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






 HOW SECURE ARE U.S. BIORESEARCH LABS? PREVENTING THE NEXT SAFETY LAPSE

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

                                HEARING

                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED FOURTEENTH CONGRESS

                             SECOND SESSION

                               __________

                             APRIL 20, 2016

                               __________

                           Serial No. 114-139



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



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                    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...........................................     4
Hon. Kathy Castor, a Representative in Congress from the State of 
  Florida, opening statement.....................................     5
Hon. Fred Upton, a Representative in Congress from the State of 
  Michigan, prepared statement...................................    84

                               Witnesses

John Neumann, Director, Natural Resources and Environment, 
  Government Accountability Office...............................     7
    Prepared statement...........................................    10
Lawrence A. Tabak, Ph.D., Principal Deputy Director, National 
  Institutes of Health...........................................    24
    Prepared statement...........................................    26
Stephan S. Monroe, Ph.D., Associate Director for Laboratory 
  Science and Safety, Centers for Disease Control and Prevention, 
  Department of Health and Human Services........................    32
    Prepared statement...........................................    34
Segaran Pillai, Ph.D., Director, Office of Laboratory Science and 
  Safety, Office of the Commissioner, Food and Drug 
  Administration, Department of Health and Human Services........    44
    Prepared statement...........................................    47
Major General Brian C. Lein, Commander, Army Medical Research and 
  Materiel Command, Biological Select Agents and Toxins Biosafety 
  Program, Department of Defense.................................    56
    Prepared statement...........................................    58

                           Submitted Material

Subcommittee exhibit binder \1\
Subcommittee memorandum..........................................    86
Subcommittee memorandum supplement...............................    94

----------
\1\ The information has been retained in committee files and also is 
available at  http://docs.house.gov/Committee/Calendar/
ByEvent.aspx?EventID=104823.
 
 HOW SECURE ARE U.S. BIORESEARCH LABS? PREVENTING THE NEXT SAFETY LAPSE

                              ----------                              


                       Wednesday, April 20, 2016

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:16 a.m., in 
room 2122 Rayburn House Office Building, Hon. Tim Murphy 
(chairman of the subcommittee) presiding.
    Members present: Representatives Murphy, McKinley, Burgess, 
Griffith, Brooks, Mullin, Hudson, Castor, Kennedy, Green, and 
Welch.
    Staff present: Jen Barbian, Counsel, Oversight and 
Investigations; Rebecca Card, Assistant Press Secretary; Ryan 
Coble, Detailee, Oversight and Investigations; Paige Decker, 
Executive Assistant; Giulia Giannangeli, Legislative Clerk, 
Commerce, Manufacturing, and Trade; Brittany Havens, 
Legislative Associate, Oversight; Charles Ingebretson, Chief 
Counsel, Oversight and Investigations; Chris Santini, Policy 
Coordinator, Oversight and Investigations; Alan Slobodin, 
Deputy Chief Counsel, Oversight; Ryan Gottschall, Democratic 
GAO Detailee; Christopher Knauer, Democratic Oversight Staff 
Director; Una Lee, Democratic Chief Oversight Counsel; 
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, and welcome to the Oversight and 
Investigation Subcommittee of Energy and Commerce hearing on 
``How Secure are U.S. Bioresearch Labs: Preventing the Next 
Safety Lapse,'' which I think I can dub ``Overturning the 
Culture of Compliancy.''
    Because this is the third time in as many years that this 
subcommittee has held a hearing on the Federal Select Agent 
Program and the Federal Government's high-containment 
laboratories.
    And each time, a panel of witnesses appear before us to 
testify about changes made in response to one failure or 
another.
    Two years ago, CDC Director Tom Frieden testified about 
changes made at the CDC after failing to follow safety 
procedures, which consequently potentially exposed dozens of 
CDC employees to anthrax.
    Dr. Frieden told us then that the CDC was implementing 
every step possible to make sure that the problems are 
addressed comprehensively in order to protect our own workforce 
and to strengthen the culture of safety and to continue our 
work protecting Americans.
    And I might add that that echoed a statement he had made 
perhaps a year or so before on the same issue, saying that he 
was going to impose other things to change the culture.
    But last year, then, the Deputy Assistant Secretary of 
Defense for Chemical and Biological Defense came before us to 
explain how at least 192 labs across the world received live 
anthrax from the Dugway Proving Ground, an Army lab in Utah. 
The Army undertook a comprehensive review of the incident and 
the deputy secretary told us that the department was 
``committed to ensuring that this doesn't occur again,'' and 
that last statement is in quotes.
    Sweeping improvements and policy changes only work if the 
policies are effective and, in this area, past policy reviews 
have not brought about the changes necessary to improve safety.
    For that reason, Ms. DeGette and myself, along with 
Chairman Upton and Ranking Member Pallone, asked the GAO to 
evaluate the biosafety, biosecurity and oversight policies for 
the eight departments and 15 component agencies that own and 
operate the Federal Government's high-containment laboratories.
    GAO has been issuing recommendations for years on the need 
for better policies and standards at high-containment labs, 
recommendations that have not been implemented. So the agency 
was well-positioned to receive our request.
    GAO found that while the departments and agencies have 
improved on their biosecurity procedures in recent years, 
comprehensive policies and better oversight of the labs are 
still needed.
    High-containment laboratories, which store the most 
dangerous pathogens, must have tight inventory control, 
rigorous training and required incidence reporting, and 
agencies and departments must have strong oversight of their 
laboratories with accountability for those who fail to follow 
the policies.
    While GAO has been doing its work, the committee has been 
conducting its own review into the discovery of smallpox vials 
at the NIH in 2014. The preliminary findings of the majority 
staff are discussed in a supplemental memorandum released 
yesterday.
    We found a number of flash points here where, if NIH or FDA 
had done just a little more than what their policies required 
or thought outside the box just a little bit, those agencies 
could have discovered the smallpox vials years earlier.
    For example, the NIH experienced a major event in 2011 when 
it learned that a researcher received an unauthorized transfer 
of antibiotic resistant plague specimens, and in 2012 when it 
discovered unregistered antibiotic-resistant anthrax included 
at an FDA lab in this very same building where the smallpox was 
discovered 2 years later.
    The 2012 discovery was prompted by a disclosure of two 
investigators during a retraining exercise prompted by the 2011 
discovery by the CDC's Division of Select Agents and Toxins not 
by any investigative work on the part of the NIH and the 2012 
discovery resulted in the CDC putting NIH on a Performance 
Improvement Plan.
    These discoveries, including two different dangerous 
pathogens, should have spurred NIH and FDA to conduct a 
comprehensive sweep of all laboratories and a comprehensive 
review of its policies at the time.
    But they didn't. When we informed NIH and FDA of our 
findings, we found agencies still reluctant to acknowledge the 
full extent of their failings.
    NIH did not even acknowledge its failings in how it 
registered into the Federal Select Agent Program, a historical 
collection of select agent samples held in sealed envelopes 
unopened since 1960.
    NIH registered the materials without opening the envelopes. 
The agency did not confirm the materials inside the envelopes 
or even verify that the samples were still secure, and they 
registered these materials not once, but twice, without opening 
the envelopes.
    When they finally did open the envelopes, they discovered 
seven additional vials of one select agent than previously 
reported. These failures just defy common sense.
    This is a culture of complacency, and it shows that it is 
not enough to change the policies. We must also change the 
culture at NIH.
    While the Department of Defense is holding 12 people 
accountable for the factors that led to the Dugway shipments, 
in contrast HHS and its agencies have not been fully 
accountable and transparent with the committee on disciplinary 
and personnel actions resulting from lab safety incidents.
    For example, the committee requested documents from the CDC 
as part of our investigation regarding the four instances of 
improperly stored anthrax at NIH. Unfortunately, the CDC 
produced redacted documents, blacking out key information.
    There was no legal basis for these redactions and CDC 
offered no explanation. This type of response is designed to 
delay and stymie congressional oversight on behalf of the 
American people and this committee will not stand for that. 
When we request documents, we expect unredacted documents.
    If these agencies are not being forthcoming with this 
committee and this Congress, then they are certainly not being 
forthcoming with the American people. For all the CDC rhetoric 
about transparency, redactions of key details in requested 
investigative documents prove otherwise.
    We all deserve better. Neither NIH nor FDA ever conducted 
an internal review of the smallpox incident along the lines of 
the reviews conducted by the CDC or the DoD, deferring instead 
to an outside review by the CDC and FBI.
    I urge these agencies to initiate internal reviews of their 
own failings leading up to the smallpox discovery and if we 
learn nothing from all of the incidents involving select agents 
over the years, it is that we can't find the next safety lapse 
if we don't go looking for it.
    [The prepared statement of Mr. Murphy follows:]

