In response to a request from the U.S. Congress, this book examines how the unique experience and extensive capabilities of the Department of Defense (DOD) can be extended to reduce the threat of bioterrorism within developing countries outside the former Soviet Union (FSU). During the past 12 years, DOD has invested $800 million in reducing the risk from bioterrorism with roots in the states of the FSU. The program's accomplishments are many fold. The risk of bioterrorism in other countries is too great for DOD not to be among the leaders in addressing threats beyond the FSU. Taking into account possible sensitivities about a U.S. military presence, DOD should engage interested governments in about ten developing countries outside the FSU in biological threat reduction programs during the next five years. Whenever possible, DOD should partner with other organizations that have well established humanitarian reputations in the countries of interest. For example, the U.S. Agency for International Development, the Centers for Disease Control and Prevention, and the World Health Organization should be considered as potential partners.
This Congressionally-mandated report identifies areas for further cooperation with Russia and other states of the former Soviet Union under the Cooperative Threat Reduction (CTR) program of the Department of Defense in the specific area of prevention of proliferation of biological weapons. The report reviews relevant U.S. government programs, and particularly the CTR program, and identifies approaches for overcoming obstacles to cooperation and for increasing the long-term impact of the program. It recommends strong support for continuation of the CTR program.
The Cooperative Threat Reduction (CTR) Program was created in 1991 as a set of support activities assisting the Former Soviet Union states in securing and eliminating strategic nuclear weapons and the materials used to create them. The Program evolved as needs and opportunities changed: Efforts to address biological and chemical threats were added, as was a program aimed at preventing cross-border smuggling of weapons of mass destruction. CTR has traveled through uncharted territory since its inception, and both the United States and its partners have taken bold steps resulting in progress unimagined in initial years. Over the years, much of the debate about CTR on Capitol Hill has concerned the effective use of funds, when the partners would take full responsibility for the efforts, and how progress, impact, and effectiveness should be measured. Directed by Congress, the Secretary of Defense completed a report describing DoD's metrics for the CTR Program (here called the DoD Metrics Report) in September 2010 and, as required in the same law, contracted with the National Academy of Sciences to review the metrics DoD developed and identify possible additional or alternative metrics, if necessary. Improving Metrics for the DoD Cooperative Threat Reduction Program provides that review and advice. Improving Metrics for the DoD Cooperative Threat Reduction Program identifies shortcomings in the DoD Metrics Report and provides recommendations to enhance DoD's development and use of metrics for the CTR Program. The committee wrote this report with two main audiences in mind: Those who are mostly concerned with the overall assessment and advice, and those readers directly involved in the CTR Program, who need the details of the DoD report assessment and of how to implement the approach that the committee recommends.
Select Agents are defined in regulations through a list of names of particularly dangerous known bacteria, viruses, toxins, and fungi. However, natural variation and intentional genetic modification blur the boundaries of any discrete Select Agent list based on names. Access to technologies that can generate or 'synthesize' any DNA sequence is expanding, making it easier and less expensive for researchers, industry scientists, and amateur users to create organisms without needing to obtain samples of existing stocks or cultures. This has led to growing concerns that these DNA synthesis technologies might be used to synthesize Select Agents, modify such agents by introducing small changes to the genetic sequence, or create entirely new pathogens. Amid these concerns, the National Institutes of Health requested that the Research Council investigate the science and technology needed to replace the current Select Agent list with an oversight system that predicts if a DNA sequence could be used to produce an organism that should be regulated as a Select Agent. A DNA sequence-based system to better define when a pathogen or toxin is subject to Select Agent regulations could be developed. This could be coupled with a 'yellow flag' system that would recognize requests to synthesize suspicious sequences and serve as a reference to anyone with relevant questions, allowing for appropriate follow-up. Sequence-Based Classification of Select Agents finds that replacing the current list of Select Agents with a system that could predict if fragments of DNA sequences could be used to produce novel pathogens with Select Agent characteristics is not feasible. However, it emphasized that for the foreseeable future, any threat from synthetic biology and synthetic genomics is far more likely to come from assembling known Select Agents, or modifications of them, rather than construction of previously unknown agents. Therefore, the book recommends modernizing the regulations to define Select Agents in terms of their gene sequences, not by their names, and called this 'sequence-based classification.
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