The Genetically Modified Organisms (Contained Use) Regulations 2014

Interpretation

2.—(1) In these Regulations—

“the 1974 Act” means the Health and Safety at Work etc. Act 1974;

“the 2000 Regulations” means the Genetically Modified Organisms (Contained Use) Regulations 2000(1);

“accident” means an incident involving a significant and unintended release of genetically modified organisms in the course of a contained use which presents an immediate or delayed hazard to human health or to the environment;

“class” in relation to a contained use involving micro-organisms, means one of the four classes set out in Schedule 1;

“competent authority” means, in relation to premises situated in, or contained use taking place in—

(a)

England and Wales, the Secretary of State and the Executive, acting jointly; or

(b)

Scotland, the Scottish Ministers and the Executive, acting jointly,

and the expressions “competent authority as regards England and Wales” and “competent authority as regards Scotland” are to be construed accordingly;

“contained use” means an activity in which organisms are genetically modified or in which genetically modified organisms are cultured, stored, transported, destroyed, disposed of or used in any other way and for which physical, chemical or biological barriers, or any combination of such barriers, are used to limit their contact with, and to provide a high level of protection for, humans and the environment;

“emergency plan” means a plan required by regulation 21;

“emergency services” means the police, fire and ambulance services;

“genetic modification” in relation to an organism means the altering of the genetic material in that organism in a way that does not occur naturally by mating or natural recombination (or both) and within the terms of this definition—

(a)

genetic modification occurs at least through the use of the techniques listed in Part 1 of Schedule 2; and

(b)

the techniques set out in Part 2 of Schedule 2 are not considered to result in genetic modification,

and “genetically modified” is to be construed accordingly;

“joint competent authority” means the competent authority as regards England and Wales and the competent authority as regards Scotland acting jointly;

“larger GMO” means an organism which is genetically modified or is the subject of genetic modification which is not a micro-organism;

“micro-organism” means a microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, and includes a virus, a viroid, and an animal or plant cell in culture;

“notifier” means, except in regulation 14, the person who submits or has submitted a notification to the competent authority under regulation 9(2), 10(2), 11(2), 12(2) or 33(3);

“organism” means a biological entity capable of replication or of transferring genetic material and includes a micro-organism, but does not include a human, human embryo or human admixed embryo and for the purposes of this definition—

(a)

“human admixed embryo” has the same meaning as in the Human Fertilisation and Embryology Act 1990(2) by virtue of section 4A(6) and (11) of that Act; and

(b)

“human embryo” has the same meaning as “embryo” in the Human Fertilisation and Embryology Act 1990 (apart from section 4A) by virtue of section 1(1) and (6) of that Act;

“person responsible for contained use” or “person responsible for the contained use” means—

(a)

a person who has the authority to determine whether a particular contained use takes place; or

(b)

a person who has control of the planning or conduct (or both) of that contained use,

and there may be more than one person responsible for the same contained use;

“premises” means both single buildings and a site made up of more than one building;

“risk assessment” means, in the context of contained use involving—

(a)

genetically modified micro-organisms, an assessment carried out as required by regulation 5(1); or

(b)

larger GMOs, an assessment carried out as required by regulation 6(1);

“transboundary movement” has the meaning assigned to it by Article 3 of Regulation (EC) No 1946/2003 of the European Parliament and the Council on transboundary movements of genetically modified organisms(3);

“user” means a person who undertakes or proposes to undertake a contained use;

“working day” means any day other than a Saturday, a Sunday, Christmas Day or Good Friday, or a bank holiday specified in Schedule 1 to the Banking and Financial Dealings Act 1971(4).

(2) A reference in these Regulations to the competent authority is to be construed as a reference to the joint competent authority in relation to premises or contained use where the relevant notification is required to be submitted to the joint competent authority in accordance with regulation 9(5) or 13(1).

(3) In these Regulations—

(a) a reference to an appropriate containment level is a reference to the containment level assigned to a contained use involving micro-organisms in accordance with paragraphs 3(i) and 4 of Part 2 of Schedule 3;

(b) any reference to a contained use in a numbered class is a reference to a contained use involving micro-organisms which has been classified as belonging to the class of that number in accordance with paragraph 3(j) and (k) of Part 2 of Schedule 3.

(4) The measures in—

(a) Part 2 of Schedule 8 are to be applied in accordance with Part 1 of that Schedule; and

(b) Tables 1a, 1b and 1c in Part 2 of Schedule 8 are to be applied in accordance with the notes set out at the end of the table in question.

(1)

S.I. 2000/2831. The 2000 Regulations and all its amending instruments are revoked by these Regulations (see regulation 35).

(2)

1990 c. 37. Sections 1(1) and (6) were substituted by section 1(2) and (5) of the Human Fertilisation and Embryology Act 2008 (c. 22) and section 4A was inserted by section 4(2) of that Act.

(3)

OJ No L 287, 5.11.2003, p1.

(4)

1971 c. 80. Schedule 1 was amended by section 1 of the St Andrew’s Day Bank Holiday (Scotland) Act 2007 (2007 asp.2).