[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]
HOW SECURE ARE U.S. BIORESEARCH LABS? PREVENTING THE NEXT SAFETY LAPSE
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FOURTEENTH CONGRESS
SECOND SESSION
__________
APRIL 20, 2016
__________
Serial No. 114-139
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
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______
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
JOE BARTON, Texas FRANK PALLONE, Jr., New Jersey
Chairman Emeritus Ranking Member
ED WHITFIELD, Kentucky BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois ANNA G. ESHOO, California
JOSEPH R. PITTS, Pennsylvania ELIOT L. ENGEL, New York
GREG WALDEN, Oregon GENE GREEN, Texas
TIM MURPHY, Pennsylvania DIANA DeGETTE, Colorado
MICHAEL C. BURGESS, Texas LOIS CAPPS, California
MARSHA BLACKBURN, Tennessee MICHAEL F. DOYLE, Pennsylvania
Vice Chairman JANICE D. SCHAKOWSKY, Illinois
STEVE SCALISE, Louisiana G.K. BUTTERFIELD, North Carolina
ROBERT E. LATTA, Ohio DORIS O. MATSUI, California
CATHY McMORRIS RODGERS, Washington KATHY CASTOR, Florida
GREGG HARPER, Mississippi JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey JERRY McNERNEY, California
BRETT GUTHRIE, Kentucky PETER WELCH, Vermont
PETE OLSON, Texas BEN RAY LUJAN, New Mexico
DAVID B. McKINLEY, West Virginia PAUL TONKO, New York
MIKE POMPEO, Kansas JOHN A. YARMUTH, Kentucky
ADAM KINZINGER, Illinois YVETTE D. CLARKE, New York
H. MORGAN GRIFFITH, Virginia DAVID LOEBSACK, Iowa
GUS M. BILIRAKIS, Florida KURT SCHRADER, Oregon
BILL JOHNSON, Ohio JOSEPH P. KENNEDY, III,
BILLY LONG, Missouri Massachusetts
RENEE L. ELLMERS, North Carolina TONY CARDENAS, California
LARRY BUCSHON, Indiana
BILL FLORES, Texas
SUSAN W. BROOKS, Indiana
MARKWAYNE MULLIN, Oklahoma
RICHARD HUDSON, North Carolina
CHRIS COLLINS, New York
KEVIN CRAMER, North Dakota
_____
Subcommittee on Oversight and Investigations
TIM MURPHY, Pennsylvania
Chairman
DAVID B. McKINLEY, West Virginia DIANA DeGETTE, Colorado
Vice Chairman Ranking Member
MICHAEL C. BURGESS, Texas JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee KATHY CASTOR, Florida
H. MORGAN GRIFFITH, Virginia PAUL TONKO, New York
LARRY BUCSHON, Indiana JOHN A. YARMUTH, Kentucky
BILL FLORES, Texas YVETTE D. CLARKE, New York
SUSAN W. BROOKS, Indiana JOSEPH P. KENNEDY, III,
MARKWAYNE MULLIN, Oklahoma Massachusetts
RICHARD HUDSON, North Carolina GENE GREEN, Texas
CHRIS COLLINS, New York PETER WELCH, Vermont
KEVIN CRAMER, North Dakota FRANK PALLONE, Jr., New Jersey (ex
JOE BARTON, Texas officio)
FRED UPTON, Michigan (ex officio)
(ii)
C O N T E N T S
----------
Page
Hon. Tim Murphy, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 1
Prepared statement........................................... 4
Hon. Kathy Castor, a Representative in Congress from the State of
Florida, opening statement..................................... 5
Hon. Fred Upton, a Representative in Congress from the State of
Michigan, prepared statement................................... 84
Witnesses
John Neumann, Director, Natural Resources and Environment,
Government Accountability Office............................... 7
Prepared statement........................................... 10
Lawrence A. Tabak, Ph.D., Principal Deputy Director, National
Institutes of Health........................................... 24
Prepared statement........................................... 26
Stephan S. Monroe, Ph.D., Associate Director for Laboratory
Science and Safety, Centers for Disease Control and Prevention,
Department of Health and Human Services........................ 32
Prepared statement........................................... 34
Segaran Pillai, Ph.D., Director, Office of Laboratory Science and
Safety, Office of the Commissioner, Food and Drug
Administration, Department of Health and Human Services........ 44
Prepared statement........................................... 47
Major General Brian C. Lein, Commander, Army Medical Research and
Materiel Command, Biological Select Agents and Toxins Biosafety
Program, Department of Defense................................. 56
Prepared statement........................................... 58
Submitted Material
Subcommittee exhibit binder \1\
Subcommittee memorandum.......................................... 86
Subcommittee memorandum supplement............................... 94
----------
\1\ The information has been retained in committee files and also is
available at http://docs.house.gov/Committee/Calendar/
ByEvent.aspx?EventID=104823.
HOW SECURE ARE U.S. BIORESEARCH LABS? PREVENTING THE NEXT SAFETY LAPSE
----------
Wednesday, April 20, 2016
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:16 a.m., in
room 2122 Rayburn House Office Building, Hon. Tim Murphy
(chairman of the subcommittee) presiding.
Members present: Representatives Murphy, McKinley, Burgess,
Griffith, Brooks, Mullin, Hudson, Castor, Kennedy, Green, and
Welch.
Staff present: Jen Barbian, Counsel, Oversight and
Investigations; Rebecca Card, Assistant Press Secretary; Ryan
Coble, Detailee, Oversight and Investigations; Paige Decker,
Executive Assistant; Giulia Giannangeli, Legislative Clerk,
Commerce, Manufacturing, and Trade; Brittany Havens,
Legislative Associate, Oversight; Charles Ingebretson, Chief
Counsel, Oversight and Investigations; Chris Santini, Policy
Coordinator, Oversight and Investigations; Alan Slobodin,
Deputy Chief Counsel, Oversight; Ryan Gottschall, Democratic
GAO Detailee; Christopher Knauer, Democratic Oversight Staff
Director; Una Lee, Democratic Chief Oversight Counsel;
Elizabeth Letter, Democratic Professional Staff Member.
OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Murphy. Good morning, and welcome to the Oversight and
Investigation Subcommittee of Energy and Commerce hearing on
``How Secure are U.S. Bioresearch Labs: Preventing the Next
Safety Lapse,'' which I think I can dub ``Overturning the
Culture of Compliancy.''
Because this is the third time in as many years that this
subcommittee has held a hearing on the Federal Select Agent
Program and the Federal Government's high-containment
laboratories.
And each time, a panel of witnesses appear before us to
testify about changes made in response to one failure or
another.
Two years ago, CDC Director Tom Frieden testified about
changes made at the CDC after failing to follow safety
procedures, which consequently potentially exposed dozens of
CDC employees to anthrax.
Dr. Frieden told us then that the CDC was implementing
every step possible to make sure that the problems are
addressed comprehensively in order to protect our own workforce
and to strengthen the culture of safety and to continue our
work protecting Americans.
And I might add that that echoed a statement he had made
perhaps a year or so before on the same issue, saying that he
was going to impose other things to change the culture.
But last year, then, the Deputy Assistant Secretary of
Defense for Chemical and Biological Defense came before us to
explain how at least 192 labs across the world received live
anthrax from the Dugway Proving Ground, an Army lab in Utah.
The Army undertook a comprehensive review of the incident and
the deputy secretary told us that the department was
``committed to ensuring that this doesn't occur again,'' and
that last statement is in quotes.
Sweeping improvements and policy changes only work if the
policies are effective and, in this area, past policy reviews
have not brought about the changes necessary to improve safety.
For that reason, Ms. DeGette and myself, along with
Chairman Upton and Ranking Member Pallone, asked the GAO to
evaluate the biosafety, biosecurity and oversight policies for
the eight departments and 15 component agencies that own and
operate the Federal Government's high-containment laboratories.
GAO has been issuing recommendations for years on the need
for better policies and standards at high-containment labs,
recommendations that have not been implemented. So the agency
was well-positioned to receive our request.
GAO found that while the departments and agencies have
improved on their biosecurity procedures in recent years,
comprehensive policies and better oversight of the labs are
still needed.
High-containment laboratories, which store the most
dangerous pathogens, must have tight inventory control,
rigorous training and required incidence reporting, and
agencies and departments must have strong oversight of their
laboratories with accountability for those who fail to follow
the policies.
While GAO has been doing its work, the committee has been
conducting its own review into the discovery of smallpox vials
at the NIH in 2014. The preliminary findings of the majority
staff are discussed in a supplemental memorandum released
yesterday.
We found a number of flash points here where, if NIH or FDA
had done just a little more than what their policies required
or thought outside the box just a little bit, those agencies
could have discovered the smallpox vials years earlier.
For example, the NIH experienced a major event in 2011 when
it learned that a researcher received an unauthorized transfer
of antibiotic resistant plague specimens, and in 2012 when it
discovered unregistered antibiotic-resistant anthrax included
at an FDA lab in this very same building where the smallpox was
discovered 2 years later.
The 2012 discovery was prompted by a disclosure of two
investigators during a retraining exercise prompted by the 2011
discovery by the CDC's Division of Select Agents and Toxins not
by any investigative work on the part of the NIH and the 2012
discovery resulted in the CDC putting NIH on a Performance
Improvement Plan.
These discoveries, including two different dangerous
pathogens, should have spurred NIH and FDA to conduct a
comprehensive sweep of all laboratories and a comprehensive
review of its policies at the time.
But they didn't. When we informed NIH and FDA of our
findings, we found agencies still reluctant to acknowledge the
full extent of their failings.
NIH did not even acknowledge its failings in how it
registered into the Federal Select Agent Program, a historical
collection of select agent samples held in sealed envelopes
unopened since 1960.
NIH registered the materials without opening the envelopes.
The agency did not confirm the materials inside the envelopes
or even verify that the samples were still secure, and they
registered these materials not once, but twice, without opening
the envelopes.
When they finally did open the envelopes, they discovered
seven additional vials of one select agent than previously
reported. These failures just defy common sense.
This is a culture of complacency, and it shows that it is
not enough to change the policies. We must also change the
culture at NIH.
While the Department of Defense is holding 12 people
accountable for the factors that led to the Dugway shipments,
in contrast HHS and its agencies have not been fully
accountable and transparent with the committee on disciplinary
and personnel actions resulting from lab safety incidents.
For example, the committee requested documents from the CDC
as part of our investigation regarding the four instances of
improperly stored anthrax at NIH. Unfortunately, the CDC
produced redacted documents, blacking out key information.
There was no legal basis for these redactions and CDC
offered no explanation. This type of response is designed to
delay and stymie congressional oversight on behalf of the
American people and this committee will not stand for that.
When we request documents, we expect unredacted documents.
