Order Code RL34160
The National Bio- and Agro-Defense Facility:
Issues for Congress
Updated November 15, 2007
Dana A. Shea
Specialist in Science and Technology Policy
Resources, Science, and Industry Division
Jim Monke
Specialist in Agricultural Policy
Resources, Science, and Industry Division
Frank Gottron
Specialist in Science and Technology Policy
Resources, Science, and Industry Division

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The National Bio- and Agro-Defense Facility: Issues for
Congress
Summary
The agricultural and food infrastructure of the United States is potentially
susceptible to terrorist attack using biological pathogens. In addition to the impacts
of such an attack on the economy, some animal diseases could potentially be
transmitted to humans. (These diseases are known as zoonotic diseases.) Scientific
and medical research on plant and animal diseases may lead to the discovery and
development of new diagnostics and countermeasures, reducing the risk and impact
of a successful terrorist attack.
To safeguard the United States against animal disease, Congress has
appropriated funds to the U.S. Department of Agriculture (USDA) to engage in
research at the Plum Island Animal Disease Center (PIADC), off the coast of New
York, on animal diseases not native to the United States. When creating the
Department of Homeland Security (DHS) in 2003, Congress transferred the PIADC
facility from USDA to DHS, though USDA continues its own research programs at
the facility. However, the DHS, in cooperation with USDA, has established a foreign
animal disease research program at PIADC. The DHS has identified PIADC as
outdated and too limited to continue as the primary research facility.
Homeland Security Presidential Directive 9 tasks the Secretaries of Agriculture
and Homeland Security to develop a plan to provide safe, secure, and state-of-the-art
agriculture biocontainment laboratories for research and development of diagnostic
capabilities and medical countermeasures for foreign animal and zoonotic diseases.
To partially meet these obligations, DHS has requested appropriations to construct
a new facility, the National Bio- and Agro-Defense Facility (NBAF). This facility
would house high-containment laboratories able to handle the pathogens currently
under investigation at PIADC, as well as other pathogens of interest. The DHS plans
to select the site in 2008 and open NBAF in 2014. The final construction cost will
depend on the site location and may exceed the $451 million projected cost. The
DHS has not yet determined what actions to take with the PIADC when construction
of the NBAF is completed.
The plans announced by DHS to establish the NBAF have raised several issues
that may prove to be of interest to Congress. Community concerns about safety and
security, previously raised about PIADC and other laboratories being built to study
dangerous pathogens, are also being raised about the NBAF. Coordination between
DHS and USDA, as well as prioritization and investment in agricultural biodefense
may be reassessed once more high-containment laboratory space becomes available.
By law, research on live foot and mouth disease (FMD) virus is not permitted
on the U.S. mainland. This policy would need to be changed before DHS could
proceed with its plans to conduct FMD research at NBAF if it were sited on the U.S.
mainland. Three bills introduced in the 110th Congress, each taking different
approaches, would modify this law (H.R. 1717, H.R. 2419, and S. 2302).

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Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
NBAF Research Goals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
NBAF Funding and Site Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Facility Site Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Expressions of Interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Prospective Sites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Finalists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Policy Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Permission to Work with Foot and Mouth Disease . . . . . . . . . . . . . . . . . . . . 8
H.R. 1717 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
S. 2302 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
USDA’s Proposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
H.R. 2419 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Need for and Scope of NBAF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Coordination of Research Activities with Other Agencies . . . . . . . . . . . . . 13
Timeliness of Construction Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Future Use of PIADC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Community Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
List of Tables
Table 1. Initially Projected NBAF Funding Requirements (2005) . . . . . . . . . . . . 4
Table 2. NBAF Funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Table 3. Changing NBAF Funding Projections . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Table 4. Consortia Selected by DHS after Expression of Interest . . . . . . . . . . . . 7
Table 5. Finalists for NBAF Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

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The National Bio- and Agro-Defense
Facility: Issues for Congress
Introduction
The agricultural and food infrastructure of the United States is a key component
of economic productivity and growth. A terrorist attack on this infrastructure could
damage the public trust in agricultural safety and quality and the nation’s ability to
provide food and other agricultural products.1 Additionally, many animal diseases
can infect humans.2 These types of diseases are termed zoonotic. Scientific and
medical understanding of such zoonotic diseases in their animal hosts may protect
the animals themselves and could also lead to the discovery and development of new
medical countermeasures for humans.
To safeguard the United States against the impacts of naturally occurring and
intentional animal disease outbreaks, the U.S. Department of Agriculture (USDA)
engages in animal disease research, including research into highly contagious animal
pathogens and animal diseases not native to the United States.3 Such research
activities have historically been performed at the Plum Island Animal Disease Center
(PIADC), located on an island near Long Island, NY.
When creating the Department of Homeland Security (DHS) in 2003, Congress
transferred the operation of the PIADC facility from USDA to DHS, though USDA
still maintains an active research program at PIADC. The DHS, in cooperation with
USDA, has established its own research and development program at PIADC. As the
federal government undertakes new efforts in human biodefense and defense against
agroterrorism, DHS has identified the PIADC facility as “reaching the end of its life
cycle” and lacking critical capabilities to continue as the primary facility performing
this research.4
Homeland Security Presidential Directive 9 (HSPD-9) tasks the Secretaries of
Agriculture and Homeland Security to develop “a plan to provide safe, secure, and
state-of-the-art agriculture biocontainment laboratories that research and develop
1 For more background on the potential of terrorism against agriculture and food, see CRS
Report RL32521, Agroterrorism: Threats and Preparedness, by Jim Monke.
2 Examples include influenza, plague, West Nile Virus, and Rift Valley Fever.
3 These diseases are sometimes referred to as foreign animal diseases (FAD).
4 Department of Homeland Security, FY2006 Science and Technology Directorate
congressional budget justification, p. 44.

