[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]
BIORESEARCH LABS AND INACTIVATION OF DANGEROUS PATHOGENS
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FOURTEENTH CONGRESS
SECOND SESSION
__________
SEPTEMBER 27, 2016
__________
Serial No. 114-173
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
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
7_____
Subcommittee on Oversight and Investigations
TIM MURPHY, Pennsylvania
Chairman
DAVID B. McKINLEY, West Virginia DIANA DeGETTE, Colorado
Vice Chairman Ranking Member
MICHAEL C. BURGESS, Texas JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee KATHY CASTOR, Florida
H. MORGAN GRIFFITH, Virginia PAUL TONKO, New York
LARRY BUCSHON, Indiana JOHN A. YARMUTH, Kentucky
BILL FLORES, Texas YVETTE D. CLARKE, New York
SUSAN W. BROOKS, Indiana JOSEPH P. KENNEDY, III,
MARKWAYNE MULLIN, Oklahoma Massachusetts
RICHARD HUDSON, North Carolina GENE GREEN, Texas
CHRIS COLLINS, New York PETER WELCH, Vermont
KEVIN CRAMER, North Dakota FRANK PALLONE, Jr., New Jersey (ex
JOE BARTON, Texas officio)
FRED UPTON, Michigan (ex officio)
(ii)
C O N T E N T S
----------
Page
Hon. Tim Murphy, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 1
Prepared statement........................................... 3
Hon. Diana DeGette, a Representative in Congress from the State
of Colorado, opening statement................................. 5
Prepared statement........................................... 6
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 7
Hon. Fred Upton, a Representative in Congress from the State of
Michigan, prepared statement................................... 82
Witnesses
Timothy Person, Ph.D., Chief Scientist, Government Accountability
Office......................................................... 9
Prepared statement........................................... 12
Daniel M. Sosin, M.D., Deputy Director and Chief Medical Officer,
Office of Public Health Preparedness and Response, Centers for
Disease Control and Prevention, Department of Health and Human
Services....................................................... 23
Prepared statement........................................... 25
Stephan S. Monroe, Ph.D., Associate Director for Laboratory
Science and Safety, Centers for Disease Control and Prevention,
Department of Health and Human Services........................ 35
Prepared statement........................................... 37
Mark Davidson, D.V.M., Associate Deputy Administrator, Veterinary
Services, Department of Agriculture............................ 47
Prepared statement........................................... 49
Answers to submitted questions............................... 97
Jeffrey Potts, Biorisk Manager, National Institutes of Health,
Department of Health and Human Services........................ 53
Prepared statement........................................... 55
Major General Barbara R. Holcomb, Commanding General, Army
Medical Research and Materiel Command.......................... 61
Prepared statement........................................... 63
Submitted Material
Subcommittee memorandum.......................................... 83
Letter of September 9, 2016, on behalf of Dayle Cristinzio,
Acting Associate Commissioner for Legislation, Food and Drug
Administration, Department of Health and Human Services, to Mr.
Upton, submitted by Mr. Murphy................................. 90
Letter of July 28, 1016 [sic], from Francis S. Collins, Director,
National Institues of Health, Department of Health and Human
Services, to Mr. Upton, submitted by Mr. Murphy................ 93
BIORESEARCH LABS AND INACTIVATION OF DANGEROUS PATHOGENS
----------
TUESDAY, SEPTEMBER 27, 2016
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 2:02 p.m., in
Room 2322 of the Rayburn House Office Building, Hon. Tim Murphy
(chairman of the subcommittee) presiding.
Members present: Representatives Murphy, Blackburn, Flores,
Brooks, Hudson, Collins, DeGette, Schakowsky, Castor, Yarmuth,
Kennedy, Green, and Welch.
Staff present: Elena Brennan, Staff Assistant; Rebecca
Card, Assistant Press Secretary; Ryan Coble, Detailee,
Oversight and Investigations; Charles Ingebretson, Chief
Counsel, Oversight and Investigations; David Schaub, Detailee,
Oversight and Investigations; Jennifer Sherman, Press
Secretary; Alan Slobodin, Deputy Chief Counsel, Oversight;
Gregory Watson, Legislative Clerk, Communications and
Technology; Jeff Carroll, Democratic Staff Director; Ryan
Gottschall, Democratic GAO Detailee; Christopher Knauer,
Democratic Oversight Staff Director; Elizabeth Letter,
Democratic Professional Staff Member; and Miles Lichtman,
Democratic Professional Staff Member.
Mr. Murphy. While I know they just called votes, we are
going to try and do opening statements, and then we will break
for a little bit for some quick votes and come back. This is
what happens on the Hill. I apologize.
OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
All right. Well, today this subcommittee will continue our
examination of bioresearch labs and handling of dangerous
pathogens, including the 66 pathogens classified as Federal
Select Agents. Specifically, we will focus on the inactivation
of bacteria and viruses, or making dangerous organisms harmless
and incapable of spreading disease while retaining
characteristics for future use including crucial biodefense
research.
This research allows for the development of diagnostic
tests to detect emerging infectious diseases as well as
discovering vaccines and other medical countermeasures to
protect us from epidemics. First, I would like to thank the GAO
for their hard work and pivotal report as well as their
participation in today's hearing. I would also like to thank
CDC, FDA, NIH, and the Department of the Army for their
participation today. Thank you for being here.
Disastrously, recent incidents at Federal bioresearch labs
have revealed lackadaisical methods used to inactivate anthrax,
a deadly select agent. Such negligence continues to put human
lives at risk. In 2015, the Army's Dugway Proving Ground
shipped live anthrax, thought to have been successfully killed,
to contractors, subcontractors and private labs in all 50
States and nine foreign countries for more than a decade.
The dangers presented by such a careless mistake are
unacceptable, and thankfully no one was harmed so the Army
dodged a catastrophe in this matter. However, without major
overhaul, how deadly agents like anthrax are handled and how
research is conducted, the risk of repeating this mistake
remains viable.
In 2014, this subcommittee held a hearing on the shipment
of live anthrax thought to have been activated. The anthrax was
shipped from a high containment lab at CDC to another lab at
CDC with a lower level of biosafety. And the transfer of live
anthrax potentially exposed over 80 CDC employees.
An internal CDC review and USDA inspection found multiple
failures. Unapproved inactivation techniques were used; a
virulent strain of anthrax was unnecessarily used in the
research; lab staff lacked training and knowledge required to
inactivate anthrax; lack of standard operating procedures for
inactivation; inability to find anthrax samples; and
disinfectant used for decontamination was expired.
These kinds of incidents drove direct action from the White
House--a Federal laboratory stand-down was ordered in the
summer of 2014. However, and disappointingly, even with
consciousness raised about the lab safety, bioresearch labs
persist in questionable inactivation practices today.
Recently, we learned that the CDC in Ft. Collins, Colorado
sent a shipment of Zika, dengue, and chikungunya virus to CDC
Atlanta. The viruses were used in control panels for a trioplex
diagnostic test under emergency use authority. Despite CDC Ft.
Collins' knowledge that the inactivation had not been
confirmed, the shipment was sent. Let me restate that.
Dangerous, live viruses including Zika were handled and shipped
across the country. CDC Ft. Collins told CDC Atlanta don't open
the package until inactivation was confirmed, and ultimately,
thankfully, the package was not opened.
This continued problem of mistakenly shipping live anthrax
and other pathogens led the committee to make a bipartisan
request to the GAO to evaluate issues relevant to inactivation.
By coincidence, the request was made 2 weeks before the
discovery of the massive anthrax inactivation problems at
Dugway.
Today, the GAO will present its finding and recommendations
on the inactivation of dangerous pathogens. Failed inactivation
has been long overlooked by regulators and the research
community. The GAO brings us several important findings. First,
the GAO found that the Federal Select Agent Program operated by
both the Departments of Health and Human Services and
Agriculture does not require laboratories to identify incidents
involving failed inactivation in its reporting, resulting in
inconsistent and incomplete reports.
From 2003 until 2015, the Select Agent Program reported ten
incidents, but GAO documented an additional 11 situations in
which select agents were not effectively inactivated. Since the
Select Agent Program lacks standard practices for identifying
such incidents, we simply don't know how often they occur or
why. This is extremely disturbing.
In their report, the GAO noted the need for better and more
consistent follow-up when problems with inactivation are
discovered. The GAO found that the Federal Select Agent
regulators were inconsistent in both their referrals for
further investigation and in their enforcement approach. As one
example, two incidents at CDC under investigation by the USDA
in 2014 were not referred for further investigation. The lack
of consistency by select agent regulators, CDC, and the USDA
leaves this subcommittee and the public with zero confidence in
regulators' ability to protect the safety of the American
public.
But the GAO's most alarming discovery is the fact that
today we still don't know what it takes to effectively and
reliably inactivate certain select agent pathogens. In some
cases, the chemical or radiological dosing is not actually
effective; in other cases, the process for verifying the
inactivation is not reliable. It is extremely troubling that
after 15 years of efforts, we still lack competency in ensuring
the safety of the public from dangerous and sometimes fatal
bacteria and viruses.
This needs to be among our highest priorities for reforming
the Select Agent Program. To reiterate, it has been 15 years
since we became aware of the need for a Select Agent Program
and clearly there is a lot of work to do.
I do want to commend the Army for its response to the
shocking shipments of anthrax from the Dugway laboratory, and I
want to acknowledge the cooperation we have received from both
the NIH and the FDA. Both have worked to identify improvements
needed and to implement those changes, including creating new
offices and committing additional resources.
