[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]






                   REVIEW OF CDC ANTHRAX LAB INCIDENT

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

                                HEARING

                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED THIRTEENTH CONGRESS

                             SECOND SESSION

                               __________

                             JULY 16, 2014

                               __________

                           Serial No. 113-160


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]



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                    COMMITTEE ON ENERGY AND COMMERCE

                          FRED UPTON, Michigan
                                 Chairman
RALPH M. HALL, Texas                 HENRY A. WAXMAN, California
JOE BARTON, Texas                      Ranking Member
  Chairman Emeritus                  JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky                 Chairman Emeritus
JOHN SHIMKUS, Illinois               FRANK PALLONE, Jr., New Jersey
JOSEPH R. PITTS, Pennsylvania        BOBBY L. RUSH, Illinois
GREG WALDEN, Oregon                  ANNA G. ESHOO, California
LEE TERRY, Nebraska                  ELIOT L. ENGEL, New York
MIKE ROGERS, Michigan                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
PHIL GINGREY, Georgia                JIM MATHESON, Utah
STEVE SCALISE, Louisiana             G.K. BUTTERFIELD, North Carolina
ROBERT E. LATTA, Ohio                JOHN BARROW, Georgia
CATHY McMORRIS RODGERS, Washington   DORIS O. MATSUI, California
GREGG HARPER, Mississippi            DONNA M. CHRISTENSEN, Virgin 
LEONARD LANCE, New Jersey                Islands
BILL CASSIDY, Louisiana              KATHY CASTOR, Florida
BRETT GUTHRIE, Kentucky              JOHN P. SARBANES, Maryland
PETE OLSON, Texas                    JERRY McNERNEY, California
DAVID B. McKINLEY, West Virginia     BRUCE L. BRALEY, Iowa
CORY GARDNER, Colorado               PETER WELCH, Vermont
MIKE POMPEO, Kansas                  BEN RAY LUJAN, New Mexico
ADAM KINZINGER, Illinois             PAUL TONKO, New York
H. MORGAN GRIFFITH, Virginia         JOHN A. YARMUTH, Kentucky
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Missouri
BILLY LONG, Missouri
RENEE L. ELLMERS, North Carolina
              Subcommittee on Oversight and Investigations

                        TIM MURPHY, Pennsylvania
                                 Chairman
MICHAEL C. BURGESS, Texas            DIANA DeGETTE, Colorado
  Vice Chairman                        Ranking Member
MARSHA BLACKBURN, Tennessee          BRUCE L. BRALEY, Iowa
PHIL GINGREY, Georgia                BEN RAY LUJAN, New Mexico
STEVE SCALISE, Louisiana             JANICE D. SCHAKOWSKY, Illinois
GREGG HARPER, Mississippi            G.K. BUTTERFIELD, North Carolina
PETE OLSON, Texas                    KATHY CASTOR, Florida
CORY GARDNER, Colorado               PETER WELCH, Vermont
H. MORGAN GRIFFITH, Virginia         PAUL TONKO, New York
BILL JOHNSON, Ohio                   JOHN A. YARMUTH, Kentucky
BILLY LONG, Missouri                 GENE GREEN, Texas
RENEE L. ELLMERS, North Carolina     HENRY A. WAXMAN, California (ex 
JOE BARTON, Texas                        officio)
FRED UPTON, Michigan (ex officio)


















  
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Tim Murphy, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................     1
    Prepared statement...........................................     3
Hon. Diana DeGette, a Representative in Congress from the state 
  of Colorado, opening statement.................................     4
Hon. Fred Upton, a Representative in Congress from the state of 
  Michigan, opening statement....................................     6
    Prepared statement...........................................     7
Hon. Henry A. Waxman, a Representative in Congress from the state 
  of California, opening statement...............................     8
Hon. Phil Gingrey, a Representative in Congress from the State of 
  Georgia, prepared statement....................................   111

                               Witnesses

Thomas R. Frieden, Director, Centers for Disease Control and 
  Prevention.....................................................    10
    Prepared statement...........................................    13
    Answers to submitted questions...............................   115
Jere Dick, Associate Deputy Administrator, Animal and Plant 
  Health Inspection Services, U.S. Department of Agriculture.....    26
    Prepared statement...........................................    28
Nancy Kingsbury, Managing Director, Applied Research and Methods, 
  Government Accountability Office...............................    32
    Prepared statement...........................................    34
Sean Kaufman, President and Founding Partner, Behavioral-Based 
  Improvement Solutions, LLC.....................................    72
    Prepared statement...........................................    75
Richard Ebright, Rutgers University, Board of Governors, 
  Professor of Chemistry and Chemical Biology....................    85
    Prepared statement \1\.......................................    88

                           Submitted Material

Minority memo....................................................   112
Document binder \2\

----------
\1\ The appendices to Mr. Ebright's testimony are available at 
  http://docs.house.gov/meetings/IF/IF02/20140716/102479/HHRG-
  113-IF02-Wstate-EbrightR-20140716-SD001.pdf.
\2\ The document binder is available at http://docs.house.gov/
  Committee/Calendar/ByEvent.aspx?EventID=102479.

 
                   REVIEW OF CDC ANTHRAX LAB INCIDENT

                              ----------                              


                        WEDNESDAY, JULY 16, 2014

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call at 10:00 a.m., in 
room 2123, Rayburn House Office Building, Hon. Tim Murphy 
(chairman of the subcommittee) presiding.
    Present: Representatives Murphy, Blackburn, Gingrey, 
Harper, Griffith, Johnson, Long, Ellmers, Barton, Upton (ex 
officio), DeGette, Braley, Schakowsky, Castor, Tonko, Green, 
and Waxman (ex officio).
    Staff Present: Sean Bonyun, Communications Director; 
Leighton Brown, Press Assistant; Karen Christian, Chief 
Counsel, Oversight; Noelle Clemente, Press Secretary; Andy 
Duberstein, Deputy Press Secretary; Carrie-Lee Early, Detailee, 
Oversight; Brad Grantz, Policy Coordinator, O&I Brittany 
Havens, Legislative Clerk; Sean Hayes, Deputy Chief Counsel, 
O&I Emily Newman, Counsel, O&I Alan Slobodin, Deputy Chief 
Counsel, O&I Phil Barnett, Staff Director; Peter Bodner, 
Counsel; Brian Cohen, Staff Director, O&I, Senior Policy 
Advisor; Lisa Goldman, Counsel; and Elizabeth Letter, Press 
Secretary.

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

    Mr. Murphy. Good morning. The subcommittee on Oversight and 
Investigations today examines the Center for Disease Control 
and Prevention's anthrax incident last month that potentially 
exposed dozens of CDC researchers to live anthrax because 
established safety procedures were not followed.
    Last Friday, the CDC director announced the findings of 
CDC's own internal review of the incident and the corrective 
actions being taken. CDC's review identified a fundamental 
flaw. The Agency had no written study plan to ensure the safety 
of its workers and the proper handling of live biological 
agents.
    Like anthrax, the Department of Agriculture's investigation 
revealed more disturbing detail. During the inspection, CDC 
workers could not locate some of their anthrax samples. It took 
more than a week for the inspectors and CDC management to track 
down the anthrax samples that are in CDC's custody. Agriculture 
inspectors also uncovered that CDC was transferring dangerous 
material from biological containment labs in Ziploc bags. 
Disinfectant that CDC labs use for decontamination has expired. 
This is troubling, and it is completely unacceptable.
    The Centers for Disease Control and Prevention is supposed 
to be the gold standard of the U.S. public health system, and 
it has been tarnished. We rely on CDC to protect us and uphold 
the highest standards of safety, but the recent anthrax event 
and newly-disclosed incidents have raised very serious 
questions about CDC's ability to safeguard properly-selected 
agents in its own labs.
    The CDC director has called the potential anthrax exposure 
a wakeup call, but our investigation has uncovered this is not 
CDC's first wakeup call. I am not even sure ``wakeup call'' is 
the proper term. It is a gross and dangerous understatement. It 
was a potentially very dangerous failure. Wakeup call is 
catching something before the danger exists. Once a person is 
exposed to the serious pathogens, the danger is of a much 
higher magnitude.
    In 2006, the CDC Bioterrorism Lab sent live anthrax to two 
outside labs on the mistaken belief that the shipped anthrax 
was inactivated. Later that same year, inadequate inactivation 
procedures led another CDC lab to inadvertently ship live 
botulinum to an outside lab. In 2009, CDC learned from newly-
available test methods that a strain of brucella, which can 
cause a highly-contagious infection, had been shipped to 
outside labs since 2001 because researchers had believed that 
it was a less dangerous strain. One must question the 
scientific qualifications of these scientists.
    Reports by government watchdogs demonstrate that these 
events are not isolated incidents. Between 2008 and 2010, the 
HHS Office of Inspector General, or OIG, issued three reports 
documenting concerns that CDC labs, such as ensuring physical 
security of select agents and ensuring personnel receive 
required training. An audit in 2010 found that a CDC scientist 
discovered select agents in a drawer in an unsecured lab during 
a reorganization, and another CDC scientist found 16 vials of a 
select agent stored in an unsecured freezer that was reportedly 
left over from an outbreak investigation many years earlier.
    This is reminiscent of the recent discovery of smallpox 
vials in a storage room on the NIH campus. This smallpox was in 
a place that no one knew it was there, and it was also 
discovered by accident.
    In 2011, the OIG found that CDC did not monitor and enforce 
effectively certain select agent regulations at Federal 
laboratories, including those at the CDC. In addition to the 
Inspector General audits, several GAO reports in recent years 
have raised concerns about oversight of high containment labs, 
including those at CDC.
    Despite the number of red flags, these incidents keep 
happening. We learned last Friday that CDC scientists in March 
shipped influenza strains to a Department of Agriculture lab 
that was contaminated with a very deadly flu virus. This cross-
contamination was discovered on May 23rd, 2014, but it took 6 
weeks for this to be reported to CDC leadership.
    What we have here is a pattern of reoccurring issues, of 
complacency, and a lax culture of safety. This is not sound 
science, and this will not be tolerated. These practices put 
the health of the American public at risk. It is sloppy, and it 
is inexcusable.
    Now, Dr. Frieden, I thank you for testifying today. I have 
questions about whether the corrective actions you have 
announced will ultimately solve the problems. We will be 
looking forward to your testimony. CDC has already reassigned 
one lab official from his duties. Taking personnel actions, 
though, will not address problems that based on the number of 
incidents and reports over the years appear to be systemic.
    CDC needs to reassure that proper policies are implemented 
and followed. Dr. Frieden, you said last Friday that you were 
distressed about the delay of notification about the influenza 
shipments. I want to know if you are concerned about why CDC 
workers are not reporting everything, and whether you have 
reason to believe that they may be afraid to report these 
incidents.
    CDC is not going to solve human errors unless it gets as 
much information as possible from its own people. Since 2007, 
there have been 17 reports at CDC indicating that a worker was 
potentially exposed to a select agent or toxin. Thankfully, as 
far as we are aware, no one at CDC has become sick from 
improper handling of select agents. But CDC should not assume 
that its luck with these near miss events will continue. Sooner 
or later that luck will run out, and someone will get very sick 
or die.
    CDC needs to strengthen its safety procedures. The risk 
from these deadly pathogens require failsafe mechanisms and 
redundancies similar to those used in other contexts, such as 
handling weapons. The subcommittee will also review the 
oversight system of Federal laboratories, compliance with 
select agent regulations, and to explore the possibility of an 
independent agency to oversee the CDC labs.
    I thank all the witnesses for testifying today, and I now 
recognize the ranking member, Ms. DeGette.
    [The prepared statement of Mr. Murphy follows:]

                 Prepared statement of Hon. Tim Murphy

    The subcommittee today examines the CDC anthrax incident 
last month that potentially exposed dozens of CDC researchers 
to live anthrax because established safety procedures were not 
followed.
    Last Friday, the CDC Director announced the findings of 
CDC's own internal review of the incident and the corrective 
actions being taken. CDC's review identified a fundamental 
flaw: the agency had no written study plan to ensure the safety 
of its workers and the proper handling of live biological 
agents, like anthrax. The Department of Agriculture's 
investigation revealed more disturbing details. During the 
inspection, CDC workers could not locate some of their anthrax 
samples. It took more than a week for the inspectors and CDC 
management to track down the anthrax samples that are in CDC's 
custody. Agriculture inspectors also uncovered that CDC was 
transferring dangerous materials from biocontainment labs in 
Ziploc bags. Disinfectant that CDC labs used for 
decontamination was expired.
    This is troubling and it is completely unacceptable.
    The Centers for Disease Control is supposed to be the gold 
standard in the U.S. public health system and it has been 
tarnished. We rely on CDC to protect us and uphold the highest 
standards of safety. But the recent anthrax event and newly 
disclosed incidents have raised very serious questions about 
the CDC's ability to safeguard properly select agents in its 
own labs.
    The CDC Director has called the potential anthrax exposure 
a ``wake up'' call. But as our investigation has uncovered, 
this is not CDC's first ``wake up'' call. I'm not even sure 
``wake up'' call is the proper term.
    A ``wake up call?'' That is a gross and dangerous 
understatement. It was a potentially very dangerous failure. A 
``wake up'' call is catching before the danger occurs.
    Once a person is exposed to a serious pathogen, the danger 
is of a much higher magnitude.
    In 2006, the CDC bioterrorism lab sent live anthrax to two 
outside labs on a mistaken belief that the shipped anthrax was 
inactivated. Later that same year, inadequate inactivation 
procedures led another CDC lab to inadvertently ship live 
botulinum to an outside lab.
    In 2009, CDC learned from newly available test methods that 
a strain of Brucella, which can cause a highly contagious 
infection, had been shipped to outside labs since 2001 because 
researchers had believed that it was a less dangerous strain. 
One must question the scientific qualification of such 
scientists.
    Reports by government watchdogs demonstrate that these 
events are not isolated incidents. Between 2008 and 2010, the 
HHS Office of Inspector General (OIG) issued three reports 
documenting concerns at CDC labs such as ensuring physical 
security of select agents and ensuring personnel received 
required training. An audit in 2010 found that a CDC scientist 
discovered select agents in a drawer in an unsecured lab during 
a reorganization, and another CDC scientist found 16 vials of a 
select agent stored in an unsecured freezer that was reportedly 
left over from an outbreak investigation many years earlier. 
This is reminiscent of the recent discovery of smallpox vials 
in a storage room on the NIH campus. The smallpox was 
undocumented, no one knew it was there, only discovered by 
accident. In 2011, the OIG found that CDC did not monitor and 
enforce effectively certain select agent regulations at Federal 
laboratories, including those at the CDC. In addition to the 
Inspector General audits, several GAO reports in recent years 
have raised concerns about oversight of high-containment labs, 
including those at the CDC.
    Despite the number of red flags, these incidents keep 
happening. We learned last Friday that CDC scientists in March 
shipped influenza strains to a Department of Agriculture lab 
that was contaminated with a very deadly flu virus. This cross 
contamination was discovered on May 23, 2014, but it took six 
weeks for this to be reported to CDC leadership.
    What we have here is a pattern of recurring issues, of 
complacency, and a lax culture of safety. This is not sound 
science and we will not tolerate these practices that put the 
health of the American public at risk. It is sloppy and 
inexcusable.
    Dr. Frieden, I thank you for testifying today. I have 
questions about whether the corrective actions you have 
announced will ultimately solve the problem. CDC has already 
reassigned one lab official from his duties. Taking personnel 
actions, though, will not address problems that--based on the 
number of incidents and reports over the years--appear to be 
systemic. CDC needs to ensure that proper policies are 
implemented and followed. Dr. Frieden, you said last Friday 
that you are distressed about the delay in notification about 
the influenza shipments. I want to know if you are concerned 
about why CDC workers are not reporting everything and whether 
you have any reason to believe they may be afraid to report 
these incidents. Is this going to be like the Veterans 
Administration, frought with coverups and dependent on 
whistleblowers, outside investigators, and accidental 
discoveries.
    CDC is not going to solve human errors unless it gets as 
much information as possible from its own people.
    Since 2007, there have been 17 reports at CDC indicating 
that a worker was potentially exposed to a select agent or 
toxin. Thankfully, as far as we are aware, no one at CDC has 
become sick from improper handling of select agents. But CDC 
should not assume that its luck with these near-miss events 
will continue. Sooner or later, that luck will run out and 
someone will die. CDC needs to strengthen its safety 
procedures. The risks from these deadly pathogens require fail-
safe mechanisms and redundancies similar to those used in other 
contexts such as handling weapons.
    The subcommittee will also review the oversight system of 
Federal laboratories' compliance with select agent regulations, 
and to explore the possibility of an independent agency to 
oversee the CDC labs.
    I thank all the witnesses for testifying today.

