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 scientists, even those who aren't primarily involved in it, can actually then get interested and add their expertise to it.
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Mr. BARCIA. Thank you.
Ms. MORELLA. Mr. Bartlett.
Mr. BARTLETT. Thank you very much. I wonder if you could spend just a moment letting the audience know how unique a Level 4 containment facility is and how few of them there are in the world?
Dr. FAUCI. Yes. A Level 4 facility is the highest level facility for a microbe. There are very of the in this country. There is one if Fort Dietrich, there is one at the CDC in Atlanta, there is one operational in Texas and one planned in Texas. We are planning two additional ones right now, and those are the two I mentioned. The one that we are going to be partnering with the Department of Defense up at Fort Dietrich to make that a much more enhanced biodefense arena, and one that we are going to be putting in Rocky Mountain Laboratory, which is an NIH facility in Hamilton, Montana. So there is really, literally, only a handful of this high containment facility, which allows you to work with microbes, if done correctly, with essentially no possibility of there being any contamination. Because the way you get into the facility, they have what are called lock rooms, that you can't get into one door without locking the other. All of the negative pressure makes air come in and then get filtered out as opposed to leaking out into the environment. And anything that one uses, be it the clothing you wear, the material that you use, all gets processed in a way that would make contamination impossible. So it is the highest level of containment for protection not only of the researchers but also the people within the environment of the facility.
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Mr. BARTLETT. And worldwide?
Dr. FAUCI. Worldwide, there are just, again, one or two others. There are very, very few.
Mr. BARTLETT. The Soviet Union, now Russia, has——
Dr. FAUCI. The Soviet Union, absolutely, yes.
Mr. BARTLETT. They have been a leader—probably have as much knowledge and experience in this area as we have. I would recommend the book by Ken Alibek, who ran their bioprepared program.
Dr. FAUCI. Yes. It is a very interesting book.
Mr. BARTLETT. It is called Biohazard. If you haven't read the book, it is worth reading. I wonder if you could tell us the difference between communicable and infectious. Some of these diseases, of course, like anthrax, are very infectious, but not communicable, not very communicable. And diseases like smallpox, they are very communicable. Are you familiar with the Dark Winter studies?
Dr. FAUCI. Yes, I am. There is a great deal of similarity and overlap between communicable and infectious, but communicable means it can be communicated from one person to another person. You gave the excellent example that I would have given. Anthrax is an infectious agent. It is infectious. You can get it from a spore, you can get very sick from it, you can die from it, but it is not communicable from one person to another. So all communicable diseases are infectious by the very nature of their ability to be communicable, but not every infectious disease is communicable from one person to another. And the Dark Winter scenario was a scenario that was a mathematical model type of an approach of what would happen if there was a deliberate release of smallpox in the community of Oklahoma, which is the one that they originally did it in, and they projected out what the available responses would be, what would happen in the spread secondary and tertiary from that initial, and it was, as you very well know, was somewhat of a frightening prospect.
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Mr. BARTLETT. Yes. I think that the infection spread to 35 states and 15 countries before it was brought under control, and this is one of the important differences in these agents. Some of them are very infectious, like anthrax. Others are very communicable, like smallpox, and they are really scary. And Ebola, you know, is scary in terms of the individual who has it, but in terms of mass infection, it is not all that scary, but smallpox, one that we are very familiar with, if you are my age, you still carry a scar from the vaccination of smallpox. We are not vaccinated now. We are at pretty high risk for smallpox. We have only what—15 million now for a population of 280 million?
Dr. FAUCI. The dilutional study is bringing that to 77 million, and we have procured to have an additional 155, and Aventis Pasture Company is giving us an additional 75. So by the end of this calendar year, we should have enough to vaccinate everyone if we need to.
Mr. BARTLETT. Now, if we need, to, of course, about one person in a million or so dies from the smallpox vaccination, and a lot of people get sick. Now, when we took them years ago, that wasn't a problem, because if you get smallpox, what—35 percent of the people, roughly, who get it will die. So you are reducing that statistic, but with a death now and then and some illnesses, it is not a problem, but what would be the indicators when we would vaccinate everybody, since if you simply vaccinate everybody now, you would kill about what—300 people in the country and make a bunch of them sick?
Dr. FAUCI. Right. The indication right now, and that is what I had mentioned before, I believe before you came in, is that the CDC recommendation and policy now is what is called a ring vaccination, where if you have an identification of a case here and there, you vaccinate the contacts and the contacts of the contacts. There is a lot of consideration now in open fora throughout the country which will culminate in a June 20th meeting of the Advisory Committee on Immunization Practices to re-look at that and see if there might be some modification of that, where you preemptively vaccinate first responders, such as emergency room personnel, physicians, and nurses, and people in clinics, police, firemen, etcetera, to discuss that, and then to hold in abeyance the decision of mass vaccination. There is very little at this time indication that there will be a preemptive recommendation for universal vaccination. They may come to the possibility of making available for people who understand the risks. That, again, is discussable and will probably come up with a—not probably—will have a recommendation by the end of June. So that is imminent in the next couple of weeks.
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Mr. BARTLETT. Since it is several days after infection before you have any symptoms, and since we have a very mobile society—for instance, if the World Cup, for instance, in South Korea, the agent were released there, how many countries would it be before you knew that it was there?
Dr. FAUCI. It would be a very difficult situation to contain, yes.
Mr. BARTLETT. And the same thing is true in our country of a World Series game or something like that, where people come from all over the country and then disseminate quickly. Yes, a major, major problem. Glad you are there and looking at it. Thank you very much, Madam Chairman.
Ms. MORELLA. Thank you. I want to thank you, Dr. Fauci. We are going to let you go and I do want to thank very much, Dr. Zerhouni and Dr. Bement, for allowing us to question you a little bit first. May we also for all of you have permission to send questions to you that we may not get to for some responses? Thank you very much.
Dr. BEMENT. I would be delighted.
Dr. FAUCI. Thank you very much. I appreciate the opportunity.
Ms. MORELLA. Thank you. Dr. Bement and Dr. Zerhouni, you both direct world class research institutions right here in the County, and I know that your two organizations have collaborated in the past in such areas as Advanced Technology program, the CARB, the Center for Advanced Research in Biotechnology, located on Shady Grove Road, and I just wondered is there anything that can be done to strengthen the NIH and NIST interactions so that your collective resources can be stronger than ever; particularly, now, during our war on terrorism? And I wonder—Dr. Bement, why don't you start off first.
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Dr. BEMENT. Yes. We are very pleased with the longstanding relationship that we have had with the National Institutes of Health through the CARB facility. This includes very important work in laboratory biochemical diagnostics, and protein structures, genomics, and tissue engineering. But also, we have had good collaboration in imaging, computer tomography, radiotherapy, and so forth, which are well within Dr. Zerhouni's field of expertise. In fact, we are already working a joint meeting between the two of us, and I have a long agenda to discuss with Dr. Zerhouni just on the subject of homeland security, but also on other areas where we can couple the strengths of physical science with bioscience to develop whole new paradigms which will also impact homeland security.
Ms. MORELLA. So you have—you already are meeting and continuing to plan further meetings?
Dr. BEMENT. I am meeting with his Director of Extramural Programs, I think this week or next week, and based on that meeting, we are going to set the stage for the two of us meeting.
Ms. MORELLA. Do you have any idea to have you both working together and combining resources, not duplicating, Dr. Zerhouni?
Dr. ZERHOUNI. Well, let me just say that it is actually even more critical, more important than ever, for NIST and NIH to work together. In fact, when you look at the background science, as I mentioned in my opening statement, there is a tremendous convergence between physical sciences that NIST is an expert at, and biological science, as you just heard, we have new technologies that allow us to explore biological systems at a level that is unprecedented. And I think that both NIH and NIST need to work together. As a matter of fact, even without biodefense, but even more so now because of the biodefense emergency that we are facing. There is no question that we are synergistic in many ways, and I am looking forward to, in fact, going to programs that will enhance our response and our capabilities, and I think we can do that, and we will.
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Ms. MORELLA. Dr. Zerhouni, I just wondered do you have any specific information about how any of the institutes at NIH will be restructured under the President's new plan for a Department of Home Land Defense? I know there will probably be some organizational changes. I am curious about, also, how we can best facilitate that process.
Dr. ZERHOUNI. At the present time, we are looking at the consequences of the President's decision. We are trying to be as helpful as we can. As you mentioned, we have been actually asked for our input, both at the departmental level and—NIST is coming to the rescue right there.
Ms. MORELLA. It is a good thing we have our emergency responders here.
Dr. ZERHOUNI. This is his 301st response. He was talking about—we should congratulate you for your——
Ms. MORELLA. She said it is now 301 this year.
Dr. ZERHOUNI. So at this point, there is no firm plan as to exactly whether or not any institute will be restructured. As far as I understand, at this point, we are looking at all the scenarios that could play out in the best interest of biodefense. As Dr. Fauci mentioned, there is a fabric of research that is already existing within NIH and within the extramural community. The universities are funded by NIH that are looking at infectious disease and reemerging infections like tuberculosis and others. The body of science that you need to address those areas of research is exactly the same that you would need for biodefense. So we are looking at the implications of restructuring, if needed. At this point, there is no firm plan that I can comment on at this point.
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Ms. MORELLA. Were you a part of the consultation in making the decision—the decision making?
Dr. ZERHOUNI. I was not part of the consultation in the decision making regarding the Department of Homeland Security, but I am certainly part of the consultation regarding the implications of the formation of the Department.
Ms. MORELLA. As, indeed, you should be. Dr. Zerhouni, when I chaired the Technology Subcommittee with Mr. Barcia as my anchor, Ranking Member, one of my primary issues was to try to work out as best I could technology transfer between agencies like NIH and the private sector. We passed a number of laws that I had introduced during that time to facilitate, and I know that NIH has taken advantage of many of those public-private partnerships. In fact, I think you have an office for technology transfer, and you have mentioned some in your testimony, too. I just wondered, and maybe you haven't had a chance to look into it yet, but are there things that we should be doing to expedite that technology transfer? Is it working well enough? Should the laws be modified to improve the exchange of ideas and technology? I am thinking, particularly, in order to combat terrorism. Should there be like emergency clauses that deal with liability, monopoly issues—if you would like to comment on that—is the system working well?
Dr. ZERHOUNI. Yes. For my prior life at Johns Hopkins, I was actually overseeing the Office of Technology Transfer. I am somewhat familiar with the issues related to technology transfer. The one thing I would like to tell you, first and foremost, is that Congress did an outstanding job over the years in making sure that the technology that is developed through the Federal funding is translated into economic benefits, and I think all the economic studies are showing that, in fact, the biomedical research investment in our country has led to significant transfer of technology. Currently, universities around the country receive significant returns. The NIH itself has been a—is the biggest recipient, actually, of technology transfer returns in the Federal Government, so we are doing something right. However, when you look at the complexity of patenting right now and you look at the potential conflicts that are going to occur in patenting certain key technologies, in the context of patent laws, it could actually have a deleterious effect in not just biodefense but in technology transfer in general. So those are very, very technical areas that I would definitely love to work with Congress and others to try to clarify those rules. An example is the patenting of genetic materials, genes, and to what extent a patent can prevent the development of cures or valuable products downstream is unclear at this point, because the science is evolving at a very high pace, and the patent laws not necessarily predict what applications are going to come out of it. So the big issue, I think, in technology transfer right now are the cross obligations and the cross limitations that occur because of the patenting of very fundamental aspects of biology, and that is an important issue to consider, I think. Biodefense by itself, certainly, we are going to have to accelerate the transfer in the biodefense area, both from the standpoint of market conditions—in other words, encourage private industry to develop products, even though in biodefense itself, since the occurrence, if you will, of events is unpredictable, it is also very difficult for them to predict what market there will be for some of the technology that we will need. That will require a lot of studying, but I am really very interested and very willing to work on that issue.
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Ms. MORELLA. Very appropriate, excellent answer, because things do change, and we need to take a look at that patenting situation and accelerate in biodefense. Dr. Bement, I know my time has expired for this first round, but would you like to just comment on technology transfer as NIST sees it, and do you think it is working okay?
Dr. BEMENT. Yes, Ms. Morella. NIST is primarily involved in infrastructure science and technology, so that the benefits from these technologies are broadly shared across society and industry at large. So in many instances, we do not patent. We report our results in the open literature for that reason. So in some respects, we pay attention not only to technology transfer, but also, technology shaping, because our role is to shape the technology for broad use in industry, and State governments, and also, first responder communities with regard to homeland security. And we do that not only in developing performance standards, but also in developing performance guidelines, and also, convening workshops for training so that these technologies cannot only be used reliably, but also, interoperably and safely. And that is pretty much the thrust of our technology transfer activities.
Ms. MORELLA. All right. Mr. Barcia, I would like to recognize you for any questions.
Mr. BARCIA. Thank you, Chairman Morella. I have one question for Dr. Bement. Well, actually, it is a double question, but it would seem to me that NIST's talents would also—could very well be put to good use in assisting in critical infrastructure protection. And in addition to serving on the Science Committee in Congress, I also serve on the House Committee on Transportation and Infrastructure. And in particular, in helping—do you think that NIST can play a role in helping to devise how to build and maintain a comprehensive assessment of our nation's infrastructure sectors? And that certainly would not be a small task, but nonetheless, it may be one that we may have to face at some point in the future.
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So I have two relatively brief questions. Where do you see NIST fitting into the Department of Homeland Security, and do you believe it would be better for NIST to become a part of the new Department of Homeland Security or only be used as a resource by the new department, should it come to pass?
Dr. BEMENT. Well, thank you for asking that question, Representative Barcia, because NIST, apparently, has activities, Memorandums of Understanding, and joint programs, some of which are funded by almost all the agencies except perhaps the Secret Service, that are identified to go into the Department of Homeland Security. So we are continuing to interface with these departments very carefully as they begin to define their missions. Coming back to your question on transportation, a lot of our work—and I should say that currently we have 100 projects funded at $60 million, 40 of which is appropriated funding, and the other $20 million of which is funded by other agencies—that covers the broad gamut of cyber security, building and fire research, and so forth. A lot of this really does focus on transportation and critical infrastructure protection.
In critical infrastructure protection, we are primarily interested in utilities and have cost cutting arrangements with Fairfax County Water Authority, for example, PEPCO, the American Gas Association, to be sure that their information systems are secure and not subject to intervention. We also work with the Transportation Security Laboratory and Agency with regard to airport security and security of port authorities and other places where cargo, and passengers, and packages, and luggage, and so forth need to be screened, and we set the X-ray standards for that screening. But we are also working on a detector technologies that will also be applicable not only to chemical agents, but biological agents, as well as nuclear materials, and this gets into some very sophisticated detector technology, which includes X-rays, gamma rays, neutron detectors, and so forth.
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And I should add that we are also working with the Department of Agriculture with regard to food imports into this country, which is another area of vulnerability that we have to be very attentive to, and again, looking at ways of irradiating food where there might be bioterrorism involved.
Mr. BARCIA. On the one question I asked on NIST fitting into the Department of Homeland Security, I want to thank you for your response. You don't see any challenges in terms of working closely with the new department or having, perhaps, a more longstanding infrastructure within the department on NIST?
Dr. BEMENT. As you know, Representative Barcia, we already have Memorandums of Understanding with FEMA, for example, for developing a fast response protocol for building and structural disasters. We have interactions with CIAO as far as cyber security is concerned, security sensitive information, and also, for critical infrastructure protection with transportation security, which I have already touched on. But a lot of the work in the proposed Department of Homeland Security is to work with local and State governments to coordinate activities with the Federal Government, and it is there I think that NIST can play a very supportive role, because as you know, we have robust interactions with state and local governments through our standards programs, and so we feel we can assist in the coordinating role, but also, in our normal standards roles with the new department.
Mr. BARCIA. Thank you very much for your testimony.
Ms. MORELLA. Thank you, Mr. Barcia. Mr. Bartlett.
