Laboratory Biosecurity Guidance - WHO

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WHO/CDS/EPR/2006.6Biorisk managementLaboratory biosecurityguidanceSeptember 2006EPIDEMIC AND PANDEMICALERT AND RESPONSE

Biorisk managementLaboratory biosecurityguidanceSeptember 2006

World Health Organization 2006All rights reserved.The designations employed and the presentation of the material in this publication do not imply theexpression of any opinion whatsoever on the part of the World Health Organization concerning the legalstatus of any country, territory, city or area or of its authorities, or concerning the delimitation of itsfrontiers or boundaries. Dotted lines on maps represent approximate border lines for which there maynot yet be full agreement.The mention of specific companies or of certain manufacturers’ products does not imply that they areendorsed or recommended by the World Health Organization in preference to others of a similar naturethat are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.All reasonable precautions have been taken by the World Health Organization to verify the informationcontained in this publication. However, the published material is being distributed without warranty ofany kind, either express or implied. The responsibility for the interpretation and use of the material lieswith the reader. In no event shall the World Health Organization be liable for damages arising from itsuse.

Biorisk management Laboratory biosecurity guidance September 2006Table of ContentsAbbreviations. iiDefinitions . iiiPreface . - 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 -i

Biorisk management Laboratory biosecurity guidance September 2006AbbreviationsBSL3Containment laboratory – Biosafety Level 3BSL4Maximum containment laboratory – Biosafety Level 4FAOFood and Agriculture Organization of the United NationsGMOGenetically modified organismLBM3Laboratory biosafety manual, third edition, 2004LBGBiorisk management: laboratory biosecurity guidance, first edition, 2006OIEWorld Organisation for Animal HealthVBMValuable biological materialsWHOWorld Health Organizationii

Biorisk management Laboratory biosecurity guidance September 2006DefinitionsThe following terms are defined in the context in which they are used in this document.AccountabilityAccountability ensures that valuable biological materials (VBM, see definition below) arecontrolled and traced as intended, by formally associating the specified materials with theindividuals who provide oversight and are held responsible for them.BioethicsThe study of the ethical and moral implications of biological discoveries, biomedicaladvances, 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 toa successful biorisk management culture.Biological laboratoryA facility within which microorganisms, their components or their derivatives are collectedhandled and/or stored. Biological laboratories include clinical laboratories, diagnosticfacilities, regional and/national reference centres, public health laboratories, research centres(academic, pharmaceutical, environmental, etc.) and production facilities (manufacturers ofvaccines, pharmaceuticals, large scale GMOs, etc) for human, veterinary and agriculturalpurposes.BioriskThe probability or chance that a particular adverse event (in the context of this document:accidental infection or unauthorized access, loss, theft, misuse, diversion or intentionalrelease), possibly leading to harm, will occur.Biorisk assessmentThe process to identify acceptable and unacceptable risks (embracing biosafety risks (risks ofaccidental infection) and laboratory biosecurity risks (risks of unauthorized access, loss, theft,misuse, diversion or intentional release)) and their potential consequences.Biorisk managementThe analysis of ways and development of strategies to minimize the likelihood of theoccurrence of biorisks. The management of biorisk places responsibility on the facility and itsmanager (director) to demonstrate that appropriate and valid biorisk reduction (minimization)procedures have been established and are implemented. A biorisk management committeeshould be established to assist the facility director in identifying, developing and reachingbiorisk management goals.BiosafetyLaboratory biosafety describes the containment principles, technologies and practices that areimplemented to prevent the unintentional exposure to pathogens and toxins, or their accidentalrelease (2).iii

