The Genetically Modified Organisms (Contained Use) Regulations 2014

PART 3 Conduct of Contained Use

Principles of occupational and environmental safety

18.—(1) A user who undertakes a contained use involving micro-organisms must ensure that the risks to human health and the environment arising from the contained use are reduced to the lowest level that is reasonably practicable.

(2) The measures to be taken in order to comply with the duty under paragraph (1) must include the general principles of good microbiological practice and of good occupational safety and hygiene set out in Schedule 7.

(3) A user who undertakes a contained use involving larger GMOs must ensure that the risks to human health arising from the contained use are reduced to the lowest level that is reasonably practicable.

(4) For contained use involving larger GMOs, the general principles set out in Schedule 7 must be applied to the extent that they are appropriate.

Containment and control measures for contained use involving micro-organisms

19.—(1) A user who undertakes a contained use involving micro-organisms must apply the containment measures set out in the applicable table in Part 2 of Schedule 8, where and to the extent required in the column of the appropriate containment level.

(2) A user need not apply a containment measure required for the appropriate containment level where—

(a) the risk assessment, or any review of the risk assessment, shows that the containment measure is not necessary or practicable for a specific activity;

(b) the notifier of the contained use has provided justification in writing to the competent authority; and

(c) the notifier has received the written agreement of the competent authority that the containment measure need not be applied.

(3) A person responsible for the contained use must review the containment measures applied—

(a) at suitably regular intervals; and

(b) immediately, if that person suspects that—

(i) the containment measures are no longer adequate;

(ii) the class assigned to the contained use 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(iii) in the light of new scientific or technical knowledge, the risk assessment is no longer valid.

Containment and control measures for contained use involving larger GMOs

20.—(1) A user who undertakes a contained use involving larger GMOs must apply the containment measures selected in the risk assessment for the contained use.

(2) A person responsible for the contained use must review the containment measures applied—

(a) at suitably regular intervals; and

(b) immediately, if that person suspects that—

(i) the containment measures are no longer adequate; or

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

Emergency plans

21.—(1) Where an assessment carried out under regulation 5(1) shows that, as a result of any reasonably foreseeable accident—

(a) the health or safety of persons outside the premises in which the contained use is undertaken is liable to be seriously affected; or

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

a person responsible for the contained use must 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.

(2) Where an assessment carried out under regulation 6(1) shows that, as a result of any reasonably foreseeable accident, the health or safety of persons outside the premises in which the contained use is undertaken is liable to be seriously affected, a person responsible for the contained use must 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.

(3) An emergency plan must—

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

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

(4) A person responsible for the contained use which is the subject of an emergency plan must—

(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; and

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

Information relating to accidents

22.  If an accident occurs, a person responsible for the contained use must immediately inform the competent authority of the accident and must 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, in the case of a genetically modified micro-organism, on the environment; and

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