[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]



                    REDUCING THREATS TO OUR NATION'S
                  AGRICULTURE: AUTHORIZING A NATIONAL
                     BIO AND AGRO-DEFENSE FACILITY

=======================================================================

                                HEARING

                               before the

                        SUBCOMMITTEE ON EMERGING
                      THREATS, CYBERSECURITY, AND
                         SCIENCE AND TECHNOLOGY

                                 of the

                     COMMITTEE ON HOMELAND SECURITY
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             FIRST SESSION

                               __________

                              MAY 23, 2007

                               __________

                           Serial No. 110-40

                               __________

       Printed for the use of the Committee on Homeland Security
                                     
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  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
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                     COMMITTEE ON HOMELAND SECURITY

               BENNIE G. THOMPSON, Mississippi, Chairman

LORETTA SANCHEZ, California,         PETER T. KING, New York
EDWARD J. MARKEY, Massachusetts      LAMAR SMITH, Texas
NORMAN D. DICKS, Washington          CHRISTOPHER SHAYS, Connecticut
JANE HARMAN, California              MARK E. SOUDER, Indiana
PETER A. DeFAZIO, Oregon             TOM DAVIS, Virginia
NITA M. LOWEY, New York              DANIEL E. LUNGREN, California
ELEANOR HOLMES NORTON, District of   MIKE ROGERS, Alabama
Columbia                             BOBBY JINDAL, Louisiana
ZOE LOFGREN, California              DAVID G. REICHERT, Washington
SHEILA JACKSON LEE, Texas            MICHAEL T. McCAUL, Texas
DONNA M. CHRISTENSEN, U.S. Virgin    CHARLES W. DENT, Pennsylvania
Islands                              GINNY BROWN-WAITE, Florida
BOB ETHERIDGE, North Carolina         MARSHA BLACKBURN, Tennessee
JAMES R. LANGEVIN, Rhode Island      GUS M. BILIRAKIS, Florida
HENRY CUELLAR, Texas                 DAVID DAVIS, Tennessee
CHRISTOPHER P. CARNEY, Pennsylvania
YVETTE D. CLARKE, New York
AL GREEN, Texas
ED PERLMUTTER, Colorado
VACANCY

       Jessica Herrara-Flanigan, Staff Director & General Counsel
                     Rosaline Cohen, Chief Counsel
                     Michael Twinchek, Chief Clerk
                Robert O'Connor, Minority Staff Director

                                 ______

   SUBCOMMITTEE ON EMERGING THREATS, CYBERSECURITY, AND SCIENCE AND 
                               TECHNOLOGY

               JAMES R. LANGEVIN, Rhode Island, Chairman

ZOE LOFGREN, California              MICHAEL T. McCAUL, Texas
DONNA M. CHRISTENSEN, U.S. Virgin    DANIEL E. LUNGREN, California
Islands                              GINNY BROWN-WAITE, Florida
BOB ETHERIDGE, North Carolina        MARSHA BLACKBURN, Tennessee
AL GREEN, Texas                      PETER T. KING, New York (Ex 
VACANCY                              Officio)
BENNIE G. THOMPSON, Mississippi (Ex 
Officio)

                    Jacob Olcott, Director & Counsel
        Dr. Chris Beck, Senior Advisor for Science & Technology
                       Carla Zamudio-Dolan, Clerk
       Dr. Diane Berry, Minority Senior Professional Staff Member

                                  (ii)
















                            C O N T E N T S

                              ----------                              
                                                                   Page

                               STATEMENTS

The Honorable James R. Langevin, a Representative in Congress 
  From the State of Rhode Island, Chairman, Subcommittee on 
  Emerging Threats, Cybersecurity, and Science and Technology:
  Oral Statement.................................................     1
  Prepared Statement.............................................     2
The Honorable Michael T. McCaul, a Representative in Congress 
  From the State of Texas, Ranking Member, Subcommittee on 
  Emerging Threats, Cybersecurity, and Science and Technology:
  Oral Statement.................................................     3
  Prepared Statement.............................................     4
The Honorable Bennie G. Thompson, a Representative in Congress 
  From the State of Mississippi, Chairman, Committee on Homeland 
  Security.......................................................     5
The Honorable Bob Etheridge, a Representative in Congress From 
  the State of North Carolina....................................    19

                               Witnesses

Dr. Edward Knipling, Administrator, Agricultureal Research 
  Service, U.S. Department of Agriculture:
  Oral Statement.................................................    11
  Prepared Statement.............................................    13
    Accompanied by:
Mr. Kevin Shea, Assistant Administrator, Animal and Plant Health 
  Inspection Service, U.S. Department of Agriculture.............    18
Dr. John Vitko, Head Chemical and Biological Division, Science 
  and Technology Directorate, U.S. Department of Homeland 
  security:
  Oral Statement.................................................     7
  Prepared Statement.............................................     8

 
                    REDUCING THREATS TO OUR NATION'S
                  AGRICULTURE: AUTHORIZING A NATIONAL
                     BIO AND AGRO-DEFENSE FACILITY

                              ----------                              


                        Wednesday, May 23, 2007

             U.S. House of Representatives,
                    Committee on Homeland Security,
           Subcommittee on Emerging Threats, Cybersecurity,
                               and Science, and Technology,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 1:58 p.m., in 
Room 311, Cannon House Office Building, Hon. James Langevin 
[chairman of the subcommittee] presiding.
    Present: Representatives Langevin, Thompson, Christensen, 
Etheridge, and McCaul.
    Mr. Langevin. [Presiding.] The subcommittee will come to 
order. The subcommittee is meeting today to receive testimony 
on the need for a national bio-and agro-defense facility.
    Good afternoon, and welcome to the Subcommittee on Emerging 
Threats, Cybersecurity, and Science and Technology hearing on 
the need to reduce threats to our nation's agriculture sector.
    Today, the subcommittee will receive testimony regarding 
the National Bio-and Agro-Defense Facility, known as NBAF. We 
are all well aware that biological threats, both man-made and 
naturally occurring, present a real danger to the security of 
the United States. In previous hearings, we have heard from 
experts on how best to protect against a variety of biological 
threats and how to strengthen programs like BioShield, to 
effectively procure countermeasures. Today, we will focus our 
attention on protecting against zoonotic diseases, which affect 
both animals and humans, and can be devastating to our 
agricultural sector.
    The agriculture industry is a critical component of our 
economy and is responsible for much of our nation's food 
supply. We must therefore do everything possible to ensure its 
safety and security, and this includes strengthening our 
defenses against zoonotic diseases. Investing in research and 
development will yield new and innovative technologies and 
allow us to effectively combat these diseases. These advances 
will aid in our understanding of disease transmission and 
development of countermeasures to mitigate disease outbreaks.
    For over 50 years, the Plum Island Animal Disease Center 
has served this nation as a key research facility for foreign 
animal diseases. That facility is now over a half-century old, 
and both of the departments represented here today agree that 
an upgraded facility is necessary. For years, Plum Island was 
one of many animal disease research centers run by the U.S. 
Department of Agriculture, and it fulfilled a unique function 
partly due to its placement on an island off the U.S. mainland.
    Current law, which dates back to 1948, requires that live 
foot-and-mouth disease virus must be studied on an island to 
protect against an outbreak on the U.S. mainland. This law has 
served us well through the years, but experts, including our 
witnesses today, believe that current containment technology is 
safe enough for this virus to be studied on the U.S. mainland 
within the confines of a proper facility.
    Today, we will hear from officials both from DHS and USDA 
on a proposal to change current law to allow for a National 
Bio-and Agro-Defense Facility. The NBAF will be a new and 
secure facility--located on the mainland--capable of housing a 
broad range of zoonotic diseases. The NBAF will significantly 
enhance our knowledge of these agents and will advance our 
capability to produce effective countermeasures.
    We have certainly seen the devastation that can be caused 
by the outbreak of zoonotic diseases, such as foot-and-mouth 
disease. The outbreak of foot-and-mouth disease in the United 
Kingdom in 2001 caused 2,000 cases of the disease in farms 
throughout the British countryside. To stop the spread of the 
disease, seven million sheep and cattle were killed, and all 
together the crisis is estimated to have cost Britain eight 
billion pounds, the equivalent of $15 billion.
    This crisis emphasizes the ongoing need for foot-and-mouth 
disease research to provide vaccines and other countermeasures 
to protect the cattle, dairy, pork and sheep industries. It 
also highlights the importance of having a state-of-the-art 
facility with BioSafety Level 3 and 4 capabilities to ensure 
that the diseases studied there will not present a threat to 
the food and agriculture sectors of our economy. I believe that 
the proposed facility can meet these challenges, and I laud 
both the Department of Homeland Security and the Department of 
Agriculture for their forward thinking on this issue.
    As you know, the committee is currently working on a bill 
introduced by Ranking Member McCaul to authorize such a 
facility. I am a proud cosponsor of that legislation and I 
commend the ranking member for his leadership on this issue. 
The committee has been talking to our colleagues on the 
Committee on Agriculture, members of the administration 
represented by our witnesses here today, and several 
professional organizations regarding the bill language. We 
appreciate the feedback of our experts, such as our witnesses 
here today, and we plan to have the bill ready for a markup in 
a few weeks.
    I again want to thank the witnesses for being here today, 
and I look forward to your testimony.
    The chair now recognizes the ranking member of the 
subcommittee, the gentleman from Texas, Mr. McCaul, for an 
opening statement.

