[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]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
______
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
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
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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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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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