Laboratory Biosecurity Handbook

In recognition of the vital need to protect legitimate facilities from the theft and sabotage of dangerous pathogens and toxins, the "Laboratory Biosecurity Handbook" serves as a guide to the implementation of security programs. It discusses biological weapons activity, key principles of biosecurity, and its integration into existing frameworks, as well as security risk assessments.

By achieving a delicate balance between systems and practices, proper laboratory biosecurity reduces the risk of legitimate bioscience facilities becoming sources of pathogens and toxins for malicious use. Effective design and implementation of laboratory biosecurity depends on cooperation among individuals from diverse communities, including scientists, technicians, policy makers, security engineers, and law enforcement officials. Providing guidance to the broad international community, Laboratory Biosecurity Handbook addresses the objectives of biosecurity and the ways in which they overlap or conflict with those of biosafety. The book describes the risks of working with dangerous pathogens and toxins in the current era of international terrorism. The authors characterize the global spread of legitimate biotechnology and relate it to the rise of transnational terrorism, emphasizing the need for biosecurity measures even in legitimate bioscience. The book discusses biosecurity risk assessment-a practical methodology that allows laboratory management and biosafety/biosecurity officers to analyze and determine the level of risk, and serves as a basis for managing those risks. The book includes questionnaires that can assist the process of collecting data for a biosecurity vulnerability assessment, example standard operating procedures and memoranda of understanding, and other useful reference material.Addressing a variety of operating environments and the particular challenges they face when designing and implementing laboratory biosecurity, this book can assist bioscience facilities ranging from the large to the small, from those that focus on diagnosis or vaccine development, to those only minimally involved with infectious diseases. The detailed recommendations help avoid a "one-size-fits-all" approach to security and save limited resources. The book shows institutions how to develop and implement a biosecurity plan, and helps ensure that all components are included in the overall system, whether existing or new.

INTRODUCTIONLaboratory Biosecurity and the Risks of BioterrorismLaboratory Biosecurity and International ObligationsLaboratory Biosecurity and National RegulationsApproach/Objectives of this BookRISK ASSESSMENT Overview of Biosecurity Risk Assessment MethodologyCharacterize Assets and ThreatsEvaluate ScenariosCharacterize the RiskRisk ReductionCOMPONENTS OF BIOSECURITYPhysical SecurityPersonnel SecurityMaterial Control and AccountabilityTransport SecurityInformation SecurityPROGRAM MANAGEMENTRole and ResponsibilitiesBiosecurity System DesignResponse ForcePerformance TestingDocumentationAssessments and AuditsTraining and ExercisesSPECIFIC BIOSECURITY RECOMMENDATIONSLow-Risk FacilityModerate-Risk FacilityHigh-Risk FacilityExtreme Risk FacilitySpecific Biosecurity Recommendations - Low-Risk FacilitySpecific Biosecurity Recommendations - Moderate-Risk FacilitySpecific Biosecurity Recommendations - High-Risk FacilitySpecific Biosecurity Recommendations - Extreme High-Rick FacilityCONCLUSIONSList of AcronymsGlossaryAppendix A-Vulnerability Assessment QuestionnairesAppendix B-Example Biosecurity Risk Assessment MethodologyAppendix C-Biosecurity Plan TemplateAppendix D-Example Memorandum of Understanding with Local Law EnforcementAppendix E-SOP for Testing Access Control SystemsAppendix F-Biosecurity Guidance and Regulations