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

Made: 6th August 2001

Coming into operation: 25th September 2001

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Part I — Interpretation and General

Citation and commencement

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Interpretation

2

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Application

3

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Meaning of “work” and “at work”

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Modification of the Health and Safety at Work (Northern Ireland) Order 1978

5

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Part II — Risk assessment and notification of activities involving Genetic Modification

Risk assessment of activities involving genetically modified micro-organisms

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Risk assessment of activities involving genetically modified organisms other than micro-organisms

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Review and recording of risk assessments

8

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Notification of the intention to use premises for the first time for activities involving genetic modification

9

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Notification of class 2 activities involving genetic modification of micro-organisms

10

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Notification of class 3 or class 4 activities involving genetic modification of micro-organisms

11

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Notification of activities involving genetic modification of organisms other than micro-organisms

12

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Notification of connected programmes of work

13

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Duties on receiving notifications and additional information

14

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Additional provisions relating to notifications

15

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Part III — Conduct of activities involving Genetic Modification

Establishment of a genetic modification safety committee

16

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Principles of occupational and environmental safety

17

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Containment and control measures for activities involving genetic modification of micro-organisms

18

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Containment and control measures for activities involving genetic modification of organisms other than micro-organisms

19

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Emergency plans

20

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Information relating to accidents

21

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Part IV — Disclosure of Information and Publicity

Disclosure of information provided pursuant to regulations 9 to 15

22

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Disclosure of information provided pursuant to regulation 21

23

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Register of notifications

24

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Part V — Miscellaneous and General

Exemption certificates

25

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Enforcement and civil liability

26

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Fees for notifications and applications

27

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Transitional provisions

28

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Appeals

29

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Application within territorial waters

30

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Revocations, amendments and savings

31

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SCHEDULE 1 — Classes of activity involving genetic modification

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

SCHEDULE 2

Part I — Examples of techniques constituting genetic modification

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Part II — Techniques which are not considered to result in genetic modification

2

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Part III — Techniques to which these regulations do not apply

3

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4

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SCHEDULE 3

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

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2

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Part II — Steps to be included when carrying out an assessment for the purposes of regulation 6

3

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4

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5

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SCHEDULE 4

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

1

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2

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Part II — Steps to be included when carrying out an assessment for the purposes of regulation 7

3

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

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SCHEDULE 6

Part I — Information required for a notification under regulation 10(1)

1

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Part II — Information required for a notification under regulation 11(1)

2

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Part III — Information required for a notification under regulation 12(1)

3

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

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SCHEDULE 8 — Containment measures

Part I

1

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2

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3

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Part II

1

Laboratory suite: isolation (Note 1)

2

Laboratory: sealable for fumigation

3

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

4

Entry to lab via airlock (Note 2)

5

Negative pressure relative to the pressure of the immediate surroundings

6

Extract and input air from the laboratory shall be HEPA filtered

7

Microbiological safety cabinet/enclosure

8

Autoclave

9

Access restricted to authorised personnel only

10

Specific measures to control aerosol dissemination

11

Shower

12

Protective clothing

13

Gloves

14

Efficient control of disease vectors (eg rodents and insects) which could disseminate GMMs

15

Specified disinfection procedures in place

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

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Inactivation of GMMs in contaminated material and waste

18

Laboratory to contain its own equipment

19

An observation window or alternative is to be present so that occupants can be seen

20

Safe storage of GMMs

21

Written records of staff training

1

Permanent structure (Note 1)

2

Entry via a separate room with two interlocking doors

3

Control of contaminated run-off water

4

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

5

Effective control of pollen, seeds and other plant material which could disseminate GMMs

6

Procedures for transfer of living material between the plant growth facilities, protective structure and laboratory shall control dissemination of GMMs

1

Isolation of animal unit (Note 1)

2

Animal facilities (Note 2) separatedwhere and by lockable doors

3

Animal facilities (cages, etc) designed to facilitate decontamination (waterproof and easily washable material)

4

Floor, walls and ceiling easily washable

5

Appropriate filters on isolators or isolated rooms (Note 3)

6

Incinerator for disposal of animal carcasses

7

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

8

Animals kept in appropriate containment facilities, such as cages, pens or tanks but not isolators

1

Viable micro-organisms shall be contained in a system which separates the process from the workplace and wider environment (closed system)

2

Closed systems located within a controlled area

3

Control of exhaust gases from the closed system

4

Control of aerosols during sample collection, addition of material to a closed system or transfer of material to another closed system

