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HOW SECURE ARE U.S. BIORESEARCH LABS? 

PREVENTING THE NEXT SAFETY LAPSE 

HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED FOURTEENTH CONGRESS 

SECOND SESSION 

APRIL 20, 2016 

Serial No. 114–139 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

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 .......................................................................................... 4 

Hon. Kathy Castor, a Representative in Congress from the State of Florida, 

opening statement ................................................................................................ 5 

Hon. Fred Upton, a Representative in Congress from the State of Michigan, 

prepared statement .............................................................................................. 84 

WITNESSES

John Neumann, Director, Natural Resources and Environment, Government 

Accountability Office ............................................................................................ 7 

Prepared statement .......................................................................................... 10 

Lawrence A. Tabak, Ph.D., Principal Deputy Director, National Institutes 

of Health ............................................................................................................... 24 

Prepared statement .......................................................................................... 26 

Stephan S. Monroe, Ph.D., Associate Director for Laboratory Science and 

Safety, Centers for Disease Control and Prevention, Department of Health 

and Human Services ............................................................................................ 32 

Prepared statement .......................................................................................... 34 

Segaran Pillai, Ph.D., Director, Office of Laboratory Science and Safety, Office 

of the Commissioner, Food and Drug Administration, Department of Health 

and Human Services ............................................................................................ 44 

Prepared statement .......................................................................................... 47 

Major General Brian C. Lein, Commander, Army Medical Research and Materiel Command, Biological Select Agents and Toxins Biosafety Program, 

Department of Defense ........................................................................................ 56 

Prepared statement .......................................................................................... 58 

SUBMITTED MATERIAL

Subcommittee exhibit binder 1

Subcommittee memorandum .................................................................................. 86 

Subcommittee memorandum supplement .............................................................. 94 

1The information has been retained in committee files and also is available at http:// 

docs.house.gov/Committee/Calendar/ByEvent.aspx?EventID=104823. 

(1) 

HOW SECURE ARE U.S. BIORESEARCH LABS? 

PREVENTING THE NEXT SAFETY LAPSE 

Wednesday, April 20, 2016 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The subcommittee met, pursuant to call, at 10:16 a.m., in room 

2122 Rayburn House Office Building, Hon. Tim Murphy (chairman 

of the subcommittee) presiding. 

Members present: Representatives Murphy, McKinley, Burgess, 

Griffith, Brooks, Mullin, Hudson, Castor, Kennedy, Green, and 

Welch. 

Staff present: Jen Barbian, Counsel, Oversight and Investigations; Rebecca Card, Assistant Press Secretary; Ryan Coble, 

Detailee, Oversight and Investigations; Paige Decker, Executive 

Assistant; Giulia Giannangeli, Legislative Clerk, Commerce, Manufacturing, and Trade; Brittany Havens, Legislative Associate, Oversight; Charles Ingebretson, Chief Counsel, Oversight and Investigations; Chris Santini, Policy Coordinator, Oversight and Investigations; Alan Slobodin, Deputy Chief Counsel, Oversight; Ryan 

Gottschall, Democratic GAO Detailee; Christopher Knauer, Democratic Oversight Staff Director; Una Lee, Democratic Chief Oversight Counsel; Elizabeth Letter, Democratic Professional Staff 

Member. 

OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA 

Mr. MURPHY. Good morning, and welcome to the Oversight and 

Investigation Subcommittee of Energy and Commerce hearing on 

‘‘How Secure are U.S. Bioresearch Labs: Preventing the Next Safety Lapse,’’ which I think I can dub ‘‘Overturning the Culture of 

Compliancy.’’ 

Because this is the third time in as many years that this subcommittee has held a hearing on the Federal Select Agent Program 

and the Federal Government’s high-containment laboratories. 

And each time, a panel of witnesses appear before us to testify 

about changes made in response to one failure or another. 

Two years ago, CDC Director Tom Frieden testified about 

changes made at the CDC after failing to follow safety procedures, 

which consequently potentially exposed dozens of CDC employees 

to anthrax. 

2 

Dr. Frieden told us then that the CDC was implementing every 

step possible to make sure that the problems are addressed comprehensively in order to protect our own workforce and to strengthen the culture of safety and to continue our work protecting Americans. 

And I might add that that echoed a statement he had made perhaps a year or so before on the same issue, saying that he was 

going to impose other things to change the culture. 

But last year, then, the Deputy Assistant Secretary of Defense 

for Chemical and Biological Defense came before us to explain how 

at least 192 labs across the world received live anthrax from the 

Dugway Proving Ground, an Army lab in Utah. The Army undertook a comprehensive review of the incident and the deputy secretary told us that the department was ‘‘committed to ensuring 

that this doesn’t occur again,’’ and that last statement is in quotes. 

Sweeping improvements and policy changes only work if the policies are effective and, in this area, past policy reviews have not 

brought about the changes necessary to improve safety. 

For that reason, Ms. DeGette and myself, along with Chairman 

Upton and Ranking Member Pallone, asked the GAO to evaluate 

the biosafety, biosecurity and oversight policies for the eight departments and 15 component agencies that own and operate the 

Federal Government’s high-containment laboratories. 

GAO has been issuing recommendations for years on the need for 

better policies and standards at high-containment labs, recommendations that have not been implemented. So the agency was 

well-positioned to receive our request. 

GAO found that while the departments and agencies have improved on their biosecurity procedures in recent years, comprehensive policies and better oversight of the labs are still needed. 

High-containment laboratories, which store the most dangerous 

pathogens, must have tight inventory control, rigorous training and 

required incidence reporting, and agencies and departments must 

have strong oversight of their laboratories with accountability for 

those who fail to follow the policies. 

While GAO has been doing its work, the committee has been conducting its own review into the discovery of smallpox vials at the 

NIH in 2014. The preliminary findings of the majority staff are discussed in a supplemental memorandum released yesterday. 

We found a number of flash points here where, if NIH or FDA 

had done just a little more than what their policies required or 

thought outside the box just a little bit, those agencies could have 

discovered the smallpox vials years earlier. 

For example, the NIH experienced a major event in 2011 when 

it learned that a researcher received an unauthorized transfer of 

antibiotic resistant plague specimens, and in 2012 when it discovered unregistered antibiotic-resistant anthrax included at an FDA 

lab in this very same building where the smallpox was discovered 

2 years later. 

The 2012 discovery was prompted by a disclosure of two investigators during a retraining exercise prompted by the 2011 discovery by the CDC’s Division of Select Agents and Toxins not by 

any investigative work on the part of the NIH and the 2012 disVerDate Mar 15 2010 10:30 Oct 17, 2016 Jkt 037690 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X139BIOLABSASKOK090616\114X139BIOLABSPDFMADE WAY
3 

covery resulted in the CDC putting NIH on a Performance Improvement Plan. 

These discoveries, including two different dangerous pathogens, 

should have spurred NIH and FDA to conduct a comprehensive 

sweep of all laboratories and a comprehensive review of its policies 

at the time. 

But they didn’t. When we informed NIH and FDA of our findings, we found agencies still reluctant to acknowledge the full extent of their failings. 

NIH did not even acknowledge its failings in how it registered 

into the Federal Select Agent Program, a historical collection of select agent samples held in sealed envelopes unopened since 1960. 

NIH registered the materials without opening the envelopes. The 

agency did not confirm the materials inside the envelopes or even 

verify that the samples were still secure, and they registered these 

materials not once, but twice, without opening the envelopes. 

When they finally did open the envelopes, they discovered seven 

additional vials of one select agent than previously reported. These 

failures just defy common sense. 

This is a culture of complacency, and it shows that it is not 

enough to change the policies. We must also change the culture at 

NIH. 

While the Department of Defense is holding 12 people accountable for the factors that led to the Dugway shipments, in contrast 

HHS and its agencies have not been fully accountable and transparent with the committee on disciplinary and personnel actions 

resulting from lab safety incidents. 

For example, the committee requested documents from the CDC 

as part of our investigation regarding the four instances of improperly stored anthrax at NIH. Unfortunately, the CDC produced redacted documents, blacking out key information. 

There was no legal basis for these redactions and CDC offered 

no explanation. This type of response is designed to delay and stymie congressional oversight on behalf of the American people and 

this committee will not stand for that. When we request documents, we expect unredacted documents. 

If these agencies are not being forthcoming with this committee 

and this Congress, then they are certainly not being forthcoming 

with the American people. For all the CDC rhetoric about transparency, redactions of key details in requested investigative documents prove otherwise. 

We all deserve better. Neither NIH nor FDA ever conducted an 

internal review of the smallpox incident along the lines of the reviews conducted by the CDC or the DoD, deferring instead to an 

outside review by the CDC and FBI. 

I urge these agencies to initiate internal reviews of their own 

failings leading up to the smallpox discovery and if we learn nothing from all of the incidents involving select agents over the years, 

it is that we can’t find the next safety lapse if we don’t go looking 

for it. 

[The prepared statement of Mr. Murphy follows:] 

4 

PREPARED STATEMENT OF HON. TIM MURPHY

This is the third time in as many years that this subcommittee has held a hearing 

on the Federal Select Agent Program and the Federal Government’s high-containment laboratories. Each time, a panel of witnesses appears before us to testify about 

changes made in response to one failure or another. 

Two years ago, CDC Director Tom Frieden testified about changes made at the 

CDC after failing to follow safety procedures potentially exposed dozens of CDC employees to anthrax. Dr. Frieden told us then that the CDC was implementing every 

step possible to ‘‘make sure that the problems are addressed comprehensively in 

order to protect our own workforce, and to strengthen the culture of safety, and to 

continue our work protecting Americans.’’ 

Last year, the Deputy Assistant Secretary of Defense for Chemical and Biological 

Defense came before us to explain how at least 192 labs across the world received 

live anthrax from the Dugway Proving Ground, an Army lab in Utah. The Army 

undertook a comprehensive review of the incident and the Deputy Secretary told us 

that the Department was ‘‘committed to ensuring that this doesn’t occur again.’’ 

Sweeping improvements and policy changes only work if the policies are effective. 

And, in this area, past policy reviews have not brought about the changes necessary 

to improve safety. For that reason, Ms. DeGette and myself, along with Chairman 

Upton and Ranking Member Pallone, asked the GAO to evaluate the biosafety, biosecurity, and oversight policies for the 8 departments and 15 component agencies 

that own and operate the Federal Government’s high-containment laboratories. 

GAO has been issuing recommendations for years on the need for better policies and 

standards at high-containment labs-recommendations that have not been implemented-so the agency was well-positioned to receive our request. 

GAO found that, while the departments and agencies have improved on their biosecurity policies in recent years, comprehensive policies and better oversight of the 

labs are still needed. High-containment laboratories, which store the most dangerous pathogens, must have tight inventory controls, rigorous training, and required incidence reporting. And agencies and departments must have strong oversight of their laboratories with accountability for those who fail to follow the policies. 

While GAO has been doing its work, the committee has been conducting its own 

review into the discovery of smallpox vials at the NIH in 2014. The preliminary 

findings of the majority staff are discussed in a supplemental memorandum released 

yesterday. We found a number of flash points where, if NIH or FDA had done just 

a little more than what their policies required, or thought outside the box just a 

little bit, those agencies could have discovered the smallpox vials years earlier. 

For example, the NIH experienced a major event in 2011, when it learned that 

a researcher received an unauthorized transfer of antibiotic resistant plague specimens, and in 2012, when it discovered unregistered, antibiotic resistant anthrax, including at an FDA lab in the very same building where the smallpox was discovered 

2 years later. The 2012 discovery was prompted by a disclosure of two investigators 

during a re-training exercise prompted by the 2011 discovery by the CDC’s Division 

of Select Agents and Toxins, not by any investigative work on the part of the NIH. 

And the 2012 discovery resulted in the CDC putting NIH on a Performance Improvement Plan. These discoveries, including two different dangerous pathogens, 

should have spurred NIH and FDA to conduct a comprehensive sweep of all laboratories, and a comprehensive review of its policies, at the time. But they didn’t. 

When we informed NIH and FDA of our findings, we found agencies still reluctant 

to acknowledge the full extent of their failings. NIH did not even acknowledge its 

failings in how it registered into the Federal Select Agent Program a historical collection of select agent samples held in sealed envelopes unopened since 1960. NIH 

registered the materials without opening the envelopes. The agency did not confirm 

the materials inside the envelopes, or even verify that the samples were still secure. 

And they registered these materials not once, but twice, without opening the envelopes. When they finally did open the envelopes, they discovered 7 additional vials 

of one select agent then previously reported. These failures defy common sense. This 

is a culture of complacency, and shows that it is not enough to change the policieswe must also change the culture at NIH. 

While the Department of Defense is holding 12 people accountable for the factors 

that led to the Dugway shipments, in contrast HHS and its agencies have not been 

fully accountable and transparent with the committee on disciplinary and personnel 

actions resulting from lab safety incidents. For example, the committee requested 

documents from the CDC as part of our investigation regarding the four instances 

of improperly stored anthrax at NIH. Unfortunately, the CDC produced redacted 

documents, blacking out key information. There was no legal basis for these 

5 

redactions, and CDC offered no explanation. This type of response is designed to 

delay and stymie Congressional oversight on behalf of the American people. When 

we request documents, we expect unredacted documents. If these agencies are not 

being forthcoming with Congress, then they are certainly not being forthcoming 

with the American people. For all the CDC rhetoric about transparency, redactions 

of key details in requested investigative documents prove otherwise. We all deserve 

better. 

Neither NIH nor FDA ever conducted an internal review of the smallpox incident 

along the lines of the reviews conducted by the CDC or the DOD, deferring instead 

to an outside review by the CDC and FBI. I urge these agencies to initiate internal 

reviews of their own failings leading up to the smallpox discovery. If we’ve learned 

nothing from all of the incidents involving select agents over the years, it is that 

we can’t find the next safety lapse if we don’t go looking for it. 

Mr. MURPHY. I now recognize the ranking member pro tem, Ms. 

Castor, for her opening. 

OPENING STATEMENT OF HON. KATHY CASTOR, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF FLORIDA 

Ms. CASTOR. Well, thank you, Mr. Chairman, for calling this important hearing, and welcome to our witnesses today. 

The House Energy and Commerce Committee has been monitoring high-containment biolabs and the select agent program for 

nearly a decade and I believe that it is vital that we continue our 

oversight of these critical programs. 

The committee held a hearing earlier this year about the importance of biodefense preparedness and we know that high-containment laboratories play a valuable role in that effort by conducting 

research, to improve our defenses against biological attacks and 

strengthening our response capabilities. 

The Federal Government’s work on identifying and containing 

public health risks from these type of biological agents is essential 

but it also poses many risks. 

Everyone has been disturbed by the news of accidental releases 

or transfers of select agents such as anthrax, ebola and avian flu 

over the past few years. These incidents raise broader questions 

about the safety of our high-containment laboratories across the 

country. 

And while I’m encouraged that no one has fallen ill as a result 

of those incidents, these pathogens need to be handled with the utmost safety and security. They could be extremely dangerous if 

they fell into the wrong hands or if infection spread to the general 

public. 

The labs that handle these dangerous pathogens must be held to 

the highest standards. Yet, these recent incidents raise questions 

about whether or not we can trust high-containment labs to safely 

handle select agents and other dangerous pathogens. 

I want to understand what these recent lapses can teach us 

about broader problems within the agencies and departments that 

handle select agents across the Federal Government as well within 

the private sector. 

So we’ve asked the GAO to appear before us today to testify 

about their latest report on the need for up to date policies and 

stronger oversight mechanisms at our high-containment labs. 

I look forward to hearing from you about your findings and recommendations and how they can be used to enhance safety and security at all of our nation’s high-containment labs. 

6 

This GAO report underscores the need to strengthen our Federal 

oversight of labs that are working with dangerous pathogens. I also 

want to hear from witnesses about the role that Congress can play 

in making sure this program operates safely and without more of 

the operational lapses that seem all too common for such a serious 

program. 

Is the current regulatory framework sufficient? Do the enforcement agencies have sufficient resources to ensure that oversight is 

robust? What are the agencies in front of us doing to improve their 

labs and prevent future incidents? 

I look forward to hearing your testimony and I yield back. 

Mr. MURPHY. Gentlelady yields back. Is there anyone on our side 

who wants to make an opening statement? And I guess there’s no 

one else on your side either, just want to read your statement 

again. 

To the panel, there was another hearing going on at Energy and 

Commerce in which two subcommittees are—many of us are on 

both, so you may see people coming and going. 

I may stay here for the whole thing because I want to hear. This 

is just so you’re aware. It may look a little chaotic at times, but 

that’s how it is. 

I ask unanimous consent that members’ written opening statements from other members be introduced in the record, and without objection the documents will be entered into the record. 

Now let me introduce today’s panel. First witness on today’s 

panel is Mr. John Neumann, director of natural resources and environment at the Government Accountability Office. 

He currently leads efforts in the science and technology area including the management and oversight of Federal research and development programs and we appreciate this time today. 

We’d also like to welcome Dr. Lawrence Tabak, principal deputy 

director with the National Institute of Health. He previously served 

as the acting principal director of NIH in 2009. We look forward 

to hearing his insights. Good to see you again, Doctor. 

Dr. Stephen Monroe serves as the associate director for laboratory science and safety at Centers for Disease Control and Prevention. Previously, he was the acting associate director for the Laboratory of Science and Safety. 

We look forward to learning from his expertise today on today’s 

hearing and thank you for being here. 

Dr. Segaran Pillai serves as director of the Office of Laboratory 

Science and Safety, the director of the Office of Commissioner and 

director of the Office of Chief Scientist at the Food and Drug Administration, and look forward to hearing your insights as well. 

And finally, we welcome Major General Brian Lein, Commanding 

General, U.S. Army Medical Research and Materiel Command in 

Fort Detrick and Deputy for Medical Systems to the Assistant Secretary of the Army for Acquisition, Logistics and Technology, Department of the Army at the U.S. Department of Defense. Appreciate you being here today. I believe Eisenhower was a logistics 

guy, too. Good for you. Good work. 

Well, to all of you today, you are aware that the committee is 

holding an investigative hearing. When doing so it’s the practice of 

7 

taking testimony under oath. Do any of you have any objections to 

testifying under oath? 

Seeing no objections, the chair then advises you that under the 

rules of the House and the rules of the committee you are entitled 

to be advised by counsel. Do any of you desire to be advised by 

counsel today? 

And seeing no request for that, in that case would you all please 

rise and raise your right hand and I’ll swear you in. 

[Witnesses sworn.] 

Mr. MURPHY. Thank you. You may all be seated. 

You are now all under oath and subject to the penalties set forth 

in Title 18 Section 1001 of the United States Code. I call upon you 

each to give a 5-minute opening statement. 

In so doing, make sure your microphone is on, pull it as close to 

you as possible when you speak into it, and if you can see the red 

light on the table—when that goes on, your 5 minutes is up. 

Can I just have yourself about 2 or 3 inches from the microphone? You have to pull it really close. Bring it close to your 

mouth. Thank you very much. You may begin, Mr. Neumann. 

STATEMENTS OF JOHN NEUMANN, DIRECTOR, NATURAL RESOURCES AND ENVIRONMENT, GOVERNMENT ACCOUNTABILITY OFFICE; LAWRENCE A. TABAK, PH.D., PRINCIPAL 

DEPUTY DIRECTOR, NATIONAL INSTITUTES OF HEALTH; 

STEPHAN S. MONROE, PH.D., ASSOCIATE DIRECTOR FOR 

LABORATORY SCIENCE AND SAFETY, CENTERS FOR DISEASE CONTROL AND PREVENTION, DEPARTMENT OF 

HEALTH AND HUMAN SERVICES; SEGARAN PILLAI, PH.D., DIRECTOR, OFFICE OF LABORATORY SCIENCE AND SAFETY, 

OFFICE OF THE COMMISSIONER, FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; 

MAJOR GENERAL BRIAN C. LEIN, COMMANDER, ARMY MEDICAL RESEARCH AND MATERIEL COMMAND, BIOLOGICAL 

SELECT AGENTS AND TOXINS BIOSAFETY PROGRAM, DEPARTMENT OF DEFENSE 

STATEMENT OF JOHN NEUMANN 

Mr. NEUMANN. I want to thank you, Chairman Murphy and 

Ranking Member DeGette and members of the subcommittee, for 

inviting me here today to discuss GAO’s report on the oversight of 

high-containment laboratories, which was publicly released for this 

hearing. 

Over the last 2 years, safety lapses at Federal high-containment 

laboratories have raised concerns about department and agency 

oversight of these facilities. 

These labs work with hazardous biological agents such as the 

virus that causes smallpox, a contagious and sometimes fatal infectious disease to humans, as well as live anthrax bacteria which has 

the potential to seriously threaten both human and animal health. 

High-containment labs do important work with pathogens such 

as developing vaccines and counter measures and conducting research to understand emerging infectious diseases. 

However, some of these pathogens also have the potential for 

high-consequence accidents if handled improperly. Today, I would 

like to briefly highlight the findings from our report. 

8 

First, we found that most of the eight departments and 15 agencies with high-containment labs do not have comprehensive or up 

to date policies. 

We considered policies to be comprehensive if they included the 

following six key elements for managing pathogens in high-containment labs, the first one being incident reporting, inventory control, 

inspections, clear roles and responsibilities, training and adherence 

to the leading biosafety guidance for laboratories published by CDC 

and NIH. 

While departments and agencies had policies in place, as I noted 

most were not comprehensive, meaning that they did not include 

all these elements. 

In addition, some policies were not up to date as they had not 

been reviewed and updated in accordance with their internal review schedules and in some cases these policies had not been reviewed in close to 10 years. 

These policies and the six key elements are an important foundation for lab safety. But policies alone will not ensure the lab personnel are adhering to them. This brings me to our second finding. 

Most of the department’s agencies were using inspections or audits as a primary way of overseeing their high-containment labs. 

But they were often not routinely reporting inspection results to 

senior officials. 

Getting these inspection results to senior officials is important 

because these results can be used to identify trends and systemic 

safety issues and ensure that needed improvements are made 

across all the labs. 

Finally, at the time of our review, DoD and HHS were making 

some progress in implementing recommendations from previous 

laboratory safety reviews that they conducted after the 2014 and 

2015 safety lapses. 

However, we found that DoD and CDC had not developed time 

frames for implementing some of these recommendations and without time frames DoD and CDC will be limited in their ability to 

track progress towards implementing these needed improvements. 

We made a total of 33 recommendations to the Federal departments and agencies with these high-containment labs to ensure 

that they have comprehensive and up to date policies as well as 

stronger oversight mechanisms at their labs. 

There was brought agreement by the eight departments with our 

recommendations and several have already begun taking actions to 

address them. 

In closing, I would like to note that our report that we are discussing today is the latest in a body of work that GAO has developed over the last 10 years on the Federal oversight of high-containment laboratories. 

We continue to monitor this issue by drawing on expertise from 

across our agency including our health care experts, our chief scientists and experts from my own group, the science and technology 

area. 

As you know, we are conducting additional work for the subcommittee specifically looking at the inactivation of pathogens in 

high-containment labs and we expect to issue that report to you in 

the next several months. 

9 

Thank you, Chairman Murphy, and members of the subcommittee for holding this hearing and continuing your oversight 

of this important issue. 

This concludes my prepared remarks. I would be pleased to respond to any questions you may have. 

[The statement of Mr. Neumann follows:] 

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Mr. MURPHY. Thank you, Mr. Neumann. 

Dr. Tabak, you’re recognized for 5 minutes. Again, pull the 

microphone very close to you so we can hear. 

STATEMENT OF LAWRENCE A. TABAK 

Dr. TABAK. Good morning, Mr. Chairman, Ranking Member Castor and distinguished members of the subcommittee. It is an honor 

to appear before you today to discuss how the NIH implements biosafety and biosecurity measures for high-containment laboratories. 

I know I speak for Dr. Collins when I say that our concerns for 

safety must equal our passion for research. I can attest that senior 

leadership at the NIH is committed to the principle that safety 

lapses provide concrete opportunities for thorough critical self-assessment and self-improvement. 

NIH has an important mission to conduct research that will lead 

to the development of treatments, diagnostics and vaccines to address public health needs including medical counter measures. 

The study of biologic-select agents and toxins is necessary to develop new interventions with the potential to save millions of lives. 

NIH also recognizes the importance of ensuring that the research 

is conducted in the safest manner possible. 

In the summer of 2014, six sealed decades-old ampules of smallpox were found in a cold storage room in an FDA laboratory building located on the NIH campus. The presence of smallpox was 

alarming to the entire NIH community and initiated much action 

on the part of NIH leadership. 

Upon making this discovery, all of the proper notifications and 

security steps were taken. The CDC and the FBI were contacted 

and joint custody of the ampules was transferred to the CDC. 

NIH has established protocols and procedures which included 

proper training regarding select agent handling ensured that at no 

time was anyone on campus or the public at risk. 

NIH takes this incident very seriously and we have implemented 

new policies and procedures to prevent such an event from occurring again. 

First, NIH identified and inventoried all potential hazardous biological material stored in all NIH-owned and leased facilities. During this sweep, which took place from July through September 

2014, nearly 35 million samples were inventoried. 

Additionally, NIH and other Federal agencies launched a National biosafety stewardship month. Extramurally funded institutions were asked to voluntarily join the Federal laboratories and 

reviewing their procedures, training and inventories of infectious 

agents and toxins. 

Longer term, NIH has strengthened our inventory management 

controls. We have developed and implemented the potentially hazardous biological material management plan which addresses accountability at all levels of NIH. The plan establishes a mandatory 

centralized database of all potentially hazardous biological materials as well as procedures for annual updates of inventories and 

random audits of laboratories’ hazardous biological holdings. 

Each institute and center was required to appoint an individual 

to be responsible for common shared use and storage areas and 

25 

there are new policies in place requiring participation of personnel 

who work in secure select agent laboratories. 

In February 2015, the external laboratory safety work group to 

the CDC advisory committee to the director reviewed our policies 

and practices. 

The ELSW affirmed that NIH’s response to the discovery of 

smallpox was prototypical and that NIH had implemented all of 

the recommendations made. The report states, and I quote, ‘‘The 

NIH intramural DOHS program is a model program for institutions supporting extramural NIH research as well as for other institutions and agencies.’’ 

The GAO review of high-containment laboratories that we meet 

here today to discuss found NIH’s policies for laboratory management to be comprehensive. NIH implemented all of the GAO’s recommendations and we addressed all of the six elements that the 

GAO identified as being key. 

In closing, as principal deputy director of the NIH, I can assure 

this subcommittee that the senior leadership at NIH took appropriate action in 2014 and continues to act today to ensure the safety of the public and the scientist whose mission it is to find new 

ways to enhance health, lengthen life and reduce illness and disability. 

We remain committed to preserving the public’s trust and NIHsupported research activities through best safety practices and 

strong leadership. 

Thank you, Mr. Chairman. 

[The statement of Dr. Tabak follows:] 

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Mr. MURPHY. Thank you. 

Before I recognize Dr. Monroe, I just want to clarify something 

I think was admitted from your testimony. The six sealed decadesold ampules of smallpox were found and two of those were viable. 

Am I correct? 

Dr. TABAK. That was discovered afterwards, yes. 

Mr. MURPHY. OK. But that was left out. I think that’s critical for 

your testimony and I hope you would amend it to say that they 

were still alive. 

Dr. Monroe, you are recognized for 5 minutes, please. 

STATEMENT OF STEPHAN S. MONROE 

Dr. MONROE. Good morning, Chairman Murphy, Representative 

Castor, other members of the subcommittee. Thank you for the opportunity to testify before you today on CDC’s ongoing effort to 

strengthen the quality and safety of our laboratories. 

I’m Dr. Steve Monroe, associate director for laboratory science 

and safety at CDC. In this new position, I serve as the single point 

of accountability for laboratory science and safety and I report directly to the CDC director, Tom Frieden. 

I come to this role with 29 years of experience as a microbiologist 

at the agency. CDC laboratories remain an indispensable link in 

protecting the public’s health. 

Recently, we were pleased to welcome Chairman Murphy to our 

NIOSH facility in Pittsburgh and Ranking Member DeGette to our 

vector-borne diseases facility in Colorado where she saw first hand 

our frontline laboratory staff working 24/7 to address the ongoing 

Zika crisis. 

Ensuring that all our laboratory work is performed with the utmost commitment to quality and to the safety of our workers and 

the community is and will remain of top priority for the agency. 

In July 2014, Dr. Frieden testified before this subcommittee in 

the wake of a number of unacceptable safety incidents at CDC laboratories. Following the incident, CDC received multiple rigorous 

reviews of the agency’s laboratory safety practices. 

We continue to implement and track progress on each of the 

more than 200 recommendations we received through that process. 

While more work remains to be done, the progress made to date 

has been significant, particularly in CDC’s laboratory oversight 

structure and approach. 

My office oversees safety at all CDC laboratories. This includes 

overseeing our select agent compliance but it’s distinct from CDC’s 

Division of Select Agents and Toxins, which along with USDA regulates laboratories as part of the Federal select agent program. 

My office ensures that CDC complies with select agent regulations in our own laboratories but it does not have authority over 

and is not involved in overseeing or enforcing the Federal select 

agency program. 

An integral part of our reforms has been to foster a culture of 

safety in CDC’s laboratories. Transparency and reporting are fundamental to such a culture. 

One of my first acts in this role was to issue an agency wide 

memorandum to reiterate CDC’s requirement for staff to report all 

safety issues and to provide clear direction on how to do so. 

33 

Another key achievement was the creation of the Laboratory 

Safety Review Board which is reviewing and approving all protocols from the transfer of biological materials out of BSL–3 and 

BSL–4 high-containment laboratories, a key issue identified in the 

2014 incident. 

CDC also established the laboratory leadership service, a fellowship program that prepares early career scientists to become future 

laboratory leaders. 

Finally, CDC is committed to advancing the science of safety, applying the same rigorous scientific methods to laboratory safety 

that we use to confront threats to the public’s health. 

Last month, my office launched an intramural research fund to 

support agency laboratories in pursuing innovative solutions to laboratory safety challenges. 

Last month, we saw a test of CDC’s new laboratory oversight 

structure when a CDC worker was diagnosed with a salmonella infection that was likely acquired from their work in a CDC BSL– 

2 laboratory. 

The worker has fully recovered and no other people appear to 

have been exposed. While the exposure should not have happened, 

CDC responded to this incident with urgency and transparency. 

We will continue to strive to prevent incidents from happening. 

But if they do, we will do everything we can to identify and address 

the factor that contribute to the incident and do so swiftly, comprehensively and openly. 

GAO’s report on high-containment laboratories provides additional and valuable feedback on areas where CDC is succeeding 

and where continued improvements are required. 

We already hard at work to address the issues GAO highlighted 

including finalizing our time lines for the remaining safety recommendations and working with HHS and our sister agencies on 

the Biosafety and Biosecurity Coordinating Council which will address some of the policies called for by GAO. 

For CDC, laboratory safety is not a singular objective that can 

be checked off once completed. Rather, it is an ongoing commitment 

to a healthy and functioning culture of safety where monitoring 

and reporting are valued, issues are rapidly and openly addressed 

and efficient systems are in place to prevent a safety issue from becoming a safety incident. 

Since Dr. Frieden testified before this subcommittee, CDC has 

made great progress in advancing this culture of safety at our laboratories. But more work remains to be done. 

While the risks of working with these pathogens can never be 

completely eliminated, we will continue to reduce risks wherever 

possible. This includes diligently working to address the recommendations from the GAO. 

Thank you for the opportunity to testify and I would be glad to 

answer any questions you may have. 

[The statement of Dr. Monroe follows:] 

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Mr. MURPHY. Thank you, Dr. Monroe. 

Dr. Pillai, you’re recognized for 5 minutes. Turn the microphone 

on and bring it up very close to you, please. Even closer. Get a lot 

closer. That’s good. 

STATEMENT OF SEGARAN PILLAI 

Dr. PILLAI. Good morning, Chairman Murphy, Ranking Member 

Castor and members of the subcommittee. I’m Dr. Segaran Pillai, 

director of the Office of Laboratory Science and Safety within the 

Office of the Commissioner at the FDA within the Department of 

Health and Human Services. 

Thank you for the opportunity to appear before you today to discuss FDA’s efforts to ensure the safety and security of our laboratories and the people who work in them. FDA’s laboratories provide 

a critical role in fulfilling FDA’s regulatory mission. 

FDA’s laboratories, like all laboratories, must comply with all applicable Federal, State, and local safety requirements. 

To ensure this, the agency is deeply committed to ensuring compliance with relevant laws and regulations through a combination 

of training, issuance of specific policies and procedures, appropriate 

oversight by the safety offices in the centers and by fostering an 

agency wide culture of safety and security in our laboratories. 

Upon discovery of the vials of Variola at an FDA laboratory located on the NIH campus in July of 2014, the FDA commissioner 

established the Laboratory Safety Practices and Policy working 

group. 

The goal of the work group was to lead a careful and deliberate 

review of FDA’s biosafety and biosecurity programs and to identify 

and implement methods to improve laboratory safety practices 

across the agency. 

One of the first key actions of the working group was to complete 

a clean sweep, a full visual audit of all storage areas and laboratories. The vast majority of the FDA’s roughly 670,000 vials of samples were properly stored. 

However, there were two instances where select agents were improperly stored in secured locations. In both cases, the CDC’s division for select agents and toxins was notified and the materials 

were destroyed. 

In May of 2015 members of the advisory committee to the director of CDC’s External Laboratory Safety working group conducted 

a thorough onsite review of the FDA’s laboratory safety policies 

and procedures. 

During this three-day visit, the work group met with key FDA 

officials to discuss the circumstances surrounding the discovery of 

the Variola samples on the NIH campus and review the policy elements of biosecurity and inventory control, laboratory safety training programs, laboratory security operations as well as the compliance programs. 

The resulting report released in July the 10th, 2015 contained 

eight observations that included a total of 30 recommendations. We 

have implemented many of those recommendations and are making 

steady progress on the remaining recommendations that resulted 

from the review in order to build and strengthen FDA’s comprehensive laboratory safety and security program. 

45 

In addition, FDA continues to work diligently to centralize appropriate laboratory safety practices including standardizing policies, 

procedures and defining inventory policies and audit procedures. 

To gauge the cultural safety at FDA, we held a series of 13 focus 

groups with laboratory staff throughout the agency. The focus of 

the focus groups was to raise safety awareness and identify trends 

and risk areas. 

Accountability, safety culture, communication and training were 

identified at critical areas by the focus groups. One of the key findings was in general staff was not afraid of reprisal if they were to 

report safety-related issues or concerns. 

FDA is also planning additional ways to engage laboratory staff 

in a variety of settings including focus groups, town hall meetings 

and other forums to provide a positive and productive outlet for 

employees to communicate their thoughts and ideas for improving 

safety and security at the FDA laboratories. 

An integral way to promote cultural safety and security and ensure compliance with legal and regulatory requirements is through 

training. FDA is in the process of implementing a core curriculum 

for biosafety and biosecurity training for all FDA personnel working in the biomedical research laboratories. 

This cross cutting agency work safety training program will instill and strengthen a culture of safety and compliance throughout 

the agency. 

In addition to the above, FDA also issued a new agency wide inventory control and management policy for biological agents and 

toxins. 

Using a central electronic inventory control and management 

system will allow the agency to provide efficient oversight of all biological agents and toxins located at the centers and offices. 

The recommendations from both the Laboratory Safety working 

group and GAO reports further validates our strategic approach 

and provides essential feedback for FDA as we continue to enhance 

our laboratory safety and security practices and policies. 

The Government Accounting Offices reported that as of December 2015, FDA has met five of the six elements and policies for 

managing biological agents in the high-containment laboratories. 

Although FDA’s currently policy did not provide for laboratory 

incidents to be reported to the senior agency officials, incident reporting does occur within each of the FDA centers and offices and 

an analysis of the root cause is performed annually. 

I’m also working closely with the FDA’s safety offices to develop 

a more comprehensive reporting mechanism to capture laboratory 

accidents, incidents, near misses and laboratory-acquired infections. 

This new reporting mechanism will be implemented in the coming months and will require all centers and offices to report all 

such events to my office. 

The FDA’s Office of Laboratory Science and Safety will establish 

an official FDA wide policy and work with the HHS biosafety and 

biosecurity coordinating council to recommend appropriate criteria 

and procedures for reporting incidents to the HHS leadership in a 

timely manner. 

46 

Since the discovery of the vials of Variola, FDA senior officials 

have taken direct and definitive actions to improve FDA’s laboratory safety and security policies, practices and to foster a culture 

of safety and security across the agency. 

I want to assure you that FDA stands fully committed to enhancing the safety and security to protect both our staff and the public. 

No regulations or guidelines can ensure safe—— 

Mr. MURPHY. I need you to conclude because you’re about a 

minute and a half over. 

Dr. PILLAI [continuing]. Applied toward daily activities. Individuals and organizational commitment to the cultural safety influences all aspects of safe and secure laboratory practices. 

This includes a willingness to report incidents and concerns, 

apply lessons learned and ensure timely communications of potential risk as well as the ability to respond to an incident judiciously. 

Mr. MURPHY. Thank you. 

Dr. PILLAI. Safety in the laboratory involves experience and 

knowledge gained over time and how to recognize and minimize 

risk and control assets. As we share and apply this critical knowledge to our daily activities we are confident that the level of risk 

will decrease and the goal of reducing risk to the lowest possible 

level. 

Thank you very much for—— 

Mr. MURPHY. Thank you. 

Dr. PILLAI. I’ll be happy to answer any questions. 

[The statement of Dr. Pillai follows:] 

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Mr. MURPHY. General Lein, you’re recognized for 5 minutes. 

STATEMENT OF BRIAN C. LEIN 

MG LEIN. Good morning, Chairman Murphy, Ranking Member 

Castor, distinguished members of the subcommittee. Thank you for 

the opportunity to update you on the Department of Defense’s actions taken to address the development, implementation and valid 

oversight policy and procedures for the safe handling and transfer 

of biologic select agents and toxins. 

Eight DoD labs work with these agents with the primary focus 

on developing medical counter measures, vaccines and drugs as 

well as diagnostic devices to protect our forces. 

I’m the commanding general of the U.S. Army medical research 

and material command and in support of the surgeon general of 

the Army as the DoD executive agent and responsible official for 

the BSAT. 

In this role, I am responsible for harmonization of policy, technical review and inspection guidelines throughout the Department 

of Defense. I will detail the actions that have been taken, the current work and the plan for the future since we first learned of the 

anthrax shipments incidents in March of 2015. 

Immediately after the notification the deputy secretary of defense 

issued a moratorium on BSAT production and shipments to allow 

for a thorough investigation, review of potential problems and to 

ensure the safety of our laboratory personnel. 

Additionally, the deputy secretary of defense designated the secretary of the Army as the executive agent for DoD BSAT biosafety 

program. The director of the Army staff also directed a full accountability review of the life sciences division of Dugway Proving 

Grounds. 

And finally, the secretary of the Army also directed the establishment of a biosafety task force to develop recommendations and implement necessary changes to ensure the long-term safety and security of the Department of Defense BSAT program. 

The end result of all of these actions led to a critical reorganization of oversight responsibilities, accountability, inspections and 

implemented new policies and procedures which are detailed in the 

written testimony. 

In December of 2015 the investigating officer for the incident at 

the life sciences division of Dugway concluded that the inadvertent 

shipment of viable bacillus anthracis is a serious breach of regulations. A copy of this report has been previously made available to 

the committee. 

The report included several recommendations including scientific 

recommendations, institutional recommendations and recommendations to hold individuals accountable for the failure to take action 

in response to mishaps, failure to execute oversight and ensure 

compliance with protocols and regulations and failure to exercise 

care in the performance of their duties. 

All personnel actions as a result of the investigation are currently being addressed at the appropriate level of command. I am 

pleased to report that the biosafety task force capitalized on the 

best subject matter experts inside and outside the Department of 

Defense to adopt science-based policies and proven management 

57 

procedures for the military services to operate in a safe and secure 

manner for the foreseeable future. 

The task force developed four significant recommendations to ensure the long-term safety and security of the biologic select agents 

and toxins program. 

We anticipate that by March of 2017 all the recommendations 

will be in place. The anthrax inactivation study will be completed 

and shared with all other Federal agencies. 

The BSAT biosafety program office will be fully staffed and operational. The biosafety scientific peer review panel and the integrated IT solution for tracking and inventorying all BSAT samples 

will be implemented. 

Establishing strong and robust processes that are continually 

evaluated and improved is our best defense against potential 

human error or management lapses. 

We believe the systems we are developing will provide the necessary checks and balances to prevent or minimize the impacts of 

future accidental and human or procedural missteps. 

We recognize that quality policies and procedures do not stand 

alone. They must be incorporated with personnel training, evaluation, feedback followed by review, oversight, documentation and reporting in order to have a systematic approach to managing the 

successful and safe performance of these personnel and institutions. 

It is also necessary that we partner with other Federal and private organizations to ensure the transparency and the uniformity 

of this program. 

We are developing a system that incorporates these essential elements to continue the safety performance of this critical research 

and for the development of detection systems and counter measures. 

Finally, both accountability and a standardized inspection process are both critical to the success of this program. Both have undergone significant revision and centralization. 

Thank you for the opportunity to share our program with this 

committee. I look forward to answering any follow-on questions. 

[The statement of Major General Lein follows:] 

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Mr. MURPHY. Thank you. I recognize myself for 5 minutes. 

General, I see you have a parachutist badge on you there. I’m assuming you’ve jumped a few times. Did you pack your own parachute? 

MG LEIN. No, sir. 

Mr. MURPHY. Someone just said don’t worry about this? A 

stranger says, ‘‘here’s your parachute, everything’s fine’’? Did you 

doublecheck things? 

MG LEIN. Yes, sir. 

Mr. MURPHY. Absolutely. 

MG LEIN. That’s part of the JR—the prejump inspection that’s 

required—— 

Mr. MURPHY. Exactly. 

MG LEIN [continuing]. Not by you, just by you, but by—— 

Mr. MURPHY. By everybody, right? 

MG LEIN [continuing]. By your senior—— 

Mr. MURPHY. And I’m assuming also it’s standard in the military, someone hands you a weapon and says, ‘‘Don’t worry, it’s not 

loaded,’’ you check it anyways, right? 

MG LEIN. Yes, sir. 

Mr. MURPHY. So I go back to the thing, because it could be dangerous and you don’t want to jump without a parachute that works. 

So I go back to this omission, Doctor, and when I asked you to 

clarify this point of the six vials and two of them were alive they 

were treated as if they were not and you said oh, it was only later 

on it was discovered. 

That is the core of this hearing and why we keep coming back 

here, because you treated them as if they weren’t. And the fact is 

the way they were handled too they could have broken. We would 

have exposure of small pox. 

But this is what we mean about the culture of complacency. We 

just assume, oh, these couldn’t possibly be alive. You treat it like 

it’s a loaded gun. You treat it like it’s alive, and you didn’t. 

And even when I asked for a clarification, you once again said, 

‘‘Oh, we didn’t discover that until later.’’ That’s the point of this 

hearing, that you’re supposed to treat it as if it is. 

Now, let me talk about it, the NIH did not undertake an internal 

investigation of the root cause and circumstances that led to the 

boxes containing smallpox being overlooked apparently for decades, 

even though an international agreement and later Federal law and 

the regulations required the NIH to account for all smallpox vials 

in these facilities. 

Now, our understanding is that the NIH did not do the internal 

investigation because of the ongoing CDC and FBI investigation 

and the subsequent referral to HHS Office of Inspector General. Is 

that correct? 

Dr. TABAK. Yes, sir. 

Mr. MURPHY. However, in 2012 the NIH conducted an internal 

investigation into the improperly stored antibiotic-resistant anthrax incidence while the CDC was investigating. So the pending 

CDC investigation did not prevent the NIH from conducting an interim investigation into the improperly stored anthrax. Is that correct? You have to turn the microphone on and pull it close to you. 

69 

Dr. TABAK. We did conduct and investigation at that time to ascertain where the samples were derived from and who had the 

samples, and then subsequently reviewed samples from everybody 

who was a registered user of bacillus anthracis and then following 

that a survey of all investigators who were registered for select 

agents. 

Mr. MURPHY. We note you led a task force in 2015 to investigate 

the serious problems with NIH Clinical Center of Pharmaceutical 

Development section during an ongoing FDA investigation. 

So the pending FDA investigation did not prevent the NIH from 

conducting an internal investigation into the NIH PDS. Is that correct? 

Dr. TABAK. Yes, sir. 

Mr. MURPHY. Now, the Department of Defense launched their accountability investigation while the CDC and the FBI were still investigating those shipments of live anthrax from Dugway Proving 

Grounds. 

Since the DoD started their internal investigation during this 

pending investigation, why was it that the current—that NIH could 

have started all their internal investigations into the root causes 

back in July of 2014? Why couldn’t that be started back then? 

Dr. TABAK. It’s been our policy not to initiate investigations of 

this type while there’s an ongoing investigation from either the FBI 

and/or the IG. 

Mr. MURPHY. Why not? 

Dr. TABAK. We understand that we are not supposed to compromise those investigations in any way. 

Mr. MURPHY. DoD managed to do it. DoD said, hey, safety comes 

first, we’re checking into this. We’re kicking down doors. And you 

guys say, hey, let’s hold off on this, when you could have been investigating. 

Dr. TABAK. We held off on what has been termed the root cause 

analysis. But we did not stand by idly. We did in fact institute 

many additional procedures to enhance the safety of what we were 

doing. 

Mr. MURPHY. I don’t believe you, because we already established 

that in moving those smallpox vials you didn’t treat them as if they 

were live and even though you said this morning, well, we didn’t 

discover that until later, you should treat it as if it is alive. 

So in August of 2014, CDC Division of Select Agents and Toxins 

sent a memorandum to NIH detailing the findings of a joint CDC/ 

FBI investigation into the discover of the smallpox vials. 

At this point, the joint CDC/FBI investigation was over. So 

couldn’t the NIH have started their internal investigations based 

on the finding of this report and did you know about this report 

back in August of 2014? You’re still saying you couldn’t have done 

anything? 

Dr. TABAK. Again, it was an ongoing IG investigation and in fact 

we still have not been formally notified by the IG that that investigation is closed. 

Mr. MURPHY. Well, I’m out of time. I will turn it over to Ms. Castro for 5 minutes. 

Ms. CASTOR. After a number of the incidents involving anthrax 

and ebola and other dangerous pathogens it was very important for 

70 

this committee to ask the GAO to produce a detailed over view and 

report because when it comes to working with these deadly pathogens there simply is no room for error and rigorous safety policies 

must be followed. 

GAO looked at eight departments and 15 agencies to assess their 

high-containment lab policies and oversight. GAO’s report concludes that the majority of policies were not comprehensive and 

some were out of date or nonexistent. 

Mr. Neumann, could you walk us through this key finding and 

why having comprehensive and up to date policies is important? 

Mr. NEUMANN. Sure, I’d be happy to. 

Certainly, we know that there’s important research being done 

and, you know, when there’s a safety incidence it interferes with 

this research. 

So when you don’t have policies in place or procedures that ensure that those are being carried out it puts that research at risk 

and also puts personnel at risk. And what we found is that this 

comprehensive oversight was not in place. 

Some policies that would really help the foundation of the lab 

safety culture were not in place and furthermore there weren’t the 

oversight mechanisms that can ensure that these policies are being 

carried out. 

And then, finally, leadership was not informed of some key incidents and the inspection result was all important for ensuring that 

these labs are being overseen properly. 

Ms. CASTOR. OK. So let’s get more specific. Your report concluded 

that the departments and agencies are using inspections as their 

primary activity to oversee the management of hazardous biological 

materials. 

However, as you testified, some agencies do not routinely report 

the results of these inspections to senior officials. What issues are 

presented by this finding of incomplete information sharing? 

Mr. NEUMANN. Well, certainly, without having those inspection 

results or incident reports, leadership can’t determine if there’s systemic issues that need to be addressed across the labs. 

Ms. CASTOR. During your oversight and interviews, were all of 

the agencies forthcoming? Did they provide the materials you requested? Was there any resistance to providing any information to 

GAO? 

Mr. NEUMANN. No, all the agencies and departments complied 

with our request and we worked very closely with them to identify 

the policies and procedures. 

So we got great cooperation from the agencies. 

Ms. CASTOR. OK. General Lein, many think that in addition to 

all of these inspections and oversight and policies that one of the 

greatest risks we face is from theft or misuse of a deadly pathogen 

and we certainly had an incident of that at Fort Derrick in 2001. 

Tell us, since 2001 what have you done to strengthen all of your 

oversight and your ability to root out potential theft or misuse of 

deadly pathogens. 

MG LEIN. Ma’am, thank you. 

We’ve done several things in inventory management process with 

100 percent review of what’s in each one of the labs on an annual 

basis at the Research Institute of Infectious Disease. 

71 

Everybody that works in the lab has got to be vetted for security 

processes, coming to the lab and to work into the lab, and then recently we are completely redoing who it is and where it is that we 

ship all of our agents. 

So we used to have the critical re-agent program which was the 

process whereby external labs would get the information from us 

or get the samples from us. It did not have full accountability of 

all the systems and there were often labs that were able to—because of a direct contract were able to send. 

We have since shut that down, and after the moratorium was 

lifted everything will have to get requested through this new office 

with the requirement of a peer review before it even gets shipped 

out of ensuring that they need the highest level of toxin and why 

can’t we substitute a lesser level of toxin that can never be moved 

into a BSAT program. 

And so associated with that there will also be a use-by date like 

the carton of milk and that that specimen that we send out must 

be used by and then we must get a message back from the lab that 

we sent it to that it’s either used or they destroyed it or they’re returning the specimen back to us. 

So we maintain full accountability of all of the specimens that 

we’ve got within our program. 

Ms. CASTOR. I’d like to ask this—the CDC, Dr. Monroe, what 

policies and procedures are newly in place to prevent theft or misuse of deadly pathogen? 

Dr. MONROE. Thank you. First, I would emphasize that our laboratory safety review board, which reviews all the policies for inactivation and transfer of materials from our highest containment 

biosafety level three and four labs. 

Has looked at those policies both initially when they were initially released from the moratorium imposed by Dr. Frieden and 

then on an annual basis. And so we’ve come up now on having annual review of some of those procedures. 

Importantly, all of those procedures include a step that we we 

refer to as secondary verification. So as has been pointed out, it’s 

not only important to have the right policies but you have to show 

that there’s adherence to those policies. 

And by having the secondary verification step of either a second 

person watching or a time stamp or something that verifies that an 

activation procedure was done as described in the policy is a critical part of our inactivation policies for anything that’s brought out 

from high-containment to lower levels of containment. 

In terms of the personnel, we also, along with others, have instituted a so-called personnel suitability program for those that have 

access to the highest risk pathogens—the so-called tier one pathogens. 

Ms. CASTOR. Thank you. 

Mr. MURPHY. I have to follow up with you, Dr. Tabak, on just 

on that line of questioning about the timing of your own investigation. 

We were informed that CDC was recently notified by the HHS 

Office of Inspector General to close out all the NIH referrals, given 

that there’s no known pending potential investigation will the NIH 

now commit to conducting an internal investigation? 

72 

Dr. TABAK. Absolutely. 

Mr. MURPHY. Thank you. I now recognize Mr. McKinley, vice 

chairman of the committee. 

Mr. MCKINLEY. I thank you, Mr. Chairman. 

Mr. Neumann, if I could spend a little time on your report. 

You’ve got a chart on Page 5 of the six elements that you were referring to in compliance. 

I know that they’re not all the same in weight. So I don’t know 

which ones are more important than others in compliance. Would 

you suggest to us which are the ones that we should be spending 

more attention to of those six elements? 

Unless you’re going to tell me they’re all equal, which I doubt. 

Mr. NEUMANN. Well, I think we determined that there were 60 

elements. We didn’t weight them. But incident reporting is certainly one that has more immediate impact. If incidents are reported to senior leadership they can take action on the systemic 

issues that are identified. 

Mr. MCKINLEY. OK. If that’s number one, what would number 

two be? 

Mr. NEUMANN. Like I said, inventory control also is very important—— 

Mr. MCKINLEY. I understand. 

Mr. NEUMANN [continuing]. Because keeping track of the specimens. Each of these have their importance. Training, for example. 

Mr. MCKINLEY. Inventory control might be number two? 

Mr. NEUMANN. Excuse me? 

Mr. MCKINLEY. Inventory control might be number two? 

Mr. NEUMANN. In my mind, yes. Definitely there’s an important 

step. 

Mr. MCKINLEY. I’m just trying to understand not everything is 

going to be equal. So I’m trying to—for example, in your report you 

say that two of the agencies wouldn’t cooperate or said they didn’t 

think anything more was necessary—Department of Energy and 

the EPA. And I looked at your chart and I see the EPA under their 

pesticide program those are the two—number one and number 

two—in your mind that they’re not complying with and yet they 

think everything is copasetic. 

Mr. NEUMANN. Yes, and we disagreed with their position. 

Mr. MCKINLEY. Thank you. 

Do you disagree then with DoE as well? Because Doe also has 

numbers of violations as well in that. The others seem to think 

that they’re in compliance. 

Mr. NEUMANN. Yes, I think that we believe that these recommendations are important in establishing the foundation for the 

lab safety. 

Mr. MCKINLEY. Well, I think that if—what I’ve heard here a little bit is it sounds like everyone at the panel all thinks they’re in 

compliance, that everything is just fine. 

But I know in 2009 your department put together a report that 

said that there needs to be an oversight, someone to look over all 

the agencies. 

But that was rejected as being cumbersome and overly broad. Do 

you still think it’s cumbersome, overly broad? Or is it something 

that’s necessary, because you just heard the testimony. Everyone 

73 

thinks they’re in control. But there’s a real question in America 

whether they are. So what do you think? 

Mr. NEUMANN. Well, our recommendation still stands open. The 

one we made in 2009 was looking more broadly at all high-containment labs, not just the Federal labs. 

This report we focused on the Federal high-containment labs. 

But that recommendation we still openly stand by that. But there 

could be better oversight with a single entity to oversee all these 

labs given the fragmentated—— 

Mr. MCKINLEY. One of them that might help but I’m afraid of a 

software type thing is IV&V. Do you see how IV&V might have an 

impact here whereas the IV&V—I don’t want to suggest what I— 

you’re familiar with IV&V? 

Mr. NEUMANN. I’m not familiar with that, no. 

Mr. MCKINLEY. Independent verification and validation? 

Mr. NEUMANN. Oh, yes. Yes. Uh-huh. 

Mr. MCKINLEY. OK. NASA has been using it successfully ever 

since the rocket explosion. Others have used it. Unfortunately, the 

Obama administration chose not to use IV&V when they put out 

the registration and, you know, the computer system all collapsed 

under the registration. 

I don’t know whether that would help out. Would IV&V be of any 

help to these or is that just going to be checking the box? 

Mr. NEUMANN. Well, certainly, any type of verification is going 

to be useful. There needs to be a system of independent 

verification, inventory control, all these different steps to ensure 

that you have—— 

Mr. MCKINLEY. But would they just check the box, or if there’s 

no one overlooking their shoulder, who’s going to know that they’ve 

actually done something as a result of checking the box? 

Mr. NEUMANN. Well, that’s why the oversight mechanisms are so 

important that leadership be paying attention to the labs and ensuring that they’re being inspected and they’re reviewing the results of those inspections to see where there might be lapses. 

Mr. MCKINLEY. So in the time, is that something that perhaps 

you would—the GAO would look at as a recommendation that 

maybe IV&V should be implemented under each of these labs? 

Mr. NEUMANN. We didn’t look specifically at that but I think the 

leadership oversight is going to be really important to ensure that 

these mechanisms are actually operating, not just policies. 

Mr. MCKINLEY. My question is would you consider that in the future in looking at that to see whether or not there might—other 

agencies have found it to be very useful and I’m just wondering 

whether or not you see it from your perspective with the lab will 

they simply just use it to check the box and not do anything about 

it? 

Mr. NEUMANN. Well, I definitely would like to take some time to 

think that over. Perhaps we can provide a response for the record. 

Mr. MCKINLEY. If you would, please. And my time has expired 

so I thank you, Mr. Chairman. I yield back my time. 

Mr. MURPHY. Thank you. I now recognize Mr. Griffith of Virginia 

for 5 minutes. 

Mr. GRIFFITH. Thank you very much, Mr. Chairman. Thank you 

all for participating in this hearing today. 

74 

Dr. Tabak, I understand that the historical collection that contains the smallpox vials where there was a problem that had been 

previously discussed is not the only historical collection at NIH. 

In fact, in 2002 or 2003, NIH registered a historical collection 

that included plague and Burkholderia samples using the information listed on labels for sealed envelopes. Isn’t that correct? 

Dr. TABAK. Yes, sir. 

Mr. GRIFFITH. And did anyone at NIH open the envelopes at the 

time to check not only the accuracy of the samples but also to ensure that the samples were intact? 

Dr. TABAK. To my knowledge, they did not. 

Mr. GRIFFITH. And I also understand that in 2007 the NIH office 

responsible for overseeing compliance with select agent regulations 

reregistered these select agents again without opening the sealed 

envelopes. Isn’t that correct? 

Dr. TABAK. It is. The reason they did not open them at the time 

is that they were not registered to work with that particular agent 

in the laboratory where they were brought. 

Mr. GRIFFITH. So the individuals who were looking at it weren’t 

registered to deal with the plague or Burkholderia? 

Dr. TABAK. The laboratory was not registered and so they needed 

to file an amendment so that they could in fact work with those 

agents. 

Mr. GRIFFITH. OK. So they did that and then from my understanding in 2008 they finally opened the envelopes up and the materials contained were not the same as what had been registered 

back in 2002, 2003 with the select agent program twice earlier. 

They weren’t the same as had been previously registered and 

that one of the envelopes contained more vials of Burkholderia 

than was listed. Isn’t that accurate? 

Dr. TABAK. That is correct. It has been described to me as a clerical error that indeed they did know that there were 39 vials but 

unfortunately it was transcribed inaccurately, and so that’s my understanding of it. 

Mr. GRIFFITH. So there were 39 vials, but they had it written 

down as 32? 

Dr. TABAK. I may be misspeaking but, yes, there was a difference 

of, I believe, seven vials. 

Mr. GRIFFITH. Now, I was not—obviously, I’m familiar with the 

plague. I was not familiar with Burkholderia, and so I looked it up 

online. So my sources are Internet sources. They may or may not 

be accurate. 

So you get me straight if I’ve got it wrong. But it looks like it 

depicts mostly horses but there are a couple of species or subspecies of the bacteria that affect human beings. 

Do you know whether the samples that were discovered in 2008 

were the type of species of Burkholderia that affect horses or were 

they the type that affect humans? 

Dr. TABAK. I do not know the answer to that. 

Mr. GRIFFITH. And could you please find that out for us because 

in my research it indicated that at least two of the species not only 

affect humans but are considered possible agents for biological warfare? 

75 

Dr. TABAK. Indeed, and this is why they were treated as select 

agents and contained. But I will find out the answer for the record, 

sir. 

Mr. GRIFFITH. If you could let me know I would greatly appreciate that. Dr. Pillai—did I say it right? All right. 

And you’re now with the Office of Laboratory Science and Safety 

at the FDA and it’s a fairly new office. What is the budget for your 

office and how many staff do you have? 

Dr. PILLAI. So as you mentioned, it’s fairly a new office that we 

are trying to stand up at the current time. We have actually 

worked out this for the division and planned a mission for the office and have actually pulled together a budget and we have put 

in the budget request to our senior leadership, the Office of Operations, to the Office of the Commissioner, and both of those offices 

are working diligently to ensure that we get the necessary budget 

support needed to stand up the office. The request that we have proposed was $2.8 million to basically 

staff with 14 members to ensure that we can address all the safety 

and security-related issues at FDA. 

Mr. GRIFFITH. All right. And can you get us that once it’s been 

approved by the other folks? Can you get us a copy of that budget? 

Dr. PILLAI. Absolutely. 

Mr. GRIFFITH. I would appreciate that, and who is it that you report to? 

Dr. PILLAI. At the current time I report to the Office of the Chief 

Scientist and to the Commissioner through the Office of the chief 

scientist. The external laboratory safety working group’s recommendation was for this position to be a direct report to the commissioner. 

As you are fully aware, that we have a new commissioner on 

deck at the current time, Dr. Robert Califf. Dr. Califf is taking a 

look at all of the organizational structures at the current time and 

you’ll make a final call and decision as to what the department 

structure should be. 

Mr. GRIFFITH. All right. I do appreciate that. I see my time is up 

and I yield back. Thank you, sir. 

Mr. MURPHY. Thank you. I now recognize Mrs. Brooks for 5 minutes. 

Mrs. BROOKS. Thank you, Mr. Chairman. 

As the panelists might know, yesterday both NATO and the European Union intelligence officials indicated that there are, quote, 

‘‘justified concerns,’’ end quote, that ISIS is working on obtaining 

biological material needed to carry out an attack. 

With persistent analysis like this supporting the notion that terrorists are actively looking to acquire a weapon of mass destruction, I certainly hope that our Government will redouble our efforts 

in protecting sensitive materials from getting into the wrong 

hands. 

We also know that in October it was revealed that a 26-year-old 

Moroccan-born man who had worked in a sensitive area in a nuclear power plant in Belgium died in the spring while fighting for 

ISIS. 

This terrorist had passed a background check and had access to 

a secure area where the nuclear reactor is located. Obviously, it 

76 

can happen in the biological space as well. We shouldn’t forget that 

the perpetrator of the ’01 anthrax incident was a scientist who 

worked at the Government’s biodefense labs at Fort Derrick. 

I bring that up because we can have all the policies and procedures in place and we can have taken corrective actions and so 

forth. But I’m curious, Mr. Neumann, did you and GAO look at the 

security level of personnel in your report? 

Mr. NEUMANN. We did not. We looked at the policies we had in 

place to ensure that they had all these key elements. We looked at 

the oversight mechanisms to make sure they were checking them 

and we looked at—— 

Mrs. BROOKS. I understand that. But what about security and 

background checks? Why did you not look at security and background when it has to do with personnel actually following or not 

following these procedures? 

Mr. NEUMANN. This was a broad look at all the Federal departments and agencies or the eight departments and 50 agencies. So 

just getting a sense of their policy and procedures they have in 

place and the oversight mechanisms was quite a large volume of 

work. 

So we didn’t drill down in specific aspects of this. But that’s definitely an area that we could, you know, potentially follow up on if 

there’s interest in that. 

But it’s part of making sure that you have the checks and balances with the policies and the oversight mechanisms to make sure 

that all the policies are being followed. 

Mrs. BROOKS. And I certainly appreciate it and don’t want to 

take away from your work. But I do think that is of critical importance and I’m going to ask very briefly, because I have a different 

line of questioning for Dr. Tabak, but if you could please each agency indicate, and I may ask for the record, we may submit questions 

for the record with respect to what level of security clearances do 

your personnel have who have access to these deadly pathogens, 

how often are they cleared, because it’s very common for many 

agencies to have that clearance process when an individual comes 

in to an agency, but often maybe not checked on routinely every 

few years, and I’m curious about that, as well as what is the level 

of security clearance that the personnel must have. 

So I will be submitting those questions for the record for each of 

your agencies. I believe that Major General indicated that certainly 

people are vetted, and I assume that people are vetted within your 

agencies. 

But having been a former U.S. attorney and going through security background checks I’m very interested in knowing what level 

of security clearances all of the personnel that have any access. 

I’m not just talking about the scientists. I’m talking about all levels of personnel. I’m curious to know what level of background 

checks are performed. 

Dr. Tabak, I’m very curious to know because the majority staff 

investigation found that the National Cancer Institute of Frederick 

does not report to the NIH Safety Office on the main campus. Who 

does the safety officer at NCI Frederick report to? 

Dr. TABAK. Ultimately, to the director of the NCI. 

Mrs. BROOKS. Who do they directly report to? 

77 

Dr. TABAK. They report up to the scientific director of the NCI 

Frederick and then in turn that individual reports up to the director of the NCI who, of course, reports up to the director of NIH. 

Mrs. BROOKS. So is the NIH management of safety—is it centralized or is it decentralized across the various campuses? I’ve just 

visited your incredible campus. It’s a very, very large place. Is it 

decentralized or is it centralized? 

Dr. TABAK. In the case of the NCI Frederick they have this separate reporting chain. Everything else is centralized in one place. 

Mrs. BROOKS. And we heard from Mr. Neumann that—do you receive reports of select agent inspection results now? 

