Laboratory biosecurity guidance - World Health Organization

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Biorisk management • Laboratory biosecurity guidance • September 2006 aspect of laboratory biosecurity that should also be addressed. In biological laboratories, this responsibility lies with the facility managers, the principal investigators and the laboratory staff: all laboratory personnel have a responsibility to take reasonable precautions against theft or misuse of such equipment. Such responsibilities should be clearly outlined in the biorisk management protocol of a facility. On the other hand, security measures for laboratory equipment should be commensurate with the potential risks and imposed in a manner that does not unreasonably hamper research or access to these assets. As for VBM, not all pieces of laboratory equipment have comparable sensitivity or the same potential for dual-use. Some equipment, e.g. bioreactors, incubators, aerosol disseminators or aerosol test chambers, are among those that may conceivably be used for both legitimate and illegitimate purposes. Specific and detailed laboratory biosecurity measures, procedures and practices may mitigate the risks of their inappropriate use. Physical biosecurity Physical biosecurity, comprised of engineering, structural and security personnel elements, is intended to select, control and document access to laboratories and to the materials they contain, and to limit improper removal of VBM and equipment. Access controls are used to limit access to restricted areas to individuals who have proper authorization and to keep track of traffic in and out of these areas. Physical biosecurity measures may become more stringent and more costly as the value of the assets increases and as the location of the materials to be protected is approached. Personnel management Personnel management procedures should define the roles, responsibilities and authorities of laboratory personnel who need to handle, use, store, transfer and/or transport VBM, and the manner in which the organization ensures that individuals are appropriate for the positions they hold. These procedures should clearly describe and document the training, experience, competency and suitability requirements for individuals who have access to VBM, ensuring that members of the workforce have appropriate personal and technical qualifications and skills. Documented procedures for the recruitment of personnel should be clearly established and followed. The professional and bioethical eligibility and suitability for working with VBM of all personnel who have regular authorized access to sensitive materials is also central to effective laboratory biosecurity risk management. A mechanism should be developed to ensure that the integrity of the facility will not be compromised through the absence of key individuals. Such a mechanism should include succession planning for management, scientific, technical and administrative personnel to ensure that critical knowledge of safe and secure operation of the facility does not reside with a single individual, in the event of his/her unavailability or departure. Documented procedures for dismissal of personnel to be disallowed access - 26 -
Biorisk management • Laboratory biosecurity guidance • September 2006 to the facility should be developed. Provisions describing personnel management should also address procedures and training for visitors, contractors, subcontractors, suppliers, cleaning and maintenance staff. Information security Information security establishes prudent policies for handling sensitive details on VBM. Examples of sensitive information may include laboratory security plans and inventories, and storage locations of VBM. Information security should ensure that the required and appropriate level of confidentiality is preserved by the system that is used to acquire, store, manipulate and manage information. It is important to establish practical realistic steps that can be taken to safeguard and track VBM. A comprehensive documentation and description of VBM represents the caretaker role of the current laboratory managers to accurately pass on the historical archive of VBM. Some of the information may be confidential but should be available for use by future generations. Such documentation may also prove useful to help discharge a facility from possible allegations. It is also important to document the existence, location and access to the information for future interests, as security concerns change over time. The objective of information security is to limit access to individuals who have a need to access the information. This may be achieved through marking and secure storage requirements as well as through processes intended to control the manner in which the information is communicated and to whom. Protection of information should be consistent with the level of risk it poses in terms of potentially compromising a VBM. The higher the level of risk associated with the VBM the institution holds, the greater protection the information associated with the security system will require. Overdoing or exaggerating the sensitivity or level of suspicion can have unintended negative repercussions. This is a difficult process which may require careful consideration and reflection. Therefore laboratory management and relevant authorities should develop appropriate policies that govern the marking and handling of information and how that information is gathered, maintained, distributed, documented, accessed, shared and stored within the facility and with appropriate counterparts. Management of laboratory biosecurity activities Effective laboratory management is a fundamental requirement for both laboratory biosafety and laboratory biosecurity. In order for laboratory managers to be committed, involved and supportive to the safe and secure practice of science, they should bear the responsibility of articulating the need and rationale for both laboratory biosafety and laboratory biosecurity activities. Setting out national performance expectations, i.e. placing responsibility on the facility to demonstrate that appropriate and valid risk - 27 -
Page 1 and 2: EPIDEMIC AND PANDEMIC ALERT AND RES
Page 3 and 4: © World Health Organization 2006 A
Page 5 and 6: Abbreviations Biorisk management
Page 7 and 8: Biorisk management • Laboratory b
Page 9 and 10: Preface Biorisk management • Labo
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Page 37 and 38: 7. Training Biorisk management •
Page 39 and 40: 9. References Biorisk management
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Laboratory biosecurity guidance - World Health Organization

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