[The prepared statement of Mr. Murphy follows:]
Prepared statement of Hon. Tim Murphy
Today this subcommittee will continue our examination of
bioresearch labs and the handling of dangerous pathogens,
including the 66 pathogens classified as Federal ``select
agents.'' Specifically, we will focus on the inactivation of
bacteria and viruses, or making dangerous organisms harmless
and incapable of spreading disease while retaining
characteristics for future use--including crucial biodefense
research. This research allows for the development of
diagnostic tests to detect emerging infectious diseases, as
well as discovering vaccines and other medical countermeasures
to protect us from epidemics.
First, I would like to thank the GAO for their hard work
and pivotal report, as well as their participation in today's
hearing. I'd like to also thank CDC, FDA, NIH and the
Department of the Army for their participation today.
Disastrously, recent incidents at Federal bioresearch labs
have revealed lackadaisical methods used to inactivate anthrax,
a deadly select agent. Such negligence continues to put human
lives at risk. In 2015, the Army's Dugway Proving Ground
shipped live anthrax--thought to have been successfully
killed--to contractors, sub-contractors and private labs in all
50 States and nine foreign countries for more than a decade.
The dangers presented by such a careless mistake are
unacceptable. Thankfully, no one was harmed, so the Army dodged
a catastrophe in this matter. However, without major overhaul
of how deadly agents, like anthrax, are handled and how
research is conducted, the risk of repeating this mistake is
remains viable.
In 2014, this subcommittee held a hearing on live anthrax
that was shipped out--once again--thought to have been
inactivated. The anthrax was shipped from a high-containment
lab at CDC to another lab at CDC with a lower level of
biosafety. The transfer of live anthrax potentially exposed
over 80 CDC employees. An internal CDC review and USDA
inspection found multiple failures: unapproved inactivation
techniques were used; a virulent strain of anthrax was
unnecessarily used in the research; lab staff lacked training
and knowledge required to inactivate anthrax; lack of standard
operating procedures for inactivation; inability to find
anthrax samples; and disinfectant used for decontamination was
expired. These kinds of incidents drove direct action from the
White House--a stand-down was ordered in the summer of 2014.
However, and disappointingly, even with consciousness
raised about lab safety, bioresearch labs persist in
questionable inactivation practices today. Recently we learned
that the CDC in Fort Collins, Colorado sent a shipment of Zika,
Dengue, and chikungunya viruses to CDC Atlanta. The viruses
were used in control panels for a trioplex diagnostic test
under emergency use authority. Despite CDC Ft. Collins'
knowledge that the inactivation had not been confirmed, the
shipment was sent. Live viruses--including Zika--were handled
and shipped across the country. CDC Ft. Collins told CDC
Atlanta not to open the package until inactivation was
confirmed. Ultimately, the package was not opened.
This continued problem of mistakenly shipping live anthrax
and other pathogens led the committee to make a bipartisan
request to the GAO to evaluate issues related to inactivation.
By coincidence, the request was made two weeks before the
discovery of the massive anthrax inactivation problem at
Dugway. Today, the GAO will present its findings and
recommendations on the inactivation of dangerous pathogens.
Failed inactivation has been long overlooked by regulators and
the research community. GAO brings us several important
findings. First, the GAO found that the Federal Select Agent
Program, operated by both the Departments of Health and Human
Services and Agriculture, does not require laboratories to
identify incidents involving failed inactivation in its
reporting resulting in inconsistent and incomplete reports.
From 2003 until 2015, the Select Agent Program reported 10
incidents, but GAO documented an additional 11 situations in
which select agents were not effectively inactivated. Since the
Select Agent Program lacks standard practices for identifying
such incidents, we don't know how often they occur, or why.
The GAO also noted the need for better and more consistent
follow-up when problems with inactivation are discovered.
According to GAO's report, the Federal select agent regulators
were inconsistent in both their referrals for further
investigation and in their enforcement approach. As one
example, two incidents at CDC under investigation by USDA in
2014 were not referred for further investigation. The lack of
consistency by select agent regulators--CDC and USDA--leaves
this subcommittee and the public with zero confidence in
regulators' ability to protect the safety of the American
public.
GAO'S most alarming discovery is the fact that today, we
still don't know what it takes to effectively and reliably
inactivate certain select agent pathogens. In some cases, the
chemical or radiological ``dosing'' is not actually effective;
in other cases, the process for verifying the inactivation is
not reliable. It is extremely troubling that after 15 years of
efforts, we still lack competency in ensuring the safety of the
public from dangerous, and sometimes fatal, bacteria and
viruses. This needs to be among our highest priorities for
reforming the Select Agents Program.
To reiterate, it has been 15 years since we became aware of
the need for an effective Select Agents Program. Clearly,
there's still a lot of work to do.
I do want to commend the Army for its response to the
shocking shipments of anthrax from the Dugway laboratory, and
also I want to acknowledge the cooperation that we've received
from both the NIH and the FDA; both have worked to identify
improvements needed and to implement those changes, including
creating new offices and committing additional resources.
Mr. Murphy. I welcome and thank all the witnesses for
testifying today, and I now recognize Ranking Member Ms.
DeGette.
OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF COLORADO
Ms. DeGette. Mr. Chairman, sadly, there are 6 minutes left
on the vote on the floor, so I will consolidate my opening
statement. I will ask unanimous consent to put the full
statement in the record and also all the other statements of
the other members. And I just want to register my displeasure
with this process this morning not letting Members fully speak.
As the chairman said, we are continuing to examine the
issue of inactivation and whether we have the proper scientific
understanding and processes to ensure pathogens are inactivated
by shipping or releasing them. Of course, this gained public
attention following the Army's Dugway Proving Ground incident,
where researchers for years had been shipping live anthrax to
labs across the world inadvertently.
Researchers must inactivate pathogens for a variety of
reasons. For example, Federal agencies, universities, and
others inactivate disease-causing agents so that vaccine
development and diagnostic testing can occur in lower safety
labs. This work is critical for promoting medical advancements
and bolstering public health preparedness. It is part of this
committee's ongoing bipartisan efforts to accelerate the path
of cures and medical breakthroughs.
But as valuable as this research may be, it can also be
very dangerous. All of the agencies here today share the
responsibility for making sure that harmful pathogens are being
handled without posing a risk to the public. Now it is true we
have all taken the inactivation events we are talking about
today very seriously. I know all of the agencies here have been
acting to try to implement reforms to ensure that past mistakes
aren't repeated. I am eager to hear about those efforts, but I
also want to know what more needs to be done to address the
possible risk to public health.
The GAO is here to testify about their body of work, and
what they have done is identify a number of issues around the
reporting and referral of incidents regarding incomplete
inactivation. For example, the number of incidents of incorrect
inactivation is unknown. The GAO found that the Select Agent
Program failed to identify at least 11 inactivation incidents
in the last 12 years. How many more are there? We don't know.
I am really interested in hearing from the witnesses about
their plans to implement the GAO's recommendations and how we
can go further. I am also interested to hear about the
scientific gaps that exist for the inactivation process for
pathogens. High containment labs across the country still have
not adopted a uniform approach to the inactivation of dangerous
pathogens, which of course increases the risk that this may
happen again.
This is something we just simply have to get right. And so
I think research is really important to national security and
the process of working with these pathogens must minimize all
potential risk. I guess we are lucky that nobody has been
injured or killed from exposure to these agents in the last few
years, but just because we have had good luck doesn't mean that
we should take this for granted. And I know nobody here does. I
know nobody here does.
So I am looking forward to working with everybody here and
I am looking forward to working with you and the other members
of the committee, Mr. Chairman, to make sure that in fact we
get this right. With that I will submit the rest of my
statement for the record and the other opening statements of
the other Democratic members.
[The prepared statement of Ms. DeGette follows:]
Prepared statement of Hon. Diana DeGette
Thank you, Mr. Chairman.
This hearing offers the subcommittee a valuable opportunity
to check in on the progress that the Federal Select Agent
Program has made in improving practices and procedures at high-
containment laboratories. These places handle pathogens that
have the potential to pose a severe threat to public health and
safety.
Our specific today is whether we have the proper scientific
understanding and processes to ensure that pathogens are
inactivated before shipping or releasing them.
This issue gained public attention last year when it
revealed that the Army's Dugway Proving Ground had been
inadvertently shipping live anthrax to labs across the world
for years.
Researchers must inactivate pathogens for a variety of
reasons. For example, Federal agencies, universities, and
others inactivate disease causing agents so that vaccine
development and diagnostic testing can occur in lower safety-
level labs. This work is crucial for promoting medical
advancements and bolstering public health preparedness. It is a
critical part of this committee's bipartisan efforts to
accelerate the pace of cures and medical breakthroughs.
However, as valuable as this research may be, it can also
be very dangerous. All of the agencies here today share the
responsibility of making certain that harmful pathogens are
being handled without posing undue risks to the public.
I know that we all have taken the inactivation events we
are talking about today very seriously. All the agencies before
us have been implementing reforms to ensure that past mistakes
are not repeated. We're all eager to hear about those efforts.
But we also want to understand what more needs to be done
to address this possible risk to public health.
We have a witness from the GAO with us today to testify
about the oversight of high-containment laboratories. GAO's
most recent report focuses on inactivation procedures at these
labs.
GAO researchers have identified a number of issues related
to the reporting and referral of incidents involving incomplete
inactivation. For example, they found the total number of
incidents of incorrect inactivation is unknown. They found that
the Select Agent Program failed to identify at least 11
inactivation incidents in the last 12 years. They also found
the Select Agent Program did not consistently refer
inactivation incidents to HHS or USDA for further investigation
and enforcement.
These findings underscore the need for further
coordination, clarity, and guidance within the Select Agent
Program. The report offers recommendations to the CDC, NIH, and
APHIS, particularly regarding how to regulate the possession,
use, and transfer of these pathogens.
I am particularly interested in hearing from each of our
witnesses about their plans to implement the GAO's
recommendations.
Mr. Chairman, I am also eager to learn about the scientific
gaps that still exist regarding inactivation processes for
pathogens. High-containment labs across the Government have
still not adopted a uniform approach to inactivation of
dangerous pathogens, which increases the risk that incomplete
inactivation occurs.
We must get this right.
Research on select agents and other harmful pathogens is a
critical national security endeavor. However, the process of
working with these pathogens must minimize all possible risk.
If something goes wrong in this program, there could be
disastrous consequences.
We are fortunate that no one in the United States has been
injured from exposure to select agents in the number of
incidents in the past few years. However, our good fortune does
not diminish the threat that the mishandling of these pathogens
poses to the health and welfare of millions of Americans. At
the end of the day, I need to be able to tell my constituents
that the hundreds of laboratories around the country that
handle these pathogens--including the CDC's facility in Fort
Collins that sits just outside my district--are doing so safely
and with care.
I know the agencies represented before us today understand
what is at stake here. We have seen promising efforts to
investigate incidents, conduct Government-wide reviews, and
implement recommendations. And we know that institutional and
cultural changes take time.
I look forward to working with all parties before us today
to make this program safer, mishaps less common, and
accountability more robust.
I thank the Chairman and I yield back.
Mr. Murphy. And when we return, if the members still want
to give theirs or the ranking member does.
Mrs. Blackburn, you can be recognized for 1 minute, and
then we are going to have to run.
OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE
Mrs. Blackburn. That is exactly right, we are going to have
to run to the floor. But I do want to welcome you all.
And as the chairman has said and the ranking member has
said, we have been here before on this issue. July 16th, 2014,
we had a hearing on this issue. I have visited the CDC to look
at processes and procedures, and it is such a concern to us.
Even in your own report you have found what is at the core of
this problem. The lack of approval, the lack of written
instructions, there is not a best practices process in place.
So the GAO, we are delighted to have you here and want to
talk with you about three of your findings--the tracking, the
gaps, scientific gaps that exist, and then the Federal Select
Agent Program and the inconsistencies there. So we thank you so
much for being here. Mr. Chairman, I thank you for your
attention to the issue.
Mr. Murphy. Thank you. And so the panelists, we are going
to run down and vote. Half an hour or so, I guess, the voting;
we will be back. So you get a slight reprieve and then we will
be right back. Thank you.
[Recess.]
Mr. Murphy. All right. OK, thank you. Then we will move on.
So I ask unanimous consent that any other Members' written
opening statements be introduced in the record, and without
objection, the documents will be entered into the record.
Let me introduce the witnesses for today's hearing, then.
Dr. Tim Persons will lead off our panel. Dr. Persons was
appointed chief scientist of the U.S. Government Accountability
Office in July 2008. As such, he is a member of the Senior
Executive Service of the U.S. Federal Government; also serves
as a director for GAO's Center for Science Technology and
Engineering. We thank Dr. Persons for being with us today and
look forward to his comments.
I would also like to welcome Dr. Daniel Sosin from the
Centers for Disease Control and Prevention. With over 30 years
of public health, analytical science, and emergency response
and medical training experience at the CDC, Dr. Sosin now
serves as deputy director and chief medical officer for the
Office of Public Health Preparedness and Response. Thank you
for being here, Dr. Sosin.
Next, we welcome Dr. Steve Monroe, associate director for
Laboratory Science and Safety at the Centers for Disease
Control and Prevention. With an extensive background in
microbiology and infectious disease, I look forward to hearing
from Dr. Monroe on steps taken to improve lab safety policies
at the Federal level.
And next up, I introduce Dr. Mark Davidson who is associate
deputy administrator at the U.S. Department of Agriculture's
Veterinary Service Program. In this role Dr. Davidson oversees
the program's national import/export activities as well as all
agricultural select agent services. We thank him for being with
us today and look forward to his testimony.
Joining us today from the National Institutes of Health we
have Mr. Jeff Potts. Mr. Potts serves as the biorisk manager of
the NIH where he oversees the coordination of all high
containment laboratories within the NIH intramural research
program. We thank Mr. Potts for being here.
And finally, we will welcome Major General Barbara Holcomb,
commanding general of Medical Research and Materiel Command at
Fort Detrick and chief of the U.S. Army Nurse Corps. We thank
Major General Holcomb for being here and providing her
expertise on behalf of the biological select agents and toxins
biosafety program at the Department of Defense.
Again I want to thank all of our witnesses for being here
and I appreciate that. You are all aware that this committee is
holding an investigative hearing, and when doing so we have the
practice of taking testimony under oath. Do any of you have any
objections to taking testimony under oath?
Seeing no objections, the Chair then advises all of 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? Seeing none then, in that
case would you all be please rise and raise your right hand and
I will swear you in.
[Witnesses sworn.]
Mr. Murphy. Thank you. You are all now under oath and
subject to the penalties set forth in Title 18, Section 1001 of
the United States Code. We will have you each give a 5-minute
opening statement starting with Dr. Persons. Make sure the
microphone is on. Pull it as close as you as possible and pay
attention to the timing light if it is on.
Thank you, Dr. Persons.
STATEMENTS OF TIMOTHY PERSONS, PH.D., CHIEF SCIENTIST,
GOVERNMENT ACCOUNTABILITY OFFICE; DANIEL M. SOSIN, M.D., DEPUTY
DIRECTOR AND CHIEF MEDICAL OFFICER, OFFICE OF PUBLIC HEALTH
PREPAREDNESS AND RESPONSE, CENTERS FOR DISEASE CONTROL AND
PREVENTION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; STEPHAN S.
MONROE, PH.D., ASSOCIATE DIRECTOR FOR LABORATORY SCIENCE AND
SAFETY, CENTERS FOR DISEASE CONTROL AND PREVENTION, DEPARTMENT
OF HEALTH AND HUMAN SERVICES; MARK DAVIDSON, D.V.M., ASSOCIATE
DEPUTY ADMINISTRATOR, VETERINARY SERVICES, DEPARTMENT OF
AGRICULTURE; JEFFREY POTTS, BIORISK MANAGER, NATIONAL
INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES;
AND MAJOR GENERAL BARBARA R. HOLCOMB, COMMANDING GENERAL, ARMY
MEDICAL RESEARCH AND MATERIEL COMMAND
STATEMENT OF TIMOTHY PERSONS
Dr. Persons. Will do, sir. Thank you.
Chairman Murphy, Ranking Member DeGette, and members of the
subcommittee, I'm pleased to be here to discuss our findings in
the report on inactivation issued last week. As you may know,
inactivation is a process for destroying the hazardous effects
of pathogens while retaining their characteristics for research
as in developing vaccines. This delicate balance between
eliminating a pathogen's destructive effects and preserving its
attributes for study and research must be achieved with safety
as a top priority.
The Federal Select Agent Program oversees many of our
Nation's high containment labs jointly through the CDC and
APHIS. In accordance with this committee's long-term strategic
interest in the program's oversight, you asked us to begin our
work before the May 2015 revelations concerning a DoD lab's
unintended shipment over the course of 12 years of live
Bacillus anthracis--that is, the bacterium that causes
anthrax--to almost 200 laboratories worldwide. Although
regulating these strategically important labs is and will
remain a complex endeavor, the nature and extent of this
specific challenge had not yet been anticipated when you made
your request.
There are three findings from our report. As for the first,
we found that the total number of incidents involving
incomplete inactivation is both unknown and unknowable. While
the program reported that ten incidents occurred from 2003
through 2015, GAO identified an additional 11 that the program
did not initially identify. Taken together, these 21 incidents
involved a variety of pathogens, labs and inactivation methods
as shown in the figure before you. Because the program cannot
easily identify these incidents, it does not know how often
they occur or why they occur. This makes it difficult to
develop guidance for mitigating future ones.
Lying behind this difficulty are, first, the fact that
currently no clear and consistent definition of inactivation
exists in the guidance or regulations the program and the NIH
have promulgated; and second, the program's forms are currently
not structured to specifically identify this type of incident.
As a result, researchers regulated by the program cannot
consistently identify and report these incidents, which means
in turn that regulators cannot provide an accurate number of
them.
Our second key finding is the three critical challenges
that affect the implementation of inactivation in high
containment labs. The challenges we identified are, one, the
gaps in scientific knowledge; two, the limited Federal guidance
on how to develop and implement inactivation protocols; and
three, the inconsistent use of safeguards.
With respect to gaps in knowledge we found that scant
resources are dedicated to research and to the publication of
research on inactivation methods. With respect to limited
guidance, we found that while inactivation protocols are often
developed throughout a lab sometimes they vary within the same
department, potentially increasing biosafety and/or biosecurity
risk. With respect to safeguards we found among other things a
general lack of cultural emphasis on safety in several labs we
visited. This lack increase is the risk of human error which in
turn can result in exposure to dangerous pathogens.
Our third key finding is that CDC and APHIS neither
referred violations consistently to their inspector general nor
consistently enforced regulations related to these incidents.
For example, we found that CDC and APHIS did not use the same
set of criteria for referring violations for further
investigation and did not clearly document the bases for
referring or not referring violations.
We found that it was not clear why some incidents were
referred and enforced and others were not. For example, the
program required one private and two academic labs to develop
corrective action plans following incidents, but never required
Federal labs to develop corrective action plans on similar
occasions until the Dugway revelations in 2015. Without
consistent criteria and documentation of decisions for
referring violations and enforcing regulations, the program
cannot ensure that its regulatory approach to overseeing high
containment labs is applied consistently.
Mr. Chairman, these findings in conjunction with our work
over the past decade raise serious questions about the nature,
extent, and consistency of the oversight that the program
provides. We have identified problems and made recommendations
concerning systemic issues, including among others the lack of
a strategic understanding of the nature and extent of the
national need for high containment labs, the duplicative,
fragmented and self-policing oversight structure, and the need
for updated policies and stronger oversight.
