The Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015

Type Ni-Statutory-Rule
Publication 2015-09-18
Last updated 2026-02-23
State In force
Jurisdiction Northern Ireland
Department Government Printer for Northern Ireland
PDF Download
articles Not indexed
Reform history JSON API

Made: 18th September 2015

Coming into operation: 23rd October 2015

The Regulations give effect without modifications to proposals submitted to the Department by the Health and Safety Executive for Northern Ireland under Article 13(1A)[^f00007] of the 1978 Order after the Executive had carried out consultations in accordance with Article 46(3)[^f00008] of the 1978 Order.

PART 1 — Interpretation and General

Citation and commencement

1

These Regulations may be cited as the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015 and shall come into operation on 23rd October 2015.

Interpretation

2

Application

3

and, in each case, that activity is conducted in accordance with any conditions or limitations attached to that consent;

; or

Meaning of “work” and “at work” and modification of the 1978 Order

4

PART 2 — Risk Assessment and Notification of Contained Use

Risk assessment of contained use involving micro-organisms

5

Risk assessment of contained use involving larger GMOs

6

Review and recording of risk assessments

7

Advice from a genetic modification safety committee

8

with expertise in risk assessment relating to contained use.

Notification of premises to be used for contained use

9

Notification of class 2 contained use

10

a user may undertake the class 2 contained use if the notifier has received the acknowledgement of receipt.

Notification of class 3 or class 4 contained use

11

Notification of contained use involving larger GMOs

12

Single notifications for connected programmes of work

13

Changes of circumstances relating to notifications

14

the provision of that information will be treated as notification of those premises for the purposes of regulation 9(2).

Duty to notify significant changes affecting risks

15

the notifier shall immediately send to the competent authority full details in writing of the change or the new information.

Action of notifier and user on receipt of request for additional information

16

Withdrawal of notification

17

A notifier may withdraw a notification by giving written notice to the competent authority, provided that the contained use to which the notification related has not commenced.

PART 3

Conduct of Contained Use

Principles of occupational and environmental safety

18

Containment and control measures for contained use involving micro-organisms

19

Containment and control measures for contained use involving larger GMOs

20

Emergency plans

21

a person responsible for the contained use shall ensure that, before the contained use commences, a suitable emergency plan is prepared with a view to securing the health and safety of those persons or the protection of the environment or both.

Information relating to accidents

22

If an accident occurs, a person responsible for the contained use shall immediately inform the competent authority of the accident and shall provide the following information—

PART 4 — Duties and Powers of the Competent Authority

Duties of competent authority on receiving a notification

23

The competent authority shall examine a notification and accompanying documentation submitted under regulation 9(2), 10(2), 11(2), or 12(2) for—

Requests for additional information

24

Powers of competent authority in relation to contained use

25

The competent authority may at any time by notice in writing to a notifier—

and the notifier and any user undertaking the contained use shall comply with that notice.

Exemption certificates

26

from all or any of the requirements of, or prohibitions imposed by, these Regulations.

it is satisfied about the matters referred to in paragraph (4).

Duties of competent authority on receipt of information about accidents

27

Where the competent authority is informed of an accident in accordance with regulation 22, it shall—

Register of notifications

28

Information not to be included in the register

29

PART 5 — Miscellaneous and General

Enforcement and civil liability

30

Appeals

31

Competent authority address

32

Anything required to be submitted or sent to the competent authority under these Regulations shall be sent to the Executive at the address published for this purpose on its website which may be, or include, an address for submission by electronic means.

Saving and transitional provisions

33

Consequential Amendments

34

(2) No fee shall be returned to a notifier where the notifier withdraws a notification under regulation 17 of the 2015 Regulations or the competent authority returns a notification under regulation 24(6) of the 2015 Regulations.

(3) In this regulation, “the 2015 Regulations” means the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015 and “notifier” and “competent authority” have the same meaning as in those Regulations.

35

Revocations

36

The following shall be revoked—

SCHEDULE 1 — Classes of contained use

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

SCHEDULE 2

PART 1 — Techniques constituting genetic modification

1

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

PART 2 — Techniques 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 recombinant nucleic acid molecules or of genetically modified organisms made by techniques other than those listed in Part 3—

PART 3 — Techniques to which these Regulations do not apply

3

These Regulations (except regulation 18) 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 made by one or more of the following techniques—

4

In paragraph 3—

SCHEDULE 3

PART 1 — Matters to be taken into account in carrying out an assessment for the purposes of regulation 5

1

The following matters shall be taken into account in carrying out an assessment for the purposes of regulation 5—

2

In paragraph 1, “potentially harmful effects” includes—

PART 2 — Steps to be included when carrying out an assessment for the purposes of regulation 5

3

An assessment carried out for the purposes of regulation 5 shall include—

4

To assign a contained use to the appropriate containment level for the purposes of paragraph 3(i), the person carrying out the risk assessment shall—

5

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

SCHEDULE 4

PART 1 — Matters 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—

2

In paragraph 1, “potentially harmful effects” includes—

PART 2 — Steps 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—

SCHEDULE 5 — Information required for a notification under regulation 9(2)

A notification required for the purposes of regulation 9(2) shall contain the following information—

SCHEDULE 6 — Information required for a notification under regulations 10(2), 11(2) or 12(2)

A notification required for the purposes of regulation 10(2), 11(2) or 12(2) shall contain the following information except where it is required only for a specified regulation—

SCHEDULE 7 — General 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—

SCHEDULE 8

PART 1 — General

1

In this Schedule—

2

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

3

For the purposes of this Schedule—

PART 2 — Containment measures

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