Advertisement
Review Article| Volume 26, ISSUE 2, P299-312, June 2006

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

      The attacks on the World Trade Center towers and the Pentagon on 9/11/2001 and the subsequent anthrax letters in the United States woke up America to the reality of the bioterrorism threat. As of January 2006, the perpetrator(s) of the anthrax letters have not been apprehended; however, the origins of the Select Agent Program and biological surety (biosurety) date back farther. In 1995, the world was shocked by the March sarin attack on the Tokyo subway system by the Aum Shinrikyo sect, which was followed by the April attack by Timothy McVeigh and Terry Nichols on the Murrah Federal Building in Oklahoma City. In May of 1995, Larry Wayne Harris, a member of the extremist group Aryan Nations, was arrested when federal authorities were notified by health officials that he had obtained samples of Yersinia pestis [

      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.

      ]; however, he was found guilty only of wire fraud, because it was not illegal to possess Y. pestis! In April 1996, Congress enacted Public Law (PL) 104-132, Antiterrorism and Effective Death Penalty Act of 1996 [

      Antiterrorism and Effective Death Penalty Act of 1996, Public Law 104–132, Title V—Nuclear, Biological, and Chemical Weapons Restrictions, April 24, 1996.

      ]. Title V—Nuclear, Biological, and Chemical Weapons Restrictions, Subtitle B—Biological Weapons Restrictions established enhanced penalties and controls of biological agents. The Secretary of the United States Department of Health and Human Services (DHHS) was asked to promulgate a list of biological agents and issue rules to regulate transfers of the listed biological agents.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribers receive full online access to your subscription and archive of back issues up to and including 2002.

      Content published before 2002 is available via pay-per-view purchase only.

      Subscribe:

      Subscribe to Clinics in Laboratory Medicine
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

      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.

        • 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. 1996; 61: 55189-55200
        • Zilinskas R.A.
        Iraq's biological weapons. The past as future?.
        JAMA. 1997; 278: 418-424
        • Christopher G.W.
        • Cieslak T.J.
        • Pavlin J.A.
        • et al.
        Biological warfare. A historical perspective.
        JAMA. 1997; 278: 412-417
      3. 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.

        • Carr K.
        • Henchal E.A.
        • Wilhelmsen C.
        • et al.
        Implementation of biosurety systems in a Department of Defense medical research laboratory.
        Biosecur Bioterror. 2004; 2: 7-16
      4. Department of the Army Interim Guidance Message 1, Establishing the Army Biological Surety Program, December 21, 2001.

      5. 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.

      6. FAQ for Select Agent Regulation. (42 CFR 73). Available at: http://www.cdc.gov/od/sap/faq.htm. Accessed January 8, 2006.

        • 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. 2002; 240: 76887-76905
        • 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. 2002; 240: 76907-76938
      7. Memorandum—Deputy Secretary of Defense. SUBJ: Safeguarding Biological Select Agents. February 4, 2003. Washington, DC.

      8. Department of the Army Interim Guidance Message 4, Implementing the Department of Defense Biosecurity Policy, July 29, 2003. Washington, DC.

      9. Department of Defense Directive 5210.88, Safeguarding Biological Select Agents and Toxins. February 11, 2004. Washington, DC.

        • 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. 2005; 70: 13293-13325
        • 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. 2005; 70: 13241-13292
      10. Memorandum—Army Deputy Chief of Staff. G-3/5/7, SUBJ: Implementation of the Army Biological Surety Program. January 7, 2005. Washington, DC.

      11. 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.

        • 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. 2005; 70: 61047-61049
      12. Notification of Exclusion. Available at: http://www.cdc.gov/od/sap/sap/exclusion.htm. Accessed January 28, 2006.

      13. 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.

      14. 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.

      15. AR 10–16, U.S. Army Nuclear and Chemical Agency, January 25, 2005. Washington, DC.

      16. Richmond J.Y. McKinney R.W. Biosafety in microbiological and biomedical laboratories. 4th edition. US Department of Health and Human Services, Washington, DC1999
      17. Department of the Army Pamphlet 385–69, Biological Defense Safety Program, December 31, 1993. Washington, DC.

      18. 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.

      19. 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.