Order Code RL32891
CRS Report for Congress
Received through the CRS Web
The National Biodefense Analysis
and Countermeasures Center:
Issues for Congress
Updated November 21, 2006
Dana A. Shea
Specialist in Science and Technology Policy
Resources, Science, and Industry Division
Congressional Research Service ˜ The Library of Congress

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The National Biodefense Analysis and
Countermeasures Center: Issues for Congress
Summary
The mission of the National Biodefense Analysis and Countermeasures Center
(NBACC) is to understand current and future biological threats; assess vulnerabilities
and determine potential consequences; and provide a national capability for
conducting forensic analysis of evidence from bio-crimes and bio-terrorism. The
NBACC is operational, with a program office and several component centers
occupying interim facilities.
A laboratory facility dedicated to executing the NBACC mission and to contain
two NBACC component centers is being built at Fort Detrick, Maryland, as part of
the National Interagency Biodefense Campus. The laboratory facility, with an
estimated construction cost of $141 million, will be the first Department of
Homeland Security laboratory specifically focused on biodefense. Its programmatic
contents and component organization appear to be evolving, as conflicting
information has been provided during previous budget cycles.
Congressional oversight of programs, especially those performed in federal
facilities for homeland security purposes, is considered key to maintaining
transparency in biodefense. Policy issues that may interest Congress include the
operation of the NBACC facility as a federally funded research and development
center, transparency and oversight of research activities performed through the
center, and the potential for duplication and coordination of research effort between
the Department of Homeland Security and other federal agencies.

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Contents
Funding and Organizational Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Missions of Component Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Policy Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
NBACC Facility Construction and Operation . . . . . . . . . . . . . . . . . . . . 5
Oversight of NBACC Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Prioritization of NBACC Research Activities . . . . . . . . . . . . . . . . . . . 11
Biosafety Level 4 Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Coordination with Other Federal Agencies . . . . . . . . . . . . . . . . . . . . . 13
Interaction of the Biodefense Knowledge Center with the NBACC
Facility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

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The National Biodefense Analysis and
Countermeasures Center: Issues for
Congress
Transparency and oversight of research and development in biodefense is an
area of international interest, as development of biological weapons is prohibited
under the Biological and Toxin Weapons Convention. Congressional oversight of
federal programs, especially those performed in federal facilities for homeland
security purposes, is considered to play a key role in ensuring transparency. The
DHS and the Department of Health and Human Services (HHS) have leading roles
in protecting civilians against biological weapons. The National Biodefense Analysis
and Countermeasures Center (NBACC) is a program office within the DHS Science
and Technology Directorate that funds biodefense research and other activities. The
mission of the NBACC program is to understand current and future biological
threats; assess vulnerabilities and determine potential consequences; and provide a
national capability for conducting forensic analysis of evidence from bio-crimes and
terrorism.
DHS has requested and received appropriated funding for the construction of
a biodefense facility dedicated to homeland security activities and overseen by the
NBACC program. This facility, the first DHS laboratory focused on biodefense, has
drawn the attention of Congress, arms control experts, local community groups, and
others. This report will outline the organizational structure of NBACC, describe its
mission, and report the funding DHS has received for construction of its facility. It
will then discuss select policy issues, such as funding for NBACC facility
construction, oversight of NBACC research, and the potential for duplication of
federal effort between NBACC and other agencies.
Funding and Organizational Structure
Funds for NBACC programs are provided through the DHS Science and
Technology Directorate. Activities funded include both intramural and extramural
efforts. The programs within NBACC, as well as the construction of the NBACC
facility, have been reported as part of the Science and Technology Directorate’s
Biological Countermeasures portfolio. The NBACC program currently conducts
research through partnerships and agreements with federal and private institutes.1
1 FY2006 Budget Justification, Science and Technology Directorate, Department of
Homeland Security, available online at [http://ucop.edu/research/homelandsecurity
/documents/STFY2006CJ2022005Final1.pdf]

