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

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Regulation 2(1)

SCHEDULE 1Classes of activity involving genetic modification

ClassDescription
1Activities of no or negligible risk, for which containment level 1 is appropriate to protect human health and the environment
2Activities of low risk, for which containment level 2 is appropriate to protect human health and the environment
3Activities of moderate risk, for which containment level 3 is appropriate to protect human health and the environment
4Activities of high risk, for which containment level 4 is appropriate to protect human health and the environment.

Regulations 2(1) and 3(2)

SCHEDULE 2

Part IExamples of techniques constituting genetic modification

1.  Examples of the techniques which constitute genetic modification which are referred to in sub-paragraph (a) of the definition of “genetic modification” in regulation 2(1) are—

(a)recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules, produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation;

(b)techniques involving the direct introduction into an organism of heritable genetic material prepared outside the organism, including micro-injection, macro-injection and micro-encapsulation;

(c)cell fusion or hybridization techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally.

Part IITechniques which are not considered to result in genetic modification

2.  The following techniques are not considered to result in genetic modification provided that they do not involve the use of genetically modified organisms made by techniques other than those listed in Part III or the use of recombinant nucleic acid molecules, namely—

(a)in vitro fertilisation;

(b)natural processes including conjugation, transduction or transformation;

(c)polyploidy induction.

Part IIITechniques to which these regulations do not apply

3.  These Regulations (except regulation 17) shall not apply to the following techniques of genetic modification, provided that they do not involve the use of recombinant nucleic acid molecules or of genetically modified organisms other than those recombinant nucleic acid molecules or genetically modified organisms produced by one or more of the following techniques of genetic modification—

(a)mutagenesis;

(b)cell fusion (including protoplast fusion) of prokaryotic species which can exchange genetic material through homologous recombination;

(c)cell fusion (including protoplast fusion) of cells of any eukaryotic species, including production of hybridomas and plant cell fusions;

(d)self-cloning, where the resulting organism is unlikely to cause disease or harm to humans, animals or plants.

4.  In paragraph 3—

(a)“self-cloning” means the removal of nucleic acid sequences from a cell of an organism which may or may not be followed by reinsertion of all or part of that nucleic acid (or a synthetic equivalent), whether or not altered by enzymic or mechanical processes, into cells of the same species or into cells of phylogenetically closely related species which can exchange genetic material by homologous recombination; and

(b)self-cloning may include the use of recombinant vectors, with an extended history of safe use in the particular organism, to manipulate and reinsert the nucleic acid sequences, but the vectors shall not consist of any genetic elements other than those designed for vector structure, vector replication, vector maintenance or marker genes.

Regulations 2(2), 3(5) and 6(2)

SCHEDULE 3

Part IMatters to be taken into account in carrying out an assessment for the purposes of regulation 6

1.  The following matters shall be taken into account in carrying out an assessment for the purposes of regulation 6—

(a)any potentially harmful effects, in particular those associated with—

(i)the recipient micro-organism,

(ii)the inserted genetic material (originating from the donor organism),

(iii)the vector,

(iv)the donor micro-organism (where that donor micro-organism is used during the activity involving genetic modification), and

(v)the resulting genetically modified micro-organism;

(b)the characteristics of the activity;

(c)the severity of the potentially harmful effects; and

(d)the likelihood of the potentially harmful effects being realised.

2.  In paragraph 1, “potentially harmful effects” includes—

(a)disease to humans including allergenic or toxic effects;

(b)disease to animals or plants;

(c)adverse effects resulting from the inability to treat disease or offer an effective prophylaxis;

(d)adverse effects resulting from establishment or dissemination of the genetically modified micro-organisms in the environment;

(e)adverse effects resulting from the natural transfer of genetic material to or from other organisms;

(f)adverse effects resulting from the likely interaction of the genetically modified micro-organism with other organisms at the premises where the activity involving genetic modification is to be conducted.

