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THE FEDERAL PERSPECTIVE ON THE STATE OF 

OUR NATION’S BIODEFENSE 

HEARING 

BEFORE THE

COMMITTEE ON 

HOMELAND SECURITY AND 

GOVERNMENTAL AFFAIRS 

UNITED STATES SENATE 

ONE HUNDRED FOURTEENTH CONGRESS 

SECOND SESSION 

APRIL 14, 2016 

Available via the World Wide Web: http://www.fdsys.gov/ 

Printed for the use of the 

Committee on Homeland Security and Governmental Affairs 

( 
(II) 

COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS 

RON JOHNSON, Wisconsin Chairman 

JOHN MCCAIN, Arizona 

ROB PORTMAN, Ohio 

RAND PAUL, Kentucky 

JAMES LANKFORD, Oklahoma 

MICHAEL B. ENZI, Wyoming 

KELLY AYOTTE, New Hampshire 

JONI ERNST, Iowa 

BEN SASSE, Nebraska 

THOMAS R. CARPER, Delaware 

CLAIRE MCCASKILL, Missouri 

JON TESTER, Montana 

TAMMY BALDWIN, Wisconsin 

HEIDI HEITKAMP, North Dakota 

CORY A. BOOKER, New Jersey 

GARY C. PETERS, Michigan 

CHRISTOPHER R. HIXON, Staff Director 

GABRIEL S. SUDDUTH, Senior Professional Staff Member 

LEXIA M. LITTLEJOHN, U.S. Coast Guard Detailee 

GABRIELLE A. BATKIN, Minority Staff Director 

JOHN P. KILVINGTON, Minority Deputy Staff Director 

ROBERT H. BRADLEY II, Minority Professional Staff Member 

MARIAN P. GIBSON, Minority U.S. Department of Homeland Security Detailee 

LAURA W. KILBRIDE, Chief Clerk 

BENJAMIN C. GRAZDA, Hearing Clerk 
(III) 

C O N T E N T S 

Opening statements: Page 

Senator Johnson ............................................................................................... 1 

Senator Carper ................................................................................................. 2 

Senator Booker ................................................................................................. 20 

Senator Peters .................................................................................................. 22 

Senator Ernst .................................................................................................... 25 

Senator Portman .............................................................................................. 27 

Senator McCaskill ............................................................................................ 29 

Prepared statements: 

Senator Johnson ............................................................................................... 37 

Senator Carper ................................................................................................. 39 

WITNESS 

THURSDAY, APRIL 14, 2016 

Richard J. Hatchett, M.D., Acting Director, Biomedical Advanced Research 

and Development Authority, Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services ........... 4 

Stephen C. Redd, M.D., Director, Office of Public Health Preparedness and 

Response, Centers for Disease Control and Prevention .................................... 6 

Kevin Shea, Administrator, Animal and Plant Health Inspection Service, 

U.S. Department of Agriculture .......................................................................... 7 

Aaron M. Firoved, Ph.D., Director, National Biosurveillance Integration Center, Office of Health Affairs, U.S. Department of Homeland Security ............ 9 

Christopher P. Currie, Director, Homeland Security and Justice, U.S. Government Accountability Office .................................................................................. 11 

ALPHABETICAL LIST OF WITNESSES

Currie, Christopher P.: 

Testimony .......................................................................................................... 11 

Prepared statement .......................................................................................... 82 

Firoved, Aaron M., Ph.D.: 

Testimony .......................................................................................................... 9 

Prepared statement .......................................................................................... 77 

Hatchett, Richard J., M.D.: 

Testimony .......................................................................................................... 4 

Prepared statement .......................................................................................... 41 

Redd, Stephen C., M.D.: 

Testimony .......................................................................................................... 6 

Prepared statement .......................................................................................... 59 

Shea, Kevin.: 

Testimony .......................................................................................................... 7 

Prepared statement .......................................................................................... 70 

APPENDIX 

Response to post-hearing questions for the Record: 

Mr. Hatchett ..................................................................................................... 101 

Mr. Redd ............................................................................................................ 128 

Mr. Shea ............................................................................................................ 155 

Mr. Firoved ....................................................................................................... 171 

Mr. Currie ......................................................................................................... 224 

(1) 

1The prepared statement of Senator Johnson appears in the Appendix on page 37. 

THE FEDERAL PERSPECTIVE ON THE STATE 

OF OUR NATION’S BIODEFENSE 

THURSDAY, APRIL 14, 2016 

U.S. SENATE, COMMITTEE ON HOMELAND SECURITY

AND GOVERNMENTAL AFFAIRS, Washington, DC. 

The Committee met, pursuant to notice, at 10:02 a.m., in room 

SD–342, Dirksen Senate Office Building, Hon. Ron Johnson, Chairman of the Committee, presiding. 

Present: Senators Johnson, Portman, Ayotte, Ernst, Sasse, Carper, McCaskill, Tester, Booker, and Peters. 

OPENING STATEMENT OF CHAIRMAN JOHNSON1

Chairman JOHNSON. Good morning. This hearing will come to 

order. I certainly want to thank all of the witnesses for taking the 

time to attend and for taking the time to write your thoughtful testimonies. We appreciate it. It will all be in the record. 

This is an important hearing. I guess I would consider this our 

second hearing on this subject. We had Governor Tom Ridge and 

Senator Joe Lieberman here, earlier, with their Blue Ribbon Study 

Panel on Biodefense, which is a very well-thought-out document 

with a lot of detail. Probably the main takeaway from that was the 

fact that we just have no central authority to kind of accumulate 

all of the data, to accumulate the budgets, and really to direct potential activity—particularly in the event of a significant outbreak, 

whether it is—and, of course, we have dealt with Ebola and avian 

influenza. We have had hearings on both of those—and, now, the 

Zika virus. 

In Wisconsin, we have something—and I cannot pronounce 

it—Elizabethkingia meningoseptica. I think I might have actually 

gotten that right. It has infected about 59 people, already 18 people 

in our State. I appreciate the work the Centers for Disease Control 

and Prevention (CDC) has already done on that, responding very 

quickly to a letter I sent. It sounds like you have really taken that 

very seriously and have been trying to find the common cause. 

Very interesting, I guess. Troubling in many respects, but, anyway, 

this is an important hearing. 

I do ask consent that my opening written statement be entered 

in the record. But, as with any hearing, the main goal is to lay out 

a reality, so we all understand really what we are facing here. And, 
2 

1The prepared statement of Senator Carper appears in the Appendix on page 39. 

when it comes to the different types of biothreats, these can be very 

serious. 

Maybe the good news about all of them is that the same types 

of procedures, processes, and kind of management structure can be 

put in place to respond to just about any of them, because the 

threats are always changing, as we are seeing just the different 

type of pathogens and the different biological threats that I just 

listed. 

So, again, I appreciate all of your work and effort in this. I appreciate you coming here. 

With that, I will turn it over to Senator Carper. 

OPENING STATEMENT OF SENATOR CARPER1

Senator CARPER. Thank you, Mr. Chairman. I understand there 

is a vote at 10:30. 

Chairman JOHNSON. Yes. 

Senator CARPER. Do you want to just keep rolling, or do you 

want us to recess for the vote? Do you have to think about it? 

Chairman JOHNSON. It would probably be nice to keep rolling if 

we could, so why don’t we try—you and I will tradeoff. Thank you. 

Senator CARPER. OK. Good. So, when the vote starts, I will 

leave—with the Chairman’s concurrence—and go vote and come 

back right away. And, you guys can just keep talking. And then, 

we will start asking questions. 

Thank you all for coming. Mr. Chairman, thank you for bringing 

this together. This is an even more important hearing, given what 

is going on with the Zika virus. But, as the Chairman has said, last 

fall we convened a hearing to examine a report by this Blue Ribbon 

Study Panel on Biodefense chaired by a couple of our good 

friends—Joe Lieberman and Tom Ridge. And, one of the main 

points in their report was, there ought to be somebody in the Administration, one senior person, to lead it. They thought the Vice 

President would be a pretty good one, and so we will see. We had 

a meeting with the Vice President and the two co-chairs, and we 

will see where that leads. 

But there is a lot of work to be done, and, fortunately, the panel 

provided recommendations to further enhance our ability to prevent, to detect, to respond to, and to recover from a biological incident. 

Today, we have the opportunity to discuss those recommendations with the heads of several agencies—senior people in several 

agencies, who would be responsible for implementing some of the 

recommendations of the earlier panel. I am eager to hear your 

thoughts and also hear how you believe we can further improve our 

country’s biodefense system. This is an important conversation to 

have in the context of recent global events, including a couple that 

are emerging even as we speak. 

Ebola continues to threaten West Africa, and—after claiming 

thousands of lives—the spread of the virus has declined significantly, thanks in no small part to the investments that America 

has made in the health systems of the countries that were hardest 

hit by the epidemic. I think it is one of the proudest chapters in 
3 

our Nation’s history as of late, and I am very proud of the work 

that was done, including by some of you and the folks that you 

lead. But, that said, the recent news of more cases in Guinea and 

Liberia underlines the need to continue supporting our international partners in their efforts to combat this disease. 

We are also almost one year removed from a significant outbreak 

of highly pathogenic avian flu, which decimated some parts of our 

Nation’s poultry industry. The Chairman’s State was badly affected, as were a number of others in the Midwest. And, while infections of poultry have been limited in number so far this year, 

thank God, we must remain vigilant and continue to enforce good 

biosafety practices at poultry farms across the country to safeguard 

against another epidemic. 

Meanwhile, we are quickly approaching the beginning of mosquito season in most parts of the United States. Unfortunately, this 

presents us with a new threat—this one in the form of the Zika 

virus that we are hearing a whole lot about. The virus has spread 

explosively throughout Central and South America. It has already 

reached Puerto Rico and other U.S. territories and is expected to 

spread further as the weather warms. The World Health Organization (WHO) estimates that as many as 4 million people in the 

Americas could contract Zika by the end of the year. Researchers 

continue to learn more about the virus every day—but it is clear 

that the health impacts can be devastating, particularly for pregnant women and their unborn children. We have all heard that the 

CDC has just recently confirmed this week something that a lot of 

folks have speculated for a while—that the Zika virus is a cause 

of severe birth defects. 

While most of the Zika cases diagnosed in American citizens to 

date have been traced to travel abroad, we must be prepared for 

the virus to present itself locally to us. So, it has been encouraging 

to see a proactive, coordinated response from the President and his 

Administration to this threat. For example, Federal agencies are 

helping State and local governments enhance their capacity to better detect and track the virus. There are also significant mosquito 

control efforts underway in areas that are most at risk. 

We also know that medical countermeasures and vaccine development are being rigorously pursued. We applaud that. To help 

fund these efforts, the Administration announced last week its intent to redirect almost $600 million from other programs—including funds originally designated for Ebola—and spend it on Zika response efforts. I believe the President made the right call in this 

instance. I am glad he has done this. While these efforts continue, 

Congress should continue to carefully consider the President’s request for additional resources to combat this threat. 

In addition, we must ensure that our public health officials have 

the tools that they need to protect us from Zika and to prepare us 

for future threats. But, at the same time, we should not let our foot 

off of the gas when it comes to our efforts to contain dangerous diseases such as Ebola and avian influenza. 

With that, we welcome each of you. Thank you for your service, 

and thank you for your testimony today. 

Chairman JOHNSON. Thank you, Senator Carper. 
4 

1The prepared statement of Dr. Hatchett appears in the Appendix on page 41. 

It is the tradition of this Committee to swear in witnesses, so if 

you will all rise and raise your right hand. Do you swear the testimony you will give before this Committee will be the truth, the 

whole truth, and nothing but the truth, so help you, God? 

Dr. HATCHETT. I do. 

Dr. REDD. I do. 

Mr. SHEA. I do. 

Mr. FIROVED. I do. 

Mr. CURRIE. I do. 

Chairman JOHNSON. Somebody has a snappy tune there. 

Our first witness is Dr. Richard Hatchett. Dr. Hatchett is the 

Acting Director of the Biomedical Advanced Research and Development Authority (BARDA) and the Acting Deputy Assistant Secretary in the Office of the Assistant Secretary for Preparedness and 

Response (ASPR) in the Department of Health and Human Services (HHS). That is a big title. Among his many past roles, Dr. 