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CRS-2
To provide a unique home for research overseen by the NBACC program, DHS
is constructing an NBACC laboratory at Fort Detrick, MD as part of the National
Interagency Biodefense Campus. Funds for the laboratory, estimated to cost $128
million, have been appropriated over FY2003-2005. Construction commenced on
the NBACC facility in June 2006.
The NBACC facility is expected to be operated as a federally funded research
and development center (FFRDC).2 The U.S. Army Medical Research Acquisition
Activity, acting as the contracting authority for DHS in this instance, released a
Request for Proposals (RFP) for the operation of the NBACC facility.3 If established
as an FFRDC, the NBACC facility would be a government-owned, contractor-
operated facility similar to the Department of Energy National Laboratories. The
DHS wants the contract operator to manage the facility and provide the technical
expertise and program execution to support DHS’s needs.4
The identity of the NBACC facility component centers has evolved since the
facility’s conception. Different information has been presented to Congress through
various DHS testimony and documentation over the course of this evolution. In
2003, the FY2004 DHS budget justification and testimony by DHS Assistant Under
Secretary for Science and Technology Albright stated that four centers would
comprise NBACC: the Biodefense Knowledge Center (BKC), the Bioforensics
Analysis Center, the Biothreat Assessment Support Center, and the
Bio-Countermeasures Testing and Evaluation Center.5 In 2004, the FY2005 DHS
budget justification and testimony by Assistant Under Secretary Albright stated that
NBACC consisted of three organizational units: the Biodefense Knowledge Center,
the National Bioforensic Analysis Center (NBFAC), and the Biological Threat
Characterization Center (BTCC).6 In 2005, the FY2006 DHS budget justification
and testimony by DHS Under Secretary for Science and Technology McQueary refer
to the NBACC facility as having two component parts: the National Bioforensic
2 See 70 Fed. Reg. 41777 (July 20, 2005).
3 The RFP closed on May 15, 2006. The NBACC request for proposals can be found online
at [http://www-usamraa.army.mil/pages/announce/NBACC/index.htm].
4 Department of Homeland Security, Science and Technology Directorate, Office of
Research and Development, Draft Solicitation for a National Biodefense Analysis and
Countermeasures Center (NBACC) Operating Contract for the Department of Homeland
Security, May 31, 2005.
5 Dr. Albright also stated that the Plum Island Animal Disease Center would execute some
NBACC programs. Testimony of Dr. Penrose C. Albright, Assistant Under Secretary for
Science and Technology, Department of Homeland Security, before the House Select
Committee on Homeland Security, October 30, 2003.
6 The Biological Threat Characterization Center appeared to encompass both the Biothreat
Assessment Support Center and the Bio-Countermeasures Testing and Evaluation Center.
Testimony of Dr. Penrose C. Albright, Assistant Under Secretary for Science and
Technology, Department of Homeland Security, before the House Select Committee on
Homeland Security, June 3, 2004.

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Analysis Center and the Biological Threat Characterization Center.7 This two center
configuration is reportedly the final configuration for the NBACC facility.8
The two NBACC component centers identified in the FY2006 DHS budget, the
Biological Threat Characterization Center and the National Bioforensic Analysis
Center, are operating in interim facilities pending construction of the NBACC
laboratory building.9 The BTCC has ongoing activities in a number of government
and private laboratories. The NBFAC is housed at the United States Army Medical
Research Institute for Infectious Disease (USAMRIID), located in Fort Detrick, MD,
and operates as a joint federal effort, including representatives of DHS, the Federal
Bureau of Investigation, and the Army.10 The NBFAC is currently receiving,
handling, and performing forensic analysis on biological samples.11
Apparently originally conceived as part of the NBACC facility, the Biodefense
Knowledge Center was dedicated on September 10, 2004, and is located at the
Department of Energy’s Lawrence Livermore National Laboratory. This center
operates as an independent center though its work is closely coordinated with that of
the NBACC facility centers. While funding for the BKC originates from within the
Biological Countermeasures portfolio, the BKC is funded independently, not as a
component of the NBACC program.12 The BKC draws on the expertise of scientists
at Lawrence Livermore National Laboratory and three additional national
laboratories: the Pacific Northwest National Laboratory, Sandia National
Laboratories, and Oak Ridge National Laboratory. Three Department of Homeland
Security University Centers of Excellence, located at the University of Minnesota,
the University of Southern California, and Texas A&M University, also collaborate
with the Biodefense Knowledge Center.13
7 Testimony of Dr. Charles E. McQueary, Under Secretary for Science and Technology,
Department of Homeland Security, before the House Committee on Science, February 16,
2005.
8 Personal Communication with DHS staff, November 14, 2006.
9 Testimony of Dr. John Vitko, Jr., Director, Biological Countermeasures Portfolio,
Department of Homeland Security, before the House Committee on Government Reform,
Subcommittee on National Security, Emerging Threats, and International Relations, June
14, 2005.
10 Testimony of Major General Lester Martinez-Lopez, Commanding General, U.S. Army
Medical Research and Materiel Command, before the House Committee on Veterans’
Affairs, August 26, 2004.
11 FY2006 Budget Justification, Science and Technology Directorate, Department of
Homeland Security, found online at [http://ucop.edu/research/homelandsecurity
/documents/STFY2006CJ2022005Final1.pdf].
12 Both the BKC and the NBACC program are part of a larger, science-based, threat
characterization activity within DHS. Personal Communication with DHS staff, November
14, 2006.
13 Lawrence Livermore National Laboratory, “Department of Homeland Security Under
Secretary to Dedicate New Biodefense Knowledge Center,” Press Release, September 10,
2004.

