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Directive 2009/41/EC of the European Parliament and of the CouncilShow full title

Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (Text with EEA relevance)

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ANNEX IVU.K.

CONTAINMENT AND OTHER PROTECTIVE MEASURES General principles U.K.

1.These tables present the normal minimum requirements and measures necessary for each level of containment.U.K.

Containment is also achieved through the use of good work practices, training, containment equipment and special installation design. For all activities involving GMMs the principles of good microbiological practice and the following principles of good occupational safety and hygiene shall apply:

(i)

to keep workplace and environmental exposure to any GMM to the lowest practicable level;

(ii)

to exercise engineering control measures at source and to supplement these with appropriate personal protective clothing and equipment when necessary;

(iii)

to test adequately and maintain control measures and equipment;

(iv)

to test, when necessary, for the presence of viable process organisms outside the primary physical containment;

(v)

to provide appropriate training of personnel;

(vi)

to establish biological safety committees or subcommittees, if required;

(vii)

to formulate and implement local codes of practice for the safety of personnel, as required;

(viii)

where appropriate, to display biohazard signs;

(ix)

to provide washing and decontamination facilities for personnel;

(x)

to keep adequate records;

(xi)

to prohibit eating, drinking, smoking, applying cosmetics or the storing of food for human consumption in the work area;

(xii)

to prohibit mouth pipetting;

(xiii)

to provide written standard operating procedures where appropriate to ensure safety;

(xiv)

to have effective disinfectants and specified disinfection procedures available in case of spillage of GMMs;

(xv)

to provide safe storage for contaminated laboratory equipment and materials, when appropriate.

2.The titles of the tables are indicative:U.K.

  • Table I A presents minimum requirements for laboratory activities.

  • Table I B presents additions to and modifications of Table I A for glasshouse/growth-room activities involving GMMs.

  • Table I C presents additions to and modifications of Table I A for activities with animals involving GMMs.

  • Table II presents minimum requirements for activities other than laboratory activities.

In some particular cases, it might be necessary to apply a combination of measures, from Table I A and Table II, of the same level.

In some cases users may, with the agreement of the competent authority, not apply a specification under a particular containment level or combine specifications from two different levels.

In these tables ‘optional’ means that the user may apply these measures on a case-by-case basis, subject to the assessment referred to in Article 4(2).

3.In implementing this Annex, Member States may in addition incorporate in the following tables the general principles set out in points 1 and 2, with a view to clarifying the requirements.U.K.

Table I A

Containment and other protective measures for laboratory activities

a
Isolation

=

the laboratory is separated from other areas in the same building or is in a separate building.

b
Airlock

=

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.

c

Activities where transmission does not occur via airborne route.

d
HEPA

=

High efficiency particulate air.

e

Where viruses which are not retained by HEPA filters are used, extra requirements will be necessary for extract air.

f

With validated procedures, allowing the safe transfer of material into an autoclave outside the lab, and providing an equivalent level of protection.

SpecificationsContainment levels
1234
1Laboratory suite: isolationaNot requiredNot requiredRequiredRequired
2Laboratory: sealable for fumigationNot requiredNot requiredRequiredRequired
Equipment
3Surfaces resistant to water, acids, alkalis, solvents, disinfectants and decontamination agents, and easy to cleanRequired (bench)Required (bench)Required (bench, floor)Required (bench, floor, ceiling, walls)
4Entry to lab via airlockbNot requiredNot requiredOptionalRequired
5Negative pressure relative to the pressure of the immediate environmentNot requiredNot requiredRequired except forcRequired
6Extract and input air from the laboratory should be HEPAd-filteredNot requiredNot requiredRequired (HEPA — extract air except forc)Required (HEPA— input and extract aire)
7Microbiological safety postNot requiredOptionalRequiredRequired
8AutoclaveOn siteIn the buildingEn suitefIn lab = double-ended
System of work
9Restricted accessNot requiredRequiredRequiredRequired
10Biohazard sign on the doorNot requiredRequiredRequiredRequired
11Specific measures to control aerosol disseminationNot requiredRequired minimiseRequired preventRequired prevent
13ShowerNot requiredNot requiredOptionalRequired
14Protective clothingSuitable protective clothingSuitable protective clothingSuitable protective clothing and (optional) footwearComplete change of clothing and footwear before entry and exit
15GlovesNot requiredOptionalRequiredRequired
18Efficient vector control (e.g. for rodents and insects)OptionalRequiredRequiredRequired
Waste
19Inactivation of GMMs in effluent from hand-washing sinks or drains and showers and similar effluentsNot requiredNot requiredOptionalRequired
20Inactivation of GMMs in contaminated material and wasteOptionalRequiredRequiredRequired
Other measures
21Laboratory to contain its own equipmentNot requiredNot requiredOptionalRequired
23An observation window or alternative is to be present so that occupants can be seenOptionalOptionalOptionalRequired

Table I B

Containment and other protective measures for glasshouses and growth-rooms

The terms ‘glasshouse’ and ‘growth-room’ refer to a structure with walls, a roof and a floor designed and used principally for growing plants in a controlled and protected environment.

All provisions of Table I A shall apply with the following additions/modifications:

a

The glasshouse shall consist of a permanent structure with a continuous waterproof covering, located on a site graded to prevent entry of surface-water run-off, and with self-closing lockable doors.

b

Where transmission can occur through the ground.

SpecificationsContainment levels
1234
Building
1Glasshouse: permanent structureaNot requiredRequiredRequiredRequired
Equipment
3Entry via a separate room with two interlocking doorsNot requiredOptionalOptionalRequired
4Control of contaminated run-off waterOptionalMinimiseb run-offPrevent run-offPrevent run-off
System of work
6Measures to control undesired species such as insects, rodents, arthropodsRequiredRequiredRequiredRequired
7Procedures for transfer of living material between the glasshouse/growth-room, protective structure and laboratory shall control dissemination of GMMsMinimise disseminationMinimise disseminationPrevent disseminationPrevent dissemination

Table I C

Containment and other protective measures for activities in animal units

All provisions of Table I A shall apply with the following additions/modifications:

a
Animal unit

:

a building or separate area within a building containing facilities and other areas such as changing rooms, showers, autoclaves, food storage areas, etc.

b
Animal facility

:

a facility normally used to house stock, breeding or experimental animals or one which is used for the performance of minor surgical procedures.

c
Isolators

:

transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate.

SpecificationsContainment levels
1234
Facilities
1Isolation of animal unitaOptionalRequiredRequiredRequired
2Animal facilitiesb separated by lockable doorsOptionalRequiredRequiredRequired
3Animal facilities designed to facilitate decontamination (waterproof and easily washable material (cages, etc.))OptionalOptionalRequiredRequired
4Floor and/or walls easily washableOptionalRequired (floor)Required (floor and walls)Required (floor and walls)
5Animals kept in appropriate containment facilities such as cages, pens or tanksOptionalOptionalOptionalOptional
6Filters on isolators or isolated roomcNot requiredOptionalRequiredRequired

Table II

Containment and other protective measures for other activities

SpecificationsContainment levels
1234
General
1Viable micro-organisms should be contained in a system which separates the process from the environment (closed system)OptionalRequiredRequiredRequired
2Control of exhaust gases from the closed systemNot requiredRequired, minimise disseminationRequired, prevent disseminationRequired, prevent dissemination
3Control of aerosols during sample collection, addition of material to a closed system or transfer of material to another closed systemOptionalRequired, minimise disseminationRequired, prevent disseminationRequired, prevent dissemination
4Inactivation of bulk culture fluids before removal from the closed systemOptionalRequired, by validated meansRequired, by validated meansRequired, by validated means
5Seals should be designed so as to minimise or prevent releaseNo specific requirementMinimise disseminationPrevent disseminationPrevent dissemination
6The controlled area should be designed to contain spillage of the entire contents of the closed systemOptionalOptionalRequiredRequired
7The controlled area should be sealable to permit fumigationNot requiredOptionalOptionalRequired
Equipment
8Entry via airlockNot requiredNot requiredOptionalRequired
9Surfaces resistant to water, acids, alkalis, solvents, disinfectants and decontamination agents, and easy to cleanRequired (bench if any)Required (bench if any)Required (bench if any, floor)Required (bench, floor, ceiling, walls)
10Specific measures to adequately ventilate the controlled area in order to minimise air contaminationOptionalOptionalOptionalRequired
11The controlled area should be maintained at an air pressure negative to the immediate surroundingsNot requiredNot requiredOptionalRequired
12Extract and input air from the controlled area should be HEPA filteredNot requiredNot requiredRequired (extract air, optional for input air)Required (input and extract air)
System of work
13Closed systems should be located within a controlled areaNot requiredOptionalRequiredRequired
14Access should be restricted to nominated personnel onlyNot requiredRequiredRequiredRequired
15Biohazard signs should be postedNot requiredRequiredRequiredRequired
17Personnel should shower before leaving the controlled areaNot requiredNot requiredOptionalRequired
18Personnel should wear protective clothingRequired (work clothing)Required (work clothing)RequiredComplete change before exit and entry
Waste
22Inactivation of GMMs in effluent from hand-washing sinks and showers or similar effluentsNot requiredNot requiredOptionalRequired
23Inactivation of GMMs in contaminated material and waste, including those in process effluent before final dischargeOptionalRequired, by validated meansRequired, by validated meansRequired, by validated means

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