Order Code RL32891
CRS Report for Congress
Received through the CRS Web
The National Biodefense Analysis
and Countermeasures Center:
Issues for Congress
April 25, 2005
Dana A. Shea
Analyst in Science and Technology Policy
Resources, Science, and Industry Division
Congressional Research Service ˜ The Library of Congress
The National Biodefense Analysis and
Countermeasures Center: Issues for Congress
Summary
The construction of the National Biodefense Analysis and Countermeasures
Center (NBACC), with an estimated construction cost of $128 million, will be the
first Department of Homeland Security laboratory specifically focused on biodefense.
Its programmatic contents and component organization are unclear, as conflicting
information has been provided during each of the past three 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 which may interest Congress include funding for the
construction of the NBACC facility, transparency of research activities performed
through the center, and the potential for duplication of effort between the Department
of Homeland Security and other federal agencies. This report will be updated as
circumstances warrant.
Contents
Organizational Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Mission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Policy Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Funding for NBACC Facility Construction . . . . . . . . . . . . . . . . . . . . . . 4
Public Oversight of NBACC Research . . . . . . . . . . . . . . . . . . . . . . . . . 5
Biosafety Level 4 Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Coordination with Department of Health and Human Services . . . . . . 7
Location of the BKC at a Non-Department of Homeland Security
Facility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
List of Tables
Table 1. Funding for NBACC Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
The National Biodefense Analysis and
Countermeasures Center: Issues for
Congress
Oversight of federal research and development in biodefense is an area of
international interest, as only defensive research activities are allowed under the
Biological and Toxin Weapons Convention. Congressional oversight of programs,
especially those performed in federal facilities for homeland security purposes, is
considered key to maintaining transparency in biodefense. The Department of
Homeland Security (DHS) and the Department of Health and Human Services (HHS)
play leading roles protecting civilians against biological weapons. The Department
of Homeland Security has requested and received appropriated funding for the
construction of the National Biodefense Analysis and Countermeasures Center
(NBACC), a biodefense facility dedicated to homeland security activities. This
facility, the first DHS laboratory focused on biodefense, has drawn the attention of
Congress, arms control experts, 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 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.
Organizational Structure
Resources for the National Biodefense Analysis and Countermeasures Center
are provided through the Department of Homeland Security’s Science and
Technology Directorate. NBACC research programs are funded as part of the
Biological Countermeasures portfolio, while construction of the NBACC facility is
listed separately.
Descriptions of the organizational structure of NBACC are conflicting. In 2003,
the FY2004 DHS budget justification and testimony by Assistant Under Secretary
Albright before the House Select Committee on Homeland Security stated that four
centers would comprise NBACC: the Biothreat Assessment Support Center, the
Biodefense Knowledge Center, the Bioforensics Analysis Center, and the
Bio-Countermeasures Testing and Evaluation Center.1 In 2004, the FY2005 DHS
budget justification and testimony by Assistant Under Secretary Albright before the
House Select Committee on Homeland Security stated that NBACC would be
1Dr. 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.
CRS-2
comprised of three organizational units: the Biodefense Knowledge Center, the
National Bioforensic Analysis Center, and the Biological Threat Characterization
Center.2 The Biological Threat Characterization Center appeared to encompass both
the Biothreat Assessment Support Center and the Bio-Countermeasures Testing and
Evaluation Center. In 2005, the FY2006 DHS budget justification and testimony by
Under Secretary McQueary before the House Committee on Science refer to NBACC
as having two component parts: the National Bioforensic Analysis Center and the
Biological Threat Characterization Center.3 The Biodefense Knowledge Center now
appears to not be part of the NBACC facility, though it may still be part of the
NBACC program. As part of the federal biodefense research and development
network, NBACC will also coordinate and collaborate with other entities, such as the
Plum Island Animal Disease Center, the National Institutes of Health, and the United
States Army Medical Research Institute for Infectious Disease (USAMRIID).
Programs undertaken by NBACC are currently conducted through partnerships
and agreements with federal and private institutes.4 The two NBACC facility
components identified in the FY2006 DHS budget are in interim facilities pending
construction of the NBACC laboratory building at Ft. Detrick, MD. The National
Bioforensic Analysis Center (NBFAC) is housed at USAMRIID, located in Ft.
Detrick, MD, and operates as a joint federal effort, including representatives of DHS,
the Federal Bureau of Investigation, and the Army.5 The NBFAC is currently
receiving, handling, and performing forensic analysis on biological samples.6 The
other component center, the Biological Threat Characterization Center (BTCC),
eventually will be located with the National Bioforensic Analysis Center in the new
NBACC laboratory.
The third potential component, the Biodefense Knowledge Center (BKC), was
dedicated on September 10, 2004, and is located at the Department of Energy’s Los
Alamos National Laboratory. Whether this center will continue as an independent
center or be brought into the NBACC in unclear. The BKC will draw 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, will
2Testimony 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.
3Testimony of Dr. Charles E. McQueary, Under Secretary for Science and Technology,
Department of Homeland Security, House Committee on Science, February 16, 2005.
4FY2006 Budget Justification, Science and Technology Directorate, Department of
Homeland Security.
5Testimony 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.
6FY2006 Budget Justification, Science and Technology Directorate, Department of
Homeland Security.
CRS-3
also collaborate with the Biodefense Knowledge Center.7 The BTCC and the BKC
are developing “material threat” assessments and formal risk assessments of
pathogens of interest.
The programs within NBACC, as well as the construction of the NBACC
facility, are part of the Biological Countermeasures portfolio of the DHS Science and
Technology Directorate. The appropriated funding for this portfolio in FY2005, not
including NBACC construction costs, is $362.65 million; $35 million was
appropriated for NBACC facility construction.8
Mission
The mission of the National Biodefense Analysis and Countermeasures Center
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.9 The missions of the
component parts of NBACC support this overall NBACC mission.
The BKC’s mission has multiple parts. One is to provide scientific assessments
and information to the Homeland Security Operations Center regarding potential
bioterrorism events.10 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 will aid
in assessing potential bioterrorism agents as “material threats” for the purpose of the
Project Bioshield countermeasure procurement process.11
The NBFAC was designated in Homeland Security Presidential Directive 10,
Biodefense for the 21st Century, as the lead federal facility to conduct and facilitate
7Lawrence Livermore National Laboratory, “Department of Homeland Security Under
Secretary to Dedicate New Biodefense Knowledge Center,” Press Release, September 10,
2004.
8FY2006 Budget Justification, Science and Technology Directorate, Department of
Homeland Security.
9Testimony 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.
10The 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.
11In order for a countermeasure to be procured using Project BioShield funds, the DHS
Secretary must determine that a “material threat” requiring such a countermeasure exists.
For more information on Project BioShield, see CRS Report RS21507, Project BioShield,
by Frank Gottron.
CRS-4
the technical forensic analysis and interpretation of materials recovered following a
biological attack.12 NBFAC conducts analysis of evidence from a bio-crime or
terrorist attack to attain a “biological fingerprint” in order to identify perpetrators and
determine the origin and method of attack. In fulfillment of this mission, NBFAC
is developing forensic tools, methods, and strain repositories for pathogens of
concern.
The BTCC will conduct studies and laboratory experiments designed to address
gaps in understanding current and future biological threats, assess vulnerabilities,
conduct risk assessments, and determine potential impacts. Types of studies and
experiments to be performed include assessing potential biothreat pathogens,
developing strategies for defeating genetically engineered pathogens, and expanding
current capabilities in testing non-human primates exposed to biological aerosols.13
Policy Issues
Funding for NBACC Facility Construction. The total construction cost
for the NBACC facility has been determined by DHS to be $128 million. A contract
to build the facility is scheduled to be granted in FY2005.14 Construction is projected
to be finished in FY2008. Funds for this construction were appropriated in FY2003-
FY2005. See Table 1. No NBACC construction funds were requested by DHS for
FY2006, and DHS states that no additional resources are required for construction
of the facility.15 At the end of FY2004, the Science and Technology Directorate as
a whole carried over $21.3 million as unobligated funds. All other appropriated
funds appear to have been reprogrammed into other program elements. In FY2005,
$35 million was appropriated for NBACC construction.
Table 1. Funding for NBACC Construction
(Dollars in thousands)
FY2003
FY2003
FY2004
FY2004
FY2005
FY2006
Appropriated
Actual
Appropriated
Actual
Appropriated
Request
5,000
1,600
88,000
4,319a
35,000
0
Source: DHS Budget Justification FY2006
a This value is not consistent through the FY2006 budget justification. On p. 65, approximately $4.3
million is given as the amount obligated, while on p. 42, only $0.4 million is stated as obligated. The
higher value has been used here.
12This activity is conducted in support of the lead federal agency as determined by the
National Response Plan.
13Presentation 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.
14Testimony 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.
15FY2006 Budget Justification, Science and Technology Directorate, Department of
Homeland Security.
CRS-5
Since no additional funds have been requested for the construction of the
NBACC facility, and previously appropriated funds appear to have been used for
other purposes, it is unclear what funds will be used to construct the NBACC facility
in future years. One possibility is that funds will be reprogrammed from other
program elements into construction costs for the NBACC facility. Another
possibility is that future costs for other program elements have been offset through
use of funds appropriated for NBACC construction, and that future funding for these
costs will be used in the construction of the NBACC facility. A third option is that
future budget requests will contain requests for additional appropriations for NBACC
construction.
Public Oversight of NBACC Research. Arms control experts and other
stakeholders have raised concerns about the research to be performed by NBACC at
the Ft. Detrick facility. They assert that the research being undertaken might violate
or might be interpreted as violating the Biological and Toxin Weapons Convention.16
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.17 Some research activities performed by the BTCC and the NBFAC,
however, either in interim facilities or at the to-be-constructed NBACC facility, may
be classified in nature.18
Some agencies use institutional biosafety committees (IBCs) as a mechanism
for overseeing compliance issues.19 In order to assess federally funded extramural
research and development programs which have potential dual-use capabilities, the
Department of Health and Human Services has established the National Science
Advisory Board for Biosecurity, a board whose duties include providing expert
advice on ways to minimize potential misuse of dual-use research. The IBCs are
seen as a mechanism for implementing at the institutional level the recommendations
developed by the NSABB. The DHS has stated that an IBC will be established on
site, but it is unclear what role the IBC will have in assessing research programs. The
primary purpose of an IBC is to ensure that recombinant DNA research follows the
NIH Guidelines for Research Involving Recombinant DNA Molecules. IBCs are
required by NIH guidelines to seat community members on the committee, in
16Milton Leitenberg, James Leonard, and Richard Spertzel, “Biodefense Crossing the Line,”
Politics and the Life Sciences, Vol. 22, (2003).
17U.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.
18U.S. Department of Homeland Security and Army Garrison, Fort Detrick MD, op. cit.
19While IBCs are responsible for oversight of recombinant DNA research, these
responsibilities need not be so restricted. Department of Health and Human Services,
National Institutes of Health, Guidelines for Research Involving Recombinant DNA
Molecules (NIH Guidelines), April 2002.
CRS-6
addition to scientists and safety officials from the institution. The NIH guidelines are
requirements for recipients of NIH funding regarding recombinant DNA techniques,
but other institutions are encouraged to follow the NIH guidelines.20
The degree to which the research programs of NBACC are transparent and
actively overseen may become an area of Congressional interest. The establishment
of an IBC at NBACC may provide a potential public oversight mechanism,
reassuring the local community and others with respect to the research being
performed at NBACC. Some 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.21
Biosafety Level 4 Construction. The NBACC facility will include
laboratory space at the highest level of biosafety containment, Biosafety Level 4
(BSL-4). The volume of laboratory space at the BSL-4 level has historically been
small, with federal facilities available at the CDC 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 Disease (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.22
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 who
oppose the United States.23 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.24
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.25 Similar concerns have been raised regarding
20Department of Health and Human Services, National Institutes of Health, Guidelines for
Research Involving Recombinant DNA Molecules (NIH Guidelines), April 2002.
21The Sunshine Project, Mandate for Failure - The State of Institutional Biosafety
Committees in an Age of Biological Weapons Research, October 4, 2004.
22National Institute of Allergy and Infectious Diseases, “NIAID Funds Construction of
Biosafety Laboratories,” Press Release, September 30, 2003.
23Eileen Choffnes, “Bioweapons: New Labs, More Terror?” Bulletin of the Atomic
Scientists, Vol. 58, September/October 2002.
24For 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.
25Scott 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
(continued...)
CRS-7
the construction of the NIAID BSL-4 facilities.26 Others assert that such a release is
unlikely, given the high safety requirements of a BSL-4 facility.27
Coordination with Department of Health and Human Services. 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). Other programs addressing
nonmedical countermeasures, such as those funded by the Department of Energy,
were transferred to the Department of Homeland Security.28 With the establishment
of the NBACC, research and development activities in areas being pursued by the
BTCC will be closely related to those performed through HHS.29 Coordination of
effort between HHS and DHS may be a topic of Congressional interest.
The DHS Secretary is charged with coordinating homeland security research and
development activities across the federal government. If this charge is accomplished
effectively, there may be good coordination of the two programs. For example, basic
and applied research and development could be performed through HHS, and
advanced development and testing could be performed through DHS. On the other
hand, if coordination is ineffective, there may be significant potential for overlap and
duplication of effort.
Location of the BKC at a Non-Department of Homeland Security
Facility. Congress may also have concerns about the establishment of the BKC at
a Department of Energy National Laboratory, rather than at a DHS facility. The
feasibility study performed for NBACC identified several potential routes for the
construction of NBACC. A phased approach, in which the BKC was initially formed
outside of the Ft. Detrick facility and then incorporated into the facility at a later date,
was one route identified. Whether such a phased approach is under consideration,
how the information and experience located in the BKC at Lawrence Livermore
National Laboratory would be transferred to the Fort Detrick facility, and whether
such a phased approach should be undertaken are unresolved questions.
25(...continued)
Garrison, Fort Detrick MD, op. cit.
26Frank 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
27U.S. Department of Homeland Security and Army Garrison, Fort Detrick MD, op. cit.
28P.L. 107-296, Section 302.
29For 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.