Evaluation of the Health and Safety Risks of the New USAMRIID High-Containment Facilities at Fort Detrick, Maryland (2010) / Chapter Skim
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2 Comparative Evaluation of Procedures and Regulations for Biocontainment Facilities
2 Comparative Evaluation of Procedures and Regulations for Biocontainment Facilities
Pages 18-36
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From page 18... ...
In this chapter and elsewhere in this report, the term "biosurety" refers collectively to systems and procedures used to safeguard biological select agents and toxins (BSAT) against theft, loss, diversion, or unauthorized access or use and to ensure that operations are conducted in a safe, secure, and reliable manner.
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FIGURE 2-1 USAMRIID's Biosurety Program. The program includes systems and procedures to properly safeguard BSAT against theft, loss, diversion, or unauthorized access or use, and to ensure that operations are conducted in a safe, secure, and reliable manner.
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, NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH 2009) , and CDC oversight for Select Agents and Toxins (42 CFR 73)
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The committee reviewed current practices at USAMRIID, as well as the plans for the new facility as presented in the EIS. The wastewater collection, conveyance, and treatment systems at Fort Detrick are segregated into two separate systems: one that serves to contain and treat what is for the most part domestic wastewater generated on the base, and the other, which collects and treats all wastewaters associated with BSAT research, including its animal research operations.
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, as well as Army standards AR 385-69 and DA PAM 385-69, NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH 2009) , and CDC oversight for Select Agents and Toxins (42 CFR 73)
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and USDA. For example, relative to certifying containment equipment, the USAMRIID SOP entitled Biological Safety Cabinet, Chemical Fume Hood, Class I Safety Enclosures, and HEPA Filtered Clean Benches Certification Program requires that any of these devices used in BSL-3 or BSL-4 laboratories be certified semi-annually.
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From page 24... ...
The protocols are closely monitored by the IBC and by NIH, which oversees such work through the Recombinant DNA Advisory Committee and its guidelines. The IBC membership includes knowledgeable USAMRIID scientists, a representative from the Barquist Army Health Clinic, and a virologist not affiliated with USAMRIID.
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32 Q fever (primarily inhalation) Anthrax vaccine provided for Biological Safety Conferences begin (Fort 18 Venezuelan equine encephalitis (VEE; researchers Detrick, Plum Island, CDC, National primarily inhalation)
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publishes Report of the Committee of 1 tularemia Inquiry into the Small Pox Outbreak in 1 VEE London in March and April 1973, which recommends BSCs for aerosol production activities CDC biosafety office established after Rocky Mountain Spotted Fever deaths Asilomar Conference focuses scientific community on potential biosafety hazards related to recombinant DNA (1975) NIH publishes Guidelines for Research Involving Recombinant DNA Molecules (1976)
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From page 27... ...
published BSCs are added to biological research laboratories Federal regulations published; CDC issues permits for importation of infectious agents 1980s 1 tularemia BMBL I is published (1983) ; compliance 1 dengue fever is a requirement for NIH-funded research 1 Q fever laboratories American Biological Safety Association (ABSA)
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pestis incident Select Agent Rule CDC funds construction of BSL-3 laboratories in state public health laboratories Canadian maximum containment laboratories are constructed; first laboratory at University of Texas Medical Branch (UTMB) completed; Georgia State University (GSU)
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Ground breaking for new USAMRIID laboratory (2009) AR50-X and AR50-1 – Army Biological Surety Program DoD Instruction 5210.88 – Safeguarding BSAT Army IGM Oct 08 – Interim Guidelines for the Shipment of BSAT Army IGM Jan 09 – Interim Guidance for Biological Mishap Notification, Investigation, and Reporting Army IGM May 09 – Interim Guidance for BSAT Inventory and Accountability Army IGM May 09 – Personnel Reliability Program and Personnel 29 Security Investigation Interim Guidance a Oster et al.
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From page 30... ...
. BIOSURETY Biosurety programs involve systems and procedures to properly safeguard BSAT against theft, loss, diversion, or unauthorized access or use.
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. The Biological Personnel Reliability Program was initiated in 2003, and every new employee undergoes a 10-week process of personal interviews with questions on drug and alcohol use, mental health, financial issues, and any interactions with law enforcement.
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A recent NRC report, Responsible Research with Biological Select Agents and Toxins (NRC 2009) , recommends training in scientific ethics and dual-use research, and that the training be designed to foster community responsibility.
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Second, it is important to maintain communications among USAMRIID, the Barquist Army Health Clinic, and the Frederick County Health Department to ensure timely reporting of cases to the State. In particular, because there is routine and frequent turnover of medical
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6) Are changes in current practices, PPE, engineering controls, or administrative controls for work with F
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USAMRIID undertook a complete BSAT inventory to double-check the accuracy of the automated inventory management system in accordance with new Army and DOD requirements that the inventory system account for 100 percent of BSAT material in its possession. A "stand-down" was ordered until every freezer and refrigerator was inventoried and all BSAT materials were identified and accounted for.
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From page 36... ...
and breaches in containment (B. anthracis spores)
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