the process of inactivating anthrax spores. 
The review stated that this uncertainty led to the creation of 
protocols that do not completely or permanently inactivate 
anthrax spores. And although this instance only recently raised 
questions about the inadequacy of these procedures, the 
Department knew of this uncertainty for quite a while.
    So Dr. Hassell, if the Department was aware of the 
potential inadequacy of the inactivation process using gamma 
irradiation, why didn't the Department have better verification 
procedures to ensure the spores were properly inactivated 
before shipping them?
    Dr. Hassell. So that is a good question because it really 
separates there were two issues involved. One was the 
inactivation was ineffective, and then the other one was that 
the viability testing didn't catch the fact that the first was 
not 100 percent effective.
    Regarding the inactivation, there are several scientific 
publications and, you know, peer-reviewed journals in the 
scientific literature that have shown different what we call 
death curves for killing anthrax. What we need to do now is to 
try to pull all those together, get a consensus view of those, 
work with a body of subject matter experts, work in consensus 
with CDC and try to figure out what----
    Ms. Castor. Well, why didn't you do that before if the 
Department knew of this uncertainty for a while?
    Dr. Hassell. It appears that that was somewhat localized, 
that it wasn't universally acknowledged.
    Ms. Castor. What does that mean?
    Dr. Hassell. Well, each individual laboratory set its own 
standards. And so this wasn't raised up to a central body----
    Ms. Castor. And you are acknowledging now that was not 
acceptable. Those standards were not acceptable.
    Dr. Hassell. Was not acceptable and going forward, it will 
have to be done in concert so the----
    Ms. Castor. So is the DoD reviewing all of its protocols 
and procedures to ensure that there are not similar gaps in the 
scientific literature for the inactivation of other dangerous 
toxins and pathogens?
    Dr. Hassell. We will be doing that, definitely. We are 
going to take a----
    Ms. Castor. So you are doing that for anthrax and for other 
toxins?
    Dr. Hassell. Right. We are going to see if there are any 
lessons learned from that that we can then apply across the 
board.
    Ms. Castor. How confident are you that people are going to 
take that seriously? There are gaps in science. There are 
discrepancies. How will you come to reconcile? Certainly you 
would err on the side of safety?
    Dr. Hassell. Yes, ma'am, absolutely.
    Ms. Castor. But take us through what is going to happen 
specifically in that review.
    Dr. Hassell. Well, anthrax is particularly hard to kill. So 
we are taking on the biggest challenge up front. So that should 
give us our biggest challenges, both in the activation and on 
this viability testing afterwards. Things that we learn from 
both of those we will then take forward and apply them.
    Ms. Castor. And when there is a difference of opinion, who 
is going to be the responsible party where we can go back and 
say, wow. We had this hearing. The DoD said, another agency 
said we will address these gaps. If and when we have to have 
another hearing, who is it that we will identify? Or if you 
could provide that to the committee because there is this 
problem with no personal accountability, don't you agree?
    Dr. Hassell. Yes, ma'am, and the second part of this 
investigation we will be looking at the accountability. We will 
have some of those people identified, and we will certainly 
provide that to the committee.
    Ms. Castor. Thank you. I would like to turn to Dr. Sosin to 
ask some questions about the CDC's role in overseeing the 
Select Agent Program. Dr. Sosin, why is there such variation 
across labs as to how they inactivate anthrax?
    Dr. Sosin. Thank you for your question. As mentioned 
earlier, there are a variety of needs for materials that come 
from dead anthrax, and the laboratories, some research, some 
production for proficiency testing of labs, et cetera, have 
different roles and purposes as well. So CDC historically has 
required a validated procedure, either published and followed 
or validated within that laboratory and proof of sterility 
testing. I think to your earlier question about accountability, 
the exemption of a select agent, anthrax becoming now exempt 
because it is dead, is a requirement of the Federal Select 
Agent Program. And until we have a procedure that increases 
confidence that we can safely do that----
    Ms. Castor. Because----
    Dr. Sosin [continuing]. We will not lift that moratorium.
    Ms. Castor. Well, I appreciate that, but you can see that 
we are very concerned.
    Dr. Sosin. Absolutely.
    Ms. Castor. Are we to expect similar variations in 
inactivation protocols for other select agents and toxins? And 
how do we address that?
    Dr. Sosin. As Dr. Hassell pointed out, the nature of a 
spore being extremely hearty and difficult to kill, plus the 
fact in this instance we were, or the Department of Defense was 
trying to kill the organisms without disrupting the organism 
creates a challenge in safety. The attempt now is to set an 
appropriately wide margin. If you go back to the chairman's 
figure that he showed, the DoD shows the dosing and a gap 
between the kill curve and the dosing. That gap wasn't 
happening here. Clearly there were production runs that were 
growing anthrax and should have highlighted that the procedure 
was not adequate.
    Going forward we will make sure that there is a safety 
margin and achieve consensus with the broad input that we have 
opportunity to get to assure that we are taking the right 
margin.
    Ms. Castor. I am out of time. Thank you.
    Mr. Murphy. Thank you. Now I recognize Mr. Griffith for 5 
minutes.
    Mr. Griffith. Thank you very much, Mr. Chairman. Dr. 
Hassell, if you could, we have got folks out there receiving 
this. You answered a previous question related to the foreign 
nations and said some of those were DoD facilities. Were they 
all DoD facilities? And if not DoD facilities, were all the 
facilities that were completely controlled by the United States 
Government? Yes or no.
    Dr. Hassell. No.
    Mr. Griffith. So some of these would have gone to 
facilities not controlled by the United States Government. How 
certain can we be that these folks who were receiving live 
samples, and I believe it was over the course we now know of 
like 10 years, didn't discover this before they necessarily 
told us and have been out there growing some of their own 
samples and siphoning off some? So when we are told that you 
all hunted it down and you have killed or acquired all of the 
live anthrax, how certain of that can we be? Because it doesn't 
sound like to me we can be very certain if somebody was taking 
some of that anthrax and skimming off some of the live for use 
in other ways.
