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EPIDEMIC AND PANDEMIC ALERT AND RESPONSE Biorisk management Laboratory biosecurity guidance September 2006 WHO/CDS/EPR/2006.6 Biorisk management Laboratory biosecurity guidance September 2006 © World Health Organization 2006 All rights reserved. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distin- guished by initial capital letters . All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either express or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Biorisk managementLaboratory biosecurity guidance • September 2006 i Table of Contents Abbreviations ii Definitions iii Preface 1 - 1. Introduction 2 - 2. Laboratory biosecurity as a complement to laboratory biosafety 7 - 2.1 Commonalities and conflicts: laboratory biosafety vs. laboratory biosecurity - 8 - 3. The biorisk management approach 11 - 3.1 Choice of the expression "laboratory biosecurity" 11 - 3.2 The biorisk management culture 12 - 4. Biorisk management 14 - 4.1 Securing valuable biological materials (VBM) 14 - 4.2 Distinctions within VBM 15 - 5. Countering biorisks 19 - 5.1 Accountability for VBM 19 - 5.2 Potential misuse of bioscience 20 - 5.3 Legitimate research, codes of conduct and codes of practice 20 - 6. Laboratory biosecurity programme 23 - 6.1 Laboratory biosecurity risk assessment 23 - 6.2 Responsibility for VBM 24 - 6.3 Elements of a laboratory biosecurity plan 25 - 7. Training 29 - 8. Conclusion 30 - 9. References 31 - 10. Bibliography 33 - Biorisk managementLaboratory biosecurity guidance • September 2006 ii Abbreviations BSL3 Containment laboratory – Biosafety Level 3 BSL4 Maximum containment laboratory – Biosafety Level 4 FAO Food and Agriculture Organization of the United Nations GMO Genetically modified organism LBM3 Laboratory biosafety manual, third edition, 2004 LBG Biorisk management: laboratory biosecurity guidance, first edition, 2006 OIE World Organisation for Animal Health VBM Valuable biological materials WHO World Health Organization Biorisk managementLaboratory biosecurity guidance • September 2006 iii Definitions The following terms are defined in the context in which they are used in this document. Accountability Accountability ensures that valuable biological materials (VBM, see definition below) are controlled and traced as intended, by formally associating the specified materials with the individuals who provide oversight and are held responsible for them. Bioethics The study of the ethical and moral implications of biological discoveries, biomedical advances, and their applications as in the fields of genetic engineering and drug research (adopted from 1). In this document, bioethics is one of the three components that contribute to a successful biorisk management culture. Biological laboratory A facility within which microorganisms, their components or their derivatives are collected handled and/or stored. Biological laboratories include clinical laboratories, diagnostic facilities, regional and/national reference centres, public health laboratories, research centres (academic, pharmaceutical, environmental, etc.) and production facilities (manufacturers of vaccines, pharmaceuticals, large scale GMOs, etc) for human, veterinary and agricultural purposes. Biorisk The probability or chance that a particular adverse event (in the context of this document: accidental infection or unauthorized access, loss, theft, misuse, diversion or intentional release), possibly leading to harm, will occur. Biorisk assessment The process to identify acceptable and unacceptable risks (embracing biosafety risks (risks of accidental infection) and laboratory biosecurity risks (risks of unauthorized access, loss, theft, misuse, diversion or intentional release)) and their potential consequences. Biorisk management The analysis of ways and development of strategies to minimize the likelihood of the occurrence of biorisks. The management of biorisk places responsibility on the facility and its manager (director) to demonstrate that appropriate and valid biorisk reduction (minimization) procedures have been established and are implemented. A biorisk management committee should be established to assist the facility director in identifying, developing and reaching biorisk management goals. Biosafety Laboratory biosafety describes the containment principles, technologies and practices that are implemented to prevent the unintentional exposure to pathogens and toxins, or their accidental release (2). Biorisk managementLaboratory biosecurity guidance • September 2006 iv Code of conduct, code of ethics, code of practice Non-legislated guidelines which one or more organizations and individuals voluntarily agree to abide by, that set out the standard of conduct or behavior with respect to a particular activity (adopted from 1). Control Control is the combination of engineered and procedural measures that ensure valuable biological material (VBM, see definition below) are used only as intended. Dual-use Initially used to refer to the aspects of certain materials, information and technologies that are useful in both military and civilian spheres. The expression is increasingly being used to refer not only to military and civilian purposes, but also to harmful misuse and peaceful activities (adopted from 1). Genetically modified organisms (GMO) Organisms whose genetic material has been altered using techniques generally known as "recombinant DNA technology". Recombinant DNA technology is the ability to combine DNA molecules from different sources into one molecule in a test tube. GMOs are often not reproducible in nature, and the term generally does not cover organisms whose genetic composition has been altered by conventional cross-breeding or by "mutagenesis" breeding, as these methods predate the discovery (1973) of recombinant DNA techniques. Hazard A danger or source of danger; the potential to cause harm. Laboratory biosecurity Laboratory biosecurity describes the protection, control and accountability for valuable biological materials (VBM, see definition below) within laboratories, in order to prevent their unauthorized access, loss, theft, misuse, diversion or intentional release. Misuse The misuse of valuable biological materials (VBM, see definition below) describes their inappropriate or illegitimate use, despite existing and subscribed agreements, treaties and conventions (3). Threat The likelihood for an adverse event to occur, as an expression of intention to inflict evil, injury, disruption or damage. Transfer of VBM Legal and/or administrative policies and procedures relating to the oversight and approval process for the transfer of custody and/or ownership of valuable biological materials (VBM, see definition below) between countries, entities (organizations, institutions, facilities, etc.) or individuals. Biorisk managementLaboratory biosecurity guidance • September 2006 v Transport of VBM Procedures and practices to correctly categorize, package, document and safely and securely transport valuable biological materials (VBM, see definition below) from one place to another, following applicable national and/or international regulations. Valuable biological materials (VBM) Biological materials that require (according to their owners, users, custodians, caretakers or regulators) administrative oversight, control, accountability, and specific protective and monitoring measures in laboratories to protect their economic and historical (archival) value, and/or the population from their potential to cause harm. VBM may include pathogens and toxins, as well as non-pathogenic organisms, vaccine strains, foods, genetically modified organisms (GMOs), cell components, genetic elements, and extraterrestrial samples. Biorisk managementLaboratory biosecurity guidance • September 2006 - 1 - Preface The economic consequences and scientific concern resulting from the laboratory- acquired SARS-CoV infections of 2003-2004 in Singapore, Taipei and Beijing not only raised biosafety awareness in the affected facilities, but most importantly promoted review by the concerned scientific community and national regulatory bodies, demonstrating high political commitment to biosafety practices in laboratories. The incidents triggered the improvement of national biosafety policies. Other countries affected, whether directly or indirectly, also expressed wide-ranging concern. As a result, WHO has recently witnessed a worldwide increase in the demand for biosafety guidance and support that culminated in 2005 with the adoption by the World Health Assembly of resolution WHA58.29 on Enhancement of laboratory biosafety (4). The Laboratory biosafety manual (LBM3), published in 2004 in its third edition (2), has already provided guidance to laboratory workers on how to perform laboratory work safely, to laboratory managers on how to set up a managerial approach to biosafety and to regulatory authorities, to help them consider necessary aspects for the development of adequate national biosafety regulations. A top-down approach associated with bottom-up support for biosafety regulations has been very successful in advancing the biosafety agenda. The present document aims to expand the laboratory biosecurity concepts introduced in LBM3, and to strike a balance between the long-known biosafety procedures and practices described in LBM3 and the more recently introduced and broader biosecurity concepts. It further introduces the overarching "biorisk management" approach that has resulted from careful thinking, comprehensive study of prevailing practices and recommendations, review of international norms and standards, and relevant ethical considerations Shortcomings currently observed in a number of settings are discussed, and practical solutions are proposed. The document is intended for the use of relevant national regulatory authorities, laboratory directors (laboratory managers) and laboratory workers, all of whom play key roles in the field of biosciences and in public health in general. Biorisk managementLaboratory biosecurity guidance • September 2006 - 2 - 1. Introduction Background Disease diagnosis, human or animal sample analysis, epidemiological studies, scientific research, and pharmaceutical developments: all of these activities are carried out in biological laboratories in the private or public sectors. Biological materials are handled worldwide in laboratories for numerous genuine, justifiable and legitimate purposes, where small and large volumes of live microorganisms are replicated, where cellular components are extracted and many other manipulations undertaken for purposes ranging from educational, scientific, medicinal and health-related to mass commercial and/or industrial production. Among them, an unknown number of the facilities, large and small, work with dangerous pathogens or their products every day. The general public expects laboratory personnel to act responsibly and not to expose the community to biorisks, to follow safe working practices (biosafety) associated with practices that will help keep their work and materials safe and secure (biosecurity), and to follow an ethical code of conduct (bioethics). Often suspicious of work taking place in laboratories, the uninformed public may even feel threatened by the presence of a biological laboratory in their neighborhood. It is the technical and moral duty of laboratory managers and laboratory workers, with the support of national authorities, to reassure the general public, to persuade them that the activities being conducted are beneficial and necessary, and to prove that the biorisks inherent to laboratory work are controlled with appropriate safeguards to meet their expectations. However, despite advances in technology, the availability of more and more sophisticated instruments for laboratory use, increasingly effective techniques and the availability of personal protective equipment, human error remains one of the most important factors at the origin of accidents. Poor concentration, denial of responsibilities, inappropriate accountability, incomplete record-keeping, suboptimal facility infrastructure, refusal to acknowledge ethical considerations, lack of (or lack of respect for) codes of conduct, etc. may be at the origin of laboratory-acquired infections, loss of material and inappropriate manipulations, or even possibly intentional misbehaviour. Pathogens and toxins have been used, even in the recent past, to threaten and harm people, to disrupt society, economies and the political status quo (5). This has happened in spite of applicable international agreements banning the use of biological agents for malicious use. As those who carry out such acts show disregard for ethical values (6), do not respect the right of people to a safe and peaceful life, or do not recognize global treaties and conventions, several regulatory approaches to limit unauthorized access to biological agents and toxins available in biological laboratories are now being carefully considered and implemented worldwide. Three examples illustrate the need to respond to the international community and articulate biosecurity in the laboratory: [...]... Effective laboratory biosecurity is a societal value that underwrites public confidence in biological science (17) Securing laboratory equipment Although laboratory biosecurity mainly focuses on protection of VBM, safeguarding laboratory equipment from unauthorized access, misuse or removal is an important - 25 - Biorisk managementLaboratory biosecurity guidance • September 2006 aspect of laboratory biosecurity. .. responsible biorisk management The availability of vaccines, other preventive measures and treatments are important factors in minimizing the consequences of natural or intentional releases of biological material Guidance on considerations for performing laboratory biosecurity risk assessments is provided below - 13 - Biorisk managementLaboratory biosecurity guidance • September 2006 4 Biorisk management. .. encouraged to consider adopting a biorisk management approach adapted to their particular situation and developing guiding principles to be implemented in response to the specific needs of their facilities -6- Biorisk managementLaboratory biosecurity guidance • September 2006 2 Laboratory biosecurity as a complement to laboratory biosafety Laboratory biosafety and biosecurity mitigate different risks,... - Biorisk managementLaboratory biosecurity guidance • September 2006 comprehensive biorisk management approach should help these facilities to accomplish their duties appropriately Minimizing biorisks Comprehensive biorisk assessments and their results should help laboratories containing VBM institute systems and controls to provide the required degree of assurance that biosafety and laboratory biosecurity. .. present in the laboratory However, as a laboratory biosecurity measure to better protect sensitive VBM, LBM3 now recommends limiting the information on biohazard signs to the laboratory biosafety level, the name and telephone number of the responsible investigator, and emergency contact information (Fig 1) - 10 - Biorisk managementLaboratory biosecurity guidance • September 2006 3 The biorisk management. .. transfer notifications should be established and their access secured - 22 - Biorisk managementLaboratory biosecurity guidance • September 2006 6 Laboratory biosecurity programme A comprehensive laboratory biosecurity programme involves: 1 identification of VBM 2 associated agent-based microbiological risk assessment and laboratory biosecurity risk assessment 3 bioethical and scientific analysis of research... countries In the context of public health, laboratory biosecurity expands laboratory biosafety into a complementary dimension 3.2 The biorisk management culture One of the goals of the biorisk management approach is to develop a comprehensive laboratory biosafety and biosecurity culture, allowing biosafety and biosecurity to become part of the daily routine of a laboratory, improving the overall level... food supplies after production -4- Biorisk managementLaboratory biosecurity guidance • September 2006 The purpose of this document is to define the scope and applicability of "laboratory biosecurity" recommendations, narrowing them strictly to human, veterinary and agricultural laboratory environments The operational premise for supporting national laboratory biosecurity plans and regulations generally... biological agents for harm (16) Additional guidance on these issues is provided in Public health response to biological and chemical weapons, WHO guidance, second edition, 2004 - 16 - Biorisk managementLaboratory biosecurity guidance • September 2006 Vaccines and other pharmaceutical products Another significant group of VBM with respect to laboratory biosecurity are the microbial strains used for... entrance must be obtained from the Responsible Investigator named above Figure 1 Biohazard warning sign for laboratory doors -9- Biorisk managementLaboratory biosecurity guidance • September 2006 Conflicts In the absence of careful implementation, various aspects of biosafety may conflict with laboratory biosecurity For example, controls that reduce unauthorized access might also hinder an emergency response . AND RESPONSE Biorisk management Laboratory biosecurity guidance September 2006 WHO/CDS/EPR/2006.6 Biorisk management Laboratory biosecurity guidance September. Biorisk management • Laboratory biosecurity guidance • September 2006 - 7 - 2. Laboratory biosecurity as a complement to laboratory biosafety Laboratory

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