                                #  #  #

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

    Ms. DeGette. Thank you very much, Mr. Chairman. Last month, 
scientists at CDC's BRRAT Laboratory in Atlanta made a series 
of mistakes that could have had deadly consequences. They 
transferred anthrax spores to two other labs, potentially 
exposing dozens of individuals to anthrax. Luckily, nobody has 
yet fallen ill.
    Like all of us, I am deeply troubled by what we have 
learned about this incident. How did it happen? CDC conducted 
its own internal investigation that identified numerous 
failures. There was no standard operating procedure for the 
analysis being conducted by the CDC scientists. There was no 
approved study plan. The scientists used a pathogenic strain of 
anthrax when a non-pathogenic strain could have been used. The 
scientists used unapproved sterilization techniques for 
pathogenic anthrax, and then proceeded to transfer the material 
without confirming that it was inactive.
    This is obviously an alarming series of failures, but there 
were other problems at CDC that made this incident worse. CDC 
has provided to the committee a disturbing report from the U.S. 
Department of Agriculture Animal and Plant Health Inspection 
Service, APHIS. After the anthrax incident, APHIS conducted its 
own inspection of the facility. Inspectors identified serious 
problems in lab operations and decontamination procedures, but 
also detailed major problems with the CDC's response to the 
incident, reporting that the Agency was inadequately prepared 
to handle the cleanup or to treat those who were potentially 
exposed.
    I think we can all agree the reports on this incident are 
bad. But what is even more troubling to me is that in context, 
they reveal a broad problem with the CDC's safety culture. We 
have received report after report from GAO, the HHS IG, and 
APHIS offering a multitude of warnings and recommendations on 
operations of high containment labs. CDC's after action report 
identified four other cases in the last decade where CDC 
shipped dangerous pathogens offsite.
    The Democratic committee staff prepared a memo describing 
the results from six different APHIS inspections at the CDC 
Roybal facility in 2013 and '14. Overall, in the six 
inspections, APHIS identified dozens of observations of 
concerns, 29 related to facilities and equipment, 27 related to 
safety and security, and 39 related to documentation and record 
keeping. In some cases, the APHIS observations revealed that 
what appeared to be only paperwork problems, but in other 
cases, they found many more serious problems. They found 
reports of scientists using torn gloves and exhaust hoods 
blowing fumes in the wrong direction. Not one of these six 
inspections gave the CDC a totally clean bill of health.
    Now, I would like to make this memo part of the record, Mr. 
Chairman. I think your staff has seen it.
    Mr. Murphy. Without objection.
    Ms. DeGette. The record shows that CDC had ample warnings 
and should have been focused on the problems in their high 
containment labs long before the June anthrax release. I just 
do not understand why they did not heed those warnings. Dr. 
Frieden has indicated that he was as surprised as anybody by 
the scope of the problems. And the fact, Dr. Frieden, you were 
so surprised is a problem in and of itself because what it 
shows is that there is a fundamental problem with the culture 
of identifying and reporting safety problems up the chain of 
command.
    Now, I am sorry to say, Mr. Chairman, these lab safety 
issues are not new to me or the committee. This is one of the 
detriments of having been on this committee for 18 years. We 
have had multiple hearings on this problem at the CDC over the 
years. In 2006 and 2007, we had terrible problems at the CDC 
facility in Fort Collins, Colorado just north of my district 
where we had vector-borne diseases that were being very 
sloppily handled.
    Fortunately, we built a new facility since then up in Fort 
Collins. It is a beautiful facility, and we are able to handle 
these diseases. But, you know, these issues are not resolving 
themselves. And so, Dr. Frieden, you have got a strong record 
at the CDC. I know you have got answers and recommendations, 
and you are acting aggressively to make sure this does not 
happen again. I appreciate that. We all appreciate that. But 
what we all need to know is what the plan is to change the 
culture at the CDC. We cannot legislate. We can do a lot, but 
we cannot legislate a culture change. It has to come from 
within the Agency.
    I am also glad to have GAO and APHIS witnesses here because 
in retrospect, your warnings were prescient and should have 
been taken more seriously.
    I can assure you these warnings are being taken very 
seriously right now, not just by the Agency, but by the people 
here on this panel. Thank you very much, Mr. Chair.
    Mr. Murphy. Thank you. The gentlelady's time has expired. 
And I will recognize the chairman of the full committee, Mr. 
Upton, for 5 minutes.

   OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF MICHIGAN

    Mr. Upton. Well, thank you, Mr. Chairman. This is a very 
serious hearing for sure. 2 years ago after allegations about 
problems in CDC's Building 18, the home of the world's 
deadliest agents and pathogens, this committee investigated 
whether the CDC was complying with Federal safety requirements 
in the operation of its main lab facilities.
    In response to our concerns, CDC Director Tom Frieden sent 
the committee a letter in September of '12. The CDC letter, 
which I would like to include in the record, outlined the 
Agency's efforts to ensure better oversight and safe handling 
of select agents at CDC labs.
    These measures included rigorous training, constant review 
of safety measures, multiple layers of engineering and 
operational systems. The letter also stated that a senior 
official, who was not identified, would be designated to report 
directly to the CDC director on safety at CDC labs. These 
measures sound very similar to the corrective actions that Dr. 
Frieden outlined last week to address the current lab crisis. 
Why should we believe this time that things are, in fact, going 
to be different?
    We asked CDC 2 years ago to identify each biosafety 
incident that had taken place at its main lab since January 1st 
of '05. CDC provided the committee with a list back in 2012, 
but we now know from CDC's internal investigation released last 
Friday that, in fact, the list was not complete. Improper 
shipments of pathogens in '06, including anthrax, were not 
included in CDC's list of safety incidents that, in fact, was 
provided to this committee.
    CDC staff has now acknowledged to committee staff that the 
'06 incidents, which were reported to the HHS IG, should have 
been included. We do not know why they were not. This raises 
the question of whether CDC leadership is receiving all the 
information about its own biosafety systems.
    Add to the possible anthrax exposure, the delayed notice 
provided to CDC leadership about Avian flu shipments, and the 
discovery of smallpox vials in a cardboard box in an FDA 
storage room on the NIH campus, and these incidents no longer 
appear isolated. A dangerous, very dangerous, pattern is 
emerging, and there are a lot of unknowns out there as well.
    When dealing with pathogens, such as the ones being 
discussed today, unknowns are frankly unacceptable. What you do 
not know can hurt you. Why do these events keep happening? What 
is going to be next? CDC needs to solve the safety problem now 
as a team. The Agency needs to get as much info as possible 
from its workers about the true state of biosafety at CDC, and 
keep this committee and the American people fully informed. 
There is zero tolerance for unlocked refrigerators and Ziploc 
bags. Those days have to be over.
    I yield to Marsha Blackburn.
    [The prepared statement of Mr. Upton follows:]

                 Prepared statement of Hon. Fred Upton

    Two years ago, after allegations about problems in CDC's 
Building 18--the home to the world's deadliest agents and 
pathogens--this committee investigated whether the CDC was 
complying with federal safety requirements in the operation of 
its main lab facilities. In response to our concerns, CDC 
Director Tom Frieden sent the committee a letter in September 
2012.
    The CDC letter, which I would like to include in the 
record, outlined the agency's efforts to ensure better 
oversight and safe handling of select agents at CDC labs. These 
measures included rigorous training, constant review of safety 
measures, and multiple layers of engineering and operational 
systems. The letter also stated that a senior official--who was 
not identified--would be designated to report directly to the 
CDC Director on safety at CDC labs. These measures sound very 
similar to the corrective actions Dr. Frieden outlined last 
Friday to address the current lab crisis. Why should we believe 
this time that things will be different?
    We asked CDC 2 years ago to identify each biosafety 
incident that had taken place at its main lab since January 1, 
2005. CDC provided the committee with a list back in 2012--but 
we now know from CDC's internal investigation report released 
last Friday that the list was not complete. Improper shipments 
of pathogens in 2006, including anthrax, were not included in 
CDC's list of safety incidents that was provided to this 
committee. CDC staff has now acknowledged to committee staff 
that the 2006 incidents, which were reported to the HHS 
Inspector General, should have been included. We don't know why 
they were not. This raises the question of whether CDC 
leadership is receiving all the information about its biosafety 
systems.
    Add to the possible anthrax exposure the delayed notice 
provided to CDC leadership about avian flu shipments and the 
discovery of smallpox vials in a cardboard box in an FDA 
storage room on the NIH campus, and these incidents no longer 
appear isolated; a dangerous pattern is emerging, and there are 
a lot of unknowns out there. When dealing with pathogens such 
as the ones being discussed today, unknowns are unacceptable.
    What you don't know can hurt you. Why do these events keep 
happening? What will be next? CDC needs to solve this safety 
problem now, as a team. The agency needs to get as much as 
information as possible from its workers about the true state 
of biosafety at CDC, and keep this committee and the American 
people fully informed on its progress. There is zero tolerance 
for unlocked refrigerators and Ziploc bags--those days are 
over.

    Ms. Blackburn. I thank the chairman for yielding. I want to 
thank our panel for being here. And as you can hear, on a 
bipartisan basis we have plenty of questions for you. We are 
deeply concerned about the incidents that have occurred at the 
Federal labs that are run by the Department of Health and Human 
Services, CDC, with the anthrax specimens.
    Dr. Frieden, we appreciate the time you spent with us last 
week, but I think we do have plenty of questions for you about 
the safety and the carefulness. We would think that the 
priority would be safety and caring and making certain that you 
are tending to that culture of safety within these labs.
    NIH, with the vials of smallpox, and the fact that this was 
in an unused portion of a storage room. Who all would have 
access to that? And then, of course, the cross-contamination of 
the influenza sample.
    We have all talked about these three events. And the fact 
that they have occurred within this framework of time, the fact 
that there seemed to be a dismissiveness of the serious nature 
of these occurrences, the fact that the CDC's own report 
pointed out some of the contributing factors in this, and the 
lack of a standard operating procedure, and best practices; and 
the fact that this is known among the employees at that Agency.
    We know that there are some remediation measures that have 
been implemented, but the culture of safety or lack thereof 
continues to be a concern to us for public health. I yield back 
my time.
    Mr. Murphy. Thank you. I now recognize Mr. Waxman for 5 
minutes.

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    Mr. Waxman. Thank you very much, Mr. Chairman, for holding 
this hearing. I think it is important for us to investigate 
this incident involving the release of potentially viable 
anthrax on CDC's campus in Atlanta.
    When I was chairman of the Oversight Committee, we held 
hearings after the 2001 anthrax attacks. We looked at the 
safety of postal workers and the public in handling mail, and 
the Postal Service and CDC's response to those attacks. We had 
hearings again in 2003 and 2005 where we found there were still 
gaps in biological detection of anthrax and in communicating 
test results and risks to the public.
    Those hearings showed why CDC's work on identifying and 
containing public health risks from these types of biological 
agents is so important. But this work can also pose risks, and 
that is why this oversight hearing is important.
    In 2009 when I was chairman of the full committee, we held 
a hearing on the proliferation of high containment bio labs and 
the lack of oversight over such facilities. Mr. Dingell also 
held a hearing in 2007, so this is not our first introduction 
to this subject.
    At our request, GAO, the Government Accountability Office, 
also looked into lab safety. GAO reported in a number of 
studies, one as recently as 2013, on the problems associated 
with the government's fragmented piecemeal approach to these 
labs. No single agency has oversight over all high containment 
bio labs. There are no national standards for operation, and we 
have no record of how many labs even exist.
    The Health and Human Services Inspector General also issued 
numerous reports on high containment labs and their handling of 
select agents. The Inspector General identified issues with the 
treatment of select agents and the safety of the individuals 
working with these dangerous pathogens. The Inspector General 
recommended that the Centers for Disease Control labs improve 
training for individuals handling select agents, improve record 
keeping, and take appropriate measures to improve safety.
    The American people count on the Centers for Disease 
Control to protect them, and we want to be able to assure them 
that CDC is conducting its research in safe and secure ways.
    I am supportive of Dr. Frieden's efforts at CDC. We have 
worked with him on numerous issues in the last 5 years, and he 
has shown himself to be an effective leader and a strong 
communicator. And I appreciate the quick actions that he has 
taken in response to this incident. I am encouraged to see that 
Dr. Frieden has appointed Dr. Michael Bell to oversee 
laboratory safety protocols and procedures. This investigation 
has shown us that CDC needs to change its safety culture, and I 
hope that Dr. Bell can help instill a new mindset at the 
Agency.
    Still, I am concerned that it took the exposure of dozens 
of CDC staff to anthrax to finally spur CDC to action. So we 
want answers from the CDC about how this incident was allowed 
to happen in the first place. And I look forward to hearing 
from APHIS and GAO about the problems they have identified in 
the past, how CDC should implement their recommendations moving 
forward, and what role Congress should play in making sure that 
happens.
    Mr. Chairman, this is not the first hearing on the subject. 
We have looked at it before. We need now finally to be sure 
that all the recommendations that we have had are put in place 
so that we can stop something like this from happening again.
    Thank you, and I yield back my time.
    Mr. Murphy. Thank you. I now would like to introduce the 
witnesses on the first panel for today's hearing. First, Dr. 
Thomas Frieden is the director of the Centers for Disease 
Control and Prevention. Today Dr. Frieden is accompanied by Mr. 
Joseph Henderson, who is the deputy director of the Office of 
Security and Emergency Preparedness at the Centers for Disease 
Control. Dr. Jere Dick is the associate deputy administrator of 
the Animal and Plant Health Inspection Services at the U.S. 
Department of Agriculture. Dr. Nancy Kingsbury is the managing 
director of Applied Research and Methods at the U.S. Government 
Accountability Office. And, Dr. Gingrey, did you want to 
introduce someone who is from your district?
    Mr. Gingrey. Mr. Chairman, thank you very much for giving 
me the opportunity. I know this witness is on the second panel, 
and it will be a little while before we will be hearing from 
the second panel. But it is an honor and a pleasure to 
introduce off of the second panel Sean Kaufman.
    Mr. Kaufman is the president and founding partner of a 
company called Behavioral-Based Improvement Solutions. His 
background is long-term employment with the CDC before forming 
his own company in my district, the 11th Congressional District 
of Georgia in Woodstock, Georgia.
    And I would encourage all the members on both sides of the 
aisle, if you have not had a chance--I know we try to read all 
of the testimony, but sometimes we skip one or two along the 
way. But I will assure you that the written testimony from Mr. 
Kaufman really hits the nail right on the head in regard to 
this overall issue, and I would recommend it to you. And I am 
proud to introduce him to you in anticipation of the second 
panel.
    Mr. Chairman, thank you very much, and I yield back.
    Mr. Murphy. Thank you, Dr. Gingrey.
    To the panel, you are aware that the committee is holding 
an investigative hearing, and when doing so has the practice of 
taking testimony under oath. Do any of you have objections to 
taking testimony under oath?
    All the witnesses indicate no.
    The chair then advises you all that you are 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 during today's testimony?
    All the witnesses indicate no.
    In that case, would you all please rise and raise your 
right hand, and I will swear you in. Stand, please.[Witnesses 
sworn.]
    Mr. Murphy. Thank you. All the witnesses answered in the 
affirmative. You are now under oath and subject to the 
penalties set forth in Title 18, Section 1001 of the United 
States Code. You may now give a 5-minute summary of your 
written statement. Dr. Frieden, you are recognized.

TESTIMONIES OF THOMAS R. FRIEDEN, DIRECTOR, CENTERS FOR DISEASE 
      CONTROL AND PREVENTION; JERE DICK, ASSOCIATE DEPUTY 
  ADMINISTRATOR, ANIMAL AND PLANT HEALTH INSPECTION SERVICES, 
   U.S. DEPARTMENT OF AGRICULTURE; NANCY KINGSBURY, MANAGING 
      DIRECTOR, APPLIED RESEARCH AND METHODS, GOVERNMENT 
                     ACCOUNTABILITY OFFICE

                 TESTIMONY OF THOMAS R. FRIEDEN

    Dr. Frieden. Chairman Murphy, Ranking Member DeGette, 
members of the subcommittee, thank you very much for this 
opportunity to appear before you. I am Dr. Tom Frieden, 
director of the CDC. With me is Mr. Joe Henderson, who heads 
our Office of Security, Safety and Asset Management.
    I will review the problems that have come to light in the 
past month and tell you what we are doing now to address 
improving lab safety. The fact that it appears that no one was 
harmed and that there were no releases does not excuse what 
happened. What happened was completely unacceptable. It should 
never have happened.
    If I leave you with just one thought about today's hearing 
as it relates to CDC, it is this. With the recent incidents, we 
recognize the pattern at CDC where we need to greatly improve 
the culture of safety, and I am overseeing sweeping measures to 
improve that culture of safety.
    CDC works 24/7, and our scientists protect Americans from 
threats, including naturally-occurring threats, like Ebola, and 
MERS, and drug-resistant bacteria, and manmade threats, such as 
anthrax. But we must do that work more safely, and we will.
    There is a recap of the recent incidents that are 
summarized in our report, which has been completed, and we are 
just at the outset of our investigation of the influenza 
contamination. I would be pleased to go through the two 
diagrams that we have provided to the subcommittee which 
outline what we know to date. But in brief, the anthrax 
incident shows deeply troubling problems: a lack of proper 
protocol, incorrect inactivation procedures, failure to ensure 
that we were transferring materials that were sterile when we 
thought they were sterile, use of a virulent strain when a non-
dangerous form would have been appropriate.
    In the influenza cross-contamination, we are still trying 
to understand how the cross-contamination occurred and 
investigating how there could have been such a long delay in 
notification. The risk to employees from the anthrax exposure 
was at most very small, and the risk of release to the public 
was non-existent. But that does not change the fact that these 
were unacceptable events. They should never have happened.
    In the past, as the committee has outlined, there were a 
number of specific incidents, and I do believe that CDC staff 
worked hard to address the specific findings of past 
investigations. But I think we missed a critical pattern. 
Instead of just focusing on those, when we issued the anthrax 
report, we provided not only these two incidents, but the prior 
episodes of what has happened because what we are seeing is a 
pattern that we missed. And the pattern is an insufficient 
culture of safety.
    We are now implementing every step we can 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. I have taken a 
number of specific steps. I have issued a moratorium on the 
transfer of all biological materials outside of all BSL-3 and 4 
laboratories at CDC. I have closed the two laboratories that 
were involved in this situation until we are sure that they can 
be reopened safely. I have appointed Dr. Michael Bell, a senior 
scientist, to be Director of Laboratory Safety reporting 
directly to me as the single point of accountability. He will 
review the moratorium and lift it lab by lab when we are 
confident that can be done safely. He will also facilitate 
expansion and use of that safety culture throughout CDC.
    CDC scientists are world famous for their rigor in 
scientific investigation, and we will now apply that same rigor 
to improving the safety in our own laboratories. I am convening 
a high-level working group within CDC internally to advise us 
on every step of the process and an external advisory group of 
outside experts who are top in the world to take a fresh look 
and see what we can do to do better.
    We will look at every inactivation and transfer protocol 
and other protocols and improve them as needed. We will look at 
future incidents, if they occur, with a command structure which 
should have been used earlier in the anthrax exposure. I will 
ensure that appropriate discipline is taken as indicated by our 
investigations, and will apply lessons learned from this 
experience to our function as a regulatory agency and our 
select agents' regulatory program.
    In hindsight, we realized that we missed a crucial pattern, 
a pattern of incidents that reflected the need to improve the 
culture of safety at CDC. But as with many things, recognition 
is only the first step, and we are taking a number of 
additional actions to establish and strengthen a culture that 
prioritizes the safety of our own staff, encourages reporting 
of actual and potential situations that may place staff and 
others at risk, openly assesses those risks, and implements 
redundant systems to keep risks to the absolute minimum.
    Part of that culture will be increased reporting of 
problems or potential problems. One of the aspects of an 
effective culture of safety is rapid reporting of problems so 
if we do uncover problems in the coming weeks and months, this 
may well be the result of strengthening our culture of safety 
rather than failing to address it.
    We have concrete actions underway to change processes that 
allowed these incidents to happen, reduce the likelihood of an 
occurrence in the future, and apply the lessons broadly. We 
will do everything possible to live up to the high standards 
that Congress and the American public rightfully expect us to 
achieve.
    I look forward to your questions, and thank you for 
inviting me to testify today, and for your interest in this 
important topic.
    [The prepared testimony of Dr. Frieden follows:]
    
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    Mr. Murphy. Thank you.
    Dr. Dick, you are next. Make sure your microphone is on. 
Push it very close to your mouth. Thank you. It is not on. The 
green light. There you go.

                     TESTIMONY OF JERE DICK

    Mr. Dick. Thank you. Mr. Chairman and members of the 
subcommittee, thank you for the opportunity to testify today 
about the Animal and Plant Health Inspection Service's 
inspection into the release of possibly live anthrax at the 
CDC's Roybal campus. I am Dr. Jere Dick, associate 
administrator for APHIS within USDA.
    APHIS conducted a thorough inspection of the incident to 
learn how it happened and determine appropriate remedial 
measures. We will continue to monitor the CDC's response to 
ensure all necessary corrective action is taken, and that when 
work resumes at the laboratories, it will be done in full 
compliance with the health and safety of the employees and the 
public at the forefront.
    USDA was designated by Congress as the partner with CDC in 
the oversight of select agents because of our expertise and 
experience, safely working with select agents over the past 
century, through our efforts to prevent dangerous disease 
agents from impacting U.S. agriculture and the environment. For 
decades, APHIS has also safely operated high containment 
laboratories that handle select agents, including those of 
concern for human health. Our personnel are leading 
diagnosticians, and experts in the effective working of high 
containment laboratories.
    To ensure objectivity, APHIS and CDC signed a memorandum of 
understanding in October of 2012, which makes APHIS the lead 
inspection agency for CDC entities.
    Since the MOU was finalized, APHIS has carried out 11 
inspections of the four CDC laboratories.
    APHIS takes any potential release of a select agent or 
toxin very seriously, with the goal of quickly ensuring that 
the release is contained and determining what led to the 
release to ensure no future incidents. On June 13th, CDC 
officials discovered a potential release of anthrax and 
notified APHIS. CDC voluntarily closed impacted labs on June 
16th.
    APHIS made its inspection a priority and quickly began its 
work to ensure that all select agents were secured, and that 
there were no other breaches in biosafety or biosecurity. The 
specially-trained APHIS inspection team of veterinarians and a 
plant pathologist spent nearly 2 weeks, beginning on June 23rd, 
conducting a facility review of the laboratories and interviews 
with CDC personnel. APHIS briefed CDC officials on July 2nd, 
outlining deficiencies so that they could immediately begin 
taking corrective actions.
    APHIS found that the laboratory did not use an adequate 
inactivation protocol and did not ensure that the protocol was, 
in fact, validated. The initial response to this incident by 
the CDC laboratories was inadequate both in securing as well as 
disinfecting laboratories. For example, individuals without 
approval to handle select agents were able to access space 
containing or potentially contaminated with anthrax at least 4 
days after the incident was discovered. We also found that 
employees did not have appropriate training in some instances.
    We found no clear management oversight of the incident at 
the labs and no clear single manager overseeing the overall CDC 
incident response, which resulted in employee confusion about 
how to respond. In addition, CDC's Occupational Health Clinic 
was not prepared to respond to the potential exposure of a 
large number of workers.
    APHIS currently has in place a cease and desist order with 
select agents and toxins at the two impacted select agent 
laboratories. We will require that corrective actions be taken 
to ensure the integrity of these research programs. We have 
directed CDC to provide APHIS with its plan for coming into 
compliance by July 25th. And before allowing CDC to resume 
select agent work in the laboratories, APHIS will conduct a re-
inspection to ensure that all corrective actions have been 
taken.
    Mr. Chairman, this concludes my testimony. I would be happy 
to answer any questions that you or the members of the 
subcommittee have.
    [The prepared testimony of Mr. Dick follows:]
    
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    Mr. Murphy. Thank you, Dr. Dick.
    Ms. Kingsbury, you are recognized for 5 minutes. Please 
point that microphone very close to your mouth. A lot closer 
than that.
    Ms. Kingsbury. Thank you, Mr. Chairman, for inviting----
    Mr. Murphy. Bring it really--ma'am. Dr. Kingsbury?
    Ms. Kingsbury. Pardon me?
    Mr. Murphy. Bring the mic really close, please.
    Ms. Kingsbury. Really close.
    Mr. Murphy. Really close. Thank you.
    Ms. Kingsbury. Is that better? Yes. OK.

                  TESTIMONY OF NANCY KINGSBURY

    Ms. Kingsbury. Thank you very much for inviting us to come 
to talk to you about some of our past work on biosafety issues. 
As Mr. Waxman noted in his statement, we have been doing this 
work for quite a while. We started with the original anthrax 
attacks, and we have gone on to a number of other issues over 
the years.
    Basically, our past work has a couple of major themes. One 
of them is a lack of strategic planning and oversight of the 
whole picture of biosafety laboratories. APHIS and CDC are only 
a part of that picture, and since 2001, there have been an 
increasing number of biosafety laboratories both within that 
sector, but also across the whole government. There are six or 
seven different agencies involved, and no one entity has been 
charged with developing a strategic plan.
    We became particularly concerned about that as budgets 
began to shrink, recognizing that the management and operation 
of these laboratories is an expensive venture. And if they are 
not properly maintained, other kinds of problems can arise.
    We have also observed that there is a continued lack of 
national standards for designing, constructing, commissioning, 
and operating these laboratories. There is guidance. The 
biosafety and microbiological and biomedical laboratories 
guidance is available, but it is not required, and there is no 
process by which an entity needs to make sure that they are 
following that guidance. We think this broader government 
perspective about both how many of these laboratories we need 
and for what purpose, and also a better framework for oversight 
is still needed.
    We have done some work since the most recent episode became 
public. We did take a team to Atlanta. I want to thank Dr. 
Frieden for his staff's cooperation with us when we were there. 
Coming together with something I am prepared to sit here and 
talk about on something like 10 days' notice is a bit of a 
challenge for us, but his staff was very good at providing 
everything we asked for.
    I am not going to add very much to that debate. I think the 
two previous witnesses have covered the details pretty well. 
The one thing I would add, however, is while we agree that 
there is a requirement to have standard operating procedures 
that are reviewed at appropriate levels for biosafety, we 
believe it is also important that those procedures be 
validated. And by that we mean independently tested so that we 
can be assured that if these procedures are followed, there 
will be no further episodes. So I will just add that one 
thought to the debate about the incident itself.
    Thank you very much, Mr. Chairman. That concludes my 
statement.
    [The prepared testimony of Ms. Kingsbury follows:]

