Appendix F
Selected U.S. Government Departments and Agencies with Relevant Programs

DEPARTMENT OF STATE

Bureau of International Security and Nonproliferation, Office of Cooperative Threat Reduction

The Biosecurity Engagement Program (BEP) focuses on five areas:

  1. Pathogen security and biosafety projects: working with international bioscience laboratories in the areas of pathogen security and biosafety, including assistance in risk assessment, safety and security consultations, and design and implementation

  2. Training: training scientists, laboratory managers, and policy makers on surveillance, diagnostics, biosafety, and pathogen security to raise awareness and to promote effective laboratory practices

  3. Surveillance and diagnostics: assisting with, designing, and implementing surveillance and molecular diagnostic systems that strengthen infectious disease detection and response

  4. Grants Assistance Program: providing funding to institutions for projects that advance BEP objectives

  5. Global cooperation: reducing the risk of biological threats by collaborating with partner governments to develop biosafety and pathogen security standards that are consistent with national and international guidelines, norms, and requirements (www.state.gov/t/isn/58381.htm)



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Appendix F Selected U.S. Government Departments and Agencies with Relevant Programs DEPARTMENT OF STATE Bureau of International Security and Nonproliferation, Office of Cooperative Threat Reduction The Biosecurity Engagement Program (BEP) focuses on five areas: 1. Pathogen security and biosafety projects: working with international bioscience laboratories in the areas of pathogen security and biosafety, includ- ing assistance in risk assessment, safety and security consultations, and design and implementation 2. Training: training scientists, laboratory managers, and policy makers on surveillance, diagnostics, biosafety, and pathogen security to raise awareness and to promote effective laboratory practices 3. Surveillance and diagnostics: assisting with, designing, and implement- ing surveillance and molecular diagnostic systems that strengthen infectious disease detection and response 4. Grants Assistance Program: providing funding to institutions for proj- ects that advance BEP objectives 5. Global cooperation: reducing the risk of biological threats by collabo- rating with partner governments to develop biosafety and pathogen security standards that are consistent with national and international guidelines, norms, and requirements (www.state.go/t/isn/.htm) 

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 APPENDIX F Bureau of International Security and Nonproliferation, Office of Chemical and Biological Weapons Threat Reduction The Chemical and Biological Weapons Threat Reduction Office has respon- sibility for implementing diplomatic efforts to impede and roll back the threat of biological and chemical weapons and to dissuade and impede states and enti- ties from pursuing, using, or proliferating these weapons and related equipment and technology. It has lead responsibility for bilateral and multilateral efforts to implement and strengthen the Biological Weapons Convention (BWC) and the Chemical Weapons Convention. Key functions include the following: • Developing and promoting dynamic policies and programs on a bilateral basis to combat the threat posed by biological weapons and related materials • Advancing and protecting key U.S. national security interests within the multilateral framework of the BWC • Leading the development and implementation of Australia Group export controls and catch-all controls for biological-weapons-applicable items and technology • Preparing recommendations for bureau and departmental principals on sanctions and implementing sanctions laws and other penalties as they relate to biological weapons and associated technology and equipment. (www.state. go/t/isn/.htm) Bureau of Verification, Compliance, and Implementation The bureau’s core missions are to ensure that appropriate verification requirements and capabilities are fully considered and properly integrated throughout the development, negotiation, and implementation of arms con- trol, nonproliferation, and disarmament agreements and commitments and to ensure that other countries’ compliance is carefully watched, rigorously assessed, appropriately reported, and resolutely enforced. In this regard, the bureau is responsible for preparing the President’s annual report to Congress on Adherence to and Compliance with Arms Control, Nonproliferation, and Disarmament Agreements and Commitments, including the BWC. (www.state. go/t/ci/) Bureau of Oceans and International Environmental and Scientific Affairs Two offices within this bureau have programs that contribute to enhanced biosecurity, biosafety, and disease control. These include the Office of Science and Technology Cooperation and the Office of International Health Affairs. The latter office has a mission of promoting U.S. security and global economic growth through global health. It works with agencies throughout the U.S. gov- ernment to facilitate policy making regarding environmental health, infectious

