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Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2001

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Regulations 2(3) and 18(1)

SCHEDULE 8Containment measures

Part I

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; and

“risk assessment” means the assessment carried out in accordance with regulation 6.

2.  For the purposes of this Schedule, where, in the final column of Table 1b or Table 1c, a measure is specified as—

(a)a modification, it shall be read in substitution for the relevant measure in Table 1a;

(b)additional, it shall be read as an addition to the measures in Table 1a, subject to the substitution, where appropriate, of an individual measure in Table 1a by a measure specified as a modification in the Table in question.

3.  For the purposes of this Schedule—

(a)Table 1a describes containment measures applicable to activities involving genetic modification of micro-organisms in laboratories;

(b)Table 1a, read with Table 1b, describes containment measures applicable to activities involving genetic modification of micro-organisms in plant growth facilities;

(c)Table 1a, read with Table 1c, describes containment measures applicable to activities involving genetic modification of micro-organisms in animal units;

(d)Table 2 describes containment measures applicable to activities involving genetic modification of micro-organisms in premises other than those referred to in Tables 1a, 1b and 1c.

Part II

Table 1a:

Containment measures for activities involving genetic modification of micro-organisms in laboratories

Containment MeasuresContainment Levels
1234

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 requirednot requiredrequiredrequired

2  Laboratory: sealable for fumigation

not requirednot requiredrequiredrequired
Equipment

3  Surfaces impervious to water, resistant to acids, alkalis, solvents, disinfectants and decontamination agents and easy to clean

required for benchrequired for benchrequired for bench and floorrequired for bench, floor ceiling and walls

4  Entry to lab via airlock (Note 2)

not requirednot requiredrequired where and to extent the risk assessment shows it is requiredrequired

5  Negative pressure relative to the pressure of the immediate surroundings

not requiredrequired where and to extent the risk assessment shows it is requiredrequiredrequired

6  Extract and input air from the laboratory shall be HEPA filtered

not requirednot requiredHEPA filters required for extract airHEPA filters required for input and extract air (Note 3)

7  Microbiological safety cabinet/enclosure

not 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/ enclosureClass III cabinet required

8  Autoclave

required on siterequired in the buildingrequired in the laboratory suite (Note 4)double ended autoclave required in laboratory
System of work

9  Access restricted to authorised personnel only

not requiredrequiredrequiredrequired (via airlock key procedure)

10  Specific measures to control aerosol dissemination

not requiredrequired so as to minimiserequired so as to preventrequired so as to prevent

11  Shower

not requirednot requiredrequired where and to extent the risk assessment shows it is requiredrequired

12  Protective clothing

suitable 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

13  Gloves

not requiredrequired where and to extent the risk assessment shows they are requiredrequiredrequired

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 requiredrequiredrequiredrequired

15  Specified disinfection procedures in place

required where and to extent the risk assessment shows they are requiredrequiredrequiredrequired
Waste

16  Inactivation of GMMs in effluent from handwashing sinks and showers and similar effluents

not requirednot requiredrequired where and to extent the risk assessment shows it is requiredrequired

17  Inactivation of GMMs in contaminated material and waste

required by validated meansrequired by validated meansrequired by validated meansrequired by validated means
Other measures

18  Laboratory to contain its own equipment

not requirednot requiredrequired, so far as is reasonably practicablerequired

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 requiredrequired where and to extent the risk assessment shows it is requiredrequiredrequired

20  Safe storage of GMMs

required where and to extent the risk assessment shows it is requiredrequiredrequiredsecure storage required

21  Written records of staff training

not requiredrequired where and to extent the risk assessment shows they are requiredrequiredrequired

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 MeasuresContainment LevelsAdditional/ modification
1234

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 requiredrequiredrequiredrequiredModification
Equipment

2  Entry via a separate room with two interlocking doors

not 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

3  Control of contaminated run-off water

required where and to extent the risk assessment shows it is requiredrequired so as to prevent run-offrequired so as to prevent run-offrequired so as to prevent run-offAdditional
System of work

4  Effective control of disease vectors such as insects, rodents and arthropods which could disseminate GMMs

requiredrequiredrequiredrequiredAdditional

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 requiredrequired so as to minimise disseminationrequired so as to prevent disseminationrequired so as to prevent disseminationAdditional

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 disseminationrequired so as to prevent disseminationrequired so as to prevent disseminationrequired so as to prevent disseminationAdditional

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 MeasuresContainment LevelsAdditional/modification
1234

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 requiredrequiredrequiredrequiredModification

2  Animal facilities (Note 2) separatedwhere and by lockable doors

required to extent the risk assessment shows they are requiredrequiredrequiredrequiredAdditional

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 requiredrequired where and to extent the risk assesment shows they are requiredrequiredrequiredAdditional

4  Floor, walls and ceiling easily washable

required where and to extent the risk assessment shows they are requiredrequired for floorrequired for floor and wallsrequired for floor, walls and ceilingModification

5  Appropriate filters on isolators or isolated rooms (Note 3)

not requiredrequired where and to extent the risk assessment shows they are requiredrequiredrequiredAdditional

6  Incinerator for disposal of animal carcasses

required to be accessiblerequired to be accessiblerequired to be accessiblerequired to be on siteAdditional

7  Appropriate barriers at the room exit, and at drains or ventilation duct work

requiredrequiredrequiredrequiredAdditional

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 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

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 MeasuresContainment Levels
1234
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 requiredrequiredrequiredrequired

2  Closed systems located within a controlled area

not requiredrequired where and to extent the risk assessment shows they are requiredrequiredrequired and required to be purpose built

3  Control of exhaust gases from the closed system

not requiredrequired so as to minimise releaserequired so as to prevent releaserequired 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 requiredrequired so as to minimise releaserequired so as to prevent releaserequired 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 requiredrequired by validated meansrequired by validated meansrequired by validated means

6  Seals shall be designed so as to minimise or prevent release

not requiredrequired so as to minimise releaserequired so as to prevent releaserequired 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 isrequired where and to extent the risk assessment shows it is requiredrequired requiredrequired

8  The controlled area sealable to permit fumigation

not requiredrequired where and to extent the risk assessment shows it is requiredrequired where and to extent the risk assessment shows it is requiredrequired

9  Biohazard signs posted

required where and to extent the risk assessment shows it is requiredrequiredrequiredrequired
Equipment

10  Entry via airlock

not requirednot requiredrequired where and to extent the risk assessment shows it is requiredrequired

11  Surfaces resistant to water, acids, alkalis, solvents, disinfectants and decontamination agents and easy to clean

required for any benchrequired for any benchrequired for floor and any benchrequired 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 requiredrequired where and to extent the risk assessment shows they are requiredrequired where and to extent the risk assessment shows they are requiredrequired

13  The controlled area maintained at an air pressure negative to the immediate surroundings

not requirednot requiredrequired where and to extent the risk assessment shows it is requiredrequired

14  Extract and input air from the controlled area shall be HEPA filtered

not requirednot requiredrequired for extract air, optional for input airrequired for input and extract air
System of work

15  Access restricted to authorised personnel only

not requiredrequiredrequiredrequired

16  Decontamination and washing facilities provided for personnel

requiredrequiredrequiredrequired

17  Personnel shall shower before leaving the controlled area

not requirednot requiredrequired where and to extent the risk assessment shows it is requiredrequired

18  Personnel shall wear protective clothing

work clothing requiredwork clothing requiredrequiredcomplete change required before exit and entry

19  Written procedures and records of staff training

not requirednot requiredrequiredrequired
Waste

20  Inactivation of GMMs in effluent from handwashing sinks and showers or similar effluents

not requirednot requiredrequired where and to extent the risk assessment shows it is requiredrequired

21  Inactivation of GMMs in contaminated material and waste including those in process effluent before final discharge

required by validated meansrequired by validated meansrequired by validated meansrequired by validated means

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