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    
    Mr. Murphy. Thank you, Dr. Kingsbury. I will now recognize 
myself for 5 minutes.
    Dr. Frieden, is anthrax a biological agent that has been or 
could be used in warfare?
    Dr. Frieden. Yes.
    Mr. Murphy. And the mishandling of anthrax can have some 
real consequences. If someone were sickened by anthrax, what 
would some of the symptoms be?
    Dr. Frieden. Anthrax can cause a variety of symptoms, but 
the most severe forms are respiratory anthrax, which can cause 
severe illness or death.
    Mr. Murphy. I have an image here of some workers handling 
testing for anthrax, et cetera. One sees that generally 
you're--this is not in a lab, but some other workers 
investigating. When I tour labs, and thank you for this slide, 
the number of levels there of what is required for breathing, 
for covering clothes before and after is pretty severe.
    I have got to ask this question. Now, these are lined, but 
this is a Ziploc bag. And I haveto think what in heaven's name 
would go through the minds of some scientists thinking a Ziploc 
bag is enough to protect someone from anthrax when we have 
other instances of all that paraphernalia someone has to wear 
when they are dealing with anthrax. Have you talked to these 
personnel involved with transporting anthrax and asked them 
why?
    Dr. Frieden. I have been directly involved in the 
investigation. I will be directly involved in the remediation 
of the problems that we find. Many of the issues that are 
mentioned in the APHIS findings relate to what was done with 
the material that was believed to have been inactivated. So 
once the laboratory had said here is killed anthrax, it was 
handled by the staff in those lower containment laboratories as 
if it were not infectious.
    Our subsequent studies suggest that it is likely that it 
was not, but the core error there was the failure to----
    Mr. Murphy. But, Dr. Frieden, this is like saying I did not 
know the gun was loaded, but somebody got shot. But you should 
always assume it is. For someone to say, well, I did not think 
the anthrax was live is not acceptable. And quite frankly, I 
wonder if you have the ability to not only reprimand such 
personnel, but to fire them, to suspend them from working with 
pathogens that are deadly.
    Quite frankly, do they understand that the extent to which 
this went could have left them in a condition where they were 
charged with criminal negligence, or negligent homicide, or 
reckless endangerment? Do they understand the seriousness of 
this to the American public health?
    Dr. Frieden. I think, first, your idea, Mr. Chairman, of a 
two-key system as is used in other circumstances is quite 
appropriate here both within the high containment laboratories 
and to verify that stuff coming out is safe if it does come 
out, because stuff has to come out of those laboratories to be 
tested or worked with elsewhere.
    In terms of disciplinary proceedings, what we want to do is 
strike the right balance. On the one hand, we recognize the 
need to make sweeping improvements in our culture of safety, 
and part of that means that staff need to feel comfortable any 
time saying, ``hey, there may be a problem here,'' coming 
forward. At the same time, if our investigation finds that 
there is negligence, that people knowingly failed to report, or 
took actions that were likely to or should have been known to 
endanger themselves or others, then we will take appropriate 
action.
    Mr. Murphy. Well, I am looking at Dr. Dick, who has said 
that people who were not approved were able to handle select 
agents, were able to access space containing or potentially 
contaminated with anthrax at least through June 17th, 4 days 
after the incident was discovered. Now, my assumption is these 
scientists and their aides are pretty smart people, but it is 
extremely disturbing to think that they are not thinking of 
this.
    But let me ask this. It has been a week since you learned 
about the March 2014 CDC shipment of H5N1 influenza. And there 
was a 6-week delay in notifying. Have you found out why there 
was a 6-week delay, and was there a cover-up involved in that, 
or are the bureaucratic hurdles too high? What was the cause?
    Dr. Frieden. I have only gotten some very preliminary 
information on that. I will make a general point, however. When 
we look at emergencies in emergency departments or intensive 
care units in the healthcare sector, the biggest problem is not 
usually a failure to respond effectively when people recognize 
there is an emergency. It is a failure to recognize that the 
situation is an emergency or something that requires immediate 
attention. But we have not completed our investigation of that, 
and we will look at all possibilities.
    Mr. Murphy. Is there any kind of notification or alarm 
system that lets people know when there has been a release or a 
problem there?
    Dr. Frieden. There are multiple alarm systems within CDC. 
In this case, it was a cross-contamination of a culture, so 
somehow, and we have not figured out how yet, a relatively low 
virulence Avian influenza was cross-contaminated in our 
laboratory with the high pathogenic H5N1.
    Mr. Murphy. I get more alarms going off when you try and 
walk out of Walmart with a shirt that has not been paid for. 
You see those happening all the time. Is there any evidence of 
cover-up here from employees not wanting to let someone else 
know that somebody else----
    Dr. Frieden. No. We have seen at this point no evidence of 
a cover-up, but we do see the need to strengthen the culture of 
safety that encourages reporting any time there is a problem or 
a potential problem so that we can assess it and take rapid and 
prompt action.
    Mr. Murphy. Thank you. I now recognize Ms. DeGette for 5 
minutes.
    Ms. DeGette. Thank you, Mr. Chairman. Dr. Kingsbury, let me 
just make sure that I heard your testimony right. You testified 
that there is an increasing number of labs that are handling 
these bioagents, correct?
    Ms. Kingsbury. Correct.
    Ms. DeGette. And you said that there is really no one 
agency in charge, is that correct?
    Ms. Kingsbury. Correct.
    Ms. DeGette. Now, you said that today, but in 2007, the GAO 
testified before this committee the same thing, no single 
government agency was responsible for tracking all of these 
labs.
    Ms. Kingsbury. That is correct.
    Ms. DeGette. That is correct, too. Dr. Frieden, are you 
aware of this finding by the GAO going back all the way to 
2007?
    Dr. Frieden. Yes, I am.
    Ms. DeGette. And do you agree with Dr. Kingsbury that there 
are an increasing number of labs handling these bioagents?
    Dr. Frieden. If we look over the past 10 years or so, it is 
my understanding that there is an increasing number.
    Ms. DeGette. And do you agree with her that there has never 
been one agency in charge despite the red flags going up all of 
these years?
    Dr. Frieden. There is a clear division of responsibilities 
between CDC and APHIS in terms of select agent oversight, 
inspection, and enforcement. Several years ago at my direction, 
we turned over the inspection of CDC's select agent 
laboratories to APHIS, which has conducted them since that 
point. But the overarching issue of laboratory safety is one 
that does touch many parts of both the public sector and the 
non-governmental sector.
    Ms. DeGette. So are you saying that APHIS is in charge now 
since you put that into effect the last few years?
    Dr. Frieden. In terms of the inspection of laboratories 
which are working with select agents, there is a clear division 
of responsibility between ourselves and APHIS.
    Ms. DeGette. Does that mean APHIS is in charge, yes or no?
    Dr. Frieden. APHIS is in charge of investigating CDC's 
select agent laboratories. APHIS is not in charge of the 
overall enterprise.
    Ms. DeGette. So do you think we need to clarify who is 
going to be in charge of the overall enterprise?
    Dr. Frieden. We are certainly willing to look at every 
suggestion to improve laboratory safety and biosecurity.
    Ms. DeGette. Do you think it would be useful if we had one 
agency in charge of all of the inspections and making sure 
people were doing things in the right way?
    Dr. Frieden. I have seen several suggestions for how we 
could improve the process BSL-3 oversight and select agent 
oversight. And my sense is that each of these ideas is 
certainly worth exploring.
    Ms. DeGette. What do you think about that, Dr. Kingsbury? 
Do you think it would be useful to have one agency in charge?
    Ms. Kingsbury. Well, we have said for a number of years, as 
you know, that there needs to be some entity in charge of a 
national strategy, not necessarily in charge of every 
laboratory in the country. The other thing I would point out--
--
    Ms. DeGette. So you are saying an agency in charge of 
developing the protocols and how you are going to do this?
    Ms. Kingsbury. And ensuring biosafety and biosecurity. But 
the more important issue, and from a strategic point of view, 
is how many of these laboratories do we really need, for what 
purpose, against what threat. One of the interesting things 
that I have become a little bit more sensitive to in the last 
few weeks is that the whole structure we have that CDC and 
APHIS are involved in is around the select agent agents, and 
there are a lot of other bugs out there in other laboratories 
that are not select agents that also need to be protected. And 
there is very little visibility about that sector of this 
enterprise.
    Ms. DeGette. And, Dr. Frieden, I am going to assume that 
you are going to agree with Dr. Kingsbury that it would be very 
useful to have national safety and security standards that 
would apply to everybody. Is that correct?
    Dr. Frieden. I am not sure I understood the question. I am 
sorry.
    Ms. DeGette. OK. Well, what GAO says is that we do not have 
one single agency developing national biosafety and security 
standards, and as a result, we have all these labs doing this 
type of research, a proliferating number of labs. But there is 
nobody developing standards across all those agencies.
    Dr. Frieden. I think there are many aspects of both 
biosafety and biosecurity which merit careful investigation. 
And if we can figure out better ways to do them, we are 
certainly completely open to that----
    Ms. DeGette. And do you think the protocol should apply to 
everybody?
    Dr. Frieden. The protocols may be very specific for the 
different situations, but they should all adhere to the highest 
standard of safety.
    Ms. DeGette. Dr. Dick, what is your opinion of this?
    Mr. Dick. I think that there should be a single oversight 
body. Right now for the Select Agent Program, there is a single 
oversight body made up of the Division of Select Agents and 
Toxins at CDC. There is a single oversight body in Agriculture 
that makes up the other half of that Select Agent Program.
    Together we meet on a monthly basis. We have the directors 
and assistant directors of the programs that are in the two 
programs, and we have OGC and other counsel present.
    Ms. DeGette. But if that is the case, why are we having all 
these problems then?
    Mr. Dick. And so, what we need, what we have is a single 
set of biosafety and biosecurity regulations that are followed 
by both sides.
    Ms. DeGette. But we do not have that now, is that what you 
are saying?
    Mr. Dick. No. What I am saying is that I think we currently 
do have that. I do agree with Dr. Frieden that eventually after 
we get done with this investigation, we should take a very 
close look at all of the issues and see if there are updates 
that need to be made to biosafety and biosecurity.
    Mr. Murphy. Thank you. I now recognize Dr. Gingrey for 5 
minutes for questions.
    Mr. Gingrey. Mr. Chairman, thank you. And I am going to 
address my questions of this panel to Dr. Frieden. Dr. Frieden, 
thank you very much for being here and providing the 
subcommittee with your testimony. I actually have a number of 
questions for you, in fact four, and I will get right to those 
since time is of the essence.
    Firstly, can you please describe the policies and 
procedures CDC has in place to handle biosafety issues that may 
arise from human error like what happened in the Bioterrorism 
Rapid Response and Advanced Technology Laboratory in Atlanta on 
June the 5th?
    Dr. Frieden. We have extensive policies and procedures. But 
what we are doing now is implementing a moratorium on all 
transfers out of BSL-3 and BSL-4 laboratories while we review 
each laboratory's policies and procedures to ensure that there 
is appropriate inactivation before any materials are 
transferred out.
    Mr. Gingrey. And I appreciate that answer, and you 
explained that to us I think last week in an informal setting, 
and I think that is a good thing. That leads to my second 
question. What is the impact and the cost of the BRRAT 
Laboratory shut down? You shut down those two laboratories for 
X number of days. Do you have a cost estimate in regard to them 
being offline for a period of time?
    Dr. Frieden. I do not have a cost estimate for that. The 
impact of the moratorium is potentially significant, and so we 
are working rapidly to rigorously assess protocols and where 
there are situations such as the diagnosis of drug resistant 
tuberculosis, or helping to control the Ebola outbreak, or 
beginning work on next year's flu vaccine. We will work to 
ensure that we can do that safely in time, but there are real 
challenges with this moratorium.
    One of the things that the BRRAT Lab does, the lab that was 
associated with the anthrax incident, is to provide to the 
Laboratory Response Network, a network of over 150 
laboratories, proficiency testing to make sure that they can 
rapidly identify anthrax and other dangerous pathogens safely. 
So we will figure out a way to do that safely in time.
    Mr. Gingrey. Well, I would think time is of the essence in 
regard to cost. But as you say, safety is the most important 
factor. You got to get it right, and I certainly agree with 
that.
    Should inactivated select agents be added back to the 
select agent list?
    Dr. Frieden. I think that what we need to ensure is that 
any inactivation is done completely because once something is 
inactivated, it may be able to be used. It may be necessary to 
use that, for example, to diagnose it. And you would not want 
to have to follow select agent requirements without diagnosing 
something in a hospital lab, or a clinical lab, or even in the 
field.
    But the key point here is to have that two-key system that 
the chairman mentioned in that meeting, that two-key system to 
make sure that when an inactivation is undertaken, it is 
validated and verified that the materials are inactive.
    Mr. Gingrey. The last question, Dr. Frieden. In your 
testimony, you noted you only learned of the March 13th, 2014 
shipment from the CDC influenza lab of a virus that was cross-
contaminated with H5N1 to a USDA laboratory on July the 9th. So 
that is from March 13th when it actually occurred to when you 
were informed or learned of it July the 9th.
    Can you please describe how you are going to improve 
communications of these incidents up and down the chain of 
command?
    Dr. Frieden. Thank you. In fact, it was the afternoon of 
our meeting, which was in the morning, when I learned about 
this, if I remember correctly. What your question gets to is 
really the crux of the matter, which is how do we improve the 
culture of safety at CDC? And I think that is going to involve 
a number of steps that we think will succeed, but will take 
time.
    We need to encourage reporting. We need to encourage all 
staff to take responsibility in addition to having a single 
point of accountability for laboratory safety. We need to have 
a clear vision of working safely. We are, after all, the 
prevention agency, and we want to apply that same rigor that we 
apply to our work in the field and in disease control to 
preventing any incident from happening in our laboratory.
    We also want to build on many of the organizational 
strengths and identify the laboratories that are doing this 
very well within CDC and identify the practices that they are 
taking that will prevent these incidents.
    And finally, I think coming up with ways to monitor 
progress and track progress, and identifying what are called 
the critical control points. What are the flashpoints? What are 
the areas where problems may occur, and then developing 
redundant, effective, validated, monitored ways to address 
those critical control points, whether it is inactivation, or 
transfer of materials, or making sure that materials 
transferred only contain those materials.
    We have terrific scientists at CDC, and they are now 
focusing their creativity, their energy, their commitment on 
improving our culture of safety.
    Mr. Gingrey. Dr. Frieden, thank you very much. And, Mr. 
Chairman, I will yield back my 30 seconds.
    Mr. Murphy. Thank you. I now recognize Mr. Waxman for 5 
minutes.
    Mr. Waxman. Thank you, Mr. Chairman. Dr. Frieden, last 
Friday when you released the CDC report on the anthrax 
incident, you announced you were imposing a moratorium on CDC 
transferring any biological samples out of any BSL-3 or BSL-4 
labs until they had conducted a lab-by-lab assessment. 
Additionally, you closed the Bioterrorism Rapid Response and 
Advanced Technology, or the BRRAT Laboratory, and announced 
that it will remain closed until it is approved to reopen under 
safer conditions. These seem like appropriate interim steps 
until CDC can undertake a comprehensive safety review and 
ensure that the proper procedures and protocols are in place 
moving forward.
    Dr. Frieden, how long do you anticipate this moratorium 
lasting and the BRRAT lab being closed?
    Dr. Frieden. The short answer to your question is as long 
as it takes to ensure that they can open safely. The longer 
answer is that there are some things that need to resume, for 
example, proficiency testing for select agents in the 
Laboratory Response Network. And that is something that we will 
look at very carefully. But I am committed that we will not 
open them until we can open them safely.
    Mr. Waxman. What steps are you taking to lift the 
moratorium and reopen the facilities? When will you know or how 
will you know when it is safe to do so?
    Dr. Frieden. I have appointed Dr. Michael Bell, who is a 
top expert at CDC not only in laboratory science, but also in 
safety. He works within the hospital infection control and 
safety unit of CDC to oversee a high-level working group 
reporting to me. And they will develop in the next day or so, 
finalized criteria by which they will assess each of the 
laboratories.
    And then each laboratory will look at its own protocols and 
practices and determine whether they are validated, effective, 
and scientifically proven, and implemented in a way that we can 
be sure they will be applied. And then each laboratory will 
apply to him for resumption and lifting of the moratorium. I 
will review his recommendations and ultimately approve 
laboratory-by-laboratory a reopening of this process.
    I would just mention this is not a small thing because many 
of our laboratories that have BSL-3 laboratories have adjacent 
BSL-2 laboratories. And much of their work has to be done in 
the BSL-2, so they inactivate in the BSL-3 and then move it to 
the BSL-2. That work has all stopped at this point until we can 
ensure that we are doing it safely. And this is one of the 
things that really is a tipping point for improving the culture 
of safety at CDC.
    Mr. Waxman. One of the more disturbing findings of CDC's 
own report on this incident is that scientists use a pathogenic 
strain of anthrax when they could have used a non-pathogenic 
strain, is that not correct?
    Dr. Frieden. Yes, that is.
    Mr. Waxman. Well, when the moratorium is lifted and the 
BRRAT Lab is reopened, will you have clearer standards and 
protocols to make sure scientists are not unnecessarily using 
potentially dangerous strains of bacteria when it is not 
necessary?
    Dr. Frieden. Yes.
    Mr. Waxman. GAO and APHIS both conducted investigations of 
the BRRAT Laboratory following the June anthrax exposure. Dr. 
Kingsbury and Dr. Dick, you believe the moratorium and lab 
closure an appropriate response to this incident, do you not?
    Mr. Dick. Yes, I do.
    Mr. Waxman. OK. We should not forget today that the reason 
CDC conducts their special agent research is to help keep the 
American public safe. CDC serves a critical role for studying 
dangerous pathogens and finding cures and vaccines for deadly 
diseases. These labs are critical to our Nation's response to 
bioterrorism threats. So I am interested in learning about how 
this moratorium and the lab closures are affecting the critical 
research that these labs were conducting.
    Dr. Frieden, how do the moratorium and lab closures limit 
CDC's research capabilities? What happens to the studies, some 
of which I am guessing were operating on detailed schedules 
that were being conducted in the labs?
    Dr. Frieden. We are looking at the moratorium now in detail 
and identifying any laboratories which need to resume transfers 
for individual patient care or for public health response with 
highest priority. And we expect that those laboratories we will 
be able to get reopened for transfer very soon.
    But we have already heard from, for example, the laboratory 
that deals with drug-resistant tuberculosis, the laboratory 
that deals with Ebola, and the laboratory that deals with Avian 
influenza, that they have deadlines coming up for either 
patient care or public health response. And we will address 
that very quickly. But we will always put safety first.
    Mr. Waxman. How do the closures and moratorium affect 
research occurring at other labs outside of the Roybal campus?
    Dr. Frieden. We provide proficiency testing and other 
materials to laboratories, and so there may be impacts on some 
of our partners. But the one that we are most aware of now and 
we will work to address before the deadline is provision of 
materials that companies need to make next year's flu vaccine. 
And we anticipate being able to do that on time.
    Mr. Waxman. My time has expired, but it seems to me that 
protecting the safety and health of your scientists, the 
moratorium, and the lab closures appear to be the appropriate 
response. Thank you, Mr. Chairman.
    Mr. Murphy. Thank you. The gentleman's time has expired. I 
now recognize Mr. Barton for 5 minutes.
    Mr. Barton. Thank you, Mr. Chairman. In answer to a 
previous question, Dr. Kingsbury raised the point about how 
many laboratories there are. The GAO has indicated that there 
are probably too many laboratories.
    My first question would be to you, Dr. Frieden. Why do we 
have so many laboratories, and are they all necessary?
    Dr. Frieden. I do not know that there is a right number of 
laboratories out there. Our job within CDC is to make sure that 
we only work with dangerous pathogens where it is necessary to 
do that and that we do so safely. And we will be taking a fresh 
look everywhere we work with these pathogens internally at CDC 
to make sure that it is kept to the minimum necessary to serve 
the function of responding to infectious disease outbreaks.
    We still have anthrax in nature and respond to events like 
that. We still have Ebola with the largest outbreak in history 
now in West Africa. So the challenges we have are substantial.
    In terms of outside laboratories, our function in the 
Division of Select Agents and Toxins is to ensure that the 
laboratories that are there are operating safely.
    Mr. Barton. Well, it would seem that one way to increase 
security would be to have fewer locations and fewer 
laboratories. I mean, if you are only using the extreme case, 
if you are trying to protect a hundred, that is going to be 
more difficult than if you are just trying to protect one.
    I do not know what the magic number is, but I think 
especially since the GAO has said there are probably too many, 
that would be worthy of a look-see. Dr. Kingsbury, do you have 
an opinion on that?
    Ms. Kingsbury. Well, I am not sure we have actually said 
there may be too many. I think what we have actually said is 
nobody knows how many there are, and nobody knows how many we 
need. And that goes beyond the scope----
    Mr. Barton. Well, that is even worse in a way.
    Ms. Kingsbury. Yes. That goes beyond the scope of CDC and 
APHIS. And until there can be some kind of strategic look at 
what our requirements actually are, and they may be changing 
because of things like the Ebola outbreak and so forth. But 
somebody ought to be thinking about this, I think, a little bit 
more broadly than a single agency at a time. And that is 
basically our point.
    Mr. Barton. Well, I am going to ask the question. Why are 
there 435 members of Congress? What is magic about 435? And the 
answer is that is as many seats or desks at the time they could 
put on the House floor. When they got 435, they could not put 
anymore, and so it is an odd number, and they just stopped. But 
there is nothing magic about it.
    Ms. Kingsbury. That is correct.
    Mr. Barton. And the same thing with the laboratory 
situation. I think there should be a strategic review, and the 
sooner the better.
    The staff has asked me to ask this question. It concerns 
the fact that beginning in 2012, the United States Department 
of Agriculture and the Centers for Disease Control entered into 
a memorandum of understanding that allows the USDA Animal and 
Plant Health Inspection Service to inspect the CDC laboratories 
for compliance with the Federal Select Agent Program. Since the 
Select Agent Program was authorized in 2002, the CDC had been 
inspecting its own laboratory. Why did CDC decide to turn its 
inspection process over to the Department of Agriculture? Was 
that because CDC did not think that it could do the job itself? 
I will ask Dr. Frieden that.
    Dr. Frieden. We have made a number of improvements both in 
our own laboratories and in our regulatory function through the 
Division of Select Agents and Toxins. And as I looked at this 
issue, I was concerned that there was at least the appearance 
that we could not be objective in inspecting our own 
laboratories.
    I did not believe that was the case. I believed that one 
part of CDC which has no organizational affiliation with 
another could do that objectively, but I did not think the 
appearance was a good idea. So I requested and APHIS graciously 
agreed to take over inspections of our own campus so that there 
would not be that appearance of a problem.
    Mr. Barton. If you had to do it over again, would you do 
the same thing? Was it a good decision to let USDA do the 
inspection?
    Dr. Frieden. Yes. I believe that decision was appropriate. 
If I had it to do over again, I wish I had recognized the 
pattern of incidents that we now recognize, which is why we put 
those prior incidents into our July 11th report.
    Mr. Barton. OK. With that, Mr. Chairman, I yield back, or I 
can tell an Aggie joke. I yield back, Mr. Chairman.
    Mr. Murphy. OK. Thank you. He yields back. Now, I will 
recognize Ms. Castor for 5 minutes.
    Ms. Castor. Thank you very much, Mr. Chairman and the 
ranking member, for calling this hearing today. I had the 
opportunity to visit the CDC last spring, and on the surface 
they appear very serious about laboratory security. And yet 
every few years there are these lapses, and now an anthrax 
scare, and an Avian flu issue that was not reported in a timely 
manner.
    And we have very high expectations for everyone at the CDC. 
I am impressed with everything that is happening there, but for 
the high containment biological laboratories, to have these 
lapses is not acceptable.
    So it is really troubling that although numerous government 
agencies over the past few years have warned CDC about problems 
at the high containment labs, it appears CDC has not heeded 
those warnings. We know of at least 14 separate reports, 
letters, and lab investigations from GAO, the U.S. Animal and 
Plant Health Inspection Service, and HHS Inspector General that 
documented a series of safety lapses and lack of oversight at 
CDC high containment labs.
    Dr. Kingsbury, your testimony is invaluable here. Can you 
tell us more about the concerns GAO has identified with regard 
to safety lapses at the high containment labs? You have said 
now someone has got to look at the number of labs across the 
country as well. Who is that? What entity is that? What are 
your recommendations there?
    Ms. Kingsbury. I wish I was in a position to say I know the 
answer to that. One of the difficulties that we faced in making 
that suggestion is that when you look around the government, 
because they are being built and managed across multiple 
agencies and each agency has its own mission and its own focus, 
it is difficult to think about who would be the single agency.
    We have discussed the issue with the Office of Science and 
Technology Policy at the White House, but while they have some 
overarching responsibilities, they do not have staff and 
management officials that would permit actually doing it that 
way.
    So we do not really have a good answer to that question, 
but we think it is worth just keeping the issue on the table, 
particularly in tight budget times.
    Ms. Castor. You mentioned in your opening statement that 
you have heightened concerns because of budget cuts. Talk a 
little bit about that. Is there a particular area we should be 
focused on?
    Ms. Kingsbury. Well, it is just that, as I said in my 
statement, the building, and management, and upgrade of these 
kinds of laboratories is relatively expensive compared to just 
building ordinary buildings. And so, if we are going to have X 
number of laboratories, I would like to see the strategy that 
was going to permit us even in tight budget times to continue 
to fund them, to continue to upgrade them when necessary, and 
to manage the biosafety and biosecurity programs that are 
necessary to keep them safe. So that total picture just is not 
available now, and that worries us.
    Ms. Castor. OK. Dr. Dick, do you think this has anything to 
do with budget cuts?
    Mr. Dick. I do not believe that it has anything to do 
directly with budget cuts. We have been able to accomplish our 
mission in support of the Select Agent Program over the recent 
years and provide the funding that is necessary.
    Ms. Castor. OK. And before the June anthrax incident, APHIS 
conducted at least six separate investigations at CDC's Roybal 
campus facilities in 2013 and 2014. Can you summarize your 
findings in those investigations?
    Mr. Dick. Yes. I think there were a number of findings, 
some of which were found in the recent finding, some of which 
were not. Simple things that people maybe think are simple, 
unlocked refrigerators, those kinds of things, up to and 
including more serious incidents, if you will around 
inactivation protocols not being up to date.
    Ms. Castor. And, Dr. Frieden, it is troubling. I mean, this 
has gone on for years now with GAO, APHIS, the Inspector 
General, outside experts calling attention to these issues. And 
I am encouraged because you have been forthcoming in your 
statements. You have not been defensive. But what is your 
current action plan now going forward in detail? Is there a 
culture among researchers? What is it, and get specific for us 
from this day forward with these recommendations, what are you 
going to do in the timeframe? Thank you.
    Dr. Frieden. Well, first, I think for path incidents, the 
staff at CDC and the scientists did take the reports seriously 
and did respond to those individual reports. What we missed was 
a pattern. And you are absolutely right that that pattern was 
an inadequate culture of safety. So the overarching challenge 
now is to ensure that we establish and strengthen a culture of 
safety in all of our laboratories throughout all of CDC. And 
there are a number of steps that we are doing to begin to do 
that.
    The first is the moratorium so that we can stop and think 
about that particular procedure of inactivation, make sure it 
is done right, the appointment of a single point of 
accountability for laboratory safety throughout CDC, the 
establishment of a working group that that person and Mr. 
Henderson will lead. The invitation to an external advisory 
group, and I intend to invite some of the leading independent 
experts of the country by the end of this week to serve on that 
advisory group for CDC. A hard look at all of the critical 
control points where there may be a problem with lab safety, 
and reviewing to make sure that we have protocols in place that 
are validated and verified. It gets back to that trust but 
verify approach.
    We need to make sure that we are empowering our laboratory 
staff to report and to identify ways to improve safety and 
security. We also need to verify that that is happening.
    Mr. Murphy. OK, thank you. The gentlelady's time has 
expired. I will now recognize Ms. Blackburn of Tennessee for 5 
minutes.
    Ms. Blackburn. Thank you, Mr. Chairman. Dr. Frieden, I want 
to come back to you. And if you will go to tab 15, the USDA 
APHIS investigation, and let us look at that. This started 10 
days after the event. There were 18 days after possible 
exposure, and you had a lot of really awful basic errors. Even 
you admit there is not a culture of safety. There is not that 
double check system.
    And it is something that when you look at worker safety, 
how it was compromised, and then the management lacking the 
basic information on what substances to use to have the 
contamination cleaned up.
    So looking at this tab and that investigation, I want you 
to detail for the committee what new policies have been 
designed as a result of this and how did CDC guarantee that the 
new policies are followed, effective immediately.
    You know, our hospitals and organizations get all sorts of 
new rules from HHS on Friday afternoons at 4:00. They are 
effective immediately. So I want you to detail for us how you 
implemented that and what the new policies are.
    Dr. Frieden. So effective immediately, all transfers not 
just from these two laboratories, but from every single BSL-3 
and BSL-4 laboratory at CDC have been stopped. Effective 
immediately, these two laboratories, the BSL-3 part of the 
influenza laboratory, and the BRRAT Lab for the bioterror 
response, have been closed. Those two laboratories will not be 
reopened until both APHIS and I are confident that they can be 
reopened safely.
    We have also appointed a single point of accountability to 
look at this and to review before we reopen, before we begin 
any more transfers, procedures that are in place to ensure that 
they can be done safely.
    Ms. Blackburn. How could it possibly have transpired that 
your management team could not even decide on the formula of 
bleach to use to clean up the contamination or to see whether 
the on-site clinic was thorough and consistent in examining the 
staff potentially exposed to the anthrax?
    Dr. Frieden. In the first week after the anthrax potential 
exposure was identified, we did not respond in the way that we 
would respond to an outside emergency. And that is one of our 
after action findings that when we deal with emergencies, 
whether it is Ebola, or fungal meningitis, or another problem, 
we activate our Emergency Operations Center. Or even if we do 
not activate it, we utilize the resources of that center to 
have a systematic, structured, intensive, immediate response. 
That was not done for the first week after the anthrax 
potential exposure, and that is something that we will be sure 
to do in the event of any such internal event in the future.
    Ms. Blackburn. Let me ask you this. Did the management team 
get preferential treatment to the point that they were unaware 
that the staff was turned away?
    Dr. Frieden. No. Absolutely not.
    Ms. Blackburn. OK. And then why did the staff not feel 
confident in expressing their worries to their managers so that 
they could get adequate treatment?
    Dr. Frieden. I am not certain what is behind that. I do 
know that part of encouraging and strengthening the culture of 
safety is making sure that people are encouraged and, in fact, 
reinforced and rewarded for bringing forth problems if they 
think there are problems and potential problems.
    Ms. Blackburn. Do you think it had to do with the existing 
work culture that was there at the CDC?
    Dr. Frieden. I think at CDC scientists are so used to risk, 
they go out into dangerous places where they are not sure what 
the risks are going to be. But sometimes if you work year in 
and year out with pathogens that are scary, you can get inured 
to that danger.
    Ms. Blackburn. OK. Let me ask you another question. Once 
the June incident was discovered, why? Why did it take you so 
long to track down the anthrax, and why was there not a record 
of where this was stored?
    Dr. Frieden. Well, on June 13th, as soon as we identified 
that there was the potential that any of the plates that were 
sent out of the containment lab were not sterile, we 
immediately recovered those plates and put them back in the 
secure facilities. That is the best of my understanding.
    Ms. Blackburn. Why was there not a record of where it was 
stored, and why was it stored in unlocked refrigerators, stuck 
in an un-posted room or in hallways?
    Dr. Frieden. My understanding, and we will have to confirm 
that in the coming days, is that those findings relate to 
primarily the materials that were believed to have been sterile 
and sent out of the laboratory. It is not as if there were 
anthrax cultures being kept in an unlocked, unsecured place.
    I think the point there was there was that once that 
initial error was made of thinking something had been 
inactivated when it had not been or may not have been 
inactivated, then that material was then out of the containment 
space. That is my understanding.
    Ms. Blackburn. Thank you. Mr. Chairman, I yield back.
    Mr. Murphy. All right. I now recognize Mr. Green of Texas 
for 5 minutes.
    Mr. Green. Thank you, Mr. Chairman. First, for all of our 
panel, there are a number of Federal agencies that handle some 
of these substances, not just CDC. Is there a general protocol 
that all the agencies look at and coordinate handling these 
substances? Dr. Frieden?
    Dr. Frieden. When it comes to select agents, then both CDC 
and APHIS establish standards and then inspect and enforce 
those standards. Other than select agents, there are agency-by-
agency or entity-by-entity approaches that may be specific to 
the type of research or to the type of agent.
    Mr. Green. OK. So there is some umbrella type standard for 
all Federal agencies.
    Dr. Frieden. For select agents there is.
    Mr. Green. OK. Dr. Kingsbury, can you summarize your 
recommendations for us, and can you elaborate on which of these 
recommendations would require congressional action?
    Ms. Kingsbury. If you are talking about our 
recommendations, I think that resolving this issue of whether 
there is a national strategy probably cannot be done without 
congressional action, and it will take some thought to get us 
there.
    Mr. Green. OK. Dr. Frieden, do you agree with these 
recommendations, and will you be implementing them that you can 
within your control?
    Dr. Frieden. In terms of laboratory safety recommendations 
for CDC, we will do everything to implement these 
recommendations. The report that we released on July 11th has a 
number of steps that we are already beginning to implement.
    Mr. Green. OK. Any of them require congressional action, or 
is that something you control within your Agency?
    Dr. Frieden. At this point, I am not aware of anything that 
would require congressional action for us to take appropriate 
steps.
    Mr. Green. Dr. Dick, do you have any recommendations for 
Congress or CDC that Congress needs to deal with?
    Mr. Dick. At this point in this investigation, we do not 
have anything that cannot be controlled through the Select 
Agent Program and our work with CDC.
    Mr. Green. OK. Dr. Frieden, does CDC, based on the findings 
in your report, have any recommendation to Congress? You have 
none for us?
    Dr. Frieden. We are focused at this point on doing our jobs 
as well as possible, ensuring that we strengthen laboratory 
safety throughout CDC, and use the findings from this 
experience to strengthen our regulatory function through our 
Division of Select Agents and Toxins, which inspects and 
regulates hundreds of entities around the country that work 
with these materials.
    Mr. Green. OK. Let me ask you about the CDC budget. And 
again, I have heard other questions from my colleagues that 
this was not a budget issue as much. Has CDC received adequate 
funding from Congress to conduct its safety mission, period? 
Obviously you have other missions.
    Dr. Frieden. I think the challenges for safety are more 
than just funding. There are a variety of issues in 
implementing safety policies and procedures, and I do not think 
the primary issue here is a lack of funding.
    Mr. Green. OK. Some of the witnesses we have been hearing 
from today have stated CDC employees need better training and 
that there needs to be better standard operating procedures, 
but overall there is a problem with the culture at CDC. Dr. 
Frieden, do you agree with these assertions?
    Dr. Frieden. I do agree with them. I think that while we 
have scientists who are the best in the world at what they do, 
they have not always applied that same rigor that they do to 
their scientific experiments to improving safety. And that is 
why we are taking a number of steps to strengthen the culture 
of safety at CDC.
    And part of that is to encourage reporting of potential or 
actual problems. And because of that it is possible, though I 
do not know of anything at this point that I am aware of, it is 
possible that in the coming weeks and months we will hear of 
other things in the past or that occur. And that may be a 
reflection that we have strengthened that culture of safety 
rather than that we failed to address it.
    Mr. Green. Well, if it is an issue of culture, and again, 
like you said, you have some great labs, and I am familiar with 
some of them. Is it just because they deal with these dangerous 
substances so often they get lax, and they are more interested 
in what they are working with than maybe the safety of what 
they are dealing with?
    Dr. Frieden. I think that is a significant part of it, that 
if you work with something, even if it is a deadly microbe, day 
in and day out, year after year, you get a level of familiarity 
that may lead to doing things that you really should not do. 
And that is why we have to have double checks in place, 
policies, and protocols, training, and a culture of safety with 
the vision that we will work to minimize risk such that no 
worker and the public are never exposed to a risk that could 
have been prevented in our laboratories.
    Mr. Green. And I guess that complacency, it needs to be 
monitored literally every day 24/7 because of what you do. Is 
that part of what you are trying to do at CDC with the guidance 
for other agencies?
    Dr. Frieden. Absolutely. That is what we have done by 
establishing a single point of accountability for laboratory 
safety, an empowered working group that will work with that 
individual, but emphasizing that even with that individual and 
even with that group, laboratory safety is really something 
that everyone who touches a laboratory needs to be conscious of 
and think of ways to continuously improve.
    Mr. Green. OK. Mr. Chairman, I would hope that we would 
have a follow-up in a few months to see the success. And again, 
it is almost like re-training some of the smartest people in 
the country to be certain what they are doing with the 
substance they are dealing with. And I yield back my time.
    Mr. Murphy. I think that is a good idea, but I do want to 
add also, Dr. Kingsbury, when you were responding to Mr. 
Green's question about other congressional authorization would 
be required, can you get this committee details on what that 
would be?
    Ms. Kingsbury. I do not actually have a basis on which to 
be specific about what might need to be done. I think we 
probably need to continue to work with your staff to talk 
through what some of the options might be going forward.
    Mr. Murphy. Thank you. Mr. Harper is recognized for 5 
minutes.
    Mr. Harper. Thank you, Mr. Chairman, and thank you for 
holding this hearing on a very important issue. And certainly 
some agencies can be dysfunctional and there is no concern or 
no real harm in that. But the CDC is one that cannot be 
dysfunctional, so we are very concerned about safety within the 
labs for obviously the workers there, and certainly for the 
public on how we are going to address that.
    And if I could, Dr. Frieden, to refer to Tab 7. That is a 
letter that you sent in September 2012 to the committee 
responding to concerns about CDC lab safety. In that you stated 
that a senior official was designated to report directly to you 
about safety issues and those things there. Who was that senior 
official?
    Dr. Frieden. I will have to get back to you about that to 
get you the name and the details of what was done pursuant to 
that letter.
    Mr. Harper. OK. Then obviously the question would be, and I 
wish you could have answered today, was who was that senior 
official, and what were the results of that action. And then 
the question that perhaps you can answer now is how is the 
appointment of Dr. Michael Bell as the new CDC point person 
over lab safety when we do not even know who the old point 
person was, how is that going to be more effective other than 
we know his name?
    Dr. Frieden. What I believe to be the case is that we did 
in 2012 similar to what we did in other incidents was we did 
address comprehensively the specific problems that were 
identified. So there were concerns about some airflow issues. 
There were concerns about some of the security issues in our 
laboratories.
    And while I would never say that we are 100 percent 
resolved on those things, we really focused on those particular 
problems. What we missed was the broader pattern, and that is 
what Dr. Bell is overseeing now.
    Mr. Harper. So does this mean that there will be always a 
point person, is that what your plan----
    Dr. Frieden. Yes. Dr. Bell is the person now. We will 
transition that to a single point of accountability for lab 
safety. And one of the things that Dr. Bell and his group will 
do is to recommend where that entity should sit within CDC to 
be most effective.
    Mr. Harper. Dr. Dick, the CDC reported that since 2007 
there have been two surprise inspections of CDC, both performed 
by CDC's Division of Select Agents and Toxins before APHIS took 
over inspections of CDC labs. Since 2012 I am showing that 
APHIS has conducted 11 inspections of CDC labs. I would like to 
know why APHIS has not conducted any surprise inspections of 
CDC labs, or have they done that?
    Mr. Dick. Thank you for the question. We conduct surprise 
inspections to enforce compliance between renewal inspections, 
which is every 3 years. As we stated, we came on in late 2012 
as the oversight entity for CDC. At the Roybal Lab, we actually 
have been there six, seven if you include this last incident, 
times in that year and a half. So we have not had an 
opportunity to do a surprise inspection since we are there 
regularly.
    Mr. Harper. So the last time a surprise inspection was done 
was when?
    Mr. Dick. We have not done a surprise inspection prior to 
taking over in 2012. I am not familiar with before that.
    Mr. Harper. And obviously I will not ruin the surprise by 
asking when one is planned. But it does seem like we----
    Mr. Dick. We intend to follow up on----
    Mr. Harper [continuing]. That that is a great tool to have.
    Mr. Dick. Absolutely, and certainly first and foremost we 
are going to be following up on the current incident with them 
and making a revisit when CDC indicates that they are ready for 
us to revisit. And then we will be doing surprise inspections 
after that point.
    Mr. Harper. Let us say that, and this is for you, Dr. 
Frieden, or for you, Dr. Dick. If it is determined that a 
dangerous biological agent has been stolen, who do you report 
that to?
    Dr. Frieden. So we have a protocol for dealing with theft. 
There has been no theft of a biological agent reported from 
either CDC or any of the regulated facilities in the 10 years 
of the program to my knowledge. When there are concerns for 
potential theft or misplacement, we work with law enforcement, 
including the FBI, to do a joint investigation. I would just 
mention that our expansion of surprise inspections was 
something that we directed over the last few years at CDC 
because we felt that was very important to do.
    Mr. Harper. So you said there have been no reports of 
stolen agents.
    Dr. Frieden. That is my understanding.
    Mr. Harper. But what about missing biological agents?
    Dr. Frieden. There have been losses at certain facilities, 
and in those circumstances we also coordinate with the FBI. 
Usually it is an issue of inventory control, so as earlier we 
were talking about critical control points, such as 
inactivation of virulent pathogens. Similarly, inventory is a 
critical control point.
    Mr. Harper. Yield back.
    Mr. Murphy. Thank you. I do want to ask clarification of 
Mr. Harper's question, though. When he asked about theft of an 
item, your inventory control is not so tight that someone could 
not, I mean, someone could take something, replicate it, and 
walk out with something. Am I correct on that?
    Dr. Frieden. Inventory control is one of the critical 
controls to prevent loss or theft. But there have been to my 
knowledge no thefts reported from any of the select agent 
regulated labs, including CDC's, over the past decade.
    Mr. Murphy. Well, there was at the Army one in Texas, I 
believe, a few years ago.
    Dr. Frieden. I am not familiar with that.
    Mr. Murphy. Thank you. Mr. Tonko, you are recognized for 5 
minutes.
    Mr. Tonko. Thank you, Mr. Chair. Welcome to our panelists. 
The CDC is responsible for registration and oversight of all 
laboratories that possess, use, or transfer select agents that 
could pose a threat to human health, while APHIS is responsible 
for those select agents that pose a threat to animal or plant 
health. Select agents that pose a threat to both human and 
animal health, like anthrax, are regulated by both CDC and 
APHIS.
    So that being said, Dr. Kingsbury, can you tell us what GAO 
has found with regard to the increase in the number of high 
containment bio labs?
    Ms. Kingsbury. I have got that on. I am not sure I 
understand your question. I think within the Select Agent 
Program, I think there is information about how many 
laboratories there are, and they are regularly inspected as 
these gentlemen have just been saying.
    Our concern about the national strategy is that there are a 
lot of other laboratories that deal with highly infectious 
pathogens that are not considered to be select agents, and 
nobody knows how many of those laboratories there are.
    Mr. Tonko. But with the high containment bio labs, in that 
given category, is there an increase that has been measured by 
your review?
    Ms. Kingsbury. I mean, I did not hear the word.
    Mr. Tonko. Is there an increase in the number of----
    Ms. Kingsbury. There has been an increase since the anthrax 
attacks in 2001. The last time we actually tried to count them 
was 2 or 3 years ago, and I think at that point it looked like 
there were slightly fewer than there had been the year before, 
which we sort of think is maybe just a budget problem. But 
that, again, is the only ones that people are actually aware 
of.
    I think there are private entities and perhaps State 
government entities that have BSL-3 and BSL-4 laboratories that 
are not overseen in the same way and that is of a little 
concern to us.
    Mr. Tonko. Well, what accounts for the growing numbers of 
these labs that you suggested are out there?
    Ms. Kingsbury. Well, following the anthrax attacks in 2001, 
there are a number of agencies whose missions touched on the 
issue of biological weapons and whether those pathogens could 
be used to attack our country. And so each within their own 
sphere developed a program to counter those possible threats, 