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 APPENDIX F diseases (for example, severe acute respiratory syndrome [SARS], avian influ- enza, pandemic influenza, and polio), health in postconflict situations, surveil- lance and response, bioterrorism, and health security. (www.state.go/g/oes/) U.S. Agency for International Development (USAID) USAID has two central program offices that support activities related to biosafety, biosecurity, and disease surveillance: the Office of Agriculture and the Bureau of Global Health. The Office of Agriculture provides funding to the Consultative Group on International Agricultural Research (CGIAR). CGIAR is an informal group of donors (about 60 at present) that is headquartered at the World Bank in Washington, D.C. It sponsors 16 international research centers throughout the world (13 in developing countries), which address a wide array of basic food commodities and natural resource issues, including animal and plant health. In addition, CGIAR is currently sponsoring a Challenge Program, which is designed to tackle problems of global and regional importance that bring a wide variety of researchers together. A small number of other international research centers outside CGIAR also carry out important related work. CGIAR itself represents a multilateral activity, but has always had a bilateral dimension in that the centers take on special projects that are national in nature. In either case, the emphasis is on producing public goods that are freely available. The Office of Agriculture also supports the development of biotechnology by inte- grating technology development and the establishment of policy frameworks to ensure the safe and effective application of the technology in developing countries. The Bureau of Global Health works to improve global health, including child, maternal, and reproductive health, and to reduce abortion and disease, especially HIV/AIDS, malaria, and tuberculosis. It supports field health pro- grams, advances research and innovation in selected areas relevant to overall agency health objectives, and transfers new technologies to the field through its own staff work, coordination with other donors, and a portfolio of grants and contracts with an annual budget in excess of $1.6 billion. A major element of the program is the strengthening of developing-country health systems. (www. usaid.go) DEPARTMENT OF ENERGY National Nuclear Security Administration, Office of Nonproliferation and International Security The Office of Nonproliferation and International Security (NIS) provides technical and policy support for U.S. efforts to implement and improve inter-

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 APPENDIX F national nonproliferation activities. There are three functional offices under NIS and a policy office that coordinates crosscutting activities. NIS advances U.S. government efforts to combat weapons of mass destruction (WMD) pro- liferation by (1) strengthening nonproliferation regimes and arrangements; (2) expanding the reach of the nonproliferation regime by promoting foreign com- pliance export controls, safeguards, and physical protection commitments; and (3) verifying the elimination of proliferation programs and stockpiles of WMD materials. The office’s international work includes providing policy and techni- cal support to nonproliferation negotiations, bilateral programs with foreign governments, and collaboration within multilateral organizations. (nnsa.energy. go/nuclear_nonproliferation/.htm) Global Initiatives for Proliferation Prevention This program works to prevent proliferation of weapons of mass destruc- tion. It provides grants, in partnership with U.S. private firms, to former WMD experts in Russia, other states of the former Soviet Union (FSU), Libya, Iraq, and other regions. These grants support the redirection of these experts into sustained nonmilitary employment. Department of Energy National Laboratories: Sandia National Laboratories, International Biological Threat Reduction Program Sandia’s Global Security Center Program on International Biological Threat Reduction is designed to enhance U.S. and international security. It has three major goals: (1) enhancing safety and containment of dangerous bio- logical agents in bioscience facilities, (2) strengthening capacities to detect and control dangerous biological agents, and (3) improving the understanding and mitigation of biological threats. Its programs include conducting risk, threat, and vulnerability assessments; providing technical assistance to safely transport dangerous biological agents; conducting training; assisting in reviewing and drafting biosafety, biosecurity, and biocontainment procedures; and conduct- ing assessments to understand biological threats and risks. (www.biosecurity. sandia.go/home.html) DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Global Health Affairs The Office of Global Health Affairs represents the department in dealings with other governments, other federal departments and agencies, international organizations, and the private sector on international health issues. It develops U.S. policy and strategy positions related to health issues. It facilitates involve-

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 APPENDIX F ment of the Public Health Service in support of these positions and in collabo- ration with other agencies, including USAID, and other organizations. The office also administers the Biotechnology Engagement Program, funded by the Department of State. The program’s major objectives are (1) to redirect FSU expertise and resources from military to civilian research and (2) to develop collaborative public health projects involving scientists from Department of Health and Human Services (HHS) agencies. Its three goals are as follows: 1. Nonproliferation: discouraging the proliferation of weapons-related expertise and engaging former weapons scientists in civilian-oriented research 2. Scientific innovation: funding high-quality research projects that facili- tate development of new medical and pharmaceutical technologies and provide evidence-based science to support health policy decisions 3. Sustainability: providing technical support and scientific collaboration to enable scientists to patent and market their discoveries and successfully compete for other sources of funding (www.globalhealth.go/) Centers for Disease Control and Prevention (CDC) CDC’s overarching goal is to ensure that people around the world will live safer, healthier, and longer lives through health promotion, health pro- tection, and health diplomacy. Three of the most relevant programs are the (1) Global Disease Detection (GDD) Program, (2) Field Epidemiology and Laboratory Training Program, and (3) Sustainable Management Development Program. The GDD Program includes efforts to strengthen detection and response capacity for avian influenza, build regional surveillance and reference laboratory capacity, and increase in-country surveillance and outbreak response capacity. The two other programs provide training in applied epidemiology and public health through a competency-based curriculum supporting labora- tory-based surveillance and outbreak response and strengthened public health management capacity. The GDD Program is designed to develop and strengthen global health capacity to identify and respond to emerging infections and bioterrorist threats around the world. GDD Regional Centers are located in Kenya, Thailand, Guatemala, China, Egypt, and Kazakhstan. Programs and resources in these countries are linked to headquarters and connected through a joint mission to respond to disease outbreaks anywhere in the world. The scientists who work in these programs have expertise in infectious disease detection and control (ranging from international leadership in the control of common infectious syn- dromes such as pneumonia to cutting-edge laboratory detection of rare viruses such as Ebola and SARS coronavirus). During nonemergency settings, the cen- ters work with country partners to build public health capacity in nonroutine

