Title: WHO Laboratory Biosafety Manual

Summary of Provisions:

The Laboratory Biosafety Manual (3rd Edition, 2004) gives guidance on: laboratory practice, equipment, facilities, waste disposal and decontamination for each biosafety level; the training, immunisation and health surveillance of staff; and the safe handling and transport of microorganisms. There are four biosafety levels, which concern "the design features, construction, containment facilities, equipment, practices and operational procedures required" for work with a specific risk group of microorganisms. The risk groups are:

1. "no or low community risk"
2. "moderate individual risk, low community risk"
3. "high individual risk, low community risk" and
4. "high individual and community risk" (p.2)

Specific to the area of biotechnology, guidance is given on Biosafety and Recombinant DNA Technology (Chapter 16). Work involving genetically modified organisms should be subject to biosafety risk assessment which will assist identification of the appropriate containment level for that work. In this assessment:

"The properties of the donor organism, the nature of the DNA sequences that will be transferred, the properties of the recipient organism, and the properties of the environment must all be evaluated." (Chapter 16, p.101)

The Manual also advises risk assessment and use of appropriate biosafety levels for transgenic animals and plants, and that viral vectors adapted to be 'replication-defective' should nonetheless be kept at the same biosafety level as the parent virus would be (p.102).

There is also a chapter on Laboratory Biosecurity Concepts (chapter 9). Biosecurity is "designed to prevent the loss, theft, misuse, diversion or intentional release of pathogens and toxins", and so while many implementing measures will overlap, it is different from biosafety (which aims to prevent unintentional exposure and accidental release(p.47). The concept is outlined in the Manual, but guidance on biosecurity is provided in a separate document the Laboratory Biosecurity Guidance (also summarised on this site).

Summary of Development

The Manual 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/).

Its 3rd Edition was published in 2004. It expanded previous coverage of biotechnology issues and introduced discussion of biosecurity and its relationship to biosafety.

Laboratory Biosafety Manual

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Related Summaries on the Genomics Gateway Site:

World Health Organisation

Guidance on Regulations for the Transport of Infectious Substances

Laboratory Biosecurity Guidance

Page last updated 26th March 2009.

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