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2

Ensuring Appropriate Use of Biological Assets

Beginning in the late-1990s, for more than a decade joint projects that addressed appropriate use of biological assets dominated much of the bioengagement agenda.

This early impetus for addressing security concerns was driven primarily by the U.S. government. At that time the Russian economy was in a state of free fall, with resources available from the Russian governmental or nongovernmental sectors for scientific activities being very limited. While the Russian government was hesitant at first to participate in cooperative activities designed primarily to contain sensitive technologies, the Russian scientific workforce was desperate for financial relief. The government soon became interested in cooperation in biosecurity, provided there were also opportunities for advancing its scientific agendas. But Russian ministries simply did not have funds to make major contributions to joint activities.

At times, Russian scientists were able to use limited funds available at the institution level to support cooperation. More often, they relied on U.S. financial support while contributing some labor and supporting services without compensation to joint efforts, as discussed in the Introduction to this report. In any event, the program priorities and approaches were largely in the hands of the U.S. organizations that provided the bulk of the financial resources.

A significant inaugural event highlighting opportunities for cooperation was a conference in Kirov in 1997. This conference brought together for the first time a number of important senior investigators from the United States and Russia who were responsible for research that involved highly dangerous pathogens (Box 2-1).

Then a significant pathfinder activity, which was to lead to larger investments



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2 Ensuring Appropriate Use of Biological Assets Beginning in the late-1990s, for more than a decade joint projects that addressed appropriate use of biological assets dominated much of the bioengage- ment agenda. This early impetus for addressing security concerns was driven primarily by the U.S. government. At that time the Russian economy was in a state of free fall, with resources available from the Russian governmental or nongovernmental sectors for scientific activities being very limited. While the Russian government was hesitant at first to participate in cooperative activities designed primarily to contain sensitive technologies, the Russian scientific workforce was desperate for financial relief. The government soon became interested in cooperation in biosecurity, provided there were also opportunities for advancing its scientific agendas. But Russian ministries simply did not have funds to make major con- tributions to joint activities. At times, Russian scientists were able to use limited funds available at the institution level to support cooperation. More often, they relied on U.S. financial support while contributing some labor and supporting services without com- pensation to joint efforts, as discussed in the Introduction to this report. In any event, the program priorities and approaches were largely in the hands of the U.S. organizations that provided the bulk of the financial resources. A significant inaugural event highlighting opportunities for cooperation was a conference in Kirov in 1997. This conference brought together for the first time a number of important senior investigators from the United States and Rus- sia who were responsible for research that involved highly dangerous pathogens (Box 2-1). Then a significant pathfinder activity, which was to lead to larger investments 39

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40 U.S.-RUSSIAN RELATIONSHIP IN BIOLOGICAL SCIENCE AND BIOTECHNOLOGY Box 2-1 International Conference in Kirov, Russia, on Severe Infectious Diseases The Volga-Vyatka State Scientific Center of Applied Biotechnology, with the support of the International Science and Technology Center, brought together more than 50 specialists from more than 20 organizations in Russia and the United States, with Japanese scientists also participat- ing, to discuss epidemiology, express-diagnostics, and prevention of infectious diseases. The group recommended accelerated development of vaccines, antiviral preparations, and antibiotics; greater use of mo- lecular biology to design effective vaccines; and development of highly sensitive and specific methods of rapid diagnosis. The conference set the stage for continued international involvement in activities in Kirov and the neighboring territories, where former defense scientists could be brought together easily with other specialists in fields of mutual interest. SOURCE: Proceedings of Conference, 1997. Complete reference cited in Appendix A.2. that would support joint activities, was a series of eight pilot projects at two key Russian research centers during the late 1990s (Box 2-2). These projects demon- strated the feasibility of collaboration at previously closed Russian facilities while significantly redirecting capabilities of these facilities to civilian endeavors at a critical time of financial uncertainty. Following the success of seven of the eight pilot projects, the overall program was soon supported by the Russian government and several U.S. government agencies. As to the eighth project, further work on opisthorchiasis was not considered a priority by either side. Cooperation rapidly expanded and in time encompassed many different types of research at a number of research institutions. Building on these early activities, the U.S. government devoted tens of mil- lions of dollars annually, with Russian institutions contributing comparable levels of support, for biosecurity activities in Russia. Initially, the principal U.S. funder was the Department of Defense (DOD), which covered many of the direct costs of the programs. The direct costs that were covered by DOD eventually totaled more than $200 million. (See Appendix C.2 for the DTRA contributions.) In addition, the Department of State (DOS) also began supporting biosecurity activities in Russia in the late 1990s. DOS gradually increased its contributions to a level of annual support of about $20 million during 2006. These funds were also focused primarily on covering a large segment of the direct costs. (See Appendix C.1.)

