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The Biological Threat Reduction Program of the Department of Defense|From Foreign Assistance to Sustainable Partnerships 5 Future of the Biological Threat Reduction Program The Department of Defense (DOD) estimates expenditures of about $200 million annually for the next five to ten years for the Biological Threat Reduction Program (BTRP), a major increase over current expenditure levels.1 BTRP plans to have significant activities under way in all of the countries of the former Soviet Union except Russia, Belarus, and the Baltic states in the next several years. Reflecting steady budgetary growth, the President’s request to Congress for Fiscal Year (FY) 2008 included $144 million for BTRP.2 However, the Senate Armed Services Committee has recommended increasing this level to $194 million with an additional $10 million provided for activities beyond the former Soviet Union (FSU).3 Many details of these projections are not publicly available. However, it is clear that the projections do not include funds for further work on Infrastructure Elimination. This program component is scheduled to be financed to completion with FY 2007 funds, as discussed in Chapter 2. Based on available information, an estimated 90 percent of the funds currently being considered by DOD for the future are to support biosecurity/biosafety and Threat Agent Detection and Response (TADR) activities. The remainder is for the Cooperative Biological Research (CBR) component of BTRP. Of course, DOD may at any time request reprogramming authority from the Congress within the overall Cooperative Threat Reduction program if priorities and opportunities change.4 The committee strongly supports this long-term DOD commitment to preventing the proliferation of biological weapons. As discussed throughout this report, the national security payoffs from a robust and far reaching program in this field are considerable. While BTRP has already made many contributions in promoting U.S. security interests, BTRP and related U.S. programs have touched only a small portion of the challenges of preventing proliferation of biological weapons. The security of many institutions in the FSU and in other areas of the world with biological assets of potential interest to terrorist groups is clearly inadequate. A large number of facilities need urgent upgrading to improve security and to strengthen research and service capabilities. Many talented scientists need additional support to encourage them to concentrate their efforts on public health and agriculture problems. Enhancing facility security and supporting underutilized scientific workforces could help prevent serious adverse impacts on 1 Project staff discussions with DOD and Defense Threat Reduction Agency (DTRA) officials, June 11, 2007. On June 8, 2007, DTRA announced its intention to select several integrating contractors for the program with total expenditures up to $4 billion during the next ten years. DOD and DTRA officials consider this estimate somewhat high to cover currently unanticipated requirements. 2 U.S. Department of Defense. 2007. Cooperative threat reduction annual report to Congress: Fiscal Year 2008. Cooperative Threat Reduction Program, p. 41. 3 Senate Report 110-77, National Defense Authorization Act for Fiscal Year 2008. Available on-line at http://origin.www.gpoaccess.gov/serialset/creports/. Accessed June 14, 2007. 4 U.S. Department of Defense. 2007. Cooperative threat reduction annual report to Congress Fiscal Year 2008. Cooperative Threat Reduction Program, p. 41.
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The Biological Threat Reduction Program of the Department of Defense|From Foreign Assistance to Sustainable Partnerships geographically dispersed U.S. interests should there be aggressive efforts by adversaries to carry out threats of bioterrorism. The projected funding levels will enable the U.S. government, acting through BTRP as well as other programs, to continue its global leadership in addressing the dual-use dilemma associated with advancements in biological science and biotechnology. Such advancements are intertwined with important public health, agriculture, and scientific issues. Also, BTRP has repeatedly demonstrated that it not only can accomplish specific objectives in the U.S. government’s efforts to prevent the proliferation of biological weapons but can also encourage partner governments and other international governments to expand their support of programs that complement BTRP. BTRP is by far the largest U.S. government biological nonproliferation program, and it is the only program that is growing. Thus, it should play an even more important role in reducing the likelihood of bioterrorism in an important geographical region. In general the committee supports the program priorities selected by BTRP for future years. However, this chapter suggests several modified approaches in the development and implementation of BTRP, with special emphasis on new models to improve the effectiveness of research collaboration Program Activities for FY 2008 DOD has announced that BTRP plans to use the funds requested for FY 2008 for the following activities: Russia: Support planned cooperative research