5

Inactivation of bulk culture fluids before removal from the closed system

6

Seals shall be designed so as to minimise or prevent release

7

The controlled area designed to contain spillage of the entire contents of the closed system

8

The controlled area sealable to permit fumigation

9

Biohazard signs posted

10

Entry via airlock

11

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

12

Specific measures to adequately ventilate the controlled areas in order to minimise air contamination

13

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

14

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

15

Access restricted to authorised personnel only

16

Decontamination and washing facilities provided for personnel

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Personnel shall shower before leaving the controlled area

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Personnel shall wear protective clothing

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Written procedures and records of staff training

20

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

21

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

SCHEDULE 9 — Fees 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

SCHEDULE 10 — Transitional provisions

Interpretation

1

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Risk assessment

2

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Notification of premises

3

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Notification of activities involving genetic modification

4

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Notification of proposed activities involving genetic modification

5

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Duties on receiving notifications and additional information

6

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Additional provisions relating to notification

7

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Emergency plans

8

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Disclosure of information

9

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Register of notifications

10

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Reference to previous notification

11

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SCHEDULE 11 — Premises and activities within territorial waters

Interpretation

1

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Offshore installations

2

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Wells

3

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Pipelines

4

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Mines

5

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Other activities

6

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Signed

Sealed with the Official Seal of the Department of Enterprise, Trade and Investment on 6th August 2001.

Michael J. Bohill — A senior officer of the — Department of Enterprise, Trade and Investment

Explanatory note

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Footnotes

[^f00001]: Formerly the Department of Economic Development; see S.I. 1999/283 (N.I. 1), Article 3(5)

[^f00002]: S.I. 1991/755

[^f00003]: 1972 c. 68; the enabling powers conferred by section 2(2) were extended by virtue of section 1 of the European Economic Area Act 1993 (c. 51)

[^f00004]: See Article 2(2) of S.I. 1978/1039 (N.I. 9)

[^f00005]: Article 17 must be read with S.I. 1992/1728 (N.I. 17), Articles 3(2) and 4(2)

[^f00006]: S.I. 1978/1039 (N.I. 9); the general purposes of Part II referred to in Article 17(1) were extended by S.I. 1992/1728 (N.I. 17), Article 3(1). Article 47A was inserted by Article 3, and Article 2 was amended by Articles 4 and 8, of S.I. 1997/1774 (N.I. 16)

[^f00007]: Article 13(1) was amended by S.I. 1998/2795 (N.I. 18), Article 4

[^f00008]: Article 46(3) was amended by S.I. 1998/2795 (N.I. 18), Article 6(1) and Schedule 1, paragraphs 8 and 18(c)

[^f00009]: Cm 2073 and 2183

[^f00010]: 1993 c. 51

[^f00011]: S.I. 2000/2831

[^f00012]: 1971 c. 80

[^f00013]: 1954 c. 33 (N.I.)

[^f00014]: S.I. 1991/1714 (N.I. 19)

[^f00015]: O.J. No. L117, 8.5.90, p. 15, as amended by Commission Directive 94/15/EC (O.J. No. L103, 22.4.94, p. 20) and Commission Directive 97/35/EC (O.J. No. L169, 27.6.97, p. 72)

[^f00016]: O.J. No. L124, 24.8.93, p. 1, as amended by Commission Regulation (EC) 649/98 (OJ No. L88, 24.3.98, p. 7)

[^f00020]: S.I. 1978/1039 (N.I. 9); Articles 18 to 20 and 31 were amended by, and Article 34A was inserted by, S.I. 1998/2795 (N.I. 18), Article 6(1) and Schedule 1.

[^f00021]: S.R. 1994 No. 1

[^f00022]: S.R. 1999 No. 90

[^f00023]: S.R. 1997 No. 269

[^f00024]: S.R. 1994 No. 143

[^f00025]: S.R. 1996 No. 250

[^f00026]: S.R. 1999 No. 14

[^f00028]: S.R. 1996 No. 442

[^f00029]: S.R. 1998 No. 125

[^f00030]: S.R. 2000 No. 120

[^f00031]: 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)

[^f00032]: S.R. 1994 No. 143, as amended by S.R. 1996 No. 250 , S.R. 1999 No. 14 and S.R. 1999 No. 150

Editorial notes

“Information not to be included in the register

24A

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9

Animals kept in isolators

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