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The new NBACC facility is to be part of the federal biodefense research and
development network. As such, its activities are to be coordinated with those of
other network members, including the Plum Island Animal Disease Center, the
National Institutes of Health (NIH), and USAMRIID.
Missions of Component Centers
The mission of the NBACC program is to understand current and future
biological threats; assess vulnerabilities and determine potential consequences; and
provide a national capability for conducting forensic analysis of evidence from
bio-crimes and terrorism.14 Each of the NBACC facility component centers executes
a piece of this overall program mission. Also, the Biodefense Knowledge Center
appears to collaborate with these centers to assist them in meeting mission goals.
The Biological Threat Characterization Center is to conduct studies and
laboratory experiments designed to find and address critical gaps in understanding
current and future biological threats, assess vulnerabilities, conduct risk assessments,
and determine potential impacts. An apparent goal of this program is to provide a
science-based assessment of possible biological threats, focusing on those pathogens
deemed by the Centers for Disease Control and Prevention to have the potential for
high consequence. Types of research to be performed in characterizing biological
threats include, but are not limited to, investigating potential biothreat pathogens,
studying pathogen stability and viability, and assessing lethality through
dose/response studies.15 An earlier presentation on NBACC program activities also
included developing strategies for defeating genetically engineered pathogens, and
expanding current capabilities in testing non-human primates exposed to biological
aerosols.16
The National Bioforensic Analysis Center was designated in Homeland Security
Presidential Directive 10 (HSPD-10), Biodefense for the 21st Century,17 as the lead
federal facility to conduct and facilitate the technical forensic analysis and
interpretation of materials recovered following a biological attack.18 The NBFAC
conducts analysis of evidence from a bio-crime or terrorist attack to obtain a
“biological fingerprint” in order to identify perpetrators and determine the origin and
method of attack. Consequently, when housed in the NBACC facility, the NBFAC
14 Testimony of Dr. Penrose C. Albright, Assistant Under Secretary for Science and
Technology, Department of Homeland Security, before the Senate Committee on Health,
Education, Labor, and Pensions, February 8, 2005.
15 Department of Homeland Security, Broad Agency Announcement BAA 05-2, February
2005.
16 Presentation by LTC George Korch, Leading Edge of Biodefense — The National
Biodefense Analysis and Countermeasures Center, at the Department of Defense Pest
Management Workshop, February 2004.
17 Executive Office of the President, The White House, Biodefense for the 21st Century,
Homeland Security Presidential Directive 10, April 28, 2004.
18 This activity is conducted in support of the lead federal agency as determined by the
National Response Plan.

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CRS-5
would provide the federal government with a centrally coordinated, validated
bioforensic analysis facility.19 To meet this mission, NBFAC is developing forensic
tools, methods, and strain repositories for pathogens of concern.
The Biodefense Knowledge Center supports NBACC facility component centers
and has its own functions and missions. One is to provide scientific assessments and
information to the Homeland Security Operations Center regarding potential
bioterrorism events.20 Another is to be a repository of biodefense information,
including genomic sequences for pathogens of concern, the existence and location
of vaccines, bioforensics information, and information about individuals, groups, or
organizations that might be developing these pathogens. Finally, the BKC aids in
assessing potential bioterrorism agents as “material threats” for the purpose of the
Project Bioshield countermeasure procurement process.21 The BTCC and the BKC
jointly make these assessments.
Policy Issues
NBACC Facility Construction and Operation. The total construction cost
for the NBACC facility is currently estimated by DHS to be $141 million, a $13
million increase from the initially requested $128 million.22 Original funds for the
construction were appropriated in FY2003 — FY2005. The additional $13 million
were reprogrammed from other portfolios.23
Construction began in June 2006 and is projected to be finished in FY2008.
Community response to the NBACC facility construction has been mixed. The
construction of the NBACC facility, along with new laboratory space for other
federal agencies, at the Fort Detrick site has been identified as beneficially spurring
19 Department of Homeland Security, Broad Agency Announcement BAA 05-2, February
2005.
20 The Homeland Security Operations Center collects and analyzes information from
multiple sources to help deter, detect, and prevent terrorist acts. The HSOC provides
real-time situational awareness and monitoring, coordinates incidents and response
activities, and issues advisories and bulletins concerning threats to homeland security.
Department of Homeland Security, “Fact Sheet: Homeland Security Operations Center
(HSOC),” Press Release, July 8, 2004.
21 In order for a countermeasure to be procured using Project BioShield funds, the DHS
Secretary must determine that a “material threat” from a particular agent exists. For more
information on Project BioShield, see CRS Report RS21507, Project BioShield, by Frank
Gottron.
22 DHS attributes the increase in cost as generally due to increases in materials and
construction expenses, rather than to a shift in scope or scale. Personal communication with
DHS staff, September 22, 2006.
23 The construction contract for the NBACC facility is reportedly a fixed cost, contractor’s
liability contract, where the contractor is liable for any additional costs above those agreed
upon in the contract. Thus the $141 million is described by DHS as a ceiling above which
the total cost to DHS may not rise. Personal Communication with DHS staff, November 14,
2006.

