Part II
Table 1a:
Containment measures for activities involving genetic modification of micro-organisms in laboratories
| Containment Measures | Containment Levels | |||
|---|---|---|---|---|
| 1 | 2 | 3 | 4 | |
NOTES 1. In the Table above, “isolation” means, in relation to a laboratory, separation of the laboratory from other areas in the same building, or being in a separate building. 2. 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. 3. Where viruses are not retained by the HEPA filters, extra requirements will be necessary for extract air. 4. Where the autoclave is outside the laboratory in which the activity involving genetic modification of micro-organisms is being undertaken, but within the laboratory suite, there shall be validated procedures for the safe transfer of material into that autoclave, which provide a level of protection equivalent to that which would be achieved by having an autoclave in that laboratory. | ||||
1 Laboratory suite: isolation (Note 1) | not required | not required | required | required |
2 Laboratory: sealable for fumigation | not required | not required | required | required |
| Equipment | ||||
3 Surfaces impervious to water, resistant to acids, alkalis, solvents, disinfectants and decontamination agents and easy to clean | required for bench | required for bench | required for bench and floor | required for bench, floor ceiling and walls |
4 Entry to lab via airlock (Note 2) | not required | not required | required where and to extent the risk assessment shows it is required | required |
5 Negative pressure relative to the pressure of the immediate surroundings | not required | required where and to extent the risk assessment shows it is required | required | required |
6 Extract and input air from the laboratory shall be HEPA filtered | not required | not required | HEPA filters required for extract air | HEPA filters required for input and extract air (Note 3) |
7 Microbiological safety cabinet/enclosure | not required | required where and to extent the risk assessment shows it is required | required, and all procedures with infective materials required to be contained within a cabinet/ enclosure | Class III cabinet required |
8 Autoclave | required on site | required in the building | required in the laboratory suite (Note 4) | double ended autoclave required in laboratory |
| System of work | ||||
9 Access restricted to authorised personnel only | not required | required | required | required (via airlock key procedure) |
10 Specific measures to control aerosol dissemination | not required | required so as to minimise | required so as to prevent | required so as to prevent |
11 Shower | not required | not required | required where and to extent the risk assessment shows it is required | required |
12 Protective clothing | suitable protective clothing required | suitable protective clothing required | suitable protective clothing required; footwear required where and to extent the risk assessment shows it is required | complete change of clothing and footwear required before entry and exit |
13 Gloves | not required | required where and to extent the risk assessment shows they are required | required | required |
14 Efficient control of disease vectors (eg rodents and insects) which could disseminate GMMs | required where and to extent the risk assessment shows it is required | required | required | required |
15 Specified disinfection procedures in place | required where and to extent the risk assessment shows they are required | required | required | required |
| Waste | ||||
16 Inactivation of GMMs in effluent from handwashing sinks and showers and similar effluents | not required | not required | required where and to extent the risk assessment shows it is required | required |
17 Inactivation of GMMs in contaminated material and waste | required by validated means | required by validated means | required by validated means | required by validated means |
| Other measures | ||||
18 Laboratory to contain its own equipment | not required | not required | required, so far as is reasonably practicable | required |
19 An observation window or alternative is to be present so that occupants can be seen | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required | required |
20 Safe storage of GMMs | required where and to extent the risk assessment shows it is required | required | required | secure storage required |
21 Written records of staff training | not required | required where and to extent the risk assessment shows they are required | required | required |
Table 1b:
Containment measures for activities involving genetic modification of micro-organisms in plant growth facilities (to be read with Table 1a as indicated in paragraph 3)
| Containment Measures | Containment Levels | Additional/ modification | |||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | ||
NOTE 1. A permanent structure refers to a fixed structure with walls, a roof and a floor. Where the permanent structure is a greenhouse, that structure shall also have a continuous waterproof covering and self-closing lockable outer doors, and be located on a site designed to prevent the entry of surface run-off water. | |||||
| Building | |||||
1 Permanent structure (Note 1) | required where and to extent the risk assessment shows it is required | required | required | required | Modification |
| Equipment | |||||
2 Entry via a separate room with two interlocking doors | not required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required (via airlock key procedure) | Additional |
3 Control of contaminated run-off water | required where and to extent the risk assessment shows it is required | required so as to prevent run-off | required so as to prevent run-off | required so as to prevent run-off | Additional |
| System of work | |||||
4 Effective control of disease vectors such as insects, rodents and arthropods which could disseminate GMMs | required | required | required | required | Additional |
5 Effective control of pollen, seeds and other plant material which could disseminate GMMs | required where and to extent the risk assessment shows it is required | required so as to minimise dissemination | required so as to prevent dissemination | required so as to prevent dissemination | Additional |
6 Procedures for transfer of living material between the plant growth facilities, protective structure and laboratory shall control dissemination of GMMs | required so as to minimise dissemination | required so as to prevent dissemination | required so as to prevent dissemination | required so as to prevent dissemination | Additional |
Table 1c:
Containment measures for activities involving genetic modification of micro-organisms in animal units (to be read with Table 1a as indicated in paragraph 3)
| Containment Measures | Containment Levels | Additional/modification | |||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | ||
NOTES 1. In the Table above, “animal unit” means a building, or separate area within a building, containing an animal facility and other areas including changing rooms, showers, autoclaves and food storage areas. 2. In the Table above and in Note 1 above, “animal facility” means a facility normally used to house stock, breeding or experimental animals or one which is used for the performance of minor surgical procedures on animals. 3. In the Table above, “isolators” means transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate. | |||||
| Facilities | |||||
1 Isolation of animal unit (Note 1) | required where and to extent the risk assessment shows it is required | required | required | required | Modification |
2 Animal facilities (Note 2) separatedwhere and by lockable doors | required to extent the risk assessment shows they are required | required | required | required | Additional |
3 Animal facilities (cages, etc) designed to facilitate decontamination (waterproof and easily washable material) | required where and to extent the risk assessment shows they are required | required where and to extent the risk assesment shows they are required | required | required | Additional |
4 Floor, walls and ceiling easily washable | required where and to extent the risk assessment shows they are required | required for floor | required for floor and walls | required for floor, walls and ceiling | Modification |
5 Appropriate filters on isolators or isolated rooms (Note 3) | not required | required where and to extent the risk assessment shows they are required | required | required | Additional |
6 Incinerator for disposal of animal carcasses | required to be accessible | required to be accessible | required to be accessible | required to be on site | Additional |
7 Appropriate barriers at the room exit, and at drains or ventilation duct work | required | required | required | required | Additional |
8 Animals kept in appropriate containment facilities, such as cages, pens, tanks or isolators | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | Additional |
Table 2:
Containment measures for activities involving genetic modification of micro-organisms in premises other than those referred to in Tables 1a, 1b and 1c
| Containment Measures | Containment Levels | |||
|---|---|---|---|---|
| 1 | 2 | 3 | 4 | |
| General | ||||
1 Viable micro-organisms shall be contained in a system which separates the process from the workplace and wider environment (closed system) | required where and to extent the risk assessment shows it is required | required | required | required |
2 Closed systems located within a controlled area | not required | required where and to extent the risk assessment shows they are required | required | required and required to be purpose built |
3 Control of exhaust gases from the closed system | not required | required so as to minimise release | required so as to prevent release | required so as to prevent release |
4 Control of aerosols during sample collection, addition of material to a closed system or transfer of material to another closed system | required where and to extent the risk assessment shows it is required | required so as to minimise release | required so as to prevent release | required so as to prevent release |
5 Inactivation of bulk culture fluids before removal from the closed system | required where and to extent the risk assessment shows it is required | required by validated means | required by validated means | required by validated means |
6 Seals shall be designed so as to minimise or prevent release | not required | required so as to minimise release | required so as to prevent release | required so as to prevent release |
7 The controlled area designed to contain spillage of the entire contents of the closed system | required where and to extent the risk assessment shows it is | required where and to extent the risk assessment shows it is required | required required | required |
8 The controlled area sealable to permit fumigation | not required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required |
9 Biohazard signs posted | required where and to extent the risk assessment shows it is required | required | required | required |
| Equipment | ||||
10 Entry via airlock | not required | not required | required where and to extent the risk assessment shows it is required | required |
11 Surfaces resistant to water, acids, alkalis, solvents, disinfectants and decontamination agents and easy to clean | required for any bench | required for any bench | required for floor and any bench | required for bench, floor, ceiling and walls |
12 Specific measures to adequately ventilate the controlled areas in order to minimise air contamination | required where and to extent the risk assessment shows they are required | required where and to extent the risk assessment shows they are required | required where and to extent the risk assessment shows they are required | required |
13 The controlled area maintained at an air pressure negative to the immediate surroundings | not required | not required | required where and to extent the risk assessment shows it is required | required |
14 Extract and input air from the controlled area shall be HEPA filtered | not required | not required | required for extract air, optional for input air | required for input and extract air |
| System of work | ||||
15 Access restricted to authorised personnel only | not required | required | required | required |
16 Decontamination and washing facilities provided for personnel | required | required | required | required |
17 Personnel shall shower before leaving the controlled area | not required | not required | required where and to extent the risk assessment shows it is required | required |
18 Personnel shall wear protective clothing | work clothing required | work clothing required | required | complete change required before exit and entry |
19 Written procedures and records of staff training | not required | not required | required | required |
| Waste | ||||
20 Inactivation of GMMs in effluent from handwashing sinks and showers or similar effluents | not required | not required | required where and to extent the risk assessment shows it is required | required |
21 Inactivation of GMMs in contaminated material and waste including those in process effluent before final discharge | required by validated means | required by validated means | required by validated means | required by validated means |