and each got funded by the Congress to build additional 
laboratories and so forth. So it is just a fragmented program 
that had a very strong rationale at the beginning, but right 
now I think there is perhaps a different rationale that might 
be articulated. But nobody is in charge of doing that.
    Mr. Tonko. So with this increase in the number of labs and 
these various missions associated, what would your 
recommendations be to addressing----
    Ms. Kingsbury. Well, we have made recommendations that 
there should be a single entity that has responsibility for 
developing a national strategic plan and national standards for 
the operations of high containment laboratories. The dilemma is 
figuring out how to do that in the current environment with 
competing interests among the agencies involved and so forth. 
There is even a competing interest issue in the Congress since 
different committees of the Congress have different 
jurisdictions over these different agencies.
    So it is a tough problem to solve, but we think it would be 
worth spending some time even at a theoretical strategic level 
to begin to address this issue and think through how we would 
go about doing it in the future.
    Mr. Tonko. And, Dr. Frieden, what are your views here in 
terms of the growing numbers of these labs and how to move 
forward with the activity here in the U.S.?
    Dr. Frieden. I do think this is a complicated topic for 
which there is probably not a quick and simple solution. But 
just logically, the more places work with dangerous pathogens 
goes on, the more possibility there is of accidents or 
accidental releases. So ensuring the work that happens is 
happening in a safe environment is critical.
    And the key concept I think we have to apply is risk 
benefit. I do not think we can ever guarantee zero risk for 
some of the things that are done, but we can do everything 
humanly possible to get that risk as low as possible. But we 
have to ensure that the benefit is something that is reasonably 
likely to occur.
    Mr. Tonko. Thank you. Thank you very much. With that I 
yield back, Mr. Chair.
    Mr. Murphy. Thank you. I now recognize Mr. Griffith for 5 
minutes.
    Mr. Griffith. Thank you, Mr. Chairman. I appreciate that, 
and I appreciate you all being here today to testify to us.
    Dr. Frieden, if I could get you to turn to Tab 5 in the 
booklet. And as you look at that Tab 5, that is the HHS 
Inspector General report regarding the CDC Roybal facility, 
which says it was sent to you. Have you seen this before at 
some point? The front page says it was sent to you.
    Dr. Frieden. I have it.
    Mr. Griffith. OK. And then if I could direct you to page 5, 
and on page 5 it says that the Inspector General's Office could 
not verify that 10 out of 30 sample-approved individuals for 
select agents had received the required training. And do you 
see that on that page?
    Dr. Frieden. Yes.
    Mr. Griffith. And likewise it says that select agent 
inventory records are incomplete, and you also acknowledge that 
that is on that page?
    Dr. Frieden. Yes.
    Mr. Griffith. And then if go over to page 6, the report 
says that there were agents stored in areas not listed in the 
registration. You see that at the top of the page as well, page 
6.
    Dr. Frieden. Yes.
    Mr. Griffith. Thank you. And one example given is that 
scientists found a vial of select agent in a drawer and another 
scientist discovered 16 vials stored in an unsecured freezer. 
Do you see that in that paragraph?
    Dr. Frieden. Yes.
    Mr. Griffith. Yes. And the report on page 6 also states 
that there were unauthorized transfers and packages received by 
unapproved individuals. Now, my concern is this. This is at the 
Roybal facility. Were these not the same kind of violations 
that then popped up and were found in subsequent inspections by 
the USDA in 2013 and 2014, and then revealed again in the 
matter that brings us here today in the anthrax and influenza 
incidents of 2014? Are they not the same types of problems?
    Dr. Frieden. The answer is yes and no. The specific 
problems that were found led to a specific response. For 
example, on security we implemented layers of security. We 
strengthened the systems. We improved personal background 
checks and security. So in each of these, we felt----
    Mr. Griffith. Let me ask you this question. Did you all do 
a system-wide after these problems were discovered because we 
have 2010, and then we have got 2013, and earlier in 2014? Did 
you all ever do a system-wide re-check?
    Dr. Frieden. Not adequately. Not adequately. We addressed 
the specific problems, I believe, with a sincere effort to 
rectify them, but what we missed was the broader pattern that 
we are now addressing by strengthening our culture of safety in 
our labs.
    Mr. Griffith. All right, and I do appreciate that, and I 
know that you are having to answer a lot of tough questions, 
and I appreciate your demeanor here today. I do think that is 
appropriate and appreciated.
    That being said, let us look over page 7, and then on top 
of page 8 there are five recommendations there. If you could 
read those out loud that take place, and then let me know if 
they were followed up on.
    Dr. Frieden. Well, I can shorten this by saying that the 
key one is the fifth, and the fifth has to do with confirming 
that materials are inactive before transferring them. And that 
was specifically what was not done in the anthrax incident. So 
if we had applied this broadly, this incident would not have 
happened.
    Specifically, just to give you a sense of it, in 2006, the 
same laboratory, the BRRAT Lab, had a pretty similar incident, 
and that is why I directed that it be put into our July 11th 
report. And after that incident, they implemented a standard 
operating procedure for that particular type of biological 
material leaving their laboratory. But when they had a 
different type of biological laboratory--excuse me--biological 
material leaving the same laboratory, they did not apply that 
standard operating procedure that would have inactivated it.
    So I do think it is the lack of adequate pattern 
recognition that has led us until these last few weeks not to 
undertake the kind of comprehensive, sweeping change and 
improvement in our laboratory safety culture that we are now 
implementing.
    Mr. Griffith. Well, I appreciate that. Now, what about the 
other four? Number five may have been the most important, but 
could you look at the other four?
    Dr. Frieden. The first has to do with physical security 
measures, and I believe we have taken a number of steps there. 
There are still steps that we need to do better on in that area 
having to do with staff coming in and not swiping in every 
time.
    Mr. Griffith. And you have indicated you are going to have 
training, which is number three. What about number two?
    Dr. Frieden. Yes. I think we have made a great deal of 
progress on ensuring that only approved individuals are allowed 
access to select agents, and Mr. Henderson can speak more to 
that.
    Mr. Griffith. All right. You have got 20 seconds to do 
number four.
    Dr. Frieden. Inventory is an area where we have done a 
number of things, but given the recent incident at NIH and the 
fact that inventory is a flashpoint, we will be reviewing all 
of our inventory work. It is a massive job to do it right, but 
we will do that as well.
    Mr. Griffith. Well, and I appreciate that. The safety of 
the American public rests in your hands. Thank you, and I yield 
back. Thank you.
    Mr. Murphy. Thank you. I now recognize Ms. Schakowsky for 5 
minutes.
    Ms. Schakowsky. Thank you, Mr. Chairman. And I want to 
thank the witnesses. As you can see from the tone of this 
hearing, there is complete bipartisan concern about what 
happened here. And what I wanted to concentrate on is not the 
incidents themselves, but then the response in particular to 
the anthrax release.
    The CDC report described delays in identification of 
potentially exposed individuals, and potentially affected lab 
rooms, and communication of the possible release of anthrax to 
all CDC staff that may have been exposed, and that there was no 
clear lead for response to this incident in the first week.
    So, I know you have discussed a number of these things, but 
it is the management piece once a problem was discovered. And 
so, I wanted to ask you, Dr. Frieden, what was your response to 
this finding?
    Dr. Frieden. This was our finding, and we indicated that 
when we deal with outside events, and we are currently dealing, 
for example, with Ebola in West Africa where we have the 
largest outbreak ever, we activate our Emergency Operations 
Center, or sometimes we will use the facilities of the 
Emergency Operations Center to manage our response more 
effectively.
    We should have done that the moment we learned of the 
potential exposure. What that allows us to do is break down a 
big problem into smaller problems and address them one by one: 
communications, employee safety, clinical care, 
decontamination, scientific evaluation and investigation. And 
so, instead of doing that in a systematic way, it was done 
unsystematically, and not as well as it should have been done.
    In those first few days, which I remember vividly, we were 
really focused on the employees who may have been exposed and 
making sure that they got into care and got on treatment.
    Ms. Schakowsky. But it took a while to even identify who 
those people were.
    Dr. Frieden. Yes. In the effort to do that, we identified 
that we did not have the kind of systems that were needed or 
the systems that we had in place were not used promptly, for 
example, viewing security camera coverage to see who had come 
into and left the facilities on time. That was not done because 
one part of the Agency did not know or did not use those 
resources. The root cause of that problem was not activating 
our Incident Command System.
    Ms. Schakowsky. OK. Dr. Dick, can you elaborate on that 
finding about response?
    Mr. Dick. Yes. I think our findings were very similar to 
Dr. Frieden's. We had an independent team that came in during. 
There was still an ongoing investigation by CDC and their 
staff, and our Select Agent Group was interviewing employees 
and workers from the various sections that were responding to 
this.
    We found very similar findings to those that he just 
indicated.
    Ms. Schakowsky. You know, I wanted to follow up for a 
second on what the chairman was saying about the possibility of 
even stealing something that is a threat. You know, in the 
smallpox incident, it turned out that the vials were discovered 
at NIH, but they could have been somewhere else. Nobody seemed 
to know. And that is really disturbing, too, that, you know, 
who knows? Somebody could have taken them out. So I am not sure 
when you say that nothing has been stolen, that it also says 
that nothing could have been stolen. Respond to that, Dr. 
Frieden?
    Dr. Frieden. Well, we have taken a number of steps to 
strengthen the security aspects of select agent registration. 
Those steps include suitability assessments for all people who 
work with tier one agents. They include looking at cyber 
security issues and personnel reliability, ongoing access of 
personnel who have access to tier one agents, increased 
physical security standards, incident response plans, and 
ongoing training. So I do think that the concern for theft is 
real.
    Some of these organisms still occur in nature and ensuring 
that where there are laboratories not just in this country, but 
around the world, that you test on them.
    Ms. Schakowsky. Well, let us worry about this country right 
now, and smallpox, of course, would be a big concern. Let me 
just end with this, if I could, Mr. Chairman. Whenever I hear 
the word ``culture,'' and a ``cultural problem,'' I know we 
have a real challenge on our hands, you know. Hand washing 
change the face of medicine. It is not sexy, and people do not 
win Nobel Prizes over that kind of thing. But it really as part 
of the culture has made our medical system much more 
successful, huge advance.
    And so, these kinds of small things that deal with culture, 
and attitude, and awareness of these kinds of very simple 
things, we need to really figure out, you need primarily to 
figure out how to make them part of the everyday thinking of 
your staff. And, you know, we are willing participants here. 
And I yield back.
    Dr. Frieden. Thank you.
    Mr. Murphy. Thank you. I now recognize Mr. Johnson of Ohio 
for 5 minutes.
    Mr. Johnson. Thank you, Mr. Chairman. And I, too, want to 
thank our witnesses for joining us today. Dr. Frieden, it looks 
like you are the guy on the hot seat. You are getting peppered 
with all the questions, and I have got a few for you as well.
    You know, the mission of CDC laboratories, as you well 
know, includes carrying out work to protect the American public 
against bioterrorist activities. Now, critical lab activities 
are shut down pending the outcome of your remedial evaluation 
and reform. So how will CDC be able to address any bioterrorism 
or other emergencies which might occur before they reopen?
    Dr. Frieden. There is just one particular laboratory that 
is shut. There are multiple other laboratories at CDC that 
continue their operation that would be able to respond to 
bioterrorist and a potential bioterrorist incident.
    Mr. Johnson. OK. So there is no concern on your part that 
because of these CDC errors that we may be limiting our ability 
to protect the public.
    Dr. Frieden. No, I am confident that the incidents that we 
saw did not cause any release of agents into the community. 
They most likely did not cause any actual exposure to CDC 
staff. But they really are a tipping point in our recognition 
of the need to improve our laboratory safety. But we are still 
fully functional in terms of being able to respond to an event.
    It is just that step of sending something out of a high 
containment space into a lower containment space that I have 
issued a moratorium on, and we will lift that laboratory by 
laboratory as soon as we are confident we can do that safely.
    Mr. Johnson. OK. Is the CDC planning to use the National 
Science Advisory Board for Biosecurity as the external 
committee to advise CDC on laboratory quality and safety?
    Dr. Frieden. What I intend to do is to invite an external 
advisory group specific to look at CDC and specific to tell us 
every way they think we can do better in----
    Mr. Johnson. But what about the National Science Advisory 
Board for Biosecurity? Are you going to be using them?
    Dr. Frieden. That is not our current plan to the best of my 
understanding.
    Mr. Johnson. OK, because NIH on Sunday purged almost half 
of the members from that board, and I was inquisitive about 
whether you knew about this, why the Administration took this 
action, and whether or not NIH consulted. Do you use that 
advisory board for anything?
    Dr. Frieden. I would have to get back to you. It is 
primarily managed by NIH, so I would have to defer to them for 
the management of that group.
    Mr. Johnson. All right. Well, that is good. That eliminates 
one question for you then. For Dr. Dick, in light of the 
anthrax incident investigation APHIS recently completed, do you 
think that prior inspections of CDC laboratories were 
sufficient?
    Mr. Dick. I do.
    Mr. Johnson. OK. Well, given the fact select agents were 
stored in undesignated places, should such problems have come 
to light fully as a result of prior inspections?
    Mr. Dick. Yes. I think the important thing to recognize is 
that when we review their protocols, the protocols were in 
place. And because of the primary cause of this incident, and 
that was that this bacteria was not inactivated, it was 
transferred to a laboratory that would not necessarily have to 
have a locked cabinet. And so, therefore, when we provide our 
report on select agents, as was indicated earlier, we also 
report on those laboratories where that select agent went, in 
this case not deactivated.
    Mr. Johnson. OK. All right. Well, that concludes my 
questions, Mr. Chairman. I yield back the balance of my time.
    Mr. Murphy. Thank you. I now recognize Mr. Long for 5 
minutes.
    Mr. Long. Thank you, Mr. Chairman. Dr. Frieden, are you 
familiar with this picture?
    Dr. Frieden. I certainly am.
    Mr. Long. Well, I am going to turn 59 years old in less 
than a month, and this vial is dated 17 months before I was 
born. And apparently it was located in a cooler where?
    Dr. Frieden. On the NIH campus.
    Mr. Long. Last week.
    Dr. Frieden. A little over that.
    Mr. Long. In recent----
    Dr. Frieden. Yes.
    Mr. Long. Recently.
    Dr. Frieden. Yes.
    Mr. Long. So this vial of smallpox that is older than I am 
had been in a cooler, am I given to understand, in one 
location? I cannot even imagine a cooler running for 60 years, 
61 years.
    Dr. Frieden. My understanding is that it was a walk-in cold 
room that was used for storage.
    Mr. Long. And someone walked in and discovered this 
smallpox.
    Dr. Frieden. What happened was that that laboratory, as I 
understand it, was transitioned from NIH to FDA many years ago 
when FDA took over some of those functions. FDA is moving into 
its new facilities. In the course of moving, it was doing a 
complete inventory of everything in its facility, and the 
workers there discovered a large box that had this vial and 
others in it.
    Mr. Long. Workers like moving workers?
    Dr. Frieden. No, laboratory scientists.
    Mr. Long. Lab workers.
    Dr. Frieden. Sorry, laboratory scientists, yes.
    Mr. Long. OK. Well, recently there was a case of someone 
that wanted to remove information from NSA, and he got in a 
position to do that. And with a $1,500 thumb drive, he was able 
to take all kinds of severe government secrets with him out of 
his position he had worked in. Does it bother you at all that 
people could, if they had cruelty and meanness in mind, that 
they could get into a cooler like this and take a 61-year-old 
vial of smallpox?
    Dr. Frieden. We are certainly concerned that smallpox, 
which should not have been there, was there for many years. And 
we want to ensure that on our campus, and NIH is looking at 
their campus, and FDA at theirs, there are not other examples 
of collections because this was a collection of organisms that 
are in place and in places where they should not be.
    This particular box was clearly created by a scientist who 
was very experienced or a group of scientists. The materials 
were essentially freeze dried, or lyophilized is the scientific 
term for it, and then sealed in that ampule that you held up 
the picture of. And that was done before smallpox eradication 
was undertaken, so it was not done with malicious intent. It 
was done just to preserve something for future----
    Mr. Long. No, no, I know that, but just the fact that this 
could lay around for 61 years. I cannot even conceive of that 
thought. But let me take you to a press conference last Friday 
now that we have moved from 61-plus years ago. At a press 
conference last Friday, you indicated that the CDC does 
research to figure out how better to treat people if they are 
exposed and prevent it, if they are exposed, and how better to 
prevent it through vaccination. You also stated the fact that 
anthrax continues to occur in nature, that anthrax has been 
used as a weapon.
    My question is this. How many CDC laboratory workers 
received the FDA licensed anthrax vaccine prior to the anthrax 
incident last month as recommended by the CDC, its Advisory 
Committee on Immunization Practices committee for lab workers 
since 2002?
    Dr. Frieden. I would have to get back to you on the exact 
number, but we offer anthrax vaccine to anyone for whom anthrax 
vaccine is indicated. We do not require people to get 
vaccinated, but we offer it to anyone who might be exposed 
through their laboratory or epidemiologic work.
    Mr. Long. So you think that is a pretty active program?
    Dr. Frieden. Oh, yes.
    Mr. Long. Do you have any idea? I mean, you say you have to 
get back to me, which is fine if you will. I appreciate it.
    Dr. Frieden. I would have to get back to you.
    Mr. Long. OK, because it is reported that you told Reuters 
on June 30th the fact that anthrax exposure was even a concern 
or that it might have happened is unacceptable. Employees 
should never have to be concerned about the safety from 
preventable exposures. And as you note, to date more than 12 
million doses of BioThrax, the FDA licensed anthrax vaccine, 
have been administered to more than 3 million individuals. So 
if you can get back to me with that, I would appreciate it.
    Dr. Frieden. I will.
    Mr. Long. And with that, Mr. Chairman, I yield back.
    Mr. Murphy. Thank you. I now recognize Ms. Ellmers of North 
Carolina for 5 minutes.
    Ms. Ellmers. Thank you, Mr. Chairman, and thank you to our 
panel. This is a very good discussion, and I appreciate your 
candid responses. I think that at this point the most important 
thing that we all can do is get to the bottom of it and correct 
the issues at hand so that these things do not happen again.
    I did want to clarify something. Dr. Frieden, there was a 
question posed to you about the number of missing possible 
toxic substances. And I know you had acknowledged that over 
time there has been an account of some missing, but not stolen, 
correct? If something is missing, how do you determine that it 
absolutely was not stolen? And if anyone else on the panel 
would like to comment on that, I would appreciate it as well.
    Dr. Frieden. So to give you an example, there may have been 
a package that was sent from one location to another and had a 
select agent in it. It did not arrive at the second location. 
The FBI was involved in that investigation, and the FBI 
concluded in one particular case as an example that the package 
had been inadvertently destroyed, but it had not been stolen or 
lost. Is there anything you would like to add to that?
    Mr. Henderson. Just one thing I think is important is we 
take the notion of chain of custody very seriously, so we are 
always trying to be mindful of where the select agents are 
stored, and if they are in transport, we have eyes on them or 
somebody trusted to be with them as much as possible. 
Occasionally, Dr. Frieden is correct, there could be an 
accounting issue where something has been destroyed and they 
did not complete the paperwork, and then we have to go and try 
to understand what happened. And there have been a couple of 
instances like that.
    Ms. Ellmers. OK. Thank you for clarifying that for me. And 
again, getting back to just some of the toxic substances that 
have been found in boxes that may not have stated what they 
were in a refrigerated walk-in storage or otherwise. When the 
NIH ran across their most recent problem, they put in place 
what they call a clean sweep. And I know you had said that 
there was a transition between NIH and FDA. Were they already 
in the process? I mean, is that what the clean sweep is that 
you were talking about, or did they institute the clean sweep 
afterwards?
    Dr. Frieden. My understanding is that both NIH and FDA are 
doing complete inventory checks and follow-up to the discovery 
of the smallpox vials.
    Ms. Ellmers. OK. So once that happened-- So I guess my 
question for you is, is the CDC doing the same?
    Dr. Frieden. Yes. We will undertake a comprehensive 
inventory review at all of our facilities.
    Ms. Ellmers. At all the facilities.
    Dr. Frieden. That is my understanding.
    Ms. Ellmers. Including the one that is shut down now 
obviously.
    Dr. Frieden. Yes. Yes.
    Ms. Ellmers. But all of them.
    Dr. Frieden. All of our lab facilities.
    Ms. Ellmers. Great. Well, thank you. I have time if anyone 
wants to use it, Mr. Chairman. But I yield back right now if no 
one else wants my time.
    Mr. Murphy. Right. I believe that concludes our first 
panel. So I thank all the witnesses for coming today, and we 
will just let you step away while we prepare the second panel.
    I would also remind everybody that we will have some 
follow-up questions for you, so please get back to us quick.
    Ms. DeGette. Mr. Chairman, will you yield for one second?
    Mr. Murphy. Yes, I will be glad to.
    Ms. DeGette. I would just hope that we would have this 
panel back in the fall after Dr. Frieden completes his 
investigation and puts his controls in place. I think it is 
really important for us to know what they are doing, and I know 
they are working hard on this.
    Mr. Murphy. I agree with that, and we would like to hear 
again, so we will have you back.[Recess.]
    Mr. Murphy. Well, while they are getting ready, I will get 
the next panel introduced. We will have Mr. Sean Kaufman, who 
is the President and Founding Partner of Behavioral-Based 
Improvement Solutions, LLC. We also have Dr. Richard Ebright, 
who is a Board of Governors Professor of Chemistry and Chemical 
Biology at Rutgers University, and Laboratory Director at the 
Waksman Institute of Microbiology.
    While the witnesses are stepping up here, I will be 
swearing them in. Are you sitting in your right seats there? I 
am sorry, I do not know what the means. Mr. Kaufman, are you 
ready? Where is Dr. Ebright? The witness is AWOL I guess.
    What we may do to get going here, Mr. Kaufman, let me swear 
you in so you can get started on your testimony, and then we 
will swear in Dr. Ebright when he returns.
    So you are aware the committee is holding an investigative 
hearing and doing so has a practice of taking testimony under 
oath. Do you have any objections to testifying under oath?
    Mr. Kaufman. No.
    Mr. Murphy. And advise you under the rules of the House, 
you can be advised by counsel. Do you have a desire to be 
advised by counsel during testimony today?
    Mr. Kaufman. That is correct.
    Mr. Murphy. You do have counsel with you?
    Mr. Kaufman. I do not.
    Mr. Murphy. OK, thank you. Could you please raise your 
right hand and I will swear you in.[Witness sworn.]
    Mr. Murphy. Thank you very much. You are now under oath 
subject to the penalties set forth in Title 18, Section 1001 of 
the United States Code. You may now give a 5-minute summary of 
your written statement. Go ahead.

