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The Genetically Modified Organisms (Contained Use) Regulations 1992

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Regulation 12(4)

SCHEDULE 6CONTAINMENT MEASURES FOR MICRO-ORGANISMS OF GROUP II

1.  The containment measures for Type B operations using micro-organisms from Group II shall be chosen by the user from the levels in the Table below as appropriate to the micro-organism and the operation in question in order to ensure the protection of health of the general population and the environment.

2.  Type B operations shall be considered in terms of their unit operations. The characteristics of each operation will dictate the physical containment to be used at that stage. This will allow the selection and design of process, plant and operating procedures best fitted to ensure adequate and safe containment. Two important factors to be considered when selecting the equipment needed to implement the containment are the risk of, and the effects consequent on, equipment failure. Engineering practice may require increasingly stringent standards to reduce the risks of failure as the consequence of that failure becomes less tolerable.

Containment Levels
B2B3B4
SPECIFICATIONS

1.  Viable micro-organisms should be contained in a system which physically separates the process from the environment (closed system)

YesYesYes

2.  Exhaust gases from the closed system should be treated so as to:

Minimise releasePrevent releasePrevent release

3.  Sample collection, addition of materials to a closed system and transfer of viable micro-organisms to another closed system, should be performed so as to:

Minimise releasePrevent releasePrevent release

4.  Bulk culture fluids should not be removed from the closed system unless the viable micro-organisms have been:

Inactivated by validated meansInactivated by validated chemical or physical meansInactivated by validated chemical or physical means

5.  Seals should be designed so as to:

Minimise releasePrevent releasePrevent release

6.  Closed systems should be located within a controlled area

OptionalOptionalYes, and purpose-built

(a)Biohazard signs should be posted

OptionalYesYes

(b)Access should be restricted to nominated personnel only

OptionalYesYes, via airlock

(c)Personnel should wear protective clothing

Yes, work clothingYesYes, A complete change

(d)Decontamination and washing facilities should be provided for personnel

YesYesYes

(e)Personnel should shower before leaving the controlled area

NoOptionalYes

(f)Effluent from sinks and showers should be collected and inactivated before release

NoOptionalYes

(g)The controlled area should be adequately ventilated to minimise air contamination

OptionalOptionalYes

(h)The controlled areas should be maintained at an air pressure negative to atmosphere

NoOptionalYes

(i)Input air and extract air to the controlled area should be HEPA filtered

NoOptionalYes

(j)The controlled area should be designed to contain spillage of the entire contents of the closed system

OptionalYesYes

(k)The controlled area should be sealable to permit fumigation

NoOptionalYes

7.  Effluent treatment before final discharge

Inactivated by validated meansInactivated by validated chemical or physical meansInactivated by validated physical means

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