We have recommended among other things that a single
oversight entity be identified to determine, one, the number,
location and mission of the labs needed to meet national goals
to counter biological security threats; two, the aggregate
risks associated with their proliferation; and three, the type
of oversight needed.
Although some of our recommendations have been implemented,
a key recommendation regarding the need for a single entity has
not been addressed even while biosafety and biosecurity lapses
have continued, increasing the risk of exposure to workers and
the general public. In this era of rapidly emerging infectious
diseases and ongoing threats to national and homeland security,
the time for getting both biosafety and biosecurity right
across our research enterprise is now.
Chairman Murphy, Ranking Member DeGette, and members of the
subcommittee, this concludes my prepared remarks. I am happy to
respond to any questions you may have.
[The statement of Dr. Persons follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you, Doctor. Now Dr. Sosin, you are
recognized for 5 minutes.
STATEMENT OF DANIEL M. SOSIN
Dr. Sosin. Chairman Murphy, Ranking Member DeGette,
distinguished members of the subcommittee, thank you for the
opportunity to testify before you today regarding the
contributions of the Centers for Disease Control and Prevention
to the Federal Select Agent Program. I'm Dr. Daniel Sosin,
deputy director and chief medical officer of the Office of
Public Health Preparedness and Response at the CDC.
Much has changed since I testified before the subcommittee
last year regarding our response to the inactivation failure
involving Bacillus anthracis spores at Dugway Proving Ground.
Since last November, I have been privileged to lead the
Division of Select Agents and Toxins through significant
change. Inspection reports are more timely, clear, risk-based,
and consistent. The regulated community is stronger partner in
achieving standards of biosafety and pathogen security.
Incident response planning is more proactive and public
awareness of select agent work and oversight is improving.
But our work is by no means done, and I am pleased to
introduce Dr. Sam Edwin who joined the CDC 3 weeks ago as the
new director of the Division of Select Agents and Toxins, and
who will continue CDC's commitment to improving the Federal
Select Agent Program.
I would like to recognize the important contributions that
GAO has made to understanding challenges with the inactivation
of pathogens, and proposing ways to improve laboratory practice
and Government oversight. We concur with the recommendations
related to the Federal Select Agent Program and have already
initiated efforts to address them.
As recommended in GAO's new report, the Department of
Health and Human Services is expecting to publish a final rule
which will improve oversight of inactivation protocols. We are
also developing guidance to be released concurrently that will
assist the regulated community with implementation of the new
requirements. We are improving incident reporting and data
collection also recommended in the GAO report by updating the
form used to report theft loss or release of select agents and
toxins. We expect that incomplete inactivation as a potential
cause of exposure to select agents will now be explicitly
captured.
We are working to improve consistency in how we assess
severity of inspection findings to focus attention where it is
needed most. We are using this process to better standardize
the application of enforcement actions, including referral to
the Inspector General as was recommended by GAO. These steps
will increase the consistency and transparency of oversight.
Research done on select agents and toxins saves lives by
supporting the development of vaccines and drugs and the tools
needed to identify these pathogens when disease can
successfully be treated or prevented. We continually strive to
balance our mission to advance safety and security with our
commitment to science. The scientific methods and objectives of
research with biological agents are diverse and complex, and we
must be careful not to overprescribe methods and interfere with
medical advances.
We are increasing regulatory compliance through
collaboration with the regulated community which shares a
common interest in biosafety and pathogen security and also
bears responsibility for assessing the risk of their work and
applying appropriate safety measures. We also use the
experience and judgment of our inspectors, over 60 percent of
whom hold Ph.D.s in microbiology and most of the rest master's
degrees, to provide guidance on risk assessment and risk
management as well as review the work of the laboratory
scientists during inspections.
When necessary we set specific method requirements through
rule change as we are doing with the inactivation of select
agents. For 70 years the scientists and staff at CDC have been
on the front lines of public health tackling pandemics and
threats to the health of the American people. The Division of
Select Agents and Toxins is responsive in making improvements,
including the GAO recommendations on inactivation.
Work with select agents saves lives and we are balancing
the need for regulatory constraints with the benefits of
scientific discovery. I assure you that we have and will
continue to work diligently and thoughtfully to evolve this
oversight program and protect Americans from biological
threats. We welcome the subcommittee's input as we continue on
this path. Happy to take questions.
[The statement of Dr. Sosin follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you.
Dr. Monroe, you are recognized for 5 minutes.
STATEMENT OF STEPHAN S. MONROE
Dr. Monroe. Good afternoon, Chairman Murphy, Ranking Member
DeGette, members of the subcommittee. Thank you for the
opportunity to testify before you today. I am Dr. Steve Monroe,
CDC's associate director for Laboratory Science and Safety. I
serve as the single point of accountability for the quality and
safety of CDC's laboratories, and I report directly to the CDC
director, Dr. Tom Frieden.
My office was created last year to provide oversight of the
safety and quality of CDC's internal laboratories. This is
distinct from the regulatory role of CDC's Division of Select
Agents and Toxins. I exercise no authority over the Federal
Select Agent Program's regulations or their enforcement
activities. My office does ensure that those CDC laboratories
that work with select agents comply with the select agent
regulations. Moreover, our responsibility for laboratory safety
includes comprehensive oversight of biological, chemical and
radiation safety in all CDC laboratories whether or not they
work with select agents.
CDC's laboratories play an indispensable role in protecting
the public's health. Our laboratories screen newborns for rare
illnesses, detect outbreaks that threaten American communities,
and invent new ways to detect emerging infectious diseases. The
inactivation of pathogens in CDC's laboratories is a critical
part of this work.
Inactivation destroys a pathogen's ability to cause
infection which allows subsequent laboratory work to occur at
lower levels of containment. This both enhances safety for
workers at CDC and expands the number of laboratories able to
work on pathogens that would typically require higher levels of
containment. Inactivation enables the generation of vaccines
for viruses like influenza and polio, helps scientists find new
ways to diagnose disease, and protects the safety of laboratory
staff and the public.
However, it is critical that when laboratories inactivate
pathogens they do so safely, completely and verifiably. The
incomplete inactivation of Bacillus anthracis in a CDC
laboratory in 2014 was a seminal event that led to major safety
reforms within CDC including the creation of my position and
office. I take very seriously the importance of safe
inactivation of pathogens in our laboratories.
This afternoon I want to briefly highlight two ways we are
strengthening pathogen inactivation at CDC. The first is the
creation of the Laboratory Safety Review Board. This group is
charged with reviewing every protocol for the inactivation and
transfer of biological materials out of CDC's BSL-3 and BSL-4
laboratories to lower levels of containment. It examines every
part of the protocol, reviews every standard operating
procedure, and ensures that scientists who perform inactivation
have appropriate skills and training. Its creation is a
signature safety reform and represents a fundamental change in
the oversight of inactivation of pathogens in CDC's
laboratories.
The second way we aim to strengthen inactivation at CDC and
throughout laboratories in general is through enhancements to
the reference guide, ``Biosafety in Microbiological and
Biomedical Laboratories,'' or BMBL. The BMBL created in
partnership with the National Institutes of Health is a
comprehensive guide on biosafety practices and policies for
laboratories working with pathogens.
In recognition of the BMBL's influence with the laboratory
community, the GAO report on inactivation recommended and CDC
and NIH concurred that the upcoming revision to BMBL include
clear definitions of inactivation and clear and consistent
guidance for the development and implementation of inactivation
protocols. CDC and NIH are working together to incorporate this
definition and guidance in the next version of BMBL.
Laboratory safety and CDC is not a single objective that
can be accomplished and checked off, but rather is an ongoing
commitment to a culture of safety that demands constant
dedication. Ensuring our laboratories perform effective
inactivation of pathogens is an important example of CDC's
commitment to this culture. We have made major strides in
strengthening the agency's approach to inactivation and will
continue to monitor and improve our efforts in this area.
Thank you for the opportunity to testify on this important
matter. I welcome any questions you may have.
[The statement of Dr. Monroe follows:]
[[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you.
Dr. Davidson, you are recognized for 5 minutes.
STATEMENT OF MARK DAVIDSON
Dr. Davidson. Mr. Chairman, Ranking Member DeGette, and
members of the subcommittee, I thank you for the opportunity to
testify at today's important hearing. I'm Dr. Mark Davidson,
associate deputy administrator for Veterinary Services within
the U.S. Department of Agriculture's Animal and Plant Health
Inspection Service.
APHIS and the Centers for Disease Control and Prevention
jointly oversee the Federal Select Agent Program. We ensure
that anyone possessing, using, or transferring biological
select agents or toxins that have the potential to pose a
severe threat to the public, plant, or animal health does so
safely and securely. This is a role that we take very
seriously.
With my agency's focus on protecting and preserving
American agriculture, APHIS scientists understand well the
consequences these select agents and toxins can have. We
recognize the gravity of recent incidents and I can assure you
that our actions have strengthened the Federal Select Agent
Program. While we cannot completely eliminate all risk, we have
overlapping safeguards and processes in place to reduce the
risk to low as possible.
In addition to today's GAO review, the Federal Select Agent
Program has participated in a broad stakeholder review and
other Federal-level studies of the program. These reviews have
given us a robust set of recommendations to strengthen our
oversight of the program. We have implemented a majority of
these recommendations and are diligently addressing the
remaining recommendations. This includes the five
recommendations for APHIS in today's GAO report.
We are in the process of finalizing a proposed rule and
regulated guidance that will provide clarity for the regulated
community and the Select Agent Program about the roles and
responsibilities for the inactivation of select agents. The
rule will clarify what is required to achieve inactivation, and
the related guidance will lay out standards to help researchers
and others validate inactivation protocols. Once these
inactivation standards are in place we will hold those that we
regulate accountable for meeting the standards.
To that end, we are finalizing revisions to the standard
incident reporting forms the program uses. We will now collect
information about incomplete inactivation and other causes of
release so that we can monitor and track issues that arise
ensuring accountability for those who work with select agents
and increasing our ability to analyze trends to reduce the risk
of future incidents.
We are also in the final stages of developing a new
enforcement system to ensure consistency across the Federal
Select Agent Program. The three-tiered system assigns
violations into categories based on severity and standardizes
how the Federal Select Agent Program will respond to those
violations. With implementation of the system which will
include consistent consequences for violations related to the
new inactivation guidance, enforcement under the Federal Select
Agent Program will be more consistent and our stakeholders will
have a clearer understanding of their responsibility.
Again APHIS takes any potential release of a select agent
or toxin very seriously, but I assure you we are working
closely with our Federal partners and the regulated community
to develop strong cultures of safety and responsibility and
policies and procedures that are science-based and to the
maximum extent possible ensure the safety and security of these
potentially dangerous select agents while allowing the valuable
research to continue.
Mr. Chairman, this concludes my statement and I would be
happy to answer any questions you or the members of the
committee may have.
[The statement of Dr. Davidson follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you, Dr. Davidson.
I now recognize Mr. Potts for 5 minutes. Turn your
microphone on, please, and bring it close.
STATEMENT OF JEFFREY POTTS
Mr. Potts. Good afternoon, Mr. Chairman, Ranking Member
DeGette, and distinguished members of the subcommittee. It is
an honor to appear before you today to discuss NIH's role in
the oversight of biosafety and biosecurity measures in high
containment laboratories, including those that work with
biological select agents and toxins.
The GAO report released today provides valuable analysis
and recommendations that will inform policies and procedures on
inactivation moving forward. NIH is committed to working with
our Federal partners in implementing these recommendations. I
am the NIH Biorisk Manager, and I'm responsible for providing
regulatory compliance oversight and expert guidance to the
intramural research community for matters involving high-
consequence pathogens.
Consistency is essential to biosafety practice. At NIH all
high containment laboratories are held to the same operational
standards. Working with a team of certified biological safety
professionals, we oversee laboratories on the main campus in
Bethesda, Maryland; Frederick, Maryland; and Hamilton, Montana.
The NIH has an important mission to conduct research that will
lead to the development of new treatments, diagnostics, and
vaccines to address public health needs, including medical
countermeasures to address the ever-evolving threat of
infectious diseases.
Methods for inactivating pathogens are an essential
component of this research. Inactivation methods allow for the
removal of a biological material from a high containment
laboratory for downstream use. At NIH, inactivation methods and
viability testing protocols are developed through collaboration
of investigators and Biorisk Management staff, reviewed by the
Biosafety Officer, and ultimately review and approval by the
NIH Institutional Biosafety Committee. These policies and
procedures are applicable to all pathogens that may be removed
from a high containment laboratory.
The research community at large looks to two essential
publications when conducting biological research: the ``NIH
Guidelines for Research Involving Recombinant or Synthetic
Nucleic Acid Molecules,'' commonly referred to as the NIH
Guidelines; and the Centers for Disease Control and Prevention/
NIH publication, ``Biosafety in Microbiological and Biomedical
Laboratories,'' referred to as the BMBL.
In addition to these guidance documents, work with select
agents is regulated by either CDC and/or USDA. NIH will look to
these two agencies to establish minimum criteria and
definitions for inactivation. It is important that every effort
is made to harmonize language to ensure a clear and consistent
message, as well as provide guidance for development,
validation, and implementation of inactivation protocols.
The GAO report called for greater consistency in the
collection of data related to biosafety incidents involving
incomplete inactivation or failures. In order to provide
greater accuracy in data collection and retrieval concerning
inactivation failures, NIH revised its ``Template for Reporting
Incidents'' subject to the NIH Guidelines. Internally, NIH has
begun keeping records on the destination to which inactivated
samples are distributed or shipped. In the upcoming revision of
the BMBL, guidance will be included on documenting the shipment
of such inactivated material.
NIH is committed to biosafety outreach to the broader
research community. NIH will once again sponsor National
Biosafety Month this October. Throughout the month, all
research institutions are encouraged to refocus their attention
on their biosafety policies, practices, and procedures.
This year, the outreach effort will encourage institutions
to evaluate their biosafety programs, collaborate with other
biosafety professionals, and commit resources to ensure they
have a robust biosafety governance structure in place. In an
effort to foster continuous discussion on this topic, in May
2017 the NIH will host its third Safety by Design Symposium and
Workshop. The topic of the symposium will be ``Microbial
Inactivation--Lessons Learned, and a Way Forward.'' This
symposium will provide a venue for scientific and safety
personnel to share experiences regarding the use of various
inactivation modalities, successes and failures, and scientific
information gaps.
In closing, I want to ensure the subcommittee that NIH
remains committed both to the safety of the public and the
scientists 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 in NIH
research activities through best safety practices and strong
leadership. Thank you for the opportunity to testify. I'll be
glad to answer any questions you may have.
[The statement of Mr. Potts follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you, Mr. Potts.
General Holcomb, you are recognized for 5 minutes.
STATEMENT OF BARBARA R. HOLCOMB
MG Holcomb. Good afternoon, Chairman Murphy, Ranking Member
DeGette, distinguished members of the subcommittee. Thank you
for this opportunity to brief you on the DoD's actions since
the last hearing on the 20th of April 2016 concerning the safe
handling of biological select agents and toxins, or BSAT.
I'm the commanding general of the U.S. Army Medical
Research and Materiel Command, and I am here in support of the
Army Surgeon General who is the DoD Executive Agent Responsible
Official for the DoD BSAT Biosafety Program. The Executive
Agent Responsible Official oversees BSAT biosafety policy,
technical review, and inspection guidelines across the DoD.
Today, I will briefly describe several actions the DoD
accomplished since the last hearing, and also describe our
plans for future validation procedures, oversight, and
implementation of governance policies for biosafety. The
Executive Agent Responsible Official chartered the DoD BSAT's
Biosafety Program office in March of 2016 and is now
establishing processes and hiring staff. This office advises
the Executive Agent Responsible Official on all biosafety
matters pertaining to BSAT lab operations, risks, and
oversight. This office also serves as the DoD interface with
regulatory agencies, ensures standardization of safety
procedures, and identifies best practices to enhance biosafety
across the full spectrum of DoD BSAT operations.
The Life Science Division production facility, from which
the inadvertent live anthrax shipments were sent, was
reassigned to the Dugway Proving Ground in the U.S. Army
Edgewood Chemical Biological Center this past July. The
transfer places the facility under a chain of command and
direct administrative control which has a robust BSAT
experienced staff assigned under the Research, Development and
Engineering Command in the Army Materiel Command.
We established a BSAT Biosafety and Scientific Review Panel
in February 2016. Since its establishment, this panel has met
face-to-face and has conducted multiple teleconferences to
review and assess biosafety concerns associated with procedures
conducted at DoD BSAT laboratories, review and assess
scientific evidence that supports mitigation of biosafety
concerns, and provide recommendations on their acceptability
for continued use or initiation of use to enhance biosafety
across DoD BSAT programs.
On the 25th of July 2016, the Secretary of the Army signed
the Army directive 2016-24 titled, ``Department of Defense
Biological Select Agents and Toxins Biosafety Program.'' This
directive establishes policy and assigns several
responsibilities to applicable DoD and service activities. This
directive replaces the previous Secretary of the Army BSAT
moratorium with additional safeguards regarding production,
handling, testing, and shipment of inactive, live and
derivatives of BSAT, and also critical reagent program
associated materials. However, the Deputy Secretary of Defense
moratorium for inactivated anthrax remains in effect for
production, handling, and shipment.
We are working on several initiatives which are intended to
enhance harmonization and standardization of practices and
procedures across the DoD network of laboratories. We initiated
studies to better define conditions for inactivation and
viability testing of BSAT, and irradiation inactivation study
for anthrax is underway and is scheduled for completion in
October 2016.
The BSAT Biosafety Program office is planning for a
contract for the development of a quality management system
focused on monitoring critical biosafety and biosecurity
control points in BSAT operations at all DoD laboratories.
Other initiatives include development of a joint inspection
team, biosafety and scientific review of all BSAT protocols and
procedures, and possible unified oversight for biosafety and
biosecurity to enhance risk management for BSAT operations. My
written testimony provides a description of these and other
initiatives.
We value the analysis provided by the GAO. Their
observations will inform DoD BSAT Biosafety Program efforts and
improve oversight. The DoD is addressing our BSAT oversight of
inactivation documentation, improving guidance for development
and validation of inactivation protocols, and developing
consistent enforcement of investigations and referrals.
We look forward to coordinating and cooperating with the
Department of Health and Human Services and the Department of
Agriculture as they respond to the GAO recommendations. Thank
you for the opportunity to testify today and I am happy to
answer your questions.
[The statement of Major General Holcomb follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. I thank you, General, and thank you, panel. I
now recognize myself for 5 minutes of questions. And I want to
start by saying, as Ms. DeGette and Mrs. Blackburn and others
in this committee have said, we have been here before. With
these agencies we have seen some of these problems occur. We
are hearing again you take it seriously. We hear about the
number of scientists with advanced degrees, the rules of
accountability, et cetera.
But this is a pretty severe threat, and we have had more
cases here of anthrax and pathogens being released than we have
had done by terrorists in this country. Now at this level,
luckily, we have not seen somebody die from this, but it is
serious and you all recognize the seriousness. But let me just
start off with this important question here.
Dr. Monroe, should the CDC put out a public announcement
that any lab scientist who fails to implement the policies or
inactivation of dangerous pathogens is subject to personnel
action?