 Prepared Opening Statement of the Honorable James Langevin, Chairman, 
   Subcommittee on Emerging Threats, Cybersecurity, and Science and 
                               Technology

         Good Afternoon.
         Today the subcommittee will receive testimony 
        regarding the National Bio-and Agro-Defense Facility (NBAF).
         As this subcommittee has become well aware due to 
        numerous hearings on the topic, biological threats, both 
        manmade and naturally occurring, present a real danger to the 
        security of the United States.
         A critical piece of our defenses against such threats 
        are scientific and technological advances in our understanding 
        of disease transmission, and development of countermeasures to 
        mitigate disease outbreaks.
         The Agriculture industry is one of the backbones of 
        our economy.
         In addition to economic impacts, zoonotic diseases, 
        those diseases that affect both animals and humans, are a 
        threat to public safety.
         For over 50 years, the Plum Island Animal Disease 
        Center has served this nation as a key research facility for 
        foreign animal diseases.
         That facility is now over 50 years old and both of the 
        Departments represented here today agree that an upgraded 
        facility is necessary.
         Plum Island was for years one of many animal disease 
        research centers run by the U.S. Department of Agriculture 
        (USDA).
         It did fulfill a unique function, however, because of 
        it's placement on an island off the U.S. mainland.
         Current law, which dates back to 1948, requires that 
        live foot and mouth disease virus be studied on an island to 
        protect against an outbreak on the U.S. mainland.
         This law has served us well through the years, but 
        experts, including our witnesses today, believe that current 
        containment technology is safe enough for this virus to be 
        studied on the U.S. mainland within the confines of a proper 
        facility.
         No one takes this proposed change in policy lightly.
         The outbreak of foot and mouth disease in the United 
        Kingdom in 2001 caused 2,000 cases of the disease in farms in 
        most of the British countryside.
         To stop the spread of the disease, seven million sheep 
        and cattle were killed.
         The crisis is estimated to have cost Britain #8 
        billion pounds or $15 billion.
         This crisis emphasizes the ongoing need for foot and 
        mouth disease research to provide vaccines and other 
        countermeasures to protect the cattle, dairy, pork, and sheep 
        industries.
         It also highlights the importance of having a state of 
        the art facility with BioSafety Level 3 and 4 capabilities to 
        ensure that the diseases studied there will not present a 
        threat to the food and agriculture sectors of our economy.
         I believe that the proposed facility can meet these 
        challenges, and I commend both the Department of Homeland 
        Security and the Department of Agriculture for their forward 
        thinking on this issue.
         As you know, the committee is currently working on a 
        bill introduced by Ranking Member McCaul to authorize such a 
        facility.
         I am a proud cosponsor of that legislation.
         The committee has been talking to our colleagues in 
        the Committee on Agriculture, members of the administration 
        represented by our witnesses today, and several professional 
        organizations regarding the bill language.
         We appreciate the feedback of our experts and we plan 
        to have the bill ready for a markup in a few weeks.
         The information that we receive today will continue to 
        inform that process.
         I thank the witnesses for being here today and I look 
        forward to you testimony.

    Mr. McCaul. I thank the chairman for holding this hearing 
today.
    I must say, while I was disappointed that my provision 
authorizing the National Bio-and Agro-Defense Facility was 
stripped from the DHS authorization bill, I do appreciate and 
applaud your efforts and Chairman Thompson's to move H.R. 1717 
as a stand alone bill, and look forward to marking it up in the 
coming weeks.
    I realize that the problem we ran into with this provision 
being included in the authorization, along with many others, 
were due to overlapping interests with other committees. Even 
so, I don't think there is any disagreement that NBAF is a 
crucial component to our nation's strategy to defend against 
agro-terrorism, and that NBAF will address unmet needs.
    As I have stated before, there is currently no BSL-4 
capability for research on zoonotic diseases, and we shouldn't 
let turf battles prevent the department from addressing these 
issues and having the tools that it needs to protect this 
country. My staff is currently in the process of fine-tuning 
H.R. 1717, along with your staff, to make it clear that NBAF 
will be a coordinated interagency effort with an over-arching 
homeland security mission. They are reaching out to the 
relevant stakeholders in the agricultural community such as the 
National Cattlemen's Beef Association and the Animal 
Agriculture Coalition to ensure that H.R. 1717 addresses and 
meets the needs of the agricultural community.
    Clearly, the time is right now to foster collaboration 
between veterinary medicine, human medicine, public health and 
the environmental health sciences. DHS is positioned to do this 
with NBAF. Through the years, DHS's fundamental research and 
DHS's targeted advance development of this facility will help 
protect the veterinary, food and agriculture industries of the 
United States.
    I hope we--``we'' being the congressional committees with 
the oversight of agro-terrorism activities--can lead by example 
and present a unified effort to move H.R. 1717 forward.
    I want to thank our witnesses for appearing here today. I 
hope your due diligence and the NBAF site selection process 
continues unabated as we look to this future capability. I look 
forward to hearing from each of you about how you are working 
together on foreign animal and zoonotic disease research and 
how that relationship will transition when NBAF stands up.
    I yield back my time.

Prepared Opening Statement of the Honorable Michael T. McCaul, Ranking 
 Member, Subcommittee on Emerging Threats, Cybersecurity, and Science 
                             and Technology

