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OUTBREAKS, ATTACKS, AND ACCIDENTS: 

COMBATING BIOLOGICAL THREATS 

HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED FOURTEENTH CONGRESS 

SECOND SESSION 

FEBRUARY 12, 2016 

Serial No. 114–117 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

LARRY BUCSHON, Indiana 

BILL FLORES, Texas 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

KEVIN CRAMER, North Dakota 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

PETER WELCH, Vermont 

BEN RAY LUJA ́ N, New Mexico 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

YVETTE D. CLARKE, New York 

DAVID LOEBSACK, Iowa 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

TIM MURPHY, Pennsylvania 

Chairman 

DAVID B. MCKINLEY, West Virginia 

Vice Chairman 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

H. MORGAN GRIFFITH, Virginia 

LARRY BUCSHON, Indiana 

BILL FLORES, Texas 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

KEVIN CRAMER, North Dakota 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

DIANA DEGETTE, Colorado 

Ranking Member 

JANICE D. SCHAKOWSKY, Illinois 

KATHY CASTOR, Florida 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

YVETTE D. CLARKE, New York 

JOSEPH P. KENNEDY, III, Massachusetts 

GENE GREEN, Texas 

PETER WELCH, Vermont 

FRANK PALLONE, JR., New Jersey (ex 

officio) 

(II) 

(III) 

C O N T E N T S 

Page 

Hon. Tim Murphy, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 1 

Prepared statement .......................................................................................... 3 

Hon. Diana DeGette, a Representative in Congress from the State of Colorado, opening statement ...................................................................................... 5 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, prepared statement ........................................................................ 6 

WITNESSES

Donna E. Shalala, Panel Member, Blue Ribbon Study Panel on Biodefense ..... 8 

Prepared statement .......................................................................................... 11 

Answers to submitted questions ...................................................................... 102 

James C. Greenwood, Panel Member, Blue Ribbon Study Panel on Biodefense 21 

Prepared statement .......................................................................................... 24 

Answers to submitted questions ...................................................................... 104 

Tara O’Toole, M.D., Executive Vice President, In-Q–Tel ..................................... 32 

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

Answers to submitted questions ...................................................................... 112 

Gerald W. Parker, Jr., D.V.M., Associate Vice President, Public Health Preparedness and Response, Texas A&M Health Science Center ......................... 43 

Prepared statement .......................................................................................... 45 

Answers to submitted questions ...................................................................... 115 

SUBMITTED MATERIAL

Subcommittee memorandum .................................................................................. 76 

(1) 

OUTBREAKS, ATTACKS, AND ACCIDENTS: 

COMBATING BIOLOGICAL THREATS 

FRIDAY, FEBRUARY 12, 2016 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittee met, pursuant to call, at 9:00 a.m., in room 

2123, Rayburn House Office Building, Hon. Tim Murphy (chairman 

of the subcommittee) presiding. 

Members present: Representatives Murphy, Burgess, Blackburn, 

Griffith, Bucshon, Flores, Brooks, Mullin, Collins, Cramer, Upton 

(ex officio), DeGette, Castor, Tonko, Kennedy, Green, and Welch. 

Also present: Representative Bilirakis. 

Staff present: Leighton Brown, Deputy Press Secretary; Rebecca 

Card, Assistant Press Secretary; Karen Christian, General Counsel; Brittany Havens, Oversight Associate; Charles Ingebretson, 

Chief Counsel, Oversight and Investigations; Graham Pittman, 

Legislative Clerk; Chris Santini, Policy Coordinator, Oversight and 

Investigations; Alan Slobodin, Deputy Chief Counsel, Oversight; 

Dylan Vorbach, Legislative Clerk; Ryan Gottschall, Democratic 

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

Mr. MURPHY. Good morning. We will begin this hearing, to a 

large extent. We’re going to be having votes in a couple hours, so 

we’ll want to make sure we move quickly through this. 

Before I start, I want to acknowledge that our good friend and 

ranking member of the committee, Frank Pallone, is not with us 

today because his father died. We keep his family in our prayers. 

And although I did not personally know Frank Pallone, Sr., I know 

he raised a good son. And so we thank him for that. And we’ll continue on from there. 

Next, I’m joined today also with my colleague, who is wearing 

Denver Broncos orange. And congratulations for a Super Bowl. 

They must be a good team because they beat the Steelers. 

Now, on with our hearing. 

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

Good morning. We’re reminded on a nearly basis that there are 

those who are seeking to do us harm through a variety of means, 

including biological attacks. The threats from attack and disease 

2 

outbreaks are growing and ever changing, and we are ill prepared 

to detect and respond to these threats as rapidly needed. 

Put simply, we have been caught flatfooted too many times in 

the past. We face a deadly enemy we cannot see. Our methods to 

find it are woefully inadequate. And we may not even know it’s 

there until it’s too late, and this is frightening. The Federal Government’s ambivalence towards biological threats must end. 

Today the biological threats confronting the U.S. generally fall 

into three distinct categories: one, a naturally occurring; two, accidental incidents; and, three, intentional acts which are often associated with acts of terrorism. We must be ready to guard against and 

respond to each of these threats appropriately. 

Now, it’s easier for nation-states and terrorists to obtain the resources necessary to produce biological weapons than ever before, 

and given the ease with which one can obtain and transport these 

resources, it is difficult for the intelligence community to collect, 

analyze, and produce intelligence about biological threats. The 

threat of a biological attack is not as remote as one would hope. 

Now, at the same time, pandemic and other highly pathogenic 

disease are occurring with greater frequency and spreading more 

quickly throughout the world. As human populations put increasing pressure on remote areas and with ease of global travel, we will 

see more and more infectious diseases emerge. Since 2002, the 

world has seen outbreaks of SARS, Chikungunya, cholera, influenza, measles, Ebola, MERS, and now Zika. 

The U.S. response to Ebola was a humbling reminder of the 

adage that everyone has a plan until they are punched in the face. 

We were not prepared for Ebola, and actions were described with 

confidence one day and determined to be ineffective the next. This 

is what shakes the public’s confidence, and instead of ensuring that 

the U.S. had strong central leadership, the administration’s answer 

was to appoint an Ebola czar who served for 3 months. 

Sadly, the ad hoc approach continues. A Zika outbreak now 

threatens the continental U.S. What the world initially thought 

was a mild illness could in fact have far greater consequences if the 

virus also brings increases in microencephaly, Guillain-Barre syndrome, eye disorders, and potential for later developmental problems in children. 

While the administration has submitted a $1.8 billion emergency 

request to combat Zika, its latest budget request continues to leave 

funding gaps of more than $1.8 billion in Project BioShield’s Special Reserve Fund and pandemic flu countermeasures. 

Over the last 3 years, this committee has examined the impacts 

of and our preparedness for natural and accidental biological incidents. We’ve held hearings on our flawed response to the Ebola crisis, the need for better preparedness for pandemic and seasonal influenzas, the unsafe practices by the Department of Defense and 

the Centers for Disease Control on the handling of live anthrax, 

and the Department of Homeland Security’s broken BioWatch system. In the coming weeks we will examine the Federal response to 

the Zika virus. 

Each of these topics has a common denominator: the Federal 

Government was not adequately prepared. For years, we have 

lunged from crises to crises, reacting to what just occurred, instead 

3 

of planning for the next outbreak or attack. The subcommittee’s 

oversight work has made a difference in each area, but I am very 

concerned that the Federal Government lacks an overall plan for 

biodefense. Instead of being reactionary, we must be proactive, 

with a new approach. 

Last fall, the Blue Ribbon Study Panel on Biodefense published 

its ‘‘National Blueprint for Biodefense.’’ The Panel examined the 

current state of biodefense in the United States, examining issues 

related to prevention, deterrence, preparedness, detection, and response, to name a few. This is not a book that should sit dusty on 

a shelf but one that people should read. And I am pleased that two 

distinguished commission members, Secretary Donna Shalala and 

former chairman of this subcommittee, Congressman Jim Greenwood, are here today to speak about the important work of this 

Panel. We thank you. 

The Panel’s findings that we are, quote, ‘‘dangerously vulnerable,’’ unquote, to a biological event because we lack leadership and 

an overall strategy are frightening. The Panel made 33 recommendations, many which fall within the jurisdiction of the Energy and Commerce Committee and impact work that this subcommittee has done and will continue to do. 

The need for improved leadership echoes throughout the Panel’s 

report and is unfortunately a theme we have heard far too often 

about the Federal Government. Without leadership, there is no coordination of biodefense research, preparedness, and other issues, 

and without leadership, there is no strategy. 

The Panel also makes a number of specific recommendations. We 

must improve our biosurveillance and biodetection capabilities. We 

need to detect pathogens in the air in hours and eventually minutes, not days. Agencies already collecting surveillance data should 

share it, not squirrel it away. We need a platform that allows for 

rapid diagnostic testing and vaccine development that can be applied not only to the diseases and pathogens we currently know 

about, but also to the ones we have not yet discovered. 

The Energy and Commerce Committee, and this subcommittee in 

particular, must take the lead in understanding and improving our 

biodefense capabilities. 

I thank our witnesses for being with us today. We look forward 

to hearing your testimony. 

[The prepared statement of Mr. Murphy follows:] 

PREPARED STATEMENT OF HON. TIM MURPHY

We are reminded, on nearly a daily basis, that there are those who seek to do 

us harm through a variety of means, including biological attacks. The threats from 

attack and disease outbreaks are growing and ever changing, and we are ill prepared to detect and respond to these threats as rapidly as needed. Put simply, we 

have been caught flat-footed too many times in the past. The Federal Government’s 

ambivalence towards biological threats must end. 

Today, the biological threats confronting the U.S. generally fall within three distinct categories: 1, naturally occurring; 2, accidental incidents; and 3, intentional 

acts, which are often associated with acts of terrorism. We must be ready to guard 

against and respond to each of these threats. 

It is easier for nation-states and terrorists to obtain the resources necessary to 

produce biological weapons than ever before. And, given the ease with which one 

can obtain these resources, it is difficult for the intelligence community to collect, 

4 

analyze, and produce intelligence about biological threats. The threat of a biological 

attack is not as remote as one would hope. 

At the same time, pandemic and other highly pathogenic diseases are occurring 

with greater frequency and spreading more quickly throughout the world. As human 

populations put increasing pressure on remote areas and with ease of global travel, 

we will see more and more infectious diseases emerge. Since 2002, the world has 

seen outbreaks of SARS, Chikungunya, cholera, influenza, measles, Ebola, MERS, 

and now Zika. 

The U.S. response to Ebola was a humbling reminder of the adage that everyone 

has a plan until they are punched in the face. We were not prepared for Ebola. Actions that were described with great confidence one day were likely determined to 

be ineffective the next. This is what shakes the public’s confidence. Instead of ensuring that the U.S. had strong, central leadership, the administration’s answer was 

to appoint an Ebola czar who served for three months. 

Sadly, the ad hoc approach continues. A Zika outbreak threatens the continental 

U.S. What the world initially thought was a mild illness could, in fact, have far 

greater consequences if the virus also brings increases in microcephaly, GuillainBarre (gee-YAN-buh-RAY) Syndrome, eye disorders, and potential for later developmental problems in children. While the administration has submitted a $1.8 billion 

emergency request to combat Zika, its latest budget request continues to leave funding gaps of more than $1.8 billion in Project Bioshield’s Special Reserve Fund and 

pandemic flu countermeasures. 

Over the last 3 years, this subcommittee has examined the impacts of and our 

preparedness for natural and accidental biological incidents. We have held hearings 

on our flawed response to the Ebola crisis, the need for better preparedness for pandemic and seasonal influenzas, the unsafe practices by the Department of Defense 

and the Centers for Disease Control on the handling of live anthrax, and the Department of Homeland Security’s broken BioWatch system. In the coming weeks we 

will examine the Federal response to the Zika virus. 

Each of these topics has a common denominator-the Federal Government was not 

adequately prepared. For years, we have lunged from crisis to crisis, reacting to 

what just occurred instead of planning for the next outbreak or attack. The subcommittee’s oversight work has made a difference in each area, but I am very concerned that the Federal Government lacks an overall plan for biodefense. The time 

for a new approach is long past due. Instead of being reactionary, we must be 

proactive. 

Last fall, the Blue Ribbon Study Panel on Biodefense published its ‘‘National 

Blueprint for Biodefense.’’ The Panel examined the current state of biodefense in the 

United States, examining issues related to prevention, deterrence, preparedness, detection, and response, to name a few. I am pleased that two very distinguished commission members, Secretary Donna Shalala and the former chairman of this subcommittee, Congressman Jim Greenwood, are here today to speak about the important work of the Panel. 

The Panel’s findings—that we are ‘‘dangerously vulnerable’’ to a biological event 

because we lack leadership and an overall strategy—are frightening. The Panel 

made 33 recommendations, many of which fall within the jurisdiction of the Energy 

and Commerce Committee and impact work that this subcommittee has done and 

will continue to do. 

The need for improved leadership echoes throughout the Panel’s report, and is unfortunately a theme we hear far too often about the Federal Government. Without 

leadership there is no coordination of biodefense research, preparedness, and other 

issues. Without leadership there is no strategy. 

The Panel also makes a number of specific recommendations. We must improve 

our biosurveillance and biodetection capabilities. We need to detect pathogens in the 

air in hours and eventually minutes—not days. Agencies already collecting surveillance data should share it, not squirrel it away. We need a platform that allows for 

rapid diagnostic testing and vaccine development that can be applied not only to the 

diseases and pathogens we currently know about, but also to the ones we have not 

yet discovered. 

The Energy and Commerce Committee, and this subcommittee in particular, must 

take the lead in understanding and improving our biodefense capabilities. 

Mr. MURPHY. And I now recognize the ranking member of the 

subcommittee, Ms. DeGette, for 5 minutes. 

5 

OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF COLORADO 

Ms. DEGETTE. Thank you so much, Mr. Chairman. I too want to 

welcome our witnesses, in particular former Congressman Greenwood, who sat right there in the chair you’re sitting in for many 

years and who sat next to me while we had a lot of the hearings 

on these issues that you mentioned in your opening statement 

today. And I know he’s just as frustrated as you and I are about 

the fact that we still continue to lurch from crisis to crisis in this 

country without any kind of unified or comprehensive response to 

some of these issues. 

When I was listening to your opening statement, Mr. Chairman, 

I thought to myself, ‘‘Who says bipartisanship is dead?’’ because my 

opening statement mirrors your opening statement to the point of 

talking about some of the very same examples that you discussed. 

So I won’t read the whole opening statement, because I do not subscribe to the adage that everything’s been said but it hasn’t been 

said by everybody. So I’ll put it into the record. I just want to highlight a couple of the issues. 

We’ve got the Zika virus going on, as you mentioned, right now, 

and we’re scrambling once again after the fact to deploy the appropriate resources to protect our citizens as this spreads. Last year, 

it was the Ebola outbreak. We did finally organize to respond to 

that, and we’re still trying to put the systems in place to make sure 

that Ebola doesn’t spring up again. 

This ‘‘National Blueprint for Biodefense’’ made a number of important findings on how to respond to these natural-occurring 

threats, but also how to respond to deliberate attack. As you mentioned, Mr. Chairman, the Panel made three dozen recommendations to better posture our Government to respond to these emerging biothreats. 

Now, for those of us who were here during the fall of 2001, we 

remember vividly those little few envelopes of anthrax that arrived 

on Capitol Hill and the chaos that it caused within the Congress. 

Offices were closed. Buildings were fumigated. Some congressional 

business was suspended. Thousands of staffers and Members of 

Congress lined up to get tested for exposure. And even worse, of 

course, some of the workers in the postal centers died. 

Now, this was a relatively small attack. So imagine what would 

happen if we had a large attack in a major metropolitan area or 

someplace else. That’s why we have to be organized to deal with 

these things, and that’s what brings us back to the findings of this 

Panel. 

There are a number of really important recommendations, and I 

recommend to every member of this Panel and every member of the 

audience that you read the actual blueprint, because it is sobering. 

But I think that the top observation that’s made in this blueprint 

is that the Nation is underprepared for a bioattack because we still 

lack centralized biodefense leadership. The Panel recommends appointment of a single national leader under which preparedness for 

and response to biological threats could be consolidated. 

The Panel recommends this authority be institutionalized in the 

Office of the Vice President of the United States. And what the 

6 

Panel says is that this will, quote, ‘‘ensure that biodefense will be 

addressed by every administration at the highest levels with adequate access to the President.’’ I think this is a very unique recommendation and one that we should explore. 

And I just want to say one more thing, Mr. Chairman. One of 

the grand traditions of the Oversight and Investigation Subcommittee is to shine light on issues like this and to actually move 

the dialogue forward. So I was really gratified to hear you saying 

in your opening statement that you don’t just intend to have this 

hearing today and let this go. 

I think if we really have a series of hearings diving deeply into 

the recommendations of the committee and take their recommendation that we have some of these hearings, we actually can make a 

long-term difference in how this Nation is prepared. And that may 

be the very best legacy that not only this Blue Ribbon committee, 

but also this subcommittee of Energy and Commerce can leave. 

With that, I’ll put my full statement in the record, but I’d also 

like to ask unanimous consent to put Ranking Member Pallone’s 

full statement in the record due to his inability to be here with his 

father’s death. 

Thank you very much, and I yield back. 

Mr. MURPHY. All right. Yes. And I’ll just ask unanimous consent 

that any other members’ written opening statements be introduced 

into the record. And without objection, they will be entered. 

[The prepared statement of Mr. Pallone follows:] 

PREPARED STATEMENT OF HON. FRANK PALLONE, JR. 

Thank you for holding this hearing. Combating biological threats is a critical issue 

that has not been given adequate attention, but I’m hopeful today’s hearing can be 

another important step towards increasing our Nation’s preparedness. 

The Blue Ribbon Panel on Biodefense has conducted a comprehensive review of 

the Federal Government’s efforts to address the biological threat and identified 

what remains to be done. Before us today are two distinguished Panel members who 

are no strangers to this committee: Secretary Shalala, who led the Department of 

Health and Human Services for 8 years, and Congressman Jim Greenwood, the 

former chairman of this subcommittee. In addition, I’d like to welcome two individuals who offered their expertise to the Panel: Dr. Tara O’Toole, who served as Undersecretary for Science and Technology at the Department of Homeland Security, 

and Dr. Gerald Parker, who has provided leadership on these issues at the Departments of Health and Human Services, Homeland Security, and Defense. Thank you 

to all of our witnesses for being here and for sharing your expertise. 

This is not the first high-level commission to examine our Nation’s biodefense preparedness. Experts have repeatedly warned that our ability to respond to biological 

threats must be improved. However, previous commissions did not produce changes 

that sufficiently prepared this Nation for the threats that will be discussed today. 

That brings us to the Blue Ribbon Study Panel and our hearing today. The Blue 

Ribbon Panel, following extensive study, has suggested a series of oversight hearings addressing fourteen key areas, many of which fall under this committee’s jurisdiction. 

We need to ensure that this Panel’s work does not become yet another undertaking by experts whose recommendations go unanswered. Congressional oversight 

is key to ensuring that Federal departments and agencies are meeting their mandates and doing so in an effective and efficient way. And therefore, I urge the committee to follow through on the Panel’s recommendations by holding not just this 

session, but a series of hearings to assess the Nation’s ability to prepare for and 

respond to biological threats. 

I would like to thank our panelists once again for coming and sharing their expertise. I look forward to hearing from each of you about what our Nation can do to 

improve our biodefense network. 

7 

Mr. MURPHY. And I believe, Mr. Chairman, you don’t have an 

opening statement. And, again, given the rush, we want to make 

sure we hear everything and every member gets a chance to ask 

questions before votes. We’ll just move forward. 

So I will introduce the witnesses on the panel for today’s hearing. 

The first witness on today’s panel is the Honorable Donna 

Shalala—welcome here, it is an honor to have you here—former 

Secretary of Health and Human Services, and here today as a 

member of the Blue Ribbon Study Panel on Biodefense. Over the 

course of her career, Secretary Shalala has demonstrated a strong 

commitment to public service, from the Peace Corps to the Department of Housing and Urban Development. She is a recipient of the 

Medal of Freedom and currently serves as president and CEO of 

the Clinton Foundation. 

We appreciate your time here today. 

Next, my friend and colleague from Pennsylvania, the Honorable 

Jim Greenwood, former Congressman from the Eighth Direct of 

Pennsylvania, chairman of the subcommittee from 2001 to 2004. 

Mr. Greenwood is also a member of the Blue Ribbon Study Panel 

on Biodefense and has served since 2005 as president and CEO of 

the Biotechnology Innovation Organization. In this capacity he has 

worked with Bio’s 1,200 member organizations to aid in the development of biotech solutions to major challenges in agriculture and 

health care. 

And we also look forward to hearing your insights. 

Next, Dr. Tara O’Toole, who serves as a senior fellow and executive vice president at In-Q–Tel, a nonprofit strategic investment 

firm that works to facilitate connection and cooperation between 

venture-backed technology startups with the U.S. intelligence community. Dr. O’Toole formerly served as Under Secretary of Science 

and Technology at the Department of Homeland Security and Assistant Secretary for Environmental Health and Safety at the Department of Energy. 

I’m looking forward to hearing your expertise today during the 

hearing, and thank you also for being here. 

And now I’ll yield to Mr. Flores, who will introduce our next witness from Texas. 

Mr. FLORES. Thank you, Mr. Chairman. Also, I thank you for 

holding this hearing today and for the courtesy of allowing me to 

introduce one of my classmates and a fellow Texas Aggie and a renowned expert on public health. Dr. Jerry Parker serves as the vice 

president for public health preparedness and response at the Texas 

A&M Health Science Center. At Texas A&M he oversees the largest Federal public-private partnership with the Health and Human 

Services’ Biomedical Advanced Research and Development Authority, commonly referred to as BARDA, for vaccine development and 

manufacture. 

Prior to his current role at A&M, Dr. Parker had a distinguished 

career in public and military service, including serving as a Deputy 

Assistant Secretary of Defense for Chemical and Biological Defense, and in that position he was responsible for the military’s 

readiness on many of the issues that are before us today. Dr. 

Parker also served as a Principal Deputy Assistant Secretary in the 

Office of the Assistant Secretary for Preparedness and Response at 

8 

HHS and in a similar role at the Department of Homeland Security. 

Again, Mr. Chairman, thank you for allowing me the time to introduce Dr. Parker. His senior leadership positions at the Texas 

A&M Health Science Center, the Department of Defense, HHS, and 

DHS are critical to the topic before this committee. 

And thank you, Dr. Parker, for being with us today. 

I yield back. 

Mr. MURPHY. The gentleman yields back. And if there’s no more 

comments, we’ll proceed here. 

So you’re all aware that this committee is holding an investigative hearing and when doing so has had the practice of taking testimony under oath. 

Do any of our witnesses have any objections to giving testimony 

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 during testimony 

today? 

And all the witnesses say no. 

In that case, if you would all please rise and raise your right 

hand, I’ll swear you in. 

[Witnesses sworn.] 

Mr. MURPHY. Thank you. All the witnesses said, ‘‘I do.’’ 

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

Title 18, Section 1001 of the United States Code. We will now entertain each of you with a 5-minute summary of your opening 

statement. We will begin with Ms. Shalala. You’re recognized for 

5 minutes. Just turn the microphone on and pull it close to you. 

STATEMENTS OF DONNA E. SHALALA, PANEL MEMBER, BLUE 

RIBBON STUDY PANEL ON BIODEFENSE; JAMES C. GREENWOOD, PANEL MEMBER, BLUE RIBBON STUDY PANEL ON 

BIODEFENSE; TARA O’TOOLE, M.D., EXECUTIVE VICE PRESIDENT, IN–Q-TEL; AND GERALD W. PARKER, JR., D.V.M., ASSOCIATE VICE PRESIDENT, PUBLIC HEALTH PREPAREDNESS 

AND RESPONSE, TEXAS A&M HEALTH SCIENCE CENTER 

STATEMENT OF DONNA E. SHALALA 

Ms. SHALALA. Good afternoon, Mr. Chairman, Congresswoman 

DeGette, and members of the subcommittee. I’ve submitted a 

lengthy testimony for the record. Thank you for inviting us here to 

present our views and recommendations of the bipartisan Blue Ribbon Study Panel on Biodefense. I’m pleased to be joining former 

Representative Jim Greenwood. We’re here on behalf of our cochairs, former Senator Joe Lieberman and Governor Tom Ridge, 

and the other members of our Panel, former Senate Majority Leader Tom Daschle and former Homeland Security Advisor Ken 

Wainstein. It’s also good to see Dr. Jerry Parker, who is one of our 

ex officios, as well as Dr. Tara O’Toole, who constantly advises all 

of us on this important subject. 

We are deeply concerned about the biological threat, whether intentionally induced, naturally occurring, or accidentally released. 

9 

And I want to emphasize those three issues, because this is not a 

report just on intentionally induced biological threat. It also covers 

the naturally occurring ones or the accidentally released. 

I want to take a moment to address the threat now, but let me 

recommend that you get a classified briefing at your earliest opportunity. Make no mistake, we’ve been told that our enemies are seriously considering the use of biological weapons. During the invasion of Afghanistan, the United States uncovered evidence that Al 

Qaeda was trying to develop biological weapons. More recently, 

ISIL has gained control of enough land, physical infrastructure, scientific expertise, and professional military personnel to potentially 

create and deploy biological weapons, and they have expressed 

their intent to use them. 

Additionally, the verification protocols associated with the Biological Weapons and Toxin Convention are weak and do not do 

what the world needs them to do, differentiate between legitimate 

and malicious activities. 

We’re equally concerned about the threat of naturally occurring 

diseases with catastrophic pandemic potential. It’s often very difficult for our scientists to guess the correct combination of viruses 

that will even make up the strain of influenza that will circulate 

the following year. Nevertheless, diseases do not have to kill millions to produce impact. There are a number of diseases that have 

affected my own State of Florida and New York and Puerto Rico 

and the U.S. Virgin Islands and American Samoa over the last 2 

years. 

Now Zika virus is on the move as well, in some cases resulting 

in microencephaly in newborns who contract it from their mother. 

The first case of local transmission has occurred in the United 

States, in Dallas, which of course was the first city with an Ebola 

case. This transmission did not occur from mosquitoes. It was sexually transmitted. Imagine the devastating societal consequences if 

we cannot stop the spread of this disease. 

Accidental releases also contribute to biological risk. I’m sure 

that you’re aware of the recent laboratory biosecurity and biosafety 

mishaps at a number of our high-level laboratories. The organisms 

in which these laboratories work are too serious, too infectious, and 

too deadly for us to react indignantly, only to forget after a few 

months and move on to the next challenge. 

Our change must be institutionalized and sustained, and that is 

our fundamental message today. Our attention span tends to increase and decrease cyclically as different events occur and their 

impacts fade over time. Since I was Secretary of Health and 

Human Services, I have seen three administrations increase and 

decrease their emphasis on biological threats, usually in response 

to and after recovering from incidents such as the anthrax events 

of 2001, SARS, H1N1, MERS, and Ebola, and now we’re all gearing 

up again for the Zika virus. 

We need a leader at the highest level of Government to take responsibility and develop a comprehensive strategy and a unified 

budget and lead the whole of the Government, along with nongovernmental partners, to improve our national biodefense and to 

do so attentively and consistently. We recommend that that person 

be the Vice President of the United States, one of the few who can 

10 

get the Government agencies and the nongovernmental partners to 

work together. 

We are not necessarily talking about new programs or funding. 

Instead, we believe we can build on existing programs and infrastructure. And let me give you a few examples. 

We ought to be able to take an environmental biodetection system that was originally designed for the battlefield, for example, 

evaluate it, and if it seems useful, then modify it to fulfill our 

needs domestically. We should see how we could build on our preexisting pervasive and familiar system of community pharmacies to 

get pharmaceuticals to localities in the midst of a biological incident and maybe create smaller caches in advance. We cannot depend solely on a federally driven public-point-of-dispensing model. 

Or take our hospitals, which meet accreditation criteria associated 

with funding provided by the Centers for Medicare and Medicaid 

Services. We can use that to address various specialties, like trauma, for example. 

Doing the same for biodefense would cultivate better hospital 

preparedness for major infectious disease events. In doing so, we 

could create a stratified hospital system in advance of a biological 

event, knowing exactly which facilities are best positioned to handle cases. 

The funding that we could get through—— 

Mr. MURPHY. Ms. Shalala—— 

Ms. SHALALA [continuing]. Is far greater than what is currently 

available through the Hospital Preparedness Program. While we 

support this grant program, it is simply never going to be 

resourced enough to meet the need. 

Mr. MURPHY. Could you just give a wrap-up because you’re over 

a couple minutes. I just want to make sure we have time for everybody. 

Ms. SHALALA. I’m closing. 

Mr. MURPHY. OK. 

Ms. SHALALA. In closing, I just want to note that Congress plays 

a critical role in providing necessary oversight and legislation. We 

need all of you to consider these recommendations and, hopefully, 

to move forward. And now, after you’ve heard from Jim Greenwood, 

we’d be happy to answer any questions you have. 

[The prepared testimony of Ms. Shalala follows:] 

11 


Hearing of the House Committee on Energy and Commerce 

Subcommittee on Oversight and Investigations 

"Outbreaks, Attacks, and Accidents: Combating Biological Threats" 

February 12,2016 

Statement for the Record 

The Honorable Donna E. Shalala 

Panel Member, Blue Ribbon Study Panel on Biodefense 

Chairman Murphy, Ranking Member DeGette, and Members of the Subcommittee: thank you for 

inviting us here to present the views and recommendations of the bipartisan Blue Ribbon Study 

Panel on Biodcfense. I am pleased to join my co-panelist, former Representative Jim 

Greenwood. We are here on behalf of our co-chairs, former Senator Joe Lieberman and 

Governor Tom Ridge, and the other members of our Panel. former Senate Majority Leader Tom 

Daschlc, and former Homeland Security Advisor Ken Wainstein. 

We are here today to discuss the collective findings and concerns of our Study Panel. While we 

are optimistic that our nation's weaknesses in biodefense can be addressed, we want to convey to 

you our deep concern about this threat. As you know, naturally occurring and intentionally 

introduced diseases decimated populations throughout history, and remain among the most 

dangerous of hazards of the modern world. We are particularly concerned about emerging 

infectious diseases, and what they mean for the health of Americans and that of the global 

community. The emergence Chikungunya, an incurable disease that results in paralysis, is 

striking. Unlike other viruses that have yet to land on our shores, Chikungunya is already here, 

with thousands of cases in Puerto Rico, Florida, and New York. Zika virus is following a similar 

progression, beginning in discrete, remote, and tropical locations and then widening its reach. 

We appreciate the good work this committee has done to assess and mitigate these kinds of 
12 


globally emerging infections, with its oversight on disease surveillance, pandemic influenza, and 

other serious public health issues. We know that you, too, arc familiar with the catastrophic 

potential of highly pathogenic disease and the challenges inherent in managing them. 

Infectious diseases impact the security of every American. Yet our Panel found that our attention 

to the threat is not commensurate with the threat. We highly recommend that you obtain a 

classified briefing on the biological threat as soon as possible and get the Intelligence 

Community's perspective on the potential for biological terrorism and warfare, as well as the 

national security implications of catastrophic naturally occurring disease events. 

While the Clinton Administration paid increased attention to the biological threat, that interest 

waned prior to the anthrax events of200 l. Letters containing weaponized anthrax closed the 

Hart Senate Office Building for three months, wreaked havoc with the U.S. Postal Service, 

reduced business productivity, cost the nation more than one billion dollars by some estimates, 

and most significantly, took five lives and sickened seventeen more. After those events, 

Congress and the White House renewed their efforts to improve the nation's biodefense posture. 

They created new programs, increased laboratory and other needed capacities, developed and 

stockpiled medical countermeasures (MCM), increased budgets, hired experts, improved 

protective equipment, re-oriented parts of our intelligence and law enforcement enterprises, and 

in general, took the threat seriously for a few more years. They lost focus again as years went by 

without another such attack- despite the fact that criminals continue to commit smaller-scale 

biocrimes, terrorists groups continue to pursue bioweapons, and emerging infectious diseases 

continue to march forward. The biological threat is real and present, but our attention span is not. 
13 


We are not the first to come before Congress to tell you that the United States is not taking the 

biological threat seriously enough and that the nation is not preparing sufficiently to deal with a 

major biological event. The U.S. Commission on National Security/21st Century raised the issue 

fifteen years ago, the National Commission on Terrorist Attacks upon the United States raised it 

twelve years ago, the Commission on the Intelligence Capabilities of the United States 

Regarding Weapons of Mass Destruction raised it eleven years ago, and the Commission on the 

Prevention of Weapons of Mass Destruction Proliferation and Terrorism (WMD Commission) 

raised it eight years ago. Further, the Intelligence Community states that the biological threat 

exists and is serious, while simultaneously admitting to weaknesses in its biological collection 

and analysis activities in this regard. 

When we began our work with the Panel in 20 14, we wanted to know: (I) if the United States 

was still vulnerable to the same weaknesses in biodefense that the WMD Commission found in 

2008; and (2) what, if anything, we are doing to heed the advice of that Commission and 

previous panels to take decisive action in defending against biological events of the order that 

could cause catastrophic loss oflife, societal disruption, and loss of confidence in government? 

We held public meetings with more than sixty experts (e.g., current and former lawmakers and 

federal officials, local health department representatives, emergency service providers, 

academicians, business executives, and other thought leaders), We scrutinized the status of 

prevention, deterrence, preparedness, detection, response, attribution, recovery, and mitigation. 

The spectrum of activities that Republican and Democratic Administrations, as well as many 

policy experts, deem necessary for biodefense. We used this expert input, and conducted 
14 


significant additional research, as outlined in the report's Methodology section. We examined the 

national state of defense against intentionally introduced, accidentally released, and naturally 

occurring biological threats and released our findings in our bipartisan report, "A National 

Blueprint tor Biodefense: Major Reform Needed to Optimize Efforts," in October 2015. 

Our findings were clear. We identified substantial achievements in our capacity to defend against 

major biological events, but also found serious gaps in biodefense that continue to leave our 

nation vulnerable. We found that our preparedness is inversely proportional to the severity of the 

threat, such that the more catastrophic the potential consequences, the less prepared we are. 

We also discussed a number of ways we can more effectively address the threat, using resources 

and infrastructure already have in place. For example, while the Strategic National Stockpile has 

its role, we also found that community pharmacies (ubiquitous throughout the nation) possess the 

supply chains, experience with pharmaceutical distribution, and access systems with which the 

public is already familiar. I believe that these could be used to much greater effect during the 

response to a biological event and that they may play a significant role in solving the Strategic 

National Stockpile's inventory management problems. The Institute of Medicine, by mandate of 

appropriations law, is undertaking a detailed examination of this question and related distribution 

and dispensing challenges this week. 

We believe- as did the WMD Commission before us that U.S. biodefense lacks a point person. 

Responsibility for biodefense is one of the federal government's most important functions, with 

pieces falling within national, homeland, public health, and economic security. As such, it 

4 
15 


requires a highly complex and sophisticated enterprise. We have not attained the necessary 

integration of vision and activity. As a result, the activities we undertake arc insufficiently 

coordinated, collaborative, and innovative. Neither the President nor Congress has charged and 

authorized an individual to create a cohesive, effective, and efficient whole of the fractionated 

parts of a dozen departments and agencies responsible for some aspect of biodefense. The last 

three Presidents appointed special assistants, czars, and others, but jurisdictional and budgetary 

authorities, guidance, and accountability eluded the individuals holding these positions. We 

believe that a biodefense leader and the vision, oversight, and accountability that such an 

individual brings- could have prevented or mitigated weaknesses in a wide range of activities, 

including management of the Select Agent Program, implementation of global disease 

surveillance, and rapid response to public health crises. 

Our main recommendation is to install a leader at the highest level of government who 

recognizes the severity of the biological threat and possesses the authority and political will to 

defend against it. We recommend that this top-level leader be the Vice President of the United 

States. The Vice President has a direct line to the President and, when imbued with authority, can 

act as the President's proxy. The primary goal of centralizing leadership is to place coordination 

and oversight responsibility in a location with: ( 1) sufficient jurisdictional and budget authority, 

regardless of personalities or party in power; and (2) executive decision-making ability. The Vice 

President possesses these attributes. We also recommend that the Vice President establish and 

lead a Biodefense Coordination Council, which we envision to be a coalition of public and 

private sector partners who work together to address biodefense requirements. 

(Recommendations 1 and 2) 
16 


We provide 33 recommendations in our report, as well as specific short-, medium-, and longterm programmatic, legislative, and policy actions for each of these recommendations. Each of 

these can improve our Nation's ability to prevent, deter, prepare for, detect, respond to, attribute, 

recovery from, or mitigate biological events. Together, they comprise a blueprint for biodefense. 

I would like to highlight three here: 

I. Strategy development: The nation currently lacks a well-considered and comprehensive 

biodefense strategy. Our top priority must be to develop the National Biodefense Strategy 

of the United States of America. This strategy should be all-inclusive and harmonized, 

identifying all implementation requirements (e.g., Executive Branch organizational 

structures and requirements, lead and supporting roles, modernization and realignment 

plans, and dedicated resources). The strategy should also include a mechanism for 

holding department and agencies accountable for properly executing their responsibilities 

as leads or participants. We recommend that White House staff collate existing strategies 

and plans, identify requirements within extant policies, and assess spending history and 

value. They should then draft a comprehensive strategy that policymakers can use to 

assess where the nation is falling short of meeting strategic goals and objectives. We also 

recommend that the President implement a unified biodefense budget. This will allow the 

President and Congress to determine appropriate resource allocation and conduct 

oversight systematically. (Recommendation 3) 

2. Hospital preparedness: Preparedness of our hospitals rises to the fore each time a 

natural disaster (e.g., Hurricane Katrina) or significant pandemic (e.g., Ebola) occurs. We 
17 


want to see more deliberate and systematic planning. We recommend four areas of focus: 

clinical infection control guidance, tighter management of Hospital Preparedness 

Program funds, development of incentives for hospitals to prepare by linking incentives 

to Centers for Medicare and Medicaid Services reimbursement, and establishment of a 

biodefense hospital system. While these tasks are numerous, a great deal of thinking has 

been done on how to implement them. It is now time to implement. Some of this will 

require legislative authority, or at least encouragement, and we ask you to consider 

moving bills as necessary to achieve these goals. (Recommendations 18-21) 

3. Global health leadership: While our Panel focuses mostly on domestic policy, we 

recognize the foreign origins of many emerging diseases, and the impacts that global 

health has on U.S. health. We further understood that the United States plays an 

important role in global health security. We, therefore, want to see the United States 

renew its leadership role in the Biological and Toxin Weapons Convention by 

strengthening efforts toward implementation, setting goals for the 2016 review 

conference, and developing actionable recommendations for verification. Secondly, we 

propose that the United States should lead a new effort to develop a capable global public 

(and animal) health response apparatus. The World Health Organization is important, but 

it is equally important to recognize what it does not do. It is not an operational response 

organization. The United States should convene global health leaders to develop a plan 

for a new model of response predicated on public-private partnerships. This planning 

could be achieved through the existing multilateral efforts of the Global Health Security 

Agenda. (Recommendations 25 and 33). 
18 


We believe all of our 33 recommendations are necessary to advance national biodefense and our 

other recommendations address a variety of additional issues. For example, enhanced 

intelligence collection, protection of pathogen data and cybersecurity, overhaul of the Select 

Agent Program, support of hospital preparedness and public health preparedness grants, U.S.-Icd 

global health security efforts, and biological weapons prohibition diplomacy will also make us 

stronger- if executed efficiently, effectively, and in concert. 

Congress plays a critical role in conducting necessary oversight and providing needed authorities 

and funding. Our report provides a number of recommendations to amend legislation and 

coordinate congressional oversight. In addition, we provide an extensive list of topics that we 

believe are still in need of oversight, twelve of which we hope you, your colleagues, and the 

Senate will consider. 

Thank you again for the opportunity to appear before you today. We would also like to thank 

Hudson Institute and the Inter-University Center for Terrorism Studies at Potomac Institute for 

Policy Studies, our institutional sponsors, and all of the organizations that supported our efforts. 

We look forward to working with you to strengthen national biodefense. 

Please see our bipartisan report, "A National Blueprint for Biodefense: Major Reform Needed to 

Optimize Efforts" for our 33 recommendations and associated action items. 
19 


Recommendations of the Blue Ribbon Study Panel for Biodefense: 

I. Institutionalize biodefense in the Office of the Vice President of the United States. 

2. Establish a Biodefense Coordination Council at the White House, led by the Vice 

President. 

3. Develop, implement, and update a comprehensive national biodefense strategy. 

4. Unify biodefense budgeting. 

5. Determine and establish a clear congressional agenda to ensure national biodefense. 

6. Improve management of the biological intelligence enterprise. 

7. Integrate animal health and One Health approaches into biodefense strategies. 

8. Prioritize and align investments in medical countermeasures among all federal 

stakeholders. 

9. Better support and inform decisions based on biological attribution. 

10. Establish a national environmental decontamination and remediation capacity. 

II. Implement an integrated national biosurveillance capability. 

12. Empower non-federal entities to be equal biosurveillance partners. 

13. Optimize the National Biosurveillance Integration System. 

14. Improve surveillance of and planning for animal and zoonotic outbreaks. 

15. Provide emergency service providers with the resources they need to keep themselves 

and their families safe. 

16. Redouble efforts to share information with state, local, territorial, and tribal partners. 

I 7. Fund the Public Health Emergency Preparedness cooperative agreement at no less than 

authorized levels. 

9 
20 


18. Establish and utilize a standard process to develop and issue clinical infection control 

guidance for biological events. 

19. Minimize redirection of Hospital Preparedness Program funds. 

20. Provide the financial incentives hospitals need to prepare for biological events. 

21. Establish a biodefense hospital system. 

22. Develop and implement a Medical Countermeasure Response Framework. 

23. Allow for forward deployment of Strategic National Stockpile assets. 

24. Harden pathogen and advanced biotechnology information fi·om cyber attacks. 

25. Renew U.S. leadership of the Biological and Toxin Weapons Convention. 

26. Implement military-civilian collaboration for biodcfense. 

27. Prioritize innovation over incrementalism in medical countenneasurc development. 

28. Fully prioritize, fund, and incentivize the medical countermeasure enterprise. 

29. Reform Biomedical Advanced Research and Development Authority contracting. 

30. Incentivize development of rapid point-of-care diagnostics. 

31. Develop a 21st Century-worthy environmental detection system. 

32. Review and overhaul the Select Agent Program. 

33. Lead the way toward establishing a functional and agile global public health response 

apparatus. 

10 
21 

Mr. MURPHY. Thank you very much. 

Mr. Greenwood, you’re recognized for 5 minutes. 

STATEMENT OF JAMES C. GREENWOOD 

Mr. GREENWOOD. Thank you, Mr. Chairman. I’m tempted to ask 

unanimous consent to insert your opening statement and the opening statement of Ranking Member DeGette as a preface to our report, because it’s gratifying to see how aligned you already are with 

our recommendations. 

So thank you for inviting me to discuss preparedness for biological threats on behalf of the bipartisan Blue Ribbon Study Panel on 

Defense. As the former chair of this subcommittee, I am especially 

honored to be testifying here today. 

The hearing is quite timely, not because a catastrophic biological 

event has recently occurred, but because one has not occurred on 

U.S. soil. Whether it’s the reintroduction of smallpox by a terrorist, 

a dirty bomb in an urban center, or another pandemic influenza 

outbreak, as the Panel notes in our report, we are underprepared 

to respond to these threats, and we must take immediate steps to 

be better prepared. 

It has been a great privilege to serve on the study panel with my 

esteemed colleagues. Our report starts from the premise that the 

biological threat is real and it is growing. While we are better prepared today than we were a decade ago due to Federal and private 

sector investments, the fact is we are still dramatically underprepared. Our report outlines 33 recommendations. And as Secretary 

Shalala stated, we as a Panel all strongly support the first recommendation calling for a centralization of leadership over biodefense in the Office of the Vice President. 

I would like to further focus on the recommendations related to 

strengthening the public-private partnership, as industry plays a 

key role in protecting our Nation. Consider a company with a novel 

technology applicable to the biothreats of emerging diseases identified by HHS. This company wants to partner with the Government. 

But there are so many unique market challenges. Unlike products 

with a viable commercial market, the market for most medical 

countermeasures, or MCMs, is defined and supported solely by the 

Federal Government, making it a major source of research funding 

and the primary purchaser of vaccines, therapies, and diagnostics 

against these unique threats. 

Many companies begin research at their own risk, conducting 

R&D even before receiving Federal Government funds. Over the 

last few years, Government funding for MCM R&D has been decreasing, just as the number of threats have been increasing. The 

investor community views these products as risky and a distraction 

from similar products that have a clear commercial value, making 

it difficult to raise the necessary R&D funds for MCMs in the private capital markets. The regulatory pathway is not always clear. 

Lastly, industry has seen a precipitous drop in the level of funds 

for the purchase of the final MCMs. For many companies the biggest risk is that they will invest significant internal funds and time 

developing a product only to find there is no clear procurement 

strategy from the U.S. Government due to sudden shifts in priorities or dearth of funds. 

22 

Given all this, we strongly support the need for a comprehensive 

multiyear strategic plan and unified budget that clearly outlines 

the priorities for R&D and procurement of medical countermeasures and pandemic influenza products. Such a strategic document would provide much needed transparency on governmental 

priorities and projected requirements, thus helping companies determine what products to pursue in this partnership. 

The MCM enterprise must be fully funded. The Project BioShield 

Special Reserve Fund, the SRF, was created to provide companies 

with a guaranteed market for MCMs by establishing a 10-year advanced appropriation of $5.6 billion. The SRF has indeed proved 

successful in attracting companies to invest in MCM R&D. Twelve 

MCMs were procured during a 10-year period, and there are over 

200 MCMs in the pipeline. But the progress made due to Congress’ initial $5.6 billion in- vestment is now in jeopardy. The SRF was reauthorized at $2.8 billion for fiscal year 2014 through 2018, but rather than a set-aside 

sum of money, the program has been funded through annual appropriations and much lower than the authorized amount. Unless 

funding increases, we are risking a $600 million to a $1 billion 

shortfall. Such a sustained deficit endangers the progress we have 

made and puts the 200 product candidates in the pipeline at risk. 

Similarly, pandemic influenza has been woefully underfunded 

the last few years. Pandemic influenza is a known threat that is 

very challenging given its versatile and persistent nature. It is imperative that our pandemic preparedness include advanced development of vaccines, antivirals, and diagnostics, rapid response capability building, and the replenishment of vaccine and antiviral 

stockpiles. Our plan calls for Congress to provide a legislative authorization to define and guide pandemic influenza programs in 

order to ensure that they receive the funding needed. 

Novel incentives could demonstrate the Government’s commitment to MCM development. One of the most important incentives 

in the report is the priority review voucher, the PRV program, for 

pathogens designated as material threats. The PRV is a proven and 

valuable incentive that has helped to spur investment in other 

complex and neglected areas of R&D, such as neglected tropical 

diseases. An extension of the PRV program to include material 

threats is viewed by many as a way to offset the dramatic decline 

in procurement funding for MCMs. Adding MCM targets to the 

PRV program may help convince investors that the Government is 

committed to this endeavor and provide increased certainty that 

MCMs have value. 

Improvement must be made in the contracting process as well. 

In addition to robust sustained funding, the public-private partnership must be strengthened through improvements to the contracting process within BARDA to make it more efficient and predictable. Streamlining is key to ensuring that there are not excessive delays in the implementation of vital research. 

I therefore call on Congress to swiftly pass H.R. 3299, the 

Strengthening Public Health Emergency Response Act of 2015. 

This bill focuses on many of the issues I’ve raised today and represents a strong initial step toward implementing the recommendations of the Panel. 

23 

This subcommittee plays an integral role through your oversight 

of Federal biodefense programs. I commend the committee’s recent 

attention to pandemic influenza preparedness and the letters the 

committee sent to the administration about flu vaccine supply and 

development and strategic plans. I hope that the Energy and Commerce Committee and this subcommittee continue to exam the 

issues of biopreparedness further. 

The threats facing our Nation are real and many. Having products to support our national preparedness relies on the work of a 

few dozen biopharmaceutical companies. The only way these companies can continue vital R&D and capacity building is if the U.S. 

Government demonstrates a strong commitment to them by providing clear priorities, sustained funding, and real incentives. If we 

invest well now in the broader set of known threats, we will be better prepared to pivot and respond when faced with an unknown 

threat. 

Thank you again for the opportunity to testify on the work of the 

Blue Ribbon Study commission. I commend the subcommittee for 

examining the state of our national preparedness for biological 

threats, and I look forward to your questions. 

[The prepared testimony of Mr. Greenwood follows:] 

24 


House Committee on Energy and Commerce 

Hearing of the Subcommittee on Oversight and Investigations 

"Outbreaks, Attacks, and Accidents: Combating Biological Threats" 

February 12, 2016 

The Honorable James C. Greenwood 

Panel Member, Blue Ribbon Study Panel on Biodefense 

Statement for the Record 

Chairman Murphy, Ranking Member DeGette, and Members of the Subcommittee: 

Thank you for inviting me to discuss preparedness for biological threats on behalf of the 

bipartisan Blue Ribbon Study Panel on Biodefense. As former Chair of the Energy and 

Commerce Subcommittee on Oversight and Investigations, I am especially honored to be 

testifying here today. 

This hearing is quite timely. Not because a catastrophic biological event has recently 

occurred but because one has not occurred. The kinds of events we are here to discuss 

today are health disasters we hope to never see on U.S. soil in our lifetime. Nonetheless, 

we must be prepared for these types of events. A dirty bomb in an urban center. The 

dispersion of anthrax in the metro system. The malevolent reintroduction of smallpox. The 

natural emergence of another Ebola-like disease or another pandemic influenza outbreak. 

As the Panel notes in our report, we are underprepared to respond to these threats and we 

must take immediate steps to address these gaps. 

For the last year, it has been a privilege to join former Senator Joe Lieberman, 

former Governor Tom Ridge, former Department of Health and Human Services (HHS) 

Secretary Donna Shalala, former Senate Majority Leader Tom Daschle, and former 

Homeland Security Advisor Ken Wainstein on the Study Panel. Our goal was to assess U.S. 

capabilities with respect to potentially catastrophic biological events and to identify actions 

to advance our preparedness. We all decided to serve on this Panel, even before the global 

1 
25 


events of the Ebola outbreak unfolded, because of concerns that the nation was 

insufficiently prepared. 

Our report, A National Blueprint for Biodefense: Leadership and Major Reform 

Needed to Optimize Efforts, was released in October 2015. The report starts from the 

premise that the biological threat is real and growing. As you are quite aware, the federal 

government has undertaken many initiatives- especially since the anthrax attacks of 2001 

-to fortify U.S. biodefense capabilities to address this threat. From fielding environmental 

detection units to stockpiling medical countermeasures (MCMs) to building public health 

capacity, we are better prepared today than we were a decade ago. But the fact is, we are 

still dramatically underprepared to respond to a biological event of truly disastrous 

proportions. 

The reason for this is neither lack of interest nor of effort, but a lack of whole-ofgovernment coordination required to achieve this goal. To date, many of the federal 

activities undertaken to improve our preparedness have been implemented in a strategic 

vacuum. There is no comprehensive national strategy for biodefense, and no corresponding 

unified budget for biodefense. As a result, Congress lacks the most important tools it needs 

for thorough biodefense oversight. Without them, the appropriation of funding for the 

enterprise is ultimately limited to discrete agency-by-agency visions for expenditures. 

Further, for biopharmaceutical companies that want to aid in our preparedness, a national 

strategy and unified budget are vital for defining the research and subsequent funding 

priorities that industry needs to plan their investments. 

Consider a company that has a novel technology that could be applied to the biothreats or emerging diseases identified by HHS as threats to the U.S. This company wants 

to partner with the government to address these urgent public health threats but there are 

so many uncertainties and unique market challenges. Unlike products with a viable 

commercial market, the market for most MCMs is defined and supported solely by the 

2 
26 


federal government. Therefore, the federal government is often the only research funding 

source and the only purchaser of vaccines, therapies and diagnostics against these unique 

threats. Many companies begin their research at their own risk, conducting early R&D even 

before receiving government funds in order to better understand the pathogen and the 

disease. Over the last few years, government funding for R&D has been decreasing, just as 

the number of threats has been increasing. The investor community views these products 

as risky and a distraction from similar products that have a clear commercial value, making 

it almost impossible to raise the necessary R&D funds for MCMs in the private capital 

markets. The regulatory pathway is not always clear, especially for an emerging infectious 

disease, and so determining the clinical trial strategy can be complex. Lastly, industry has 

seen a precipitous drop in the level of funds for purchase of the final MCMs. For many 

companies the biggest risk is that they will invest significant internal funds and time 

developing a product only to find there is no clear procurement strategy from the U.S. 

government, foreign governments or non-governmental organizations due to sudden shifts 

in priorities or a dearth of funds. 

Our report outlines 33 recommendations, but today I would like to focus on the 

recommendations related to strengthening the public-private partnership that supports the 

development of MCMs (Recommendations 28-29). Congressional leadership could have a 

powerful impact on the implementation of these recommendations, as well as others. 

For example, we recommend that the medical countermeasure enterprise be 

prioritized, fully funded, and incentivized. As stated above, we strongly support the need 

for a comprehensive multi-year strategic plan and unified budget that clearly outlines the 

priorities for research, development and procurement of medical countermeasures, 

pandemic influenza and emerging infectious diseases. Such a strategic document would 

provide much needed transparency on government priorities and projected requirements, 

thus helping companies determine what products to pursue in the partnership. The unified 

3 
27 


budget would help support the funding requests necessary for our national and global health 

security. 

The Project BioShield Special Reserve Fund (SRF) was created by Congress in 2004 

to provide companies with a guaranteed market for their medical countermeasure products 

by establishing a ten-year advanced appropriation of $5.6 billion. Paired with funding for 

early stage research support from the NIH and the Biomedical Advanced Research and 

Development Authority (BARDA), the SRF proved successful in attracting companies to 

invest in MCM R&D. BARDA reports that 12 MCMs against chemical, biological, radiological, 

and nuclear threats were procured during that ten-year authorization period. There are now 

more than 200 MCMs in the pipeline and' they expect to procure another 12 MCMs by 

2018. 2 

But the progress made due to Congress' initial $5.6 billion investment is now in 

jeopardy. The SRF was reauthorized at $2.8 billion for the period of FY 2014 through 2018, 

but rather than a set-aside sum of money, the program has been funded through annual 

appropriations, and funded much lower than the authorization amount. Congress 

appropriated only $255 million in both FY 2014 and FY 2015. This year, the funding amount 

for the SRF was doubled to $510 million, and industry partners appreciate the commitment 

to the MCM enterprise that this increase demonstrates, especially in a tough fiscal climate. 

Unless funding continues to increase, though, we are risking a $600 million to $1 billion 

shortfall below the authorized level. Such a sustained deficit in funding endangers the 

progress we have made in building up the MCM enterprise and puts the 200 product 

candidates in the pipeline at risk of never being stockpiled for use in an emergency. I hope 

that all Members of Congress will make the Special Reserve Fund a priority by supporting its 

funding throughout the appropriations process each year and exercising oversight to ensure 

that the program is being funded and administered appropriately. 

'R. Robinson. BARDA Industry Day. October 2015. 2 U.S. HHS PHEMCE. Multiyear Budget Fiscal Years 2014-2018. 

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Similarly, pandemic influenza has been woefully underfunded the last few years 

considering the threat posed to Americans by this evolving virus year after year. The 

Centers for Disease Control and Prevention (CDC) estimates that the 2009 H1N1 pandemic 

infected 43 to 89 million people and killed between 8,000 and 18,000 people. 3 Unlike 

emerging infectious diseases, pandemic influenza is a known threat that is particularly 

challenging given the dynamic, versatile and persistent nature of these viruses. It is 

imperative that our pandemic preparedness capabilities keep up with the multiple strains 

that threaten us each year. Constant vigilance in vaccine development and stockpiling, as 

well as surveillance, is essential. We must not let the urgent threat of the moment 

overshadow our efforts to prepare against the long-term and continuous threats from 

pandemic influenza. 

From FY 2004 through FY 2013, pandemic influenza activities at HHS included 

advanced development of vaccines, antivirals and diagnostics, pre-pandemic rapid response 

capability building, and the replenishment of pre-pandemic vaccine and antiviral stockpiles. 

These activities were primarily funded through supplemental appropriations of $6.23 billion 

in FY 2006 and $8.23 billion in FY 2009. It is our understanding that these supplemental 

balances have been nearly exhausted, yet only $72 million per year in FY 2015 and FY 2016 

has been appropriated. The discrepancy in funding stems, in part, from the fact that 

pandemic influenza activities at HHS lack an explicit authorization. Recommendation 28 in 

our plan calls for Congress to provide a legislative authorization to define and guide 

pandemic influenza programs, in order to ensure that they receive the prioritization and the 

concomitant funding required to address this urgent and repeated threat. 

The Report lists several excellent mechanisms that demonstrate the government's 

commitment to development and acquisition of MCMs. One of the most important 

incentives that the U.S. government can use is the priority review voucher (PRV) program 

3 Centers for Disease Control and Prevention. Pandemic Flu History. http://www.ftu.gov/pandemic/history/ 

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for pathogens designated as material threats. The PRV is a proven and valuable incentive 

that has helped to spur investment in other complex and neglected areas of R&D, such as 

rare pediatric diseases and neglected tropical diseases. An extension of the PRV program to 

include material treats is viewed by many companies as a way to offset the dramatic decline 

in procurement funding for MCMs. Adding MCM targets to the PRV program may help 

convince investors that the government is committed to this endeavor and provide 

increased certainty that MCMs can have value in the marketplace. 

As we all learned during the recent Ebola outbreak, it is important to invest in MCMs 

prior to an outbreak. When we try to jumpstart R&D efforts while an outbreak is happening, 

we are already too late. And I would remind this Committee that Ebola had been on the 

material threat list for many years. The scientific process takes years, often decades, and 

science can only be sped up so much. So we must make our best attempts to prepare for 

the broadest possibilities by investing in novel technologies and supporting a strong private 

sector base in infectious diseases that can assist when needed. While we do not know what 

disease will emerge next, if we invest well now in the broader set of known threats, we will 

be better positioned to pivot and respond when faced with an unknown threat. 

In addition to robust, sustained funding, the public-private partnership must be 

strengthened through improvements to the contracting process. Recommendation 29 calls 

for changes to the contracting process within BARDA to make it more efficient and 

predictable, as well as for better coordination between the government agencies who are 

partnering with companies on R&D. Streamlining processes to eliminate unnecessary red 

tape is key to ensuring that there are not preventable and excessive delays in the 

implementation of vital research. Furthermore, these reductions would help companies 

manage their business planning and decrease uncertainty. 

While strong leadership is needed from all branches of government, Congress has an 

important role to play. Congress must exercise its authority on these issues in a more 

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proactive and coordinated manner. This Subcommittee can play an integral role in this 

process by exercising additional oversight over federal biodefense programs. I commend the 

Committee's recent attention to pandemic influenza preparedness and the letters the 

Committee sent to the Administration last year with questions about flu vaccine supply and 

development, healthcare system capacities and strategic plans. The Panel proposes a 

number of Congressional oversight hearings in Appendix A of our report, many of which fall 

into the Energy and Commerce Committee's jurisdiction, such as examining BARDA's 

mission space, the development of a unified biodefense strategy for the federal government, 

bio-surveillance programs, global health response, and MCM innovation, among others. I 

hope that the Energy and Commerce Committee and this Subcommittee continue to 

examine the issue of bio-preparedness further. 

Finally, I'd like to close by specifically calling for the swift passage of H.R. 3299, the 

Strengthening Public Health Emergency Response Act of 2015, which has been introduced 

by Representatives Susan Brooks and Anna Eshoo. Passage of this bill would represent a 

strong initial step toward implementing the recommendations of the Blue Ribbon Study 

Panel. The bipartisan bill includes a number of the Panel's recommendations, including 

streamlining contracting processes, coordinating stockpiling plans, and increasing 

transparency around future MCM funding needs. H.R. 3299 also addresses our 

recommendation that the government identify and institute new, meaningful incentives for 

MCM development. The bill would do so by extending the tropical disease PRV program to 

biological agents included on the Department of Homeland Security's (DHS's) material 

threat list. I hope all the members of this Subcommittee will consider cosponsoring this 

important legislation and actively work to advance it. 

The threats facing our nation are real and many. They are splashed across the 

headlines each day. ISIS has repeatedly threatened the use of biological weapons. In the 

last year, avian influenza has decimated Midwestern poultry flocks and posed the risk of 

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31 


infecting humans. And a new infectious disease seems to emerge regularly, whether it is 

influenza, SARS, MERS, Ebola, chikungunya, or Zika. And we have already had several 

small-scale targeted attempts such as the 2001 anthrax mailings, which required $27 

million just to decontaminate the Hart Senate Office Building. 4 Thus far we have been 

relatively lucky in terms of the impact to our society, economy, and public health, but when 

something happens on a catastrophic scale, the American public will expect the government 

to be ready to respond. 

The good news is that the domestic policy challenges we face are not insurmountable 

and correcting these issues will put us on the road for success and accountability. Once the 

governance structure and the tools are in place, we believe that the entire enterprise will 

run more smoothly, that gaps will be easier to identify, that capabilities will improve. 

Thank you again for the opportunity to testify on the work of the Blue Ribbon Study 

Panel on Biodefense. I commend the Subcommittee for examining the state of our national 

preparedness for biological threats. I look forward to your questions. 

'U.S. GAO. Capitol Hill Anthrax Incident: EPA's Cleanup was Successful; Opportunities Exist to Enhance contract 

Oversight. June 2003. 

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32 

Mr. MURPHY. Thank you, Chairman Greenwood. 

And now, Dr. O’Toole, you’re recognized for 5 minutes. 

STATEMENT OF TARA O’TOOLE 

Dr. O’TOOLE. Thank you, Mr. Chairman. I am very happy to be 

here today to discuss this topic, which has been a preoccupation of 

mine for most of my professional career. I want to thank you for 

your kind introduction and emphasize the views I express are my 

own, not those of In-Q–Tel. 

I want to start by congratulating the Blue Ribbon Study Panel 

on their excellent report, which I hope will be highly influential. I 

especially endorse and share the Panel’s sense of urgency about repairing the country’s vulnerability to highly consequential bioevents. 

Today, I want to briefly address three issues. First, I want to emphasize the nature and the significance of biological weapons 

threats and explain why it is a first-tier national security problem. 

Secondly, I want to describe why naturally occurring epidemics 

almost certainly will increase in frequency and impact in the coming years. Natural epidemics, it is important to understand, are different from deliberate bioattacks. The latter would be faster, fiercer, and it may be that many victims are beyond rescue. But if we 

cannot handle natural outbreaks more effectively and efficiently, 

we have no defense against biological weapons. 

Thirdly, there is a major revolution in our understanding of how 

the biological world works and our ability to manipulate it. The advances in bioscience and biotechnologies should be part of the foundation of U.S. biodefense against both natural and deliberate 

epidemics. These advances are going to be extremely beneficial to 

humankind across many different fields that go beyond biomedicine. But it also means that we now have created a world in which 

there is wide access to advanced biological knowledge and the materials needed to build and disseminate biological weapons. 

As the Defense Science Board said in 2001, an age ago in terms 

of scientific advances, there are no technical barriers to nonstate 

actors, including terrorist groups and lone wolves, carrying out devastating bioattacks that could kill millions and cost billions. But 

these advances in science and in biotechnology also, for the first 

time, give us powerful tools that could allow us to prevent and to 

rapidly detect and quench epidemics, whatever their cause. And 

I’m going to give you some examples of critical technologies which 

might help realize the Panel’s assertion that innovation is a key ingredient and that dramatic improvements in biodefense are within 

reach. 

First of all, the potential destructive power of biological weapons 

is akin to that of nuclear weapons. In 1993, the Congressional Office of Technology Assessment estimated that a kilogram of aerosolized anthrax dropped on Washington, DC, in ideal weather conditions would result in 1 to 3 million deaths. That’s about the same 

toll as a 1-megaton hydrogen bomb. 

These statements are not based on speculation, but on decades 

of development and field testing by the U.S. military during the Offensive Biological Weapons program of the United States, which 

was ended by President Nixon in 1969. We also know that the 

33 

USSR had a massive secret offensive BW program created after 

they signed the Biological Weapons Convention in 1972. These 

were both ambitious, and at least in the case of the U.S., highly 

successful programs. During the cold war, the U.S. field tested 

many different bioweapons in realistic conditions, including releases from air, boats, ships, and subways. Declassified U.S. documents from the ’60s clearly recognized the strategic power of bioweapons. We do not now know the fate of the Soviet effort. 

In the half-century since the U.S. ended its Offensive BW program, there has been a revolution in bioscience. Advances in many 

fields, including pharmacology and aerosol biological, and our ability to read, write, and edit DNA, the code of life, have resulted in 

tremendous beneficial achievements. But these advances have also 

meant the global spread of bioknowledge and access to sophisticated biotechnologies. The materials and know-how needed to build 

a bioweapon have many legitimate uses. These are dual-use technologies, and as the chairman said, this makes the task of collecting intelligence about covert bioweapons programs exceedingly 

difficult. 

We are going to see an increase in the tempo of naturally occurring epidemics, which we can talk about in the discussion. 

I want to end by saying that there are two critical technologies 

that have not gotten sufficient attention in our biodefense program. 

The first is rapid diagnostics, upon which we’ve spent very little 

money and for which there is a very big market problem that 

makes it difficult for private companies to pursue diagnostics. And 

the second is vaccines. 

I see that I am out of time, Mr. Chairman, so I will await your 

questions. Thank you. 

[The prepared testimony of Dr. O’Toole follows:] 

34 


U.S. House of Representatives 

Committee on Energy and Commerce 

Subcommittee on Oversight and Investigations 

Outbreaks, Attacks and Accidents: Combatting Biological Threats 

February 12, 2016 

Testimony of Tara O'Toole, MD, MPH; Executive Vice President, In-Q- Tel 

Introduction 

Chairman Murphy, Ranking Member DeGette, and members of the committee, thank 

you for the opportunity to address the vital issue of the national security threats 

posed by biological attacks and natural epidemic disease. I am a physician and 

public health professional. From 2009-13, I served in the Department of Homeland 

Security as Under Secretary of Science and Technology, and as Assistant Secretary 

for Environment, Safety and Health in the Department of Energy from 1993-7. In the 

decade between government positions, I was a Professor of Public Health at johns 

Hopkins University and Professor of Medicine and Public Health at the University of 

Pittsburgh. In each of these positions I helped found and directed university centers 

devoted to understanding the threat of bioterrorism and of epidemics of infectious 

disease, and how such events might be prevented or mitigated. 

Currently, I am executive vice president at ln-Q-Tel, a non-profit organization 

created by Congress in 1999 that provides the US Intelligence Community with 

access to innovative small companies in the private sector. My current project 

focuses on identifying existing and emerging technologies emerging from the life 

sciences that could significantly improve the nation's ability to rapidly detect and 

quench destabilizing epidemics, whether natural or engineered. 

I wish to congratulate the members and staff of the Blue Ribbon Study Panel on 

Biodefense for their important- and hopefully highly influential - report, A National 

Blueprint for Biodefense. I especially endorse and share the Panel's sense of urgency 

about repairing the country's vulnerability to highly consequential bioevents. We 

have lately been reminded of the potentially devastating effects of natural epidemics 

and terrible losses and disruption they impose. As the Blue Ribbon Study Panel 

wrote, 

The biological threat has not abated. At some point, we will be attacked with a 

biological weapon and will certainly be subjected to deadly naturally occurring 

infectious diseases and accidental exposures, for which our response will be 

insufficient. There are two reasons for this: 1) lack of appreciation for the extent, 

severity and reality of the biological threat; and 2) lack of political will. These 

conditions have reinforced each other. 

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-A National Blueprint for Biodefense, Bipartisan Blue Ribbon Study Panel on 

Biodefense, October, 2015, p.3 

Today, I will address three points: 

1) The coming decades will include more frequent and more disruptive epidemics 

due to naturally occurring infectious disease as a result of population and 

commercial pressures. 

2) The deliberate usc of biological weapons, whether by nation states, terrorist 

groups or lone wolf actors, represents a strategic threat to US national security. The 

potential destructive power ofbioweapons is equivalent to that of nuclear weapons, 

and advances in science and technology have removed any technical barriers to 

building and disseminating highly lethal bioattacks over large areas. Yet, as the Blue 

Ribbon Panel emphasizes, the U.S. has not moved with determination to reduce our 

vulnerability to such attacks. 

3) The "revolution" in biological science and biotechnologies now underway could -

with sufficient foresight, imagination and resources -be used to rapidly detect and 

quench epidemics- whether from natural causes or bioterror. I will suggest some 

critical technologies which might help realize the Study Panel's assertions that 

"dramatic improvements [in biodefense] are within reach". 

The Frequency and Impact of Natural Infectious Disease Outbreaks is 

Increasing 

The world is increasingly likely to face an increasing tempo of epidemics of 

infectious disease in the 21st century, and these epidemics are more likely to spread 

quickly and be socially and economically disruptive. As a consequence of expanding 

populations and commercial pressures causing human intrusion into once remote 

ecosystems, people have come in contact with new microbes such as Ebola and 

HIV I AIDS. Two thirds of the more than 30 newly emergent diseases of the past 20 

years have been zoonoses - diseases which infect both animals and humans - and 

the majority of zoonoses arise from wildlife. 

Many other factors contribute to the increased risk of epidemics, including the rise 

of "megacities", where tens of millions of people Jive without clean water, basic 

sanitation or adequate nutrition and in close contact with animals they raise for 

food or buy in wet markets. Highly interconnected and rapid global patterns of trade 

and travel also facilitate the spread of disease. SARS, for example, a virus that 

originates in bats, "jumped" to humans in 2003. A single person infected with SARS 

transmitted the virus to four others staying in the same Hong Kong hotel. These 

individuals then traveled to four continents within 24 hours. The total cost of this 

relatively small epidemic- only 8000 cases occurred worldwide before public 

health officials halted the outbreak- was estimated to cost the affected regions 

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about $60 billion in gross expenditures and business losses over just a single 

quarter in 2003. 

Other infectious disease outbreaks are spread by insects, usually mosquitoes or 

ticks, as we are witnessing now with the Zika virus outbreak in South America, and 

as we have seen with mosquito-borne West Nile virus which was discovered in the 

US in 1999 and is now indigenous across the continent, as well as with Dengue and 

Chikungunya. Some infectious diseases seem to lie dormant for years, only to "reemerge". Others are caused by microbes that mutate into new forms to which 

humans lack immunity or which are resistant to once useful antibiotics or vaccines. 

Influenza virus, which continuously mutates, necessitating frequent changes the 

molecular targets of flu vaccine, is the poster child of viral mutation. 

Biological Weapons are a Strategic- and Growing- National Security Threat 

There is a long and well documented history of biological weapons use, although it 

was not until the Cold War that technology enabled the creation of bioweapons with 

a strategic reach. Both the US and the USSR had ambitious offensive bioweapons 

programs. President Nixon ended the US program in 1969. The USSR created 

Biopreparat, a secret, sophisticated, large-scale offensive BW program after signing 

the Biological Toxins and Weapons Convention in 1972. Details of Biopreparat were 

revealed by defectors in the 90s, and included the production and stockpiling of tons 

of the bacteria that causes anthrax and smallpox virus, and engineering drugresistant pathogens. The current status of Russian offensive or defensive 

bioweapons efforts is unknown, though it does retain closed biology labs under 

military control. 

Although the history of the US offensive bioweapons program is not widely 

remembered, the program was ambitious and highly successful. During the Cold 

War, both nations considered aerosolized bioweapons to be adjuncts to nuclear 

weapons attacks. The US field-tested many different bioweapons in realistic 

conditions, including releases from air, boats, ships and in subways. Nowdeclassified documents from the US Department of State written in 1975 recognized 

the strategic potential and possible terrorist use of these weapons: 

"Certain biological agents appear to pose as great a threat to human life as 

thermonuclear weapons. They appear to be at least as effective and are available to 

terrorists." 

-Mass Destruction Terrorism Study, Dept. of State, 9/19 /75; E.O. 12958, as 

amended; Declassified 8/10/2010 

In 1993, the Congressional Office of Technology Assessment calculated that 100 

kilograms of aerosolized anthrax released in Washington, DC under ideal weather 

conditions would cause approximately as many deaths as a one megaton hydrogen 

bomb. Common appreciation of the proven destructive power ofbioweapons has 

been warped by the experience of the 2001 anthrax mailings, which employed gram 

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amounts of anthrax in a very ineffective delivery device. Although the impact of 

these attacks included 5 deaths and effectively terrorized the nation, the 2001 

attacks are not an accurate reflection of the lethality of what was contained in those 

envelopes. 

This is not the place for a detailed examination of the US Offensive Weapons 

program, but the 25 year history of this program yielded important scientific 

understanding ofbioweapons and their effects. Many important discoveries are not 

yet integrated into US biodefense plans. For example, a well-prepared bioweapon -

using 1960s technologies -would likely deliver a much higher dose of virus or 

bacteria than would a natural infection, greatly reducing the "incubation" time 

between exposure and symptoms, and possibly inciting an overwhelming systemic 

infection that could not be successfully treated with antibiotics. Very high exposure 

doses might also thwart protection from vaccines, and could alter the manifestation 

of illness in ways that make clinical diagnosis difficult. 

The US and Soviet Cold War, state-sponsored bioweapons programs were ambitious 

military efforts (Biopreparat employed 50,000 people at its peak), which required 

significant innovation and experimentation given the era's limited understanding of 

biological science and biotechnology. Since then, there has been a veritable 

revolution in our understanding of and ability to manipulate Jiving organisms. These 

advances have occurred in pursuit of new ways to treat diseases, including the 

search for new drugs and new ways to deliver them. 

As the Defense Science Board reported in 2001, the technical barriers which 

confronted bioweapons efforts in the 60s no longer pose barriers to terrorist groups 

mounting large-scale bioattacks: 

... Major impediments to the development of biological weapons - strain availability, 

weaponization technology and delivery technology - have been largely eliminated in 

the last decade by the rapid, global spread of biotechnology." 

Defense Science Board, Biological Defense, June 2001. p.18 

But these dual-use technologies have made successful creation and dissemination of 

a bioattacks by non-state actors far more feasible than was the case in 2001. 

Advances in pharmacology, in aerosol biology (essential for the protection of crops 

and for inhalation delivery of drugs), and in our ability to read, write and edit the 

genetic code - the "code of life" - have resulted in global spread of biological 

knowledge and the use of biotechnologies. 

The materials and know-how needed to build and disseminate a powerful biological 

weapon are now cheap and widely available in commercial markets. Advances in 

biotechnology continue to increase accessibility to this knowledge, making assembly 

and dissemination of such weapons simpler and more fool-proof. As technologies 

mature, they become more accessible, easier to use. Biological techniques that once 

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required great skill and effort are now available in handy kits one can buy on the 

Internet and are used by scientists, technicians and amateur biologists around the 

world. Moreover, because bioweapons are self-replicating organisms, adversaries 

could easily develop multiple weapons, increasing the scale or number of attacks. 

It is important to recognize that the knowledge and materials needed to build and 

disseminate a biological attack have many legitimate uses. This makes the task of 

collecting intelligence about covert biological weapons programs exceedingly 

difficult, as the Silberman/Robb Report on Weapons of Mass Destruction Intelligence 

Capabilities made clear. Moreover, assigning attribution for bioattacks will be 

exceedingly difficult unless we catch the perpetrators in the act. 

Finally, the burden of defending against bioattacks or natural epidemics falls on the 

medical and public health communities. These systems are already highly stressed, 

fragmented, and under resourced, and largely not under federal control. The US lost 

over 50,000 state public health officials since 2008 as a result of the financial 

downturn. As we saw with our 2009 experience with HlNl influenza, and again 

with last year's Ebola crisis, even the United States has a very limited capacity to 

make effective vaccines in time to make a difference. 

Towards an Effective Biodefense 

It is essential that the country become more effective and efficient at preventing, 

detecting, mitigating and quenching epidemics, whether natural or man-made. The 

Blue Ribbon Panel on Biodefense makes dozens of recommendations and advocates 

a more muscular and centralized leadership of US biodefense programs now 

scattered across multiple federal agencies. 

l would like to offer for Congress' consideration, a few suggestions about how we 

might build a robust biodefense. 

Disease Surveillance Requires a Strategy, Rapid Diagnostic Tests, and 

Sustained Funding 

Needed: Strategic Approach to Biosurveillance 

The BRP rightly describes surveillance as a "foundational" capability of public 

health. But "surveillance" is a broad term used to describe many purposes and 

approaches. Multiple efforts over decades on the part of many smart and dedicated 

people, and investments of billions of dollars have brought some progress, but have 

not dramatically improved the nation's ability to see epidemics coming or to attain 

useful situational awareness once they arrive. 

We need to plan and execute a strategic approach to epidemic surveillance that is 

practical and sustainable and balanced between the need to detect emerging 

epidemics and predict their course, and the need to provide actionable situational 

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awareness once epidemics or bioattacks are underway. We should begin with a 

rigorous examination of why so many surveillance projects have failed or delivered 

disappointing results -and what has worked. 

Pro-M ED- Program for Monitoring Emerging Diseases 

One bio-surveillance approach, which spotted and warned of several emerging 

diseases- including SARS, MERS and Zika- before WHO or governments did so, is 

ProM ED, which is a non-profit effort, now supported by the Infectious Disease 

Society of America, which receives email reports about disease events around the 

world and posts these messages on email. ProMED has been a uniquely useful 

surveillance tool, and has repeatedly shown its worth in spite of its small size and 

lack of complex analytics. It survives on a very small budget which it strains to meet 

from private donations and other non-profits. The secret sauce of ProM ED has been 

attributed to its network 70 volunteer professionals- physicians, veterinarians, and 

plant scientists from around the world- who review and monitor incoming 

messages, using their own networks to deciding what to post and offering added 

details or explanation. This "human intelligence" helps make ProM ED's reports 

more trusted- and crucially, actionable. 

NBIS- the National Biological integration System 

I urge caution before the country invests further in a complex DHS surveillance 

program called NBIS- the National Biological Integration System -that is supported 

by the Study Panel. NBIS was first conceived over a decade ago, I believe on the 

basis of erroneous assumptions about the availability and usefulness of digitalized 

health information, overly optimistic expectations about what data could be 

collected and analyzed by the federal government and how meaningful such data 

would be to decision makers. Long experience across the federal government has 

shown that large, ambitious electronic information systems are difficult to build and 

often fail. GAO has documented many reasons for these failures, including unclear 

goals, rapid turnover among inadequately skilled project managers, failure to 

consult with stakeholders, inadequate funding, etc. I suggest that this program 

should be part of the strategic review of surveillance programs and should proceed 

only after we know what, exactly, we are building, how it will work, and who will 

use it. 

OneHealth -Animal and Human Health are Intertwined 

As the Study Panel emphasizes, we must do a far better job on surveillance of 

animals in the wild and in agriculture since the majority of newly emerging diseases 

originate in animal populations. The likely "hotspots" for spillover of animal 

diseases into humans are those places where large communities of animals and 

humans converge: the jungles and forests in tropical zones of Africa, South America 

and Southeast Asia. Most of our surveillance efforts are, however, focused on 

temperate zones, and on human disease, so that zoonoses such as SARS, MERS, 

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40 


Nipah virus, etc. are not recognized until a critical mass of human illness becomes 

apparent. 

Months or even years may pass before animal disease "spills over" into human 

populations. We should take advantage of this "long fuse" to prepare for oncoming 

outbreaks- or even better, to stop them. Rapid genomic screening technologies 

offer new approaches to understanding animal diseases, but field surveillance in 

general is terribly underfunded, as are established USDA and Dept. of Interior 

programs for monitoring agricultural and wild animals. 

Rapid Diagnostics Tests- Critically Important Tools for Epidemic Control 

As we saw with Ebola and are seeing now with Zika, it is very difficult to make sense 

of what is happening or to control epidemics without rapid diagnostic tests that can 

distinguish who is truly infected with the pathogen in question -and needs to be 

isolated or treated -and who is not. Rapid diagnostic tests that can be used in the 

field or at clinical points of care without requiring elaborate laboratory facilities are 

an essential strategic tool in quenching epidemics. 

The lack of such rapid diagnostics greatly increased the toll and duration of the West 

Africa Ebola epidemic. Our inability to accurately diagnose Zika virus infection is 

hampering our ability to understand what is happening in South America. We have 

many innovative technologies for creating new diagnostics, but market forces do not 

reward investments in this area. The regulatory hurdles for licensing a new 

diagnostic are sometimes unclear, and as challenging as those for new drug, but 

diagnostics yield a much smaller return on investment. Plus, current health care 

billing practices do not value diagnostics. Until the Ebola crisis of last year, BARD A 

had not invested in diagnostic development. This must change. 

I have repeatedly written and testified before Congress on the subject of BioWatch, 

and would be fairly considered a critic of the program. The governing concept of 

BioWatch, a collection of environmental sensors located in cities and critical locales 

across the US and intended to detect specific, aerosolized bioweapons agents, is that 

detection of airborne agents will enable an earlier "response" to a bioattack and thus 

save lives. BioWatch was first deployed in 2003, but over the years, questions have 

been raised as to whether BioWatch detections are reliable and actionable; whether 

investments in BioWatch sensors are cost-effective or sustainable, and whether 

BioWatch detections will really speed "response times". A recent GAO report 

examines in detail some of the technical problems associated with prototypes of the 

"next generation" BioWatch technology being funded by DHS. The decade-plus 

experience with BioWatch operations has also revealed a number of practical, 

operational and strategic problems with the program that also deserve attention 

before we embark on a new, expensive and technologically complex surveillance 

program. 

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Vaccines are Essential to Epidemic Response 

The US should strongly consider pursuing an ambitious strategy to take advantage 

of recent developments in bioscience to rapidly develop, test and manufacture 

vaccines against emergent infectious diseases. This would require a consolidated 

approach to vaccine development and testing, and the engagement of both small 

innovative companies and big Pharma companies. The US should endeavor to 

determine the best ways to design vaccines against new pathogens, create efficient 

safety testing protocols under NIH supervision, and seek to improve the speed and 

lower the risk of large scale manufacturing. 

Vaccines have long been recognized as among the most effective interventions in 

modern medicine. Vaccines are the most cost-effective and efficacious ways to 

protect against large, lethal epidemics of infectious disease. An effective vaccine was 

the key to the eradication of smallpox in 1970. 

Bioscience has since generated many new and exciting vaccine technologies - we 

actually have an "embarrassment of riches" in this field according to Dr. Phil Russell, 

an eminent vaccine specialist and former head of Walter Reed and the US Army 

Medical Research Institute for Infectious Diseases. But the country currently has no 

effective strategy for taking advantage of these new technologies. Vaccines take time 

to develop, in part because human trials of safety and efficacy are needed before 

they are used in the field. If they have not been fully tested and are sitting in a 

stockpile- an expensive business- then they must be manufactured by big drug 

companies who set aside their business plans to make emergency products or by 

"warm base" manufacturing plants which are built specifically to "stand ready" to go 

in times of need- also a very costly proposition. 

Many small biotech companies are engaged in this field and eager to help- these 

companies are scientifically cutting-edge and agile enough to quickly design new 

approaches to fit emerging problems. But innovative small companies need reliable 

funding streams to produce their products. They cannot wait for months or years 

while the government contracting and acquisition system grinds away. Several 

Ebola vaccines were being slowly advanced over years before the West African 

crisis- both DOD and HHS were funding such vaccines, but funds were limited, and 

no human safety testing had occurred when the magnitude of the 2015 crisis 

became apparent. 

Manufacturing vaccines at scale requires the skills and facilities of big 

pharmaceutical companies such as Merck and Glaxo-SmithKline (GSK), and these 

companies rather heroically leaped into action to produce enough Ebola vaccine for 

initial trials and use. HHS, NIAID and FDA as well as the involved companies also 

performed well once the crisis was upon us. But the process itself was complicated 

and messy and required a lot of negotiation -among multiple US actors and abroad. 

We need a much smoother and more understandable and predictable decision 

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42 


process. Vaccine design and production is one area in which a consolidated US 

government approach would be valuable. The US government must also establish 

more predictable, transparent and efficient ways of partnering with the private 

sector. 

The january 1, 2016, cover story of Science magazine was titled "Unfilled VialsScientifically Feasible Vaccines Against Major Diseases are Stalled for Lack of 

Funds." Science polled 50 experts who ranked the top 10 vaccines in order of R&D 

priority based on feasibility and need. There is a broad consensus about which 

vaccines would work and which would address a pressing public health need. What 

is missing is a methodical process and funding mechanism from moving these 

vaccines from "the freezer to the field". A collaboration between government and 

industry to design, test and stockpile vaccines against the ten pathogens most likely 

to cause large, lethal epidemics is not a crazy idea. It would cost more than the 

country has traditionally spent on all of biodefense. 

Until we come up with a coherent strategy for rapid design and manufacture of 

effective vaccines, the US defense against lethal epidemics -both naturally 

occurring and due to bioterror attacks- will rely mostly on nineteenth century 

public health methods of contact tracing and isolation. The mortality rate among 

Ebola victims who made it to modern hospitals and received state-of -the -art 

supportive care was much lower than the death rate in Africa. In a big epidemic, a 

very small percentage of Americans will be accommodated in intensive care units. In 

such a situation, vaccines are the world's best bet. Let's get serious about using 

American ingenuity to create them. 

Today, the digital revolution of the 20th century is converging with extraordinary 

advances in bioscience to create a "biorevolution" that will have immense benefits 

for humankind. Bioscience and biotechnology is fueling critically important 

discoveries in medicine, but biology will also be key to solving many of the major 

problems confronting us- providing safe and sustainable food supply; enhancing 

pollution free manufacturing; creating new sources of energy; dealing with an 

increasingly ageing population. As the Economist magazine wrote, "Biology will be to 

the 21st century what physics was to the 20th." It is past time to use one of the United 

States' greatest strengths - our ability to innovate- and turn it towards building a 

robust and enduring biodefense. 

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Mr. MURPHY. Thank you. 

Now we recognize Dr. Parker for 5 minutes. 

STATEMENT OF GERALD W. PARKER, JR. 

Dr. PARKER. Thank you. Good morning, Chairman Murphy and 

Ranking Member DeGette. And thank you for the invitation to appear before you today. It is an honor to be here with Secretary 

Shalala and Congressman Greenwood, who are representing the 

Blue Ribbon Panel, and Under Secretary O’Toole, who is one of our 

Nation’s highest regarded biodefense leaders. 

I put an exclamation point on the bioterror threat. For my part, 

I’ve been involved in biodefense since 1982 to the present, from the 

cold war to the rise of violent extremism, and the rapidly growing 

risk of naturally occurring transboundary emerging infectious diseases. I have been at the eye of the storm witnessing the evolving 

biological threat over my career. 

Today, I am more concerned than ever about the risk of biological threats, including biological warfare, bioterrorism, and emerging infectious diseases. Biological threats are serious, whether naturally occurring, from an attack, or accidental release. The American public is starting to realize the threat of emerging infectious 

diseases following Ebola and now presumably Zika. Although the 

threat of biological warfare, and particularly biological terrorism, is 

very real too, it is less well understood. 

If there’s any good news here, the number of countries thought 

to be conducting some type of illicit biological weapons activity, it 

has gone down from the end of the cold war from about 12 to 5. 

But those countries include China, Iran, Russia, Syria, and North 

Korea, and their operational scenarios for use are no longer limited 

to military targets. 

Today, the risk from a bioterror attack from nonstate actors, violent extremist groups, or individuals on civilian populations is a reality. Biological weapons are sometimes called the poor man’s atom 

bomb, a term first used during the cold war because biological 

weapons, as we have heard, have the potential to cause mass casualties on the scale of a nuclear weapon. But even a simple bioterror attack, as we heard earlier today, can have devastating consequences, such as occurred from the anthrax letter attacks in 2001 

that took 5 lives, sickened 17 more, and over 32,000 people took 

antibiotics because of potential exposure, and it could have been 

much worse from that simple attack. 

Some question the seriousness of the risk today because further 

bioattacks have not followed. And fortunately additional attacks 

have not occurred, which I partially attribute to successful counterterrorism strategies. Why further attacks have not occurred given 

the relative ease of mounting such an attack, coupled with our vulnerability, is up for debate. 

I do not want to overstate and particularly underestimate the 

threat and risk of a biological attack, and I also cannot predict the 

future. But we cannot ignore that extremists intend to do us harm 

by any means, and they are not morally constrained in the methods they use. The intent to acquire and use weapons of mass destruction by the likes of Al Qaeda, ISIL, and others is known. Intelligence gathering is extremely difficult to detect a biological capaVerDate Mar 15 2010 10:45 Apr 24, 2017 Jkt 037690 PO 00000 Frm 00047 Fmt 6633 Sfmt 6633 I:\114THCONGRESS\114X117BIOTHREATSJKTREQ022117\114X117BIOTHREATSPENDIN
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bility and imminent threat, but we should not take the lack of intelligence as lack of threat. The discovery of an ISIL computer containing plans to develop plague as a bioweapon should give us 

pause. Just this week the Director of National Intelligence confirmed reports that the Islamic State used a chemical warfare 

agent in Iraq and Syria. 

The Islamic State is growing rapidly, has resources, controls necessary infrastructure and safe havens, and is recruiting scientists 

that could be capable of developing chemical and biological weapons. It may also be only a matter of time before a biologist becomes 

a self-inspired violent extremist. We must assume the threat is real 

and serious. 

In addition to bioterror attacks, naturally occurring emerging infectious diseases continue to happen with greater frequency. Pandemic potential influenza viruses, SARS, MERS–CoV, West Nile 

Virus, Chikungunya, dengue, Ebola, and now Zika are real experiences that tell us we may be on the verge of a global pandemic any 

time. Our biological threat preparedness response enterprise must 

also be ready any time. 

Biological threats are not new, but we seem to pay attention only 

when an outbreak occurs or an attack occurs and ignore it between 

outbreaks. The time between outbreaks, or the interepidemic period, though, is precisely when urgent actions are needed to optimize resources to hone our preparedness and response systems. 

Before closing, I would also like to add that initiatives in global 

health security and One Health are critical too, and they enable 

work in the prevention side. I would like to thank the members of 

the subcommittee again for this opportunity, and I’m happy to answer any questions you may have. Thank you. 

[The prepared testimony of Dr. Parker follows:] 

45 


Hearing of the House Committee on Energy and Commerce 

Subcommittee on Oversight and Investigations 

February 12, 2016 

Statement for the Record 

Gerald W. Parker, Jr, DVM, PhD 

Chairman Murphy, Ranking Member DeGette and Members of the Subcommittee: thank 

you for inviting me to present at this hearing, Outbreaks, Attacks and Accidents: 

Combating Biological Threats. 

1 am honored to testify and share my experience on the evolving biological threat 

before you today, and to be here with Secretary Shalala and Congressman Greenwood 

who will report on the Biodefense Blue Ribbon Panel study, "A National Blueprint for 

Biodefense: Leadership and Reform Needed To Optimize Efforts." 1 am also honored 

to be here with Under Secretary O'Toole. one of the Nation's highest regarded leaders 

in biodefense. 

For my part, I have been involved in biodefense since 1982 to the present- from the Cold 

War to the rise of violent extremism; and the rapidly growing risk of naturally occurring, 

trans-boundary emerging infectious diseases. I have been at the eye of the storm 

witnessing the evolving biological threat over my career. Today, I am more concerned 

than ever about the risk of biological threats including biological warfare, bioterrorism 

and emerging infectious diseases. Although we are much better prepared today, the recent 

Ebola response indicates we have a long way to go. 

There are three messages that I would like to make to the Committee: 

1. Biological Threats are real, and the bioterror threat has the potential to cause mass 

casualties on a scale similar to a nuclear weapon 

2. The inter-epidemic period requires urgent action to optimize available resources 

and biopreparedness 

3. Strong centralized leadership will be necessary to drive urgent action in the interepidemic period 

In recorded history, communicable diseases decimated populations on many occasions, 

and nations harnessed their power to create powerful biological weapons in the 20'h 

century. Some in the scientific community once thought that infectious diseases were 

conquered after the advent of antibiotics and vaccines, such as smallpox and polio 

vaccines. The global community similarly thought the world would be free of 

biological weapons after the Biological and Toxins Weapons Convention (BWC) went 

into force in 1975. Unfortunately, those projections were wrong. 
46 


Antimicrobial resistance has emerged rapidly, and newly emerging and reemerging 

infectious diseases with devastating consequences are the new normal, as we saw last 

year with Ebola and as we arc seeing now with MERS-CoV and, potentially, Zika. 

Biological weapons development and stockpiling continued even by signatories of the 

BWC, some on a massive scale such as the former Soviet Union; and biological weapons 

proliferation continues to be a major concern and threat today. The Department of State 

assesses that China, Iran, North Korea, Russia and Syria continue to engage in illicit 

biological weapons activities, and are failing to comply with the BWC. 

Biological threats are not new, but we seem to pay attention only when an outbreak or 

attack occurs, and ignore it between outbreaks. The time between outbreaks - or the 

inter-epidemic period - is precisely when urgent actions are needed to optimize 

preparedness and response systems. However, the current strategy appears that we wait 

for an outbreak to occur before initiating urgent actions, to include providing emergency 

appropriations instead of taking urgent actions to optimize available resources and 

improve outcomes during the inter-epidemic period. The current approach is akin to 

fighting the last outbreak instead of properly preparing for the future one. More 

importantly, this is the exactly the scenario that the passage of Pandemic and All 

Hazards Preparedness Act (PAHPA) and the creation of the Biomedical Advanced 

Research and Development Authority (BARD A) in 2006 was meant to change. 

Congress did act to create a program to prepare the Nation during this inter-epidemic 

period, yet we continue to operate in "crisis mode" seemingly every year. 

While many hazards plague the modern world, I believe those rooted in modern 

microbiology are among the most dangerous. I am well aware that your committee must 

address many issues well beyond this topic, and it can be difficult prioritizing 

competing demands. But through your work on biodefense and emergency public 

health preparedness you are well aware of the impact of emerging infectious diseases 

and bioterror threats. You are also aware that solutions to these threats require a 

multidisciplinary, integrated team approach through an enterprise that spans national, 

state, local and tribal governments, as well as industry, academia, other NGOs, families 

and individuals. 

The Evolving Biological Threat: When the BWC went into force in 1975, the 

capabilities of nation states to develop and stockpile biological weapons were 

unquestioned. Biological warfare, and now bioterrorism, has the potential to cause 

mass casualties on the scale of nuclear weapons. Biological weapons, also known as 

the ''poor-man's atom bomb" are far less costly to produce and the weapon payload 

microbial pathogens- are readily available from nature, can be developed in 

clandestine laboratories with far less technical barriers and delivered by relatively 

simple and available devises. 

The United States engaged in a biological warfare program from 1943 to 1969 not only to 

develop biological weapons for offensive use, but also to develop countermeasures to 

defend against the use of biological weapons by the former Soviet Union and other 

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47 


enemies. The United States terminated the offensive biological weapons program in 

1969 largely on moral grounds, and because the use of biological weapons was not the 

best weapon to achieve tactical military objectives- not because they were not effective 

strategically. 

Recent re-analysis and modeling/simulation of data from technical reports of that era 

provide new insights on the mass casualty potential of pathogens used as weapons on 

civilian populations. Today, 4 decades after the BWC went into force, modern 

biotechnology and molecular biology know-how that was once were the domain of only 

nation states, is now available to non-state actors and disaffected small groups of 

scientists around the world, even individual scientists. 

In 1995, the citizens of Tokyo and the world were awakened to the reality of chemical 

terrorism. The Aum Shinrikyo extremist cult in Japan unleashed a crude, but effective 

sarin chemical weapon on the Tokyo subway system, killing 12 and injuring over a 

thousand people causing wide spread panic. Law enforcement and other investigators 

learned after the attack that the Aum Shinrikyo also unsuccessfully attempted anthrax 

bioterror attacks. Fortunately their bioterror attacks failed, but only because the Aum's 

biologists selected an avirulent anthrax vaccine strain. Otherwise, there could have 

been an untold number of anthrax casualties. 

On the heels of the Aum Shinrikyo attacks declaring the reality ofWMD terrorism and 

reported proliferation of biological warfare scientific expertise and materials, 

bioterrorism first became a major national security concern. 

Public health authorities similarly became alarmed because local public health would be 

on the frontline of a bioterror attack in the United States. The laboratory response 

network, the strategic national stockpile and training on the medical management of 

biological casualties were established in 1998 that began bioterror preparedness for the 

civilian population. But, interest quickly waned and concerns were voiced that 

bioterror preparedness was taking away from day-to-day public health. Progress on 

bioterror preparedness stalled until the anthrax letter attacks in 200 l in the wake of the 

tragic events of September II th that began the era of catastrophic terrorism on the 

United States Homeland. 

The anthrax letter attacks marked the first significant act of bioterrorism in the United 

States. That attack was one of the easiest bioterror attacks to confront, yet the impact 

was far reaching. As bad as it was, it could have been much worse had the pathogen 

involved been a contagious agent, resistant to antibiotics, an unknown pathogen, or 

delivered in a covert widespread aerosol attack across multiple jurisdictions. As it was, 

the anthrax letters shut down the Hart Senate Office Building for three months, wreaked 

havoc with the U.S. Postal Service, reduced business productivity, cost the nation more 

than one billion dollars, and most importantly, took five lives and sickened seventeen 

more. More than 30,000 people required post exposure antibiotics and countless more 

worried well casualties. The medical, public health, law enforcement, and 

intelligence responses were massive across public and private sectors. Although the 
48 


response enterprise worked very hard and with the best available knowledge at the 

time, serious weaknesses were revealed in almost ever aspect of the response. 

The Executive and Legislative Branches scrambled to respond and improve the nation's 

biodefense posture. We created new programs, increased laboratory and other needed 

capacities, developed and stockpiled medical countermeasures, increased budgets, hired 

experts, established public health and hospital preparedness programs for infectious 

disease control and training, re-oriented parts of our intelligence and law enforcement 

enterprises. In general, we took the threat seriously for a few years and made significant 

biopreparedness progress. The focus then waned as years went by. 

Some question the seriousness of the threat today because further bioattacks have not 

followed. Fortunately, further attacks have not occurred, which I partially attribute to 

successful counter terrorism strategies. 

Why further attacks have not occurred, given the relative ease of mounting such an 

attack coupled with our vulnerability is up for debate. I do not want to overstate nor 

underestimate the threat and risk of a bioterror attack. But, we cannot ignore that 

violent extremists intend to do us harm by any means, and they arc not constrained in 

the methods they select to use. The intent to acquire and use weapons of mass 

destruction by the likes of AI Qaeda, the Islamic State of Syria and the Levant (ISIL) 

and others is known. Intelligence gathering is extremely difficult, particularly for the 

bioterror threat, but we should not take the lack of tactical intelligence as lack of a 

threat. It may be that violent extremist groups so far have yet to recruit an individual 

with the necessary skills, or that a biologist has not become a self inspired violent 

extremist. We ignore this threat at our peril. 

As reported by RolfMowatt-Larssen in a study from the Harvard Kennedy School's 

Belford Center for Science and International Affairs, "The AI Qaeda Weapons of Mass 

Destruction Threat: Hype of Reality", senior AI Qaeda leadership were committed to 

acquiring nuclear and biological weapons for their strategic mass casualty potential, 

and they collaborated with the most senior leaders of other extremist groups indicating 

that this intent is not limited to just AI Qaeda. 

The discovery of an ISIL computer containing plans to develop plague as a bio-weapon 

underscores this concern. Just yesterday the Director of National Intelligence 

confirmed reports that the Islamic State used a chemical warfare agent in Iraq and 

Syria, the first confirmation of such use by an extremist group since the Aum 

Shinrikyo's attack 20 years ago. The Islamic State is growing rapidly, has resources, 

necessary infrastructure, controls safe havens, and is apparently recruiting scientists that 

would be capable of developing chemical and biological weapons. We must assume 

the threat is real and serious. 

There are many reports that have already told us that the United States is not taking the 

biological threat seriously enough and is unprepared to deal with a catastrophic 

biological event. The U.S. Commission on National Sccurity/21 st Century raised the 

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49 


issue fifteen years ago, the National Commission on Terrorist Attacks upon the United 

States raised it twelve years ago, the Commission on the Intelligence Capabilities of the 

United States Regarding Weapons of Mass Destruction raised it eleven years ago, and 

the Commission on the Prevention of Weapons of Mass Destruction Proliferation and 

Terrorism (WMD Commission) raised it eight years ago. Further, while the Intelligence 

Community admits to weaknesses in their biological collection and analysis activities, it 

does not dispute the fact that the biological threat exists and is serious. 

In addition to bioterror attacks, naturally occurring, emerging and reemerging transboundary infectious diseases continue along their damaging trajectory. The human 

immunodeficiency virus, pandemic potential influenza viruses, severe acute respiratory 

syndrome, middle east respiratory syndrome, west nile virus, chikungunya, dengue, 

Ebola, and now Zika are real experiences that tell us we may be on the verge of a global 

pandemic anytime. Our biological threat preparedness enterprise must also be ready 

anytime. 

The need for strong leadership: There is widespread acknowledgement that the global 

response to Ebola in 2014/2015 was severely deficient. The domestic response to Ebola 

was unacceptable too, and tells us that despite significant progress and with the 

dedicated and untiring work by many in the biopreparedness enterprise- we are still 

unprepared and have much work to do. 

The preparedness and response enterprise goes well beyond public health and includes 

federal, state, local and tribal governments, as well as industry, academia and other 

NGOs. It is a vast enterprise that requires complex public-private partnerships to 

achieve success- and strong leadership. 

The Biodefense Blue Ribbon Panel report, "a National Blueprint for Biodefense: 

Leadership and Major Reform Needed to Optimize Efforts" provides 33 

recommendations that spans the framework from threat awareness, prevention and 

protection, surveillance and detection, response and recovery. But from my view, the 

Panel's most important recommendations are the need for strong centralized leadership, 

coupled to a focused biodefense policy coordinating council and a new biodefense 

strategy. 

This is a much more daunting task than it appears at first glance to establish centralized 

leadership and a new comprehensive strategy. l have worked in federal interagency 

coordinating initiatives in the Clinton, Bush and Obama Administrations with many hard 

working, dedicated colleagues. It is my experience that in the vast interagency process 

there are many competing demands, and the process itself significantly delays progress. 

In my opinion, the best model employed to date to harness the vast federal interagency 

enterprise before an outbreak was the Pandemic Influenza Strategy and Pandemic 

Implementation Plan that followed the pandemic emergency supplemental appropriation 

in 2006. Centralized leadership and the implementation plan were the operative 

components that drove progress with metrics toward positive outcomes. The 
50 


implementation plan had over 300 action items and identified lead and supporting 

department/agencies, as well as called for effective public/private partnerships. 

Accountability was built into the plan and departments were held accountable for 

progress. Frankly, some felt this was micromanagement and superseded 

department/agency authorities, and maybe it did at times. But, the plan enabled the vast 

enterprise with our private sector and academic partners to make progress that otherwise 

would not have been possible. This plan also served us very well in the response to the 

2009 Influenza Pandemic, where BARD A was able to get every major influenza vaccine 

maker under contract and producing vaccine in a matter of weeks. 

Enhanced intelligence collection, overhaul of the Select Agent Program, hospital 

preparedness, public health preparedness, laboratory capacities, medical 

countermeasures development and deployment, and other actions together with U.S.-

led international efforts in global health security, and biological weapons prohibition 

diplomacy will lead us to a position of much greater strength- if executed efficiently, 

effectively, and in an integrated fashion. 

From my experience, I cannot overstate the importance of the Biodefense Blue Ribbon 

Panel's recommendation on the need for strong centralized leadership, however 

implemented, and a new biodefense strategy and focused implantation plan. Without 

this, we will continue to make progress, but incrementally at best and we will not be in a 

position to drive urgent action during the inter-epidemic period when urgent action is 

needed the most. 

Thank you again for this opportunity to appear before you and share my experiences on 

this important national security topic. 

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51 

Mr. MURPHY. I thank you, Dr. Parker, and all the panelists. It’s 

pretty sobering testimony we hear. So let me start off and recognize myself for 5 minutes. 

First, Dr. O’Toole, you refer to this as a first-tier national security problem and that bioattacks are faster and fiercer. So it seems 

like these natural outbreaks, they really are test runs for prevention. How we handled Ebola, how we handled SARS, how we will 

handle the Zika virus gives us an opportunity to work on prevention, detection, and responding. But I don’t think we are at all 

where we need to be. So given that, is there reason to be more concerned or less concerned about the threats of bioterrorism? 

Dr. O’TOOLE. Well, Mr. Chairman, I think you’re right. I think 

our response to naturally occurring epidemics should be seen as 

test runs. Everyone here has lived through a lot of natural 

epidemics at this point, and we have gotten better. 

Again, I think for the first time we can actually contemplate the 

strategy of creating a foundation such that we could rapidly design 

and build, for example, a vaccine suitable for a particular threat in 

a much shorter time than is now the case. And I think we do have 

to prepare for a whole array of threats which we’re not going to be 

able to predict. 

The other issue that Dr. Shalala mentioned is that a lot of our 

response depends on the State and local public health departments. 

They have lost almost 50,000 people since 2008. And so one could 

argue that our capacity to respond to an epidemic today has diminished compared to then, and that’s a problem. 

Mr. MURPHY. Thank you. 

Secretary Shalala and Congressman Greenwood, would it be fair 

to say that your bipartisan Panel’s general concern is that biological threats are increasing while important aspects of U.S. biodefense preparedness are actually declining or inadequate. Is that 

a proper conclusion? Ms. Shalala? 

Ms. SHALALA. Yes, I think that’s fair. And to echo Dr. O’Toole, 

our infrastructure for dealing with these has gotten weaker, starting with the State and local response. One of the things that we 

forgot in the Ebola discussion is the States are our first line of defense. We’ve been putting resources and building the public health 

infrastructure for years with essentially block grants from the 

CDC. 

Those have been weakened. And if you don’t have a State and 

local response—think about the outbreak of diseases caused by food 

poisoning, for example. It’s that infrastructure that is the first line 

of defense for these biological issues that we’re talking about. If we 

don’t have a strong State role, with their laboratories, with their 

tracking systems, then it’s very difficult for us to pick up something 

that’s going to recur, that we know that’s going the recur over a 

long period of time. 

That’s why we talk about the Vice President, because it’s very 

difficult for anyone else to pull in all the actors, the private sector 

actors as well as the public sector agencies. 

Mr. MURPHY. Well, given these things, Chairman Greenwood, so 

as we have increasing number of these naturally occurring and accidentally occurring bioattacks, is our diminished capacity just beVerDate Mar 15 2010 10:45 Apr 24, 2017 Jkt 037690 PO 00000 Frm 00055 Fmt 6633 Sfmt 6633 I:\114THCONGRESS\114X117BIOTHREATSJKTREQ022117\114X117BIOTHREATSPENDIN
52 

cause we’re strained or because we have actually lost ground in 

dealing with these issues overall? 

Mr. GREENWOOD. Well, I think your original question—is the 

threat growing while the capacity to defend against it is decreasing?—the answer to that question is absolutely yes. So if you think 

about the bioterror threat and you think about ISIS and you look 

at what they’ve been able to do with rifles and assault weapons 

and so forth, it’s clear and it’s obvious that their intention is to kill 

as many infidels and apostates as they possible can. And you can 

do a heck of a lot better job at that using chemical and biological 

weapons than you can with convention armaments. They want to 

do that, and there is evidence that’s been cited I think already that 

they are trying to figure out how to use bubonic plague. They are 

trying to have a plan to poison the Turkish water system. So the 

intention is clear. 

While that’s happening, the same technology, synthetic biology, 

gene editing, that is enabling our companies to do amazing things 

in terms of developing new drugs and new products, is also making 

it easier to formulate these new weapons. 

And so the threat is growing. And to see that in the face of all 

of that the Federal Government’s commitment to funding BARDA, 

to funding our abilities to develop these countermeasures is diminishing is frightening. 

I’m glad you’re having this hearing now, because the hearing you 

don’t want to have is the one that happens after tens of thousands 

of people have lost their lives and you’re sitting here asking yourselves and Government officials why we weren’t ready. 

Mr. MURPHY. Thank you. And that could happen at any time. 

I see my time’s up, and I’ll recognize Ms. DeGette for 5 minutes. 

Ms. DEGETTE. Thank you very much. 

Mr. Greenwood, you’re exactly right. This is what keeps me up 

at night, is the responsibility that this subcommittee has to actually move the ball forward, not just to have these hearings every 

so often. And the chairman will tell you, every year, like in about 

July, I start nagging to have a hearing on pandemic flu before 

we’re actually in the middle of the flu season. But I think what the 

Blue Ribbon Panel is saying is we need to go even further than 

that. We need to have a system in place that’s not based on response after the fact. Would that be your assessment too? 

Mr. GREENWOOD. Absolutely. And if I may, let me describe to you 

what that system is. 

The only thing that stands between these pandemic viruses and 

intentional bioterror attacks, the only thing that stands between 

those things and the safety of our people is, frankly, a handful of 

private companies in this country who were willing to take the risk 

of developing countermeasures. And as has been said, this is 

unique. You don’t sell those countermeasures at Walmart. 

Ms. DEGETTE. Right. 

Mr. GREENWOOD. The only potential procurer of those is the Federal Government. And those companies, like every little biotech 

company, rely on investors. And those investors can put their 

money into a conventional biotech company, they can put it into an 

IT company, they can put it anywhere they want. They are looking 

for return on investment. 

53 

Ms. DEGETTE. Right. 

Mr. GREENWOOD. And if they see a system that’s uncertain due 

to lack of certainty that these products will be procured, they’re 

going to put their money elsewhere. 

Ms. DEGETTE. And we’ve really seen this in the pandemic influenza program and trying to prepare for that. And with these cuts, 

so I’m wondering, maybe, Secretary Shalala, you can talk about 

how the funding cuts have hampered a response to the potential 

pandemic flu outbreaks. 

Ms. SHALALA. And I wouldn’t underestimate, in addition to the 

private sector, those very fragile biotech companies, the importance 

of the National Institutes of Health and the fundamental science 

that we’re doing, because if you don’t have that, you wouldn’t have 

the companies. So it’s a combination of things. 

Ms. DEGETTE. Yes. The problem is you need to get the basic research. And then you also need to have the robust pandemic flu 

program so that you can support development of the vaccine by the 

private company. So it really is a partnership. 

Ms. SHALALA. Exactly. And vaccines have not been a major priority of the multinational pharmaceutical companies. They don’t 

make enough money from them. 

Ms. DEGETTE. Right. 

Ms. SHALALA. They are marginal, particularly when the Government is the only purchaser. 

Ms. DEGETTE. Right. 

Ms. SHALALA. As was pointed out here, they don’t have a lot of 

confidence that we’re going to give them the kind of margins they 

can get from other kinds of investments. So this is a real challenge. 

Let me make one other point. Health as a national defense issue 

is relatively new. Twenty years ago, no one was thinking about a 

national security issue related to some aspect of health. So think 

of this as the cutting edge of a dramatic new conceptualization of 

our defense. We’re actually talking about the defense of a nation 

and about the health aspect of that. 

Ms. DEGETTE. Right. Let me ask you, why is it that the Panel 

recommends centralized leadership in the Vice President’s office to 

coordinate all of this? 

Ms. SHALALA. Well, since I sat in the major agency responsible 

for many of these issues, and since we now have a Homeland Security agency, the fact is that the responsibilities for different aspects 

of this are spread across the Government. And even the lead agency concept will not solve that or, in my judgment, a czar sitting in 

the White House. The czars work best when there’s an emergency. 

But if you really want to build up the infrastructure, you have 

to have a powerful person. And you can’t have that in a Cabinet 

agency which is a peer of all the other Cabinet agencies. So the 

Vice President is the only person that can cut through that, talk 

to the private sector, and simultaneously talk to State and local 

governments, and put all those pieces together. He’s also the only 

person that can demand a unified budget out of the OMB and 

across the Government. 

Ms. DEGETTE. And this was a bipartisan recommendation. 

Ms. SHALALA. It was as bipartisan recommendation. And I have 

to tell you, I hesitated, as someone who sat in a Government agenVerDate Mar 15 2010 10:45 Apr 24, 2017 Jkt 037690 PO 00000 Frm 00057 Fmt 6633 Sfmt 6633 I:\114THCONGRESS\114X117BIOTHREATSJKTREQ022117\114X117BIOTHREATSPENDIN
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cy, a powerful Government agency, I hesitate to transfer power to 

a Vice President or to the White House in general. As you know, 

Cabinet agencies have a certain amount of tension with White 

Houses. But at the end of the day, this is one of the areas where 

you need a unified budget. The only place we have a unified budget 

is actually in intelligence. So this is a parallel to that, to pull all 

the pieces together, and it’s important enough to identify the Vice 

President. And Vice Presidents always have some time to take on 

other responsibilities. 

Ms. DEGETTE. Thank you very much. Thanks. 

Ms. SHALALA. With all due respect to our very nice Vice President. 

Mr. MURPHY. I’m sure he’ll be pleased that you said he has lots 

of time on his hands. 

Ms. SHALALA. We have discussed this with the current Vice 

President. It’s not he particularly that we identified, but the office 

itself. 

Mr. MURPHY. We’ll bring him in here and ask him about that. 

I recognize Mr. Flores for 5 minutes. 

Mr. FLORES. Hard to follow that. 

Dr. Parker, you emphasized in your testimony that we should be 

urgently preparing for biological threats in the time between outbreaks. And in 2006, as you know, Congress created BARDA to do 

exactly this. But as you explained, we continue to seem to go in crisis mode only when we have an outbreak. So what else should the 

Government do in these interepidemic periods? 

Dr. PARKER. Well, thank you, Congressman Flores. And actually 

in answering your question, I’m going to come right back to the 

centralized leadership and how important that is. And I’ll answer 

it actually with an example in my own experience and my own career. 

In that very same time in 2006, as the Pandemic and All-Hazards Preparedness Act was passed, BARDA was created, we got 

very concerned about pandemic influenza to the point that an 

emergency supplemental was appropriated in that time, $7 billion. 

It was accompanied by a very strong White House-led pandemic influenza strategy, coupled to a pandemic influenza implementation 

plan. 

This is the closest example I think that has happened to date 

that kind of reflects the centralized leadership biodefense strategy 

that we actually did for pandemic influenza that accompanied an 

appropriation that really covered almost all the department agencies, State, local, private sector, that were involved in pandemic 

preparedness back at that time. 

This implementation plan contained over 300 action items. It 

identified lead department agencies and supporting department 

agencies. It was very detailed. In fact, in my own department at 

the time, HHS, there was a lot of complaints that it was micromanaging and maybe superseding department authorities. Maybe it 

was. But we got stuff done. It allowed us to establish things that 

otherwise we would not have been able to do. 

And so I just offer that as an example of something that we’ve 

already done. Let me also add that we were very responsible for 

meeting our milestones and metrics that were part of this impleVerDate Mar 15 2010 10:45 Apr 24, 2017 Jkt 037690 PO 00000 Frm 00058 Fmt 6633 Sfmt 6633 I:\114THCONGRESS\114X117BIOTHREATSJKTREQ022117\114X117BIOTHREATSPENDIN
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mentation plan, both in the executive branch and to Congress, because all congressional committees that had the appropriate oversight for their department agencies were regularly being updated. 

Hearings were happening on progress of that plan. 

So I just offer that up as an example of something in the past 

that I think is in the spirit of what the Panel has recommended 

that would drive us a long way forward to doing what we need to 

do in that interepidemic period and before an attack occurs. 

Mr. FLORES. Well, thank you. I think that’s helpful. 

Also I want to compliment you on the great work that you’re 

doing in the BARDA public-private partnership. 

Dr. O’Toole, the World Health Organization recently assessed 

that the potential impact of synthetic biology on smallpox preparedness and control and the WHO scientific group found that the 

risk of reemergence of smallpox has increased due to the low cost 

and widespread availability of technology and know-how on how to 

create the smallpox virus. 

So the BRSP focused heavily on the threats that we face today. 

Can you tell me what’s possible given the rapid advances in synthetic biology, and how have these advances in synthetic biological 

escalated the threat? 

Dr. O’TOOLE. Virtually anything is possible today theoretically. 

Smallpox is an ancient huge virus. It would be very difficult to create synthetically a functional smallpox virus. There are many other 

choices available. We know, for example, that the Soviets created 

a vaccine-resistant plague strain. 

New gene-editing techniques make that kind of creation of resistant viruses quite straightforward, although nonresistant pathogens 

can do a great deal of damage too. I’m not sure it makes sense to 

go to the trouble of making a synthetic bug. 

But what we are missing is the opportunities on the upside that 

synthetic biological and other advances allow. 

Mr. FLORES. Right. 

Dr. O’TOOLE. OK? I mean, we are in a revolutionary phase of biological science, and virtually none of this is being leveraged against 

our biodefense needs. We need a lot more than improved contracting procedures in BARDA. We need a commitment to revolutionize the way we make vaccines. Same thing with diagnostics. 

We can do this. We can shift the advantage to biodefense. But 

we can’t do this with incremental, you know, tweaks on the programs we have now, in my opinion. We need a much deeper investment in bioscience and biotech. 

Mr. FLORES. OK. Thank you. That’s helpful. 

I’ve exhausted my time. I yield back. 

Mr. MURPHY. Thank you. 

I now recognize Mr. Tonko for 5 minutes. 

Mr. TONKO. Thank you, Mr. Chairman. 

Welcome to our witnesses. 

Dr. O’Toole, in your testimony, you speak of the need to take advantage of recent developments in bioscience to rapidly develop 

tests and manufacture vaccines against emergent infectious diseases. Can you speak to the role that the centers for innovation in 

advanced development and technology play in this process? And is 

56 

this program indicative of the types of public-private partnerships 

we should be pursuing in this space? 

Dr. O’TOOLE. I’m sorry, sir, I didn’t hear. Centers for—— 

Mr. TONKO. Centers for innovation in advanced development and 

technology. 

Dr. O’TOOLE. Yes, they can play a very critical role. For example, 

new diagnostics have a very difficult time getting approval to be 

paid for. So that discourages innovative biotech companies from 

making them. Imagine the difference it would make if we had a 

rapid diagnostic test right now for Zika and we could very clearly 

say, ‘‘You’re infected, what is the outcome of your pregnancy?’’ or, 

‘‘You’re not infected.’’ Same thing for Ebola. Image if we were able 

to tell within minutes if somebody was infected with Ebola, preferably before they’re symptomatic. 

The technologies for a whole host of new diagnostics are out 

there. The path to making money on them is very, very troubled, 

both from a regulatory point of view—it is almost as hard as it is 

to get a new drug through and the return on investment is not 

nearly as great—and also from the payment mechanism. So, yes, 

the centers have a tremendous role to play. 

Mr. TONKO. Thank you. 

And Secretary Shalala, how does the first recommendation that 

you’ve shared with us today get off the ground? Should there be a 

congressional mandate to have the executive branch explore and 

implement if experts agree it’s needed? What are the next steps to 

take us forward? 

Ms. SHALALA. You know, I’m not sure what the answer to that 

question is, whether Congress can designate the Vice President of 

the United States. It’s a different branch. You certainly could make 

a recommendation in this area. And I think the fact that this committee would make a recommendation as part of a more integrated 

piece of authorizing legislation would have an effect. 

It is a new recommendation. If you look through all of the other 

commission reports, this is the first time this has been elevated to 

this level. So I think both a combination of the visibility and some 

enthusiasm from Congress, from this committee in particular, 

would convince the next President of the United States to look at 

it very seriously. 

And of course there are budget implications in that, particularly 

tying it to an integrated budget approach, which I think we all 

think is extremely important, and in which there have been very 

few examples at a very high level. Probably intelligence is the 

major one. The defense kinds of ones, you know, the defense agency 

itself usually leads. So it would take some identification by this 

committee, I think, that would make a difference. 

Mr. GREENWOOD. Congressman, can I give 15 seconds on that? 

Mr. TONKO. Sure, sure. 

Mr. GREENWOOD. I’m not a lawyer, let alone a constitutional lawyer, but I think that the Congress can provide the authorization to 

the Vice President, and then perhaps it’s up to the President and 

the Vice President to decide to utilize that authorization. But I 

think that’s probably the way it would work. 

Mr. TONKO. Thank you. Thank you to both of you. 

57 

And, Secretary Shalala, given the complications created by transferring technology from an innovator company to the centers for innovation and advanced development in technology, do you believe 

it would be beneficial to establish a single location wherein the 

complete process from innovation to manufacture can take place 

quickly and nimbly in order to rapidly respond to the various 

emerging threats? 

Ms. SHALALA. You know, periodically the leaders of Government 

on both parties have looked at that process and seen whether we 

can fast track it so that we can get products faster to market. 

There are so many jurisdictional issues, if a product has to go 

through the FDA process, for example, if it’s exempted from the 

FDA process. 

So I think that that’s an example where a Vice President looking 

at the process and making recommendations about the integration, 

because it’s a piece of the larger strategy, where that would make 

a difference. We certainly did that when we looked at, during my 

time when we looked at fast tracking AIDS drugs, for example, and 

we were able to take different elements and put them together in 

a way that protected safety, but also moved the needle very quickly 

in that area. But that’s why, because there are so many agencies 

of jurisdiction, you need someone to think it through. 

Mr. TONKO. Thank you to each of you. 

And Mr. Chair, I yield back. 

Mr. MURPHY. Thank you. 

I now recognize Mrs. Brooks for 5 minutes. 

Mrs. BROOKS. Thank you, Mr. Chairman. 

And thank you to our esteemed panel for being here today. 

I was a U.S. attorney in 2001 and was part of the response in 

the anthrax attacks, and actually had an office where that powder 

was sent to. You know, multiple Government offices were receiving 

powder, which, you know, terrified that employee who opened the 

mail not knowing if it was actually anthrax or if it was just powder. And I have to tell you, I thought, and I was in Federal service 

until 2007 and it felt like we were moving forward, but I have to 

tell you, until this report came out, and until we have seen kind 

of the lack of adequate response to Ebola, quite frankly, I really do 

believe we have stepped back and that we have just moved from 

crisis to crisis. 

But I just encourage my colleagues, this is an outstanding report 

with 33 recommendations. It is a roadmap. It is a blueprint. And 

it is in part the basis upon which Congresswoman Eshoo and I introduced 3299, the Strengthening Public Health Emergency Response Act of 2015. And I want to talk about that because I really 

appreciate all of these recommendations. I encourage my colleagues 

throughout Congress to read this book, because you as experts 

talked to experts around the country as well. It’s not just the people on the Panel. A lot of work went into this. So I commend your 

work. 

Mr. Greenwood, can you please share with us the merit that you 

see in returning the contracting authority to BARDA, back to 

BARDA, which is in my bill, and can you talk about the importance 

of that and what has happened and why we’re not able to get, you 

58 

know, vaccines and our medical countermeasures through the pipeline as fast as we need them? 

Mr. GREENWOOD. Well, thank you. Originally, the contracting authority was with BARDA and it was changed. It was moved to, I’m 

going to refer to my notes here, it was moved to the office, an office 

called the Acquisitions Management, Contracts and Grants Office. 

And the problem is that the technical experts are not there, and 

they are, in fact, at BARDA. And, in fact, because of certain regulations, there’s a firewall between the two, and sometimes they actually cannot speak to one another. 

Imagine how frustrating it is for a company trying to get a contract and it’s talking to folks who know a lot about contracts but 

they don’t know a lot about this issue, about medical countermeasures. And so I think it makes all of the sense in the world to 

eliminate that level of bureaucracy, put the contracting back at 

BARDA where it belongs so that the experts in the field can talk 

to the experts in the company with whom they are attempting to 

create contracts. 

Mrs. BROOKS. Thank you. 

And with respect to the companies trying to get vaccines into our 

stockpiles, can you and Dr. Shalala please talk about the fact that 

we don’t have a sufficient coordinating mechanism in our National 

Strategic Stockpile also identified? So we don’t even have, if I’m not 

mistaken, the right coordination between CDC and BARDA to have 

the right vaccines in our stockpile. Can you talk about that? 

Ms. SHALALA. Yes. And we made recommendations in that regard, because the system is weak now and needs to be strengthened. And thank you, Congresswoman, for your leadership on this 

issue as well. 

Mrs. BROOKS. Thank you. 

Mr. Greenwood, any comments with respect to the stockpile? 

Mr. GREENWOOD. Well, I think it goes to the essential point, 

which is that we are not organized as a Government to effectively 

and quickly respond to either pandemics or bioterror because the 

authorities are diffuse, they don’t always talk to one another. And 

that is exactly why a central unified plan, a strategic plan, a central budget, and giving the authority to the Vice President makes 

all the sense. 

Mrs. BROOKS. And I think citizens believe and know we have 

these stockpiles, and believe that they are adequately filled with 

the proper, right types of vaccines. Would anyone else like to comment on our National strategic stockpile? 

Dr. O’Toole. 

Dr. O’TOOLE. I’m the chair of the National Academy committee 

on the Strategic National Stockpile right now, and they have made 

tremendous progress in the last 20 years. The problem with the 

stockpile is that the new drugs that are going into it are largely 

biologicals, and they are very expensive, and they expire in 2 or 3 

years. So there is a pipeline of new countermeasures coming in 

that increases inexorably the cost of the stockpile and everybody’s 

budget is staying flat. 

So the limitations on the countermeasures we have in the stockpile, first of all, are budgetary limitations. I mean, this is an expensive proposition. The stockpile already holds about $7 billion worth 

59 

of stuff. But we are talking about having to cover multiple cities 

with these sometimes very expensive drugs and vaccines. We need 

a cheaper way to do it. Which is why I say you are never going to 

be able to create a stockpile that has everything you want in it 

against every contingency. We have to move to a strategy of being 

able to quickly design and manufacture at scale what we need. 

Mrs. BROOKS. Thank you all for sounding the alarm. I appreciate 

your leadership. 

I yield back. 

Mr. MURPHY. Thank you. 

I now recognize Mr. Mullin for 5 minutes. 

Mr. MULLIN. Thank you, Chairman. 

And thank you for the witnesses being here. 

I first want to thank Ms. Shalala—I hope I say that right—and 

Mr. Greenwood for this report. I’ll tell you, the more that I learn 

about it, the more I wish I wouldn’t read it. I’m serious. It’s very 

troubling when you understand the false security that we have 

even from something as simple, yet dangerous, as the flu to the 

most serious threats that we’re facing today. 

And in a previous hearing, I was talking about our CDC’s National Stockpile, Strategic Stockpile that we have, and in particular 

the weaknesses that we have there. And following Mrs. Brooks 

here, I want to get a little bit more in depth about what you see 

as maybe our biggest weakness, maybe the biggest two weaknesses, some of the biggest threats we have with the stockpile, 

some recommendations. Don’t get into it too deep. Just maybe one 

or two that we can start working on in the committee here. 

Ms. SHALALA. Well, I actually think Dr. O’Toole is the expert on 

the stockpile issue and that she has outlined what the challenges 

are in the stockpile. It doesn’t cover everything. It’s expensive to 

maintain because they have a short shelf life. It was a good idea 

at the time, but constantly having to renew it is our biggest challenge. 

I think that most of us think that there are other issues we can 

address, and certainly scientific issues that would give us a longer 

life in some of these areas. And I think on the production side, 

Tara, our ability to produce something faster and not being totally 

dependent on the stockpile is probably where your IOM commission 

is going. 

Mr. MULLIN. You know, yesterday I had a meeting with some 

biodefense individuals and they were telling me that, you know, 

there is technology that they’re looking at that would extend the 

shelf life through maybe a dry freeze. Is that correct? And then 

also, they are retesting it too, and some of it that was designed it’ll 

go 2 or 3 years has lasted as long as 15 years. So they’re constantly 

retesting it. 

But how do we dispense it? How do we get it out? Having it in 

a stockpile is OK, but it doesn’t do us any good if it’s housed one 

place and we can’t get it to where it’s needed. 

Ms. SHALALA. One of our recommendations was to use the existing community pharmacies. The original idea was to use the VA’s 

because they are spread across the country and they do keep a certain amount of supplies. 

60 

Mr. MULLIN. We’re having enough problems with the VA right 

now. 

Ms. SHALALA. And they’re well located, the VA hospital system 

and warehouse system. The Government has also contracted with, 

I think with FedEx, to move pallets around the country. And the 

reason for that is because the military is not well situated to do 

that kind of thing. So there has been extensive discussions in the 

Government and a strategy for moving pallets of drugs very quickly 

using—I think the contract was with the FedEx system originally 

to move pallets around the country when there are outbreaks. 

Mr. MULLIN. Ms. O’Toole. 

Dr. O’TOOLE. The big problem with the stockpile is traversing 

what’s called the last mile. It’s not about delivering the stockpile 

to the State public health departments. It’s about getting it into 

the hands of people. And as you can imagine, that dispensing function is very complex. 

Washington State is going through pharmacies. That won’t work 

in every State, particularly rural States, although most Americans 

live within reach of a pharmacy. Advanced deployment is also 

being used in those very few States that can move very, very quickly to dispense, such as New York City. 

One thing that would definitely help is more money for State 

health departments and local health departments to do drills on 

dispensing. These are invaluable, but they are very time consuming 

and expensive, and they simply don’t have the money to do them. 

New York City does them, some of the big municipalities do them. 

But making those a more viable way to practice would, I think, 

make an appreciable difference. 

Mr. MULLIN. That’s a great recommendation. 

Mr. Parker—Dr. Parker. 

Dr. PARKER. Yes, I just wanted to come back. Everything you’re 

asking actually really comes back to centralized leadership. We’ve 

been talking about lyophilization of vaccines for 15 years or more, 

the last model of dispensing medical countermeasures from our 

SNS. That is the hardest challenge. 

In fact, there was an executive order in about 2009, 2010, and 

I was just discussing this with one of my colleagues from public 

health from Chicago yesterday. It seems that that work has just 

disappeared. But with centralized leadership, focused work on how 

to solve that last mile of actually dispensing the medical countermeasures would go on, and we need that. Because it’s one thing to 

have a stockpile with Cipro and Tetracycline, and it’s one thing to 

be able to get it FedExed to get it to an urban center. But actually 

getting it into people’s hands is a huge unsolved problem. 

Mr. MULLIN. Thank you. I’m out of time. I appreciate it. 

Mr. MURPHY. Thank you. I now recognize Ms. Castor for 5 minutes. 

Ms. CASTOR. Well, good morning, and thank you to the Panel 

your terrific work on this important subject. 

And Ms. Shalala, the folks at the University of Miami were so 

appreciative, and everyone across the country, for your service. I 

know they miss you there. But it’s great to see that you continue 

on in your service. 

61 

I wanted to focus on hospital preparedness. During the Ebola 

outbreak in Africa in 2014, we took a critical look at hospital preparedness and its important role in our Nation’s response biological 

events. At that time, in response to that, the President requested 

emergency supplemental funding for Ebola. The Congress responded. Now, with Zika, we’re having to do that again. This 

doesn’t seem to be the most efficient way to prepare for emergencies. 

I’d like to ask a few questions about this, about what we can do 

to assist hospitals throughout the country in their response. You 

know, we had some that were very well prepared, like Emory University, what a terrific job they did because of their association 

with the CDC. And NIH, of course, was at the forefront in that 

Ebola response. But some did not do quite as well. And there’s no 

mystery that if that had been more serious, that a lot of hospitals 

across the country would have struggled. 

So what lessons do you think we learned from this, from the 

Ebola outbreak in Africa and the few cases that came to the U.S.? 

I’d like to ask maybe Ms. O’Toole first. 

Dr. O’TOOLE. Hospital preparedness is very important. I think 

between 2002 and 2008 it did improve, for two reasons. First of all, 

disaster response drills are required for accreditation by JCAHO, 

by the hospital-accrediting facility. Again, for hospitals doing those 

kinds of drills, it’s expensive and difficult. 

There also was a CDC/HHS flow of money to hospitals to help 

them with bioterrorism and pandemic flu preparedness. And what 

happened with that money is the hospital started forming coalitions. In my city, in 2001, Baltimore, the mayor for the first time 

got all the CEOs of the hospitals together in one room. This is a 

private sector competitive industry. They don’t necessarily cooperate, let alone collaborate. 

And those CDC funds made a real difference. These regional coalitions of hospitals were used to figuring out how they were going 

to share resources, share information, et cetera, et cetera. That 

funding has been cut in half since 2010. That makes a big difference. 

Ms. CASTOR. Secretary Shalala, the Panel’s report mentions that 

disease-specific preparedness funding is the most inefficient and 

costly manner in which to fund preparedness. What are the alternatives to disease-specific programs, especially since many States 

have frayed their public health infrastructure? How can we respond better and give the hospitals in our local communities the 

tools they need? 

Ms. SHALALA. We have specific recommendations in this area, including a steady stream of funding. We recommend that it be done 

through the accreditation system and through CMS. 

In addition to that, we have recommended a tiered system. Every 

hospital in this country cannot be prepared for every complex disease. So both the regional coordination, but more importantly, identifying those hospitals that can have special rooms set aside. 

In Florida, for example, all of us looked at—particularly at the 

great public hospital in Miami, whether we could build separate 

rooms with separate access to handle Ebola patients, and in fact 

went through an exercise to make that possible. 

62 

A great public hospital that sees all sorts of diseases probably is 

the best place to do that, as well as academic hospitals around the 

country. So creating a tiered system in which we know where we 

would send patients—once they are stabilized obviously—that 

would have the capacity and the separation to be able to handle 

these diseases is certainly the way to go. 

We have some specific recommendations both on funding, on the 

accreditation process, but in particular on creating a tiered system 

in this country that would give us coverage across the country as 

there are outbreaks. 

Ms. CASTOR. I think that is a very important recommendation 

and I would encourage the committee to act on it as soon as possible. Thank you very much. 

Mr. MURPHY. Thank you. 

I recognize Mr. Cramer for 5 minutes. 

Mr. CRAMER. Thank you, Mr. Chairman. 

And thanks to the panelists. 

I want to focus on this incentive issue, Congressman, that you’ve 

raised. 

And I will admit right up front that what I’m about to do is very 

dangerous. I want to think out loud for a little bit. And then I also 

admit that you’re not going to adequately inform and educate me 

in 5 minutes. So you’re going to have to come to my office and help 

me work through this idea, because you’ve all done a great job, as 

has the Panel, the Blue Ribbon Panel, in scaring me to death. So 

I’m adequately prepared to understand the threat, and I think 

that’s very important. 

But in our political world, of course, when it comes to the appropriations process, part of why I think you don’t see Congress acting 

or the Government acting proactively is because we respond to the 

people we represent. And they will blame us when we’re not prepared and they’ll blame us when we spent money foolishly. And of 

course we’re talking about finding a way to invest in something 

that we hope is never needed. And so that’s our political dilemma. 

I would, starting with you, Congresswoman Greenwood, and others if you want to weigh in, maybe just to elaborate a little on the 

SRF, the PRV, how we could help pharmaceuticals, the private sector, feel comfortable with the investment and the innovation. And 

we’ve talked a fair bit about it, but if there’s a way we could elaborate just a little bit more to help me better understand how we’re 

going to do this. 

And I might also emphasize, is there a way to put a cost-benefit 

analysis on this? For example, Ms. Castor was talking about emergency responding. That’s a cost. That’s a cost that could be avoided, 

perhaps, if we were better prepared. Right? 

So has there been some work done in that arena that helps me 

assure my constituents that we’re not just appropriating, but that 

we’re efficiently and effectively governing? 

Mr. GREENWOOD. Well, thank you for admitting that we frightened you. And, obviously, our constituents, your constituents are 

not clamoring for this, because it is a sleeper. 

No one is thinking that this is going to happen. And as I said 

earlier, the hearing you don’t want to have is the one about why 

we were unprepared for the event that was so tragic. 

63 

So I think to some extent leadership involves informing your constituents, and this hearing is an important part of that, that this 

threat is real. I calculate when it comes to bioterror that they have 

the—the terrorists have the motive. They are trying to acquire the 

means. And despite our best efforts to deflect that, over time the 

likelihood of that happening is one over one, OK, it is going to happen. 

Mr. CRAMER. Uh-huh. 

Mr. GREENWOOD. And we have to be—you have to believe that, 

we have to believe that the threat is real. 

So in terms of what works to be prepared, we talked about the 

contracting reform, which is a minor thing but an important thing, 

and Congresswoman Brooks is a leader on that. We’ve talked about 

the need for there to be sufficient funding to actually procure these 

MCMs when they’re developed. The Secretary was completely correct when she said not to underestimate basic research at the NIH; 

that’s critical. 

But when it comes, just like in every other medicine that we develop, when it comes to actually developing the product and manufacturing the product, the private sector is the only place where 

that is done. And to invest money in that—the companies are willing to take the risk that maybe they will fail at the science, but 

the investors are not willing to take the risk that if they succeed 

the Federal Government is not going to be prepared to reward 

them by procuring the product. 

So that’s critical. And you need enough money over time to be 

certain, so there’s a certainty that when you get to the end of the 

road and you get your product approved, that Congress hasn’t 

moved the money around and it’s no longer there. 

Mr. CRAMER. Secretary Shalala, you may want to weigh in on 

this. But one of the things—I appreciate your national defense 

analogy, because I was thinking a lot about, you know, we spend 

billions of dollars on weapons we hope we never use, right? Now 

they do have the benefit of being a deterrent, understandably. But 

it isn’t dissimilar. We have to constantly make this case. So I 

thank you for that. And the centralized leadership as well. I’m still 

struggling with the whole Vice President thing myself. But the 

more you talk about it, the more sense it makes. So I appreciate 

that. 

Is there anything else anybody would add to what the Congressman said about the investment piece? 

Dr. PARKER. Yes, I would like to add a little bit, and perhaps 

maybe just pull on the contracting itself as well. As we’ve heard, 

many of the companies in this space that are really contributing to 

biodefense, and particularly those that are bringing the more innovative solutions, are struggling themselves. 

And the typical FAR-based Government contracting is really contrary to the biotechnology industry in and of itself. 

And so I would think, you know, I have actually been encouraged 

recently with some pronouncements by DOD to begin to start using 

some authorities they already have, like other transaction authorities. 

So I think just also taking a look at what are other things and 

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sible that the innovative biotechnology companies would actually 

do business with us in the Government is something to look at as 

well, sir. 

Mr. CRAMER. Thank you very much. And if we could solve the 

DOD contracting in the context of this, that would be a bonus. That 

would be a cost-benefit analysis. Thank you. 

Mr. MURPHY. Thank you. 

I recognize now Mr. Green of Texas for 5 minutes. 

Mr. GREEN. If we could solve the DOD contracting, we could 

probably have them audited. 

I want to welcome our panel here. 

The Blue Ribbon Study Panel on Biodefense highlighted 

vulnerabilities in our ability to combat emerging and reemerging 

infectious diseases, particularly drug-resistant infections, which 

could cause catastrophic loss of life and have already started to 

make even minor infections fatal. Without greater investment in 

antibiotics we face a future that resembles the days before these 

miracle drugs were developed, one in which people died of common 

infections, many medical advancements we take for granted become impossible, including surgery, chemotherapy, and organ 

transplantation. 

The challenges presented by the rise of drug-resistant bacteria 

for which we have no effective treatments are representative of the 

challenge facing medical countermeasure product development. The 

market forces simply do not work and fail to foster the kind of 

pipeline we need. 

In 2012, this committee passed and Congress passed the GAIN 

Act, and again in this current session, in the 21st Century Cures 

Act, we worked to remove the financial and regulatory barriers to 

antibiotic drug development. 

Secretary Shalala, can you elaborate on the study’s recommendation for incentivizing the development of medical countermeasures 

for emerging infectious diseases with pandemic potential? Specifically, please explain why there is such a need for Government to 

play a leadership role in this space. 

Ms. SHALALA. Well, I think it’s pretty straightforward that the 

only purchaser will be the Government. There’s not a private sector 

market for these particular biologicals. And, therefore, the Government both has to incentivize the companies financially so that— 

and I think the other thing to understand—Jim, could explain this 

better than I can—these are relatively small companies, often with 

a small number of products. We’ve known a lot about the biotech 

industry. They’re fragile. I like to use the word ‘‘fragile’’ when you 

talk about them. So that unless they know that they’re going to be 

compensated and reimbursed for the cost of development, not just 

the cost of production, but the cost of development, unless there are 

financial incentives, I don’t know how we’re going to move very 

quickly in this area. 

We’ve had some experience. Congressman Waxman in the Orphan Drug Act. We had a lot of diseases in which there were very 

small markets, at least initially, and the Congress in its wisdom 

passed legislation that encouraged companies to invest in creating 

drugs and treatments for a very small part of the population. 

65 

Our problem here is we start small, but we may need a production line that’s huge at the end of the day. I don’t know any other 

way to do it except with financial incentives. I just don’t know. I 

think everything that we’ve learned, it’s not just that I’m a capitalist, it’s just that, from our point of view at a public policy issue, 

when the market is going to be the Government there is no other 

way to get a very small number of industry people to invest unless 

they know there’s going to be a market at the end of the day. 

Mr. GREEN. Jim. And, again, welcome back to your committee. 

Mr. GREENWOOD. Thank you, Congressman. So nice to see you. 

One of the proposals we have is the priority review voucher, the 

PRV. And the beauty of it, I mean, if you look at—Congress, in its 

wisdom, looked at neglected tropical diseases, and we knew that 

there’s no financial pull, that these diseases that occur in places 

like Africa, the countries are so poor that they really can’t afford 

to buy the product. So investors just aren’t putting their money 

there. 

When Congress created the priority review voucher, it works 

beautifully, because what it does is it says to a company, if I can 

get a drug approved, even if I don’t make enough return on my investment from the procurement of that product, another, maybe a 

large biopharmaceutical company, will pay me. And these things 

have gone, there are only two or three of them have been sold, but 

they go—have gone for $200 million, $300 million, $400 million. 

It doesn’t cost the taxpayers a penny. Pfizer or Merck or Glaxo 

or somebody buys that, which just simply gives them a 

foreshortened review period for some other product. And that 

doesn’t cost the taxpayers any money either. They pay their 

PDUFA fee, they get their product approved. And sometimes they 

don’t get their product approved. But if they do it, it gets approved 

a little faster. It gets on the market. And by the way, then it goes 

off patent sooner anyway. So it still doesn’t have any cost to society. 

Mr. GREEN. Mr. Chairman, I know I’m out of time, but we had 

legislation that’s in the Senate that would fast track, because we 

recognize the Government is going to be the one that has to do it, 

because free enterprise can’t invest that money for something. But 

there is legislation and hopefully the Senate will deal with Cures 

and the complete package that our full committee approved overwhelmingly. 

Thank you, Mr. Chairman. 

Mr. GREENWOOD. Thank you, Congressman. 

Mr. MURPHY. That would be nice. 

I recognize the vice chair of the full committee—I’m sorry, Doctor—well, Mrs. Blackburn. 

Mrs. BLACKBURN. Yes, that woman from Tennessee. 

I tell you what, Dr. Parker, I am so happy to see an Aggie on 

the panel. I’ve got Aggies in my family, and they always bring 

good, commonsense, seasoned wisdom to the table. So happy to see 

you there, and of course Mr. Greenwood, and how much we appreciate your insights on this and your dedication to the biotechnologies and the work that you’ve done there. 

Just a couple of things that I want to touch base on. In talking 

with some of my research centers—and in Tennessee we have such 

66 

an aggressive biotechnology group. And when I was in the State 

senate, I helped to formulate that group. And so they’ve got a good 

underpinning. And it doesn’t matter if it’s Vanderbilt or St. Jude’s 

or whatever. They talk to me a good bit about the right balance between Government and regulatory oversight and then the ability to 

incent. 

And, Mr. Greenwood, I’m so pleased that you just mentioned the 

priority review voucher for the MCMs. I just think this is, when 

you look at these medical countermeasures, that is just so important that we have that. And it doesn’t matter if it is a material 

threat, if it is something like Zika, we have to have a way to go 

about this. 

But I want to come to something that Dr. O’Toole mentioned, 

and then, Congressman Greenwood, if you will kind of answer to 

that. Basically her point was you move products to a point of 

scalability, and then if you need something, you’re ready to move 

with it and can push that scalability quickly. 

So let’s go back to that voucher, Mr. Greenwood, and if you’ll continue that conversation and kind of build that, the importance of 

that, how you would address these for something that is a material 

threat. Or like the Zika virus, which right now there is not a vaccine and people are saying: What are you going to do, why didn’t 

you know this was a problem, the Olympics are coming to Brazil, 

people have been vacationing for months in the zone that is affected, et cetera. 

So let’s go back to the importance of having that priority review 

process for this type of occurrence. 

Mr. GREENWOOD. So there’s great uncertainty for a company to— 

we’ve seen our companies, and proudly, jumping into the Zika issue 

and trying to do some research on it very quickly to develop products. But I remember a member company of Bio that was involved 

in trying to—it looked like it was close to having something on 

Ebola. And they almost didn’t want to talk about it because their 

stock was fluctuating like this. All of a sudden everybody would invest in that company and then another company was doing something and people would pull out. And it created unpredictability 

and volatility. And so it’s an example of how the norms of economics don’t work in this field at all. 

So the priority review voucher takes away one of the uncertainties. And that uncertainty is that it doesn’t take away the uncertainty of: Can we make this product, and will it be safe, and will 

it be effective? That’s always a risk. And I will tell you that doing 

that is harder than putting a man on the moon. Most companies 

fail and most projects fail. So it’s hugely risky to even bother trying. But if you do try and you do succeed, the only reason your investors are giving you the leeway to go and do that is because they 

think that somehow they will get a return, a fair return on that 

investment. 

One way to do that is to have enough money in the Reserve Fund 

and have it there not just year by year, but have it there multiple 

years so that companies can know and their investors can know, 

if we succeed here, they will buy the product and we will get our 

investment back. 

67 

But the priority review voucher is an entirely different way to do 

that, and because they have become so valuable, it is a huge driver, 

it is a huge incentive. Because if you can succeed—let’s say that 

right now we had a priority review voucher for Zika, right, companies would know that if they could succeed, not only would they 

have the great satisfaction of being able to spare people from this 

disease and, God forbid, more children born with microencephaly, 

but that they would have this voucher they could then take to the 

marketplace and sell it at a very nice return and use that money 

to invest in the next countermeasure. 

So I think it’s a no-brainer to me. I know that there’s some political questions about it, but I don’t think there should be because 

it costs the taxpayers nothing, it costs society nothing, and it provides nothing but benefit. 

Thank you. 

Mrs. BLACKBURN. Thank you. 

I yield back. 

Mr. MURPHY. Thank you. The gentlelady yields back. 

I now recognize Dr. Burgess of Texas for 5 minutes. 

Mr. BURGESS. Thank you, Mr. Chairman. 

Thanks to our panelists for being here today. I apologize for 

missing part of the hearing. We’re having our budget season. Mr. 

Greenwood, you’ll remember what that is like. So never a dull moment around here today. 

Dr. O’Toole, I just want to ask you, because we’ve had several 

hearings over the past several years. Just for context, my congressional career goes from SARS now to Zika, long enough for people 

back home to say ‘‘term limits,’’ but on the other hand, there may 

be some value in seeing some of this stuff over a continuum. 

But you reference in your testimony about what are called laboratory developed tests. And Zika really comes in focus because, 

OK, you’ve got a polymerase chain reaction, but only a few places 

can do it. It’s pretty valuable, pretty accurate, but it’s hard to get. 

You got to go through a health department to get it. There is an 

IGM antibody, but it will cross-react with some other viruses, so 

you are not really sure if your result is accurate. 

But would you just speak to the regulatory hurdles that you describe in your testimony and laboratory developed tests? Because 

we in this committee have been studying that. There is a movement, as you may be aware, to move the regulation of laboratory 

developed tests from CLIA, the Clinical Lab Improvement Amendment, which is basically administered through the Centers for 

Medicare and Medicaid Services, over into the Food and Drug Administration, and requires basically the licensing of laboratory developed tests just as if they were a new drug or device. And we 

know the problems with the timeline of those things. So could you 

just speak to that briefly? 

Dr. O’TOOLE. Yes. Thank you for the question, Congressman. 

First of all, the reason FDA is so concerned about diagnostics is 

that they can have life-or-death consequences. And we might want 

to think about different standards for diagnostics during public 

health emergencies. 

68 

Mr. BURGESS. Yes, I’m going to interrupt you for a minute. That 

is called clinical judgment, and you and I understand that because 

we trained as physicians, and that has to be part of the equation. 

It took me 3 years to get from Dr. Shuren at the FDA a list of 

the problems that he was worried about with the development of 

laboratory developed tests. Where are the outliers? Where are the 

problems? To his credit, the last time he was in here, a few months 

ago, he did produce a list of 20 tests that he said that these may 

be problematic. But there are 11,000 laboratory developed tests out 

there, and they are useful every day of the week in a clinician’s office. So I’m sorry, but continue. 

Dr. O’TOOLE. So let me narrow the problem down to tests that 

we need for infectious disease, and particularly during epidemics, 

OK? And we need a variety of different kinds of tests. As you know, 

you want a very sensitive test when you have a low prevalence, but 

you don’t want that same test when you’re in the middle of an epidemic. So it gets tricky. 

However, here’s the problem. It’s very difficult to validate a new 

diagnostic against Ebola, or even Zika, if you don’t have curated 

samples of those diseases. In my view, the Government—you can 

put this in DOD, you can put it in HHS, you can put it in FDA— 

the Government should develop a curated bank of diseases about 

which we are worried so that companies, especially these small, 

agile, fragile companies, could come and test their diagnostics 

against them so that they could much more rapidly give FDA useful data on how well their test works. That’s one. 

Secondly, I think just as FDA has emergency use rules for medical countermeasures during public health emergencies, we ought 

to think about emergency use rules for diagnostics, which I think 

we can actually create rather rapidly and manufacture quickly during public health—— 

Mr. BURGESS. Yes, I will just tell you, last year or 18 months ago 

during the peak of the Ebola outbreak in September, I went to a 

hearing at the Foreign Affairs Committee where we heard that the 

FDA had actually put a clinical hold on, I think, a drug called 

TKM–Ebola that was at that time in use in treating patients with 

Ebola. I mean, I didn’t want to hear about clinical holds, I wanted 

to hear about clinical trials. So it really did seem like they were 

an obstacle faced with this worldwide scourge. 

Dr. Shalala, I just need to ask you a quick question on your— 

and I just appreciate your listing out the recommendations of the 

Blue Ribbon Task Force. In my political training, which, granted, 

was a street-level course, I was sort of taught that you only do 

three things. If you produce a list of 33 things, no one listens to 

you after the 3rd one. 

But I did read through your list, and it is a good list, it’s an exhaustive. I hope it’s not static. Because one of the things that we’ve 

worked on, on the 21st Century Cures bill, is the whole issue of 

interoperability of electronic health records. And if we do not address that fact in this—in the recommendations that you have, I 

think that’s actually going to stymie the ability for researchers and 

clinicians to communicate rapidly, de-identify data, to be sure, respect patient privacy rights. But at the same time, we need to have 

69 

that ability for rapid learning within the system, whatever develops. 

Ms. SHALALA. Well, as you know, there has been a lot of progress 

on electronic medical records in this country and continues to be. 

And you’re absolutely right, it’s the touchstone piece. 

I should say that even though we have 33 recommendations, we 

have actually staggered them, to identify those that we think Congress should do immediately that have more of a midterm value 

and a longer-term strategy. So we very carefully laid out a strategy 

that would be workable for Congress. 

Mr. BURGESS. Thank you, Mr. Chairman. 

Ms. SHALALA. And the Federal agencies at the same time. These 

are not just recommendations for Congress. 

Mr. BURGESS. Very good. I yield back. 

Mr. MURPHY. Thank you. The gentleman yields back. 

I now recognize Mr. Bilirakis for 5 minutes. 

Mr. BILIRAKIS. Thank you, Mr. Chairman. I appreciate this very 

much. Thank you for allowing me to sit in on this very important 

hearing. 

As the former chairman of the Emergency Preparedness, Response, and Communications Subcommittee for Homeland Security, 

I recognize a need for the country to be proactive, not just reactive, 

to a host of biological threats, both natural and manmade. I’m glad 

that I can continue to be involved in the Energy and Commerce 

Committee. So I appreciate being given the opportunity to sit in on 

this subcommittee. 

Secretary Shalala, earlier you mentioned that the State and local 

agencies are the first in line of defense against outbreaks and attacks. You also said that much of their funding through block grant 

programs has been weakened. What should we do to enable State 

and local entities to be prepared to respond to outbreaks or attacks? Is there enough of a focus on medical surge capacity and 

mass prophylaxis capabilities? Do we need flexibility in our grant 

programs? 

Ms. SHALALA. Well, we have flexible grant programs. I think they 

are not well funded. That is our point, I think in the report, is that 

the funding has either been level or gone down over a number of 

years. The CDC’s grant to the States is pretty flexible. I mean, 

there’s some exceptions in it. But the States are really underfunded 

in terms of their infrastructure. As was pointed out, we have lost 

50,000 public health experts across the country in the States because of—— 

Mr. MURPHY. Could you turn your microphone on, please? 

Ms. SHALALA. Oh, I’m sorry. 

We’ve lost 50,000 public health employees in our States and local 

governments as well, and that has to be properly funded. The tradition has been to have almost a block grant that goes from CDC 

to the States. I believe in that tradition. I believe in the relationship between the CDC and States and local governments to build 

an infrastructure. Because the CDC is not a line agency. When 

we’re in an emergency we think they are. But it’s really the States 

and the local governments and their public health departments 

that are responsible for both the tracking, the identification for all 

of us in this country. And we have to make sure that infrastrucVerDate Mar 15 2010 10:45 Apr 24, 2017 Jkt 037690 PO 00000 Frm 00073 Fmt 6633 Sfmt 6633 I:\114THCONGRESS\114X117BIOTHREATSJKTREQ022117\114X117BIOTHREATSPENDIN
70 

ture—the States are under great fiscal pressure in this country and 

we have to make sure that infrastructure is beefed up, that stays 

in place. 

Mr. BILIRAKIS. Thank you. 

The next question is for the panel. You all mentioned the lack 

of comprehensive biodefense strategy and the need for centralized 

leadership. What, if any, protocol is in place now to enable coordination between the agencies, such as DHS, CDC, HHS, and various 

State agencies, when there is a disease outbreak? And what capability gaps exist in coordinating efforts between agencies? What 

makes coordination a challenge? We can start with the Secretary. 

Ms. SHALALA. Well, I think earlier I talked about the fact that 

there were multiple agencies that are involved when we have an 

outbreak like this. And while HHS has very strong responsibilities 

and has the scientific and public health expertise, Homeland Security, the Defense Department, I mean, there are all sorts of agencies across the board. 

And we have made a very strong recommendation that the Vice 

President be the ongoing coordinator in this country because the 

lead agency concept no longer works when you have various jurisdictions involved; and in particular, when you need to work with 

the private sector, with State and local governments. Unlike 

FEMA, which basically can order people around, it’s very difficult 

for one agency. And I say this reluctantly because, as the former 

HHS Secretary, I wanted to own the world. 

But when you don’t have proper jurisdiction, when you don’t 

have the leverage, then you have to elevate it, elevate both the responsibility. And we are much more sophisticated about the role of 

the private sector, the development of diagnostics, and that this 

has to all be part of our overall strategy in this country. 

Dr. PARKER. Yes, I just want to add to that, and the need to be 

able to elevate it. And that centralized leadership not only is needed at the Federal level, and to try to close these gaps between each 

individual department and agency because they want to exercise 

their own authorities, but there are gaps between them. 

But this will transcend all the way down to the State, local, private sector level. And it’s only if you have centralized leadership 

coming from the White House, however that’s done, it’s going to 

help kind of break that and transcend that leadership. 

And as an example you mentioned surge medical at the local 

level. It’s not just a public health thing. In fact, it’s going to be 

more logistics. That’s why emergency management and other disciplines are going to be so necessary to effect, in your example, 

surge medical dispensing of antibiotics. It’s more logistics. Public 

health doesn’t do logistics. 

So that’s really why it’s so important, this centralized leadership 

concept is just so critical, everything comes back to it, and it transcends the Federal, State, local, private sector levels, to close these 

gaps that we have between the multiple disciplines and agencies 

that have to contribute to biodefense. 

Thank you. 

Mr. BILIRAKIS. Thank you. 

I’ll yield back. Thank you, Mr. Chairman. 

Mr. MURPHY. Thank you. 

71 

I now recognize Mr. Griffith of Virginia for 5 minutes. 

Mr. GRIFFITH. Thank you very much. 

Thank you all for being here today. 

Dr. O’Toole, during the Ebola outbreak there were weaknesses 

identified in our system that we are now witnessing again with 

Zika: surveillance, detection, diagnostics. Overall, how would improved surveillance of animal disease outbreaks strengthen our 

surveillance of human disease outbreaks and make us better prepared for dealing with epidemics? 

Dr. O’TOOLE. Well, the majority of emerging infectious diseases 

come from animals. They’re diseases that affect both humans and 

animals. So we definitely need to do a better job looking at those 

hotspots where we are likely to see spillover from one species to 

humans. 

Most of those hotspots are in tropical zones, in the jungles of 

South America and Asia and Africa. Most of our surveillance is in 

temperate zones, for starters. And we are now beginning to have 

tools such as high-sequencing genomics, high-speed genomics that 

could actually give us a much better handle of what diseases might 

be able to spill over. So we ought to think about funding field surveillance of these hotspot ecosystems, for starters. 

Secondly, we ought to fund much more rigorously the USDA’s existing program for looking at agricultural animals, because, you 

know, modern methods of agriculture put sometimes tens of thousands of animals together, creating our own industrial hotspots for 

spillover, and we have seen that with flu and the loss of turkeys 

and chickens in the past years. 

Thirdly, for humans, we have to have a much more strategic approach to surveillance. We’ve spent billions, literally billions on 

surveillance in the past 15 years. Some things have worked; some 

things haven’t. We’ve done a terrible job at lessons learned. And we 

ought to go back and figure out what really has made a difference. 

Part of that is, again, we sound like broken records, funding 

State health departments, because that’s where, you know, the rubber meets the road. But we have to help State health departments 

do a better job. 

Diagnostics, again, critical, critical, critical, critical. Clinical disease is very vague. If you don’t have the diagnostics to say this is 

Zika and this is dengue, you’re going to have a hard time figuring 

out what’s going on at the beginning and at the middle of an epidemic. 

I would be very careful about investing large amounts of money 

in particular surveillance programs unless you know exactly what 

they’re supposed to do, whether they work, and who’s going to use 

that information. 

Mr. GRIFFITH. Well, and my next question was going to be that, 

you know, are we doing an adequate job of integrating human, animal, and environment health. I think you already answered that 

by saying no, we’re not doing such a good job of integrating those. 

Secretary Shalala, how can we improve integrating those three 

components to develop a more comprehensive strategy to ensure 

that we are prepared for whatever’s next? 

Ms. SHALALA. I think our major recommendation is that we put 

this responsibility in the Office of the Vice President; that we really 

72 

need a national leader with the clout to integrate all these pieces 

and to help us—actually to help us think through a strategy, because the integration itself will have to be done by agencies and 

by others. But the strategy, having the metrics for it, keeping people accountable, we’ve all recommended that we elevate that to the 

Office of the Vice President. 

Mr. GRIFFITH. I appreciate that. 

Dr. O’Toole, lots of concerns being raised about Zika and our athletes competing this summer in the Olympics; not only our athletes, but all the spectators who will go down, the coaches, the family member, et cetera. Do you believe that we will be ready? Obviously, the Brazilians are going to have to do some things and this 

is an international effort. But do you believe that we are going to 

be ready to be able to defend our folks or have the biodefense efforts ready to defend our athletes and spectators and coaches and 

family members who go to the Olympics this year? 

Dr. O’TOOLE. Well, I understand the deep concern that Zika has 

raised. Whenever children are affected, you know, grownups get 

deeply, deeply worried, and that’s what’s happening here. 

I will say that there are dozens of very dangerous mosquito, and 

even tick-borne diseases, that have been with us for millennia. And 

you can to some extent protect yourself from mosquito bites by 

using DEET and dressing well and sleeping in places with screens 

and so forth. That’s not a perfect protection. It’s not a zero risk. 

We have to wait and see until we have more information about 

what is really going on. We’ve known there has been more or less 

an epidemic of dengue and Chikungunya. And dengue is a serious 

disease in South America for a few years. That hasn’t stopped people from going down there. 

I think we have to wait till there is more scientific data about 

Zika. I know NIH is working on a vaccine. I wish we had one. But 

I think if I were a young woman who was pregnant or getting pregnant, I’d think twice about going to South America right now. But 

I think for most people there are ways to at least mitigate the risk. 

Mr. GRIFFITH. All right. Thank you. 

I yield back. 

Mr. GREENWOOD. Mr. Chairman, would you indulge me 30 seconds on the Zika question? 

Mr. MURPHY. Yes. 

Mr. GREENWOOD. Thank you. 

I just wanted to point out that, aside from medical countermeasures on Zika, there’s a whole field of looking at how to bioengineer mosquitos, which we already know how to do, so that they 

are actually—they’re all males, they don’t bite, and they mate with 

the females, and the progeny don’t survive. And I think that’s a 

fascinating new technology that may be part of the solution to this 

problem. 

Mr. MURPHY. Thank you. Thank you. I know we have votes in 

a few minutes. 

But Mrs. Brooks, if you have one quick follow-up question. 

Mrs. BROOKS. One quick follow-up question—thank you, Mr. 

Chairman—to Mr. Greenwood, with respect to the priority review 

voucher program. 

73 

Can you share with us existing PRV programs for rare pediatric 

disease or neglected tropical diseases increasing the biotech investments in this area? Can you give us some examples where you’ve 

seen that already happen? 

Mr. GREENWOOD. I probably have that in my notes, and if I had 

time, I’d be whispered to behind. But I’d just say—— 

Mrs. BROOKS. And if you would like to submit it for the record, 

that would be fine. 

Mr. GREENWOOD. We’ll submit that for the record. 

[The information appears at the conclusion of the hearing.] 

Mr. GREENWOOD. But suffice it to say that it is working. It has 

created, both in the area of pediatrics and in the area of neglected 

tropical diseases, it has generated a tremendous amount of interest 

and investment. And it is working perfectly well, just as a Congress intended, and I have no doubts that it would well in this field 

as well. 

Mrs. BROOKS. And do you believe that if we added the DHS’ material threats to the FDA’s PRV program, it would spur additional 

development of the medical countermeasures? 

Mr. GREENWOOD. I think that is precisely what needs to be done, 

and I have no doubt whatsoever that it will be successful in inspiring investment in this very dangerous field. 

Mrs. BROOKS. Thank you all. 

I yield back. 

Mr. MURPHY. Dr. Burgess, do you need a quick follow-up question? 

Mr. BURGESS. Yes. 

And, Secretary Shalala, you’ve spoken about the Vice President 

as sort of the overseer of all of this, and I appreciate the fact that 

there are too many agencies and too many people involved, and 

when too many people are in charge, no one’s in charge, and I get 

that. 

Ms. SHALALA. And too many committees of jurisdiction. 

Mr. BURGESS. And I don’t quite share your enthusiasm for putting this into the executive branch. Perhaps it should be a Speaker’s position. But, nevertheless, I will just tell you, I was down at 

the border, that Low Rio Grande border last weekend, and you realize you’ve got a CDC map that shows Mexico and Central America being purple with Zika, and my State’s the other side of a relatively narrow river. It just seems to me we don’t pay enough attention to border control. I know you can’t stop mosquitos at the 

border, but really the issue is stopping people who are infected or 

potentially infected. 

And right now we are undergoing another surge of unaccompanied minors and family units. And to the best of my ability to 

detect, we’re not looking, and that is a point of great concern to me. 

So all of the other things we’ve talked about are extremely important, but let us not forget border control, because that’s an issue 

as well. 

Ms. SHALALA. Well, I’ll leave that to your comments. But I would 

say that we also have to beef up global health, and that is PAHO, 

the Pan American Health Organization, which is part of the World 

Health Organization. 

74 

We can’t stop mosquitos from coming across borders, whether it’s 

in people or they’re just flying across. But it’s not only beefing up 

our own infrastructure. One of the things that we learned with 

Ebola is that the World Health Organization doesn’t have the kind 

of authorities it needs. It doesn’t have the resources they need. 

And so it’s not just a State and local issue or a Federal issue, 

it’s also an international issue. And I think your point about border 

security is also. But I would put it in the context of international 

health security and looking at the agencies that we have now, the 

international agencies that we have now. 

And we know that they’re weak. We learned that during Ebola 

and previously. And this committee also might have a hearing, because there have been recent reports on the international health 

organizations, to take a look at those relationships as well. 

Mr. MURPHY. Thank you. 

I know they’re going to call votes at any moment here. I just 

want to follow up with two quick questions. If you can’t answer this 

here, get back to us. I’d like an answer from each of you.If you 

know of countries that have model programs to do the very thing 

you’re describing, we’d love to know about that. Does anybody 

know any offhand, or would you like the get back to us on that? 

Mr. GREENWOOD. My only comment, Mr. Chairman, is that if we 

don’t have it, I’d be very surprised if anyone else in the world—— 

Mr. MURPHY. That’s what I feared. 

Ms. SHALALA. To be fair, there are centralized health systems in 

smaller places that may be more integrated, but I think that we 

have different levels of Government, different levels of responsibility. We can’t use their models. We’ll have to put our own system 

together. 

Mr. MURPHY. Thank you. 

Another question, just hope you can get information to us for the 

record. Given the recent GAO report on the failings of BioWatch 

programs, including the lack of valid performance data, should we 

continue to fund it? Do you have an answer for that, or do you 

want to get back to us? 

Mr. GREENWOOD. I’m sorry. Would you repeat the question, Mr. 

Chairman? 

Mr. MURPHY. Should the Federal Government continue to fund 

the BioWatch program given the recent GAO report on its failings 

and problems, including the lack of valid performance data? 

Mr. GREENWOOD. I think we probably will get back to you on the 

record with that. 

[The information appears at the conclusion of the hearing.] 

Mr. MURPHY. Ms. O’Toole, can you answer that? 

Dr. O’TOOLE. I’m a longtime critic of BioWatch, but I think you 

should continue to fund the current program for a defined period 

of time until we have a strategy for what we’re going to go do next. 

I think the notion that BioWatch, or even the next-gen BioWatch, 

a series of environmental sensors, can protect the country is wrongheaded. The technology just isn’t good enough. Its cost-effectiveness 

ratio is just not advantageous. 

We need a new generation of technology. It’s not there yet. 

Again, diagnostics would make a big difference. You do need these 

75 

sorts of sensors to protect high-risk targets and national security 

events and so forth. 

The problem with BioWatch right now is it is not characterized, 

as GAO points out very graphically and I think accurately. We 

don’t know that it works. It’s not clear that it doesn’t work. It has 

a very limited range of bugs that it looks for. And to really cover 

an area of a city you would need a lot of those machines. So it 

would be very expensive. 

Mr. MURPHY. Thank you. 

Well, with that I want the committee—first of all, thank you—— 

Ms. DEGETTE. Can I just say one thing? 

Mr. MURPHY. Oh, yes. Ms. DeGette. 

Ms. DEGETTE. Thank you. 

First of all, with all due respect to my friend from Texas, I don’t 

think that any kind of border control, even building a wall, is going 

to stop these vector-borne diseases from coming over. And I know 

that’s not what you mean. 

But what it does really highlight is how we are an international 

community. It’s not just the mosquitos coming. We even had Ebola 

cases come here because of international travel. And so that’s why 

it’s so unbelievably critical that we take this report seriously and 

that we really work hard as a committee. 

And, Mr. Chairman, I just want to commend you again for calling this hearing. I know you’re planning to have a classified briefing when we come back from the February recess, and I think 

that’s a good other step. 

And then I would just finally offer my input and the input of the 

minority staff and members to help come up with a robust hearing 

schedule for the rest of the year. I think if there’s nothing else we 

do than spend our time on this report and the recommendations, 

trying to get our arms around it and get that sense of urgency to 

our respective leaderships, then it will have been successful. 

And I want to thank everybody again from the commission for 

doing this deep dive because it really is important. 

Mr. MURPHY. And let me also announce on March 2 we will have 

a hearing on the Zika virus where many of these issues will come 

up, we’ll take a deep dive in that, as well as what my friend said 

about getting into a classified briefing on some of biodefense issues, 

critically important, and should be a wakeup call for America. But 

as you’ve said a couple times, Mr. Greenwood, we may not do these 

things until after the fact, and that would be a tragedy. So we’ll 

get moving on that. 

So in conclusion, again, I want to thank all the witnesses and 

members for participating in today’s hearing. I remind members 

they have 10 business days to submit questions for the record. I 

ask all the witnesses to agree to respond promptly to the questions. 

And with that, this committee hearing is adjourned. 

[Whereupon, at 11:05 a.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

76 


U.S. HOUSE OF REPRESENTATIVES 

COMMITTEE ON ENERGY AND COMMERCE 

February 10,2016 

TO: Members, Subcommittee on Oversight and Investigations 

FROM: Committee Majority Staff 

RE: Hearing entitled "Outbreaks, Attacks, and Accidents: Combatting Biological 

Threats" 

The Subcommittee on Oversight and Investigations will hold a hearing on Friday, 

February 12, 2015, at 9:00a.m. in 2123 Rayburn House Office Building, entitled "Outbreaks, 

Attacks, and Accidents: Combatting Biological Threats." The Subcommittee will hear testimony 

from members of the Blue Ribbon Study Panel on Biodefense and other experts on (a) the 

current threat of natural, intentional, and accidental biological events against the United States, 

(b) the extent of our preparedness for such an event, (c) the need to modernize our approach to 

biodefense preparedness, including addressing the lack of leadership on the issue within the 

Federal government, and (d) other specific recommendations by the Blue Ribbon Panel that fall 

within the jurisdiction of the Energy and Commerce Committee. 

I. WITNESSES 

• Donna Shalala, Panel Member, Blue Ribbon Study Panel on Biodefense; 

• James Greenwood, Panel Member, Blue Ribbon Study Panel on Biodefense; 

• Tara O'Toole, M.D., M.P.H., Senior Fellow and Executive Vice President, In-Q-Tel; 

• Gerald Parker, D.V.M., Ph.D., M.S., Associate Vice President, Public Health 

Preparedness and Response, Center for Innovation in Advanced Development and 

Manufacturing, Texas A&M University. 

II. BACKGROUND 

a. The Blue Ribbon Study Panel on Biodefense Report 

The Blue Ribbon Study Panel on Biodefcnsc (Panel) was established in 2014 to assess 

gaps and provide recommendations to improve U.S. biodefense. The Panel, chaired by Senator 

Joe Lieberman and Secretary Tom Ridge, charged itself with this work and did not receive a 

commission from Congress or the President. The Panel held a series of public hearings, hearing 

from experts at all levels of government, industry, academia, and advocacy, before issuing its 

report in October 2015. 
77 


Majority Memorandum for February 10,2016, Subcommittee Oversight and Investigations Hearing 

Page 2 

The Panel's report makes clear that this threat is not new. In fact, many of their 

recommendations are based on previous recommendations made by earlier panels or 

commissions. For example: 

• The U.S. Commission on National Sccurity/21 st Century, also known as the HartRudman Commission, "recognized the potential lor epidemics to become pandemics and 

the dual-use nature of scientific discoveries."1 

• The Commission on Terrorist Attacks on the United States, also known as the 9/11 

Commission, "posited that more than two dozen terrorist groups were pursuing biological 

materials but that high-level government leaders were expressing various levels of 

concern regarding this threat."2 

• The Commission on the Intelligence Capabilities of the United States Regarding 

Weapons of Mass Destruction echoed the concerns ofthe earlier commissions and 

"described in excruciating detail the failings and weaknesses of the [Intelligence 

Community] regarding the biological threat."3 

• The Commission on the Prevention of Weapons of Mass Destruction Proliferation and 

Terrorism ·'determined that the priority placed on addressing the biological threat was too 

low to ensure national security."4 

Many of the Panel's recommendations-33 in all-address the need for a comprehensive 

plan for biodefense with a clear leader. Better leadership is needed to achieve coordination and 

accountability, improve collaboration, and drive innovation across the numerous biodefense 

programs in the Federal government in particular. 

Unlike previous commissions, the Blue Ribbon Panel does not plan to disband now that 

their report has been released. This year, the Panel will begin assessing the government's 

implementation of its recommendations. The Panel also plans to begin an agency-by-agency 

review the United States' biodefense preparedness, which will be more specific than the 

overview assessment discussed in the Panel's report. 

i. The Threat of Natural and Intentional Biological Events 

The Panel believes that the biological threat to the United States-including natural and 

intentional incidents-is growing. Our understanding of, and response to, the threat must be 

elevated accordingly. 

1 Bipartisan Report of the Blue Ribbon Study Panel on Biodcfense, A National Blueprint for Biodefense.· Leadership 

and Major Reform Needed to Optimi=e Tfforts 5 (Oct. 2015) [hereinafter Panel Report]. 2 !d. 

'!d. 

'!d. 
78 


Majority Memorandum for February 10,2016, Subcommittee Oversight and Investigations Hearing 

Page 3 

Pandemic and other highly pathogenic or emerging diseases arc occurring with greater 

frequency and spreading more quickly throughout the world. The same mosquito, for example, 

spreads the Zika, Dengue fever, and Chikungunya viruses. These diseases do not just affect the 

human population. Naturally occurring diseases also have an impact on livestock, crops, and 

dairy or produce supplies. 

Since 2002, the world has seen outbreaks of severe acute respiratory syndrome (SARS), 

Chikungunya, Zika, cholera, influenza, measles, Ebola, and Middle East respiratory syndrome 

(MERS). Most ofthese outbreaks have occurred since 2008. 5 Appendix!, a timeline of 

outbreaks since 2002, demonstrates the increasing frequency of infectious disease outbreaks, 

epidemics, and pandemics. As noted by the Commission on a Global Health Risk Framework, 

the rate of emergence of new infectious diseases appears to be increasing.6 This seems to be the 

result of the following factors: greater probability of zoonotic (animal to human) transmission 

because of increased population and consequently greater human-wildlife interaction and 

increased livestock production, and ever-increasing global trade and travel. 7 

With respect to the intentional (e.g., terrorist) threat, it is easier for nation states and 

terrorists to obtain the resources necessary to produce biological weapons than ever before. 

Further, given in part the ease with which one can obtain these resources, it is difficult for the 

intelligence community to collect, analyze, and produce intelligence about biological threats. 

Former Representative Mike Rogers who chaired the House Permanent Select Committee on 

Intelligence told the Panel, "the longer [terrorist groups] have freedom of operation in any space 

that contains those kinds of clements, I think that's dangerous to the United States and our 

European allies."8 Many groups, including terrorist organizations, domestic militia groups, and 

lone wolves, have expressed the intent to use and have shown some capability to develop 

biological weapons. While events of this nature have previously been described as "low 

probability-high consequence," the better classification of likehood and consequence today is 

"indeterminate."9 

A recent report published by Gryphon Scientific for an Nil I advisory committee details 

terrorist and extremist events tied to biological warfare since 1972. With respect to the 

capabilities of transnational terrorist groups in particular, Gryphon Scientific found that the 

groups are "well-funded, well-organized, well-armed, and highly motivated .... They are 

capable of orchestrating complex attacks and have suitable resources to orchestrate long-term 

plots .... They may have a chemical or biological weapons program involving scientifically 

trained individuals .... "

10 Appendix 2, a timeline of bioterror events since 1972 and currently 

designated foreign terrorist organizations, shows the historical progression of bioterror attacks 

and the large number of groups who may attempt to procure biological weapons. This historical 

information, coupled with the "indeterminate" risk assessment, demonstrates that the likelihood 

of such an attack is not as remote as one would hope. 

5 Sands. eta/., The Neglected Dimension of Global Security ~A Framework for Countering Infectious Disease 

Crises, NEW E~GLANDJ.Of MEDICINE (Jan. 13, 2016) 6 ld at 4. 

7 !d. 

8 Panel Report. supra note I, at 4 9 Briefing by Dr. Tara O'Toole to Committee staff(Feb. 3, 2016). 10 Gryphon Scientific, Risk and Benefit Analysis of Gain of Function Research 850 (Dec. 20 15). 
79 


Majority Memorandum for February 10,2016, Subcommittee Oversight and Investigations Hearing 

Page 4 

With respect to ISIS in particular, recent press reports indicate that ISIS militants are 

seeking biological weapons. According to non-classified sources, in August 2015, a Syrian rebel 

group reported that they found a laptop belonging to ISIS that included documents on biological 

weaponry." On October 7, 2015, Brigadier General Maria Gervais, head of the Army's 

Chemical, Biological, Radiological and Nuclear School stated, "Intelligence has recently 

discovered that ISIS intends to pursue biological agents and is also trying to figure out how to 

weaponized bubonic plague through the use of infected animals." 12 In November 2015, ISIS 

executed the head of the Department of Physics at the Department of the University ofMosul, 

reportedly because of his refusal to develop biological weapons. 13 

Nearly all of the pathogens at issue in either a bioterrorism event or a pandemic arc 

zoonotic, which means that they reach humans through animals. Emerging infectious diseases, 

for example, arc often first seen in areas where human populations arc putting pressure on 

remote wildlife habitats, such as near a rainforest. 14 Accordingly, the Panel promotes a "One 

Health" approach, utilizing disease surveillance and detection in both human and animal 

populations. 

ii. The Need for Leadership and Collaboration on Biodefense Issues 

The Panel believes that the lack of leadership and the fractured nature of responsibilities 

on biodefcnse issues is a major factor in our lack of preparedness for an intentional or natural 

biological event. 

Currently, biological responsibilities are spread across numerous departments, agencies, 

and programs. There is no central leadership in the U.S. government accountable for strategic 

planning, budgeting, or coordination. The Department of Defense handles biological programs 

related to national security. The Department of Health and Human Services (HHS) has 

responsibility for biological threats to humans, while the Department of Agriculture (USDA) has 

similar responsibilities for animals and plants. 

Each of the last three Presidents has addressed biodefense staffing differently. During 

President Clinton's administration, former Secretary of Health and Human Services Donna 

Shala!a detailed an assistant surgeon general from the U.S. Public Health Service to the National 

Security Council. 15 During the Bush administration, Assistant to the President Tom Ridge 

created a biodefense directorate in the Homeland Security Council staffed with a Special 

11 Harold Doornbos & Jenan Moussa, Found: The Islamic State ·s Terror Laptop of Doom, FOREIGN POL'Y (Aug. 28, 

20 14) (ami/able al http://foreignpolicy .com/20 14/08/28/found-the-is1amic-states-terror-laptop-of-doom/) (last 

accessed Feb. 5, 20 16). 11 Sarah Sicard. !S/L Determined to Acquire Biological Weapons, NAT'L DEF. MAG. (Oct. 7, 2014) (available a/ 

http://www.nationaldefensemagazine.org/blog/listsiposts/post.aspx?ID~ 1632) (last accessed Feb. 5, 20 16). 13 Abdelhak Mamoun, Source.· ISIS executes Head()[ Physics Department for refi!Sing to de\·elop bioweapons in 

Mosul, Iraqi News (Nov. 12, 2015) (available at http://www.iraqinews.eom/iraq-war/source-isis-executes-headphysics-department-refusing-develop-bioweapons-mosul/) (last accessed Feb. 5, 2016). 

::Briefing by Dr. Tara O'Toole to Committee staff(Feb. 3, 2016). 

Panel Report, supra note I, at 7. 
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Majority Memorandum for February 10,2016, Subcommittee Oversight and Investigations Hearing 

Page 5 

Assistant to the President and three additional staffers. 16 President Obama merged the staffs of 

the National Security Council and the Homeland Security Council, eliminating the biodefense 

office. Currently, the various biosecurity functions are distributed through the National Security 

Council. In 2014, President Obama also appointed an Ebola czar, who has since retired, to 

coordinate the Federal government's response to that crisis from the White House. 17 

The Panel believes the current biological preparedness and response construct is too 

fragmented to ensure an effective national strategy. Accordingly, it recommends that biodefense 

be institutionalized in the Office of the Vice President. In the opinion of the Panel, the Vice 

President should receive the necessary jurisdiction and authority to coordinate the various 

biological groups throughout the federal government, and also receive authority to review and 

advise on all biodefense budgetary issues. 18 The Panel further recommends that the Vice 

President establish a biodefense coordination council within the White House and develop, 

implement, and update a comprehensive national strategy for biodefense. 19 

iii. Preparing for a Biological Event 

The Panel identified numerous specific areas where the Federal government must 

improve its efforts to implement an end-to-end biodefense system. According to the Panel, the 

United States "remains unprepared for known, unknown, and unexpected threats."20 

The 2014 Ebola outbreak demonstrated the current state of preparedness for an outbreak. 

Most hospitals were unprepared to handle the disease. In a departure from normal procedures in 

which the Occupational Safety and Health Administration (OSHA) developed guidelines for 

hospitals, the Centers for Disease Control and Prevention (CDC) instead developed flawed 

guidelines. The Panel described the overall preparedness at the hospital level: 

Flawed guidelines released by the CDC to hospitals (which addressed issues not 

under CDC purview, such as [personal protective equipment] and hospital 

operations), inadequate coordination between CDC and OSHA regarding federal 

messaging and waste management, poor training regarding the implementation of 

the requirements described in those guidelines, and insufficient attention paid to 

some potentially useful hospital disaster plans exacerbated already insufficient 

levels of preparedness. 21 

In the wake of the Ebola outbreak, HHS provided grants to help hospitals better address 

Ebola in the future. Yet, as the Panel points out, disease-specific funding is inefficient and is not 

the best way to fund preparedness for future attacks-which may or may not involve the same 

pathogen. 

16/d. 

17 /d. 18 !d. at 9. 19 /d at 11-15. 

'

0 /d. at 52. 21 !d. At 38. 
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Majority Memorandum for February 10,2016, Subcommittee Oversight and Investigations Hearing 

Page 6 

Efficiently and effectively preparing for biological events will require innovation in 

several key areas. Accurate biosurveillance and biodetection capabilities are among the most 

critical elements of an end-to-end approach. The systems must work quickly-detecting the 

presence of a pathogen in hours, not days. The Panel recommends that the Federal government 

implement an integrated national biosurveillance capability that works, unlike the numerous 

surveillance and detection systems-including the ineffective BioWatch program-currently in 

usc. Further, this network should share data among the various agencies, including that collected 

by the CDC, USDA, and other entities, and also improve surveillance of animal pathogen data. 

BioWatch, a Department of Homeland Security (DHS) biosurveillance program launched 

in 2003, is criticized by the Panel for failing to realize its potential over the last 12 years. 

Bio Watch detectors, deployed in a few dozen cities, collect air samples for a select number of 

bioterror pathogens. The samples are analyzed by non-Federal public health laboratories. The 

Panel described the limitations of the system: "it relies on winds blowing in optimal directions"; 

"it can take up to 36 hours to alert the possible presence of a pathogen"; "specimens are 

inactivated, preventing determinations of whether live organisms were released"; "it cannot 

differentiate between normal background bacteria and harmful pathogens"; and "it cannot 

identify atypical threats."22 DHS failed to acquire next-generation technology that could have 

reduced time-to-detection to as few as 6 hours, so the program uses the same technology as it did 

upon deployment in 2003. The Panel recommends that a new, advanced environmental detection 

system be developed to replace BioWatch. As discussed below, the U.S. Governmental 

Accountability Office (GAO) also recommends that the government in effect end BioWatch. 

The development of flexible medical countermeasures will allow for a timely response to 

a number of different scenarios. While traditional vaccines can address specific threats, 

platforms that allow for rapid vaccine development and production may have the flexibility to 

address as-yet-unknown threats. The development of rapid diagnostic tests would aid physicians 

in identifying emerging diseases or select agent pathogens. For example, the availability of such 

a rapid diagnostic test would have significantly improved patient screening during the Ebola 

crisis. In order to develop new medical countermeasures and rapid diagnostic tests, the Panel 

believes that government research agencies, such as Biomedical Advanced Research and 

Development Authority and the National Institutes of Health, should prioritize innovation over 

incrementalism in research and development. 

b, Additional Panel Recommendations Within the Committee's .Jurisdiction 

The Blue Ribbon Panel report includes 33 recommendations across the entire 

government. Many recommendations fall within this Committee'sjurisdiction, including: 

• Prioritize emerging and reemerging infectious diseases. The Panel recommends that 

the Secretary of Health and Human Services, along with the Secretaries of Agriculture 

and Defense, develop a multi-criteria tool to prioritize emerging infectious disease 

threats. 23 

22 !d. at 59. 23 !d. at2l. 
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Majority Memorandum for February 10,2016, Subcommittee Oversight and Investigations Hearing 

Page 7 

• Prioritize and align investments in medical countermeasures (MCM) among all 

Federal stakeholders. Federal agencies must prioritize and budget tor the right 

countermeasures, focusing in greater part on specific product goals and end-user needs, 

such as medical countermeasures for specific diseases or pathogens (i.e., Ebola) 24 

• Establish and utilize a standard process to develop and issue clinical infection 

control guidance for biological events. Federal agencies must standardize the 

development of clinical guidelines before an event occurs, and not change those 

processes in the midst of an event.25 

• Develop and implement a medical countermeasure response framework. An 

operational plan to distribute and dispense MCMs could speed the allocation of vaccines 

or other countermeasures from the Strategic National Stockpile or local supplies.26 

• Allow for forward deployment of Strategic National Stockpile assets. Providing 

assets to qualified cities in advance is a near-term solution while a broader medical 

countermeasure response framework is developed27 

• Harden pathogen and advanced biotechnology information from cybcr attacks. 

Databases containing genetic sequences of pathogens, advanced methods for genetic 

engineering, or other biological information may be stored on cloud systems vulnerable 

to cyber attack.28 

• Review and overhaul the Select Agent Program. The regulatory regime of the 

program docs not fully address underlying issues, including pathogen safety and 

security?9 

• Address prioritization and funding for influenza preparedness. The Panel 

recommends that Congress consider providing complementary legislative authorization to 

define and guide pandemic influenza programs.30 

c. Other Recent Reports on Biopreparedness 

Since the Blue Ribbon Panel's Report was published, several reports published by the 

GAO and one by the DHS Office of Inspector General (OIG) have been released. Given that 

these reports were released after publication of the Blue Ribbon Report on Biodefense, the Panel 

was not able to consider the findings of these reports and incorporate them into their 

work. These reports highlight the importance of the work done by the Panel and the 

"!d. at 22. 

"Id at 38. 

"Id.at43. 

"!d. at 44. 28 /d. at 46. 29 !d. at 60. 30 !d. at 56. 
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Majority Memorandum for February 10,2016, Subcommittee Oversight and Investigations Hearing 

Page 8 

recommendations that they made. The findings and recommendations of each report are 

summarized below. 

i. BioWatch 

On October 23, 2015, GAO released a report entitled, "Biosurveillance: DHS Should Not 

Pursue BioWatch Upgrades or Enhancements Until System Capabilities are Established." The 

GAO found that DHS docs not have reliable information about BioWatch Generation 2's (Gen2) ability to detect a biological attack and as a result is not able to make informed decisions about 

whether or not we should upgrade the system. DHS still lacks performance requirements that 

would allow for accurate interpretation of test results and the ability to make conclusions about 

BioWatch's effectiveness and reliability. It was also discovered that DHS tested Gen-2 by using 

simulated biothreat agents in a chamber, rather than in real world settings, which limited the 

validity of the results. Despite all of this uncertainty, DHS took steps to acquire and test a new 

generation for BioWatch, Gen-3. DHS canceled Gen-3 acquisition in April2014. However, 

GAO reports there are components ofGen-3 that could be applied to upgrade Gen-2 rather than 

acquiring a next generation. As a result of their findings, GAO recommended that DHS wait to 

pursue upgrades to Gen-2 until it can establish the system's current capabilities with certainty, 

and DHS generally concurred with GAO's recommcndation. 31 

ii. Emerging Animal Diseases 

On December 15, 2015, GAO released a report entitled, "Emerging Animal Diseases: 

Actions Needed to Better Position USDA to Address Future Risks." The GAO found that the 

USDA failed to take regulatory action during the initial response to the outbreaks of Swine 

Enteric Coronavirus Diseases that started in May 2013, because the agency did not believe that 

such action was necessary. USDA supported industry-led efforts, but due to a lack of data 

collection, USDA does not have information regarding the location of where the outbreak 

originated. USDA also acknowledged that they failed to follow their guidance that requires them 

to perform epidemiological investigations at the onset of an outbreak. Due to USDA's inaction, 

it is unlikely that we will ever know the source ofthc disease. In June 2014, USDA issued an 

order with reporting requirements of newly infected herds. They have also drafted guidance, but 

the guidance docs not include important details involved in a response, such as roles and 

responsibilities. As a result of their findings, GAO recommended that USDA develop a process 

to help guarantee its guidance for investigation of animal diseases is followed and clarify and 

document how it will respond to emerging diseases. USDA generally agreed with GAO's 

recommendations32 

iii. Air Travel 

On December 16, 2015, GAO released a report entitled, "Air Travel and Communicable 

Diseases: Comprehensive Federal Plan Needed for U.S. Aviation System's Preparedness." The 

31 U.S. Gov't Accountability Office, Biosurveil!ance: DHS Should Not Pursue BioWatch Upgrades or 

Enhancements Until System Capabilities are Established (Oct. 20 15) (GA0-16-99). 32 U.S. Gov't Accountability Office, Emerging Animal Diseases: Actions Needed to Beller Position USDA to 

Address Future Risks (Dec. 2015) (GA0-16-132). 
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Majority Memorandum for February I 0, 2016, Subcommittee Oversight and Investigations Hearing 

Page 9 

GAO found that all of the airports and airlines that they reviewed during this study have plans in 

place tor responding to communicable disease threats. However, the United States does not have 

a comprehensive national aviation-preparedness plan that would prevent and contain the spread 

of diseases from air travel. There is not a requirement for U.S. airports and airlines to have 

preparedness plans, therefore it is unknown which airports and airlines have existing 

plans. While conducting this study, GAO spoke with aviation stakeholders who flagged 

challenges in responding to communicable disease threats and actions they took or would take in 

response; including difficulties sharing timely and accurate information about threats, training, 

and access to equipment that would help them control exposure to communicable diseases. As a 

result of their findings, GAO recommended that the U.S. Department of Transportation (DOT) 

work with relevant stakeholders to develop a national aviation-preparedness plan for 

communicable diseases. DOT agreed that a plan is needed, but suggested that public health 

agencies would be more appropriate to lead the effort. Despite DOT's reaction to the GAO's 

recommendation, GAO still believes that DOT would be the most appropriate agency to 

spearhead this work.33 

iv. Ebola Response 

On January 6, 2016, the DHS OIG released a report entitled, "Ebola Response Needs 

Better Coordination, Training, and Execution." The DHS OIG found that while the DHS 

responded quickly to put appropriate screenings in place, there was a lack of coordination, 

training, and consistent screening of people entering the United States. DHS and HHS did not 

establish roles and responsibilities for domestic Ebola screening and as a result, there was weak 

coordination among the relevant agencies, personnel did not receive adequate training, and 

people with exposure risk may have entered into the U.S. without going through the proper 

screening measures. As a result of their findings, the O!G developed I 0 recommendations and 

DHS concurred with all of them. The recommendations include but are not limited to, specific 

steps to improve coordination with relevant agencies, providing guidance and resources to ports 

of entry, revising training requirements, and updating guidance and screening procedures. The 

OIG considers 7 of their recommendations resolved and closed, but 3 recommendations require 

additional steps to ensure that they are properly addressed. 34 

III. ISSUES 

The following issues will be examined at the hearing: 

I. The nature of the current threats against the United States and around the world, 

including intentional, natural, and accidental threats. 

2. The lack of leadership or organization ofbiodefense activities and research across the 

Federal government. 

33 U.S. Gov't Accountability Office, Air Travel and Communicable Diseases: Comprehensive Federal Plan Needed 

for US Aviation System's Preparedness (Dec. 2015) (GA0-16-127). 34 U.S. Dep't of Homeland Sec., Office of Inspector General, DHS' Ebola Response Needs Beller Coordination. 

7i·aining, and Execlllion (Jan. 6, 2016) (OIG-16-18). 
85 


Majority Memorandum for February 10, 20!6, Subcommittee Oversight and Investigations Hearing 

Page 10 

3. The role of Federal, State, and local authorities in preparing for and responding to 

biological events. 

4. The role of the Congress, and the Energy and Commerce Committee in particular, in 

shaping the response to biodefense issues. 

IV. STAFF CONTACTS 

If you have any questions regarding the hearing, please contact Alan Slobodin, Jen 

Barbian, or Brittany Havens at (202) 225-2927. 
86 


Appendix 1: Figure l From Sands, eta!., 1t1e Neglected Dimension r~fGlobal Security-A Framework 

fiJr Countering hJ(ectious Disease Crises, NFW EN<iLANll J. OF MEDICINE (Jan. !3, 2016) 
87 


Appendix 2: Excerpt from Gryphon Scientific, Risk and Benefit Analysis of Gain of Function Research 

850 (Dec. 20 15) 

16.8 Terrorist and Extremist Events Tied to Biological Warfare 

Tabk 16.3. Chtonok>gy ol terronst and nirenust events tii:d to bJ<~IogKal wartart (B\\') 

Date of event 

(most re.centto 

oldest) 

August 28,2014 

2013 

I········ ............... 

May2012 

ll!'l !bid 

"~' !bid. 

""' !bid. 

""' !bid. 14(l Ibid 

Croup Descriptk>n of event 

Islamic State of Faretgn l'aJicy joum:ilists report on the obtained contents of one 3lleged lraqandthe lSIL member's laptop:>.«~~ lt held over 3 5,000 files dedkated to Jihad, a Levant (lSIL, few ofwlliclt discussed BW'«n ISIS, Daesh) 

C>rnmwlist 

Farty of the Fltilippines military claims that Nl' A used feces to spike explosive devices Fhili ppines/ tccausesepsis,in what appears tc be a modem take on the Viet C>ngpunji New Feople's .stick technique.- The Nl' A denies this .

2

''" Anny 

(CPF/Nl'A} 

!·'· 

Revolutionary 

Armed Forces A defused FMC gas cyttnder bomb rep<>rtedly had feces mixed with 

of Colombia shrapnel in order to c&J.Se sepst. upon injury.1406 

(FMC) 

""' Huak!Doornbos, Jeru.nMoussa, "Fouro: Tho l.d.unic State's TerrorLaptopofDoom," l"oreign PoJi,."')l, August28,2014, 

http://fol'Oignpoliq.comt2Ql4/0S/2 Slfourul-tho-i.damic-states-l=or-laptoJ>'of.:dooml. Acee=d June 30, 201 S. 

'"" !bid. ""' 't>hihppine Arley tlruls hum.anf«.o~, snaJ;, "'"'om in wouroedsokliers' wl>tlruls," Nv>danao Examiner, Scptembe:4, 2013, 

http:/!xniruim;,o=ni:ner.comlphilippine-army-firuls-humm-~.sn.h>""""rn-in-wouruled-soklie:s-wl>tlrulsl. A~ 

Junc JD, 201 5. 1401i Thid. 

""' "Anny destroys minefiold in southwest Colombia," Co!ambta &!pam, May 11, 2012, 

http:/lcolomln.areporu .comlminefiold-and-""Jllo.li"""found-in-southwest-colornbial. Access«! August 11, 2015. 
88 


Appendix 2: Excerpt from Gryphon Scientific, Risk and Ben~fit Analysis of Gain of Function Research 

850 (Dec. 20 15) 

Table 16.3. Chronolog~ oftrrrorist and t"Xtl·t·mi~t eH:nts ti(•d to biological narfnn· (B\\) 

Date of event Group Description of event 

(most recent to 

oldest) 

"Indian 

2010 Mujahedeen 

j A 2010 email claiming to be from the "Indian Mujahedeen(Assam)" group 

threatens biological warfare against India unless its demands are meL 2407 

(Assam)" However, no evidence exists that this group had or has a BW capahility. 

I Senior AQ member Abu-Salih al Somali authors "Terror Franchise: The 

Unstoppable Assassin, TECHS Vital role for its success" sometime after 

After 2009, AIQaeda(AQ 2009.2408 The document ends with a detailed list of military topics about 

which the author is requesting the "techs" to research and share hu;truction up to 2011 Central) manuals and videos. BW topics figure prominently on this list, and are I marked as "immediately needed."2409 The document is captured in the 2011 

raid that killed Bin Laden. 2410 

Al Qaida in the 

2009 Islamic Highly contested news of a BW training camp accident. 2411.2412,2413 

2407 

2408 

2409 

(AQIM) 

"Extremists Warn of Biological Strike in India/' Nuclear Threat Initiative Global Security N~vswire, October 4, 2010, 

http://www .nti.orglgsn/article/extremists~warn~of-biologicaJ-strike-in-indiaf. Accessed Jtme 30, 2015. 

David Francis, "AJ Qaeda's Blueprint For How To Start a Homegrown Terror Franchise/' Foreign Policy, May 20,2015, 

http://f0reign_policy.com/20l5/05/201al-qaedas-blueprint-for-how-to-start-a-homegrown-terror-franchlse/. Accessed June 30, 

2015. 

Office of the Director of National Intelligence, Bin Laden's Bookshelf," http://www.dni.gov/index.php/reoourceslbin-ladenbook...;helf?start-=-l. Retrieved under the "Now Declassified Ma1erial" folder: Abu-Salih A1 Somali, "Terror Franchise: The 

Unstoppable Assassin, 1ECHS Vital role for its success/' p. 2, 5, IO, 

http://www.dni.gov/files/docurnentsfub11englishf1'error%20:Franchise. pdf. Accessed June 30, 2015. 

[bid 24 n For a critical review of these accmmts, see: Rene Pita, Rohan G1maratna, Philip Henika, "Al Qaeda in the Islamic Maghreb 

(AQ!M) and the Alleged Production of the Etiological Agent ofPlague," ASA Newsleller 13! (April2009): p. l, 21-22, 

http://www.asanltr.com/news1etter/09-2/articles/092a.pdf. Accessed July 17,2015. 2412 For the accounts themselves, see: 

Eli Lake, "Al Qaeda bungles arms experiment," The Washington Times, January 19, 2009, 

http://wwwwashingtontimes.com/ne\'.~/2009ijan/19/al-qaeda-btmgles-arms-experimentl. Accessed July 14, 2015. And:. 24 B Olivier Guitta, "·AJ-Qaeda in the islamic Maghreb: A Threat for the West/' Defence Against Terrorism Review 3, no. 1 

{Spring 20!0): p. 57-58, http:llwww.coedat.nato.int/pub1icationidatrlvolume5103-AI· 

Qaeda_in_the_ls1amic __ Maghreb_A_Threat.for_.tll<_ West pdf. Accessed July 14, 2015. 
89 


Appendix 2: Excerpt from Gryphon Scientific, Risk and Benefit Analysis of Gain of Function Research 

850 (Dec. 20 15) 

I abh.• 16 .. '. Cbnmolog~ of tl'ITorist and extremist e\ t·nts tied to biological" arta1 t• (B\\) 

Date of event Group Description of event 

(most recent to 

oldest) 

The FBI's complaint filing against Aafia Siddiqui during her trial stated 

that at the time of Aafia Siddiqui's arrest on July 17, 2008, Afghanistan 

National Police found "numeroll> chemical substances in gel and liquid 

form that were sealed in glass bottles and glass jars," as well as "numerous 

documents describing the creation of explosives, chemical weapons, and 

other weapons involving biological material and radiological agents/' 

"documents detailing United States military assets" personal papers 

including "descriptions of various landmarks in the United States, 

including in New York City." and "handwritten notes that referred to a 

"mass casualty attack" and that listed various locations in the United 

July 17, 2008 I [Aafia Siddiqui States, including Plum Island, the Empire State Building, the Statue of 

alleged case] Liberty, Wall Street, and the BrooklynBridge."2414 The govemment's 

2414 

:!415 

24!6-

sentencing submission for the case also holds that her "thumb drive 

contained documents [ ... ] including: [ ... ] discussions of the construction of 

chemical and biological weapons."2415 The prosecution argued that Aafia 

Siddiqui's "conduct was the very definition of a federal crime of 

' 1 terrorism."2416 The media reported to the effect that she was a "suspected 

1 al-Qaeda operative;" Saddiqui and her family deny this allegation, and her 

trial did not involve an assessment of this accusation. 2417.241 8·24 19.2420,2421 

Since then, the Taliban, the Tehrik-i-Tali ban Pakistan, AI Qaeda, and most 

recently !S!L have offered (some on multiple occasions) to trade Saddiqui 

against hostages. 2422.2423,2424.2425,2426.24:!7 

Plum Island is the site of the Plum Island Animal Disease Center, although the prosecution did not elaborate on the alleged 

targets. 

United States District Court Southern District ofNew York, United States of America v. Aafia Siddiqui (defendant), "Sealed 

Complaint: Violations of 18 U.S.C §§ 11 I, I I 14, p. 1-3, http://www.justice.gov/arehive/opalpr/2008/Augnstlsiddiqui-aafiacomplaint.pdf. Accessed June 30,2015 

United States District Court Southern District of New York, United States of America v. Aafia Siddiqui (defendant), 

"Government's Sentencing Submission," Attomey for the United States of America: Preet Bharam, United States Attorney 

for the Southern District of New York, Assistant United States Attomeys of Cmmsel, Christopher L LaVigne, David M. 

Rody, Jenna M. Dabbs, Case 1:08-cr-00826-RMB, Document 250, Filed August 29,2010. 

http://web.archive.org/web/20 1203 1 4163620/http:/ /www.nefafoundation.org/rniscellaneous/US _ v_ Siddiqui_ usgsentmemo.p 

df. AccessedJ\me30, 2015. 

Ibid 2411 "Dr. Aafia to boycott trial," The Nation, November 21,2009, http://nation.com.pk!Politicsi2I ·NovM20091Dr·Aafia-to· 

boycott-trial. Accessed June 30, 20 I 5. 24111 Benjamin Weiser, "indictment Hints of Plan to Attack Landmarks," The New York Times. September 2, 2008, 

http://www .nytimes .com/2008/09/03h!yregion/03 indict. html? _ r-1 &. 24 l

9 Petra Bartosiewicz, "AJ-Qaeda Woman? PuttingAafia Siddiqui on Trial," Time, January 18,2010, 

http:/ /content.time. com/time/nation/article/0,8599, I 9 54598,00.htrnl. 2420 Juliane von :Mittelstaedt, "America's Most Wanted: 'The Most Dangerous Woman in the World,' Spiegel Online, November 

27, 2008, http://www.spiegel.de/intemationallworldJamerica~s~most·wanted-the·most-dangerous·woman~in-theMwor)d-a· 

593 I 95-druck.html. 2421 "Federal jury convicts Paklstani woman of attempted mmder of US personnel," Jurist, Febmary 4, 2010, 

http:/ljurist.orgipaperchase/20 I 0/02/federal-jury-convicts-pakistani-woman.php. 2422 Mushtaq Yusutzai, "Tali ban to execute US soldier lf Aafia not released," The News, February 5, 2010, 

http://www.webcitation.org/query?ml=http%3A%2F%2FWWVt.thenews.eom.pk%2.Ftop_story_detail.asp%3Fld%3D27072, 2423 Bill Roggio, "Zawahiri claims al Qaeda is holding US citizen hostage," Long War Journal Threat Matrix, December 1, 

2011, https:/ /web archive. org/web/20 150 l 03043251 ,bttp:l/www.1ongwarjourral.org/threat. 

2424 

matrix/archives/20 11/12/zawahiri_ claims_ al_ qaeda _ holdi.php. 

"Taliban confirm they have Swiss hostages," Agence France Presse, July 29, 2011, retrieved at The Express Tribune: 

http:!/tribtme.com.pk!story/220022/tehrik~i-taliban·say-they-have~swiss-hostages/. 
90 


Appendix 2: Excerpt from Gryphon Scientific, Risk and Benefit Analysis of Gain of Function Research 

850 (Dec. 20 15) 

I able 163. ( ht·onolog~ of tt>t-rorist and t'Xtremi~t t'\ents tied to biological \\arfatt• (tl\\) 

Date of event Group Description of event 

(most recent to 

oldest) 

The Chinese government alleges that Emeti Yakuf; an alleged terrorist 

East Turkistan connected to the East Turkistan Islamic Movement, threatened to use 

2008 Islamic biological and chemical weapons to disrupt the 2008 Olympics held in 

Movement China, and that he trained group members on making poisons. 2428 This 

individual was reportedly killed in a 2012 U.S. drone strike in Pakistan. 2429 

f-····-·· ... ---·-· 

AI-Aqsa The group issues a statement claiming that they possess chentical and 

June 27, 2006 Martyrs biological weapons, in an attempt to deter l.sraeli military action. 2430 This 

Brigade claim is regarded as spurious. 2

4 31 

MSNBC reporters state that their initial field tests for botulinum and ricin 

toxins came up positive at a site in Iraq used by the group, but that no B. 

April 4, 2003 Ansar al-lslam anthracis was detected; then-Secretary of State C,olin Powell had 

(AAI) previously said the camp held a poison laboratory. 2432 However, in 

retrospect, the site does not appear to have produced toxins. The site is not 

mentioned in the report of the Iraq Survey Group2433 

I Jemaab Arrest ofRiduan lsarnuddin, the director of operations for Jemaab i August 2003 lslamiyalt lslamiyab who organized for Yazid Sufaat's transfer to AQ. 2434•

2435 

Revolutionary 

June 2002 Armed Forces A defused F ARC gas cylinder bomb reportedly had feces mixed with 

of Colombia shrapnel in order to cause sepsis upon injury.2436 

·-- (FAR C) ~---~·-~ ----·'-··-·-

N:ts Nima Elbagir, Ingrid Fonnanek, "'Malian troops take key town; humanitarian crisis grows," CNN, January 21, 2013, 

http://www cnn.com/201310 1 /21 /worldlafricalmali-unrestl. 2426 Jan Lopatka, ed. Alison Williams, "Video of kidnapped Czechs demands release of jailed Pakistani," Reuters, June 26, 

2013, http://www.reutm .comlarticle/20 13/06/26/us-pakistan-czech-kidnapping-idUSBRE95POXJ20130626. 

,., James Fielding, lvtarco Giannangeli, ''British Aid Worker Executed By Taliban," Daily Express, October 10, 20!3, 

bttp:/lweb arcbive.orglweb/20 1 OJ 0 150023511http:l/www.dailyexpress.co.uk/posts/vkwl2045 33/British·aid·workerexecuted-by~ Tali ban. 2428 "'Eastern Turkistan• terrorists identified," China Dai~v. October 21,2008, http;//'\\'WW.chinadaily.com.cn/china!2008-

l 0/2 !/contcnt_7!26503.htm. 

JAZQ Declan Walsh, Eric Schmitt, "Militant Leader Belleved Dead in Pakistan Drone Strike,'' The New York Times, August 24, 

2012, http://www.nytimeKcom/20 12/08/25/world/asialus-drone-strikes-kill-18-in-pakistan.htmJ?_r=l. 2430 '"Al-Aqsa Martyrs Brigade in Palestine Claims to Have Developed Chemical and Biological Weapons and Threatens Their 

Use in Israel,'' SITE Alonitoring Service Enterprise, June 27,2006, https://ent.siteintelgroup.com/Jihadist-News/6-27-06-alaqsa-rnartyrs-in-palestine-creates-wrrx:i.html. 2431 Michael Moodie, Markus Binder," Jihadists and Chemical Weapons,'' Jihadists and Weapons of A-lass Destruction, eds. 

Gary Ackerman, Jeremy Tamsett (13oca Raton: CRC Press, 2009), p. 143. 2432 Preston Mendenhall .. "Positive test for terror toxins in Iraq," .MSNBCcom, April 4, 2003, 

http://www.nbcnews.com/id/3070394/ns/world~news/tlpositive-test~terror-toxins~iraq/#.VXdWckbrJ~A 24 B Milton Leitenberg, Assessing the Biological Weapons and Bioterrorism Threat, Strategic Sh1dJes Institute monograph~ 

December 2005, p. 26-27, http://www.strategicstudiesinstitute.army.millpdffileslpub639.pdf 2434 Joel Roberts, "Thailand PM: Hambali Was Plotting," CBS News, August !7, 2003, http://www.cbsnews.com/newsllhailand· 

pm-barnbali-was~plottingl. 

K'5 RolfMowatt~Larssen, "AJ Qaeda Weapons of Mass Destruction Threat: Hype or Reality?" Paper, Harvard Kennedy School 

Belfer Center for Science and International Affairs. January 2010, p. 28, 

http:/ ;belfercenter. ksg.harvard.edu/pubhcation/19852/al_ qaeda _weapons_ of_ mass_ destruction_ threat.html. 243& Mariano C. Bartolome, Maria Jose Espona, "Chemical and Biological Terrorism in Latin America: The Revolutionary 

Armed Forces of Colombia," The ASA Newsletter 03-5, no. 98 (October 31, 2003), http://www.asanltr.comlnewsletter/03- 5/articles/03 5c. htm 
91 


Appendix 2: Excerpt from Gryphon Scientific, Risk and Benefit Analysis of Gain of Function Research 

850 (Dec. 20 15) 

lablt' 16.3. Chronolog~ ot terrorist an<\ e:s:tn:'mist t.'H·nts tit.•d to biological '\arfan• (U\\) 

Date of event Group Description of event 

(most recent to 

oldest) 

A!Qaeda(AQ Rauf Ahmed is detained in Pakistan, and Y azid Sufaat is arrested in I Central); 1 December 200 l Jemaah Malaysia2437•

2438 Pakistan subsequently cuts off FBI access to Rauf Ahmed 

in 2003; the latter is now free. 2439 I 

1·---------·- lslamiyah 

I Yazid Sufaat flees Afghanistan for Bogor, Indonesia, to escape from the I 

I 2001 Jemaah October 2001 U.S. intervention.2440 He reportedly seeks to set up a new 

lslan1iyah BW progr.un in-country upon arrival, but fails to recruit a microbiologist at I an Indonesian institute. 2441 •

24'

121443 

r::~·:1ber and [Amerithrax 

1 "At least five envelopes containing significant quantities of Bacillus 

· anthracis" were mailed to U.S. targets.2444 The attacks killed five and 

October 2001 I case] sickened seventeen other individuals. 244' FBI concluded that Bruce E. 

Ivins, a researcher at USA.lv!RIID (U.S.A.) had sent the letters. 2446 

1999-2001 

AIQaeda(AQ 

Central); 

Jemaah 

Islamiyah 

, Zawahiri launches a BW program in 1999, and hiresRauf Ahmed. 2441·"48 

Alm1ed establishes a covert laboratory in Afghanistan.2449 By 2000, 

Zawahiri recruits Yazid Sufaat.2450 U.S. outing of the Taliba:n disrupts the 

plan and the laboratory is discovered.'"""" 

1998 to May 

2000 

"Palestinian 

Group" 

A Palestinian group (unlmov.m) was reportedly caught in a counterfeiting 

scheme whereby expired eggs contaminated with salnlonella were stamped 

with counterfeit stamps and sold. 24:B Israeli news reporting on their capture 

2437 

in May 2000 implied that this was to sicken Israelis. 24" 

Joby \Varrick, "Suspect and A Setback in Al-Qaeda Anthrax Case," The Washington Post, October 31, 2006, 

http://www.washingtonpost.com!wp-dyn/contentiarticle/2006/I0/30/AR200610300!250.hbnl. 

Maria Ressa, "Reports: Al Qaeda operative sought anthrax," CNN, October 10,2003, 

http://edition.c!U1.com/2003/WORLD/asiapct7southeastll Oil 0/alqaeda.anthrax/. 

Joby Warrick, "Suspect and a Setback in Al-Qaeda Anthrax Case." 

Judith Miller, ·'U.S. Has New Concerns About Anthrax Readiness," The New Yark Times, December 28,2003, 

http:/Jwww,nytimes.com/2003/ 12!28/us/us~has-new~concerns~about-anthrax~readiness.htrnl. 

244) fbid. 

2442 

2443 

2444 

2446 

244'/ 

2448 

2449 

2450 

Maria Ressa, "Reports: AI Qaeda operative sought anthrax;" 

Rene Pita, Rohan Gtu1aratna, "Revisiting Al-Qa 'ida's Anthrax Program," 

The United States Department of Justice, "Amerithrax Investigative Summary, Released Pursuant to the Freedom of 

Infonnation Act," Fcbmary 19,2010, p. 1. http:/hvv.twjustice.gov/archive/amerithrax!docs/amx-investigative-summary.pdf. 

!bid. 

Ibid. 

Alan Cullison, "Inside AI-Qaeda's Hard Drive," The Atlantic, September 2004, 

http://www .theatlantic.com/magazine/archive/2004/09/inside-al-qaeda-s-hard-drive/303428/. 

RolfMowatt-Larssen, "Al Qaeda Weapons of Mass Destruction 11lreat Hype or Reality?" 

Ibid. 

Rene Pita, Rohan Gunaratna, "Revisiting Al-Qaida's Anthrax Program," ere Sentinel Vol. 2 Issue 5, May2009, 

https://www.ctc.usma.edu/posts/revisiting-al-qalda%E2%80%99s-antbrax-program. 2451 fbid, 2452 

].454 

RolfMowatt-Larssen, "How to Get Terrorists to Talk," The National Interest, February !8, 2015, p.2, 

http:/ /nationalinterest.org/featurelhow¥get-terrorists-talk-12270?page=2. 

Jason Pate, C.ravin Cameron, "Covert Biological Weapons Attacks against Agrlcultural Targets: Assessing the Impact against 

U.S. Agriculture," BCSIA Discussion Paper 2001-9, ESDP Discussion Paper ESDP-200 l-05, John F. Kennedy School of 

Government, Harvard University, August 2001, p.8, 

http:/ !belfercenter.kig.harvard.edu/files/covert_ biological_ weapons attacks against agricultural targets.pdf. fbid. - . - -

I 

i 
92 


Appendix 2: Excerpt from Gryphon Scientific, Risk and Benefit Analysis of Gain of Function Research 

850 (Dec. 20 15) 

'Iablt• 16 •. '. ( hr·ottnlog~ oftt•t-rorist and t·xtn-mbt t'\t'llts tit•tl to biological \\arfa~t· (B\\) 

Date of event Group Description of event 

(most recent to 

oldest) 

Chechen group 

One Russian newspaper claimed that Salman Raduyev, a prominent 

leader, had threatened to steal biological weapons from ex-Soviet February 1999 under Salman warfare laboratories unless the government released two Raduyev cap!u';'ed wometL 2455 TIJis report could not be verified.2456 

members of the group sent emails threatening to use biological agents "Republic of June 1998 against federal officials; no biological agents were uncovered at the time of Texas" their arrest.2457 

·-·-··----r-·--

Apri11998 Pale.stinian A Jordanian newspaper cites a leading figure in tl1e organization as having 

Islamic Jihad discussed the possibility of using BW.24" This remains unconfirmed. ........ -- .............. ··--------. ------·---··-------·---------·------------ National 

March The ELN detonate an explosive device reportedly spiked with fecal matter 6, 1998 Liberation to cause sepsis upon injury. 2459 

Army(ELN) 

Counter Agar and B. cereus in a petri dish apparently labelled "anthracs" [SIC} and 

"Yersinia" was sent to a Jewish organization in Washington. 2460 Holocaust '\\-11ether 

1997 Lobbyists of this was an anthrax hoax or the group thought the package contained B. 

Hillel anthracis is not known; the package contained a hate latter that further 

misidentified the petri dish as con~ining a '"chemical wurfare'~ agent. 2461 

1---- ......... 1--------------

1996 

I ~ustice , A group calling itself the "Justice Department" mails razors to fur retailers 

[ epart~le; in Canada in 1996 which they claim are covered with HIV -infected blood; 

~m~ n tl I whether they really did so is not known. 2462 

March 15, 1995 

rat Jca group j 

A Sh' 'k The group ineffectually attempts to disperse botulmum toxm from three 

um mrt yo sprayer-suitcases in the Kasumigaseki metro station (Japan).2463 

November 4, A Sh. 'k j The group fails in an assassination attempt involving botulinum toxin 

1994 unJ mrt yo mixed with juice-'464 

--

2455 

2458 

2459 

2460 

--- "' "··-----~- ·-"·-·--·--------------·---

W. Seth Carns, JJiotenorism and Biocrimes: The Illicit Use ofBiological Agents Since 1900, Working Paper (Washington: 

Center for Colllltet}lroJiferation Research, National Defense University, Febmary 2001 Revision), p. 107. 

Ibid. 

For instance, the Russian think-tank PIR Center does not include this incident in their list of North Caucasus CBRNthreat 

events. PI.R Center, "\'\l'NID Terrorism Originated in North Caucasus: Again on the Agenda?" PIR Center Report, April 26, 

2013, http://www .pircenter .org/en/articles/1312-wmd -terrorism-originated~in-north-caucasus-again-on·the-agenda. 

W. Seth Carus, Biotmorism and Biocrimes: The Illicit Use ofBiological Agents Since 1900, p. 108-109, p. 186. 

Ibid. 

Mariano C. Bartolome, Maria Jose Espona, "Chemical and Biological Terrorism in Latin America: The Revolutionary 

Anued Forces of Colombia." 

\V. Seth Cams, Bi01errorism and Biocrimes: The Illicit Use of Biological Agents Since 1900, p. 1 10-111; 

TI1e B'nai B 'rith International Jewish Monthly, Volume Ill, (1996), p. 67, https:llbooks.google.comlbooks?i<:FV--

3AA.AAIAAJ &q=anthracis+ Y ersinia+Counter+Holocaust+Lobbyists+oft-Hillel&dq=anthracis+ Y ersinia+Counter+Holocau 

st+Lobbyists+of+Hillel&hl~en&sa~X&ved~OCC~Q6AEwA2oVCbMI98TMwLK!xglVOEaMChOgNACO. 2461 W. Seth Carus, Bioterrorism and Biocrimes: The rHlcit Use of Biological Agents Since 1900, p. Ill. 

Ibid. 2462 

2.463 

2464 

Richard DallZig, Marc Sagcman, Terrance Leighton, Lloyd Hough, Hidemi Yuki, Rui Kotani, Zachary M. Hosford, "Aum 

Shinrikyo: Insights into how terrorists develop biological and chemica] weapons, second edltion," Center for a New 

American Security, December 2012, p. 21, 

http://www.cnas.org/fi]es/documents!pubtications/CNAS_AumShinrikyo __ SecondEdition_Engllsh.pdf 

Ibid 
93 


Appendix 2: Excerpt from Gryphon Scientific, Risk and Benefit Analysis of Gain of Function Research 

850 (Dec. 20 15) 

Date of event 

(most recent to 

oldest) 

1993 

Group 

Animal 

Liberation 

Front (ALF) 

[animal rights 

Description of event 

A spokesman for the Animal Liberation Front (ALF) claims that bombs 

planted in the U.K. by members of the collective had been pnrposefully 

tainted with HIV, but authorities dismiss this aceount.2465 

f····--·----·----.. --··t .. rn·_d __ k_·_ru __ ~g-ro_u~p~]--l!---------------------------------------------------------~ November 1 8, 

1993 Aum Shinrikyo The group disperses 20 liters of botulinum toxin slurry from a car sprayer 

in a failed assassination attempt. 2466 

. -·-·-----·---------------------------- ___ ,_ -------------·------------1 

Following failed attacks with tl>e liquid product, the group sets up a 

dry production line for B. anthracis. 2461 

-- ---f------ ·--... ..,, .. _____________________________ .......................... --------·--i 

The group produces some I 0 to 20 tons of slurry containing B. 

(perhaps not pathogenic), which are then ineffecturuly released 

trucks in some 10 to 20 attacks.246a 

The group produces roughly 20 tons of slurry containing B. anthracis 

(perhaps not pathogenic), and ineffectually sprays the product from the 

roof of one of its facilities. 2469 

The group produces several hundred tons of slurry as part of their 

botulinum toxin production program.2471 They disseminate this material in 

20 to 40 different attempted attacks in this time period, all without 

success.2

"

72 

Seiichi Endo, the leader of the group's BW program, harvests C. botulinum 

from soil in 

September 1984 Rajneeshees 

S. typhimurium is used to contruninate at least 10 restaurant salad bars in 

The Dalles, Oregon (U.S.A.), causing at least 751 people to fall iii.2474,2475,2476 

2465 

2466 

2467 

246S 

2470 

>PI 

2472 

W. Setl1 Carns .. Bioterrorism and Biocrimes: The Illicit Use of Biological Agents Since 1900, p. 76. 

Richard Danzig et al., "Aum Shinrikyo: Insights into how terrorists develop biological and chemical weapons, second 

edition," 

Ibid. 

Ibid. 

Ibid. 

Ibid. 

Richard Danzig et al., "Aum Sbinrikyo: Insights into how terrorists develop biological and chemical weapons, second 

edition," Center for a New American Security, December 2012, p. 20, 

http://www.cnas. org/filesldocurnents/publicationsiCNAS _ AurnShinrikyo _ SecondEdition _English. pdf>. 

Ibid. 

2474 

2473 Richard Danzig et at, ''Aum Shinrikyo: Insights into how terrorists develop biological and chemical weapons, second 

edition," Center for a New American Security, December 2012, p. 18·20, 

http:/lwww.cnas.org/filesldocumentslpublicationsiCNAS_AumShinrikyo_SecondEdition_English.pdf. 

Thomas J. et. al (1997), "A Large Comrnllllity Outbreak of Salmonellosis Caused by Intentional Contamination of 

247) 

247& 

Restaurant Salad Bars," Journal of the American Medical Association 278, no. 5, 

http://www.cdc.gov/phlp/docs/forensic _epidemiology/ Additional%20:Materials/ Articles/Torok:Oio20et%20al.pdf; 

W. Seth Carus, "The Rajneesbees (1984)." Toxic Terror: Assessing Terrorist Use of Chemical and Biological Weapons, ed. 

Jonathan Tucker (Cambridge: The MIT Press, 2001), p. 115; 

W. Seth Carus, "Rajneeshees," Encyclopedia of Bioten'Orism Defonse, 2"d Edition, eds. Rebecca Katz, Raymond A 

Zilinskas (Hoboken: John Wiley & Sons, 2011), p. 383-384. 
94 


Appendix 2: Excerpt trom Gryphon Scientific, Risk and Benefit Analysis of Gain of Function Research 

850 (Dec. 20 IS) 

fable 163. Chronolo~~ ofterro.-ist and t·~trt•mist l'\t'Uts til'rl to biological \'\arfan.• (H\\) 

Date of event Group Description of event 

(most recent to 

oldest) 

August 29, 1984 Rlljneeshees Two Wasco C.ounty commissioners were given water deliberately tainted 

with S. typhimurium by Rajneeshees; both fe.ll ill. 2477 

Reports, based on admissions made by Rlljneesh members, 

BW attacks prior to August 1984.2478 These are unconfirmed because none 

1984 Rajneeshees of the attacks were successful and because there may have been a desire to 

exaggerate wrongdoings by one of the chief organizers (Puja), who was 

hated.2479 

Dark Harvest In an apparent follow-on to the October 10, 1981 incident described below, 

October 14, 1981 [ eco-radical British police received an anonymous tip that led them to a metal box 

allegedly containing B. anthracis.2480 However, unlike in the October 10 group] incident, the soil did not contain B. anthracis-'481 

The eco-radical group "Dark Harvest" took B. anthracis-contaminated soil 

Dark Harvest from Gruinard Island (a then-contaminated British military WWII site 

October 10, 1981 [ceo-radical used to test B. anthracis bombs) and spread it on the grounds ofPorton 

Do"11 in 1981 (Britain's main biodefense and chemical warfare defense group] establishment, and previously the center orchestrating Britain's biological 

weapons progrmu) 2482 The soil did contain B. anthracis. 2483 

1980s Tamil A single unconfinned account of Tamil "militants" threatening biological 

"militants~* warfare.2484 

The German-based, now-defunct, Red Army Faction (RAF) reportedly 

maintained a botulinum toxin laboratory in Paris) France until it was 

Red Army uncovered in October 1980. 24" A recent review of this case has east doubt 

October 1980 on parts of the underlying story, however, an.d German authorities Faction apparently remain convinced that "no evidence whatsoever [exists] that 

members of the 'RAF' had plmmed or prepared an attack using biological 

L •. ___ ..... _,___ 1 agents. 

W. Seth Carns, "Rajneeshees," p. 534. 

Ibid, p. 534-535. 2479 

2480 

W. Seth Cams, Bioterrorism and Biocrimes: The Illicit Use of Biological Agents Since 1900, p. 534. !bid. 24Sl Ibid. 

2482 W. Seth Carns, Bioterrorism and Biocrimes: TI1e Illicit Use of Biological Agents Since 1900, p. 58. 24S3 Ibid 2434 Ibid. 24SS 

24S6 

.1487 

W. Seth Carns, Bioterrorism and Biocrimes: The Illicit Use of Biological Agents Since 1900, p. I 56~ I 57. 

!bid . 

The review in question is: 

Terence Taylor, Tim Trevan, "The Red Army Faction (1980)/' Toxic Ten-or: Assessing Ten-orist Use of Chemical and 

Biological Weapons, ed. Jonathan B. Tucker (Cambridge: MIT Press, 2000), 
95 


Appendix 2: Excerpt from Gryphon Scientific, Risk and Benefit Analysis of Gain of Function Research 

850 (Dec. 20 15) 

Iahlt.• 16.3. Chronolog~ oftt.•l-rorist and extrNnist t.'\ents tit·d to biological "arfan• (B\\) 

Date of event Group Description of event 

(most recent to 

oldest) 

POLISARJO; One unconfirmed report of a February 1975 offer by a group called 

Februal)' 1975 Basque POLISARIO to coordinate poisoning of water supplies."" Even if 

Fatherland and POLIS ARlO did make such a threatening offer, no evidence exists that 

Liberty (ETA) • l>m N lll>Tn sought a BW capability. 2489•

2490 

of two R.l.S.E. founders for having reportedly planned to 

January 18, 1972 R.l.S.E. contaminate Chicago's municipal water system with Salmonella typhi 

(causative agent of typhoid fever). 2491 

---------- ...... 

16.9 Designated Foreign Terrorist Organizations and Biological Weapons 

Designated Foreign Publicly Historically BW efforts Notes 

Terrorist threatened had a BW believed 

Organizations2492 BW? program?2493 ongoing? 

Abu Nidal Organization NO NO (ANO) 

A single news report that police 

captured publicly-available reading 

Abu Sayyaf Group material on biological and chemical 

NO NO warfare during the capture of six (ASG) suspected group members. 2494 

\Vhether the group members were 

members of ASG or Jl is unclear. 

Attempted production ofBW 

agent; launched failed BW attacks. 

Aum Shinrikyo (AUM) NO YES NO See the detailed entry below. 

Leadership and BW -program 

members captured. 

One unconfirmed report of a 

Basque Fatherland and NO NO February 1975 offer by a gronp 

Liberty (ETA) called Polisario to coordinate 

poisoning of water supplies. 2495 

2488 W. Seth Carns, Bioterrorism and Biocrimes: The Illicit Use of Biological Agents Since 1900, p. 121. 24S9 

2490 

POI.ISARO stands for "Frente Popular para Ia Liberacion de Saquia ei-Hamra y Rio de Oro," and is a group that seeks to 

overthrow Moroccan control of Western Sahara and create an independent state for Sahrawi tribes based on Islamic culmre. 

Gail H. Nelson, "POLISARIO," Encyclopedia ofBioterrorism Defense, 2"" EdUion, eds. Rebecca Katz, Raymond A 

Zilinskss (Hoboken: John Wiley & Sons, 2011), p. 510-512. 2491 W. Seth Carus, "RISE: A Case Study," Encyclopedia of Bioterrorism Defense, Jnd Edition, eds. Rebecca Katz, Raymond A 

Zilinskas (Hoboken: John Wiley & Sons, 2011 ), p. 542. 2492 

2493 

2494 

2495 

U.S. Department of State, "Foreign Tenorist Organizations." <http:/lwww.state.govijlct!rls/other/desi123085.htm>. 

Where a "BW program" is defined as a ml1ltary program for the production of a bjo]ogical pathogen. 

Christian Enemark, Dlsease and Security: Natural plagues and biological weapons in East Asia (Abingdon: Routledge, 

2007), p. 106. 

W. Seth Carus, Bioterrorism and Biocrimes: The Illicit Use of Biological Agents Since 1900, Working Paper (Washington: 

Center for Counterproliferation Research, National Defense University, February 2001 Revision), p. 121. 
96 


Appendix 2: Excerpt from Gryphon Scientific, Risk and Benefit Analysis of Gain of Function Research 

850 (Dec. 2015) 

Designated Foreign 

Terrorist 

Organizations1491 

1 Gama'a al-Islamiyya 

1 (Islamic Group) (!G) 

I 

! Hamas I 

j Harakat ui-Mujahidin 

I (HUM) 

I 

I 

Kurdistan Workers Party 

j (PKK) (Kongra-Gel) 

Liberation Tigers of 

Tamil Ee!am (LTTE) 

I PFLP-General 

1 Command (PFLP-GC) 

2496 Ibid. 

2497 [bid, 

2498 Ibid. 

Publicly Historically 

threatened had a BW 

BW? program?2493 

NO NO 

NO NO 

NO NO 

NO NO 

Unconfirmed NO 

NO NO 

NO NO 

BW efforts Notes 

believed 

ongoing? 

Reported interest in chemical 

poisons. 2496 

A single tmconfrrmed Turkish 

newspaper report of Cobra poison 

smuggling for profit.2497 

A single unconfirmed account of 

Tamil umilitants" threatening 

NO biological warfare in the 1980s. 2498 

Report ofLTTE use of chlorine for 

chemical warfare-. 2499 Group has 

been defeated. 

Unknown Reports that ELN used feces to if spike explosive devices to cause continuing sepsis, in what appears to be a war use of modern take on the VietCong punji biological stick teclmique.2500 

material 

A single unconfrrmed April I 998 

Jordanian newspaper report citing a 

leading figure in the organization 

as having discussed the possibility 

of using BW. 2501 

2499 

2500 

James J. F. Forest, Sammy Salama, "Jihadist Tactics and Targeting,'~ Jihadists and Weapons of Mass Destruction, eds. Gary 

Ackerman, Jeremy Tamsett (Boca Raton: CRC Press, 2009), p. 80. 

Mariano C. Bartolome, Maria Jose Espona, "Chemical and Biological Terrorism in Latin America: The Revolutionary 

Armed Forces of Colombia," The ASA Newslel/er03-5, no. 98 (October 31, 2003), http:llwww.asanltr.comlnewsletter/03-

5/articles/035c.htm 7501 W. Seth Cams, Bioterrorism and Blocrimes: TI1e Illiclt Use ofBiological Agents Since 1900, p. l09, 186. 
97 


Appendix 2: Excerpt from Gryphon Scientific, Risk and Benefit Analysis of Gain of Function Research 

850 (Dec. 20 15) 

Designated Foreign Publicly Historically BW efforts Notes 

Terrorist threatened had aBW believed 

Organizations2492 BW? program?2493 ongoing? 

I Revolutionary Armed 

NO, albeit Continued Reports that F ARC used feces to 

reported war war use of spike explosive devices to cause 

1 Forces of Colombia NO use of sepsis, in what appears to be a biological ' (FARC) biological modern take on the VietCong punji material material stick technique.2502•

2503.2504 

Revolutionary 

Organization 17 NO NO 

November (17N) I 

Attempted production ofBW 

agent, with unknown results. See 

detailed entry below. Efforts 

believed to be 

al-Qaida in the Islamic 

Maghreb (AQIM) 

YES 

(by proxy 

withAQ) 

YES YES 

By proxy with AQ (central); highly 

contested news reports of a BW 

training camp accident in 2009.2505,2506,.2507 

al-Qa'ida in the Arabian 

Peninsula (AQAP) 

YES 

(by proxy 

withAQ) 

Unknown 

Possibly by proxy with AQ 

(central). No information formally 

ties this group with AQ's BW 

program. The group reportedly 

considered contaminating U.S. 

food with ricin and cyanide~ 

although no open source 

indications suggest the group 

selected this tactic for 

operationalization.2508 

2503 

2504 

2SOS 

2507 

2508 

Mariano C. Bartolome, Maria Jose Espona, «Chemical and Biological Terrorism in Latin America: The Revolutionary 

Armed Forces of Colombia'' 

Pablo Esteban Parra Gallego, "IEDs: A Major TI1reat for a Struggling Society," TheJourno/ oJERW and Mine Action 13, 

no. 3 (Winter 2009), http://www.jrnu.edulcisr/joumal!l3.3/;pecialreportlgallego/gallego.shtml 

"Anny destroys minefield in southwest Colombia," Colombia Reports, May 17, 20!2, 

http://colombiareports<comlminefie ldwand~explosives·fm.md-in-southwest-colombial. 

For a critical review of these accolmts, see: Rene Pita, Rohan Gtmaratna, Philip Henika, "AI Qaeda in the Islamic Maghreb 

(AQIM) and the Alleged Production of the Etiological Agent ofP!ague," ASA Newsletter 131 (April 2009): p. l, 21-22, 

http://www.asanltr.com/newsletterl09-2/articlesl092a.pdf. 

For the accotmts themselves, see: 

Eli Lake, "AI Qaeda bungles arms experiment," The Washington Times, January 19, 2009, 

http:/ /v.'WW. washingtontimes. com/news/2009/jan/19/al·qaeda~bungles~arms-experimenU 

Olivier Guitta, "Al~Qaeda in tlle Islamic Maghreb: A Threat for the West," Defence Against Terrorism Review 3, no. 1 

(Spring 2010): p. 57-58, http://www.coedat.nato.intlpub1icationldatrivolume5/03-AlQaeda _in_ the_ Islamic_ Maghreb_ A_ Threat_for _the_ West. pdf. 

Mike M. Ahlers, Briao Todd, "Al Qaeda group contemplated poisoning food in U.S., officials say," December 22, 2010, 

http://www.cnn.com/2 0 I 0/US/ J 2121/al.qaeda.poison.ploti. 
98 


Appendix 2: Excerpt from Gryphon Scientific, Risk and Benefit AnaZysis of Gain of Function Research 

850 (Dec. 20 15) 

Designated Foreign Publicly llistorically BW efforts Notes 

Terrorist threatened had a BW believed 

Organizations2492 BW? program?2493 ongoing? 

Islamic Movement of I 

Uzbekistan (IMU) NO I NO 

I Real Irish Republican 

Army(RIRA) NO NO 

NO NO 

The group claimed to possess 

chemical and biological weapons in 

2006 in an attempt to deter Israeli 

military action."09 This chum is 

regarded as spurious. 2510 

Commooist Party of the 'NO, albeit Recent Philippines military claim 

reported war that NP A used feces to spike Philippines/New NO use of e.xplosive devices to cause sepsis; People's Anny biological see FARC and ELN entries.2ll 1 The (CPP/NPA) 1 material NP A denies this. 

Attempted production ofBW, 

mostly as part of Al Qaeda' s 

YES program, with unknown results. 

Jemaah lslamiya (JI) (By proxy YES NO See detailed entry. Group 

withAQ) membership, including leadership 

and individuals involved in the BW 

program, decimated. 

Pakistani police reportedly 

Lashkar i Jhangvi (LJ) NO NO tmcovered chemical laboratories 

belonging to the group. 2512 

"'' Michael Moodie, Markus Binder, "Jihadists and Chemical Weapons," Jihadists and Weapons of Mass Destruction, eds. 

Gary Ackennan, Jeremy Tamsett (Boca Raton: CRC Press, 2009), p. 143 2510 Ibid. 2511 "PhiHppine Army finds human feces, snake venom in wounded soldiers• wounds," Nindanao Examiner, September 4, 2013, 

http://mindanaoexaminer.comlphilippine-army-finds-hmnan-feces-snake-venorn-in-wounded-soldiers-wounds/. 2512 National Consortium for the Study of Terrorism and Responses to Terrorism (START), "TetTorist Organization Profiles: 

Lashkar-e-Jhangvei," http :/lwww. start. umd. edu/tops/terrorist_ organizationyrofile.asp?id""65. 
99 


Appendix 2: Excerpt from Gryphon Scientific, Risk and Benefit Analysis of Gain of Function Research 

850 (Dec. 20 15) 

'I ahh.• 16.4. ( u1 n.•ntl) dt•si~natt•d l•on•ign I t•t-rorist Ot·ganizations and B\\ 

Designated Foreign Publicly Historically BW efforts Notes 

Terrorist threatened bad a BW believed 

Organizations2492 BW? program?2493 ongoing? 

Initial reports held that the group 

had a poison laboratory in Iraq that 

Unsubstantial manufactured botulinum and ricin 

Ansar al-lslam (AAI) NO ed reports of NO toxin. 2513 However, in retrospect, 

interest in the site does not appear to have 

toxins produced tDxins. The site is not 

mentioned in the report of the Iraq 

Survey Group.2514 

Continuity Irish 

Republican Army NO NO 

(CIRA) 

~~:~\~~~c Fighting NO 

2513 

2:514 

Preston MendenhaH, "Positive test for terror toxins in Iraq," MSNBCcom, April 4, 2003, 

hnp:llwww.nhcnews.com/id/3070394/nslworld_newslt/positive-test-terror-toxins-iraqi#.VXdWckbrJ-A 

Milton Leitenberg, Assessing the Biological Weapons and Bioterrorism Threat, Strategic Studies Institute monograph, 

December 2005, p. 26-27, http:llw"~<~v.strategicstudiesinstitute.arrny<millpdffileslpub639.pdf 
100 


Appendix 2: Excerpt from Gryphon Scientific, Risk and Benefit Analysis of Gain of Function Research 

850 (Dec. 2015) 

fabh.• 1lJ.4. ( urrentl) designatt:d Foreign Icrrorist Organb:ations and H\\ 

Designated Foreign Publicly Historically BW efforts Notes 

Terrorist threatened had a BW believed 

Organizations2

A92 BW? program?l493 ongoing? 

Emerging group with enormous 

resources. Repmts of chemical 

munitions use (chlorine, phosphine, 

and mustard).2515,2516.2Sl1,25l8.Z519 

One individual member had a 

laptop with over 35,000 tiles 

Islamic State of Iraq and dedicated to Jihad, a few of which 

discussed BW.2520 Concern over the Levant (formerly al- NO Unknown alleged looting of biological Qa'ida in Iraq) laboratories in Syria. 2521 In 2014, 

DHS secretary Jeh Johnson stated 

that his service had "seen no 

specific credible intelligence that 

ISIS is attempting to use any sort of 

disease or virus to attack our 

homeland.""" 

I ~~~~ic Jihad Onion NO 

Islami/Bangladesh NO NO 

i (HUJI-B) 

al-Shabaab NO NO ·---·--------- Revolutionary Struggle NO NO (RS) ··--···-·····- • Kata'ib Hizballah (KH) NO NO 

"' ,; 

(HUH) NO NO 

2515 

25!6 

2.517 

2518 

2519 

252(} 

Torn Coghlan, Catherine Philp, Ammar Sharnary, "Jihadists unleash chemical weapons in battle for Tlkrit,H The Times, 

March 14, 2015, <http://www.thetimes.co.uk/tto/news/worldlmiddleeast/article438l52l.ece>. 

"Chlorine bomb attacks by jihadists are growing threat to the UK, warns chemical warfare expert," The Independent, May 

25, 2015, http://www. independent co. uklnev...-s/uk.lhome~news/chlorlne·bomb·attacks-by·jihadists·are-growing-tbreat-to-theuk-wams-chemical-warfare-expert-1 02 7494 7 .htr>ll. 

Phosphine, chemical formula PH3, is used as a fumigant, but is toxic if inhaled. Ibid; also see: Sajila Saseendran, "Ministry 

mulls banning 'killer' pesticide," Khaleej Times, September 2, 2014, 

http://www.khaleejtimes. comlarticle/2014090 1 I ARTICLE/3090 19899/l 002. 

Nabih Bulos, ~'Islamic State confirmed to have used mustard gas against Kurds in Syria," The Telegraph, August 15, 2015, 

http://www. telegraph.co.uk!news/worldnews/middleeast/syria/11 S0523 5/!slamlc-State-confirmed·to-have-used·mustardgas-against·Kurds~in·SyriaJltml. 

Paul Blake, "US oflicial: ·rs making and using chemical weapons in Iraq and Syria'," BBC News, September II, 2015, 

http://www. bbc.corw'news/wor Jd-us-canada~ 34211838 

Harald Doornbos, Jenan Moussa, '"'Found: The Islamic State's Terror Laptop of Doom," Foreign Policy, August 28,2014, 

bttp:ll!oreignpolicy.com/20 14108/28/found-tbe-islamic-states-terror-laptop-of-dooml. 2521 Ari Soffer, "Experts Warn of Al Qaeda Biological Weapons Threat," brae! National News, October 16,2013, 

http://www.israelnationalnews.com/News!News.aspx!l72897#.VXddiUbrJ-A. 2522 "Use ofEbola virus as bioterrorweapon highly tmlikely: Experts," Homeland Security News Wire, November 11, 20I4, 

http:/ /v.-•-'·.'w.homelandsecuritynewswire .comldr20 1411 ll·use-of-ebola-virus-as-bioterror-weapon-bigbly-unlikeJy-experts. 
101 


Appendix 2: Excerpt from Gryphon Scientific, Risk and Benefit Analysis of Gain of Function Research 

850 (Dec. 20 15) 

' I Indian Mujahedeen (IM) I . 

I 

j Jemaah Anshorut Tauhid 

i (JAT) 

Abdallah Azzam 

Brigades ( AAB) 

YES 

NO 

NO 

NO 

NO 

NO 

NO 

believed 

ongoing? 

A 2010 email claiming to be from 

"tndian Mujahedeen (Assam)" 

threatened biological warfare 

unless its demands were met. 2523 

Splinter group from Jemaah 

lslamiyah. 

Emerging group. Concern over 

alleged looting of biological 

laboratories in Syria. 2:524 

1523 ''Extremists Warn of Biological Strike in Indla~" Nuclear Threat Initiative Global Security Newswire, October 4, 2010, 

http://www.nti.org/gsn/articJe/extremists·wam~of-biological-strike~in-indial. 2524 Ari Soffer, ''Experts Warn of Al Qaeda Biological Weapons Threat'' 
102 


FRED UPTON, MICHIGAN 

CHAIRMAN 

ONE HUNDRED FOURTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

C!Congrc~~ of tbe 11niteb ~tate~ 

J!)ousc of l\cprcscntatibcs 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515--6115 MaJority {2021225 2927 

M•'loflty {20?17?5-3641 

AprilS, 2016 

The Honorable Donna E. Shalala 

Panel Member 

Blue Ribbon Study Panel on Biodefense 

575 Park Avenue, Suite 901 

New York, NY 10065 

Dear Secretary Shalala: 

Thank you for appearing before the Subcommittee on Oversight and Investigations on Friday, 

February 12,2016, to testify at the hearing entitled "Outbreaks, Attacks, and Accidents: Combatting 

Biological Threats." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (I) the name of the 

Member whose question you are addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on Tuesday, April19, 2016. Your responses should be 

mailed to Giulia Giannangcli, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn 

House Office Building, Washington, D.C. 20515 and e-mailed in Word format to 

Giulia.Giannangeli@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

~~ Tim Murphy 

Chairman 

Subcommittee on Oversight and Investigations 

cc: The Honorable Diana DeGette, Ranking Member, Subcommittee on Oversight and Investigations 

Attachment 
103 


Answer to Post-Hearing Question for the Record 

Submitted to the Honorable Donna E. Shalala 

from Representative Michael C. Burgess, MD, Subcommittee on Oversight and Investigations, 

House Committee on Energy and Commerce 

"Outbreaks, Attacks, and Accidents: Combating Biological Threats" 

February 12, 2016 

The Honorable Michael C. Burgess, MD 

l. As a physician, I understand that the development and validation of precise diagnostics 

for emerging outbreaks is crucial to combating biological threats such as Zika virus. 

We need to quickly develop diagnostics for these purposes and work to ensure that 

public health laboratories and hospital laboratories throughout the country are able to 

screen people for the disease and that patients have access to these tests. I'm concerned 

that the CDC is creating barriers for laboratories to quickly disseminate the test and by 

not enabling competing tests, there's no way to assess whether or not the CDC test is 

adequate. Please describe the process CDC engages in for sharing necessary 

information, test reagents, and reference materials to laboratories develop tests for 

emerging infectious diseases. I've also heard that despite the lack of cooperation from 

the CDC, some physicians have already developed tests for Zika virus at Texas 

Children's Hospital and Stanford University. Have you considered collaborating with 

these academic medical centers on developing diagnostics? 

While our Study Panel is aware of the CDC process for sharing information, test 

reagents, and reference materials with laboratories for the purposes of developing 

tests for emerging infectious diseases, we do not possess sufficient information 

with which to describe this process in detail for you. We recommend that you 

obtain this information directly from the CDC. 

Our Study Panel does not engage in the development of diagnostics. We do highly 

recommend government collaboration with academia and the private sector 

toward this end. The CDC and other government agencies should inform their 

activities with the existing expertise and progress within the U.S. biomedical 

enterprise. It would be better for the CDC to collaborate with academic medical 

centers and foster such innovation than for the CDC to operate in a vacuum, or 

worse, engage in unhealthy competition with the private sector. 
104 


FRED UPTON, MICHIGAN 

CHAIRMAN 

ONE HUNDRED FOURTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

(![:ongrersrs of tbc 1\nttcb ~tate% 

~omic of l\cpwsrntatibcs 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN House Orne£ BuiLDING 

WASHINGTON, DC 20515--6115 

The Honorable James C. Greenwood 

President and CEO 

Biotechnology Innovation Organization 

1201 Maryland Avenue, S.W., Suite 900 

Washington, DC 20024 

Dear Chairman Greenwood: 

Major1ty !?0?)?70·?927 

Mmonty (70?)275~3G41 

AprilS, 2016 

Thank you for appearing before the Subcommittee on Oversight and Investigations on Friday, 

February 12, 2016, to testify at the hearing entitled "Outbreaks, Attacks, and Accidents: Combatting 

Biological Threats." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (I) the name of the 

Member whose question you are addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

Also attached are Member requests made during the hearing. The format of your responses to 

these requests should follow the same format as your responses to the additional questions for the 

record. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on Tuesday, April 19, 2016. Your responses should be 

mailed to Giulia Giannangeli, Legislative Clerk, Committee on Energy and Commerce, 2!25 Rayburn 

House Office Building, Washington, D.C. 205!5 and e-mailed in Word format to 

Giulia.Giannangeli@mail.house,gm:. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

~s~ 

TimM~hp Chairman 

Subcommittee on Oversight and Investigations 

cc: The Honorable Diana DeGette, Ranking Member, Subcommittee on Oversight and Investigations 

Attachments 
105 


Answers to Post-Hearing Questions for the Record 

and Member Requests for the Record 

Submitted to the Honorable James C. Greenwood 

from Representative Tim Murphy, Chairman, Representative Michael C. Burgess, 

MD, and Representative Susan Brooks 

Subcommittee on Oversight and Investigations 

House Committee on Energy and Commerce 

"Outbreaks, Attacks, and Accidents: Combating Biological Threats" 

February 12, 2016 

The Honorable Tim Murphy 

1. During the hearing, we discussed a recent GAO report on the failings of the 

BioWatch programs. In your view, should the Federal government continue to 

fund such programs in the absence of valid performance data? (Question for 

the Record and Member Request for the Record} 

As our Study Panel states on page 59 of our bipartisan report, A National 

Blueprint for Biodefense: Leadership and Major Reform Needed to Optimize 

Efforts, "The biodetectors designed to inform biosurveillance of the air 

(commonly referred to as environmental detection) have not progressed 

significantly since their initial deployments ... The BioWatch program was 

launched in 2003 with great urgency, but its potential remains unrealized. As 

of 2015, BioWatch uses the same technology - manual filter collection and 

laboratory polymerase chain reaction testing- as it did twelve years ago ... The 

entire BioWatch system is dying for lack of innovation ... To date, no fully 

automated, tested, and evaluated autonomous detection system has been 

deployed that adequately addresses the airborne biological threat or sufficiently 

provides operational response information." 

Recommendation 31 of our report calls for the development of an 

environmental detection system that takes advantage of 21st Century 

technology. We believe that Congress should consider funding the development 

of advanced environmental detection systems to replace BioWatch. Ideally, we 

would recommend that the Secretary of Homeland Security replace BioWatch 

Generation 1 and 2 detectors within five years with the systems developed per 

action item 31a of our report. If they cannot be replaced within that timeframe, 

we recommend the Secretary of Homeland Security evaluate whether or not 

they should still be in service. Congress should require that the Department of 

Homeland Security and any other federal agencies that deploy biodetection 

systems: 1) measure and evaluate performance on a periodic basis; 2) make 

good faith efforts to obtain evaluative feedback from state, local, and other 

hosts for their systems; 3) use resulting data to improve upon current and 

inform future systems; and 4) provide these data and analysis to Congress for 

its use in oversight. If the responsible departments do not obtain these data, 

conduct analyses, use those analyses to optimize biodetection and 

Page 1 of 7 
106 


biosurveillance performance and inform procurements, and report data and 

analyses to Congress, Congress should no longer provide funding for, and 

responsible federal departments and agencies should no longer maintain, these 

programs. 

The Honorable Michael C. Burgess, M.D. 

1. Are there any strategies the Blue Ribbon panel considered regarding the 

availability of diagnostic testing to achieve rapid local response as well as 

surveillance? Has the Panel explored the role of diagnostics in outbreaks? 

The Blue Ribbon Study Panel dedicated an entire meeting to discussing 

surveillance and detection issues in some depth. The meeting, on March 12, 

2015, consisted of five panels with 19 speakers that included a former CDC 

Director, former Chief Medical Officer from the U.S. Department of Homeland 

Security, state laboratory directors, public health professionals, industry 

representatives, and many others. 

The Blue Ribbon Study Panel recognizes that diagnostic tests play a critical role 

in the detection of and response to an outbreak. Our report notes that 

availability of point-of-care diagnostic testing would have significantly improved 

management of the Ebola outbreak last year. Without point-of-care testing, 

screening of suspected patients was often based on little more than 

thermometer readings and a series of questions. Diagnostics would have 

significantly improved quarantine and isolation decisions at home and abroad, 

and offered information that would have spared treatments when they are not 

needed. Diagnostic testing is a valuable tool to help responders establish 

situational awareness, screen and triage patients who have been exposed, and 

determine appropriate intervention strategies. 

The Panel assessed that the technologies needed for the quick patient-side 

diagnostics of the kind used in doctors' offices to screen for influenza exist or 

are in development in the private sector. However, the U.S. government has 

not been prioritizing or adequately incentivizing the development of these 

technologies to maturity. Without rapid point-of-care diagnostics, the Nation 

remains vulnerable to biological threats. In Recommendation 30 of our report, 

the Panel recommends that the government develop requirements for rapid 

point-of-care diagnostics for all material biological threats and emerging 

infectious diseases. The Director of the Biomedical Advanced Research and 

Development Authority should determine the suite of rapid diagnostics that are 

needed, prioritize their development and acquisition, and implement a plan to 

work with industry and academia to achieve success in meeting its 

requirements. 

2. In 2009 during the H1N1 flu epidemic, as soon as the genetic sequence of the 

virus was identified, hospital and public health labs were able to rapidly 

develop laboratory procedures to test patients suspected of having the flu. 

While the FDA does have the ability to issue an emergency use authorization 

for commercially manufactured test kits, it is laboratory developed testing 

procedures that provide necessary and timely local testing. You may be aware 

Page 2 of 7 
107 


that the FDA intends to finalize guidance requiring premarket review for all 

laboratory developed testing procedures. I'm concerned that these proposed 

changes to FDA policy could hinder the development of these diagnostics and 

create regulatory challenges in these situations when time is of the essence. 

What recommendations do you have for the FDA on how to ensure that hospital 

labs are able to mobilize quickly to provide diagnostics for outbreaks such as 

the Zika virus and other even more pathogenic infectious diseases? 

Hospital and other laboratories (e.g., public health laboratories) develop and 

use assays to test clinical samples for pathogens of serious public health 

concern; as a result, they play a critical role in our ability to quickly assess 

and respond to emergent epidemics like that caused by Zika. In my role as 

President and CEO of the Biotechnology Innovation Organization (BIO), I have 

worked with companies developing a range of diagnostic products. Any FDA 

regulatory pathway designed to expedite the emergency development of 

diagnostic tests should be clear, apply a uniform standard, and be flexible 

enough so that In Vitro Diagnostic (IVD) test kit manufacturers, independent 

laboratories, and academic medical centers alike are able to leverage the 

mechanism in response to disease outbreaks. BIO welcomes the opportunity 

to work with the FDA to assist the Agency in developing a streamlined and 

efficient approach to regulating these types of emergency use tests. The FDA 

should continue to incorporate stakeholder feedback when developing 

regulatory policies for these tests and consider practical approaches that 

maximize the ability for diagnostic test developers to comply to ensure 

availability of these important products during times of emergency. 

3. In the opening statement you mentioned that the medical countermeasures 

market is small, and lacks market incentives for investment. You also 

mentioned that the current regulatory pathways that exist for emerging 

infectious diseases can be unclear, which results in low innovation in the space. 

Aside from necessary appropriations from the BioShield Special Reserve Fund, 

what are some additional recommendations you or the panel could make to 

spur innovation in medical countermeasures? 

As we state on page 55 of our report, the best way to incentivize industry to a 

level that allows it to participate in biodefense programs and pursue truly 

innovative ideas is to: 1) fund MCM development to legislatively authorized 

levels; 2) re-establish multiyear advanced appropriations through the 

[BioShield Special Reserve Fund]; and 3) eliminate unnecessary red tape within 

the partnership. To further enhance the environment for innovation, especially 

as the partnership model between government and industry evolves, many 

have urged Congress and BARDA to adopt other incentives that would 

invigorate MCM developers. 

The Panel calls upon the ASPR and DASD for Chemical and Biological Defense 

to convene non-governmental stakeholders to identify meaningful incentives 

that are independent of Congressional appropriations for MCM developers and 

manufacturers. Among the incentives that should be explored are successbased milestone payments and monetary prizes; minimum 

Page 3 of 7 
108 


procurements/advanced market commitments; guaranteed pricing; patent 

extensions; orphan drug status expansions; wild-card exclusivity; transferable 

data exclusivity extensions; and priority review vouchers (PRVs). 

Several of these recommendations are addressed in existing legislation. H.R. 

3299, the Strengthening Public Health Emergency Response Act (Senate 

companion iss. 2055, the Medical Countermeasure Innovation Act), Introduced 

by Representatives Susan Brooks and Anna Eshoo, includes provisions to 

streamline contracting processes, coordinate stockpiling plans, and increase 

transparency around future MCM funding needs. The bill also provides a 

meaningful incentive for medical countermeasure development by extending 

the neglected tropical disease PRV program to the 13 deadly pathogens 

identified by the Department of Homeland Security as material threats to U.S. 

national security. 

The PRV Is a proven and valuable incentive that has helped to spur investment 

in other complex and neglected areas of R&D. Congress has recognized this 

and recently acted to pass a bipartisan bill adding Zika to the PRV program in 

an effort to encourage the private sector to prioritize and expedite the 

development of drugs and vaccines to treat and prevent Zika. An extension of 

the PRV program to include material treats is viewed by many as a way to offset 

the dramatic decline in federal procurement funding for MCMs. Adding MCM 

targets to the PRV program may help convince investors that the government 

is committed to this endeavor and provide increased certainty that MCMs can 

have value in the marketplace. 

Our report calls for a revolution in the U.S. approach to the development of 

medical countermeasures for emerging infectious diseases with pandemic 

potential. BARDA, NIAID, and DOD should establish a joint program to rapidly 

develop MCMs as the need arises. The recent experience with Ebola showed us 

that rapid mobilization of government resources and private sector ingenuity 

could significantly shorten the amount of time needed to develop viable 

countermeasure candidates. We must glean lessons learned from this 

experience that could be applied to a new development and manufacturing 

paradigm. Establishment of an antigen bank as described on Page 54 of our 

report could help operationalize a plug-and-play strategy using proven platform 

technologies for use in an emergency for both human and animal pathogens. 

The Panel's broader recommendations for improving the biodefense enterprise, 

such as institutionalizing leadership for biodefense in the Office of the Vice 

President, development of a comprehensive national biodefense strategy, and 

a unified budget, would also provide more stability, transparency, and certainty 

to companies looking to invest In MCMs. When companies know that the 

government is a committed partner in this endeavor, investment and 

innovation will likely increase. 

As we state on pages 52 of our report, "The Nation remains unprepared for 

known, unknown, and unexpected threats." To address these threats, the 

federal government should work closely with indl!stry to develop new strategies 

Page 4 of7 
109 


that strike the right balance between stockpiling MCMs against known high 

consequence/low probability threats, and surge manufacturing for emerging 

and unknown threats. Due to the limited market for these products, federal 

funding for the Special Reserve Fund, BARDA, and pandemic influenza 

programs is extremely critical to maintaining an environment conducive to MCM 

innovation, and it remains the most important incentive the federal government 

can provide. The current shortfall we are facing for the Special Reserve Fund 

risks leaving critical products unfinished, and puts the nation in danger of losing 

the important progress we have made to date. 

4. As a physician, I understand that the development and validation of precise 

diagnostics for emerging outbreaks is crucial to combating biological threats 

such as Zika virus. We need to quickly develop diagnostics for these purposes 

and work to ensure that public health laboratories and hospital laboratories 

throughout the country are able to screen people for the disease and that 

patients have access to these tests. I'm concerned that the CDC is creating 

barriers for laboratories to quickly disseminate the test and by not enabling 

competing tests, there's no way to assess whether or not the CDC test is 

adequate. Please describe the process CDC engages in for sharing necessary 

information, test reagents, and reference materials to laboratories to develop 

tests for emerging infectious diseases. I've also heard that despite the lack of 

cooperation from the CDC, some physicians have already developed tests for 

Zika virus at Texas Children's Hospital and Stanford University. Have you 

considered collaborating with these academic medical centers on developing 

diagnostics? 

While our Study Panel is aware of the CDC process for sharing information, test 

reagents, and reference materials with laboratories for the purposes of 

developing tests for emerging infectious diseases, we do not possess sufficient 

information with which to describe this process in detail for you. We recommend 

that you obtain this information directly from the CDC. 

I can offer some additional insight from my role as the President and CEO of 

the Biotechnology Innovation Organization (BIO). BIO itself, an industry trade 

organization, has not entered into any collaborations with academic medical 

centers to develop diagnostics. However, many of our member companies have 

entered into various collaborations with academic medical centers, state and 

federal governments, non-governmental organizations (NGO), and other 

organizations and agencies to develop medical countermeasures to respond to 

emerging infectious diseases, pandemic influenza, and material threats and 

they will continue to do so in the future. 

In a 2015 BIO report titled, "Advancing Translational Research for Biomedical 

Innovation," we highlighted that industry direct funding for university 

biomedical-related research stands at 49% of all industry-funded university 

research in 2013, reaching $1.73 billion or just over 5% of total university 

biomedical-related research. Industry is relying more and more on academic 

research for technological development and the launch of new products. This 

is evident by a sharp rise in the share of patents associated with new therapies 

Page 5 of 7 
110 


citing academic research over the past decade. Industry-university research 

collaborations continue to evolve and BIO will play in critical role in bridging the 

worlds of biotechnology industry and academic research. 

The Honorable Susan Brooks 

1. Your testimony notes the past effectiveness of priority review vouchers {PRVs) 

in incentivizing research. Please identify existing PRV programs for rare 

pediatric diseases and neglected tropical diseases, and share your assessment 

of any related increases in biotech investments in these areas. (Question for 

the Record and Member Request for the Record) 

Year 

2009 

2012 

2014 

2014 

2015 

2015 

2015 

2015 

2015 

Priority review vouchers provide a powerful incentive to stimulate drug 

development in complex and underserved diseases or conditions. The current 

programs focus on neglected tropical diseases (NTDs) and rare pediatric 

diseases which, like medical countermeasures, often lack the market 

opportunity to attract significant investment. The priority review voucher is 

awarded to a company when a new product for a qualifying disease is 

approved. The company may use the voucher to expedite the review of 

another product by 4 months or they may sell the voucher to another 

company. Recent sale prices for priority review vouchers demonstrate the 

significant value of this incentive to manufacturers. 

To date, nine priority review vouchers have been awarded three through 

the neglected tropical disease program and six through the rare pediatric 

disease program. A chart summarizing these awards is included below. 

Disease Drua Comoanv 

Malaria Coartem Novartis 

( artemether/lu mefantri ne) 

Tuberculosis Sirturo (bedaquiline) Janssen (J&J) 

Morquio A Vimizim (elosulfase alfa) BioMarin 

syndrome 

Leishmaniasis Imoavido (miltefosine) Kniqht 

High-risk Unituxin (dinutuximab) United 

neuroblastoma Theraoeutics 

Rare bile acid Cholbam Asklepion 

synthesis disorders 

Hereditary orotic Xuriden Well stat 

aciduria 

Hypophosphatasia Strensiq ( asfotase alfa) Alexion 

Lysosomal acid Kanuma (sebelipase alfa) Alexion 

lipase (LAL) 

deficiency 

Proaram 

NTD 

NTD 

Rare 

oediatric 

NTD 

Rare 

pediatric 

Rare 

pediatric 

Rare 

oediatric 

Rare 

oediatric 

Rare 

pediatric 

BIO believes that these programs, and the neglected tropical disease priority 

review program in particular, have been successful in stimulating new drug 

Page 6 of 7 
111 


development in these critical areas of unmet medical need. In evaluating the 

impact of these programs on investment in the areas of neglected tropical 

disease and rare pediatric disease, however, the available data are not 

sufficiently granular to identify investment in rare pediatric disease and 

neglected tropical disease from broader categories of biopharmaceutical 

investment. 

Using the number of clinical development programs as a proxy for overall 

investment in neglected tropical diseases, we have seen an increase in 

research and development pipeline activity and, therefore, investment in the 

area of neglected tropical diseases. At present, there are at least 43 clinical 

development programs focused on the eligible neglected tropical diseases, 

including 13 for Malaria, 12 for Tuberculosis, and 10 for Ebolavirus. This is 

supported by the larger overall trend observed in venture (private company) 

investment In infectious disease, which has seen a 220% increase between 

2012 and 2015, and is presumed to include a significant increase in 

investment in neglected tropical diseases. 

Regarding pediatric rare diseases, as a recent GAO study noted, it is stili "too 

early to gauge the effectiveness" of the rare pediatric disease priority review 

voucher program. The rare pediatric disease voucher program was created in 

2012 with the passage of the Food and Drug Administration Safety and 

Innovation Act (FDASIA). Unlike the neglected tropical disease voucher 

program, which is permanent, the authority of the Secretary to award 

vouchers was set to terminate one year after the award of the third voucher 

under this program (which was awarded in March 2015). Though the 

program received an extension through September 2016 in last year's 

Omnibus package, the unclear future of the program and lack of permanence 

introduces significant uncertainty and unpredictability for sponsors who are 

considering the risky, long, and costly investment into a clinical development 

program for rare pediatric condition. For this reason, BIO has supported and 

continues to work with Congress to make the program permanent, so the full 

potential of the program can be realized in stimulating new drug development 

of new therapies for devastating childhood diseases. 

Page 7 of 7 
112 


FRED UPTON, MICHIGAN 

CHAIRMAN 

ONE HUNDRED FOURTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

<tCongreS'S' of tbe Wntteb ~tateS' 

T!)ou~c of 1\rpre~entatt\Jes 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE ButLDJNG 

WASHINGTON, DC 20515-6115 1'0aJornyl702)22b2927 

Mmor·ty (]021 n~ 3641 

AprilS, 2016 

Dr. Tara O'Toole, M.D., M.P.H. 

Senior Fellow 

IQT 

2107 Wilson Boulevard, Suite 1100 

Arlington, VA 2220 I 

Dear Dr. O'Toole: 

Thank you for appearing before the Subcommittee on Oversight and Investigations on Friday, 

February 12, 2016, to testifY at the hearing entitled "Outbreaks, Attacks, and Accidents: Combatting 

Biological Threats." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (I) the name of the 

Member whose question you are addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on Tuesday, April 19, 2016. Your responses should be 

mailed to Giulia Giannangeli, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn 

House Office Building, Washington, D.C. 20515 and e-mailed in Word format to 

Giulia.Giannangeli@mrul.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

Sincerely, 

·T~~ TimM/Jpt(J 

Chairman 

Subcommittee on Oversight and Investigations 

cc: The Honorable Diana DeGette, Ranking Member, Subcommittee on Oversight and Investigations 

Attachment 
113 


To: Subcommittee on Oversight and Investigations, February 12, 2016 

"Outbreaks, Attacks and Accidents: Combatting Biological Threats 

Question from: 

The Honorable Michael C. Burgess, MD 

1. As a physician, I understand that the development and validation of precise diagnostics for 

emerging outbreaks is crucial to combating biological threats such as Zika virus. We need to 

quickly develop diagnostics for these purposes and work to ensure that public health 

laboratories and hospital laboratories throughout the country are able to screen people for 

the disease and that patients have access to these tests. I'm concerned that the CDC is 

creating barriers for laboratories to quickly disseminate the test and by not enabling 

competing tests, there's no way to assess whether or not the CDC test is adequate. Please 

describe the process CDC engages in for sharing necessary information, test reagents, and 

reference materials to laboratories to develop tests for emerging infectious diseases. I've also 

heard that despite the lack of cooperation from the CDC, some physicians have already 

developed tests for Zika virus at Texas Children's Hospital and Stanford University. Have you 

considered collaborating with these academic medical centers on developing diagnostics? 

ANSWER: 

Thank you for the question, Congressman. Accurate diagnostic tests are essential tools for rapidly 

identifying and quenching epidemics of infectious disease. The strategic importance of diagnostic tests is 

not well recognized, and not reflected in government funding for infectious disease, and there are 

multiple, significant market issues which discourage the private sector from developing diagnostics for 

infectious disease, in spite of a wealth of technologies which could be utilized. Some of these 

impediments include regulatory hurdles- particularly regulatory uncertainty; poor return on investment 

for diagnostics compared to therapeutics; significant hurdles associated with getting new tests approved 

for payment by layers of insurers; and even hospital resistance to using new tests because billing 

practices are "locked-in" to electronic health records and difficult to change. 

I am not familiar with the details of CDC's efforts to develop and disseminate diagnostic tests for Zika 

virus. Typically, CDC- which is, at heart, a reference laboratory- seeks to develop highly accurate tests 

that serve as the standard for all other tests and then disseminates the procedures and reagents for 

conducting such tests to state public health labs and other reference laboratories around the country. It 

takes time to develop and validate such tests and to procure and distribute the necessary instructions, 

reagents, etc. These tests may diffuse into clinical care settings or other test processes may be 

developed by diagnostic companies, achieve FDA approval and become the usual method of diagnosis in 

clinical labs because they are deemed sufficiently accurate and seen as cheaper, easier, faster, etc. 

Sophisticated clinical laboratories, including for-profit labs and many hospital labs, have sometimes 

developed their own diagnostic tests, to provide faster results, reduce costs or to address specific 

clinical questions. Over time, the number of such tests has grown. This is not necessarily a bad 

development, but it does make it difficult to compare the results of different tests across institutions. 
114 


As I know you recognize, Congressman, the usefulness and performance characteristics of a diagnostic 

test, known as the Positive Predictive Value (PPA), varies depending on the "use case" and setting in 

which it is employed. The PPA of a test measures the percentage of the time a test accurately reports a 

"positive" result when the infection or condition of interest is actually present. PPA, and its counterpart, 

the Negative Predictive Value (the percent of time a Negative test result accurately reports that the 

infection being tested for is truly not present), are measures of the sensitivity and specificity of the test 

and the prevalence of the disease or condition in the population being tested. 

The dilemma with Zika virus is that CDC- and the country have a legitimate and pressing interest in 

ensuring that the reference diagnostic tests in use are accurate and reliable. Meanwhile, patients and 

their physicians are desperate for a diagnosis and clamoring for an acceptable diagnostic in the absence 

of a commercially available test, thus putting pressure on hospitals to develop their own methods. 

Different tests being developed by different hospitals, without careful standardization and comparison, 

guarantees differences in performance- i.e. differences in False Positive, False Negative results from 

test to test. Without an understanding of how "bespoke" tests compare to a "gold standard", clinicians 

cannot make informed judgments of test results, and CDC will be unable to assemble a clear picture of 

the incidence or prevalence of Zika in the population. The stakes on both sides are quite high, but in the 

long term, it is clearly in the public interest to have a reliable reference diagnostic as well as other 

diagnostic tests designed for specific use cases. 

ln-Q-Tel is not in a position to develop diagnostic tests, but as part of our BiologyNext Initiative, we are 

examining new diagnostic technologies- especially how new tools might enable the rapid design and 

manufacture of cheap diagnostics that deliver results within an hour- and market issues associated 

with private sector development. One can imagine the West Africa Ebola outbreak might have been 

controlled faster and with fewer victims had we had such diagnostic tools at hand or were able to 

develop them quickly. Thank you for noting the efforts at Stanford and Texas Children's Hospital to 

develop Zika diagnoses. My colleagues and I are interested in learning more about their work and will 

pursue. 

It is important to recognize that diagnostic tests for infectious disease are strategically important to 

attempts to achieve early recognition and containment of disease outbreaks. Without clear diagnostic 

confirmation of cases, decision makers almost always delay action until a large number of cases have 

accumulated, erasing any doubt of an outbreak- and by then, the challenge of quenching the outbreak 

is more challenging. Lots of effective diagnostic technologies are available, some offering rapid readouts. Major impediments to developing such tests include regulatory uncertainty, the difficulty of 

obtaining curated samples of the infectious agent in question to validate tests, poor return on 

investment due to billing practices, and the US government's failure to recognize the importance of and 

provide support for (e.g. through BARDA) rapid, reliable clinical diagnostic tests that could be used at 

point-of -care. 

Submitted by: Tara O'Toole, MD, MPH 

Aprilll, 2016 
115 


FRED UPTON, MICHIGAN 

CHAIHMAN 

ONE HUNDRED FOURTEENTH CONGRESS 

FHANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

C!Congre~~ of tbe Wntteb $tate~ 

~ouge of ~epregentntibeg 

COMMITIEE ON ENERGY AND COMMERCE 

2125 RAYRURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 M~)On\y (202)2?5··2927 

fv'muf!ly (202)225-3641 

April 5, 2016 

Dr. Gerald W. Parker, D.V.M, Ph.D. 

Associate Vice President, Public Health Preparedness and Response 

The Texas A&M University System 

1747 Pennsylvania Avenue, N.W., Suite 400 

Washington, DC 20006 

Dear Dr. Parker: 

Thank you for appearing before the Subcommittee on Oversight and Investigations on Friday, 

February 12,2016, to testify at the hearing entitled "Outbreaks, Attacks, and Accidents: Combatting 

Biological Threats." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (I) the name of the 

Member whose question you are addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on Tuesday, April 19,2016. Your responses should be 

mailed to Giulia Giannangeli, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn 

House Office Building, Washington, D.C. 20515 and e-mailed in Word format to 

Giulia.Giannangeli@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

Sincerely, 

~~~ TimMb/pt<T 

Chairman 

Subcommittee on Oversight and Investigations 

cc: The Honorable Diana DeGette, Ranking Member, Subcommittee on Oversight and Investigations 

Attachment 
116 


Gerald W. Parker, Jr, DVM, PhD, MS 

Associate Vice President, Public Health Preparedness and Response 

Principal Investigator, Center for Innovation in Advanced Development and Manufacturing (CJADM) 

Interim Director, Institute for Infectious Animal Diseases (HAD) 

Texas A&M University 

U.S. House Committee on Energy and Commerce 

Subcommittee on Oversight and Investigations hearing on Friday, February 12,2016 entitled "Outbreaks, 

Attacks, and Accidents: Combatting Biological Threats." 

The Honorable Michael C. Burgess, M.D. (TX- 26) 

As a physician, I understand that the development and validation of precise diagnostics for 

emerging outbreaks is crucial to combating biological threats such as Zika virus. We need to 

quickly develop diagnostics for these purposes and work to ensure that public health laboratories 

and hospital laboratories throughout the country are able to screen people for the disease and that 

patients have access to these tests. I'm concerned that the CDC is creating barriers for laboratories 

to quickly disseminate the test and by not enabling competing tests, there's no way to assess 

whether or not the CDC test is adequate. Please describe the process CDC engages in for sharing 

necessary information, test reagents, and reference materials to laboratories to develop tests for 

emerging infectious diseases. I've also heard that despite the lack of cooperation from the CDC, 

some physicians have already developed tests for Zika virus at Texas Children's Hospital and 

Stanford University. Have you considered collaborating with these academic medical centers on 

developing diagnostics? 

Response to the Additional Question for the Record 

The importance of near-real time biosurveillance, laboratory capacity and accurate point of need 

diagnostics for emerging and reemerging infectious diseases, as well as biodcfense cannot be overstated. 

Development efforts for rapid detection/diagnostics, whether from natural outbreaks or deliberate attacks 

have not been given sufficient long-tenn attention and programmatic priority. 

l hope you can see from this statement that I share your understanding and concern that we urgently need 

more development programs now for accurate and rapid Zika point of care diagnostics for patients in the 

health care setting. But we also need long-term, sustainable and focused rapid detection/diagnostic 

programs for emerging infectious diseases not only for patients, but also in a broader one health context 

that encompasses the human/animal nexus because most emerging infectious diseases that we have 

experienced, and can expect to see in the future are zoonotic. The gaps and funding shortfalls in 

veterinary diagnostic laboratory capabilities and capacities are much worse compared to the gaps in the 

CDC laboratory response network and need to be addressed too. 

The unfolding Zika outbreak is serious, and once again highlights the importance of rapid and accurate 

diagnostics. There arc no FDA approved Zika diagnostics available, but the CDC is gearing up and 

working hard to respond to this serious crisis to support state and local public health authorities. I cannot 

speak on behalf of the CDC regarding their laboratory testing procedures, so it is recommended that the 

committee ask the CDC directly how they are making infonnation, testing materials and test results 
117 


available to laboratories and health care providers. But, I will summarize what I understand from 

publica!ly available information, personal experiences and interaction with public health colleagues on 

how CDC is supporting local and state health authorities, as well as clinicians and their patients regarding 

Zika diagnostics. 

Zika virus is a nationally notifiable disease. State, local and territorial health departments are encouraged 

to report laboratory-confirmed cases of any arbovirus, such as Zika, to CDC through ArboNET, the 

national surveillance system for arborviral diseases. Healthcare providers should report suspected Zika 

cases to their local, state or territorial health department according to laws or regulations for reportable 

diseases in their jurisdiction. Clinicians should consult with, and obtain information for submitting 

clinical samples for Zika testing from their health department ofjurisdiction. 

The CDC has developed two diagnostic tools; I) the CDC Zika lgM Capture Enzyme-Linked 

lmmunosorbent Assay (ZIKA MAC-ELISA) to detect antibodies the body makes in response to an 

infection that may indicate a recent Zika and/or related arbovirus infection such as Dengue, and 2) the 

Trioplex Real-time Reverse Transcription Polymerase Chain Reaction (Trioplcx rRT-PCR) assay to 

detect the presence of Zika, Chikungunya or Dengue genetic material to determine which infection a 

patient may have. 

The CDC requested, and the FDA recently issued an Emergency Use Authorization (EUA) for these two 

CDC diagnostic tests. The CDC will distribute these tools and reagents to qualified laboratories in the 

laboratory response network, but only those labs certified by the CDC to perform high-complexity tests. 

Test results require careful interpretation, and CDC provides laboratories, health care providers and tested 

individuals with information regarding these Zika laboratory diagnostics, to include limitations of the 

tests and guidance for interpretation of test results in the context of a patient's travel history, clinical 

history and other epidemiologic criteria. There is no indication that CDC plans to distribute these 

diagnostic tools to hospitals or other health care settings, but rather limit their availability to a relatively 

few specialized CDC approved public health laboratories. 

Clinicians must submit samples for testing to their local or state public health department of jurisdiction, 

and not to CDC directly. Test results will be reported back to the state or local health departments of 

jurisdiction, not directly to clinicians. CDC's website indicates laboratory results are currently taking at 

least 3 weeks to report after receipt of a sample, and that health departments, clinicians and patients 

should expect longer reporting delays as summer approaches. 

Clinicians and patients alike urgently need point of care Zika diagnostics that provide rapid, accurate 

results. Advanced diagnostics being developed by hospitals, academia and industry, such as the Texas 

Children's and Houston Methodist Hospital collaborative in Texas are very encouraging. My colleagues 

and l at Texas A&M University will promote and collaborate with Texas Children's and Houston 

Methodist Hospital, as well as other institutions in Texas and globally on emerging infectious disease 

diagnostics and biosurveillance systems, to include Zika diagnostics. I have been in direct contact with 

the Texas Children's Hospital collaborative as well as a similar effort at UTMB through Governor 

Abbot's Texas Task Force on Emerging Infectious Disease Preparedness. It is clear that Zika testing 

demands will outpace CDC approved laboratory capacity, if it has not done so already as CDC laboratory 

reporting already requires at least 3 weeks. Hospital-based diagnostics offer the potential to provide test 

results in hours, not weeks; and to overcome a public health laboratory capacity bottleneck. Hospital2 
118 

Æ 


based local testing also enables rapid, direct and local clinician to clinical laboratory pathology 

consulation further improving patient outcomes. However, with any new diagnostic technology that is 

not yet FDA approved, usc in a clinical setting must be done in strict compliance with clinical laboratory 

standards and regulations. 

3