Dr. Monroe. So whenever there's an issue that we recognize
with inactivation failures or other issues related to dangerous
pathogens, we immediately, my office is involved in finding out
what the root cause is.
Mr. Murphy. But I mean from the onset, the onset, employees
notified. This could have been gross negligence. It could have
been willful disregard, reckless endangerment, something else.
Do the employees understand now the seriousness of this and
that they will be held personally accountable if they do not
respond to the rules you are setting forth?
Dr. Monroe. That is a part of our cultural responsibility.
The disciplinary action is a management decision that's outside
of my office.
Mr. Murphy. We just want to make sure. Dr. Davidson, how
about within the USDA and APHIS?
Dr. Davidson. All of our scientists have an important role
to uphold the integrity, and each case will be investigated for
the release and then if management action would be needed.
Mr. Murphy. Mr. Potts, how about NIH? Has it clearly been
stated to the employees there?
Mr. Potts. So in our training with all of our employees we
stress the importance of following the standard operating
procedures, and all protocols are to have been previously
approved. Like Mr. Davidson, or Dr. Davidson--I'm sorry--based
on the investigation, if we find that there is a willful or
negligence involved we would pursue those actions.
Mr. Murphy. That is better. General Holcomb.
MG Holcomb. DoD scientists authorized to work with Tier 1
BSAT are required to be enrolled in a biological personnel
reliability program. Failure to comply with applicable
regulations and policies are grounds for disqualification from
the personnel reliability program and the privilege to work
with Tier 1 BSAT agents.
Mr. Murphy. Thank you. I appreciate that. That is the kind
of clear message I think we need to hear, and I appreciate the
Army standing up and doing that because there can't be any ifs,
ands, or buts on that. There can't be anything. We are here as
a committee to protect the safety of our country and you too.
And so we don't want to hear anymore equivocating on this
because where there is a tiny bit of leeway here, it is a
problem.
Look, we all understand. We know people make mistakes. But
when we have heard time and time again everything from what, we
have heard refrigerators left unlocked, people coming in with
the same passkey, people putting things through Ziploc bags.
The messes continue and we are just not really clear yet and
convinced that things are taking place.
Dr. Sosin and Dr. Davidson, so your agencies are in
agreement with the GAO recommendations but it still comes down
to it. Help us understand, why do we trust you? Why should we
trust you now? What is different in this culture?
Dr. Sosin. Many aspects of our program have changed. I'd be
happy to talk to you more about how inspections have improved,
how the work with the regulated community including
opportunities for best practice sharing, training, have
improved, how incident response activities have improved, and
transparency. All of these called in a broader range of Federal
reports. I think you can look at what has happened in the year
since we have been here and see many changes, including each
one of the GAO recommendations that came out in the recent
report.
Mr. Murphy. Dr. Davidson.
Dr. Davidson. As Dr. Sosin said, we work very closely
together in implementing the changes, and through the different
reviews--the Federal reviews, the GAO--we have found gaps that
we needed to address. And we've been very active in the work
we've done with our inspectors, you know, through the steps
we're taking for the GAO in addressing the regulations' clear
guidance and policies. And we've got to continue to always look
towards improvement.
Mr. Murphy. Well, let me ask one of those areas. So the GAO
report said that there needed to be specific coding and tracks
on reports. Is this issue solved now, Dr. Sosin?
Dr. Sosin. I didn't understand, specific tracking?
Mr. Murphy. With regard to the specific coding to track
reports of the inactivation cases. Is there a specific way, do
you have that in concrete now?
Dr. Sosin. So yes, we have----
Mr. Murphy. OK. Dr. Davidson, do you have that concretely
set up now?
Dr. Davidson. Yes, we've worked together to----
Mr. Murphy. I have only got a few seconds. Mr. Potts, do
you have that concrete, specifically set up now when there is
an inactivation case, clear reporting set up?
Mr. Potts. Yes, the NIH recombinant DNA guidelines were
updated in August of this year to include a specific category
for inactivation failures.
Mr. Murphy. And General Holcomb, you have that too?
MG Holcomb. Yes, we do.
Mr. Murphy. Thank you. I am out of time. I recognize Ms.
DeGette.
Ms. DeGette. Thanks.
In reviewing the GAO's August 2016 report, there is now six
additional recommendations to improve oversight of these high
containment laboratories in the Select Agent Program. And we
have seen a number of recommendations, you know, I have been on
this subcommittee 20 years, so over the last 10 years we have
seen a number of recommendations that were always trying to
improve on the program.
And so having seen this over all these years, I have to
ask. Does the existing structure with responsibilities spread
across the different agencies really provide the oversight we
need despite ongoing efforts? So I want to ask you a couple of
questions about this, Dr. Persons. Successfully addressing the
six recommendations is going to require considerable
coordination across several agencies; is that correct?
Dr. Persons. That is correct.
Ms. DeGette. Do you believe that can be achieved, and if
so, how?
Dr. Persons. I believe that it is possible to do
coordination. Of course, GAO does a good deal of work not just
on this topic but on Government coordination in general. I
would simply say often coordination's easy to conceive of,
sometimes challenging to do on these things. And I think as our
recommendations show, we had key things that we found to try
and address that; coordination being essential to most if not
all of them.
Ms. DeGette. In earlier work you found that existing
oversight of high containment laboratories is, quote,
fragmented, at times duplicative, and relies on self-policing,
end quote; is that correct?
Dr. Persons. That's correct.
Ms. DeGette. And given these ongoing efforts, I guess I am
wondering if you believe the current structure provides
adequate oversight with the adjustments that people are
testifying about here today, or rather do we need a single
oversight entity for this program?
Dr. Persons. So thank you for the question, Ms. DeGette. I
think that the current system, it's important to go back and
answer this in context. The way the Federal Select Agent
Program evolved really goes back to the post-Oklahoma City
bombing and then it layered in with legislation through the
Patriot Act in post-9/11 and so on. And I think what was
important, and this was confirmed by several of our experts
that we spoke with, is just the context of biosecurity vis-a-
vis biosafety, overimposed against, I mean.
So I think there is work to be done in the biosafety arena
and, one, since inactivation is largely a biosafety related
issue and I think it, as one type of incident, I think it
exposed the challenges in the regulatory structure which is
largely built around select agents, meaning those things that
were a concern or a threat in a national homeland security
sense.
Ms. DeGette. So to reiterate my question, given those
challenges that you just described and the time frame, do you
think it would be practicable to have a new, single oversight
entity for oversight of these high containment labs?
Dr. Persons. Well, ma'am, we're right now, as you know for
this committee, on our follow-on work companion to this we are
looking at a comparative structure and we'll be able to say
more in an evaluative sense about the sufficiency and the
efficacy of what we're doing. We're looking internationally
with partners who do this.
Ms. DeGette. So you don't--excuse me. You don't have a
conclusion about whether we would need a single entity or not
yet, but you are working on it. Is that fair?
Dr. Persons. I believe it would be a thing to seriously
consider given the need in terms of again the biosafety domain
and inculcating that.
Ms. DeGette. OK. Are there ways short of a single entity to
better centralize the oversight and regulation of the Select
Agent Program and high containment labs?
Dr. Persons. I'm not able to comment on that other than
working within the existing system on our recommendations to
make it better, which we do, as the various witnesses have
testified here.
Ms. DeGette. Thank you. I would like to ask the rest of the
witnesses what they think about this concept of a centralized
agency to oversee this program. Dr. Sosin.
Dr. Sosin. Ranking Member DeGette, I believe there's a
misunderstanding about what the Federal Select Agent Program is
authorized to do. It's authorized to oversee a specific set of
select agents and toxins, not the laboratories. So the Federal
Select Agent Program is not authorized.
Ms. DeGette. Right, but you could authorize some agency to
oversee it. Hi, I am Congress. Congress could authorize that.
Do you think that is a good idea, yes or no?
Dr. Sosin. I don't have enough information to know whether
the benefit over----
Ms. DeGette. OK.
Dr. Monroe?
Dr. Monroe. There's not currently one agency that has the
breadth of expertise that would be needed to run that
oversight.
Ms. DeGette. So we would have to set it up.
Dr. Davidson.
Dr. Davidson. I agree. You know, as we work as a single
entity, the breadth that we all bring from our scientists and
our multidisciplinary expertise is robust, and the key is the
factors we work on in coordination.
Ms. DeGette. Mr. Potts.
Mr. Potts. So I think the current structure is working. I
think each agency that has a voice at the table is providing
their expert opinion and their guidance to----
Ms. DeGette. And you think we can coordinate enough to make
it work?
Mr. Potts. I think we can coordinate it and there's efforts
ongoing----
Ms. DeGette. General Holcomb.
MG Holcomb. Within DoD we have done that work. We've
consolidated oversight over all of the DoD labs regardless of
service, so for us that's what makes sense.
Ms. DeGette. Thank you. Thank you, Mr. Chairman.
Mr. Murphy. I recognize the gentleman from New York, Mr.
Collins.
Mr. Collins. Thank you, Mr. Chairman. I know we have met
before, and again with all full disclosure I was the founder
and CEO of a company that operates two level 3 containment labs
with a select agent license. So I am very familiar with what
you have been doing, and we have been inspected certainly by
the CDC and USDA, and I give everyone kudos for the type of
inspectors that went out, the thoroughness of them and so
forth. And speaking from the private sector, would never have
any real concerns on the oversight that I have seen by the CDC
and the USDA over private labs.
So my concerns fall into two areas. One, it is very simple
to deactivate, inactivate virus, very straightforward
especially if you are not trying to protect the RNA or DNA and
you are just killing it off. I mean it is simple,
straightforward. Hard to imagine anyone would go through that
process and ship anything that wasn't inactivated. That would
just be, I think, gross negligence.
