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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation 3 Phase 1: A Pathogens Initiative to Expand Cooperation ◆ ◆ ◆ ◆ ◆ A WINDOW OF OPPORTUNITY FOR INITIATING JOINT EFFORTS The recent activities initiated by the National Academy of Sciences (NAS) in Russia and discussed in Chapter 2 have helped open a window of opportunity for engaging significant elements of the former Soviet biological weapons (BW) community in joint projects of public health significance directed to dangerous pathogens. As evidenced by the major time commitments of key Russian specialists in working with the NAS committee and staff, Russian officials and scientists are clearly interested in expanding cooperative endeavors in the near future. Meanwhile, ISTC support of projects at Biopreparat research institutes is increasing, and the Department of Energy (DOE) recently announced a new program for supporting former Soviet BW specialists under the auspices of the Initiatives for Proliferation Prevention (IPP). These developments have added to the desires of the Russian scientific community for expanded cooperation that includes infusions of financial resources from abroad. Russian readiness to expand cooperation involving one of the most sensitive components of the former Soviet military establishment can be attributed to a variety of other developments as well, including the following: As Biopreparat seeks new roles for providing services to the Ministry of Health and producing items for the civilian market, its research institutes–after favorable initial experiences with the International Science and Technology Center (ISTC) projects and limited success with foreign companies–are increasingly interested in participating in public health efforts with foreign partners. Many Russian nuclear research institutes and production enterprises have participated effectively in international programs, including organizations that have been involved in sensitive activities; leaders of the biological defense community are interested in establishing analogous international programs. The Ministry for Science and Technology has assumed increasing responsibility for financing and approving civilian activities at institutes that, in Soviet times, were involved in BW-related research; the ministry 's interest in the benefits of international cooperation is well known throughout the Russian scientific community. The autonomy of political leaders is increasing in regions of Russia where research and related facilities involved in former Soviet BW efforts are located. Most regional leaders want to capitalize on the advanced technological capabilities of such facilities to promote educational opportunities and economic growth. It is likely that a number of regional governors recognize the importance of foreign partnerships in achieving this goal. As one example, the Communist governor of the Kirov region indicated to committee members a readiness to encourage such cooperation in biotechnology. In government agencies in Moscow and at some research institutes, international cooperation, including scientific cooperation, in combating bioterrorism that could strike Russia is a topic of increasing interest.
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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation As noted previously, resistance to international cooperation persists within the Ministry of Defense (MOD). However, MOD apparently has not objected to Biopreparat's outreach, and some well-informed Russian colleagues believe that in the future, MOD will allow its institutes to join in cooperative efforts. Also, the interest of the Russian Defense Council in promoting cooperation and its reported endorsement of the NAS activity are encouraging. Biopreparat institutes and enterprises were a major component of the former Soviet BW complex. Effective engagement of Biopreparat specialists and institutes therefore warrants a substantial bilateral effort even if MOD remains reluctant to participate. Although Russian interest in cooperation is increasing, the future political course within Russia remains difficult to predict, and curtailment of bilateral cooperation with the United States in sensitive areas could be among the early targets if a reversal of the current movement toward political and economic reform occurs. As cooperation becomes more ingrained in the scientific community, joint efforts are more likely to survive severe political shocks, which underscores the importance of establishing and broadening such cooperation as soon as possible. In view of the foregoing considerations, the committee believes that prompt action to follow up on recent steps toward expanded bilateral cooperation is very important. RECOMMENDATION FOR A PATHOGENS INITIATIVE Drawing on its positive experiences during 1996 and 1997 and current Russian interest in expanding cooperation, the committee recommends that a Pathogens Initiative focused on the public health aspects of dangerous pathogens begin as soon as possible. It will substantially expand the initial program of pilot projects described in Chapter 2 and will build on the limited efforts of several U.S. government agencies in this specialized field as presented in Table E-1. If the Department of Defense (DOD) decides to support a Pathogens Initiative, as recommended in this report, the program will provide significant civilian research opportunities for defense scientists. The assurance of regular paychecks will reduce the economic incentives for these scientists to look elsewhere for financial support, including states of proliferation concern. Thus, the program will directly support DOD's mission to prevent diffusion of critical technical know-how that could assist in developing BW capabilities. The core of a Pathogens Initiative should be joint research projects directed to the epidemiology, prophylaxis, diagnosis, and therapy of diseases associated with dangerous pathogens, as well as related fundamental research. The approaches for selecting and administering such projects developed during the implementation of pilot projects, described in Chapter 2, should serve as the initial framework for an expanded research program. The Pathogens Initiative is projected to last five years, beginning in fiscal year (FY) 1998. The research and other components involved are discussed below. As the program matures, additional activities may be included and some recommended activities and approaches may be modified to reflect the experience gained. If successful, the Pathogens Initiative should lead quite naturally to a state of sustained, transparent cooperation with Russia. This cooperation should be at a level of activity that provides attractive opportunities for a significant number of specialists from each country while at the same time concentrating research at a limited number of high-quality facilities in Russia. A favorable political environment is necessary, and the joint efforts envisaged should, in turn, contribute to improved bilateral political relationships. A possible template for sustained cooperation as a follow-up development to the Pathogens Initiative is presented in Chapter 4.
