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CONTAINMENT AND OTHER PROTECTIVE MEASURES General principles

1. These tables present the normal minimum requirements and measures necessary for each level of containment. Containment is also achieved through the use of good work practices, training, containment equipment and special installation design. For all activities involving GMMs the principles of good microbiological practice and the following principles of good occupational safety and hygiene shall apply:

(i) to keep workplace and environmental exposure to any GMM to the lowest practicable level;

(ii) to exercise engineering control measures at source and to supplement these with appropriate personal protective clothing and equipment when necessary;

(iii) to test adequately and maintain control measures and equipment;

(iv) to test, when necessary, for the presence of viable process organisms outside the primary physical containment;

(v) to provide appropriate training of personnel;

(vi) to establish biological safety committees or subcommittees, if required;

(vii) to formulate and implement local codes of practice for the safety of personnel, as required; (viii) where appropriate, to display biohazard signs;

(ix) to provide washing and decontamination facilities for personnel;

(x) to keep adequate records;

(xi) to prohibit eating, drinking, smoking, applying cosmetics or the storing of food for human consumption in the work area;

(xii) to prohibit mouth pipetting; (xiii) to provide written standard operating procedures where appropriate to ensure safety;

(xiv) to have effective disinfectants and specified disinfection procedures available in case of spillage of GMMs;

(xv) to provide safe storage for contaminated laboratory equipment and materials, when appropriate.

2. The titles of the tables are indicative: Table I A presents minimum requirements for laboratory activities. Table I B presents additions to and modifications of Table I A for glasshouse/growth-room activities involving GMMs. Table I C presents additions to and modifications of Table I A for activities with animals involving GMMs. Table II presents minimum requirements for activities other than laboratory activities. In some particular cases, it might be necessary to apply a combination of measures, from Table I A and Table II, of the same level. In some cases users may, with the agreement of the competent authority, not apply a specification under a particular containment level or combine specifications from two different levels. In these tables ‘optional’ means that the user may apply these measures on a case-by-case basis, subject to the assessment referred to in Article 4(2).

3. In implementing this Annex, Member States may in addition incorporate in the following tables the general principles set out in points 1 and 2, with a view to clarifying the requirements. Table I A Containment and other protective measures for laboratory activities

Specifications Containment levels 1 2 3 4 1 Laboratory suite: isolation Not required Not required Required Required 2 Laboratory: sealable for fumigation Not required Not required Required Required Equipment 3 Surfaces resistant to water, acids, alkalis, solvents, disinfectants and decontamination agents, and easy to clean Required (bench) Required (bench) Required (bench, floor) Required (bench, floor, ceiling, walls) 4 Entry to lab via airlock Not required Not required Optional Required 5 Negative pressure relative to the pressure of the immediate environment Not required Not required Required except for Required 6 Extract and input air from the laboratory should be HEPA-filtered Not required Not required Required (HEPA — extract air except for) Required (HEPA— input and extract air) 7 Microbiological safety post Not required Optional Required Required 8 Autoclave On site In the building En suite In lab = double-ended System of work 9 Restricted access Not required Required Required Required 10 Biohazard sign on the door Not required Required Required Required 11 Specific measures to control aerosol dissemination Not required Required minimise Required prevent Required prevent 13 Shower Not required Not required Optional Required 14 Protective clothing Suitable protective clothing Suitable protective clothing Suitable protective clothing and (optional) footwear Complete change of clothing and footwear before entry and exit 15 Gloves Not required Optional Required Required 18 Efficient vector control (e.g. for rodents and insects) Optional Required Required Required Waste 19 Inactivation of GMMs in effluent from hand-washing sinks or drains and showers and similar effluents Not required Not required Optional Required 20 Inactivation of GMMs in contaminated material and waste Optional Required Required Required Other measures 21 Laboratory to contain its own equipment Not required Not required Optional Required 23 An observation window or alternative is to be present so that occupants can be seen Optional Optional Optional Required

