SECURITY AND TRANSFER RESTRICTION CODES

LABORATORY PROCEDURES FOR MICROORGANISMS

REFERENCE NO.: M/1998/1.05

TITLE: SECURITY AND TRANSFER RESTRICTION CODES

Due to great differences in respect of pathogenicity, microorganisms have been classified on the basis of hazard by international and national authorities. The World Health Organization (WHO) groups microorganisms according to their hazard in 4 groups. Whereas the definitions of the different risk groups (or classes) are generally agreed, the classification of species to one of the (Risk) Groups or Class 1, 2, 3 or 4 may vary in different countries.

Lists of species classified in the European Union in group 2, 3 or 4 has been published in several European directives [see M/1999/1.03]

A permit from health authorities may be required for the export, import of and/or work with organisms of (Risk) Group/Class 3 and 4. In some countries a working permit is also required to handle group 2 organisms.

2 organisms.
1. Human and animal pathogens (from Laboratory Biosafety Manual, 2^nd edition, WHO, 1993)

Risk Group 1 (no or very low individual and community risk): A microorganism that is unlikely to cause human or animal disease;

Risk Group 2 (moderate individual risk, low community risk): A pathogen that can cause human or animal disease but is unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment. Laboratory exposure may cause serious infection, but effective treatment and preventive measures are available and the risk of spread of infection is limited;

Risk Group 3 (high individual risk, low community risk): A pathogen that usually causes severe human or animal disease but does not ordinarily spread from one infected individual to another. Effective treatment and preventive measures are available;

Risk Group 4 (high individual and community risk): A pathogen that usually causes serious human or animal disease and that can be readily transmitted from one individual to another, directly or indirectly. Effective treatment and preventive measures are not usually available.

2. Plant pathogens

The classification of plant pathogens varies for different countries, as the criteria are not only the pathogenicity or virulence of a species or strain, but also its occurrence in a particular country and the availability of possible hosts. Many countries require import permits for certain species. For the use of plant pathogenic microorganisms or for transport restrictions of plant pathogenic microorganisms national and/or European directives should be consulted (see M/1998/1.03). Data sheets on "Quarantine Pests for Europe" have been published by CAB International in association with the European and Mediterranean Plant Protection Organization (EPPO) in 1997 (Smith, I.M. et al. (Editorial Committee): "Quarantine Pests for Europe. Data sheets on quarantine pests for the European and Mediterranean Plant Protection Organization", 2^nd edition, CAB International, Wallingford, 1997, ISBN 0-85199-154-8 )

3. Toxinogenic microorganisms

Certain toxin producing bacteria and fungi are considered as a potential danger for public health. In different countries import and/or export restrictions may exist. The export of certain toxin producing microorganisms is controlled by national regulations and regulations of the European Union.

4. Prevention of Biological Warfare Proliferation: Export Control of Dual-Use Goods by the EU

The export of certain pathogenic and toxin producing microorganisms is controlled by national regulations and regulations of the European Union (see M/1998/1.03).

Security codes

1. Human and animal pathogenicity codes

Group 1 - unlikely to cause disease Corresponds to (Risk)Group or Class 1.

Group 2 - may cause disease Corresponds to (Risk)Group or Class 2. Restricted to laboratories. In some countries a working permit is required.

Group 3 - causing severe disease Corresponds to (Risk)Group or Class 3. Restricted to laboratories. Acceptance-of-Responsibility form required. In some countries a working permit is required.

Group 4 - causing severe disease Corresponds to (Risk)Group or Class 4. Contains no bacteria, fungi or yeasts.

Lists of bacteria and fungi classified with one of the above group have been published (see M/1998/1.03). More detailed lists have been published:

Guidelines "Safe Biotechnology" B 006 Risk groups of biological agents: Bacteria (in German).

Guidelines "Safe Biotechnology" B 007 Risk groups of biological agents: Fungi (in German)

A classification of fungi into biosafety categories is also proposed by de Hoog. The list includes all species accepted in the recent medical literature (G.S. de Hoog, Risk assessment of fungi reported from humans and animals, Mycoses 39, 407-417, 1996).

For an example of an Acceptance-of-Responsibility form for potentially pathogenic materials see M/1998/1.05 Appendix 1.

2. Plant pathogens.

For plant pathogenic microorganisms no classification system exists. In Europe, restrictions for certain species have been published (see M/1998/1.03 ). The import of plant pathogenic microorganisms may be prohibited by some countries.

3. Toxin or mycotoxin producers (T 1-3).

The export of (myco)toxin producing microorganisms may be controlled by national regulations or regulations of the European Union (control of export of dual-use goods, see M/1998/1.03). The distribution of hallucinogenic fungi may restricted by national regulations.. The following classification is proposed:

T1 - not toxic Only for laboratories.

T2 - hallucinogenic Acceptance-of-Responsibility form required [Example see M/1998/1.05 Appendix 2].

T3 - severe toxins Legal restrictions (dual-use goods, country-dependent) (aflatoxin, trichothecene etc.).

Acceptance-of-Responsibility form required [ Example see M/1998/1.05 Appendix 3].

4. Transfer restriction codes

Transfer agreement; distribution only after written consent of requester not to distribute the strain or use it for commercial purposes without agreement with depositor. An example of a Transfer Agreement form is given in M/1998/1.05 Appendix 4

Guidelines prepared for CABRI by DSMZ, CBS and BCCM, 17 May 1998
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