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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 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

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 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

PETER WELCH, Vermont 

BEN RAY LUJA ́ N, New Mexico 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

YVETTE D. CLARKE, New York 

DAVID LOEBSACK, Iowa 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

TIM MURPHY, Pennsylvania 

Chairman 

DAVID B. MCKINLEY, West Virginia 

Vice Chairman 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

H. MORGAN GRIFFITH, Virginia 

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 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

DIANA DEGETTE, Colorado 

Ranking Member 

JANICE D. SCHAKOWSKY, Illinois 

KATHY CASTOR, Florida 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

YVETTE D. CLARKE, New York 

JOSEPH P. KENNEDY, III, Massachusetts 

GENE GREEN, Texas 

PETER WELCH, Vermont 

FRANK PALLONE, JR., New Jersey (ex 

officio) 

(II) 

(III) 

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 

(1) 

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 

2 

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 inacVerDate Mar 15 2010 11:54 Dec 16, 2016 Jkt 037690 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X173BIOLABS\114X173BIOLABSWORKING WAYNE
3 

tivation 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, 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. 

Thankfully, no one was harmed, so the Army dodged a catastrophe in this matter. 

4 

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. 

5 

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. 

6 

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. 

7 

I know the agencies represented before us today understand what is at stake 

here. We have seen promising efforts to investigate incidents, conduct Governmentwide 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 inVerDate Mar 15 2010 11:54 Dec 16, 2016 Jkt 037690 PO 00000 Frm 00011 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X173BIOLABS\114X173BIOLABSWORKING WAYNE
8 

fectious 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. 

9 

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 

10 

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 

11 

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:] 

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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 

24 

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:] 

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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 LabVerDate Mar 15 2010 11:54 Dec 16, 2016 Jkt 037690 PO 00000 Frm 00039 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X173BIOLABS\114X173BIOLABSWORKING WAYNE
36 

oratories,’’ 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:] 

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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 

48 

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:] 

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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 

54 

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:] 

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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-toface 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. 

62 

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:] 

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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 

72 

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 

73 

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. 

74 

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 

75 

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 secVerDate Mar 15 2010 11:54 Dec 16, 2016 Jkt 037690 PO 00000 Frm 00079 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X173BIOLABS\114X173BIOLABSWORKING WAYNE
76 

tor 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 arthropodborne 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 

77 

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? 

78 

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. 

79 

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. 

80 

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? 

81 

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 nonselect agents then and when you deactivate those, so whether it is 

82 

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 nonselect 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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