projects to improve vaccines and to identify better antiviral medications for smallpox. About $5.2 million has been allocated for this purpose. However, Russian policies that are unacceptable to DOD and lack of BTRP access to locations believed to be sites for repositories of dangerous pathogens limit the program, and no funding will be sought for FY 2009 and beyond other than for the possible continuation of smallpox-related research. Georgia: Continue construction of a Central Reference Laboratory (CRL), which will secure all dangerous pathogens in the country and will provide a capability to characterize pathogens and validate diagnoses. Within the CRL, the pathogen repositories (one for human and one for veterinary pathogens) and an accompanying small suite of laboratory space will be built to Biosafety Level 3 (BSL-3) standards. Uzbekistan: Continue construction of epidemiological monitoring stations and provide training for personnel to respond to and rapidly diagnose disease outbreaks. Collaborative research projects will continue to be developed and implemented. Kazakhstan: If tax issues can be resolved, initiate work on a CRL, continue to construct/renovate epidemiological monitoring stations, and provide training for personnel to respond to and rapidly diagnose disease outbreaks. Collaborative research projects will continue to be developed and implemented. Azerbaijan: Construct/renovate four epidemiological monitoring stations and provide training for personnel to respond to and rapidly diagnose disease outbreaks. Continue to develop and implement cooperative research projects. Ukraine: Construct/renovate five epidemiological monitoring stations. Continue to provide diagnostics and epidemiological equipment and training to respond
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The Biological Threat Reduction Program of the Department of Defense|From Foreign Assistance to Sustainable Partnerships to and rapidly diagnose disease outbreaks. Collaborative research projects will continue to be developed and implemented.5 Modifying the Orientation of BTRP BTRP was developed in Washington as an assistance program for states that were on an economic decline following the splintering of the Soviet Union into 15 newly independent nations. While a highly directed program based on the near-term security interests of the United States and tightly managed by American commercial contractors was appropriate during the 1990s, greater attention should now be given to having a program that serves the interests of the partner governments more broadly, as well as serving longer-term U.S. interests. This orientation will help (1) encourage cooperation of partner governments, institutions, and specialists, (2) enlist colleagues in common efforts that will continue for many years to help ensure that dual-use technologies are directed to peaceful pursuits, and (3) set the stage for sustainability of programs initiated through BTRP that should be maintained over the long term by partner institutions. To this end, the committee emphasizes the following: BTRP should be transformed from a Washington-directed program of assistance to a genuinely collaborative program of partnerships with governments of the states of the former Soviet Union, built on strong relationships between important scientific, public health, and agriculture institutions and between specialists in these states and their counterparts in the United States. Should BTRP expand into other geographical areas, collaboration rather than assistance should be a guiding principle whenever possible. In short, establishing the long-term viability of partnerships at many levels is as important as deriving the products of individual projects. A critical early step in this regard is for BTRP to fully engage partner governments, institutions, and specialists in the selection and design of proposed cooperative activities from the outset. Greater attention should be given to balancing the priorities of partners and of BTRP. BTRP should be flexible so that BTRP activities can be effectively integrated with partner priorities, especially if they are to address major public health goals of both countries. Also, the likelihood of sustainability by partners of activities initiated through BTRP should be considered before projects are undertaken. Greater attention should also be given to the activities of local and multinational companies that may have interests in collaboration with BTRP. Joint programs should be considered, with partner governments encouraged to provide tax and other incentives to promote such collaboration when they serve the governments’ interests. Involvement of 5 Benkert, J.A. 2007. Statement for the record by Joseph A. Benkert, principal deputy assistant secretary of defense for global security affairs, to the Senate Committee on Armed Services, Subcommittee on Emerging Threats and Capabilities, April 11, 2007, p. 8-9. Available on-line at http://armed-services.senate.gov/statemnt/2007/April/Benkert%2004-11-07.pdf. Accessed June 14, 2007. Since the date when this presentation was made, progress has been made in resolving tax issues in Kazakhstan, according to comments made by BTRP officials to project staff on June 11, 2007.
