LABORATORY PROCEDURES FOR PLANT CELL LINES
REFERENCE NO.: PC/1998/1/6
TITLE: SECURITY , QUALITY AND TRANSFER RESTRICTION CODES
Due to great differences in respect of pathogenicity, micro-organisms have been classified on the basis of hazard by international and national authorities. Whereas the definitions of the different risk groups (or classes) are generally agreed, the classification of species to one of the (Risk) Groups I, II, III or IV (or Class I - IV) may vary in different countries. A list of species classified in the European Union in group 2, 3 or 4 has been published (Council Directive 93/88/EEC of 12 October 1993 amending Directive 90/679/EEC on the protection of workers from risk related to exposure to biological agents at work).
The World Health Organisation (WHO) groups micro-organisms according to their hazard in 4 groups. The definitions given by other authorities may differ slightly.
A permit from health authorities may be required for the export, import of and/or work with organisms of (Risk) Group/Class III and IV. In some countries a working permit is also required to handle group 2 organisms.
Human and animal pathogens
Risk Group 1 (low or very low individual and community risk): A micro-organism 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.
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 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. In Europe the "Commission Directive 92/103/EEC of 1 December 1992 amending Annexes I-IV of council directive 77/93/EEC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community" should be consulted. 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 1992.
Prevention of Biological Warfare Proliferation: Export Control of Dual-Use Goods by the EU
The "Council Regulation EC no 3381/94 on the Control of Exports of Dual-Use Goods from the Community of 19th December 1994" is effective from 1st July 1995 and controls the export of biological materials pathogenic to humans, animals or plants, of toxins and of genetically modified micro-organisms.
The list of biological materials is Annex I of the "Council Decision of 19th December 1994 on the Joint Action adopted by the Council on the Basis of Article J.3 of the Treaty on European Union concerning the Control of Export of Dual-Use Goods from the Community' (94/9421PESC) (Publication L367/8/CEC of 31.12.1994).
Council Regulation 3381/94 is amended by "Council Regulation (EC) no 837/95 of 10th April 1995 (Publication L90/1 of 21.04.1995)". Council Decision 94/9421PESC is amended by "Council Decision of 10th April 1995 (95/127/PESC) (Publication L90/2 of 21.04. 1995)".
Security codes of collections
Human and animal pathogenicity codes
Group 1 - unlikely to cause disease Corresponds to (Risk)Group or Class 1. Restricted to laboratories.
Group 2 - may cause disease Corresponds to (Risk)Group or Class 2. Restricted to laboratories. In some countries working permit necessary.
Group 3 - causing severe disease Corresponds to (Risk)Group or Class 3. Restricted to laboratories. Acceptance-of-Responsibility form required. In some countries working permit needed.
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 in: Council Directive 93/88/EEC of 12 October 1993 amending Directive 90/679/EEC on the protection of workers from risk related to exposure to biological agents at work.
More detailed lists have been published:
Merkblätter "Sichere Biotechnologie" B 006 Eingruppierung biologischer Agenzien: Bakterien.
Merkblätter "Sichere Biotechnologie" B 007 Eingruppierung biologischer Agenzien: Pilze
Merkblätter "Sichere Biotechnologie" B 008 Einstufung gentechnischer Arbeiten: Gentechnisch veränderte Organismen
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).
Toxin or mycotoxin producers (T 1-3).
T1 - not toxic Restricted to laboratories.
T2 - hallocinogenic Acceptance-of-Responsibility form required
T3 - severe toxins Restrictions (legal restriction (dual-use goods,(aflatoxin, trichothecene etc.) country-dependent). Acceptance-of-Responsibility form required.
No classification system existing. Restrictions according to regulations of different countries.
Quality codes of collections
0 Quality as on arrival, strain typical (full maintenance, distribution)
1 Quality decreased, loss of certain characters (full maintenance, no or restricted distribution)
2 Incomplete identification (full maintenance, restricted distribution, not in catalogue)
3 Quality low, no maintenance, no distribution
4 No longer in collection
Transfer restriction codes of collections
1 Transfer agreement; distribution only after written consent of requester not to distribute the strain or use it for commercial purposes without agreement with depositor.
Guidelines prepared for CABRI by DSMZ, 20 Jan. 1998
© The CABRI Consortium 1999-2013.