                 Prepared statement of Hon. Tim Murphy

    This is the third time in as many years that this 
subcommittee has held a hearing on the Federal Select Agent 
Program and the Federal Government's high-containment 
laboratories. Each time, a panel of witnesses appears before us 
to testify about changes made in response to one failure or 
another.
    Two years ago, CDC Director Tom Frieden testified about 
changes made at the CDC after failing to follow safety 
procedures potentially exposed dozens of CDC employees to 
anthrax. Dr. Frieden told us then that the CDC was implementing 
every step possible to ``make sure that the problems are 
addressed comprehensively in order to protect our own 
workforce, and to strengthen the culture of safety, and to 
continue our work protecting Americans.''
    Last year, the Deputy Assistant Secretary of Defense for 
Chemical and Biological Defense came before us to explain how 
at least 192 labs across the world received live anthrax from 
the Dugway Proving Ground, an Army lab in Utah. The Army 
undertook a comprehensive review of the incident and the Deputy 
Secretary told us that the Department was ``committed to 
ensuring that this doesn't occur again.''
    Sweeping improvements and policy changes only work if the 
policies are effective. And, in this area, past policy reviews 
have not brought about the changes necessary to improve safety. 
For that reason, Ms. DeGette and myself, along with Chairman 
Upton and Ranking Member Pallone, asked the GAO to evaluate the 
biosafety, biosecurity, and oversight policies for the 8 
departments and 15 component agencies that own and operate the 
Federal Government's high-containment laboratories. GAO has 
been issuing recommendations for years on the need for better 
policies and standards at high-containment labs-recommendations 
that have not been implemented-so the agency was well-
positioned to receive our request.
    GAO found that, while the departments and agencies have 
improved on their biosecurity policies in recent years, 
comprehensive policies and better oversight of the labs are 
still needed. High-containment laboratories, which store the 
most dangerous pathogens, must have tight inventory controls, 
rigorous training, and required incidence reporting. And 
agencies and departments must have strong oversight of their 
laboratories with accountability for those who fail to follow 
the policies.
    While GAO has been doing its work, the committee has been 
conducting its own review into the discovery of smallpox vials 
at the NIH in 2014. The preliminary findings of the majority 
staff are discussed in a supplemental memorandum released 
yesterday. We found a number of flash points where, if NIH or 
FDA had done just a little more than what their policies 
required, or thought outside the box just a little bit, those 
agencies could have discovered the smallpox vials years 
earlier.
    For example, the NIH experienced a major event in 2011, 
when it learned that a researcher received an unauthorized 
transfer of antibiotic resistant plague specimens, and in 2012, 
when it discovered unregistered, antibiotic resistant anthrax, 
including at an FDA lab in the very same building where the 
smallpox was discovered 2 years later. The 2012 discovery was 
prompted by a disclosure of two investigators during a re-
training exercise prompted by the 2011 discovery by the CDC's 
Division of Select Agents and Toxins, not by any investigative 
work on the part of the NIH. And the 2012 discovery resulted in 
the CDC putting NIH on a Performance Improvement Plan. These 
discoveries, including two different dangerous pathogens, 
should have spurred NIH and FDA to conduct a comprehensive 
sweep of all laboratories, and a comprehensive review of its 
policies, at the time. But they didn't.
    When we informed NIH and FDA of our findings, we found 
agencies still reluctant to acknowledge the full extent of 
their failings. NIH did not even acknowledge its failings in 
how it registered into the Federal Select Agent Program a 
historical collection of select agent samples held in sealed 
envelopes unopened since 1960. NIH registered the materials 
without opening the envelopes. The agency did not confirm the 
materials inside the envelopes, or even verify that the samples 
were still secure. And they registered these materials not 
once, but twice, without opening the envelopes. When they 
finally did open the envelopes, they discovered 7 additional 
vials of one select agent then previously reported. These 
failures defy common sense. This is a culture of complacency, 
and shows that it is not enough to change the policies-we must 
also change the culture at NIH.
    While the Department of Defense is holding 12 people 
accountable for the factors that led to the Dugway shipments, 
in contrast HHS and its agencies have not been fully 
accountable and transparent with the committee on disciplinary 
and personnel actions resulting from lab safety incidents. For 
example, the committee requested documents from the CDC as part 
of our investigation regarding the four instances of improperly 
stored anthrax at NIH. Unfortunately, the CDC produced redacted 
documents, blacking out key information. There was no legal 
basis for these redactions, and CDC offered no explanation. 
This type of response is designed to delay and stymie 
Congressional oversight on behalf of the American people. When 
we request documents, we expect unredacted documents. If these 
agencies are not being forthcoming with Congress, then they are 
certainly not being forthcoming with the American people. For 
all the CDC rhetoric about transparency, redactions of key 
details in requested investigative documents prove otherwise. 
We all deserve better.
    Neither NIH nor FDA ever conducted an internal review of 
the smallpox incident along the lines of the reviews conducted 
by the CDC or the DOD, deferring instead to an outside review 
by the CDC and FBI. I urge these agencies to initiate internal 
reviews of their own failings leading up to the smallpox 
discovery. If we've learned nothing from all of the incidents 
involving select agents over the years, it is that we can't 
find the next safety lapse if we don't go looking for it.

    Mr. Murphy. I now recognize the ranking member pro tem, Ms. 
Castor, for her opening.

  OPENING STATEMENT OF HON. KATHY CASTOR, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF FLORIDA

    Ms. Castor. Well, thank you, Mr. Chairman, for calling this 
important hearing, and welcome to our witnesses today.
    The House Energy and Commerce Committee has been monitoring 
high-containment biolabs and the select agent program for 
nearly a decade and I believe that it is vital that we continue 
our oversight of these critical programs.
    The committee held a hearing earlier this year about the 
importance of biodefense preparedness and we know that high-
containment laboratories play a valuable role in that effort by 
conducting research, to improve our defenses against biological 
attacks and strengthening our response capabilities.
    The Federal Government's work on identifying and containing 
public health risks from these type of biological agents is 
essential but it also poses many risks.
    Everyone has been disturbed by the news of accidental 
releases or transfers of select agents such as anthrax, ebola 
and avian flu over the past few years. These incidents raise 
broader questions about the safety of our high-containment 
laboratories across the country.
    And while I'm encouraged that no one has fallen ill as a 
result of those incidents, these pathogens need to be handled 
with the utmost safety and security. They could be extremely 
dangerous if they fell into the wrong hands or if infection 
spread to the general public.
    The labs that handle these dangerous pathogens must be held 
to the highest standards. Yet, these recent incidents raise 
questions about whether or not we can trust high-containment 
labs to safely handle select agents and other dangerous 
pathogens.
    I want to understand what these recent lapses can teach us 
about broader problems within the agencies and departments that 
handle select agents across the Federal Government as well 
within the private sector.
    So we've asked the GAO to appear before us today to testify 
about their latest report on the need for up to date policies 
and stronger oversight mechanisms at our high-containment labs.
    I look forward to hearing from you about your findings and 
recommendations and how they can be used to enhance safety and 
security at all of our nation's high-containment labs.
    This GAO report underscores the need to strengthen our 
Federal oversight of labs that are working with dangerous 
pathogens. I also want to hear from witnesses about the role 
that Congress can play in making sure this program operates 
safely and without more of the operational lapses that seem all 
too common for such a serious program.
    Is the current regulatory framework sufficient? Do the 
enforcement agencies have sufficient resources to ensure that 
oversight is robust? What are the agencies in front of us doing 
to improve their labs and prevent future incidents?
    I look forward to hearing your testimony and I yield back.
    Mr. Murphy. Gentlelady yields back. Is there anyone on our 
side who wants to make an opening statement? And I guess 
there's no one else on your side either, just want to read your 
statement again.
    To the panel, there was another hearing going on at Energy 
and Commerce in which two subcommittees are--many of us are on 
both, so you may see people coming and going.
    I may stay here for the whole thing because I want to hear. 
This is just so you're aware. It may look a little chaotic at 
times, but that's how it is.
    I ask unanimous consent that members' written opening 
statements from other members be introduced in the record, and 
without objection the documents will be entered into the 
record.
    Now let me introduce today's panel. First witness on 
today's panel is Mr. John Neumann, director of natural 
resources and environment at the Government Accountability 
Office.
    He currently leads efforts in the science and technology 
area including the management and oversight of Federal research 
and development programs and we appreciate this time today.
    We'd also like to welcome Dr. Lawrence Tabak, principal 
deputy director with the National Institute of Health. He 
previously served as the acting principal director of NIH in 
2009. We look forward to hearing his insights. Good to see you 
again, Doctor.
    Dr. Stephen Monroe serves as the associate director for 
laboratory science and safety at Centers for Disease Control 
and Prevention. Previously, he was the acting associate 
director for the Laboratory of Science and Safety.
    We look forward to learning from his expertise today on 
today's hearing and thank you for being here.
    Dr. Segaran Pillai serves as director of the Office of 
Laboratory Science and Safety, the director of the Office of 
Commissioner and director of the Office of Chief Scientist at 
the Food and Drug Administration, and look forward to hearing 
your insights as well.
    And finally, we welcome Major General Brian Lein, 
Commanding General, U.S. Army Medical Research and Materiel 
Command in Fort Detrick and Deputy for Medical Systems to the 
Assistant Secretary of the Army for Acquisition, Logistics and 
Technology, Department of the Army at the U.S. Department of 
Defense. Appreciate you being here today. I believe Eisenhower 
was a logistics guy, too. Good for you. Good work.
    Well, to all of you today, you are aware that the committee 
is holding an investigative hearing. When doing so it's the 
practice of taking testimony under oath. Do any of you 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?
    And seeing no request for that, in that case would you all 
please rise and raise your right hand and I'll swear you in.
    [Witnesses sworn.]
    Mr. Murphy. Thank you. You may all be seated.
    You are now all under oath and subject to the penalties set 
forth in Title 18 Section 1001 of the United States Code. I 
call upon you each to give a 5-minute opening statement.
    In so doing, make sure your microphone is on, pull it as 
close to you as possible when you speak into it, and if you can 
see the red light on the table--when that goes on, your 5 
minutes is up.
    Can I just have yourself about 2 or 3 inches from the 
microphone? You have to pull it really close. Bring it close to 
your mouth. Thank you very much. You may begin, Mr. Neumann.

  STATEMENTS OF JOHN NEUMANN, DIRECTOR, NATURAL RESOURCES AND 
  ENVIRONMENT, GOVERNMENT ACCOUNTABILITY OFFICE; LAWRENCE A. 
TABAK, PH.D., PRINCIPAL DEPUTY DIRECTOR, NATIONAL INSTITUTES OF 
   HEALTH; STEPHAN S. MONROE, PH.D., ASSOCIATE DIRECTOR FOR 
LABORATORY SCIENCE AND SAFETY, CENTERS FOR DISEASE CONTROL AND 
 PREVENTION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; SEGARAN 
   PILLAI, PH.D., DIRECTOR, OFFICE OF LABORATORY SCIENCE AND 
       SAFETY, OFFICE OF THE COMMISSIONER, FOOD AND DRUG 
ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; MAJOR 
  GENERAL BRIAN C. LEIN, COMMANDER, ARMY MEDICAL RESEARCH AND 
MATERIEL COMMAND, BIOLOGICAL SELECT AGENTS AND TOXINS BIOSAFETY 
                 PROGRAM, DEPARTMENT OF DEFENSE

                   STATEMENT OF JOHN NEUMANN

    Mr. Neumann. I want to thank you, Chairman Murphy and 
Ranking Member DeGette and members of the subcommittee, for 
inviting me here today to discuss GAO's report on the oversight 
of high-containment laboratories, which was publicly released 
for this hearing.
    Over the last 2 years, safety lapses at Federal high-
containment laboratories have raised concerns about department 
and agency oversight of these facilities.
    These labs work with hazardous biological agents such as 
the virus that causes smallpox, a contagious and sometimes 
fatal infectious disease to humans, as well as live anthrax 
bacteria which has the potential to seriously threaten both 
human and animal health.
    High-containment labs do important work with pathogens such 
as developing vaccines and counter measures and conducting 
research to understand emerging infectious diseases.
    However, some of these pathogens also have the potential 
for high-consequence accidents if handled improperly. Today, I 
would like to briefly highlight the findings from our report.
    First, we found that most of the eight departments and 15 
agencies with high-containment labs do not have comprehensive 
or up to date policies.
    We considered policies to be comprehensive if they included 
the following six key elements for managing pathogens in high-
containment labs, the first one being incident reporting, 
inventory control, inspections, clear roles and 
responsibilities, training and adherence to the leading 
biosafety guidance for laboratories published by CDC and NIH.
    While departments and agencies had policies in place, as I 
noted most were not comprehensive, meaning that they did not 
include all these elements.
    In addition, some policies were not up to date as they had 
not been reviewed and updated in accordance with their internal 
review schedules and in some cases these policies had not been 
reviewed in close to 10 years.
    These policies and the six key elements are an important 
foundation for lab safety. But policies alone will not ensure 
the lab personnel are adhering to them. This brings me to our 
second finding.
    Most of the department's agencies were using inspections or 
audits as a primary way of overseeing their high-containment 
labs. But they were often not routinely reporting inspection 
results to senior officials.
    Getting these inspection results to senior officials is 
important because these results can be used to identify trends 
and systemic safety issues and ensure that needed improvements 
are made across all the labs.
    Finally, at the time of our review, DoD and HHS were making 
some progress in implementing recommendations from previous 
laboratory safety reviews that they conducted after the 2014 
and 2015 safety lapses.
    However, we found that DoD and CDC had not developed time 
frames for implementing some of these recommendations and 
without time frames DoD and CDC will be limited in their 
ability to track progress towards implementing these needed 
improvements.
    We made a total of 33 recommendations to the Federal 
departments and agencies with these high-containment labs to 
ensure that they have comprehensive and up to date policies as 
well as stronger oversight mechanisms at their labs.
    There was brought agreement by the eight departments with 
our recommendations and several have already begun taking 
actions to address them.
    In closing, I would like to note that our report that we 
are discussing today is the latest in a body of work that GAO 
has developed over the last 10 years on the Federal oversight 
of high-containment laboratories.
    We continue to monitor this issue by drawing on expertise 
from across our agency including our health care experts, our 
chief scientists and experts from my own group, the science and 
technology area.
    As you know, we are conducting additional work for the 
subcommittee specifically looking at the inactivation of 
pathogens in high-containment labs and we expect to issue that 
report to you in the next several months.
    Thank you, Chairman Murphy, and members of the subcommittee 
for holding this hearing and continuing your oversight of this 
important issue.
    This concludes my prepared remarks. I would be pleased to 
respond to any questions you may have.
    [The statement of Mr. Neumann follows:]
    
