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

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Regulations 2(2) and 19(1)

SCHEDULE 8

This schedule has no associated Explanatory Memorandum

PART 1General

1.  In this Schedule—

“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—

(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—

(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 2Containment measures

Table 1a

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

Containment MeasuresContainment Levels
1234
(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
1Laboratory suite: isolation(1)not requirednot requiredrequiredrequired
2Laboratory: sealable for fumigationnot requirednot requiredrequiredrequired
Equipment
3Surfaces impervious to water, resistant to acids, alkalis, solvents, disinfectants and decontam-ination agents and easy to cleanrequired for any benchrequired for any benchrequired for any bench and floorrequired for any bench, floor, ceiling and walls
4Entry to laboratory via airlock(2)not requirednot requiredrequired where and to extent the risk assessment shows it is requiredrequired
5Negative pressure relative to the pressure of the immediate surroundingsnot requirednot requiredrequired except for activities where transmission does not occur by the airborne routerequired
6Extract and input air from the laboratory must be HEPA filterednot requirednot requiredHEPA filters required for extract air except for activities where transmission does not occur by the airborne routeHEPA filters required for input and extract air(3)
7Micro-biological safety cabinet /enclosurenot requiredrequired where and to extent the risk assessment shows it is requiredrequired, 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

8Autoclaverequired on siterequired in the buildingrequired in the laboratory suite(4)double ended autoclave required in laboratory
System of work
9Access restricted to authorised personnel onlynot requiredrequiredrequiredrequired (via airlock key procedure)
10Biohazard sign on doornot requiredrequiredrequiredrequired
11Specific measures to control aerosol dissem-inationnot requiredrequired so as to minimiserequired so as to preventrequired so as to prevent
12Showernot requirednot requiredrequired where and to extent the risk assessment shows it is requiredrequired
13Protective clothingsuitable protective clothing requiredsuitable protective clothing requiredsuitable protective clothing required; footwear required where and to extent the risk assessment shows it is requiredcomplete change of clothing and footwear required before entry and exit
14Glovesnot requiredrequired where and to extent the risk assessment shows they are requiredrequiredrequired
15Efficient control of disease vectors (e.g. rodents and insects) which could disseminate GMMsrequired where and to extent the risk assessment shows it is requiredrequiredrequiredrequired
Waste
16Inactivation of GMMs in effluent from hand-washing sinks and showers and similar effluentsnot requirednot requiredrequired where and to extent the risk assessment shows it is requiredrequired
17Inactivation of GMMs in contaminated material and wasterequired by validated means where and to extent the risk assessment shows it is requiredrequired by validated meansrequired by validated means, with waste inactivated within the laboratory suiterequired by validated means, with waste inactivated within the laboratory
Other measures
18Laboratory to contain its own equipmentnot requirednot requiredrequired, so far as is reasonably practicablerequired
19An observation window or alternative is to be present so that occupants can be seenrequired where and to extent the risk assessment shows it is requiredrequired where and to extent the risk assessment shows it is requiredrequired where and to extent the risk assessment shows it is requiredrequired
20Safe storage of GMMsrequired where and to extent the risk assessment shows it is requiredrequiredrequiredsecure storage required
21Written records of staff trainingnot requiredrequired where and to extent the risk assessment shows it is requiredrequiredrequired

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 MeasuresContainment LevelsAdditional/ modification
1234
(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
1Permanent structure(1)required where and to extent the risk assessment shows it is requiredrequiredrequiredrequiredmodification
Equipment
2Entry via a separate room with two interlocking doorsnot requiredrequired where and to extent the risk assessment shows it is requiredrequired where and to extent the risk assessment shows it is requiredrequired (via airlock key procedure)additional
3Control of contaminated run-off waterrequired where and to extent the risk assessment shows it is requiredrequired so as to minimise run-offrequired so as to prevent run-offrequired so as to prevent run-offadditional
System of work
4Effective control of disease vectors such as insects, rodents and arthropods which could disseminate GMMsrequiredrequiredrequiredrequiredadditional
5Effective control of pollen, seeds and other plant material which could disseminate GMMsrequired where and to extent the risk assessment shows it is requiredrequired so as to minimise dissem-inationrequired so as to prevent dissem-inationrequired so as to prevent dissem-inationadditional
6Procedures for transfer of living material between the plant growth facilities, protective structure and laboratory shall control dissemination of GMMsrequired so as to minimise dissem-inationrequired so as to minimise dissem-inationrequired so as to prevent dissem-inationrequired so as to prevent dissem-inationadditional

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 MeasuresContainment LevelsAdditional/ modification
1234
(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
1Isolation of animal unit(1)required where and to extent the risk assessment shows it is requiredrequiredrequiredrequiredmodification
2Animal facilities(2) separated by lockable doorsrequired where and to extent the risk assessment shows it is requiredrequiredrequiredrequiredadditional
3Animal facilities (cages, etc.) designed to facilitate decontamin-ation (waterproof and easily washable material)required where and to extent the risk assessment shows it is requiredrequired where and to extent the risk assessment shows it is requiredrequiredrequiredadditional
4Floor, walls and ceiling easily washablerequired where and to extent the risk assessment shows it is requiredrequired for floorrequired for floor and wallsrequired for floor, walls and ceilingmodification
5Appropriate filters on isolators or isolated rooms(3)not requiredrequired where and to extent the risk assessment shows it is requiredrequiredrequiredadditional
6Appropriate barriers at the room exit, and at drains or ventilation duct workrequiredrequiredrequiredrequiredadditional
7Animals kept in appropriate containment facilities, such as cages, pens or tanks but not isolatorsrequired where and to extent the risk assessment shows it is requiredrequired where and to extent the risk assessment shows it is requiredrequired where and to extent the risk assessment shows it is requiredrequired where and to extent the risk assessment shows it is requiredadditional
8Animals kept in isolatorsnot requiredrequired where and to extent the risk assessment shows it is requiredrequiredrequiredmodification

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 MeasuresContainment Levels
1234
General
1Viable 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 requiredrequiredrequiredrequired
2Closed systems located within a controlled areanot requiredrequired where and to extent the risk assessment shows it is requiredrequiredrequired
3Control of exhaust gases from the closed systemnot requiredrequired so as to minimise releaserequired so as to prevent releaserequired so as to prevent release
4Control of aerosols during sample collection, addition of material to a closed system or transfer of material to another closed systemrequired where and to extent the risk assessment shows it is requiredrequired so as to minimise releaserequired so as to prevent releaserequired so as to prevent release
5Inactivation of bulk culture fluids before removal from the closed systemrequired where and to extent the risk assessment shows it is requiredrequired by validated meansrequired by validated meansrequired by validated means
6Seals shall be designed so as to minimise or prevent releasenot requiredrequired so as to minimise releaserequired so as to prevent releaserequired so as to prevent release
7The controlled area designed to contain spillage of the entire contents of the closed systemrequired where and to extent the risk assessment shows it is requiredrequired where and to extent the risk assessment shows it is requiredrequiredrequired
8The controlled area sealable to permit fumigationnot requiredrequired where and to extent the risk assessment shows it is requiredrequired where and to extent the risk assessment shows it is requiredrequired
9Biohazard signs postednot requiredrequiredrequiredrequired
Equipment
10Entry via airlocknot requirednot requiredrequired where and to extent the risk assessment shows it is requiredrequired
11Surfaces resistant to water, acids, alkalis, solvents, disinfectants and decontamination agents and easy to cleanrequired for any benchrequired for any benchrequired for any bench and floorrequired for any bench, floor, ceilings and walls
12Specific measures to ventilate adequately the controlled areas in order to minimise air contaminationrequired where and to extent the risk assessment shows they are requiredrequired where and to extent the risk assessment shows they are requiredrequired where and to extent the risk assessment shows they are requiredrequired
13The controlled area maintained at an air pressure negative to the immediate surroundingsnot requirednot requiredrequired where and to extent the risk assessment shows it is requiredrequired
14Extract and input air from the controlled area must be HEPA filterednot requirednot requiredrequired for extract air; required where and to extent the risk assessment shows they are required for input airrequired for input and extract air
System of work
15Access restricted to authorised personnel onlynot requiredrequiredrequiredrequired
16Personnel must shower before leaving the controlled areanot requirednot requiredrequired where and to extent the risk assessment shows it is requiredrequired
17Personnel shall wear protective clothingwork clothing requiredwork clothing requiredrequiredcomplete change required before exit and entry
18Written procedures and records of staff trainingnot requiredrequired where and to extent the risk assessment shows they are requiredrequiredrequired
Waste
19Inactivation of GMMs in effluent from hand-washing sinks and showers or similar effluentsnot requirednot requiredrequired where and to extent the risk assessment shows it is requiredrequired
20Inactivation of GMMs in contaminated material and waste including those in process effluent before final dischargerequired by validated means where and to extent the risk assessment shows it to be requiredrequired by validated meansrequired by validated meansrequired by validated means

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