If these agencies are not being forthcoming with this
committee and this Congress, then they are certainly not being
forthcoming with the American people. For all the CDC rhetoric
about transparency, redactions of key details in requested
investigative documents prove otherwise.
We all deserve better. Neither NIH nor FDA ever conducted
an internal review of the smallpox incident along the lines of
the reviews conducted by the CDC or the DoD, deferring instead
to an outside review by the CDC and FBI.
I urge these agencies to initiate internal reviews of their
own failings leading up to the smallpox discovery and if we
learn nothing from all of the incidents involving select agents
over the years, it is that we can't find the next safety lapse
if we don't go looking for it.
[The prepared statement of Mr. Murphy follows:]
Prepared statement of Hon. Tim Murphy
This is the third time in as many years that this
subcommittee has held a hearing on the Federal Select Agent
Program and the Federal Government's high-containment
laboratories. Each time, a panel of witnesses appears before us
to testify about changes made in response to one failure or
another.
Two years ago, CDC Director Tom Frieden testified about
changes made at the CDC after failing to follow safety
procedures potentially exposed dozens of CDC employees to
anthrax. Dr. Frieden told us then that the CDC was implementing
every step possible to ``make sure that the problems are
addressed comprehensively in order to protect our own
workforce, and to strengthen the culture of safety, and to
continue our work protecting Americans.''
Last year, the Deputy Assistant Secretary of Defense for
Chemical and Biological Defense came before us to explain how
at least 192 labs across the world received live anthrax from
the Dugway Proving Ground, an Army lab in Utah. The Army
undertook a comprehensive review of the incident and the Deputy
Secretary told us that the Department was ``committed to
ensuring that this doesn't occur again.''
Sweeping improvements and policy changes only work if the
policies are effective. And, in this area, past policy reviews
have not brought about the changes necessary to improve safety.
For that reason, Ms. DeGette and myself, along with Chairman
Upton and Ranking Member Pallone, asked the GAO to evaluate the
biosafety, biosecurity, and oversight policies for the 8
departments and 15 component agencies that own and operate the
Federal Government's high-containment laboratories. GAO has
been issuing recommendations for years on the need for better
policies and standards at high-containment labs-recommendations
that have not been implemented-so the agency was well-
positioned to receive our request.
GAO found that, while the departments and agencies have
improved on their biosecurity policies in recent years,
comprehensive policies and better oversight of the labs are
still needed. High-containment laboratories, which store the
most dangerous pathogens, must have tight inventory controls,
rigorous training, and required incidence reporting. And
agencies and departments must have strong oversight of their
laboratories with accountability for those who fail to follow
the policies.
While GAO has been doing its work, the committee has been
conducting its own review into the discovery of smallpox vials
at the NIH in 2014. The preliminary findings of the majority
staff are discussed in a supplemental memorandum released
yesterday. We found a number of flash points where, if NIH or
FDA had done just a little more than what their policies
required, or thought outside the box just a little bit, those
agencies could have discovered the smallpox vials years
earlier.
For example, the NIH experienced a major event in 2011,
when it learned that a researcher received an unauthorized
transfer of antibiotic resistant plague specimens, and in 2012,
when it discovered unregistered, antibiotic resistant anthrax,
including at an FDA lab in the very same building where the
smallpox was discovered 2 years later. The 2012 discovery was
prompted by a disclosure of two investigators during a re-
training exercise prompted by the 2011 discovery by the CDC's
Division of Select Agents and Toxins, not by any investigative
work on the part of the NIH. And the 2012 discovery resulted in
the CDC putting NIH on a Performance Improvement Plan. These
discoveries, including two different dangerous pathogens,
should have spurred NIH and FDA to conduct a comprehensive
sweep of all laboratories, and a comprehensive review of its
policies, at the time. But they didn't.
When we informed NIH and FDA of our findings, we found
agencies still reluctant to acknowledge the full extent of
their failings. NIH did not even acknowledge its failings in
how it registered into the Federal Select Agent Program a
historical collection of select agent samples held in sealed
envelopes unopened since 1960. NIH registered the materials
without opening the envelopes. The agency did not confirm the
materials inside the envelopes, or even verify that the samples
were still secure. And they registered these materials not
once, but twice, without opening the envelopes. When they
finally did open the envelopes, they discovered 7 additional
vials of one select agent then previously reported. These
failures defy common sense. This is a culture of complacency,
and shows that it is not enough to change the policies-we must
also change the culture at NIH.
While the Department of Defense is holding 12 people
accountable for the factors that led to the Dugway shipments,
in contrast HHS and its agencies have not been fully
accountable and transparent with the committee on disciplinary
and personnel actions resulting from lab safety incidents. For
example, the committee requested documents from the CDC as part
of our investigation regarding the four instances of improperly
stored anthrax at NIH. Unfortunately, the CDC produced redacted
documents, blacking out key information. There was no legal
basis for these redactions, and CDC offered no explanation.
This type of response is designed to delay and stymie
Congressional oversight on behalf of the American people. When
we request documents, we expect unredacted documents. If these
agencies are not being forthcoming with Congress, then they are
certainly not being forthcoming with the American people. For
all the CDC rhetoric about transparency, redactions of key
details in requested investigative documents prove otherwise.
We all deserve better.
Neither NIH nor FDA ever conducted an internal review of
the smallpox incident along the lines of the reviews conducted
by the CDC or the DOD, deferring instead to an outside review
by the CDC and FBI. I urge these agencies to initiate internal
reviews of their own failings leading up to the smallpox
discovery. If we've learned nothing from all of the incidents
involving select agents over the years, it is that we can't
find the next safety lapse if we don't go looking for it.
Mr. Murphy. I now recognize the ranking member pro tem, Ms.
Castor, for her opening.
OPENING STATEMENT OF HON. KATHY CASTOR, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF FLORIDA
Ms. Castor. Well, thank you, Mr. Chairman, for calling this
important hearing, and welcome to our witnesses today.
The House Energy and Commerce Committee has been monitoring
high-containment biolabs and the select agent program for
nearly a decade and I believe that it is vital that we continue
our oversight of these critical programs.
The committee held a hearing earlier this year about the
importance of biodefense preparedness and we know that high-
containment laboratories play a valuable role in that effort by
conducting research, to improve our defenses against biological
attacks and strengthening our response capabilities.
The Federal Government's work on identifying and containing
public health risks from these type of biological agents is
essential but it also poses many risks.
Everyone has been disturbed by the news of accidental
releases or transfers of select agents such as anthrax, ebola
and avian flu over the past few years. These incidents raise
broader questions about the safety of our high-containment
laboratories across the country.
And while I'm encouraged that no one has fallen ill as a
result of those incidents, these pathogens need to be handled
with the utmost safety and security. They could be extremely
dangerous if they fell into the wrong hands or if infection
spread to the general public.
The labs that handle these dangerous pathogens must be held
to the highest standards. Yet, these recent incidents raise
questions about whether or not we can trust high-containment
labs to safely handle select agents and other dangerous
pathogens.
I want to understand what these recent lapses can teach us
about broader problems within the agencies and departments that
handle select agents across the Federal Government as well
within the private sector.
So we've asked the GAO to appear before us today to testify
about their latest report on the need for up to date policies
and stronger oversight mechanisms at our high-containment labs.
I look forward to hearing from you about your findings and
recommendations and how they can be used to enhance safety and
security at all of our nation's high-containment labs.
This GAO report underscores the need to strengthen our
Federal oversight of labs that are working with dangerous
pathogens. I also want to hear from witnesses about the role
that Congress can play in making sure this program operates
safely and without more of the operational lapses that seem all
too common for such a serious program.
Is the current regulatory framework sufficient? Do the
enforcement agencies have sufficient resources to ensure that
oversight is robust? What are the agencies in front of us doing
to improve their labs and prevent future incidents?
I look forward to hearing your testimony and I yield back.
Mr. Murphy. Gentlelady yields back. Is there anyone on our
side who wants to make an opening statement? And I guess
there's no one else on your side either, just want to read your
statement again.
To the panel, there was another hearing going on at Energy
and Commerce in which two subcommittees are--many of us are on
both, so you may see people coming and going.
I may stay here for the whole thing because I want to hear.
This is just so you're aware. It may look a little chaotic at
times, but that's how it is.
I ask unanimous consent that members' written opening
statements from other members be introduced in the record, and
without objection the documents will be entered into the
record.
Now let me introduce today's panel. First witness on
today's panel is Mr. John Neumann, director of natural
resources and environment at the Government Accountability
Office.
He currently leads efforts in the science and technology
area including the management and oversight of Federal research
and development programs and we appreciate this time today.
We'd also like to welcome Dr. Lawrence Tabak, principal
deputy director with the National Institute of Health. He
previously served as the acting principal director of NIH in
2009. We look forward to hearing his insights. Good to see you
again, Doctor.
Dr. Stephen Monroe serves as the associate director for
laboratory science and safety at Centers for Disease Control
and Prevention. Previously, he was the acting associate
director for the Laboratory of Science and Safety.
We look forward to learning from his expertise today on
today's hearing and thank you for being here.
Dr. Segaran Pillai serves as director of the Office of
Laboratory Science and Safety, the director of the Office of
Commissioner and director of the Office of Chief Scientist at
the Food and Drug Administration, and look forward to hearing
your insights as well.
And finally, we welcome Major General Brian Lein,
Commanding General, U.S. Army Medical Research and Materiel
Command in Fort Detrick and Deputy for Medical Systems to the
Assistant Secretary of the Army for Acquisition, Logistics and
Technology, Department of the Army at the U.S. Department of
Defense. Appreciate you being here today. I believe Eisenhower
was a logistics guy, too. Good for you. Good work.
Well, to all of you today, you are aware that the committee
is holding an investigative hearing. When doing so it's the
practice of taking testimony under oath. Do any of you have any
objections to testifying under oath?
Seeing no objections, the chair then advises you that under
the rules of the House and the rules of the committee you are
entitled to be advised by counsel. Do any of you desire to be
advised by counsel today?
And seeing no request for that, in that case would you all
please rise and raise your right hand and I'll swear you in.
[Witnesses sworn.]
Mr. Murphy. Thank you. You may all be seated.
You are now all under oath and subject to the penalties set
forth in Title 18 Section 1001 of the United States Code. I
call upon you each to give a 5-minute opening statement.
In so doing, make sure your microphone is on, pull it as
close to you as possible when you speak into it, and if you can
see the red light on the table--when that goes on, your 5
minutes is up.
Can I just have yourself about 2 or 3 inches from the
microphone? You have to pull it really close. Bring it close to
your mouth. Thank you very much. You may begin, Mr. Neumann.
STATEMENTS OF JOHN NEUMANN, DIRECTOR, NATURAL RESOURCES AND
ENVIRONMENT, GOVERNMENT ACCOUNTABILITY OFFICE; LAWRENCE A.
TABAK, PH.D., PRINCIPAL DEPUTY DIRECTOR, NATIONAL INSTITUTES OF
HEALTH; STEPHAN S. MONROE, PH.D., ASSOCIATE DIRECTOR FOR
LABORATORY SCIENCE AND SAFETY, CENTERS FOR DISEASE CONTROL AND
PREVENTION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; SEGARAN
PILLAI, PH.D., DIRECTOR, OFFICE OF LABORATORY SCIENCE AND
SAFETY, OFFICE OF THE COMMISSIONER, FOOD AND DRUG
ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; MAJOR
GENERAL BRIAN C. LEIN, COMMANDER, ARMY MEDICAL RESEARCH AND
MATERIEL COMMAND, BIOLOGICAL SELECT AGENTS AND TOXINS BIOSAFETY
PROGRAM, DEPARTMENT OF DEFENSE
STATEMENT OF JOHN NEUMANN
Mr. Neumann. I want to thank you, Chairman Murphy and
Ranking Member DeGette and members of the subcommittee, for
inviting me here today to discuss GAO's report on the oversight
of high-containment laboratories, which was publicly released
for this hearing.
Over the last 2 years, safety lapses at Federal high-
containment laboratories have raised concerns about department
and agency oversight of these facilities.
These labs work with hazardous biological agents such as
the virus that causes smallpox, a contagious and sometimes
fatal infectious disease to humans, as well as live anthrax
bacteria which has the potential to seriously threaten both
human and animal health.
High-containment labs do important work with pathogens such
as developing vaccines and counter measures and conducting
research to understand emerging infectious diseases.
However, some of these pathogens also have the potential
for high-consequence accidents if handled improperly. Today, I
would like to briefly highlight the findings from our report.
First, we found that most of the eight departments and 15
agencies with high-containment labs do not have comprehensive
or up to date policies.
We considered policies to be comprehensive if they included
the following six key elements for managing pathogens in high-
containment labs, the first one being incident reporting,
inventory control, inspections, clear roles and
responsibilities, training and adherence to the leading
biosafety guidance for laboratories published by CDC and NIH.
While departments and agencies had policies in place, as I
noted most were not comprehensive, meaning that they did not
include all these elements.
In addition, some policies were not up to date as they had
not been reviewed and updated in accordance with their internal
review schedules and in some cases these policies had not been
reviewed in close to 10 years.
These policies and the six key elements are an important
foundation for lab safety. But policies alone will not ensure
the lab personnel are adhering to them. This brings me to our
second finding.
Most of the department's agencies were using inspections or
audits as a primary way of overseeing their high-containment
labs. But they were often not routinely reporting inspection
results to senior officials.
Getting these inspection results to senior officials is
important because these results can be used to identify trends
and systemic safety issues and ensure that needed improvements
are made across all the labs.
Finally, at the time of our review, DoD and HHS were making
some progress in implementing recommendations from previous
laboratory safety reviews that they conducted after the 2014
and 2015 safety lapses.
However, we found that DoD and CDC had not developed time
frames for implementing some of these recommendations and
without time frames DoD and CDC will be limited in their
ability to track progress towards implementing these needed
improvements.
We made a total of 33 recommendations to the Federal
departments and agencies with these high-containment labs to
ensure that they have comprehensive and up to date policies as
well as stronger oversight mechanisms at their labs.
There was brought agreement by the eight departments with
our recommendations and several have already begun taking
actions to address them.
In closing, I would like to note that our report that we
are discussing today is the latest in a body of work that GAO
has developed over the last 10 years on the Federal oversight
of high-containment laboratories.
We continue to monitor this issue by drawing on expertise
from across our agency including our health care experts, our
chief scientists and experts from my own group, the science and
technology area.
As you know, we are conducting additional work for the
subcommittee specifically looking at the inactivation of
pathogens in high-containment labs and we expect to issue that
report to you in the next several months.
Thank you, Chairman Murphy, and members of the subcommittee
for holding this hearing and continuing your oversight of this
important issue.
This concludes my prepared remarks. I would be pleased to
respond to any questions you may have.
[The statement of Mr. Neumann follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you, Mr. Neumann.
Dr. Tabak, you're recognized for 5 minutes. Again, pull the
microphone very close to you so we can hear.
STATEMENT OF LAWRENCE A. TABAK
Dr. Tabak. Good morning, Mr. Chairman, Ranking Member
Castor and distinguished members of the subcommittee. It is an
honor to appear before you today to discuss how the NIH
implements biosafety and biosecurity measures for high-
containment laboratories.
I know I speak for Dr. Collins when I say that our concerns
for safety must equal our passion for research. I can attest
that senior leadership at the NIH is committed to the principle
that safety lapses provide concrete opportunities for thorough
critical self-assessment and self-improvement.
NIH has an important mission to conduct research that will
lead to the development of treatments, diagnostics and vaccines
to address public health needs including medical counter
measures.
The study of biologic-select agents and toxins is necessary
to develop new interventions with the potential to save
millions of lives. NIH also recognizes the importance of
ensuring that the research is conducted in the safest manner
possible.
In the summer of 2014, six sealed decades-old ampules of
smallpox were found in a cold storage room in an FDA laboratory
building located on the NIH campus. The presence of smallpox
was alarming to the entire NIH community and initiated much
action on the part of NIH leadership.
Upon making this discovery, all of the proper notifications
and security steps were taken. The CDC and the FBI were
contacted and joint custody of the ampules was transferred to
the CDC.
NIH has established protocols and procedures which included
proper training regarding select agent handling ensured that at
no time was anyone on campus or the public at risk.
NIH takes this incident very seriously and we have
implemented new policies and procedures to prevent such an
event from occurring again.
First, NIH identified and inventoried all potential
hazardous biological material stored in all NIH-owned and
leased facilities. During this sweep, which took place from
July through September 2014, nearly 35 million samples were
inventoried.
Additionally, NIH and other Federal agencies launched a
National biosafety stewardship month. Extramurally funded
institutions were asked to voluntarily join the Federal
laboratories and reviewing their procedures, training and
inventories of infectious agents and toxins.
Longer term, NIH has strengthened our inventory management
controls. We have developed and implemented the potentially
hazardous biological material management plan which addresses
accountability at all levels of NIH. The plan establishes a
mandatory centralized database of all potentially hazardous
biological materials as well as procedures for annual updates
of inventories and random audits of laboratories' hazardous
biological holdings.
Each institute and center was required to appoint an
individual to be responsible for common shared use and storage
areas and there are new policies in place requiring
participation of personnel who work in secure select agent
laboratories.
In February 2015, the external laboratory safety work group
to the CDC advisory committee to the director reviewed our
policies and practices.
The ELSW affirmed that NIH's response to the discovery of
smallpox was prototypical and that NIH had implemented all of
the recommendations made. The report states, and I quote, ``The
NIH intramural DOHS program is a model program for institutions
supporting extramural NIH research as well as for other
institutions and agencies.''
The GAO review of high-containment laboratories that we
meet here today to discuss found NIH's policies for laboratory
management to be comprehensive. NIH implemented all of the
GAO's recommendations and we addressed all of the six elements
that the GAO identified as being key.
In closing, as principal deputy director of the NIH, I can
assure this subcommittee that the senior leadership at NIH took
appropriate action in 2014 and continues to act today to ensure
the safety of the public and the scientist whose mission it is
to find new ways to enhance health, lengthen life and reduce
illness and disability.
We remain committed to preserving the public's trust and
NIH-supported research activities through best safety practices
and strong leadership.
Thank you, Mr. Chairman.
[The statement of Dr. Tabak follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you.
Before I recognize Dr. Monroe, I just want to clarify
something I think was admitted from your testimony. The six
sealed decades-old ampules of smallpox were found and two of
those were viable. Am I correct?
Dr. Tabak. That was discovered afterwards, yes.
Mr. Murphy. OK. But that was left out. I think that's
critical for your testimony and I hope you would amend it to
say that they were still alive.
Dr. Monroe, you are recognized for 5 minutes, please.
STATEMENT OF STEPHAN S. MONROE
Dr. Monroe. Good morning, Chairman Murphy, Representative
Castor, other members of the subcommittee. Thank you for the
opportunity to testify before you today on CDC's ongoing effort
to strengthen the quality and safety of our laboratories.
I'm Dr. Steve Monroe, associate director for laboratory
science and safety at CDC. In this new position, I serve as the
single point of accountability for laboratory science and
safety and I report directly to the CDC director, Tom Frieden.
I come to this role with 29 years of experience as a
microbiologist at the agency. CDC laboratories remain an
indispensable link in protecting the public's health.
Recently, we were pleased to welcome Chairman Murphy to our
NIOSH facility in Pittsburgh and Ranking Member DeGette to our
vector-borne diseases facility in Colorado where she saw first
hand our frontline laboratory staff working 24/7 to address the
ongoing Zika crisis.
Ensuring that all our laboratory work is performed with the
utmost commitment to quality and to the safety of our workers
and the community is and will remain of top priority for the
agency.
In July 2014, Dr. Frieden testified before this
subcommittee in the wake of a number of unacceptable safety
incidents at CDC laboratories. Following the incident, CDC
received multiple rigorous reviews of the agency's laboratory
safety practices.
We continue to implement and track progress on each of the
more than 200 recommendations we received through that process.
While more work remains to be done, the progress made to date
has been significant, particularly in CDC's laboratory
oversight structure and approach.
My office oversees safety at all CDC laboratories. This
includes overseeing our select agent compliance but it's
distinct from CDC's Division of Select Agents and Toxins, which
along with USDA regulates laboratories as part of the Federal
select agent program.
My office ensures that CDC complies with select agent
regulations in our own laboratories but it does not have
authority over and is not involved in overseeing or enforcing
the Federal select agency program.
An integral part of our reforms has been to foster a
culture of safety in CDC's laboratories. Transparency and
reporting are fundamental to such a culture.
One of my first acts in this role was to issue an agency
wide memorandum to reiterate CDC's requirement for staff to
report all safety issues and to provide clear direction on how
to do so.
Another key achievement was the creation of the Laboratory
Safety Review Board which is reviewing and approving all
protocols from the transfer of biological materials out of BSL-
3 and BSL-4 high-containment laboratories, a key issue
identified in the 2014 incident.
CDC also established the laboratory leadership service, a
fellowship program that prepares early career scientists to
become future laboratory leaders.
Finally, CDC is committed to advancing the science of
safety, applying the same rigorous scientific methods to
laboratory safety that we use to confront threats to the
public's health.
Last month, my office launched an intramural research fund
to support agency laboratories in pursuing innovative solutions
to laboratory safety challenges.
Last month, we saw a test of CDC's new laboratory oversight
structure when a CDC worker was diagnosed with a salmonella
infection that was likely acquired from their work in a CDC
BSL-2 laboratory.
The worker has fully recovered and no other people appear
to have been exposed. While the exposure should not have
happened, CDC responded to this incident with urgency and
transparency.
We will continue to strive to prevent incidents from
happening. But if they do, we will do everything we can to
identify and address the factor that contribute to the incident
and do so swiftly, comprehensively and openly.
GAO's report on high-containment laboratories provides
additional and valuable feedback on areas where CDC is
succeeding and where continued improvements are required.
We already hard at work to address the issues GAO
highlighted including finalizing our time lines for the
remaining safety recommendations and working with HHS and our
sister agencies on the Biosafety and Biosecurity Coordinating
Council which will address some of the policies called for by
GAO.
For CDC, laboratory safety is not a singular objective that
can be checked off once completed. Rather, it is an ongoing
commitment to a healthy and functioning culture of safety where
monitoring and reporting are valued, issues are rapidly and
openly addressed and efficient systems are in place to prevent
a safety issue from becoming a safety incident.
Since Dr. Frieden testified before this subcommittee, CDC
has made great progress in advancing this culture of safety at
our laboratories. But more work remains to be done.
While the risks of working with these pathogens can never
be completely eliminated, we will continue to reduce risks
wherever possible. This includes diligently working to address
the recommendations from the GAO.
Thank you for the opportunity to testify and I would be
glad to answer any questions you may have.
[The statement of Dr. Monroe follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you, Dr. Monroe.
Dr. Pillai, you're recognized for 5 minutes. Turn the
microphone on and bring it up very close to you, please. Even
closer. Get a lot closer. That's good.
STATEMENT OF SEGARAN PILLAI
Dr. Pillai. Good morning, Chairman Murphy, Ranking Member
Castor and members of the subcommittee. I'm Dr. Segaran Pillai,
director of the Office of Laboratory Science and Safety within
the Office of the Commissioner at the FDA within the Department
of Health and Human Services.
Thank you for the opportunity to appear before you today to
discuss FDA's efforts to ensure the safety and security of our
laboratories and the people who work in them. FDA's
laboratories provide a critical role in fulfilling FDA's
regulatory mission.
FDA's laboratories, like all laboratories, must comply with
all applicable Federal, State, and local safety requirements.
To ensure this, the agency is deeply committed to ensuring
compliance with relevant laws and regulations through a
combination of training, issuance of specific policies and
procedures, appropriate oversight by the safety offices in the
centers and by fostering an agency wide culture of safety and
security in our laboratories.
Upon discovery of the vials of Variola at an FDA laboratory
located on the NIH campus in July of 2014, the FDA commissioner
established the Laboratory Safety Practices and Policy working
group.
The goal of the work group was to lead a careful and
deliberate review of FDA's biosafety and biosecurity programs
and to identify and implement methods to improve laboratory
safety practices across the agency.
One of the first key actions of the working group was to
complete a clean sweep, a full visual audit of all storage
areas and laboratories. The vast majority of the FDA's roughly
670,000 vials of samples were properly stored.
However, there were two instances where select agents were
improperly stored in secured locations. In both cases, the
CDC's division for select agents and toxins was notified and
the materials were destroyed.
In May of 2015 members of the advisory committee to the
director of CDC's External Laboratory Safety working group
conducted a thorough onsite review of the FDA's laboratory
safety policies and procedures.
During this three-day visit, the work group met with key
FDA officials to discuss the circumstances surrounding the
discovery of the Variola samples on the NIH campus and review
the policy elements of biosecurity and inventory control,
laboratory safety training programs, laboratory security
operations as well as the compliance programs.
The resulting report released in July the 10th, 2015
contained eight observations that included a total of 30
recommendations. We have implemented many of those
recommendations and are making steady progress on the remaining
recommendations that resulted from the review in order to build
and strengthen FDA's comprehensive laboratory safety and
security program.
In addition, FDA continues to work diligently to centralize
appropriate laboratory safety practices including standardizing
policies, procedures and defining inventory policies and audit
procedures.
To gauge the cultural safety at FDA, we held a series of 13
focus groups with laboratory staff throughout the agency. The
focus of the focus groups was to raise safety awareness and
identify trends and risk areas.
Accountability, safety culture, communication and training
were identified at critical areas by the focus groups. One of
the key findings was in general staff was not afraid of
reprisal if they were to report safety-related issues or
concerns.
FDA is also planning additional ways to engage laboratory
staff in a variety of settings including focus groups, town
hall meetings and other forums to provide a positive and
productive outlet for employees to communicate their thoughts
and ideas for improving safety and security at the FDA
laboratories.
An integral way to promote cultural safety and security and
ensure compliance with legal and regulatory requirements is
through training. FDA is in the process of implementing a core
curriculum for biosafety and biosecurity training for all FDA
personnel working in the biomedical research laboratories.
This cross cutting agency work safety training program will
instill and strengthen a culture of safety and compliance
throughout the agency.
In addition to the above, FDA also issued a new agency wide
inventory control and management policy for biological agents
and toxins.
Using a central electronic inventory control and management
system will allow the agency to provide efficient oversight of
all biological agents and toxins located at the centers and
offices.
The recommendations from both the Laboratory Safety working
group and GAO reports further validates our strategic approach
and provides essential feedback for FDA as we continue to
enhance our laboratory safety and security practices and
policies.
The Government Accounting Offices reported that as of
December 2015, FDA has met five of the six elements and
policies for managing biological agents in the high-containment
laboratories.
Although FDA's currently policy did not provide for
laboratory incidents to be reported to the senior agency
officials, incident reporting does occur within each of the FDA
centers and offices and an analysis of the root cause is
performed annually.
I'm also working closely with the FDA's safety offices to
develop a more comprehensive reporting mechanism to capture
laboratory accidents, incidents, near misses and laboratory-
acquired infections.
This new reporting mechanism will be implemented in the
coming months and will require all centers and offices to
report all such events to my office.
The FDA's Office of Laboratory Science and Safety will
establish an official FDA wide policy and work with the HHS
biosafety and biosecurity coordinating council to recommend
appropriate criteria and procedures for reporting incidents to
the HHS leadership in a timely manner.
Since the discovery of the vials of Variola, FDA senior
officials have taken direct and definitive actions to improve
FDA's laboratory safety and security policies, practices and to
foster a culture of safety and security across the agency.
I want to assure you that FDA stands fully committed to
enhancing the safety and security to protect both our staff and
the public. No regulations or guidelines can ensure safe----
Mr. Murphy. I need you to conclude because you're about a
minute and a half over.
Dr. Pillai [continuing]. Applied toward daily activities.
Individuals and organizational commitment to the cultural
safety influences all aspects of safe and secure laboratory
practices.
This includes a willingness to report incidents and
concerns, apply lessons learned and ensure timely
communications of potential risk as well as the ability to
respond to an incident judiciously.
Mr. Murphy. Thank you.
Dr. Pillai. Safety in the laboratory involves experience
and knowledge gained over time and how to recognize and
minimize risk and control assets. As we share and apply this
critical knowledge to our daily activities we are confident
that the level of risk will decrease and the goal of reducing
risk to the lowest possible level.
Thank you very much for----
Mr. Murphy. Thank you.
Dr. Pillai. I'll be happy to answer any questions.
[The statement of Dr. Pillai follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. General Lein, you're recognized for 5 minutes.
STATEMENT OF BRIAN C. LEIN
MG Lein. Good morning, Chairman Murphy, Ranking Member
Castor, distinguished members of the subcommittee. Thank you
for the opportunity to update you on the Department of
Defense's actions taken to address the development,
implementation and valid oversight policy and procedures for
the safe handling and transfer of biologic select agents and
toxins.
Eight DoD labs work with these agents with the primary
focus on developing medical counter measures, vaccines and
drugs as well as diagnostic devices to protect our forces.
I'm the commanding general of the U.S. Army medical
research and material command and in support of the surgeon
general of the Army as the DoD executive agent and responsible
official for the BSAT.
In this role, I am responsible for harmonization of policy,
technical review and inspection guidelines throughout the
Department of Defense. I will detail the actions that have been
taken, the current work and the plan for the future since we
first learned of the anthrax shipments incidents in March of
2015.
Immediately after the notification the deputy secretary of
defense issued a moratorium on BSAT production and shipments to
allow for a thorough investigation, review of potential
problems and to ensure the safety of our laboratory personnel.
Additionally, the deputy secretary of defense designated
the secretary of the Army as the executive agent for DoD BSAT
biosafety program. The director of the Army staff also directed
a full accountability review of the life sciences division of
Dugway Proving Grounds.
And finally, the secretary of the Army also directed the
establishment of a biosafety task force to develop
recommendations and implement necessary changes to ensure the
long-term safety and security of the Department of Defense BSAT
program.
The end result of all of these actions led to a critical
reorganization of oversight responsibilities, accountability,
inspections and implemented new policies and procedures which
are detailed in the written testimony.
In December of 2015 the investigating officer for the
incident at the life sciences division of Dugway concluded that
the inadvertent shipment of viable bacillus anthracis is a
serious breach of regulations. A copy of this report has been
previously made available to the committee.
The report included several recommendations including
scientific recommendations, institutional recommendations and
recommendations to hold individuals accountable for the failure
to take action in response to mishaps, failure to execute
oversight and ensure compliance with protocols and regulations
and failure to exercise care in the performance of their
duties.
All personnel actions as a result of the investigation are
currently being addressed at the appropriate level of command.
I am pleased to report that the biosafety task force
capitalized on the best subject matter experts inside and
outside the Department of Defense to adopt science-based
policies and proven management procedures for the military
services to operate in a safe and secure manner for the
foreseeable future.
The task force developed four significant recommendations
to ensure the long-term safety and security of the biologic
select agents and toxins program.
We anticipate that by March of 2017 all the recommendations
will be in place. The anthrax inactivation study will be
completed and shared with all other Federal agencies.
The BSAT biosafety program office will be fully staffed and
operational. The biosafety scientific peer review panel and the
integrated IT solution for tracking and inventorying all BSAT
samples will be implemented.
Establishing strong and robust processes that are
continually evaluated and improved is our best defense against
potential human error or management lapses.
We believe the systems we are developing will provide the
necessary checks and balances to prevent or minimize the
impacts of future accidental and human or procedural missteps.
We recognize that quality policies and procedures do not
stand alone. They must be incorporated with personnel training,
evaluation, feedback followed by review, oversight,
documentation and reporting in order to have a systematic
approach to managing the successful and safe performance of
these personnel and institutions.
It is also necessary that we partner with other Federal and
private organizations to ensure the transparency and the
uniformity of this program.
We are developing a system that incorporates these
essential elements to continue the safety performance of this
critical research and for the development of detection systems
and counter measures.
Finally, both accountability and a standardized inspection
process are both critical to the success of this program. Both
have undergone significant revision and centralization.
Thank you for the opportunity to share our program with
this committee. I look forward to answering any follow-on
questions.
[The statement of Major General Lein follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you. I recognize myself for 5 minutes.
General, I see you have a parachutist badge on you there.
I'm assuming you've jumped a few times. Did you pack your own
parachute?
MG Lein. No, sir.
Mr. Murphy. Someone just said don't worry about this? A
stranger says, ``here's your parachute, everything's fine''?
Did you doublecheck things?
MG Lein. Yes, sir.
Mr. Murphy. Absolutely.
MG Lein. That's part of the JR--the prejump inspection
that's required----
Mr. Murphy. Exactly.
MG Lein [continuing]. Not by you, just by you, but by----
Mr. Murphy. By everybody, right?
MG Lein [continuing]. By your senior----
Mr. Murphy. And I'm assuming also it's standard in the
military, someone hands you a weapon and says, ``Don't worry,
it's not loaded,'' you check it anyways, right?
MG Lein. Yes, sir.
Mr. Murphy. So I go back to the thing, because it could be
dangerous and you don't want to jump without a parachute that
works.
So I go back to this omission, Doctor, and when I asked you
to clarify this point of the six vials and two of them were
alive they were treated as if they were not and you said oh, it
was only later on it was discovered.
That is the core of this hearing and why we keep coming
back here, because you treated them as if they weren't. And the
fact is the way they were handled too they could have broken.
We would have exposure of small pox.
But this is what we mean about the culture of complacency.
We just assume, oh, these couldn't possibly be alive. You treat
it like it's a loaded gun. You treat it like it's alive, and
you didn't.
And even when I asked for a clarification, you once again
said, ``Oh, we didn't discover that until later.'' That's the
point of this hearing, that you're supposed to treat it as if
it is.
Now, let me talk about it, the NIH did not undertake an
internal investigation of the root cause and circumstances that
led to the boxes containing smallpox being overlooked
apparently for decades, even though an international agreement
and later Federal law and the regulations required the NIH to
account for all smallpox vials in these facilities.
Now, our understanding is that the NIH did not do the
internal investigation because of the ongoing CDC and FBI
investigation and the subsequent referral to HHS Office of
Inspector General. Is that correct?
Dr. Tabak. Yes, sir.
Mr. Murphy. However, in 2012 the NIH conducted an internal
investigation into the improperly stored antibiotic-resistant
anthrax incidence while the CDC was investigating. So the
pending CDC investigation did not prevent the NIH from
conducting an interim investigation into the improperly stored
anthrax. Is that correct? You have to turn the microphone on
and pull it close to you.
Dr. Tabak. We did conduct and investigation at that time to
ascertain where the samples were derived from and who had the
samples, and then subsequently reviewed samples from everybody
who was a registered user of bacillus anthracis and then
following that a survey of all investigators who were
registered for select agents.
Mr. Murphy. We note you led a task force in 2015 to
investigate the serious problems with NIH Clinical Center of
Pharmaceutical Development section during an ongoing FDA
investigation.
So the pending FDA investigation did not prevent the NIH
from conducting an internal investigation into the NIH PDS. Is
that correct?
Dr. Tabak. Yes, sir.
Mr. Murphy. Now, the Department of Defense launched their
accountability investigation while the CDC and the FBI were
still investigating those shipments of live anthrax from Dugway
Proving Grounds.
Since the DoD started their internal investigation during
this pending investigation, why was it that the current--that
NIH could have started all their internal investigations into
the root causes back in July of 2014? Why couldn't that be
started back then?
Dr. Tabak. It's been our policy not to initiate
investigations of this type while there's an ongoing
investigation from either the FBI and/or the IG.
Mr. Murphy. Why not?
Dr. Tabak. We understand that we are not supposed to
compromise those investigations in any way.
Mr. Murphy. DoD managed to do it. DoD said, hey, safety
comes first, we're checking into this. We're kicking down
doors. And you guys say, hey, let's hold off on this, when you
could have been investigating.
Dr. Tabak. We held off on what has been termed the root
cause analysis. But we did not stand by idly. We did in fact
institute many additional procedures to enhance the safety of
what we were doing.
Mr. Murphy. I don't believe you, because we already
established that in moving those smallpox vials you didn't
treat them as if they were live and even though you said this
morning, well, we didn't discover that until later, you should
treat it as if it is alive.
So in August of 2014, CDC Division of Select Agents and
Toxins sent a memorandum to NIH detailing the findings of a
joint CDC/FBI investigation into the discover of the smallpox
vials.
At this point, the joint CDC/FBI investigation was over. So
couldn't the NIH have started their internal investigations
based on the finding of this report and did you know about this
report back in August of 2014? You're still saying you couldn't
have done anything?
Dr. Tabak. Again, it was an ongoing IG investigation and in
fact we still have not been formally notified by the IG that
that investigation is closed.
Mr. Murphy. Well, I'm out of time. I will turn it over to
Ms. Castro for 5 minutes.
Ms. Castor. After a number of the incidents involving
anthrax and ebola and other dangerous pathogens it was very
important for this committee to ask the GAO to produce a
detailed over view and report because when it comes to working
with these deadly pathogens there simply is no room for error
and rigorous safety policies must be followed.
GAO looked at eight departments and 15 agencies to assess
their high-containment lab policies and oversight. GAO's report
concludes that the majority of policies were not comprehensive
and some were out of date or nonexistent.
Mr. Neumann, could you walk us through this key finding and
why having comprehensive and up to date policies is important?
Mr. Neumann. Sure, I'd be happy to.
Certainly, we know that there's important research being
done and, you know, when there's a safety incidence it
interferes with this research.
So when you don't have policies in place or procedures that
ensure that those are being carried out it puts that research
at risk and also puts personnel at risk. And what we found is
that this comprehensive oversight was not in place.
Some policies that would really help the foundation of the
lab safety culture were not in place and furthermore there
weren't the oversight mechanisms that can ensure that these
policies are being carried out.
And then, finally, leadership was not informed of some key
incidents and the inspection result was all important for
ensuring that these labs are being overseen properly.
Ms. Castor. OK. So let's get more specific. Your report
concluded that the departments and agencies are using
inspections as their primary activity to oversee the management
of hazardous biological materials.
However, as you testified, some agencies do not routinely
report the results of these inspections to senior officials.
What issues are presented by this finding of incomplete
information sharing?
Mr. Neumann. Well, certainly, without having those
inspection results or incident reports, leadership can't
determine if there's systemic issues that need to be addressed
across the labs.
Ms. Castor. During your oversight and interviews, were all
of the agencies forthcoming? Did they provide the materials you
requested? Was there any resistance to providing any
information to GAO?
Mr. Neumann. No, all the agencies and departments complied
with our request and we worked very closely with them to
identify the policies and procedures.
So we got great cooperation from the agencies.
Ms. Castor. OK. General Lein, many think that in addition
to all of these inspections and oversight and policies that one
of the greatest risks we face is from theft or misuse of a
deadly pathogen and we certainly had an incident of that at
Fort Derrick in 2001.
Tell us, since 2001 what have you done to strengthen all of
your oversight and your ability to root out potential theft or
misuse of deadly pathogens.
MG Lein. Ma'am, thank you.
We've done several things in inventory management process
with 100 percent review of what's in each one of the labs on an
annual basis at the Research Institute of Infectious Disease.
Everybody that works in the lab has got to be vetted for
security processes, coming to the lab and to work into the lab,
and then recently we are completely redoing who it is and where
it is that we ship all of our agents.
So we used to have the critical re-agent program which was
the process whereby external labs would get the information
from us or get the samples from us. It did not have full
accountability of all the systems and there were often labs
that were able to--because of a direct contract were able to
send.
We have since shut that down, and after the moratorium was
lifted everything will have to get requested through this new
office with the requirement of a peer review before it even
gets shipped out of ensuring that they need the highest level
of toxin and why can't we substitute a lesser level of toxin
that can never be moved into a BSAT program.
And so associated with that there will also be a use-by
date like the carton of milk and that that specimen that we
send out must be used by and then we must get a message back
from the lab that we sent it to that it's either used or they
destroyed it or they're returning the specimen back to us.
So we maintain full accountability of all of the specimens
that we've got within our program.
Ms. Castor. I'd like to ask this--the CDC, Dr. Monroe, what
policies and procedures are newly in place to prevent theft or
misuse of deadly pathogen?
Dr. Monroe. Thank you. First, I would emphasize that our
laboratory safety review board, which reviews all the policies
for inactivation and transfer of materials from our highest
containment biosafety level three and four labs.
Has looked at those policies both initially when they were
initially released from the moratorium imposed by Dr. Frieden
and then on an annual basis. And so we've come up now on having
annual review of some of those procedures.
Importantly, all of those procedures include a step that we
we refer to as secondary verification. So as has been pointed
out, it's not only important to have the right policies but you
have to show that there's adherence to those policies.
And by having the secondary verification step of either a
second person watching or a time stamp or something that
verifies that an activation procedure was done as described in
the policy is a critical part of our inactivation policies for
anything that's brought out from high-containment to lower
levels of containment.
In terms of the personnel, we also, along with others, have
instituted a so-called personnel suitability program for those
that have access to the highest risk pathogens--the so-called
tier one pathogens.
Ms. Castor. Thank you.
Mr. Murphy. I have to follow up with you, Dr. Tabak, on
just on that line of questioning about the timing of your own
investigation.
We were informed that CDC was recently notified by the HHS
Office of Inspector General to close out all the NIH referrals,
given that there's no known pending potential investigation
will the NIH now commit to conducting an internal
investigation?
Dr. Tabak. Absolutely.
Mr. Murphy. Thank you. I now recognize Mr. McKinley, vice
chairman of the committee.
Mr. McKinley. I thank you, Mr. Chairman.
Mr. Neumann, if I could spend a little time on your report.
You've got a chart on Page 5 of the six elements that you were
referring to in compliance.
I know that they're not all the same in weight. So I don't
know which ones are more important than others in compliance.
Would you suggest to us which are the ones that we should be
spending more attention to of those six elements?
Unless you're going to tell me they're all equal, which I
doubt.
Mr. Neumann. Well, I think we determined that there were 60
elements. We didn't weight them. But incident reporting is
certainly one that has more immediate impact. If incidents are
reported to senior leadership they can take action on the
systemic issues that are identified.
Mr. McKinley. OK. If that's number one, what would number
two be?
Mr. Neumann. Like I said, inventory control also is very
important----
Mr. McKinley. I understand.
Mr. Neumann [continuing]. Because keeping track of the
specimens. Each of these have their importance. Training, for
example.
Mr. McKinley. Inventory control might be number two?
Mr. Neumann. Excuse me?
Mr. McKinley. Inventory control might be number two?
Mr. Neumann. In my mind, yes. Definitely there's an
important step.
Mr. McKinley. I'm just trying to understand not everything
is going to be equal. So I'm trying to--for example, in your
report you say that two of the agencies wouldn't cooperate or
said they didn't think anything more was necessary--Department
of Energy and the EPA. And I looked at your chart and I see the
EPA under their pesticide program those are the two--number one
and number two--in your mind that they're not complying with
and yet they think everything is copasetic.
Mr. Neumann. Yes, and we disagreed with their position.
Mr. McKinley. Thank you.
Do you disagree then with DoE as well? Because Doe also has
numbers of violations as well in that. The others seem to think
that they're in compliance.
Mr. Neumann. Yes, I think that we believe that these
recommendations are important in establishing the foundation
for the lab safety.
Mr. McKinley. Well, I think that if--what I've heard here a
little bit is it sounds like everyone at the panel all thinks
they're in compliance, that everything is just fine.
But I know in 2009 your department put together a report
that said that there needs to be an oversight, someone to look
over all the agencies.
But that was rejected as being cumbersome and overly broad.
Do you still think it's cumbersome, overly broad? Or is it
something that's necessary, because you just heard the
testimony. Everyone thinks they're in control. But there's a
real question in America whether they are. So what do you
think?
Mr. Neumann. Well, our recommendation still stands open.
The one we made in 2009 was looking more broadly at all high-
containment labs, not just the Federal labs.
This report we focused on the Federal high-containment
labs. But that recommendation we still openly stand by that.
But there could be better oversight with a single entity to
oversee all these labs given the fragmentated----
Mr. McKinley. One of them that might help but I'm afraid of
a software type thing is IV&V. Do you see how IV&V might have
an impact here whereas the IV&V--I don't want to suggest what
I--you're familiar with IV&V?
Mr. Neumann. I'm not familiar with that, no.
Mr. McKinley. Independent verification and validation?
Mr. Neumann. Oh, yes. Yes. Uh-huh.
Mr. McKinley. OK. NASA has been using it successfully ever
since the rocket explosion. Others have used it. Unfortunately,
the Obama administration chose not to use IV&V when they put
out the registration and, you know, the computer system all
collapsed under the registration.
I don't know whether that would help out. Would IV&V be of
any help to these or is that just going to be checking the box?
Mr. Neumann. Well, certainly, any type of verification is
going to be useful. There needs to be a system of independent
verification, inventory control, all these different steps to
ensure that you have----
Mr. McKinley. But would they just check the box, or if
there's no one overlooking their shoulder, who's going to know
that they've actually done something as a result of checking
the box?
Mr. Neumann. Well, that's why the oversight mechanisms are
so important that leadership be paying attention to the labs
and ensuring that they're being inspected and they're reviewing
the results of those inspections to see where there might be
lapses.
Mr. McKinley. So in the time, is that something that
perhaps you would--the GAO would look at as a recommendation
that maybe IV&V should be implemented under each of these labs?
Mr. Neumann. We didn't look specifically at that but I
think the leadership oversight is going to be really important
to ensure that these mechanisms are actually operating, not
just policies.
Mr. McKinley. My question is would you consider that in the
future in looking at that to see whether or not there might--
other agencies have found it to be very useful and I'm just
wondering whether or not you see it from your perspective with
the lab will they simply just use it to check the box and not
do anything about it?
Mr. Neumann. Well, I definitely would like to take some
time to think that over. Perhaps we can provide a response for
the record.
Mr. McKinley. If you would, please. And my time has expired
so I thank you, Mr. Chairman. I yield back my time.
Mr. Murphy. Thank you. I now recognize Mr. Griffith of
Virginia for 5 minutes.
Mr. Griffith. Thank you very much, Mr. Chairman. Thank you
all for participating in this hearing today.
Dr. Tabak, I understand that the historical collection that
contains the smallpox vials where there was a problem that had
been previously discussed is not the only historical collection
at NIH.
In fact, in 2002 or 2003, NIH registered a historical
collection that included plague and Burkholderia samples using
the information listed on labels for sealed envelopes. Isn't
that correct?
Dr. Tabak. Yes, sir.
Mr. Griffith. And did anyone at NIH open the envelopes at
the time to check not only the accuracy of the samples but also
to ensure that the samples were intact?
Dr. Tabak. To my knowledge, they did not.
Mr. Griffith. And I also understand that in 2007 the NIH
office responsible for overseeing compliance with select agent
regulations reregistered these select agents again without
opening the sealed envelopes. Isn't that correct?
Dr. Tabak. It is. The reason they did not open them at the
time is that they were not registered to work with that
particular agent in the laboratory where they were brought.
Mr. Griffith. So the individuals who were looking at it
weren't registered to deal with the plague or Burkholderia?
Dr. Tabak. The laboratory was not registered and so they
needed to file an amendment so that they could in fact work
with those agents.
Mr. Griffith. OK. So they did that and then from my
understanding in 2008 they finally opened the envelopes up and
the materials contained were not the same as what had been
registered back in 2002, 2003 with the select agent program
twice earlier.
They weren't the same as had been previously registered and
that one of the envelopes contained more vials of Burkholderia
than was listed. Isn't that accurate?
Dr. Tabak. That is correct. It has been described to me as
a clerical error that indeed they did know that there were 39
vials but unfortunately it was transcribed inaccurately, and so
that's my understanding of it.
Mr. Griffith. So there were 39 vials, but they had it
written down as 32?
Dr. Tabak. I may be misspeaking but, yes, there was a
difference of, I believe, seven vials.
Mr. Griffith. Now, I was not--obviously, I'm familiar with
the plague. I was not familiar with Burkholderia, and so I
looked it up online. So my sources are Internet sources. They
may or may not be accurate.
So you get me straight if I've got it wrong. But it looks
like it depicts mostly horses but there are a couple of species
or subspecies of the bacteria that affect human beings.
Do you know whether the samples that were discovered in
2008 were the type of species of Burkholderia that affect
horses or were they the type that affect humans?
Dr. Tabak. I do not know the answer to that.
Mr. Griffith. And could you please find that out for us
because in my research it indicated that at least two of the
species not only affect humans but are considered possible
agents for biological warfare?
Dr. Tabak. Indeed, and this is why they were treated as
select agents and contained. But I will find out the answer for
the record, sir.
Mr. Griffith. If you could let me know I would greatly
appreciate that. Dr. Pillai--did I say it right? All right.
And you're now with the Office of Laboratory Science and
Safety at the FDA and it's a fairly new office. What is the
budget for your office and how many staff do you have?
Dr. Pillai. So as you mentioned, it's fairly a new office
that we are trying to stand up at the current time. We have
actually worked out this for the division and planned a mission
for the office and have actually pulled together a budget and
we have put in the budget request to our senior leadership, the
Office of Operations, to the Office of the Commissioner, and
both of those offices are working diligently to ensure that we
get the necessary budget support needed to stand up the office.
The request that we have proposed was $2.8 million to
basically staff with 14 members to ensure that we can address
all the safety and security-related issues at FDA.
Mr. Griffith. All right. And can you get us that once it's
been approved by the other folks? Can you get us a copy of that
budget?
Dr. Pillai. Absolutely.
Mr. Griffith. I would appreciate that, and who is it that
you report to?
Dr. Pillai. At the current time I report to the Office of
the Chief Scientist and to the Commissioner through the Office
of the chief scientist. The external laboratory safety working
group's recommendation was for this position to be a direct
report to the commissioner.
As you are fully aware, that we have a new commissioner on
deck at the current time, Dr. Robert Califf. Dr. Califf is
taking a look at all of the organizational structures at the
current time and you'll make a final call and decision as to
what the department structure should be.
Mr. Griffith. All right. I do appreciate that. I see my
time is up and I yield back. Thank you, sir.
Mr. Murphy. Thank you. I now recognize Mrs. Brooks for 5
minutes.
Mrs. Brooks. Thank you, Mr. Chairman.
As the panelists might know, yesterday both NATO and the
European Union intelligence officials indicated that there are,
quote, ``justified concerns,'' end quote, that ISIS is working
on obtaining biological material needed to carry out an attack.
With persistent analysis like this supporting the notion
that terrorists are actively looking to acquire a weapon of
mass destruction, I certainly hope that our Government will
redouble our efforts in protecting sensitive materials from
getting into the wrong hands.
We also know that in October it was revealed that a 26-
year-old Moroccan-born man who had worked in a sensitive area
in a nuclear power plant in Belgium died in the spring while
fighting for ISIS.
This terrorist had passed a background check and had access
to a secure area where the nuclear reactor is located.
Obviously, it can happen in the biological space as well. We
shouldn't forget that the perpetrator of the '01 anthrax
incident was a scientist who worked at the Government's
biodefense labs at Fort Derrick.
I bring that up because we can have all the policies and
procedures in place and we can have taken corrective actions
and so forth. But I'm curious, Mr. Neumann, did you and GAO
look at the security level of personnel in your report?
Mr. Neumann. We did not. We looked at the policies we had
in place to ensure that they had all these key elements. We
looked at the oversight mechanisms to make sure they were
checking them and we looked at----
Mrs. Brooks. I understand that. But what about security and
background checks? Why did you not look at security and
background when it has to do with personnel actually following
or not following these procedures?
Mr. Neumann. This was a broad look at all the Federal
departments and agencies or the eight departments and 50
agencies. So just getting a sense of their policy and
procedures they have in place and the oversight mechanisms was
quite a large volume of work.
So we didn't drill down in specific aspects of this. But
that's definitely an area that we could, you know, potentially
follow up on if there's interest in that.
But it's part of making sure that you have the checks and
balances with the policies and the oversight mechanisms to make
sure that all the policies are being followed.
Mrs. Brooks. And I certainly appreciate it and don't want
to take away from your work. But I do think that is of critical
importance and I'm going to ask very briefly, because I have a
different line of questioning for Dr. Tabak, but if you could
please each agency indicate, and I may ask for the record, we
may submit questions for the record with respect to what level
of security clearances do your personnel have who have access
to these deadly pathogens, how often are they cleared, because
it's very common for many agencies to have that clearance
process when an individual comes in to an agency, but often
maybe not checked on routinely every few years, and I'm curious
about that, as well as what is the level of security clearance
that the personnel must have.
So I will be submitting those questions for the record for
each of your agencies. I believe that Major General indicated
that certainly people are vetted, and I assume that people are
vetted within your agencies.
But having been a former U.S. attorney and going through
security background checks I'm very interested in knowing what
level of security clearances all of the personnel that have any
access.
I'm not just talking about the scientists. I'm talking
about all levels of personnel. I'm curious to know what level
of background checks are performed.
Dr. Tabak, I'm very curious to know because the majority
staff investigation found that the National Cancer Institute of
Frederick does not report to the NIH Safety Office on the main
campus. Who does the safety officer at NCI Frederick report to?
Dr. Tabak. Ultimately, to the director of the NCI.
Mrs. Brooks. Who do they directly report to?
Dr. Tabak. They report up to the scientific director of the
NCI Frederick and then in turn that individual reports up to
the director of the NCI who, of course, reports up to the
director of NIH.
Mrs. Brooks. So is the NIH management of safety--is it
centralized or is it decentralized across the various campuses?
I've just visited your incredible campus. It's a very, very
large place. Is it decentralized or is it centralized?
Dr. Tabak. In the case of the NCI Frederick they have this
separate reporting chain. Everything else is centralized in one
place.
Mrs. Brooks. And we heard from Mr. Neumann that--do you
receive reports of select agent inspection results now?
Dr. Tabak. I do indeed.
Mrs. Brooks. OK. Does Dr. Collins?
Dr. Tabak. I notify Dr. Collins when there are variations--
if there are issues that are problematic.
Mrs. Brooks. And we've heard that according to HHS comments
and response to the GAO's report, the associate director of
research services is the designated agency safety and health
official. Does this individual report to your or Dr. Collins
about lab safety issues?
Dr. Tabak. The responsible official reports through a chain
of the director of division of occupational health services who
reports to our director of the Office of Research Services who
reports to our Deputy Director for Management, who in turn, you
know, works through me to Dr. Collins.
But each individual is required to move up the chain if the
next person up does not respond for some reason and indeed when
there are serious issues we are all immediately notified
simultaneously.
Mrs. Brooks. OK. Thank you. I yield back.
Mr. Murphy. Just clarifying, Dr. Monroe, who do you report
to?
Dr. Monroe. I report directly to Dr. Tom Frieden, the CDC
Director.
Mr. Murphy. OK. Thank you.
I recognize Mr. Hudson for 5 minutes.
Mr. Hudson. Thank you, Mr. Chairman, and thank you to the
panel for being here.
Dr. Pillai, the NIH office that had the smallpox boxes was
reassigned to the FDA in 1972. Why didn't the FDA do any sort
of inventory over the room when it was transferred to control
at that point or at any time from 1972 to 2014.
It seems to me that one simple inventory, something that
businesses back in my district do every year, would have caught
this mistake.
Dr. Pillai. I agree with you totally. I think this is one
of the failure points that we have encountered for this
incident. You know, one of the key points that I'd like to make
is that by nature laboratory scientists, right, they tend to
attend to the materials that belongs to them and they don't
really look into other people's properties or materials and
this is one of those areas where it was a shared laboratory
storage cold room, basically.
So there was no one single individual assigned to be
responsible for the inventory or whatever was contained in that
cold storage facility.
Mr. Hudson. Has that been changed now?
Dr. Pillai. That's been changed. What they've done is ever
since this incidence has taken place we have actually assigned
a single individual to be responsible for any cold storage
areas that's been shared by multiple scientists and all the
materials in the cold storage must be labelled with the PI's
name along with the content and the date so that you can
actually do a very simple easy inventory control process as to
who it belongs to and what the contents are.
Mr. Hudson. Appreciate that answer. When we asked FDA why
it failed to utilize proper inventory controls in the cold
storage room we were told that this room is apparently not
subject to inventory controls since there was no accountable
Government property inside the cold storage room.
Accountable Government property is a term that's defined as
all computers and pieces of equipment with a value of more than
$5,000. But how could FDA know there's no accountable
Government property if they hadn't done an inventory?
Dr. Pillai. That's a very good point. In most cases, cold
storage facilities actually are used to store reagents and
supplies and things of that nature, which usually doesn't
amount to greater than $5,000.
As such, there's usually not a custodial individual
assigned to the cold storage areas where you're basically
storing medias and things of that nature. This is one of those
incidents that we do not anticipate such a problem to take
place.
We would have put in appropriate safety protocols and
policies in place to address that. But this was a valuable
lesson learned and we are looking forward to implementing the
appropriate policies and procedures and managers can ensure
that this doesn't happen again.
Mr. Hudson. So your opinion now--any kind of critical
reagent programs, they have a value of some $500 to $1,000
apiece. I mean, would, in your opinion, they now be considered
this Government property that needs to be inventoried? I mean,
has there been a change of mind set in terms of--instead of
just making $5,000 and up we need to have an inventory of
everything?
Dr. Pillai. I mean, talk about equipments and things of
that nature--if you're talking about an instrument and
equipment and anything to the nature that is a custodial
individual assigned to ensure the responsible--to ensure and be
responsible for that particular property.
When in the case of the cold room the situation is
different whereby what we are doing is we are getting a full
inventory control of what the contents are.
This is where you usually store biological materials as
well as freezes and things of that nature. So we have
implemented a policy at FDA to have a full inventory control of
all the biological agents, not just the BSL-3 agents but also
the risk two agents as well as the risk three agents.
So now we have a full account of every materials where they
are stored, the location, who it belongs to and every time an
individual takes the material for work to work on it or to add
a new agent to the list, they update that information on a
daily basis.
So this will allow us to control this select agents and
high consequence pathogens in a much more efficient manner.
Mr. Hudson. So just to clarify, so going forward, vials of
biological pathogens are no longer not considered important
enough to be inventoried or as an accountable Government
property there's no discrepancy now?
Is that what you're telling me in terms of having a dollar
amount? If it's a pathogen, it's going to be inventoried?
Dr. Pillai. That's right. If it's a high-consequence
pathogen or it is a hazardous biological agents and toxins it
will be in the inventoried.
Mr. Hudson. OK. Thank you for that.
Mr. Chairman, I see I'm running out of time. I'll go ahead
and yield back.
Mr. Murphy. If I could just take the last few seconds, let
me ask the panel here, except for DoD: So within this, given
all the sweeps that you've done are there any more orphan
pathogens of any kind that are not identified who they're with?
Dr. Tabak, are there any more? You've done all these
sweeps. Everything has been checked. Is there any more vial
samples, anything that you don't know where it's come from, who
it belongs to?
Dr. Tabak. Not to our knowledge.
Mr. Murphy. Dr. Monroe.
Dr. Monroe. Everything has been inventoried.
Mr. Murphy. Dr. Pillai.
Dr. Pillai. Yes, every agent has been inventoried and
accounted for by the FDA.
Mr. Murphy. Thank you. Mr. Mullin, you're recognized for 5
minutes.
Mr. Mullin. Thank you, Mr. Chairman. I'm going to follow up
on your questions, too.
Even after we got the information that anthrax had been
basically not kept good records on and it had been shipped
around, being used for experiments, people not knowing where
they're at.
Once you discovered this you decided to do an inventory and
look for anthrax, if any more had taken place. And
specifically, NIH limited the search to only anthrax. Why was
this?
Dr. Tabak. If I may clarify, this was done in two steps.
The initial search indeed was limited to those investigators
working with bacillus anthracis. But after we discovered
additional issues, we expanded that to include all principal
investigators working with any select agent.
Mr. Mullin. When did you expand that?
Dr. Tabak. During that same year, sir. And so----
Mr. Mullin. What was the discovery of that?
Dr. Tabak. I'm sorry?
Mr. Mullin. What did you discover in that? Because when you
started searching for anthrax you found other cases even after
it was revealed that it wasn't properly followed and the
procedures wasn't followed. You found other issues with
anthrax. So what else did you find?
Dr. Tabak. So subsequently we searched cold storage areas
with any principal investigator working with select agents.
We searched over 6 million vials, vial by vial. And so that
was a very comprehensive search that was undertaken. So it was
a two-step process. I know----
Mr. Mullin. But what else did you discover? Other than
anthrax what else was being improperly labeled and shipped
around without the knowledge of NIH?
Dr. Tabak. The search only revealed, to my knowledge,
things related to different forms of anthrax.
Mr. Mullin. Mr. Tabak, just please help me here with your
knowledge. We're talking about very serious consequences if
this gets out, and to your knowledge you can't give me a
definite answer?
We're talking about serious diseases. We're talking about
things that could be used against us. We're talking about if
they leaked out it could have serious consequences throughout
areas of contact.
And you're telling me your knowledge. I'm asking for
specifics.
Dr. Tabak. Sir, I understand the gravity of the situation.
I'm giving you the response that I can give you. I will provide
for the record additional details so that I can----
Mr. Mullin. Is it classified? Is that why you can't give
me----
Dr. Tabak. No, sir. It is not.
Mr. Mullin. OK. So the response--that's what I'm trying to
get to. And, sir, I mean absolutely no disrespect. But as
something as this serious I would think you would have definite
answers for.
Dr. Tabak. And I am trying not to misspeak and so I'm
giving you the best answer I can.
Mr. Mullin. I apologize with that.
Dr. Tabak. And for the record, I will give you with
certainty if any additional agents besides those related to
anthrax were found in this 2008 time frame.
Mr. Mullin. So what caused you guys to open the research
and search for further information. After you had simply opened
it up for anthrax, what led you to decide, hey, let's look
farther into this?
Dr. Tabak. When we discovered additional vials of anthrax
that were unaccounted for and anthrax spores that were
unaccounted for in laboratories and it was at that point that
we decided that we needed to broaden the search and do a vial
by vial for everybody who had the use of select agents.
Mr. Mullin. Do you have any additional cases showed up with
anthrax?
Dr. Tabak. So we found 30 vials in one laboratory----
Mr. Mullin. That were unaccounted for, 30? Thirty in one
laboratory?
Dr. Tabak. These were unaccounted for. These were findings
that we made. Thirty vials in one laboratory that had not been
entered properly.
Four vials in a second laboratory that had not been entered
properly and in six vials a third laboratory that had not been
entered properly.
Mr. Mullin. Was this due to procedures not being followed
or procedures not in place?
Dr. Tabak. I believe in one instance procedures were not
followed and I would say in the other two instances I believe
it was really due to human error.
Mr. Mullin. Thank you. I look forward to your response on
the other one too. Thank you for getting back to me and Mr.
Chairman, I'll yield back.
Mr. Murphy. Thank you. I don't know if Ms. Castor has any
more questions. I want to ask a couple more quick ones. Mrs.
Brooks, did you want to be recognized for a quick question?
Mrs. Brooks. Thank you, Mr. Chairman.
Very briefly, and this would be to Major General Lein.
In its report, GAO recommended to DoD that it require all
high-containment labs including those not registered with the
select agent program to report the results of any agency
inspections to DoD.
DoD told GAO that it had no plans to implement such a
requirement. Why does the department disagree with GAO on this
issue and why not require reporting inspections of all high-
containment labs and not just the select agent registered labs?
MG Lein. Ma'am, I have to get back to you on that. We
should be reporting all of the--not just the labs but all of
our high-containment labs. So I owe you a response to that.
Mrs. Brooks. Thank you. We agree.
MG Lein. So just follow on the recommendations from the GAO
report.
Mrs. Brooks. OK. We'll look forward to your response, or
changes and procedures. Thank you. I yield back.
Mr. Murphy. Thank you. I have a couple more questions. I
think we're waiting for Dr. Burgess. But Dr. Tabak, has the NIH
ever taken any personnel actions related to not complying with
select agent regulations?
Dr. Tabak. Because of the sensitivity of personnel actions,
sir, I would hope that we could discuss that with you and the
committee in another venue.
Mr. Murphy. Can you tell us numbers?
Dr. Tabak. Again, because of the numbers involved, sir, I
would--because of the----
Mr. Murphy. Is that a yes, that something has happened?
Dr. Tabak. I'm sorry, sir?
Mr. Murphy. So is it a yes that some personnel action has
happened, but you would talk about the other things privately?
Dr. Tabak. I would prefer to, sir, we discuss that in
another venue with you.
Mr. Murphy. Well, we're trying to get the answer to this.
So Government employees? They're Government employees?
Dr. Tabak. Yes, sir.
Mr. Murphy. Generally, are they Government employees, and
I--wasn't some personnel action taken among people who
mishandled the procedures for the anthrax?
MG Lein. Yes, sir. Twelve recommendations for 12 personnel
at Life Sciences.
Mr. Murphy. OK. And I don't need to know their names or
anything, but action took place. So you are taking some action,
yes?
I'd be willing to talk about some other things with--I
mean, I think both sides would like assurance on that.
Dr. Tabak. Again, sir, because of the relatively small
numbers of individuals I think we would be breaching
confidentiality to have a conversation publicly.
Mr. Murphy. Yes or no? Actions taken place?
Dr. Tabak. Actions were initiated.
Mr. Murphy. OK. That helps us. We can proceed. Has the FDA
began an interim investigation to the root cause or facts and
circumstances surrounding the discovery of smallpox vials in an
FDA laboratory on the NIH campus--into root cause?
Dr. Pillai. So like my colleague, Dr. Tabak, given the fact
that there was an FBI investigation complemented with a CDC
select agent followed by an OIG inspection that is ongoing we
have decided not to interfere with the process and have laid
back. My understanding is that the OIG investigation is coming
to an end and given the fact that that report is going to be
available to us in the near term we are initiating a process to
understand the root cause for the event that took place in 2014
and understand what the failure points are and then we plan to
mitigate those failure points through implementation of
appropriate policies and procedures.
Mr. Murphy. OK. So it's the OIG inspection is over?
Dr. Pillai. That's my understanding. My understanding is--
--
Mr. Murphy. Yes, it's true? And so did you have a plan in
place saying hey, as soon as this investigation is over we're
ready to move forward?
Dr. Pillai. Right.
Mr. Murphy. So you do have a plan ready?
Dr. Pillai. We have a plan.
Mr. Murphy. So when you said--but now you're discussing it.
It should be the moment you were told you said now let's roll
with ours. So it is happening now?
Dr. Pillai. Yes.
Mr. Murphy. And after FDA personnel found a smallpox vials
they transferred them to the NIH responsible official
apparently without taking any steps to package and transfer the
vials in a safe manner.
In fact, the FBI and CDC highlighted that the individuals
who carried the boxes to NIH responsible officer heard the
vials clinking together. What steps should this individual have
taken in transporting the vials?
Dr. Pillai. This is one of those situations where we had
not anticipated to take place. So there were no appropriate
safety procedures and protocols for the transfer of such
materials from one----
Mr. Murphy. I'm stopping you there. That's why we're having
this hearing.
Dr. Pillai. Right.
Mr. Murphy. So how long has FDA been involved with
diseases? Since your beginning.
Dr. Pillai. Right.
Mr. Murphy. So you ought to have some--for you to tell me
you had not anticipated that you'd be transporting something
that's a viable pathogen with deadly results--you had not
anticipated that? I'm sorry, that's just not acceptable,
Doctor. That's why we keep having these hearings.
How many personnel from the FDA have been involved in
investigating this problem?
Dr. Pillai. I totally agree with you.
Mr. Murphy. How many personnel from the FDA have been
involved in investigating this problem?
Dr. Pillai. There is a large group of individuals involved.
Mr. Murphy. Five? A hundred?
Dr. Pillai. I would say not as much as a hundred but a
significant number of folks.
Mr. Murphy. How many hours have been spent on this?
Dr. Pillai. I would say probably many hours, to be honest.
Mr. Murphy. I don't know what many means.
Dr. Pillai. I don't have the exact number of hours.
Mr. Murphy. Hundreds of hours?
Dr. Pillai. Probably.
Mr. Murphy. Dr. Monroe, how many hours involved with CDC in
investigating these things?
Dr. Monroe. Investigating----
Mr. Murphy. Investigating these problems with pathogens and
transport and some of these difficulties? Any idea?
Dr. Monroe. I would have to, you know, get back with an
estimate of the number of hours. But, for each of the incidents
that CDC was directly involved with, we had an internal team
plus the external select team.
Mr. Murphy. Quite a few, Dr. Tabak, I'm assuming? You may
not know the numbers, but quite a few hours were involved?
Dr. Tabak. Yes, indeed.
Mr. Murphy. So I think we'd rather have your scientists
involved with science in identifying causes of diseases and
cures for them. But the fact that we have had multiple hearings
on this and Mr. Neumann, you were involved with hours of work
in this, too, and there's lots of things your office has been
doing, as well.
And then to say--Dr. Tabak, to go back to the point, you
didn't even mention to this committee again that some of those
pathogens were alive. Dr. Pillai, you're saying we didn't have
a procedure in place for transporting these things.
Dr. Pillai. But we do have procedures.
Mr. Murphy. But you had said----
Dr. Pillai. But not for pathogens of this nature. This
event was unusual in the sense that when the discovery was
made, it was made by scientists who are not familiar with the
policies and procedures of dealing with select agents.
Mr. Murphy. Whoa, whoa, whoa. This is an office that deals
with select agents. They didn't know how to transport them? I
just find this astonishing.
So here's where I'm getting to with this.
Dr. Pillai. Right.
Mr. Murphy. We've also been informed in the past--I'm not
sure if it was CDC or someone--we have to understand these are
scientists, and sometimes they get a little absent-minded and
you have to--I don't accept that.
The American public doesn't accept that. Someone had
salmonella. Thank goodness that person recovered, right?
But this can have deadly consequences. These are offensive
weapons. I'm pleased that DoD has taken definitive action on
this. This was a tragic mistake--unfortunate mistake. Luckily
caught it, taken definitive action. I just don't find it
acceptable the scientific community kind of gives it the shrug.
Now, we've seen that shrug before when GM was here and
someone, you know, decided we're going to shrink a spring in a
steering column and, you know, save a few cents on each car and
some people died. Oh, well. No one spoke up.
When Volkswagen was here someone mysteriously came up with
some sort of a software formula and--suddenly, in the morning
we didn't know how to pass the EPA tests, in the afternoon we
suddenly did, and no one said, ``How'd you do that?''
And so now they're facing so many billions of dollars worth
of suits and other fines. I don't know if that company is going
to survive.
But those are cars, and here we're talking about diseases,
and I would hope the lesson you take from this committee--and
I'm tired of going over this because we keep having this
conversation.
But if your scientists are saying, ``Gee, we never thought
about how to transport something that's deadly--never really
thought about that''--then find a new job.
Look, we all make mistakes. I mean, we're human. We make
mistakes, that's what it is. I get that. I have no problem with
that.
I just want to make sure we have some sense of learning,
and if someone says well, yes, never had a protocol of how to
transport deadly diseases from one place to another, and the
bottles are clinking together--gee, what do I do about that?
They weren't transporting bottles to return--a Coke for
deposits and they're clinking together. I hope that you're
going to do a lot more with training as this proceeds.
Well, it looks like other members are not going to be here.
So I ask unanimous consent that the document binder be
introduced into the record and to authorize staff to make any
appropriate redactions.
Without objection, the documents will be entered into the
record with any redactions the staff determines are
appropriate.
[The information has been retained in committee files and
also is available at http://docs.house.gov/Committee/Calendar/
ByEvent.aspx?EventID=104823.]
Mr. Murphy. In conclusion, I thank all the witnesses and
members that participated in today's hearing. I remind members
they have 10 business days to submit questions for the record.
I ask the witnesses to all agree to respond promptly to the
questions, and with that this committee is adjourned.
[Whereupon, at 11:43 a.m., the hearing was adjourned.]
[Material submitted for inclusion in the record follows:]
Prepared statement of Hon. Fred Upton
Mr. Chairman, thank you for holding this hearing. The
subcommittee meets again as in previous years about the
challenge of improving safety at the Federal Government's high-
containment laboratories. During 2014 and 2015 several lapses
in safety at HHS agency and Defense Department labs could have
exposed Federal personnel and other individuals to hazardous
biological agents.
In response to these concerns, there have been executive-
branch wide efforts and internal agency efforts to improve lab
safety. At the request of the bipartisan leadership of the
committee, the GAO will present its report on oversight at
Federal high-containment labs. The GAO will tell us that much
work still needs to be done. Most of the Federal agencies need
more comprehensive or up-to-date policies.
However, to really stop this troubling pattern of safety
lapses at our bioterrorism labs, changes on paper will not be
enough if the agencies are not addressing cultural and
behavioral factors. To its credit, the Department of Defense
and the Centers for Disease Control have conducted internal,
soul-searching reviews into the root causes of incidents. These
internal investigations revealed various failures at both the
systemic and individual level. As noted in the CDC testimony,
these deep and critical internal reviews are essential to
reforming lab safety.
With regard to the lapse involving the discovery of the
smallpox vials in an FDA lab on the NIH campus, both the NIH
and the FDA have yet to conduct the necessary self-examination
and introspection to fully understand the weaknesses and
failures that led to smallpox being unknowingly stored in an
unregistered, and improperly secured conditions. I hope this
hearing helps the NIH and the FDA to undertake such reviews. We
want NIH, FDA, and all our Federal laboratories to be
successful in implementing lab safety improvements. These labs
conduct vital research that can lead to the development of
treatments, diagnostic, and vaccines to address public health
needs. This research is also important to our defense efforts
against bioterrorism, a serious threat to our troops, our
nation, and our allies.
Finally, it is disappointing that the CDC produced blacked-
out documents in response to my confidential request letter on
behalf of the committee to obtain key investigative information
about improperly stored anthrax at the NIH and the FDA in 2012.
There is no legal basis for the CDC to withhold such
information from its authorizing committee in Congress. I would
urge the CDC to live up to its claims of transparency and
accountability, and to work cooperatively with this committee,
as has occurred in the past.
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