    
    
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    Mr. Murphy. Thank you, Mr. Neumann.
    Dr. Tabak, you're recognized for 5 minutes. Again, pull the 
microphone very close to you so we can hear.

                 STATEMENT OF LAWRENCE A. TABAK

    Dr. Tabak. Good morning, Mr. Chairman, Ranking Member 
Castor and distinguished members of the subcommittee. It is an 
honor to appear before you today to discuss how the NIH 
implements biosafety and biosecurity measures for high-
containment laboratories.
    I know I speak for Dr. Collins when I say that our concerns 
for safety must equal our passion for research. I can attest 
that senior leadership at the NIH is committed to the principle 
that safety lapses provide concrete opportunities for thorough 
critical self-assessment and self-improvement.
    NIH has an important mission to conduct research that will 
lead to the development of treatments, diagnostics and vaccines 
to address public health needs including medical counter 
measures.
    The study of biologic-select agents and toxins is necessary 
to develop new interventions with the potential to save 
millions of lives. NIH also recognizes the importance of 
ensuring that the research is conducted in the safest manner 
possible.
    In the summer of 2014, six sealed decades-old ampules of 
smallpox were found in a cold storage room in an FDA laboratory 
building located on the NIH campus. The presence of smallpox 
was alarming to the entire NIH community and initiated much 
action on the part of NIH leadership.
    Upon making this discovery, all of the proper notifications 
and security steps were taken. The CDC and the FBI were 
contacted and joint custody of the ampules was transferred to 
the CDC.
    NIH has established protocols and procedures which included 
proper training regarding select agent handling ensured that at 
no time was anyone on campus or the public at risk.
    NIH takes this incident very seriously and we have 
implemented new policies and procedures to prevent such an 
event from occurring again.
    First, NIH identified and inventoried all potential 
hazardous biological material stored in all NIH-owned and 
leased facilities. During this sweep, which took place from 
July through September 2014, nearly 35 million samples were 
inventoried.
    Additionally, NIH and other Federal agencies launched a 
National biosafety stewardship month. Extramurally funded 
institutions were asked to voluntarily join the Federal 
laboratories and reviewing their procedures, training and 
inventories of infectious agents and toxins.
    Longer term, NIH has strengthened our inventory management 
controls. We have developed and implemented the potentially 
hazardous biological material management plan which addresses 
accountability at all levels of NIH. The plan establishes a 
mandatory centralized database of all potentially hazardous 
biological materials as well as procedures for annual updates 
of inventories and random audits of laboratories' hazardous 
biological holdings.
    Each institute and center was required to appoint an 
individual to be responsible for common shared use and storage 
areas and there are new policies in place requiring 
participation of personnel who work in secure select agent 
laboratories.
    In February 2015, the external laboratory safety work group 
to the CDC advisory committee to the director reviewed our 
policies and practices.
    The ELSW affirmed that NIH's response to the discovery of 
smallpox was prototypical and that NIH had implemented all of 
the recommendations made. The report states, and I quote, ``The 
NIH intramural DOHS program is a model program for institutions 
supporting extramural NIH research as well as for other 
institutions and agencies.''
    The GAO review of high-containment laboratories that we 
meet here today to discuss found NIH's policies for laboratory 
management to be comprehensive. NIH implemented all of the 
GAO's recommendations and we addressed all of the six elements 
that the GAO identified as being key.
    In closing, as principal deputy director of the NIH, I can 
assure this subcommittee that the senior leadership at NIH took 
appropriate action in 2014 and continues to act today to ensure 
the safety of the public and the scientist whose mission it is 
to find new ways to enhance health, lengthen life and reduce 
illness and disability.
    We remain committed to preserving the public's trust and 
NIH-supported research activities through best safety practices 
and strong leadership.
    Thank you, Mr. Chairman.
    [The statement of Dr. Tabak follows:]
    
    
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    Mr. Murphy. Thank you.
    Before I recognize Dr. Monroe, I just want to clarify 
something I think was admitted from your testimony. The six 
sealed decades-old ampules of smallpox were found and two of 
those were viable. Am I correct?
    Dr. Tabak. That was discovered afterwards, yes.
    Mr. Murphy. OK. But that was left out. I think that's 
critical for your testimony and I hope you would amend it to 
say that they were still alive.
    Dr. Monroe, you are recognized for 5 minutes, please.

                 STATEMENT OF STEPHAN S. MONROE

    Dr. Monroe. Good morning, Chairman Murphy, Representative 
Castor, other members of the subcommittee. Thank you for the 
opportunity to testify before you today on CDC's ongoing effort 
to strengthen the quality and safety of our laboratories.
    I'm Dr. Steve Monroe, associate director for laboratory 
science and safety at CDC. In this new position, I serve as the 
single point of accountability for laboratory science and 
safety and I report directly to the CDC director, Tom Frieden.
    I come to this role with 29 years of experience as a 
microbiologist at the agency. CDC laboratories remain an 
indispensable link in protecting the public's health.
    Recently, we were pleased to welcome Chairman Murphy to our 
NIOSH facility in Pittsburgh and Ranking Member DeGette to our 
vector-borne diseases facility in Colorado where she saw first 
hand our frontline laboratory staff working 24/7 to address the 
ongoing Zika crisis.
    Ensuring that all our laboratory work is performed with the 
utmost commitment to quality and to the safety of our workers 
and the community is and will remain of top priority for the 
agency.
    In July 2014, Dr. Frieden testified before this 
subcommittee in the wake of a number of unacceptable safety 
incidents at CDC laboratories. Following the incident, CDC 
received multiple rigorous reviews of the agency's laboratory 
safety practices.
    We continue to implement and track progress on each of the 
more than 200 recommendations we received through that process. 
While more work remains to be done, the progress made to date 
has been significant, particularly in CDC's laboratory 
oversight structure and approach.
    My office oversees safety at all CDC laboratories. This 
includes overseeing our select agent compliance but it's 
distinct from CDC's Division of Select Agents and Toxins, which 
along with USDA regulates laboratories as part of the Federal 
select agent program.
    My office ensures that CDC complies with select agent 
regulations in our own laboratories but it does not have 
authority over and is not involved in overseeing or enforcing 
the Federal select agency program.
    An integral part of our reforms has been to foster a 
culture of safety in CDC's laboratories. Transparency and 
reporting are fundamental to such a culture.
    One of my first acts in this role was to issue an agency 
wide memorandum to reiterate CDC's requirement for staff to 
report all safety issues and to provide clear direction on how 
to do so.
    Another key achievement was the creation of the Laboratory 
Safety Review Board which is reviewing and approving all 
protocols from the transfer of biological materials out of BSL-
3 and BSL-4 high-containment laboratories, a key issue 
identified in the 2014 incident.
    CDC also established the laboratory leadership service, a 
fellowship program that prepares early career scientists to 
become future laboratory leaders.
    Finally, CDC is committed to advancing the science of 
safety, applying the same rigorous scientific methods to 
laboratory safety that we use to confront threats to the 
public's health.
    Last month, my office launched an intramural research fund 
to support agency laboratories in pursuing innovative solutions 
to laboratory safety challenges.
    Last month, we saw a test of CDC's new laboratory oversight 
structure when a CDC worker was diagnosed with a salmonella 
infection that was likely acquired from their work in a CDC 
BSL-2 laboratory.
    The worker has fully recovered and no other people appear 
to have been exposed. While the exposure should not have 
happened, CDC responded to this incident with urgency and 
transparency.
    We will continue to strive to prevent incidents from 
happening. But if they do, we will do everything we can to 
identify and address the factor that contribute to the incident 
and do so swiftly, comprehensively and openly.
    GAO's report on high-containment laboratories provides 
additional and valuable feedback on areas where CDC is 
succeeding and where continued improvements are required.
    We already hard at work to address the issues GAO 
highlighted including finalizing our time lines for the 
remaining safety recommendations and working with HHS and our 
sister agencies on the Biosafety and Biosecurity Coordinating 
Council which will address some of the policies called for by 
GAO.
    For CDC, laboratory safety is not a singular objective that 
can be checked off once completed. Rather, it is an ongoing 
commitment to a healthy and functioning culture of safety where 
monitoring and reporting are valued, issues are rapidly and 
openly addressed and efficient systems are in place to prevent 
a safety issue from becoming a safety incident.
    Since Dr. Frieden testified before this subcommittee, CDC 
has made great progress in advancing this culture of safety at 
our laboratories. But more work remains to be done.
    While the risks of working with these pathogens can never 
be completely eliminated, we will continue to reduce risks 
wherever possible. This includes diligently working to address 
the recommendations from the GAO.
    Thank you for the opportunity to testify and I would be 
glad to answer any questions you may have.
    [The statement of Dr. Monroe follows:]
    
    
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    Mr. Murphy. Thank you, Dr. Monroe.
    Dr. Pillai, you're recognized for 5 minutes. Turn the 
microphone on and bring it up very close to you, please. Even 
closer. Get a lot closer. That's good.

