International transfer and laboratory containment of animal pathogenic agents

Article 5.8.1.

Object

To prevent the introduction and spread of animal diseases caused by pathogenic agents.

Article 5.8.2.

Introduction

1. The consequences of the introduction into a country of an infectious disease or an animal pathogenic agent or new strain of pathogenic agent from which it is currently free, are potentially very serious. This is because animal health, human health, the agricultural economy and trade may all be adversely affected to a greater or a lesser degree. Countries will already have in place a range of measures, such as requirements for pre-import testing and quarantine, to prevent such introductions through the importation of live animals or their products.

2. However, there is also the risk that disease may occur as a result of the accidental release of animal pathogenic agents from laboratories that are using them for various purposes such as research, diagnosis or the manufacture of vaccines. Such pathogenic agents may already occur in the country or they may have been imported deliberately or inadvertently. It is therefore necessary to have in place measures to prevent their accidental release. These measures may be applied either at national borders by prohibiting or controlling the importation of specified pathogenic agents or their carriers (see Article 5.8.4.) or within national boundaries by specifying the conditions under which laboratories must handle them. In practice, a combination of external and internal controls is likely to be applied depending on the risk to animal health posed by the pathogenic agent in question.

Article 5.8.3.

Classification of pathogenic agents

Pathogenic agents should be categorised in accordance with the risk they pose to both human and animal health. They are grouped into four risk categories. Detailed information is provided in the Terrestrial Manual.

Article 5.8.4.

Importation of animal pathogenic agents

1. The importation of any animal pathogenic agent, pathological material or organisms carrying the pathogenic agent should be permitted only under an import licence issued by the relevant authority. The import licence should contain conditions appropriate to the risk posed by the pathogenic agent and, in relation to air transport, the appropriate standards of the International Air Transport Association concerning the packaging and transport of hazardous substances. The import licence for risk groups 2, 3 or 4 should only be granted to a laboratory that is licensed to handle the particular pathogenic agent as in Article 5.8.5.

2. When considering applications to import pathological material from other countries, the authorities should have regard to the nature of the material, the animal from which it is derived, the susceptibility of that animal to various diseases and the animal health situation of the country of origin. It may be advisable to require that material is pre-treated before import to minimise the risk of inadvertent introduction of a pathogenic agent.

Article 5.8.5.

Laboratory containment of animal pathogenic agents

1. Guidance on the laboratory containment of animal pathogenic agents and on the import conditions applicable to them is found in Chapter 1.1.2.  of the Terrestrial Manual. Additional guidance on human safety is also found in this chapter.

2. A laboratory should be allowed to possess and handle animal pathogenic agents in group 3 or 4 only if it can satisfy the relevant authority that it can provide containment facilities appropriate to the group. However, depending on the particular circumstances of an individual country, the authority might decide that the possession and handling of certain pathogenic agents in group 2 should also be controlled. The authority should first inspect the facilities to ensure they are adequate and then issue a licence specifying all relevant conditions. There should also be a requirement for appropriate records to be kept and for the authority to be notified if it is suspected that a material being handled contains a pathogenic agent not covered by the licence. The authority should visit the laboratory periodically to ensure compliance with the licence conditions. It is important that authority staff carrying out the visit should not have any contact with species susceptible to the pathogenic agents being handled at the laboratory for a specified period after visiting the laboratory. The length of this period will depend on the pathogenic agent.

3. Licences should specify:

   1. how the pathogenic agent is to be transported and the disposal of the packaging;

   2. the name of the person responsible for the work;

   3. whether the pathogenic agent may be used in vivo (and if so whether in laboratory animals or other animals) and/or only in vitro;

   4. how the pathogenic agent and any experimental animals should be disposed of when the work is completed;

   5. limitations on contact by laboratory staff with species susceptible to the pathogenic agents being used;

   6. conditions for the transfer of pathogenic agents to other laboratories;

   7. specific conditions relating to the appropriate containment level and biosecurity procedures and practices.

nb: first adopted in 1998; most recent update adopted in 2008.