Hatchett has served at the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH), 

on the White House National Security staff, and in the White 

House Homeland Security Council (HSC) as the Director for Biodefense Policy. Dr. Hatchett. 

TESTIMONY OF RICHARD J. HATCHETT, M.D.,1 ACTING DIRECTOR, BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY, OFFICE OF THE ASSISTANT SECRETARY 

FOR PREPAREDNESS AND RESPONSE, U.S. DEPARTMENT OF 

HEALTH AND HUMAN SERVICES 

Dr. HATCHETT. Chairman Johnson, Ranking Member Carper, and 

distinguished Members of the Senate Committee on Homeland Security and Governmental Affairs, good morning. Thank you for inviting me to testify on the state of our Nation’s biodefense. I am 

Richard Hatchett, Acting Director of the Biomedical Advanced Research and Development Authority, and my testimony today will 

focus on steps taken by the Office of the Assistant Secretary for 

Preparedness and Response to strengthen our Nation’s health security as well as the contributions of my own office toward that end. 

We have made substantial progress in the past 10 years to advance the State of our national biodefense. Thanks to the support 

of this Committee and others in Congress, we have established 

BARDA and continue to make critical investments in biodefense 

and our health care system. However, as highlighted by recent 

challenges, such as Ebola, Middle East Respiratory Syndrome 

(MERS), and Zika, there remain gaps in our preparedness. 

As this Committee is aware, a recent report by the Blue Ribbon 

Study Panel on Biodefense has indicated that the United States is 

underprepared for biological threats and that the Nation is dangerously vulnerable to biological events—whether natural, intentional, or unintentional in origin. 

Where the civilian, public health, and medical response to such 

events is concerned, the ASPR is charged, by statute, to play a 

strong leadership role. The ASPR serves as the principal adviser to 

the Secretary of Health and Human Services on all matters related 
5 

to Federal medical preparedness and response for public health 

emergencies. The ASPR chairs the HHS Disaster Leadership Group 

(DLG), which convenes in response to complicated emergencies, 

and the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), which coordinates medical countermeasures development efforts across the interagency. The ASPR is the author 

and custodian of the National Health Security Strategy (NHSS), 

which focuses on protecting public health during an emergency. 

The ASPR oversees 2 critical programs that support medical response. 

The first, the Hospital Preparedness Program (HPP), enhances 

medical preparedness and resiliency at the community level 

through its support of health care coalitions. 

The second, the National Disaster Medical System (NDMS), deploys medical personnel and related assets when local resources 

are overwhelmed. 

The PHEMCE, for its part, promotes the development and acquisition of medical countermeasures for chemical, biological, radiological, and nuclear threats (CBRN), pandemic influenza, and 

emerging infectious diseases. PHEMCE coordination and decisionmaking encompass all stages of the medical countermeasure life 

cycle, from identifying requirements and developing target product 

profiles through product development to distribution and dispensing. The PHEMCE has an outstanding record of success and 

is now being studied as a model for global preparedness against 

emerging infectious diseases. 

To date, at least 23 medical countermeasures that BARDA has 

supported have been approved, licensed, or cleared by the Food and 

Drug Administration (FDA) under PHEMCE’s purview. Of these, 

15 have been approved since 2011 and 5 have been approved in the 

last 12 months. 17 products—ranging from anthrax antitoxins and 

smallpox vaccines to anti-neutropenia cytokine therapeutics for 

acute radiation syndrome and an array of products for the management of thermal burns—have been added to the Strategic National 

Stockpile (SNS) under Project BioShield, with another 7 anticipated between now and the end of fiscal year (FY) 2018. 

Overall, since the year 2000, the FDA has approved 89 medical 

countermeasures for CBRN threats and pandemic influenza, as 

well as 17 supplemental changes to already approved applications 

and 71 modifications to diagnostic devices. This investment in preparedness has already paid dividends. Because of the workforce 

and capabilities we have developed over the last 10 years, we are 

much better prepared to respond quickly to emerging threats. 

The PHEMCE, for example, facilitated the rapid development 

and deployment of vaccines, therapeutics, and diagnostics during 

the Ebola epidemic and is now fully engaged in the response to 

Zika. 

We know, from experience, that a well-coordinated PHEMCE response is a critical enabler of a rapid science and industry response. The PHEMCE succeeds not because a set of government offices succeeds, but because response efforts across the whole of society are supported and coordinated. To respond effectively to threats 

as diverse and unpredictable as the biological threats we face, 

nothing less than a whole-of-society response will work. 
6 

1The prepared statement of Dr. Redd appears in the Appendix on page 59. 

Thank you again for the invitation to speak with you, and, at 

this time, I would be happy to address any questions you may 

have. 

Chairman JOHNSON. Thank you, Dr. Hatchett. 

Our next witness is Dr. Stephen Redd. Dr. Redd is the Director 

of the Office of Public Health Preparedness and Response at the 

Centers for Disease Control and Prevention. Dr. Redd, who has 

been part of the Public Health Service for over 30 years, is responsible for all of the CDC’s public health preparedness and response 

activities. Is it pronounced Dr. Redd? 

Dr. REDD. Yes, sir. 

Chairman JOHNSON. OK, great. Thank you. Dr. Redd. 

TESTIMONY OF STEPHEN C. REDD, M.D.,1 DIRECTOR, OFFICE 

OF PUBLIC HEALTH PREPAREDNESS AND RESPONSE, CENTERS FOR DISEASE CONTROL AND PREVENTION 

Dr. REDD. Chairman Johnson, Ranking Member Carper, and distinguished Members of the Committee, my name is Stephen Redd. 

As you have just heard, I am the Director of the Office of Public 

Health Preparedness and Response at the CDC, and it is my pleasure to appear today to discuss the work the CDC is doing to prepare and respond to threats to the health of the public. 

As you know, the CDC works to protect the public’s health by 

helping communities improve readiness and response. This is for 

chemical, biological, and radiation emergencies—whether those are 

naturally occurring events like the Ebola epidemic or the Zika 

virus epidemic, intentional, or accidental. 

There are two key programs at the CDC that enable us to prevent, detect, and respond to public health threats: the Public 

Health Emergency Preparedness (PHEP) Program and the Strategic National Stockpile. Both programs had their origins before 

September 11, 2001 (9/11) and the anthrax attacks of 2001. They 

were greatly expanded after those events in recognition of the need 

to improve the ability of the public health system to respond in 

scale and in speed. 

The Public Health Emergency Preparedness Program’s overall 

aim is to prepare the Nation to respond to public health emergencies. Since 2002, $10 billion has been devoted to this effort. The 

program funds 62 awardees: all 50 States, 4 large cities, and 8 territories. And what it actually funds are staff: epidemiologists, laboratory experts, and risk communication experts as well as emergency operations centers, laboratory equipment, planning and exercising efforts, and efforts to respond—or to correct things that are 

identified in exercises and natural events. 

The Strategic National Stockpile is the national repository of lifesaving medicines, vaccines, and medical supplies, such as mechanical ventilators. Currently, the stockpile holds over $7 billion in assets. It operates as part of the Public Health Emergency Medical 

Countermeasure Enterprise, which you have heard about. The 

stockpile procures, stores, and delivers supplies in times of emergency. 
7 

1The prepared statement of Mr. Shea appears in the Appendix on page 70. 

Both the Public Health Emergency Preparedness Program and 

the Strategic National Stockpile were instrumental in the Ebola response and are being used now as part of the Zika response. So let 

me now turn to Zika. 

As of yesterday, 41 countries have reported local transmission of 

the Zika virus. In the continental United States, over 300 travelassociated cases have been reported. About 1 in 10 of these are in 

pregnant women. 7 have been acquired through sexual transmission. There currently are no local transmissions by mosquitoes, 

but the problem exists here because of these travel-associated cases 

and sexually-transmitted cases. In Puerto Rico, there is transmission from mosquitoes—over 300 cases. About 1 in 6 of these are 

in pregnant women. 

Just to talk about some of the things that we are doing in the 

response to Zika, you heard from Senator Carper that yesterday 

the CDC authored a publication that concluded that the Zika virus 

infection causes severe birth defects. That article also identified a 

number of the outstanding scientific questions. 

On April 1, we convened the Zika Action Plan Summit in Atlanta. This brought together State and local health officials to review the latest scientific information and to jump-start planning at 

the State and local levels. 

We also issued travel guidance for women who are pregnant 

within 72 hours of identifying the virus in the brains of children 

and fetuses that had died. We have developed laboratory tests. We 

are working closely with local health departments and we are implementing mosquito control measures with the government of 

Puerto Rico to prevent transmission to pregnant women. 

Public health threats are ever present. Due to the investments 

from Congress, the Nation is better prepared to prevent, detect, 

and respond to health emergencies than we were before the events 

of September 2001. And, at the CDC, we are on the frontlines to 

protect Americans from health threats wherever those threats 

occur. From recent experience, we know that we will be called upon 

to respond in the future. 

Thank you. 

Chairman JOHNSON. Thank you, Dr. Redd. 

Our next witness is Mr. Kevin Shea. Mr. Shea is the Administrator of the U.S. Department of Agriculture’s (USDA) Animal and 

Plant Health Inspection Service (APHIS). Mr. Shea carries out the 

agency’s broad mission of protecting and promoting American agriculture, regulating genetically engineered organisms, administering 

the Animal Welfare Act, and carrying out wildlife damage management activities. Mr. Shea. 

TESTIMONY OF KEVIN SHEA,1 ADMINISTRATOR, ANIMAL AND 

PLANT HEALTH INSPECTION SERVICE, U.S. DEPARTMENT 

OF AGRICULTURE 

Mr. SHEA. Thank you, Mr. Chairman, Senator Carper, Senator 

Ayotte, and Senator Booker. I appreciate you all being here today 

to hear us. 
8 

At APHIS, over 8,000 men and women work around the world 

to protect American agriculture and natural resources against 

plant and animal pests and diseases. We want to keep them out 

of the country, but if they do get into the country, we have the expertise and the tools to detect them, to control them, and, hopefully, to eradicate them. 

Although the crux of our mission is plant and animal health, we 

understand that, of course, there is a crucial link between plant 

and animal health and human health. Our partnerships with the 

CDC and other Federal and State agencies emphasize this ‘‘One 

Health’’ (OH) approach. 

Animal health can affect human health and human health can 

affect animal health. That is why it is so important that we communicate and coordinate with each other. That is why the emphasis on ‘‘One Health’’ in the ‘‘National Blueprint for Biodefense’’ is 

so important and why we strongly support it and appreciate that 

they emphasized it. 

I want to highlight just a few examples of what APHIS does with 

our partners. 

First, we created, within our Veterinary Services Program, a One 

Health Coordination Center (OHCC). This center works closely 

with our internal veterinarians to make sure that they are considering the human health aspects of animal health programs. 

At the same time, they work with their counterparts in the 

human health arena to make sure those agencies have an understanding of how what they do can affect agriculture and animal 

health. Because this communication is so important, we have embedded an APHIS veterinarian in Atlanta with the CDC to exchange information literally every day. 

We always share information with our partners about our wellestablished zoonotic disease surveillance efforts, and when we have 

information about potentially damaging diseases, we share that 

quickly. Of course, this Committee knows—as the Chairman and 

Senator Carper alluded to earlier—you all know the devastating 

impact avian influenza had last year on our producers, but also the 

impact it had on the availability and price of eggs and turkey. 

1,000 APHIS employees and thousands of contractors and State 

employees did the important frontline work to control that disease, 

but, behind the scenes, our partnerships with the groups with us 

today were there and were very important. Our scientists shared 

information with the CDC about avian influenza—about the virus. 

We had no reason to think that that virus was going to be a human 

health threat, but avian influenza viruses mutate. And so, we were 

constantly supplying information to the CDC so they could develop 

candidate vaccines if indeed it ever should have jumped over to be 

a human health problem. 

We also are working very closely with our colleagues in the Fish 

and Wildlife Service to test wild birds. And, the good news is, we 

tested 43,000 wild birds over the last 9 months and have found no 

more examples of high-path avian influenza in those birds. So, that 

is some hopeful information. 

