Homeland Security: New Department Could Improve Biomedical R&amp;D Coordination but May Disrupt Dual-Purpose Efforts
Published: 2002-07-09T00:00:00

Fast Facts:

Highlights:
section_title: What GAO Found
paragraphs: Title III of the proposed Homeland Security Act of 2002 would transfer responsibility for certain chemical, biological, radiological, and nuclear research and development programs and activities to the new department. The proposed Department of Homeland Security would develop national policy for, and coordination of, the federal government's civilian research and development efforts to counter chemical, biological, radiological, and nuclear threats. Although the new department could improve coordination of existing research and development programs, the proposed transfer of control and priority setting for research from the organizations where the research would be conducted could be disruptive. Transferring control over these programs, including priority setting, to the new department has the potential to disrupt some programs that are critical to basic public health. The President's proposal is not clear on how both the homeland security and the biomedical research objectives would be accomplished. However, if an agency's mission fits with homeland security, its transfer to the new department is appropriate.

section_title: Letter
paragraphs: I appreciate the opportunity to be here today to discuss one component— the potential effect on biomedical research—of the proposed creation of  the Department of Homeland Security. Since the terrorist attacks of  September 11, 2001, and the subsequent anthrax incidents, there has been  concern about the ability of the federal government to prepare for and  coordinate an effective public health response to such events, given the  broad distribution of responsibility for that task at the federal level. Our  earlier work found, for example, that more than 20 federal departments  and agencies carry some responsibility for bioterrorism research,  preparedness, and response and that these efforts are fragmented.
The President’s proposed Homeland Security Act of 2002 would bring  many of the federal entities with homeland security responsibilities,  including biomedical research and development, into one department.  Title III of the proposed legislation would transfer responsibility for  certain chemical, biological, radiological, and nuclear research and  development programs and activities to the new department. Much of the  research in these areas is sponsored by or conducted at the Department of  Health and Human Services’ (HHS) National Institutes of Health (NIH).  The proposal would also transfer the Laboratory Registration/Select Agent  Transfer Program—which controls biological agents with the potential for  use in bioterrorism—from HHS’s Centers for Disease Control and  Prevention (CDC) to the new department.
In order to assist the Subcommittee in its consideration of this extensive  reorganization of our government, my remarks will focus on the potential  effects of a reorganization on biomedical research under Title III of the  President’s proposal. My testimony today is based largely on our previous  and ongoing work on homeland security, as well as a review of the  proposed legislation.
In summary, the proposed Department of Homeland Security would be  tasked with developing national policy for and coordination of the federal  government’s civilian research and development efforts to counter  chemical, biological, radiological, and nuclear threats. GAO has  consistently stated that there is a need for a strategic plan and better  coordination of existing research and development programs. The new  department could improve coordination of the biomedical research and  development efforts. We are concerned, however, that the proposed  transfer of control and priority setting for research from the organizations  where the research would be conducted could be disruptive to dual- purpose programs, which have important synergies that need to be  maintained. Transferring control over these programs, including priority  setting, to the new department has the potential to disrupt some programs  that are critical to basic public health responsibility. The President’s  proposal is not sufficiently clear on how both the homeland security and  the biomedical research objectives would be accomplished. Because the  select agent program’s mission fits with homeland security, its transfer to  the new department is appropriate.
subsections: section_title: Background
paragraphs: In response to global challenges the government faces in the coming years,  we have a unique opportunity to create an extremely effective and  performance-based organization that can strengthen the nation’s ability to  protect its borders and citizens against terrorism. There is likely to be  considerable benefit over time from restructuring some of the homeland  security functions, including reducing risk and improving the economy,  efficiency, and effectiveness of these consolidated agencies and programs.  Realistically, however, in the short term, the magnitude of the challenges  that the new department faces will clearly require substantial time and  effort, and will take additional resources to make it fully effective.
The Comptroller General has testified that the Congress should consider  several very specific criteria in its evaluation of whether individual  agencies or programs should be included or excluded from the proposed  department. Those criteria include the following:    Mission Relevancy: Is homeland security a major part of the agency or  program mission? Is it the primary mission of the agency or program?
Similar Goals and Objectives: Does the agency or program being  considered for the new department share primary goals and objectives  with the other agencies or programs being consolidated?
Leverage Effectiveness: Does the agency or program being considered for  the new department promote synergy and help to leverage the  effectiveness of other agencies and programs or the new department as a  whole? In other words, is the whole greater than the sum of the parts?
Gains Through Consolidation: Does the agency or program being  considered for the new department improve the efficiency and  effectiveness of homeland security missions through eliminating  duplications and overlaps, closing gaps, and aligning or merging common  roles and responsibilities?  Integrated Information Sharing/Coordination: Does the agency or program  being considered for the new department contribute to or leverage the  ability of the new department to enhance the sharing of critical  information or otherwise improve the coordination of missions and  activities related to homeland security?
Compatible Cultures: Can the organizational culture of the agency or  program being considered for the new department effectively meld with  the other entities that will be consolidated? Field structures and  approaches to achieving missions vary considerably between agencies.  Impact on Excluded Agencies: What is the impact on departments losing  components to the new department? What is the impact on agencies with  homeland security missions left out of the new department?
In the President’s proposal, the new Department of Homeland Security  would be responsible for conducting a national scientific research and  development program, including developing national policy and  coordinating the federal government’s civilian efforts to counter chemical,  biological, radiological, and nuclear weapons or other emerging terrorist  threats. The new department would carry out its civilian health-related  biological, biomedical, and infectious disease defense research and  development through agreements with HHS, unless otherwise directed by  the President. As part of this responsibility, the new department would  establish priorities and direction for programs of basic and applied  research on the detection, treatment, and prevention of infectious diseases  such as those programs conducted by NIH.
NIH supports and carries out biomedical research to study, prevent, and  treat infectious and immunologic human diseases. Infectious diseases  include those caused by new, emerging, and reemerging infectious agents,  including those that are intentionally introduced as an act of bioterrorism.  The emphasis of antiterrorism research supported by NIH has been in four  areas: (1) design and testing of new diagnostic tools; (2) design,  development, and clinical evaluation of therapies; (3) design,  development, and clinical evaluation of vaccines; and (4) other basic  research, including genome sequencing.
The President’s proposal also would transfer the select agent program  from HHS to the new department. Currently administered by CDC, this  program’s mission is ensuring the security of those biologic agents that  pose a severe threat to public health and safety and could be used by  terrorists. The proposal provides for the new department to consult with  appropriate agencies, which would include HHS, in maintaining the select  agent list and to consult with HHS in carrying out the program.
section_title: Proposed Department Could Improve Coordination of Research and Development Programs
paragraphs: The proposed Department of Homeland Security would be tasked with  developing national policy for and coordinating the federal government’s  civilian research and development efforts to counter chemical, biological,  radiological, and nuclear threats. The new department also could improve  coordination of biomedical research and development efforts. In addition  to coordination, the role of the new department would need to include  forging collaborative relationships with programs at all levels of  government and developing a strategic plan for research and development.
We have previously reported that the limited coordination among federal  research and development programs may result in a duplication of efforts.  Coordination is hampered by the extent of compartmentalization of efforts  because of the sensitivity of the research and development programs,  security classification of research, and the absence of a single  coordinating entity to help prevent duplication. For example, the  Department of Defense’s (DOD) Defense Advanced Research Projects  Agency was unaware of U.S. Coast Guard plans to develop methods to  detect a biological agent on an infected cruise ship and therefore was  unable to share information on its research to develop biological detection  devices that could have been applicable to buildings infected this way.