    Dr. Hassell. So the non-DoD facilities that you refer to, 
those are some of our most trusted allies. We do many things 
with these allies across the board, not just for chembio----
    Mr. Griffith. They are trusted, but if they wanted to do 
research on biological weapons, this would have given them an 
opportunity to acquire that or at least to acquire the base 
material to start the cultures with. Isn't that true? Yes or 
no.
    Dr. Hassell. It is true, but they were already doing most 
of that work. They just--we were trying to use a common 
material across the board so everyone was testing on the same 
material so that we could compare the results that we have.
    Mr. Griffith. And how----
    Dr. Hassell. But they do have those programs already.
    Mr. Griffith. How comfortable are you that those facilities 
had better protocols than we do in that we don't have some 
worker who might have taken what was supposed to be some dead 
cells, generated the live cells, and gone out with a sample 
that he might have then got, he or she may have then given to a 
foreign agent?
    Dr. Hassell. In some of those cases, they already have the 
material now. Like I say this was soon-to-be dead material, and 
we do have records that that's all been destroyed.
    Mr. Griffith. What you found has all been destroyed but 
since it was live, there could be more than what you knew 
about. Yes or no. Yes, the answer is yes. All right. Let's move 
on.
    Dr. Sosin, you said that the CDC acted reasonably in 
tracking down the live anthrax and then securing or killing it. 
Dr. Crosse, you indicated that you would give them a B once it 
was discovered, but Mr. Demske, you didn't get notified until 
yesterday to investigate the problem that was discovered in 
May. Isn't that correct?
    Mr. Demske. That is correct, yes.
    Mr. Griffith. So we have got at least 60 days since the 
problem was discovered before you were notified. Isn't that 
true?
    Mr. Demske. Yes.
    Mr. Griffith. I don't consider that a B or acting 
reasonably. Do you?
    Mr. Demske. Well, we are not the front lines of an emergent 
situation. That would have to go to the FDA and with the 
scientists and the CDC. So it is normal for CDC to do 
investigative work on its own before it would refer a matter to 
us, and that actually helps us because the evidence is more 
developed when we receive it.
    Mr. Griffith. So you think 60 days is reasonable before 
you're notified to do your investigation?
    Mr. Demske. Yes.
    Mr. Griffith. OK. And as a part of that, they are doing 
their investigations and so forth. But don't you think it is 
kind of interesting that you got notified yesterday? Do you 
think that our hearing might have sped that time up a little 
bit?
    Mr. Demske. I have no information about that.
    Mr. Griffith. But when you filed your testimony, you said 
to date OIG has not received a referral for any more recent 
potential violations involving Dugway which was in reference to 
the 2008 and 2010 incidents.
    Mr. Demske. That is right. We submitted the testimony on 
Friday. At that time we had not received it. I would say--my 
opinion is that oversight by this committee is a very effective 
way at spurring attention to this matter within the Government.
    Mr. Griffith. I just wish we didn't have to do it so often. 
Dr. Sosin, you are the acting director of National Center for 
Injury Prevention and Control. I noticed in the report referred 
to by the chairman earlier that Stephen Moore is the Acting 
Director of his department. What is the relationship between 
your two areas and why is everybody over there acting and 
nobody is permanent?
    Dr. Sosin. I am sorry. The information you have about my 
acting director role is old. I was previously for nine months 
acting director there. I have been for nearly or over a decade 
actually the Deputy Director for the Office of Public Health 
Preparedness and Response. Dr. Monroe I think you are referring 
to is the Acting Associate Director for Laboratory Science and 
Safety, is an outstanding laboratory scientist who comes from 
the Center of Emerging Infections.
    Mr. Griffith. And he is----
    Dr. Sosin. And he is in an acting role because we are 
trying to hire a top-notch laboratory scientist to lead the 
Laboratory Safety and Science effort.
    Mr. Griffith. And do you answer to him or do you just work 
with him?
    Dr. Sosin. I work with him.
    Mr. Griffith. I yield back. Thank you, Mr. Chairman.
    Mr. Murphy. Mr. Pallone, you are now recognized for 5 
minutes.
    Mr. Pallone. Thank you. As the investigation into the 
Dugway incident continues, we are learning that more and more 
labs received these lives anthrax shipments in addition to the 
86 labs to which DoD directly sent shipments. There had been 
additional 106 labs that received secondary transfers. So we 
are now talking about nearly 200 labs. And as more labs are 
involved, the opportunities for error only increase.
    So I do want to understand whether it is necessary to have 
so many different labs involved with dangerous biological 
agents. I know Ms. DeGette mentioned this in her opening 
statement. So Dr. Crosse, do you have an opinion on the number 
of labs that are working with anthrax?
    Dr. Crosse. Well, I don't think we know the number of labs 
that are working with anthrax. I think that is one of the 
issues. Well, we have information of where the--are you talking 
about the----
    Dr. Sosin. I just heard entities.
    Dr. Crosse. Yes.
    Dr. Sosin. Anthrax is a select agent.
    Dr. Crosse. That is right. I am sorry. Anthrax we do know. 
We do not know all of the high-containment laboratories that 
exist. We have controls for a subset of dangerous pathogens. 
There are other highly infectious pathogens that require a 
biosafety level three laboratory, and they do not all have to 
be registered with the Select Agent Program. We do know for 
anthrax. My apologies.
    Mr. Pallone. So Dr. Crosse, GAO has recommended the 
establishment of the single Federal entity to conduct 
Government-wide strategic planning and oversight for high-
containment labs. This would include developing national 
standards for designing, constructing, operating, and 
maintaining such labs. Can you elaborate on this 
recommendation?
    Dr. Crosse. Yes. We think it is important that there be a 
more comprehensive set of plans for how many labs are needed. 
You know, there have been a great increase in the number of 
labs over the last decade. Since the anthrax attacks in 2001, a 
number of different Federal agencies have expanded the number 
of labs that they have. Academic institutions have built labs. 