Part IISteps to be included when carrying out an assessment for the purposes of regulation 6

3.  An assessment carried out for the purposes of regulation 6 shall include—

(a)identification of any harmful properties of the recipient and, where appropriate, the donor micro-organism;

(b)identification of any harmful properties associated with the vector or inserted material, including any alteration in the recipient’s existing properties;

(c)consideration of relevant Community legislation, including Council Directive 90/679/EEC(1) on the protection of workers from risks related to exposure to biological agents at work, other classification schemes referring to plant and animal pathogens, and other international and national classification schemes for genetically modifed micro-organisms;

(d)identification of the provisional level of risk associated with the genetically modified micro-organism;

(e)consideration of—

(i)the characteristics of the environment likely to be exposed,

(ii)the characteristics of the activity involving genetic modification of micro-organisms, and

(iii)any activities involving genetic modification of micro-organisms which cannot be adequately controlled by standard laboratory procedures, and which present risks which require controls for each individual case;

(f)adjustment of the provisional level of risk in the light of the matters referred to in sub-paragraph (e);

(g)selection of the appropriate containment measures from those specified in the applicable Table in Schedule 8 on the basis of the provisional level of risk as adjusted in accordance with sub-paragraph (f);

(h)assignment of the activity involving genetic modification of micro-organisms to the appropriate containment level, in accordance with paragraph 4;

(i)classification of that activity in the class of the same number as that of the appropriate containment level; and

(j)review and reconsideration of that classification in the light of the completed assessment.

4.  To assign an activity involving genetic modification of micro-organisms to the appropriate containment level for the purposes of paragraph 3(h), the person carrying out the assessment for the purposes of regulation 6 shall—

(a)first identify for each selected containment measure the column in the applicable Table in Schedule 8 having the lowest number in which that selected containment measure is shown as being required, regardless of whether or not such requirement is subject to any qualification;

(b)then select the highest number of all the columns identified in accordance with sub-paragraph (a); and

(c)then assign the activity involving genetic modification in question to the containment level of that highest number.

5.  In paragraph 4, “selected containment measure” means an appropriate containment measure selected in accordance with paragraph 3(g).

Regulation 7(2)

SCHEDULE 4

Part IMatters to be taken into account in carrying out an assessment for the purposes of regulation 7

1.  The following matters shall be taken into account in carrying out an assessment for the purposes of regulation 7—

(a)the identification of any potentially harmful effects, in particular those associated with—

(i)the recipient organism,

(ii)the inserted genetic material (originating from the donor organism),

(iii)the vector,

(iv)the donor organism, and

(v)the resulting genetically modified organism;

(b)the characteristics of the activity involving genetic modification;

(c)the severity of the potentially harmful effects; and

(d)the likelihood of the potentially harmful effects being realised.

2.  In paragraph 1, “potentially harmful effects” includes—

(a)disease to humans including allergenic or toxic effects;

(b)acting as a human disease vector or reservoir;

(c)adverse effects to humans arising from change in behaviour or in physical nature;

(d)adverse effects arising from the inability to treat human disease or offer effective prophylaxis.

Part IISteps to be included when carrying out an assessment for the purposes of regulation 7

3.  An assessment carried out for the purposes of regulation 7 shall include—

(a)identification of the harmful properties of the recipient and, where appropriate, the donor organism;

(b)identification of any harmful properties associated with the vector or inserted material, including any alteration in the existing properties of the recipient;

(c)identification of the provisional level of risk associated with the genetically modified organisms;

(d)selection of containment and other protective measures on the basis of—

(i)the provisional level of risk, and

(ii)the characteristics of the activity involving genetic modification;

(e)adjustment of the level of risk in the light of the matters referred to in sub-paragraph (d); and

(f)review and reconsideration of the containment and other protective measures in the light of the steps required by sub-paragraphs (a) to (e).

Regulations 9(1), 15(2), 15(3) and 24(3)

SCHEDULE 5Information required for a notification under regulation 9(1)

A notification required for the purposes of regulation 9(1) shall contain the following information—

(a)the name, address and telephone number and any fax number and any e-mail address of the notifier;

(b)the name of the employee of the notifier with specific responsibility for the supervision and safety of activities involving genetic modification;

(c)information on the training and qualifications of that employee;

(d)details of the genetic modification safety committee established pursuant to regulation 16;

(e)the address of the premises where the activity involving genetic modification is to be carried out and a general description of the premises;

(f)the nature of the work to be undertaken;

(g)the class of any activity involving genetic modification of micro-organisms;

(h)where the first activity to be carried out in those premises is an activity involving genetic modification in class 1—

(i)a summary of the assessment of that activity made for the purposes of regulation 6(1),

(ii)any advice received in relation to that assessment from the genetic modification safety committee established pursuant to regulation 16,

(iii)information on waste management, and

(iv)confirmation that the emergency services and any body or authority liable to be affected by an accident to which any emergency plan relates will be informed of the contents of the emergency plan and of any relevant revisions made in pursuance of regulation 20(3); and

(i)where the first activity to be carried out in those premises involves genetic modification of organisms which are not micro-organisms and that activity is not notifiable under regulation 12(1)—

(i)a copy of the assessment made for the purposes of regulation 7(1), and

(ii)confirmation that the emergency services and any body or authority liable to be affected by an accident to which any emergency plan relates will be informed of the contents of the plan and of any relevant revisions made in pursuance of regulation 20(3).

Regulations 10(1), 11(1), 12(1), 15(2), 15(3) and 24(3)

SCHEDULE 6

Part IInformation required for a notification under regulation 10(1)

1.  A notification required for the purposes of regulation 10(1) shall contain the following information—

(a)the name, address and telephone number and any fax number and any e-mail address of the notifier;

(b)the centre number allocated by the competent authority in respect of the premises at which the activity involving genetic modification of micro-organisms is to be undertaken and the date of the notification required by regulation 9(1) relating to those premises;

(c)the name of the employee of the notifier with specific responsibility for supervision and safety;

(d)information on the training and qualifications of that employee;

(e)the recipient or parental micro-organism to be used;

(f)the donor micro-organism to be used;

(g)where applicable, the host-vector system to be used;

(h)the source and intended function of the genetic material involved in the modification;

(i)the identity and characteristics of the genetically modified micro-organism;

(j)the purpose of the activity involving genetic modification of micro-organisms, including its expected results;

(k)the approximate culture volumes to be used;

(l)a description of the containment and other protective measures to be applied, including—

(i)information on waste management, including the type and form of wastes to be generated, their treatment, ultimate form and destination, and

(ii)justification for not applying any containment measure at containment level 2;

(m)a copy of the assessment carried out pursuant to regulation 6(1);

(n)any advice received in relation to that assessment from the genetic modification safety committee established pursuant to regulation 16;

(o)the information necessary for the competent authority to evaluate any emergency plan; and

(p)confirmation that the emergency services and any body or authority liable to be affected by an accident to which any emergency plan relates will be informed of the contents of the plan and of any relevant revisions made in pursuance of regulation 20(3).

Part IIInformation required for a notification under regulation 11(1)

2.  A notification required for the purposes of regulation 11(1) shall contain the following information—

(a)the name, address and telephone number and any fax number and any e-mail address of the notifier;

(b)the centre number allocated by the competent authority in respect of the premises at which the activity involving genetic modification of micro-organisms is to be undertaken and the date of the notification required by regulation 9(1) relating to those premises;

(c)the name of the employee of the notifier with specific responsibility for supervision and safety;

(d)information on the training and qualifications of that employee;

(e)the recipient or parental micro-organism to be used;

(f)the donor micro-organism to be used;

(g)where applicable, the host-vector system to be used;

(h)the source and intended function of the genetic material involved in the modification;

(i)the identity and characteristics of the genetically modified micro-organism;

(j)the culture volumes to be used;

(k)a description of the containment and other protective measures to be applied, including—

(i)information on waste management, including the type and form of wastes to be generated, their treatment, ultimate form and destination,

(ii)in the case of activities involving genetic modification of micro-organisms in class 3, justification for not applying any containment measure at containment level 3, and

(iii)in the case of activities involving genetic modification of micro-organisms in class 4, justification for not applying any containment measure at containment level 4;

(l)the purpose of the activity involving genetic modification of micro-organisms, including its expected results;

(m) a description of the parts of the installation;

(n)information on any accident prevention and emergency plans, including—

(i)any specific hazards arising from the location of the installation,

(ii)the preventive measures applied, including safety equipment, alarm systems and containment methods,

(iii)procedures and plans for verifying the continuing effectiveness of the containment measures,

(iv)a description of the information provided to workers,

(v)the information necessary for the competent authority to evaluate any emergency plan, and

(vi)confirmation that the emergency services and any body or authority liable to be affected by an accident to which any emergency plan relates will be informed of the contents of the plan and of any relevant revisions made in pursuance of regulation 20(3); and

(o)a copy of the assessment referred to in regulation 6(1).

Part IIIInformation required for a notification under regulation 12(1)

3.  A notification required for the purposes of regulation 12(1) shall contain the following information—

(a)the name, address and telephone number and any fax number and any e-mail address of the notifier;

(b)the centre number allocated by the competent authority in respect of the premises at which the activity involving genetic modification of organisms other than micro-organisms is to be undertaken and the date of the notification required by regulation 9(1) relating to those premises;

(c)the name of the employee of the notifier with specific responsibility for supervision and safety;

(d)information on the training and qualifications of that employee;

(e)the recipient or parental organism to be used;

(f)the donor organism to be used;

(g)where applicable, the host-vector system to be used;

(h)the sources and intended functions of the genetic material involved in the modification;

(i)the identity and characteristics of the genetically modified organism;

(j)the purpose of the activity involving genetic modification of organisms other than micro-organisms, including its expected results;

(k)a description of the containment and other protective measures to be applied, including information on waste management, including the type and form of wastes to be generated, their treatment, ultimate form and destination;

(l)a copy of the assessment referred to in regulation 7(1);

(m)the information necessary for the competent authority to evaluate any emergency plan; and

(n)confirmation that the emergency services and any body or authority liable to be affected by an accident to which any emergency plan relates will be informed of the contents of that plan and of any relevant revisions made in pursuance of regulation 20(3).

Regulation 17(2) and (3)

SCHEDULE 7General principles of good microbiological practice and of good occupational safety and hygiene

The general principles of good microbiological practice and of good occupational safety and hygiene are as follows—

(a)keeping workplace and environmental exposure to any genetically modified micro-organism to the lowest reasonably practicable level;

(b)exercising engineering control measures at source and supplementing these with appropriate personal protective clothing and equipment where necessary;

(c)testing adequately and maintaining control measures and equipment;

(d)testing, where necessary, for the presence of viable process organisms outside the primary physical containment;

(e)providing appropriate training of personnel;

(f)formulating and implementing local codes of practice for the safety of personnel, as required;

(g)displaying biohazard signs where appropriate;

(h)providing washing and decontamination facilities for personnel;

(i)keeping adequate records;

(j)prohibiting in the work area eating, drinking, smoking, applying cosmetics or the storing of food for human consumption;

(k)prohibiting mouth pipetting;

(l)providing written standard operating procedures where appropriate to ensure safety;

(m)having effective disinfectants and specified disinfection procedures available in case of spillage of genetically modified micro-organisms; and

(n)providing safe storage for contaminated laboratory equipment and materials where appropriate.

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

Regulation 27(1)

SCHEDULE 9Fees for notifications and applications

Notification of the intention to use premises for the first time for the purpose of undertaking activities involving genetic modification under regulation 9(1).£200
Notification of an activity involving genetic modification in class 2 under regulation 10(1), except a notification to which paragraph 4(1) or paragraph 5(1) of Schedule 10 applies.£400
Notification of the intention to use premises for the first time for the purpose of undertaking activities involving genetic modification under regulation 9(1) at the same time as notification of an activity involving genetic modification in class 2 under regulation 10(1).£400
Notification of an activity involving genetic modification in class 3 under regulation 11(1), except a notification to which paragraph 4(2) or paragraph 5(2) of Schedule 10 applies.£430
Notification of the intention to use premises for the first time for the purpose of undertaking activities involving genetic modification under regulation 9(1) at the same time as notification of an activity involving genetic modification in class 3 under regulation 11(1).£430
Notification of an activity involving genetic modification in class 4 under regulation 11(1), except a notification to which paragraph 4(2) or paragraph 5(2) of Schedule 10 applies.£500
Notification of the intention to use premises for the first time for the purpose of undertaking activities involving genetic modification under regulation 9(1) at the same time as notification of an activity involving genetic modification in class 4 under regulation 11(1).£500
Notification of an activity involving genetic modification of organisms other than micro-organisms under regulation 12(1).£400
Notification of the intention to use premises for the first time for the purpose of undertaking activities involving genetic modification under regulation 9(1) at the same time as notification of an activity involving genetic modification of organisms other than micro-organisms under regulation 12(1).£400
Notification of additional information under regulation 15(4).£300
Application for the written agreement of the competent authority under regulation 18(2) where the application is made after a notification has been submitted pursuant to regulation 9(1), 10(1), 11(1) or 12(1).£300

Regulation 28

SCHEDULE 10Transitional provisions

Interpretation

1.  In this Schedule—

(a)“the 1994 Regulations” means the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 1994(2); and

(b)“the relevant date” means the date on which these Regulations come into operation.

Risk assessment

2.—(1) Where a person undertakes an activity involving genetic modification of micro-organisms which he commenced before the relevant date, he shall ensure that an assessment is carried out in accordance with regulation 6 as if the date of the commencement of that activity were 25th October 2001.

(2) Where a person undertakes an activity involving genetic modification of organisms other than micro-organisms which he commenced before the relevant date, he shall ensure that an assessment is carried out in accordance with regulation 7 as if the date of the commencement of that activity were 25th October 2001.

Notification of premises

3.  Where before the relevant date a person had notified the Executive in accordance with regulation 8(1) of the 1994 Regulations of his intention to undertake an activity involving genetic modification at premises for the first time, the requirements of regulation 9 shall be deemed to be satisfied, provided that, before 27th December 2001, that person submits to the competent authority a notification containing—

(a)the information specified in paragraph (g) of Schedule 5; and

(b)the information specified in paragraph (h)(iii) and (iv) of Schedule 5 where the activity involving genetic modification is a class 1 activity to be undertaken on or after 27th December 2001 at the premises referred to in the notification submitted pursuant to regulation 8(1) of the 1994 Regulations.

Notification of activities involving genetic modification

4.—(1) Where a person had notified the Executive of his intention to undertake an activity involving genetic modification of micro-organisms in accordance with regulation 9(1) of the 1994 Regulations and immediately before the relevant date that person was entitled under the 1994 Regulations to undertake that activity, and where that activity involving genetic modification of micro-organisms is in class 2, the requirements of regulation 10 shall be deemed to be satisfied in relation to that activity, provided that before 27th December 2001 that person submits to the competent authority a notification containing—

(a)in the case of an activity referred to in regulation 9(2)(a) of the 1994 Regulations, the information specified in Part I of Schedule 6;

(b)in the case of an activity referred to in regulation 9(3) or regulation 9(4)(a) of the 1994 Regulations, the information specified in paragraphs (c), (d), (l), (m), (o) and (p) of Part I of Schedule 6; and

(c)in the case of an activity referred to in regulation 9(5) of the 1994 Regulations, the information specified in paragraphs (c), (d), (l)(ii) and (p) of Part I of Schedule 6.

(2) Where a person had notified the Executive of his intention to undertake an activity involving genetic modification of micro-organisms in accordance with regulation 9(1) of the 1994 Regulations and immediately before the relevant date that person was entitled under the 1994 Regulations to undertake that activity, and where that activity involving genetic modification of micro-organisms is in class 3 or class 4, the requirements of regulation 11 shall be deemed to be satisfied in relation to that activity, provided that—

(a)before 25th November 2001, that person submits to the competent authority a notification containing the information specified in Part II of Schedule 6; and

(b)before 27th December 2001, the competent authority gives its consent in writing to continue to undertake the activity involving genetic modification of micro-organisms in question.

(3) Where a person had notified the Executive of his intention to undertake an activity involving the genetic modification of organisms other than micro-organisms in accordance with regulation 9(1) of the 1994 Regulations and immediately before the relevant date that person was entitled under the 1994 Regulations to undertake that activity, the requirements of regulation 12 shall be deemed to be satisfied.

(4) Where a person submits a notification in accordance with this paragraph, he shall at the same time provide the competent authority with a short description of the activity involving genetic modification to which the notification relates.

Notification of proposed activities involving genetic modification

5.—(1) Where a person had notified the Executive of his intention to undertake an activity involving genetic modification of micro-organisms in accordance with regulation 9(1) of the 1994 Regulations but immediately before the relevant date that person was not entitled under the 1994 Regulations to undertake that activity for any reason other than the reason mentioned in sub-paragraph (4), and where that activity involving genetic modification of micro-organisms is in class 2, that person may submit to the competent authority a notification containing—

(a)in the case of an activity referred to in regulation 9(2)(a) of the 1994 Regulations, the information specified in Part I of Schedule 6;

(b)in the case of an activity referred to in regulation 9(3) or regulation 9(4)(a) of the 1994 Regulations, the information specified in paragraphs (c), (d), (l), (m), (o) and (p) of Part I of Schedule 6; and

(c)in the case of an activity referred to in regulation 9(5) of the 1994 Regulations, the information specified in paragraphs (c), (d), (l)(ii) and (p) of Part I of Schedule 6,

in which case the provisions of these Regulations shall apply as if that person had submitted a notification pursuant to regulation 10(1) on the date he submitted the notification pursuant to this sub-paragraph, save that regulation 24 shall apply as modified in accordance with paragraph 10.

(2) Where a person had notified the Executive of his intention to undertake an activity involving genetic modification of micro-organisms in accordance with regulation 9(1) of the 1994 Regulations but immediately before the relevant date that person was not entitled under the 1994 Regulations to undertake that activity for any reason other than the reason mentioned in sub-paragraph (4), and where that activity involving genetic modification of micro-organisms is in class 3 or class 4, that person may submit a notification containing the information specified in Part II of Schedule 6, in which case the provisions of these Regulations shall apply as if that person had submitted a notification pursuant to regulation 11(1) on the date he submitted the notification pursuant to this sub-paragraph, save that regulation 24 shall apply as modified in accordance with paragraph 10.

(3) Where a person had notified the Executive of his intention to undertake an activity involving the genetic modification of organisms other than micro-organisms in accordance with regulation 9(1) of the 1994 Regulations but immediately before the relevant date that person was not entitled under the 1994 Regulations to undertake that activity for any reason other than the reason referred to in sub-paragraph (4), the provisions of these Regulations shall apply as if that person had submitted a notification in accordance with regulation 12 on the relevant date, save that regulation 24 shall apply as modified in accordance with paragraph 10.

(4) The reason referred to in sub-paragraphs (1), (2) and (3) is that the Executive has informed the person who submitted the notification in question that he may not commence the activity involving genetic modification to which the notification relates.

(5) Where a person submits a notification in accordance with this paragraph, he shall at the same time provide the competent authority with a short description of the activity involving genetic modification to which the notification relates.

Duties on receiving notifications and additional information

6.  Regulation 14(1) to (5) shall apply to a notification submitted pursuant to the 1994 Regulations which, by virtue of paragraph 4 of this Schedule, is treated as satisfying the requirements of these Regulations as it applies to a notification submitted pursuant to these Regulations.

Additional provisions relating to notification

7.  Regulation 15 shall apply in cases where a notification has been submitted pursuant to regulation 8 or 9 of the 1994 Regulations as it applies where a notification has been submitted pursuant to these Regulations.

Emergency plans

8.  Where before the relevant date a person had ensured that a plan had been prepared in accordance with regulation 13 of the 1994 Regulations, that plan shall be treated as satisfying the requirements of regulation 20, provided that, immediately following the assessment to be carried out in accordance with paragraph 2, the plan is reviewed and, where necessary, revised pursuant to regulation 20(3).

Disclosure of information

9.  Regulations 22 and 23 shall apply to information notified or provided under the 1994 Regulations as they apply to information provided under these Regulations.

Register of notifications

10.—(1) Subject to sub-paragraph (2), regulation 24 shall apply to a notification submitted in accordance with paragraphs 3, 4 and 5 as it applies to a notification submitted in accordance with regulations 9(1), 10(1), 11(1) and 12(1).

(2) Paragraphs (2), (3) and (4) of regulation 24 shall not apply to a notification submitted in accordance with paragraphs 3, 4 and 5 and shall be replaced by the following provisions, namely—

(a)in relation to a notification submitted in accordance with paragraph 3, the register shall contain the name and address of the person who submitted that notification, and the reference number given by the Executive to the notification under the 1994 Regulations of the premises in question;

(b)in relation to a notification submitted in accordance with paragraph 4, the register shall contain—

(i)the name and address of the person who submitted that notification,

(ii)a short description of the activity involving genetic modification to which the notification relates, and any reference number given by the Executive to the notification of that activity under the 1994 Regulations,

(iii)the date on which any information had been notified under regulation 10(4) of the 1994 Regulations, and

(iv)where appropriate, confirmation that a consent has been granted under paragraph 4(2)(b); and

(c)in relation to a notification submitted in accordance with paragraph 5, the register shall contain—

(i)the name and address of the person who submitted that notification,

(ii)a short description of the activity involving genetic modification to which the notification relates, and any reference number given by the Executive to the notification of that activity under the 1994 Regulations,

(iii)the date on which any information had been notified under regulation 10(4) of the 1994 Regulations, and

(iv)where appropriate, confirmation that a consent has been granted under regulation 11(3) or 11(4).

(3) The competent authority shall include in the register—

(a)by 25th January 2002, the information referred to in sub-paragraph (2)(a);

(b)by 25th February 2002, the information referred to in sub-paragraph (2)(b); and

(c)within fourteen days of the receipt of a notification submitted under paragraph 5, the information referred to in sub-paragraph (2)(c).

Reference to previous notification

11.  Where a person submits a notification in accordance with paragraph 3, 4 or 5, he shall at the same time provide the competent authority with the following information—

(a)his name, address and telephone number and any fax number and any e-mail address; and either

(b)in the case of a notification submitted in accordance with paragraph 3—

(i)the date of,

(ii)any reference number given by the Executive to, and

(iii)the date of any information notified to the Executive under regulation 10 of the 1994 Regulations relating to,

the notification in question submitted under regulation 8(1) of the 1994 Regulations; or

(c)in the case of a notification submitted in accordance with paragraph 4 or 5—

(i)the date of,

(ii)any reference number given by the Executive to, and

(iii)the date of any information notified to the Executive under regulation 10 of the 1994 Regulations relating to,

the notification in question submitted under regulation 9(1) of the 1994 Regulations.

Regulation 30

SCHEDULE 11Premises and activities within territorial waters

Interpretation

1.—(1) In this Schedule—

“designated area” means any area designated by order under section 1(7) of the Continental Shelf Act 1964(3) and “within a designated area” includes over and under it;

“offshore installation” shall be construed in accordance with paragraph 2(4) and (5);

“stand-by vessel” means a vessel which is ready to give assistance in the event of an emergency on or near an offshore installation;

“vessel” includes a hovercraft and any floating structure which is capable of being staffed.

(2) For the purposes of this Schedule, any structures and devices on top of a well shall be treated as forming part of the well.

(3) For the purposes of this Schedule, a person shall be deemed to be engaged in diving operations throughout any period from the time when he commences to prepare for diving until the time when—

(a)he is no longer subjected to raised pressure;

(b) he has normal inert gas partial pressure in his tissues; and

(c)if he entered the water, he has left it,

and diving operations include the activity of any person in connection with the health and safety of a person who is, or is deemed to be, engaged in diving operations.

(4) Any reference in this Schedule to premises and activities (howsoever described) includes a reference to any person, article or substance on those premises or engaged in or, as the case may be, used or for use in connection with any such activity but does not include a reference to an aircraft which is airborne.

Offshore installations

2.—(1) This paragraph applies to—

(a)any offshore installation and any activity on it;

(b)any activity, including diving operations, in connection with an offshore installation, or any activity which is immediately preparatory thereto, whether carried on from the installation itself, on or from a vessel or in any other manner, other than—

(i)transporting, towing or navigating the installation; or

(ii)any activity on or from a vessel being used as a stand-by vessel; or

(c)diving operations involving the survey and preparation of the sea bed for an offshore installation.

(2) Subject to sub-paragraph (3), in this Schedule “offshore installation” means a structure which is, or is to be, or has been, used while standing or stationed in water, or on the foreshore or other land intermittently covered with water—

(a)for the exploitation, or exploration with a view to exploitation, of mineral resources by means of a well;

(b)for the storage of gas in or under the shore or bed of any water or the recovery of gas so stored;

(c)for the conveyance of things by means of a pipe; or

(d)mainly for the provision of accommodation for persons who work on or from a structure falling within any of the provisions of this sub-paragraph,and which is not an excepted structure.

(3) For the purposes of sub-paragraph (2), the excepted structures are—

(a)a structure which is connected with dry land by a permanent structure providing access at all times and for all purposes;

(b)a well;

(c)a structure which has ceased to be used for any of the purposes specified in sub-paragraph (2) and has since been used for a purpose not so specified;

(d)a mobile structure which has been taken out of use and is not for the time being intended to be used for any of the purposes specified in sub-paragraph (2); and

(e)any part of a pipeline.

Wells

3.—(1) This paragraph applies to—

(a)a well and any activity in connection with it; or

(b)an activity which is immediately preparatory to any activity in head (a).

(2) Sub-paragraph (1) includes keeping a vessel on station for the purpose of working on a well but otherwise does not include navigation or an activity connected with navigation.

Pipelines

4.—(1) This paragraph applies to—

(a)a pipeline;

(b)any pipeline works; or

(c)any of the following activities in connection with pipeline works—

(i)the loading, unloading, fuelling or provisioning of a vessel;

(ii)the loading, unloading, fuelling, repair and maintenance of an aircraft on a vessel,

being in either case a vessel which is engaged in pipeline works.

(2) In this paragraph—

  • “pipeline” means a pipe or system of pipes for the conveyance of any thing, together with—

    (a)

    any apparatus for inducing or facilitating the flow of any thing through, or through a part of, the pipe or system;

    (b)

    any apparatus for treating or cooling any thing which is to flow through, or through part of, the pipe or system;

    (c)

    valves, valve chambers and similar works which are annexed to, or incorporated in the course of, the pipe or system;

    (d)

    apparatus for supplying energy for the operation of any such apparatus or works as are mentioned in heads (a) to (c);

    (e)

    apparatus for the transmission of information for the operation of the pipe or system;

    (f)

    apparatus for the cathodic protection of the pipe or system; and

    (g)

    a structure used or to be used solely for the support of a part of the pipe or system;

    but not including a pipeline of which no initial or terminal point is situated in the United Kingdom or within territorial waters, United Kingdom territorial waters adjacent to Great Britain or a designated area;

  • “pipeline works” means—

    (a)

    assembling or placing a pipeline or length of pipeline including the provision of internal or external protection for it;

    (b)

    inspecting, testing, maintaining, adjusting, repairing, altering or renewing a pipeline or length of pipeline;

    (c)

    changing the position of or dismantling or removing a pipeline or length of pipeline;

    (d)

    opening the bed of the sea for the purposes of the works mentioned in heads (a) to (c), and tunnelling or boring for those purposes;

    (e)

    any activities incidental to the activities described in heads (a) to (d);

    (f)

    diving operations in connection with any of the works mentioned in heads (a) to (e) or for the purpose of determining whether a place is suitable as part of the site of a proposed pipeline and the carrying out of surveying operations for settling the route of a proposed pipeline.

Mines

5.—(1) This paragraph applies to the working of a mine and work for the purpose of, or in connection with, the working of any part of a mine.

(2) In this paragraph “mine” and “working of a mine” have the same meaning as in the Mines Act (Northern Ireland) 1969(4).

Other activities

6.—(1) Subject to sub-paragraph (2), this paragraph applies to—

(a)the construction, reconstruction, alteration, repair, maintenance, cleaning, demolition and dismantling of any building or other structure not being a vessel, or any preparation for any such activity;

(b)the loading, unloading, fuelling or provisioning of a vessel;

(c)diving operations;

(d)the construction, reconstruction, finishing, refitting, repair, maintenance, cleaning or breaking up of a vessel except when carried out by the master or any officer or member of the crew of that vessel; or

(e)the maintaining on a station of a vessel which would be an offshore installation were it not a structure to which paragraph 2(3)(d) relates.

(2) This paragraph does not apply to vessels which are registered outside the United Kingdom and are on passage through territorial waters.

(1)

OJ No. L 374, 31.12.90, p. 1, as amended by Council Directive 93/88/EEC (OJ No. L 268, 29.10.93, p. 71), Commission Directive 95/30/EC (OJ No. L 155, 6.7.95, p. 41), Commission Directive 97/59/EC (OJ No. L 282, 15.10.1997, p. 33) and Commission Directive 97/65/EC (OJ No. L 335, 6.12.1997, p. 17)

(3)

1964 c. 29; section 1(7) was amended by the Oil and Gas (Enterprise) Act 1982 (c. 23), Schedule 3, paragraph 1

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