The Genetically Modified Organisms (Contained Use) Regulations 1992

PART I INTERPRETATION AND GENERAL

Citation and commencement

1.  These Regulations may be cited as the Genetically Modified Organisms (Contained Use) Regulations 1992 and shall come into force on 1st February 1993.

Interpretation

2.—(1) In these Regulations, unless the context otherwise requires—

“the 1989 Regulations” means the Genetic Manipulation Regulations 1989(1);

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

“approved” means approved in writing for the time being by the Executive;

“activity involving genetic modification” means any operation involving the contained use of a genetically modified organism;

“contained use” means any operation in which organisms are genetically modified or in which such genetically modified organisms are cultured, stored, used, transported, destroyed or disposed of and for which physical barriers or a combination of physical barriers with chemical or biological barriers or both, are used to limit their contact with the general population and the environment;

“the contained use Directive” means Council Directive No. 90/219/EEC(2) on the contained use of genetically modified micro-organisms;

“the Executive” means the Health and Safety Executive;

“genetic modification” in relation to an organism means the altering of the genetic material in that organism by 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 I of Schedule 1; and

(b)

the techniques listed in Part II of that Schedule are not considered to result in genetic modification,

and “genetically modified” shall be construed accordingly;

“genetic modification safety committee” means the committee established in accordance with regulation 11;

“micro-organism” means a microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material including animal or plant cell cultures;

“organism” means a biological entity capable of replication or of transferring genetic material and includes a micro-organism;

“self-cloning” means the removal of nucleic acid from a cell or organism, followed by the re-insertion of all or part of that nucleic acid — with or without further enzymic, chemical or mechanical steps — into the same cell type (or cell-line) or into a phylogenetically closely related species which can naturally exchange genetic material with the donor species;

“Type A operation” means any activity involving genetically modified microorganisms for the purposes of teaching, research, development, or for non-industrial or non-commercial purposes on a scale at which the practices and conditions of the operations relative to the culture, volume and numbers of organisms involved is such that—

(a)

the system used to keep the organisms under containment reflects good microbiological practice and good occupational safety and hygiene; and

(b)

it is possible easily to render the organisms inactive by standard laboratory decontamination techniques;

“Type B operation” means any activity involving the genetic modification of microorganisms other than a Type A operation.

(2) Genetically modified organisms shall be classified—

(a) in the case of micro-organisms—

(i) as Group I micro-organisms if they comply with such of the criteria set out in Part I of Schedule 2 as are applicable to the particular case, determined in accordance with the guidelines set out in Part II of that Schedule which gives effect to Commission Decision 91/448/EEC(3), or

(ii) as Group II micro-organisms if they do not comply with the said criteria; or

(b) in the case of genetically modified organisms other than micro-organisms, in accordance with the criteria set out in Part III of Schedule 2.

(3) In these Regulations, unless the context otherwise requires—

(a) a reference to a numbered Part, regulation or Schedule is a reference to the Part, regulation or Schedule in these Regulations so numbered; and

(b) a reference to a numbered paragraph is a reference to the paragraph so numbered in the regulation or Schedule in which that reference occurs.

Application

3.—(1) These Regulations shall have effect with a view to protecting persons against risks to their health, whether immediate or delayed, and for the protection of the environment, arising from activities involving genetically modified organisms.

(2) Regulations 8 to 12 shall not apply to the transport of genetically modified organisms by road, rail, inland waterway, sea or air.

(3) These Regulations shall not apply to the genetic modification of organisms solely by any of the techniques referred to in Part III of Schedule 1 or to any organisms so modified.

(4) Insofar as these Regulations relate to the protection of the environment, they shall only apply to genetically modified micro-organisms.

(5) Nothing in these Regulations shall prejudice any requirement imposed by or under any enactment which relates to public health or the protection of the environment.

(6) These Regulations shall not extend to Northern Ireland.

Meaning of “work” “at work”

4.  For the purpose of these Regulations and Part I of the Health and Safety at Work etc. Act 1974(4) the meaning of “work” shall be extended to include any activity involving genetic modification and the meaning of “at work” shall be extended accordingly.

Modification of section 3(2) of the Health and Safety at Work etc. Act 1974

5.  Section 3(2) of the Health and Safety at Work etc. Act 1974 shall be modified in relation to an activity involving genetic modification so as to have effect as if the reference to a self-employed person therein is a reference to any person who is not an employer or an employee and the reference in it to his undertaking includes a reference to such an activity.

(1)

S.I. 1989/1810.

(2)

OJ No. L117, 8.5.90, p.1.

(3)

OJ No. L 239, 12.8.91, p.23.

(4)

1974 c. 37.