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 APPENDIX F disease detection and response interventions that help to strengthen systems that will be used in times of crisis. However, in response to major international emergencies or large-scale disease outbreaks, the centers typically function as members of the Global Outbreak Alert and Response Network, which is coor- dinated with the World Health Organization (WHO). (www.cdc.go/) Food and Drug Administration The Food and Drug Administration works with the HHS Office of Global Health Affairs encouraging teams of former weapons scientists from the FSU and U.S. experts to develop joint projects and apply for support and coopera- tion in areas of research and development that address urgent public health concerns in the FSU. This work will help develop and expand commercial dis- covery and production of drugs, vaccines, biological test kits, and other quality products and technologies designed to meet current public health needs in the region. (www.fda.go/) National Institutes of Health (NIH): National Institute of Allergy and Infectious Diseases (NIAID) NIAID conducts and supports a global program of research aimed at improving diagnosis, treatment, and prevention of immunologic, allergic, and emerging infectious diseases. This research has led to new therapies, vac- cines, diagnostic tests, and other technologies that have improved the health of millions of people in the United States and around the world. The NIAID strategic plan focuses on the following major themes: HIV/AIDS; other infec- tious diseases; allergy, immunology, and immune-related diseases; and research resources, infrastructure, training, and communications. In 2007, about $375 million was available for international research. NIAID provides a wide variety of services to its researchers, including testing, DNA sequencing, and biological research repositories. The institute also has a formal strategic plan for biode- fense research. (www.nih.go/about/almanac/organization/NIAID.htm) NIH: The Fogarty International Center The Fogarty Center supports and facilitates global health research con- ducted by U.S. and foreign investigators. Its Informatics Training for Global Health Program supports training for low- and middle-income country insti- tutions in partnership with U.S. institutions and investigators. This training will increase their ability to conduct multisite clinical trials and international disease surveillance and prevention programs. (www.nih.go/about/almanac/ organization/FIC.htm)

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 APPENDIX F NIH: National Science Advisory Board for Biosecurity (NSABB) The NSABB was established in 2005 to recommend strategies for oversee- ing and responsibly handling life sciences research that could yield information and technologies with the potential for benevolent or malevolent application. The NSABB has provided recommendations to the U.S. government regard- ing dual-use research of concern and is working with international partners to strengthen the management of dual-use research. The NSABB’s international committee has conducted three roundtable dialogues in partnership with WHO. The first, held in February 2007, focused on the importance of life sciences research and the need to protect advances in the life sciences while minimizing risks to international and national security. The second, attended by American and international scientific organizations, considered dual-use research and the need to develop a strategy to engage the international scientific community. The most recent roundtable, held in November 2008 and attended by more than 130 participants from 40 countries, focused on awareness raising and education; a culture of responsibility and codes of conduct; review of guidelines for preparation and review of research proposals; and scientific presentations, publications, and communication. (oba. od.nih.go/biosecurity/about_nsabb.html) DEPARTMENT OF AGRICULTURE Foreign Agricultural Service (FAS) The main objective of FAS programs is to improve foreign market access for U.S. agricultural goods. In addition, FAS carries out a broad array of international training, technical assistance, and other collaborative activities with developing and transitional countries to facilitate trade and promote food security. Some activities are designed to detect and mitigate animal and plant diseases. To increase the benefits to developing nations participating in global agricultural markets, FAS offers numerous trade capacity-building programs. Also, FAS helps nations understand and prepare for meeting World Trade Organization requirements. (www.fas.usda.go/) Agricultural Research Service (ARS), Office of International Research Programs (OIRP) OIRP is the service’s principal contact for international activities. Its mis- sion is to enhance the productivity, effectiveness, and impact of ARS’s national programs through mutually beneficial international activities. Its goals are (1) to facilitate international cooperation and exchange to benefit U.S. agriculture and the consumer, (2) to participate in activities that promote the strategic interests of the U.S. government, and (3) to extend the capacity of the national

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 APPENDIX F programs to address international problems confronting U.S. agriculture. It also administers two cooperative research grant programs, the ARS-Former Soviet Union Scientific Cooperation Program and the Biosecurity Engagement Program. Both programs use funds from the Department of State that support research on agricultural pathogens and diseases in a variety of foreign countries. (www.ars.usda.go) The Animal and Plant Health Inspection Service (APHIS) APHIS works to protect the health and value of American agriculture and natural resources. Its international mission is to protect and promote agricul- tural health through internationally based animal and plant health expertise. The International Service develops and implements programs that identify health threats outside U.S. borders to reduce those threats at the source. This activity includes training and technology transfer to help developing countries build their animal and plant health infrastructures, thereby helping to reduce the likelihood of undetected threat pathways into the United States. The service cosponsors cooperative foreign pest and disease operation programs in other countries. Targeted pests include screwworm, fruit flies, and tropical bont ticks. Classical swine fever is also of concern. APHIS also operates a Center for Epi- demiology and Animal Health in Fort Collins, Colorado, which is responsible for tracking animal diseases on a worldwide basis. (www.aphis.usda.go/)