The Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015

PART 2 N.I. Containment measures

Commencement Information

I1 Sch. 8 Pt. 2 in operation at 23.10.2015, see reg. 1

Table 1a

Containment measures applicable to contained use involving micro-organisms in laboratories

	Containment Measures	Containment Levels
		1	2	3	4
(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.
Facilities
1	Laboratory suite: isolation(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 decontam-ination 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 airlock(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	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 air(3)
7	Micro-biological 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 suite(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	Biohazard sign on door	not required	required	required	required
11	Specific measures to control aerosol dissem-ination	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)

	Containment Measures	Containment Levels				Additional/ modification
		1	2	3	4
(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.
Facilities
1	Permanent structure(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 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 dissem-ination	required so as to prevent dissem-ination	required so as to prevent dissem-ination	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 dissem-ination	required so as to minimise dissem-ination	required so as to prevent dissem-ination	required so as to prevent dissem-ination	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))

	Containment Measures	Containment Levels				Additional/ modification
		1	2	3	4
(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.
Facilities
1	Isolation of animal unit(1)	required where and to extent the risk assessment shows it is required	required	required	required	modification
2	Animal facilities(2) 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 decontamin-ation (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 rooms(3)	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 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 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 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	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 they are 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 shall 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