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

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Part IIIConduct of activities involving Genetic Modification

Establishment of a genetic modification safety committee

16.  A person who carries out an assessment pursuant to regulation 6 or 7 shall establish a genetic modification safety committee to advise him in relation to that assessment.

Principles of occupational and environmental safety

17.—(1) A person who undertakes an activity involving genetic modification shall ensure that—

(a)the exposure of humans and the environment to genetically modified micro-organisms is reduced to the lowest level that is reasonably practicable; and

(b)harm to humans arising from an activity involving genetic modification of organisms other than micro-organisms is reduced to the lowest level that is reasonably practicable.

(2) For any activity involving genetic modification of micro-organisms, the measures to be taken in order to comply with the duty under paragraph (1) shall include the general principles of good microbiological practice and of good occupational safety and hygiene set out in Schedule 7.

(3) For any activity involving genetic modification of organisms other than micro-organisms, the general principles set out in Schedule 7 shall be applied insofar as they are appropriate.

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

18.—(1) Subject to paragraph (2), a person who undertakes an activity involving genetic modification of micro-organisms shall apply the containment measures set out in the applicable Table in Schedule 8, where and to the extent required in the column of the appropriate containment level.

(2) Where a risk assessment, or any review of that assessment carried out in accordance with regulation 8, shows that a particular containment measure of the appropriate containment level is not necessary for the activity involving genetic modification of micro-organisms to which the assessment relates, the person undertaking that activity, after providing full justification to, and with the written agreement of, the competent authority, need not apply that containment measure for the activity in question.

(3) A person who undertakes an activity involving genetic modification of micro-organisms shall review the containment measures applied by him in accordance with paragraph (1)—

(a)at suitably regular intervals; and

(b)forthwith if that person suspects that—

(i)the containment measures are no longer adequate,

(ii)the class in relation to the activity involving genetic modification of micro-organisms identified in the risk assessment is no longer appropriate, or

(iii)in the light of new scientific or technical knowledge, the risk assessment is no longer valid.

(4) In this regulation, “risk assessment” means an assessment carried out pursuant to regulation 6.

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

19.—(1) A person who undertakes an activity involving genetic modification of organisms other than micro-organisms shall apply the containment measures selected in accordance with the assessment made pursuant to regulation 7(1).

(2) That person shall review the containment measures applied by him in accordance with paragraph (1)—

(a)at suitably regular intervals; and

(b)forthwith if that person suspects that—

(i)the containment measures applied are no longer adequate, or

(ii)in the light of new scientific or technical knowledge, the assessment referred to in paragraph (1) is no longer valid.

Emergency plans

20.—(1) Where an assessment carried out pursuant to regulation 6(1) shows that, as a result of any reasonably foreseeable accident—

(a)the health or safety of persons outside the premises in which an activity involving genetic modification is carried on is liable to be seriously affected; or

(b)there is a risk of serious damage to the environment,

the person undertaking that activity shall ensure that, before the activity to which the assessment relates begins, a suitable plan is prepared with a view to securing the health and safety of those persons and the protection of the environment.

(2) Where an assessment carried out pursuant to regulation 7(1) shows that, as a result of any reasonably foreseeable accident, the health or safety of persons outside the premises in which an activity involving genetic modification is undertaken is liable to be seriously affected, the person undertaking that activity shall ensure that, before the activity to which the assessment relates begins, a suitable plan is prepared with a view to securing the health and safety of those persons.

(3) Every emergency plan—

(a)shall include the measures to be taken in the event of an accident to which the plan relates; and

(b)shall be reviewed and, where necessary, revised at suitably regular intervals.

(4) The person undertaking the activity involving genetic modification which is the subject of an emergency plan shall—

(a)inform the emergency services and any body or authority liable to be affected by an accident to which the plan relates of the contents of the plan and of any relevant revisions made in pursuance of paragraph (3); and

(b)make the plan and any such revisions publicly available.

Information relating to accidents

21.—(1) Where an accident occurs, the person undertaking the activity involving genetic modification shall forthwith inform the competent authority of the accident and shall provide the following information—

(a)the circumstances of the accident;

(b)the identity and quantity of the genetically modified organisms concerned;

(c)any information necessary to assess the effects of the accident on the health of the general population and on the environment; and

(d)any measures taken in response to the accident.

(2) Where the competent authority is informed of an accident in pursuance of paragraph (1), it shall—

(a)ensure that any necessary measures are taken;

(b)immediately inform those EEA States which could be affected by the accident;

(c)collect, where possible, the information necessary for a full analysis of the accident and, where appropriate, make recommendations to avoid similar accidents in the future and to limit their effects; and

(d)send to the European Commission—

(i)the information provided under paragraph (1)(a), (b) and (d),

(ii)information on the effectiveness of the measures taken in response to the accident, and

(iii)an analysis of the accident, including recommendations to limit its effects and to avoid similar accidents in the future.

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