                  STATEMENT OF SEGARAN PILLAI

    Dr. Pillai. Good morning, Chairman Murphy, Ranking Member 
Castor and members of the subcommittee. I'm Dr. Segaran Pillai, 
director of the Office of Laboratory Science and Safety within 
the Office of the Commissioner at the FDA within the Department 
of Health and Human Services.
    Thank you for the opportunity to appear before you today to 
discuss FDA's efforts to ensure the safety and security of our 
laboratories and the people who work in them. FDA's 
laboratories provide a critical role in fulfilling FDA's 
regulatory mission.
    FDA's laboratories, like all laboratories, must comply with 
all applicable Federal, State, and local safety requirements.
    To ensure this, the agency is deeply committed to ensuring 
compliance with relevant laws and regulations through a 
combination of training, issuance of specific policies and 
procedures, appropriate oversight by the safety offices in the 
centers and by fostering an agency wide culture of safety and 
security in our laboratories.
    Upon discovery of the vials of Variola at an FDA laboratory 
located on the NIH campus in July of 2014, the FDA commissioner 
established the Laboratory Safety Practices and Policy working 
group.
    The goal of the work group was to lead a careful and 
deliberate review of FDA's biosafety and biosecurity programs 
and to identify and implement methods to improve laboratory 
safety practices across the agency.
    One of the first key actions of the working group was to 
complete a clean sweep, a full visual audit of all storage 
areas and laboratories. The vast majority of the FDA's roughly 
670,000 vials of samples were properly stored.
    However, there were two instances where select agents were 
improperly stored in secured locations. In both cases, the 
CDC's division for select agents and toxins was notified and 
the materials were destroyed.
    In May of 2015 members of the advisory committee to the 
director of CDC's External Laboratory Safety working group 
conducted a thorough onsite review of the FDA's laboratory 
safety policies and procedures.
    During this three-day visit, the work group met with key 
FDA officials to discuss the circumstances surrounding the 
discovery of the Variola samples on the NIH campus and review 
the policy elements of biosecurity and inventory control, 
laboratory safety training programs, laboratory security 
operations as well as the compliance programs.
    The resulting report released in July the 10th, 2015 
contained eight observations that included a total of 30 
recommendations. We have implemented many of those 
recommendations and are making steady progress on the remaining 
recommendations that resulted from the review in order to build 
and strengthen FDA's comprehensive laboratory safety and 
security program.
    In addition, FDA continues to work diligently to centralize 
appropriate laboratory safety practices including standardizing 
policies, procedures and defining inventory policies and audit 
procedures.
    To gauge the cultural safety at FDA, we held a series of 13 
focus groups with laboratory staff throughout the agency. The 
focus of the focus groups was to raise safety awareness and 
identify trends and risk areas.
    Accountability, safety culture, communication and training 
were identified at critical areas by the focus groups. One of 
the key findings was in general staff was not afraid of 
reprisal if they were to report safety-related issues or 
concerns.
    FDA is also planning additional ways to engage laboratory 
staff in a variety of settings including focus groups, town 
hall meetings and other forums to provide a positive and 
productive outlet for employees to communicate their thoughts 
and ideas for improving safety and security at the FDA 
laboratories.
    An integral way to promote cultural safety and security and 
ensure compliance with legal and regulatory requirements is 
through training. FDA is in the process of implementing a core 
curriculum for biosafety and biosecurity training for all FDA 
personnel working in the biomedical research laboratories.
    This cross cutting agency work safety training program will 
instill and strengthen a culture of safety and compliance 
throughout the agency.
    In addition to the above, FDA also issued a new agency wide 
inventory control and management policy for biological agents 
and toxins.
    Using a central electronic inventory control and management 
system will allow the agency to provide efficient oversight of 
all biological agents and toxins located at the centers and 
offices.
    The recommendations from both the Laboratory Safety working 
group and GAO reports further validates our strategic approach 
and provides essential feedback for FDA as we continue to 
enhance our laboratory safety and security practices and 
policies.
    The Government Accounting Offices reported that as of 
December 2015, FDA has met five of the six elements and 
policies for managing biological agents in the high-containment 
laboratories.
    Although FDA's currently policy did not provide for 
laboratory incidents to be reported to the senior agency 
officials, incident reporting does occur within each of the FDA 
centers and offices and an analysis of the root cause is 
performed annually.
    I'm also working closely with the FDA's safety offices to 
develop a more comprehensive reporting mechanism to capture 
laboratory accidents, incidents, near misses and laboratory-
acquired infections.
    This new reporting mechanism will be implemented in the 
coming months and will require all centers and offices to 
report all such events to my office.
    The FDA's Office of Laboratory Science and Safety will 
establish an official FDA wide policy and work with the HHS 
biosafety and biosecurity coordinating council to recommend 
appropriate criteria and procedures for reporting incidents to 
the HHS leadership in a timely manner.
    Since the discovery of the vials of Variola, FDA senior 
officials have taken direct and definitive actions to improve 
FDA's laboratory safety and security policies, practices and to 
foster a culture of safety and security across the agency.
    I want to assure you that FDA stands fully committed to 
enhancing the safety and security to protect both our staff and 
the public. No regulations or guidelines can ensure safe----
    Mr. Murphy. I need you to conclude because you're about a 
minute and a half over.
    Dr. Pillai [continuing]. Applied toward daily activities. 
Individuals and organizational commitment to the cultural 
safety influences all aspects of safe and secure laboratory 
practices.
    This includes a willingness to report incidents and 
concerns, apply lessons learned and ensure timely 
communications of potential risk as well as the ability to 
respond to an incident judiciously.
    Mr. Murphy. Thank you.
    Dr. Pillai. Safety in the laboratory involves experience 
and knowledge gained over time and how to recognize and 
minimize risk and control assets. As we share and apply this 
critical knowledge to our daily activities we are confident 
that the level of risk will decrease and the goal of reducing 
risk to the lowest possible level.
    Thank you very much for----
    Mr. Murphy. Thank you.
    Dr. Pillai. I'll be happy to answer any questions.
    [The statement of Dr. Pillai follows:]
    
    
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    Mr. Murphy. General Lein, you're recognized for 5 minutes.

                   STATEMENT OF BRIAN C. LEIN

    MG Lein. Good morning, Chairman Murphy, Ranking Member 
Castor, distinguished members of the subcommittee. Thank you 
for the opportunity to update you on the Department of 
Defense's actions taken to address the development, 
implementation and valid oversight policy and procedures for 
the safe handling and transfer of biologic select agents and 
toxins.
    Eight DoD labs work with these agents with the primary 
focus on developing medical counter measures, vaccines and 
drugs as well as diagnostic devices to protect our forces.
    I'm the commanding general of the U.S. Army medical 
research and material command and in support of the surgeon 
general of the Army as the DoD executive agent and responsible 
official for the BSAT.
    In this role, I am responsible for harmonization of policy, 
technical review and inspection guidelines throughout the 
Department of Defense. I will detail the actions that have been 
taken, the current work and the plan for the future since we 
first learned of the anthrax shipments incidents in March of 
2015.
    Immediately after the notification the deputy secretary of 
defense issued a moratorium on BSAT production and shipments to 
allow for a thorough investigation, review of potential 
problems and to ensure the safety of our laboratory personnel.
    Additionally, the deputy secretary of defense designated 
the secretary of the Army as the executive agent for DoD BSAT 
biosafety program. The director of the Army staff also directed 
a full accountability review of the life sciences division of 
Dugway Proving Grounds.
    And finally, the secretary of the Army also directed the 
establishment of a biosafety task force to develop 
recommendations and implement necessary changes to ensure the 
long-term safety and security of the Department of Defense BSAT 
program.
    The end result of all of these actions led to a critical 
reorganization of oversight responsibilities, accountability, 
inspections and implemented new policies and procedures which 
are detailed in the written testimony.
    In December of 2015 the investigating officer for the 
incident at the life sciences division of Dugway concluded that 
the inadvertent shipment of viable bacillus anthracis is a 
serious breach of regulations. A copy of this report has been 
previously made available to the committee.
    The report included several recommendations including 
scientific recommendations, institutional recommendations and 
recommendations to hold individuals accountable for the failure 
to take action in response to mishaps, failure to execute 
oversight and ensure compliance with protocols and regulations 
and failure to exercise care in the performance of their 
duties.
    All personnel actions as a result of the investigation are 
currently being addressed at the appropriate level of command. 
I am pleased to report that the biosafety task force 
capitalized on the best subject matter experts inside and 
outside the Department of Defense to adopt science-based 
policies and proven management procedures for the military 
services to operate in a safe and secure manner for the 
foreseeable future.
    The task force developed four significant recommendations 
to ensure the long-term safety and security of the biologic 
select agents and toxins program.
    We anticipate that by March of 2017 all the recommendations 
will be in place. The anthrax inactivation study will be 
completed and shared with all other Federal agencies.
    The BSAT biosafety program office will be fully staffed and 
operational. The biosafety scientific peer review panel and the 
integrated IT solution for tracking and inventorying all BSAT 
samples will be implemented.
    Establishing strong and robust processes that are 
continually evaluated and improved is our best defense against 
potential human error or management lapses.
    We believe the systems we are developing will provide the 
necessary checks and balances to prevent or minimize the 
impacts of future accidental and human or procedural missteps.
    We recognize that quality policies and procedures do not 
stand alone. They must be incorporated with personnel training, 
evaluation, feedback followed by review, oversight, 
documentation and reporting in order to have a systematic 
approach to managing the successful and safe performance of 
these personnel and institutions.
    It is also necessary that we partner with other Federal and 
private organizations to ensure the transparency and the 
uniformity of this program.
    We are developing a system that incorporates these 
essential elements to continue the safety performance of this 
critical research and for the development of detection systems 
and counter measures.
    Finally, both accountability and a standardized inspection 
process are both critical to the success of this program. Both 
have undergone significant revision and centralization.
    Thank you for the opportunity to share our program with 
this committee. I look forward to answering any follow-on 
questions.
    [The statement of Major General Lein follows:]
    
    
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    Mr. Murphy. Thank you. I recognize myself for 5 minutes.
    General, I see you have a parachutist badge on you there. 
I'm assuming you've jumped a few times. Did you pack your own 
parachute?
    MG Lein. No, sir.
    Mr. Murphy. Someone just said don't worry about this? A 
stranger says, ``here's your parachute, everything's fine''? 
Did you doublecheck things?
    MG Lein. Yes, sir.
    Mr. Murphy. Absolutely.
    MG Lein. That's part of the JR--the prejump inspection 
that's required----
    Mr. Murphy. Exactly.
    MG Lein [continuing]. Not by you, just by you, but by----
    Mr. Murphy. By everybody, right?
    MG Lein [continuing]. By your senior----
    Mr. Murphy. And I'm assuming also it's standard in the 
military, someone hands you a weapon and says, ``Don't worry, 
it's not loaded,'' you check it anyways, right?
    MG Lein. Yes, sir.
    Mr. Murphy. So I go back to the thing, because it could be 
dangerous and you don't want to jump without a parachute that 
works.
    So I go back to this omission, Doctor, and when I asked you 
to clarify this point of the six vials and two of them were 
alive they were treated as if they were not and you said oh, it 
was only later on it was discovered.
    That is the core of this hearing and why we keep coming 
back here, because you treated them as if they weren't. And the 
fact is the way they were handled too they could have broken. 
We would have exposure of small pox.
    But this is what we mean about the culture of complacency. 
We just assume, oh, these couldn't possibly be alive. You treat 
it like it's a loaded gun. You treat it like it's alive, and 
you didn't.
    And even when I asked for a clarification, you once again 
said, ``Oh, we didn't discover that until later.'' That's the 
point of this hearing, that you're supposed to treat it as if 
it is.
    Now, let me talk about it, the NIH did not undertake an 
internal investigation of the root cause and circumstances that 
led to the boxes containing smallpox being overlooked 
apparently for decades, even though an international agreement 
and later Federal law and the regulations required the NIH to 
account for all smallpox vials in these facilities.
    Now, our understanding is that the NIH did not do the 
internal investigation because of the ongoing CDC and FBI 
investigation and the subsequent referral to HHS Office of 
Inspector General. Is that correct?
    Dr. Tabak. Yes, sir.
    Mr. Murphy. However, in 2012 the NIH conducted an internal 
investigation into the improperly stored antibiotic-resistant 
anthrax incidence while the CDC was investigating. So the 
pending CDC investigation did not prevent the NIH from 
conducting an interim investigation into the improperly stored 
anthrax. Is that correct? You have to turn the microphone on 
and pull it close to you.
    Dr. Tabak. We did conduct and investigation at that time to 
ascertain where the samples were derived from and who had the 
samples, and then subsequently reviewed samples from everybody 
who was a registered user of bacillus anthracis and then 
following that a survey of all investigators who were 
registered for select agents.
    Mr. Murphy. We note you led a task force in 2015 to 
investigate the serious problems with NIH Clinical Center of 
Pharmaceutical Development section during an ongoing FDA 
investigation.
    So the pending FDA investigation did not prevent the NIH 
from conducting an internal investigation into the NIH PDS. Is 
that correct?
    Dr. Tabak. Yes, sir.
    Mr. Murphy. Now, the Department of Defense launched their 
accountability investigation while the CDC and the FBI were 
still investigating those shipments of live anthrax from Dugway 
Proving Grounds.
    Since the DoD started their internal investigation during 
this pending investigation, why was it that the current--that 
NIH could have started all their internal investigations into 
the root causes back in July of 2014? Why couldn't that be 
started back then?
    Dr. Tabak. It's been our policy not to initiate 
investigations of this type while there's an ongoing 
investigation from either the FBI and/or the IG.
    Mr. Murphy. Why not?
    Dr. Tabak. We understand that we are not supposed to 
compromise those investigations in any way.
    Mr. Murphy. DoD managed to do it. DoD said, hey, safety 
comes first, we're checking into this. We're kicking down 
doors. And you guys say, hey, let's hold off on this, when you 
could have been investigating.
    Dr. Tabak. We held off on what has been termed the root 
cause analysis. But we did not stand by idly. We did in fact 
institute many additional procedures to enhance the safety of 
what we were doing.
    Mr. Murphy. I don't believe you, because we already 
established that in moving those smallpox vials you didn't 
treat them as if they were live and even though you said this 
morning, well, we didn't discover that until later, you should 
treat it as if it is alive.
    So in August of 2014, CDC Division of Select Agents and 
Toxins sent a memorandum to NIH detailing the findings of a 
joint CDC/FBI investigation into the discover of the smallpox 
vials.
    At this point, the joint CDC/FBI investigation was over. So 
couldn't the NIH have started their internal investigations 
based on the finding of this report and did you know about this 
report back in August of 2014? You're still saying you couldn't 
have done anything?
    Dr. Tabak. Again, it was an ongoing IG investigation and in 
fact we still have not been formally notified by the IG that 
that investigation is closed.
    Mr. Murphy. Well, I'm out of time. I will turn it over to 
Ms. Castro for 5 minutes.
    Ms. Castor. After a number of the incidents involving 
anthrax and ebola and other dangerous pathogens it was very 
important for this committee to ask the GAO to produce a 
detailed over view and report because when it comes to working 
with these deadly pathogens there simply is no room for error 
and rigorous safety policies must be followed.
    GAO looked at eight departments and 15 agencies to assess 
their high-containment lab policies and oversight. GAO's report 
concludes that the majority of policies were not comprehensive 
and some were out of date or nonexistent.
    Mr. Neumann, could you walk us through this key finding and 
why having comprehensive and up to date policies is important?
    Mr. Neumann. Sure, I'd be happy to.
    Certainly, we know that there's important research being 
done and, you know, when there's a safety incidence it 
interferes with this research.
    So when you don't have policies in place or procedures that 
ensure that those are being carried out it puts that research 
at risk and also puts personnel at risk. And what we found is 
that this comprehensive oversight was not in place.
    Some policies that would really help the foundation of the 
lab safety culture were not in place and furthermore there 
weren't the oversight mechanisms that can ensure that these 
policies are being carried out.
    And then, finally, leadership was not informed of some key 
incidents and the inspection result was all important for 
ensuring that these labs are being overseen properly.
    Ms. Castor. OK. So let's get more specific. Your report 
concluded that the departments and agencies are using 
inspections as their primary activity to oversee the management 
of hazardous biological materials.
    However, as you testified, some agencies do not routinely 
report the results of these inspections to senior officials. 
What issues are presented by this finding of incomplete 
information sharing?
    Mr. Neumann. Well, certainly, without having those 
inspection results or incident reports, leadership can't 
determine if there's systemic issues that need to be addressed 
across the labs.
    Ms. Castor. During your oversight and interviews, were all 
of the agencies forthcoming? Did they provide the materials you 
requested? Was there any resistance to providing any 
information to GAO?
    Mr. Neumann. No, all the agencies and departments complied 
with our request and we worked very closely with them to 
identify the policies and procedures.
    So we got great cooperation from the agencies.
    Ms. Castor. OK. General Lein, many think that in addition 
to all of these inspections and oversight and policies that one 
of the greatest risks we face is from theft or misuse of a 
deadly pathogen and we certainly had an incident of that at 
Fort Derrick in 2001.
    Tell us, since 2001 what have you done to strengthen all of 
your oversight and your ability to root out potential theft or 
misuse of deadly pathogens.
    MG Lein. Ma'am, thank you.
    We've done several things in inventory management process 
with 100 percent review of what's in each one of the labs on an 
annual basis at the Research Institute of Infectious Disease.
    Everybody that works in the lab has got to be vetted for 
security processes, coming to the lab and to work into the lab, 
and then recently we are completely redoing who it is and where 
it is that we ship all of our agents.
    So we used to have the critical re-agent program which was 
the process whereby external labs would get the information 
from us or get the samples from us. It did not have full 
accountability of all the systems and there were often labs 
that were able to--because of a direct contract were able to 
send.
    We have since shut that down, and after the moratorium was 
lifted everything will have to get requested through this new 
office with the requirement of a peer review before it even 
gets shipped out of ensuring that they need the highest level 
of toxin and why can't we substitute a lesser level of toxin 
that can never be moved into a BSAT program.
    And so associated with that there will also be a use-by 
date like the carton of milk and that that specimen that we 
send out must be used by and then we must get a message back 
from the lab that we sent it to that it's either used or they 
destroyed it or they're returning the specimen back to us.
    So we maintain full accountability of all of the specimens 
that we've got within our program.
    Ms. Castor. I'd like to ask this--the CDC, Dr. Monroe, what 
policies and procedures are newly in place to prevent theft or 
misuse of deadly pathogen?
    Dr. Monroe. Thank you. First, I would emphasize that our 
laboratory safety review board, which reviews all the policies 
for inactivation and transfer of materials from our highest 
containment biosafety level three and four labs.
    Has looked at those policies both initially when they were 
initially released from the moratorium imposed by Dr. Frieden 
and then on an annual basis. And so we've come up now on having 
annual review of some of those procedures.
    Importantly, all of those procedures include a step that we 
we refer to as secondary verification. So as has been pointed 
out, it's not only important to have the right policies but you 
have to show that there's adherence to those policies.
    And by having the secondary verification step of either a 
second person watching or a time stamp or something that 
verifies that an activation procedure was done as described in 
the policy is a critical part of our inactivation policies for 
anything that's brought out from high-containment to lower 
levels of containment.
    In terms of the personnel, we also, along with others, have 
instituted a so-called personnel suitability program for those 
that have access to the highest risk pathogens--the so-called 
tier one pathogens.
    Ms. Castor. Thank you.
    Mr. Murphy. I have to follow up with you, Dr. Tabak, on 
just on that line of questioning about the timing of your own 
investigation.
    We were informed that CDC was recently notified by the HHS 
Office of Inspector General to close out all the NIH referrals, 
given that there's no known pending potential investigation 
will the NIH now commit to conducting an internal 
investigation?
    Dr. Tabak. Absolutely.
    Mr. Murphy. Thank you. I now recognize Mr. McKinley, vice 
chairman of the committee.
    Mr. McKinley. I thank you, Mr. Chairman.
    Mr. Neumann, if I could spend a little time on your report. 
You've got a chart on Page 5 of the six elements that you were 
referring to in compliance.
    I know that they're not all the same in weight. So I don't 
know which ones are more important than others in compliance. 
Would you suggest to us which are the ones that we should be 
spending more attention to of those six elements?
    Unless you're going to tell me they're all equal, which I 
doubt.
    Mr. Neumann. Well, I think we determined that there were 60 
elements. We didn't weight them. But incident reporting is 
certainly one that has more immediate impact. If incidents are 
reported to senior leadership they can take action on the 
systemic issues that are identified.
    Mr. McKinley. OK. If that's number one, what would number 
two be?
    Mr. Neumann. Like I said, inventory control also is very 
important----
    Mr. McKinley. I understand.
    Mr. Neumann [continuing]. Because keeping track of the 
specimens. Each of these have their importance. Training, for 
example.
    Mr. McKinley. Inventory control might be number two?
    Mr. Neumann. Excuse me?
    Mr. McKinley. Inventory control might be number two?
    Mr. Neumann. In my mind, yes. Definitely there's an 
important step.
    Mr. McKinley. I'm just trying to understand not everything 
is going to be equal. So I'm trying to--for example, in your 
report you say that two of the agencies wouldn't cooperate or 
said they didn't think anything more was necessary--Department 
of Energy and the EPA. And I looked at your chart and I see the 
EPA under their pesticide program those are the two--number one 
and number two--in your mind that they're not complying with 
and yet they think everything is copasetic.
    Mr. Neumann. Yes, and we disagreed with their position.
    Mr. McKinley. Thank you.
    Do you disagree then with DoE as well? Because Doe also has 
numbers of violations as well in that. The others seem to think 
that they're in compliance.
    Mr. Neumann. Yes, I think that we believe that these 
recommendations are important in establishing the foundation 
for the lab safety.
    Mr. McKinley. Well, I think that if--what I've heard here a 
little bit is it sounds like everyone at the panel all thinks 
they're in compliance, that everything is just fine.
    But I know in 2009 your department put together a report 
that said that there needs to be an oversight, someone to look 
over all the agencies.
    But that was rejected as being cumbersome and overly broad. 
Do you still think it's cumbersome, overly broad? Or is it 
something that's necessary, because you just heard the 
testimony. Everyone thinks they're in control. But there's a 
real question in America whether they are. So what do you 
think?
    Mr. Neumann. Well, our recommendation still stands open. 
The one we made in 2009 was looking more broadly at all high-
containment labs, not just the Federal labs.
    This report we focused on the Federal high-containment 
labs. But that recommendation we still openly stand by that. 
But there could be better oversight with a single entity to 
oversee all these labs given the fragmentated----
    Mr. McKinley. One of them that might help but I'm afraid of 
a software type thing is IV&V. Do you see how IV&V might have 
an impact here whereas the IV&V--I don't want to suggest what 
I--you're familiar with IV&V?
    Mr. Neumann. I'm not familiar with that, no.
    Mr. McKinley. Independent verification and validation?
    Mr. Neumann. Oh, yes. Yes. Uh-huh.
    Mr. McKinley. OK. NASA has been using it successfully ever 
since the rocket explosion. Others have used it. Unfortunately, 
the Obama administration chose not to use IV&V when they put 
out the registration and, you know, the computer system all 
collapsed under the registration.
    I don't know whether that would help out. Would IV&V be of 
any help to these or is that just going to be checking the box?
    Mr. Neumann. Well, certainly, any type of verification is 
going to be useful. There needs to be a system of independent 
verification, inventory control, all these different steps to 
ensure that you have----
    Mr. McKinley. But would they just check the box, or if 
there's no one overlooking their shoulder, who's going to know 
that they've actually done something as a result of checking 
the box?
    Mr. Neumann. Well, that's why the oversight mechanisms are 
so important that leadership be paying attention to the labs 