Some States have built labs. And a lot of private entities have 
built labs. And they are very expensive. We don't know what 
really is needed.
    As we have heard today, they are developing their own 
validation procedures. And there's not necessarily an assurance 
of consistency. And so while inspections can be performed at 
that these laboratories, the kinds of reportings of problems 
have only typically been going to a level above the laboratory, 
too. So they are not going up to the top of departments or to 
organizations.
    And so I think that we are concerned that there hasn't been 
kind of a consistent set of standards in place, a consistent 
understanding of what the needs are, a consistent plan 
developed for where these laboratories ought to be built and 
maintained, and what the costs are going to be over the long 
term for maintaining this kind of infrastructure and whether it 
is in line with the needs.
    Mr. Pallone. Well, have you gotten feedback from the 
Federal Government agencies that operate these high-containment 
labs with regard to this recommendation to establish a single 
Federal entity? I know you mentioned some obstacles to that, 
but what other obstacles would there be to implement it?
    Dr. Crosse. Well, you know, I think that it is not clear 
where that organization should be located. As we've heard 
today, it is difficult to retrofit this kind of control on top 
of an existing enterprise. Different departments want to have 
control over what their own needs are. Different companies want 
to be able to compete for contracts from the Federal 
Government. And so going back and retrofitting them kind of 
control is complicated. We have not gotten traction on the 
concept of moving forward to try to centralize this control.
    Mr. Pallone. Let me just then ask again, do you believe 
that the establishment of these national standards and 
oversight might address some of the gaps that led to the recent 
incidents at DoD and CDC? And how could Congress help in 
establishing uniform standards and procedures?
    Dr. Crosse. We do believe that having more consistent lines 
of authority would be helpful. DoD I think in its report on the 
Dugway incidents has pointed out that the different 
laboratories handling anthrax were in different chains of 
command and never came together, that there wasn't a sharing of 
information, and they didn't have top-level knowledge of what 
was going on in these laboratories and how the procedures were 
being conducted. That is the type of thing we think would be 
helpful, and we would be happy with you and members of the 
committee to try to develop some kind of proposals.
    Mr. Pallone. Thank you. Thank you, Mr. Chairman.
    Mr. Murphy. Thank you. I now recognize Dr. Bucshon for 5 
minutes.
    Mr. Bucshon. Thank you, Mr. Chairman. I mean, to me this 
hearing is astounding, honestly. And I hate to admit but in the 
4 \1/2\ years that I have been here, this is not the only 
Government agencies that we are hearing, testifying in front of 
a Congress saying they are establishing new policies. Sorry we 
messed up. Sorry we did this. Sorry we did that. And you know 
why? Because there is no accountability. There is no 
accountability across the Federal Government in my view. No one 
is responsible. People are in their jobs for short periods of 
time. Dr. Hassell, you have been on your job for a year. If we 
really pressed you, you would say, well, I don't know. I have 
only been in my job for a year, so I don't know what they did 
before me. I mean, this is a decade-long process, and I 
personally get tired of hearing about how we are establishing 
new policies in this. This is anthrax. We should have had 
policies for decades. It is ridiculous.
    And you know, that is the problem. There is almost contempt 
against congressional oversight. Every hearing I go to--and it 
is almost people walk out of the room and they go, well, they 
didn't get us this time and they can't get us. There's nothing 
they can do to us. That is what--I mean, this is just 
ridiculous.
    So Dr. Hassell, how can there not be standardize protocols 
for this in the Federal Government after decades and decades of 
this? How can that not happen? I mean, that is just the 
question I have. Dr. Hassell, how could--you made the 
statement, you know, ``We are standardizing how we deal with 
this.'' How can it not be standardized?
    Dr. Hassell. I could answer for DoD. Part of it was, as 
noted earlier, that the different chains of command have been 
one of the fundamental problems here because each laboratory 
reports up to a different chain. They meet too high up in the 
organization. So yes, I have been in place for a year, but I 
take this very personally.
    Mr. Bucshon. I am not criticizing you.
    Dr. Hassell. Right. No, no----
    Mr. Bucshon. I am just saying----
    Dr. Hassell. No, no, but I am saying I take----
    Mr. Bucshon. In fairness, you have only been there a year. 
You are right. You can't be accountable for what happened 10 
years ago. I agree with you.
    Dr. Hassell. But I own it now, so I take personal 
responsibility to work with other people in the department to 
make sure these things are standardized, and I will not 
recommend to the Undersecretary that we lift the moratorium 
until I am confident that we have the proper scientific basis 
for our operations and that we have received, we have achieved 
the right level of standardization----
    Mr. Bucshon. I appreciate that. The reality is that, if 
people were losing their jobs, this would be standardized. And 
Dr. Sosin, I mean, you said--they asked, how do you solve this 
problem? You said, well, I don't know how we solve the problem 
essentially is what you said in your earlier testimony.
    I mean, I know how to solve it. How many people across the 
Government have been fired over this problem? Who has lost 
their job at CDC, at DoD? Or who is still doing the same thing, 
even though they literally sent a national security risk, 
anthrax, around the world? And as Mr. Griffith found out, non-
DoD properties. I don't care if they are allies. That doesn't 
matter.
    And not to mention the fact how many people are protected 
from being fired because they are part of a Federal Government 
union that does not allow them to be held accountable.
    Dr. Sosin. Congressman----
    Mr. Bucshon. I want to know answers.
    Dr. Sosin. I would love to have you come visit CDC and see 
how accountable the scientists and professional staff are at 
CDC. We take this incredibly seriously. There are----
    Mr. Bucshon. I am not saying that you don't----
    Dr. Sosin. There are regulations and rules----
    Mr. Bucshon [continuing]. But who has lost their jobs? Who 
lost their job?
    Dr. Sosin. There are regulations and rules around the use 
and transfer of anthrax, live anthrax. This particular incident 
was about an exempted material, which was not considered a 
select agent. And new actions will be taken to address it.