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investment and development in the surrounding area.24 However, some local
advocates and citizen groups have protested the construction of the NBACC
facility.25 They cite concerns regarding security, safety, and secrecy surrounding the
facility.26
The DHS plans to operate the NBACC facility as an FFRDC, overseen in a
manner akin to the Department of Energy National Laboratories. The NBACC
FFRDC contractor would have the responsibility for carrying out the projects and
program developed by the NBACC program office. This includes bringing the
existing interim centers into the new NBACC facility, when constructed, and
continuing those activities currently ongoing, such as the biological risk assessment
process.
Oversight of NBACC Research. The degree to which the research
programs of the NBACC program and component centers are transparent and actively
overseen may become an area of Congressional interest. Two factors have
contributed to an increased focus by biosecurity advocates on NBACC research
activities: the degree to which classified research may be performed by the NBACC
program and the extent and quality of review for compliance with the Biological and
Toxin Weapons Convention (BWC). Because of the potential for classified research
to be performed at the NBACC facility, some biodefense experts have identified the
lack of transparency as problematic for international relations and treaty
compliance.27 Other experts assert that such issues of transparency can be dealt with
so long as a process for review and compliance with applicable treaties is developed
and maintained. These issues and the Department’s efforts to address these factors
are described below.
Classified Research. Some research activities performed by the BTCC and
the NBFAC, either in interim facilities or at the to-be-constructed NBACC facility,
may be classified in nature.28 The NBACC facility is being constructed in such a
manner that the entire building can be certified as a Sensitive Compartmented
24 Greg Barrett, “Frederick County Gets Popular, Pricey,” Baltimore Sun, March 3, 2006;
Ike Wilson, “Frederick, MD City Official Says Economic Development Is Gaining
Strength,” Frederick News-Post, March 17, 2006; and Dana Hedgpeth, “Moving Up the
Corridor; Frederick County Enjoys a Boom in Office-Building Development,” Washington
Post, May 15, 2006.
25 Erika Check, “Locals Rally to Combat Biodefense Labs,” Nature, August 30, 2006.
26 See, for example, Nelson Hernandez, “Protesters Decry Fort Detrick Expansion; Planned
Biodefense Campus Called Environmental Threat at Frederick Rally,” Washington Post,
June 6, 2005; Fredrick Kunkleand, “Fort Detrick Neighbors Jittery Over Expansion;
Bioweapons Work Possible, Some Fear,” Washington Post, February 27, 2005; and “Fort
Detrick’s New ‘Mayor’ Aims to Be Good Neighbor,” Associated Press, August 3, 2005.
27 Lois R. Ember, “Testing the Limits,” Chemical and Engineering News, August 15, 2005.
28 Department of Homeland Security, Request for Information, February 25, 2005, and U.S.
Department of Homeland Security and Army Garrison, Fort Detrick MD, Final
Environmental Impact Statement - Construction and Operation of the National Biodefense
Analysis and Countermeasures Center (NBACC) Facility by the Department of Homeland
Security at Fort Detrick, Maryland, December 23, 2004.

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Information Facility (SCIF).29 The FFRDC contractor operating the NBACC facility
must be capable of providing employees cleared at the Top Secret/Sensitive
Compartmented Information (TS/SCI) level.30 Planning for the future use of the
NBACC facility is still underway, so the balance of classified and unclassified
activities is not yet finalized. Thus, the extent to which the capability to perform
classified research will be utilized is undetermined.31
Initially, only a portion of the NBACC facility may operate under classified
circumstances, with this amount increasing or decreasing depending on evolving
research priorities. The NBACC FFRDC RFP provides high security expectations
for the contractor’s future capabilities, stating:
The Government has estimated final operations work force at 120 people, with
virtually all of them (>95%) requiring TS/SCI clearance. The offerors are
expected to propose a strategy and commensurate workforce for initial operations
and transition. The Government estimates that 20-25% of the Contractor’s
workforce during initial operations will require TS/SCI clearances. The
Government estimates that >40-60% of the Contractor’s workforce during
transition will require TS/SCI clearances.32
Requiring that virtually all of the NBACC FFRDC workforce be eligible for,
and eventually possess, clearance for classified information may provide advantages
over requiring only a sub-section of the workforce to obtain requisite clearance. One
advantage may be increased flexibility in workforce management given changing
workload. Another may be an increased ability to generate synergy between research
skills and knowledge due to a larger pool of qualified researchers able to converse
about a particular problem.33
Conversely, some experts are concerned about the potential proliferation of
dual-use research results and biological techniques specific to such sensitive research
topics.34 They argue that as more scientists are trained and brought into biological
29 Joby Warrick, “The Secretive Fight Against Bioterror,” Washington Post, July 30, 2006.
30 U.S. Army Medical Research Acquisition Activity, Solicitation for A National Biodefense
Analysis and Countermeasures Center Operating Contract, a Federally Funded Research
and Development Center for The Department of Homeland and Security, Amendment 3 —
Questions & Answers, HSHQDC-06-R-00017, April 24, 2006. This solicitation closed May
15, 2006.
31 Personal communication with DHS staff, September 22, 2006.
32 U.S. Army Medical Research Acquisition Activity, Solicitation for A National Biodefense
Analysis and Countermeasures Center Operating Contract, a Federally Funded Research
and Development Center for The Department of Homeland and Security, Amendment 3 —
Questions & Answers, HSHQDC-06-R-00017, April 24, 2006. This solicitation closed May
15, 2006.
33 Personal communication with DHS staff, November 14, 2006.
34 The phrase “dual-use” has many definitions. This report defines “dual-use” as “ research
with legitimate scientific purpose that may be misused to pose a biologic threat to public
health and/or national security.” This definition parallels that found in the charter of the
(continued...)

