2

Evaluation of Design, Operations,
and Response Planning as Related
to the Risk Assessment

DESIGN PLANS

The updated site-specific risk assessment (uSSRA) of the National Bio-and Agro-Defense Facility (NBAF) indicates that design modifications have been incorporated in the 65% design planning phase to enhance the facility’s overall biosafety and biosecurity. Members of the committee reviewed the facility’s 65% design phase documents to understand the assumptions about the release probabilities for the uSSRA and to verify that design concerns and recommendations raised by the previous National Research Council committee (NRC, 2010) had been adequately addressed. However, it was beyond the committee’s task to formally review or pass judgment on the actual engineering of the facility. Therefore, the comments provided below are not to be construed as an evaluation of the safety of the facility.

Members examined the plans and specifications, verified the presence of critical system components, and determined that calculations on waste streams were conservative. Many design solutions used and validated in the latest generation of high- and maximum-biocontainment facilities had been adopted and in some cases improved upon in the NBAF 65% design plans—an indication that some important lessons learned were incorporated during the design process. Committee members identified process flows for the entry and exit of materials, personnel, and animals and determined that they were logical and well conceived. In this context, design issues raised by the previous committee (NRC, 2010) were addressed in the 65% designs. The committee concurs with the uSSRA that design elements can enhance the safety of the biosafety level 3 agriculture (BSL-3Ag) and



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2 Evaluation of Design, Operations, and Response Planning as Related to the Risk Assessment DESIGN PLANS The updated site-specific risk assessment (uSSRA) of the National Bio- and Agro-Defense Facility (NBAF) indicates that design modifications have been incorporated in the 65% design planning phase to enhance the facil- ity’s overall biosafety and biosecurity. Members of the committee reviewed the facility’s 65% design phase documents to understand the assumptions about the release probabilities for the uSSRA and to verify that design concerns and recommendations raised by the previous National Research Council committee (NRC, 2010) had been adequately addressed. However, it was beyond the committee’s task to formally review or pass judgment on the actual engineering of the facility. Therefore, the comments provided below are not to be construed as an evaluation of the safety of the facility. Members examined the plans and specifications, verified the presence of critical system components, and determined that calculations on waste streams were conservative. Many design solutions used and validated in the latest generation of high- and maximum-biocontainment facilities had been adopted and in some cases improved upon in the NBAF 65% design plans—an indication that some important lessons learned were incorpo- rated during the design process. Committee members identified process flows for the entry and exit of materials, personnel, and animals and de- termined that they were logical and well conceived. In this context, design issues raised by the previous committee (NRC, 2010) were addressed in the 65% designs. The committee concurs with the uSSRA that design elements can enhance the safety of the biosafety level 3 agriculture (BSL-3Ag) and 19

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20 NBAF UPDATED SITE-SPECIFIC RISK ASSESSMENT BSL-4 areas, and can reduce the risk of release of high-containment patho- gens in aerosol, solid, and liquid waste streams. STANDARD OPERATING PROCEDURES, PERSONNEL TRAINING, AND EMERGENCY RESPONSE PLANNING The committee recognizes that the uSSRA has made substantial ad- vances over the 2010 SSRA in describing how the NBAF would develop standard operating procedures, personnel training, and emergency response planning. The uSSRA mentions future plans to further describe in detail, finalize, and operationalize such plans, policies, and procedures once the facility designs and construction have matured. Although the training and preparedness requirements of the Federal Select Agent Program established under the Public Health Security and Bioterrorism Preparedness and Re- sponse Act of 2002 are well documented, the uSSRA does not include the Department of Homeland Security (DHS) plans for personnel training in security, laboratory procedures, and emergency response as required by P.L. 112-10. Omission of that information from the uSSRA leads the com- mittee to believe that preparations for this requirement have not been fully considered by DHS. The content of the uSSRA suggests that BSL-3 and BSL-4 laboratories similar to the NBAF (such as those at Pirbright, UK, and Winnipeg, Can- ada) were queried for insight into standard operating procedures, person- nel training, and emergency response planning. That is a substantial step beyond what was provided in the 2010 SSRA. However, many facilities in the United States, both federally and privately funded, work with select agents under the same regulations that the NBAF will have to operate un- der, and they could have provided additional insights into lessons learned, best practices, and the other issues addressed in the uSSRA. The uSSRA provides a detailed list of emergency response best practices drawn from international, federal, and Kansas state resources to inform NBAF preparedness efforts. Absent from the list to draw upon for best practices are the National Fire Protection Association Standard on Disaster/ Emergency Management and Business Continuity Programs (NFPA 1600) and the Emergency Management Accreditation Program Standard, both of which provide current accepted practice information for emergency management programs. The uSSRA did not mention that Riley County has achieved National Weather Service StormReady status, an important achievement in all hazards and severe weather preparedness. Overall, the conclusion reached in the uSSRA is that more efforts will be required in the future to develop and implement standard operating procedures, personnel training, and emergency response planning. Addi- tional information will need to be obtained from all relevant sources to

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21 EVALUATION OF DESIGN, OPERATIONS, AND RESPONSE PLANNING fully inform the NBAF operators of the risks in order to optimize plans and procedures. Such relevant resources for key information include DHS’s National Biodefense Analysis and Countermeasures Center, the National Institute of Allergy and Infectious Diseases’s Regional Biocontainment Laboratories and National Biocontainment Laboratories, the Department of Defense’s U.S. Army Medical Research Institute for Infectious Diseases, the Centers for Disease Control and Prevention, and other publicly and privately funded containment laboratories. Operators, scientists, biosafety officers, and response personnel from those facilities could offer significant insight into threats and hazards, lessons learned, crisis communication, and operations concerns to more fully inform those for the NBAF. Similarly, Riley County uses a hazard vulnerability analysis tool, which provides the best overarching view of the threats judged to pose the greatest risks to the county because of their probability of occurring, various vulnerabili- ties that exist in the area, and the consequences to people, property, the environment, and other assets (Patrick Collins, Riley County Emergency Management, personal communication, February 17, 2012). That may be instructive for the NBAF risk management and emergency planning process. The uSSRA indicates that these three critical areas will be addressed in the future when the NBAF begins construction and when it is closer to being operational. This raises the possibility that risks that needed to have been considered were never actually considered or modeled as part of the current risk assessment and which might be uncovered or recognized in the future. REFERENCE NRC (National Research Council). 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security’s Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press.

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