and ensuring that they're being inspected and they're reviewing 
the results of those inspections to see where there might be 
lapses.
    Mr. McKinley. So in the time, is that something that 
perhaps you would--the GAO would look at as a recommendation 
that maybe IV&V should be implemented under each of these labs?
    Mr. Neumann. We didn't look specifically at that but I 
think the leadership oversight is going to be really important 
to ensure that these mechanisms are actually operating, not 
just policies.
    Mr. McKinley. My question is would you consider that in the 
future in looking at that to see whether or not there might--
other agencies have found it to be very useful and I'm just 
wondering whether or not you see it from your perspective with 
the lab will they simply just use it to check the box and not 
do anything about it?
    Mr. Neumann. Well, I definitely would like to take some 
time to think that over. Perhaps we can provide a response for 
the record.
    Mr. McKinley. If you would, please. And my time has expired 
so I thank you, Mr. Chairman. I yield back my time.
    Mr. Murphy. Thank you. I now recognize Mr. Griffith of 
Virginia for 5 minutes.
    Mr. Griffith. Thank you very much, Mr. Chairman. Thank you 
all for participating in this hearing today.
    Dr. Tabak, I understand that the historical collection that 
contains the smallpox vials where there was a problem that had 
been previously discussed is not the only historical collection 
at NIH.
    In fact, in 2002 or 2003, NIH registered a historical 
collection that included plague and Burkholderia samples using 
the information listed on labels for sealed envelopes. Isn't 
that correct?
    Dr. Tabak. Yes, sir.
    Mr. Griffith. And did anyone at NIH open the envelopes at 
the time to check not only the accuracy of the samples but also 
to ensure that the samples were intact?
    Dr. Tabak. To my knowledge, they did not.
    Mr. Griffith. And I also understand that in 2007 the NIH 
office responsible for overseeing compliance with select agent 
regulations reregistered these select agents again without 
opening the sealed envelopes. Isn't that correct?
    Dr. Tabak. It is. The reason they did not open them at the 
time is that they were not registered to work with that 
particular agent in the laboratory where they were brought.
    Mr. Griffith. So the individuals who were looking at it 
weren't registered to deal with the plague or Burkholderia?
    Dr. Tabak. The laboratory was not registered and so they 
needed to file an amendment so that they could in fact work 
with those agents.
    Mr. Griffith. OK. So they did that and then from my 
understanding in 2008 they finally opened the envelopes up and 
the materials contained were not the same as what had been 
registered back in 2002, 2003 with the select agent program 
twice earlier.
    They weren't the same as had been previously registered and 
that one of the envelopes contained more vials of Burkholderia 
than was listed. Isn't that accurate?
    Dr. Tabak. That is correct. It has been described to me as 
a clerical error that indeed they did know that there were 39 
vials but unfortunately it was transcribed inaccurately, and so 
that's my understanding of it.
    Mr. Griffith. So there were 39 vials, but they had it 
written down as 32?
    Dr. Tabak. I may be misspeaking but, yes, there was a 
difference of, I believe, seven vials.
    Mr. Griffith. Now, I was not--obviously, I'm familiar with 
the plague. I was not familiar with Burkholderia, and so I 
looked it up online. So my sources are Internet sources. They 
may or may not be accurate.
    So you get me straight if I've got it wrong. But it looks 
like it depicts mostly horses but there are a couple of species 
or subspecies of the bacteria that affect human beings.
    Do you know whether the samples that were discovered in 
2008 were the type of species of Burkholderia that affect 
horses or were they the type that affect humans?
    Dr. Tabak. I do not know the answer to that.
    Mr. Griffith. And could you please find that out for us 
because in my research it indicated that at least two of the 
species not only affect humans but are considered possible 
agents for biological warfare?
    Dr. Tabak. Indeed, and this is why they were treated as 
select agents and contained. But I will find out the answer for 
the record, sir.
    Mr. Griffith. If you could let me know I would greatly 
appreciate that. Dr. Pillai--did I say it right? All right.
    And you're now with the Office of Laboratory Science and 
Safety at the FDA and it's a fairly new office. What is the 
budget for your office and how many staff do you have?
    Dr. Pillai. So as you mentioned, it's fairly a new office 
that we are trying to stand up at the current time. We have 
actually worked out this for the division and planned a mission 
for the office and have actually pulled together a budget and 
we have put in the budget request to our senior leadership, the 
Office of Operations, to the Office of the Commissioner, and 
both of those offices are working diligently to ensure that we 
get the necessary budget support needed to stand up the office.
    The request that we have proposed was $2.8 million to 
basically staff with 14 members to ensure that we can address 
all the safety and security-related issues at FDA.
    Mr. Griffith. All right. And can you get us that once it's 
been approved by the other folks? Can you get us a copy of that 
budget?
    Dr. Pillai. Absolutely.
    Mr. Griffith. I would appreciate that, and who is it that 
you report to?
    Dr. Pillai. At the current time I report to the Office of 
the Chief Scientist and to the Commissioner through the Office 
of the chief scientist. The external laboratory safety working 
group's recommendation was for this position to be a direct 
report to the commissioner.
    As you are fully aware, that we have a new commissioner on 
deck at the current time, Dr. Robert Califf. Dr. Califf is 
taking a look at all of the organizational structures at the 
current time and you'll make a final call and decision as to 
what the department structure should be.
    Mr. Griffith. All right. I do appreciate that. I see my 
time is up and I yield back. Thank you, sir.
    Mr. Murphy. Thank you. I now recognize Mrs. Brooks for 5 
minutes.
    Mrs. Brooks. Thank you, Mr. Chairman.
    As the panelists might know, yesterday both NATO and the 
European Union intelligence officials indicated that there are, 
quote, ``justified concerns,'' end quote, that ISIS is working 
on obtaining biological material needed to carry out an attack.
    With persistent analysis like this supporting the notion 
that terrorists are actively looking to acquire a weapon of 
mass destruction, I certainly hope that our Government will 
redouble our efforts in protecting sensitive materials from 
getting into the wrong hands.
    We also know that in October it was revealed that a 26-
year-old Moroccan-born man who had worked in a sensitive area 
in a nuclear power plant in Belgium died in the spring while 
fighting for ISIS.
    This terrorist had passed a background check and had access 
to a secure area where the nuclear reactor is located. 
Obviously, it can happen in the biological space as well. We 
shouldn't forget that the perpetrator of the '01 anthrax 
incident was a scientist who worked at the Government's 
biodefense labs at Fort Derrick.
    I bring that up because we can have all the policies and 
procedures in place and we can have taken corrective actions 
and so forth. But I'm curious, Mr. Neumann, did you and GAO 
look at the security level of personnel in your report?
    Mr. Neumann. We did not. We looked at the policies we had 
in place to ensure that they had all these key elements. We 
looked at the oversight mechanisms to make sure they were 
checking them and we looked at----
    Mrs. Brooks. I understand that. But what about security and 
background checks? Why did you not look at security and 
background when it has to do with personnel actually following 
or not following these procedures?
    Mr. Neumann. This was a broad look at all the Federal 
departments and agencies or the eight departments and 50 
agencies. So just getting a sense of their policy and 
procedures they have in place and the oversight mechanisms was 
quite a large volume of work.
    So we didn't drill down in specific aspects of this. But 
that's definitely an area that we could, you know, potentially 
follow up on if there's interest in that.
    But it's part of making sure that you have the checks and 
balances with the policies and the oversight mechanisms to make 
sure that all the policies are being followed.
    Mrs. Brooks. And I certainly appreciate it and don't want 
to take away from your work. But I do think that is of critical 
importance and I'm going to ask very briefly, because I have a 
different line of questioning for Dr. Tabak, but if you could 
please each agency indicate, and I may ask for the record, we 
may submit questions for the record with respect to what level 
of security clearances do your personnel have who have access 
to these deadly pathogens, how often are they cleared, because 
it's very common for many agencies to have that clearance 
process when an individual comes in to an agency, but often 
maybe not checked on routinely every few years, and I'm curious 
about that, as well as what is the level of security clearance 
that the personnel must have.
    So I will be submitting those questions for the record for 
each of your agencies. I believe that Major General indicated 
that certainly people are vetted, and I assume that people are 
vetted within your agencies.
    But having been a former U.S. attorney and going through 
security background checks I'm very interested in knowing what 
level of security clearances all of the personnel that have any 
access.
    I'm not just talking about the scientists. I'm talking 
about all levels of personnel. I'm curious to know what level 
of background checks are performed.
    Dr. Tabak, I'm very curious to know because the majority 
staff investigation found that the National Cancer Institute of 
Frederick does not report to the NIH Safety Office on the main 
campus. Who does the safety officer at NCI Frederick report to?
    Dr. Tabak. Ultimately, to the director of the NCI.
    Mrs. Brooks. Who do they directly report to?
    Dr. Tabak. They report up to the scientific director of the 
NCI Frederick and then in turn that individual reports up to 
the director of the NCI who, of course, reports up to the 
director of NIH.
    Mrs. Brooks. So is the NIH management of safety--is it 
centralized or is it decentralized across the various campuses? 
I've just visited your incredible campus. It's a very, very 
large place. Is it decentralized or is it centralized?
    Dr. Tabak. In the case of the NCI Frederick they have this 
separate reporting chain. Everything else is centralized in one 
place.
    Mrs. Brooks. And we heard from Mr. Neumann that--do you 
receive reports of select agent inspection results now?
    Dr. Tabak. I do indeed.
    Mrs. Brooks. OK. Does Dr. Collins?
    Dr. Tabak. I notify Dr. Collins when there are variations--
if there are issues that are problematic.
    Mrs. Brooks. And we've heard that according to HHS comments 
and response to the GAO's report, the associate director of 
research services is the designated agency safety and health 
official. Does this individual report to your or Dr. Collins 
about lab safety issues?
    Dr. Tabak. The responsible official reports through a chain 
of the director of division of occupational health services who 
reports to our director of the Office of Research Services who 
reports to our Deputy Director for Management, who in turn, you 
know, works through me to Dr. Collins.
    But each individual is required to move up the chain if the 
next person up does not respond for some reason and indeed when 
there are serious issues we are all immediately notified 
simultaneously.
    Mrs. Brooks. OK. Thank you. I yield back.
    Mr. Murphy. Just clarifying, Dr. Monroe, who do you report 
to?
    Dr. Monroe. I report directly to Dr. Tom Frieden, the CDC 
Director.
    Mr. Murphy. OK. Thank you.
    I recognize Mr. Hudson for 5 minutes.
    Mr. Hudson. Thank you, Mr. Chairman, and thank you to the 
panel for being here.
    Dr. Pillai, the NIH office that had the smallpox boxes was 
reassigned to the FDA in 1972. Why didn't the FDA do any sort 
of inventory over the room when it was transferred to control 
at that point or at any time from 1972 to 2014.
    It seems to me that one simple inventory, something that 
businesses back in my district do every year, would have caught 
this mistake.
    Dr. Pillai. I agree with you totally. I think this is one 
of the failure points that we have encountered for this 
incident. You know, one of the key points that I'd like to make 
is that by nature laboratory scientists, right, they tend to 
attend to the materials that belongs to them and they don't 
really look into other people's properties or materials and 
this is one of those areas where it was a shared laboratory 
storage cold room, basically.
    So there was no one single individual assigned to be 
responsible for the inventory or whatever was contained in that 
cold storage facility.
    Mr. Hudson. Has that been changed now?
    Dr. Pillai. That's been changed. What they've done is ever 
since this incidence has taken place we have actually assigned 
a single individual to be responsible for any cold storage 
areas that's been shared by multiple scientists and all the 
materials in the cold storage must be labelled with the PI's 
name along with the content and the date so that you can 
actually do a very simple easy inventory control process as to 
who it belongs to and what the contents are.
    Mr. Hudson. Appreciate that answer. When we asked FDA why 
it failed to utilize proper inventory controls in the cold 
storage room we were told that this room is apparently not 
subject to inventory controls since there was no accountable 
Government property inside the cold storage room.
    Accountable Government property is a term that's defined as 
all computers and pieces of equipment with a value of more than 
$5,000. But how could FDA know there's no accountable 
Government property if they hadn't done an inventory?
    Dr. Pillai. That's a very good point. In most cases, cold 
storage facilities actually are used to store reagents and 
supplies and things of that nature, which usually doesn't 
amount to greater than $5,000.
    As such, there's usually not a custodial individual 
assigned to the cold storage areas where you're basically 
storing medias and things of that nature. This is one of those 
incidents that we do not anticipate such a problem to take 
place.
    We would have put in appropriate safety protocols and 
policies in place to address that. But this was a valuable 
lesson learned and we are looking forward to implementing the 
appropriate policies and procedures and managers can ensure 
that this doesn't happen again.
    Mr. Hudson. So your opinion now--any kind of critical 
reagent programs, they have a value of some $500 to $1,000 
apiece. I mean, would, in your opinion, they now be considered 
this Government property that needs to be inventoried? I mean, 
has there been a change of mind set in terms of--instead of 
just making $5,000 and up we need to have an inventory of 
everything?
    Dr. Pillai. I mean, talk about equipments and things of 
that nature--if you're talking about an instrument and 
equipment and anything to the nature that is a custodial 
individual assigned to ensure the responsible--to ensure and be 
responsible for that particular property.
    When in the case of the cold room the situation is 
different whereby what we are doing is we are getting a full 
inventory control of what the contents are.
    This is where you usually store biological materials as 
well as freezes and things of that nature. So we have 
implemented a policy at FDA to have a full inventory control of 
all the biological agents, not just the BSL-3 agents but also 
the risk two agents as well as the risk three agents.
    So now we have a full account of every materials where they 
are stored, the location, who it belongs to and every time an 
individual takes the material for work to work on it or to add 
a new agent to the list, they update that information on a 
daily basis.
    So this will allow us to control this select agents and 