The new department would need to develop mechanisms to coordinate  and integrate information about ongoing research and development being  performed across the government related to chemical, biological,  radiological, and nuclear terrorism, as well as harmonize user needs.  Although the proposal tasks the new department with coordinating the  federal government’s “civilian efforts” only, the new department also  would need to coordinate with DOD because DOD conducts biomedical  research and development efforts designed to detect and respond to  weapons of mass destruction. Although DOD’s efforts are geared toward  protecting armed services members, they may also be applicable to the  civilian population. Currently, NIH is working with DOD on biomedical  research and development efforts, and it is important for this collaboration  to continue. An example of NIH and DOD’s efforts is their support of  databases to compare the sequences and functions of poxvirus genes.  These searchable databases enable researchers to select targets for  designing antiviral drugs and vaccines, and serve as repositories for  information on well documented poxvirus strains to aid in detection and  diagnosis.
The President’s proposal could help improve coordination of federal  research and development by giving one person the responsibility for a  single national research and development strategy that could address  coordination, reduce potential duplication, and ensure that important  issues are addressed. In 2001, we recommended the creation of a unified  strategy to reduce duplication and leverage resources, and suggested that  the plan be coordinated with federal agencies performing the research as  well as with state and local authorities. Such a plan would help to ensure  that research gaps are filled, unproductive duplication is minimized, and  that individual agency plans are consistent with the overall goals.
section_title: Transfer of Control Over Dual-Purpose Research and Development Raises Concern
paragraphs: We are concerned about the implications of the proposed transfer of  control and priority setting for dual-purpose research programs. For  example, some research programs have broad missions that are not easily  separated into homeland security research and research for other  purposes. We are concerned that such dual-purpose research activities  may lose the synergy arising from their current placement.
The President’s proposal would transfer the responsibility for civilian  biomedical defense research and development programs to the new  department, but the programs would continue to be carried out through  HHS. These programs, now primarily sponsored by NIH, include a variety  of efforts to understand basic biological mechanisms of infection and to  develop and test rapid diagnostic tools, vaccines, and antibacterial and  antiviral drugs. These efforts have dual-purpose applicability. The  scientific research on biologic agents that could be used by terrorists  cannot be readily separated from research on emerging infectious  diseases. For example, research being carried out on antiviral drugs in the  NIH biodefense research program is expected to be useful in the  development of treatments for hepatitis C. NIH biodefense research on  enhanced immunologic responses to protect against infection and disease  is critical in the development of interventions against both naturally  occurring and man-made pathogens.
The proposal to transfer to the new department responsibility for research  and development programs that would continue to be carried out by HHS  raises many concerns. Although there is a clear need for the new  department to have responsibility for setting policy, developing a strategy,  providing leadership, and coordinating research and development efforts  in these areas, we are concerned that control and priority-setting  responsibility will not be vested in those programs best positioned to  understand the potential of basic research efforts or the relevance of  research being carried out in other, nonbiodefense programs. For  example, NIH-funded research on a drug to treat cytomegalovirus  complications in patients with HIV is now being investigated as a  prototype for developing antiviral drugs against smallpox.
There is the potential that the proposal would allow the new department  to direct, fund, and conduct research related to chemical, biological,  radiological, nuclear, and other emerging threats on its own. This raises  the potential for duplication of effort, lack of efficiency, and an increased  need for coordination with other departments that would continue to  carry out relevant research. Design and implementation of a research  agenda is most efficient at the level of the mission agency where scientific  and technical expertise resides. Building and duplicating the existing  facilities and expertise in the current federal laboratories needed to  conduct this research would be inefficient.
section_title: Mission of Select Agent Program Is Aligned with New Department
paragraphs: The proposal would transfer the Laboratory Registration/Select Agent  Transfer Program from HHS to the new department. The select agent  program, recently revised and expanded by the Public Health Security and  Bioterrorism Preparedness and Response Act of 2002, generally requires  the registration of persons and laboratory facilities possessing specific  biologic agents and toxins—called select agents—that have the potential  to pose a serious threat to public health and safety. Select agents include  approximately 40 viruses, bacteria, rickettsia, fungi, and toxins. Examples  include Ebola, anthrax, botulinum, and ricin. The 2002 act expanded the  program’s requirements to include facilities that possess the agents as well  as the facilities that transfer the agents.
The mission of the select agent program appears to be closely aligned with  homeland security. As we stated earlier, one key consideration in  evaluating whether individual agencies or programs should be included or  excluded from the proposed department is the extent to which homeland  security is a major part of the agency or program mission. By these  criteria, the transfer of the select agent program would enhance efficiency  and accountability.
section_title: Concluding Observations
paragraphs: The President’s proposal would address some shortcomings noted earlier  in this statement. Better coordination could reduce wasteful duplication  and increase efficiency. The mission of the select agent program is aligned  with the new department and, therefore, the transfer of the program would  enhance efficiency and accountability. However, we are concerned about  the broad control the proposal grants to the new department for  biomedical research and development. Although there is a need to  coordinate these activities with the other homeland security preparedness  and response programs that would be brought into the new department,  there is also a need to maintain the priorities for current dual-purpose  biomedical research. The President’s proposal does not adequately  address how to accomplish both objectives or how to maintain a priority- setting role for those best positioned to understand the relevance of  biomedical research. We are also concerned that the proposal has the  potential to create an unnecessary duplication of federal research  capacity.
Mr. Chairman, this completes my prepared statement. I would be happy to  respond to any questions you or other Members of the Subcommittee may  have at this time.
section_title: Contact and Acknowledgments
paragraphs: For further information about this testimony, please contact me at   (202) 512-7118. Robert Copeland, Marcia Crosse, and Deborah Miller also  made key contributions to this statement.
section_title: Related GAO Products
subsections: section_title: Homeland Security
paragraphs: Homeland Security: Intergovernmental Coordination and Partnership  Will Be Critical to Success. GAO-02-901T. Washington, D.C.: July 3, 2002.
Homeland Security: Intergovernmental Coordination and Partnership  Will Be Critical to Success. GAO-02-900T. Washington, D.C.: July 2, 2002.
Homeland Security: Intergovernmental Coordination and Partnership  Will Be Critical to Success. GAO-02-899T. Washington, D.C.: July 1, 2002.
Homeland Security: New Department Could Improve Coordination but  May Complicate Priority Setting. GAO-02-893T. Washington, D.C.: June  28, 2002.
Homeland Security: Proposal for Cabinet Agency Has Merit, but  Implementation Will Be Pivotal to Success. GAO-02-886T.   Washington, D.C.: June 25, 2002.
Homeland Security: New Department Could Improve Coordination but  May Complicate Public Health Priority Setting. GAO-02-883T.  Washington, D.C.: June 25, 2002.
Homeland Security: Key Elements to Unify Efforts Are Underway but  Uncertainty Remains. GAO-02-610. Washington, D.C.: June 7, 2002.
Homeland Security: Responsibility and Accountability for Achieving  National Goals. GAO-02-627T. Washington, D.C.: April 11, 2002.
Homeland Security: Progress Made; More Direction and Partnership  Sought. GAO-02-490T. Washington, D.C.: March 12, 2002.
Homeland Security: Challenges and Strategies in Addressing Short- and  Long-Term National Needs. GAO-02-160T. Washington, D.C.:   November 7, 2001.
Homeland Security: A Risk Management Approach Can Guide  Preparedness Efforts. GAO-02-208T. Washington, D.C.: October 31, 2001.
Homeland Security: Need to Consider VA’s Role in Strengthening Federal  Preparedness. GAO-02-145T. Washington, D.C.: October 15, 2001.
Homeland Security: Key Elements of a Risk Management Approach.  GAO-02-150T. Washington, D.C.: October 12, 2001.
Homeland Security: A Framework for Addressing the Nation’s Efforts.  GAO-01-1158T. Washington, D.C.: September 21, 2001.
section_title: Public Health
paragraphs: Bioterrorism: The Centers for Disease Control and Prevention’s Role in  Public Health Protection. GAO-02-235T. Washington, D.C.:   November 15, 2001.
Bioterrorism: Review of Public Health Preparedness Programs. GAO-02- 149T. Washington, D.C.: October 10, 2001.
Bioterrorism: Public Health and Medical Preparedness. GAO-02-141T.  Washington, D.C.: October 9, 2001.
Bioterrorism: Coordination and Preparedness. GAO-02-129T.  Washington, D.C.: October 5, 2001.
Bioterrorism: Federal Research and Preparedness Activities. GAO-01- 915. Washington, D.C.: September 28, 2001.
Chemical and Biological Defense: Improved Risk Assessment and  Inventory Management Are Needed. GAO-01-667.   Washington, D.C.: September 28, 2001.
West Nile Virus Outbreak: Lessons for Public Health Preparedness.  GAO/HEHS-00-180. Washington, D.C.: September 11, 2000.
Chemical and Biological Defense: Program Planning and Evaluation  Should Follow Results Act Framework. GAO/NSIAD-99-159.   Washington, D.C.: August 16, 1999.
Combating Terrorism: Observations on Biological Terrorism and Public  Health Initiatives. GAO/T-NSIAD-99-112. Washington, D.C.:   March 16, 1999.
section_title: Combating Terrorism
paragraphs: National Preparedness: Technologies to Secure Federal Buildings. GAO- 02-687T. Washington, D.C.: April 25, 2002.
National Preparedness: Integration of Federal, State, Local, and Private  Sector Efforts Is Critical to an Effective National Strategy for Homeland  Security. GAO-02-621T. Washington, D.C.: April 11, 2002.
Combating Terrorism: Intergovernmental Cooperation in the  Development of a National Strategy to Enhance State and Local  Preparedness. GAO-02-550T. Washington, D.C.: April 2, 2002.
Combating Terrorism: Enhancing Partnerships Through a National  Preparedness Strategy. GAO-02-549T. Washington, D.C.: March 28, 2002.
Combating Terrorism: Critical Components of a National Strategy to  Enhance State and Local Preparedness. GAO-02-548T. Washington, D.C.:  March 25, 2002.
Combating Terrorism: Intergovernmental Partnership in a National  Strategy to Enhance State and Local Preparedness. GAO-02-547T.  Washington, D.C.: March 22, 2002.
Combating Terrorism: Key Aspects of a National Strategy to Enhance  State and Local Preparedness. GAO-02-473T. Washington, D.C.:   March 1, 2002.
Chemical and Biological Defense: DOD Should Clarify Expectations for  Medical Readiness. GAO-02-219T. Washington, D.C.: November 7, 2001.
Anthrax Vaccine: Changes to the Manufacturing Process. GAO-02-181T.  Washington, D.C.: October 23, 2001.
Chemical and Biological Defense: DOD Needs to Clarify Expectations for  Medical Readiness. GAO-02-38. Washington, D.C.: October 19, 2001.
Combating Terrorism: Considerations for Investing Resources in  Chemical and Biological Preparedness. GAO-02-162T.   Washington, D.C.: October 17, 2001.
Combating Terrorism: Selected Challenges and Related  Recommendations. GAO-01-822. Washington, D.C.: September 20, 2001.
Combating Terrorism: Actions Needed to Improve DOD Antiterrorism  Program Implementation and Management. GAO-01-909.   Washington, D.C.: September 19, 2001.
Combating Terrorism: Comments on H.R. 525 to Create a President’s  Council on Domestic Terrorism Preparedness. GAO-01-555T.   Washington, D.C.: May 9, 2001.
Combating Terrorism: Accountability Over Medical Supplies Needs  Further Improvement. GAO-01-666T. Washington, D.C.: May 1, 2001.
Combating Terrorism: Observations on Options to Improve the Federal  Response. GAO-01-660T. Washington, DC: April 24, 2001.
Combating Terrorism: Accountability Over Medical Supplies Needs  Further Improvement. GAO-01-463. Washington, D.C.: March 30, 2001.
Combating Terrorism: Comments on Counterterrorism Leadership and  National Strategy. GAO-01-556T. Washington, D.C.: March 27, 2001.
Combating Terrorism: FEMA Continues to Make Progress in  Coordinating Preparedness and Response. GAO-01-15.   Washington, D.C.: March 20, 2001.
Combating Terrorism: Federal Response Teams Provide Varied  Capabilities; Opportunities Remain to Improve Coordination. GAO-01- 14. Washington, D.C.: November 30, 2000.
Combating Terrorism: Need to Eliminate Duplicate Federal Weapons of  Mass Destruction Training. GAO/NSIAD-00-64. Washington, D.C.:   March 21, 2000.
Combating Terrorism: Chemical and Biological Medical Supplies Are  Poorly Managed. GAO/T-HEHS/AIMD-00-59. Washington, D.C.:   March 8, 2000.
Combating Terrorism: Chemical and Biological Medical Supplies Are  Poorly Managed. GAO/HEHS/AIMD-00-36. Washington, D.C.:   October 29, 1999.
Combating Terrorism: Observations on the Threat of Chemical and  Biological Terrorism. GAO/T-NSIAD-00-50. Washington, D.C.:   October 20, 1999.
Combating Terrorism: Need for Comprehensive Threat and Risk  Assessments of Chemical and Biological Attacks. GAO/NSIAD-99-163.  Washington, D.C.: September 14, 1999.
Chemical and Biological Defense: Coordination of Nonmedical Chemical  and Biological R&D Programs. GAO/NSIAD-99-160. Washington, D.C.:  August 16, 1999.
Combating Terrorism: Use of National Guard Response Teams Is  Unclear. GAO/T-NSIAD-99-184. Washington, D.C.: June 23, 1999.
Combating Terrorism: Observations on Growth in Federal Programs.  GAO/T-NSIAD-99-181. Washington, D.C.: June 9, 1999.
Combating Terrorism: Analysis of Potential Emergency Response  Equipment and Sustainment Costs. GAO/NSIAD-99-151.   Washington, D.C.: June 9, 1999.
Combating Terrorism: Use of National Guard Response Teams Is  Unclear. GAO/NSIAD-99-110. Washington, D.C.: May 21, 1999.
Combating Terrorism: Observations on Federal Spending to Combat  Terrorism. GAO/T-NSIAD/GGD-99-107. Washington, D.C.: March 11, 1999.
Combating Terrorism: Opportunities to Improve Domestic Preparedness  Program Focus and Efficiency. GAO/NSIAD-99-3. Washington, D.C.:  November 12, 1998.
Combating Terrorism: Observations on the Nunn-Lugar-Domenici  Domestic Preparedness Program. GAO/T-NSIAD-99-16. Washington, D.C.:  October 2, 1998.
Combating Terrorism: Observations on Crosscutting Issues. GAO/T- NSIAD-98-164. Washington, D.C.: April 23, 1998.
Combating Terrorism: Threat and Risk Assessments Can Help Prioritize  and Target Program Investments. GAO/NSIAD-98-74. Washington, D.C.:  April 9, 1998.
Combating Terrorism: Spending on Governmentwide Programs  Requires Better Management and Coordination. GAO/NSIAD-98-39.  Washington, D.C.: December 1, 1997.
section_title: Disaster Assistance
paragraphs: Disaster Assistance: Improvement Needed in Disaster Declaration  Criteria and Eligibility Assurance Procedures. GAO-01-837.   Washington, D.C.: August 31, 2001.
Chemical Weapons: FEMA and Army Must Be Proactive in Preparing  States for Emergencies. GAO-01-850. Washington, D.C.: August 13, 2001.