Biorisk management Laboratory biosecurity guidance September 2006Code of conduct, code of ethics, code of practiceNon-legislated guidelines which one or more organizations and individuals voluntarily agreeto abide by, that set out the standard of conduct or behavior with respect to a particularactivity (adopted from 1).ControlControl is the combination of engineered and procedural measures that ensure valuablebiological material (VBM, see definition below) are used only as intended.Dual-useInitially used to refer to the aspects of certain materials, information and technologies that areuseful in both military and civilian spheres. The expression is increasingly being used to refernot 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 combineDNA molecules from different sources into one molecule in a test tube. GMOs are often notreproducible in nature, and the term generally does not cover organisms whose geneticcomposition has been altered by conventional cross-breeding or by "mutagenesis" breeding,as these methods predate the discovery (1973) of recombinant DNA techniques.HazardA danger or source of danger; the potential to cause harm.Laboratory biosecurityLaboratory biosecurity describes the protection, control and accountability for valuablebiological materials (VBM, see definition below) within laboratories, in order to prevent theirunauthorized access, loss, theft, misuse, diversion or intentional release.MisuseThe misuse of valuable biological materials (VBM, see definition below) describes theirinappropriate or illegitimate use, despite existing and subscribed agreements, treaties andconventions (3).ThreatThe likelihood for an adverse event to occur, as an expression of intention to inflict evil,injury, disruption or damage.Transfer of VBMLegal and/or administrative policies and procedures relating to the oversight and approvalprocess for the transfer of custody and/or ownership of valuable biological materials (VBM,see definition below) between countries, entities (organizations, institutions, facilities, etc.) orindividuals.iv

Biorisk management Laboratory biosecurity guidance September 2006Transport of VBMProcedures and practices to correctly categorize, package, document and safely and securelytransport valuable biological materials (VBM, see definition below) from one place toanother, following applicable national and/or international regulations.Valuable biological materials (VBM)Biological materials that require (according to their owners, users, custodians, caretakers orregulators) administrative oversight, control, accountability, and specific protective andmonitoring 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 andtoxins, as well as non-pathogenic organisms, vaccine strains, foods, genetically modifiedorganisms (GMOs), cell components, genetic elements, and extraterrestrial samples.v

Biorisk management Laboratory biosecurity guidance September 2006PrefaceThe economic consequences and scientific concern resulting from the laboratoryacquired SARS-CoV infections of 2003-2004 in Singapore, Taipei and Beijing not onlyraised biosafety awareness in the affected facilities, but most importantly promotedreview by the concerned scientific community and national regulatory bodies,demonstrating high political commitment to biosafety practices in laboratories. Theincidents triggered the improvement of national biosafety policies. Other countriesaffected, whether directly or indirectly, also expressed wide-ranging concern. As aresult, WHO has recently witnessed a worldwide increase in the demand for biosafetyguidance and support that culminated in 2005 with the adoption by the World HealthAssembly 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 laboratorywork safely, to laboratory managers on how to set up a managerial approach tobiosafety and to regulatory authorities, to help them consider necessary aspects for thedevelopment of adequate national biosafety regulations. A top-down approachassociated with bottom-up support for biosafety regulations has been very successful inadvancing the biosafety agenda.The present document aims to expand the laboratory biosecurity concepts introduced inLBM3, and to strike a balance between the long-known biosafety procedures andpractices described in LBM3 and the more recently introduced and broader biosecurityconcepts. It further introduces the overarching "biorisk management" approach that hasresulted from careful thinking, comprehensive study of prevailing practices andrecommendations, review of international norms and standards, and relevant ethicalconsiderations 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 playkey roles in the field of biosciences and in public health in general.-1-

Biorisk management Laboratory biosecurity guidance September 20061. IntroductionBackgroundDisease diagnosis, human or animal sample analysis, epidemiological studies, scientificresearch, and pharmaceutical developments: all of these activities are carried out inbiological laboratories in the private or public sectors. Biological materials are handledworldwide in laboratories for numerous genuine, justifiable and legitimate purposes,where small and large volumes of live microorganisms are replicated, where cellularcomponents are extracted and many other manipulations undertaken for purposesranging from educational, scientific, medicinal and health-related to mass commercialand/or industrial production. Among them, an unknown number of the facilities, largeand small, work with dangerous pathogens or their products every day.The general public expects laboratory personnel to act responsibly and not to exposethe community to biorisks, to follow safe working practices (biosafety) associated withpractices that will help keep their work and materials safe and secure (biosecurity), andto follow an ethical code of conduct (bioethics). Often suspicious of work taking placein laboratories, the uninformed public may even feel threatened by the presence of abiological laboratory in their neighborhood. It is the technical and moral duty oflaboratory managers and laboratory workers, with the support of national authorities, toreassure the general public, to persuade them that the activities being conducted arebeneficial and necessary, and to prove that the biorisks inherent to laboratory work arecontrolled with appropriate safeguards to meet their expectations.However, despite advances in technology, the availability of more and moresophisticated instruments for laboratory use, increasingly effective techniques and theavailability of personal protective equipment, human error remains one of the mostimportant factors at the origin of accidents. Poor concentration, denial ofresponsibilities, inappropriate accountability, incomplete record-keeping, suboptimalfacility infrastructure, refusal to acknowledge ethical considerations, lack of (or lack ofrespect for) codes of conduct, etc. may be at the origin of laboratory-acquiredinfections, loss of material and inappropriate manipulations, or even possiblyintentional misbehaviour.Pathogens and toxins have been used, even in the recent past, to threaten and harmpeople, to disrupt society, economies and the political status quo (5). This hashappened in spite of applicable international agreements banning the use of biologicalagents for malicious use. As those who carry out such acts show disregard for ethicalvalues (6), do not respect the right of people to a safe and peaceful life, or do notrecognize global treaties and conventions, several regulatory approaches to limitunauthorized access to biological agents and toxins available in biological laboratoriesare now being carefully considered and implemented worldwide.Three examples illustrate the need to respond to the international community andarticulate biosecurity in the laboratory:-2-

Biorisk management Laboratory biosecurity guidance September 20061. Smallpox has been eradicated some 26 years ago. However, its causative agent,variola virus, remains stored in two WHO Collaborating Centres undermaximum containment. The accidental or deliberate reintroduction of variolavirus into the environment threatens not only public health, but also theeconomy and political stability of the whole world. For this reason, the knownremaining variola virus stocks are subject to WHO scrutiny for the researchthey are subject to (7), and each site is regularly assessed by WHO for itsbiosafety and laboratory biosecurity (8). Despite these existing internationalarrangements, this guidance document offers an opportunity for furtherimprovement of their working and storage conditions.2. As the final stages of the poliomyelitis eradication campaign approach, steadyprogress is being made towards the safe-keeping of facilities containingpoliovirus samples and stocks, which will then be advised to decide whether tokeep these polioviruses and upgrade their biosafety containment andbiosecurity levels and tighten their codes of conduct, transfer their poliovirussamples to a better-equipped reference laboratory, or destroy the remainingstocks. Experience gained and lessons learnt from the containment of variolaviruses post eradication offer an invaluable opportunity to plan for the poliopost eradication phase and for the development of most appropriate bioriskmanagement plans and goals.3. Laboratory biosecurity provisions may not have impeded the release of theanthrax letters in the USA in 2001 (5). In hindsight however, laboratorybiosecurity provisions to write records on research and activity, access shareddocumentation, consult approved research projects and available results data,may have helped discharge alleged facilities and perpetrators from the list ofpossible suspects.Historical awareness of the dual-use (9) of agents, equipment and technology, is alsoconsidered in the development of laboratory biosecurity guiding principles.Current situationFacilities containing biological agents may represent tempting procurementopportunities, thus advocacy for security-related scrutiny of biological facilities, theirpersonnel and their visitors is increasing worldwide. In recent years, several countrieshave developed and implemented laboratory biosecurity legislation to regulatepossession, use and access to biological materials to permit their appropriate use.Despite the advances of some countries, in many other countries and for manylaboratories, guidance or specific requirements for the appropriate handling andstorage of valuable biological materials (VBM, described below) do not yet exist. Thisraises the following questions: How are these agents generally kept in such countries?Who has access to them? What kind of research is allowed and conducted with them?Who oversees this research? Who has the ultimate responsibility for these agents?Who should have access to information related to these agents, including research-3-

Biorisk management Laboratory biosecurity guidance September 2006results and storage details? Should research results be published? Is there a scrutinyfor the publication of research data?Many open questions still remain in the context of laboratory biosecurity, and muchstill needs to be done to reassure the public, scientists, laboratory managers, regulators,national authorities and the international community that the appropriate measures toprevent, manage, control and minimize the biorisks associated with possessing andhandling infectious agents are in place. The biorisk management approach described inthis document, encompassing biosafety and laboratory biosecurity, represents a steptowards the clarification of these questions.Globally, one common trend can be identified: rather than providing a prescriptiveapproach to addressing biosafety and related issues, and requesting compliance with aset of strict rules, the move to a goal-setting approach describing performanceexpectations for facilities, and placing the responsibility on si

Biorisk management Laboratory 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

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