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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation Organizational Structure If a Pathogens Initiative is undertaken, the topic of expanded bilateral cooperation directed toward dangerous pathogens should be considered and endorsed at the intergovernmental level at an early date. When the committee began discussing cooperation with Russian colleagues during the fall of 1996, Russian officials and scientists advocated prompt consideration of the initiative by the Gore-Chernomyrdin Commission (GCC). They argued, in particular, that endorsement at the intergovernment level would strongly encourage MOD to become involved and would help resolve many of the policy, implementation, and budget issues confronting other participating Russian organizations. The pilot projects did not appear to constitute a sufficiently robust program to warrant consideration at the GCC level during 1997. Also, these projects could be implemented quickly through the ISTC with little need for political endorsement at a higher level. However, an expanded program will raise the political as well as scientific stakes considerably, and intergovernment endorsement could be helpful in providing impetus for an expansion in addition to encouraging coordination among related bilateral efforts. The committee believes that the strong support of both governments is important for successful implementation of a Pathogens Initiative. It recommends that the two governments provide political support for such a program through the GCC or through another appropriate intergovernmental mechanism. In addition to obtaining intergovernment endorsement of the Pathogens Initiative, the U.S. government should support a well-qualified technical working group to meet regularly with the Russian working group established by Biopreparat in the spring of 1997 to interact with the committee. The two working groups could address many of the details of cooperation for presentation to both governments. The suggestions of the Russian working group thus far have been constructive and realistic. The initial membership of the Russian working group is set forth in Box 2-1. A Pathogens Initiative also should be accompanied by a stronger mechanism within the U.S. government for coordinating technical programs that involve cooperation with former Soviet BW specialists, including joint research on dangerous pathogens. Several organizations—including the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA)—have special technical capabilities that should be combined with nongovernment scientific capabilities to provide a focal point for coordination of scientific and technical aspects of the program. This coordinating body could greatly facilitate coordination of the Pathogens Initiative with closely related activities carried out through other U.S. government channels such as the ISTC and IPP. Coordination of these activities should also extend to global programs of infectious disease prevention and control, such as the World Health Organization (WHO) Division of Emerging and Other Communicable Diseases, Surveillance and Control (EMC). An important concern is the possibility of a downturn in U.S.-Russian relations that is so severe it requires the termination of cooperative efforts. If such a change came abruptly, little could be done to safeguard against possible diversion of Russian expertise to prohibited activities. However, if Russian performance of the project agreements became impossible, the U.S. could terminate the agreements with 30 days notice and retrieve unspent funds.