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CRS-8
threat assessment studies, the risk of diversion of material, information, or scientific
technique to others may increase. While acknowledging that the use of security
background checks can reduce this risk, they assert that this risk can not be
eliminated.35
Compliance and Oversight. Some arms control experts and other
stakeholders have raised concerns about the research to be performed by NBACC at
the Fort Detrick facility. They assert that the research being undertaken might violate
or might be interpreted as violating the Biological and Toxin Weapons Convention.36
While research activities may uphold both the letter and the spirit of the BWC,
outsider observers may lack confidence in, or harbor suspicions about, those research
activities being performed.37
Strong internal oversight and review of these research activities may allay some
of these concerns or suspicions. As put by Petro and Carus,
Thus, any federal program that focuses on threat characterization research will
likely require strict administrative guidelines and procedures to ensure that all
activities are legally compliant.38
The DHS asserts such a strong review process exists, as an internal process to the
Department.39 The DHS has developed and implemented a management directive
regarding compliance with arms control agreements.40
Adhering to this directive, DHS has established both a compliance assurance
program office and a Compliance Review Group to determine whether the NBACC
34 (...continued)
National Science Advisory Board for Biosecurity. Department of Health and Human
Services, National Science Advisory Board for Biosecurity Charter, March 4, 2004.
35 Jonathan B. Tucker, “Biological Threat Assessment: Is the Cure Worse Than the
Disease,” Arms Control Today, October, 2004.
36 Milton Leitenberg, James Leonard, and Richard Spertzel, “Biodefense Crossing the Line,”
Politics and the Life Sciences, Vol. 22, (2003).
37 For example, Mark Wheelis and Malcolm Dando, “Back to Bioweapons?” The Bulletin
of the Atomic Scientists, Vol. 59, No. 1, January/February 2003. See also, James B. Petro
and W. Seth Carus, “Biological Threat Characterization Research: A Critical Component
of National Biodefense,” Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and
Science, Vol. 3, Number 4, December, 2005.
38 James B. Petro and W. Seth Carus, “Biological Threat Characterization Research: A
Critical Component of National Biodefense,” Biosecurity and Bioterrorism: Biodefense
Strategy, Practice, and Science, Vol. 3, Number 4, December, 2005.
39 Joby Warrick, “The Secretive Fight Against Bioterror,” Washington Post, July 30, 2006.
40 Department of Homeland Security, Compliance with, and Implementation of, Arms
Control Agreements, Management Directive 6300, August 26, 2005. This management
directive applies to all DHS components, including all entities directly engaged in work by
DHS, and covers all applicable binding arms control agreements.

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research activities are in compliance with the BWC, among other duties.41, 42 The
Compliance Review Group is composed of senior DHS officials, including those
with oversight of pertinent research areas. The compliance assurance program office
has been established separately from the research program offices, so that research
management and compliance oversight activities do not become conflated.
Currently, all NBACC research activities are reviewed, and compliance
determinations are made, before the research activities begin. If questions persist
about whether a research activity may pose a compliance concern, the compliance
assurance program office and the Compliance Review Group are empowered to
require additional, clarifying information be presented before a compliance
determination is made. Should the Compliance Review Group not reach consensus
regarding a particular research activity, the final judgement is reportedly made by the
DHS Secretary, who is obligated to ensure DHS activities are in compliance.43
While such an internal compliance review process may be robust, some arms
control experts have been critical of compliance processes that remain entirely
internal to a single agency. Such critics assert that interagency review, such as
including representatives from the Department of State, or review performed or
coordinated through the White House, for example through the National Security
Council or the Homeland Security Council, would provide greater expert input and
further divorce the compliance review from the programmatic and budgetary aspects
of a research program.44
Other possible mechanisms for review of potentially contentious research exist
outside of the Department. To assess federal research and development programs
that may have potential dual-use capabilities, the Department of Health and Human
Services has established the National Science Advisory Board for Biosecurity. This
board’s duties include providing expert advice on ways to minimize potential misuse
of dual-use research.45 The NSABB is expected to generate guidance on assessing
dual-use research through local oversight at research institutions. The NSABB was
41 An overview of the nascent compliance review process was presented in June 2005 at the
Meeting of the States Parties to the Convention on the Prohibition of the Development,
Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their
Destruction, Meeting of Experts, in Geneva, Switzerland. See online at
[http://daccessdds.un.org/doc/UNDOC/GEN/G05/619/03/PDF/G0561903.pdf?OpenElem
ent]
42 This office also determines whether research activities are in compliance with other
pertinent treaties and regulations, such as the select agent regulations regarding pathogen
possession and security. Personal communication with DHS staff, November 14, 2006.
43 Personal communication with DHS staff, November 14, 2006.
44 See, for example, Jonathan B. Tucker, “Biological Threat Assessment: Is the Cure Worse
Than the Disease,” Arms Control Today, October, 2004; and Milton Leitenberg, Assessing
the Biological Weapons and Bioterrorism Threat, December 2005.
45 For more information on the NSABB, see online at [http://www.biosecurityboard.gov/].
See also CRS Report RL33342, Oversight of Dual-Use Biological Research: The National
Science Advisory Board for Biosecurity, by Dana A. Shea.

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CRS-10
not given responsibility to view or assess classified research programs, so it might
be of limited utility in overseeing such research.
Transparency. Selective transparency in activities performed at the NBACC
facility and funded by the NBACC program is considered both essential and difficult
to enact. While the ability for outside observers to identify and understand the
activities underway at the NBACC facility and funded through the NBACC program
is deemed by some experts as key to maintaining international confidence in the US
biodefense program, such openness must preserve the protection granted to
information deleterious to national security.46 It is difficult to determine what an
appropriate balance is when weighing the potential release of information relating to
national vulnerabilities against assuring others of the benign focus of biodefense
research.
How to best achieve needed transparency while preserving necessary
information restriction is a matter of contention. Some arms control experts claim
that openness in the US biodefense program should be held as the model for other
countries. Other biosecurity experts assert that special care must be taken to assure
that information that would disclose a potential vulnerability is not inadvertently
released.
Once possible mechanism for achieving transparency is the inclusion of local
community members into the oversight process for NBACC research. In other areas
of contentious biological research, local review boards, such as institutional biosafety
boards (IBC), have been used to oversee research activities. Typically, the primary
purpose of an IBC is to ensure that recombinant DNA research follows the NIH
Guidelines for Research Involving Recombinant DNA Molecules.47 IBCs are required
by NIH guidelines to seat community members on the committee, in addition to
scientists and safety officials from the institution. IBCs have also been highlighted
as possible mechanisms for implementation of NSABB recommendations. The DHS
has stated that an IBC will be established at the NBACC facility, but it is unclear
what role the IBC would have in assessing research programs. Inclusion of such
persons may be problematic in light of the potential for classified or law-enforcement
sensitive nature of some activities.
The establishment of an IBC at NBACC may provide a potential public
oversight mechanism, reassuring the local community and others with respect to the
46 For example, see Jonathan B. Tucker, “Biological Threat Assessment: Is the Cure Worse
Than the Disease?” Arms Control Today, October, 2004; and James B. Petro, Theodore R.
Plasse, Jack A. McNulty, “Biotechnology: Impact on Biological Warfare and Biodefense,”
Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science, Vol. 1, No. 3,
September, 2003.
47 While IBCs are responsible for oversight of recombinant DNA research, these
responsibilities need not be so restricted. The NIH guidelines are requirements for
recipients of NIH funding regarding recombinant DNA techniques, but other institutions are
encouraged to follow the NIH guidelines. Department of Health and Human Services,
National Institutes of Health, Guidelines for Research Involving Recombinant DNA
Molecules (NIH Guidelines), April 2002.

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research being performed at NBACC. Some advocates have assailed the utility of the
IBCs though, asserting that the IBCs often do not provide effective oversight of
research facilities where they are established.48
Another possible mechanism might be developing independent, external
oversight of research activities, using scientific experts, possibly using members of
the National Academies, to assess research programs.49 The DHS has established an
advisory committee through the National Academies to provide input into the
NBACC research process.50 The advisory committee’s suggestion and activities have
not, as yet, been widely discussed or publicized. Formalizing the committee input
mechanism or more widely disseminating the results of the advisory committee’s
activities may be considered by critics sufficient to allay transparency concerns.
The Department of Homeland Security states that research performed by the
Department is solely for defensive purposes, will be in accord with treaty obligations,
and will be published, to the maximum extent possible, in the open scientific
literature.51 As such, they maintain they are committed to assessing and reducing
biodefense vulnerabilities, adhering to scientific standards and practices, and
exercising sufficient and appropriate levels of openness. The Department points to
its internal compliance review process, the establishment of a standing advisory
committee, and its plan to conduct much of its research in an unclassified manner as
evidence that their critics’ concerns are overstated.52
Prioritization of NBACC Research Activities. Another area of concern
within the arms control community and increasingly within Congress is the lack of
a clear research plan for NBACC programs or for the NBACC facility. The research
performed through the NBACC program is intended to fill in knowledge gaps
regarding pathogens, test the effectiveness of biological countermeasures, and to
48 The Sunshine Project, Mandate for Failure — The State of Institutional Biosafety
Committees in an Age of Biological Weapons Research, October 4, 2004.
49 Lois R. Ember, “Testing the Limits,” Chemical and Engineering News, August 15, 2005.
50 While a standing National Academy of Sciences committee has been established to
support the NBACC program’s research, it provides scientific review, not review of policy
or compliance matters. Personal communication with DHS staff, September 22, 2006. See
also, Board on Army Science and Technology, Committee on Biodefense Analysis and
Countermeasures, online at
[http://www7.nationalacademies.org/BAST/BAST_Biodefense_Analysis_Committee.html].
51 U.S. Department of Homeland Security and Army Garrison, Fort Detrick MD, Final
Environmental Impact Statement - Construction and Operation of the National Biodefense
Analysis and Countermeasures Center (NBACC) Facility by the Department of Homeland
Security at Fort Detrick, Maryland, December 23, 2004. See also Justin Rood, “DHS
Germwar Research Bugs Nonproliferation Watchdogs,” CQ Homeland Security, September
24, 2004 and David Ruppe, “Proposed U.S. Biological Research Could Challenge Treaty
Restrictions, Experts Charge,” Global Security Newswire, June 30, 2004.
52 Personal communication with DHS staff, November 14, 2006.

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assess the risk posed by new and future activities in biological science.53 Such
research will likely span both classified and unclassified areas.
Arms control experts have expressed concern that the research being considered
at the NBACC facility may not be properly based on assessed risk, but instead might
be based on other characteristics, such as potential consequence or the ability of a
nation state to develop such a weapon. These experts suggest that a more proper
prioritization would focus on the capabilities of terrorists, rather than rogue nations.
They also suggest that improper prioritization of research activities may lead to an
arms race within the biodefense community, as scientists engaged in biodefense
attempt to develop countermeasures to more dangerous pathogens developed in their
own laboratories.54
Since the NBACC program deals with matters of homeland security, detailed
public scrutiny of its research activities might be seem by some to possibly
compromise homeland security. If that is the case, some advocates argue that a
robust, public prioritization and planning mechanism should be developed.55 They
argue that such an effort will bolster confidence that proper prioritization and
planning will occur, even if detailed results are not available. Others might argue
that such structures already exist and are in place, citing the array of advisory boards
and committees available to DHS in developing strategic planning.56 Since the
efficacy of planning and prioritization is open to interpretation, developing
appropriate metrics to assess this process may pose a challenge.
Biosafety Level 4 Construction. The NBACC facility is to include
laboratory space at the highest level of biosafety containment, Biosafety Level 4
(BSL-4). Such laboratories are required for performing experiments using the most
dangerous pathogens, like viral hemorrhagic fevers such as Ebola virus. The volume
of BSL-4 laboratory space has historically been small, with federal facilities available
53 Dr. Maureen McCarthy, Director, Office of Research and Development, Department of
Homeland Security, Public Comments at the Center for Strategic and International Studies,
October 31, 2005.
54 David Ruppe, “Homeland Security Threat Priorities Draw Criticism,” Global Security
Newswire, November 2, 2005.
55 A similar approach has been taken on a small scale with the Biological Risk Assessment
required under Homeland Security Presidential Directive 10. The results of the risk
assessment are classified, but the methodology is not and is open to review by the National
Academies. See Board on Mathematical Sciences and Their Applications, Committee on
Methodological Improvements to the Department of Homeland Security’s Biological Agent
Risk Analysis, Methodological Improvements to the Department of Homeland Security’s
Biological Agent Risk Analysis, online at
[http://www8.nationalacademies.org/cp/projectview.aspx?key=48682].
56 For example, P.L. 107-296, the Homeland Security Act of 2002, established a Science and
Technology Advisory Council for the Department of Homeland Security’s Science and
Technology Directorate. This advisory council dissolved in 2005. The Department also
requested support from the National Academies in establishing a standing Committee on
Biodefense Analysis and Countermeasures. For more information, see online at
[http://www7.nationalacademies.org/bast/BAST_Biodefense_Analysis_Committee.html].

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at the Centers for Disease Control and Prevention in Atlanta, GA and at USAMRIID
in Fort Detrick, MD. Federal efforts are increasing the available BSL-4 laboratory
space. The National Institute of Allergy and Infectious Diseases (NIAID) has funded
the construction of two new BSL-4 facilities, one at the University of Texas Medical
Branch at Galveston and one at the Boston University Medical Center.57
The increase in BSL-4 laboratory space is likely to result in a corresponding
increase in the number of scientists trained in the techniques required to handle
contagious, deadly pathogens. Some posit that such an increase will lead to further
dissemination of information regarding biothreat agents, possibly to scientists whose
future efforts could threaten the United States.58 Others argue that the increase in
BSL-4 laboratory facilities and trained scientists will lead to a more robust
biodefense capability, providing more rapid breakthroughs in pathogen identification
and countermeasure development.59
The construction of a DHS BSL-4 facility dedicated to threat characterization
has raised community fears with regard to potential pathogen leakage, theft, or loss,
and possible indirect health impacts.60 Similar concerns have been raised regarding
the construction of the NIAID BSL-4 facilities.61 The DHS and DOD assert that such
a release is unlikely, given the high safety requirements of a BSL-4 facility.62
Coordination with Other Federal Agencies. How the NBACC program
and NBACC facility coordinate their efforts with other federal agencies may attract
Congressional interest. When the Department of Homeland Security was formed,
most programs addressing medical countermeasures to biological threats remained
under the authority of the Department of Health and Human Services (HHS). Most
civilian programs addressing nonmedical countermeasures, such as those funded by
57 National Institute of Allergy and Infectious Diseases, “NIAID Funds Construction of
Biosafety Laboratories,” Press Release, September 30, 2003.
58 Eileen Choffnes, “Bioweapons: New Labs, More Terror?” Bulletin of the Atomic
Scientists, Vol. 58, September/October 2002.
59 For a representative argument, see testimony of Dr. Anthony Fauci, Director, NIAID,
NIH, before the Subcommittee on Bioterrorism and Public Health Preparedness, Senate
Committee on Health, Education, Labor and Pensions, February 8, 2005.
60 Nelson Hernandez, “Protesters Decry Fort Detrick Expansion,” Washington Post, June 6,
2005. Scott Shane, “With Biodefense Plan, Fear of Repercussions,” The Baltimore Sun,
April 29, 2004. See also public comments in U.S. Department of Homeland Security and
Army Garrison, Fort Detrick MD, Final Environmental Impact Statement - Construction
and Operation of the National Biodefense Analysis and Countermeasures Center (NBACC)
Facility by the Department of Homeland Security at Fort Detrick, Maryland, December 23,
2004.
61 Frank James, “Anti-bioterror Labs Raise Risk to U.S., Critics Say; Accidents, Costs Cited
as 14 Are Planned for Nation,” Chicago Tribune, December 5, 2004.
62 U.S. Department of Homeland Security and Army Garrison, Fort Detrick MD, Final
Environmental Impact Statement - Construction and Operation of the National Biodefense
Analysis and Countermeasures Center (NBACC) Facility by the Department of Homeland
Security at Fort Detrick, Maryland, December 23, 2004.