         Thank you Chairman Langevin for holding this hearing 
        today. While I was deeply disappointed that my previously 
        accepted provision authorizing the National Bio and Agro-
        Defense Facility was stripped from the DHS Authorization bill 
        at the last minute, I appreciate your efforts to move HR 1717 
        as a stand alone bill and look forward to marking it up in the 
        coming weeks.
         I recognize that part of the problem we ran into on 
        this provision, and with many others that were removed from the 
        authorization bill, were due to overlapping interests with 
        other Committees.
         With the NBAF in particular, there is no way around 
        the interests of the homeland security and the agriculture 
        communities coinciding. The NBAF will be a facility that 
        supports the mission of not just DHS, but USDA as well and, in 
        some cases, the Department of Health and Human Services.
         The integrated nature of NBAF is the heart of the 
        issue, and it's at the heart of what will drive NBAF's success 
        in supplying our Nation with the tools it needs to combat 
        agroterrorism.
         I don't think that there is any disagreement among the 
        agencies or among the agriculture and homeland security 
        communities that NBAF is a crucial component to our Nation's 
        strategy to defend against agroterrorism, and address unmet 
        needs. HSPD 9 identified the need to increase and enhance our 
        laboratory infrastructure for studying foreign animal and 
        zoonotic diseases. NBAF will not only retain the research and 
        diagnostic development and validation now being conducted at 
        the aging Plum Island Animal Disease Center, but it will 
        greatly enhance capabilities.
         There currently is no BSL 4 capability for this type 
        of research. NBAF will provide this unique capability.
         We shouldn't let turf battles and power struggles 
        prevent the Department from having the mechanisms it needs to 
        establish this facility and open its doors to collaborative 
        research among the agencies and the agriculture community at 
        large.
         My staff is in the process of fine tuning HR 1717 to 
        make it more clear that while NBAF's walls will be owned by 
        DHS, inside you'll find a coordinated, interagency effort with 
        an overarching homeland security mission. They are reaching out 
        to the relevant stakeholders in the agricultural community, 
        such as the National Cattlemen's Beef Association and the 
        Animal Agriculture Coalition, to ensure that H.R. 1717 
        addresses and meets the needs of the agriculture community.
         The NBAF will exemplify the concept of ``one 
        medicine,'' where research will be conducted at the interface 
        of animal, human, public and ecosystem health.
         Think of the health threats that have grabbed 
        headlines over the past decade--bird flu, mad cow disease, 
        SARS, West Nile virus, monkey pox, antimicrobial resistance. 
        These have heightened awareness of the role animal populations 
        play in transmitting health risks to humans the world over.
         75% of the emerging infectious disease threats 
        affecting people in the past decade are zoonotic, meaning they 
        also affect or arise from animals. Approximately 80 % of the 
        top biological threat agents are zoonotic diseases.
         But when we speak of threats to human health, we must 
        think beyond disease transmission from animals to humans. Some 
        animal diseases, even if they don't affect human health, have 
        adverse consequences on the well being of the human population.
         For example, while Foot and Mouth Disease, a foreign 
        animal disease, only affects cows, swine, sheep, goats, and 
        other hooved animals, it also has secondary impacts on our 
        domestic and global economy. An outbreak of FMD could result in 
        billions of dollars of economic impact. Tens of thousands of 
        people would be affected with regard to jobs, income, and an 
        altered way of life.
         The Department of Homeland Security has brought a 
        sense of urgency to research efforts to produce countermeasures 
        for diseases of high consequence to humans and animals, the 
        economy, and the environment. These include the foreign animal 
        and zoonotic diseases I have mentioned.
         Clearly the time is right to embrace the one medicine 
        concept and foster collaboration between veterinary medicine, 
        human medicine, public health, and the environmental health 
        sciences.
         DHS is positioned to do this with the NBAF. Through 
        the USDA's fundamental and innovative efforts and DHS' targeted 
        advanced development, this facility will serve the future needs 
        of and help protect the veterinary, food, and agriculture 
        industries of the U.S.
         I hope we--``we'' being the congressional committees 
        with oversight of agroterrorism activities--can lead by 
        example, present a unified effort to move HR 1717 forward and 
        instill in the agencies which we oversee the same unity of 
        effort which encompasses the principle of the ``one medicine'' 
        concept.
         I want to thank our witnesses for appearing before us 
        today. I hope your due diligence in the NBAF site selection 
        process continues unabated as we look to this future 
        capability. I look forward to hearing from each of you about 
        how you are currently working together on foreign animal and 
        zoonotic disease research and diagnostics and how that 
        relationship will transition when NBAF stands up.

    Mr. Langevin. I thank the ranking member.
    The chair now recognizes the chairman of the full 
committee, the gentleman from Mississippi, Mr. Thompson, for an 
opening statement.
    Mr. Thompson. Thank you very much, Mr. Chairman. I want to 
thank you for holding this hearing on what is clearly a vital 
issue facing our nation.
    Many of us remember the stir caused when former Secretary 
of Health and Human Services Tommy Thompson announced his 
resignation, warning that the U.S. food supply could be a 
lethal target for terrorists and we are at significant risk of 
a flu pandemic.
    Homeland Security Presidential Directive 9, issued in 2004, 
identified the need for safe, secure and state-of-the-art 
biosafety laboratories that research and develop diagnostic 
capabilities for foreign animal and zoonotic diseases--those 
that infect both animals and humans. We understand that Plum 
Island Animal Disease Center in New York is currently 
performing much of this research and is nearing the end of its 
life cycle.
    The threat of foreign animal diseases, especially zoonotic 
diseases, to the public health and the agriculture industries 
has been a reality for many years. The Committee on Homeland 
Security recognizes the need for increased vigilance in 
fighting and protecting against the spread of current and 
future infectious diseases that threaten public health and 
agriculture.
    We also understand that the current research lab at Plum 
Island was designed primarily to study the accidental 
introduction of foreign disease agents, and not the additional 
research needed to prepare for an intentional bioterrorism 
attack.
    I am pleased this committee is moving forward with efforts 
to address the issue of the aging research facility, act on the 
guidance offered through HSPD-9, and assess the current working 
relationships between the DHS and USDA.
    I look forward to hearing from the witnesses today 
regarding the need for an NBAF facility and meeting the 
requirements of Homeland Security Presidential Directive 9. I 
thank the chairman for his time and I yield back the balance.
    Mr. Langevin. I thank the chairman.
    The other members of the subcommittee are reminded that 
under the committee rules, opening statements may be submitted 
for the record.
    I would like to now welcome our witnesses. Our first 
witness, Dr. John Vitko, is currently the division head of the 
Chemical and Biological Division of the Science and Technology 
Directorate in the Department of Homeland Security. In that 
role, he has the overall responsibility for all DHS S&T to 
deter, detect and mitigate a biological or chemical attack on 
the people, infrastructure, or agriculture of this nation.
    Prior to that, John was director of exploratory systems at 
Sandia National Laboratory in Livermore, California, where he 
has been since receiving his Ph.D. in physics from Cornell 
University in 1975.
    Our second witness is Dr. Edward Knipling, the 
administrator of the Agricultural Research Service. He began 
his career with the Agricultural Research Service in 1968 as a 
research plant physiologist in Gainesville, Florida. He has 
held many positions in ARS, including area director, associate 
deputy administrator, director, and deputy administrator of the 
Beltsville Agricultural Research Center. Dr. Knipling served as 
acting administrator and associate administrator of ARS in 
December 1997. Dr. Knipling was appointed administrator of ARS 
in July, 2004.
    He earned his BS degree in 1961 in forestry from Virginia 
Tech University. He received his MA degree in 1963 and Ph.D. in 
1966 in plant physiology from Duke University.
    Dr. Knipling will be giving testimony for both himself and 
our other witness, Mr. Kevin Shea. Kevin Shea was appointed 
associate administrator of the Animal and Plant Health 
Inspection Service, APHIS, on September 9, 2004. In his 
position, he is responsible for ensuring the smooth day-to-day 
functions of APHIS. Mr. Shea spent 4 years as head of APHIS's 
policy and program development staff. Before becoming director 
of PPD, Mr. Shea served as director of APHIS's budget and 
accounting division for 8 years, and similar positions within 
APHIS where he has been almost continuously since 1978, taking 
a 1 year hiatus to practice litigation.
    Mr. Shea graduated from the University of Maryland at 
College Park and earned his juris doctorate from the University 
of Baltimore School of Law.
    Gentlemen, welcome here today. Without objection, the 
witnesses' full statements will be inserted into the record. I 
will now ask each witness to summarize their statement in 5 
minutes, beginning with Dr. Vitko.
    Welcome.

  STATEMENT OF JOHN VITKO, Jr. HEAD, CHEMICAL AND BIOLOGICAL 
  DIVISION, SCIENCE AND TECHNOLOGY DIRECTORATE, DEPARTMENT OF 
                       HOMELAND SECURITY