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ENSURING APPROPRIATE USE OF BIOLOGICAL ASSETS 41 Box 2-2 Joint Pilot Projects Initiated in 1997 At State Research Center of Virology and Biotechnology Vector, Koltsovo • Study of prevalence, genotype distribution, and molecular variabil- ity of isolates of hepatitis C virus. • Study of monkeypox virus genome. • Study of genetic and serological diversity of hantaviruses. • Development of advanced diagnostic kit for opisthorchiasis. • Study of antiviral activities of glycyrrhizic acid and derivatives against Marburg, Ebola, and human immunodeficiency viruses. At State Research Center for Applied Microbiology, Obolensk • Analysis of clinical strains of tuberculosis and mycobacteriosis. • Investigation of immunological effectiveness of delivery in vivo of Brucella main outer membrane protein by the anthrax toxin components. • Monitoring of anthrax. SOURCE: Scientists, Engineers, and Track-Two Diplomacy, p. 51. Complete reference cited in Appendix A.2. Other U.S. organizations launched smaller biology-oriented programs in cooperation with a variety of Russian research institutions and service providers, largely in the health and agricultural sectors. U.S. government departments and agencies carried out most joint projects with interested Russian institutes through the good offices of the International Science and Technology Center (ISTC) in Moscow. Some research projects were financed through the regular contributions of the U.S. government to the core budget of the ISTC. The ISTC’s partner program provided a second mechanism for international financing of projects that soon far exceeded activities supported by funds provided through the ISTC’s core budget. (See Appendix E.2.) Several dozen Russian production enterprises and research institutes that had been involved in the defense programs of the former Soviet Union were in difficult economic straits during the 1990s, as their budgets rapidly declined. Of particular importance was the fate of the Biopreparat complex, which had provided a research and production framework for the USSR’s defense program. Box 2-3 describes Biopreparat’s capabilities in the early 2000s, when the indus- trial conglomerate was beginning to recover following its near collapse during the 1990s.

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42 U.S.-RUSSIAN RELATIONSHIP IN BIOLOGICAL SCIENCE AND BIOTECHNOLOGY Box 2-3 Biopreparat: An Early Focus of Redirection Activities The joint stock company integrates 20 industrial enterprises that manu- facture 1,000 different products. More than 36,000 workers are involved in production. Biopreparat accounts for 35 percent of Russia’s total out- put of medical products valued annually at $280 million in drugs and $50 million in engineering articles. Biopreparat has four state research centers, six research institutes, two pilot design bureaus, and two design institutes. Its personnel number 6,000 scientists and specialists in micro- biology, biotechnology, gene engineering, immunology, and biophysics. SOURCE: Biopreparat Brochure, 2003. By 2008, DOS had become the largest U.S. source of funding for biology- related nonproliferation projects in Russia, as DOD began to phase out its Coop- erative Threat Reduction Program in the country. However, by this time the resources available to DOS were well below the earlier levels that had been provided by DOD or DOS. For a number of years, within the budgets of DOS, some funds had been earmarked for use by the Department of Health and Human Services, the Agricul- tural Research Service, and the Environmental Protection Agency. Their common mission was to support activities in Russia that would redirect scientists who had worked on defense-oriented projects to civilian efforts in the technical areas of interest to the three U.S. organizations. The Russian government warmly wel- comed cooperation with these organizations. By 2012, annual expenditures by DOS for new cooperative projects related to biosecurity with Russian counterparts had declined to less than $1 million per year. Also, funds of the other three U.S. government agencies earmarked for sup- port of bioengagement activities were no longer available. However, DOD was providing limited support to other government departments and agencies and universities to maintain a minimal level of contacts with scientific institutions in Russia. Several other U.S. organizations have financed activities at lower levels to help prevent inappropriate proliferation of dangerous technologies developed in Russia. The largest contributor of these organizations has been the Department of Energy, which has supported a number of bioengagement projects that were designed to lead to commercial activities. The Global Initiatives for Proliferation Prevention has been the source of the funding (see Appendix C.3). In addition,

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ENSURING APPROPRIATE USE OF BIOLOGICAL ASSETS 43 a few projects with limited scope were financed by private foundations, such as the Nuclear Threat Initiative. Gradually, Russian authorities were able to provide more funding for scien- tific cooperation within the framework of U.S.-supported nonproliferation pro- grams. By 2008, many of the difficult biosecurity concerns had been addressed jointly, particularly upgrading physical security systems within selected Russian institutes. However, the issue of consolidation of pathogens within institutes and within clusters of institutes was a concern that, in the view of the U.S. govern- ment, did not receive the attention that it deserved. Throughout the lifetimes of the foregoing nonproliferation programs, the focus of cooperative efforts increasingly emphasized the scientific benefits from cooperation. Special attention was given to strengthening approaches to com- mercialization of technologies and to promotion of transparency. Of course, the more traditional nonproliferation approaches, such as enhanced physical security, continued to be important to both governments and to Russian institutes that were slowly recovering from economic difficulties. In general, over the years, Russian institutions developed and implemented several types of nonproliferation projects within the framework of programs sup- ported by several U.S. government agencies. These programs were intended to • Dismantle portions of Russian facilities that had the capability to pro- duce large quantities of anthrax and other pathogens of concern. However, only one significant activity was carried out in Russia—at the Sibbiopharm facility in Berdsk. (See Box 2-4.) A primary focus for this type of activity in the region was U.S. support for dismantlement of other facilities in Kazakhstan. Box 2-4 Conversion of Sibbiopharm Production Association Facility at Berdsk, 2006–2010 The Department of State contributed significant funding in helping to convert a facility of concern into a pharmaceutical production facility that produced enzymatic preparations used by the feedstuff, plant protec- tion, and food industries. Several large fermenters capable of producing material of defense interest were dismantled, and the entire facility was modernized, including installation of new equipment, renovation of se- lected premises, and provision of technical consultations on commercial aspects. SOURCE: Civilian Research and Development Foundation, which assisted the Department of State in implementation of this project, March 2012.

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44 U.S.-RUSSIAN RELATIONSHIP IN BIOLOGICAL SCIENCE AND BIOTECHNOLOGY Box 2-5 Examples of Institutes Where Physical Security Upgrades Were Installed • State Research Center of Virology and Biotechnology Vector, Koltsovo • State Research Center for Applied Microbiology, Obolensk • All-Russian Research Institute of Phytopathology, Bolshie Vyazemy • Federal Center of Toxicological and Radiation Safety, Kazan • Federal Center for Animal Health, Vladimir • Plant of Biopreparations, Pokrov SOURCE: Russian senior science manager, 2011. • Increase physical security at Russian facilities where dangerous patho- gens were stored and/or used for research and related purposes. Dozens of proj- ects were implemented. (See Box 2-5 for examples of the Russian facilities that were involved.) • Support research and related activities that would utilize the skills of the Russian workforce, and particularly the skills of former defense scientists, to strengthen the basic and applied research infrastructures of Russia. This support was substantial and extended into pilot production of medical and agricultural- related items. (See Appendixes C.1, C.2, C.3, and C.4 for examples of activities.) • Carry out consultations and related activities concerning disease sur- veillance capabilities and outbreaks of infectious diseases of regional and global concern. Both countries had extensive surveillance capabilities in place. The cooperation was directed in large measure to rapid and reliable diagnostics, synchronization of surveillance approaches among different countries and with the World Health Organization (WHO), and standardization and distribution of surveillance data. The focus of cooperative biosecurity programs involving a number of U.S. and Russian organizations gradually broadened. The two sides agreed that the best way to reduce the likelihood and consequences of misuse of dangerous pathogens—whether naturally occurring or illicitly obtained by malcontents— was to strengthen the overall public health system of Russia and the supporting scientific infrastructure. The emphasis was on development of approaches that would assist in the prevention, detection, diagnosis, and therapy of infectious diseases, whatever the sources of the diseases. The joint activities that evolved covered a broad swath of projects. From the outset, cooperative research projects were high on the priority list. Initially, there