 TESTIMONIES OF SEAN KAUFMAN, PRESIDENT AND FOUNDING PARTNER, 
 BEHAVIORAL-BASED IMPROVEMENT SOLUTIONS, LLC; RICHARD EBRIGHT, 
RUTGERS UNIVERSITY, BOARD OF GOVERNORS, PROFESSOR OF CHEMISTRY 
                      AND CHEMICAL BIOLOGY

                  TESTIMONY OF SEAN G. KAUFMAN

    Mr. Kaufman. Fantastic. Thank you. Chairman Murphy, Ranking 
Member DeGatte, and the members of the subcommittee, thank you 
for the opportunity to be here to testify on the Centers for 
Disease Control and Prevention anthrax laboratory incident.
    Let me begin by commending the CDC, specifically the 
actions taken to protect the workforce and inform the general 
public during this very serious issue. I stand by my belief 
that when someone does something wrong, we cannot forget what 
they have done right, and in general we must not forget that 
CDC has an outstanding history of service.
    For over 10 years I have been providing biosafety training 
programs for individuals working in high containment 
laboratories. My background is in behavioral science, and I 
specialize in motivating individuals to behave to mitigate 
risks associated with infectious diseases.
    There are three main challenges we face when doing 
scientific research: the agent, the people working with the 
agent, and the organization where the work is being done. The 
first challenge of working safely with infectious agents has 
been for decades, and can be, appropriately mitigated. 
Effective engineering controls, personal protective equipment, 
and standard operating procedures are already in place. 
However, it is important to recognize that one person and one 
error, whether it is unintentional or intentional, can negate 
all these controls in an instant.
    This leads me to the second challenge we face when looking 
at safe science, and that is the people working with the agent. 
Human risk factors, such as risk perceptions, attitudes, 
behavior, complacency, outrage, apathy, and perceived mastery 
must be addressed to sustain optimal performance of the 
scientific workforce.
    We must accept and learn from and control for human error 
in the laboratory environment. In other words, we must stop 
focusing on the who and start focusing on the why, how, and 
what went wrong, passing no judgment other than we are all 
human, which would lead to solutions minimizing further human 
error.
    Our final and greatest challenge is the existing social 
norms or safety culture within an organization. Let me repeat 
myself. The greatest challenge we face specific to safe science 
is not the agent. It is not the worker. It is the culture of 
the organization. The culture of an organization permits norms 
to be developed, and it is within these norms that behavior is 
either deemed acceptable or unacceptable.
    As a former proud CDC employee, I am very, very 
disappointed by what I am hearing. It has been and remains very 
clear that this issue is a systemic one or an organizational 
issue rather than an issue of a laboratory director and two 
scientists. I have become irritated by the unnecessary finger 
pointing and statements surrounding disciplinary actions of 
scientists who worked in parallel with the culture of the 
organization and made an unintentional error.
    The incident highlights the need for scientific protocols 
to be reviewed and verified, ensuring they work and they can be 
done by those working in a laboratory. This incident highlights 
the need to ensure those protocols are followed, and if they 
are not, consequences aimed at minimizing future failures are 
immediately applied.
    This incident calls for more evidence-based biosafety 
research to determine what specifically works and minimize 
risks associated with the challenges that we face, which again 
are the agent, the people, and the organization.
    In the years I have been doing training, I have been forced 
to speak a common language around the world. No matter where 
you are in the United States of America or around the world, 
people can relate to the concept of neighborhood, house, and 
family. I have used a home, sweet home approachfor establishing 
a healthy culture in my laboratory trainings.
    Please consider this analogy. A laboratory is a home. The 
scientists working within the laboratory are a family. The 
scientific protocols are the house rules. If one member of the 
family breaks the house rules, it puts the whole family at 
risk. If breaking the rules is not addressed, the whole house 
is at risk and begins to affect other houses in the 
neighborhood.
    Let me clarify. If scientists do not follow their house 
rules, it impacts other laboratories within the organization. 
CDC is a neighborhood that houses hundreds of houses or 
actually has hundreds of labs. If the neighborhood does not 
establish a set of ground rules for all the houses, then each 
house begins to do their own thing, and inevitably the 
neighborhood is at risk.
    Building a culture of safety starts with establishing a 
commitment to the residents, or the scientists, of that 
neighborhood or that organization. We do not banish family 
members for unintentional errors. We encourage homeowners or 
labs directors to come together and find solutions. We 
establish consequences for neighborhood members, scientists who 
blatantly choose to break neighborhood rules. We support each 
other, especially when unintentional accidents occur.
    We talk about incidents, not hide them, so the whole 
neighborhood learns and grows from them. We recognize that 
together we are safer. This commitment is contagious and 
spreads to homes throughout the neighborhood, and that includes 
laboratories throughout an organization. This is just the start 
of culture change, folks. The seed we plant today is what we 
will reap 5 years from now.
    Somewhere out there may be a scientist or an organization 
who finds something unexpected in a freezer, or as a human 
being makes an unintentional error. A choice has to be made. Do 
I report this or not? I ask this committee to facilitate a 
process which encourages organizations to report incidents and 
accidents rather than punishing them for doing so.
    CDC remains a national treasure, and the United States of 
America remains the land of opportunity for scientists and 
biological research. Placing untested mandates as a result of 
this incident on scientists and institutions of research may 
not only push science and innovation outside of infectious 
disease research, but worse, it could shift it to other regions 
of the world.
    I ask this committee to continue to take a leadership role 
while considering the implications of this hearing and future 
legislation. I look forward to your questions.
    [The prepared testimony of Mr. Kaufman follows:]

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

       
    Mr. Murphy. Thank you, Mr. Kaufman.
    Dr. Ebright, you were not available when I swore him in, so 
I am going to have to swear you in. But first ask you when we 
are doing an investigative hearing, we take testimony under 
oath. Do you have any objection to testifying under oath?
    Mr. Ebright. I do not.
    Mr. Murphy. And the chair advises under the rules of the 
House and the rules of the committee you are entitled to be 
advised by counsel. Do you desire to be advised by counsel 
today?
    Mr. Ebright. I do not.
    Mr. Murphy. In that case, would you please rise and raise 
your right hand, and I will swear you in.[Witness sworn.]
    Mr. Murphy. Thank you. You are now under oath and subject 
to the penalties set forth in Title 18, Section 1001 of the 
United States Code. You may now give a 5-minute verbal summary 
of your written statement.

                  TESTIMONY OF RICHARD EBRIGHT

    Mr. Ebright. Mr. Chairman, members of the committee, thank 
you for inviting me to discuss the 2014 CDC anthrax incident 
and its implications. I am a Board of Governors professor of 
chemistry and chemical biology at Rutgers University and 
laboratory director at the Waksman Institute of Microbiology. I 
will discuss three topics: first, the 2014 CDC anthrax 
incident; second, broader biosafety and biosecurity issues in 
CDC bioweapons agent laboratories, also known as select agent 
laboratories; and, three, broader biosafety and biosecurity 
issues at the more than 1,000 other government, academic, and 
corporate select agent laboratories across the U.S. that are 
regulated by the CDC.
    My assessments are based on information in published CDC, 
HHS OIG, USDA OIG, GAO documents, published press reports, and 
on my knowledge of biosafety and biosecurity standards for work 
with bacterial pathogens. I turn first to the 2014 CDC anthrax 
incident.
    I note that the 2014 CDC anthrax incident did not involve 
one violation in one laboratory, but instead involved an entire 
series of violations. The 2014 CDC anthrax incident involved 
multiple violations of biosafety and biosecurity 
recommendations in each of three different CDC laboratories. 
There were at least seven distinct violations in total. Had any 
of three violations in one CDC laboratory not occurred, the 
incident would not have occurred. Had any of four violations in 
two other CDC laboratories not occurred, the impact of the 
incident would have been mitigated.
    I note further that the incident reprised nearly exactly a 
2004 incident. In the 2004 incident, workers at Southern 
Research Institute in Frederick, Maryland used an inappropriate 
procedure to inactivate a sample of anthrax bacteria, used an 
inappropriate procedure to verify inactivation, and sent 
putitatively inert, but actually viable, anthrax bacteria to 
Oakland Children's Hospital, where eight persons were exposed 
before learning that the anthrax bacteria were viable.
    The CDC, as the agency with regulatory responsibility for 
select agent work relevant to human health, investigated the 
2004 Oakland anthrax incident, and in 2005 issued a report on 
the incident. The 2005 CDC report included revised biosafety 
and biosecurity recommendations both for laboratories that 
prepare and provide inactivated anthrax bacteria and for 
laboratories that receive and use those inactivated anthrax 
bacteria.
    Had the CDC implemented the recommendations in its own 2005 
report, the 2014 CDC anthrax incident could not have occurred. 
But the CDC did not implement the recommendations in its 2005 
report. The fact that the CDC in 2014 made exactly the same 
errors that had been made in the 2004 Oakland anthrax incident 
shows that the CDC did not learn from that incident.
    I turn now to biosafety and biosecurity in CDC's select 
agent laboratories. I submit that the 2014 CDC anthrax incident 
is not an isolated incident, but it is instead part of a 
pattern, and a pattern that could have been recognized a half 
decade ago, and should have been. Last week, a CDC report 
listed multiple other incidents, none previously disclosed to 
the public, in which CDC laboratories sent putitatively 
inactivated or attenuated, but actually viable and virulent 
select agents to other laboratories. These previously 
undisclosed CDC select agent incidents are fundamentally 
similar to the 2014 incident. In particular two previously 
undisclosed incidents from 2006 involved anthrax and appeared 
to be essentially identical to the current incident. All of 
these incidents raise both safety and security concerns.
    I note further that HHS OIG audits have documented further 
biosafety and biosecurity violations in CDC select agent labs. 
HHS OIG audits of the CDC select agent labs in 2008, 2009, and 
2010 reported major violations. These violations included 
failures to ensure physical security, failures to restrict 
access, and failures to document inventories. They also 
included the failure to provide required training to workers 
with training being unverifiable for fully one in three workers 
in the most recent available report. Perhaps most egregiously, 
the violations included unauthorized transfers to select agent 
labs to other laboratories or individuals.
    I note further that press reports from 2007 to the present 
have documented further biosafety and biosecurity deficiencies 
in CDC select agent laboratories. Examples just to summarize 
include inadequate provisions for emergency backup power, 
failure to maintain negative pressure airflow in bio 
containment areas, non-functioning doors, non-functioning door 
seals, jury-rigged repairs with duct tape, failure to close 
entry doors, failure to latch entry doors, failure to assign 
distinct key codes to the key cards for select agent 
laboratories, and in at least one case, the discovery of an 
unescorted, unauthorized person in a restricted area. Taken 
together, the available documents indicate that the CDC has not 
adequately ensured biosafety and biosecurity in its own labs, 
and are consistent with pervasive and systematic violations of 
biosafety and biosecurity in its own labs.
    I turn now to biosafety and biosecurity at CDC.
    Mr. Murphy. Could you summarize the rest of your statement 
here because we are----
    Mr. Ebright. Regulated select agent labs. The CDC and the 
USDA have regulatory responsibility for biosafety and 
biosecurity in the approximately 1,000 other U.S. select agent 
labs: government, academic, and corporate. There is no basis 
for confidence that biosafety and biosecurity standards are 
higher or that select agent inspections are more stringent at 
CDC regulated, non-CDC select agent labs, than in CDC select 
agent labs. There also is no basis for confidence that 
biosafety and biosecurity standards are higher or that select 
agent inspections are more stringent at USDA regulated select 
agent laboratories than CDC select agent laboratories.
    Deficiencies in select agent standards at these CDC 
regulated and USDA regulated other laboratories are amply 
documented in an HHS and USDA OIG audits.
    Mr. Murphy. Doctor, we are over time. I will give you 15 
more seconds.
    Mr. Ebright. One final point, which is I note that the CDC 
and USDA not only performed and fund select agent work, but 
also regulate biosafety and biosecurity for select agent work. 
This represents a clear conflict of interest. This systematic 
clear conflict of interest may at least partly account for the 
deficiencies that I have mentioned. Thank you.
    [The prepared testimony of Mr. Ebright follows:]
    
