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Executive Summary The great achievements of molecular biology and genetics over the last 50 years have produced advances in agriculture and industrial processes and have revolutionized the practice of medicine. The very technologies that fueled these benefits to society, however, pose a potential risk as well the possibility that these technologies could also be used to create the next generation of biological weapons. Biotechnol- ogy represents a "dual use" dilemma in which the same technologies can be used legitimately for human betterment and misused for bioterrorism. This report reflects the increasing attention being paid by scientists and policymakers to the potential for misuse of biotechnology by hostile individuals or nations and to the policy proposals that could be applied to minimize or mitigate those threats. The term "misuse of biotechnology" is a phrase that captures a wide spectrum of potentially dangerous activities from spreading common pathogens (e.g., spraying Salmonella on salad bars) to sci-fi plots of transforming pathogens into the next "Andromeda strain." Our Committee addressed one important part of this spectrum of risks of potential misuse: the capacity for advanced biological research activities to cause disruption or harm, potentially on a catastrophic scale. Broadly stated, that capacity consists of two elements: (1) the risk that dangerous agents that are the subject of research will be stolen or diverted for malevolent purposes; and (2) the risk that the research results, knowl- edge, or techniques could facilitate the creation of "novel" pathogens with unique properties or create entirely new classes of threat agents. The charge to the Committee was to:

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2 BIOTECHNOLOGY RESEARCH IN AN AGE OF TERRORISM Review the current rules, regulations, and institutional arrange- ments and processes in the United States that provide oversight of re- search on pathogens and potentially dangerous biotechnology research, within government laboratories, universities and other research institu- tions, and industry. Assess the adequacy of current U.S. rules, regulations, and institu- tional arrangements and processes to prevent the destructive application of biotechnology research. Recommend changes in these practices that could improve U.S. capacity to prevent the destructive application of biotechnology research while still enabling legitimate research to be conducted. Although the focus of the report is on the United States, this coun- try is only one of many pursuing biotechnology research at the highest level. The techniques, reagents, and information that could be used for offensive purposes are readily available and accessible. Moreover, the expertise and know-how to use or misuse them is distributed across the globe. Without international consensus and consistent guidelines for overseeing research in advanced biotechnology, limitations on cer- tain types of research in the United States would only impede the progress of biomedical research here and undermine our own national interests. It is entirely appropriate for the United States to develop a system to provide oversight of research activities domestically, but the effort will ultimately afford little protection if it is not adopted interna- tionally. This is a challenge for governments, international organiza- tions, and the entire international scientific community. Efforts to meet that challenge are under way, but they must be quickly expanded, strengthened, and harmonized. THE CURRENT AND EVOLVING REGULATORY ENVIRONMENT In the United States, the USA PATRIOT Act of 2001 and the Bioterrorism Preparedness and Response Act of 2002 already establish the statutory and regulatory basis for protecting biological materials from inadvertent misuse. Once fully implemented, the mandated registration for possession of certain pathogens (the "select agents"), designation of restricted individuals who may not possess select agents, and a regula- tory system for the physical security of the most dangerous pathogens within the United States will provide a useful accounting of domestic labo- ratories engaged in legitimate research and some reduction in the risk of pathogens acquired from designated facilities falling into the hands of terrorists. The Committee stresses that implementation of current legisla- tion must not be overly restrictive given the critical role that the develop-

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EXECUTIVE SUMMARY 3 ment of effective vaccines, diagnostics, therapeutics, and detection sys- tems, along with a responsive public health system, will play in providing protection against bioterrorism and other serious health threats. Other- wise these legislative solutions may unintentionally limit the research on dangerous pathogens by legitimate laboratories and investigators. To be effective, a harmonized international system for the regulatory oversight of the possession of dangerous pathogens and toxins, comparable to the one being put in place in the United States, is needed. With regard to oversight of research, no country has developed guidelines and practices to address all aspects of biotechnology research. The Committee has concluded that existing domestic and international guidelines and regulations for the conduct of basic or applied genetic engineering research may ensure the physical safety of laboratory work- ers and the surrounding environment from contact with or exposure to pathogenic agents or "novel" organisms. However, they do not currently address the potential for misuse of the tools, technology, or knowledge base of this research enterprise for offensive military or terrorist pur- poses. In addition, no national or international review body currently has the legal authority or self-governance responsibility to evaluate a proposed research activity prior to its conduct to determine whether the risks associated with the proposed research, and its potential for mis- use, outweigh its potential benefits. The Committee concluded that the existing fragmentary system must be adapted, enhanced, supplemented, and linked to provide a system of oversight that will give confidence that the potential risks of misuse of dual use research are being ad- equately addressed while enabling vital research to go forward. The sig- nificant increases in funding that will be going to research on biodefense precisely the sort of research likely to pose the most severe dual use dilemmas reinforce the argument for creating such a comprehensive system, both nationally and internationally. A PROPOSED NEW SYSTEM The system the Committee proposes would establish a number of stages at which experiments and eventually their results would be re- viewed to provide reassurance that advances in biotechnology with po- tential applications for bioterrorism or biological weapons development receive responsible oversight. The system relies heavily on a mix of vol- untary self-governance by the scientific community and expansion of an existing regulatory process that itself grew out of an earlier response by the scientific community to the perceived risks associated with gene-splic- ing research. This is the system created to implement the National Insti- tutes of Health Guidelines for Research Involving rDNA Molecules ("the

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4 BIOTECHNOLOGY RESEARCH IN AN AGE OF TERRORISM Guidelines". We recognize that successfully implementing the system we propose will require significant additional resources at each stage; we do not attempt to provide an estimate of these costs. Recommendation 1: Educating the Scientific Community We recommend that national and international professional societies and related organizations and institutions create programs to educate scientists about the nature of the dual use dilemma in biotechnology and their responsibilities to mitigate its risks. Adequately addressing the potential risks that research in advanced biotechnology could be used by hostile parties will require educating the community of life scientists, both about the nature of these risks and about the responsibilities of scientists to address and to manage them. At present, awareness of the potential for misuse of biological knowledge varies widely in the research community. Researchers currently working with select agents are already taking steps to contain these agents physi- cally and protect against planned or unplanned harm. But most life scien- tists have had little direct experience with the issues of biological weap- ons and bioterrorism since the advent of the Biological Weapons Convention in the early 1970s, so these researchers lack the experience and historical precedent of considering the potential for misuse of their . c discoveries. We recommend that the professional societies in the life sciences un- dertake a regular series of meetings and symposia, in the United States and overseas, to provide both knowledge and opportunities for discus- sion. It could be useful for one of the major professional societies or sci- ence policy organizations to convene a meeting of all the major societies to discuss how best to implement such a program. Industry groups and associations of higher education and research could also usefully under- take the education of their members about the risks and their implications for research practices. Substantive knowledge of the potential risks is not sufficient, how- ever. The Committee believes that biological scientists have an affirma- tive moral duty to avoid contributing to the advancement of biowarfare or bioterrorism. Individuals are never morally obligated to do the impos- sible, and so scientists cannot be expected to ensure that the knowledge they generate will never assist in advancing biowarfare or bioterrorism. However, scientists can and should take reasonable steps to minimize this possibility. The Committee believes that it is the responsibility of the re- search community, including scientific societies and organizations, to de- fine what these reasonable steps entail and to provide scientists with the education, skills, and support they need to honor these steps.

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EXECUTIVE SUMMARY 5 Recommendation 2: Review of Plans for Experiments We recommend that the Department of Health and Human Services (DHHS) augment the already established system for review of experi- ments involving recombinant DNA conducted by the National Insti- tutes of Health to create a review system for seven classes of experi- ments (the Experiments of Concern) involving microbial agents that raise concerns about their potential for misuse. This part of the system includes both the criteria for deciding which experiments will be subject to review and the process by which the re- view will take place. The Criteria for Review. The Committee identified seven classes of ex- periments that it believes illustrate the types of endeavors or discoveries that will require review and discussion by informed members of the sci- entific and medical community before they are undertaken or, if carried out, before they are published in full detail. They include experiments that: 1. Would demonstrate how to render a vaccine ineffective. This would apply to both human and animal vaccines. Creation of a vaccine- resistant smallpox virus would fall into this class of experiments. 2. Would confer resistance to therapeutically useful antibiotics or antiviral agents. This would apply to therapeutic agents that are used to control disease agents in humans, animals, or crops. Introduction of ciprofloxacin resistance in Bacillus anthracis would fall in this class. 3. Would enhance the virulence of a pathogen or render a nonpathogen virulent. This would apply to plant, animal, and human pathogens. Introduction of cereolysin toxin gene into Bacillus anthracis would fall into this class. 4. Would increase transmissibility of a pathogen. This would in- clude enhancing transmission within or between species. Altering vector competence to enhance disease transmission would also fall into this class. 5. Would alter the host range of a pathogen. This would include making nonzoonotics into zoonotic agents. Altering the tropism of viruses would fit into this class. 6. Would enable the evasion of diagnostic/detection modalities. This could include microencapsulation to avoid antibody-based detection and/or the alteration of gene sequences to avoid detection by established molecular methods. 7. Would enable the weaponization of a biological agent or toxin.

