Title: WHO Laboratory Biosecurity Guidance

Summary of Provisions:

The Laboratory Biosecurity Guidance aims to prevent the "unauthorized access, loss, theft, misuse, diversion or intentional release" of what it refers to as 'valuable biological materials' (VBM). These are defined as:

"Biological materials that require... 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." (p.v)

This means that the Guidance applies not only to pathogens, toxins, and other biological materials that may be put to hostile use, but also to biological materials that have value for other reasons.

Biosecurity programmes will need to be specifically designed for each laboratory setting because of the range of uses to which VBM can be put. Programmes should also be able to adapt as needs change over time. The protective measures required will vary with the type of VBM, the quantity used and the activities being performed.

The dual-use nature of many pathogens and toxins is noted and laboratories are expected to ensure they adequately protected. The Guidance raises particular concerns about "genetically engineered pathogens that express enhanced or unique virulence properties" because "there may be no known effective treatment for exposed and infected persons or animals." (p.16)

Seven particular elements of biosecurity programmes are identified:

"1. Identify VBM that require protection on the basis of regularly performed biorisk assessments.
2. Establish clear guidance, roles, responsibilities and authorities for those who work with or have access to VBM and to the facilities that contain them.
3. Promote a culture of awareness, shared sense of responsibility, ethics and respect of codes of conduct within the international life science community.
4. Develop policies that do not hinder the efficient sharing of reference materials and scientific data, clinical and epidemiological specimens and related information, and that do not impede the conduct of legitimate research.
5. Strengthen collaboration between the scientific, technical and security sectors.
6. Provide appropriate training to employees of laboratory facilities.
7. Strengthen emergency response and recovery plans on the assumption that biorisk management systems can only minimize, but never really eliminate, every conceivable threat." (p.30)

Summary of Development

The Guidance is part of the World Health Organisation's Biosafety Programme, which aims to "reduce to the extent possible the spread of disease caused by accidents or inappropriate handling or usage of pathogenic organisms" (http://www.who.int/csr/labepidemiology/projects/biosafety/en/).

The concept of biosecurity was brought into the Biosafety Programme in Chapter 9 of the 2004 edition of the Laboratory Biosafety Manual. The Laboratory Biosecurity Guidance, published in September 2006, broadens the concept (which was previously focused solely on biological materials that could be used to cause harm) and provides detailed guidance on achieving laboratory biosecurity. It is a response to growing international concern about the possibility of individuals or groups managing to get hold of dual-use biological materials through a lack of security at laboratory facilities.

Laboratory Biosecurity Guidance

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Related Summaries on the Genomics Gateway Site:

World Health Organisation

Guidance on Regulations for the Transport of Infectious Substances

Laboratory Biosafety Manual

Biological and Toxin Weapons Convention

Page last updated 26th March 2009.

Comments/enquiries to catherine.rhodes-2 'at' manchester.ac.uk