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The Biological Threat Reduction Program of the Department of Defense|From Foreign Assistance to Sustainable Partnerships the private sector would be a clear signal of the moving of the program from an assistance activity to a program based on shared financial as well as scientific interests. Establishment of BSL-3 Laboratory Capabilities Returning to the proposed plans for the next few years, which are still in an early formative stage, DOD intends to support construction of CRLs with BSL-3 capabilities throughout the region. About $250 million is earmarked for this activity. In addition to the CRL currently under construction in Georgia and the CRL planned for Kazakhstan, additional CRLs are planned as follows: Uzbekistan: BTRP will design and construct a CRL. Ukraine: BTRP will design and construct a CRL. Azerbaijan: The partner government will assume responsibility for financing a CRL, with technical assistance provided by BTRP as needed. Kyrgyzstan: It is anticipated that the Canadian government and the European Union will assume responsibility for financing a CRL, with consideration given to standardization of design and compatibility of systems throughout the region. The cost of constructing and equipping each CRL is estimated at $60 million. Maintenance and operating costs will probably be at least $5 million annually. BTRP plans to assume responsibility for supporting maintenance and operation of the CRLs that it constructs for five-year “warranty” periods. Continued financing after the end of the five-year period has not yet been adequately addressed. A number of preliminary suggestions have been made including the linking of CRLs with existing or planned field stations of the Centers for Disease Control and Prevention (CDC) or with overseas U.S. Army or Navy medical research units. These connections would both enhance the prestige of the CRLs, which should strengthen the ability of the CRLs to raise funds, and provide the CRLs with direct access to technical and perhaps limited financial support. With regard to Georgia, the prime minister has requested that DOD and the U.S. Department of Health and Human Services (DHHS) become partners with his government to develop and sustain a CRL near Tbilisi. Presumably, DOD and DHHS would remain permanently involved after termination of BTRP's presence and would provide some level of financial support. One approach would be to use the model of the five existing DOD overseas laboratories. The committee is unaware of a DHHS response to this request as of July 15, 2007. The CRLs that are being planned have many important attributes—providing a basis for integrating research on different species, linking diagnostics and epidemiology, consolidating and securing strains, and establishing a strong base for cooperative research and for applications of research results. The design that has been developed for the CRLs is state-of-the-art. The CRLs should help move the scientific workforces of the countries where they are established into an era of modern technology. However, the committee has reservations about inclusion of BSL-3 laboratory capabilities in the CRLs. As noted in Chapter 2, the committee is concerned by the costs of the investments in BSL-3 laboratory capabilities and the associated life-cycle costs. Achieving and
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The Biological Threat Reduction Program of the Department of Defense|From Foreign Assistance to Sustainable Partnerships sustaining a BSL-3 capability would account for a large percentage of the construction and operating costs of the CRLs as currently planned. The frequency of use of BSL-3 capabilities may not be sufficiently high to warrant the costs of placing such capabilities in each country. Regional approaches might be more appropriate. In any event, BTRP should document the likely demand for use of BSL-3 laboratories in the region and the potential funding sources that would support such use in the long term. This information would provide an improved basis for determining where such facilities should be located. Also, the committee is concerned that a CRL with BSL-3 laboratory capability could fall into the hands of an irresponsible government that might emerge within one of the countries in the future. In principle, the facility could become a significant instrument in supporting nefarious activities that ironically promote rather than constrain proliferation of biological weapons. Of course, it could be argued that a determined adversary could carry out dangerous activities in less safe facilities, and therefore there is little risk that the BSL-3 capability will increase the likelihood of hostile activities. However, an adversary having uninhibited access to a BSL-3 laboratory would introduce considerable instability into the region and would certainly raise the perceived biothreat level. The committee therefore recommends that the U.S. government consider retaining indefinitely partial ownership of any CRL with BSL-3 capability that is established with BTRP support. Such retention of ownership has important implications, as follows: The U.S. government will be committed to ensuring that the CRL will operate for the indefinite future and to this end will be obligated to find financial support when needed. Thus, the U.S. government will take great care in carrying out the necessary feasibility assessments in advance of construction to document the need for a BSL-3 capability that will serve U.S. as well as local interests, thereby reducing the likelihood that enhanced capabilities will become “white elephants” that are not adequately used. As a part owner, the U.S. government should be in a good position to ensure that the BSL-3 capability is not misused even if there are political changes in the country and will be able to advocate precautions against misuse at facilities built by others throughout the region. There may be alternatives to U.S. ownership such as long-term intergovernmental agreements. However, when financial responsibilities are involved, there is a high level of interest in the future of the facilities that is difficult to match. Whatever the approach that is to be adopted, a detailed blueprint that integrates activities within and across countries in this important area is needed. Expanding the CBR Program With the exception of Russia, the number of cooperative research projects in each of the countries where BTRP is currently active is scheduled to increase, according to BTRP plans. But the increase will be modest since the bulk of BTRP funding is to be invested in facility modifications. Some ongoing research projects will probably be extended while new projects are initiated. In general, these projects are to be designed to
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The Biological Threat Reduction Program of the Department of Defense|From Foreign Assistance to Sustainable Partnerships support the TADR system, focusing research efforts on those disease agents and syndromes that are relevant to the TADR network. DOD seems to underestimate the important contributions of well-conceived collaborative research projects to preventing the proliferation of biological weapons, particularly following the BTRP-financed upgrading of research facilities. The percentage of BTRP funds devoted to CBR should be significantly increased. It is the human dimension of a nation’s infrastructure, reflected in large measure in its research capabilities, that is the critical determinant in a nation’s effort to control dual-use assets while also translating the contributions of BTRP investments into products that will improve health and agriculture systems. As discussed in Chapter 1, international engagement among researchers working in science, health, and agriculture is central to the global effort to reduce the likelihood of terrorism—whether promoted by facility insiders or initiated by outsiders. Research is a critical component of the approach to preventing proliferation of biological weapons advocated throughout this report. To this end, BTRP should give greater emphasis to a comprehensive, multifaceted approach to international engagement for achieving biosecurity, public health, and agriculture objectives. The approach should include development of countermeasures to bioterrorism, enhanced facility security, collaborative surveillance activities, expanded cooperative research, development of common biosafety procedures, adoption of good laboratory practices and good manufacturing practices, development of human resources, and related activities. BTRP seems to recognize the importance of this principle, but needs to increase the support of human resource development to ensure an appropriate balance among the many elements of the comprehensive approach. At the same time, within the interagency process, BTRP should continue to play a key role in U.S. efforts directed to containment of highly dangerous pathogens and associated activities. But BTRP, in cooperation with other U.S. government departments and agencies, also needs to be a strong advocate for and active participant in addressing broader science, health, agriculture, and biosecurity issues. However, the United States cannot on its own transform the narrow global focus on physical security for enhancing biosecurity to a more comprehensive approach throughout the world. If BTRP makes significant progress in a variety of fields such as good laboratory and good manufacturing approaches, enhanced disease surveillance, and development of common biosafety procedures, its activities should become models for emulation by others—both its immediate partner organizations and other national and international organizations. In this regard, the G-8 Global Partnership can provide an excellent forum for dissemination of BTRP experience. A critically important aspect of BTRP’s research activities is the participation of well-qualified American collaborators who have strong professional interests in the success of projects that are financed. BTRP has expended considerable resources to this end, but the results have been spotty. While a few excellent American collaborators are currently involved in BTRP projects, some projects have had little more than token
