SPEAKERS CONTENTS INSERTS
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80–094PS
2002
HOMELAND SECURITY: THE FEDERAL
AND REGIONAL RESPONSE
FIELD HEARING
BEFORE THE
SUBCOMMITTEE ON ENVIRONMENT, TECHNOLOGY,
AND STANDARDS
COMMITTEE ON SCIENCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTH CONGRESS
SECOND SESSION
JUNE 10, 2002
Serial No. 107–76
Printed for the use of the Committee on Science
Available via the World Wide Web: http://www.house.gov/science
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COMMITTEE ON SCIENCE
HON. SHERWOOD L. BOEHLERT, New York, Chairman
LAMAR S. SMITH, Texas
CONSTANCE A. MORELLA, Maryland
CHRISTOPHER SHAYS, Connecticut
CURT WELDON, Pennsylvania
DANA ROHRABACHER, California
JOE BARTON, Texas
KEN CALVERT, California
NICK SMITH, Michigan
ROSCOE G. BARTLETT, Maryland
VERNON J. EHLERS, Michigan
DAVE WELDON, Florida
GIL GUTKNECHT, Minnesota
CHRIS CANNON, Utah
GEORGE R. NETHERCUTT, JR., Washington
FRANK D. LUCAS, Oklahoma
GARY G. MILLER, California
JUDY BIGGERT, Illinois
WAYNE T. GILCHREST, Maryland
W. TODD AKIN, Missouri
TIMOTHY V. JOHNSON, Illinois
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MIKE PENCE, Indiana
FELIX J. GRUCCI, JR., New York
MELISSA A. HART, Pennsylvania
J. RANDY FORBES, Virginia
RALPH M. HALL, Texas
BART GORDON, Tennessee
JERRY F. COSTELLO, Illinois
JAMES A. BARCIA, Michigan
EDDIE BERNICE JOHNSON, Texas
LYNN C. WOOLSEY, California
LYNN N. RIVERS, Michigan
ZOE LOFGREN, California
SHEILA JACKSON LEE, Texas
BOB ETHERIDGE, North Carolina
NICK LAMPSON, Texas
JOHN B. LARSON, Connecticut
MARK UDALL, Colorado
DAVID WU, Oregon
ANTHONY D. WEINER, New York
BRIAN BAIRD, Washington
JOSEPH M. HOEFFEL, Pennsylvania
JOE BACA, California
JIM MATHESON, Utah
STEVE ISRAEL, New York
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DENNIS MOORE, Kansas
MICHAEL M. HONDA, California
Subcommittee on Environment, Technology, and Standards
VERNON J. EHLERS, Michigan, Chairman
CONSTANCE A. MORELLA, Maryland
CHRISTOPHER SHAYS, Connecticut
CURT WELDON, Pennsylvania
NICK SMITH, Michigan
GIL GUTKNECHT, Minnesota
CHRIS CANNON, Utah
FELIX J. GRUCCI, JR., New York
MELISSA A. HART, Pennsylvania
WAYNE T. GILCHREST, Maryland
J. RANDY FORBES, Virginia
SHERWOOD L. BOEHLERT, New York
JAMES A. BARCIA, Michigan
LYNN N. RIVERS, Michigan
ZOE LOFGREN, California
MARK UDALL, Colorado
ANTHONY D. WEINER, New York
BRIAN BAIRD, Washington
JOSEPH M. HOEFFEL, Pennsylvania
JOE BACA, California
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JIM MATHESON, Utah
RALPH M. HALL, Texas
PETER ROONEY Subcommittee Staff Director
MIKE QUEAR Democratic Professional Staff Member
ERIC WEBSTER Professional Staff Member
CAMERON WILSON Professional Staff Member/Chairman's Designee
MARTY SPITZER Professional Staff Member
SUSANNAH FOSTER Professional Staff Member
ELYSE STRATTON Majority Staff Assistant
MARTY RALSTON Democratic Staff Assistant
C O N T E N T S
June 10, 2002
Witness List
Hearing Charter
Opening Statements
Statement by Representative Constance A. Morella, Ranking Majority Member, Subcommittee on Environment, Technology, and Standards, Committee on Science, U.S. House of Representatives
Written Statement
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Statement by Representative James A. Barcia, Ranking Minority Member, Subcommittee on Environment, Technology, and Standards, Committee on Science, U.S. House of Representatives
Written Statement
Panel I
Dr. Elias Zerhouni, Director, National Institutes of Health
Oral Statement
Written Statement
Biography
Dr. Arden L. Bement, Jr., Director, National Institute of Standards and Technology
Oral Statement
Written Statement
Biography
Dr. Anthony S. Fauci, Director, National Institute of Allergy and Infectious Diseaes, National Institutes of Health
Oral Statement
Written Statement
Biography
Discussion
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Panel II
Major Julie Pavlin, Chief, Department of Field Studies, Walter Reed Army Institute of Research
Oral Statement
Written Statement
Biography
Mr. Edward J. McCallum, Director, Combating Terrorism Technology Support Office, Department of Defense
Oral Statement
Written Statement
Biography
Mr. Robert A. Malson, President, DC Hospital Association; Chairman, Washington Metropolitan Council of Governments Bioterrorism Task Force
Oral Statement
Written Statement
Biography
Discussion
Appendix 1: Answers to Post-Hearing Questions
Dr. Elias Zerhouni, Director, National Institutes of Health
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HOMELAND SECURITY: THE FEDERAL AND REGIONAL RESPONSE
MONDAY, JUNE 10, 2002
House of Representatives,
Subcommittee on Environment, Technology,
and Standards,
Committee on Science,
Washington, DC.
The Subcommittee met, pursuant to call, at 12:03 p.m., in Large Hearing Room, Stella B. Werner Council Office Building, 100 Maryland Avenue, Rockville, Maryland, Hon. Constance A. Morella presiding.
80094a.eps
HEARING CHARTER
SUBCOMMITTEE ON ENVIRONMENT, TECHNOLOGY, AND STANDARDS
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COMMITTEE ON SCIENCE
U.S. HOUSE OF REPRESENTATIVES
Homeland Security: The Federal
and Regional Response
MONDAY, JUNE 10, 2002
12:00 P.M.–2:00 P.M.
LARGE HEARING ROOM,
STELLA B. WERNER COUNCIL OFFICE BUILDING
100 MARYLAND AVE., ROCKVILLE, MD 20850
1. Purpose
On Monday, June 10th, 2002 at 12:00 noon, the Subcommittee on Environment, Technology, and Standards of the House Committee on Science will hold a hearing on Homeland Security: The Federal and Regional Response. The hearing will examine both federal and regional responses to terrorism, and the pivotal role Maryland plays in that effort.
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The events of September 11th have motivated an extraordinary response among federal, state, and local agencies to reduce our nation's vulnerability to terrorist attacks. The Subcommittee will examine wide-ranging federal anti-terrorism efforts at the National Institute of Standards and Technology and the National Institutes of Health as well as local and regional responses developed through the Department of Defense, the Technical Support Working Group (TSWG), and the Washington Metropolitan Council of Governments (COG). Topics will include computer and technology security, bioterrorism and medical response, regional coordination, public and private research and development, and first responder needs. The Subcommittee is especially interested in how the various agencies work with private entities and entrepreneurs to maximize both speed and efficiency in dealing with new terrorist threats.
The Subcommittee will explore several questions including:
1. What efforts have NIST and NIH initiated since September 11th to respond to the threat of terrorism?
2. What are the likely threats we face from cyber- and bio-terrorism and what steps have NIST and NIH taken to develop countermeasures?
3. What technologies are available to detect and respond to cyber and biological attacks?
4. How are agency resources being utilized to address these threats? In what areas are NIST and NIH efforts sufficiently funded from existing accounts and what areas require reprogramming or supplemental support?
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5. How are NIST and NIH coordinating their efforts with other federal agencies, local governments, and the private sector?
6. How do local governments in the greater Washington, DC region plan to coordinate their response to potential incidents of terrorism? What should they be looking for from the Federal Government?
2. Witnesses
Testifying before the Committee will be witnesses representing various government entities located throughout the region, but primarily from Montgomery County. There will be two panels, one discussing large-scale federal research efforts at NIST and NIH, the second discussing more specific procurement, surveillance, and response issues at both the federal and regional level.
The following witnesses will address the Committee:
Panel One:
Dr. Elias Zerhouni, Director, National Institutes of Health. Dr. Zerhouni became the 15th director of NIH on May 2, 2002. Previously he was the executive vice dean of Johns Hopkins University School of Medicine, chair of the Russell H. Morgan department of radiology and radiological science, and Martin Donner professor of radiology and professor of biomedical engineering.
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Dr. Arden Bement, Director, National Institute of Standards and Technology. NIST has figured prominently in anti-terrorism efforts concerning sensor development, computer security as well as other areas. Prior to his appointment as NIST director, Dr. Bement served as the David A. Ross Distinguished Professor of Nuclear Engineering and head of the School of Nuclear Engineering at Purdue University.
Dr. Antony Fauci, Director, National Institute of Allergy and Infectious Diseases. Dr. Fauci has directed NIAID since 1984, where he oversees an extensive research portfolio of basic and applied research to prevent, diagnose, and treat infectious and immune-mediated illnesses, including HIV/AIDS and other sexually transmitted diseases, illness from potential agents of bioterrorism, tuberculosis, malaria, auto-immune disorders, asthma and allergies.
Panel Two:
Major Julie Pavlin, Chief, Department of Field Services, Walter Reed Army Institute of Research. Maj. Pavlin is an expert in both military and civilian surveillance of infectious diseases and bioterrorism.
Mr. Ed McCallum, Director, Combating Terrorism Technology Support Office, Department of Defense. Ed McCallum was a former colonel in the Special Forces with service in Vietnam. He worked in Department of Energy Office of Safeguards and Security for twenty years.
Mr. Robert Malson, Chairman, Metropolitan Council of Governments Bioterrorism Task Force and President of the DC Hospital Association. Mr. Malson heads the COG bioterrorism effort and is responsible for coordinating the regional response to a biological attack.
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Panel I
Ms.MORELLA. Thank you all for being here. I am going to call to order the Subcommittee on Environment, Technology, and Standards of the House of Representatives Committee on Science. Our topic today is Homeland Security: The Federal and Regional Response. I know that people are going to think that I was in on this whole plan for a Department of Homeland Security. Although I think it is a good concept and we need to implement it as quickly as possible, I did not know about this when we scheduled this field hearing, but I am pleased we are able to have the field hearing of the Subcommittee here in Montgomery County, Maryland, which is certainly the place where so much is happening in this area.
So today, it is my great pleasure to chair it. We have an incredibly distinguished panel. I know they will have a myriad of insights to share and I intend to get to them as quickly as we can. I know the time is very precious. I also want to thank my distinguished colleague from Michigan, who traveled quite far just to be here with us today, Mr. Jim Barcia, and I know that we are going to have a great hearing with Jim. Thank you very much. Particularly, because today we don't have votes on the Floor of the House, so he made the trip just to be with us. I know that Mr. Bartlett will be joining us soon, also.