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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation Research Collaboration The lessons learned in selecting, developing, and implementing the six pilot projects serve as important building blocks for the program. In particular, they suggest important new directions for collaboration. For example, at the beginning of deliberations, the committee hesitated to become too deeply involved with pathogens that have been historic BW agents. However, as discussed in Chapter 1, it is now much clearer that investigations of pathogens with BW potential are not only feasible but desirable if the goal of mutual assurance that activities and intentions are consistent with international obligations is to be achieved. A number of leading specialists in both countries fully recognize the importance of transparency as key to preventing the dual-use issue from becoming a major impediment to such cooperation, and transparency assumes its rightful level of significance when applied to the pathogens of greatest concern. The recommended research effort of the Pathogens Initiative involves 15 three-year joint projects initiated each year. This recommendation is based on the following considerations: Significant joint research activities should be located at the most important Russian institutions with research capabilities related to dangerous pathogens that were established in the framework of the Soviet BW program. (Although Box 1-2, Box 1-3, and Box 1-4 provide a list of candidate institutes, not all of them will compete successfully for joint projects.) This program should include MOD institutes when they are prepared to participate. It is estimated that from the pool of 45 active projects when the program is fully operational, an average of 3 projects will be located at each participating Russian institution. Following the pattern established during development of the pilot projects, teams of U.S. experts should visit all potential participating institutes of interest to ensure that their proposals are consistent with current capabilities. The 15 projects initiated each year could engage about 150 Russian researchers on a full-time basis over a period of three years, or a larger number if there are some part-time participants. Using the ISTC estimate of $10,000 to support one full-time Russian specialist in Russia per year (including salary, equipment and supplies, technician and administrative support personnel, travel, and limited overhead), the average three-year cost to the United States is estimated at $300,000 for each project. Because up to 45 projects will be active at any given time, more than 450 important Russian researchers will be participating, including a limited number of part-time participants (see Table E-2 for phasing of joint research projects). Such part-time participants will be contractually obligated to spend the remainder of their time on activities acceptable under the Biological Weapons Convention (BWC). According to Russian colleagues, more than 10,000 scientists are still associated with institutions of the former Soviet BW complex, with an estimated 1,500 having the high-level skills necessary to carry out work on dangerous pathogens.1 Thus, the program will involve a substantial proportion of the leading specialists of interest. If all U.S. efforts in this field are well coordinated, joint projects could engage most of the leading defense scientists. The committee believes that the pool of U.S. specialists is sufficiently large that appropriate collaborators will be available to participate in a program of this size. Each U.S. collaborator will receive an average of $165,000 for the three-year period. It is assumed that one-half of the U.S. collaborators will host research visits of 3 to 12 months by Russian colleagues and one-half will send postdoctoral 1 Well-informed senior Russian specialists advised the committee that of the 9,000 scientists in the Biopreparat dangerous pathogens. Other well-informed Russian scientists stated that between 150 and 200 scientists are currently complex; about 1,000 could be considered highly skilled senior researchers with considerable experience related to working on biological defense issues at MOD facilities. Still others contended that there are several hundred senior researchers at the plague institutes and other civilian facilities who previously conducted work related to dangerous pathogens with financial support from MOD.
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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation scientists or graduate students to Russia for 3 to 6 months by drawing on these funds. The principal investigator and collaborator will also make exchange visits, and the funds will cover these costs as well as provide some salary and overhead reimbursement. Some projects will involve long-term exchanges in both directions, some will call for one-way long-term exchanges, and others will include only short-term exchanges of one to several weeks. In any event, the desirability of long-term exchanges involving serious side-by-side research is clear. Some U.S. institutions, such as USAMRIID and CDC, can provide collaborators for a limited number of projects. Other U.S. organizations, particularly universities, will serve as hosts for most of the projects. In this regard, a special effort is needed to ensure that the U.S. research and development community is aware of the Pathogens Initiative and that interested scientists from many institutions have the opportunity to apply to participate in the programs developed. In short, focused joint research activities of this magnitude will make a substantial contribution to public health and national security and will concentrate research on dangerous pathogens at carefully selected facilities in each country. Framework for the Effort The committee recommends clustering collaborative research projects in the following seven program areas: anthrax, melioidosis and glanders, plague, orthopox viruses, viral hemorrhagic fevers, other dangerous pathogens and diseases of public health concern, and cross-cutting basic research related to dangerous pathogens. The first five areas are directed to important agents and diseases historically