OIE-1.01.03-Biosecurity Standard for Managing Biological Risk in The Veterinary Laboratory(2015)

OIE-1.01.03-Biosafety and Biosecurity Standard for Managing Biological Risk in The Veterinary Diagnostic Laboratory and Animal Facilities(2015)

Chapter 1.1.0 Management of Veterinary Laboratories outlines the overall requirements and

responsibilities to be addressed in the management of veterinary laboratories, of which

management of the biological risks associated with the operation of a laboratory is an important

aspect. This chapter outlines the principles on which the specific management of biological risks

associated with veterinary laboratories and experimental animal handling facilities should be based.

The terminology is aligned with the OIE nomenclature for risk analysis, including the four

components, namely hazard identification, risk assessment, risk management and risk

communication, used in Chapter 2.1 Import Risk Analysis of both the OIE Terrestrial Animal Health

Code and OIE Aquatic Animal Health Code. In this way the process is consistent with and

standardised against risk analysis processes already used by OIE Member Countries.

Adoption of the risk analysis approach to management of biological risks for biosafety and

biosecurity in veterinary laboratories and animal facilities provides Member Countries with a means of

tailoring their relevant national animal health policies and procedures regarding their laboratories to

their particular circumstances and priorities. The biological risk management approach gives

countries a mechanism to protect their human and animal populations from inadvertent or

intentional release of or exposure to animal pathogens in an evidence-based, transparent,

economically viable and sustainable manner. The approach is applicable in all countries from

technologically advanced to in-transition or resource-limited countries.

The risk analysis approach moves towards a comprehensive biological risk management

framework that is science-based and specific to an individual country and laboratory’s

circumstances. The process could accommodate the assigning of pathogens to risk groups relevant

to the country and the subsequent restriction of the associated work to laboratory facilities defined

by containment levels tailored to the types of risk identified if this suits an individual country’s

requirements as identified by its biological risk analysis. This chapter and the associated Guideline

3.5 Managing biorisk: examples of aligning risk management strategies with assessed biorisks

provide the framework for implementation of the risk management approach.

Veterinary laboratories and animal facilities routinely handle biological materials that may constitute

or contain infectious agents and toxins that may cause adverse animal or public health and

economic effects due to uncontrolled release inside or outside the laboratory. Laboratory and

animal facilities managers are responsible for providing a management system that ensures safe

and secure handling, storage, and transport of these biological materials (a biological risk

management system). This is needed not only to protect laboratory workers from inadvertent

exposures and infection, but also to protect the local and regional animal populations, human

populations, and environment from accidental or intentional release and spread of biological agents

and toxins from laboratories. These considerations should also apply to animals and potential

arthropod vectors that are handled in veterinary laboratories and animal facilities. The term

“biological material” is used throughout this chapter to include all potential sources of biological risk

for which laboratory management may be responsible. To classify the potential biological risk posed

by the presence and handling of a particular biological material, laboratory managers should apply

a systematic and evidence-based approach.

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