[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
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.gpoaccess.gov/congress/
index.html
__________
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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.]