If you are trying to protect the RNA and DNA that gets a
little trickier. And certainly, when you are into anything like
bacteria where you could have spores, so you test it. You grow
it, you test it, it is inactivated but you have got spores. The
spores pop later, germinate. We have had some discussion
before. We found it could be months down the road. And I know,
Dr. Sosin, you thought it might be days, but our finding was it
was months; certainly with tuberculosis we did find that.
So I guess one thing I would urge, and we have talked
before, is to have a very, very rigid inactivation procedure
for bacteria in particular which can be grown, inactivated,
tested, it is inactivated and then subsequently, especially,
you know, down the road when the spores pop. So could you maybe
speak to that a little bit especially on the bacteria side?
Dr. Sosin. Sure. The viability testing of agents following
inactivation procedures is absolutely critical, will be a part
of the new requirements. Specific to spore formers, specific to
Bacillus anthracis, since the Dugway incident we have
disallowed the treatment of, or the inactivation of Bacillus
anthracis spores to be used for future use as non-select
agents. So until we have clarity of the science of how long
that period of viability testing needs to be, we will not lift
that prohibition on treating Bacillus anthracis spores as
inactivated.
Mr. Collins. I would just encourage you, really, to test
that out and look months down the road not days down the road.
I mean it can't hurt, and maybe not just anthrax but other
things like tuberculosis.
Now the other thing that we have gotten into here, and I
suppose maybe just for clarification the committee should know
and we all know we ship live virus all the time. You know, that
is including Zika and dengue and others. This is not an
uncommon thing in the United States today to have private labs
including ones I was involved with growing virus and shipping
live virus. There is no prohibition against that.
To some extent I get the feeling people think all pathogens
should be inactivated and that is just not the way it is. Some
researchers need live virus and we rely on safety protocols
within the industry. And I think they are very tight, and by
and large folks who work in a laboratory in a spacesuit realize
how dangerous the materials are they are working with.
But one thing I read here, Dr. Monroe, and I worry a little
about when Federal Government wants to compete with the private
sector when the private sector is doing things fine. And so
today there are technologies I know of where you can treat
virus, totally protect the RNA and DNA but inactivate it,
patent it, and it would beg the question why the Federal
Government wouldn't look to license those technologies as
opposed to trying to compete with the private sector and look
for funding, as I read here, to establish new inactivation
methods for something like Zika where those inactivation
methods are already available in the private sector covered by
patents that totally protect the RNA and DNA and make it
inactive. So why would the Government be looking to do
something that is already available in the private sector?
Dr. Monroe. Thank you, sir. So what you're referring to, I
believe, is a program that we established this fiscal year to
do intramural research to look at this issue of inactivation,
disinfection and other activities around the science behind the
laboratory safety that we're involved with. And we do have a
project that includes looking at alternative ways to inactivate
Zika and other arthropod-borne viruses as a part of that work.
Mr. Collins. Yes. You are aware the private sector can
already do this?
Dr. Monroe. Yes, sir. But again it depends on what the
specific use is for the material that's going to be used
downstream. And so for our scientists it's important to have a
method that'll work for their activities.
Mr. Collins. OK. I would just encourage you to make sure
that you know, you look at the private sector options too.
Dr. Monroe. Very good.
Mr. Collins. Fair enough. Thank you, Mr. Chairman. I yield
back.
Mr. Murphy. Thank you. Ms. Castor, you are recognized for 5
minutes.
Ms. Castor. Well, thank you, Mr. Chairman. And thank you to
our witnesses for being here today.
GAO made six recommendations in its August 2016 report to
reduce the risk of incidents involving incomplete inactivation
of dangerous pathogens. I would like to hear from each of the
agencies on your reaction to GAO's recommendations and the
length of time you believe it will take you to implement them.
First, GAO suggested that to increase the scientific
information on inactivation and viability testing, the
Secretaries of Health and Human Services and Agriculture should
coordinate research efforts. This will help close gaps in the
science of inactivation across high containment laboratories.
So I would like to ask CDC and NIH, APHIS and DoD, at this
point what are the specific scientific gaps that need to be
addressed, in other words what is still unknown about the
science of inactivation and what is the significance of that
lack of knowledge, and what will be involved in closing these
gaps? When do you believe this recommendation could be
substantially achieved?
Why don't we start on this side with CDC.
Dr. Monroe. So as I just alluded to, within CDC we did
allocate funds within this fiscal year for some intramural work
to look at specific issues around inactivation and other issues
with laboratory safety. Part of the problem here is again the
notion that there's not one perfect way to inactivate any
pathogen because it really depends on what you're going to do
with that pathogen in the downstream uses.
There has been some coordination among agencies, for
instance, and Major General Holcomb can describe this, alluded
to this already in her testimony that the efforts at DoD to
look specifically at using irradiation to inactivate Bacillus
anthracis. Because we were aware that that work was going on at
DoD, there's no work that's comparable to that that's going on
currently at CDC.
Dr. Davidson. So at USDA, as Dr. Monroe talked about, we
each have individual areas that we work. One of the things that
we're doing with inactivation is training at conferences to
help people understand everything that has to go into an
inactivation protocol and the steps that have to be taken to
validate that protocol. From there our specific research is for
individual agents that we work with within our high containment
laboratories.
Mr. Potts. So NIH has active research projects and some
external collaborations which have addressed some scientific
gaps. At NIH we are constantly looking at new science, new
techniques. There are new pathogens that are discovered or
reemerging, so the science is always going to be following
that. So we're committed to constantly pursuing this.
At NIH we have a process where every pathogen, every
inactivation protocol, is brought before the IBC and is
rigorously looked at for viability testing to make sure that
the protocol is actually effective. We have ongoing
collaborations with other agencies within the Federal
Government to align the guidance documents and the verbiage for
some of the definitions.
MG Holcomb. The DoD is currently conducting a series of
experiments to validate an optimal dose for irradiation of
Bacillus anthracis spores. The initial study has identified a
method for standardization of spore preparations, a radiation
dose that will produce a sterility assurance level of 10 to the
negative 6 which is the equivalent to a probability of one in a
million, and a method to validate the radiation dose received
by samples for optimal inactivation of spores.
The sterility assurance level of 10 to the negative 6 was
achieved with a radiation dose of 42 kilograys in the current
study, and the upper range was 50, the lower range used was 25.
The sterility assurance level is a measure of confidence for
sterility that's commonly used by the medical device industry.
We must continue to address the confounding variables that can
be used in various types of samples, and until those are
completed and reviewed and accepted by the Select Agent Program
we will continue to manage irradiated spores as BSAT.
Ms. Castor. Terrific.
Dr. Persons, it would appear that before implementing some
of your other recommendations, such as the creation of a
comprehensive and consistent guidance on inactivation
protocols, the agencies must first increase their scientific
understanding on inactivation and close the gaps that we have
been discussing and they have identified. Would you agree, are
you hopeful this can be done in a timely way, and will GAO
monitor these agencies for progress in closing the scientific
gaps?
Dr. Persons. So thank you for the question, Ms. Castor.
Yes, we believe it's possible. We do believe that extensive
coordination is necessary, and it sounds from the witnesses'
statements today that's begun. And yes, GAO will keep an eye on
this moving forward for this committee.
Ms. Castor. Thank you very much.
Mr. Murphy. Thank you.
Ms. Brooks, you are recognized for 5 minutes.
Mrs. Brooks. Thank you, Mr. Chairman. And I am really
pleased at the level of attention this committee, in particular
the subcommittee, has given over the past year to our
biodefense enterprise. As the chairman knows, I am focused
along with my colleague across the aisle, Congresswoman Eshoo,
on strengthening our Nation's biodefense enterprise with the
Bill 3299 which would help us get at the problem by
incentivizing responsible procurement of vaccinations and
treatments needed to combat an outbreak or an attack.
However, as we have focused on in past hearings on this
subject, breaches undermine the entire biodefense enterprise
and are as much a matter of public health security as they are
of national security. And fortunately we haven't had lapses
like this leading to widespread contamination, but I am just
curious and want to explore a little bit with respect to the
lab safety and inconsistent enforcement.
And while I am focused on Federal Government and industry
partnering to develop medical countermeasures and bolster our
national strategic stockpile, I am curious. And if we use
anthrax as an example, a pathogen for which we obviously, is
currently stockpiled, are the lab workers and the scientists
and other staff given the necessary vaccines before working
around these dangerous pathogens? I would ask Major General
Holcomb, are they given vaccines?
MG Holcomb. Most are, the military are. The civilian and
contractors it's not a requirement. They're offered the
opportunity. They certainly have all the PPE, the personal
protective equipment, needed to work, but we cannot force them
to take a vaccine for something that they don't choose to do.
Mrs. Brooks. How about Dr. Monroe and CDC, what is the
status of vaccines for those working in the space?
Dr. Monroe. At CDC, likewise, specifically for anthrax,
workers who work with live anthrax are offered the vaccine as a
prophylactic, and then we do keep supplies in our occupational
health clinic of the appropriate antibiotics in case there
would be an exposure in the lab.
Mrs. Brooks. And that is what I wanted to follow up. So are
there sufficient antivirals and antitoxins on site in case of
exposure, for everybody?
Dr. Monroe. There are for, you know, the workers who are
working in the laboratory. With the incident that we had in
2014, where there was the potential that there were workers who
were exposed in other parts of the agency who would not
normally, we may not in all cases have a stockpile on site
within CDC to treat, you know, essentially every employee at
the agency.
Mrs. Brooks. What is the process in place if that were to
be necessary?
Dr. Monroe. But we would have access through the Strategic
National Stockpile. If there were truly an incident where there
was widespread release of an agent, we would be able to with
the other resources available bring in enough antibiotic to
treat the appropriate population.
Mrs. Brooks. Dr. Sosin, you seem as if you wanted to add.