Table I B Containment and other protective measures for glasshouses and growth-rooms The terms ‘glasshouse’ and ‘growth-room’ refer to a structure with walls, a roof and a floor designed and used principally for growing plants in a controlled and protected environment. All provisions of Table I A shall apply with the following additions/modifications: Specifications Containment levels 1 2 3 4 Building 1 Glasshouse: permanent structure Not required Required Required Required Equipment 3 Entry via a separate room with two interlocking doors Not required Optional Optional Required 4 Control of contaminated run-off water Optional Minimise run-off Prevent run-off Prevent run-off System of work 6 Measures to control undesired species such as insects, rodents, arthropods Required Required Required Required 7 Procedures for transfer of living material between the glasshouse/growth-room, protective structure and laboratory shall control dissemination of GMMs Minimise dissemination Minimise dissemination Prevent dissemination Prevent dissemination Table I C Containment and other protective measures for activities in animal units

All provisions of Table I A shall apply with the following additions/modifications: Specifications Containment levels 1 2 3 4 Facilities 1 Isolation of animal unit Optional Required Required Required 2 Animal facilities separated by lockable doors Optional Required Required Required 3 Animal facilities designed to facilitate decontamination (waterproof and easily washable material (cages, etc.)) Optional Optional Required Required 4 Floor and/or walls easily washable Optional Required (floor) Required (floor and walls) Required (floor and walls) 5 Animals kept in appropriate containment facilities such as cages, pens or tanks Optional Optional Optional Optional 6 Filters on isolators or isolated room Not required Optional Required Required Table II Containment and other protective measures for other activities

Specifications Containment levels 1 2 3 4 General 1 Viable micro-organisms should be contained in a system which separates the process from the environment (closed system) Optional Required Required Required 2 Control of exhaust gases from the closed system Not required Required, minimise dissemination Required, prevent dissemination Required, prevent dissemination 3 Control of aerosols during sample collection, addition of material to a closed system or transfer of material to another closed system Optional Required, minimise dissemination Required, prevent dissemination Required, prevent dissemination 4 Inactivation of bulk culture fluids before removal from the closed system Optional Required, by validated means Required, by validated means Required, by validated means 5 Seals should be designed so as to minimise or prevent release No specific requirement Minimise dissemination Prevent dissemination Prevent dissemination 6 The controlled area should be designed to contain spillage of the entire contents of the closed system Optional Optional Required Required 7 The controlled area should be sealable to permit fumigation Not required Optional Optional Required Equipment 8 Entry via airlock Not required Not required Optional Required 9 Surfaces resistant to water, acids, alkalis, solvents, disinfectants and decontamination agents, and easy to clean Required (bench if any) Required (bench if any) Required (bench if any, floor) Required (bench, floor, ceiling, walls) 10 Specific measures to adequately ventilate the controlled area in order to minimise air contamination Optional Optional Optional Required 11 The controlled area should be maintained at an air pressure negative to the immediate surroundings Not required Not required Optional Required 12 Extract and input air from the controlled area should be HEPA filtered Not required Not required Required (extract air, optional for input air) Required (input and extract air) System of work 13 Closed systems should be located within a controlled area Not required Optional Required Required 14 Access should be restricted to nominated personnel only Not required Required Required Required 15 Biohazard signs should be posted Not required Required Required Required 17 Personnel should shower before leaving the controlled area Not required Not required Optional Required 18 Personnel should wear protective clothing Required (work clothing) Required (work clothing) Required Complete change before exit and entry Waste 22 Inactivation of GMMs in effluent from hand-washing sinks and showers or similar effluents Not required Not required Optional Required 23 Inactivation of GMMs in contaminated material and waste, including those in process effluent before final discharge Optional Required, by validated means Required, by validated means Required, by validated means

Isolation= the laboratory is separated from other areas in the same building or is in a separate building. Airlock= entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors. HEPA= High efficiency particulate air. Animal unit: a building or separate area within a building containing facilities and other areas such as changing rooms, showers, autoclaves, food storage areas, etc. Animal facility: a facility normally used to house stock, breeding or experimental animals or one which is used for the performance of minor surgical procedures. Isolators: transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate.