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United States of America Page 1 of 276 United States of America Confidence Building Measure Return covering 2011 Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction Submitted to the United Nations on 9 July 2012 Page 2 of 276 Declaration form on Nothing to Declare or Nothing New to Declare for use in the information exchange Year of last Nothing declaration if Measure Nothing to declare new to nothing new to declare declare A, Part 1 A, Part 2 (i) A, Part 2 (ii) A, Part 2 (iii) B C E F 1997 G Date: 9 July 2012 State Party to the Convention: United States of America Date of ratification/accession to the Convention: 26 March 1975 National point of contact: Mr. Christopher Park, Department of State Page 3 of 276 9 July 2012 Report of the United States of America to the United Nations Department for Disarmament Affairs Pursuant to the procedural modalities agreed upon in April 1987 at the "Ad Hoc Meeting of Scientific and Technical Experts for STATES Parties to the Convention on the Prohibition of the Development, Production, and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction," the United States of America submits the following information under Article V of the Convention: Confidence Building Measure A, Part 1 Exchange of data on research centres and laboratories pages 4-21 Confidence Building Measure A, Part 2 Exchanges of information on national biological defence research and development programmes (i) Declaration page 23 (ii) Description pages 24-57 (iii) Facilities pages 58-220 Confidence Building Measure B Exchange of information on outbreaks of infectious diseases and similar pages 221-233 occurrences caused by toxins Confidence Building Measure C Encouragement of publication of results and promotion of use of knowledge pages 234- 239 Confidence Building Measure E Declaration of legislature, regulations, and other measures pages 240- 247 Confidence Building Measure G Declaration of vaccine production facilities pages 248-258 Appendix A List of the Biological Select Agents and Toxins, and NIAID Category A, B and C pages 259-263 Priority Pathogens Appendix B Compiled list of biological agents and toxins used for biodefense research pages 264-276 Page 4 of 276 Form A, Part 1 (i) BWC - Confidence Building Measure Exchange of data on research centres and laboratories United States of America 9 July 2012 Page 5 of 276 Form A, Part 1 Exchange of data on research centres and laboratories1 In accordance with the agreement at the Third Review Conference, later amended by the Seventh Review Conference, that States Parties provide data on "each facility, within their territory or under their jurisdiction or control anywhere, which has any maximum containment laboratories meeting those criteria for such maximum containment laboratories as specified in the latest edition of the WHO1 Laboratory Biosafety Manual and/or OIE2 Terrestrial Manual or other equivalent guidelines adopted by relevant international organisations, such as those designated as biosafety level 4 (BL4, BSL4 or P4) or equivalent standards.” The United States is providing data on all facilities operating at biosafety level 4 during 2011. Data on BSL-4 facilities currently under construction will be included in future U.S. CBM submissions beginning with the submission covering the year each such facility becomes operational. In previous submissions, the United States has provided data on the Plum Island Animal Disease Center (PIADC) in Form A, Part 1 (i) as well as Form A, Part 2 (iii) due to the facility's historical significance. Beginning with the present submission, comprehensive data on the PIADC will be found exclusively in Form A, Part 2 (iii). 1 World Health Organization 2 World Organization for Animal Health Page 6 of 276 Form A, Part 1 (i) Exchange of data on research centres and laboratories1 1. Name(s) of facility2. National Biodefense Analysis and Countermeasures Center (NBACC) Declared in accordance with Form A, Part 2 (iii) 2. Responsible public or private organization or company. U.S. Department of Homeland Security Science & Technology Directorate operated by Battelle National Biodefense Institute LLC 3. Location and postal address. 8300 Research Plaza Fort Detrick, Maryland 21702 United States Fort Detrick, MD 4. Source(s) of financing of the reported activity, including indication if the activity is wholly or partly financed by the Ministry of Defence. U.S. Department of Homeland Security (DHS) 5. Number of maximum containment units3 within the research centre and/or laboratory, with an indication of their respective size (m2). BSL 4 Laboratory 976 m2 6. Scope and general description of activities, including type(s) of microorganisms and/or toxins as appropriate. NBACC conducts studies to fill in information gaps to better understand current and future biological threats; to assess vulnerabilities; and to determine potential impacts to guide the development of countermeasures such as detectors, drugs, vaccines, and decontamination technologies. When needed, NBACC conducts experimental programs to better characterize the benefits and risks of changes in U.S. biodefense preparations. NBACC also develops bioforensic assays and provides operational forensic analysis to support the attribution of Page 7 of 276 biocrime and bioterrorism. The types of agents registered for use at NBACC are BSL-2 toxins, BSL-2 gram positive and gram negative bacterial agents, BSL-2 viral agents, BSL-3 gram positive and gram negative bacterial agents, BSL-3 viral agents, and BSL-4 viral agents. 1 The containment units which are fixed patient treatment modules, integrated with laboratories, should be identified separately. 2 For facilities with maximum containment units participating in the national biological defence research and development programme, please fill in name of facility and mark "Declared in accordance with Form A, Part 2 (iii)". 3 In accordance with the 1983 WHO Laboratory Biosafety Manual, or equivalent. Page 8 of 276 Form A, Part 1 (i) Exchange of data on research centres and laboratories1 1. Name(s) of facility2. U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) Declared in accordance with Form A, Part 2 (iii) 2. Responsible public or private organization or company. U.S. Army Medical Research and Materiel Command 3. Location and postal address. 1425 Porter Street Fort Detrick Frederick, Maryland 21702-5011 United States 4. Source(s) of financing of the reported activity, including indication if the activity is wholly or partly financed by the Ministry of Defence. U.S. Department of Defense (DOD) - wholly 5. Number of maximum containment units3 within the research centre and/or laboratory, with an indication of their respective size (m2). BSL 4 Laboratory 1186 m2 6. Scope and general description of activities, including type(s) of microorganisms and/or toxins as appropriate. USAMRIID conducts research to develop strategies, products, information, procedures and training programs for medical defense against biological warfare threats and infectious diseases. Medical products developed to protect military personnel against biological agents include vaccines, drugs, diagnostic capabilities and various medical management procedures. Additional information can be found at: http://www.usamriid.army.mil/ Page 9 of 276 1 The containment units which are fixed patient treatment modules, integrated with laboratories, should be identified separately. 2 For facilities with maximum containment units participating in the national biological defence research and development programme, please fill in name of facility and mark "Declared in accordance with Form A, Part 2 (iii)". 3 In accordance with the 1983 WHO Laboratory Biosafety Manual, or equivalent. Page 10 of 276 Form A, Part 1 (i) Exchange of data on research centres and laboratories1 1. Name(s) of facility2. CDC, Office of Infectious Diseases (OID) Declared in accordance with Form A, Part 2 (iii) 2. Responsible public or private organization or company. Centers for Disease Control and Prevention 3. Location and postal address. 1600 Clifton Road N.E. Atlanta, Georgia 30333 United States 4. Source(s) of financing of the reported activity, including indication if the activity is wholly or partly financed by the Ministry of Defence. Centers for Disease Control and Prevention (CDC) Internal (Laboratory Directed Research and Development LDRD) U.S. Department of Health and Human Services (HHS) U.S. Department of Homeland Security (DHS) U.S. Environmental Protection Agency (EPA) 5. Number of maximum containment units3 within the research centre and/or laboratory, with an indication of their respective size (m2). BSL 4 Laboratory 136 m2 2 BSL 4 Laboratory 271 m 2 BSL 4 Laboratory 136 m 6. Scope and general description of activities, including type(s) of microorganisms and/or toxins as appropriate. Activities include developing diagnostic assays for public health, conducting molecular and antigenic characterization of microorganism, determining pathogenicity and virulence of infectious agents, determining natural history of infectious organisms, and conducting epidemiologic studies and surveillance for diseases. Biodefense activities include those with select agents (the select agents list is available at: http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html). Page 11 of 276 1 The containment units which are fixed patient treatment modules, integrated with laboratories,
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