On September 11, our nation was attacked in an unprecedented and truly horrific way. The horror of the collapse of the twin towers, the destruction of the Pentagon, and the subsequent threats and official warnings have had all of us on edge. Yet we have not been sitting idly by waiting for the next shoe to drop. America's worst moment may have come on a fateful morning in September, but some of its best have been coming continuously for the past nine months. The heroics immediately following the attack have morphed into a concerted, sustained effort across a variety of fronts to secure our nation.
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Nowhere is this more true than in our scientific enterprise. They don't always get the headlines or the credit, but their contributions are vital nonetheless. What is more, some of the most important work is going on right here in Maryland. Montgomery County is the home of the National Institutes of Health, the National Institute of Standards and Technology, Walter Reed Army Institute of Research, as well as others. Important Department of Defense agencies are also close by, located at Fort Dietrich and in northern Virginia. And of course, this area is a hotbed of biotech, information security, and other technologically focused corporations who have invested both of their time and the talents in providing solutions to our various security problems. I consider it a real privilege to represent a number of these organizations and I am very proud of the role that Maryland is playing in our nation's defense.
Today we are going to do three very important things. First, we are going to hear from two of the lead Federal research agencies dealing with security and homeland defense. We will hear how the National Institutes of Health has reorganized to fill the gaps in our knowledge about potential biological threats and the progress that has been made in dealing with our deficiencies in these areas. We have the top leadership of this organization with us today, so I know that we are going to get the straight story. Also, the National Institute of Standards and Technology has instigated a wide range of initiatives ranging from computer security to infrastructure issues our buildings to new sensors and biometrics. These agencies are replete with ideas and we will get a chance today to learn about some of the most promising efforts.
Second, we are going to delve into the nuts and the bolts of the issue. Research and development isn't valuable without implementation and use. The technology we develop has to get down to the first responders on the regional, state, and local level. Monitoring must be upgraded to insure a timely response. Plans have to be put in place to take advantage of what we already know. And finally, we must make sure that we are taking advantage of the ingenuity of the American people. Despite the hard work of the distinguished scientists at our top laboratories, not all of the good ideas disseminate from them alone, and we must be prepared to glean the best proposals from industry and private enterprise as well. Our second panel is devoted to experts in these areas and I am looking forward to hearing about our progress on those fronts.
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Finally, it is the duty of the Congress to oversee the activities taking place under our jurisdiction and I take this responsibility, as Mr. Barcia does, very seriously. I have the utmost respect for the agencies represented here, although I know that not everything always goes as planned. And so it will be good to hear about the successes, but also, maybe the failures where the resources are insufficient to meet the needs. We want to find out what the Congress can do to improve things and what legislative remedies the witnesses might recommend. I know that we have the very best people for this discussion and I look forward to a frank conversation about our needs.
And so now it is my privilege to recognize the Ranking Member of the Subcommittee, Mr. Barcia, for any opening statement he may have.
[The prepared statement of Ms. Morella follows:]
PREPARED STATEMENT OF REPRESENTATIVE CONSTANCE A. MORELLA
Today it is my great pleasure to chair this field hearing. We have an incredibly distinguished panel, who I know have a myriad of insights to share and I intend to get to them quickly. I also want to thank my distinguished colleague from Michigan, Mr. Barcia, who has come all the way from Michigan to be with us today. I know we are going to have a great hearing.
On September 11th, our nation was attacked in an unprecedented and truly horrific way. The horror of the collapse of the twin towers, the destruction at the Pentagon, and the subsequent threats and official warnings have had all of us on edge. Yet we have not been sitting idly by waiting for the next shoe to drop. America's worst moment may have come on a fateful morning in September, but some of its best have been coming continuously for the past nine months. The heroics immediately following the attack have morphed into a concerted, sustained effort across a variety of fronts to secure our nation.
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No where is this more true than in our scientific enterprise. They don't always get the headlines or the credit, but their contributions are vital nonetheless. What's more some of the most important work is going on right here in Maryland. Montgomery County is the home of the National Institutes of Health, the National Institute of Standards and Technology, Walter Reed Army Institute of Research, as well as others. Important Department of Defense agencies are also close by, located at Ft. Deitrich and in Northern Virginia. And of course, this area is a hotbed of biotech, information security, and other technologically focused corporations who have invested both of their time and the talents in providing solutions to our various security problems. I consider it a real privilege to represent a number of these organizations and I am proud of the role Maryland is playing in our nation's defense.
Today we are going to do three very important things. First, we are going to hear from two of the lead federal research agencies dealing with security and homeland defense. We will hear how the National Institutes of Health have reorganized to fill the gaps in our knowledge about potential biological threats and the progress they have made in dealing with our deficiencies in these areas. We have the top leadership of this organization with us today, so I know we will get the straight story. Also the National Institute of Standards and Technology has instigated a wide range of initiatives ranging from computer security, to infrastructure issues with our buildings, to new sensors and biometrics. These agencies are replete with ideas and we will get a chance today to learn about their most promising efforts.
Second, we are going to delve into the nuts and bolts of the issue. Research and development isn't valuable without implementation and use. The technology we develop has to get down to the first responders on the regional, state, and local level. Monitoring must be upgraded to insure a timely response. Plans have to be put in place to take advantage of what we already know. And finally, we must make sure we are taking advantage of the ingenuity of the American people. Despite the hard work of the distinguished scientists at our top laboratories, not all of the good ideas disseminate from them and we must be prepared to glean the best proposals from industry and private enterprise as well. Our second panel is devoted to experts in these areas and I am looking forward to hearing about our progress on these fronts.
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Finally, it is the duty of the Congress to oversee the activities taking place under our jurisdiction and I take this responsibility very seriously. I have the utmost respect for the agencies represented here, although I know not everything they do goes as planned. I will be very interested to hear about the successes, but also the failures and where the resources are insufficient to meet the needs. I want to find out what the Congress can do to improve things and what legislative remedies the witnesses might recommend. I know we have the very best people for this discussion and I look forward to a frank conversation about our needs. Thank you.
Mr. BARCIA. Thank you very much, Madam Chair. I want to commend you on your impeccable timing for this afternoon's hearing and say it is also a privilege to be here with you. I have the privilege of being your Ranking Member of this Subcommittee for many years, and I have always appreciated the very fair and bipartisan manner in which you have approached the business before this Subcommittee. And it has been a real privilege for me to work with you, and I am delighted to be in your district today. I was just saying that I appreciate very much the opportunity to be with all of you, and I have appreciated very much the working relationship that I have enjoyed with Representative Morella over the years that I have served as the Ranking Member of this Subcommittee. And I think today's timing on this issue before the Subcommittee is impeccable, Madam Chair. In less than a week after President Bush presented his recommendation to Congress on the creation of a Department of Homeland Security, here we are receiving testimony on the topic. The President's speech was a wakeup call to all of us. Creation of a new department is no simple task especially on a timetable like the one laid out by President Bush. However, I believe there is bipartisan support to reshape the Federal Government in a way that better secures our citizens at home.
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I am interested in how the gentlemen on the first panel believe their agencies will inform or become a part of this new department. I realize this is a new document for everyone. We have not had a lot of time to review the various recommendations and proposals, but it is critical that the discussion begin in earnest as we begin deliberations on the President's proposal. The members of the second panel also are very distinguished and well qualified to comment on whether they believe the President's proposal will address the problem; namely, will a Department of Homeland Security reduce the bureaucracy in a way to allow the Federal Government to better combat terrorism. I, especially, appreciate the opportunity of hearing Dr. Fauci and appreciate his willingness to appear before us today and know his time with us is very limited. Therefore, I will close my remarks at this point and look forward to your insightful testimony. Thank you, Madam Chair.
[The prepared statement of Mr. Barcia follows:]
PREPARED STATEMENT OF JAMES A. BARCIA
Mrs. Morella, I want to commend you on your perfect timing for this afternoon's hearing. Less than a week after President Bush presented his recommendation to Congress on the creation of a Department of Homeland Security, here we are, receiving testimony on the topic.
The President's speech was a wake up call to all of us. Creation of a new department is no simple task, especially on a timetable like the one lay out by President Bush. However, I believe there is bipartisan support to reshape the federal government in a way that better secures our citizens at home.
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I am interested in how the gentleman on the first panel believe their agencies will inform or become a part of this new Department. I realize this is a new document for everyone, however, some discussions must have occurred by now. If they have not, that, too, would be a useful piece of information.
The members of the second panel are well qualified to comment on whether they believe the President's proposal will address the problem. Namely, will a Department of Homeland Security reduce the bureaucracy in a way to allow the Federal Government to better combat terrorism?
I appreciate Dr. Fauci's willingness to appear before us today and know his time with us is limited. Therefore, I will close my remarks at this point and look forward to your insightful testimony.
Ms. MORELLA. Thank you very much, Congressman Barcia. Let me just mention a few of the people who are here, and I will do it pretty quickly. First of all, we have State Senator Jean Roesser, who is here. We have Councilman Howie Denis, who is here. They may want to stand. We have Dyan Brasington, President of the Maryland High-Tech Council. I want to thank her and Cathy Manning for helping also to get information out to all of you who are here. We have representatives of Law Enforcement/First Responders. We have Gordon Ahyoge, who is the Montgomery County Fire Administrator. We have Lynn Frank, who is the Montgomery County Chief of Public Health. We have Dr. Carol Garvey, Director of Public Health. We have Dr. Strausberg, the Chief of the NIST Police; Bob Page of the NIST Emergency Services. We have Ben Wu, my former staff person on that subcommittee, who is now the Deputy Undersecretary of Technology in the Department of Commerce. I know that from NIH, we also have Jan Hedetniemi, who has done community liaison.
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Okay. Let me just briefly introduce the first panel. It is a real honor—I truly mean that, gentlemen—to have such a distinguished group before us, although, it seems like I am really introducing a group of old friends rather than an all star lineup of witnesses. On my left, to your right, is Dr. Elias Zerhouni. He is a relatively newly confirmed Director of the National Institutes of Health. Dr. Zerhouni comes to us from Johns Hopkins, where he was Executive Vice Dean in the School of Medicine and a Chief Professor of Radiology and Biomedical Engineering. He is both an accomplished researcher and administrator. And during his tenure at Johns Hopkins, he has revamped the school's academic leadership, placing them on the forefront of a number of fields, as well as maintaining an active and critical research portfolio. His understanding of both scientific and administrative needs will make him an ideal Director for the National Institutes of Health. I look forward to working with him as we have with his many predecessors. I also think this is his very initial appearance before Congress in his official capacity, and so I think we can feel pretty privileged here in Montgomery County to have his first appearance before Congress right in our own jurisdiction. We wish him well and thank him very much for his new challenge and for being with us.
Seated next to him is Dr. Arden Bement. He is the Director of the National Institute of Standards and Technology. He is no stranger to the Science Committee. He has already testified, I think, even since taking his position about four or five times in the six months that he has been at the helm of NIST. And during his show of tenure, Dr. Bement has already distinguished himself as a true leader. He has quickly responded and repositioned the agency in order for the agency to respond to the County's Homeland Security needs while continuing to build NIST's core mission. Prior to coming to Maryland, Dr. Bement was the head of the Nuclear Engineering Program School at Purdue University, where he championed programs to reach out and bring in more women into engineering. I greatly appreciate all of his efforts at NIST and look forward to our continuing to work together.
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And finally, we come to Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases. I think that anywhere in the Nation, they would be able to recognize him, because he has been involved with the media so often because of the wonderful work he does. Dr. Fauci is the veteran on the panel, having been at his current post for over 17 years. I was amazed to note, too, that you have actually been with NIH for 34 years. That must be what keeps him young, Dr. Zerhouni. He is a true pioneer in the treatment of immune medicated diseases—or mediated diseases—and one of the world's most oft cited scientists, one of our nation's greatest experts on bioterrorism. We are very fortunate to have had his tireless leadership at NIH. I do want to also point out that he just recently received the Albany Medical Center Prize in Medicine and Biomedical Research. This prize, I understand, is second only to the Nobel Prize worldwide. So I want to thank all of you for being here, and we will start off then and have an opportunity to ask questions. Dr. Zerhouni, I recognize you, sir.
STATEMENT OF DR. ELIAS ZERHOUNI, DIRECTOR, NATIONAL INSTITUTES OF HEALTH
Dr. ZERHOUNI. Thank you, Madam Chairwoman and Members of the Subcommittee.
Ms. MORELLA. Let us make sure that we can hear you, too. Good.
Dr. ZERHOUNI. I am Dr. Elias Zerhouni, the Director of the National Institutes of Health, and thank you for the opportunity to appear before you today to discuss the role of NIH in biodefense and the coordination of NIH's activity with public and private partnerships. Over the past few weeks, I have assumed my job, and I can tell you that biodefense has been at the top of the agenda. And Dr. Fauci, who is here with me today and can provide you with the details, has been an absolute critical contributor for his institute and his team of scientists, since September 11, have enormously advanced our understanding of the biodefense needs of the country.
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And likewise, I would like to congratulate you on your sense of timing. As you know, the President announced plans for the creation of the Department of Homeland Security, and this department will be responsible for several distinct capabilities and institutions that focus on specific elements of this mission. We will unify, through this department, much of the Federal Government's effort to develop and implement scientific and technological counter measures. In the context of biodefense, this approach will allow us to integrate chemical, biological, radiological, and nuclear terrorist threats and the response to them. The Department will also provide direction and establish priorities for national research and development, for related tests and evaluation, and for the development of procurement of new technology and equipment to counter the threat. The Department will incorporate and focus the intellectual energy and extensive capacity of several important scientific institutions, which include the NIH and other Department of Health and Human Services agencies, the Lawrence Livermore National Laboratory, which is currently part of the Department of Energy, and the Plum Island Animal Disease Center, which is part of the Department of Agriculture.
The Department would unify our defenses against human, animal, and plant diseases that could be used as terrorist weapons, and the Department would sponsor outside research, development, and testing to invent new vaccines, antidotes, diagnostics, and therapies against biological and chemical warfare agents; to recognize, identify, and confirm the occurrence of an attack; and to minimize the morbidity and mortality caused by any biological or chemical agent. And we will be working very closely with the Administration on the development of this overall plan. I can tell you that Dr. Fauci spent much of his last three days coordinating with the Department the response that NIH will participate in.
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Now, by biodefense research at NIH began long before the spate of anthrax cases that shook the Nation last year. NIH has been working collaboratively with other Federal agencies, including the Department of Defense and the Office of Homeland Security, but also with nongovernmental partners. We conducted basic research and vaccine development regarding agents that potentially could be used as weapons of bioterrorism. NIH also works closely with state and local officials as part of an overall strategy of national biodefense. Now, the President's budget request for Fiscal Year 2003, which includes $1.7 billion for NIH biodefense, will enable us to expand our ongoing activities in areas of basic research we have not gone into before, but most importantly, apply and bring the progress of biomedical science to the biodefense effort, such as genomics, comparative genomics of various organisms, diagnostics to detect organisms early, vaccine and therapeutics development. It includes funds for the construction of additional biosafety laboratories to ensure that all Americans, especially, our local neighbors, will not be exposed to unnecessary risks resulting from biodefense research.
I am also here to testify about NIH's collaborations with the private sector. These collaborations are particularly important today, for we stand on the threshold of the most exciting and promising era of biomedical research in history. Over the next decade, we can expect to see exponential growth in our understanding of human disease and ways of minimizing, in some cases eliminating, human suffering from a variety of vexing diseases. Collaboration has never been more important to our success and progress will depend on being able to assemble multidisciplinary teams of scientists, cost-cutting initiatives, and public-private partnerships. NIH is actively pursuing research partnerships and collaborations across the world, and some of our most valuable partners are and will be right here in Montgomery County.
I want you to know about one example of these partnerships before I finish, which happens to involve biodefense research. On May 9, 2002, the National Institute of Allergy and Infectious Diseases announced the results of research that completed the genetic comparison of two important isolates of the anthrax bacteria. The Ames strain that was responsible for the anthrax attack in October, in September and October, and an isolate from the recent Florida anthrax attacks. Now, the study was conducted by scientists at the Institute for Genomic Research, the TIGR Institute here in Montgomery County, as well as researches from Northern Arizona University. Now, NIAID partnered with the Office of Naval Research, the National Science Foundation, and other agencies to fund the research. What is more important is they did it in a record time. Now, the study demonstrates how the new technologies were developed for other areas of biomedical research, such as whole-genome sequencing, which has allowed us to complete the human genome, and all the computational methods that were developed for that have been directly applied to biodefense to crack the genome of these bacteria.
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Now, with that example, I will just, basically, like to say that we are committed to working with the community around us. We are committed to work with the community throughout the Nation, communities throughout the Nation, and most importantly, with the private sector in terms of accelerating our ability to defend ourselves against biodefense agents. With that, I will finish my testimony.
[The prepared statement of Dr. Zerhouni follows:]
PREPARED STATEMENT OF ELIAS ZERHOUNI
Madam Chairwoman and Members of the Subcommittee,
I am Dr. Elias Zerhouni, the Director of the National Institutes of Health. Thank you for the opportunity to appear before you today to discuss NIH's role in biodefense and public-private research partnerships. Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), whose institute has the lead responsibility for biodefense research, also is here today and will provide you with details on our current plans regarding this important area of homeland security.
As you know, last week the President announced plans for the creation of a Department of Homeland Security. This Department would be responsible for several distinct capabilities and institutions that focus on specific elements of this mission. The Department would unify much of the Federal Government's efforts to develop and implement scientific and technological countermeasures to chemical, biological, radiological, and nuclear (CBRN) terrorist threats. The Department would also provide direction and establish priorities for national research and development, for related tests and evaluations, and for the development and procurement of new technology and equipment to counter the CBRN threat. The Department would incorporate and focus the intellectual energy and extensive capacity of several important scientific institutions, including NIH and other Department of Health and Human Services (DHHS) agencies, Lawrence Livermore National Laboratory (currently part of the Department of Energy) and the Plum Island Animal Disease Center (Department of Agriculture).
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The Department would unify our defenses against human, animal, and plant diseases that could be used as terrorist weapons. The Department would sponsor outside research, development, and testing to invent new vaccines, antidotes, diagnostics, and therapies against biological and chemical warfare agents; to recognize, identify, and confirm the occurrence of an attach; and to minimize the morbidity and mortality caused by any biological or chemical agent. We will be working with the Administration on the development of this overall plan.
Biodefense research at NIH began long before the spate of anthrax cases that shook the Nation last year. NIH has been working collaboratively with other Federal agencies, including the Department of Defense and the Office of Homeland Security, and also with our non-governmental partners, in conducting basic research and vaccine development regarding agents that potentially could be used as weapons of bioterrorism. NIH also works closely with state and local officials as part of an overall strategy of national biodefense. The President's budget request for Fiscal Year 2003, which includes $1.75 billion for NIH biodefense, will enable us to expand our ongoing activities in such areas as basic research, comparative genomics, diagnostics, and vaccine and therapeutics development. It also includes funds for the construction of additional biosafety laboratories to ensure that all Americans—especially our local neighbors—will not be exposed to unnecessary risks resulting from biodefense research.
Incidentally, NIH also was involved in regional efforts to respond to anthrax attacks last fall. A detailed assessment of the fatal cases of inhalation anthrax that occurred in two District of Columbia postal workers was conducted by an NIH Clinical Center researcher, in collaboration with physicians in Maryland and Washington, D.C. The results were published in the Journal of the American Medical Association, and were presented so that physicians would know what to look for when diagnosing suspected anthrax patients. The study was conducted in collaboration with the Johns Hopkins Center for Civilian Biodefense Studies, physicians at the Greater Southeast and Southern Maryland Hospitals, and the Washington, D.C. and Maryland Medical Examiners Offices.
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Following the September 11 events, the National Institute of Environmental Health Sciences (NIEHS), through its Worker Training Program, prepared rescue and recovery personnel who would be working amidst the rubble at the World Trade Center site. We also sent NIH medical personnel to the site to provide assistance during the rescue period.
The NIEHS is funding six training grants and six research grants to address immediate and long-term worker and community health protections arising from the World Trade Center attacks. A total of $6 million will support education and training efforts, including training new and current hazardous material teams for the New York City Fire Department, environmental remediation workers, site cleanup workers and hazardous material teams that respond to weapons of mass destruction. In addition, a total of $4.5 million will support research organizations' efforts to conduct exposure assessment, epidemiology, and community outreach in the Lower Manhattan area. One of the recipient organizations collaborating with NIH is the Johns Hopkins University in Baltimore, which will develop a registry of the estimated 3,000 to 4,000 workers involved in cleanup at the World Trade Center site, for study by questionnaire and function tests, and to conduct outreach to the workers.
The NIH is also conducting research to explore the ways in which the September 11 attacks affected substance abuse issues and mental health. A recent study funded by the National Institute of Drug Abuse (NIDA), and reported in the June 1 issue of the American Journal of Epidemiology, found that smoking and alcohol and marijuana use increased among residents of Manhattan during the five to eight weeks after the terrorist attacks on the World Trade Center. Conducted by researchers at the New York Academy of Medicine, the survey showed that almost one third of the nearly 1000 people interviewed reported an increased use of alcohol, marijuana, or cigarettes following the September 11 attacks.
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In April, the National Institute of Mental Health (NIMH) awarded new grants for research on mental health needs resulting from the September 11 attacks. NIMH funded these studies through its Rapid Assessment Post Impact of Disaster (RAPID) grants program, which solicits and expedites pilot projects. As an example of the research funded under this program, one of the projects will include a survey of the New York metropolitan area to determine what effects the 9/11 attacks have had on symptoms, mental disorders and use of mental health services. In another project, researchers will assess post-traumatic stress disorder (PTSD) in clinicians who treated survivors of the attacks. Knowledge gleaned from these new grants will help us address mental health consequences of future disasters and reduce suffering.
NIH also serves on HHS Secretary Tommy Thompson's recently established Council on Private Sector Initiatives to Improve Security, Safety, and Quality of Health Care. This Council was established to provide a fair, systematic and consistent system to handle requests from individuals and firms seeking review of their innovative ideas and products and to encourage strong collaborations between government and industry. NIH officials have met with a number of private sector individuals and companies about their ideas and products related to biodefense to provide technical assistance and to make them aware of funding opportunities. These are but a few ways in which the NIH continues to respond to the challenges and potential threats to the Nation's citizenry.
Dr. Fauci will elaborate on NIH's biodefense research portfolio.
As you requested, I am also here to testify about NIH's collaborations with the private sector. These collaborations are particularly important today, for we stand on the threshold of the most exciting and promising era of biomedical research in history. Over the next decade, we can expect to see exponential growth in our understanding of human disease and ways of minimizing, and in some cases eliminating, human suffering from a variety of vexing diseases. Collaboration has never been more important to our success. Progress will depend on being able to assemble multidisciplinary teams of scientists, cross-cutting initiatives, and public-private partnerships.
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NIH is actively pursuing research partnerships and collaborations across the world. And some of our most valuable partners are and will be right here in Montgomery County.
I want you to know about one example of these partnerships, which happens to involve biodefense research. On May 9, 2002, the NIAID announced the results of research that completed the genetic comparison of two important isolates of the anthrax bacterium: the well-known Ames strain and an isolate from the recent Florida anthrax attacks. The study was conducted by scientists at The Institute for Genomic Research (TIGR), based in Montgomery County, as well as researchers from Northern Arizona University. NIAID partnered with the Office of Naval Research, the National Science Foundation, and other agencies to fund the research. The study demonstrates how a new technology—whole-genome sequencing—and computational methods can successfully analyze anthrax and other bacterial outbreaks, both naturally-occurring and planned releases. These techniques will enable researchers to more accurately trace the origin of individual bacterial strains, determine if those strains have been genetically modified, and assess differences in their ability to cause disease or resist antibiotics.
To build on this research, the NIAID has awarded additional funding to TIGR, in collaboration with Northern Arizona University, for an expanded, comprehensive genomic analysis of at least 14 B. anthracis strains and closely related bacteria. This success is one of the early fruits of the six-year, $25 million contract NIAID entered into last year with TIGR to establish a functional genomics resource center. With NIAID support, scientists from TIGR and other institutions have already finished sequencing the DNA of many pathogens, including those that can cause tuberculosis, cholera, chlamydial infections and syphillis. The Pathogen Functional Genomics Resource Center at TIGR will continue to be a valuable central training and resource facility supporting research on pathogens.
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Another local example of NIH partnerships with the private sector is the $58 million in awards to sequence the genome of the rat to Celera Genomics, located in Montgomery County, and Baylor School of Medicine, made jointly by the National Human Genome Research Institute (NHGRI), and the National Heart, Lung and Blood Institute (NHLBI) in 2001.
The rat genome sequence will further accelerate genomic-based research leading to improved understanding of how human genes work. The scientists involved in this project are using a strategy that combines elements of a hierarchical shotgun, or map-based approach, and a whole-genome-shotgun approach.
Data from the project will be released weekly into public databases at the National Center for Biotechnology Information. Scientists from TIGR are also collaborating in this effort.
Partnerships between NIH and the private sector often involve transfers of technologies from our intramural research laboratories to commercial companies for further research and development. Such transfers involve the creation of new therapeutic drugs and vaccines, diagnostics, and research resources to assist the research enterprise in developing new products to improve public health. The NIH is one of the premier biotechnology transfer operations in the world and generates approximately 70 percent of the royalty income from the entire Federal Government.
Of the nearly 1,500 currently active licenses the NIH administers, 77 are with firms in Montgomery County, Maryland. These firms include the following: GenVec, Inc., AlbaPharm, EntreMed, MedImmune, 20/20 Gene Systems, OmniViral Therapeutics, Genetic Therapy, Inc., RegeneRx Biopharmaceuticals, Veritas, Invitrogen, BioReliance Corporation, and Intracel Corp.
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Currently, technologies developed in NIH laboratories are a part of over 200 products on the market, including 15 therapeutic drugs and vaccines. Two of those therapeutic drugs are produced and distributed by MedImmune, Inc., a firm headquartered in Montgomery County.
One of the drugs is Synagis, a monoclonal antibody used for the prevention and treatment of serious lower respiratory tract disease by respiratory syncytial virus (RSV). RSV is the most common cause of pneumonia and bronchiolitis in infancy and early childhood. Synagis is the world's first monoclonal antibody licensed by the FDA for any infectious disease.
The other drug is NeuTrexin, a treatment used to treat infections in AIDS patients that do not respond well to standard therapy.
The NIH also has a number of public-private partnerships through the Cooperative Research and Development Agreement (CRADA) mechanism. The purpose of a CRADA is to make government facilities, intellectual property, and expertise available for collaborative interactions to further the development of scientific and technological knowledge into useful, marketable products. Currently we have 274 active CRADA projects active at the NIH. Of those active CRADAs, 25 are with Maryland companies, including several with components located in Montgomery County: EntreMed, Novavax, Gene Logic, Human Genome Sciences and MedImmune, to name a few. Partnerships and mechanisms such as those I have mentioned also will prove useful in our efforts related to biodefense.
This concludes my statement, Madame Chairwoman. I will be pleased to answer any questions you may have.
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BIOGRAPHY FOR ELIAS ZERHOUNI
On May 2, 2002, Dr. Elias Zerhouni was confirmed by the U.S. Senate to be the 15th Director of the National Institutes of Health.
Elias Adam Zerhouni, M.D., 51, was most recently executive vice dean of Johns Hopkins University School of Medicine, chair of the Russell H. Morgan department of radiology and radiological science, and Martin Donner professor of radiology and professor of biomedical engineering. Before that, he was vice dean for research at Johns Hopkins. Since 2000, he has been a member of the National Academy of Sciences' Institute of Medicine. He has served on the National Cancer Institute's board of scientific advisors since 1998. In 1988, he was a consultant of the World Health Organization, and in 1985 he was a consultant to the White House under President Ronald Reagan.
During his tenure at Johns Hopkins, Dr. Zerhouni developed a comprehensive strategic Plan for research and helped reorganize the school's academic leadership. He also led efforts to restructure the school of medicine's clinical practice association. Working with elected officials, Dr. Zerhouni planned a major biotechnology research park and urban revitalization project near the Johns Hopkins medical campus. He also helped obtain for Johns Hopkins researchers such resources as the university's first microarray core facility, a center on informatics. Recently, he led a successful effort to establish the Institute for Cell Engineering at Johns Hopkins, to take advantage of the emerging fields of proteomics and stem cell research.
Before leaving Johns Hopkins, Dr. Zerhouni was a principal investigator on three NIH grants and co-investigator on two others. He has authored or co-authored 157 publications and 11 book chapters. He also holds, singularly and jointly, a total of eight patents. His research accomplishments include developing computed tomography densitometry techniques that can determine whether nodules found on the lung are benign or malignant. He developed a method of high resolution CT for both anatomic and physiologic studies of the lungs. He also pioneered a way of assessing heart function via magnetic resonance imaging (MRI). As Chair of Radiology at Johns Hopkins, he established with community radiologists a company specializing in the delivery of outpatient, high-tech imaging services that subsequently was acquired by the American Radiology Services Corporation. Another company he helped establish, Surgi-Vision, Inc., has licensed novel, image-guided clinical technology from his laboratories. While at Johns Hopkins he also engaged in a collaborative effort with General Electric to develop innovative high-speed MRI technology.
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Dr. Zerhouni was born in Nedroma, Algeria, one of eight children. He came to the United States at age 24, having earned his medical degree at the University of Algiers School of Medicine in 1975. He completed his residency in diagnostic radiology at Johns Hopkins in 1978 as chief resident. He was made assistant professor there in 1979 and associate professor in 1985. Between 1981 and 1985 he worked in the department of radiology at Eastern Virginia Medical School and its affiliated DePaul Hospital. Dr. Zerhouni was appointed director of the MRI division at Johns Hopkins in 1988, was appointed full professor in 1992 and then became chairman of the radiology department in January 1996. He became a naturalized United States citizen in 1990.
Dr. Zerhouni is married to Nadia Azza, a pediatrician and medical school classmate whom he met when both qualified for the Algerian national swimming team during high school. The couple has three children: Will, 25, is a second-year student at Harvard Law School; Yasmin, 22, recently finished her undergraduate work at Columbia University and will pursue a Master's degree in education at Columbia; and Adam, 16, attends the Severn School in Severna Park, Maryland. Fluent in English, French and Arabic, and conversant in German, Dr. Zerhouni plays lute and piano and shares an enthusiasm for opera, tennis, and scuba diving with his wife.
Ms. MORELLA. Thank you very much, Dr. Zerhouni. You know, that buzzer—I didn't do that. That is—Montgomery County Council has that programmed, which is the five-minute warning. So I may not adhere to it that closely, but just so that you know. Dr. Bement.
STATEMENT OF DR. ARDEN L. BEMENT, JR., DIRECTOR, NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY
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Dr. BEMENT. Chairwoman Morella and Representative Barcia, thank you for this opportunity to testify today about the contributions of NIST to strengthen Homeland Security. First of all, I would like to thank Ms. Morella for her tireless support of NIST programs. We at NIST agree wholeheartedly that the description of Representative Morella as the Angel of NIST.
First, let me address our response to the September 11th attack. NIST responded immediately, and not only to the attack but to the October anthrax bioterrorism, in many different ways. NIST Building and Fire Research Laboratory experts joined teams of scientists and engineers studying how the Pentagon and the World Trade Center buildings failed in the attacks. NIST participated in preliminary investigations of the cause of the collapse of the World Trade Center buildings with FEMA and many other partners. NIST, as the Committee is well aware, is preparing to lead a more detailed investigation of the disaster to learn how existing and future buildings could be made safer against possible future attacks and natural disasters.
To help identify victims of the World Trade Center and Pentagon attacks, the Armed Forces Institute of Pathology used NIST measurements to test new DNA analysis techniques to identify attack victims who would not otherwise have been identified due to small fragmented sample size.
After the anthrax attacks, NIST worked with the Armed Forces Radiobiology Research Institute and the U.S. Postal Service to ensure that commercial radiation facilities could effectively sterilize U.S. mail contaminated with anthrax.
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I also want to tell you about some of NIST's ongoing work to strengthen Homeland Security. Many of these efforts are in close coordination with Federal agencies. In the future, as we expand these efforts, we, in turn, plan to expand our relationship with agencies like the NIH and the President's proposed Department of Homeland Security in order to ensure the proper coordination. NIST's Office of Law Enforcement Standards, or OLES, works with Federal agencies, industry, and the emergency responder community to develop performance standards for such things as communication equipment, body armor, and hazardous materials suits. OLES standards help protect emergency responders and enable them to do their jobs more effectively.
NIST is working with the Transportation Security Administration to develop measurements and standards to ensure the effectiveness of new technologies to detect potential explosives at airports and other public places.
Additionally, NIST is developing a Quality Assurance/Proficiency Assessment program for the Chemical Counter-Terrorism Laboratory Network. This program would ensure that laboratories needed during a chemical weapons attack would be able to analyze urine and blood samples to determine what agents were used, who was exposed, and how much exposure occurred.
Besides NIST's tradition responsibilities for developing standards and guidelines to protect sensitive information in non-classified Federal computer systems, recent laws enacted since September 11 have mandated NIST's assistance in the development of a national biometric identification system. This system will be used to identify people entering the United States who are applying for visas. NIST is working to develop the necessary standards and test to certify the performance of this new national system.
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NIST is also preparing for the future of cyber security through its world class programs in quantum computing. Quantum mechanics provides an entirely new and uniquely powerful way for computing and communications, potentially, replacing the current binary computing and digital communications procedure, and thus, having enormous potential impacts in Homeland Security. Chairwoman Morella, I want to thank you and other members of the Science Committee for your efforts in helping NIST secure funding for the Advanced Measurements Laboratory in Gaithersburg. This $235 million state of the art laboratory facility will greatly assist NIST in our efforts to turn quantum information from a research idea into real applications in cyber security and communications.
Now, I would like to touch on local emergency preparedness. NIST's support of Homeland Security also extends to interactions with local agencies. NIST emergency responders train regularly with Montgomery County fire, police, and county emergency management personnel. NIST also monitors and responds to mutual aid calls using the county fire frequency. I believe in 2001 we responded 300 times. NIST works closely with Montgomery County emergency management on many different issues. To cite just a couple of examples, NIST is a member of the Montgomery County Local Emergency Preparedness Council and chairs its Federal Installations Committee, which includes all the Federal installations within Montgomery County. NIST has also been a member of the Montgomery County Chem-Bio Task Force since its inception, and assists with County preparedness against chemical and biological terrorism.
The examples I have cited today demonstrate NIST's commitment to support Homeland Security, and many more examples are included in my written testimony. This concludes my prepared remarks, and I would be pleased to answer your questions.
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[The prepared statement of Dr. Bement follows:]
PREPARED STATEMENT OF ARDEN L. BEMENT, JR.
Representative Morella and Representative Barcia thank you for this opportunity to testify today about the contributions of the National Institute of Standards and Technology (NIST) to strengthen homeland security. I would like to tell you about some of the many ways NIST works closely with people, companies, and organizations across the Nation and here in Montgomery County to help protect our nation against terrorism.
A strong economy and a strong technology base are the Nation's greatest resources to protect our homeland. NIST has the unique mission of providing the measurements and standards that the private sector, universities, and government agencies need to develop new technologies, to create new products and services, to conduct research, and to effectively carry out their responsibilities. NIST measurements and standards and our cost-shared support of new technologies enable new homeland security technologies to be developed and effectively used, and help strengthen our economy in general.
Like other government and private sector organizations, NIST increased its focus on homeland security after September 11 and the October anthrax attacks. But NIST has a long and productive history of supporting national security since our founding in 1901 as the National Bureau of Standards. Our measurements and standards provided crucial support for the development of radar, nuclear weapons, aircraft instruments, and other key technologies that helped the U.S. succeed in past conflicts. And now NIST provides support for technologies to help win the war on terrorism and protect our homeland.
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In addition to our long-standing support of national security, NIST responded to the immediate aftermath of last fall's terrorist attacks, and NIST is supporting the technologies that will help prevent or minimize future threats. We conduct all our work in close cooperation with partners in industry, universities, federal and local governments, and other organizations, including many here in Montgomery County. I want to share some examples with you.
Initial September 11 Attack Response
NIST responded immediately to the September 11 attacks and October anthrax bioterrorism in many different ways.
NIST building and fire experts joined teams of scientists and engineers studying how the Pentagon and World Trade Center buildings failed in the attacks, laying the groundwork to learn lessons that could help save lives in future attacks or natural disasters. NIST experts presented a report to the U.S. Army Corps of Engineers in November, 2001 of recommendations for rebuilding and retrofitting the Pentagon that would improve the Pentagon's resistance to similar attacks. In New York, teams of search and rescue robots that had been tested on a special NIST urban rescue course penetrated areas too small and too hazardous for emergency responders and located full and partial remains of several victims at the World Trade Center site. NIST served as the technical coordinator for the Law Enforcement Panel for a conference on ''Protecting Emergency Responders: Lessons Learned from Terrorist Attacks.'' This conference helped emergency responders learn how to better protect themselves and more effectively do their jobs in disasters such as the Pentagon and World Trade Center attacks.
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After the World Trade Center towers survived the initial aircraft impacts, the engineering community was stunned that the towers and other nearby steel frame buildings collapsed due to the effects of fire—that had never happened before to such buildings. NIST participated in preliminary investigations of the cause of the collapses of the World Trade Center buildings with the Federal Emergency Management Agency (FEMA) and many other partners. And NIST is preparing to lead a more detailed investigation of the disaster to learn how existing and future buildings can be made safer against possible future attacks and natural disasters.
To help identify victims of the World Trade Center and Pentagon attacks, the Armed Forces Institute of Pathology used NIST measurements to test new DNA analysis techniques to identify attack victims that would not otherwise have been identified due to small sample size.
After the October bioterrorist attacks, NIST worked with federal agencies and the private sector to ensure that commercial radiation facilities could effectively sterilize U.S. mail contaminated with anthrax. NIST has been working in a task force with the Armed Forces Radiobiology Research Institute in Bethesda, the U.S. Postal Service, and other agencies to solve this challenging problem. NIST worked closely with Postal Service workers from the Firstfield Post Office and the Suburban Postal Facility in Gaithersburg to assemble test boxes of mail for use in certifying that commercial radiation facilities could effectively kill anthrax in real samples of mail. The support of the local postal workers and officials was crucial to the rapid federal response to the anthrax crisis.
When the Hart Senate Office Building in Washington was contaminated with anthrax, NIST experts in ventilation systems and air quality modeled the different ways air flow in the building may have disseminated the anthrax spores. These models helped the Environmental Protection Agency plan the decontamination of the building.
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NIST provided much additional support in the immediate aftermath of the attacks. I also want to tell you about some of NIST's ongoing work to strengthen homeland security.
Chemical, Biological, Radiological, Nuclear, and Explosive (CBRNE) Threats
NIST measurements and standards help the Nation detect chemical, biological, radiological, nuclear and explosive (CBRNE) threats and prepare to respond to a possible CBRNE attack. The NIST Office of Law Enforcement Standards (OLES) works with federal agencies to evaluate technologies used by the emergency responder and criminal justice communities. OLES works with industry and the emergency responder community to develop communications standards to help emergency responders from different communities and agencies work together effectively at a disaster site. OLES standards help protect emergency responders and enable them to do their jobs more effectively by certifying the performance of protective gear such as body armor and hazardous materials suits. After the attacks, NIST accelerated development of a series of Emergency First Responder Equipment Guides, in conjunction with the National Institute of Justice (NIJ). NIST also accelerated work with the National Institute for Occupational Safety and Health (NIOSH), and the U.S. Army Soldier Biological and Chemical Command (SBCCOM) to develop the standard for Self Contained Breathing Apparatus to protect emergency responders.
NIST is working with the Transportation Security Administration to develop measurements and standards to ensure the effectiveness of new technologies to detect potential explosives at airports and other public places. NIST collaborates with Canada, Mexico, Russia, and some developing countries on radiation measurements and detectors to help safeguard dangerous materials that could be used to make nuclear weapons or ''dirty bombs.'' NIST is developing measurements to determine the geographical source of nuclear materials and analyze urine specimens of suspected terrorists to reveal if they have been working with nuclear weapons materials.
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NIST is developing a Quality Assurance/Proficiency Assessment program for the ''Chemical Counter-Terrorism Laboratory Network,'' which will initially be comprised of the state public health laboratories of Virginia, New York, New Mexico, California, and Michigan, as well as the Centers for Disease Control and Prevention (CDC). This program would ensure that laboratories needed during a chemical weapons attack would be able to analyze urine and blood samples to determine what agents were used, who was exposed, and how much exposure occurred.
Cybersecurity
With information technology such a crucial part of our economy, national security, and critical infrastructures, we are vulnerable to cyber attacks as well as physical attacks. NIST has strong and diverse cyber security programs that are an increasingly important part of homeland security.
More than 20 million people enter the U.S. each year, and there is currently no way to effectively, accurately, and quickly verify the identity of visitors and visa applicants. Federal laws enacted since September 11 mandate the development of a national biometric identification system, using unique physical characteristics such as fingerprints, facial features, and eye patterns to identify people entering the U.S. or applying for visas. The law recognizes that many biometric identification technologies exist, but that standards and tests are needed to ensure that a nationwide system can accurately identify individuals and communicate key information throughout the system. The law requires NIST to work with other federal agencies to develop the standards and tests that will certify the performance of the national system.
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Keeping sensitive information secure is a crucial part of cyber security. NIST works with industry to develop and certify security tools such as the Advanced Encryption Standard for encoding sensitive information. NIST operates a Cryptographic Module Validation Program (CMVP) to ensure that software to encode information meets national standards. All tests under the CMVP are conducted by third-party laboratories accredited by NIST's National Voluntary Laboratory Accreditation Program.
Utilities increasingly use information technology to control complex distribution networks and monitor the performance of the system. Electric power, water supplies, gas pipelines, and other utility systems are thus vulnerable to cyber attack. NIST is working with PEPCO, the Fairfax County Water Authority, and the American Gas Association (AGA) headquartered in Washington, D.C., and other utilities and organizations to develop cyber security requirements.
NIST co-hosts with the Small business Administration and FBI regional computer security workshops especially designed for small businesses and not-for-profit organizations. Workshop participants explore practical tools and techniques that can help them identify computer security needs and implement the right security solutions we will be holding the next workshop July 11 in Washington, D.C. In addition, NIST has developed a diagnostic tool that small-to-medium sized businesses can use to evaluate the security of their information systems.
NIST is also preparing for the future of cyber security through its world-class programs in quantum computing and quantum communications. Quantum mechanics, the strange behavior of matter on the atomic scale, provides an entirely new and uniquely powerful way for computing and communications, potentially replacing the current binary computing and digital communications based on ones and zeros, and having enormous potential impacts in homeland security. A quantum computer using just 300 atoms could simultaneously store more than 1080 numbers (1 followed by 80 zeros), which is larger than the total number of atoms in the universe. This enormous computational power would be particularly valuable in cryptography, making codes that are unbreakable by today's best supercomputers, or breaking codes in seconds that couldn't be cracked in years by the most powerful binary computers. Quantum information can also be used for perfectly secure communications, where the act of eavesdropping immediately alerts the other parties that the communication has been intercepted. NIST teams led by its two Nobel Prize winning scientists are working with other agencies to develop the science, measurements, and standards needed to turn quantum information from a research idea into real applications in cyber security and communications.
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Local Emergency Preparedness
NIST has a significant police force and fire/rescue service at its Gaithersburg campus. NIST emergency responders train regularly with Montgomery County fire, police, and county emergency management personnel. NIST also monitors and responds to mutual aid calls using the county fire frequency and is leading a project to transition the county frequency to 800 MHz. NIST responded to more than 300 mutual aid calls during 2001, of which two were potential anthrax incidents and one was a HAZMAT response to a mercury incident. NIST police and county law enforcement personnel share appropriate information about criminal activities.
NIST works closely with Montgomery County emergency management on many different issues. For example,
NIST is a member of the Montgomery County Local Emergency Preparedness Council (LEPC), and Chair of the Federal Installations Committee (FIC) for the LEPC. (FIC includes all the federal installations within Montgomery County)
NIST is involved with Montgomery County planning for a test of the Emergency Operations Center to be held in February, 2003.
Montgomery County Fire and Rescue Service Chief Ted Jarboe is a NIST guest researcher and is a co-author on a soon-to-be released NIST Special Publication entitled ''Aid for Decontamination of Fire and Rescue Service Protective Clothing and Equipment After Chemical, Biological, and Radiological Exposures'' and on ''Aid for Fire and Rescue Service Operations Associated with Chemical, Biological, and Radiological Environments.''
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Montgomery County Fire and Rescue Service Captain Robert Vettori works part-time at NIST in the fire program on his off duty hours.
Montgomery County fire chiefs and other officials attend NIST's Ionizing Radiation Safety Committee meeting where they are briefed on the radiation sciences work at NIST and the safety and training programs available for staff and emergency personnel.
NIST has also been a member of the Montgomery County Chem/Bio Task Force since its inception and assists with county preparedness against chemical and biological terrorism.
These examples demonstrate NIST's commitment to homeland security, across the Nation and in the local community. They also demonstrate the base upon which NIST hopes to build an enhanced effort to support homeland security. It is an absolutely critical national need, and it is a fundamental element of our strategic plan.
I am grateful to Mrs. Morella for holding this hearing, and for her long support of NIST's programs.
This concludes my prepared remarks. I will be pleased to answer your questions.
BIOGRAPHY FOR ARDEN L. BEMENT, JR.
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Arden L. Bement, Jr., was sworn in as the 12th director of NIST on Dec. 7, 2001. Bement oversees an agency with an annual budget of about $819 million and an onsite research and administrative staff of about 3,000, complemented by a NIST-sponsored network of 2,000 locally managed manufacturing and business specialists serving smaller manufacturers across the United States. Prior to his appointment as NIST director, Bement served as the David A. Ross Distinguished Professor of Nuclear Engineering and head of the School of Nuclear Engineering at Purdue University. He has held appointments at Purdue University in the schools of Nuclear Engineering, Materials Engineering, and Electrical and Computer Engineering, as well as a courtesy appointment in the Krannert School of Management. He was director of the Midwest Superconductivity Consortium and the Consortium for the Intelligent Management of the Electrical Power Grid.
Bement came to his position as NIST director well versed in the workings of the agency, having previously served as head of the Visiting Committee on Advanced Technology, the agency's primary private-sector policy adviser; as head of the advisory committee for NIST's Advanced Technology Program; and on the Board of Overseers for the Malcolm Baldrige National Quality Award.
Bement joined the Purdue faculty in 1992 after a 39-year career in industry, government, and academia. These positions included: Vice President of Technical Resources and of Science and Technology for TRW Inc. (1980–1992); Deputy Under Secretary of Defense for Research and Engineering (1979–1980); Director, Office of Materials Science, DARPA (1976–1979); Professor of Nuclear Materials, MIT (1970–1976); Manager, Fuels and Materials Department and the Metallurgy Research Department, Battelle Northwest Laboratories (1965–1970); and senior research associate, General Electric Co. (1954–1965).
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Along with his NIST advisory roles, Bement served as a member of the U.S. National Science Board, the governing board for the National Science Foundation, from 1989 to 1995. He also chaired the Commission for Engineering and Technical Studies and the National Materials Advisory Board of the National Research Council; was a member of the Space Station Utilization Advisory Subcommittee and the Commercialization and Technology Advisory Committee for NASA; and consulted for the Department of Energy's Argonne National Laboratory and Idaho Nuclear Energy and Environmental Laboratory.
He has been a director of Keithley Instruments Inc. and the Lord Corp. and was a member of the Science and Technology Advisory Committee for the Howmet Corp. (a division of ALCOA).
Bement holds an Engineer of Metallurgy degree from the Colorado School of Mines, a Master's degree in metallurgical engineering from the University of Idaho, a doctorate degree in metallurgical engineering from the University of Michigan, an honorary doctorate degree in engineering from Cleveland State University, and an honorary doctorate degree in science from Case Western Reserve University. He is a member of the U.S. National Academy of Engineering.
Ms. MORELLA. Thank you very much, Dr. Bement. I would like all of you to know that your full testimony is given to the Subcommittee. It will be included in the official record, so I appreciate the fact that you have been giving us a synopsis of it. Dr. Fauci, pleased to recognize you, sir.
STATEMENT OF DR. ANTHONY S. FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF HEALTH
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Dr. FAUCI. Thank you very much, Ms. Morella, Mr. Barcia. I appreciate the opportunity to appear before this Committee, and I want to again thank you, as our relationship over the years has been wonderful with regard to your support of the National Institutes of Health. Thank you very much for that.
I am going to spend just a few minutes going over some of the activities, as well as the plans, at the NIH, vis-à-vis our biodefense research efforts. On this poster right here, it brings up a point that I think needs to be understood regarding the scope of the effort and the complexity of the effort of the NIH, and that is the difference between biowarfare and bioterrorism. The military is responsible for defense against biowarfare, which in many respects is really rather limited because of the strategic and tactical endpoints of warfare, as well as the relative homogenate of the population they need to protect. The National Institutes of Health is responsible for biodefense and protection of the civilian population, which is not just healthy men and women between the ages of 18 and 50-ish, but actually, children, the elderly, pregnant women, people on medications, people with underlying illnesses. So for that reason, our mission is by definition more complex.
With regard to the agents that we are directing our efforts at, you will hear the terminology ''Category A.'' We came up with that; we, being the biomedical research, as well as the public health community, based on probability and extent of impact of agents that might be used in bioterrorism. And as you can see on this slide, up there is smallpox, anthrax, plague, botulism, tularemia, and what we call the hemorrhagic fevers, including Ebola. There are programs that have been going on anti-dating September 11, and as Dr. Zerhouni mentioned, the initiatives and the activities at the National Institutes of Health and funded by our grantees and contractors included these agents long before September the 11th, so we already hit the ground running on these.
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We are all aware now that the President's budget for the Fiscal Year 2003 includes a rather large increase for the National Institutes of Health with regard to our biodefense, and this has to do with a number of different components, as shown here from the basic research and development, which is the matrix of everything we do at NIH, to the specific milestones of drugs, vaccines, and diagnostics, to the clinical research that will prove or disprove the safety and efficacy, as well as to research facilities which are important to us not only for the safety of the researches, but as Dr. Zerhouni pointed out, for the safety of the community in which the research takes place.
This particular slide shows something that is available to everyone on the NIH/NIAID website. It is our strategic plan for biodefense research as well as our research agenda. So as in all things that we try to do at the NIH, it is transparent, so anyone can click onto our website and get a very good feel of what our plans and our research agenda is. This just schematically diagrams some of that. It is, again, always emphasizing it is founded on basic research; particularly, again, as Dr. Zerhouni mentioned, the genomics study of the sequences and the functional genomics of microbes, such as smallpox and anthrax; the definable endpoints of anti-microbials, vaccines, and diagnostics; and again, the expansion of research facilities, not only for our researchers here at the NIH and in Frederick, Maryland, but for the extramural community that will be undertaking some of these research projects.
We have partnerships in our biodefense research. We know now with the activities that have taken place last week, that the center of that gravity is going to be the Office of Homeland Security. The Department of Health and Human Services is responsible for that slice of the pie which is biodefense and bioterrorism, whereas the Office of Homeland Security includes everything from intelligence now, to border security, to airline security, etcetera. We will be, as part of the Department of Health and Human Services, interacting with a variety of other government agencies, including Agriculture, Defense, Energy, and importantly, our industrial partners. And this is very important, because much of what we do with regards to vaccines, and diagnostics, and therapeutics must be done in collaboration as we have historically done at the NIH with industry.
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The next slide shows how within the Department the NIH fits in. We are responsible for the basic research and the development of interventions. The Centers for Disease Control is what we call the first responders, the surveillants, physicians, and epidemiologists who go out into the field to determine just what has happened, what the extent of it is, as we supply the matrix for the basic research that allows a true biodefense effort.
Our accomplishments, I must say, have really, I believe, been rather striking from the time that we have initiated this. You have probably read about some of this in the newspapers with regard to smallpox. At the time that the September 11th event occurred and the anthrax, the President asked us at the NIH and at the CDC, what happens if we have a smallpox attack. We only had 15 million doses. In a very rapid series of studies conducted at the NIH, and by our extramural grantees, we showed that, in fact, we could dilute that 1 to 5, to now have 75–77 million doses, as well as the purchase of additional couple of hundred. We are working on a new second generation anthrax vaccine as well as some very important advances in understanding not only the pathogenesis but trials for a Phase I vaccine trial for Ebola.
And finally, on this last slide, I want to emphasize something that we have been emphasizing for a very long period of time, and this is emerging and reemerging infectious diseases, whether they are naturally occurring or whether they are deliberately released, really form part of a broad arena that the NIH has been involved with for decades, just as we are concerned by flu pandemics, which had an extraordinary impact on society. The 1918 epidemic, there were 25 million people died; 750,000 in the United States. We are all very familiar with the terrible scourge of the HIV epidemic, with already now 23 million people dead worldwide and 40 million people infected. We will do the biodefense work, be it with anthrax, smallpox, tularemia, hemorrhagic fever, in the same context that we do naturally emerging disease. Do the best possible basic science, and from that, have applications that can be used to protect our populations.
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I will stop there, Ms. Morella, and I would be happy to answer any questions with the rest of the panel.
[The prepared statement of Dr. Fauci follows:]
PREPARED STATEMENT OF ANTHONY S. FAUCI
The September 11, 2001, attacks on the World Trade Center and Pentagon changed forever our collective thinking with regard to the Nation's vulnerability to terrorist attacks. Superimposed on the events of September 11 were the first recorded cases of anthrax in the United States to result from an intentional human act. In addition to the tragic human toll of the anthrax attacks, the fear and disruption that they engendered were extraordinary, as were the associated economic costs.
The threat of bioterrorism has been addressed for years in the research portfolios of civilian agencies such as the National Institutes of Health (NlH), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), as well as by the Department of Defense (DOD). Indeed, research on emerging and re-emerging diseases in general, including pathogens that could be intentionally released into human populations, has accelerated in recent years. However, the anthrax attacks of 2001 revealed significant gaps in our overall preparedness against bioterrorism, giving a new sense of urgency to biodefense efforts. In addition, recent revelations of massive, covert bioweapons programs in the former Soviet Union (where tons of deadly agents were stockpiled) and elsewhere underscore the need to significantly and rapidly bolster our ability to protect our citizens from anthrax, smallpox and other potential bioterror threats.
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BIODEFENSE AND HOMELAND SECURITY
Homeland defense is a multifaceted endeavor, of which biodefense is a critical component. Our nation's ability to detect and counter bioterrorism depends to a large degree on the information generated by biomedical research on pathogenic microbes and the host response to these microbes; much of this research is supported by the NIH. The role of NIH biodefense research is to develop the tools necessary to protect civilians from potential agents of bioterrorism; this effort complements the long and successful history of the DOD in developing interventions to protect our troops against biological warfare. The threat of a bioterrorist attack against civilians differs in several ways from biowarfare directed at military personnel. Civilian populations are more vulnerable to such attacks because of their diversity with regard to age and health status. Civilians, unlike military personnel, generally will not have received vaccines to prevent infections with microbes that may be used as bioweapons. Moreover, the range of pathogenic microbes that might be used in a bioterrorist attack on civilians is much broader than what might be effectively used against the military. As we learned in the anthrax incidents of 2001, a bioterror attack against civilians is likely to be sudden and unexpected, requiring rapid diagnostics and therapies. While the NIH and DOD have a long-standing history of fruitful collaboration, these agencies have somewhat unique roles to play in the biodefense effort. In this regard, we feel a special responsibility to the public, who look to the NIH as the backbone of civilian biodefense through its biomedical research programs.
You have heard from Dr. Zerhouni about the President's proposal for a Department of Homeland Security to unify much of the Federal Government's efforts to develop and implement scientific and technological countermeasures to chemical, biological, radiological, and nuclear threats. The NIAID looks forward to working closely with the Administration as overall plans for this new department are implemented.
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IMMEDIATE NIH RESPONSES TO BIOTERRORISM
Since the fall of 2001, the NIH has moved quickly to accelerate basic and clinical research related to the prevention, diagnosis and treatment of diseases caused by potential agents of bioterrorism. These efforts have focused on the ''Category A'' agents considered by CDC to be the worst bioterror threats. These agents include the viruses that cause smallpox and hemorrhagic fevers such as Ebola; the bacteria that cause anthrax, plague, and tularemia; and botulinum toxin, as well as the many other pathogens that could potentially be used by bioterrorists. Category A agents cause high death rates or serious illness, are relatively easy to spread, and could cause panic or require special steps for public health preparedness. In the weeks and months following the first anthrax case in Florida, the NIH:
Accelerated the development of a ''new generation'' bio-engineered anthrax vaccine based on a portion of the anthrax bacterium known as protective antigen;
Conducted a study to show that existing stocks of smallpox vaccine could be diluted at least 5-fold, providing an immediate ''cushion'' of vaccine protection in case of a smallpox attack;
Expanded the genomic sequencing of the anthrax bacterium to include analysis of more than 15 strains, allowing the so-called Ames strain and the strain found at the site of the initial anthrax cases in Florida to be compared. The sequencing of the Florida strain was funded by the National Science Foundation;
Accelerated screening of antiviral compounds for activity against smallpox and related viruses;
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Announced two pivotal studies, one that explains how the toxins of the anthrax bacterium destroys cells, and a second that demonstrated novel approaches to blocking the toxins;
Accelerated development of a promising Ebola virus vaccine developed by researchers at the Dale and Better Bumpers Vaccine Research Center of the National Institute of Allergy and Infectious Diseases (NIAID); and
Launched seven new fiscal year 2002 initiatives to expedite biodefense research (see http://www.niaid.nih.gov/newsroom/releases/accelbio.htm)
The response from the scientific community to the FY 2002 biodefense initiatives has been extraordinary; almost 700 proposals have been received. The outpouring of interest from concerned academic and industrial scientists, many of them leaders in their fields, has been unprecedented.
For fiscal year 2003, the President has proposed a $1.75 billion budget in biodefense research funding for NIH, which will enable the NIAID and other NIH institutes to expand ongoing projects and establish new initiatives as part of a comprehensive and sustained biodefense research program. We recently announced new opportunities for biodefense and emerging infectious diseases research as well as training and career development opportunities. Soon, we plan to announce 18 more biodefense research initiatives that focus on the research priorities delineated below. Of particular note are the planned renovation and construction of biosafety level (BSL)–3 and BSL–4 facilities and the proposed funding of regional Centers of Excellence for Biodefense and Emerging Diseases Research. The Centers of Excellence for Biodefense and Emerging Diseases will not only provide state-of-the-science research capacity, but also will link to CDC and state and local health departments to provide permanent, regional expertise on agents of bioterror and other emerging and re-emerging diseases.
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THE NIH BIODEFENSE RESEARCH AGENDA
As the lead agency at NIH for infectious diseases and immunology research, NIAID has developed a Strategic Plan for Biodefense Research, as well as a detailed Biodefense Research Agenda for CDC Category A Agents, with short-, intermediate-, and long-term goals. These documents can be found on the NIAID WWW site at http://www.niaid.nih.gov/dmid/bioterrorism. As part of the strategic planning process for our biodefense research agenda, the NIAID brought together many of the Nation's top experts for a Blue Ribbon Panel on Bioterrorism and its Implications for Medical Research. The panel comprised researchers from academic medical centers, private industry as well representatives from government and civilian agencies and the military. Participants were selected for their scientific expertise on the infectious agents considered to be major bioterror threats and on the host responses to pathogenic microbes, as well as for their scientific leadership and broad research experience.
The Strategic Plan and Research Agenda stress two over-arching and complementary components: basic research into agents with bioterrorism potential and the specific and non-specific host defense mechanisms against those agents; and applied research with pre-determined milestones for the development of new or improved diagnostics, vaccines and therapies. We focus on research in six key areas:
Microbial Biology. Research into the basic biology and disease-causing mechanisms of pathogens underpins all our efforts to develop interventions against agents of bioterrorism. NIAID supports extensive research to better understand the factors that influence the virulence and invasiveness of pathogens, as well as those that determine antibiotic resistance. An important new tool in understanding any microbe is our ability to rapidly obtain microbial genome sequence information, including that of potential bioterror agents. Many such agents, including smallpox and related viruses, already have been sequenced. Others are in the process of being sequenced, including multiple strains of the anthrax bacterium Bacillus anthracis, as well as the bacteria that cause, plague, botulism, Q fever, brucellosis and glanders. Coupled with recent advances in biochemistry, microbiology, and immunology, genomic information contributes greatly to efforts to develop new or improved diagnostic tests, therapies and vaccines for major bioterror threats. In particular, comparative genomics (comparing the sequences of different strains of particular organisms) will be an important component of future research, helping us to understand what makes a particular organism either harmful or benign.
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Host Response to Microbes. In order to develop safe and effective vaccines, accurate diagnostics, and immunotherapeutics against microbes that may be used as bioterrorist agents, research has been accelerated to improve our understanding of the complex parameters of two components of the human immune system: innate and adaptive immunity. Because most potential bioterror agents would infect via the respiratory or oral routes, special attention is being paid to studies of mucosal immunity at these sites.
Vaccines. NIAID has bolstered research efforts on vaccines against many of the infectious agents considered to be bioterrorist threats, with an eye toward producing products that are safe and effective in civilian populations of varying ages and health status. As noted above, a clinical trial at several NIAID Vaccine and Treatment Evaluation Units (VTEUs) has demonstrated that the existing U.S. supply of smallpox vaccine—15.4 million doses—could successfully be diluted at least five-fold and retain its potency, effectively expanding the number of individuals who could potentially be vaccinated against smallpox (see http://www.niaid.nih.gov/newsroom/releases/smallpox.htm). In addition, the ongoing production of a ''second-generation'' smallpox vaccine produced in cell culture will increase our supply to approximately 286 million doses by the end of 2002. Moreover, the U.S. Department of Health and Human Services recently announced that it will be receiving more than 75 million additional doses of smallpox vaccine that has been stored by a pharmaceutical company since 1972; this additional vaccine supply will be tested for safety and immunogenicity by NIAID. In the long-term, basic research promises to provide a third generation of smallpox vaccines that could be used in all segments of the population, including pregnant women and people with weakened immune systems. One such vaccine nearing phase I clinical trials is based on a virus called Modified vaccinia virus Ankara (MVA), which is related to the current smallpox vaccine strain, but may cause fewer adverse reactions.
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Additional bioterrorism vaccines also are in development. As noted above, a new anthrax vaccine, based on a bioengineered component of the anthrax bacterium called recombinant protective antigen (rPA), will soon enter human trials. On the NIH campus, researchers at the NIAID Dale and Betty Bumpers Vaccine Research Center have developed a DNA vaccine that protected monkeys from infection with Ebola virus, and that will soon be tested in human volunteers.
Therapeutics. To provide the capability of treating victims of a bioterrorist attack, NIH supports the development and clinical testing of therapeutics for the diseases that result from such attacks. NIH research goals include identifying several drugs for each agent of bioterror; developing ''broad-spectrum'' medicines that are effective against multiple agents; and designing new drugs for known and potentially drug-resistant microbes. This research involves the development of new antimicrobials and antitoxins, as well as the screening of existing antimicrobial agents to determine whether they have activity against potential bioterror agents. For example, in collaboration with DOD and with support from CDC, NIAID has rigorously screened more than 500 antiviral drugs against smallpox-related viruses. One of these agents is an antiviral drug called cidofovir, which is approved by the Food and Drug Administration (FDA) for treating certain AIDS-related viral infections. Both intravenous and oral versions of cidofovir have shown potent activity against smallpox and/or related viruses in test tube studies and in animal models. NIAID has taken the lead in developing a protocol that would allow cidofovir to be used in emergency situations for the treatment of smallpox.
Concurrently, other potential anti-smallpox agents are being investigated, and several promising leads will be further tested. The recently established Orthopoxvirus Genomics and Bioinformatics Resource Center, a collaborative project of NIAID, the Defense Advanced Research Projects Agency (DARPA), CDC, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and the American Type Culture Collection, promises to accelerate the development of new treatments—as well as vaccines—by providing sequence and functional comparisons of viral genes that will yield targets for the design of antivirals and vaccines.
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Together with the FDA, CDC, and DOD, NIH has accelerated testing of promising new anthrax therapies. As mentioned above, NIAID-supported investigators recently published two studies in the scientific journal Nature that help to explain how anthrax toxin destroys cells. In one study, researchers identified the site on the cell that binds the anthrax toxin and have developed a compound that may disable it. Another group of investigators has characterized the structure of a major component of the anthrax toxin. The information gained through these studies will likely hasten the development of new drugs to treat anthrax.
Diagnostics. An unusual upturn in cases of a disease, or a disease outbreak, likely will be the first sign of a bioterrorist attack. It is critically important to rapidly identify the microbe in the people who have become ill or in the environment where they work and live. NIAID supports research to develop ways to identify natural and bioengineered microbes, and to quickly establish a microbe's sensitivity to drug therapy.
Research Resources. Basic research and the development of new vaccines, therapeutics, and diagnostics depend on the availability of specialized research resources, such as genomics/proteomics information, appropriate animal models, standardized reagents, and high-containment laboratory facilities. As noted above, NIH plans to establish regional Centers of Excellence for Biodefense and Emerging Diseases Research, develop centralized research reagent repositories, and expand the number of BSL–3 and BSL–4 facilities necessary to work with the most dangerous pathogens.
In addition to physical resources, NIAID will recruit and train the best and the brightest individuals at various levels to execute the research agenda.
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SPIN-OFFS OF BIOTERRORISM RESEARCH FOR OTHER DISEASES
We anticipate that the large investment in biodefense research will have many positive ''spin-offs,'' similar to the manner in which HIV/AIDS research has advanced the understanding and treatment of many other diseases. NIH research on microbial biology and on the pathogenesis of organisms with bioterror potential will almost certainly lead to an enhanced understanding of other more common and naturally occurring infectious diseases that afflict people here and abroad. In particular, the advancement of knowledge should have enormous positive impact on our ability to diagnose, treat and prevent major diseases such as malaria, tuberculosis, HIV/AIDS, and a spectrum of emerging and re-emerging diseases such as West Nile fever, dengue, influenza, and multi-drug resistant microbes. The NIH biodefense research program also will greatly enhance our understanding of the molecular and cellular mechanisms of the innate immune system and its relationship to the adaptive immune system. This clearly will help in the search for new ways to treat and prevent a variety of immune-mediated diseases such as systemic lupus erythematosus, rheumatoid arthritis and other auto-immune diseases. In addition, new insights into the mechanisms of regulation of the human immune system will have positive spin-offs for diseases such as cancer, immune-mediated neurological diseases, allergic and hypersensitivity diseases, as well as for the prevention of rejection transplanted organs.