    Mr. Vitko. Thank you. Good afternoon, Chairman Langevin, 
Ranking Member McCaul, full committee Chairman Thompson, and 
distinguished members of the subcommittee.
    My name is Dr. John Vitko. I am the head of the Chemical 
and Biological Division of the Science and Technology 
Directorate of the Department of Homeland Security. In that 
role, I have overall responsibility for all DHS science and 
technology programs related to bio-and agro-defense, and work 
very closely with our colleagues in the United States 
Department of Agriculture.
    In that role, I am pleased to appear before you today to 
speak to the need for the National Bio-and Agro-Defense 
Facility, NBAF, and to give you some idea of the important work 
that will be done there. NBAF is vitally needed to meet the 
foreign animal and zoonotic disease challenges for today and 
for the next 50 years.
    There are three key drivers underlying that need. One, 
foreign animal and zoonotic diseases can have a major impact on 
our economy, food supply and public health. The threats to the 
nation's agriculture and public health have changed 
dramatically since the time of the establishment of Plum 
Island. These changes include the globalization of travel and 
trade, the broadened size and scope of the U.S. livestock and 
agricultural industry, newly emerging diseases, and now the 
threat of agro-terrorism.
    Second, the Plum Island Animal Disease Center, which has 
been the first line of the nation's defense against foreign 
animal diseases for the past 50 years, is unable to fully 
address this growing threat of agro-terrorism. Its limited 
laboratory space, especially that for testing large animals, is 
limiting the pace of the development of vaccines for foot-and-
mouth disease, and also the ability to expand programs 
addressing the numerous other high-priority foreign animal 
diseases of concern.
    Third, the nation lacks a facility for addressing high-
consequence zoonotic diseases that infect both large animals 
and humans. The impact of disease agents such as Rift Valley 
fever, Nipah, and Hendra viruses underscore the growing threat 
posed by emerging zoonotic diseases.
    As already referenced by Chairman Thompson, the president, 
in his defense of United States agriculture and food, called 
for planning for state-of-the-art agricultural biocontainment 
laboratories that research and develop diagnostic capabilities 
for foreign animal and zoonotic diseases. That same HSPD called 
for expanding the development of current and new 
countermeasures against both intentional and natural 
introductions of those diseases.
    NBAF is being designed to fulfill both those requirements 
and to support our needs and our partners in the United States 
Department of Agriculture. NBAF will provide state-of-the-art 
biocontainment laboratories for the development, testing, and 
evaluation of diagnostics and countermeasures of foreign animal 
and zoonotic diseases.
    It will integrate those aspects of animal and public health 
research that are key to fulfilling that mission. It will help 
attract, train and retain future generations of researchers, 
technicians, diagnosticians, veterinary and medical personnel. 
By so doing, it will continue to meet evolving needs in 
defending against agro-terrorism over the next 5 decades.
    NBAF is being designed to concurrently develop multiple 
priority vaccine candidates, and to enable the broad range of 
activities needed to support that development. Those activities 
include basic research on how organisms infect animals and how 
that infection is transmitted from animal to animal; 
identification of lead candidates for new vaccines and 
antivirals; novel delivery systems, think of that as ways of 
administering medicine to speed response actions; pilot lot 
production and testing of vaccines; clinical testing to support 
licensure and for inclusion in national veterinary stockpiles; 
the development of diagnostics to rapidly identify, 
characterize and control outbreaks; and the training of 
veterinarians to establish a rapid response capability 
throughout the United States.
    NBAF will be operated in partnership with and support of 
our colleagues in the Department of Agriculture, in much the 
same manner that we are currently operating the Plum Island 
Animal Disease Center.
    In summary, NBAF is vital to meeting the agro-defense needs 
of the nation for the next 50 years, just as PIADC has been 
vital to meeting those needs for the past 50 years. Therefore, 
we at DHS are committed to making NBAF a reality to support our 
partners in the Agricultural Research Service, and in the 
Animal and Plant Health Inspection Service.
    Thank you. This concludes my testimony.
    [The statement of Mr. Vitko follows:]

               Prepared Statement of Dr. John Vitko, Jr.

INTRODUCTION
    Good afternoon, Chairman Langevin, Ranking Member McCaul, and 
distinguished members of the Subcommittee. I am pleased to appear 
before you today to discuss the Nation's critical need for the 
Department of Homeland Security's National Bio and Agro Defense 
Facility.
    There is a need for a secure, state-of-the-art agriculture 
biocontainment facility that researches and diagnoses foreign animal 
and zoonotic diseases. Currently, there is only a limited research 
laboratory capacity in the Nation for large animal BioSafety Level-3 
(BSL-3Ag) studies, and there is no BSL-4 research space for the study 
of threat agents that infect both large animals and humans. If the 
United States is to have the proper capability to rapidly identify and 
control outbreaks of high-threat foreign animal and zoonotic disease 
agents, whether natural or intentional, it must begin investing in 
additional biocontainment capacity and capability.
    Numerous infectious animal diseases are present throughout the 
world that threaten the nation's public health, agriculture and 
economy. For example, recall the foot-and-mouth disease outbreak in the 
U.K. in 2001 and the catastrophic losses that this outbreak caused that 
nation, and from which it is still recovering now six years later. The 
economic loss was well into the billions, affecting agricultural 
industries but having a wider impact on other industries including 
tourism. The impact would be far greater in the U.S, with its much 
larger livestock population, larger herds, and extensive shipment 
across the country.
    As evidenced by recent examples, including West Nile Fever and 
Avian Influenza, existing and emerging foreign animal and zoonotic 
diseases pose an immediate threat not only to our agricultural industry 
but also to our public health.
    Realizing this threat, the President issued Homeland Security 
Presidential Directive 9: Defense of the U.S. Agriculture and Food. 
HSPD-9 requires the Secretaries of Agriculture and Homeland Security , 
Health and Human Services, and the Administrator of the Environmental 
Protection Agency to ``develop a plan to provide safe, secure and 
state-of-the-art agricultural biocontainment laboratories that research 
and develop diagnostic capabilities for foreign animal and zoonotic 
diseases'' and further states that ``The Secretaries of Homeland 
Security, Agriculture. . .will accelerate and expand development of 
current and new countermeasures against intentional introduction or 
natural occurrence of catastrophic animal, plant and zoonotic 
diseases.'' As will be elaborated in the following sections, NBAF 
fulfills a critical role in meeting both these requirements and 
ensuring that the nation's public health, food and agriculture are 
protected for the next 50 years.
    In pursuing NBAF, DHS will work closely with its partners in the 
United States Department of Agriculture under the same terms and spirit 
as it currently does at the Plum Island Animal Disease Center.

The Need for NBAF
    For more than 50 years, the Plum Island Animal Disease Center 
(PIADC) has served as the nation's first defense against foreign animal 
diseases. However, the threats to the Nation's agriculture and public 
health have changed dramatically since the time of PIADC's 
establishment. These changes include the globalization of travel and 
trade, the broadened size and scope of U.S. livestock and agricultural 
industry, and now the threat of agro-terrorism. PIADC's research and 
diagnostic activities stem from its mission to protect U.S. animal 
industries and exports from deliberate or accidental introduction of 
foreign animal diseases. PIADC has been a leader in researching foreign 
animal diseases, developing diagnostics and vaccines to prevent and 
contain them, and training foreign animal disease diagnosticians to 
detect them. The Homeland Security Act of 2002 transferred the 
operations of PIADC to DHS. Since that time, the DHS Science & 
Technology Directorate has been working jointly with the United States 
Department of Agriculture's Agricultural Research Service (ARS) and 
Animal and Plant Health Inspection Service (APHIS) to meet the island's 
shared mission objectives.
    However, despite significant investments in the facility's 
infrastructure, Plum Island Animal Disease Center is unable to fully 
meet the research and diagnostic capabilities required to address the 
threat of agro-terrorism. The available laboratory space at PIADC, 
especially the large animal holding laboratory space, is limiting the 
pace at which we can develop improved veterinary countermeasures. The 
joint USDA-DHS team has made significant progress in developing next-
generation vaccines for foot-and-mouth disease. The path forward for 
such state-of-the art vaccines includes taking these discoveries 
through developmental and testing phases for licensure necessary for 
inclusion in the National Veterinary Stockpile and for eventual use by 
first responders. However, the limited animal testing space at PIADC is 
limiting the number of vaccine trials that can be conducted and 
drastically extending the time frame to complete these studies. 
Additionally, because of capacity and biocontainment constraints, PIADC 
concentrates on research and diagnostic activities for only a subset of 
the highest-consequence foreign animal diseases and cannot facilitate 
expanded research into other high priority foreign animal disease and 
emerging threats of concern.
    Additionally, BSL-4 work cannot be done at PIADC. Thus, the nation 
lacks a facility to adequately address high-consequence zoonotic 
diseases that infect both large animals and humans. The impact of 
disease agents, such as Rift Valley Fever, Nipah, and Hendra, 
underscore the growing threat posed by emerging zoonotic diseases and 
the need to establish better facilities to study them.
    To address these limitations, the planned NBAF will provide the 
infrastructure necessary to research and develop diagnostics for, and 
countermeasures to, high-consequence biological threats involving 
foreign animal and zoonotic diseases by:
         Providing state-of-the art biocontainment laboratories 
        for development, test and evaluation of countermeasures for 
        foreign animal and zoonotic diseases to support their inclusion 
        in the National Veterinary Stockpile;
         Integrating those aspects of animal and public health 
        research that are key to fulfilling that mission;
         Continuing to meet evolving needs in defending against 
        agro-terrorism threats over the next five decades.
    Plum Island Animal Disease Center's capability is a critical 
national asset and essential to protecting the U.S. agriculture economy 
and food supply. No other facility now exists in this country to 
perform this research. However, due to its age, location and outdated 
design, PIADC does not meet all of the nation's current needs. The 
planned NBAF will enable us to fully meet the challenges of intentional 
or unintentional introduction of a foreign animal disease that could 
threaten public health and the food supply over the next 50 years.

The Scope of NBAF
    NBAF is being designed to provide the Nation with the ``safe, 
secure, and state-of-the-art agriculture biocontainment laboratories'' 
(HSPD-9) needed to develop countermeasures to current, emerging and 
future foreign animal and zoonotic diseases. The facility design will 
enable concurrent development of multiple priority vaccine candidates. 
It will also meet the shared interagency mission objectives of a 
successful agro-defense strategy, including:
         basic research on how an organism infects an animal 
        and how the disease is transmitted from animal to animal;
         identification of `lead candidates' for new vaccines 
        and antivirals and novel delivery systems to better facilitate 
        response actions;
         pilot lot production and proof-of-concept testing of 
        those lead candidates;
         the development of molecular diagnostics to 
        characterize the efficacy of the new countermeasures;
         clinical testing and evaluation of the countermeasures 
        to support licensure by the USDA Center for Veterinary 
        Biologics and inclusion in the National Veterinary Stockpile;
         maintain a vaccine bank that contains a secure 
        inventory of antigens that would be used to formulate a vaccine 
        in the event of an outbreak;
         develop and test diagnostics to rapidly identify, 
        characterize, and control outbreaks;
         train veterinarians, giving them first hand experience 
        in recognizing and diagnosing high consequence foreign animal 
        diseases and thereby establishing a clinical capability for 
        rapid response throughout the U.S.
    DHS, in close coordination with USDA, is actively engaged in the 
definition of these program areas and the conceptual design of facility 
aspects to best support them. Additionally, USDA personnel are active 
participants in the NBAF site selection process. The conceptual design 
is independent of the site selected and will ensure that the NBAF's 
research requirements will be met. Such a state-of-the-art facility 
will synergize with existing veterinary, medical and public health, and 
agriculture programs and will help attract, train and retain future 
generations of researchers, technicians, diagnosticians, veterinary and 
medical personnel.
    DHS has begun taking the steps to make this vision a reality. In 
January of 2006 DHS issued a notice of request for Expressions of 
Interest (EOI) for potential sites for the NBAF in the Federal Register 
and received 29 submissions from consortia in 21 states. An interagency 
review committee (DHS, USDA, HHS and DoD) evaluated the site proposals 
using four major sets of criteria which had been published in the EOI 
notice of request:
         Site proximity to Research Capabilities that can be 
        linked to NBAF mission requirements
         Site proximity to a skilled Workforce to support NBAF 
        mission requirements
         Acquisition/Construction/Operations; and
         Community Acceptance
    Based on this initial evaluation, 12 consortia in 11 states were 
asked to submit additional information on 17 sites. That information is 
currently under review. In addition, the review team and the DHS Under 
Secretary for Science and Technology are visiting each of the sites for 
further evaluation. Following the site visits, a small number of sites 
will be selected for inclusion in the Environmental Impact Statement 
(EIS). This selection will be completed by June 2007. The final site 
selection will be determined following completion of the EIS.

    Key milestones and anticipated dates in this process are summarized 
below:




Additional information due                                February, 2007
Conduct reviews                                              March, 2007
Site visits                                             April--May, 2007
Issue Notice of Intent (NOI) announcing sites                 June, 2007
  selected for evaluation in the EIS
Begin EIS                                                     July, 2007
Complete EIS; announce site selection                      October, 2008
Begin detailed design                                     November, 2008
Begin construction                                                  2010
Facility operational                                          2013--2014


Conclusion
    In summary, the planned NBAF will play a crucial role in protecting 
the Nation against current and future foreign animal and zoonotic 
diseases, whether naturally or intentionally introduced. The list of 
such high priority diseases is already long and growing. Plum Island 
has been doing an excellent job in the defense against foreign animal 
disease threats--but the age of its facilities and its limited capacity 
is pacing the development of needed countermeasures. Further, there are 
no facilities in the Nation to fully address those zoonotic diseases 
that affect both large animals and humans and attract the scientists, 
technicians, researchers, veterinarians and medical personnel needed to 
defend against current and future threats for the next 30--50 years. 
Therefore, DHS is committed to making the planned NBAF, as the next 
generation capability to support our partners in ARS and APHIS, a 
reality.

    Mr. Langevin. Thank you, Dr. Vitko. Thank you for your 
testimony.
    I would like to now recognize Dr. Knipling to summarize 
your statement for 5 minutes.

   STATEMENT OF EDWARD KNIPLING, ADMINISTRATOR, AGRICULTURAL 
        RESEARCH SERVICE, U.S. DEPARTMENT OF AGRICULTURE

    Mr. Knipling. Mr. Chairman, Chairman Thompson, Ranking 
Member McCaul, and other members of the subcommittee, I am Dr. 
Edward Knipling, administrator of the USDA Agricultural 
Research Service. Thank you for the opportunity to appear 
before the subcommittee today to present the department's views 
on the establishment of NBAF.
    I will provide brief oral comments to summarize the 
principal points in my written testimony, and to reinforce and 
supplement those just provided by Dr. Vitko of DHS.
    First, let me acknowledge once again that accompanying me 
today from USDA is Mr. Kevin Shea, associate administrator of 
the Animal and Plant Health Inspection Services, APHIS. APHIS 
is the regulatory and operations arm of the department 
responsible for protecting and promoting U.S. agriculture, 
including diagnostics, training, and development of products 
related to the prevention and control of animal diseases.
    The ARS is the intramural science research arm of the USDA. 
We make basic science discoveries and develop new technologies 
needed and used by APHIS, DHS, other agencies, and in fact the 
entire food and agricultural system to protect and advance U.S. 
agriculture.
    My comments today will address two main points: one, the 
need for and the merits of NBAF relative to the limited 
capabilities of the existing facilities at the Plum Island 
Animal Disease Center; and two, to describe the agreements and 
mechanisms USDA and DHS already have in place to ensure 
cooperation, complementarity, and coordination of our 
respective programs and operations at Plum Island and 
elsewhere, and to be continued in the new NBAF.
    Mr. Chairman, the need to establish NBAF is basically two-
fold. First, it is needed to replace the aging facility at Plum 
Island; and second, it is needed to provide additional space 
and capability, including large animal biosafety level 4 
laboratories to study and develop controls and countermeasures 
for high-consequence foreign animal pathogens that threaten the 
U.S. livestock industry, some of which could also be 
transmitted to humans, thus threatening public health as well.
    It is already well pointed out that the current facilities 
at Plum Island are outdated, and otherwise inadequate. NBAF 
will fulfill the new needs for the nation.
    Regarding USDA and DHS cooperation and coordination, the 
Homeland Security Act of 2002 required the secretary of 
homeland security and the secretary of agriculture to enter 
into an agreement to ensure that USDA is able to carry out 
research, diagnostics and other USDA activities at Plum Island. 
Accordingly, the two agencies of USDA, ARS and APHIS, and the 
Science and Technology Directorate of DHS, entered into an 
interagency agreement dated June 1, 2003, which together with 
successor annual agreements, set forth the terms for the 
management, administration and operations at Plum Island.
    According to this agreement, a board of directors is 
composed of the directors of the DHS Science and Technology 
Directorate, and the administrators of ARS and APHIS. This 
includes Dr. Vitko, myself, and the APHIS administrator, Dr. 
Ron DeHaven, represented here today by Mr. Shea.
    Additionally, a senior leadership group composed of the on-
site leaders for each agency at Plum Island implement programs 
and policies, coordinate at the local level, and report to the 
board of directors.
    A copy of the interagency agreement document executed in 
2006 for the current 2007 fiscal year has previously been 
provided to the subcommittee for the record, along with my 
written testimony. This document also spells out in general 
terms the division of program responsibilities among the three 
agencies with respect to foreign animal diseases.
    Very simply, the role of ARS is basic and applied research. 
APHIS's responsibilities include disease diagnostics, training 
and the maintenance of a vaccine stockpile. DHS's 
responsibilities are to build upon and extend USDA's work to 
develop and evaluate advanced animal disease countermeasure 
products, in concert with the private sector. Foot-and-mouth 
disease is the primary focus of the animal pathogen work at 
Plum Island, but some other diseases are also addressed.
    The complementary and coordinated responsibilities, program 
strategies and plans of work of the three agencies are outlined 
in much greater detail in the two documents also provided to 
the subcommittee for the record. These documents are entitled, 
one, ``A Comprehensive Strategy to Combat Agro-Terrorism,'' 
issued by DHS in 2004; and the second, ``A Joint DHS and USDA 
Strategy for Foreign Animal Disease Research and Diagnostic 
Programs,'' also issued in 2004.
    Mr. Chairman, this concludes my remarks. Both Mr. Shea and 
I would be pleased to answer any questions that you have of 
USDA.
    Thank you.
    [The statement of Mr. Knipling follows:]

               Prepared Statement of Dr. Edward Knipling

    Mr. Chairman, Ranking Member McCaul, and Members of the 
Subcommittee, I am Dr. Edward Knipling, Administrator of the 
Agricultural Research Service (ARS). Accompanying me is Mr. Kevin Shea, 
Associate Administrator of the Animal and Plant Health Inspection 
Service (APHIS). ARS is the primary intramural science research agency 
of USDA, operating a network of over 100 research laboratories across 
the nation on all aspects of agricultural science. APHIS is responsible 
for protecting and promoting U.S. agricultural health, administering 
the Animal Welfare Act, and carrying out wildlife damage management 
activities.
    Thank you for the opportunity to appear before the Subcommittee 
today to present the Department's views on the establishment of the 
National Bio and Agro-Defense Facility (NBAF).
    Mr. Chairman, the need to establish this facility is basically two 
fold: First, it is needed to replace the aging foreign animal disease 
research, diagnostic and training facility at Plum Island; and, second, 
it is needed to provide additional space and capability for animal 
borne diseases that can be transmitted to humans. Homeland Security 
Presidential Directive No. 9 (HSPD-9) identifies the need for ``safe, 
secure, and state-of-the-art agricultural biocontainment facilities to 
research and develop diagnostic capabilities for foreign animal and 
zoonotic diseases.'' Current limitations at existing facilities result 
in a backlog of needed space for important experiments, diagnostics, 
and training efforts.
    Despite the planned replacement of the Plum Island Animal Disease 
Center (PIADC) with NBAF, the PIADC must continue to operate during 
NBAF construction and beyond to allow adequate transition to the new 
facility and eventual facility decommissioning at Plum Island. It is 
estimated that PIADC facilities must operate for about the next 7--10 
years. The highest priority for facility upgrade includes the 
construction of additional animal holding (experiment) facilities 
(10,000 ft2) and expansion of the necropsy room capacity. The 
additional capacity is needed to address the coordinated USDA-DHS 
vaccine development program over the next 7--10 years.
    The upgrade and expansion of the necropsy facility will also 
improve our current educational facility for the foreign animal disease 
(FAD) training schools carried out by APHIS at PIADC. APHIS conducts 
these training schools on Plum Island to ensure that our Nation's corps 
of foreign animal disease diagnosticians--those specially trained 
veterinarians immediately dispatched by APHIS to investigate and, if 
necessary, respond to possible introductions of exotic animal diseases 
into the United States--have the latest scientific and technical 
information and skills necessary to carry out their work. APHIS also 
conducts its confirmatory testing for extremely contagious foreign 
animal diseases, such as foot-and-mouth disease (FMD), at the PIADC. In 
addition, the Agency houses the North American Foot-and-Mouth Disease 
vaccine bank on PIADC. The bank ensures that if FMD were to be found in 
North America and vaccination was to be used as a tool in the ensuing 
control and eradication program, adequate supply of vaccine would be 
quickly available to animal health officials.
    Under Section 310(a) of the Homeland Security Act of 2002, the 
Secretary of Agriculture transferred PIADC to the Secretary of Homeland 
Security, including the assets and liabilities of PIADC. Section 310(b) 
of the Act required the Secretary of Homeland Security and the 
Secretary of Agriculture to enter into an agreement upon such transfer 
to ensure that USDA is able to carry out research, diagnostic, and 
other activities of USDA at PIADC. USDA-ARS, USDA-APHIS and DHS-S&T 
entered into an Interagency Agreement dated June 1, 2003, (``the FY03 
Agreement) which together with successor agreements sets forth the 
Parties' agreements regarding the management, administration, and 
operations of PIADC, and the Parties' respective rights and 
responsibilities for research, diagnostic, and development activities 
at PIADC. According to this agreement, a Board of Directors (BOD) is 
composed of the Directors or Administrators of APHIS, ARS and DHS-S&T 
Directorate. A Senior Leadership Group (SLG), composed of the senior 
administrators of each agency at PIADC, executes the FY03 Agreement, 
implements policies, coordinates at the local level and reports to the 
BOD.
    DHS's work currently focuses primarily on FMD; whereas ARS, in 
addition to FMD, also addresses other diseases, specifically classical 
swine fever and vesicular stomatitis. A FMD countermeasure roadmap was 
prepared in 2004 to coordinate DHS and ARS activities. According to 
this document, ARS would maintain responsibility for basic research, 
and DHS would focus on product development. A high priority disease 
diagnostic roadmap was prepared in 2006 to coordinate DHS, ARS, and 
APHIS activities in this area.
    Mr. Chairman this concludes my remarks. We would be happy to answer 
any questions at this time.

    Mr. Langevin. Thank you, Dr. Knipling.
    I want to thank all the witnesses for their testimony 
today.
    I will remind each member that he or she will have 5 
minutes to question the panel. I now recognize myself for 
questions.
    To the panel, as I mentioned in my opening remarks, and as 
Dr. Vitko also stated, an outbreak of foot-and-mouth disease, 
otherwise known as FMD, could be extremely damaging to the 
agricultural sector and our overall economy in general. One of 
the major concerns regarding NBAF is, of course, the studying 
of live foot-and-mouth disease virus on the U.S. mainland, 
which has historically been studied on Plum Island.
    You all seem to be in agreement that FMD can be safely 
studied on the mainland. Can you please explain in more detail 
for the committee what protective measures would be in place 
and what improvements in technology have occurred to make such 
research safe? Is there any extra concern with respect to foot-
and-mouth disease that, for example, wouldn't be present with 
other pathogens such as ebola or hantavirus that would need to 
have particular concern as to why it should be studied off the 
mainland.
    This has caused concern among some in Congress and I am 
hoping that you can shed a little more light on this so that we 
can all feel comfortable that this is the right decision.
    Mr. Vitko. I would be happy to answer that first. Ed and 
Kevin may choose to add to that.
    First of all, let me say that the handling of FMD poses no 
additional concerns beyond the agents that you talked about, 
ebola and Marburg. In fact, those are much more serious because 
of their human consequences and the lack of countermeasures 
against those.
    The advances in technology that have occurred since the 
mid-1950s when Plum Island was established is in the sealing, 
containment, filtration of air systems within any of the 
biocontainment rooms, and with the development of specialized 
suits to protect those researchers from exposure to agents that 
might infect them. That technology has been successfully 
demonstrated and used for the last couple of decades, in fact, 
for dealing with the diseases that you mentioned, ebola, 
Marburg, smallpox, other highly contagious diseases.
    Mr. Knipling. Mr. Chairman, I would support those comments 
by Dr. Vitko. I would just reinforce the notion that the 
physical standards by which facilities are constructed and 
operated in terms of air pressures, filtration and so forth, 
prevent the escape of the pathogens to the environment. Foot-
and-mouth disease per se is not a zoonotic, that is, not a 
threat to human health. It is highly contagious to livestock. 
The off-shore island requirement, originally that statute goes 
all the way back to 1884, with just the extra measure of 
protection to protect the U.S. livestock industry.
    We have more than a 50-year record of safety, and along 
with the new biocontainment facility technology, we can safely 
conduct this research on the mainland.
    Mr. Langevin. Very good. Thank you.
    Dr. Knipling, your testimony mentioned that the Animal 
Research Service, ARS, has the responsibility for basic 
research, and the FMD the countermeasures roadmap, while DHS 
focuses on the development of the candidate countermeasures. 
Dr. Knipling, can you tell me what the focus of your research 
on FMD is? And Dr. Vitko, can you tell me more about 
countermeasures development?
    I would also like to ask you to characterize the work that 
is being done now, again, at Plum Island, and compare that work 
to what you envision occurring at NBAF.
    Mr. Knipling. Mr. Chairman, I would characterize our 
complementary and coordinated programs as a linear spectrum of 
activities progressing from the basic sciences to product 
development and then actual application for the industry and so 
forth.
    In terms of the basic research of ARS, we are looking at 
the fundamentals of the virus itself, that there are many 
different strains of the foot-and-mouth disease virus, for 
example. Current work stresses genomics, molecular biology, 
diagnostic techniques. And then the development of the 
innovative and unique vaccines for protection.
    We would hand off, then, these basic discoveries to DHS and 
other organizations to further develop them.
    Mr. Langevin. Thank you.
    Mr. Vitko. Picking up on that point, one specific example, 
as you may know, there is a great deal of interest in 
developing the next generation of FMD vaccines that allow one 
to differentiate infected versus vaccinated animals--an 
important issue for resuming trade should an outbreak occur.
    The researchers at ARS have identified several promising 
candidates for such DIVA vaccines. We have then taken those 
candidates, produced them in pilot-like quantities that then 
allow their testing against significant numbers of large 
animals--cattle in this case--to establish their initial 
efficacy. Now, we have begun working with a private supplier, 
an industrial partner, in scaling up that production to 
manufacturing scale lot sizes, so that we can then go on and do 
additional tests of the onset of immunity and the duration of 
immunity that are needed for licensure of this product by the 
Center for Veterinary Biologics, and for ultimate transition by 
APHIS into the National Veterinary stockpile.
    Mr. Langevin. Thank you, Mr. Vitko.
    I now recognize the ranking member of the subcommittee, the 
gentleman from Texas, Mr. McCaul, for questions.
    Mr. McCaul. I thank the chairman.
    I think to identify the need for this facility, we need to 
identify what the threat is, both from a natural standpoint, 
that could impact the food supply, but also man-made to agro-
terrorism. I wanted to see if the panel could expand upon what 
they perceive as the real threat out there, but then also the 
question of, you know, Plum Island is a level 3 facility; NBAF 
would be a level 4. I have visited level 4 facilities.
    Can you expand upon the difference there? What type of 
threat agents could be addressed at NBAF as opposed to the 
level 3 facility at Plum Island?
    Mr. Vitko. As I understand it, you have two parts to your 
question. One was around the relevant threats and how agro-
terrorism is different; and then the second around the agents 
and the different containment facilities and their 
requirements.
    Mr. McCaul. That is correct.
    Mr. Vitko. With respect to the first, agro-terrorism 
actually poses significant different threats than just a 
natural outbreak, in several major ways. We have been fortunate 
in this country that in the past the threat of foreign diseases 
would come primarily across our borders. In that case, we would 
have some knowledge of the strain that is coming and the 
introduction point would be a single or small number of 
introduction points.
    Agro-terrorism, with a conscious act or behind it, means 
that the strain could come from anywhere in the world, whether 
we have seen it or not, or have it near us or not. And it would 
be introduced not necessarily just in one location, but could 
be introduced in multiple locations. And it might not just be 
one. It might be several different ones.
    So this adds a great deal of complexity to the problem of 
what we need to address, and it shortens the timeframe that we 
have for addressing anything that we encounter.
    Now, with respect to the differences between biosafety 
level containment 3 and 4, in biosafety level containment 3, we 
have the kinds of features that both myself and Dr. Knipling 
talked about before, which was that we have control on the 
airflow and the air pressures and filtration to control the 
presence of the agent, and hoods, and that is the primary 
complement for protecting that.
    That BSL-3 is perfectly fine for dealing with agents that 
don't have significant effects on humans or for which, if they 
have effects on humans, there are readily available 
countermeasures. In those cases where that is not the case, so 
in human diseases, as we mentioned before, Marburg, ebola, 
smallpox, and in the zoonotic diseases, particularly Nipah and 
hantaviruses, where there are not readily available 
countermeasures and which can also infect humans, then there 
are additional precautions taken for protecting the worker in 
terms of suiting up restrictions, interlocks for getting in and 
out, working protocols, and those are applied.
    It is important to realize that NBAF will not be all BSL-4. 
Much of NBAF will be BSL-3 because of the need for studying a 
large number of foreign animal diseases that are in fact not 
zoonotic. But where they are zoonotic and at a high level, then 
they would be studied in a level-4 facility.
    Mr. McCaul. Thank you.
    Any of the other panel members?
    Mr. Knipling. I would add that another way to characterize 
the difference between biosafety level 3 and 4 is that the 
extra measures for level 4 are primarily to protect the human 
workers--the workers actually working in the facility. In terms 
of the laboratory physical structure and all of the air 
handling and access controls, those would be largely the same. 
But it is important that we obviously protect the workers in 
the laboratory itself, and of course prevent these pathogens 
from escaping into the environment where they could affect not 
only the livestock industry, but human health as well.
    Mr. McCaul. In my home state--and I see my time is running 
out, so I want to get this last question in--of Texas, Texas 
A&M has a National Center for Foreign Animal and Zoonotic 
Disease Research. How would you, to the panel, envision NBAF 
tying into that facility in terms of the research already being 
conducted there?
    Mr. Vitko. Currently, FASDC, the Foreign Animal Zoonotic 
Disease Center, in fact already works with Plum Island Animal 
Disease Center on both its vaccine development and its 
diagnostic development. What FAZDC does and what the consortium 
there does is develop new vaccine candidates that need to be 
tested. What NBAF would do is provide that kind of testing, but 
it would allow us to address a broader range of foreign animal 
diseases and zoonotic threats.
    Mr. McCaul. Any of the other witnesses?
    Mr. Knipling. I would just add that most all of our ARS 
laboratories across the country--some 100 facilities on all 
aspects of agricultural science--are mostly co-located with the 
land-grant universities, including Texas A&M. We have many 
examples of collaborations and cooperation with our partners in 
the university system.
    As Dr. Vitko said, right now at Plum Island, the programs 
now exist at Plum Island, the research programs are cooperative 
with Texas A&M and a number of the other university partners 
around the country, where the work can be done that doesn't 
require the on-site biosafety level 3. In some cases, those 
university cooperators come to the island and work in our 
facilities.
    Mr. McCaul. Mr. Shea? Okay.
    I yield back my time. Thank you.
    Mr. Langevin. I thank the gentleman.
    The chair now recognizes the chairman of the full 
committee, Mr. Thompson, the gentleman from Mississippi, for 
questions.
    Mr. Thompson. Thank you very much, Mr. Chairman.
    Dr. Knipling, you mentioned the relationship between DHS 
and USDA as a result of the transfer of Plum Island. Can you 
expound a little bit on how that relationship has developed 
since the transfer?
    Mr. Knipling. I would characterize it as a very fine 
relationship. Right from the start, we realized we had a shared 
responsibility. Both departments, and then within USDA, both 
ARS and APHIS have cooperated quite well right from the 
beginning. We have developed this governing structure. We have 
quarterly meetings and we address those issues.
    So I would characterize that working relationship as quite 
fine.
    Mr. Thompson. One particular aspect of that relationship 
was in the area of agriculture inspectors and how we were able 
to transfer that. Can you say to the committee whether or not 
the transfer has been successful? And CBP and everybody is 
happy now that it is one?
    Mr. Shea. Mr. Chairman, I will discuss that because that is 
part of the APHIS agency.
    Mr. Thompson. Right.
    Mr. Shea. We are working very closely with CBP, and have 
been from the beginning. We are making great strides. There are 
former APHIS employees who had the leadership roles within CBP 
over the agriculture function. We worked very closely with 
them.
    Yes, there are some challenges there, but most of the 
challenges we face in that program would have occurred 
regardless of any reorganization--increased international 
traffic, the threat of terrorism, new kinds of agricultural 
pests and pathways all exist. That is what we really have to 
deal with.
    I should also add that many of the functions of the entire 
agricultural quarantine inspection system remained with APHIS. 
APHIS sets the regulations on what can come into the country 
and not. APHIS does the risk assessments to determine that. 
APHIS has many roles still in this, working closely with CBP 
and we think that it is, indeed, getting better every day.
    Mr. Thompson. So those who might have reluctance about the 
relationship and how it has morphed into what it is today, your 
testimony is that you are satisfied that it is moving forward, 
you are being successful, and, short of any just basic things 
that come up, we are moving forward?
    Mr. Shea. Absolutely. We think it is moving forward. And 
Mr. Chairman, I know that we are all aware that some proposals 
have been made to return the inspection function to APHIS. Just 
yesterday, both Secretary Johanns and Secretary Chertoff 
jointly signed a letter to Senator Feinstein and others 
opposing such a move, because we do think that things are 
moving along very well, and we need to focus on continuing that 
improvement.
    Any change in the organizational structure we think would 
be disruptive. It would delay the improvements that we are 
jointly making between USDA and CBP. We do not think it is a 
good idea.
    Mr. Thompson. Can you provide the committee with a copy of 
this letter, jointly signed by the two secretaries?
    Mr. Shea. Absolutely, sir. We can do that.
    Mr. Thompson. All right. Mr. Chairman, I would like at 
whatever point to include that letter as part of the record for 
this hearing.
    Mr. Langevin. Without objection.
    Mr. Thompson. The last item is, have we been able to 
increase the number of inspectors since we have transferred 
that responsibility to DHS?
    Mr. Shea. Since the day of the transfer, the number of 
agricultural inspectors actually on board has increased by 30 
percent. There were over 300 vacancies at the time of the 
transfer. CBP has filled all those vacancies, plus added more 
inspectors since then.
    Mr. Thompson. Thank you.
    I yield back, Mr. Chairman.
    Mr. Langevin. Just on that point, to follow up, do those 
inspectors also go overseas? Are there overseas facilities, or 
is that just here in the United States?
    Mr. Shea. The CBP inspectors are only here in the United 
States. APHIS still sends some inspectors overseas to pre-clear 
certain items, for example bulbs from Holland. So there is 
still some of that activity within APHIS, but not within CBP.
    Mr. Langevin. Was the inspection process more robust 
overseas prior to the transfer?
    Mr. Shea. The system is exactly the same.
    Mr. Langevin. Okay. Thank you.
    The chair now recognizes the gentleman from North Carolina, 
Mr. Etheridge, for questions.
    Mr. Etheridge. Thank you, Mr. Chairman.
    Gentlemen, thank you for being here today. Let me ask you a 
question, because by and large, Plum Island, as you have 
testified in your opening comments, has pretty much focused on 
foot-and-mouth disease, that has been one of the primary 
issues. As you well know, that is still a concern of the 
public, obviously, from what we have seen and what has 
happened.
    Even though it is popularly known as mad cow disease, H5N1, 
the highly pathogenic Asian influenza and many other diseases 
could potentially devastate American agriculture as well, just 
as easily.
    My question is, how are USDA and DHS addressing these 
diseases now? And number two, how would NBAF improve federal 
research and the response efforts to these and possibly other 
epidemics that we don't know about, but certainly could pop up 
in the future?
    Mr. Knipling. With respect to avian influenza, there is a 
facility at Athens, Georgia, a biosafety level 3 facility at 
Athens, Georgia, that addresses avian influenza and has for 
more than 25 years. Fortunately, much of the information we 
know and the technology we have in place today was based upon 
the research investments made many years ago.
    It is envisioned that--
    Mr. Etheridge. That was before the tremendous growth we 
have seen in recent years.
    Mr. Knipling. That is correct. Yes.
    Mr. Etheridge. Thank you.
    Mr. Knipling. At this point, in terms of the generic 
program of NBAF, it is not planned to do poultry research in 
the new facility, although the facility is being designed very 
generically and could adapt to any new issues or priority that 
comes along, including poultry. But there are separate 
initiatives within USDA to strengthen the avian influenza 
capability at Athens, Georgia in terms of facilities and 
expanded programs.
    The mad cow disease, the transmissible spongiform 
encephalopathy, that work is being done at Ames, Iowa under 
biocontainment. We have an extensive program there on various 
aspects of that pathogen. These programs are, in turn, 
coordinated with APHIS and DHS as well.
    Mr. Etheridge. Since you mentioned it, let me ask one other 
question along that line. Currently, the secretary of 
agriculture has the authority to grant permits to federal 
agencies, state and local governments, or private persons to 
study live foot-and-mouth disease on the U.S. mainland, as you 
have indicated. To date, the secretary has not done so, and 
therefore FMD is only studied at Plum Island, as you have 
talked about, although it is studied on the mainland in Canada.
    My question is: Do you believe the secretary intends to 
grant such a permit to DHS for the NBAF facility? Or is 
congressional authority going to be required?
    Mr. Knipling. It is our expectation that the secretary of 
agriculture will authorize FMD work to be done on the mainland 
in NBAF, and that would be for all agencies. The USDA programs 
now at Plum Island will be a component of the NBAF facility. So 
yes, the secretary of agriculture intends to do that.
    Mr. Etheridge. He intends to do that. Okay, thank you. That 
is important for this committee to know, simply because of the 
authorization level.
    Secondly, what risks are there to studying FMD on the 
mainland? And how will you address this by biosecurity at NBAF? 
We need to know that, obviously. You touched on it earlier, but 
I thought I would give you an opportunity to talk about that 
specifically.
    Mr. Knipling. Well, certainly the risk is that the 
pathogen, the live virus, would escape the facility in some 
manner, either through physical air movement or breaches in the 
physical security, or a careless worker might inadvertently 
carry the pathogen to the outside. But that is what biosafety 
level 3 protocols and structures and various rigorous adherence 
to that is designed to prevent.
    Mr. Etheridge. In the last few seconds I have, is it 
possible to weaponize foot-and-mouth disease? Certainly, I 
think a lot of us, certainly in North Carolina where I am from, 
with the tremendous population we have, are really concerned 
after what happened in Europe, whether or not it could just be 
intentionally spread in areas. I know that is a major concern, 
and whoever wants to tackle that one, it would be fine with me.
    Mr. Vitko. The answer is yes. Intentional introduction of 
FMD is a realistic and possible concern and needs to be 
addressed.
    Mr. Etheridge. I hope you will share with us your thoughts 
as to how we need to address it.
    Mr. Vitko. That is exactly what we are all working on, 
which is through the development of vaccines to give the 
animals immunity, but also antivirals for the period to which 
the immunity starts. So to mark some of the progress that has 
occurred at Plum, and then give you an idea of what needs to be 
done, one of the things we have done over the past couple of 
years is characterized five of the FMD vaccines that currently 
exist in the North American FMD vaccine bank, and ensure that 
they have onset of immunity within 7 days.
    We have also had promising results on antivirals for 
bridging that timeframe. The challenge with FMD is that it is a 
virus that changes rapidly and exists in different, if you 
will, flavors. So you need to have vaccines against each of 
those individual serotypes or strains. It is the process of 
developing those that are sequential processes in the current 
limited space. So even doing that, we would be able to 
accelerate if we have NBAF.
    Mr. Etheridge. Thank you, sir.
    Thank you, Mr. Chairman.
    Mr. Langevin. Thank you.
    To follow up on that question, first, is it any more likely 
that FMD could be weaponized than, say, mad cow disease? And 
also, as we move into the next generation of bioweapons 
countermeasures, and we basically move to one drug for many 
bugs, would that type of technology protect us against the 
different mutations of FMD that you just spoke about?
    Mr. Vitko. I think it is fair to say that FMD spreads much 
more rapidly than BSE will. Okay? That is the big thing about 
FMD is it is highly virulent. It is easily transmitted and will 
spread through your animal infrastructure.
    With respect to drugs that deal with many different 
strains, the broad-spectrum drugs, that is exactly the kind of 
research that is being pursued, some by the ARS folks, some by 
Texas A&M and others, that are looking to take advantage of 
advances in genomic understanding. We have done the genome of 
the whole cow, to try to get that understanding and see what we 
can do along those ways. That is still in the research stage.
    The next generation of vaccines are still targeted at 
individual vaccines for each of the major serotypes and 
strains, but again allow you to differentiate vaccinated from 
infected animals.
    Mr. Langevin. Okay, very good.
    I want to thank the witnesses for their valuable testimony, 
and the members for their questions. The members of the 
subcommittee may have additional questions for the witnesses. 
We will ask that you respond expeditiously in writing to those 
questions.
    Hearing no further business, the subcommittee stands 
adjourned.
    [Whereupon, at 2:48 p.m., the subcommittee was adjourned.]

                                 
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