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The Genetically Modified Organisms (Contained Use) Regulations 2014
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- UK Statutory Instruments
- 2014 No. 1663
- SCHEDULE 8
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Regulations 2(2) and 19(1)
SCHEDULE 8U.K.
This schedule has no associated Explanatory Memorandum
PART 1 U.K.General
1. In this Schedule—U.K.
“GMMs” means genetically modified micro-organisms;
“HEPA” means High Efficiency Particulate Air;
“inactivation” means the complete or partial destruction of GMMs so as to ensure that any contact between the GMMs and humans or the environment is limited to an extent commensurate with the risks identified in the risk assessment and to provide a high level of protection for humans and the environment;
“plant growth facilities” means a structure, whether permanent or impermanent, designed and used principally for growing plants in a controlled and protected environment.
2. For the purposes of this Schedule where in the final column of Table 1b or 1c, a measure is specified as—U.K.
(a)a modification, it is to be read in substitution for the relevant measure in Table 1a;
(b)additional, it is to be read as an addition to the measures in Table 1a, and any measure which has been substituted for a measure in Table 1a, in accordance with paragraph 2(a).
3. For the purposes of this Schedule—U.K.
(a)Table 1a describes containment measures applicable to contained use involving micro-organisms in laboratories;
(b)Table 1a, read with Table 1b, describes containment measures applicable to contained use involving micro-organisms in plant growth facilities;
(c)Table 1a, read with Table 1c, describes containment measures applicable to contained use involving micro-organisms in animal units;
(d)Table 2 describes containment measures applicable to contained use involving micro-organisms in premises other than those referred to in Tables 1a, 1b and 1c.
PART 2 U.K.Containment measures
Table 1a
Containment measures applicable to contained use involving micro-organisms in laboratories
1 “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 contained use is being undertaken, but within the laboratory suite, there must 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. | |||||
| Containment Measures | Containment Levels | ||||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | ||
| Facilities | |||||
| 1 | Laboratory suite: isolation1 | 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 any bench | required for any bench | required for any bench and floor | required for any bench, floor, ceiling and walls |
| 4 | Entry to laboratory via airlock2 | 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 | not required | required except for activities where transmission does not occur by the airborne route | required |
| 6 | Extract and input air from the laboratory must be HEPA filtered | not required | not required | HEPA filters required for extract air except for activities where transmission does not occur by the airborne route | HEPA filters required for input and extract air3 |
| 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 | required, and all procedures with infective materials required to be contained within a cabinet/ enclosure |
| 8 | Autoclave | required on site | required in the building | required in the laboratory suite4 | 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 | Biohazard sign on door | not required | required | required | required |
| 11 | Specific measures to control aerosol dissemination | not required | required so as to minimise | required so as to prevent | required so as to prevent |
| 12 | Shower | not required | not required | required where and to extent the risk assessment shows it is required | required |
| 13 | 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 |
| 14 | Gloves | not required | required where and to extent the risk assessment shows they are required | required | required |
| 15 | Efficient control of disease vectors (e.g. rodents and insects) which could disseminate GMMs | required where and to extent the risk assessment shows it is required | required | required | required |
| Waste | |||||
| 16 | Inactivation of GMMs in effluent from hand-washing 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 where and to extent the risk assessment shows it is required | required by validated means | required by validated means, with waste inactivated within the laboratory suite | required by validated means, with waste inactivated within the laboratory |
| 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 where and to extent the risk assessment shows it is 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 it is required | required | required |
Table 1b
Containment measures applicable to contained use involving micro-organisms in plant growth facilities (to be read with Table 1a as indicated in paragraph 3(b) of Part 1)
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 must 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. | |||||||||
| Containment Measures | Containment Levels | Additional/ modification | |||||||
|---|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | ||||||
| Facilities | |||||||||
| 1 | Permanent structure1 | 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 minimise 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 must control dissemination of GMMs | required so as to minimise dissemination | required so as to minimise dissemination | required so as to prevent dissemination | required so as to prevent dissemination | additional | |||
Table 1c
Containment measures applicable to contained use involving micro-organisms in animal units (to be read with Table 1a as indicated in paragraph 3(c))
1 “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 “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 “isolators” means transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate. | ||||||||
| Containment Measures | Containment Levels | Additional/ modification | ||||||
|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | |||||
| Facilities | ||||||||
| 1 | Isolation of animal unit1 | required where and to extent the risk assessment shows it is required | required | required | required | modification | ||
| 2 | Animal facilities2 separated by lockable doors | required where and to extent the risk assessment shows it is 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 it is required | required where and to extent the risk assessment shows it is required | required | required | additional | ||
| 4 | Floor, walls and ceiling easily washable | required where and to extent the risk assessment shows it is required | required for floor | required for floor and walls | required for floor, walls and ceiling | modification | ||
| 5 | Appropriate filters on isolators or isolated rooms3 | not required | required where and to extent the risk assessment shows it is required | required | required | additional | ||
| 6 | Appropriate barriers at the room exit, and at drains or ventilation duct work | required | required | required | required | additional | ||
| 7 | Animals kept in appropriate containment facilities, such as cages, pens or tanks but not 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 | ||
| 8 | Animals kept in isolators | not required | required where and to extent the risk assessment shows it is required | required | required | modification | ||
Table 2
Containment measures applicable to contained use involving micro-organisms in premises other than those referred to in Tables 1a, 1b and 1c
| Containment Measure | Containment Levels | ||||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | ||
| General | |||||
| 1 | Viable micro-organisms must 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 it is required | required | required |
| 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 must 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 | required where and to extent the risk assessment shows it is 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 | not 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 any bench and floor | required for any bench, floor, ceilings and walls |
| 12 | Specific measures to ventilate adequately 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 must be HEPA filtered | not required | not required | required for extract air; required where and to extent the risk assessment shows it is required 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 | Personnel must shower before leaving the controlled area | not required | not required | required where and to extent the risk assessment shows it is required | required |
| 17 | Personnel must wear protective clothing | work clothing required | work clothing required | required | complete change required before exit and entry |
| 18 | Written procedures and records of staff training | not required | required where and to extent the risk assessment shows they are required | required | required |
| Waste | |||||
| 19 | Inactivation of GMMs in effluent from hand-washing sinks and showers or similar effluents | not required | not required | required where and to extent the risk assessment shows it is required | required |
| 20 | Inactivation of GMMs in contaminated material and waste including those in process effluent before final discharge | required by validated means where and to extent the risk assessment shows it to be required | required by validated means | required by validated means | required by validated means |
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