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diagnostic capabilities for foreign animal and zoonotic diseases.”5 The Secretary of
Homeland Security is to coordinate an acceleration and expansion of development
of current and new countermeasures against the intentional introduction or natural
occurrence of catastrophic animal, plant, and zoonotic diseases, including
countermeasure research and development of new methods for detection,
prevention technologies, agent characterization, and dose response relationships
for high-consequence agents in the food and the water supply.6
The Department of Homeland Security has announced that, to meet the
obligations of HSPD-9, it will establish a new facility, the National Bio- and
Agro-Defense Facility (NBAF).7 This facility would contain high-containment
laboratories able to hold the pathogens currently under investigation at PIADC as
well as other pathogens of interest. The plans announced by DHS to establish the
NBAF have raised congressional and public concerns regarding its safety and
security and policy questions about coordination between DHS and USDA regarding
the research to be conducted at NBAF.
This report outlines current progress towards establishment of the NBAF,
presents current and projected funding levels and timelines, and describes policy
issues of potential interest to Congress, such as agency coordination, possession of
viruses, construction timelines, and community safety concerns.
NBAF Research Goals
The DHS intends the new NBAF to be more than just a replacement facility for
PIADC; DHS intends it to exceed both the capacity and capabilities of the Plum
Island laboratories. The highest level of biocontainment available at PIADC is
Biosafety Level 3 Agricultural (BSL-3Ag).8 Because DHS plans to perform some
5 Executive Office of the President, The White House, “Subject: Defense of United States
Agriculture and Food,” Homeland Security Presidential Directive/HSPD-9, January 30,
2004.
6 Ibid.
7 72 Fed. Reg. 41764-41765.
8 Biosafety levels for pathogens and the recommended protective measures at each biosafety
level are developed by the Department of Health and Human Services. Department of
Health and Human Services, Centers for Disease Control and Prevention and National
Institutes of Health, Biosafety in Microbiological and Biomedical Laboratories, 5th Edition,
February 2007, available online at [http://www.cdc.gov/OD/ohs/biosfty/bmbl5/
bmbl5toc.htm]. The BSL-3Ag containment level was established by the USDA for research
with certain pathogens in large animal species. U.S. Department of Agriculture,
Agricultural Research Service, ARS Facilities Design Standards, 242.1-M ARS, July 24,
2002, available online at [http://www.afm.ars.usda.gov/ppweb/PDF/242-01M.pdf].

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experiments with some pathogens that require a higher level of protection,
approximately 10% of the NBAF’s net square footage would be BSL-4 laboratories.9
The DHS foresees multiple uses and goals for the new facility:

! serving as a unique BSL-3 and BSL-4 livestock laboratory capable
of developing countermeasures for foreign animal diseases;

! providing advanced test and evaluation capability for
threat
detection, vulnerability assessment, and countermeasure assessment
for animal and zoonotic diseases; and

! supporting countermeasure licensure.10
The research agenda for NBAF is to be at least partially based on current risk
assessments and subject to change as the risk assessments change. The DHS predicts
that the facility will focus on foot and mouth disease (FMD), classical swine fever,
African swine fever, Rift Valley fever, Nipah virus, Hendra virus, contagious bovine
pleuropneumonia, and Japanese encephalitis.11 The DHS plans to perform research
at NBAF to study how these pathogens enter the animal, what types of cell the
disease affects, what effects the disease has on cells and animals, and how newly
developed countermeasures help the animal develop protection against the disease.
NBAF Funding and Site Selection
Funding
In the DHS Science and Technology FY2006 congressional budget justification,
DHS provided a NBAF project schedule that included a summary of major
milestones, a projected time line for meeting the milestones, and projected funding
requirements by fiscal year to launch operation of a new facility in 2010. See Table
1.
9 For example, research on Nipah virus must be performed in a BSL-4 laboratory. Since the
United States has limited space to perform large animal research under BSL-4 containment,
U.S. scientists have gone outside the country, for example to Canada, to conduct such
experiments. Testimony by James Roth, Director, Center for Food Security and Public
Health, Iowa State University, before the Senate Committee on Agriculture, Nutrition, and
Forestry, July 20, 2005, available online at [http://agriculture.senate.gov/
Hearings/hearings.cfm?hearingid=1572&witnessId=4472].
10 71 Fed. Reg. 3107-3109.
11 Department of Homeland Security, Facility Research & Staffing for the National Bio and
Agro-Defense Facility, June 12, 2007. Available online at [http://www.dhs.gov/xres/labs/
gc_1181073261627.shtm].

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Table 1. Initially Projected NBAF Funding Requirements (2005)
($ in millions)
FY2005
FY2006
FY2007
FY2008
FY2009
FY2010
Total
3
23
73
129
129
94
451
Source: DHS Science and Technology Directorate, FY2006 congressional budget justification.
Actual NBAF funding has not followed this schedule. See Table 2. The DHS
has requested, and received, appropriations at a lower level than initially projected
in 2005. The DHS Science and Technology FY2006 congressional budget
justification stated that NBAF funding began in FY2005 when “$3 M was received
for a planning and feasibility study from base funding of Biological
Countermeasures.”12 However, DHS has subsequently clarified that the FY2005
funding was used elsewhere in DHS and that FY2006 and FY2007 appropriations
funded these studies.13 In FY2006, Congress appropriated $23 million to select a site
and conduct other pre-construction activities.14 In FY2007, an additional $23 million
was appropriated for site selection and other pre-construction activities.15 The
FY2007 DHS Appropriation Act also included a $125 million rescission of
unobligated prior year appropriations from Science and Technology Directorate
accounts. As part of its implementation of this law, DHS removed $11 million from
the FY2006 NBAF appropriation.16 For FY2008, the President’s budget requests $11
million to continue progress on the NBAF. Both the House and Senate FY2008
Homeland Security appropriations bills include the $11 million as requested by the
Administration (H.R. 2638, H.Rept. 110-181; S. 1644, S.Rept. 110-84).
12 Department of Homeland Security, FY2006 Science and Technology Directorate
congressional budget justification, p. 45.
13 Department of Homeland Security, personal communication, September 10, 2007.
14 H.Rept. 109-241 to accompany H.R. 2360 (P.L. 109-90), p. 78.
15 H.Rept. 109-699 to accompany H.R. 5441 (P.L. 109-295), p. 168.
16 Department of Homeland Security, personal communication, September 10, 2007.

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Table 2. NBAF Funding
($ in millions)
Action
FY2005
FY2006
FY2007
FY2008
DHS Allocation
3
DHS Reallocation
(3)
P.L. 109-90
23
P.L. 109-295
(11)
23
FY2008 Budget Request
11
Total Appropriations
0
12
23
pending
Costs Projected in 2005
(from Table 1)
3
23
73
129
Source: CRS calculations based on DHS 2006 congressional budget justification, H.Rept. 109-241,
H.Rept. 109-699, and DHS personal communication.
The DHS has changed the expected completion date for the NBAF facility from
2010 to 2014.17 A full cost schedule is not publicly available. In the February 2005
projection, DHS anticipated requesting funding throughout the construction process,
including the year DHS expected to open the facility, 2010. This raises questions
about whether the total cost of the NBAF facility will increase due to the extension
of the construction schedule. Subsequent DHS budget requests have not updated the
projected overall funding requirements. It remains unclear how this delay will affect
the future annual appropriations requests and the total cost of the project.18
The DHS Science and Technology Five-Year Research Plan projects the NBAF
costs to be $436.5 million for FY2007-FY2011. Including the $12 million in
FY2006 brings the cumulative total for FY2005-FY2011 to $448.5 million. See
Table 3. The DHS states that the overall construction cost will depend on the site
selected and that site-specific infrastructure costs may increase the total cost above
$451 million.19 Additional delays to the construction schedule may further change
the final cost of the facility due to changing material and labor costs.20
17 Department of Homeland Security, Science and Technology Directorate, Five-Year
Research and Development Plan, Fiscal Years 2007-2011, May 2007.
18 The DHS was directed to “submit a project schedule, including expected completion dates
and funding requirements for all phases of the project, to the Committees on
Appropriations” by H.Rept. 109-699. H.Rept. 109-699 to accompany P.L. 109-295, p. 168.
19 Department of Homeland Security, Science and Technology Directorate, Five-Year
Research and Development Plan, Fiscal Years 2007-2011, May 2007 and Department of
Homeland Security, personal communication, September 10, 2007.
20 Material and labor costs may be higher or lower at the time of construction than at the
time of the initial projection. An increase in total cost due to increased material expense
occurred during construction of another DHS high containment biological laboratory, the
(continued...)

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Table 3. Changing NBAF Funding Projections
($ in millions)
Year of
FY05
FY06
FY07
FY08
FY09
FY10
FY11
Total
Projection
2005
3.0
23.0 73.0
129.0
129.0 94.0
0
451.0
2007
0a
12.0a
23.0
11.0
45.6
184.9
172.0
448.5b
Source: CRS calculations and Department of Homeland Security, FY2006 congressional budget
justification; Department of Homeland Security, Science and Technology Directorate, Five-Year
Research and Development Plan, Fiscal Years 2007-2011, May 2007; and DHS, personal
communication September 10, 2007.
a. These numbers were not included in the DHS projection, but are taken from actual funding, see
Table 2.
b. The DHS did not include costs beyond FY2011 in this five year projection, although they predict
construction to continue until 2014.
The two DHS project schedules differ in the pace of anticipated funding
requests. The initial NBAF project schedule planned to receive the bulk of its
appropriated funding in the years immediately before facility completion. In contrast,
the funding schedule provided in the Five-Year Research and Development Plan,
Fiscal Years 2007-2011 plans to receive the bulk of the NBAF construction funding
up to four years prior to facility completion. The DHS may be attempting to account
for NBAF’s full funding requirements within the 2007 five-year plan.21
Facility Site Selection
The DHS has stated that the establishment of the NBAF would be a multi-stage
process. This process involves:
! obtaining expressions of interest to be the site of the NBAF;
! selecting prospective sites from these expressions of interest and
requesting further information;
! assessing the information provided and visiting these prospective
sites;
! narrowing the number of prospective sites to a list of final sites;
! preparing environmental impact studies of the final sites;
! choosing a site for the NBAF; and
! constructing the facility.
20 (...continued)
National Biodefense Analysis and Countermeasures Center. See CRS Report RL32891, The
National Biodefense Analysis and Countermeasures Center: Issues for Congress, by Dana
A. Shea.
21 The DHS states that no additional funds beyond those reported in the five year plan are
expected to be requested, barring site-specific infrastructure costs. DHS, personal
communication, September 10, 2007 and DHS, personal communication, October 4, 2007.

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The stages of the DHS process will be addressed below. The DHS is now at the
stage of requiring environmental impact studies of the final potential sites.
Expressions of Interest. In January 2006, DHS issued a Request for
Expressions of Interest from consortia interested in hosting NBAF. Consortia
responding to the DHS request included academia, industry, and non-profit institutes.
In its request, DHS described four criteria that the agency would use when
considering the expressions of interest:
! research capabilities,
! workforce,
! acquisition/construction/operating expertise, and
! community acceptance.22
Prospective Sites. In August 2006, DHS selected, from the 29 expressions
of interest, 18 sites to submit more information with respect to the four criteria. One
site was later removed from consideration by its sponsoring consortium. Although
17 sites were under consideration, only 12 consortia were involved. Some consortia
submitted multiple possible sites that were selected by DHS.23 See Table 4. An
intergovernmental review group, which included DHS, USDA, the Department of
Health and Human Services, and the Department of Defense, assessed the additional
information. The DHS then visited each site to validate the information provided and
to observe the sites.
Table 4. Consortia Selected by DHS after Expression of Interest
Consortium
Site Location
University of California/Lawrence Livermore National Laboratory
CA
Georgia Consortium for Health and Agro-Security (2 sites)
GA
Heartland BioAgro Consortium (2 sites)
KS
Kentucky and Tennessee NBAF Consortium
KY
Mid-Atlantic Bio-Ag Defense Consortium
MD
Gulf States Bio and Agro-Defense Consortium (3 sites)a
MS
University of Missouri at Columbia NBAF Consortium
MO
North Carolina Consortium for the NBAF
NC
Oklahoma State University Consortium
OK
Texas A&M University and the NBAF Consortium
TX
Texas Biological and Agro-Defense Consortium (3 sites)
TX
Wisconsin Consortium
WI
Source: DHS, online at [http://www.dhs.gov/xres/labs/gc_1170798884583.shtm].
a. One site was withdrawn from consideration in April 2007.
22 71 Fed. Reg. 3107-3109.
23 See online at [http://www.dhs.gov/xres/labs/gc_1170798884583.shtm].

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Finalists. Following the site visits, DHS selected five sites in July 2007 to
complete an Environmental Impact Statement (EIS). See Table 5. The DHS has
requested public input into the selection process through the EIS process and public
hearings.24 Following completion of the EISs, DHS expects to choose a site by
October 2008.
Table 5. Finalists for NBAF Site
Consortium
Location
University of Georgia
Georgia Consortium for Health and Agro-Security
Athens, GA
Kansas State University
Heartland BioAgro Consortium
Manhattan, KS
Flora Industrial Park
Gulf States Bio and Agro-Defense Consortium
Madison County, MS
Umstead Research Farm
North Carolina Consortium for the NBAF
Granville County, NC
Texas Research Park
Texas Biological and Agro-Defense Consortium
San Antonio, TX
Department of Homeland Securitya
Plum Island, NY
Source: DHS, online at [http://www.dhs.gov/xres/labs/gc_1184180641312.shtm] and 72 Fed. Reg.
41764-41765 (July 31, 2007).
a. According to DHS, although not included in the competitive selection process described above, the
DHS-owned PIADC will also be considered as a potential NBAF site.
Policy Issues
Policy issues relating to NBAF include limits on possession of certain
pathogens, the need for and scope of NBAF, coordination among agencies, the
NBAF construction schedule, and community concerns. Congress is considering
bills, H.R. 1717, H.R. 2419, and S. 2302, that would affect NBAF operations. The
Administration, through USDA, also has proposed legislative language.
Permission to Work with Foot and Mouth Disease
Some animal diseases, such as foot and mouth disease (FMD), are considered
highly contagious and have the potential to seriously harm the national economy if
livestock or other domestic animals are infected. The danger of accidental release
of FMD virus is difficult to quantify. While such a release has not occurred in the
24 Additional information on the potential sites and dates for public meetings about the EIS
are available at 72 Fed. Reg. 41764-41765.

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United States, accidental release from a research laboratory has occurred elsewhere.25
An accidental or intentional release of FMD virus could lead to an FMD outbreak.
The consequences of an FMD outbreak could be high.26 The likelihood of such
an outbreak, given modern biocontainment equipment and the security required under
the agricultural select agent regulations and DHS facility guidance, could be very
small.
To lessen the likelihood that an accidental laboratory release of FMD might
reach domestic animals, importation of FMD virus is prohibited, and research on live
FMD virus is limited to locations outside of the mainland of the United States. Only
if the Secretary of Agriculture provides an explicit permit under 21 U.S.C. 113a may
research on live FMD virus be performed on the mainland of the United States.27
Currently, the USDA performs FMD research only at PIADC.
The PIADC must also conform to the regulations of the Agricultural Select
Agent Program promulgated by USDA.28 Under these regulations, biological agents,
25 The July/August FMD outbreak in the United Kingdom has been associated with a likely
breach of biosecurity in a waste water drainage system at the nearby Pirbright research
facility. The investigation also identified inadequate controls on the movement of people
and vehicles from the site. (Health and Safety Executive, Final Report on Potential
Breaches of Biosecurity at the Pirbright Site 2007, September 7, 2007, available online at
[http://www.hse.gov.uk/news/archive/07aug/finalreport.pdf]. See also Martin Enserink, John
Travis, and Jocelyn Kaiser, “Labs Suspected in Foot-and-Mouth Crisis,” ScienceNOW
Daily News, August 6, 2007.)
26 Estimates of the economic impact of an FMD outbreak vary. A 2002 Purdue University
and USDA study found that an FMD outbreak in the U.S. similar to the 2001 outbreak in
the United Kingdom could reduce farm income by $14 billion. Price Waterhouse Coopers
determined loss ratios for the 2001 U.K. outbreak. When applied to the U.S. livestock
industry, the potential impact is estimated at $10 billion to $33 billion. A University of
California study in 1999 estimated the potential impacts of an FMD outbreak in California
at between $8.5 and $13.5 billion. (Beth Lautner and Steve R. Meyer, “U.S. Agriculture in
Context: Sector’s Importance to the American Economy and Its Role in Global Trade,” in
Terrence K. Kelly, Peter Chalk, James Bonomo, John Parachini, Brian A. Jackson, and Gary
Cecchine, The Office of Science and Technology Policy Blue Ribbon Panel on the Threat
of Biological Terrorism Directed Against Livestock, CF-193-OSTP, 2004, pp. 111, 113-114,
available online at [http://www.rand.org/pubs/conf_proceedings/2005/CF193.pdf]). A 2002
National Defense University study estimated that a limited outbreak of FMD on just 10
farms could have a $2 billion financial impact. (Henry S. Parker, Agricultural Bioterrorism:
A Federal Strategy to Meet the Threat, McNair Paper 65, National Defense University,
March 2002, available online at [http://www.ndu.edu/inss/McNair/mcnair65/McN_65.pdf]).
27 Because of concerns about the economic damage that might arise from the release of the
pathogen that causes foot and mouth disease into domestic animal stocks, Congress enacted
prohibitions in 1948 against performing research within the mainland of the United States.
21 U.S.C. 113a prohibits the Secretary of Agriculture from introducing live foot and mouth
disease virus to the mainland of the United States unless the Secretary determines it is
necessary and in the public interest.
28 The agricultural select agent regulations are codified at 9 C.F.R. 121 and 7 C.F.R. 331.
(continued...)

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such as pathogens and toxins, that pose a severe threat to public, animal, or plant
health have been identified and listed as “select agents.” The FMD virus is a select
agent. Entities that possess, use, or transfer these select agents are required to
develop security plans for protecting the select agents, register with the USDA
Animal and Plant Health Inspection Service (APHIS), and become certified as
eligible to possess select agents. Researchers handling select agents must pass a
security review by the Department of Justice.
When PIADC was transferred to DHS, the Secretary of Agriculture retained the
authority to prevent FMD research from being performed on the mainland of the
United States. If the NBAF is located on the mainland of the United States and is to
perform high-value foreign animal disease research, researchers at the facility will
likely need to receive such permission from the Secretary of Agriculture to perform
FMD research.29
While some experts might construe this permission as a formality, since, under
HSPD-9, DHS and USDA are to coordinate their activities in food and animal
disease research, others might see it as a potential barrier to effective and efficient
use of the NBAF. They might seek to provide the Secretary of DHS with
independent authority to perform FMD research.
H.R. 1717. As amended by the House Homeland Security Committee, H.R.
1717 would instruct USDA to issue a permit to DHS for FMD research at the NBAF.
Other existing requirements under the agricultural select agent regulations would
continue to apply, and DHS would have to meet them for the permit to remain valid.
Although this provision would compel USDA to issue a permit allowing DHS to
possess the virus, it would continue to vest authority for determining who may
possess the virus with USDA. H.R. 1717, as introduced, would have given DHS
independent authority to possess FMD virus, notwithstanding 21 U.S.C. 113a.30
S. 2302. As reported by the Senate Agriculture Committee, section 11048 of
the Senate version of the 2007 farm bill would address the possession of live foot and
mouth disease virus. It takes an approach similar to the reported version of H.R.
1717. It instructs USDA to issue a permit, under the existing provision of 21 U.S.C.
28 (...continued)
A comparable program exists for select agents that might infect humans. It is overseen by
the Centers for Disease Control and Prevention on behalf of the Department of Health and
Human Services. These select agent regulations are codified at 42 C.F.R. 73.
29 The Administrator of the Agricultural Research Service, Department of Agriculture, has
testified that, “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.” See Testimony by Edward Knipling,
Administrator, Agricultural Research Service, Department of Agriculture, before the House
Committee on Homeland Security, Subcommittee on Emerging Threats, Cybersecurity, and
Science and Technology, on May 23, 2007.
30 See footnote 27.

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113a, to DHS for possession of FMD virus at the NBAF, but the permit is subject to
compliance with select agent regulations.
USDA’s Proposal. USDA’s comprehensive proposal for the 2007 farm bill
included a provision to revise 21 U.S.C. 113a.31 The USDA provision would allow
USDA to conduct research on foot and mouth disease on the U.S. mainland. It would
prohibit anyone else from importing, transporting, or maintaining viruses that would
be on a USDA-prescribed list, unless the Secretary of Agriculture issues a permit.
However, the USDA provision also states it would not apply to select agents. This
last section of USDA’s proposal appears to negate the previous two provisions with
respect to FMD virus, since FMD virus is an agricultural select agent.
The USDA proposal appears to be inherently contradictory, as it establishes a
prohibition against entities other than the Secretary of Agriculture possessing FMD
virus without the permission of the Secretary of Agriculture, but then exempts FMD
virus from these prohibitions. The net effect of the USDA provision may be removal
of any permitting restrictions for FMD virus, thus allowing research to be performed
by those compliant with the agricultural select agent regulations.
H.R. 2419. The House-passed version of the 2007 farm bill, H.R. 2419,
contains most of the USDA proposal for foreign animal disease research labs,
including the apparently contradictory language that exempts select agents from the
permit requirements established in the bill. Unlike the USDA proposal, H.R. 2419
does not explicitly state that this provision replaces 21 U.S.C. 113a.32
Analysis. H.R. 1717, the Senate-reported farm bill (S. 2302, section 11048),
and the House-passed farm bill (H.R. 2419, section 7108) have different
ramifications for DHS’s possession of FMD and other high-consequence animal
disease viruses. H.R. 1717 and the Senate farm bill would make DHS eligible to
possess and conduct research with FMD and other high consequence animal viruses
through a USDA permit under 21 U.S.C. 113a. This eligibility would be still subject
to USDA’s authority to revoke its mandated permit, as well as its authority under the
agricultural select agent regulations.
Under the House-passed farm bill, the language leads to possibly contradictory
interpretations. The apparent contradiction in establishing a permitting process for
FMD virus possession — while excluding select agents, including FMD virus, from
this permitting process — might lead to confusion in the interpretation of the
regulatory effect of this language. This contradiction could be resolved if USDA
chose to no longer regulate FMD virus as a select agent, a decision within its
authority. However, this action might be viewed as weakening other important
security controls on FMD virus. Additionally, depending on legislative intent,
section 7108 might be interpreted as revising 21 U.S.C. 113a or instead as retaining
21 U.S.C. 113a and establishing a parallel permitting process. Finally, a plain text
reading of section 7108 might even lead to the interpretation that FMD virus research
31 See USDA’s 2007 farm bill proposal, section 7303, online at [http://www.usda.gov/
documents/fbresearch0507_1.pdf].
32 This language is found in section 7108 of H.R. 2419.

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CRS-12
is not allowed, as this section authorizes the establishment of research laboratories
working on “animal diseases in the United States,” something that FMD arguably is
not, rather than the establishment of research laboratories in the United States
working on animal diseases.33
Need for and Scope of NBAF
Other agencies and organizations in addition to DHS have identified needs that
could be met by the NBAF. At least as early as 1999, USDA recognized a need for
a BSL-4 facility capable of handling large animals. In response to a mandate by
Congress,34 USDA commissioned a strategic planning task force that recommended
that the “Agricultural Research Service must consider upgrading current Level 2 and
Level 3 bio-containment units for animals and constructing a Level 4 unit.”35 In
2005, the National Research Council (NRC) echoed the need for a BSL-4 facility
capable of handling large animals. The NRC also concluded that PIADC was at the
end of its life cycle and that it should be “replaced urgently.”36
While USDA and DHS have repeatedly stated their need for a new BSL-4
facility, it is less clear how large this facility should be. In response to questions for
the hearing record, DHS asserted that
Site criteria and requirements for NBAF were developed by an interagency
technical working group, including DHS, USDA, and HHS to evaluate sites that
would best support research in high-consequence animal and zoonotic diseases
in support of Homeland Security Presidential Directives, HSPD-9 and
HSPD-10.37
The DHS has not publically released supporting documentation relating to the
working group’s deliberations.
The DHS has projected the size of the NBAF to be 520,000 square feet, with
approximately 52,000 square feet of BSL-4 laboratory space.38 This facility would
be more than twice as large as the existing PIADC facility.39 This sizeable increase
33 H.R. 2419, section 7108 (b) (2).
34 P.L. 104-127, Subtitle D, section 884.
35 USDA, “Report on the Strategic Planning Task Force on USDA Research Facilities:
Report and Recommendations,” August 1999, p. 24.
36 National Research Council, Critical Needs for Research in Veterinary Science, (National
Academies Press: Washington, DC) 2005.
37 House Committee on Science, An Overview of the Federal R&D Budget for Fiscal Year
2007, Committee Serial No. 109-35, February 15, 2006.
38 The NBAF was initially estimated at 500,000 square feet. 71 Fed. Reg. 3107-3109. More
recent scoping documents place the size of the NBAF at 520,000 square feet. See online at
[http://www.dhs.gov/xlibrary/assets/nbaf-scopingmeetingmaterials.pdf].
39 PIADC has a combined office/laboratory space of 226,560 square feet, excluding other
buildings. USDA, “Report on the Strategic Planning Task Force on USDA Research
(continued...)

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in laboratory capacity may meet the requirements put forth by HSPD-9, as well as
establishing the expanded, modern facilities to replace PIADC and perform necessary
research activities. Full use of this expanded laboratory space may pose a challenge
to federal research planners as other federal agencies have also expanded their
research laboratory capacity, including BSL-3Ag space, providing alternative venues
for performing such research.40
The ability of DHS to effectively use the newly constructed BSL-4 and
BSL-3Ag laboratories may depend on efficient interagency cooperation in order to
identify other agency research activities that could benefit from being performed at
NBAF. The DHS and USDA investment into research areas done currently at
PIADC may also need to increase to fill the expanded capacity. Analytic study
assessing the current and future needs for BSL-3Ag and BSL-4 research may aid
DHS and USDA in effectively using the NBAF.
Coordination of Research Activities with Other Agencies
Since the NBAF would replace PIADC, research at NBAF is expected to be
collaborative between USDA and DHS. At PIADC, DHS and USDA cooperatively
set research priorities, based on risk assessment and other information. Generally,
USDA performs basic research activities while DHS develops the results of that
research and attempts to translate them into practical applications.41 However, since
NBAF also represents an expansion in capacity and capabilities over PIADC, this
relationship may change. Establishment of the new facility provides an opportunity
to evaluate previous agreements and make adjustments. Assignment of lab space to
the Department of Health and Human Services or other agencies may require
reevaluation and updates to these procedures.42
The USDA and DHS have testified that their current agreements have served
them well at PIADC, with respect to both daily operation and transfer of technical
information regarding research results and priorities.43 Such interagency coordination
may be essential in case of a crisis or in dealing with an outbreak of animal disease.
39 (...continued)
Facilities: Report and Recommendations,” August 1999.
40 For example, USDA has invested in expanded BSL-3Ag laboratories at both the National
Wildlife Research Center and the National Centers for Animal Health.
41 For further discussion of how USDA and DHS cooperate at PIADC, see Government
Accountability Office, Plum Island Animal Disease Center: DHS and USDA Are
Successfully Coordinating Current Work, but Long-Term Plans Are Being Assessed, GAO-
06-132, December 2005.
42 Because of the NBAF focus on foreign animal disease, agencies beyond USDA and DHS
may have limited roles. Department of Homeland Security, personal communication,
September 17, 2007.
43 House Committee on Homeland Security, Subcommittee on Emerging Threats,
Cybersecurity, and Science and Technology, “Reducing Threats to Our Nation’s
Agriculture: Authorizing a National Bio and Agro-Defense Facility,” Hearing Transcript,
May 23, 2007.

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The extent to which all agencies engaged in the NBAF agree on how to coordinate
roles and responsibilities may prove to be a key factor in maintaining clear lines of
authority and information and may be crucial to effective oversight of the facility.
The 110th Congress is considering these issues. Under H.R. 1717 (ordered to
be reported by the House Homeland Security Committee on August 1, 2007), the
NBAF would be run by a director appointed by DHS in consultation with USDA.
The director’s role would be limited to operating and maintaining the facility,
including ensuring security and emergency response plans. This role is less broad
than in a previous version of the bill, which would have also given the DHS-
appointed director authority over all research programming at the facility, including
USDA research. In the committee-amended bill, in addition to the director, separate
directors of research would be appointed from DHS and USDA to oversee the
research programs of each department. USDA and DHS would develop a “joint
strategy” defining the roles of USDA and DHS at the NBAF.44
Timeliness of Construction Activities
When complete, NBAF would eventually house all the research activities
underway at PIADC. The DHS considers PIADC to be approaching the end of its
design lifetime. Finishing construction of the NBAF and achieving operational status
before down-sizing or decommissioning PIADC is dependent on timely construction
activity. Because of the unique research currently performed at PIADC, the smooth
transition of this capacity may be an issue of congressional concern. Beyond the
transition of research projects, programs, and supplies, transfer of personnel and
retention of an experienced workforce may also pose a challenge to DHS and USDA.
The original schedule for the NBAF, as presented to Congress, proposed
finishing construction and commissioning the NBAF in FY2010. Since then, the
proposed schedule has been extended twice, first having operations begin in
FY2013,45 and most recently having operations begin in FY2013 to FY2014.46
The extension of the NBAF construction schedule increases the time that
PIADC will be in operation. The PIADC has historically had security, coordination,
44 In 2004, the USDA and DHS developed “A Joint DHS and USDA Strategy for Foreign
Animal Disease Research and Diagnostic Programs” to coordinate their activities with
respect to activities at PIADC. While this strategy has not been made public by DHS or
USDA, it has been discussed in congressional testimony. See Testimony by Edward
Knipling, Administrator, Agricultural Research Service, Department of Agriculture, before
the House Committee on Homeland Security, Subcommittee on Emerging Threats,
Cybersecurity, and Science and Technology, on May 23, 2007. The DHS has not updated
this strategy. Department of Homeland Security, personal communication, September 17,
2007.
45 See online at [http://www.dhs.gov/xlibrary/assets/NBAF_Timeline.pdf].
46 See online at [http://www.dhs.gov/xres/labs/gc_1170798884583.shtm].

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and other issues.47 The DHS has developed and implemented a multi-year Corrective
Action Plan to address these issues and maintain the operation of PIADC.48 Since
PIADC has been identified as approaching the end of its design lifetime, extended
operation and maintenance of these facilities may not be as cost effective or as
efficient for the research endeavor as completing and transitioning research to the
NBAF. The DHS, in FY2007, spent approximately $24 million to upgrade the
facilities at PIADC, and requested approximately $17 million more for FY2008. The
DHS does not plan to request additional funds for the upgrades beyond FY2008.49
The upgrades include designing a new animal wing and continuing activities
described in the Corrective Action Plan. The DHS expects completion of these
upgrades in FY2010.50 Further NBAF construction delays may require additional
funds be used to support PIADC’s corrective maintenance.
Future Use of PIADC
The DHS has yet to determine what actions to take with the PIADC when
construction of the NBAF is completed. The DHS has stated that one of the main
goals of the NBAF is to expand upon the existing PIADC research. According to
DHS, once NBAF is operational, PIADC research activities will transfer to it.51
The fate of the PIADC, once current research activities are transferred from it,
remains unclear. The DHS has identified that “proper decontamination and
decommissioning (D&D) of the facility after the transition will be critical to meet
regulatory compliance and eventual disposal of the site.”52 The DHS has not stated
when or how this process might occur. In discussing the development and
construction of the NBAF, DHS has stated, with regards to PIADC, that “no decision
has been made as to the future of Plum Island.”53
47 See General Accounting Office, Combating Bioterrorism: Actions Needed to Improve
Security at Plum Island Animal Disease Center, GAO-03-847, September 2003; and
Government Accountability Office, Plum Island Animal Disease Center: DHS and USDA
Are Successfully Coordinating Current Work, but Long-Term Plans Are Being Assessed,
GAO-06-132, December 2005.
48 According to DHS, the total cost of the Corrective Action Plan is approximately $56
million. The Corrective Action Plan was reported to Congress by DHS in FY2005.
Department of Homeland Security, Office of Inspector General, Additional Physical,
System, and Management Controls Can Enhance Security at Plum Island (Redacted),
OIG-07-43, May 2007.
49 Department of Homeland Security, Science and Technology Directorate, Five-Year
Research and Development Plan, Fiscal Years 2007-2011, May 2007.
50 Department of Homeland Security, Science and Technology Directorate, Five-Year
Research and Development Plan, Fiscal Years 2007-2011, May 2007.
51 Ibid.
52 Ibid.
53 Bill Bleyer, “Homeland Security Seeks Input on Plum Island Disease Lab,” Newsday,
August 21, 2007.

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The DHS is currently investing money to improve and upgrade the laboratory
facilities. Continued use of PIADC either by DHS in some other capacity or under
the control of some other entity remains an option. Alternatively, following
decommissioning, the laboratories might be removed and the site used for a different
purpose. Although many local officials have opposed expanding the number or type
of pathogens researched at PIADC, some have expressed support for the continued
operation and existence of the facility, because of its economic value to the
surrounding area.54
Community Concerns
Operation of PIADC has engendered some controversy among nongovernmental
organizations and others, who have expressed concerns about the potential for
pathogen release, illicit research, and unintended consequences.55 Local opposition
also increased following suggestions of upgrading the biocontainment facilities from
BSL-3Ag to BSL-4 to allow work on more dangerous pathogens. Those suggestions
were not acted upon.56
The expansion of other biodefense laboratories has sometimes been met with
similar community opposition. For example, construction of high-containment
laboratories funded by the National Institutes of Health has been confronted with
protests, legal challenges, and passage of local laws constraining the laboratory’s
activities.57 Activists point to the occupational exposure of laboratory workers to
pathogens and the potential of environmental release from high-containment
laboratories as evidence of the risk posed by these labs.58 Other experts point to a
long history of safe operation by other comparable laboratories and suggest that
activist concerns are overstated.
The danger of accidental pathogen release into the area surrounding the
laboratory is difficult to quantify. The consequences of an environmental pathogen
release would depend on the location of the lab. A release of an animal pathogen into
54 Ibid.
55 John Rather, “ Heaping More Dirt On Plum I.,” New York Times, February 15, 2004 and
Beth Daley, “Danger Island,” Boston Globe, September 11, 2001.
56 John Rather, “East End Germ Lab Getting an Upgrade,” New York Times, November 25,
2001.
57 For examples, see Daniel Schulman and Adam Smith, “When Bioterror Moves Next
Door,” Boston Globe, August 8, 2004; Stephen Heuser, “City Cuts Back on Plan to Regulate
Biolabs,” The Boston Globe, August 23, 2006; and Pamela Martineau, “Forum Opposing
UCD’s Plan for Biolab Draws Vocal Crowd,” Sacramento Bee, April 2, 2003.
58 Occupational exposure to dangerous, federally regulated pathogens in a laboratory at
Boston University and Texas A&M University are cited as examples of such events. (M.
Anita Barry, Report of Pneumonic Tularemia in Three Boston University Researchers,
November 2004 — March 2005, Boston Public Health Commission, March 28, 2005 and
Emily Ramshaw, “CDC Suspends A&M Research on Infectious Diseases; CDC Suspends
Bioagent Work after Exposures Not Reported Promptly,” The Dallas Morning News, July
2, 2007.)

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an area without a natural host may have relatively low consequences. Alternatively,
the release of a highly contagious pathogen into an area densely populated with
potential hosts could have relatively high consequences.59 Such concerns might be
addressed by DHS through the EIS process.60
Community acceptance, or at least minimal community resistance, was
identified as one of the NBAF site criteria. However, continued community outreach
may be a key factor in determining whether NBAF will suffer delays that have
threatened construction of other high-containment laboratories.61
59 See footnote 26.
60 The DHS has preliminarily identified human health and safety and socioeconomic effects
possibly related to facility operations as areas for analysis in the EIS process. (72 Fed. Reg.
41764-41765).
61 Barbara Goodson, “Judge Hits BU Biolab; Ruling Calls for Safety Review, May Stall
Plan,” The Boston Herald, August 4, 2006.

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