[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
                           
                           
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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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