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Mr. BARTLETT. Thank you very much. You mentioned critical infrastructure. It reminded me of a meeting that I sat in, in Vienna, Austria, in '97, I think, during the Kosovo conflict. There were ten other Members of Congress there, and three members of the Russian, and a personal representative of the Solobodan Milosevic. Eight days later, the V8 used the agreement which we developed there to end the Kosovo conflict, but one of the Russians there was Vladimir Lukine, who was the ambassador here at the end of Bush-1 and the beginning of Clinton. He was then the chairman of their international relations, foreign affairs committee, whatever they call that committee. And this is the comment that he made. The Congressman that led the delegation, Curt Wells, and understood Russian, he turned to me while he was making the comment. I had to wait, of course, for the translation. He said, Roscoe, do you hear what he is saying? Well, of course, I heard it, but I didn't understand it. And what he said was, if we really wanted to hurt you with no fear of retaliation, we would launch an SLVM, we would detonate a nuclear weapon high above your country, and we would shut down your power grid and your communications for six months or so. The third ranking Communist, Alexander Shabana, was there, and he smiled and he said, if one weapon wouldn't do it, we have some spares, like about 10,000. What he was referring to, of course, was electromagnetic pulse, which has the capability of disrupting or frying all of our electronics with an attack that looks like a simultaneous lightening strike everywhere in the country all at once. Has your institute at NIST been asked to make an assessment of what our vulnerability is?
Dr. BEMENT. No, sir, not with regard to electromagnet pulse. That is probably a role that would be better performed by Sandia National Laboratory or Los Alamos National Laboratory, where they have done EMP testing for many years.
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Mr. BARTLETT. They are looking at military systems. They aren't looking at our national infrastructure.
Dr. BEMENT. On the other hand, we have in our normal standards work for power systems been very close to that problem but on a smaller scale. I think as far as test facilities, we would not be geared up to do the actual testing, but I think we would certainly understand the size of the problem.
Mr. BARTLETT. Yes. As more of our potential enemies possess nuclear weapons, and this is probably the most asymmetric way they could use a nuclear weapon is simply to deny us the use of all of our high tech equipment. It doesn't hurt the human body, by the way, and it won't damage any building.
Dr. BEMENT. Well, there are many other possible attacks, some of which would be sabotage, including agents that you probably are well familiar with. And also, attacking our frequency standards, that would also affect our grid operations. So the electric power grid, as fragile as it is, it is not quite yet a fully operable national power grid. It is vulnerable in many ways.
Mr. BARTLETT. As you mentioned, the vulnerability of our national power grid, if a major transformer were taken out, it takes between 18 months and two years to get a new one, because there are none on the shelf. You need one and they will make one for you. The power industry has some spares, because there are some of the transformers that are so large that if it failed, a large number of their customers would be out of service. But the spare resides right beside the one that it would replace. So in a terrorist attack or an EMP attack, the spare is really not a spare. It is not on a warehouse shelf somewhere.
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When I first started studying physiology, and in another life I worked at NIH for three years, we were looking at physiology. It started, of course, with anatomy years before that, which is what you could see, and then physiology, how the human body works. And then we recognized that every physiological function was, in fact, a chemical function, and now we are recognizing that every chemical function is, in fact, an exercise in physics. So we are becoming more and more specialized and looking now at physics. And my question is, as we focus more and more on less and less, because every expert now is involved in just a tiny part of one vehicle, do we have people out there who are generalists, who are looking across the whole landscape, who can make sense of all of these many, many discoveries that we are making in these areas where we are learning more and more about less and less? Do we have the generalists anymore?
Dr. ZERHOUNI. Well, first of all, I am always pleased to meet an alumnus of the NIH, as in your case. Actually, you are putting your finger on a very important research strategy question for the country. In fact, the subspecialization that we have seen over the years has really led to a tremendous amount of new areas of research that have evolved. And as you said, it is really going from the scale of anatomy, to physiology, to lower and lower scales, and now we are at the nanotechnology scale, if you will, which is the next frontier. Now, the question you are asking can be asked at three levels. Do we have the generalists when it comes to prevention? The answer is yes. Do we have the generalists when it comes to clinical research, and this is an area of challenge, because you really can't be a generalist as much as we used to when it comes to implementing or translating the research that we do today. It is very complex, very challenging. The third is the question that I think you will relate to as a former physiologist, and that is that we have used the reductionist approach to research science. We have come from the genome to a gene, and then from a gene to a molecule, and our scientists are very well trained in teasing out what happens in a particular pathway. For example, on the surface of ourselves, we have receptors. These receptors are like antennas, a little bit like your communication system, where a molecule will dock on the receptor, which will then send a signal to the cell to do a particular thing. Well, the problem is that we have 200,000 receptors per cell so we don't know what all of them do.
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So it is an important trend, I believe, for the NIH of the future, is to come to what we call systems biology, trying to put together all of these elemental pieces of information into an understandable whole. At that point, at this level, I think we have a lot of work to do. And this is where the generalist is to be recreated, but the generalist we are talking about is the generalist at the molecular level, somebody like a theoretical physicist, for example, like Albert Einstein, who understood relativity, is what we are looking for, young people who have an understanding of systems of biology rather than just the reductional piece of it, and I am sure you can see why that would be very important to do.
Mr. BARTLETT. You mentioned the NIH of the future. When I worked at NIH, all of our institutes were named after the diseases of old men, because that is who voted the money in the Congress. Then they finally recognized there were women and children, so now we have some institutes that are named after problems of women and children, so that is the new NIH. Since one of the major concerns that we face now is bioterrorism or biowarfare, do you think that the NIH of the future may have some organization relative to these threats as well as just focusing on diseases?
Dr. ZERHOUNI. Again, as I think you can imagine, some of these threats that we are talking about in biodefense are very similar to natural threats. You were mentioning communicable and infectious diseases. The best prototype of that is the flu epidemics that we get every year. Those are natural threats and, yet, at some point, unknown to us, we do not understand when or how these pandemics can become very deadly, like in the pandemic in the early—I mean, the late 1910's. So in fact, I don't see where we are going to have in the biodefense area some specialist that have a field of science that is completely different from the rest of biomedical research. However, when it comes to early detection, biosensing, using nanotechnology, having networks of detection, then we have some special work that we can do. For example, I believe that a surveillance system to an electronic network tied up to emergency rooms, to hospitals, to various doctor offices, so that we can detect an unusual event very quickly, is something that I think the country will need for biodefense, as well as for us to know early whether or not an attack has occurred. But I think the basic research is intertwined; it is not separable. It is the same fundamental mechanism that we are looking at.
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Mr. BARTLETT. We would like to believe that the communicable diseases are a thing of the past, but I note that there are strains of tuberculosis now that are really not responsive to antibiotics and we could have a real emergence of the kind of plagues that we lived through. My father lived through the flu epidemic way back in the '40's.
Dr. ZERHOUNI. You are absolutely right. Actually, one of the major events over the past two years for NIH was the development of the vaccine against one of the most common bacteria, staphylococci. Staphylococci is the most common infection that most people get, especially, in hospitals. The problem is it has become resistant. So we have to come up with new strategies, and this new vaccine that was developed by the NIH I think was a real breakthrough.
Mr. BARTLETT. Actually, the big flu epidemic was in the teens, in World War I, when it was a worldwide epidemic and killed—I think one of you mentioned how many people were killed in this country from that. Just in parting, my grandfather was a traveling salesman, and he traveled by train, and he had to carry one suitcase in front of him and the other behind him as he went through the railroad stations because there were so many coffins piled there, people being transported during that flu epidemic. We haven't seen that kind of thing in a couple of generations now, and let us hope we don't see it again. Thank you very much.
Ms. MORELLA. Thank you. I just have one final brief question for Dr. Bement. I know that—and this ties into something you said, Dr. Zerhouni. I know NIST has done an incredible amount of research since September 11 to meet the new security needs of the Nation. I am particularly interested in the sensing technology to detect chemical, biological, and radiological weapons. I say that because my office has had an awful lot of calls from businesses with ideas and with products in those areas. And I just wondered if you could heighten the status of NIST's efforts in this area and what NIST is doing to reach out to the business community, you know, for assistance and whatever.
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Dr. BEMENT. A good bit of what we are doing right now, Ms. Morella, is in that line of trying to identify technologies that can be successfully used by responders through our Office of Law Enforcement Standards and through other laboratories of NIST. And we work very closely with the private sector. We also work very closely with co-development organizations to develop the technical standards, and we work on the performance standards as well. So in real time, we are working on new methods of what I might call highly precise mass spectoscopy, which will detect much lower limits in chemical agents, and microarray technology to detect biological agents, and also, in DNA technology, to not only automate the process beyond what is currently possible, but also to be able to analyze highly damaged DNA, such as we had to cope with in the World Trade Center. As for nuclear technology, we are looking at many new detection techniques, including gamma radiation neutron detection, so that we can cope with nuclear smuggling if we ever have to cope with that. And as far as package analysis, we are looking at new X-ray standards at ports of entry and airports to here, it is a matter of getting a balance between what you can do in terms of sensitivity and what you have to do in order to move people through the airport. That is a decision that has to be made by the port operator or the airlines, but we can certainly identify technologies that will increase the level of sensitivity.
So on all these fronts, we are looking at what industry currently has in existing technology, and helping those who have to do the procurement to understand the technology beyond the trade literature and really understand whether it performs the way it should perform, whether it performs reliably, whether it performs interoperably, and whether it will really meet their performance requirements.
Ms. MORELLA. You have a pretty good relationship with the private community, and do they have an opportunity for input?
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Dr. BEMENT. With industry, yes, indeed.
Ms. MORELLA. Very good. Again, we may be submitting questions if it is all right, but I do want to thank you very, very much for being with us, for sharing your experience, your expertise, and your plans for the future. And we in Congress are here to help in any way we can. I know the community feels that way, also. So thank you, Dr. Zerhouni. Thank you, Dr. Bement, very much.
Dr. BEMENT. You are quite welcome.
Dr. ZERHOUNI. Thank you.
Panel II
Ms. MORELLA. Now, the second panel will come forward. Let me just introduce our second panel of witnesses. Our first group really painted the big picture and gave us an overview of the overall research agenda. And this panel is going to take a more nuts and bolts approach and discuss some of our particular needs and how we are going about addressing them. This panel will be Major Julie Pavlin, who is with us from Walter Reed Army Institute of Research, located in Silver Spring. She serves there as Chief of the Department of Field Services. Major Pavlin has distinguished herself as an outstanding physician in the area of infectious diseases and is an expert on surveillance and detection of infectious outbreak. I am looking forward to your comments, Major Pavlin, on how we can improve our capabilities in this area and thank you for being with us.
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Following her will be Mr. Ed McCallum. He is the Director of Combating Terrorism Technology Support Office. He is at the Department of Defense, and this office is DOD's executive agent for the Interagency Technical Support Working Group, TSWG. It was formed as an R&D program for combating terrorism through rapid development and prototyping with heavy emphasis on utilizing ideas from private enterprises. Previously, Mr. McCallum served as Director of the Office of Safeguards and Security at the Department of Energy, where he managed protection of the U.S. Nuclear Weapons Complex and the national laboratories. Quite a bit of experience, and you are right in the limelight now.
And finally, we have Mr. Robert Malson, who is President of the District of Columbia Hospital Association. In addition to that, the is Chairman of the Washington Metropolitan Council of Government Bioterrorism Task Force. I have had the opportunity to work with Mr. Malson in my capacity as Chair of the District of Columbia Subcommittee. I share his very strong commitment to regional response issues. Mr. Malson is also an expert in emergency coordination among healthcare providers, and I look forward to his testimony on the current status of our situation as it relates to the metropolitan area and Montgomery County.
So I am pleased that you are here. Thank you for your patience in being the second panel, and we look forward to hearing from you. Major Pavlin, I will let you start off.
STATEMENT OF MAJOR JULIE PAVLIN, CHIEF, DEPARTMENT OF FIELD STUDIES, WALTER REED ARMY INSTITUTE OF RESEARCH
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Major PAVLIN. Thank you, ma'am. I am Major Julie Pavlin from the U.S. Army and the Walter Reed Army Institute of Research, and I want to thank Congresswoman Morella and her staff for inviting me to speak today on disease surveillance and response capabilities. I have been working with the Department of Defense in developing new ways to rapidly detect and counter new disease threats, whether they are from naturally occurring or from bioterrorism origins, and I am happy to share my insights and experiences with the Subcommittee.
In light of recent events with both new naturally occurring disease outbreaks and the use of biological agents as a terror weapon in the U.S., we must bolster our disease surveillance capabilities. Surveillance is our fundamental building block in detecting biological threats; again, whether they are from naturally occurring or from deliberately caused sources. Robust effective surveillance systems can allow us to rapidly detect, investigate, and respond to these potential threats, so we can limit casualties, manage public concern, and contain the spread of disease. Unfortunately, most surveillance systems for infectious diseases are passive and rely on people to report, voluntarily report, to the public health system, and they are often not sufficiently sensitive or timely for a rapid response, so we are looking at using traditional and nontraditional sources of available data to track indicators of disease outbreaks in a community.
Some of these data sources use the electronic medical record, such as outpatient diagnostic codes, ordering laboratory tests, reasons for 911, hotline calls, and purchasing over-the-counter medications or other health-related items. Other things you can look at are totally nonmedical sources of data, such as transit uses, the usage of the metro and bus systems, how many people are sick out of school or out of work, or even how much utilities are being used in the home versus the workplace or the school.
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And over the last several years, many agencies have attempted to improve public health capabilities using these different sources of data, and some of them have been remarkably effective and successful in doing so. And some examples include New York City. They were some of the earlier users of these systems, including using the over-the-counter pharmacy sales to detect diarrhea outbreaks since they have a large unprotected water source. They also look at 911 calls and emergency room visits to detect other infectious disease outbreaks.
The University of Pittsburgh has developed a real time system for disease surveillance that monitors outpatient visits, and they deployed this successfully to the Winter Olympics in Salt Lake City. Sandia National Laboratory has a rapid syndrome validation project that collects information from emergency rooms and clinic visits, and we at the Department of Defense Global Emerging Infection System have developed ESSENCE, which stands for the Electronic Surveillance System for the Early Notification of Community based Epidemics. And we work in partnership in what we call now ESSENCE II, and that is with the Johns Hopkins University Applied Physics Lab, George Washington University, Carnegie Mellon University, IBM, and others, to pull together information in the national capitol area here, and to look at that. And right now, we do have a real time operating system here and we are getting information from both military and civilian data sources and sharing that information with the Maryland, D.C., and Virginia Health Departments.
There are other surveillance systems, as I mentioned, up and running. Some of the problems is that sometimes the prime users of the systems—and that is always going to be the health departments—the state and local health departments may be unaware of them, they may not have access to them, they may not know how to use them. And for a variety of other reasons, they may not be totally used as best they can. And it is also important to note that some of these systems still need to undergo validation and evaluation, and it is premature right now to rely on them totally for complete detection capability, but most of them can be useful as adjuncts to more traditional surveillance systems. For example, the Montgomery County Health Department is working with Johns Hopkins APL in their ESSENCE II system to use this new surveillance data in an upcoming public health disaster exercise with local hospitals.
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Regions that don't have improved surveillance capabilities may be able to develop them soon with the recent increase in funds designed for improving public health capacity from the Department of Health and Human Services. It is important that we don't waste a lot of time and resources in reinventing the wheel in each location. There are many groups, both in the Government and outside the Government, that have developed these systems, and their expertise, and their experiences, and sometimes their products should be used as new locations come on line. But it is important to realize that one system can't be developed that is exportable and will work in every geographic region instantly. A lot of the computer programming, the mathematical and statistical work, can be used, but it is important that each geographic region develop a working group that consists of the data holders, because getting access to that data is the most important thing. The public health practitioners in the area that will be using the system, the first responders, and the surveillance developers need to work together to obtain the best and most reliable system for that location.
And there are many examples of public and private partnerships within and among the Department of Defense, CDC, Federal laboratories, universities, private corporations, in developing these systems. ESSENCE II is just one example. Research grants funded by DOD, such as from DARPA, the Defense Advanced Research Projects Agency, and the Defense Threat Reduction Agency highlight this need for public-private partnership and require that advantage is taken of technologies created in other venues. Indeed, as these systems mature, we are working more and more closely together, and we are picking the best and the brightest from each group and each product and using those.
You had asked me to mention the national surveillance system. There actually is no national surveillance system. The CDC is working on the National Electronic Disease Surveillance System to enhance currently existing surveillance systems and bring them together. It will greatly improve our current state of surveillance, but it is important to remember that the state and local governments are the ones that determine the relationships with the local authorities and public health responders, and they do have close working relationships, so we hope that this information will enable them to have better relationships and be able to respond better. And that concludes my prepared remarks and I would be happy to answer any questions following the testimony.