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6 BIOTECHNOLOGY RESEARCH IN AN AGE OF TERRORISM This would include the environmental stabilization of pathogens. Synthe- sis of smallpox virus would fall into this class of experiments. These categories represent experiments that are feasible with exist- ing knowledge and technologies or with advances that the Committee could anticipate occurring in the near future. Some of them represent the types of naturally occurring genetic changes in pathogens that have led to disease pandemics such as the "Spanish Flu" in 1917-1918 or the recently recognized disease "severe acute respiratory syndrome" (SARS) but that could now be engineered in the laboratory. Others have been part of the history of biowarfare research and development. The con- cerns deal with infectious agents or their products because we believe that self-replicating agents or their products pose the most imminent biological threat. The seven areas of concern address only potential microbial threats. Modern biological research is much broader, encompassing all of the health sciences, agriculture and veterinary science, and a variety of indus- trial applications. Moreover, all of these areas are changing rapidly. The great diversity as well as the pace of change make it imprudent to project the potential both for good and ill too broadly and too far into the future. Therefore, the Committee has initially limited its concerns to cover those possibilities that represent a plausible danger and has tried to avoid im- probable scenarios. Over time, however, the Committee believes it will be necessary to expand the experiments of concern to cover a significantly wider range of potential threats. The Review Process. The NIH Guidelines require creation of an Institu- tional Biosafety Committee (IBC) when research is conducted at or spon- sored by an entity receiving any NIH support for recombinant DNA re- search. Most of the 400 or so IBCs registered with NIH are at institutions that are subject to the NIH Guidelines and for whom IBC registration is mandatory. While most of these institutions are academic, some industry- based IBCs are registered with NIH as a consequence of receiving NIH support. In other instances, companies voluntarily comply with the NIH Guidelines as a means of observing a "gold standard" for safety practices. Several federal agencies and laboratories have made compliance with the NIH Guidelines a condition of their support of intramural and extramural research projects. Furthermore a number of federal IBCs are registered with NIH. All of the experiments that fall within the seven areas of concern should currently require review by an IBC. The Committee thus recom- mends relying on the system of IBCs as the first review tier for experi- ments of concern.

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EXECUTIVE SUMMARY The Committee recommends that the form researchers now use to submit their experimental designs to the IBC be amended to include an- other category where researchers would designate whether, in their judg- ment, their proposed projects fall under an area of concern. The IBC would then review that issue along with the other aspects of the project that it is evaluating, carefully weighing potential benefits versus potential danger. Occasionally, the IBC may discover that what is proposed is forbidden under current guidelines and would not approve the research. In most cases, however, it would designate the project either as acceptable to move forward or as raising concerns that need further consideration at a higher level. The Committee recommends initial review by the IBC because this provides an assessment of research at its earliest stages. By the time the work is submitted for publication, substantial information about the re- search may have already been disseminated through informal profes- sional contacts or presentations of preliminary results at scientific meet- ings. These aspects of the open culture in the life sciences emphasize how important it is to make scientists aware of their personal responsibilities to consider the balances of risks and benefits in their proposed research so they can responsibly inform the IBC. Experiments that need further consideration would be referred to an expanded Recombinant DNA Advisory Committee (RAC) and possibly to the director of the NIH for approval or denial of permission to proceed with the proposed experiment. The Committee recommends this route because so many of the experiments in the areas of concern would fall under the purview of the RAC already and because it has an established track record of facilitating research while protecting public safety. Under our recommendation, the RAC would begin to review some projects in the areas of concern from all relevant research institutions. This would be a substantial expansion from its current jurisdiction over research funded by NIH and those institutions that comply voluntarily. When the RAC takes up this new duty, the Committee proposes that it initially translate the categories of experiments of concern into a more detailed set of guidelines for IBCs to use. It should then improve and up- date these guidelines as needed as its experience with the process grows. The RAC will need substantial new resources to take on this additional task, and both it and the IBCs may need to incorporate new expertise to handle the task. Recommendation 3: Review at the Publication Stage We recommend relying on self-governance by scientists and scientific journals to review publications for their potential national security risks.

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8 BIOTECHNOLOGY RESEARCH IN AN AGE OF TERRORISM Publication of research results provides the vehicle for the widest dis- semination, including to those who would misuse them. The Committee believes strongly that this part of the system should be based on the vol- untary self-governance of the scientific community rather than formal regulation by government. Proposals to limit publication have caused great concern and contro- versy among both scientists and publishers. The norm of open communi- cation is one of the most powerful in science. To limit the information available in the methods section of journal articles would violate the norm that all experimental results should be open to challenge by others. But not to do so is potentially to provide important information to biowarfare programs in other countries or to terrorist groups. Ultimately, any process to review publications for their potential na- tional security risks would have to be acceptable to the wide variety of journals in the life sciences, both in the United States and internationally. The Committee believes that continued discussion among those involved in publishing journals and between editors and the national security community will be essential to creating a system that is considered re- sponsive to the risks but also credible with the research community. The Committee believes that the statement produced by a group of editors from major life science journals in February 2003 is an important step in this process. On the broader question of classification, the Committee believes that the principle set out by the Reagan Administration in 1985 in National Security Decision Directive 189 that the results of fundamental research should be unrestricted to the maximum extent possible and that classifi- cation should be the mechanism for what control might be required- remains valid and should continue to be the basis for U.S. policy. The Committee's support for self-governance by the scientific community through appropriate reviews by journals and other publication outlets should not be construed as endorsing the creation of "sensitive but un- classified" information in the life sciences. The Committee believes that the risks of a chilling effect on biodefense research vital to U.S. national security as the result of inevitably general and vague categories is at present significantly greater than the risks posed by inadvertent publica- tion of potentially dangerous results. A system of review based in scien- tific self-governance can, we believe, effectively address the security risks without discouraging scientists from taking part in important biodefense research. Recommendation 4: Creation of a National Science Advisory Board for Biodefense

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EXECUTIVE SUMMARY 9 We recommend that the Department of Health and Human Services cre- ate a National Science Advisory Board for Biodefense (NSABB) to pro- vide advice, guidance, and leadership for the system of review and over- sight we are proposing. The NSABB would serve a number of important functions for both the scientific community and the government. At the most general (strategic) level, it would serve as a point of continuing dialogue between the scientific community and the national security community and as a forum for addressing issues of interest or concern. At the operational (tactical) level, it would provide case-specific advice on the oversight of research and the communication and dissemi- nation of life sciences research information that is relevant for national security and biodefense purposes. Because of its important bridging func- tions, its members should include both leading scientists and national se- curity experts, including those with experience in managing scientific re- search in federal agencies. In terms of the regulatory aspects of the operation of our proposed system, we recommend that the Board periodically review and suggest updates to the "Experiments of Concern." We also recommend that the Board review and suggest updates to the list of "select agents" and to policies regarding the international exchange of biological agents. A re- view of the select agents list by DHHS is already required every two years but the Board could serve a useful and important function by providing an independent assessment as an input to that process. For the system's self-governing phases, we recommend that the NSABB serve as a resource. This could include aiding the professional societies in developing education programs, as well as providing a con- vening mechanism. It could also include assisting those producing publi- cations in the life sciences. The Board could provide a convening mecha- nism for journal editors, organizing periodic discussions among them as they develop and evaluate their review processes. The Board could re- view and comment on proposed procedures on request, and perhaps serve as a clearinghouse so that journals that have not already adopted review procedures could have ready access to examples of what others are doing. It would be very important for the Board to reach out beyond the United States to the many international publications in the life sciences and to find ways to include their leaders in discussions. The Board might also provide advice on request about particular manuscripts that raise con- cern, perhaps by organizing small groups of experts to assess the trade- offs between the scientific merits of the research, especially that with the potential to advance knowledge relevant to biodefense, and the risks of publishing information that might assist terrorists or proliferant states.

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10 BIOTECHNOLOGY RESEARCH IN AN AGE OF TERRORISM In addition to its functions related to the potential risks of research in advanced biotechnology, the Board should have the capacity to ad- vise the government on how the life sciences can contribute to alleviat- ing the risks of bioterrorism and biological weapons through new re- search in areas such as vaccine, antiviral, and antibiotic development, new detection devices and technologies, and preventive public health measures. This advisory function would serve as a continuous reminder that any system of review and oversight must operate in ways that do not put the United States and the world at risk of losing the great potential benefits of biotechnology. Having a Board that was informed and aware of the latest research developments, even including manu- scripts not yet published, would provide the capacity for "early warn- ing," alerting the government to the risks of new findings or techniques that should be met by focusing research resources on appropriate re- sponses or countermeasures. As for the organizational location for the NSABB, there are clear trade- offs between an independent board that offers its advice to government and one that is a formal advisory body to one or more federal agencies. No solution meets all the criteria, but on balance we believe that the logi- cal organizational location for the NSABB is within the Department of Health and Human Services providing advice to the secretary of that De- partment. DHHS already has a leading role in biotechnology research, particularly that related to the Experiments of Concern. Location within the DHHS would also connect the Board directly to the other parts of our proposed system, the RAC and the IBCs, while not limiting its capacity to work with other relevant agencies or private groups. International coordination and cooperation will be necessary to make any effort to mitigate the risks of bioterrorism effective. Therefore, in the view of the Committee, the establishment of an NSABB within the United States can serve as the basis for international dialogue aimed at reducing the risks of subversion of legitimate life sciences research efforts. Review systems, comparable to the one proposed involving the IBC and RAC, already exist in many nations. These were established as an outgrowth of the Asilomar conference in 1975. In the same manner, other countries should be encouraged to establish counterparts to the NSABB so that the community of life scientists globally can work together to reduce the risks of offensive applications of life sciences research. Recommendation 5: Additional Elements for Protection Against Misuse We recommend that the federal government rely on the implementa- tion of current legislation and regulation, with periodic review by the

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EXECUTIVE SUMMARY 11 NSABB, to provide protection of biological materials and supervision of personnel working with these materials. There are other elements of the current regulatory system that the Committee believes should be reviewed and evaluated because of their important impact on the conduct of research. Physical Containment. Safeguarding the collections of existing agents is an obvious priority that in large measure is being addressed through recently passed legislation and implementing regulations. The designation of cer- tain pathogens as "select agents" is an appropriate starting point for identi- fying strains and isolates that need to be secured. It is crucial to avoid well- meaning but counterproductive regulations on pathogens. Rules for containment and registration of potentially dangerous materials must be based on scientific risk assessment and informed by a realistic appraisal of their scientific implications. Moreover, scientific input is essential to ensure that these rules are clear as well as responsive to periodic assessment of the current technologies and capacities. The NSABB could be available to pro- vide advice on short notice about revising regulations in response to new developments. Rules governing transfer of materials between laboratories to prevent unauthorized distribution or diversion might also be regularly reviewed by the NSABB so that new threats could be recognized and re- sponded to and unnecessary impediments identified for removal. Trained Personnel. In some areas of technology, the limiting ingredient is the existence of trained personnel. General microbiological training suffi- cient for culturing and growing pathogenic microorganisms at levels of significant concern is available in high school and first-year college biol- ogy courses; majors in microbiology would be sophisticated enough to grow many select organisms. Moreover, training in basic microbiology is widely available outside the United States. The procedures for admitting foreign students and scientists to the United States for study and collabo- rative research must reflect the importance of keeping universities as open educational environments. Efforts to identify or control knowledgeable personnel within the United States are impractical, and surveillance of such personnel would not, in our opinion, offer much security. Recommendation 6: A Role for the Life Sciences in Efforts to Prevent Bioterrorism and Biowarfare We recommend that the national security and law enforcement commu- nities develop new channels of sustained communication with the life sciences community about how to mitigate the risks of bioterrorism.

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2 BIOTECHNOLOGY RESEARCH IN AN AGE OF TERRORISM By signing and ratifying the Biological and Toxin Weapons Conven- tion (BWC), the United States renounced the use and possession of such offensive weapons and methods to disseminate and deliver them. Given the increased investments in biodefense research in the United States, it is imperative that the United States conduct its legitimate defensive activi- ties in an open and transparent manner. This should clear the way for all biomedical scientists to contribute to the development of defensive mea- sures that would mitigate the impact of the use of such weapons against people, plants, and animals. The intelligence and law enforcement agencies need the academic sci- entists both for the expertise they might provide about the nature of cur- rent agents and the potential for new ones and for the best advice on lim- iting the spread of new technologies that would make countermeasures more difficult. It might be desirable for components of the national secu- rity community to establish advisory boards of basic scientists and clini- cians with expertise in areas such as viral disease, bacterial pathogens, biotechnology, immunology, toxins, and public health, as well as others in the area of basic molecular biology. These advisory boards could help members of the intelligence and law enforcement communities keep cur- rent in relevant areas of science and technology and provide a trusted set of advisors to answer technical questions. Recommendation 7: Harmonized International Oversight We recommend that the international policymaking and scientific commu- nities create an International Forum on Biosecurity to develop and pro- mote harmonized national, regional, and international measures that will provide a counterpart to the system we recommend for the United States. Any serious attempt to reduce the risks associated with biotechnol- ogy must ultimately be international in scope, because the technologies that could be misused are available and being developed throughout the globe. A number of countries and regional and international organiza- tions are already moving forward to develop programs and policies on aspects of the problem; the initiatives include consultations among the parties to the BWC on best practices for the security and oversight of pathogens and toxins. These approaches must be harmonized and widely adopted in order for them to be effective. Just as the scientific community in the United States must become deeply and directly engaged, the com- mitment of the international scientific community to these issues is needed to implement the recommendations contained in this report. We do not expect our recommendations to provide a "road map" that could simply be adopted internationally without significant modifications or adaptations to local or regional conditions. But any effective system

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EXECUTIVE SUMMARY 13 should include all the issues addressed by our recommendations. The Committee therefore recommends, as a next step, convening an "Interna- tional Forum on Biological Security" to begin a dialogue within and be- tween the life sciences and the policymaking communities internation- ally. Among the topics for this international forum are: Education of the scientific community globally, including curricula, professional symposia, and training programs to raise awareness of po- tential threats and modalities for reducing risks as well as to highlight ethical issues associated with the conduct of biological science. Design of mechanisms for international jurisdiction that would fos- ter cooperation in identifying and apprehending individuals who commit acts of bioterrorism. Development of an internationally harmonized regime for control of pathogens within and between laboratories and facilities. Development of systems of review to provide oversight of research, including defining an international norm for identifying and managing "experiments of concern." Development of an international norm for the dissemination of "sensitive" information in the life sciences. This and other forums should be sponsored by international organi- zations with standing and credibility within both the policymaking and scientific communities. Different topics within this broad agenda may be more appropriate for different organizations. Potential sponsors could include the World Health Organization and the United Nations Educa- tional, Scientific and Cultural Organization (UNESCO) as formal interna- tional governmental organizations with direct links to government policymakers. Among nongovernmental scientific organizations are the International Council for Science and more recently created organizations of the world's academies of science such as the InterAcademy Panel on International Issues (IAP) and the InterAcademy Council (IAC) that seek to bring the prestige and convening capacity of these bodies to bear on crucial international problems. CONCLUSION Throughout the Committee's deliberations there was a concern that policies to counter biological threats should not be so broad as to impinge upon the ability of the life sciences community to continue its role of con- tributing to the betterment of life and improving defenses against biologi- cal threats. Caution must be exercised in adopting policy measures to re- spond to this threat so that the intended ends will be achieved without

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4 BIOTECHNOLOGY RESEARCH IN AN AGE OF TERRORISM creating "unintended consequences." On the other hand, the potential threat from the misuse of current and future biological research is a chal- lenge to which policymakers and the scientific community must respond. The system proposed in this report is intended as a first step in what will be a long and continuously evolving process to maintain an optimal bal- ance of risks and rewards. The Committee believes that building upon processes that are already known and trusted and relying on the capacity of life scientists to develop appropriate mechanisms for self-governance, offers the greatest potential to find the right balance. This system may provide a model for the development of policies in other countries. Only a system of international guidelines and review will ultimately minimize the potential for the misuse of biotechnology.