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The Biological Threat Reduction Program of the Department of Defense|From Foreign Assistance to Sustainable Partnerships collaborators (see, for example, Box 5-1). Collaborators who are U.S. government employees can sometimes devote significant time to collaborative projects if they are of mainstream interest to the American collaborators. But too often, such collaboration is simply an additional assignment of marginal interest to the American scientists. Also, American academics who have been recruited have usually taken on the assignment of collaborators as an added duty, or as a temporary diversion from their primary research interests, rather than as a mainstream activity within their research programs. Box 5-1 Importance of Collaborators “American collaborators need to spend extended time in our laboratories.” Georgian senior scientist, March 2007. • • • “High quality American collaborators are very important.” Russian senior scientist, March 2007. BTRP increasingly recognizes the importance of strong and committed collaborators and that adequate financial support must be provided to collaborators. As indicated by the new projects identified in Box 5-2, collaborators are now being drawn from a variety of DOD facilities and academic institutions. Box 5-2 CBR Projects Being Developed as of June 15, 2007 Mapping Especially Dangerous Pathogens in Azerbaijan ($150,000). U.S. collaborating organizations: Walter Reed Army Institute of Research (WRAIR) and California State University, Fullerton. Clinical, Epidemiologic, and Laboratory-Based Assessment of Brucellosis in Azerbaijan ($750,000). U.S. collaborating organizations: U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), WRAIR, and Louisiana State University (LSU). Clinical, Epidemiologic, and Laboratory-Based Assessment of Brucellosis in Georgia ($750,000). U.S. collaborating organizations: USAMRIID, WRAIR, and LSU. Active Surveillance of Especially Dangerous Pathogens in the Southern Caucasus Region (Georgia) ($750,000). U.S. collaborating organizations: Armed Forces Institute of Pathology (AFIP) and the Naval Medical Research Center (NMRC). Genetic Peculiarities of Strains of Specially Dangerous Zoonotic Pathogens in Kazakhstan ($750,000). U.S. collaborating organizations: AFIP and NMRC. The following suggestions are offered to improve the availability and quality of American collaborators:
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The Biological Threat Reduction Program of the Department of Defense|From Foreign Assistance to Sustainable Partnerships For the non-Russian countries where local researchers have had very limited contact with American colleagues, BTRP should adopt the model used by the U.S. Department of Agriculture, and to some extent by the Department of Health and Human Services, which is discussed in Chapter 3. A potential investigator from the region should spend several weeks with a potential American collaborator determining whether they have common interests in specific types of research activities. Only then should BTRP encourage the development of a cooperative research project by the two collaborators. This approach varies from the initial BTRP practice of BTRP staff and contractors developing the research concepts in considerable detail and then trying to find appropriate investigators in the region and collaborators in the United States. BTRP should ensure that American collaborators as well as local researchers have access to sufficient funds to enable them to pursue related parallel research efforts. In many cases, a special BTRP funding stream to support American collaborators will be necessary. In addition to the matchmaking by BTRP for foreign scientists who do not have contacts in the United States, BTRP should have periodic grant competitions whereby local scientists prepare proposals, in cooperation with potential American collaborators, in response to solicitations on topics of special interest to BTRP. As discussed below, this approach is particularly attractive for Russia. An important aspect of such solicitations could be opportunities at upgraded facilities in the region to jointly investigate pathogen strains that are unique to the region, thereby reducing the need to ship strains across international borders. The short-term payoffs from investments in research are difficult to measure. But in the longer term they may be the most significant activities that BTRP undertakes in some countries. They should help detect misuse of pathogens and enhance capabilities to respond promptly to incidents resulting from misuse. They should set a standard of ethical approaches to research that contributes to the development of a culture of personal responsibility for biosafety and biosecurtiy. The Special Case of Russia DOD should work through existing scientific networks and establish new models as appropriate to reinvigorate BTRP in Russia by supporting cost-shared collaborative research projects, scientific conferences, and other scientific activities that promote both Russian and U.S. national security interests through engagement of outstanding established and young scientists in the two countries. Russia, with its vast ecological diversity and a large well-trained scientific workforce, should be a leader in global efforts to prevent, detect, and respond to disease outbreaks whether naturally occurring or deliberately induced. The nation’s resources—technologies, materials, and expertise—for addressing dangerous pathogens are vast and should be harnessed for peaceful purposes. Despite the oil windfall, many biological facilities remain in outmoded conditions, and highly talented specialists remain in difficult financial conditions. As the largest U.S. program with relevant experience, BTRP should have a strong outreach program to Russia.