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[The prepared statement of Major Pavlin follows:]
PREPARED STATEMENT OF MAJOR JULIE PAVLIN
Need for Improved Disease Surveillance
We must improve public health capabilities in the United States, and most importantly, the ability to rapidly detect and respond to unusual disease events. Disease surveillance represents a fundamental building block in this quest to detect biological threats—whether naturally occurring or deliberately caused. Robust, effective surveillance enables rapid detection, investigation, and early response to potential threats. These activities are essential to limit casualties, manage public concern, and contain the spread of disease. Surveillance may also be key to proper identification of perpetrators.
Unfortunately, most infectious disease surveillance systems are passive and rely on practitioners voluntarily reporting to the public health system. These surveillance systems are often not sufficiently sensitive when the condition is not reportable or diagnosable with readily available laboratory methods. Even when the diagnostic tests are available, most passive reporting systems are not timely enough to be of great value for outbreak control.
Having a large group of sensitized and astute clinicians is a key component of any surveillance system for the timely detection of biological attack scenarios. Unfortunately, clinical cases often present in a non-specific fashion and they may not be clearly clustered. For this reason, recognition can pose a challenge for even the most astute clinicians. It is thus that epidemiologists, acting as physicians for a community as a whole, must regularly perform the public health equivalent of a physical examination in order to see patterns across communities that might not be evident to the physician seeing individual patients. In light of bioterrorism, the public health practitioner's physical exam, which we call public health surveillance, must take a variety of innovative forms in order to detect any problems earlier. However, public health surveillance is more than a mechanism for mitigating health problems through early detection. Surveillance is also the backbone for action. So even if detected quickly, you still need strong, detailed epidemiological information as fast as possible to cope with the problem.
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It is evident that there are at least three reasons for having improved, innovative surveillance systems for bioterrorism and natural disease outbreaks. The first is to supplement existing, often passive, surveillance by providing ongoing, standardized, flexible and sensitive methods for identifying epidemiologically important disease phenomenon more rapidly.
Beyond early detection, an often under appreciated goal of surveillance is to define detected events in terms of person, place and time so that leaders can target limited response assets needed to take appropriate action. We learned with the recent cases of anthrax that even a very limited number of cases could tax our public health response system. It is critical to have good data, as rapidly as possible, hopefully based on systems proactively put in place, so that we can take limited resources, the limited number of clinicians, epidemiologists, and other experts and laboratory resources and focus them on the real problem.
A third important dimension of disease surveillance acknowledges there are many impacts that go well beyond direct physical health problems. Civic leaders need to have access to epidemiological information upon which to base risk communication messages. It is critical that political leaders maintain credibility in the setting of a biological attack or disease outbreak. Central to that credibility is sound epidemiologic information so they can authoritatively address concerns from the public.
Direction of Current Efforts
In light of these needs, many organizations have been developing new ways to rapidly determine the health status of a community. Collection of useful health data can be done in a variety of ways, including instituting new data collection methods, using previously collected health data in new ways, and using non-traditional sources of data. A combination of many types of data sources will probably provide the most sensitive system.
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The most accurate information is obtained through active surveillance systems that continually query patients, providers or other personnel on new potential and diagnosed cases of disease. While of great use in detecting unusual disease trends, these systems are often labor intensive and not well accepted by those having to provide the information.
However, there are many sources of health data that exist for reasons other than public health surveillance. Many of these serve a logistic or financial purpose. Some examples are outpatient and inpatient diagnostic coding for insurance claims purposes, tallies of hospital admissions or emergency room visits for personnel allocation, or records of pharmacy prescriptions for legal documentation. With the increasing use of an electronic medical record, other information such as laboratory test ordering and results, radiology orders and results, and even vital signs can be retrieved from electronic databases.
In addition, tracking data relating to human behaviors, such as school and work absenteeism, purchasing patterns, and the use of transit and entertainment venues, may provide early warning clues of illness in a population.
When integrated into a system of systems, these new surveillance products should:
1. Facilitate the rapid recognition of a disease outbreak;
2. Improve the speed of data transmission and analysis;
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3. Be capable of integration with other surveillance systems at all levels of government;
4. Provide detailed information to assist with outbreak investigations;
5. Assist in determining site of exposure through geographic information systems (GIS);
6. Assist in providing the most efficient delivery of limited medical countermeasures;
7. Evaluate success of containment and mitigation;
8. Provide historical and trend data for baseline comparisons and long-term monitoring.
Current Surveillance Efforts
Over the last several years, many agencies and municipalities have attempted to improve public health capabilities with novel and innovative approaches to surveillance. Some of these systems have demonstrated remarkable utility in monitoring the health status of communities. Examples of these systems include: New York City's monitoring of over-the-counter pharmacy sales to detect diarrhea outbreaks and using emergency room visits and 911 calls to detect other potential infectious disease outbreaks, the University of Pittsburgh's Real-time Outbreak and Disease Surveillance (RODS), Harvard University's outpatient surveillance, Sandia National Laboratory's Rapid Syndrome Validation Project (RSVP) and the Department of Defense Global Emerging Infections System's (DOD–GEIS) Electronic Surveillance System for the Early Notification of Community-based Epidemics (ESSENCE) and the expansion of this system (ESSENCE II) in partnership with the Johns Hopkins University Applied Physics Laboratory (APL) to include civilian nontraditional data sources in the National Capital Area.
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Currently, many new surveillance systems are in use in particular geographic areas. However, the prime users of these systems, the local and state health departments, may be unaware of the systems, may not have access to them, or may be unfamiliar with how to interpret the information or unwilling to use them for a variety of reasons. In addition, it is important to note that most systems are still undergoing validation and evaluation, and it is premature to rely on them for complete detection capability. However, most can now be useful adjuncts to more traditional surveillance systems. For example, Montgomery County Health Department is working with the Johns Hopkins APL to use the new surveillance data in an upcoming public health disaster exercise with local hospitals.
Regions that do not have improved surveillance capabilities should be able to develop them soon with a recent increase in funds designed for improving public health capacity from the Department of Health and Human Services. However, it is important to not reinvent the wheel and to use the products and experiences of those who have already developed operational systems. Yet, it is important to note that one system cannot be developed that can be exported and work in every geographic region. The main reason is that data sources will be different in other locations, and therefore, cannot be simply entered into a statistical program without overcoming the obstacles of obtaining the data, evaluating its usefulness and then modifying detection algorithms to fit the new sources. While much of the computer programming and mathematical and statistical work that has already been developed can be used anywhere, each geographic region will need to develop a working group consisting of data holders, public health practitioners, responders and surveillance developers to obtain the best and most reliable system for that location. Evidence of successful deployment of a system to another location include the University of Pittsburgh's and Carnegie Mellon's RODS system to Utah during the 2002 Olympics.
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Public and Private Partnerships
There are many examples of public and private partnership within and among the Department of Defense, the CDC, federal laboratories, universities, private corporations and others in developing these systems. ESSENCE II is just one example of military and civilian efforts to coordinate resources and capabilities. In this partnership, military medical data, such as outpatient visits and pharmaceutical usage is being linked with similar data from the civilian sector in the National Capital Area. In addition, Johns Hopkins APL is obtaining some nontraditional data sources such as school absenteeism, over-the-counter sales and animal health data to include into this system.
Research grants funded by such DOD organizations as the Defense Advanced Research Products Agency (DARPA) and the Defense Threat Reduction Agency (DTRA) highlight the need for public/private partnerships and require that advantage is taken of technologies created in various sectors. Indeed, as these systems mature, we are seeing more and more groups joining forces to advance the most productive aspects of each. However, there are still many duplicative efforts in all aspects of government that could benefit from better coordination.
Suggestions for Continuing Development and Deployment of Surveillance Systems
As there are more resources available than ever before to develop improved, innovative surveillance systems, it is important to list some lessons learned during early development.
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1. As already mentioned, there are many pre-existing systems in place or in development. These should be used and improved if available for specific locations, or their experiences and tools used in developing systems for other locations, to prevent wasting of precious public health resources. Similarly, existing databases should be used to the extent possible without creating new data sources that impact already busy healthcare providers.
2. No matter how technically sophisticated, these systems are useless without two important elements: reliable streams of data useful in monitoring health status, and the ability to respond if something is detected. Funds should be available to assist holders of potentially useful data to render them automated and electronic and assist with transferring them to active surveillance systems. Anonymizing privacy act data and protecting commercially sensitive data must also be performed.
3. The health departments need to be given resources so that they can respond to any detected anomalies. Many disease outbreaks are small and historically have never been detected or investigated. If these new surveillance systems are able to detect outbreaks based on early behavioral changes in a population, and the resources do not exist to adequately investigate the increased number of diseases detected since they may be detected before becoming a public health problem, then there is no use in developing or using these systems.
4. The ''customer'' of these systems needs to be involved early and often in their development. The customer in most cases is the local or state health department. They need to determine what the system should provide them and be familiar with its use and interpretation.
5. The systems must be linked to improved diagnostic capabilities to rapidly determine the cause of a detected disease outbreak.
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6. Limitations of the systems must be identified and taken into account during use. In particular, since many of the systems are using non-specific information to track human behaviors, it is impossible to positively identify the causative agent of an outbreak with these systems alone. They should be used to alert health departments to perform a more thorough investigation, and provide them with epidemiologic information to assist in them in their work.
Surveillance Interaction with Local Authorities and First Responders
There is currently no national surveillance system. The Centers for Disease Control and Prevention (CDC) is developing the National Electronic Disease Surveillance System (NEDSS) to improve the management of and enhance currently existing surveillance systems. This will allow public health professionals to more rapidly detect and respond to outbreaks of infectious diseases, whether from natural sources or bioterrorism. It will use standard data formats to electronically link many different surveillance systems. In addition, it will provide a communications infrastructure to allow rapid communication between different public health sectors and provide agreements on data access, sharing and confidentiality. This type of system will greatly improve the current state of surveillance. However, detection of disease outbreaks and determination of the need for further evaluation remains a responsibility of the state and it is up to the individual states to develop interactions with local authorities and first responders. Most state and local health departments do have close working relationships with emergency response personnel and local authorities. The information that these new surveillance systems may provide can assist in strengthening that relationship and allow for more effective communication and advanced warning of needed resources.
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The Need for a National System of Systems
We need a surveillance system that works locally but can share information and be interpreted globally. The ownership and day-to-day monitoring needs to stay at the local level, which is where the response will start and where the data can be best interpreted. However, the data need to be shared across jurisdictions to give state and national epidemiologists a composite view of health status, and also to monitor the spread of infectious disease patterns.
To alleviate privacy and other jurisdictional concerns, shared data should only be accessed by higher authorities for public health purposes. Most often, this would require only aggregate statistical analyses, and there would be little need to share individual patient data beyond the local level.
The Federal Government should take the lead in coordinating many of the independent surveillance system development efforts and facilitate modeling a system that communicates across boundaries. The creation of a National Working Group on Innovative Surveillance Strategies may help to harmonize current efforts and encourage further innovation.
Conclusion
Innovative health indicator surveillance systems represent a critical emerging area of activity because they may offer a more ''real time'' alerting system than traditional disease reporting. Clearly, more work needs to be done to characterize the efficacy of these systems and determine their true capabilities and utility. Many new approaches hold promise, but this is the time to actually evaluate the range of programs now being developed, so that we can better understand what works, what doesn't, and why.
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Current events also require us to ramp up our efforts to better marry disease surveillance activities to the needs, strategies, and methods of the law enforcement and intelligence communities. These communities have different cultures, professional standards and goals, and these issues have hampered planning and practice.
Clearly, effective disease surveillance must also be directly and integrally linked to response mechanisms. Public health authorities must have the capacity to rapidly respond, acting on emerging information, with the full range of necessary tools. These tools include both the legal framework for action and medical care facilities' expertise and treatment capabilities. Effective surveillance must also be linked to emerging knowledge and technologies including new and better diagnostics to swiftly clarify the cause of the disease outbreak and assist in providing the best preventive and treatment options.
BIOGRAPHY FOR MAJOR JULIE PAVLIN
Major Julie Pavlin received a Bachelors degree in 1986 from Cornell University, her MD degree in 1990 from Loyola University and her Masters in Public Health from Harvard University in 1993. She completed a residency in Preventive Medicine and is board certified in General Preventive Medicine and Public Health and also holds the Certificate of Knowledge in Tropical Medicine and Travelers' Health from the American Society of Tropical Medicine and Hygiene. Following residency training, her positions have included: Chief of Epidemiology for U.S. Forces in Korea, Assistant Chief of the Operational Medicine Division at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and currently the Chief, Field Studies Department in the Division of Preventive Medicine at the Walter Reed Army Institute of Research (WRAIR). While at USAMRIID, Major Pavlin was the executive producer of two satellite broadcasts on the response to and medical management of biological casualties. She has published on the epidemiology, recognition and treatment of biological casualties. She currently devotes most of her time designing surveillance systems in support of the DOD Global Emerging Infections Surveillance and Response System. Projects she is working on include innovative real-time health indicator surveillance systems for the early recognition of disease outbreaks and bioterrorism, as well as global influenza surveillance, and specific surveillance projects in Uganda and Uzbekistan.
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Ms. MORELLA. Thank you very much, Major Pavlin. I would now like to recognize Mr. McCallum.
STATEMENT OF MR. EDWARD J. MCCALLUM, DIRECTOR, COMBATING TERRORISM TECHNOLOGY SUPPORT OFFICE, DEPARTMENT OF DEFENSE
Mr. MCCALLUM. Good afternoon, Madam Chairman, Members of the Committee. Thank you for this opportunity to testify about the Technical Support Working Group which you have heard of as the TSWG already today. My name is Ed McCallum, and I am the Director of the DOD's Combating Terrorism Technology Support Office. The CTTSO provides full-time program and business management for the interagency Technical Support Working Group. The TSWG has been operating in the background quietly, funding interagency combating terrorism technology research and development for almost 20 years. However, clearly, in the aftermath of the attacks of September 11, we have garnered much more attention.
In fact, in April 1982, the President directed an interagency task force on combating terrorism to begin interagency coordination of elements. The TSWG was one of the original committees of this organization and, in fact, was recognized by then Vice President George Herbert Walker Bush as the center for development of appropriate counter terrorism technology efforts. Today, the TSWG still performs that combating terrorism technology development function as a standalone interagency organization. TSWG's mission is to conduct a national interagency research and development program for combating terrorism. We also attempt to influence longer term R&D requirements through the coordination of the basic science organizations, many of which you have heard from today, in DITRA and DARPA within the DOD.
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An interesting mission, broad charter, and fairly successful organization over the last few decades, how did we make that work. I would like to show you first a chart. It is displayed so that you can see—and I believe you have it in front of you, also—an interagency matrix organization that really works. The key to this is, as I said, the coordinator for counter terrorism, Ambassador Frank Taylor, provides policy guidance as we continue to operate in the same way over the years, and we are provided executive direction by the Assistant Secretary of Defense for Special Operations and Low Intensity Conflict. My office is the program management office to the right, which reports to SOLIC. The key to that organization is the subworking groups displayed across the bottom. Those are the functional areas which we have over the years defined as combating terrorism. They include both chemical and biological, radiological issues, all the way through personnel protection and surveillance collection and operation support. These are the primary functional areas that the interagency uses to develop and combat terrorism.
As a result of Congressional direction a few years ago, we also formed bilateral R&D efforts with several of our key allies, the UK, Canada, and Israel, and have a number of other relationships that are nonbilateral in nature for information sharing. Now, the subgroups, which I didn't go into detail in because of time, have membership from a broad number of agencies, over 80 with our last review. And in fact, most all of the agencies that are nonmedical in nature that are involved in the President's proposal for a Department of Homeland Security already participate in our various subcommittees and are active participants. So we will be standing by and working with those organizations as they move into the new Homeland Security Department to see whether their priorities change and/or the requirements are refocused.
And I think, primarily, what we wanted to talk to you about today was our business process. This is a very colorful slide, and with just a couple of minutes, I would like to go through our process. If you start at just before 12 on that chart, or just off top left center, the beginning of every year, we have a threat briefing. We bring our 250 to 300 individual scientists, and engineers, and operations people together, and have briefings from the Law Enforcement community and the Intelligence community on what the current threats and projected threat evolutions will be for the next year. The individuals then here in over the next month sit in those subgroups and develop the requirements of their communities. At the end of that, we review those and issue a broad agency announcement for the unclassified portions of those requirements. Those broad agency announcement goes out electronically. We have a complete electronic commerce system, and we solicit input from industry. In the last year, we received over 15,000 submittals from industry academia and the Federal laboratories to respond to the specific requirements developed by these subgroups.
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In our process, we go through three levels, quad chart, later a 12-page white paper, and then finally, final proposals for execution. The key point to the center part of this is that we bring together sponsors or people with money, organizations with money, subject matter experts from academia from the labs or from the Federal community, and users, to ensure that what we bring to the table are our real requirements. I will end my statement at that point and be prepared to answer any questions that you have later. Thank you.
[The prepared statement of Mr. McCallum follows:]
PREPARED STATEMENT OF EDWARD J. MCCALLUM
Introduction
Madam Chairman and Members of the Committee, thank you for this opportunity to testify about the Technical Support Working Group, which you may have heard of as the TISWIG. My name is Ed McCallum and I am the Director of the Department of Defense's Combating Terrorism Technology Support Office (CTTSO). The CTTSO, provides full-time program and business management for the interagency TSWG.
The TSWG has been operating in the background, coordinating and funding DOD and interagency combating terrorism research and development for almost 20 years. However, in the aftermath of the September 11th terrorist attacks, the TSWG has garnered much more attention.
As you know, last week the President announced plans for the creation of a Department of Homeland Security. The proposed Department's organizational units will focus on: Border and Transportation Security; Emergency Preparedness and Response; Chemical, Biological, Radiological and Nuclear Countermeasures; and Information Analysis and Infrastructure Protection. These are areas in which the TSWG has significant experience and expertise. We will be working with the Administration on the critical task of unifying our homeland security functions.
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Before I give you details of our post September 11th activities I would like to give you some background on the TSWG and its process.
TSWG Organization
In April 1982, the President assigned responsibility for the development of overall U.S. policy on terrorism to the Interdepartmental Working Group on Terrorism (IG/T) chaired by the Department of State (DOS). The TSWG was an original subgroup of the IG/T, which later became the Interagency Working Group on Counterterrorism. In its February 1986 report, a cabinet level Task Force on Combating Terrorism led by then Vice President George H.W. Bush cited the TSWG as assuring ''the development of appropriate counterterrorism technological efforts.''
Today, TSWG still performs that counterterrorism technology development function as a stand-alone interagency working group. TSWG's mission is to conduct the national interagency research and development (R&D) program for combating terrorism requirements. It also has commenced efforts to conduct and influence longer-term R&D initiatives and, reflecting the shift to a more offensive strategy in the conduct of the ''War on Terrorism,'' balance its technology and capability development efforts among the four pillars of combating terrorism: intelligence support; counterterrorism; antiterrorism; and consequence management.
TSWG Structure
TSWG operates under the policy oversight of the Department of State's Coordinator for Counterterrorism and the management and technical oversight of the Department of Defense (DOD) Assistant Secretary of Defense for Special Operations and Low-Intensity Conflict (ASD (SO/LIC) ). Participation is open to federal departments and agencies involved in combating terrorism. While the TSWG's funds are derived principally from DOD's Combating Terrorism Technology Support (CTTS) Program, DOS and other departments and agencies contribute additional funds. Other departments and agencies also provide personnel to act as project managers and technical advisors.
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The TSWG assumed an international dimension in FY93. TSWG conducts cooperative R&D with the United Kingdom, Canada, and Israel through separate bilateral agreements.
TSWG membership includes representatives from nearly eighty organizations across the Federal Government. A comprehensive listing of member organizations by subgroup is listed in our published Program Review Book and is also available on our web-site www.tswg.gov. These departments and agencies work together by advancing best practices in combating terrorism, leveraging R&D plans and budgets and sharing limited professional and scientific experience through participation in one or more subgroups. The following is a description of each of the technical subgroups, their mission, and their major focus areas.
Chemical, Biological, Radiological and Nuclear Countermeasures
Mission
Identify and prioritize interagency chemical, biological, radiological, and nuclear combating terrorism requirements and deliver technology solutions for detection, protection, decontamination, containment and mitigation.
The Chemical, Biological, Radiological and Nuclear Countermeasures (CBRNC) Subgroup identifies and prioritizes interagency user requirements for countering the terrorist employment of CBRN materials. The CBRNC Subgroup process identifies multi-agency requirements and technology solutions. The subgroup co-chairs are from the FBI Hazardous Materials Response Unit (HMRU) and the Intelligence Community. They ensure a balanced program that addresses both foreign and domestic CBRN threats. Through its participation in the InterAgency Board (IAB) for Equipment Standardization and interoperability and in coordination with NIJ, FEMA and EPA, the CBRNC Subgroup integrates technology requirements from the fire, hazardous materials, law enforcement, and emergency medical services communities into its process.
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Focus Areas
Subgroup thrust areas cover the full range of CBRN incident prevention and response to improvised CBRN devices and training. During FY 2002, the TSWG CBRNC development efforts include the following areas:
Detection—Improvements in the sampling, collection and detection capabilities, the forensic analysis of toxic industrial chemicals, chemical warfare agents at low doses, and biological warfare agents in food and water.
Protection—Developments that will improve cost and operating performance of personal and building protection equipment to provide users with a small mask that can be donned quickly to escape from the immediate area of a chemical release, protect building occupants from attack and expand protection against toxic industrial chemicals.
Decontamination—Develops capabilities that assist responders in decontamination of large numbers of civilian victims involved in a CBRN incident.
Information Resources—Develops information resources and databases that assist analysts and responders in their roles in preventing, mitigating and responding to CBRN terrorist incidents.
WMD Response Training—Development of an architecture for delivery of military and civilian CBRN Consequence Management training using Advanced Distance Learning media such as web-based, interactive CD–ROM, and virtual reality via the Internet. Training materials are also being developed as part of this focus area.
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Explosives Detection and Defeat
Mission
Identify, prioritize, and execute research and development projects that satisfy interagency requirements to safely and effectively detect and render terrorist improvised threat devices safe. Emphasis is placed on technologies that detect, diagnose, and defeat terrorist improvised explosive devices and large vehicle bombs.
The Explosives Detection and Defeat (ED&D) Subgroup charter is to develop prototype hardware and advanced techniques for detecting, diagnosing, and defeating terrorist threat devices as well as information and training systems that assist first responders to perform threat assessment of terrorist improvised explosive devices (IEDs) and large vehicle bombs (LVBs). These improvements may enhance the operational capabilities of the bomb disposal communities. X-ray diagnostics, IED defeat, next generation robotics, canine explosive detection and training tools are all undergoing advanced development and commercialization.
This group was recently divided into two subgroups, Explosive Detection (ED) and Improvised Device Defeat (IDD). The division provides an improved approach to meet user needs and manage detection requirements. It will help to better achieve TSWG's long-term development goals of detection technology and focus the identification and prioritization of both the detection and defeat requirements. The chair of the ED&D Subgroup, a Federal Aviation Administration (FAA) representative, now chairs the ED Subgroup. Representatives of the FBI Bomb Data Center (BDC) and the Bureau of Alcohol, Tobacco, and Firearms (ATF) co-chair the IDD Subgroup.
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Focus Areas
The ED&D Subgroup focuses on detection, diagnostics, and defeat of explosive devices, with an emphasis on developing robotic capabilities and various tools and equipment for use in these areas. The subgroup also identifies the various materials that may be used by terrorists when building improvised explosive devices.
Detection—Non-intrusive technologies to detect and identify explosives in vehicles, cargo, packages, and on personnel are critical. The subgroup focuses on the following detection applications: standoff detection, short-range detection and diagnostics, marking agents, and canine research. Optical and nuclear-based technologies are being investigated to determine feasibility for standoff detection. Nuclear quadrupole resonance (NQR) is being assessed for personnel screening for bulk explosives. Alternate methods for manufacturing marking agents for plastic explosives are being sought. In addition, research on canine olfaction provides a better understanding of canine detection capabilities and leads to training methods and procedures that optimize canine and handler capabilities.
Diagnostics—Once a suspect package is identified, bomb squad technicians must diagnose the item in order to apply the most effective procedure. The ED&D Subgroup strives to improve the diagnostic capabilities of bomb squads by developing advanced technologies that can be deployed remotely, operate non-intrusively, provide a diagnostic capability in confined spaces, and provide a rapid diagnostic capability for large-area coverage associated with LVBs. One such technology includes the use of a neutron-based probe, which detects and discriminates threat material from non-threat material non-intrusively. The probe provides positive identification of the type of explosive or threat material present, thus allowing the technician to perform the proper procedure on the suspect device.
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Defeat—After detecting and diagnosing an explosive device, bomb squad technicians must render the device safe. Existing tools and tactics must be improved to meet emerging terrorist threats that use sophisticated initiation systems and enhanced explosive mixtures. Outdated techniques could be detrimental for the bomb squad members. Initiatives to provide better precision, longer standoff distance and less energetic disruption are underway.
Explosive Ordnance Disposal Operational Tools—Responding to an IED incident requires detailed coordination and planning by the Bomb Technician On Scene Commander or Officer In Charge (OIC). Proper equipment, personnel, and resources must be identified and coordinated quickly and an operational plan with standard operating procedures put into effect. Operational tools are needed to provide the OIC with quick reference data and information to conduct a threat assessment as well as mission tactics to defeat the threat device. Specialized safety equipment for personnel protection and monitoring, and energetic explosive render safe tool storage, will be developed to support the IED response mission and increase the safety and effectiveness of the explosive ordnance disposal (EOD) and bomb disposal communities in performing their duties.
Remote Controlled Vehicles and Tools—With the increasing diversity and complexity of the terrorist threat, it is vital that the bomb technician conducts as much of the mission as possible remotely. The ED&D Subgroup will focus on improving the performance, affordability, and reliability of robotic platforms. These initiatives will improve the state of the art of robotic technology by developing a next generation EOD remote controlled vehicle that is modular in design, with plug and play common system architecture technology.
Emerging Explosive Threats—Terrorists use a variety of materials and mixtures when building explosive devices. The ED&D Subgroup will continue to investigate these mixtures and materials to determine their performance characteristics. The subgroup will also investigate the development of proper tools, equipment, and procedures for the bomb technician to safely and effectively defeat terrorist devices built from enhanced improvised materials.
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Infrastructure Protection
Mission
Identify, prioritize, and execute research and development projects that satisfy interagency requirements for the protection and assurance of critical Government, public, and private infrastructure systems required to maintain the national and economic security of the United States.
The Infrastructure Protection (IP) Subgroup works to ensure the uninterrupted service of the infrastructure systems that are vital to maintaining the national and economic security of the United States. These critical systems include control systems for electric power, natural gas, petroleum products, and water; telephone, radio, and television communications systems; ground, rail, and air transportation facilities; and cyber communications networks. IP R&D reflects the multivariate threat to the complex and interdependent systems, subsystems, and components of the Nation's infrastructure. Solutions include conventional security measures plus those offered by emerging technologies. Representatives from the Department of Defense and the FBI National Infrastructure Protection Center (NIPC) chair this subgroup.
Focus Areas
The IP Subgroup focus areas reflect the prioritized requirements generated with respect to the critical aspects of the Nation's infrastructure. Efforts this year focus on energy, transportation, telecommunications, water supply, and information systems.
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Physical Protection—Standardized methodologies and decision aids for vulnerability analysis and enhanced protection of critical elements are required to secure the Nation's infrastructure. These include power generation and transmission, water supplies, and health services. By understanding the dynamics of complex critical infrastructure, secure operating methodologies and strategies can be developed to prevent/mitigate widespread failures due to cascading and interactive network effects. Hidden interdependencies are a strong possibility because complex linkages and infrastructure dependencies are poorly documented or understood. This research will evaluate dynamic behavior models of cascading effects, develop common standards and practices in and between critical infrastructures, and investigate system vulnerabilities to various weapons.
Cyber Security—The prevention and mitigation of threats to computer networks is vital to Homeland Security in almost all its facets. Our society increasingly relies upon new information technologies and the Internet to conduct business, manage industrial activities, engage in personal communications, and perform scientific research. The complexity and sophistication of information technologies and their widespread integration increases the likelihood of unforeseen vulnerabilities. Unprecedented opportunities are created for criminals, terrorists, and hostile foreign nation-states to steal money or proprietary data, invade private records, conduct industrial espionage, or cause vital infrastructure elements to cease operations. This research will provide detection, prevention, response, and alert capabilities to counter such attacks and harden computer systems.
Investigative Support and Forensics
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Mission
Identify, prioritize, and execute research and development projects that satisfy interagency requirements for criminal investigation, law enforcement, and forensic technology applications in terrorism-related cases.
The Investigative Support and Forensics (IS&F) Subgroup supports research and development projects intended to provide new capabilities to law enforcement personnel, forensic scientists, and intelligence operatives responsible for investigating and interdicting terrorist incidents. Representatives of the U.S. Secret Service and FBI chair the subgroup.
Focus Areas
Focus areas include digital evidence recovery and analysis, energetic and hazardous materials examination, forensic biology and molecular biochemistry, latent print examination, questioned document examination, and surveillance technology.
Digital Evidence Recovery and Analysis—This focus area develops technology to improve the recovery and analysis of digital evidence (computer media, wireless data, and digital audio or video imagery). The IS&F Subgroup is developing a computer forensics examination system with specially configured hardware and software that can access a target computer drive, catalog the files, and identify known program executables, data files, and system software without alerting the target drive. The subgroup is also validating software tools used to examine electronic evidence and verifying their capabilities and limitations. The results of this validation will be recorded in a nationally accessible law enforcement database. In addition, the subgroup is striving to improve the investigative capabilities associated with pervasive computing (the linking of computer processors, networks, and data repositories with ''smart'' devices such as personal digital assistants and cell phones with wireless modems).
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Energetic and Hazardous Materials Examination—The IS&F Subgroup is developing advanced technologies pertaining to the recovery and detection of explosive residues of explosives in post blast debris. Current projects will develop methods to analyze and interpret difficult post-blast debris where high concentrations of extraneous materials are mixed with the low-level traces of explosive residues. Current projects will also develop improved methods for characterizing improvised explosive devices from macro-effects at post-blast scenes.
Forensic Biology and Molecular Biochemistry—This area focuses on development of techniques for recovering and analyzing DNA on material and surfaces to support forensic investigations and intelligence operations. The objective of evidence source determination is to develop techniques for the rapid analysis of stable isotope ratios at natural abundance levels for forensic applications.
Latent Print Examination—The IS&F Subgroup continues to make significant progress in latent fingerprint recovery methods. Current projects will develop more robust, less expensive, more sensitive, and environmentally-safe physical developers and visualization techniques for fingerprints; provide new technologies involving DNA recovered from fingerprints; determine the genetic basis and statistical significance of specific print features; strengthen the forensic defensibility of latent print evidence; employ digital imaging technologies to examine latent prints; and characterize and understand the chemical content of latent prints.
Questioned Document Examination—The IS&F Subgroup is characterizing the variation within a person's handwriting and proving the uniqueness of each person's handwriting through scientific analysis. The subgroup is also developing an automated system for the forensic examination and identification of suspect handwriting and documents.
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Surveillance Technology—This focus area develops advanced technologies for marking moving or stationary targets with invisible marks that may be imaged remotely, day or night, with ultraviolet or near-infrared image intensifiers supplemented by either ambient or induced illumination. Special application beacons, advanced ultraviolet optical lenses, and special application chemical tags are also under development.
Personnel Protection
Mission
To develop unique equipment and systems to alert and prevent attacks on VIP protectees. This includes hardware and tools that provide security to both the VIPs and their protectors. Inherent in this development is additional emphasis on life safety and emergency response equipment.
The Personnel Protection (PP) Subgroup focuses on the development of prototype hardware, personnel protection equipment, and diagnostic and reference tools and standards that will support greater security for VIPs who are highly visible in public environments and thus subject to terrorist attempts on their lives. In order to be effective, personnel who are charged with the safety of these VIPs must also have protective equipment that will prevent injury and tools that will improve their effectiveness. These developments benefit the operational effectiveness of federal, state, military, and local law enforcement personnel who are charged with the protection of VIPs as well as those who are engaged in the protection role. These technologies and tools also have application to protection of law enforcement and military personnel who engage in hazardous combat-like environments.
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Focus Areas
The major focus areas of the PP Subgroup are enhancing vehicle protection, improving transparent armor, developing enhanced body armor, and providing measures for dealing with sniper attacks.
Vehicle Protection and Performance—Develop technologies related to the performance, security, integrity, and armoring of fully armored passenger vehicles, including projects that provide added safety to passengers during sniper or blast attacks.
Transparent Armor Development—Identify and design tools for advanced lighter weight transparent armor that will provide improved protection over existing technology.
Enhanced Body Armor Development—Improve performance of body armor, including advanced methods to evaluate the performance of armor under varying threats. Evaluate methods to develop improved body armor and standards that will result in greater effectiveness of body armor for the users.
Counter Sniper Measures—Evaluate and develop technologies that will provide indications, warning and protection of VIPs from sniper and remote attacks.
Physical Security
Mission
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To identify and execute research and development projects that satisfy interagency requirements for physical security support to protect personnel, equipment, and facilities against terrorist attack.
The Physical Security (PS) Subgroup identifies the physical security requirements of federal agencies, both within the United States and abroad, and develops the technology to protect their personnel and property from terrorist attack. The subgroup develops this technology by creating prototype hardware, software, or systems for technical and operational evaluation by user agencies. A representative from DOD chairs this subgroup.
Focus Areas
Blast Mitigation—Building construction and retrofit techniques are being developed that will result in better protection of people and facilities from terrorist bomb blasts. The Blast Mitigation program includes extensive research and testing of building construction and retrofit techniques that concentrate on the following key areas: progressive collapse—the leading cause of fatalities; and window and wall debris—the leading cause of injuries. The techniques are laboratory-tested and then field-tested at operational sites. New construction standards are being written to incorporate the methods developed through blast testing and analysis. While these standards are under development, engineering technical letters provide immediate guidance to engineers in the field on how to retrofit and construct buildings for improved blast protection.
Entry Point Screening—The detection of explosives, chemical and radiological material, weapons, and other contraband at entry points by U.S. security forces is being improved using multiple technologies, methods, and techniques. The Entry Point Screening Program is a comprehensive program that focuses on development and testing of new technologies in five main areas of screening: personnel, vehicles, vessels, cargo, and mail. The primary concern is protecting people and facilities against large vehicle bombs. This area focuses on creating and field-testing prototypes that require a minimum number of persons to operate, are easy to use, and are effective in detection.
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Perimeter Protection—Advanced perimeter protection technologies will provide improved perimeter intrusion detection and specialized barrier capabilities. The creation of new technologies will focus on sensors and barriers that can be integrated with existing intrusion detection systems (IDS), and are fixed or deployable depending upon user requirements. A major goal of this task is to identify IDS with a high probability of detecting intruders, exceptional ability to filter out false alarms and operate continuously with high reliability, and which require low maintenance. Barrier systems must deter or prevent a breach of perimeters while demonstrating a high degree of reliability and requiring a minimum amount of maintenance.
Surveillance, Collection and Operations Support
Mission
To identify and pursue technical solutions supporting intelligence gathering and special operations directed against terrorist activities.
The Surveillance, Collection and Operations Support (SC&OS) Subgroup identifies high-priority user requirements and special technology initiatives focused primarily on countering terrorism/offensive operations. The research and development projects supported by this subgroup include reducing the capabilities and support available to terrorists and enhancing U.S. capabilities to conduct retaliatory or preemptive operations. A representative from the Intelligence Community chairs the subgroup.
Focus Areas
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Specialized Equipment for Surveillance and Intelligence Collection—Success in countering terrorism often depends on the quality of intelligence collection. These programs include improving capabilities for the covert collection and enhancement of video, imagery, and audio surveillance.
Command, Control, Communications, Computers, Intelligence, Surveillance and Reconnaissance (C4ISR)—The means to locate, identify, and track terrorists and terrorist activities is extremely critical. C4ISR programs focus on developing and improving that ability through such innovative programs and initiatives as tagging, tracking and locating; special sensors; and covert communications.
Search and Recognition Systems for Terrorist Groups and Individuals—The purpose of these programs is to develop automated tools for identifying terrorists through biometrics, pattern recognition, and database (e.g., personal information) technologies.
Information Operations—The purpose of these programs is to develop information operations (IO) tools and weapons to degrade, disrupt, deny or destroy adversary information and information systems.
Tactical Operations Support
Mission
To develop equipment and systems to support specialized force offensive operations directed against terrorist activities and groups; to make non-sensitive prototype hardware available for commercial production to assist military base commanders, state, and local enforcement agencies.
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The Tactical Operations Support (TOS) Subgroup supports tactical operations against terrorists, particularly offensive operations by specialized forces trained for assault operations. The subgroup supports technology development activities, which provide a foundation for subsequent advances, and the development of prototype special equipment designed to facilitate more effective execution of various tactical missions. The principal users of the technology developed by this subgroup include Military Special Forces, DOE security teams, and the U.S. Secret Service. A representative of DOD chairs this subgroup.
Focus Areas
The focus areas of the TOS Subgroup are advanced imaging systems, specialized access systems, chemical and radiation detectors, tactical offensive systems, and communications systems.
Advanced Imaging Systems—The development of advanced optical systems to provide improved imaging in night and obscured viewing environments.
Specialized Access Systems—These include systems that will enhance access to tactical objectives and improve tactical efficiencies in assault operations.
Chemical and Radiation Detectors—The development and evaluation of small, rugged chemical and radiation detection systems for use by specialized teams in tactical environments.
Tactical Offensive Systems—This area includes unique equipment for use in special operations tactical missions.
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Tactical Communications Systems—Unique communications systems and capabilities used in special operations environments that are developed with special consideration for the assault team's environments.
TSWG Program Funding
Funding for the TSWG program has increased significantly in the past decade, from $8 million in FY 1993 to over $80 million in FY 2002 to date. This increase reflects the increasing concern over terrorist activity and the recognized need to accelerate the development of technology to effectively address the problem. The Department of Defense provides the bulk of funding for TSWG activities. The Department of State contributes annually to TSWG core funding, while other departments and agencies share the costs of selected projects.
TSWG Business Process
Each year we convene a full meeting of TSWG members and receive current threat briefings from the intelligence community. This sets the stage for our requirements identification process. Over the month following the threat briefings, the subgroups identified above meet to identify and prioritize requirements. The highest priority requirements are then ''advertised'' and potential solutions sought.
TSWG uses a Broad Agency Announcement for unclassified requirements to maximize competition in our search for the best possible developer for each requirement. In FY 2001 CTTSO published five BAAs. We find that BAAs are ideal for our type of R&D because we have large numbers of requirements across broad technology areas yet have insufficient detail for to write detailed specifications. This leads to a wide variety of contracts. In FY 2001, TSWG funded more than 120 performers in 34 states.
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The TSWG BAA process has been evolving for more than six years. In the beginning the process was paper intensive and required tens of thousands of photocopies and hundreds of overnight mail packages. This invariably slowed the review process. Industry was not well educated on the requirements of the combating terrorism community and submissions often failed to meet requirements. Furthermore, many performers did not frequently read the Commerce Business Daily and were sometimes not aware of our solicitations. We have taken several steps to correct these and make other improvements.
1. Our requirements are written to describe a required capability instead of a desired technology.
2. Our first phase submissions are only one page. This minimizes the amount of time required for the vendor to prepare a submission and for the reviewer to complete the initial review. Several years ago we awarded a contract based on a BAA submission from a company in Arizona. That company submitted approximately 20 of the one page ''quad-charts.'' Only one was contracted for. The vendor told us that had they been required to submit more than a ''quad-chart'' they would have submitted far fewer responses and that they would not have included the one that was actually awarded. This submission developed an innovative weave for body armor that at the time was nearly 30% lighter than existing armor systems. That proposal was funded and the system has been commercially available for the last three years.
3. We use a commercially secure web-based system for solicitation, submission, review, and vendor notification. The system is known as BIDS and stands for BAA Information Delivery System. It is located at www.bids.tswg.gov. All solicitations from this page are simultaneously published in FEDBIZOPS. This system allows users worldwide to participate easily. The ''vetting'' process has multiple levels of ''review'' for every submission.
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a. Level 1—any interested reviewer is able to provide comments.
b. Level 2—a designated ''Task Manager,'' prepares a consensus review of all Level 1 reviews.
c. Level 3—a program manager prepares a summary review of all requirements under their cognizance with consideration to all potential contracts and the allowed budget.
d. Level 4—the Director/Deputy Director reviews based on office wide priorities and ensure intra-office coordination.
e. Level 5—the contracting officer provides a final review and then notifies the submitter of the results.
4. Prior to each solicitation an e-mail is sent to all registered users of BIDS to notify them that a new BAA is about to be published.
5. We hold an Advanced Planning Brief to Industry where we ''pre-release'' the BAAs and provide briefings on the requirements to be published. The briefings allow potential submitters to ask questions, get technical clarifications and meet our staff as well as form potential partnerships with other vendors. More than 1000 vendors attended this year's APBI.
6. We treat all potential performers the same manner. By this I mean that anyone ''competing'' for our program dollars cannot act as a reviewer. This includes DOD and DOE laboratories and FFRDCs. We do this to avoid any potential conflict of interest.
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Last October, the Deputy Under Secretary of Defense for Acquisition, Technology, and Logistics (DUSD (AT&L) ) requested the TSWG issue a Broad Agency Announcement (BAA) soliciting innovative ideas to support the Global War on Terrorism. He came to the TSWG because of our track record of many years of issuing BAAs in the field of combating terrorism. The solicitation was published on October 23rd and received a great deal of media attention. The response from industry, academia, and the public was overwhelming. The BAA was ''open'' for 60 days, the BAA was downloaded more than 70,000 times, our ''registered vendors'' list grew from about 300 to more than 10,000, and 12,500 submissions were received. These submissions received full reviews by technical experts and 627 submitters were asked to submit detailed ''white papers'' on their ideas. Based on an additional $34M provided by DOD specifically for this effort, we expect to award approximately 50 contracts. Full proposals will be requested for those efforts. In addition, TSWG is working with other agencies to identify funds that might be applied to other promising submissions. To date, we have identified approximately $5M of additional funds.
Since that BAA was published in response the DUSD (AT&L) request, TSWG issued two additional BAAs as part of its normal business cycle. These two BAAs generated an additional 2000 responses. We plan to apply approximately $20M to these efforts from our FY 2003 appropriation.
Our FY 2001 BAA identified a local Germantown firm, GEOMET, as the best technical solution to a requirement identified by the Department of Agriculture. They needed a system to dispose of large numbers of animal carcasses in the event of a mass disease breakout such as the Hoof and Mouth disease experienced by the United Kingdom recently. This contract has been awarded and the effort is well underway.
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The TSWG process seeks to constantly improve and we solicit feedback from not only from our management and our users but also our developer community.
Success Stories
The following are a few examples of successful tasks from the TSWG portfolio. The majority of these efforts were awarded via previous BAAs.
Support to Federal, State and Local Bomb Squads
Federal, State and Local Bomb Squads are required to have certain equipment to meet FBI accreditation requirements. This includes a protective Bomb Suit, a bomb disruption tool, portable diagnostics capability, and a set of working tools.
— TSWG, the FBI, and Sandia National Laboratory developed the PAN Disrupter several years ago to provide a render safe tool for Bomb Technicians to defeat Improvised Explosive Devices. This tool is the standard disrupter used by over 400 bomb squads throughout the United States. It will soon become the standard disrupter for the military.
— The Real-Time Radiography (RTR), a portable x-ray system developed through TSWG, the U.S. Postal Service and SAIC has revolutionized the process of IED X-Ray. Diagnostics, giving the operator the capability to conduct real-time threat assessment and diagnostic interpretation from a safe distance. The FBI is providing a system to each accredited bomb squad and the military EOD community has procured over 700 systems.
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— TSWG conducted technical evaluations of bomb suits against various explosive, chemical, and biological terrorist threat devices to document the effectiveness of these protective systems. The FBI has procured one of these systems for all accredited bomb squads.
Emergency Response Training Broadcasts
Since August 2000, the Saint Petersburg Junior College in cooperation with DOJ, FEMA the National Guard, TSWG has been managing the delivery of training to civilian and military responders. ''Consequence Management News, Equipment, and Training (CoMNET)'' is a news magazine format recurring broadcast offering Weapons of Mass Destruction (WMD) related awareness information to the Nation's civilian and military emergency response communities. ''CoMNET'' addresses this topic by presenting WMD specific news, equipment, and training segments and feature stories that are structured around training objectives and interests expressed by the Federal, State, and local response communities. ''Live Response'' is a recurring broadcast program that offers awareness information to civilian and military emergency response communities in a 60-minute live discussion panel in which members of the Federal, State, and local response communities explore topics related to WMD consequence management and engage in question and answer sessions with the program audience. The most recent broadcast reached an estimated 15,000 first responders from all 50 states and military responders around the world. ''CoMNET'' and ''Live Response'' are broadcast monthly via satellite, cable, the Internet, and private computer networks is capable of reaching approximately three million.
First Responder Biological Sampling Kit
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After the recent anthrax attacks, investigators were called to perform surface sampling over large areas such as air ducts and office spaces. However, sampling technology had advanced little beyond a cotton swab. This newly developed system was delivered to the Capitol Police in the first days of the contamination and proved easy to use while wearing gloves. The samplers release the agent easily for analysis, come in larger sizes for sampling large areas, and have more than a 20-fold collection efficiency increase. The first prototype of sampler has already been delivered for field trials and was used at several of the anthrax-contaminated sites. Perkin-Elmer developed this system.
Palmtop Hazardous Material Information Tool
''When responding to a terrorist chemical attack or a HAZMAT accident, speed means life if you're evacuating or sheltering people caught in the immediate vicinity or downwind. The Palmtop Emergency Action—Chemical or PEAC puts the essential response information in the user's fingertips in seconds. TSWG worked with a private company to increase the capabilities of their previously developed PEAC. The system provides plume modeling, required personal protective equipment, chemical properties, and other technical data. The system was deployed to U.S. forces and embassies in the Persian Gulf in May. Aristatek developed this system.
Chemical Biological Response Aide
The Chemical Biological Response Aide (CoBRATM), developed by Defense Group International, is an emergency response software package that provides a combination of electronic data resources, interactive search tools, decision aids and approved checklists and guidelines for responders to incidents of all types. It is intended for use by fire departments, HAZMAT teams, law enforcement agencies, forensic examiners, emergency medical personnel, and emergency managers. CoBRA is currently fielded with the numerous Federal, State and Local response agencies and the FBI has initiated a procurement action for 700 units.
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Vulnerability Assessments for Dams
Commercial energy facility operators and some federal agencies have found themselves inexperienced and at substantial risk in today's terrorist threat environment. This was particularly true in the case of dams and hydropower generation facilities. Capitalizing on the DOE's expertise in nuclear risk assessment, the TSWG arranged for the modification of a DOE methodology to suit the unique circumstances of dams and dam operators. The result was a set of tools for both the training and use of this tailored risk assessment methodology. It is currently in use by the Bonneville Power Administration, the Bureau of Land Reclamation and the U.S. Army Corps of Engineers. Automation of the methodology and extension of it to include bridges, tunnels and transmission lines is under consideration.
Fingerprint Recovery Techniques
TSWG and one of our international partners have jointly developed several new fingerprint recovery techniques. Using these techniques investigators were able to recover prints from several key pieces of evidence that in one case identified an assassin and in another led to the capture of a terrorist prior to an attack against civil aviation.
Entry Point Screening
Screening large vehicles for the presence of explosives or contraband is a difficult and time-consuming task. Leveraging work performed for drug detection, TSWG in cooperation with U.S. Customs the DOD Counter Drug Technology Office, and SAIC developed a system that uses gamma ray technology to locate hidden explosives in vehicles and cargo. This system is deployed in European Command. The U.S. Army has initiated procurement for approximately 50 additional units that are being assembled by SAIC in San Bernadino, CA, a similar system developed in a leveraged effort with DOD, Customs, and American Science and Engineering. This system uses transmission and backscatter x-ray to inspect vehicles. It is currently in use in the Central Command area of operation. Sometimes a lower technology approach is required. Working with U.S. Customs we developed the VIC or Vehicle Inspection Checklist. It provides step-by-step instructions for searching vehicles for threat materials. More than 30,000 have been delivered to civilian and military security forces worldwide.
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Blast Mitigation
Since 1996 TSWG has sponsored an interagency blast mitigation research program designed to minimize damage to critical public structures and reduce casualties from a terrorist explosive attack. Managed by the Defense Threat Reduction Agency, this program has resulted in numerous improvements to government facilities and the dissemination of information regarding structural hardening and retrofit techniques. Technologies developed in the program have been installed in several embassies and DOD sites including the Pentagon. The wedge struck on September 11th by AA Flight 77 had received some of the retrofits developed and tested under this program. Many have credited these retrofits with saving lives during the attack.
This testing program has included the standardized testing of blast mitigation products such as mylar film and wall-debris catch systems. The data is available to registered users via a web page.
We have learned through our blast mitigation testing that the leading cause of death in bomb blasts is progressive collapse of building columns and that the leading cause of injuries is glass and wall fragments. As a result, we have concentrated most of our efforts on finding ways to prevent fatalities and serious injuries by improving building design and developing retrofit techniques.
DNA Recovery
Several years ago a firm in Rockville, MD, Cellmark, under contract to TSWG developed and demonstrated a new method of DNA recovery that was so effective it could recover DNA from a licked stamp after a letter bomb had detonated.
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Closing Remarks
In closing, TSWG constantly strives to improve our performance in delivery of combating terrorism technologies to the broad spectrum of soldiers, sailors, marines and airmen as well as law enforcement, emergency management and intelligence personnel, both federal and local, who are fighting this war on terrorism. We are proud of our track record of delivering quality products to our customers that make a difference in both their readiness posture and operational response. We are also proud of our leading edge business practices that ensure we identify the best technical solutions to challenging operational requirements in a timely manner and at reasonable rates. This concludes my prepared remarks. I would be happy to answer any questions.
80094c.eps
Ms. MORELLA. Thank you, Mr. McCallum, and thank you for bringing these charts, too. Your testimony is of great interest to a lot of the constituents, a lot of the businesses and industry. Mr. Malson, it is good to have you with us here in Montgomery County. You point out that it truly is a region and we must work together. I recognize you, sir.
STATEMENT OF MR. ROBERT A. MALSON, PRESIDENT, DC HOSPITAL ASSOCIATION; CHAIRMAN, WASHINGTON METROPOLITAN COUNCIL OF GOVERNMENTS BIOTERRORISM TASK FORCE
Mr. MALSON. Thank you very much. Good afternoon, Madam Chairman, and Members of the Subcommittee, Colonel McCallum, and Major Pavlin. It is a pleasure to be here this afternoon. My name is Robert Malson. I am the President of the District of Columbia Hospital Association and I am the Chairman of the Metropolitan Washington Council of Governments Bioterrorism Task Force. Since November of 2001, I have also been privileged to serve on Secretary Tommy Thompson's Advisory Council on Public Health Preparedness, an entity that is chartered to advise him on matters related to improving the Department's role in responding to bioterrorism events. I appreciate very much the opportunity to speak this afternoon, and my primary focus will be on the challenges facing hospitals and healthcare systems in the National Capital Region as we strive to enhance our ability to respond to potential future terrorist acts, particularly, bioterrorism.
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And Madam Chairwoman, with your permission, I will skip over much of my prepared testimony in the interest of time.
Ms. MORELLA. Without objection, so ordered, and it will be in the record.
Mr. MALSON. Thank you very much. A major component of the National Capital Region's response network is the Metropolitan Washington Council of Governments, or COG, an organization consisting of 17 cities and counties in this region. In 1999, COG received a grant form the U.S. Public Health Service to write a plan for the region to respond to a bioterrorism attack. COG created the Bioterrorism Task Force to address the challenge, and this multi-disciplinary, multi-agency task force met monthly for almost two years and wrote the ''Planning Guidance for the Health System Response to a Bioevent in the National Capital Region.'' A name that I would just suggest is only longer than the task itself. The document was published on September 6, 2001, less than a week before the attack on the Pentagon.
Throughout the months of deliberations, our Task Force members focused on developing a consensus approach that would promote inter-jurisdictional coordination while preserving the unique characteristics and operating procedures of each member jurisdiction. This consensus resulted in three overarching concepts in the planning guidance: operational issues under the purview of local or state authorities; technical issues; and policy issues. This planning guidance is intended to be a living document and the Bioterrorism Task Force continues to meet on a regular basis to ensure that new technologies and innovations in the areas of bioterrorism preparedness and communicable disease control are considered and incorporated into the planning guidance. The full document can be viewed on the COG or the D.C. Hospital Association websites.
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On September 6, the members of the Bioterrorism Task Force breathed a collective sigh of relief as we completed two years of work and had no way of knowing that our work product would be tested under fire in less than a week. Within hours of the attack on the Pentagon on September 11, our Hospital Association's Hospital Mutual Aid Radio System, or H–MARS, quickly became the only major communication system in the region that was able to communicate important information about emergency room bed and capacity. We coordinated the communications required among all the private and military hospitals to assess the patient loads and capacity as the patients began to arrive. Our hospitals had implemented their internal emergency response plans and were ready to admit those patients. Only about 100 living victims came out of the Pentagon and half of them went to northern Virginia hospitals, half to the District, and actually, three from Andrews Air Force Base, who happened to be at the Pentagon, actually walked into Malcolm Grow Medical Center at Andrews, and all of them were not very seriously injured.
About one month later, on October the 15th, our nation fell victim to a second series of attacks, anthrax. Unlike most conventional or nuclear weapons, biological warfare differs fundamentally in that the attacks evolve over time and frequently first appear with victims presenting at local hospitals and physician offices, most frequently with flu-like symptoms. In the National Capital Region, we had, essentially, two types of attacks, the announced attacks on Capitol Hill and the unannounced attacks surfacing first with our Postal workers. As the scope of the anthrax attacks unfolded, the need to communicate with a growing army of researchers and medical responders became clear. DCHA established daily conference calls for all of our local hospitals beginning on the 17th of October, and we operated them continuously through mid-December. The core questions remain constant as the daily list of telephone participants grew to over 500 and was expanded to include officials from CDC, Capitol Hill, and others. The answers evolved as our knowledge grew, but he questions never changed. They were what are the new developments and what are we going to do about it.
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During that period, we created two new committees, our Infectious Disease and Infection Control Committee and our Stress Response and Research Committee. The Infectious Disease Committee brings together our hospitals' expertise in these issues to address capacity and to recommend necessary requirements to ensure that all of our hospitals are well prepared for biological attack or naturally occurring disease, such as West Nile Virus. The Stress Response and Research Committee allows mental health providers to develop strategies for responding to the community's immediate trauma and long-term behavioral needs that may be required in these situations. As a senior military flag officer described to me in simple quantitative terms, anthrax, he said, killed five and terrorized 300 million. Our hospital's mental health experts are working closely with all of our region's mental health departments to address and develop strategic mental health responses to terrorist attacks.
I would like at this point, Madam Chair, to move to our suggestions with regard to Federal response.
Ms. MORELLA. Good.
Mr. MALSON. Madam Chairman, as you know, all Americans expect the Federal Government to provide for the national defense. Most Americans would expect the national defense to include responding to acts of terrorism perpetrated on these shores. As clear as the concept may be, the task of carrying it out becomes particularly challenging in the National Capital Region because of the abundance of federal, state, and local agencies, all with defined authorities and jurisdictions, all within close proximity of each other. Added to the complexity is the fact that the healthcare first responders are primarily in the private sector, and traditionally, have not been included in public health and emergency planning activities. In that regard, despite the complexities, we made great strides since September 11.
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The list of biological agents—and this will be pretty close to my concluding remarks—the list of biological agents that can be weaponized for harm is long and deadly. They range, alphabetically, from anthrax, botulism, and cholera, to plague, smallpox, and tularemia. These biological killers recognize neither borders nor ZIP codes, and neither can our collective health response. While we expect our local officials to assist us in most crimes and crises, the need for regional coordination cannot be overstated when planning for a response to bioterrorism. By receiving Federal funds to the states, the governors have been given a very critical and crucial role in assuring the success of regional coordination we require, both within their states and across state lines. Interstate cooperation is essential so that each jurisdiction understands its roles and responsibilities in responding to a biological event, and a critical element of that responsibility is simply cooperating with one's neighbors. Secretary Thompson's letter of January 31 requires it. Hopefully, our governors will comply without undue Federal pressure. And with that, Madam Chair, I will conclude my prepared remarks and would be happy to respond to any questions that you or the members of the Subcommittee may have.
[The prepared statement of Mr. Malson follows:]
PREPARED STATEMENT OF ROBERT A. MALSON
Hospitals Preparedness for Bioterrorism Attacks
Good afternoon, Madam Chairman and members of the Subcommittee on Environment, Technology, and Standards of the Committee on Science of the U.S. House of Representatives. I am Robert A. Malson, President of the District of Columbia Hospital Association (DCHA) and Chairman of the Metropolitan Washington Council of Governments Bioterrorism Task Force. Since November of 2001 I have been privileged to serve on HHS Secretary Tommy Thompson's Advisory Council on Public Health Preparedness, an entity that is chartered to advise him on matters related to improving the Department's role in responding to bioterrorism events. I greatly appreciate being invited to participate in today's hearing concerning federal and regional activities on homeland security. My primary focus this afternoon will be on the challenges facing the hospitals and health care systems in the National Capital Region as we strive to enhance our ability to respond to potential future terrorist acts—particularly bioterrorism.
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DCHA was established in 1978 and represents all full service and most specialty hospitals in the District of Columbia, plus two hospitals in Maryland—Malcolm Grow Medical Center at Andrews Air Force Base and the National Naval Medical Center in Bethesda. DCHA hospitals employ more than 25,000 hospital employees who are on the front lines for any emergency response effort. I have enclosed a copy of our most recent Annual Report that sets out the breadth and scope of DCHA and its mission in greater detail.
A substantial part of DCHA's core work is accomplished in its committees and for most of the past decade the Emergency Preparedness Committee has had the primary responsibility for the development of DCHA's hospitals' preparedness and coordination protocols. The Committee meets regularly to keep representatives from all DCHA hospitals informed of current emergency preparedness issues and to discuss how to best prepare the hospitals for any major event that arises, whether from natural causes or from acts of terrorism.
The Committee was primarily responsible for the development of the Hospital Mutual Aid Radio System (H–MARS) that connects all District of Columbia hospitals' emergency rooms as well as an increasing number of hospitals in Suburban Maryland and Northern Virginia. H–MARS permits emergency room physicians and nurses to consult and coordinate with each other in real time about evolving emergencies. The system was of critical importance during the attack on the Pentagon and in the subsequent anthrax attacks a month later.
A major component in the National Capital Region's response network is the Metropolitan Washington Council of Governments (COG), an organization of seventeen cities and counties in the National Capital Region. In 1999, COG received a grant from the U.S. Public Health Service to write a plan for the Region to respond to a bioterrorism attack. COG created the Bioterrorism Task Force (BTF) to address the challenge and this multidisciplinary, multi-agency Task Force met monthly for almost two years and wrote the ''Planning Guidance for the Health System Response to a Bioevent in the National Capital Region.'' The document was published on September 6, 2001, less than a week before the attack on the Pentagon. Throughout the months of deliberations, our Task Force members focused on developing a consensus approach that would promote inter-jurisdictional coordination, while preserving the unique characteristics and operating procedures of each member jurisdiction. This consensus resulted in three overarching concepts embodied in the Planning Guidance—operational issues (under the purview of the local or State authorities), technical issues, and policy issues. This planning guidance is intended to be a living document and the BTF continues to meet on a regular basis to ensure that new technologies and innovations in the areas of bioterrorism preparedness and communicable disease control are considered and incorporated into the Planning Guidance. (The document can be viewed at the COG or DCHA websites at www.mwcog.org, or at www.dcha.org) On September 6th, the members of the Bioterrorism Task Force breathed a collective sigh of relief as we completed almost two years of hard work. We had no way of knowing that our work product would begin to be tested under fire in less than a week.
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Within hours of the attack on the Pentagon on September 11, DCHA's H–MARS quickly became the only communications system in the region that was able to communicate important information about emergency room and bed capacity. DCHA coordinated the communications required among all the private and military hospitals to assess the patient loads and capacities as the casualties began to arrive. Our hospitals had implemented their internal emergency response plans and were ready to admit patients. Only about 100 living victims came out of the Pentagon attack and they were all transported to local hospitals—about half to Northern Virginia and half to the District of Columbia.
Almost exactly one month later, on October 15, 2001, the Nation fell victim to a second series of attacks—anthrax. Unlike most conventional and nuclear weapons, biological warfare differs fundamentally in that the attacks evolve over time and frequently first appear with victims presenting at local hospitals and physicians offices, often with flu-like symptoms.
In the National Capital Region we had, essentially, two types of attacks—announced attacks on Capitol Hill and unannounced attacks surfacing here with postal workers.
As the scope of the anthrax attacks unfolded, the need to communicate with a growing army of researchers and medical responders became clear. DCHA established daily conference calls for our local hospitals beginning on the 17th of October and we operated them continuously through mid-December. The core questions remained constant as the daily list of telephone participants grew to over 500 and was expanded to included officials from CDC, Capitol Hill and others. The answers evolved as our knowledge grew but the questions remained the same. ''What are the new developments and what are we going to do about it?''
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During that period, DCHA created two new committees, the Infectious Disease and Infection Control Committee and the Stress Response and Research Committee. The Infectious Disease Committee brings together the hospitals' experts in these issues to assess capacity and recommend necessary resources required to ensure that District hospitals are well prepared for a biological attack or a naturally occurring disease such as West Nile Virus.
The Stress Response and Research Committee allows mental health providers to develop strategies for responding to the community's immediate trauma and long-term behavioral health needs that may be required in these situations. A senior military officer has described the mental health issue to me in simple, quantitative terms—''Anthrax,'' he said, ''killed five and terrorized 300 million.'' Our hospitals' mental health experts are working closely with the DC Department of Mental Health to address and develop strategic mental health responses to terrorists' attacks.
Last November, about two weeks into the anthrax attacks, I testified before you, Chairman Morella, on the hospitals responses to the two attacks. You suggested that our scope should be broadened to the entire Region. Within ten days, we formed the National Capital Regional Emergency Response, Inc. (NCR–ER). NCR–ER was established to create a forum where a cross section of private health care and other agencies and organizations could gather to enhance the regional response capabilities to terrorism over the entire private sector spectrum.
In addition to our hospitals and the Medical Society of the District of Columbia, the list of forum participants includes the American Red Cross, the Chemical & Biological Arms Control Institute, the Consortium of Universities, the Hotel Association, the National Capital Poison Control Center, the Northern Virginia Emergency Response Coalition, and a host of others. The entire list is contained in the NCR–ER brochure that is attached to this testimony. The common denominator is that all of these organizations share a common interest in emergency preparedness, and each has a unique role in enhancing the Region's response or research capabilities.
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Madam Chairman, on January 10, 2002, President Bush signed a $292 million Department of Defense Supplemental Appropriations bill at the Pentagon. All of the funds were earmarked for various response elements within the National Capital Region of the District of Columbia, Maryland and Virginia. This is a substantial investment on the part of the Federal Government and it is the responsibility of us all to ensure that we plan together to maximize the utilization of the funds and to avoid waste and duplication of efforts.
In that regard, COG has taken the lead in developing the Regional Emergency Coordination Plan Framework based, in part, upon the Federal Emergency Management Agency's Federal Response Plan. At the April DCHA Board of Directors meeting, COG Executive Director Michael Rogers explained that the centerpiece is the Regional Incident Communication and Coordination System (RICCS). RICCS is designed to link regional officials within 30 minutes of an emergency on a 24-hour per day, seven-day per week basis. RICCS can be activated to address all types of hazards, from blizzards to weapons of mass destruction. The plan framework is available for public comment and can be viewed at www.mwcog.org.
In order to comply with the terms and conditions set out in HHS Secretary Tommy Thompson's January 31, 2002, letter to every U.S. governor and to the Mayor of the District of Columbia to receive the $1.1 Billion Federal bioterrorism preparedness grants, DC Mayor Anthony Williams created a Hospitals Bio-preparedness Planning Committee and a Bioterrorism Advisory Committee. The District's two Bioterrorism Committees agreed to join forces in working together and have set their first substantive meeting for 4:30 this afternoon. They are prepared to begin work immediately. There is much to be done.
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At the top of our list is the absolute requirement to ensure that these Federal funds are being appropriately targeted for the purposes for which they were intended and to ensure that the coordination required is taking place. To achieve that goal the heads of the DC Department of Health, the Medical Society of the District of Columbia, the Medico-Chirurgical Society of the District of Columbia, and the District of Columbia Hospital Association have together selected a candidate to be offered the position of Medical Director for Bioterrorism Response Coordination for the District of Columbia. The major focus of this individual's work will be to ensure that the District's plans will be in sync with those of the National Capital Region. The individual we have selected has a strong background at the Federal level and will be available to start within weeks. His name will be announced as soon as the formal negotiations have been completed.
II
The Federal Role
Your invitation asked me to address some of the major challenges we are experiencing with coordinating multiple agencies and departments across federal, state, local and regional jurisdictions and how Federal involvement can assist to improve regional capabilities.
All Americans expect the Federal Government to provide for the national defense. Most Americans would expect the national defense to include responding to acts of terrorism perpetrated on these shores. As clear as the concept may be, the task of carrying it out becomes particularly challenging in the National Capital Region because of the abundance of Federal, State and local agencies, all with defined authorities and jurisdictions, and all within close proximity of each other. Added to the complexity is the fact that the health care first responders are primarily in the private sector and traditionally have not been included in public health and emergency planning activities. In that regard, despite the complexities, we have made great strides in the region since September 11th.
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The task of coordinating the Federal role is an awesome one and I applaud President George Bush's decision on Thursday to consolidate most of the key Federal agencies in the new Department of Homeland Security. We are working collaboratively on the emergency preparedness and operations planning, in large part due to the Federal bioterrorism grants, which require regional, as well as public-private cooperation and planning. In addition to coordinating the Federal defense response, the Federal Government needs to continue providing funding to states, local jurisdictions and private first responders to ensure that the Nation's cities and regions are appropriately equipped and prepared to respond to any biological disasters.
Madam Chairman, the list of biological agents that can be weaponized for harm is long and deadly. Alphabetically, they range from anthrax, botulism, and cholera to plague, smallpox and tularemia. These biological killers recognize neither borders nor zip codes and neither can our collective health care response. So, while we expect our local officials to assist us in most crimes and crises, the need for regional coordination cannot be overstated when planning for a response to bioterrorism. By receiving Federal funds to the states, the governors have been given a critical and crucial role in ensuring the success of the regional coordination required, both within their states and across state lines. Interstate cooperation is essential so that each jurisdiction understands its roles and responsibilities in responding to an event. A critical element of that responsibility is simply cooperating with their neighbors. Secretary Thompson's letter requires it. Hopefully, all our governors will comply without undue Federal pressure.
Regional entities, like COG, are integral partners in ensuring that all planning and operations are coordinated both vertically and horizontally. COG has been a leader in coordinating the governments' responses in the National Capital Region, and will continue to succeed thanks to the support of the region's Congressional delegation.
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As we learned from our efforts in September and October, emergency preparedness and response must be a public-private partnership that maximizes the resources that both bring to the situation. I am pleased that the Council of the District of Columbia passed the Omnibus Anti-Terrorism Act of 2002. The new law permits the Mayor to declare a ''Public Health Emergency'' and expands civil immunity to all licensed health care workers who render aid during a declared state of public health emergency. The new law mirrors the legislation introduced by you, Madam Chairman, last month at the Federal level. As you well know, this legislation is necessary because the region would rely most heavily on its private hospitals and other providers of medical care to assure timely access to services for all who live and work in the region should another event occur. Therefore, it is only appropriate that all hospitals and the corps of licensed trained health professionals be afforded immunity from civil damages. Equally important is ensuring that licensed health care providers are allowed to provide health services to emergency victims to the same extent that they are authorized to provide health services in the jurisdiction that issued the license.
We are grateful to you, Madam Chairman, for introducing legislation that would allow a licensed physician in the National Capital Region to render aid in any regional jurisdiction. We would urge you, however, to allow similar health credentialing reciprocity to all licensed health professionals in the National Capital Region—nurses, pharmacists, physician assistants, mental health counselors—to ensure that any of the area jurisdictions that may be in need of emergency medical services will have sufficient licensed personnel to render the necessary aid.
Lastly, it is important to note that anthrax attacks made clear that hospitals and health care workers are first responders to biological attacks. This fact must be recognized in the distribution of the National Pharmaceutical Stockpile (NPS). It is absolutely imperative that health care and emergency workers, and their families, be included in the roster of individuals who have priority access to antidotes and vaccines. Unless these first responders receive the necessary protection prior to or at the onset of an event, they may not be available to adequately treat the population at large. Therefore, the regional NPS distribution plan must be designed to reach the first responders in a timely and efficient manner, while also providing sufficient supplies and resources for the populations in the local jurisdictions. This is a very complex and difficult task, but all of the citizens in the National Capital Region should feel confident that they would have access to any required vaccines, prophylaxes, or medical supplies in an organized process.
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That concludes my comments. Once again, I greatly appreciate the invitation to testify today. As always, I am glad to answer any questions or provide the Subcommittee with any information if may need.
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Discussion
Ms. MORELLA. Thank you very much. Thank you, Mr. Malson. I know the kind of work you do, too, and I appreciate that, and I know your testimony is extensive that you have given us, very thorough. I appreciate that, also.
Major Pavlin, you hit on a lot of very interesting and very important points. You have articulated the need for a national disease surveillance system. Now, I guess in the absence of a national system, we have—I think you pointed out that you have some surveillance systems that are already in place in various localities, but they are underutilized. Would you comment on that, like what are the reasons for the deficiency? Are there liability and civil rights issues that prevent their use? Is it the lack of adequate resources? What can we do?
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Major PAVLIN. I think there is a number of everything you touched on. First, the reason there isn't a national surveillance system is that—and this is not my area of expertise—but the CDC and the HHS, under Federal law, can only encourage and guide the state and the local health departments and respond if requested. They cannot mandate anything that the state and local health departments should be monitoring for. So they are there to encourage, to support, and to help. But I think that in this day and age, they are also trying to coordinate the sharing of the information from surveillance systems across and between states. And in fact, with this deployment of our ESSENCE system, we now can look at every military treatment facility worldwide, and we have picked up multiple outbreaks of diseases occurring simultaneously coast to coast. So it becomes very important to have a global look as well as a local look, and you need both of those.
But there are concerns, and there are concerns with sharing information, whether it is privacy information from patient records—we have to deal with a lot of paperwork, legalities, with that. And also, one group in our section from Carnegie Melon University is developing anonymity algorithms, so they can share information and not have to share personal information. The other concern with some of these commercial sources of data, such as pharmacy sales, is commercial rights and concerns that if they share the information with us, we would share it with another pharmacy chain and, therefore, they would know what their competitors' business practices are. So there is a lot of hurdles that we are trying to overcome right now.
Ms. MORELLA. Is there a local surveillance system for the National Capital Region?
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Major PAVLIN. No. The D.C., Maryland, and Virginia Health Departments have been working since September 11, and they still do this every day, is get information from emergency rooms and participating hospitals around the area to look at just emergency room visits as well as other surveillance systems. When I say there is no national, there are many different surveillance systems. There is surveillance for HIV, there is surveillance for disease outbreaks of gastrointestinal outbreaks, for instance. There are many different surveillance systems, but to coordinate and look kind of across the board for any kind of disease outbreak, I think we are improving that greatly, and we are sharing our information that we get from our automated system with the D.C., and Maryland, and Virginia Health Departments.
Ms. MORELLA. Would Homeland Security help that to——
Major PAVLIN. I think it would. I think it would definitely help that, ma'am.
Ms. MORELLA. Mr. McCallum, speaking of that, how is the President's new cabinet level department going to affect the organization of your office and the duties assigned to it? I mean, it may be that the plan is too new for us to be able to give any definitive answers, so——
Mr. MCCALLUM. I think it is a little too new, ma'am, to really tell, but I know you didn't have a chance to look at the I chart for too long, but in the book that you have got, you will see that all of the nonmedical organizations that are in the President's new Department of Homeland Security are already participants in the technical support working group. So I would expect that the technical issues that we will look at and the capabilities that will be required will be largely the same as we are looking at now. The priorities and how they want to approach those may well change, and we will see how that goes.
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Ms. MORELLA. How many proposals are you now receiving—you know, I know that you had some success stories and, you know, details, some details of the number of projects that are funded, but I am curious about how many proposals you are receiving, and do you have the sufficient resources to meet the demands, or do you—are you forced to put aside a number of promising ideas that might come before you?
Mr. MCCALLUM. Last year, we issued five broad agency announcements and received over 15,000 submissions from industry academia and individuals in the public. This year's budget will be over $90 million, and it is up from probably about right around 42 in 1999. So we have a fairly generous amount of money from DOD, largely in the interagency, but clearly, we received far more in the way of proposals than we have dollars to support those, and we are currently working within the interagency to try to identify other monies to support good ideas.
Ms. MORELLA. Did you have a satisfactory system that you would put into place when the proposals come in, how to assess them, respond to the applicants? I mean, I have a number of people in the region, as a matter of fact, who are rather frustrated because they have got good ideas, they don't quite know how to get into the system or get a response, and I am sure you hear that, too, and there is no magic answer.
Mr. MCCALLUM. One of the ways that people can get into our system is to go to our website, www.tswg.gov. It is identified in the handouts and we have those on the public desk, also, and register in our e-commerce system we have established over the last few years. As we have grown, we found that there weren't enough human fingers in our office to handle the paperwork required to review these documents, not just in the office but throughout the country. We have a system where we receive everything electronically. The submissions are all reviewed by panels of experts that are nationwide. Since it is electronic, we have a commercially secured system, and this is all for unclassified issues, and we can go out and have people from across the country, across the city and across the country, do the evaluations. We have multiple tiers of evaluations, and ultimately, through white paper selection and then proposals, select final candidates. But the system has worked very well, and in fact, one of the considerations that I think most people in the city have heard about now is that the Office of Science and Technology Policies asked us to begin to review a number of the submissions that came in this last year on solicited proposals to protect the country. So in addition to our normal process, looking through those as we speak.
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Ms. MORELLA. I now defer to Mr. Barcia for questions and then I will get back one more round to get to Mr. Malson. Thank you. Mr. Barcia.
Mr. BARCIA. Thank you. I just have one question. All three of you did an excellent job in presenting your testimony. It was very informative and I appreciate you spending this time with us today. I have one question for Mr. Malson. It involves—you commented during your testimony and also wrote in your written testimony about the need to coordinate efforts on a regional basis in the event of a disaster or a crisis involving perhaps a bacterial outbreak or a virus of some type. You make the case that, for example, first responders and their families should be included in the roster of individuals who had priority access to antidotes and vaccines from the National Pharmaceutical stockpile. My understanding is that the stockpile is managed by the Veterans Administration.
Mr. MALSON. A segment.
Mr. BARCIA. Pardon me?
Mr. MALSON. A segment of it is.
Mr. BARCIA. Okay. A segment. And is it true that first responders, for example, in the National Capital Region are not included on that roster? Could you highlight for us how first responders would react in the event of a crisis? We know we were all here on September 11, and we know the confusion that reigned after the initial attack, and many of the offices were closed, and communication broke down. We have all been issued Blackberries because we couldn't—the cell phones were useless and the telephone system was jammed. In that type of situation, particularly, if there was some kind of airborne bacteria or virus attack, perhaps with missiles, or explosions, or something, how would the first responders have access to, and what kind of timeframe would that involve in terms of actually getting relief, and help, and assistance to people?
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Mr. MALSON. Thank you, Congressman Barcia. The first thing I would like to say is it is not always clear to people who don't work in this field how a biological attack differs from other kinds of attacks. And the main way in that it differs is that a biological attack evolves over a period of time, whereas, in other conventional attacks, something goes boom, something falls, and immediately, everyone is either a victim, or a responder, or an observer. Every single patient, every single victim who is subjected to a biological attack is in and of him or herself a separate incident. And so you may contact the agent in one jurisdiction, move home in the evening to another, report to a hospital in a third, and if there is a contagious element, you may infect people along the way, who then each of whom becomes a different incident. So it is a very, very different and far more complex matter to integrate the response, both vertically up through the ranks, federally, as well as horizontally, across that different local jurisdictions.
Your question about the importance of the National Pharmaceutical stockpile and its deployment is one that the agency, the Federal agencies, have been working on long before the attacks in October, but it has certainly gathered additional momentum and speed since that time. Again, the complexities of recognizing that President Bush controls far more Americans in Afghanistan responding to those attacks than he does here, makes it, therefore, all the more important for us to integrate our state, local, and private healthcare respondents in an extremely complex manner.
If I could just piggyback onto Ms. Morella's other question about surveillance for a moment, for our private hospitals, each of them has a surveillance system which is integrated with the patient tracking system, which is integrated with the billing system, and they are all proprietorial, so they are different from one hospital to another. In our national defense mode, to try to combine this into a national surveillance system or even a local surveillance system, the complexities become very large and so does the expense. So while we sort out through the President's new Homeland Security Department, which we support by the way, it is very important to recognize as the pervious panel has pointed out, that the healthcare response, traditionally, has been with HHS, and therefore, much of it is—will remain there regardless of what they do, because we don't know down the road whether an initial attack is really a bioterrorist event or a national event, and it takes time frequently to sort through that. So there are lots of pieces to this puzzle.
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Mr. BARCIA. Thank you very much. That was a great response. Thank you.
Ms. MORELLA. Thank you. Mr. Bartlett.
Mr. BARTLETT. Thank you very much. Major Pavlin, you mentioned the importance of a national disease surveillance system, and indeed, if we had such a system, we could probably detect a bioterrorism attack much sooner because patients that would not raise an eyebrow in the local hospital or state, but if you had national reporting, you might see something coming before you would just looking at a local area. One of the major impediments in addition to the technical one of getting everybody to submit their data, one of the major problems—you don't have it because you are in the military—but one of the major problems is the problem of privacy. Is that addressable through sanitizing these records for name and any ID, or do we need regulatory change before we can effectively implement a national disease surveillance system?
Major PAVLIN. That is a very good question. It is something we wrestle with every day. First, I do want to clarify that in the military, we do have Privacy Act, and we are as protected as any other person. I cannot release any active duty military person's medical information to anyone without specific need for them to know, just as similar to anybody else. And actually, the military surveillance system that we use here includes our family members, their children, retirees, and so on, so they are not just active duty. We do this by maintaining privacy, by removing any kind of patient identifiers from the record, removing things down to the level that is unable to identify anyone. So if we look at people by ZIP code, we know their age, we know their gender. If we know their birth date, maybe then we can identify that person. So using these anonymity algorithms that I mentioned, we can actually get this down to the level where you cannot identify someone, and that is what we are working with right now, and we can then share the information as well. And we have to convince people that these work and show and prove that they work. But that is a huge issue, and we also have most of these go through institutional review boards and human use review committees at different universities and institutions to make sure that they are in safekeeping with any other human use, such as a vaccine trial or anything else, it is the same exact thing.
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Mr. BARTLETT. Many of our military people give up a lot of their rights that other people in the society have, but you are telling me in this privacy area, we haven't given up any?
Major PAVLIN. No, not for routine medical care, no. On a battlefield, if they need to know HIV status, they can do that but——
Mr. BARTLETT. Thank you. Mr. McCallum, you mentioned that you—the coordination for counter terrorism. If you think about the future, the only kind of war that we are likely to fight, unless it is a nuclear exchange, is going to be—if it is on our soil—is going to be a terrorism kind of war because last September was the first time since 1812 that a foreign power was able to kill Americans in any significant numbers on our soil. If you think about how strongly our military capabilities are, there is no power out there that can go at us toe to toe in the future, so any attack, that is by definition pretty much going to be a terrorism attack. Is it not? Doesn't that make your organization kind of front and center in this new world?
Mr. MCCALLUM. Yes, Congressman Bartlett. We have been front and center for a few months now, no doubt. We share your opinion that, certainly, for the foreseeable future, that the world of terrorism is the likely battlefield that we will be on.
Mr. BARTLETT. And is, in fact, the only war that another power can wage against us, unless it is nuclear, and there is only one power that now could wage a near balanced nuclear war against us, and that is Russia, of course. The President mentioned that this is a war like none other we have ever fought, and in preparing for the future, we need to prepare for wars like none other we have ever fought. There is something else that you mentioned, the coordination that is necessary. And one of the big impediments to coordination are communications problems. The wavelengths are so different that if you really want to know what your colleagues are doing in fire, in police, and emergency services, and so forth, you may have to carry several different telephones. How are we going to resolve this problem? When we go digital, I know the solution is fairly straightforward. If it is digital, it really doesn't matter what the frequency was, and you could put it into a big digital mixer, and no matter what frequency it comes in, it comes out so that you can understand it. But right now, it is my understanding that in most jurisdictions, these various types of first responders cannot, in fact, communicate with each other.
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Mr. MALSON. On many levels, Mr. Bartlett, that is absolutely true. But I think the National Capital Region where we are is probably one of the leaders in the country in terms of inter-jurisdictional cooperation. For over 20 years, or 25 years, probably, our police chiefs from all of these jurisdictions have had memorandums of understanding with each other, where they can coordinate. Followed shortly after that was the fire departments, and so—and many others have been written in the last couple of decades. With bioterrorism, it is in many ways an entirely new day because we are integrating not only horizontally, across jurisdictions, but vertically. So we have our hospitals, our private physicians, but also, our veterinarians, our funeral directors, and many, many others. Probably, one of the key groups in all of that is our public health departments for each of the jurisdictions. The communications and the coordination are really the two critical elements when we are dealing with a bioterrorism event, because as I indicated earlier, it is an evolving event. And because it is evolving, the need for us to talk about what we have learned within the last few hours, do we see any new trends, and where are they heading—your comments about the surveillance is a critical element of that. So whether we carry 10 phones or 100, I don't know how we will get through all of that, but you have to be very concerned about information overload and to make sure that the right people and their institutions are at the right point and that we are doing the job of coordination that is required.
Mr. BARTLETT. Thank you very much. I appreciate your testimony, all of you. Thank you.
Ms. MORELLA. I want to thank you, also. And Mr. Malson, thank you for the support that the hospital association, the D.C. Hospital Association, has given to the legislation I introduced with regard to emergency physicians being able to cross over to Virginia, Maryland, the District of Columbia, in a national emergency, you know, assuring them that there will not be the liability so that they will do it, because they do want to do it.
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I want to ask you two questions. One, should that legislation be expanded to include first responders? Secondly, I am wondering—I know COG, with your assistance, is working on a piece of legislation that will deal with regional cooperation and a regional plan. They are planning to have that radius legislation, I am just not sure how close we are for its introduction and what it might include, if you might want to comment to us on.
Mr. MALSON. Yes. Thank you. With regard to your legislation and expanding to first responders, the traditional first responders wear uniforms, police, fire, EMS workers. With bioterrorism, of course, as we witnessed here in the region in October, the people began to show up at their local doctors and their local physicians, so they, too, become first responders by definition for this element of warfare. So your legislation in allowing our physicians to cross these jurisdictions unimpeded by licensing and liability concerns is critical. And you are correct, it does need to be expanded, in our opinion, to include the other healthcare workers who are involved. I mean, we have got pharmacists, we have got radiologists, we have got nurses, we have got all the people who constitute your public health response team who need to have the same kinds of lack of restrictions with regard to licensing and liability, and I think your legislation is the right thing to be modified to encompass that group.
And your section question about the regional cooperation, COG has since September—I think it was the 13th or 14th, has begun to focus quite heavily on how to enhance our regional response. And the COG Board of Governors, or Board of Directors, which as you know, is made up of elected representatives from all of the counties and cities around Washington, voted on April the 10th of this year to actually adopt a regional response plan modeled on the FEMA plan. So and each of our local jurisdictions are moving or have moved in that direction as well. And so we have a symmetry which helps to reduce the possibility of confusion, because we are all operating off of an ESF8, which is the one we operate off of for health response, and the Federal ESF8, and the regional ESF8, and then in the District, our own ESF8, all tailor after each other, and many of the other counties and cities are beginning to do the same thing.
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One of the things that I think has been lost in the public domain since the September and October attacks is really how much ground has been gained, both at the federal, and state, and local level, because many of these complexities don't digest very well, and it is very hard for that average citizen to keep up with it. And I think one of the tasks for the congress, if I can suggest something like this, is to help figure out how to make sure that the American people recognize how much progress has been made and how much people are working together, as well as what needs to be done.
Ms. MORELLA. I think that assurance would be great. It is true, people are most anxious with regard to what is happening, are we working together. Are you familiar with the legislation that COG is working on?
Mr. MALSON. I am familiar with a couple of pieces that they are working on, and I am sure the one you are speaking of is one of those that I have been assisting in.
Ms. MORELLA. I want to thank you very much. Do you have any other questions, Mr. Barcia, Mr. Bartlett? Would you like to ask another question?
Mr. BARTLETT. During the 1950's, everywhere you went, you saw civil defense signs pointing you to a shelter. They are now, where they still remain, rusting away, and there is now nothing in the shelter. That served to alert all Americans that we needed to cooperate and coordinate in the event of that kind of a catastrophe. Do we need something the equivalent of that today for these terrorist attacks so that people are reminded every day that we are in a new world with a different kind of enemy? Don't you think it might be useful if we had something the equivalent of the old civil defense—obviously, under probably FEMA now, so that every day we were reminded? We may, indeed, need those kinds of things in the future. Don't you think?
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Mr. MALSON. Well, sir, I think the President's initiative last Thursday was an attempt to consolidate many of these pieces together, and while it was developed in a great deal of secrecy, I think the previous panel spoke very clearly and eloquently to the need to make sure that as they dig down deeper into the weeds, that the experts down in those weeds get to share their concerns. In the organizational chart for the President's plan, I mean, he talks about under the Secretary, a state, local, and private sector coordination, so as critical as that is, you also have the emergency response group over here. And then for our concerns on the bio side, you still have HHS, which is somewhere off on another page. The need to move from that page to this, but not lose what has been developed over many, many years in expertise there, and also, the need to ensure that there is not duplication is going to be critical. And whether we have a civil defense system or the color code system that he and Director Ridge have developed, all of these are important steps. But in the American people's interest in getting back to normalcy, there is also a movement toward well, let us get fully back to normal, and at the same time, there is a need to keep the alert high. And so there is a balance so that the Government doesn't get accused of crying wolf when, in fact, the Government, probably better than anyone, recognizes the nature and degree of the threats that are out there. And certainly, Colonel McCallum and his colleagues work on this all the time, so the balance is——
Mr. BARTLETT. For years we had public drills. I don't remember anybody yelling, saying the Government was yelling wolf, wolf. I can remember when I worked at NIH, we had regular drills. The new clinical center, Building 10, was to be what—a 500-bed hospital in the event of a nuclear attack on Washington, and we just don't have that kind of public focus and public involvement now. It seems to me that we might at least consider something like that, that keeps us alert and would provide for some better response in the event that there were an incident. And the future probably holds, hopefully not, but considering who the enemy is and what kind of resources they have available to them, the future probably holds some additional problems.
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Mr. MALSON. Our focus has been, as I indicated, on communication and coordination, and we think that is where the greatest need is right now.
Mr. BARTLETT. Thank you.
Ms. MORELLA. Thank you. Well, I want to thank the three of you for being here, for being patient by being on the second panel, but more than that, by giving us the benefit of your expertise, your testimony, which includes even a lot more than we have discussed here orally. And again, I hope we can pose some questions to you and that you will feel free to come to us for any of the needs that you have. And so thank you very much, Major Pavlin, Mr. McCallum, Mr. Malson. We appreciate it very much.
And before I adjourn this Hearing, I want to thank Congressman Barcia, and I want to thank Congressman Bartlett for being here with me. And I want to thank staff who helped to make it all happen, my staff, Carl Picconatto, and Mr. Barcia's, Mark Harkins. I also want to thank Peter Rooney, Susannah Foster, Denise DeMichele, and Jonathon Dean. And I think that lists them all, so I thank you all. We are now going to adjourn this Subcommittee Hearing.
[Whereupon, at 12:17 p.m., the Subcommittee was adjourned.]
Appendix 1:
Answers to Post-Hearing Questions
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ANSWERS TO POST-HEARING QUESTIONS
Responses by Dr. Elias Zerhouni, Director, National Institutes of Health
Questions submitted by Representative Lynn N. Rivers
Q1a. Do you believe that gene patents are currently preventing or retarding the development of ''cures or valuable products downstream?''
A1a. Some recent studies have shown that in some cases the existence of patents on genetic material deters further research and restricts access to newly developed genetic tests. (See Merz, et al., in Nature, February 2002, enclosed.) However, it is usually not the existence of a patent that raises concern for the biomedical research community, but rather, the patent holder choosing to exercise its rights through licensing or other contractual agreements in a manner inconsistent with the advancement of basic research. For example, many new inventions are not final products. The discovery may be a research material or a new method or procedure, primarily useful as the means to conduct further research. Such discoveries are commonly known as research tools. There is little doubt that many research tools may be patentable and are of economic value to the holder of these rights. There is also little doubt that the value to society is greatest when such research tools are made widely available to scientists.
Another problem can occur when providers of patented biological materials attempt to extract from recipients of the materials so-called ''reach through'' rights in exchange for access to these unique resources. Such concessions by the recipient may include 1) granting the provider of the materials ownership of new inventions developed in the course of research with the materials, 2) requiring the recipient to share with the provider a portion of royalty payments resulting from licenses to new inventions made by the recipient using the biological material, or 3) granting the provider an option to an exclusive license to any new intellectual property arising from the recipient's use of the material. The inclusion of such terms in licenses or Material Transfer Agreements for biological research materials may be considered by researchers to be too onerous. As a result, this may ultimately hinder further development and commercialization of new technologies arising from research with such materials, or impede their distribution.
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The National Institutes of Health (NIH) National Human Genome Research Institute (NHGRI) has funded research on gene patenting including a recent project entitled, ''Effects of Gene Patents on Genetic Testing and Research.'' The NHGRI will also be funding other projects in this area in order to continue to gain valuable new insights into these issues.
Q1b. If so, what can be done to ameliorate these impacts?
A1b. There are several ways to strike the appropriate balance between protecting commercial interests and encouraging new research. The suggestions below can be implemented without additional statutory authority.
Encourage the Patent Trade Office (PTO) to grant patents only where utility is known. As expressed in a December 12, 2001, letter to you from Dr. Francis Collins, Director of NHGRI, NIH was concerned that the PTO was granting patents on genes or portions of genes based on insufficient information about how such genetic information might be used to diagnose, prevent, or treat disease. My predecessor, Dr. Harold Varmus, and Dr. Collins worked with the PTO on this issue to raise the bar such that patents are not granted without documentation of utility. While the PTO took steps to raise the bar, we continue to believe that the bar may still not be high enough.
Encourage sharing of biomedical research resources. Professionals working in the specialized field of biomedical licensing strive to promote a balance between commercial interests and the public interest. In those instances in which a research tool can also become a therapeutic product, licenses can be, and are, carefully craned by scope, application and field to allow use by the research community without destroying a company's commercial incentive to develop the product.
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Careful licensing that preserves this balance, however, does not always occur. The NIH has been concerned for some time about the potential adverse effects of restrictive licensing practices on access to research tools. In response to concerns from the scientific community, NIH has published guidelines on the sharing of biomedical research resources entitled, ''Principles and Guidelines for Recipients of NIH Research Grants and Contracts.'' This document helps ensure open sharing of research tools to maintain the robust research enterprise in this country. For your information, I have enclosed a copy of this guideline.
Minimize the imposition of ''reach-through'' rights. Many institutions have agreed to simplify the exchange of biological materials among investigators by supporting the use of a Uniform Biological Materials Transfer agreement. Some organizations have successfully negotiated licensing agreements that do not include inappropriate ''reach-through'' provisions. Agreements negotiated between NIH and the sources of eligible stem cells serve as a model for how this can be accomplished. The agreements provide a license to the U.S. Public Health Service to use the materials for research purposes. In addition, occasionally, industries or others holding patents or exclusive licenses to important materials (such as genetically altered mice) or methods (such as techniques for altering genes in cells) have agreed to make the protected items freely available to the not-for-profit sector.
Grant non-exclusive licenses wherever possible. The NIH negotiates non-exclusive licenses for its intramural technologies whenever possible. This allows more than one company to develop products using a particular technology, products that may ultimately compete with each other in the marketplace. We recognize that companies need an exclusive market to offset the risk, time, and expense of developing biomedical diagnostic or therapeutic products. However, companies do not necessarily need to achieve that position solely by exclusively licensing a Government technology used to develop the product. Instead, companies are frequently able to add their own proprietary technologies to the invention licensed from the Government to achieve ultimately some level of uniqueness and exclusivity for the final product. If non-exclusive licensing does not provide enough incentive for the company to develop a product, and it often does not for a potential therapeutic application, NIH will award exclusivity for specific indications or fields of use, based on the license applicant's commercial development plans at the time of the application. NIH also provides for exclusive licensees to grant sub-licenses to broaden the development possibilities when necessary for the public health. Finally, NIH insists on the continuing unencumbered availability of the licensed technology to the not-for-profit scientific community for further research.
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Encourage Public Disclosure of Inventions. The NIH has held the view that basic and fundamental information about DNA, in the absence of a clear pathway to a product should be available to all. Thus, we have fostered a policy of free and unfettered access to genome sequencing data funded by the Federal Government. At present, more than 95 percent of the 3.1 billion bases of the human genome are freely available in public databases and the remainder will be freely available once deciphered. Public access to genetic information optimizes the chances that further research will be done, leading to advances in treating human disease.
Q1c. Would a statutory research exemption (an exemption from gene patent infringement for purposes of basic research) be helpful to NIH and/or its grantees?
A1c. There may be some value in having a formalized general exemption for research. Such an exemption, however, may be difficult to craft. One issue would be differentiating between the various situations and types of organizations that participate in research. For example, would the exemption be available based on who conducts the research activity? How would such an exemption distinguish between a non-profit organization that conducts research leading to a new product from a for-profit organization that conducts research and develops a new product? Should such an exemption be available based on the type of individual/entity undertaking the project or based on the nature of the project itself? These are challenging issues. Adding to the complexity is the fact that tremendous advances have been made in biomedical science due to companies developing and disseminating biological materials for use as research tools, many of which are patented. These companies provide a vital service to the scientific community and most do not seek reach through or other types of rights. NIH would be pleased to provide technical assistance should you be interested in pursuing this idea further.
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Q1d. Do you believe that there is a significant difference in the way patents on genetic materials and patents on other innovations impact innovation?
A1d. There may be a difference in the way gene patents affect innovation. In particular, patenting of genes for which the actual biological function has not yet been firmly established treads into territory that in the past would have been considered public domain. Such patents may actually present a disincentive for others to undertake further studies of gene function, since the intellectual property has already been claimed. While this ''tragedy of the anticommons'' (as it has been called by Professor Rebecca Eisenberg) may have some parallels in other areas of intellectual property, the magnitude of the potential effect may be greater for gene patents than in. any other area.
Q1e. Please provide your views on H.R. 3966 and H.R. 3967, two bills which I have introduced that deal with human gene patenting.
A1e. Since the Administration has not yet taken a position on H.R. 3966 and H.R. 3967, NIH is not at liberty to provide you with specific comments. We would be happy, however, to meet with you to provide technical assistance on these bills.
Q2. During last fall's anthrax attacks, there was discussion of the Government exercising ''march-in-rights'' on Bayer's patent on Cipro.
A2. We are not aware of any comments on the part of the Government to exercise any march-in rights on Bayer's patent on Cipro. ''March-in'' is a term used under the Bayh-Dole Act for an agency's right to require licensing of a subject invention when the agency has determined that the contractor, or an assignee or an exclusive licensee of the contractor, has failed take appropriate action to move toward practical application of the subject invention or other actions as specified by the law (see 35 U.S.C. 203). We are not aware of any technology that is a part of Cipro which was developed with Federal funds. Therefore, march-in rights could not be exercised in this case. March-in would only apply to specific federally-funded inventions; it would not apply to privately-developed inventions.
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There had been some press accounts suggesting that Secretary Thompson had threatened to issue a compulsory license to Bayer's patent. In fact, the Secretary never threatened to require compulsory licensing of Bayer's patent on Cipro. Patent holders' intellectual property rights are protected by law against uncompensated governmental use or manufacture through 28 U.S.C. 1498. Moreover, there was no need for the Secretary to exercise this power in the situation with Bayer. The Secretary was able to negotiate a historic agreement with Bayer that ensured an unprecedented production of Cipro.
Q2a. Under what circumstances can the Government mandate that the owner of a patent grant licenses to others?
A2a. There is no general authority for the Government to mandate that the owner of a patent grant licenses to others. As noted earlier, ''march-in'' rights only apply to subject inventions and do not apply to privately developed inventions.
Q2b. If the Government did exercise its ''march-in-rights,'' what impacts on industry would you predict?
A2b. It is difficult to estimate the economic impact of march-in on any particular company, but the company would have the right to make a claim for reasonable and complete compensation.(see footnote 1) We are sure that corporate America would agree that when the health and safety of the Nation is at risk, the judicious exercise of this authority is not unwarranted.
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Enclosure A—Nature, February 2002
Enclosure B—''Principles and Guidelines for Recipients of NIH Research Grants and Contracts''
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As noted earlier, march-in rights would not apply to privately-funded inventions.