    Mr. Bucshon. What, you are going to put in some more 
policies? By action, what do you mean?
    Dr. Sosin. For example----
    Mr. Bucshon. Well, for me it means the people responsible 
for doing this lose their job.
    Dr. Sosin. For example, before a material can be considered 
killed, we need to have a validated procedure within the lab 
experience.
    Mr. Bucshon. But how--to my question, how come you haven't 
had that?
    Dr. Sosin. Hindsight----
    Mr. Bucshon. This is for decades.
    Dr. Sosin [continuing]. We should have had it. We have 
already--I have acknowledged that in hindsight, with this 
organism and the vulnerability here, we should have done this 
before.
    Mr. Bucshon. I mean, the reality----
    Dr. Sosin. And we are going to do it now.
    Mr. Bucshon. I mean, the Federal Government hasn't known 
what constitutes dead anthrax until this came up? I mean, I 
just don't----
    Dr. Sosin. The reliance is----
    Mr. Bucshon. Failing to find why there is a problem----
    Dr. Sosin [continuing]. Testing, testing the material in 
the laboratory to see if there is growth. And that process in 
this instance failed.
    Mr. Bucshon. OK. I yield back, Mr. Chairman.
    Mr. Murphy. Thank you. I now recognize Mr. Flores for 5 
minutes.
    Mr. Flores. OK. Thank you, Mr. Chairman. It is unfortunate 
that we have to have another hearing, another oversight hearing 
like this. You know, continuing along the theme that Dr. 
Bucshon raised, there was a quote in USA Today in the article 
that came out yesterday that says the root cause of all this is 
a lack of accountability. Incidents don't get reported, and 
consequences don't occur. And I think many of us have expressed 
our frustration, not only in the agencies represented here, the 
two agencies that are the subject of the problems, but across 
the Government and the VA, for instance. It has allowed for 
cover-ups on waiting lists, and only three people have been 
fired at the VA. Three hundred thousand people in the VA and 
only three have been fired. And it gets back to one of the root 
causes: It is too hard to fire a Federal union employee.
    So Dr. Hassell, of the individuals at the Dugway Proving 
Ground, what are the percentages of uniformed versus civilian 
at that facility?
    Dr. Hassell. I don't have that information, sir. I can get 
it to you. It is mostly civilian.
    Mr. Flores. And of the civilian, what percentage are 
unionized?
    Dr. Hassell. I am not sure.
    Mr. Flores. I would appreciate if you could get us 
responses from both of those.
    Dr. Hassell. Yes.
    Mr. Flores. And if that is the case, have you taken action 
against any of those employees, any civilian employee or any 
uniformed employee?
    Dr. Hassell. To date, no.
    Mr. Flores. OK.
    Dr. Hassell. There is an investigation that's starting to 
look into this. If we do take action, we want to make sure that 
it is taken at the right place, to make sure that the person 
who is truly accountable is held accountable.
    Mr. Flores. Well, that is all real nice, but how many 
mistakes are happening right now because there is no 
accountability? I mean, do you know today that we are not 
shipping other live agents around right now? Do you know that? 
How can you know?
    Dr. Hassell. As we pointed out, just because the anthrax 
itself is so hard to kill and presents such a challenge, that 
has been stopped. So that I can assure you is not happening.
    Mr. Flores. OK. Anything else? What is the next one, 
though? Where are the other vulnerabilities? I mean, we had 
Ebola last year, not from you but from the CDC. I mean, Dr. 
Sosin, how can you be sure that we don't have any other 
incidents like this going out right today.
    Dr. Sosin. Certainty is hard to provide. As we understand 
the organism and the process of assuring its sterility. There 
is no evidence that these materials that are presumed 
inactivated are not inactivated. We have seen no evidence of a 
signal event, growth or disease or injury. That doesn't mean we 
don't take this seriously, and we don't consider whether 
additional procedures need to be implemented on inactivation of 
select agents. This is certainly going on now with respect to 
anthrax and we'll apply what we would consider in a broader 
context for other selected agents.
    Mr. Flores. Just for the committee's sake, walk through the 
ownership of the different elements of the Federal Select Agent 
process as respects your two agencies. Can you tell me who owns 
what part? And I have just got a minute so can you--just give 
me the highlights, Dr. Sosin.
    Dr. Sosin. Well, I can tell you----
    Mr. Flores. What parts do you own and then where do you 
hand off to?
    Dr. Sosin. The Federal Select Agent Program is an oversight 
program so the main activities that are involved and the main 
improvements that have been made through the execution of this 
program over the last 12 years includes screening and assessing 
facilities and staff for their suitability to work with 
anthrax. That means that the facility is an appropriate 
facility, has good laboratory practice, and has appropriate 
role to work with that material. It also includes the FBI's 
review of personnel reliability, of all of those who will be 
using it, includes a set of requirements to elevate biosafety 
and biosecurity, inventory management, access controls, those 
kinds of measures. And it includes a process and an ability to 
detect and respond including the notification of jurisdictions 
that have these facilities in site including what we did here 
with the anthrax response, being able to go in, investigate, 
identify whether people are at risk, secure the samples and 
look into what caused them.
    Mr. Flores. OK. Now this process involves not only private-
sector institutions as well as public-sector institutions, is 
that correct?
    Dr. Sosin. That is correct, for the select agents.
    Mr. Flores. So where are you finding the best practices 
coming from today? I mean, Dr. Hassell was talking about going 
to the private sector to find best practices. So Dr. Hassell, 
where are we finding the best practices today? Private sector 
or public sector?
    Dr. Hassell. It is a combination of both. I am just saying 
we are going to go look at the private sector. That often 
doesn't happen in Government as the first reaction. The 
Department of Defense----
    Mr. Flores. You need to look at both.
    Dr. Sosin. The Department of Defense, the Centers for 
Disease Control, the NIH, these are outstanding facilities. 
They are doing cutting-edge, critical work which has some risk. 
These are places where best practices and not-best practices 
will occur because of the broad range of practices that do 
occur.
    Mr. Flores. OK. I have additional questions. I will submit 
them for the record later on. Thank you, Mr. Chairman.
    Mr. McKinley [presiding]. Thank you. And the gentleman from 
Oklahoma, Mr. Mullin, is recognized for 5 minutes.
    Mr. Mullin. Thank you, Mr. Chairman. I appreciate you guys 
being here. I am sure you are having a blast and enjoying your 
time here, but it is very frustrating for me to see what has 
taken place and to hear you guys say you have protocols, 
protocols. You are looking into it. You are looking into it. 
How long does it take to look into this? It is really hard for 
me to follow this. Dr. Hassell, is it the practice of the DoD, 
the labs, to send out a death certificate with select agents 
when they leave, is that correct?
    Dr. Hassell. It has been, yes.
    Mr. Mullin. It has been? How long has that been going on?
    Dr. Hassell. I believe--I apologize. I am not sure when the 
death--I think the information----
    Mr. Mullin. What kind of information is on that death 
certificate, the one that is similar to this one right here?
    Dr. Hassell. I am not sure how long that has been part of 
the process. We have been looking at just the overall 
inactivation. We have been looking at that back 12 years. I am 
not sure at what point the death certificate was initiated. I 
can--I will find out.
    Mr. Mullin. Well, this dates back to 5 years ago. So we 
know it has been going on for at least 5 years, right?
    Dr. Hassell. Right.
    Mr. Mullin. Then why is it that the private lab that found 
the active anthrax, why didn't it have a death certificate with 
it?
    Dr. Hassell. Because when it was originally tested they 
didn't see growth. One of the things we are looking into----
    Mr. Mullin. But if it shipped out--you just said it is the 
practice of DoD with any shipment that is leaving to have a 
death certificate. Why wasn't there one that was shipped to a 
private lab?
    Dr. Hassell. Oh, I am sorry. So for that particular 
operation, we were setting out blind tests. People were seeing 
whether or not----
    Mr. Mullin. With active anthrax in it?
    Dr. Hassell. It was a suit to see if people could detect 
the presence of these. This was to identify some new 
performers.
    Mr. Mullin. So we knowingly shipped live anthrax.
    Dr. Hassell. I am sorry, say again?
    Mr. Mullin. Well, you said you were shipping it to him to 
see if they could find it. It didn't have a death certificate, 
so I am assuming you knowingly shipped live anthrax to this 
private lab because it didn't have a death certificate. I 
forget what that----
    Dr. Hassell. No, it just--we did not provide the shipping 
because of what the agent was? We did not knowingly ship live 
agent, absolutely not.
    Mr. Mullin. Did the shipment then have----
    Dr. Hassell. We just did not include their----
    Mr. Mullin [continuing]. At your place or some other place 
a death certificate?
    Dr. Hassell. Yes.
    Mr. Mullin. Who produced a death certificate?
    Dr. Hassell. The originator at Dugway.
    Mr. Mullin. And what was the test that was performed to 
show that it was dead? And what is the difference between the 
tests that the private lab showed that it was live?
    Dr. Hassell. They were very similar and----
    Mr. Mullin. Well, they couldn't have because one showed it 
dead, one showed it live.
    Dr. Hassell. Well, that is what we are looking at because 
one of the key differentiators for what Dugway did----
    Mr. Mullin. So who is responsible for that? Is that Dr. 
Sosin? Is that his group? Who is responsible for showing the 
procedures to find out that it is dead?
    Dr. Hassell. Going forward we are going to adopt the CDC's 
procedure.
    Mr. Mullin. No, no, no. Who is responsible for it at that 
time, not going forward? Who is responsible for it at the time? 
If it wasn't your group, Dr. Hassell----
    Dr. Hassell. It was Dugway.
    Mr. Mullin [continuing]. Whose group was it?
    Dr. Hassell. It was Dugway. They developed----
    Mr. Mullin. And who is over Dugway?
    Dr. Hassell [continuing]. The testing.
    Mr. Mullin. Who do they fall underneath? Do they fall 
underneath Dr. Hassell, Dr. Sosin, Dr. Demske? Who oversees 
Dugway?
    Dr. Hassell. The Army.
    Mr. Mullin. OK.
    Dr. Hassell. That is why----
    Mr. Mullin. Narrow it down for me here. Help me figure out 
who is responsible. Who is the chain of command that is 
responsible for the death certificate for the procedures to 
show that the agent leaving is truly dead?
    Dr. Hassell. Are you talking about the chain of command at 
the laboratory or just for the certificate?
    Mr. Mullin. I am talking about the chain of command to find 
out that the anthrax is shipping out. This isn't a hard 
question. Who is finding out for sure the procedures to find 
that the agent is dead?
    Dr. Hassell. It would be the----
    Mr. Mullin. You don't know?
    Dr. Hassell. It would be the scientist that----
    Mr. Mullin. You don't know. Dr. Sosin, can you answer that 
question?
    Dr. Sosin. I can't answer----
    Mr. Mullin. Dr. Demske, can you answer that that question?
    Mr. Demske. Not specifically. I----
    Mr. Mullin. OK. Then this brings in my last question 
because as I was going through the background information to 
prepare for this hearing, I couldn't figure it out, either. 
There are so many different people that touched this. There is 
no clear line of chain of command. As a business owner, you 
have got to have someone responsible for something. This goes 
back to a line of questions that was already asked. No one can 
be fired because no one takes responsibility for it because no 
one has responsibility for it. We just assume that everybody is 
doing their job, and yet we are shipping out live anthrax and 
no one takes responsibility for it.
    Dr. Hassell, you said that you were going to leave it 
locked down where they couldn't be shipped, for nothing to be 
shipped until you declared a line of command and procedures, 
right? How long is that going to take?
    Dr. Hassell. It is going to take a minimum of 6 months we 
believe.
    Mr. Mullin. A minimum? If you could just find out all the 
players in it, you ought to be able to lay it out and put 
somebody in charge to oversee it.
    Dr. Hassell. I am sorry. I was referring more just to put 
the procedures--the scientific studies that need to identify 
the gaps but the----
    Mr. Mullin. My point that I am getting to is we had live 
anthrax shipped out. No one takes responsibility for it. When I 
asked a question to find out who is responsible for it, no one 
can answer it. I think we have identified the problem. It is 
time for someone to take responsibility. Thank you, Mr. 
Chairman. I yield back.
    Mr. McKinley. Thank you, and we have Collins from New York 
for 5 minutes.
    Mr. Collins. Thank you, Mr. Chairman, and maybe I should 
maybe help us all step back a second. Clearly a bacteria-grown 
agent such as anthrax or C. diff with spores, completely 
different than a virus, right? Easy to kill a virus. So part of 
the concern I have heard as one of the last questioners is we 
know there is a lot of biological agents, a lot of potential 
weapon issues going on. And I think the concern of the 
committee is if we have this with anthrax, might we have it 
with something else like SARS, like smallpox, like whatever. 
But that is where maybe--not to give you suggestions in your 
testimony. You might want to help the committee differentiate 
bacteria from virus, just to give them the confidence level. 
There is a different ball game going on.
    Now you use radiation because you are trying to penetrate 
the spore, correct? For your--you want to penetrate the spore, 
which is very hard. So the way that you prove it is dead, the 
death certificate, is you take a sample and put it in culture 
and try to grow it. Correct? You tell me--and you really didn't 
make that real clear here. I am guessing the problem is they 
put it in culture for a month, and it should have been in 
culture for 6 months. Is it safe to assume that they just 
didn't run the culture test long enough?
    Dr. Sosin. We can't identify for certain whether that was 
an issue, but it is a possibility. Anthrax grows in culture 
within 2 days generally. So it is----
    Mr. Collins. No, it can, but it can last 6 months. And this 
is where you take something like anthrax or C. diff which is a 
spore, it can pop up in 5 months' time.
    Dr. Sosin. It can survive as a spore, yes.
    Mr. Collins. That is correct. So if it is surviving as a 
spore for 5 months and somebody is creating a death certificate 
after 2 months, they are saying it is dead----
    Dr. Sosin. I am sorry, Congressman. When you put a spore in 
a fertile environment, it germinates and grows----
    Mr. Collins. Right.
    Dr. Sosin [continuing]. And that, with anthrax, happens 
within 48 hours, generally within 24 hours. So in a fertile 
environment, you would expect to see that growth.
    Mr. Collins. I can beg to differ with you. I have some 
experience in this. I have seen it where it doesn't grow in a 
month. It doesn't grow in 2 months. And then all of a sudden in 
5 months, it shows up. I would suggest respectfully that I 
believe the big issue here was it wasn't radiated with enough 
intensity, so it wasn't killed. But to validate it was dead, 
they put it in culture to see if it would grow. And if it was 
in culture for 48 hours and it didn't grow and they gave it a 
death certificate, then I can tell you what your problem is 
right now. You didn't put it in the culture long enough. I 
think in best practices in industry, in industry best 
practices, you are going to see that batch sit in the 
refrigerator or sit in the freezer for 6 months, and you are 
going to have that culture, that spore in culture for 6 months, 
not for 48 hours. And I think you would have to agree, if it is 
in that culture for 6 months, it is deader than a doornail and 
you will have more assurance than if it is only in culture for 
48 hours. And again, this is different than a virus. So I just 
think some of that confusion is going on here as to when is--
because you do the death certificate at the lab after it has 
been radiated and held in isolation until the culture test is 
run. And then you say ``OK, I didn't see anything. So it is 
dead.'' Now that entire batch is good to go as dead virus, 
hence exempt, et cetera, et cetera. And that is what happened. 
It was then shipped out exempt because it had the death 
certificate.
    But I guess the issue would be--I am assuming that is up to 
the lab to decide how long they are going to grow it in 
culture, is that correct? That is a lab procedure, not a CDC 
or----
    Dr. Sosin. At this point in time, the sterility testing, 
viability testing is a laboratory procedure, but there will be 
additional requirements as a result of this incident.
    Mr. Collins. And I do think--and that is what I would 
encourage you to do. That is why I think it falls apart. You do 
trust these labs to all be at the top of their game. But in 
best practices, and this one an example, I can assure you best 
practice in private industry on anthrax and on C. diff is 6 
months. It is 6 months of testing so you know it is dead. It is 
not 48 hours. That is best practice coming out of private 
industry. I yield back. Thank you.
    Mr. McKinley. Thank you. And we now recognize the 
congresswoman from Indiana, Mrs. Brooks, for 5 minutes.
    Mrs. Brooks. Thank you, Mr. Chairman, and thank you for 
holding this important hearing. And I have to say in my prior 
role before joining the committee, I was chair on the 
Subcommittee on Emergency Preparedness, Response, and 
Communications for Homeland Security, and it really opened my 
eyes to the vital need to better protect the American people 
and our country from bio attacks and from biodefense incidents. 
And I will say that at that time I learned that this 
administration did away with a position that had been in place 
under the Clinton administration, under the Bush 
administration, called the Special Assistant to the President 
for Biodefense. And I think we learned about that position 
being eliminated when the Ebola attack, when Ebola hit this 
country, and I think it kind of goes to the point of I think 
what Dr. Crosse is talking about is that as a Government, we 
are not--there is no central line of authority. There is no 
central entity. There is no person who all of these issues 
bubble up to that as a Government we have a massive enterprise 
with so many different well-intentioned, hard-working 
scientists and Government workers. But yet, there is--when it 
comes to biodefense for this country, it is not organized and 
we are not doing a good enough job.
    I have to tell you that later this week we are going to be 
introducing legislation that addresses the need to strengthen 
and streamline the existing biodefense initiatives BARDA and 
the CDC. And so Dr. Sosin, I have a question. If lab workers or 
other medical professionals had been exposed to live anthrax 
samples, are you confident as to whether or not we would have 
had proper vaccines and therapeutics in place to save lives?
    Dr. Sosin. Yes, I am confident we do.
    Mrs. Brooks. Are you confident, Dr. Hassell?
    Dr. Hassell. Yes, ma'am.
    Mrs. Brooks. OK. Mr. Demske and Dr. Crosse, are you 
confident that we have enough proper vaccines and therapeutics 
in place to save lives?
    Mr. Demske. I don't have sufficient information to answer 
that question.
    Dr. Crosse. Nor do I.
    Mrs. Brooks. Dr. Sosin, would that be for the workers that 
are being exposed or how about with respect to the community, 
building on Congressman Burgess' question about one of these 
individuals, if they had been exposed and presented to an ER. 
Can you, you know, explain to me what your view is if you have 
one about our national strategic stockpile and the coordination 
within the Government enterprise with respect to the national 
stockpile.
    Dr. Sosin. Thank you for that question. The strategic 
national stockpile actually did provide vaccine for the States 
that had workers who were receiving prophylaxis. So I am 
confident that we have the ability to do it. We have a vast 
supply of countermeasures for anthrax. The nature of the event 
that you might be trying to prepare for always determines 
whether you have enough. But there have been a variety of 
processes and procedures to review the requirements that have 
been set by the Federal Government for this threat, and we meet 
those current requirements.
    Mrs. Brooks. Dr. Hassell, any comments on our stockpile and 
how we can ensure that we have the medical countermeasures in 
place across the board for incidents?
    Dr. Hassell. No, ma'am. That is really my colleagues' 
purview.
    Mrs. Brooks. Dr. Crosse and Mr. Demske, what I think this 
event, going back to what this event shows us, is that while we 
are trying to respond at a managerial level. Are you familiar 
with the private sector's involvement with the medical 
countermeasures, development, and procurement? Are either of 
you involved in that at all.
    Dr. Crosse. I have done some past work looking at, for 
example, how the Federal Government has built flexible 
manufacturing facilities to be able to respond, and those are 
private sector entities. Mr. Demske?
    Mr. Demske. I am sorry. I have nothing to add.
    Mrs. Brooks. OK. I would like to go back to, and I guess if 
I could actually--I might have a little bit of time with 
respect to the death certificate.
    Building on the congressman's question about the death 
certificate, could both of you please explain with a little bit 
more detail how that process works, what is required to be 
placed on the death certificate, and if you are sending these 
spores to another lab, what is it that the one lab should have 
that the other lab then--what is common in looking at the death 
certificate. Is the organism required to be listed or it is not 
listed when you do this sample blind test? Can you please go 
into a bit more detail? I am sorry my time is up, but I would 
ask if we might have just a couple of more minutes?
    Mr. McKinley. One more.
    Mrs. Brooks. One more minute?
    Mr. McKinley. You will have to yield.
    Mrs. Brooks. And then if you could please submit any 
further explanation in writing?
    Dr. Hassell. So it might be, if I may, we can submit a more 
full explanation of how that is used. I will say, though, we 
are considering not using a death certificate in our current 
operation. At least we are reevaluating that because it may 
send the wrong message. So that is one thing when I worked more 
with my colleagues about that very issue because we have 
concerns about what message that sends.
    Mrs. Brooks. Dr. Sosin?
    Dr. Sosin. The laboratory itself makes the determination 
about death certificates and the sending process. That is not a 
select agent regulation or requirement.
    Mrs. Brooks. OK. Thank you. I yield back.
    Mr. McKinley. Thank you.
    Ms. DeGette. Chairman, I would like to strike the last 
word.
    Mr. McKinley. We have one more----
    Ms. DeGette. Oh, OK.
    Mr. McKinley. We have one more on this. The Chair now 
recognizes the Congressman from North Carolina, Mr. Hudson.
    Ms. DeGette. Sorry.
    Mr. Hudson. Thank you, Mr. Chairman, and thanks to the 
panel for bearing with us here until the end. Would you like to 
expand on that answer at all, my colleague's question about the 
death certificates and the practice? Were you able to fully 
answer that?
    Dr. Hassell. For myself, I need to get some more detail on 
that and give a better answer to that for all three of you that 
were interested in that issue.
    Mr. Hudson. OK. I offer you some time if you got anything 
else you want to say.
    Dr. Sosin. No. I know that CDC does issue a death 
certificate with materials, inactivated materials that it sends 
out on the occasions when it needs to. I do not know the 
particular details of that death certificate.
    Mr. Hudson. Well, I would appreciate it if you all would 
follow up with that because my understanding is DoD in 
particular, it is common practice to send the death 
certificate, even when you are doing this sort of blind sample. 
And in this case, it wasn't sent until much later. So I would 
love to see a little more thorough answer on that. So thank you 
for that.
    Overall, if anyone on the panel wants to, I am trying to 
grasp the mission of the Federal Select Agent Program, your 
understanding of the mission of the program, and do you think 
it is being fulfilled? I would open that up to anybody.
    Dr. Sosin. Well, clearly the incidents that you have seen 
are serious, are the kinds of indicators that we need to do 
more, and I think the important message from us is that over 
the history of this program, since the regulations, the 
authorization in 2002 and the new regs in 2003, this program 
has continued to receive input and advice from a broad spectrum 
which is needed, advice from Congress, advice from the public, 
advice from Federal and non-Federal entities to improve the 
program. And the program has changed and improved over time.
    That said, this incident and these incidents have elevated 
the importance of some procedures requiring more direct 
oversight and review, and we will address that.
    So there is a broad question, and many of those questions 
about BSL-3 that are not select agent, questions about how many 
labs. These are important, critical policy questions. Congress 
has an important role to play in them. The Federal interagency 
has an important role to play in them. CDC will contribute to 
the debate about the pros and cons of the different approaches. 
But when consensus is achieved or direction is given, we will 
follow those directions.
    Mr. Hudson. So in your opinion, the mission is worthy and 
salvageable I guess to try and use laymen's terms?
    Dr. Sosin. Absolutely.
    Mr. Hudson. OK.
    Dr. Sosin. We are committed to this work.
    Mr. Hudson. Dr. Hassell, you know, the Dugway has had 
problems in the past, continues to have problems, you know. It 
has been referenced plenty of times here today. Just in 
summation, how does this continue to keep happening and how do 
you see us getting out of this cycle?
    Dr. Hassell. So I mentioned earlier that this falls under 
the Army. So speaking on their behalf, I can tell you that the 
Army takes this very seriously, at the highest level. Now that 
is something that sounds easy to say, but I can assure you, in 
my interactions with them, this is taken very personally and 
very seriously at the highest level. So the Secretary of the 
Army on down is taking action on this. They are going to look 
at issues specific to Dugway but not limiting it to that, 
looking at the chain of command across the board. And it is not 
just so that this could be a better reporting chain up. There 
may be opportunities that arise from this for better 
interaction across from them. The laboratory at USAMRIID for 
example may have some capabilities. Perhaps the organizational 
structure was preventing them, their free flow of information. 
I am not sure that is the case, but I am hoping that is some of 
the outfall from this. But you know, just getting all the 
laboratories working better together, standardizing where it is 
appropriate, and then moving forward.
    Mr. Hudson. Well, I appreciate that. I guess I would offer 
this up to the GAO or the OIG. What existing tools does CDC 
have that it is currently not using that would allow it to 
better oversee and take corrective actions against labs that 
commit violations? Either one of you.
    Dr. Crosse. Well, we have a concern that the reporting when 
incidents occur is really just to one level up from the 
laboratory and that more senior management in an organization 
is not necessarily informed, that the Select Agent Program is 
really focused, you know, within that laboratory but not 
necessarily ensuring that accountability up the chain of 
command over that laboratory is occurring. You know, we also 
are just undertaking work at the request of this committee to 
look at inactivation procedures and the extent to which there 
are scientific questions for how that should be done, where 
there are best practices, what types of methods are being used, 
how that information is shared, you know, what the current 
scientific issues are, and how the methods are validated and 
whether that information is being shared across this 
enterprise. And that is a concern that clearly labs have been 
operating on their own, and the information has not been being 
shared across the enterprise.
    Mr. Hudson. I appreciate that. Mr. Chairman, I am out of 
time. If you wouldn't mind maybe answering in writing if you 
have just a summary of some of the tools, I would appreciate 
your testimony as well. Thank you, Mr. Chairman. I yield back.
    Mr. McKinley. Thank you. And before we conclude, I think 
Ranking Member DeGette, you had a question?
    Ms. DeGette. Yes, thank you, Mr. Chairman. I just wanted to 
thank the witnesses for coming and also relay a conversation I 
had with Chairman Murphy, which is I am really urging him to 
have a hearing later this fall, towards the end of the year, 
after you all have figured out what your improvements in the 
standardization and the oversight are going to be. What I have 
found during my many years on this committee is when we have 
some crisis like this, the witnesses come in. They say we need 
to do better. OIG and GAO come in and say there are things that 
can be done, and then another year goes by and we have another 
breach. So I have urged the chairman and I think he is in 
agreement to really hold your feet to the fire to make sure 
that these improvements, these gaps that you have identified 
are filled, that the standards and the coordination, the plans 
are completed. And I believe he will have that hearing, and on 
both sides of the aisle, we would agree that needs to be done. 
Thank you very much.
    Mr. McKinley. And I would also ask hopefully, when we talk 
to them, that we also have some accountability. You have heard 
several of the questions have been about how many people are 
going to lose their job over every fail over the last 10 years 
on this. So I think that is something that we are going to be 
looking for, is to see how many people have lost their job as a 
result of this unaccountability.
    So with that, in conclusion, I would like to thank all the 
witnesses and the members that participated in today's hearing. 
I remind members that they have 10 business days to submit 
questions for the record, and I ask that all witnesses all 
agree to respond promptly to those questions. And with that, 
the subcommittee is adjourned.
    [Whereupon, at 12:09 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

                 Prepared statement of Hon. Fred Upton

    One year ago, we held a hearing to review an incident 
involving the handling of anthrax in Ziploc bags at the CDC--a 
troubling instance where safety practices were ignored despite 
the potential for lethal consequences. That should have been a 
wake up call, yet here we are a year later, examining yet 
another anthrax incident. This time it's the ``inadvertent'' 
shipment of live anthrax from a Defense Department lab in 
Dugway, an Army facility in Utah. These shipments went across 
our country and around the world. How? Dugway failed to 
inactivate anthrax and then failed to detect that the anthrax 
was still alive.
    According to the Defense Department's most recent figures, 
live anthrax was shipped to at least 192 commercial companies, 
academic institutions, and Federal labs. Since this anthrax was 
supposed to be ``inactivated,'' the controls over who received 
the shipments weren't as stringent as they might have been if 
it was known the anthrax was live. This is not just a public 
health concern, it is also a very real national security 
concern.
    Just last week the Defense Department issued a report 
detailing its review of the events surrounding the shipments of 
live anthrax. The report acknowledged a lack of specific, 
validated standards to guide the development of protocols, 
processes, and quality assurance measures. In fact, in most 
cases, the Defense Department observed that each of its 
laboratories followed its own procedures and protocols.
    We are reminded today, this is not an isolated incident. 
The Government Accountability Office, the nonpartisan 
Government watchdog, highlights in written testimony that these 
``recent safety lapses have illustrated multiple breakdowns in 
compliance with established policies and inadequate 
oversight.'' The committee remains concerned that oversight is 
fragmented because no single entity is in charge of overseeing 
high-containment laboratories that handle select agents.
    We need to find out why these events keep happening and 
what the Federal Government plans to do to stop this troubling 
pattern of safety lapses at our bioterrorism labs. These 
blunders need to stop now. We need to learn from the mistakes 
of the past and stop repeating them once and for all. Otherwise 
I am afraid we'll be right back here next summer discussing the 
latest security lapse.

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