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
        
    [The appendices to Mr. Ebright's testimony have been 
retained in committee files and can be found at http://
docs.house.gov/meetings/IF/IF02/20140716/102479/HHRG-113-IF02-
Wstate-EbrightR-20140716-SD001.pdf.]
    Mr. Murphy. I thank the two witnesses. I will now recognize 
myself for 5 minutes.
    Mr. Kaufman, you specialize in the area of behavior and 
behavioral change, along those lines. We have heard from you 
and other witnesses today this culture of complacency is a 
concern. Congress has investigated at length problems at the 
Veterans Administration. We are outraged because of the care we 
have for our veterans. But we saw that there were cash 
incentives for people to cover things up, to shred them, to 
hide waiting lists.
    We also had in this committee hearings with Mary Barra, the 
CEO of General Motors. Americans were outraged about this, and 
it was described as the culture of complacency or the GM nod. 
Now we see this behavior problem getting into an area of which 
before if you were not a veteran or if you did not buy those 
Chevy cars, you were at least not at risk. But this, when you 
release a pathogen, it is pretty indiscriminate around anybody 
who is exposed to it.
    So does this routine familiarity around pathogens tend to 
lead people to cut some corners and just get complacent about 
this?
    Mr. Kaufman. I think that there is a--and I believe you 
know this, too. I think that there is an inherent risk in 
behavior in general. You over-behave, you run the risk of 
becoming complacent. You under-behave, you run the risk of 
being under-prepared. I think it is a very, kind of a balance, 
and that, in essence, is really, in essence, what professional 
development, and training, and assessments can be used for to 
keep that healthy balance in check.
    In this case, though, if we are talking about the anthrax 
incident in the laboratory, I do not believe that this was a 
complacency issue or even an incompetency issue. I believe this 
was a scientist that implemented a protocol from another 
laboratory where it was used for good purposes, and I would 
love to share what those purposes are. And unfortunately there 
was no process to vet that protocol.
    And so, when it was adapted from one laboratory to another, 
the inactivation time it takes to kill one agent versus another 
is a lot more with the spore forming BA or bacillus anthracis 
than it was with the brucella.
    Mr. Murphy. But we heard so many things that Dr. Ebright 
was just saying, too, the way the doors were handled, that we 
have heard about people being in an area that they were not 
authorized to be there, that a key was left in a refrigerator. 
It seems to me there are several other elements here where 
rules are in place and people are just downright sloppy.
    Mr. Kaufman. Yes. Chairman Murphy, I think the things that 
you are saying are very true, and they actually must be 
addressed and concerned. But I think they also have to be put 
into perspective. You know, this key in a freezer is almost 
like, and you used a loaded gun or a gun earlier in the 
session. It is almost like saying that I have a house, and 
inside my house I have a gun, and my house has a door with 
locks, and it also has a house alarm. And upstairs in the 
master bedroom is hidden a safe, and inside that safe is a gun 
with a trigger lock that has a key in it.
    Mr. Murphy. But that is not the case here. If a key was 
left in the refrigerator and people can come into that area, 
too, if people were all piggybacking on each other's card here, 
those are violations of rules.
    Mr. Kaufman. Chairman Murphy, like I said, I am not going 
to argue the fact that it is a problem because it is. But I am 
discussing the perspective, and I am telling you I have seen 
those refrigerators. They are not common practice refrigerators 
that people just go walking by. These refrigerators are in 
places where you actually have to have access.
    I came in as a civilian. I am not related to CDC. I have 
been to the laboratory. I have seen these freezers. They are 
not----
    Mr. Murphy. Well, but the issue is how people behaved, and 
that is a question I had for Dr. Frieden before is should 
someone be required to use their actual card so only certain 
persons can get in, whoever has authorization. It records when 
they were in there. And in some cases the deadly pathogens 
require two sets of eyes in there.
    Mr. Kaufman. Absolutely.
    Mr. Murphy. But part of this, too, I mean, I am not clear 
on what you are saying, Mr. Kaufman. I want to be clear on that 
that in some cases, are you making excuses for the persons and 
saying that there was not enough protocol? I am not sure what 
you are saying.
    Mr. Kaufman. No. No, sir. I am not making excuses. What I 
am saying is that there is a healthy respect for what truly is 
going on here, and I think we have to look at the spectrum. We 
cannot be arrogant and say this is just what happens in 
science, but we also cannot be living in an illusion where this 
is the end of the earth. We have got to stop all research. We 
have got to minimize and cut things down to a certain number of 
laboratories as a result of what happens here.
    I think we have to take a balanced approach and take a look 
at really what happened, and in the culture in which it 
happened. That is what I am saying.
    Mr. Murphy. Dr. Ebright, do you concur?
    Mr. Ebright. I disagree.
    Mr. Murphy. Can you please explain?
    Mr. Ebright. So these are problems of individuals, but they 
are problems of individuals acting in a context. That context 
has two components. The one is the laboratory culture, and we 
have talked several times or heard several times today about a 
culture of lax attitude towards safety. That is part of the 
problem. We have also heard several times today about 
researchers becoming inured to working with dangerous or 
hazardous materials. That is part of the problem.
    What has not been mentioned before with respect to culture 
is hubris, and hubris is fundamentally part of the problem 
here, a sense of the scientist that he or she should be able to 
proceed without restriction and without management. So these 
are all issues with the culture.
    But in addition to that culture, you have an institutional 
structure. You have institutional management, and then you have 
the oversight of that institution. I think these are even 
bigger problems that are even more significantly responsible 
for the issues that I described.
    I mentioned the fact that CDC and USDA regulate their own 
biosafety and biosecurity. They perform the work. They fund the 
work. That is an inherent conflict of interest. Until that 
regulatory responsibility is moved out of those two agencies 
and out of any agency that performs select agent research and 
funds select research, I believe you can predict with high 
confidence the same types of problems, the same patterns, and 
the same cultures will remain in place in CDC labs, in USDA 
labs, and in the approximately 1,000 other labs they regulate.
    Mr. Murphy. Thank you. My time is way over. I am going to 
now to recognize Ms. DeGette for 5 minutes.
    Ms. DeGette. Thank you, Mr. Chairman. I will follow up on 
your questions. Mr. Kaufman, I have no doubt that these 
individuals have no ill motives. They are well motivated. They 
are trying to do their research. And, Dr. Ebright, I think you 
would agree with that as well.
    Mr. Ebright. I would.
    Ms. DeGette. But let me just put this in context. I do not 
know if you were here when we gave our opening statements. I 
have been on this subcommittee since 1997, and I have got to 
tell you that the reason why we are so concerned here is 
because this kind of practice keeps happening over and over 
again. It is not just one isolated incident.
    As our memo that I put into the record said, there were six 
inspections. APHIS identified 29 observations of concerns of 
facilities and equipment, 27 related to safety and security, 
and 39 on documentation and record keeping. And a lot of times 
what we are dealing with in this situation is very, very 
extreme bioagents that could kill a number of people. And you 
are nodding your head, so I am assuming you understand this, 
yes or no?
    Mr. Kaufman. Yes, I do.
    Ms. DeGette. OK. So what we are trying to figure out, and 
like I say, I think the people are trying to do their job. I 
think they are well motivated. But with all due respect, we are 
not overreacting here. This has got to be solved.
    So what I want to ask you since you were here is, did you 
hear Ms. Kingsbury's testimony where she said that we need to 
have one agency at least in charge of developing national 
standards?
    Mr. Kaufman. Yes, I did.
    Ms. DeGette. And what do you think of that? And she 
admitted that it is going to be difficult to do that because of 
overlapping jurisdictions. But would you agree that it is worth 
an effort to try to do that?
    Mr. Kaufman. I know you like yes and no answers, and I am 
trying to think. I agree that we should explore what we are 
doing today and where we could go in the future, yes.
    Ms. DeGette. OK. Dr. Ebright, what do you think about that 
suggestion?
    Mr. Ebright. There definitely should be a single national 
agency that sets policy recommendations, policy standards, and 
advises on needs and how those needs should be met. There also 
should be a national entity that regulates and oversees the 
select agent work. They need not be the same, but they both 
need to be there.
    Ms. DeGette. And let me just say that we have seen this in 
this subcommittee, not just at CDC. We have also seen it in the 
labs. And we saw it at Los Alamos some years ago where some 
very highly confidential nuclear data disappeared because a 
researcher took it home to his house. It is the same kind of, 
you call it hubris or whatever. It is an assumption that there 
is important research going on, and that nothing bad is going 
to happen.
    Mr. Ebright. Correct.
    Ms. DeGette. And so, what I think is that, and in fairness 
I think what Dr. Frieden thinks, too, is you need to put 
systems in place so that it is not relying on somebody to have 
that kind of judgment where really you should have a system. 
Would you agree with that?
    Mr. Ebright. Absolutely.
    Ms. DeGette. And, Mr. Kaufman, would you also agree with 
that?
    Mr. Kaufman. Absolutely.
    Ms. DeGette. OK, great. Thanks, Mr. Chairman. I do not have 
anything further. Thank you for clarifying, and I will yield 
back.
    Mr. Murphy. Thank you. The gentlelady yields back. I will 
now recognize Ms. Blackburn of Tennessee for 5 minutes.
    Ms. Blackburn. Thank you, Mr. Chairman. I think we are all 
kind on the same path here with our questions.
    Dr. Ebright, I want to come to you. Let us go back to the 
CDC report from the 2004 anthrax incident, and you mentioned 
that. And that incident stated ``inactivated anthrax should be 
cultured both at the preparing lab before shipment and at the 
research lab several days before use to ensure sterility.'' So 
did CDC follow their own advice in this? OK, go ahead.
    Mr. Ebright. No, they did not. Apparently not in 2006. 
Definitely not in 2014.
    Ms. Blackburn. OK. So what we have is a continued pattern 
of refusing to learn from their past mistakes.
    Mr. Ebright. Indeed refusing to read their own reports and 
follow their own recommendations.
    Ms. Blackburn. OK. You are the director of a biomedical 
research lab.
    Mr. Ebright. Yes.
    Ms. Blackburn. And you do some of this same work with 
dangerous pathogens. And how important is it to you that all 
personnel in your lab strictly follow your biosafety protocols, 
and that in order to follow those biosafety protocols, they 
have an understanding that they have culture of safety that is 
lacking at CDC?
    Mr. Ebright. I think it is critically important. And for 
biosafety working with biohazardous organisms at any level--
one, two, three, or four--that message of safety has to come 
first. That safety training has to come first. And before any 
experiment is even begun, there has to be a process of risk 
benefit assessment in which the investigator enumerates the 
risks, enumerates the benefits, weights the risks against the 
benefits, assesses that the risks are outweighed by the 
benefits. And that process needs to be reviewed by another set 
of eyes.
    Ms. Blackburn. Do you follow this as standard operating 
procedures?
    Mr. Ebright. Yes we do for our biological, biohazard 
research.
    Ms. Blackburn. Yes. Is it clearly understood from all of 
your personnel, do they see this as written best practices, and 
do they understand that they are expected and required to 
follow?
    Mr. Ebright. They understand that they are expected and 
required to follow these practices. They are monitored in these 
practices, and the message consistently is that these agents 
require respect, and they must be handled with respect. And 
before any experiment, that risk benefit assessment must occur.
    Ms. Blackburn. And if one of your personnel failed to 
follow those protocols, what would you do to them?
    Mr. Ebright. Depending on the nature of the failure, they 
would face consequences up to and including termination.
    Ms. Blackburn. OK. And we do not see that pattern taking 
place at CDC.
    Mr. Ebright. We have not seen evidence for it.
    Ms. Blackburn. OK. Do you think that CDC is in need of a 
major correction, and do you have advice for CDC on what that 
correction would be?
    Mr. Ebright. Many of the things that we heard Dr. Frieden 
suggest will be undertaken at the CDC are precisely the steps 
that are required at the CDC. The question is whether this time 
will be different from the previous time, and the time before 
that, and the time before that.
    Ms. Blackburn. And if they did not do that, I think 
probably according to what you have said, you would terminate 
the whole bunch.
    Mr. Ebright. Again, in this particular case, personnel 
action will not be sufficient to resolve the issue. This issue 
is institutional and organizational.
    Ms. Blackburn. Correct.
    Mr. Ebright. They cannot have the regulatory authority to 
regulate themselves. It simply does not work. It does not work 
in many areas of human endeavor, and it definitely does not 
work in this area.
    Ms. Blackburn. Mr. Kaufman, anything to add to that?
    Mr. Kaufman. I continue to stand by my belief and my 
conviction, because over the last 10 years I have traveled the 
world, including several Federal labs in the United States, and 
I have asked scientists to please report laboratory accidents 
and incidents so we have a chance to learn from them. And if we 
take this chance now and turn it into a punitive aspect against 
scientists that make unintentional injuries, it is well-known 
that punishment does three things. It builds resentment, it 
teaches no new behavior, and it hides true behavior.
    And so, if we are going to make decisions that are going to 
decrease risk in science, we had better consider how we address 
incidents and accidents before doing so. Punitive actions, in 
my opinion, are not a way to go, certainly not against the 
scientists that unintentionally makes a mistake.
    If a scientist willingly, and there are scientists that do 
that, go against SOPs, that is a completely different job issue 
than a scientist that is doing their job within a culture and 
does not go outside of the SOP that is provided to them.
    Ms. Blackburn. Thank you. Mr. Chairman, I yield back.
    Mr. Murphy. I got a comment to that, Mr. Kaufman. It builds 
resentment. You got to be kidding me. You are telling me these 
people with Ph.D.s do not understand that anthrax is dangerous? 
Are you kidding me? They need more training? You are making 
your statement that CDC anthrax lab incident was all a result 
of training failure, safety training for scientists working at 
high containment facilities consistent multiple basis, blah, 
blah, blah. Are you kidding me? Are you making excuses for 
these scientists?
    If they do not understand that anthrax is used for a 
weapon, its spores can kill people, it killed people and harmed 
people at the U.S. Capitol, then they should not be working 
there. And it sounds like you are saying they need more 
training. Boo hoo.
    This is a bad situation. And I do not think you understand 
the seriousness of this, and it sounds like you are making 
excuses. Look at this. The Washington Post. Today's cartoon. Do 
you think the employees at CDC are proud of this? Ha ha ha. It 
is funny. No, it is not. This is tragic. It could have been 
lethal for people.
    And I hear you telling Ms. Blackburn that we are going to 
build resentment. I am sorry, I do not buy that at all.
    Mr. Kaufman. May I comment? Thank you. Thank you, Chairman 
Murphy. I again am not defending what is going with CDC. In 
fact, I have said that I am disappointed even as a former CDC--
--
    Mr. Murphy. Disappointed is not the right word. You should 
find this to be abhorrent. Any words other than yes or no, was 
it wrong or not wrong. We can make excuses for--Mary Barra sat 
here from GM, and she said this was wrong. There is no question 
about it. Dr. Frieden said this was wrong. There is no gray 
zone in this. I do not get it. I will let you respond to that.
    Mr. Kaufman. I appreciate that. I know the individuals 
involved, and when I say training is needed and training is a 
solution, there are several phases of training, and on-the-job 
specific training, which includes SOP verification, is needed 
for scientists, which has been mentioned in previous panel 
aspects as well.
    I am not making light of this situation. I am not making 
light of this situation at all. I am simply saying that if we 
choose to punish people who come forward when they make a 
mistake----
    Mr. Murphy. That is different. I am not talking.
    Mr. Kaufman. That is what I am saying.
    Mr. Murphy. That is different. We want people to be willing 
to do that.
    Mr. Kaufman. Thank you. That is what----
    Mr. Murphy. But I thought that you were saying here, and I 
think it is in your statement here, too, they need more 
training.
    Mr. Kaufman. They need on-the-job----
    Mr. Murphy. They do not training to know that this is bad. 
When you put anthrax in a Ziploc bag or any pathogen, you do 
not training to know that. So I have gone over. Mr. Griffith, 
you are recognized.
    Mr. Kaufman. That is subjective.
    Mr. Griffith. Well, and I guess my concern is that what we 
have here is a series of reports that Dr. Ebright has brought 
out some of the questioning that I did and others did earlier. 
We have had a series of reports that date back a good period of 
time, and yet the changes have not been made. And so, it is a 
concern.
    A mistake is one thing. Having a standard operating 
procedure which is so flawed that you have repeated mistakes is 
something that I have to agree with the chairman on. That is 
our problem. And I agree with you, Mr. Kaufman, you do not want 
to punish somebody who merely makes a mistake. You want him to 
come forward as quickly as possible and let us fix it. But you 
got to stop the same mistake happening over and over again.
    Dr. Ebright, how do we make these reforms happen this time?
    How do we do that because while CDC has to protect the 
American public from anthrax and other things, our job is to do 
oversight and make sure that they are doing their jobs. So how 
do we make it happen?
    Mr. Ebright. I think the two steps that Congress and the 
Administration could follow to reduce the probability that this 
happens again in CDC's own labs and in the labs that CDC and 
USDA regulate outside those facilities, the two most important 
steps are, first, to reduce the number of select agent 
laboratories. The number of select agent personnel, the volume 
of select agent research, increased by a factor of 20 to 40 
over the last decade.
    That volume of registered individuals, that volume of 
activity needs to be rolled back to close to the level of where 
it was at the beginning of that increase. That would represent 
taking the current 1,000, or more than 1,000 select agent labs 
in the U.S. and reducing it to 50.
    Mr. Griffith. All right. Let me ask you a question real 
quick. High containment select agent, are those interchangeable 
terms or they different?
    Mr. Ebright. They are very close to interchangeable.
    Mr. Griffith. OK.
    Mr. Ebright. Most select agent research, particularly most 
research, are consequences done at Biosafety Level 3. Biosafety 
Levels 3 and 4 are considered high level containment.
    Mr. Griffith. So your first recommendation is let us 
squeeze it back down to 50 instead of a thousand of these 
select agent----
    Mr. Ebright. Roughly. The increase was a factor of 20 to 
40. I would recommend we roll back a factor of 20 to a factor 
of 40. A thousand divided by 20 is 50. A thousand divided by 40 
is 25.
    Mr. Griffith. All right.
    Mr. Ebright. So that, I believe, is the single easiest, 
single fastest, and certainly most economical approach
    Mr. Griffith. All right. And you had a second because 
obviously my time is limited.
    Mr. Ebright. OK. Last one is independent entity that 
carries out the regulation and oversight of biosafety and 
biosecurity in those labs, not an agency that performs the 
work, not an agency that funds the work.
    Mr. Griffith. OK. Now, you said we need to scale back, but 
let me ask you. Why has there been an expansion? And the 
phrasing I have is the high containment laboratories, you said 
they are closed. Why has there been such a great expansion?
    Mr. Ebright. So it was in large measure, essentially in 
whole, a response to the 2001 anthrax mailings. At the time of 
2001 anthrax mailings, it was understandable because it was 
expected here and elsewhere that the U.S. was under attack with 
a biological weapon from a foreign source. It was expected that 
biology would be put on a mobilization footing to address this 
threat. We expanded by a factor of 20 to 40.
    Now, more than a decade later, more than a decade after it 
has become absolutely clear that the 2001 anthrax mailings did 
not come from a foreign source, and after it has become clear 
that the investigation believes it came from within the U.S. 
biodefense establishment, we have the strange situation that we 
have expanded that establishment by a factor of 20 to 40 
without reason and without reassessment.
    Mr. Griffith. And the risks are self-evident?
    Mr. Ebright. The risks follow mathematically. When you 
increase the number of personnel by a factor of 20 to 40, 
particularly when you recruit people without prior experience, 
new to the field, you increase risks, and you increase those 
risks by a factor of 20 to 40 or more.
    Mr. Griffith. On those points, Mr. Kaufman, are you in 
agreement that we need to scale it back some?
    Mr. Kaufman. I am not. I agree with GAO. I think that there 
is not enough information to make the decision to either back 
off or go up. We do not have a baseline. And I also would like 
to say that the capacity of high containment laboratories are 
not built for the threats we just see today. They are built for 
the threats that we do not see coming around the corner 
tomorrow.
    Mr. Griffith. Let me switch gears and ask about the 
research implications or the implications from research of re-
engineering pathogens such as the experiments by the University 
of Wisconsin scientists that generated a virus similar to the 
1918 influenza outbreak that killed tens of thousands, maybe 
hundreds of thousands worldwide, and other ways to make H5N1 
Avian flu virus more contagious in ferrets. I mean, is this 
part of the expansion or is this----
    Mr. Ebright. This is part of the expansion. This is work 
that is funded as biodefense research. And this is a prime 
example of the culture of hubris. This is work that should not 
be performed. Flat and blank, should not be performed.
    In those cases where elements of this work are deemed 
essential, when the research information could be obtained in 
no other way, then this work should only be performed in a very 
limited number of institutions, perhaps one or two nationally, 
and only after extensive review of risk benefit weighing at the 
national level, and only under the most stringent safety and 
security standards.
    Mr. Griffith. I appreciate that very much. I appreciate 
both witnesses being here. Mr. Chairman, I appreciate having 
the hearing. I like the opportunities to learn, and I have 
learned a great deal from this hearing. Thank you so much.
    Mr. Murphy. I thank the gentleman for yielding back, and I 
certainly would encourage all members of this committee to go 
visit some of the labs around the country. Particularly, go to 
CDC headquarters and see for their own eyes how this works. And 
certainly for members of the CDC who may be listening, I hope 
they understand the seriousness of what Congress views today on 
this.
    I ask unanimous consent that the members' written opening 
statements be introduced in the record, and without objection, 
the documents will be entered in the record.
    I also ask unanimous consent to put the document binder in 
the record subject to redactions by staff \*\.
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    \*\ The information has been retained in committee files and is 
also available at http://docs.house.gov/Committee/Calendar/
ByEvent.aspx?EventID=102479.
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    In conclusion, I want to thank all the witnesses and 
members who have participated in today's hearing, and remind 
members they have 10 business days to submit questions for the 
record. I would ask that all the witnesses agree to respond 
promptly to the questions.
    Thank you very much. And with that, this hearing is 
adjourned.
    [Whereupon, at 12:45 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

                Prepared statement of Hon. Phil Gingrey

    Mr. Chairman, I want to thank you for calling today's 
hearing to review the incident of potential exposure of 84 CDC 
staff to anthrax on June 5th at the Bioterror Rapid Response 
and Advanced Technology (BRRAT) laboratory in Atlanta. I want 
to thank Dr. Thomas Frieden, Director of the CDC, for being 
forthcoming in his written testimony as to the problems that 
occurred and how the agency has already taken steps to address 
them.
    I would also like to welcome a constituent of mine who will 
be testifying on the second panel, Sean Kaufman from Woodstock 
Georgia in Cherokee County, who was previously employed by the 
CDC and has unique knowledge on the inner workings of high-
containment laboratories.
    Mr. Chairman, the CDC main research facility in Atlanta is 
incredibly important for the region and the local economy. I 
hope that we can use today's hearing to learn more about how 
the agency can improve upon safety measures so that we can 
ensure that incidents that put employees in harm's way can be 
avoided in the future.
    I yield back.
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