high consequence pathogens in a much more efficient manner.
    Mr. Hudson. So just to clarify, so going forward, vials of 
biological pathogens are no longer not considered important 
enough to be inventoried or as an accountable Government 
property there's no discrepancy now?
    Is that what you're telling me in terms of having a dollar 
amount? If it's a pathogen, it's going to be inventoried?
    Dr. Pillai. That's right. If it's a high-consequence 
pathogen or it is a hazardous biological agents and toxins it 
will be in the inventoried.
    Mr. Hudson. OK. Thank you for that.
    Mr. Chairman, I see I'm running out of time. I'll go ahead 
and yield back.
    Mr. Murphy. If I could just take the last few seconds, let 
me ask the panel here, except for DoD: So within this, given 
all the sweeps that you've done are there any more orphan 
pathogens of any kind that are not identified who they're with?
    Dr. Tabak, are there any more? You've done all these 
sweeps. Everything has been checked. Is there any more vial 
samples, anything that you don't know where it's come from, who 
it belongs to?
    Dr. Tabak. Not to our knowledge.
    Mr. Murphy. Dr. Monroe.
    Dr. Monroe. Everything has been inventoried.
    Mr. Murphy. Dr. Pillai.
    Dr. Pillai. Yes, every agent has been inventoried and 
accounted for by the FDA.
    Mr. Murphy. Thank you. Mr. Mullin, you're recognized for 5 
minutes.
    Mr. Mullin. Thank you, Mr. Chairman. I'm going to follow up 
on your questions, too.
    Even after we got the information that anthrax had been 
basically not kept good records on and it had been shipped 
around, being used for experiments, people not knowing where 
they're at.
    Once you discovered this you decided to do an inventory and 
look for anthrax, if any more had taken place. And 
specifically, NIH limited the search to only anthrax. Why was 
this?
    Dr. Tabak. If I may clarify, this was done in two steps. 
The initial search indeed was limited to those investigators 
working with bacillus anthracis. But after we discovered 
additional issues, we expanded that to include all principal 
investigators working with any select agent.
    Mr. Mullin. When did you expand that?
    Dr. Tabak. During that same year, sir. And so----
    Mr. Mullin. What was the discovery of that?
    Dr. Tabak. I'm sorry?
    Mr. Mullin. What did you discover in that? Because when you 
started searching for anthrax you found other cases even after 
it was revealed that it wasn't properly followed and the 
procedures wasn't followed. You found other issues with 
anthrax. So what else did you find?
    Dr. Tabak. So subsequently we searched cold storage areas 
with any principal investigator working with select agents.
    We searched over 6 million vials, vial by vial. And so that 
was a very comprehensive search that was undertaken. So it was 
a two-step process. I know----
    Mr. Mullin. But what else did you discover? Other than 
anthrax what else was being improperly labeled and shipped 
around without the knowledge of NIH?
    Dr. Tabak. The search only revealed, to my knowledge, 
things related to different forms of anthrax.
    Mr. Mullin. Mr. Tabak, just please help me here with your 
knowledge. We're talking about very serious consequences if 
this gets out, and to your knowledge you can't give me a 
definite answer?
    We're talking about serious diseases. We're talking about 
things that could be used against us. We're talking about if 
they leaked out it could have serious consequences throughout 
areas of contact.
    And you're telling me your knowledge. I'm asking for 
specifics.
    Dr. Tabak. Sir, I understand the gravity of the situation. 
I'm giving you the response that I can give you. I will provide 
for the record additional details so that I can----
    Mr. Mullin. Is it classified? Is that why you can't give 
me----
    Dr. Tabak. No, sir. It is not.
    Mr. Mullin. OK. So the response--that's what I'm trying to 
get to. And, sir, I mean absolutely no disrespect. But as 
something as this serious I would think you would have definite 
answers for.
    Dr. Tabak. And I am trying not to misspeak and so I'm 
giving you the best answer I can.
    Mr. Mullin. I apologize with that.
    Dr. Tabak. And for the record, I will give you with 
certainty if any additional agents besides those related to 
anthrax were found in this 2008 time frame.
    Mr. Mullin. So what caused you guys to open the research 
and search for further information. After you had simply opened 
it up for anthrax, what led you to decide, hey, let's look 
farther into this?
    Dr. Tabak. When we discovered additional vials of anthrax 
that were unaccounted for and anthrax spores that were 
unaccounted for in laboratories and it was at that point that 
we decided that we needed to broaden the search and do a vial 
by vial for everybody who had the use of select agents.
    Mr. Mullin. Do you have any additional cases showed up with 
anthrax?
    Dr. Tabak. So we found 30 vials in one laboratory----
    Mr. Mullin. That were unaccounted for, 30? Thirty in one 
laboratory?
    Dr. Tabak. These were unaccounted for. These were findings 
that we made. Thirty vials in one laboratory that had not been 
entered properly.
    Four vials in a second laboratory that had not been entered 
properly and in six vials a third laboratory that had not been 
entered properly.
    Mr. Mullin. Was this due to procedures not being followed 
or procedures not in place?
    Dr. Tabak. I believe in one instance procedures were not 
followed and I would say in the other two instances I believe 
it was really due to human error.
    Mr. Mullin. Thank you. I look forward to your response on 
the other one too. Thank you for getting back to me and Mr. 
Chairman, I'll yield back.
    Mr. Murphy. Thank you. I don't know if Ms. Castor has any 
more questions. I want to ask a couple more quick ones. Mrs. 
Brooks, did you want to be recognized for a quick question?
    Mrs. Brooks. Thank you, Mr. Chairman.
    Very briefly, and this would be to Major General Lein.
    In its report, GAO recommended to DoD that it require all 
high-containment labs including those not registered with the 
select agent program to report the results of any agency 
inspections to DoD.
    DoD told GAO that it had no plans to implement such a 
requirement. Why does the department disagree with GAO on this 
issue and why not require reporting inspections of all high-
containment labs and not just the select agent registered labs?
    MG Lein. Ma'am, I have to get back to you on that. We 
should be reporting all of the--not just the labs but all of 
our high-containment labs. So I owe you a response to that.
    Mrs. Brooks. Thank you. We agree.
    MG Lein. So just follow on the recommendations from the GAO 
report.
    Mrs. Brooks. OK. We'll look forward to your response, or 
changes and procedures. Thank you. I yield back.
    Mr. Murphy. Thank you. I have a couple more questions. I 
think we're waiting for Dr. Burgess. But Dr. Tabak, has the NIH 
ever taken any personnel actions related to not complying with 
select agent regulations?
    Dr. Tabak. Because of the sensitivity of personnel actions, 
sir, I would hope that we could discuss that with you and the 
committee in another venue.
    Mr. Murphy. Can you tell us numbers?
    Dr. Tabak. Again, because of the numbers involved, sir, I 
would--because of the----
    Mr. Murphy. Is that a yes, that something has happened?
    Dr. Tabak. I'm sorry, sir?
    Mr. Murphy. So is it a yes that some personnel action has 
happened, but you would talk about the other things privately?
    Dr. Tabak. I would prefer to, sir, we discuss that in 
another venue with you.
    Mr. Murphy. Well, we're trying to get the answer to this. 
So Government employees? They're Government employees?
    Dr. Tabak. Yes, sir.
    Mr. Murphy. Generally, are they Government employees, and 
I--wasn't some personnel action taken among people who 
mishandled the procedures for the anthrax?
    MG Lein. Yes, sir. Twelve recommendations for 12 personnel 
at Life Sciences.
    Mr. Murphy. OK. And I don't need to know their names or 
anything, but action took place. So you are taking some action, 
yes?
    I'd be willing to talk about some other things with--I 
mean, I think both sides would like assurance on that.
    Dr. Tabak. Again, sir, because of the relatively small 
numbers of individuals I think we would be breaching 
confidentiality to have a conversation publicly.
    Mr. Murphy. Yes or no? Actions taken place?
    Dr. Tabak. Actions were initiated.
    Mr. Murphy. OK. That helps us. We can proceed. Has the FDA 
began an interim investigation to the root cause or facts and 
circumstances surrounding the discovery of smallpox vials in an 
FDA laboratory on the NIH campus--into root cause?
    Dr. Pillai. So like my colleague, Dr. Tabak, given the fact 
that there was an FBI investigation complemented with a CDC 
select agent followed by an OIG inspection that is ongoing we 
have decided not to interfere with the process and have laid 
back. My understanding is that the OIG investigation is coming 
to an end and given the fact that that report is going to be 
available to us in the near term we are initiating a process to 
understand the root cause for the event that took place in 2014 
and understand what the failure points are and then we plan to 
mitigate those failure points through implementation of 
appropriate policies and procedures.
    Mr. Murphy. OK. So it's the OIG inspection is over?
    Dr. Pillai. That's my understanding. My understanding is--
--
    Mr. Murphy. Yes, it's true? And so did you have a plan in 
place saying hey, as soon as this investigation is over we're 
ready to move forward?
    Dr. Pillai. Right.
    Mr. Murphy. So you do have a plan ready?
    Dr. Pillai. We have a plan.
    Mr. Murphy. So when you said--but now you're discussing it. 
It should be the moment you were told you said now let's roll 
with ours. So it is happening now?
    Dr. Pillai. Yes.
    Mr. Murphy. And after FDA personnel found a smallpox vials 
they transferred them to the NIH responsible official 
apparently without taking any steps to package and transfer the 
vials in a safe manner.
    In fact, the FBI and CDC highlighted that the individuals 
who carried the boxes to NIH responsible officer heard the 
vials clinking together. What steps should this individual have 
taken in transporting the vials?
    Dr. Pillai. This is one of those situations where we had 
not anticipated to take place. So there were no appropriate 
safety procedures and protocols for the transfer of such 
materials from one----
    Mr. Murphy. I'm stopping you there. That's why we're having 
this hearing.
    Dr. Pillai. Right.
    Mr. Murphy. So how long has FDA been involved with 
diseases? Since your beginning.
    Dr. Pillai. Right.
    Mr. Murphy. So you ought to have some--for you to tell me 
you had not anticipated that you'd be transporting something 
that's a viable pathogen with deadly results--you had not 
anticipated that? I'm sorry, that's just not acceptable, 
Doctor. That's why we keep having these hearings.
    How many personnel from the FDA have been involved in 
investigating this problem?
    Dr. Pillai. I totally agree with you.
    Mr. Murphy. How many personnel from the FDA have been 
involved in investigating this problem?
    Dr. Pillai. There is a large group of individuals involved.
    Mr. Murphy. Five? A hundred?
    Dr. Pillai. I would say not as much as a hundred but a 
significant number of folks.
    Mr. Murphy. How many hours have been spent on this?
    Dr. Pillai. I would say probably many hours, to be honest.
    Mr. Murphy. I don't know what many means.
    Dr. Pillai. I don't have the exact number of hours.
    Mr. Murphy. Hundreds of hours?
    Dr. Pillai. Probably.
    Mr. Murphy. Dr. Monroe, how many hours involved with CDC in 
investigating these things?
    Dr. Monroe. Investigating----
    Mr. Murphy. Investigating these problems with pathogens and 
transport and some of these difficulties? Any idea?
    Dr. Monroe. I would have to, you know, get back with an 
estimate of the number of hours. But, for each of the incidents 
that CDC was directly involved with, we had an internal team 
plus the external select team.
    Mr. Murphy. Quite a few, Dr. Tabak, I'm assuming? You may 
not know the numbers, but quite a few hours were involved?
    Dr. Tabak. Yes, indeed.
    Mr. Murphy. So I think we'd rather have your scientists 
involved with science in identifying causes of diseases and 
cures for them. But the fact that we have had multiple hearings 
on this and Mr. Neumann, you were involved with hours of work 
in this, too, and there's lots of things your office has been 
doing, as well.
    And then to say--Dr. Tabak, to go back to the point, you 
didn't even mention to this committee again that some of those 
pathogens were alive. Dr. Pillai, you're saying we didn't have 
a procedure in place for transporting these things.
    Dr. Pillai. But we do have procedures.
    Mr. Murphy. But you had said----
    Dr. Pillai. But not for pathogens of this nature. This 
event was unusual in the sense that when the discovery was 
made, it was made by scientists who are not familiar with the 
policies and procedures of dealing with select agents.
    Mr. Murphy. Whoa, whoa, whoa. This is an office that deals 
with select agents. They didn't know how to transport them? I 
just find this astonishing.
    So here's where I'm getting to with this.
    Dr. Pillai. Right.
    Mr. Murphy. We've also been informed in the past--I'm not 
sure if it was CDC or someone--we have to understand these are 
scientists, and sometimes they get a little absent-minded and 
you have to--I don't accept that.
    The American public doesn't accept that. Someone had 
salmonella. Thank goodness that person recovered, right?
    But this can have deadly consequences. These are offensive 
weapons. I'm pleased that DoD has taken definitive action on 
this. This was a tragic mistake--unfortunate mistake. Luckily 
caught it, taken definitive action. I just don't find it 
acceptable the scientific community kind of gives it the shrug.
    Now, we've seen that shrug before when GM was here and 
someone, you know, decided we're going to shrink a spring in a 
steering column and, you know, save a few cents on each car and 
some people died. Oh, well. No one spoke up.
    When Volkswagen was here someone mysteriously came up with 
some sort of a software formula and--suddenly, in the morning 
we didn't know how to pass the EPA tests, in the afternoon we 
suddenly did, and no one said, ``How'd you do that?''
    And so now they're facing so many billions of dollars worth 
of suits and other fines. I don't know if that company is going 
to survive.
    But those are cars, and here we're talking about diseases, 
and I would hope the lesson you take from this committee--and 
I'm tired of going over this because we keep having this 
conversation.
    But if your scientists are saying, ``Gee, we never thought 
about how to transport something that's deadly--never really 
thought about that''--then find a new job.
    Look, we all make mistakes. I mean, we're human. We make 
mistakes, that's what it is. I get that. I have no problem with 
that.
    I just want to make sure we have some sense of learning, 
and if someone says well, yes, never had a protocol of how to 
transport deadly diseases from one place to another, and the 
bottles are clinking together--gee, what do I do about that?
    They weren't transporting bottles to return--a Coke for 
deposits and they're clinking together. I hope that you're 
going to do a lot more with training as this proceeds.
    Well, it looks like other members are not going to be here. 
So I ask unanimous consent that the document binder be 
introduced into the record and to authorize staff to make any 
appropriate redactions.
    Without objection, the documents will be entered into the 
record with any redactions the staff determines are 
appropriate.
    [The information has been retained in committee files and 
also is available at  http://docs.house.gov/Committee/Calendar/
ByEvent.aspx?EventID=104823.]
    Mr. Murphy. In conclusion, I thank all the witnesses and 
members that participated in today's hearing. I remind members 
they have 10 business days to submit questions for the record. 
I ask the witnesses to all agree to respond promptly to the 
questions, and with that this committee is adjourned.
    [Whereupon, at 11:43 a.m., the hearing was adjourned.]
    [Material submitted for inclusion in the record follows:]

