Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 19
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
OCR for page 20
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
OCR for page 21
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.
OCR for page 22