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ENSURING APPROPRIATE USE OF BIOLOGICAL ASSETS 45 was little cooperation to upgrade surveillance systems, but during the early 2000s, considerable emphasis was placed on coordination of capabilities to detect and respond to outbreaks of diseases at an early stage and to limit their subsequent spread should such outbreaks occur. In short, while the early emphasis was to develop projects that had direct relationships to proliferation and bioterrorism concerns, the scope of activities rapidly diffused to effect more traditional out- comes of human and animal health activities that are addressed in the next three chapters. Appendix C.2 presents one set of DOD’s indicators of progress in improving biosecurity at individual Russian facilities. The appendix also identifies a number of cooperative research projects carried out on the basis of their potential contri- bution to improving the research infrastructure of the country, where appropriate research activities could be implemented in a transparent manner. An activity that commanded considerable attention for a number of years throughout the international security community was a collaborative program to investigate the properties of variola virus strains that have been preserved in both Russia and the United States. This effort was undertaken at the Rus- sian research center Vector. It was directly related to ongoing discussions at the WHO as to whether all remaining smallpox isolates should be destroyed or whether it was important to continue to investigate the properties of the virus. Better understanding of smallpox diagnostics and medical countermeasures was considered important in the event that the contagious disease reappeared as the result of (a) accidental release of the organism into nature from Russian or U.S. WHO-approved stocks or (b) intentional release from other currently unknown and unapproved stocks (Box 2-6). Many cooperative research activities carried out within the framework of nonproliferation programs were of considerable interest to the civilian research communities in a number of countries. For example, brucellosis is a disease of considerable concern in the agriculture field. Joint efforts within the framework of nonproliferation programs advanced scientific understanding of the charac- teristics of that particular disease (Box 2-7). Other common diseases were also addressed in the program, and some are highlighted in Chapter 3. As collaborative programs developed and expanded, DOD and interested Russian institutions organized a number of international conferences and work- shops that focused on bioproliferation concerns and the opportunities for coopera- tive research activities. The conferences, in particular, had a significant impact by helping transform previously isolated programs into reoriented transparent activities of worldwide interest. In particular, during the early 2000s, DOD supported several international conferences directed to research at Russian institutions involved in U.S.-Russian collaboration. Hundreds of investigators from Russia, from other areas of the former Soviet Union, from the United States, and from Europe reported on coop- erative projects (Box 2-8). The Russian project implementers were particularly

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46 U.S.-RUSSIAN RELATIONSHIP IN BIOLOGICAL SCIENCE AND BIOTECHNOLOGY Box 2-6 Investigations of Variola Virus at Vector (2000 to 2006) Research studies of the genomic structure of different variola virus strains were carried out. Also of interest was the identification of potential anti- viral drugs that might hold promise for the treatment of smallpox. These studies were generally successful despite delays in the approval pro- cesses in the two countries to initiate and continue activities, problems involved in delivery of funds to the researchers, difficulties encountered in exchange of reagents, and interruptions of effective communications between the Centers for Disease Control and Prevention and Vector. Co- operation on specific research projects ended in 2007. Still, the projects provided important research data for the international community and had a significant impact by establishing lasting ties among researchers from the two countries. SOURCE: Personal observations of committee members of activities from 2000 to 2006, 2011. BOX 2-7 Collaboration in Research on Brucellosis For several years, U.S. agencies supported research on vaccines that would counter the spread of brucellosis through cattle and other herds in Russia. Also of concern was the infection of bison herds in the United States. Progress was made in limiting the spread of the disease through improvement of the vaccination procedures in Russia. Comparative re- search studies identified the most promising Russian and American brucella vaccines for prophylaxis in cattle as well as in wild animals. SOURCE: Former Scientific Adviser for DOD programs, February, 2012. appreciative of these opportunities to stay abreast of important international developments of direct relevance to their research interests. For their part, the Russian investigators quickly improved the content and quality of their scientific presentations at the conferences as they became accustomed to participation in such international gatherings.

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ENSURING APPROPRIATE USE OF BIOLOGICAL ASSETS 47 Box 2-8 St. Petersburg Conferences: International Outreach Opportunities for Russian Investigators On four occasions, DOD assembled in St. Petersburg the principal in- vestigators on research projects supported by DOD throughout Russia and other countries of the region. The Institute for Highly Pure Bioprepa- rations hosted the conference sessions. These conferences were well attended, and opportunities for informal interchanges set the stage for follow-up consultations. In later years, the conferences were increasingly oriented to activities in other countries that had emerged from the Soviet Union. They were held outside Russia—in Germany and Atlanta, for ex- ample—and each involved only several Russian scientists. In brief, the networking benefits of the St. Petersburg conferences had a profound im- pact and are well remembered by both American and Russian attendees. SOURCE: Observations by committee members who attended conferences, 2011. In the early 2000s, DOS developed several programs that built on and expanded the early efforts of DOD. These DOS programs had the objective of commercialization of results of research to provide both long-term career oppor- tunities for biological scientists interested in civilian applications and new income streams for important research groups. (See Appendix C.1.) Some specific activi- ties are discussed in Chapter 4, which addresses applications of research results. Throughout this period, the ISTC with support by U.S. government depart- ments and agencies organized many training programs for Russian specialists engaged in cooperative projects. In this regard, the following topics were consid- ered particularly important, beginning in the late 1990s: • Good Laboratory Practices • Good Manufacturing Practices • Care and Use of Experimental Animals • Institutional Review Boards for Research on Human Subjects • Commercialization of Technologies Now, with shrinking budgets of both the United States and Russia to engage bilaterally in nonproliferation activities, the outlook for future collaboration involving traditional approaches to biosecurity is not bright. At the same time, both the U.S. and Russian governments recognize that important aspects of bio- technology could be misused and that there is a clear imperative for international

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48 U.S.-RUSSIAN RELATIONSHIP IN BIOLOGICAL SCIENCE AND BIOTECHNOLOGY efforts to promote within the international life sciences community the concept of transparent and responsible science. The ISTC has adopted this theme as one of its most important activities prior to closing its doors in Moscow. It should not be difficult to obtain widespread international support for the concept. While considerable progress has been made in reducing highly visible secu- rity problems, responsible research in the life sciences can only be adequately addressed on a global basis through long-term educational and practical pro- grams, together with hands-on experience in the laboratory. The two countries with the most experience in handling especially dangerous pathogens and other biological materials are in a unique position to join forces in promoting life sci- ences in a highly visible manner at the bench and in production facilities, both at home and abroad. Finally, most officials and scientists in both the United States and Russia who are familiar with bioengagement approaches to promote nonproliferation consider that the segregation of former defense scientists into a special class of participants in joint projects has long been outdated. Capabilities and responsi- bilities of investigators, not former employers of scientists, should comprise the key criterion that is used in selecting participants in cooperative activities. The foregoing discussion leads to two important conclusions. 1. The pioneering efforts of the two governments were important in helping to ensure that collaboration in research, testing, and use of potentially dangerous pathogens is carried out in a responsible manner, and they offer important lessons for the broader international scientific community. Responsible science requires transparency that accompanies international connectivity. Efforts to spread the culture of biosecurity and biosafety throughout the two countries and beyond can build on successful efforts demonstrated by many joint research projects of the past as well as by national efforts. At the same time, leading Russian and American scientists can play active roles in the international debates on handling the results of research on the influenza A/H5N1 virus and other viruses that could unexpectedly raise concerns over potential dangers to humans. Since the fall of 2011, there have been extensive international debates over the publication of results of studies of the influenza A/H5N1 virus, with American and Russian investigators playing important roles in the debates. (See Box 2-9.) Such debates will surely be pathfinders for handling other controversial findings as research on dangerous pathogens intensifies. 2. Research to improve characterization, prophylaxis, and therapy of espe- cially dangerous pathogens has had a significant and lasting impact on many related efforts. Periodic consultations among government specialists on especially danger- ous pathogens are important. At times, new research activities may be warranted, such as is the case with the variola virus. When research is being considered, the

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ENSURING APPROPRIATE USE OF BIOLOGICAL ASSETS 49 Box 2-9 Research Investigations of Influenza A/H5N1 Virus The preponderance of the evidence from clinical, seroepidemiologic, and laboratory studies supports the notion that HPAI H5N1 viruses now circulating are extraordinarily lethal to humans compared to other influ- enza viruses. SOURCE: Eric Toner and Amesh Adalja, “Is H5N1 Really Highly Lethal?” Biosecurity and Bioterrorism, Vol. 10, No. 2, 2012. involvement of the international scientific community, and particularly the WHO, may be important. Given the broad experience of American and Russian scientists in addressing such issues, their participation can provide an important core of expertise for such international consultations. FROM SECURITY TO SCIENCE AND TO APPLICATIONS In the chapters that follow, other projects that were funded within the frame- work of nonproliferation programs are highlighted, even though the chapters are devoted to scientific advancement and to applications of research results in the public- and private-sector marketplaces. This is a welcome outcome of joint security-oriented efforts. Nonproliferation efforts are most significant when the approaches that have been adopted are continued. Contributions to science and to success in responding to market demand are good indicators of the likelihood of long-term support.

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