2002/106/EC: Commission DecisionDangos y teitl llawn

CHAPTER IX U.K. Minimum safety requirements for classical swine fever laboratories

1. The minimum requirements laid down in Table 1 must be fulfilled in any laboratory where classical swine fever virus is to be manipulated, even if only in a small amount, as required by the virus isolation and neutralisation tests. However, post-mortem examinations, processing of tissues for FAT and serology using inactivated antigen, may be carried out at a lower containment level provided that basic hygiene and post-operational disinfection with safe disposal of tissues and sera apply. U.K.

2. The additional requirements laid down in Table 1 must be fulfilled by any laboratory where procedures involving extensive multiplication of virus are carried out. U.K.

3. The requirements laid down in Table 2 must be fulfilled by any laboratory where animal experiments with classical swine fever virus are carried out. U.K.

4. In any case, all stocks of classical swine fever virus must be kept in secure storage, whether deep-frozen or freeze-dried. It is recommended that freezers and refrigerators are not used for viruses other than classical swine fever, or for other materials unrelated to classical swine fever diagnosis. All individual ampoules must be clearly labelled, and comprehensive records maintained of virus stocks together with dates and results of quality-control checks. Records must also be kept of viruses added to stock, with details of the source, and of viruses issued to other laboratories. U.K.

5. It is recommended that the bio-safe unit for classical swine fever virus work should be supported by areas where classical swine fever virus is not manipulated. These other areas should be available for the preparation of glassware and media, the maintenance and preparation of non-infected cell cultures, the processing of sera and serological testing (other than methods using live classical swine fever virus), and the provision of administrative and clerical support. U.K.

Table 1

Principles of biological containment appropriate for diagnostic laboratories

	Additional requirements	Minimal requirements
General environment	Normal atmospheric pressure Double HEPA filtration of exhaust air. Dedicated rooms, used exclusively for classical swine fever diagnostic procedures.	Normal atmospheric pressure. Dedicated rooms limited to defined procedures.
Laboratory clothing	Complete change of clothes on entry. Laboratory clothing used only in the classical swine fever virus unit. Disposable gloves for all manipulations of infected material. Clothing sterilised before removal from unit, or washed within unit.	Dedicated outer clothing used only in the classical swine fever virus unit. Disposable gloves for all manipulations of infected material. Outer clothing sterilised before removal from unit, or washed within unit.
Control of personnel	Entry to unit limited to named, trained personnel. Wash and disinfect hands on leaving unit. Personnel not permitted near pigs for 48 hours after leaving unit.	Entry to unit limited to named, trained personnel. Wash and disinfect hands on leaving unit. Personnel not permitted near pigs for 48 hours after leaving unit.
Equipment	Biological safety cabinet (Class I or II) used for all manipulations of live virus. Cabinet should have double HEPA filtration of exhaust air. All equipment needed for laboratory procedures to be available within the dedicated laboratory suite.

Table 2

Bio-safety requirements for experimental animal rooms

	Requirements
General environment	Negative pressure controlled ventilation. Double HEPA filtration of exhaust air. Facility for complete fumigation/disinfection at end of experiment. All effluents treated to inactivate classical swine fever virus (heat or chemical).
Laboratory clothing	Complete change of clothes on entry. Disposable gloves for all manipulations. Clothing sterilised before removal from unit, or washed within unit.
Control of personnel	Entry to unit limited to named, trained personnel. Full shower on exit from unit. Personnel not permitted near pigs for 48 hours after leaving unit.
Equipment	All equipment required for animal procedures to be available within the unit. All materials to be sterilised on removal from unit or, in the case of animal samples, to be double wrapped in leakproof container which is surface disinfected for transport to the classical swine fever laboratory.
Animals	All animals to be slaughtered before leaving the unit, post mortem examinations to be completed within the bio-safe area, and carcasses incinerated on completion of examinations.