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the Department of Energy, were transferred to the Department of Homeland
Security.63 With the establishment of the NBACC facility, research and development
activities in some areas being pursued by the BTCC would be closely related to those
supported by HHS.64 Results of such DHS research and development activities could
also help inform and shape policy and research agendas in other departments. For
example, the risk assessment activities undertaken by DHS could potentially aid in
informing HHS strategic deliberations.65
The DHS Secretary is charged with coordinating homeland security research and
development activities across the federal government. If coordination is well-
managed, the effectiveness of research and development activities could be
optimized. Results from DHS testing and evaluation of biological countermeasures,
for example, might inform new research areas for HHS to support. On the other
hand, if coordination is ineffective, significant overlap and duplication of effort may
occur between agencies.
Additionally, effective coordination between the NBFAC and the Federal
Bureau of Investigation (FBI) would be necessary for a prompt forensics response
following a bioterrorism incident. The NBFAC has, in its interim space, completed
processing of thousands of forensic samples in support of bioterror/biocrime cases
for the FBI, acting as the lead federal facility for bioforensic analysis.66 The FBI has
entered into contracts with Department of Energy Laboratories to perform forensics
and attribution activities for nuclear materials.67 Lessons learned from these
activities may lower barriers to effective interagency actions following a biological
attack.
Some coordinative activities designed to leverage the NBACC facility
capabilities are already underway. The DHS, acting through the Science and
Technology Directorate, has entered into the Interagency Biomedical Research
Confederation at Fort Detrick. This group consists of agencies and institutes engaged
in medical or biotechnology research at Fort Detrick and also includes representatives
from the National Institutes of Health, the Agricultural Research Service, the Centers
for Disease Control and Prevention, and the Army Surgeon General. Through
committees and subcommittees established under this interagency group, these
participants attempt to coordinate work in scientific areas of mutual interest, to
63 The Homeland Security Act of 2002, P.L. 107-296, Section 302.
64 For example, research on genetic modification of model systems for pathogens has been
funded by NIAID. See G. Chaudhri, V. Panchanathan, R.M. Buller, et al., “Polarized Type
1 Cytokine Response and Cell-mediated Immunity Determine Genetic Resistance to
Mousepox,” Proc. Natl. Acad. Sci. USA, Vol. 101, June 15, 2004, pp.9057-62.
65 For an example of how current DHS risk assessment activities are to be used by HHS, see
71 Fed. Reg. 53,097 — 53,102 (September 8, 2006).
66 Dr. Bernard Courtney, National Biodefense Analysis and Countermeasures Center,
Presentation to the National Academies Committee on Methodological Improvements to the
Department of Homeland Security’s Biological Agent Risk Analysis, August 28, 2006.
67 Jim Nesbitt, “SRS Lab Wins FBI Contract,” The Augusta Chronicle, February 24, 2005.

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encourage efficient management, foster scientific interchange, and maximize research
and development productivity.68
Interaction of the Biodefense Knowledge Center with the NBACC
Facility. The feasibility study performed for NBACC identified several potential
routes for its construction. A phased approach, in which the BKC was initially
formed outside of the Fort Detrick facility and then incorporated into the facility at
a later date, was one. Another was the construction of the NBACC facility with the
BKC integrated within it. The BKC was, instead, established separately at Lawrence
Livermore National Laboratory, and now appears to be a center independent of the
NBACC facility and NBACC program.
The BKC, in its data collection, analysis, and dissemination capabilities, appears
to play a similar role to the NBACC program and facility. The degree to which
information needs and gaps identified by one of the centers may be filled by the other
center may rest heavily on internal communications and interactions. Efficient
information sharing and planning may play a key role in maximizing the
effectiveness of both centers.
68 For more information about the Interagency Biomedical Research Confederation at Fort
Detrick, see online at [http://www.detrick.army.mil/nibc/].

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