Dr. Sosin. Congresswoman, thank you. The process is that
the jurisdiction, in this case CDC Atlanta, would be the
jurisdiction of the State of Georgia, would recognize a need
for countermeasures, would make a request to the secretary of
HHS, and those materials would be provided to CDC through the
State to ensure that the staff received the prophylaxis needed.
Mrs. Brooks. Thank sounds like a lot of different
Government entities.
Dr. Sosin. It goes very fast. It's all HHS.
Mrs. Brooks. Well, that is what I--but then you mentioned
the State.
Dr. Sosin. We routinely respond to botulinum toxin, for
example, under the same mechanism.
Mrs. Brooks. OK, but you mentioned the State of Georgia as
well being involved in that. And so when you said it all goes
very fast, how fast are you talking about a process like that
taking if there were to be exposure?
Dr. Sosin. Within hours.
Mrs. Brooks. OK.
Dr. Sosin. That can be done and it has been done. And the
State of Georgia would defer to CDC to carry out the work that
needed to be done and that would increase the speed of it.
Mrs. Brooks. OK, thank you.
Major General Holcomb, with respect to DoD, with respect to
sufficient antivirals and antitoxins if there were exposure?
MG Holcomb. We also have access to the same supplies of the
national stockpile. And so we keep enough on hand to address
potential initial exposure for those working in with the agent,
but again have the same access that the other Federal agencies
have to the stockpile.
Mrs. Brooks. OK, thank you.
Dr. Monroe or Dr. Sosin, 5 of the 21 identified incidents
in 2003 to '15 were result of equipment issues, malfunctions or
failures. Would you briefly explain the alert systems built
into these machines should an issue occur?
Dr. Sosin. I'm not familiar with the specific equipment
issues associated with the findings that you mention. But the
process is when the laboratory identifies a failure of
inactivation or an exposure of a worker in general, because of
a breach of personal protective equipment or failure of
equipment, the notification goes through their responsible
official at the facility directly to CDC to notify us of the
event and we begin a process of investigating with that
facility to make sure that all necessary protective measures
are taken to protect the workers as well as secure agents. And
if necessary, if it's a significant exposure we'll bring in
State authorities and local authorities to be involved in that
process.
Mrs. Brooks. Thank you.
Dr. Monroe, are there alert systems in place? And I guess
that is what I am curious about with respect to the functioning
of the alert systems.
Dr. Monroe. Right. So what I can say is for the four
incidents of the 21 that did occur at CDC facilities, three of
those involved chemical inactivation, so the material was not
fully inactivated by the chemical processing so there was no
equipment per se that was involved. The fourth one was a mixup
of samples such that the non-inactivated samples were brought
out of the lab. So in our experience we have not had an issue
that we would relate to an equipment failure.
Mrs. Brooks. Thank you. I yield back.
Mr. Murphy. The gentlelady yields back. I now recognize the
gentleman from Texas, Mr. Green, for 5 minutes.
Mr. Green. Thank you, Mr. Chairman.
Dr. Persons, your August 2016 report makes six
recommendations to the CDC, NIH, APHIS to address the
inactivation issue. If these are implemented it should improve
safety and help mitigate the risk involved in handling these
dangerous pathogens. Dr. Persons, have the three agencies, CDC,
NIH, and APHIS, fully accepted GAO's recommendations?
Dr. Persons. Yes, sir. That's correct.
Mr. Green. Can they be implemented in a timely fashion?
Dr. Persons. I'm not able to say about the timeliness of
these. I'm going on their witness statements and testimony that
they are working on that. But I have no way to evaluate the
amount of energy or time it might take to adopt all of them.
Mr. Green. Doctor, I would like to have you expand on the
importance of GAO's recommendations as they relate to safe
handling of these pathogens. Dr. Persons, GAO recommended that
these three agencies develop clear and consistent definitions
of inactivation for use in their respective guidance documents.
Why is that recommendation important and what will it do to
improve safety?
Dr. Persons. Thank you, sir, for the question. It just
boils down to definitions are important. Understanding what
these things are in a very scientific, pristine way so that you
can manage these labs effectively is central to this. So if you
can't identify it or define it you can't manage it or mitigate
risk against it. Thank you.
Mr. Green. Can you talk about how the lack of clear
definition of inactivation contributes to the issues at both
HHS and USDA? Would a uniform definition of inactivation reduce
future incidents?
Dr. Persons. I think, sir, it won't guarantee. There's
never a way of reducing all of risk, but I do think that one of
the things we found within the report that this would do,
coming up that is with a clear definition, is bringing
canonicity, bringing sameness to the language even within the
same institution, much less when you start talking about this
department or agency interconnecting with that department or
agency I think it will help indeed.
Mr. Green. You also recommend these three agencies should
identify when incidents involving incomplete inactivation occur
and analyze the information reported to help identify the
causes of the incomplete inactivation to mitigate the risk of
future incidents. Why is it important to do that and how will
that improve safety?
Dr. Persons. So the safety culture that's needed that we're
endorsing that we have seen in parts but would like to see in
the entire enterprise is the idea of lessons learned, sharing,
so that you work through scientifically all of the ``it
depends,'' because you'll hear from one lab, they'll say it
depends on my lab and that.
And that makes sense to a degree, but in terms of what you
need to do fundamentally inactivate on a given pathogen, a
select agent and so on, there should be some common
understanding of that and some general way, or a tool in the
toolbox to be able to approach that and achieve the desired
outcome.
Mr. Green. And some of the recommendations, whether it is
one agency or the other, it is just a matter of safety from
GAO's opinion?
Dr. Persons. That's correct. We're encouraging an increase
and improvement of the coordination, the activities towards
safety including a science basis and greater validation,
verification efforts, and a more tracking, more documentation.
Mr. Green. Regarding the issue of increasing scientific
information or inactivation and viability testing, you
recommend that the secretaries of the Health and Human
Services, Agriculture, and I quote, coordinate research efforts
and take actions to help close gaps in the science of
inactivation and viable testing. What kinds of resources are
required to implement that recommendation and close this
knowledge gap?
Dr. Persons. Sir, I'm not able to say in a quantifiable way
what that would take. That would be something, I believe, as
part of the coordination to identify what the gaps are, and
then naturally of those identified gaps be able to estimate
resources to that go through the natural process for requesting
authorization, appropriations and so on. So I'm not able to
speak to that other than it does need to be done and more needs
to be done according to the agencies and the scientific
community itself.
Mr. Green. OK. Do you have any sense of how long it might
take these three agencies along with other scientists to close
these gaps in the science of inactivation?
Dr. Persons. No, sir. I don't have a specific time,
although it'll be something that'll be worked on, I'm sure, for
years to come.
Mr. Green. And it depends on appropriations though.
Dr. Persons. Yes, sir.
Mr. Green. OK. Thank you, Mr. Chairman. I thank all our
panelists for being here and for their testimony, and
particularly the GAO for your work on this subject.
Dr. Persons. Thank you, sir.
Mr. Green. And I yield back my time.
Mr. Murphy. The gentleman yields back. I just want to make
a clarification. We are going to have some Members who are
going to want to have questions for afterwards, too, and I also
want to make sure we have unanimous consent to put two letters
of the FDA and NIH into the record. Without objection, we will
have that.
[The information appears at the conclusion of the hearing.]
Mr. Murphy. One of the things I want to note too, and Mr.
Collins had brought this up briefly. Do you have protocol for
the non-select agents then and when you deactivate those, so
whether it is tuberculosis, Zika, things like that, do you have
protocols now for deactivation? Does CDC have the protocols in?
Dr. Monroe. Yes. The Laboratory Safety Review Board that I
mentioned reviews all protocols for any BSL-3 or 4 agent
regardless of whether or not it's a select agent, including
tuberculosis.
Mr. Murphy. But those with the non-select agents, for the
non-select agents?
Dr. Monroe. Yes, including tuberculosis and others.
Mr. Murphy. And DoD, you have protocols now for non-select
agents then also for some of those other diseases?
MG Holcomb. We do, and we also have an interagency,
intergovernmental panel that is reviewing all the protocols to
make sure that they're consistent and make sense based on
scientific evidence over.
Mr. Murphy. Thank you, then. I just want to say that in
conclusion I want to thank all our panelists for being here
today. And then recognize the members have, again if they have
other questions they will submit them and we ask that you all
respond to them fairly quickly. We thank the panel. We thank
you for the progress here. We hope you don't have to come back
again. We don't want to hear about any other incidents. Please
convey to all of your employees the seriousness of which this
issue is out there. And with that, this hearing is adjourned.
[Whereupon, at 4:01 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
Prepared statement of Hon. Fred Upton
Today's hearing examines a very important issue to ensure
safety at bioresearch laboratories--the inactivation of
dangerous pathogens. In order for the Federal Government to
conduct critical research on diagnostic tests or vaccines to
protect us from diseases while safeguarding national security
against bioterrorism, inactivation is a safety matter we need
to get right.
In recent years, several lapses at HHS agency and Defense
Department labs potentially exposed personnel and other
individuals to hazardous biological agents, all because these
agents were not effectively inactivated, as had been believed.
We cannot risk repeats of such episodes. Without improvements,
another incident is likely to happen, and the consequences
could be dire.
I recognize that the executive branch has taken several
steps to improve lab safety since these lapses were detected,
beginning in 2014. We are pleased to see agencies moving
forward in the right direction, and I believe GAO's recent
report on inactivation provides a major step in the right
direction. The nonpartisan watchdog has addressed an issue that
has not gained enough attention, and today, we will hear how
this report will provide much needed guidance for the
regulators of the Federal Select Agent program to conduct
proper oversight.
I thank the witnesses for their participation, and look
forward to working in a bipartisan way to improve oversight and
management of the Federal Select Agent program. Lives are on
the line, and there is zero margin for error. We can and must
do a better job.
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