Dr. TABAK. I do indeed. 

Mrs. BROOKS. OK. Does Dr. Collins? 

Dr. TABAK. I notify Dr. Collins when there are variations—if 

there are issues that are problematic. 

Mrs. BROOKS. And we’ve heard that according to HHS comments 

and response to the GAO’s report, the associate director of research 

services is the designated agency safety and health official. Does 

this individual report to your or Dr. Collins about lab safety issues? 

Dr. TABAK. The responsible official reports through a chain of the 

director of division of occupational health services who reports to 

our director of the Office of Research Services who reports to our 

Deputy Director for Management, who in turn, you know, works 

through me to Dr. Collins. 

But each individual is required to move up the chain if the next 

person up does not respond for some reason and indeed when there 

are serious issues we are all immediately notified simultaneously. 

Mrs. BROOKS. OK. Thank you. I yield back. 

Mr. MURPHY. Just clarifying, Dr. Monroe, who do you report to? 

Dr. MONROE. I report directly to Dr. Tom Frieden, the CDC Director. 

Mr. MURPHY. OK. Thank you. 

I recognize Mr. Hudson for 5 minutes. 

Mr. HUDSON. Thank you, Mr. Chairman, and thank you to the 

panel for being here. 

Dr. Pillai, the NIH office that had the smallpox boxes was reassigned to the FDA in 1972. Why didn’t the FDA do any sort of inventory over the room when it was transferred to control at that 

point or at any time from 1972 to 2014. 

It seems to me that one simple inventory, something that businesses back in my district do every year, would have caught this 

mistake. 

Dr. PILLAI. I agree with you totally. I think this is one of the failure points that we have encountered for this incident. You know, 

one of the key points that I’d like to make is that by nature laboratory scientists, right, they tend to attend to the materials that belongs to them and they don’t really look into other people’s properties or materials and this is one of those areas where it was a 

shared laboratory storage cold room, basically. 

So there was no one single individual assigned to be responsible 

for the inventory or whatever was contained in that cold storage 

facility. 

Mr. HUDSON. Has that been changed now? 

78 

Dr. PILLAI. That’s been changed. What they’ve done is ever since 

this incidence has taken place we have actually assigned a single 

individual to be responsible for any cold storage areas that’s been 

shared by multiple scientists and all the materials in the cold storage must be labelled with the PI’s name along with the content and 

the date so that you can actually do a very simple easy inventory 

control process as to who it belongs to and what the contents are. 

Mr. HUDSON. Appreciate that answer. When we asked FDA why 

it failed to utilize proper inventory controls in the cold storage 

room we were told that this room is apparently not subject to inventory controls since there was no accountable Government property inside the cold storage room. 

Accountable Government property is a term that’s defined as all 

computers and pieces of equipment with a value of more than 

$5,000. But how could FDA know there’s no accountable Government property if they hadn’t done an inventory? 

Dr. PILLAI. That’s a very good point. In most cases, cold storage 

facilities actually are used to store reagents and supplies and 

things of that nature, which usually doesn’t amount to greater than 

$5,000. 

As such, there’s usually not a custodial individual assigned to the 

cold storage areas where you’re basically storing medias and things 

of that nature. This is one of those incidents that we do not anticipate such a problem to take place. 

We would have put in appropriate safety protocols and policies 

in place to address that. But this was a valuable lesson learned 

and we are looking forward to implementing the appropriate policies and procedures and managers can ensure that this doesn’t 

happen again. 

Mr. HUDSON. So your opinion now—any kind of critical reagent 

programs, they have a value of some $500 to $1,000 apiece. I mean, 

would, in your opinion, they now be considered this Government 

property that needs to be inventoried? I mean, has there been a 

change of mind set in terms of—instead of just making $5,000 and 

up we need to have an inventory of everything? 

Dr. PILLAI. I mean, talk about equipments and things of that nature—if you’re talking about an instrument and equipment and 

anything to the nature that is a custodial individual assigned to 

ensure the responsible—to ensure and be responsible for that particular property. 

When in the case of the cold room the situation is different 

whereby what we are doing is we are getting a full inventory control of what the contents are. 

This is where you usually store biological materials as well as 

freezes and things of that nature. So we have implemented a policy 

at FDA to have a full inventory control of all the biological agents, 

not just the BSL–3 agents but also the risk two agents as well as 

the risk three agents. 

So now we have a full account of every materials where they are 

stored, the location, who it belongs to and every time an individual 

takes the material for work to work on it or to add a new agent 

to the list, they update that information on a daily basis. 

So this will allow us to control this select agents and high consequence pathogens in a much more efficient manner. 

79 

Mr. HUDSON. So just to clarify, so going forward, vials of biological pathogens are no longer not considered important enough to be 

inventoried or as an accountable Government property there’s no 

discrepancy now? 

Is that what you’re telling me in terms of having a dollar 

amount? If it’s a pathogen, it’s going to be inventoried? 

Dr. PILLAI. That’s right. If it’s a high-consequence pathogen or it 

is a hazardous biological agents and toxins it will be in the inventoried. 

Mr. HUDSON. OK. Thank you for that. 

Mr. Chairman, I see I’m running out of time. I’ll go ahead and 

yield back. 

Mr. MURPHY. If I could just take the last few seconds, let me ask 

the panel here, except for DoD: So within this, given all the sweeps 

that you’ve done are there any more orphan pathogens of any kind 

that are not identified who they’re with? 

Dr. Tabak, are there any more? You’ve done all these sweeps. Everything has been checked. Is there any more vial samples, anything that you don’t know where it’s come from, who it belongs to? 

Dr. TABAK. Not to our knowledge. 

Mr. MURPHY. Dr. Monroe. 

Dr. MONROE. Everything has been inventoried. 

Mr. MURPHY. Dr. Pillai. 

Dr. PILLAI. Yes, every agent has been inventoried and accounted 

for by the FDA. 

Mr. MURPHY. Thank you. Mr. Mullin, you’re recognized for 5 

minutes. 

Mr. MULLIN. Thank you, Mr. Chairman. I’m going to follow up 

on your questions, too. 

Even after we got the information that anthrax had been basically not kept good records on and it had been shipped around, 

being used for experiments, people not knowing where they’re at. 

Once you discovered this you decided to do an inventory and look 

for anthrax, if any more had taken place. And specifically, NIH 

limited the search to only anthrax. Why was this? 

Dr. TABAK. If I may clarify, this was done in two steps. The initial search indeed was limited to those investigators working with 

bacillus anthracis. But after we discovered additional issues, we expanded that to include all principal investigators working with any 

select agent. 

Mr. MULLIN. When did you expand that? 

Dr. TABAK. During that same year, sir. And so—— 

Mr. MULLIN. What was the discovery of that? 

Dr. TABAK. I’m sorry? 

Mr. MULLIN. What did you discover in that? Because when you 

started searching for anthrax you found other cases even after it 

was revealed that it wasn’t properly followed and the procedures 

wasn’t followed. You found other issues with anthrax. So what else 

did you find? 

Dr. TABAK. So subsequently we searched cold storage areas with 

any principal investigator working with select agents. 

We searched over 6 million vials, vial by vial. And so that was 

a very comprehensive search that was undertaken. So it was a twostep process. I know—— 

80 

Mr. MULLIN. But what else did you discover? Other than anthrax 

what else was being improperly labeled and shipped around without the knowledge of NIH? 

Dr. TABAK. The search only revealed, to my knowledge, things related to different forms of anthrax. 

Mr. MULLIN. Mr. Tabak, just please help me here with your 

knowledge. We’re talking about very serious consequences if this 

gets out, and to your knowledge you can’t give me a definite answer? 

We’re talking about serious diseases. We’re talking about things 

that could be used against us. We’re talking about if they leaked 

out it could have serious consequences throughout areas of contact. 

And you’re telling me your knowledge. I’m asking for specifics. 

Dr. TABAK. Sir, I understand the gravity of the situation. I’m giving you the response that I can give you. I will provide for the 

record additional details so that I can—— 

Mr. MULLIN. Is it classified? Is that why you can’t give me—— 

Dr. TABAK. No, sir. It is not. 

Mr. MULLIN. OK. So the response—that’s what I’m trying to get 

to. And, sir, I mean absolutely no disrespect. But as something as 

this serious I would think you would have definite answers for. 

Dr. TABAK. And I am trying not to misspeak and so I’m giving 

you the best answer I can. 

Mr. MULLIN. I apologize with that. 

Dr. TABAK. And for the record, I will give you with certainty if 

any additional agents besides those related to anthrax were found 

in this 2008 time frame. 

Mr. MULLIN. So what caused you guys to open the research and 

search for further information. After you had simply opened it up 

for anthrax, what led you to decide, hey, let’s look farther into this? 

Dr. TABAK. When we discovered additional vials of anthrax that 

were unaccounted for and anthrax spores that were unaccounted 

for in laboratories and it was at that point that we decided that 

we needed to broaden the search and do a vial by vial for everybody who had the use of select agents. 

Mr. MULLIN. Do you have any additional cases showed up with 

anthrax? 

Dr. TABAK. So we found 30 vials in one laboratory—— 

Mr. MULLIN. That were unaccounted for, 30? Thirty in one laboratory? 

Dr. TABAK. These were unaccounted for. These were findings that 

we made. Thirty vials in one laboratory that had not been entered 

properly. 

Four vials in a second laboratory that had not been entered properly and in six vials a third laboratory that had not been entered 

properly. 

Mr. MULLIN. Was this due to procedures not being followed or 

procedures not in place? 

Dr. TABAK. I believe in one instance procedures were not followed 

and I would say in the other two instances I believe it was really 

due to human error. 

Mr. MULLIN. Thank you. I look forward to your response on the 

other one too. Thank you for getting back to me and Mr. Chairman, 

I’ll yield back. 

81 

Mr. MURPHY. Thank you. I don’t know if Ms. Castor has any 

more questions. I want to ask a couple more quick ones. Mrs. 

Brooks, did you want to be recognized for a quick question? 

Mrs. BROOKS. Thank you, Mr. Chairman. 

Very briefly, and this would be to Major General Lein. 

In its report, GAO recommended to DoD that it require all highcontainment labs including those not registered with the select 

agent program to report the results of any agency inspections to 

DoD. 

DoD told GAO that it had no plans to implement such a requirement. Why does the department disagree with GAO on this issue 

and why not require reporting inspections of all high-containment 

labs and not just the select agent registered labs? 

MG LEIN. Ma’am, I have to get back to you on that. We should 

be reporting all of the—not just the labs but all of our high-containment labs. So I owe you a response to that. 

Mrs. BROOKS. Thank you. We agree. 

MG LEIN. So just follow on the recommendations from the GAO 

report. 

Mrs. BROOKS. OK. We’ll look forward to your response, or 

changes and procedures. Thank you. I yield back. 

Mr. MURPHY. Thank you. I have a couple more questions. I think 

we’re waiting for Dr. Burgess. But Dr. Tabak, has the NIH ever 

taken any personnel actions related to not complying with select 

agent regulations? 

Dr. TABAK. Because of the sensitivity of personnel actions, sir, I 

would hope that we could discuss that with you and the committee 

in another venue. 

Mr. MURPHY. Can you tell us numbers? 

Dr. TABAK. Again, because of the numbers involved, sir, I 

would—because of the—— 

Mr. MURPHY. Is that a yes, that something has happened? 

Dr. TABAK. I’m sorry, sir? 

Mr. MURPHY. So is it a yes that some personnel action has happened, but you would talk about the other things privately? 

Dr. TABAK. I would prefer to, sir, we discuss that in another 

venue with you. 

Mr. MURPHY. Well, we’re trying to get the answer to this. So 

Government employees? They’re Government employees? 

Dr. TABAK. Yes, sir. 

Mr. MURPHY. Generally, are they Government employees, and 

I—wasn’t some personnel action taken among people who mishandled the procedures for the anthrax? 

MG LEIN. Yes, sir. Twelve recommendations for 12 personnel at 

Life Sciences. 

Mr. MURPHY. OK. And I don’t need to know their names or anything, but action took place. So you are taking some action, yes? 

I’d be willing to talk about some other things with—I mean, I 

think both sides would like assurance on that. 

Dr. TABAK. Again, sir, because of the relatively small numbers of 

individuals I think we would be breaching confidentiality to have 

a conversation publicly. 

Mr. MURPHY. Yes or no? Actions taken place? 

Dr. TABAK. Actions were initiated. 

82 

Mr. MURPHY. OK. That helps us. We can proceed. Has the FDA 

began an interim investigation to the root cause or facts and circumstances surrounding the discovery of smallpox vials in an FDA 

laboratory on the NIH campus—into root cause? 

Dr. PILLAI. So like my colleague, Dr. Tabak, given the fact that 

there was an FBI investigation complemented with a CDC select 

agent followed by an OIG inspection that is ongoing we have decided not to interfere with the process and have laid back. My understanding is that the OIG investigation is coming to an end and 

given the fact that that report is going to be available to us in the 

near term we are initiating a process to understand the root cause 

for the event that took place in 2014 and understand what the failure points are and then we plan to mitigate those failure points 

through implementation of appropriate policies and procedures. 

Mr. MURPHY. OK. So it’s the OIG inspection is over? 

Dr. PILLAI. That’s my understanding. My understanding is—— 

Mr. MURPHY. Yes, it’s true? And so did you have a plan in place 

saying hey, as soon as this investigation is over we’re ready to 

move forward? 

Dr. PILLAI. Right. 

Mr. MURPHY. So you do have a plan ready? 

Dr. PILLAI. We have a plan. 

Mr. MURPHY. So when you said—but now you’re discussing it. It 

should be the moment you were told you said now let’s roll with 

ours. So it is happening now? 

Dr. PILLAI. Yes. 

Mr. MURPHY. And after FDA personnel found a smallpox vials 

they transferred them to the NIH responsible official apparently 

without taking any steps to package and transfer the vials in a safe 

manner. 

In fact, the FBI and CDC highlighted that the individuals who 

carried the boxes to NIH responsible officer heard the vials clinking 

together. What steps should this individual have taken in transporting the vials? 

Dr. PILLAI. This is one of those situations where we had not anticipated to take place. So there were no appropriate safety procedures and protocols for the transfer of such materials from one—— 

Mr. MURPHY. I’m stopping you there. That’s why we’re having 

this hearing. 

Dr. PILLAI. Right. 

Mr. MURPHY. So how long has FDA been involved with diseases? 

Since your beginning. 

Dr. PILLAI. Right. 

Mr. MURPHY. So you ought to have some—for you to tell me you 

had not anticipated that you’d be transporting something that’s a 

viable pathogen with deadly results—you had not anticipated that? 

I’m sorry, that’s just not acceptable, Doctor. That’s why we keep 

having these hearings. 

How many personnel from the FDA have been involved in investigating this problem? 

Dr. PILLAI. I totally agree with you. 

Mr. MURPHY. How many personnel from the FDA have been involved in investigating this problem? 

Dr. PILLAI. There is a large group of individuals involved. 

83 

Mr. MURPHY. Five? A hundred? 

Dr. PILLAI. I would say not as much as a hundred but a significant number of folks. 

Mr. MURPHY. How many hours have been spent on this? 

Dr. PILLAI. I would say probably many hours, to be honest. 

Mr. MURPHY. I don’t know what many means. 

Dr. PILLAI. I don’t have the exact number of hours. 

Mr. MURPHY. Hundreds of hours? 

Dr. PILLAI. Probably. 

Mr. MURPHY. Dr. Monroe, how many hours involved with CDC 

in investigating these things? 

Dr. MONROE. Investigating—— 

Mr. MURPHY. Investigating these problems with pathogens and 

transport and some of these difficulties? Any idea? 

Dr. MONROE. I would have to, you know, get back with an estimate of the number of hours. But, for each of the incidents that 

CDC was directly involved with, we had an internal team plus the 

external select team. 

Mr. MURPHY. Quite a few, Dr. Tabak, I’m assuming? You may 

not know the numbers, but quite a few hours were involved? 

Dr. TABAK. Yes, indeed. 

Mr. MURPHY. So I think we’d rather have your scientists involved 

with science in identifying causes of diseases and cures for them. 

But the fact that we have had multiple hearings on this and Mr. 

Neumann, you were involved with hours of work in this, too, and 

there’s lots of things your office has been doing, as well. 

And then to say—Dr. Tabak, to go back to the point, you didn’t 

even mention to this committee again that some of those pathogens 

were alive. Dr. Pillai, you’re saying we didn’t have a procedure in 

place for transporting these things. 

Dr. PILLAI. But we do have procedures. 

Mr. MURPHY. But you had said—— 

Dr. PILLAI. But not for pathogens of this nature. This event was 

unusual in the sense that when the discovery was made, it was 

made by scientists who are not familiar with the policies and procedures of dealing with select agents. 

Mr. MURPHY. Whoa, whoa, whoa. This is an office that deals with 

select agents. They didn’t know how to transport them? I just find 

this astonishing. 

So here’s where I’m getting to with this. 

Dr. PILLAI. Right. 

Mr. MURPHY. We’ve also been informed in the past—I’m not sure 

if it was CDC or someone—we have to understand these are scientists, and sometimes they get a little absent-minded and you 

have to—I don’t accept that. 

The American public doesn’t accept that. Someone had salmonella. Thank goodness that person recovered, right? 

But this can have deadly consequences. These are offensive 

weapons. I’m pleased that DoD has taken definitive action on this. 

This was a tragic mistake—unfortunate mistake. Luckily caught it, 

taken definitive action. I just don’t find it acceptable the scientific 

community kind of gives it the shrug. 

Now, we’ve seen that shrug before when GM was here and someone, you know, decided we’re going to shrink a spring in a steering 

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column and, you know, save a few cents on each car and some people died. Oh, well. No one spoke up. 

When Volkswagen was here someone mysteriously came up with 

some sort of a software formula and—suddenly, in the morning we 

didn’t know how to pass the EPA tests, in the afternoon we suddenly did, and no one said, ‘‘How’d you do that?’’ 

And so now they’re facing so many billions of dollars worth of 

suits and other fines. I don’t know if that company is going to survive. 

But those are cars, and here we’re talking about diseases, and 

I would hope the lesson you take from this committee—and I’m 

tired of going over this because we keep having this conversation. 

But if your scientists are saying, ‘‘Gee, we never thought about 

how to transport something that’s deadly—never really thought 

about that’’—then find a new job. 

Look, we all make mistakes. I mean, we’re human. We make 

mistakes, that’s what it is. I get that. I have no problem with that. 

I just want to make sure we have some sense of learning, and 

if someone says well, yes, never had a protocol of how to transport 

deadly diseases from one place to another, and the bottles are 

clinking together—gee, what do I do about that? 

They weren’t transporting bottles to return—a Coke for deposits 

and they’re clinking together. I hope that you’re going to do a lot 

more with training as this proceeds. 

Well, it looks like other members are not going to be here. So I 

ask unanimous consent that the document binder be introduced 

into the record and to authorize staff to make any appropriate 

redactions. 

Without objection, the documents will be entered into the record 

with any redactions the staff determines are appropriate. 

[The information has been retained in committee files and also 

is available at http://docs.house.gov/Committee/Calendar/ 

ByEvent.aspx?EventID=104823.] 

Mr. MURPHY. In conclusion, I thank all the witnesses and members that participated in today’s hearing. I remind members they 

have 10 business days to submit questions for the record. I ask the 

witnesses to all agree to respond promptly to the questions, and 

with that this committee is adjourned. 

[Whereupon, at 11:43 a.m., the hearing was adjourned.] 

[Material submitted for inclusion in the record follows:] 

PREPARED STATEMENT OF HON. FRED UPTON

Mr. Chairman, thank you for holding this hearing. The subcommittee meets again 

as in previous years about the challenge of improving safety at the Federal Government’s high-containment laboratories. During 2014 and 2015 several lapses in safety at HHS agency and Defense Department labs could have exposed Federal personnel and other individuals to hazardous biological agents. 

In response to these concerns, there have been executive-branch wide efforts and 

internal agency efforts to improve lab safety. At the request of the bipartisan leadership of the committee, the GAO will present its report on oversight at Federal highcontainment labs. The GAO will tell us that much work still needs to be done. Most 

of the Federal agencies need more comprehensive or up-to-date policies. 

However, to really stop this troubling pattern of safety lapses at our bioterrorism 

labs, changes on paper will not be enough if the agencies are not addressing cultural 

and behavioral factors. To its credit, the Department of Defense and the Centers 

for Disease Control have conducted internal, soul-searching reviews into the root 

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causes of incidents. These internal investigations revealed various failures at both 

the systemic and individual level. As noted in the CDC testimony, these deep and 

critical internal reviews are essential to reforming lab safety. 

With regard to the lapse involving the discovery of the smallpox vials in an FDA 

lab on the NIH campus, both the NIH and the FDA have yet to conduct the necessary self-examination and introspection to fully understand the weaknesses and 

failures that led to smallpox being unknowingly stored in an unregistered, and improperly secured conditions. I hope this hearing helps the NIH and the FDA to undertake such reviews. We want NIH, FDA, and all our Federal laboratories to be 

successful in implementing lab safety improvements. These labs conduct vital research that can lead to the development of treatments, diagnostic, and vaccines to 

address public health needs. This research is also important to our defense efforts 

against bioterrorism, a serious threat to our troops, our nation, and our allies. 

Finally, it is disappointing that the CDC produced blacked-out documents in response to my confidential request letter on behalf of the committee to obtain key 

investigative information about improperly stored anthrax at the NIH and the FDA 

in 2012. There is no legal basis for the CDC to withhold such information from its 

authorizing committee in Congress. I would urge the CDC to live up to its claims 

of transparency and accountability, and to work cooperatively with this committee, 

as has occurred in the past. 

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