                 Prepared statement of Hon. Fred Upton

    Mr. Chairman, thank you for holding this hearing. The 
subcommittee meets again as in previous years about the 
challenge of improving safety at the Federal Government's high-
containment laboratories. During 2014 and 2015 several lapses 
in safety at HHS agency and Defense Department labs could have 
exposed Federal personnel and other individuals to hazardous 
biological agents.
    In response to these concerns, there have been executive-
branch wide efforts and internal agency efforts to improve lab 
safety. At the request of the bipartisan leadership of the 
committee, the GAO will present its report on oversight at 
Federal high-containment labs. The GAO will tell us that much 
work still needs to be done. Most of the Federal agencies need 
more comprehensive or up-to-date policies.
    However, to really stop this troubling pattern of safety 
lapses at our bioterrorism labs, changes on paper will not be 
enough if the agencies are not addressing cultural and 
behavioral factors. To its credit, the Department of Defense 
and the Centers for Disease Control have conducted internal, 
soul-searching reviews into the root causes of incidents. These 
internal investigations revealed various failures at both the 
systemic and individual level. As noted in the CDC testimony, 
these deep and critical internal reviews are essential to 
reforming lab safety.
    With regard to the lapse involving the discovery of the 
smallpox vials in an FDA lab on the NIH campus, both the NIH 
and the FDA have yet to conduct the necessary self-examination 
and introspection to fully understand the weaknesses and 
failures that led to smallpox being unknowingly stored in an 
unregistered, and improperly secured conditions. I hope this 
hearing helps the NIH and the FDA to undertake such reviews. We 
want NIH, FDA, and all our Federal laboratories to be 
successful in implementing lab safety improvements. These labs 
conduct vital research that can lead to the development of 
treatments, diagnostic, and vaccines to address public health 
needs. This research is also important to our defense efforts 
against bioterrorism, a serious threat to our troops, our 
nation, and our allies.
    Finally, it is disappointing that the CDC produced blacked-
out documents in response to my confidential request letter on 
behalf of the committee to obtain key investigative information 
about improperly stored anthrax at the NIH and the FDA in 2012. 
There is no legal basis for the CDC to withhold such 
information from its authorizing committee in Congress. I would 
urge the CDC to live up to its claims of transparency and 
accountability, and to work cooperatively with this committee, 
as has occurred in the past.


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