linked with BW activities. In each of these areas, Russian institutions are believed to have invested significant resources in research that has been largely unknown outside Russia. The sixth program area will provide opportunities to address other pathogens and diseases of public health concern. Some pathogens of broad public health interest, such as Francisella tularensis, may be of BW concern, whereas others, such as those that cause tuberculosis and influenza, may not be historically associated with BW. This program area is particularly important in permitting key defense scientists who are interested in addressing problems unrelated to BW to participate. It will also expand the pool of potential U.S. collaborators beyond the limited number of scientists engaged in research on agents of BW concern. In addition, this area may increase the possibilities for commercially viable activities. Similarly, the seventh program area provides additional opportunities for cooperation in fundamental research related to a variety of dangerous pathogens or diseases, with immunology being an example of an area of interest. The committee's selection of these program areas followed consultations with Russian colleagues who provided assurances that these areas are of interest to Russia. They anticipate that if an expanded cooperative program is undertaken the concurrence of the Russian government about these specific areas will be forthcoming. Russian colleagues have proposed that joint Russian-U.S. teams meet to develop comprehensive approaches for addressing pathogen-specific program areas. Their concept, set forth by representatives of Biopreparat during the June meeting in Moscow, is that each program area should include projects at several institutes concerned with epidemiology, studies of strain variations, identification and diagnostic techniques, prophylaxis and treatment techniques, and application of research findings. They have
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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation suggested including within each program area a jointly agreed-upon list of candidate projects costing up to $5 million for the participating Russian institutions over a period of five years. They recognize that funds probably will not be available to support all proposed activities within the $5 million ceiling. The committee considers the Russian proposal a good point of departure for further discussion of the scope and priorities of the pathogen-specific program areas. In addition to clarifying scope and priorities, joint teams should play a useful role in encouraging the development of specific proposals by institutions in both Russia and the United States that fit within the agreed-upon program frameworks. Also, the joint teams should ensure that the Russian institutions being considered for participation in the program have the capability to provide and maintain laboratories at an adequate level. Many laboratories are currently in a state of disrepair and are frequently deprived of necessary power, water, and supporting services; substantial Russian investments are necessary if such laboratories are to be involved in the program. As previously noted, projects should be located only at facilities capable of carrying out the proposed activities; any rehabilitation of facilities is the financial responsibility of the institution proposing the project. In any event, individual project proposals should be considered through appropriate review mechanisms in both countries on a project-by-project basis. Those that are most important, in accordance with the criteria set forth in Chapter 2, should receive funding first. There is no reason to divide available funds equally among the seven areas. Indeed, division of funds should depend largely on the quality of the project proposals in competition with each other across program areas. Finally, the existing pilot projects should be incorporated into the program within the context of the program areas described. These projects were intended to provide early results on a limited scale and represent truncated versions of longer-term projects initially proposed by the Russian institutes. All received favorable evaluations, and some have good potential for long-term sustainability. Some or all of the projects may produce results that justify continuation beyond their scheduled termination dates in 1998. Involving Additional Russian Institutions If MOD indicates interest in participating in the program, the exploration of possible collaborative projects involving its institutes should receive high priority. The program also should be prepared to support MOD specialists working at Biopreparat institutes or as subcontractors to Biopreparat institutes if appropriate projects are proposed. Several Biopreparat research institutes, in addition to the two that are carrying out pilot projects, have significant capabilities and should become involved in the program. For example, the Institute of Immunology in Lyubuchany, the Institute for Highly Pure Biopreparations in St. Petersburg, and the Institute for Scientific Biological Instrumentation in Moscow are believed to have strong capabilities and have expressed interest in collaborative projects; they may be considered early candidates for projects. Other institutes are identified in Box 1-2, Box 1-3, and Box 1-4. The possibility of including Russian engineers and technical personnel who played key roles in designing the processes and equipment used in the former Soviet BW program should be explored. Their involvement in collaborative activities could help open opportunities for joint efforts to reconfigure former BW facilities under the Cooperative Threat Reduction (CTR) program. Alternatively, such technical personnel may be more appropriate participants for other U.S.-sponsored programs, such as the IPP. The Pathogens Initiative could provide brokering services for U.S. programs that do not have comparable contacts within the Biopreparat establishment. In this regard, Biopreparat facilities at Omutninsk, Pokrov, and Berdsk and engineering research institutes in Moscow and Kirov have indicated interest in collaborative activities; their scientific and engineering potential deserves careful attention.