We spent a lot of time assessing our efforts in controlling avian 

influenza last year as well as on our capability to detect it. And, 

we compiled a very substantial, very large new planning document 
9 

1The prepared statement of Dr. Firoved appears in the Appendix on page 77. 

on what we can do to prevent avian influenza from becoming a 

huge problem again. And, we had a chance to test that out already. 

In Indiana, in January, there was indeed one case of highly pathogenic influenza and 9 cases of low-pathogenic avian influenza associated with that. We were able to get on top of that, immediately, 

to wipe that out, and we have had no cases of avian influenza other 

than that since last June 17. 

Something we learned, in all of our review, was that we need to 

rebuild our capacity to respond to large animal health emergencies. 

We have 200 fewer animal health professionals—veterinarians and 

animal health technicians—than we had 10 years ago. We need to 

rebuild that workforce. And Secretary Tom Vilsack certainly recognized that, and, in the President’s budget request for FY 2017, 

there is a proposed $30 million increase for animal health emergency response because we realized just how lucky we were to get 

on top of avian influenza after all of the damage that it did do. 

Mr. Chairman, this concludes my testimony, and I appreciate the 

opportunity to be here. I would certainly be happy to answer any 

questions. 

Chairman JOHNSON. Thank you, Mr. Shea. 

Our next witness is Dr. Aaron Firoved. He is the Director for the 

National Biosurveillance Integration Center (NBIC) in the Office of 

Health Affairs (OHA) at the Department of Homeland Security 

(DHS). He previously served as the Senior Biodefense Advisor to 

the Assistant Secretary for Health Affairs and Chief Medical Officer (CMO) of the Department. 

Dr. Firoved? 

TESTIMONY OF AARON M. FIROVED, PH.D.,1 DIRECTOR, NATIONAL BIOSURVEILLANCE INTEGRATION CENTER, OFFICE 

OF HEALTH AFFAIRS, U.S. DEPARTMENT OF HOMELAND SECURITY 

Mr. FIROVED. Sir, we have generations of people being called 

‘‘Firewood’’ in my family. [Laughter.] 

Chairman Johnson, Ranking Member Carper, and distinguished 

Members of this Committee, I want to thank you for inviting me 

to speak with you today. I appreciate the opportunity to testify on 

the Department of Homeland Security’s role in biodefense, and it 

is an honor to sit beside my colleagues from HHS, the U.S. Department of Agriculture, and the Government Accountability Office 

(GAO). As you mentioned, I am the Director of the National Biosurveillance Integration Center. I am a microbiologist by training. 

I have done some work with anthrax at the NIH. And, I understood 

biodefense policy through service to this Committee, so I want to 

thank you. These experiences have given me a broad understanding of the biological threat to our homeland and a strong commitment to help improve our Nation’s biodefense and progress. 

The threats and risks posed by emerging infectious diseases and 

the use of biological agents by terrorist organizations, violent extremists, and rogue States will continue to challenge our ability to 

warn, prepare, and protect the homeland. 
10 

In the wake of these threats, the Department of Homeland Security remains fully engaged and proactive in characterizing the 

threat, providing warning of emerging and imminent diseases, and 

ensuring that the critical missions of the Department will continue, 

unabated, should a biological event occur. 

For example, during our recent Ebola virus disease outbreak in 

West Africa, DHS provided intelligence analysis to the interagency, 

State and local governments, and first responders. We directed research to better characterize the threat of Ebola persistence and fill 

gaps in public health and operational responses. And, we coordinated and implemented the enhanced screening for more than 

42,000 international passengers at 5 airports. 

Today, we continue to build upon these lessons learned from the 

responses to Ebola and apply them to other biological threats, as 

we tackle the emergence or reemergence of viruses like Zika, where 

we are ensuring that our partners continue to have timely information, our workforce is informed of protective measures, and the 

health interests of detainees in our care and custody is provided 

for. We must remain vigilant and innovative as biological threats 

continue to evolve and as new threats emerge. 

The DHS Office of Health Affairs coordinates the Department’s 

biodefense activities to understand and meet these threats, today, 

and to be ready for the threats that will emerge, tomorrow. OHA 

synthesizes biological threat information from multiple sources and 

takes a true ‘‘One Health’’ approach to biodefense and emergency 

response. 

For large-scale biological events, having knowledge as quickly as 

possible allows for informed decisions that can save American lives. 

And to this end, the Department’s operational biodetection and biosurveillance programs are critical to our Nation’s biodefense. 

The National Biosurveillance Integration Center is uniquely situated within DHS to provide a fusion of human health, animal 

health, and environmental data to ensure our Nation’s decisionmakers have timely, accurate, and actionable information. 

To accomplish this, we monitor thousands of data sources and leverage the expertise of 14 Federal departments and agencies, who 

are members of our charter—including those that you see at this 

table here—and then integrate this array of information into reports on biological incidents that could potentially cause economic 

damage, social disruption, or loss of life. 

Reports by my good colleagues at GAO and the Blue Ribbon 

Study Panel on Biodefense have acknowledged the progress that 

NBIC has made in delivering daily situational awareness to our 

partners, but we still have a lot of work to do to fully realize the 

vision that this Committee helped to start with comprehensive biosurveillance integration. 

To address this, we are developing new collaboration tools, pursuing innovative data sources and methods, and fostering greater 

stakeholder engagement. 

DHS’s BioWatch Program provides Federal, State, and local leaders with actionable information on detection of a biological agent 

to enable a coordinated and effective response. One important and 

frequently overlooked benefit of our BioWatch Program is how we 

work with each local jurisdiction to ensure that the decisionmakers 
11 

1The prepared statement of Mr. Currie appears in the Appendix on page 82. 

are familiar with how the coordinated response will unfold should 

the detection of one of these agents occur. There is no other program that provides this layer of biological defense. 

The DHS Science and Technology Directorate (S&T) is currently 

collaborating with OHA on enhancements to the BioWatch Program that will shorten the time needed to detect biological agents 

as well as address other short-term and long-term capability needs. 

One of our most critical roles is in the integration of local public 

health with emergency management, law enforcement, and intelligence community (IC) partners—and their preparation and response to biological events. One initiative we are developing in coordination with HHS is the ‘‘First Responder Vaccine Initiative.’’ 

We are evaluating the feasibility of a voluntary pre-event anthrax 

vaccination program for first responders using the anthrax vaccine 

scheduled to rotate out of CDC’s Strategic National Stockpile. I 

want to thank this Committee for moving on S. 1915, Senator 

Ayotte’s legislation authorizing this pilot program. 

I thank you for your time, and I look forward to answering your 

questions. 

Chairman JOHNSON. Thank you, Doctor. 

Our final witness is Chris Currie. Mr. Currie is the Director of 

Homeland Security and Justice at the Government Accountability 

Office, where he leads the agency’s work in evaluating emergency 

management, national preparedness, and critical infrastructure 

protection issues. In this role, Mr. Currie has led the reviews of numerous Federal programs as well as efforts to prevent, plan for, 

and respond to natural and manmade disasters and terrorist attacks. Mr. Currie. 

TESTIMONY OF CHRISTOPHER P. CURRIE,1 DIRECTOR, HOMELAND SECURITY AND JUSTICE, U.S. GOVERNMENT ACCOUNTABILITY OFFICE 

Mr. CURRIE. Thank you, Chairman Johnson, Ranking Member 

Carper, and other Members of the Committee who are here today. 

I really appreciate the opportunity to be here, and, today, I would 

like to talk about GAO’s work on biodefense. 

Defending the United States from naturally occurring or manmade biological events is a massive and difficult effort. Leadership 

and coordination are critical to such a large and fragmented effort, 

not only at the Federal level, but across levels of government and 

the private sector. The number of Federal departments at this 

table today, alone, demonstrates this point. 

In a hearing last fall, your Committee heard the findings and 

recommendations of the Blue Ribbon Study Panel on Biodefense. 

Our work through the years has come to many similar conclusions 

and recommendations. Today, I would like to talk about this 

work—ranging from coordinating the entire biodefense enterprise 

down to improving various specific programs. 

At the highest level, the Blue Ribbon Study Panel on Biodefense 

concluded that there is no central leader, no comprehensive national strategic plan, and no all-inclusive dedicated budget for bio-
12 

defense. Our work has also found that there is no national strategy 

or single focal point for biodefense. 

As an illustration, there are over two dozen Presidentially appointed officials with biodefense roles. Over 5 years ago, we recommended that the Homeland Security Council within the White 

House develop a strategy and designate a focal point for coordination. 

They did issue a strategy in 2012 for biosurveillance and designated offices within the White House as focal points—and this is 

progress and it shows a commitment to coordinating biodefense efforts. However, it just does not go far enough. 

The biosurveillance strategy does not identify resource and investment needs, which is critical to help prioritize resources across 

such a complex enterprise. We have heard that the National Security staff created a more specific implementation plan of the strategy. However, we do not know the extent to which it is actually 

being used across government and across these departments. Thus, 

we do not know if it will operationalize coordination and 

prioritization of resources, as we think it should. 

We have also identified challenges with specific agency biodefense programs, such as those within DHS. Our report last October found that 12 years after the BioWatch program was first deployed, there is still not reliable information about its capabilities. 

This is because it was put in the field so quickly without performance requirements. 

We have also found that, because BioWatch was not fully tested, 

its uncertainties and limitations are unknown. We recommended 

that DHS not pursue upgrades until it establishes system performance requirements and tests against those. 

I would also like to talk about our work on the National Biosurveillance Integration Center—also within DHS. NBIC was set 

up, in law, to be the integrator, analyzer, and innovator of biosurveillance information across the entire Federal Government. 

However, it has never fully met this bar. NBIC has implemented 

our recommendations to strengthen collaboration within its partners, like CDC, HHS, and USDA. However, we reported last year 

that persistent challenges still get in the way. 

For example, most of its primary Federal partners—those like 

CDC and HHS—told us that NBIC’s products and activities did not 

add value, did not provide new meaning, or did not help them identify biological events quicker. NBIC also still has difficulty getting 

the data it needs because partners either will not share it or there 

are restrictions to sharing that data. 

The challenges that NBIC faces are not easy to address by DHS, 

alone. We have identified options for policy or structural changes 

to help NBIC better fulfill its mission. However, these options may 

require changes in law—and it is not clear that even these would 

address the challenge. 

This brings me back to the bigger issue. As we and the Blue Ribbon Study Panel on Biodefense have noted, investments in specific 

programs should be evaluated in terms of cost and benefit, but they 

should also be prioritized against other programs across government as part of a national biodefense strategy. 
13 

Another critical part of this prioritization should be using the 

most recent threat and risk information to guide decisions. This is 

implemented to ensure that our limited resources are directed to 

the most important areas. Without a strategy that bridges across 

departments, it is difficult for decision-makers in Congress and 

those in the executive branch to make resource decisions above the 

traditional agency-by-agency approach. 

This concludes my prepared remarks. I would be happy to answer your questions. 

Chairman JOHNSON. Thank you, Mr. Currie. 

I want to kind of go back to this within the specific agencies to 

get just sort of an update on exactly where we are. I want to start 

with the USDA. Mr. Shea, the last avian outbreak occurred between December and June, and that was basically migratory birds 

flying south, correct? 

Mr. SHEA. Correct. 

Chairman JOHNSON. But, obviously, in June, they are also flying 

back. I just kind of want to get to—to what extent have we dodged 

this bullet? Have we gone through now, basically, 2 additional migratory patterns without this hitting us again? 

Mr. SHEA. Mr. Chairman, it is still too soon to say. What ended 

up being the final end to the outbreak last year really was due to 

the onset of warm weather. Once the temperatures get consistently 

above 70 degrees, the virus pretty much will not survive. 

Chairman JOHNSON. Very similar to human flu, then. 

Mr. SHEA. Yes. 

Chairman JOHNSON. OK. So we were kind of getting it coming 

and going then—migratory birds coming up, coming back—but 

then temperatures got to a certain point, and that outbreak ended. 

Mr. SHEA. Exactly. And also, what happens with the migratory 

birds, when they are flying south, they pretty much have a clear 

path. They just keep going. When they are heading north, they can 

slow down. For example, what happened last year—and the reason 

we thought it was so bad in Iowa and Wisconsin—was that the 

birds were heading north, but the weather was still too cold. They 

got to a spot where the lakes were still frozen and hung out. 

Chairman JOHNSON. I live on one of those lakes, so, yes, OK, I 

got it. So, that is pretty good news, though. 

Now, the outbreak in Indiana—is that typical, where we just on 

occasion see these small, little outbreaks and stuff and we can respond quickly? Or is that—— 

Mr. SHEA. It is typical to find low-pathogenic avian influenza 

outbreaks. They happen from time to time. What we believe happened here was probably a low-pathogenic virus that may have mutated on just the one farm. The local surrounding area where we 

had 9 or 10 other infected premises were all low-pathogenic. 

Chairman JOHNSON. OK. But, again, that was probably spreading out by migratory birds. That was just spread within that localized flock, hopefully. 

Mr. SHEA. It may have started with a migratory bird, but have 

spread as you suggest. 

Chairman JOHNSON. OK. I want to kind of revisit Ebola. I will 

go to Dr. Firoved. Has that been totally wiped out? Has that been 
14 

completely contained? Are there any active cases right now in Africa that we are aware of? 

Mr. FIROVED. Unfortunately, we have seen cases reemerge in 

Guinea and Liberia. So, I will defer to my colleague from the CDC, 

but, there is some active tracing going on. 

Chairman JOHNSON. Dr. Redd, tell me what happened there. Did 

we get to a level of zero and it is just coming back, or what? 

Dr. REDD. So, the widespread transmission that was seen in 2014 

and 2015 has been contained. What we have seen, repeatedly, in 

Liberia, Sierra Leone, and now, in Guinea, are very small clusters, 

identified after a few cases—with very rapid response, and by implementing the measures that brought the disease under control 

when it was more widespread. Unfortunately, this is not unexpected. The latest case we believe is from sexual transmission. A 

person that had Ebola in the past transmitted that disease through 

the route of sexual transmission, and then a small cluster occurred. 

And, I think that this outbreak is now being worked on very hard, 

both in Guinea and in Liberia—and those cases in Liberia are connected to the ones in Guinea. 

The thing that is different now is that the response is very vigorous. Large numbers of contacts are being identified and traced to 

be sure that, if one of those people does become sick, they will be 

put into isolation and given treatment very quickly. 

Chairman JOHNSON. Because of the tragedy that occurred there, 

is the general population far more educated on this as well as—in 

addition to the public health and safety officials who know how to 

respond? Is it a combination of that, or is it primarily—tell me 

what worked. What lessons have we learned? 

Dr. REDD. Well, I think, to go back to the lessons, the situation 

that is occurring right now is not that different than what occurred 

in March through April 2014, in terms of where the disease is occurring and the location. The thing that is different is that we have 

a much more vigorous response—so, both in Guinea and in Liberia, 

there is the capacity to identify those cases quickly and respond, 

and there is an international presence that is able to respond. 

And, to go back to 2014, the things that did not happen that 

needed to happen concerned the ability of those governments to 

rapidly identify cases, to respond effectively to them, to call for 

help when the response was not going well, as well as for the international community to be able to respond. That is basically the 

structure of the Global Health Security Agenda (GHSA) which is 

being implemented in those countries and in other countries in Africa, Asia, and the Americas. 

Chairman JOHNSON. So, again, you are basically describing real 

progress, in terms of public health and the work of safety officials. 

Has there been any progress just in terms of information to the 

general population where these things—let us face it, Ebola breaks 

out in these African countries. 

Dr. REDD. I think that there has been, and I think that, particularly, at that inflection point, depending on the country, in 2014 

and 2015, it is likely that a lot of the control was actually implemented outside of official channels, that communities understood 

the risk that Ebola caused and took measures into their own 

hands, in terms of isolation facilities, local care, etc. 
15 

I think this is actually a really important question that we need 

to have better hard data on, but it appears that that was an important part of the response—in addition to the community mobilization and communication efforts that took place. 

Chairman JOHNSON. I hate that I am going to ask this, but— 

what was the final mortality rate? How many people were really 

affected? Because, when this first broke out, we were projecting literally a few months from then there being a million people. 

Dr. REDD. Yes, sir. 

Chairman JOHNSON. So, how did we finally contain this? 

Dr. REDD. It did not reach a million people, and that estimate 

of a million people was in the absence of any control measures. So, 

I think in some ways, even though the number was massive, it was 

not what—— 

Chairman JOHNSON. It did not hurt to get the public’s attention 

so we could respond. We ended up with tens of thousands? 

Dr. REDD. Tens of thousands of cases and 10,000 or so deaths. 

And, just for context, the total number of cases, in all of the outbreaks up to that point, was around 2,500. So, around 10 times 

more cases than had ever occurred, and one of the things—just 

thinking about the sexual transmission side of it—we probably 

have twice as many male survivors as there were total cases before 

this outbreak. 

Chairman JOHNSON. Is that pretty unusual? I mean, was that because of additional treatment? Hydration? So, how many people 

were infected? How many people died? What was the survival rate? 

Dr. REDD. Yes, I mean, I can give you the exact number from reports. 

Chairman JOHNSON. I just looked at—— 

Dr. REDD. But, 25,000. And, 12,000 deaths—something like that. 

Chairman JOHNSON. From how many people infected? 

Dr. REDD. 25,000. So, about a 50-percent mortality rate, overall. 

And, when I give those numbers, I have to say that the quality of 

that information, particularly early in the outbreak when medical 

services were overrun—many deaths occurring in the community—— 

Chairman JOHNSON. I understand. I am just trying to get some 

sense—— 

Dr. REDD. Just in order of magnitude. 

Chairman JOHNSON. Where are we at, in terms of the development of a vaccine? Because Ebola has been around. We were working on a vaccine. It just was not really a top priority. I would imagine it has become a priority. Are we making progress, in terms of 

a vaccine? 

Dr. REDD. Yes, sir. I will answer that question, specifically, and 

then I will turn to my colleague from BARDA. A vaccine is actually 

being used now to control the outbreak in Guinea and Liberia. 

There were 3 clinical trials of different vaccines that were undertaken. The ones in Liberia and Sierra Leone, the vaccine got there 

after the disease was on the down trend, so they were not able to 

show effectiveness. They were able to measure the safety of the 

vaccine. A trial conducted in Guinea using a different strategy to 

use the vaccine and to measure its effectiveness did find the vaccine to be effective—and this was a containment strategy where a 
16 

case was identified and then the cluster of contacts and the contacts of the contacts were vaccinated to prevent onward transmission. And, that study did show effectiveness. 

Chairman JOHNSON. So, what level of effectiveness? I realize it 

is just a ballpark, but, I mean—— 

Dr. REDD. Yes, I would have to get back to you—— 

Chairman JOHNSON. Was it pretty darn effective? 

Dr. REDD [continuing]. On the exact number. I think that there 

are some questions about whether a person was exposed or not. It 

was not shown to be effective—or it was not tested to be effective 

before the period of 6 days after exposure. So, after that period of 

time, it did demonstrate effectiveness. I can come back to you with 

the exact number on that. 

Chairman JOHNSON. OK. 

I actually have the luxury, because I am here by myself, to keep 

asking questions. 

Did we ever get to the bottom of the infection of those nurses in 

Texas? We were, again, assuming that we kind of had this understood and we were going to take precautions—and yet, we still 

had—— 

Dr. REDD. Yes, sir. Well—— 

Chairman JOHNSON. So, did we ever solve that mystery, in terms 

of how those nurses got—— 

Dr. REDD. I am not sure we totally solved it. What we did do was 

put in place a different plan for personal protective equipment, 

which included very specific guidance on what types of protective 

equipment were needed and also put in place a strategy to train 

people to use that personal protective equipment before needing it. 

Then, there was the additional specificity of, when a person is 

being treated for Ebola, including things like observers to make 

sure that a person does not accidentally, when they are taking the 

equipment off—kind of a risk period—that something did not happen. And then, also following those individuals after the person 

was gone. Similar to the returning travelers that Dr. Firoved mentioned—tracking them daily until the potential incubation period 

was over. 

Chairman JOHNSON. So, from the start of that outbreak to kind 

of the final conclusion of it, it seems like, certainly, the procedure 

was, ‘‘We can handle this in hospitals to the point where now let 

us do it in very specialized hospitals.’’ Is that kind of the process 

and procedure in place now, that we are going to have basically 

‘‘Centers of Excellence’’ here, and, hospitals are going to have to be 

ready, because they would have to respond properly—but then 

transport individuals that proved positive? 

Dr. REDD. So, for Ebola that is the system that is in place. I 

think a lot of the discussion is about other diseases that there 

might be more cases of and trying to adapt that system, so that we 

have the right care for people who have these very severe effects. 

I think I would pass it to Dr. Hatchett. 

Chairman JOHNSON. And, by the way, Ebola is obviously a 

unique disease, but the procedures in place, those are good procedures for a number of types of situations? 

Dr. REDD. Yes, sir. I think there are a couple of characteristics 

about Ebola that are different, and that probably is, primarily, the 
17 

small number of cases and the need for the very rigorous infection 

control procedures. If there were a large number of cases, the system that we have in place would have to be changed. 

Chairman JOHNSON. Right. It would be overwhelmed. 

Dr. REDD. We are sort of in the kind of dozens of cases level of 

capability. 

Chairman JOHNSON. Dr. Hatchett, can you kind of speak to the 

progress of the vaccine—and, obviously, the effectiveness—but also 

to our ability to produce it? 

Dr. HATCHETT. Of course. Would you like me to touch on the 

Ebola treatment centers? 

Chairman JOHNSON. Sure. 

Dr. HATCHETT. So, just to answer that question and then to go 

back to the vaccine question, through ASPR’s Hospital Preparedness Program, with the assistance of the funding that was provided 

by Congress in the Ebola supplemental, we have established a 

tiered system, nationally, of Ebola treatment centers. There are 

now 9 regional Ebola treatment centers. There are 3 education and 

training centers at the pinnacle of that system, and then there is 

a system of feeding hospitals—I believe the number is 73—State or 

local Ebola treatment centers that can manage patients, temporarily, before they can be transferred to the 9 centers that are fully 

equipped. And then, there is a larger system of assessment hospitals. I believe the number is over 200, nationally. 

Chairman JOHNSON. OK. Thank you. 

I have to go vote. I am going to turn it over to Senator Carper. 

Hopefully, I can get back here, and we can kind of follow up. 

Dr. HATCHETT. I will talk about the vaccine. 

Senator CARPER [PRESIDING.] Mr. Currie, unfortunately, I had to 

leave as soon as you started to speak—and it was not cause and 

effect, but we trade off like this. We usually have 15 minutes in 

which we can vote, so this way we can keep things rolling and not 

unduly delay you. But, just take a minute and give me 

the—over in the House of Representatives, people give 1-minute 

speeches, and so, I will ask you to give us your best 1-minute 

speech, please. 

Mr. CURRIE. I will do my best, sir. So, I think from my oral statement, there were 2 big areas I wanted to focus on. First, was what 

I called the 60,000-foot level, the coordination across the biodefense 

enterprise. And then, the second piece was looking at some of the 

specific programs at DHS that we have looked at. Of course, we 

have done a lot of work at HHS and USDA as well. 

But, let me focus on the 60,000-foot level. I think a problem that 

we have identified through the years—and so has the Blue Ribbon 

Study Panel on Biodefense—is the lack of a unified strategy at the 

top—at the Federal level—to guide all of the departmental efforts 

and resources. And, all of the departments work really hard and 

do a very good job of doing their individual missions. The problem 

is, there is nobody above that has the authority or the ability to 

actually drive resource decisions and priorities. And so, that makes 

it very difficult to know if we are addressing the top priorities. And 

so, that was a key point from my opening statement. 

Senator CARPER. All right. As you know, we talked a little 

bit—I mentioned the Blue Ribbon Study Panel on Biodefense co-led 
18 

by Joe Lieberman and Tom Ridge. And, one of their recommendations spoke—or at least attempted to speak to the point you have 

just made. Let me just ask all of you, with respect to the recommendations—I think they made 33 recommendations, and a 

major recommendation was that the Vice President should be sort 

of the person to lead this. What current and planned activities are 

each of you taking, or planning to take, to address the recommendations contained in the report? What do you think about 

the recommendations for the Vice President, in this case, Joe 

Biden, leading this effort for the next 9 months and then, presumably, whoever succeeds him leading afterwards? 

Mr. CURRIE. I can start. 

Senator CARPER. Yes, please. 

Mr. CURRIE. We have not taken a formal position on whether the 

Vice President’s Office is the right place to place that responsibility 

or not. But, we understand why the Blue Ribbon Study Panel on 

Biodefense made the recommendation that the Vice President serve 

that role, because it needs to be somebody in a position of authority 

that can guide all of the Federal departments, each with their own 

powers and responsibilities, to do things and spend money a certain way. 

We made our initial recommendations along those lines to 

the National Security staff within the White House, and so I 

think—and our goal there was, again, to try to put it at a level that 

was above the departmental level. 

So far, I think we have been a little underwhelmed at the efforts 

that have come out of the response to that recommendation. There 

have been some strategies developed. The problem is that, even 

within those offices, they still have trouble dictating exactly what 

the other Federal departments are doing. 

So, I am not sure what the right entity is, but I think the problem is consistent across our work and the Panel’s work. 

Senator CARPER. All right. Thank you. Thank you very much. 

Others, please? Dr. Hatchett, what current or planned activities 

are you all taking, or planning to take, to address the recommendations contained in the report? 

Dr. HATCHETT. Thank you, Senator, for the question. We certainly participated in the process that led to the development of the 

report. We participated in the meetings. We read the report, with 

interest, when it came out. We feel that we have actually undertaken activities that address or parallel some of the recommendations in the report. I just mentioned the establishment of the Ebola 

treatment centers and the national hospital system for managing 

diseases that require high containment—that, in some ways, is 

similar to a recommendation within the report. 

We are not responding directly to the report, but we certainly 

feel that it has been a valuable contribution to the national discussion on this issue. 

Senator CARPER. What do you think of the point of Mr. Currie— 

the point that the Blue Ribbon Study Panel on Biodefense recommended the Vice President be anointed to follow up and implement the recommendations of the report? If not the Vice President, 

how about the junior Senator from, maybe, New Jersey? [Laughter.] 
19 

He does not have much going on now. He has finished his book 

and he has finished his book tour. He is looking for stuff to work 

on. No, I am just kidding. 

Dr. HATCHETT. So, we feel that we have effective cross-government mechanisms in place, already, to ensure that threats can be 

identified and responded to appropriately within the statutory 

sphere of the Assistant Secretary for Preparedness and Response, 

which is public health and medical preparedness and response. We 

actually have mechanisms in place which reduce the need for a 

central oversight figure. We have two very effective coordinating 

bodies that are interagency bodies where we work with our colleagues at the CDC, the FDA, the Department of Defense (DOD), 

etc. 

The first of these is the Disaster Leadership Group, which the 

Assistant Secretary for Preparedness and Response convenes and 

which responds to complicated emergencies. That addresses policy 

issues that will arise. In recent months, for example, we have convened two different Disaster Leadership Groups—one to address 

the Flint, Michigan water crisis and another to address the emerging Zika crisis. 

Within the domain of medical countermeasures, we have a very 

effective coordinating body, the Public Health Emergency Medical 

Countermeasures Enterprise. In my oral testimony, I cited some of 

the successes that we have demonstrated. That entity has really 

evolved—— 

Senator CARPER. I am going to ask you to hold it right there. 

Otherwise, these guys will never have a chance to say a word. Dr. 

Redd. 

Dr. REDD. There are a number of recommendations that pertain 

specifically to the CDC. I could go through those now or we could 

submit written answers to that. 

Just quickly, recommendation 15 is a collaboration with the Department of Homeland Security on anthrax vaccination. We are 

providing the vaccine for that pilot—or would if the pilot started— 

from the Strategic National Stockpile. There is a recommendation 

to develop and implement a medical countermeasure response 

framework. We actually are working with State partners through 

the Public Health Emergency Medical Countermeasure Enterprise 

to implement improvements on the distribution and dispensing of 

the stockpile. 

There is a recommendation to allow for forward deployment of 

SNS assets. That was number 23. 

We are working closely with New York City on really kind of a 

project management formula that—when they are ready to administer product from the stockpile—we get it there that quickly—so, 

matching the delivery from the stockpile to the local capacity. And, 

we will be working with other health jurisdictions to marry their 

capability and our capability. 

There is a recommendation to overhaul the Select Agent program. I think that would kind of fall into the overall category of 

a high-level policy decision. We are doing a lot of work to improve 

the Select Agent program within our authority, improving the inspection process, the process to report incidents that are identified 
20 

at the facilities, and the communication and transparency aspects 

of that. 

There actually have been 3 recent—— 

Senator CARPER. Dr. Redd, I am going to ask you just to hold it 

right there. What I think I am going to ask you is, for each answer 

for the record, give us the status of your implementation—those 

that you have begun implementation on, those that you have completed implementation on, and those you have no intention of implementing. And, you can also use that as an opportunity to respond as to whether or not you think the Vice President is the better person to oversee the implementation as opposed to Senator 

Booker, who I suggested as a possibility. When he asks his questions, maybe he can cast some light on it. 

But, just raise your hands. How many of you think that we need 

somebody like the Vice President who can sort of oversee the implementation that—without that, we are not going to make the 

kind of progress we otherwise would need? How many think that? 

If you do, raise your hand. 

[No response.] 

And, if you do not, raise your hand. 

[All hands raised.] 

All right. Thank you. 

Let the record show Booker: 2 and Joe Biden: 0. But, I saw there 

were several people leaning toward Joe as well. All right. Senator 

Booker. 

OPENING STATEMENT OF SENATOR BOOKER 

Senator BOOKER. I have lost many votes before. This is one that 

I am very happy to not win, if possible. So, I want to thank you 

very much for holding this. I think this is an urgent hearing and 

there are a lot of very consequential realities at stake. And, I want 

to thank the folks before me because your dedication to the health, 

strategy, strength, and security of our country is really admirable. 

I have some very New Jersey-based concerns—and, perhaps, I 

could start with Dr. Hatchett on the end. So, a lot of the dollars 

that are received through our State for homeland security issues 

are based upon formulas. The Hospital Preparedness Program is a 

program that, recently, New Jersey has seen a significant cut to. 

Now, it is a little incongruous to me because, in the risk profiles, 

which are calculated by the Department of Homeland Security, we 

have actually seen increases in some areas. For example, in fiscal 

year 2016, the Department of Homeland Security recognized New 

Jersey’s vulnerability to a targeted violent attack and heightened 

the State’s risk score to ‘‘threat.’’ DHS also raised our Urban Area 

Security Initiative (UASI) grants—UASI vulnerability, moving it 

from 11 to 7 on the risk index. So, we see that New Jersey, when 

it comes to risks—terrorist attacks, bioattacks, and the like—is getting more severe, but yet, at the same time, somehow, in the formula, we are being cut from the HPP program. 

And so, I am just wondering what the reason for the cut is, given 

that the Department of Homeland Security sees us—and you understand that New Jersey is—I live 10 miles from Manhattan. In 

fact, Manhattan is moving their back offices and a lot of their in-
21 

frastructure to New Jersey, which, again, DHS sees as heightening 

our risk. 

And so, I am wondering, is this, in your opinion, problematic? Is 

it incongruent, as I see it? Or, do you see it in a different way? 

Dr. HATCHETT. So, I cannot speak to the particular case of the 

New Jersey allocation, but I can say that the Urban Area Security 

Initiative risk scores are figured into the Hospital Preparedness 

Program formula. And, that formula and those allocations are reviewed annually, and so they are adjusted annually. 

There are many factors other than risk score which go into the 

formula—certainly population, etc. Given that I am not, myself, 

personally responsible for the Hospital Preparedness Program, we 

can certainly get back to you with a more detailed response. 

Senator BOOKER. Yes, I would really appreciate that—and, 

maybe, we can even meet on it, because if it is population, New 

Jersey is the most densely populated State in America. If it is critical infrastructure, we have the most dangerous, they say, couple 

of miles—there are chemical companies, you name it. I just do not 

understand how we could be going down, especially when other 

areas of the Federal Government are seeing us as being at a higher 

and higher risk for these problems. So, I would really appreciate 

it. 

Dr. HATCHETT. Yes, sir. We would be glad to do that. 

Senator BOOKER. Thank you. Thank you very much. 

Let me go really quickly over just some of my concerns, in general, about Zika and some of the other elements. 

Dr. Redd, can you explain to me the process for the New Jersey 

Public Health Emergency Preparedness Program, the PHEP Program—the award was increased this year. However, because the 

CDC is looking at additional money to allocate for Zika, we have 

seen money being taken away from the States, including New Jersey, which raises concerns, for me, that we are just moving around 

a finite pool that has urgent needs, as opposed to allocating new 

money, and that that might be weakening our preparedness. So, 

can you explain to me the process for cuts? And, were they just sort 

of blunt cuts across the board or really are we looking at the crises 

and the concerns for safety and security? 

Dr. REDD. Let me start by saying that I agree with your underlying point, which is that this is a new threat and we need the supplemental appropriation to be passed—and that would address the 

problem in the way that it needs to be addressed. 

Senator BOOKER. That is a very profound statement that I want 

to repeat one more time. You agree that this is a new threat and 

that we should be making supplemental new funding, as opposed 

to taking away urgently needed dollars from currently existing programs? 

Dr. REDD. Yes, sir. 

Senator BOOKER. Thank you for that. 

Dr. REDD. We completely agree with that. 

Senator BOOKER. That is definitely an important statement. 

Thank you. 

Dr. REDD. So, in the absence of that, there is a very difficult decision that the Administration had to make as to whether we would 

respond to the current threat or not—and the only way to respond 
22 

to the current threat was to identify funds that could be used now. 

I think your description of a blunt instrument is correct—that 

there was an across-the-board cut to the Public Health Emergency 

Preparedness Program. It was a little complicated as to how each 

dollar amount was arrived at for every grantee, but every grantee 

lost funding. 

Senator BOOKER. OK. But, there is obviously a better way to do 

it. Can you speak to me a little bit about—and maybe some other 

people might want to chime in. We seem to often be very reactive 

to crises. Do we have some kind of predictive analytics to better 

know what is coming before it dominates the headlines and fear is 

being—could we be doing a better job heading some of these crises 

off? 

Dr. REDD. I think that is a very big challenge and I think it is 

one that we continue to work on. 

To take the particular case of Zika, there are many aspects of 

this that are unprecedented. It has been 50 years since an infectious disease has been identified as the cause of a birth defect. 

There has never been a birth defect caused by an infection transmitted by a mosquito. So, if we were to use the historical record, 

this is not something that we would have predicted. I think that 

there is a need to be able to forecast more effectively than we have 

been able to do. 

A totally different problem than with Ebola—although the event 

that occurred in West Africa was also not predicted. I think that 

for that event, had we had in place the systems that are being put 

in place now, we would not have had the event that we had. We 

might have had something that is similar to what we are seeing 

now with a very rapid detection and response to a problem. 

Senator BOOKER. OK. I am going to submit one more question for 

the record because I have to go, but it is more about just general 

preparedness. I like the idea, as was said in the testimony, that 

preparedness is not an event—it is an ongoing process. But, I do 

worry about the States—having run a lot of tabletops for a lot of 

things, I worry about our overall State and Federal working coordination and preparation for a lot of the problems that I think are 

going to be seen more and more—not just here in the United 

States, but also threats coming from overseas. 

Thank you. 

Senator CARPER. Thank you so much, Senator Booker. Senator 

Peters. 

OPENING STATEMENT OF SENATOR PETERS 

Senator PETERS. Thank you, Senator Carper. And, thank you to 

our panelists for your testimony here today. I certainly concur with 

my colleagues. We appreciate you being vigilant and on the job 

each and every day. These are serious threats, and we appreciate 

your dedication to it. 

In addition to being on HSGAC here, I also serve on the Commerce Committee. And, I am currently the Ranking Member on the 

Space, Science, and Competitiveness Subcommittee. I am currently 

working with Senator Cory Gardner on a working group that is 

going to be reauthorizing the America Competes Act. And, from my 

perspective, if we are going to increase our biodefense preparedness 
23 

and work to counter diseases which can pose a threat—either intentionally or naturally—we need to fund basic scientific research 

and consider it both a national and, really, a homeland security 

priority for us. 

Last year, in a hearing examining the Blue Ribbon Study Panel 

on Biodefense, this Committee heard that that report found that 

federally funded scientific investigators are more likely to engage 

in early-stage research, versus in the private sector, where the 

focus is on specific product goals and end-user needs—and that this 

was a cause for Ebola medical countermeasures not being available 

when they were needed. 

When looking at the America Competes Act, the working group 

examined global biomedical research funding trends and found that 

private investment in the United States correlates very closely with 

government investment. When government investment in research 

and development (R&D) shrinks or it stagnates, the private sector 

pulls back as well. And, when government grows its investment, 

the private sector tends to follow suit. And yet, Federal R&D 

spending has fallen below 1 percent of GDP, which I believe is unacceptable for our future and R&D is important for biodefense as 

well as the seed corn for innovation. 

So, given the correlation between Federal and private sector investment in basic science, I am a big supporter of robust Federal 

funding for basic research and believe that research can certainly 

contribute to the next big thing—whatever that next big thing is. 

It also sparks new industries, creates jobs, and builds the economy, 

but, as we are discussing today, I think it also improves our biodefense preparedness as well. So, the challenge is in deciding the 

right ratio of basic to applied research—and appropriate funding 

levels for each—and the proper role of the private and public sectors. 

So, first, to Dr. Hatchett and Dr. Redd, could you explain how 

your agencies make use of basic science research, kind of your 

sense of where we are, where our needs are, and what you would 

like to see? 

Dr. HATCHETT. Sure. Yes, thank you for that question. Just to be 

clear, I am the Acting Director of the Biomedical Advanced Research and Development Authority. As our name implies, we work 

in the area of advanced research and development. As we understand that term, it means when we are working on medical countermeasures. These are medical countermeasures that have 

reached the clinical stage of development, where many of the problems relate to the clinical testing of the product as well as to scaling up manufacturing and working out manufacturing issues, so 

that we can be able to produce the products on a large scale. 

We have to depend on our colleagues at the National Institutes 

of Health and the Department of Defense to fund that basic research. We do not fund basic research. And, it is very important 

for us to coordinate our efforts with them so that, as they cultivate 

products and bring products forward through the earlier stages of 

discovery and development, we are ready to transition those products to advanced development. 

In the case of the Ebola vaccines—and Ebola therapeutics, for 

that matter—Ebola obviously had been on our threat list for some 
24 

time. It is one of the material threats that the Department of 

Homeland Security has identified. NIH and the Department of Defense had been supporting basic research on countermeasures and 

had been moving those countermeasures forward through the development cycle. 

When the Ebola epidemic started in 2014, none of those products 

had reached the stage where our organization was—that they were 

ready to be developed by our organization. Within a very short 

span of time, within about a year, we were able to transition 12 

products from that preclinical development to advanced development—and many of those products have actually been tested in 

West Africa. So, we do have a strong system as it relates to biodefense for supporting product development and translating products from basic research—and I could not agree with you more 

about the importance of basic research. 

Senator PETERS. Thank you. Dr. Redd. 

Dr. REDD. Yes, sir. If we had a panelist from NIH, you would 

have kind of a good description of the proportion of basic research 

and the proportion of applied research and practical application. So 

we do some basic research ourselves, but, predominantly, our mission is to protect the health of the public and to use the tools that 

are available to make sure they are effective and to make sure that 

they are disseminated. So, we are more on the end-user side of that 

spectrum from basic research to use. 

Senator PETERS. I realize that, but, I guess, the follow-up question is: So do you believe that we need to be putting more into 

basic research, as these threats seem to be developing, and, in 

some ways, at an accelerating rate—that we are probably doing 

ourselves a disservice if we are not putting more resources into the 

very foundational level of science? 

Dr. REDD. I think we do. I think we also need to make sure that 

we do not have a bottleneck at that development stage and we are 

able to get things through the system quickly to find out if they 

are going to be useful in large populations and be effective. And, 

some of those kinds of questions are difficult or are not possible to 

answer at the basic level. 

Senator PETERS. Right. Would any of the other panelists like to 

weigh in? 

Mr. FIROVED. Sure. At the Department of Homeland Security, we 

have the Science and Technology Directorate, and it is critical to 

helping the Department meet the needs of its stakeholders—whether they are first responders—helping make improvements to the 

BioWatch program—and it relies on a diverse university program 

as well—the ‘‘Centers of Excellence’’ to help us meet those needs. 

And, just recently—since we have been talking about Ebola—some 

basic understanding that has significant ramifications for biodefense have to be answered still. So, some of the questions were: 

How persistent is Ebola on surfaces? How long does it remain infectious? And so, in a study that was conducted with our partners, 

we were trying to understand what it does on the carpet of an airplane or on surfaces that our employees might encounter in an airport. 

And so, this kind of basic research has real, serious implications 

for our day-to-day operations—so it is critical. 
25 

Senator PETERS. Thank you. I appreciate it. Thank you very 

much. 

Senator CARPER. Thank you, Senator Peters. 

Looking at the list of folks, Senators Ayotte and Tester were here 

when the gavel came down. They may come back. Next on the list 

is Senator Ernst. If we are looking for somebody who has previous 

military experience, a colonel—and maybe you could be next for us. 

Then, Ben Sasse, if he returns, and then Senator Portman and 

Senator McCaskill. 

OPENING STATEMENT OF SENATOR ERNST 

Senator ERNST. Thank you, Ranking Member. I appreciate it. 

And thank you, gentlemen, for being with us today. 

This question is for anyone on the panel, please. I want to follow 

up on a question that was asked earlier by Ranking Member Carper. One of the Blue Ribbon Study Panel on Biodefense’s top recommendations was the development and implementation of a comprehensive national biodefense strategy. This Administration has 

failed to present a comprehensive strategy in a number of areas— 

whether it is defeating the Islamic State of Iraq and Syria (ISIS) 

or countering the use of social media—which has led to disparate 

efforts that lack focus. And, as the Blue Ribbon Study Panel on 

Biodefense concluded, the United States is underprepared for biological threats and it is critical that the Administration establish 

a comprehensive biodefense strategy. 

Could Mr. Currie or anyone else on the panel speak to the importance of this recommendation? 

Mr. CURRIE. Yes, ma’am. Absolutely, we think it is very important—and our findings and recommendations have been really 

similar to the Blue Ribbon Study Panel on Biodefense’s findings 

and recommendations. 

I think it is important to note that it is not easy. Part of the reason it is so difficult to do this—and this links also to their recommendation of providing the Vice President the authority to do 

this—is because it has to come at a level that is above the cabinet 

and the Department level because Departments cannot tell other 

Departments what to do. It is very difficult to allocate resources between the Departments and identify resources priorities—for example, deciding that we want less resources in one Department’s program versus more in another. And, that is exactly why such a global national strategy across the Federal Government is so important. But, it is very difficult to do. 

Senator ERNST. Yes, and we understand the difficulty, but also 

the importance and necessity of doing that. 

Would anyone else like to respond? 

Dr. HATCHETT. Yes, ma’am. Thank you for the question. While 

the Office of the Assistant Secretary for Preparedness and Response has not developed a strategy for the parameters that are described in that report, I do think it is important to point out that 

they did leave the development of a National Health Security 

Strategy. The first National Health Security Strategy was completed in December 2009 and an updated version of the strategy 

was completed in December 2014. 
26 

The National Health Security Strategy is a broader strategy. It 

does not just look at biodefense. It also focuses on securing the Nation’s health security—as the title implies. It has 5 major strategic 

objectives. The first is to promote the development of resilient communities that are capable of responding to incidents of all kinds, 

including biodefense-related threats. The second is to promote the 

development of a robust medical countermeasures enterprise. The 

third is to promote comprehensive health situational awareness, so 

that decisionmakers can respond appropriately. The fourth is to 

promote integration of public health, health care, and emergency 

management systems across the Nation at the different levels of 

government. And, the last strategic objective is to promote global 

health security, so that we can address issues like the Ebola epidemic. 

So, that is an overarching strategy that governs a great deal of 

what we do in biodefense. And, in developing that strategy, we did 

work with stakeholders at all levels of government and with our 

interagency partners. 

Senator ERNST. That is wonderful. Very good. Great first step. 

For Administrator Shea, thank you very much for being here. 

How do we integrate information about animal and human health 

without creating or perpetuating misunderstandings and fear 

among consumers, both here at home and abroad? We do see this, 

where, perhaps, the Chinese or other governments will push away 

any commodities, like produce that they feel might do them harm— 

or they can make that up. So, what are your thoughts on that? 

Mr. SHEA. I think it is very important that we stick to the 

science and we work with our colleagues on the human health side 

to be clear about the science. And, a really good example of that, 

of course, that affected your State, was what was being called 

‘‘swine flu’’ in about 2009, when we should have called it by its 

proper scientific name, ‘‘novel influenza A (H1N1).’’ And, it is so 

important to do that because the industry, which so important in 

Iowa, of course, was put at a real disadvantage because of the fear 

of an influenza that really should not have been attributed only to 

swine. So, that is why it is so important that the science be integrated and that we speak with science. And, that is why I think 

it is important that we have someone embedded at CDC—which we 

do—and that we work, on a daily basis, to make sure those messages go back and forth. 

Senator ERNST. Very good. And, also, you spoke about the swine 

flu. We can talk a little bit about the avian flu, but, yes, go ahead, 

sir. 

Mr. FIROVED. Thank you. I also wanted to point out that there 

are some robust communications that go on between these entities. 

Within our center, we actually also have a liaison with APHIS 

within the USDA, and it has proved to be critical for producing this 

‘‘One Health’’ message. And, in one case just this last fall, we were 

seeing some erroneous news reports come up about a resurgence of 

avian influenza that just were not at all accurate. But, working 

through the National Wildlife Health Center (NWHC), also with 

the Department of Interior, as well as our colleague at APHIS with 

the USDA, we are really able to push through those agencies, able 
27 

to tamp down these stories, and really able to prevent a story from 

gaining legs that could have economic consequences. 

And, so I think that the ‘‘One Health’’ approach is so critical to 

everything that we do—and we need to continue to bridge this divide. 

Senator ERNST. Great. Yes, sir? 

Dr. REDD. Just briefly—to support the Administrator here, we 

have a very intense scientific interchange with USDA on influenza 

and also for foodborne diseases. So, there are some pockets of just 

very close collaboration. 

Senator ERNST. Very good. Well, I appreciate that so much. And, 

we spoke about this earlier—or we heard about it earlier—but, as 

you know, last year the poultry sector was rocked by the Asian 

highly pathogenic avian influenza (HPAI), commonly called ‘‘bird 

flu.’’ And, this was very devastating in Iowa, where it resulted in 

the death of over 30 million birds and inflicted $1 billion of damage 

to our economy in Iowa. It was one of the worst foreign animal disease outbreaks in our Nation’s history. And, the livestock sector is 

also regularly impacted by these diseases—and they struggle to 

control them—with new ones popping up each year. We have 

talked about some of that. And, it is not inconceivable that an illintentioned actor could purposefully introduce an equally dangerous and contagious pathogen into the United States to really 

mess with our food security, our trading relationships, and our economic security. 

And, I know I am going a little over time, but, to that end, what 

is the USDA doing to prepare for the threat of bioterrorism? Can 

you give us a broad overview on that? 

Senator CARPER. Mr. Shea, I am going to ask you to suspend 

your answer just for a second. I am very much interested in your 

answer, but Senator Portman has a dead stop right now and he 

needs to go. 

Senator ERNST. OK. 

Senator CARPER. If we can just yield to him for a moment, and 

then we will go back to you. 

Senator ERNST. Thank you. Yes. 

Senator CARPER. Thank you. 

OPENING STATEMENT OF SENATOR PORTMAN 

Senator PORTMAN. Thank you, Senator Ernst, and thank you, 

Senator Carper, and thank you for having this hearing—you and 

the Chairman. This is an incredibly important area. I have a number of questions I am going to be submitting for the record, probably to each of you—at least to three of you—as I see you there. 

But, I want to focus on a single issue, Dr. Hatchett, if I could. We 

talked a lot about Ebola today. We have also talked about the Zika 

virus. And, they are very different. My understanding is that the 

way in which someone becomes contagious with Ebola creates a 

health problem in and of itself, whereas, with Zika, it is not as easily transmitted from person to person. However, it is transmitted 

from mosquitoes to people very easily. And, I just wonder what you 

think we could do, in terms of leveraging all of our assets—including one that happens to be situated in Youngstown, Ohio, which is 

the 910th. It is the airlift wing there that provides aerial spraying 
28 

for our country. They do incredible work on our firing ranges. They 

do work with regard to oil spills. But, they also do work with regard to mosquito infestations. Do they have a role here with regard 

to Zika, particularly, in spring in the southern part of the country, 

where we can see, unfortunately, a movement from Latin America 

up toward the United States? 

Dr. HATCHETT. Senator, thank you for that question. Vector control, which is what you are referring to, in terms of controlling 

mosquito populations, is an area that CDC, I think, has primary 

responsibility for, so, if I could yield to my colleague to let him address your question. 

Dr. REDD. It is hard to give a global answer to that question. The 

variability of mosquito control districts in the United States is remarkable. Some localities have really finely honed enterprises, 

while others have hardly any at all. I think that there could be a 

role for that airwing in locations that do not have the capability 

and need it. 

Something that we think is really important, that the Zika virus 

outbreak is pointing out, is the need to really revitalize those mosquito control efforts—not only for control, but really just to understand what is going on—that part of what those mosquito control 

districts do is capture mosquitoes and speciate them, and we just 

do not have the information that we need right now in the United 

States to make the best decisions. 

Senator PORTMAN. Well, thank you, Dr. Redd, and thank you, 

Senators. I want you to know the 910th is ready and willing—and 

they, again, do outstanding work. And, I think it would be a way 

to leverage some of those DOD assets to address a very real, potential biological issue that we are currently facing—just as we did 

with Ebola over the last couple of years. 

Thank you. 

Senator CARPER. Senator Ernst. 

Senator ERNST. Thank you, Ranking Member. I will go ahead 

and just submit the questions for the record in the interest of time. 

Senator CARPER. Well, go ahead and respond to the question. It 

was a good question. 

Senator ERNST. I have a hard stop also. 

Senator CARPER. That is OK. I would like to hear the answer, 

and then we will go—actually, it is a great question, so go ahead. 

Just briefly. 

Senator ERNST. Yes, bioterrorism efforts. 

Mr. SHEA. OK. Of course, we work very closely with our colleagues in Homeland Security’s Customs and Border Protection 

(CBP), who actually conduct inspections of things and people as 

they are coming into the country. So, that is our very first line of 

defense—looking for things. 

But, after that, what is important, of course, is finding any outbreak quickly. And so, surveillance is really the key. We have surveillance on farms, in markets, and in feedlots—everywhere. And, 

that surveillance comes not only from USDA people, but, more 

abundantly, from State people and from private veterinarians who 

we accredit at USDA. And, when they find a disease, they are 

duty-bound to report that to us. So, that is really the key—surveil-
29 

lance, prevention, keeping these things out of the country, and getting on it right away. 

Some other things that are going on, of course—at DHS, they are 

developing countermeasures at the Plum Island Animal Disease 

Center (PIADC)—soon to be relocated, but they are working very 

hard there to find countermeasures and detection methods. So, all 

of those things are in place now. 

Senator ERNST. Just to follow up with that then, as we are preparing for potential incidents, is it important that we have stockpiles of vaccinations or other veterinary supplies then, to safeguard? 

Mr. SHEA. Absolutely. We do have a veterinary stockpile, but it 

certainly is not robust enough to handle a really huge outbreak of 

foot-and-mouth disease, for example. We do have a good capacity 

now for the avian influenza vaccine, but we do not have a huge 

stockpile of some of the others. 

Senator ERNST. Thank you. 

Chairman JOHNSON [PRESIDING.] Senator McCaskill. 

OPENING STATEMENT OF SENATOR MCCASKILL 

Senator MCCASKILL. Thank you. 

I understand that there are several advisory committees involved 

in the material threat assessment process and the material threat 

determination process that include nongovernmental experts. 

These determinations are, in fact, the guidance that DHS uses 

when considering a particular chemical, biological, radiological, or 

nuclear weapon to be a threat and allows HHS to use the BioShield 

funding for countermeasure procurements. 

So, my question to you, Doctor, is: Is anyone on these committees 

associated with any of the companies that are actually getting the 

funds for the research and development on possible countermeasures? 

Mr. FIROVED. The Science and Technology Directorate is the organization that runs the terrorism risk assessments and the material threat assessments. While I have been involved in the process, 

I am not knowledgeable as to the membership that they rely on 

when they put those together. 

Senator MCCASKILL. If you would get that for the record, that 

would be helpful. 

Mr. FIROVED. I will, absolutely. 

Senator MCCASKILL. I have had a hearing on this, in previous 

years, with the person that you just referenced and was frustrated 

with what I thought—and I am going to go into that a little bit because I think it is relevant to the hearing today—about what we 

are warehousing and why, as well as what we are spending money 

on. 

If you look at the funding decisions, the priorities, and the tradeoffs, we spent $1.4 billion on anthrax countermeasures, alone. 2 of 

the investments were for anthrax antitoxins that cost $3,100 and 

$8,200 per dose. We also bought 10 million doses of BioThrax, 

which only has a 4-year shelf life. And, we bought that vaccine in 

2005. And then, we bought another 18.75 million doses 2 years 

later. Now, all of that money is—I mean, I understand you have 

to spend money to be prepared, even if you do not use it. I get that. 
30 

But, it appears to me that anthrax investment is crowding out 

other countermeasures in terms of funding. And, I would like someone to address that, because, while we had one anthrax attack, it 

seems to me that the cupboard is bare in a lot of other areas where 

we need to have BioShield funds being used. And, I would appreciate it if someone would address that, especially since Dr. Lurie, 

when I talked to her about anthrax, basically said that it is a 

therapeutic that, potentially, could be effective against an antibiotic-resistant anthrax infection. There was not even certainty 

that it would be. Dr. Hatchett. 

Dr. HATCHETT. Yes, ma’am. Good to see you, ma’am. Thank you 

for the question. Your question has multiple parts. I will try to be 

brief and address all of them. 

With respect to the anthrax antitoxins, we do have very limited 

treatments for anthrax disease. And, we now have 3 licensed anthrax antitoxins, so FDA has judged that, based on the best available evidence, those products are likely to be safe, effective, and 

produce a survival benefit against anthrax. Anthrax certainly is 

one of our top threats—and we have made very substantial investments to secure the Nation against future anthrax attacks. 

To address your question about whether it is crowding out other 

products, I have to say it is not. We—as the Office of the Assistant 

Secretary for Preparedness and Response—as you know, are the 

stewards of the Project BioShield funding. Over the last 12 years, 

we have added 17 products to the Strategic National Stockpile 

using Project BioShield funding. Those products include products, 

yes, to treat anthrax—both vaccines and antitoxins—but also 

antivirals and vaccines to treat smallpox, antitoxins to treat botulism, drugs and treatments for acute radiation syndrome (ARS), exposure to chemical nerve agents, and, most recently, we have 

added 4 products to the Strategic National Stockpile to address the 

risk of thermal burns that could be associated with explosions, 

bombings, or the detonation of an improvised nuclear device (IND). 

We have a number of new products that we will be procuring this 

year. We anticipate adding as many as 5 new products to the Strategic National Stockpile this year. Only 2 of those are for anthrax, 

but they also include treatments for smallpox and acute radiation 

syndrome. And, we may add as many as 5 new products next year. 

So, we have been able to buildup a diverse portfolio of medical 

countermeasures against CBRN threats. 

Senator MCCASKILL. Does the smallpox purchase include 

IMVAMUNE? 

Dr. HATCHETT. We have purchased significant amounts of 

IMVAMUNE over the last several years. 

Senator MCCASKILL. Is it not a problem that a scientific journal, 

‘‘Biosecurity and Bioterrorism,’’ said, unequivocally, that there is no 

apparent programmatic use for this vaccine at this time? In fact, 

7 years after the initial procurement, it is not recommended—the 

advisory group—the World Health Organization’s advisory group— 

said it is not recommended for emergency use. 

Dr. HATCHETT. I would respectfully disagree with the statement 

that it has no programmatic use. IMVAMUNE was created, specifically, to be a vaccine that we could give to immuno-compromised 

populations or persons who had relative contraindications for the 
31 

existing smallpox vaccine—and that includes persons with a history of atopic dermatitis. That is a substantial number of people 

who could have a potentially severe reaction to the other available 

smallpox vaccines. 

Senator MCCASKILL. That makes sense. I just am concerned because the World Health Organization’s scientific advisory group of 

experts noted, in 2014, that it was not recommended for emergency 

use—and we have spent $650 million on it. I hope that would always raise the hackles of somebody sitting in this chair who is trying to figure out what is going on. I mean, why are we spending 

that kind of money when, clearly, there are real questions about its 

efficacy and its Section 5. 

Dr. HATCHETT. We also have very substantial stockpiles of the 

Acambis vaccine, which can be administered in an emergency use 

setting. The potential concern about the IMVAMUNE vaccine is 

that it requires 2 doses to achieve immunity. For those people who 

have been exposed to persons with known smallpox, there is no absolute contraindication for the existing vaccine. And, if it is given 

up to 3 or 4 days after exposure, it can protect individuals who 

have been exposed to smallpox, and so, that may be the basis of 

that discussion. But, IMVAMUNE clearly is efficacious and clearly 

meets an unmet medical need for a large segment of the population. 

Senator MCCASKILL. I know I am out of time. I have one more. 

Do you mind? 

Chairman JOHNSON. You are doing a good job. 

Senator MCCASKILL. I want to make sure that we have time. 

I get that we are reliant on small start-up companies for developing some of these drugs because of the nature of the market and 

the nature of the research. And, the economics do not make sense 

for some of the big guys. So, I get that we have to fund a lot of 

this. But, what I do not get is—take ABthrax, for example. We 

gave Human Genome Sciences $130 million for late-stage development activities to support approval of the product, including support for non-clinical, clinical, and manufacturing facilities—as well 

as funds for the licensing and approval process. I mean, this was 

our baby—the taxpayers’ baby. 

Well, then we have to turn around and buy it from them for 

$3,000 a dose. Most people in Missouri do not understand that— 

why we would pay for the development of a drug and then have 

to pay $3,000 a pop for the drug after we paid to develop it. 

Dr. HATCHETT. So—— 

Chairman JOHNSON. Good question. 

Dr. HATCHETT. Yes, it is a good question. I will say that the pricing of medical countermeasures is complex. A factor that we have 

to take into consideration is that, because these products do not 

have commercial markets, we have to provide a sustaining revenue 

that will allow for the manufacturing base to remain intact. And, 

the price that you quoted for a monoclonal antibody therapeutic is 

very clearly in the middle of the range for other—there are dozens 

of licensed monoclonal antibody therapeutics for many other indications, and the prices for those products range from slightly less 

than the amount that you mentioned to substantially more. So, I 

would argue that it is a fair price for the product. 
32 

Senator MCCASKILL. Have we explored whether it would be 

cheaper to do this ourselves? We are paying them to develop the 

drug, and then we are the only customer, and so, we are continuing 

to pay them—I mean, it seems like, to me, that we are guaranteeing a profit for something that is wholly owned by the government. 

Dr. HATCHETT. If I could just say that we do look at different 

business models for how we support biodefense countermeasures. 

In a related domain, for emerging infectious diseases, we have a 

similar market failure problem. And, we are thinking through different potential approaches to how we can support companies and 

how far we would like the private sector to carry products and, potentially, what options we may have to ensure that we can have 

those products when we need them—which might include the scenario you mentioned. 

Senator, if I could mention another thing that I think you would 

be interested in. In framing your question initially, you did talk 

about the shelf life of products. And, BARDA does have a total lifecycle cost containment initiative that we have been supporting for 

many years, where we look at the products that we are developing 

and try to find ways to reduce that long-term carrying cost to the 

taxpayer. And so, for example, you mentioned the IMVAMUNE 

product—the smallpox vaccine. BARDA has supported the development of a lyophilized—or freeze-dried—version of that product 

which will have a longer shelf life—— 

Senator MCCASKILL. Which will help the shelf life—that is terrific. 

Dr. HATCHETT. And, we are doing that across the board. And, we 

are looking across our entire portfolio to see how we can reduce 

those costs. 

Senator MCCASKILL. Well, I have been involved in this other investigation where a guy named Martin Shkreli figured out that 

there was a limited market for a certain drug, and he went out and 

bought it, and then he jacked the price up. So, maybe, we need to 

take a page out of his book and jack the price down. Maybe, we 

figure out what the price is to buy the drug that we paid to develop 

and continue to manufacture it ourselves and drive that cost way 

down, because, now, we are taking out the profit that the private 

company is making from our investment. I mean, believe me, I do 

not quarrel with a private company being able to make money off 

of their investment. But, it seems weird that we are making the 

investment and then they can profit off of theirs for the life of the 

company. That is the kind of deal that any businessman would like 

to get. 

Dr. HATCHETT. Yes, ma’am, thank you. We are always looking at 

ways that we can be better stewards of the taxpayers’ money. We 

recognize our responsibility and we recognize that we do provide a 

great deal of that up-front investment. And so, we can take that 

for—— 

Senator MCCASKILL. Yes, I would love you to take a look at that, 

because I am not sure this business model makes a lot of sense for 

the taxpayers. 

Dr. HATCHETT. Thank you. 

Senator MCCASKILL. Thank you, Mr. Chairman. 
33 

Chairman JOHNSON. Thank you, Senator McCaskill. Senator Carper. 

Senator CARPER. Thank you, Mr. Chairman. 

I want to come back to Mr. Shea. Just briefly, I want to follow 

up on Senator Ernst’s question with respect to the avian influenza 

outbreak. Senator Johnson’s State was hit hard—and a number of 

other States in the Midwest were hit hard—especially their turkeys 

and laying hens, and we saw that happen, I think, between November 2014 and May and June of last year. And, we fully expected 

the East Coast—the ‘‘Atlantic Flyway’’—to be hit this winter—and 

it just has not happened. And, we have been pretty good with biosecurity. But, why do you think we have escaped this blow? 

Mr. SHEA. Of course, all of the scientists will tell me it is all 

speculative, but some of the reasons seem to be something like this: 

First, the virus circulating in the water fowl may have mutated 

to a less virulent form, and, therefore, when they are dropping the 

virus, it is simply not catching on like it did last year in a highly 

pathogenic form. So that is a possibility. 

Another possibility is that the biosecurity has improved—and I 

think it has improved dramatically, certainly in Delmarva, where 

poultry is so important, and throughout the Midwest and all of the 

places where poultry is. And, poultry is in so many places, of 

course. I think biosecurity is much better. 

So, I think those are some of the things that seem to have led 

to it. 

Senator CARPER. All right. Thank you. 

I do not know who to ask this question to, but I will start with 

you, Dr. Redd. Would you talk to us about what the difference— 

or similarity—is between how Ebola is transmitted from 1 human 

being to another, as compared to the Zika virus, please? 

Dr. REDD. Sure. I will start with Zika. It can be transmitted by 

an infected mosquito, it can be transmitted by sexual transmission, 

and it, probably, can be transmitted by blood transfusion. There is 

no instance where that has occurred, but it is a possibility based 

on the way other similar viruses can be transmitted in blood. 

Ebola is not transmitted by mosquitoes. It can be transmitted by 

sexual transmission, but its primary route of transmission is 

through contact. So, by coming into physical contact with the body 

secretions of a person who is infected—where the virus multiplies 

to very high titers—and then, it is really just through that direct 

contact. 

Senator CARPER. Thank you. The CDC announced this week, as 

was described earlier, that the Zika virus is now confirmed to be 

a source of significant brain damage to developing fetuses. There 

are a lot of policy consequences that flow from that. But, just take 

a minute or 2 and talk to us about what actually happens to the 

brain of—and it does not happen to all pregnant women. Why is 

that? But, what is actually happening in the brain of the developing fetus? And, what is the capability—if a child is born alive, 

what are some of the consequences there? 

Dr. REDD. So, a couple of points. This declaration is not changing 

what we are doing. Actually, part of the reason behind making this 

declaration was to try to make it easier to move quickly and, particularly, to take away any of the confusion people might be having 
34 

when they are deciding whether or not they should put insect repellent on. There is no question, now, that those preventive measures are very important to prevent something that is confirmed. 

When a fetus is infected, the brain is actually infected, and that 

was—an early finding was actual—on microscopic slides, you can 

see brain tissue and the virus right there. What we think happens 

is that the brain actually—because of this infection—actually 

shrinks, so that you have a normal fetus, then there is an infection—that brain gets infected and it gets smaller—and that is what 

causes the small heads. 

It is actually—even though the term ‘‘microcephaly’’ just means 

small head, the kind of—in these severe cases, it is actually a very 

particular kind of malformation that was very rare up until this 

point, where the plates of the skull of the fetus are actually overlapped because of that collapse. The skin has ridges in it—and that 

is not part of kind of regular microcephaly. So, it is actually a very 

specific finding. 

Now, even though there is evidence that the Zika virus causes 

this malformation, there are many questions—and you actually 

pointed out several of them. It does not seem that every pregnant 

woman who gets bitten by a mosquito has this very severe adverse 

effect—and we do not know why that is. We do not really know— 

there is a likelihood that there is a certain time during pregnancy 

that poses the greatest risk. That is a little bit of the speculation. 

We also suspect that there are other adverse events that can occur, 

which is typical of other birth defects. They rarely are just a single 

thing. And, we do not really have good information on that entire 

spectrum of disease. 

Senator CARPER. Do we have any idea of the degree to which a 

baby born with this disease—this brain disease that you have described—to what extent does it impair their ability to function? 

Dr. REDD. It really depends on the severity—and that is the 

question of the spectrum of illness. For the ones that are very severely affected, I mean, there are deaths right at the time of birth. 

So, that would be kind of the extreme—or deaths before birth. And, 

I think you can go all the way down the line—that there may be 

much less severe findings in what, right now, look like normal 

births. 

Senator CARPER. OK. And, for the panel, a last question. What 

good, just common-sense, practical advice can you give to people 

who are going to be traveling to parts of this country or to other 

countries, and are concerned about possible infection? What good 

advice can you give people? 

Dr. REDD. Well, our advice—that has expanded to include more 

places where the virus is actively being transmitted—is if you are 

pregnant, it is probably not a good idea to go. If you do go, use 

mosquito-prevention measures—an effective insect repellent, insecticide on your clothes, long sleeves, light-colored clothing, and do 

what you can to avoid being bitten by a mosquito. 

Senator CARPER. Any other advice from anybody else? 

[No response.] 

All right. Thank you. Thank you very much, Mr. Chairman. 

Thank you all. 

Chairman JOHNSON. Thank you, Senator Carper. 
35 

Just really quickly, there is only 1 species of mosquito that carries this. Is that true or not? 

Dr. REDD. There is 1 vector that is presumed to be the predominant vector. They are both Aedes mosquitoes. There is Aedes 

aegypti, which is thought to be the predominant vector. Aedes 

albopictus is thought to possibly also be a vector. 

Chairman JOHNSON. So, what is the status of the program to use 

genetically modified mosquitoes to, basically, make the population 

sterile in order to reduce the population of those? 

Dr. REDD. I will have to get back to you with the specifics on 

that. I think there are a number of—well, there is a programmatic 

approach of using indoor residual and outdoor residual spraying 

that is being used in Puerto Rico for pregnant women to prevent 

mosquitoes—basically killing mosquitoes right there—and also putting larvicides in potential breeding spaces of those mosquitoes as 

well as removing potential breeding spaces. 

There are a number of kind of experimental—or less widespread—uses, and, in all of this, we really need to learn the effectiveness of these measures because this is a very difficult mosquito—not to kill at an individual level, but to be sure that there 

are enough mosquitoes being killed to reduce transmissions. 

Chairman JOHNSON. OK. Can anybody else speak to the status 

of using genetically modified—OK. So, it is just experimental at 

best. 

Let me close out the hearing. I will just kind of go down the 

panel. Based on the Blue Ribbon Study Panel on Biodefense’s conclusion that we do not have a strategy—we do not have any kind 

of functioning leadership here, both budgetary as well as operational—you are all involved in these organizations. I have been at 

organizations that have a very well defined strategy and you know 

it. I have been at organizations that do not have a strategy—I am 

kind of in one right now—where you also know it. So, I want to 

get your evaluation and—if you are saying you agree with GAO— 

if you agree with the Blue Ribbon Study Panel on Biodefense, you 

do not have to say a whole lot more. But, if you disagree, just 

quickly tell me—what is the disconnect, in terms of what GAO and 

the Blue Ribbon Study Panel on Biodefense are talking about—a 

lack of strategy, a lack of coordination, and a lack of unity of effort? 

I will start with you, Dr. Hatchett. 

Dr. HATCHETT. Thank you. I think the problem of biodefense is 

a tremendously far-reaching problem, and it stretches to all sectors 

of society—actually, to all parts of government. Within the domain 

that we work in, which is public health and medical preparedness 

and response, I feel that we do have strong strategies, we do have 

strong collaborative mechanisms, and we have adequate structures 

in place to respond to the emergencies that we are presented with. 

Chairman JOHNSON. Dr. Redd. 

Dr. REDD. So, I think there is a policy process to make the kinds 

of changes that are being proposed—and that involves the legislature and the Executive Branch. And, this is a recommendation that 

needs to be looked at very carefully. 

Chairman JOHNSON. Mr. Shea. 

Mr. SHEA. I certainly agree with them. I would say that so many 

great things are going on between our respective agencies and I 
36 

think, if those could all be brought together, probably—certainly— 

it would be to our advantage. 

Chairman JOHNSON. OK. Dr. Firoved. 

Mr. FIROVED. Sure. I think that we are certainly taking to heart 

the Blue Ribbon Study Panel on Biodefense’s recommendations. We 

are trying to implement as many of them as we can. I think there 

are strong strategies. I think there are strong coordination mechanisms. We have touched on a few of them today, but there are 

many more. We are never going to be done. I think one of the 

things that strikes me is, after 9/11, when we were talking about 

interagency coordination to address it, so that we could connect the 

dots, there was one anecdotal story that someone stood up and 

said, ‘‘I thought we were going to do this after Pearl Harbor.’’ And 

so, this is a task that is never done. And, we will always have to 

strive and we are always going to have to grow and build these capabilities. 

Chairman JOHNSON. Listen, I come from a manufacturing background. It just gets into your genes—continuous improvements. So, 

everything always can be improved. 

Mr. Currie, just a final comment. Again, the gentlemen here 

think there are certainly strategies—certainly areas for improvement. Is that a pretty accurate assessment from your standpoint? 

Mr. CURRIE. Probably not surprising to hear we think strategy 

is important. And, I do not want to take away from some of the 

efforts that have been done. The public health strategy that Dr. 

Hatchett mentioned, I think, is probably the closest thing to such 

a comprehensive strategy. I think if I had to nail 1 key thing that 

is not being done that makes it difficult, it is this idea of being able 

to prioritize investments and prioritize efforts. Within each area, 

you can do that because the agencies and departments have control 

of those areas. But across, you cannot. 

Chairman JOHNSON. Yes, so, at the agency level, you think you 

are doing a pretty good job of prioritizing, but, again, it is that topdown allocation of resources. 

Well, again, thank you all for your time, your testimony, and 

your answers to our questions. The hearing record will remain 

open for 15 days, until April 29 at 5 p.m., for the submission of 

statements and questions for the record. 

This hearing is adjourned. 

[Whereupon, at 11:51 a.m., the Committee was adjourned.] 
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