CONCLUSION
In recent months, NIH has made substantial progress in the biodefense research effort; however, much remains to be accomplished. Our experience with HIV/AIDS and the many life-saving advances that have resulted from NIH-sponsored HIV/AIDS research provides a model or paradigm of what can be accomplished with proper commitment to biodefense research. Building on the investments the President has requested, we fully expect that our scientists will develop the tools of diagnosis, treatment and prevention that will allow us to respond effectively to, and likely deter, future bioterrorist attacks on our citizens.
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BIOGRAPHY FOR ANTHONY S. FAUCI
Dr. Anthony S. Fauci, a native of Brooklyn, New York, received his M.D. degree from Cornell University Medical College in 1966. He then completed an internship and residency at The New York Hospital-Cornell Medical Center. In 1968, Dr. Fauci came to the National Institutes of Health (NIH) as a clinical associate in the Laboratory of Clinical Investigation (LCI) at the National Institute of Allergy and Infectious Diseases (NIAID). In 1974, he became Head of the Clinical Physiology Section, LCI, and in 1980 was appointed Chief of the Laboratory of Immunoregulation, a position he still holds. Dr. Fauci became Director of NIAID in 1984.
Dr. Fauci has made many contributions to basic and clinical research on the pathogenesis and treatment of immune-mediated diseases. He has pioneered the field of human immunoregulation by making a number of basic scientific observations that serve as the basis for current understanding of the regulation of the human immune response. In addition, Dr. Fauci is widely recognized for delineating the precise mechanisms whereby immunosuppressive agents modulate the human immune response. He has developed effective therapies for formerly fatal diseases such as polyarteritis nodosa, Wegener's granulomatosis, and lymphomatoid granulomatosis. A 1985 Stanford University Arthritis Center Survey of the American Rheumatism Association membership ranked the work of Dr. Fauci on the treatment of polyarteritis nodosa and Wegener's granulomatosis as one of the most important advances in patient management in rheumatology over the previous 20 years.
Dr. Fauci has made seminal contributions to the understanding of how the AIDS virus destroys the body's defenses leading to its susceptibility to deadly infections. He has also delineated the mechanisms of induction of HIV expression by endogenous cytokines. Furthermore, he has been instrumental in developing strategies for the therapy and immune reconstitution of patients with this serious disease, as well as for a vaccine to prevent HIV infection. He continues to devote much of his research time to identifying the nature of the immunopathogenic mechanisms of HIV infection and the scope of the body's immune responses to the AIDS retrovirus.
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In 1995, an Institute for Scientific information study indicated that in the period of 1981–1994, among more than 1 million scientists throughout the world who published during that time frame, Dr. Fauci was the fifth most cited. Through the years, Dr. Fauci has served as Visiting Professor at major medical centers throughout the country. He has delivered many major lectureships all over the world and is the recipient of numerous prestigious awards for his scientific accomplishments, including 22 honorary doctorate degrees from universities in the United States and abroad.
Dr. Fauci is a member of the National Academy of Sciences, the American Philosophical Society, the Institute of Medicine of the National Academy of Sciences (Council Member), the American Academy of Arts and Sciences, and the Royal Danish Academy of Science and Letters, as well as a number of other professional societies including the American College of Physicians, the American Society for Clinical Investigation, the Association of American Physicians, the Infectious Diseases Society of America, and the American Academy of Allergy Asthma and Immunology. He serves on the editorial boards of many scientific journals; as an editor of Harrison's Principles of Internal Medicine; and as author, coauthor, or editor of more than 1,000 scientific publications, including several textbooks.
Discussion
Ms. MORELLA. Thank you. I would like to recognize the fact that we have been joined by Roscoe Bartlett, our Congressman from the neighboring area, which includes Frederick, which is the Energy Subcommittee of the Science Committee. He is not on this specific Subcommittee, but I invited him to join us and I am pleased he is here. If you would like to make any comments, Congressman Bartlett?
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Mr. BARTLETT. Thank you very much. I am pleased to be here and apologize for being late. We had a briefing in Frederick on the current drought situation. Our district still has as its major industry farming, and we have in Frederick County a larger percentage of our people on well and septic than any other county in the state, I think, and so this drought situation was of a lot of interest to our people and the press, and the meeting went longer than I anticipated. I am sorry to have been late, but very pleased to be here.
Ms. MORELLA. Thank you, Congressman Bartlett. I know, Dr. Fauci, you have a 1:00 appointment, and we wanted to try to get you out as quickly as we could so——
Dr. FAUCI. I appreciate that, but if the discussion gets hot and heavy, I will push it off.
Ms. MORELLA. Be careful when you say that. Actually, I am just going to start off with a kind of a hot and heavy question. Would you mind if I begin to direct a few questions to Dr. Fauci first, and then get into——
Dr. BEMENT. Absolutely.
Ms. MORELLA. All right. In your testimony—and you gave us a pretty extensive testimony, which is part of the record, and I found very interesting—you mentioned the construction of the additional BSL4 laboratories, and you kind of alluded to the need for such laboratories. It is my understanding that you currently have a dormant one at NIH, and I wondered if there are any proposals on the table to begin using that facility?
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Dr. FAUCI. The issue is the following, Ms. Morella. We have a BSL–4, that is a very specific BSL–4 that had been used for the study of multiple drug resistant tuberculosis. That is not what we are talking about, about the BSL–4. What is of relevance and, I believe, interest to you, and the Committee, and Montgomery County, is two buildings. One is a BSL–3, which is not a BSL–4 building, which we are calling Building B, which is planned to be constructed on the NIH campus. And it is a building in which will do research as we have in others, and there are a number of BSL–3s around. That is on the campus. The BSL–4 that you are referring to is one that we are going to in some respects partner with our colleagues in the Department of Defense, and we have discussed this in some detail with Congressman Bartlett at a meeting in his office, and we have had subsequent to that, Congressman, meetings with the surgeon general, General Peak, as well as Martinez Lopez, General Martinez Lopez of the Fort Dietrich facility, to try and fashion the construction of that BSL–4 in a way that truly synergizes with the efforts that are going on in the Department of Defense. So those are the two major facilities.
We will also be supporting, Ms. Morella, extramural construction. That will be fundamentally BSL–3, and perhaps some BSL–4. When I say extramural, I mean we are putting together a program of regional centers for biodefense and emerging diseases based on applications of people applying, so we can't tell you where they will be but, hopefully, they will be regionally represented and they will contain some BSL–3, and occasionally, a BSL–4. So as I mentioned on the slide, that is part of the entire effort is doing the appropriate facilities to be able to do the research that we are talking about.
Ms. MORELLA. Another question, Dr. Fauci. There seems to be some concern and maybe some disagreement within the scientific community about the feasibility of the development of vaccines against Class A agents and the appropriateness of their use in the general population. I wonder if you could comment on the state of the science in that regard, as well as what you think the proper protocols for their use would be.
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Dr. FAUCI. Okay. Let me just briefly give you three representative ones that were on my Category A list: anthrax, smallpox, and Ebola. We have an anthrax vaccine that has been used by the Department of Defense for sometime now. We are working in collaboration with the Department of Defense of making a second generation vaccine, which we call a recombinant and protective antigen, which is a much more refined molecularly based vaccine that would hopefully replace the more crude anthrax vaccine that is used. Anthrax vaccine is not intended for the general use of the population, but only people who might be at higher risk, and that is the reason why the military, particularly, in the Gulf War campaign, vaccinated a significant number of their personnel.
From the standpoint of how we would use it, we would probably use it for people who have to go in and do cleanup, people that might be exposed so much that they would have to be almost on continual antibiotics. Perhaps, if there are events, for example, in our Postal system that we saw then. So that is one.
The other is smallpox. We have a smallpox vaccine. We are expanding the store both by the dilutional study and by procurement of a second generation vaccine. At the NIH, we are working on a vaccine that will be years down the pike that, hopefully, will have few, if any, of the serious toxicities of the currently classically used smallpox vaccine that you and I received likely when we were both children. The policy of vaccination is now under consideration in a group of open fora that have taken place and will be taking place. There will be one on June 15 down in Washington, D.C. at the National Academy of Sciences. At the end of that period of time, the Advisory Committee for Immunization Practices will make a recommendation to the Secretary about what the policy for vaccination of the public is. It is likely that it will be a modification of the present scheme, which would be vaccinating first responders, such as medical personnel, and then considering whether or not to vaccinate others.
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And finally, very briefly, there is some very eloquent work going on now in an Ebola vaccine at the National Institutes of Health, at the Vaccine Research Center, they showed that you could protect monkeys from a challenge with Ebola and we are planning this calendar year to go into a Phase I trial on Ebola vaccine here and in developing nations.
Ms. MORELLA. I know my time has expired and I will defer to my colleagues, but just simply, will you be called on in terms of the Homeland Security Department with regard to how you think it should be structured? Do you expect that you will have a voice in——
Dr. FAUCI. In how the Department will——
Ms. MORELLA. Right.
Dr. FAUCI. I believe that the voice that I will have when we get to the detail, Dr. Zerhouni and I will be asked to comment about how that will impact both ways, vis-à-vis the NIH, because there are things that we do at the NIH that can only be done by us, that are obviously within the broad plans of the Department, and we will be working out how we are going to get the best work done and what the logistics of that would be. So in that respect, we will be called upon.
Ms. MORELLA. Thank you. I would assume so. Mr. Barcia, do you have questions?
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Mr. BARCIA. Thank you, Madam Chair. I will be brief, also, Dr. Fauci. I know that your time is limited with us today. I have one question before you leave, and I want to thank all three panelists for their very insightful and sworn testimony on this issue.
Dr. Fauci, you mentioned that you plan to place on the internet some of the plans and some of the research that you are developing in terms of our response on the web. Do you think if we placed some of that information on the web, that that possibly would assist those who wish to attack us, and at what point would you believe that certain sensitive information should be nonpublic?
Dr. FAUCI. Excellent question that we continually get asked. What is on the web now is a strategic plan for research. I would really like whoever is interested in doing us harm to see that as a possible deterrent. That is the first thing. The information that we get, the NIH has always been—and I see no reason to not continue along that broad philosophical basis—is to be transparent in what we do. So that if we sequence a microbe, to make it available to all researchers so that the good that can be gotten from people having that information to work on the positive aspects, we feel overwhelmingly outweighs the potential negative of someone using that information. Now, we can't say that somewhere in a rare event there may be something that one falls upon that you would not want it to be broad general knowledge, but we are going to labor at the NIH under the assumption that we will keep our policies as they have been.
Again, that is very different from what we know is almost ludicrous, where you put something on the net of how to make a dirty bomb. Certainly, that should not be on the internet. But what we do is, really, to disseminate knowledge so that scie