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The Biological Threat Reduction Program of the Department of Defense|From Foreign Assistance to Sustainable Partnerships For a number of years, BTRP has played a significant role, within the interagency context, in redirecting important components of the former Biopreparat defense-oriented complex, which was located primarily in Russia, toward the mainstream of national and international non-defense biological research activities. Almost all BTRP activities in Russia are now coming to conclusion. But opportunities for continued scientific engagement that would benefit international science and global security are many fold. There is considerable interest in Russia in re-establishing cooperation, although important senior health and defense officials do not favor cooperation with elements of DOD. For example, the Federal Biological Medical Agency expressed interest to the committee in 2007, and its specialists then proposed the following agenda of activities: Translation of the results of research projects carried out under BTRP into health care practice Financial support of projects to develop drugs for protection from dangerous infections Collaborative research to create a joint system of biological safety control Also, a number of prominent Russian specialists have told committee members on numerous occasions that resumption of BTRP cooperation is overdue. Against this background of benefits to the United States and strong latent interest in Russia, BTRP should reinvigorate its earlier cooperative biological research and related programs, which have almost disappeared in Russia due to a policy change within DOD in the early 2000s that led to termination of funding of new projects. BTRP may have some difficulty persuading potential Russian partners to prepare research proposals for BTRP consideration given the history of DOD’s loss of interest in dozens of sound proposals prepared at the request of BTRP. But prompt implementation of a few major research projects should improve receptivity to participation in BTRP. While DOD has had difficulties in dealing with the Russian government, the country’s biological assets within dozens of facilities are too important not to include Russia in future BTRP activities. There are well-established mechanisms for engaging important Russian institutions and specialists in cooperative activities that circumvent the need for formal agreements between DOD and recalcitrant Russian ministries and agencies. Also, a number of approaches to engagement no longer require BTRP’s commercial contractors, thereby reducing the need for logistics teams based in Russia. DOD is reluctant to engage Russia for administrative reasons—lack of an appropriate executive agent and difficulty in working through the International Science and Technology Center. Also, DOD wants Russia to formally request “assistance.” But national security opportunities clearly trump such administrative problems, and it is time that BTRP began to capitalize in a major way on investments it has already made in Russia. The emphasis should be on jointly funded high-impact research activities of mutual interest. Priority should be given to sustaining research groups with strong scientific capabilities that have emerged as the result of past investments and on commercialization of research products as discussed in Chapter 2. In this way, BTRP can capitalize on its past investments in research in Russia, recognizing that Russia now has stronger technical capabilities than a decade ago and that the Russian need for financial
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The Biological Threat Reduction Program of the Department of Defense|From Foreign Assistance to Sustainable Partnerships assistance has diminished. At the same time, effective commercialization activities will not be easy to achieve, as indicated in Box 5-3. Box 5-3 Protecting Intellectual Property “In Russia, copyright protection virtually does not work. In rare instances when researchers receive a worthwhile reward for a new drug, it is not a result of a legal mandate or requirement. It is the result of a personal agreement (not legally documented in any way) with the manager (owner) of the manufacturing company or as a result of the inventor’s leverage to control the production flow (in particular, when the inventor can terminate the production at his own volition).” Russian bioresearch manager, November 2004. SOURCE: National Research Council. 2006. Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security. Washington, D.C.: National Academies Press, p. 26. As a related step in reviving and retaining Russian and American interest in cooperative research, BTRP should consider supporting periodic international scientific conferences in Russia on infectious diseases of public health importance to both countries, including naturally occurring and intentionally released pathogens. In association with these conferences, workshops could be held on directly related topics including good laboratory practices, biosafety, and biosecurity. Such conferences could provide important windows into activities in Russia. As a reciprocal gesture, DOD might support attendance by Russian specialists at selected microbiology and virology conferences in the United States. Together, these conference venues could stimulate development of joint research activities using funding from a variety of sources. A new approach involving joint programs between consortia of laboratories in the two countries should also be considered. Such a mechanism, built around common scientific themes, could reduce administrative burdens while engaging larger numbers of participants than in the past. Russia, with its large number of strong institutes, is a good place to initiate such a program. Beyond the Former Soviet Union BTRP has no current plans to carry out activities beyond the boundaries of the FSU. At the same time, there is growing concern over the inadequate security conditions in biological facilities in South Asia and other regions as discussed in Chapter 1 and as reflected in the Congressional action concerning limited funding in FY 2008 for BTRP activities beyond the FSU. BTRP should be in a position to respond promptly to a requirement for deployment in new regions if appropriate. Cutting across all activities and all geographic regions is the expanding role of information technology (IT). As an educational tool, the backbone of surveillance networks, and the facilitator of international partnerships, the IT capabilities of partner institutions will be a critical determinant as to the effectiveness of national, regional, and
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The Biological Threat Reduction Program of the Department of Defense|From Foreign Assistance to Sustainable Partnerships global efforts to contain the spread of infectious diseases. BTRP has recognized the importance of IT in the TADR network and should continue to emphasize IT applications in all aspects of the program.
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Representative terms from entire chapter: