Clinical Laboratories, the Select Agent Program, and Biological Surety (Biosurety)

Clinics in Laboratory Medicine

Volumn 26, Issue 2, 2006, Pages 299-312

  Pastel, Ross H ^a   Demmin, Gretchen ^a   Severson, Grant ^a   Torres Cruz, Rafael ^a   Trevino, Jorge ^a   Kelly, John ^a   Arrison, Jay ^a   Christman, Joy ^a  

^a UNITED STATES ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DISEASES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ABRIN; BOTULINUM TOXIN; CHEMICAL WARFARE AGENT; CONOTOXIN; DIACETOXYSCIRPENOL; RICIN; SAXITOXIN; SHIGA TOXIN; STAPHYLOCOCCUS TOXIN; T 2 TOXIN; TETRODOTOXIN; TOXIN; VEROTOXIN;

AFRICAN HORSE SICKNESS VIRUS; AFRICAN SWINE FEVER VIRUS; AGRICULTURE; AKABANE VIRUS; ALASTRIM; ARENAVIRUS; AVIAN INFLUENZA; BACILLUS ANTHRACIS; BIOLOGICAL WARFARE; BIOSAFETY; BLUETONGUE ORBIVIRUS; BOVINE SPONGIFORM ENCEPHALOPATHY; BRUCELLA ABORTUS; BRUCELLA MELITENSIS; BRUCELLA SUIS; BURKHOLDERIA MALLEI; BURKHOLDERIA PSEUDOMALLEI; CAMEL ORTHOPOXVIRUS; CATTLE PLAGUE VIRUS; CERCOPITHECUS; CLINICAL LABORATORY; CLOSTRIDIUM BOTULINUM; CLOSTRIDIUM PERFRINGENS; COCCIDIOIDES; COCCIDIOIDES IMMITIS; COCCIDIOIDES POSADASII; COXIELLA BURNETII; EASTERN EQUINE ENCEPHALOMYELITIS VIRUS; EBOLA VIRUS; EHRLICHIA RUMINANTIUM; FOOT AND MOUTH DISEASE VIRUS; FRANCISELLA TULARENSIS; GOAT CAPRIPOX VIRUS; GOVERNMENT; HENDRA VIRUS; HERPES SIMPLEX VIRUS 1; HUMAN; INFLUENZA; INFLUENZA VIRUS; JAPANESE ENCEPHALITIS VIRUS; LABORATORY TEST; LASSA VIRUS; LAW; MARBURG VIRUS; MEASLES VIRUS; MONKEYPOX VIRUS; MYCOPLASMA CAPRICOLUM; MYCOPLASMA MYCOIDES; NAIRO VIRUS; NEWCASTLE DISEASE PARAMYXOVIRUS; NIPAH VIRUS; NONHUMAN; ORGANIZATION; PERONOSPORA; PESTIVIRUS; POXVIRUS; PRIORITY JOURNAL; PUBLIC HEALTH SERVICE; RALSTONIA SOLANACEARUM; REVIEW; RICKETTSIA PROWAZEKII; RICKETTSIA RICKETTSII; RIFT VALLEY FEVER BUNYAVIRUS; SHEEP CAPRIPOX VIRUS; SMALLPOX VIRUS; SWINE VESICULAR DISEASE ENTEROVIRUS; TERRORISM; TICK BORNE ENCEPHALITIS FLAVIVIRUS; UNITED STATES; VENEZUELAN EQUINE ENCEPHALOMYELITIS ALPHAVIRUS; VESICULAR STOMATITIS VIRUS; VIRUS; XANTHOMONAS; XYLELLA FASTIDIOSA; YERSINIA PESTIS;

BIOTERRORISM; CENTERS FOR DISEASE CONTROL AND PREVENTION (U.S.); CONTAINMENT OF BIOHAZARDS; HAZARDOUS SUBSTANCES; HUMANS; LABORATORIES; SECURITY MEASURES; UNITED STATES; UNITED STATES DEPT. OF HEALTH AND HUMAN SERVICES;

EID: 33745334316     PISSN: 02722712     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cll.2006.03.004     Document Type: Review

References (28)

1. Henry L. Harris troubled past includes mail fraud, white supremacy. Available at: http://www.lasvegassun.com/dossier/crime/bio/harris.html. Accessed January 12, 2006.
2. Antiterrorism and Effective Death Penalty Act of 1996, Public Law 104-132, Title V-Nuclear, Biological, and Chemical Weapons Restrictions, April 24, 1996.
3. Department of Health and Human Services. Centers for Disease Control and Prevention, 42 CFR Part 72, Additional Requirements for Facilities Transferring or Receiving Select Agents, October 24, 1996. Fed Reg 61 207 (1996) 55189-55200
4. Zilinskas R.A. Iraq's biological weapons. The past as future?. JAMA 278 5 (1997) 418-424
5. Christopher G.W., Cieslak T.J., Pavlin J.A., et al. Biological warfare. A historical perspective. JAMA 278 5 (1997) 412-417
6. Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA PATRIOT) Act of 2001, Public Law 107-56, Title VIII-Strengthening the Criminal Laws Against Terrorism, October 26, 2001.
7. Carr K., Henchal E.A., Wilhelmsen C., et al. Implementation of biosurety systems in a Department of Defense medical research laboratory. Biosecur Bioterror 2 1 (2004) 7-16
8. Department of the Army Interim Guidance Message 1, Establishing the Army Biological Surety Program, December 21, 2001.
9. Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Public Law 107-188, Title II-Enhancing Controls on Dangerous Biological Agents and Toxins, June 12, 2002.
10. FAQ for Select Agent Regulation. (42 CFR 73). Available at: http://www.cdc.gov/od/sap/faq.htm. Accessed January 8, 2006.
11. Department of Health and Human Services. Centers for Disease Control and Prevention, 42 CFR Part 73, Possession, Use, and Transfer of Select Agents and Toxins; Interim Final Rule. Fed Regist 240 67 (2002) 76887-76905
12. U.S. Department of Agriculture. Animal and Plant Health Inspection Service, 7 CFR Part 331 and 9 CFR Part 121, Agricultural Bioterrorism Protection Act of 2002; Possession, Use and Transfer of Biological Agents and Toxins; Interim Final Rule. Fed Regist 240 67 (2002) 76907-76938
13. Memorandum-Deputy Secretary of Defense. SUBJ: Safeguarding Biological Select Agents. February 4, 2003. Washington, DC.
14. Department of the Army Interim Guidance Message 4, Implementing the Department of Defense Biosecurity Policy, July 29, 2003. Washington, DC.
15. Department of Defense Directive 5210.88, Safeguarding Biological Select Agents and Toxins. February 11, 2004. Washington, DC.
16. Department of Health and Human Services. Centers for Disease Control and Prevention, 42 CFR 73, Possession, Use, and Transfer of Select Agents and Toxins; Final Rule. Fed Regist 70 52 (2005) 13293-13325
17. U.S. Department of Agriculture. Animal and Plant Health Inspection Service, 7 CFR Part 331 and 9 CFR Part 121 Agricultural Bioterrorism Protection Act of 2002; Possession, Use, and Transfer of Biological Agents and Toxins; Final Rule. Fed Regist 70 52 (2005) 13241-13292
18. Memorandum-Army Deputy Chief of Staff. G-3/5/7, SUBJ: Implementation of the Army Biological Surety Program. January 7, 2005. Washington, DC.
19. HHS and USDA Select Agents and Toxins. 7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73, October 14, 2005. Available at: http://www.cdc.gov/od/sap/docs/salist.pdf. Accessed January 28, 2006.
20. Department of Health and Human Services. Centers for Disease Control and Prevention, 42 CFR 73, Possession, Use, and Transfer of Select Agents and Toxins-Reconstructed Replication Competent Forms of the 1918 Pandemic Influenza Virus Containing Any Portion of the Coding Regions of All Eight Gene Segments. Fed Regist 70 202 (2005) 61047-61049
21. Notification of Exclusion. Available at: http://www.cdc.gov/od/sap/sap/exclusion.htm. Accessed January 28, 2006.
22. APHIS/CDC Form 4: Report of the Identification of a Select Agent or Toxin in a Clinical or Diagnostic Laboratory. Available at: http://www.cdc.gov/od/sap/downloads2.htm. Accessed January 28, 2006.
23. APHIS/CDC Form 1: Application For Laboratory Registration For Possession, Use, And Transfer of Select Agents And Toxins (Registration). Available at: http://www.cdc.gov/od/sap/downloads2.htm. Accessed January 28, 2006.
24. AR 10-16, U.S. Army Nuclear and Chemical Agency, January 25, 2005. Washington, DC.
25. In: Richmond J.Y., and McKinney R.W. (Eds). Biosafety in microbiological and biomedical laboratories. 4th edition (1999), US Department of Health and Human Services, Washington, DC
26. Department of the Army Pamphlet 385-69, Biological Defense Safety Program, December 31, 1993. Washington, DC.
27. Salerno RM, Barnett N, Koelm JG. balancing security and research at biomedical and bioscience laboratories. Available at: http://www.cmc.sandia.gov/links/cmc-papers/sand2003-0701c.pdf. Accessed January 12, 2006.
28. Sandia National Laboratories. Laboratory Biosecurity Implementation Guidelines, Sandia Report, SAND2005-2348P, Albuquerque, NM, April 2005. Available at: http://www.biosecurity.sandia.gov/documents/LBIG.pdf. Accessed January 12, 2006.