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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation A special opportunity to engage previously isolated specialists from Biopreparat and MOD facilities may exist in Kirov. The recently established Volgo-Vyatka Applied Biotechnology Center, which served as host for the international symposium in the Kirov region in June 1997, is well positioned to provide introductions to several important MOD and Biopreparat institutions in the region. Also, Biotin, a major Biopreparat biochemical production enterprise with extensive contacts in the region, has indicated an interest in joint projects. A follow-up visit to Kirov in the near future may be a useful step toward broadening Russian participation in the Pathogens Initiative and related engineering efforts. The Plague Research Institutes in Saratov and Stavropol have indicated interest in participating in cooperative activities, and on-site visits by U.S. experts are needed to carefully assess their capabilities. At a later date, assessments of the capabilities of the three other plague research institutes in Russia also should be considered. Finally, as suggested in previous chapters, efforts should be considered to link former Soviet BW facilities and civilian institutes in common projects. There are a number of well-known civilian institutes with relevant research interests in the Ministry of Health, the Russian Academy of Medical Sciences, the Russian Academy of Sciences, and the Russian Academy of Agricultural Sciences; they should be encouraged to cooperate with former Soviet BW facilities as appropriate. Although the past capabilities of most of the civilian institutes are well known in the West, visits to these institutes are needed to better appreciate their current capabilities after extensive losses of personnel and aging of equipment. Supporting Activities Improvement of the electronic communications capabilities of Russian institutions participating in joint projects is important for meaningful international collaboration. Communications upgrades for Russian participants can be built into large projects or clusters of small projects at the same location. Installation costs of such upgrades depend on the specific institution and could range from thousands of dollars for computers, modems, and links to local telephone circuits to hundreds of thousands of dollars for satellite facilities at remote locations such as Koltsovo. Operating expenses also must be considered because e-mail and Internet services can be costly for impoverished institutions. Given the importance of this topic and the specialized nature of an authoritative assessment of needs, early joint assessment of electronic communications capabilities within the Biopreparat complex by well-qualified experts is important. The primary focus should be on institutes with strong potential for participating in sustained collaborative efforts. In yet another area, both the Saratov Plague Institute and the Ivanovsky Institute for Virology have proposed projects for upgrading the safekeeping and utility of their strain collections, which serve as standards for the country. The Gamaleya Institute of Epidemiology and Microbiology also has national reference collections of strains, and the Chumakov Institute for Poliomyelitis and Viral Encephalitides holds a reference collection in its field. A number of other institutes have specialized collections. Russian institutes with standard reference collections or other significant collections should be encouraged to prepare project proposals for more effective utilization and maintenance of the strains; those that receive high evaluations should be considered for support. An important aspect of collaborative projects concerning pathogenic strains should be the procedures that are in place or that will be adopted to ensure transparency about how these strains are to be used. Such transparency should help ensure that the projects undertaken not contribute to activities that violate international obligations pursuant to the BWC. Although Russia has many regulations governing the handling and use of strains, the details of such regulations are not widely known outside the country. A comparison of recently promulgated U.S. and Russian regulations should be considered as a topic for a workshop or a joint project. Finally, exchanges of information about the biosafety regulatory frameworks for handling dangerous pathogens in the two countries began during initial consultations with Russian colleagues. Box 3-1
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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation lists some of the relevant Russian laws and regulations. Because such regulations are still evolving in both countries, periodic reviews should be held of requirements that could impinge on cooperative programs. Of particular interest would be early workshops to consider the following issues: registration of high-hazard laboratories, control over collections of strains of dangerous pathogens, setting and monitoring standards biosafety, and procedures for controlling the movement of dangerous pathogens within a country and between countries. Box 3-1 Selected Russian Laws, Decrees, and Regulations on the Control of Dangerous Pathogens Decree of the Russian President on ensuring the fulfillment of international obligations in the area of biological weapons, April 11, 1992 (Decree 390) Procedures for controlling export from the Russian Federation of disease agents, their genetically altered forms, and fragments of genetic material that can be used for developing bacteriological (biological) and toxin weapons, November 20, 1992 (Decision of the Russian Government, No. 892) Licensing and establishing quotas for exports and imports of biological goods and services, included in instructions of the State Customs Committee, No. 610 of December 12, 1992 Federal law on state regulation in the area of genetic engineering, June 5, 1996 (adopted by the state Duma) Safety of microorganisms of Group I-II pathogenicity, sanitary regulations of 1994, Sanitary Epidemiology Service of Russia Interim regulations concerning dangerous work with recombinant DNA, Scientific Center for Biological Research of the Soviet Academy of Sciences, Pushchino, 1978 (prepared by an interagency council) Penalties for crimes against the peace and security of mankind: Production or proliferation of weapons of mass destruction, Sections 355 and 356 of the Russian Criminal Code of 1996. NOTE: These laws, decrees, and regulations have been identified by Russian specialists as being of particular relevance to bilateral cooperation directed to research on dangerous pathogens. Project Development Activities During the early years, a variety of activities will be particularly important in developing proposals for joint research and in matching appropriate collaborators. Annual reviews of ongoing projects can help guide selection of future high-priority research themes. Also, the overall approach should be reviewed in depth at the end of the second year and adjusted as necessary. In addition, the following types of project development activities should be carried out: Brief exchange visits to enable researchers from the two countries to develop proposals for submission to funding competitions; Travel grants for Russian scientists to participate in scientific conferences in the United States, where they can make contacts and become aware of the state of international science in their fields; and Joint scientific workshops to explore new areas for possible projects, including workshops that build on the results of completed projects. Estimated Cost The estimated annual cost to the United States of a Pathogens Initiative is $6.0 million in the first year (FY 1998), $7.0 million in the second year, and $8.5 million per year in the third, fourth, and fifth years. The steady-state annual costs for the final three years will be as follows: Four and a half million dollars (53 percent) to support 15 new projects each year at Russian research institutions throughout the three-year project lifetime. The total funding of $4.5 million will be committed at the beginning but disbursed over the course of the projects. Disbursement, of course, will depend on performance in accordance with agreed-upon work plans.
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Controlling Dangerous Pathogens: A Blueprint for U.S.-Russian Cooperation Two and a half million dollars (29 percent) to support U.S. collaborators and exchange visits associated with the 15 projects for three years, with the entire amount of funds again committed but not disbursed at the beginning. One-half million dollars (6 percent) to support (1) panels of U.S. experts to review project proposals, (2) joint U.S.-Russian workshops to identify priority areas for collaboration, and (3) exploratory visits by U.S. specialists to Russian institutions with largely unknown capabilities, including, if possible, MOD institutes. One million dollars (12 percent) for program evaluation, financial management, and related support activities for the Pathogens Initiative, involving three full-time staff members. During the first two years of the Pathogens Initiative, project costs will be lower and project development costs will be higher. Thus, the recommended funding level of $6 million for FY 1998 assumes that only 10 projects are initiated; the level of $7 million for FY 1999 assumes 12 projects, leading to 15 new projects in each of the final three years at an annual cost of $8.5 million. (Table E-3 lists the allocation of funds per fiscal year.) The Russian financial contributions will cover primarily (1) the pension, health, and related benefits packages for Russian participants and (2) indirect project costs incurred at Russian facilities because the U.S. overhead contribution will be only about 7 percent of the total project costs. In addition, Russian waivers of value-added taxes and personal income taxes, in a sense, place a financial burden on the Russian government. Anticipated Results The foregoing approach will represent a significant commitment by both the United States and Russia to expand research activities and exchange information on biosafety controls over dangerous pathogens. As such, it would advance both the national security and the public health agendas of the two countries. Also, invited efforts would be significant in setting the stage for sustained long-term efforts after the five-year initiative. The Pathogens Initiative is designed to help reduce the likelihood of proliferation of dangerous technologies that are extremely difficult to control, to encourage a concentration of Russian activities at carefully selected facilities with high scientific potential, and to encourage reconfiguration of former Soviet BW facilities to address new public health challenges. It also should contribute to building confidence at the government and laboratory levels about the legitimacy of activities that are under way.
Representative terms from entire chapter: