Order Code RL34160
The National Bio- and Agro-Defense Facility:
Issues for Congress
Updated October 4, 2007
Dana A. Shea
Specialist in Science and Technology Policy
Resources, Science, and Industry Division
Jim Monke
Analyst in Agricultural Policy
Resources, Science, and Industry Division
Frank Gottron
Specialist in Science and Technology Policy
Resources, Science, and Industry Division

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, the U.S. Department of
Agriculture (USDA) engages in research on animal diseases not native to the United
States at the Plum Island Animal Disease Center (PIADC) off the coast of New York.
With the formation of the Department of Homeland Security (DHS) in 2003, the
PIADC facility was transferred from USDA to DHS, though USDA continues its
research program at the facility. DHS has established a foreign animal disease
research program in cooperation with USDA at PIADC. DHS has identified the
facility as outdated and too limited to continue to be the primary research facility.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 announced plans 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 costs will
depend on the site location and may exceed the $451 million projected cost.
The plans announced by DHS to establish the NBAF have raised several issues
that may interest 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, prioritization, and investment in agricultural biodefense may be reassessed
once more high-containment laboratory space becomes available.
By law, research on foot and mouth disease (FMD) 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. Two
bills introduced in the 110th Congress would modify this law (H.R. 1717 and H.R.
2419). These bills take different approaches to addressing this policy concern.
Although the PIADC laboratories are currently undergoing renovation and
expansion, DHS plans to decontaminate and decommission them following opening
of the proposed NBAF. Beyond that, the fate of Plum Island and its facilities remains
uncertain.

Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
NBAF Research Goals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
NBAF Funding and Site Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Facility Site Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Expressions of Interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Prospective Sites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Finalists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Policy Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Coordination of Research Activities with Other Agencies . . . . . . . . . . . . . . 8
Permission to Work with Foot and Mouth Disease . . . . . . . . . . . . . . . . . . . . 9
H.R. 1717 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
USDA’s Proposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
H.R. 2419 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Timeliness of Construction Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Future Use of PIADC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Community Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
List of Tables
Table 1. Initially Projected NBAF Funding Requirements (2005) . . . . . . . . . . . . 3
Table 2. NBAF Funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Table 3. Changing NBAF Funding Projections . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Table 4. Consortia Selected by DHS after Expression of Interest . . . . . . . . . . . . 7
Table 5. Finalists for NBAF Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

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 national 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.
With the formation of the Department of Homeland Security (DHS) in 2003, the
operation of the PIADC facility was transferred from USDA to DHS, though USDA
still maintains an active research program at PIADC. The DHS has established its
own research and development program at PIADC in cooperation with USDA. As
the federal government undertakes new efforts in human biodefense and defense
against agroterrorism, DHS has identified the PIADC facility as outdated and too
limited to continue to be the primary facility performing this research.
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
diagnostic capabilities for foreign animal and zoonotic diseases.”4 The Secretary of
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 Executive Office of the President, The White House, “Subject: Defense of United States
Agriculture and Food,” Homeland Security Presidential Directive/HSPD-9, January 30,
(continued...)

CRS-2
Homeland Security is to coordinate an acceleration and expansion of animal, plant,
and zoonotic disease countermeasure development, 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.5
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). 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 plans announced by DHS to establish the
NBAF have raised 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;
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).6 Because DHS plans to perform some experiments
with some pathogens for which this level of protection is inadequate, approximately
10% of the NBAF’s net square footage would be BSL-4 laboratories.7
4 (...continued)
2004.
5 Ibid.
6 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].
7 For example, research on Nipah virus must be performed in a BSL-4 laboratory. Since the
United States has a 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,
(continued...)

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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.8
The research agenda for NBAF is to be at least partially based on current risk
assessments and is 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.9 The DHS plans to use 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 (Table 1).
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 (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
7 (...continued)
Nutrition, and Forestry, July 20, 2005, available online at [http://agriculture.senate.gov/
Hearings/hearings.cfm?hearingid=1572&witnessId=4472].
8 71 Federal Register 3107-3109.
9 Department of Homeland Security, Facility Research & Staffing for the National Bio and
Agro-Defense Facility
, June 12, 2007. Available at [http://www.dhs.gov/xres/labs/
gc_1181073261627.shtm].

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stated that NBAF funding began in FY2005 when “$3 M was received for a planning
and feasibility study from base funding of Biological Countermeasures.”10 However,
DHS has subsequently clarified that the FY2005 funding was used elsewhere in DHS
and that FY2006 and FY2007 appropriations funded these studies.11 In FY2006,
Congress appropriated $23 million to select a site and conduct other pre-construction
activities.12 In FY2007, an additional $23 million was appropriated for site selection
and other pre-construction activities.13 The 2007 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.14 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 $11 million in the Administration’s request (H.R. 2638, H.Rept. 110-181;
S. 1644, S.Rept. 110-84).
Table 2. NBAF Funding
($ 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 2014.15 A full cost schedule is not publicly available. In the February 2005
projection, DHS anticipated requesting funding throughout the construction process,
10 Department of Homeland Security, FY2006 Science and Technology Directorate
congressional budget justification, p. 45.
11 Department of Homeland Security, personal communication, September 10, 2007.
12 H.Rept. 109-241 to accompany H.R. 2360 (P.L. 109-90), p. 78.
13 H.Rept. 109-699 to accompany H.R. 5441 (P.L. 109-295), p. 168.
14 Department of Homeland Security, personal communication, September 10, 2007.
15 Department of Homeland Security, Science and Technology Directorate, Five-Year
Research and Development Plan, Fiscal Years 2007-2011
, May 2007.

CRS-5
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.16
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
$451 million.17 Additional delays to the construction schedule may further change
the final cost of the facility due to changing material and labor costs.18
Table 3. Changing NBAF Funding Projections
($ 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
16 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 to accompany P.L. 109-295, p. 168.
17 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.
18 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
National Biodefense Analysis and Countermeasures Center. See CRS Report RL32891, The
National Biodefense Analysis and Countermeasures Center: Issues for Congress
, by Dana
A. Shea.

CRS-6
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.19
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.
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 contained 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.20
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 (Table 4).21 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.
19 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.
20 71 Federal Register 3107-3109.
21 See online at [http://www.dhs.gov/xres/labs/gc_1170798884583.shtm].

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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.
Finalists. Following the site visits, DHS selected five sites in July 2007 to
complete an Environmental Impact Statement (EIS). See Table 5. Additional
information on the potential sites and dates for public meetings about the EIS are
available at 72 Federal Register 41764-41765. Following completion of the EIS,
DHS expects to choose a site by October 2008.

CRS-8
Table 5. Finalists for NBAF Site
Consortium
Location
Georgia Consortium for Health and
University of Georgia
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 coordination among agencies, limits on
possession of certain pathogens, the NBAF construction schedule, and community
concerns. Legislation has been introduced in two committees in Congress (H.R.
1717 in the House Homeland Security Committee and H.R. 2419 in the House
Agriculture Committee). The Administration, through USDA, also has proposed
legislative language.
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 and prototypes the
results of USDA research.22 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
22 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.

CRS-9
Services or other agencies may require reevaluation and updates to these
procedures.23
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.24 Such interagency coordination
may be essential in case of a crisis or in dealing with an outbreak of animal disease.
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.
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.25
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
United States, accidental release from a research laboratory has occurred in other
23 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.
24 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.
25 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.

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countries.26 An accidental or intentional release of FMD virus could lead to an FMD
outbreak.
The consequences of an FMD outbreak could be high.27 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
FMD is limited to locations outside of the mainland of the United States. By statute,
the Secretary of Agriculture must explicitly permit research on FMD virus to be
performed on the mainland of the United States.28 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.29 Under these regulations, biological agents,
26 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 Pirbright nearby 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 Enserink, Martin,
Travis, John, and Kaiser, Jocelyn, “Labs Suspected in Foot-and-Mouth Crisis,” ScienceNOW
Daily News
, August 6, 2007.)
27 Estimates of the economic impact of an FMD outbreak vary. A 2002 Purdue University
and USDA study found that a 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, at [http://www.ndu.edu/inss/McNair/mcnair65/McN_65.pdf]).
28 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.
29 The agricultural select agent regulations are codified at 9 C.F.R. 121 and 7 C.F.R. 331.
(continued...)

CRS-11
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.30
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.31
USDA’s Proposal. USDA’s comprehensive proposal for the 2007 farm bill
included a provision to revise 21 U.S.C. 113a.32 The USDA provision would allow
USDA to conduct research on foot and mouth disease on the U.S. mainland. It would
29 (...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.
30 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.
31 See footnote 28.
32 See USDA’s 2007 farm bill proposal, sec. 7303, online at [http://www.usda.gov/
documents/fbresearch0507_1.pdf].

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prohibit anyone else from importing, transporting or maintaining viruses that would
be on a USDA-prescribed list, unless the Secretary issues a permit. The USDA
provision 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.33
Analysis. H.R. 1717 and H.R. 2419, Section 7108, have different
ramifications for DHS’s possession of FMD and other high-consequence animal
disease viruses. H.R. 1717 would make DHS eligible through a USDA permit under
21 U.S.C. 113a to possess and conduct research with FMD and other high
consequence animal viruses. 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 H.R. 2419, Section 7108, the situation is more complex. 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 as retaining 21 U.S.C. 113a and instead establishing a parallel
permitting process. Finally, a plain text reading of Section 7108 might even lead to
the interpretation that FMD virus research 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.34
33 This language is found in section 7108 of H.R. 2419.
34 H.R. 2419, Section 7108 (b) (2).

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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
FY2013,35 and most recently having operations begin in FY2013 to FY2014.36
The extension of the NBAF construction schedule increases the time that
PIADC will be in operation. The PIADC has historically had security, coordination,
and other issues.37 The DHS has developed and implemented a multi-year Corrective
Action Plan
to address these issues and maintain the operation of PIADC.38 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 FY2008.39
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 FY2010.40 Further NBAF construction delays may require additional
funds be used to support PIADC’s corrective maintenance.
35 See online at [http://www.dhs.gov/xlibrary/assets/NBAF_Timeline.pdf].
36 See online at [http://www.dhs.gov/xres/labs/gc_1170798884583.shtm].
37 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.
38 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.
39 Department of Homeland Security, Science and Technology Directorate, Five-Year
Research and Development Plan, Fiscal Years 2007-2011
, May 2007.
40 Department of Homeland Security, Science and Technology Directorate, Five-Year
Research and Development Plan, Fiscal Years 2007-2011
, May 2007.

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Future Use of PIADC
With the completion of the proposed NBAF, DHS would have to determine
what actions to take with the PIADC. 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.41
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.”42 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.”43
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.44
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.45 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.46
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
41 Ibid.
42 Ibid.
43 Bleyer, Bill, “Homeland Security Seeks Input on Plum Island Disease Lab,” Newsday,
August 21, 2007.
44 Ibid.
45 Rather, John, “ Heaping More Dirt On Plum I.,” New York Times, February 15, 2004 and
Daley, Beth, “Danger Island,” Boston Globe, September 11, 2001.
46 Rather, John, “East End Germ Lab Getting an Upgrade,” New York Times, November 25,
2001.

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activities.47 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.48 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
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.49 Such concerns might be
addressed by DHS through the EIS process.50
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.51
47 For examples, see Schulman, Daniel, and Smith, Adam, “When Bioterror Moves Next
Door,” Boston Globe, August 8, 2004; Heuser, Stephen, “City Cuts Back on Plan to
Regulate Biolabs,” The Boston Globe, August 23, 2006; and Martineau, Pamela “Forum
Opposing UCD’s Plan for Biolab Draws Vocal Crowd,” Sacramento Bee, April 2, 2003.
48 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.)
49 See footnote 27.
50 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, July 31, 2007).
51 Goodson, Barbara, “Judge Hits BU Biolab; Ruling Calls for Safety Review, May Stall
Plan,” The Boston Herald, August 4, 2006.