Genetically Modified Organisms (Contained Use) Regulations 1992
| Jurisdiction | UK Non-devolved |
1992 No. 3217
HEALTH AND SAFETY
The Genetically Modified Organisms (Contained Use) Regulations 1992
Made 15th December 1992
Laid before Parliament 23th December 1992
Coming into force 1st February 1993
The Secretary of State, being the designated1Minister for the purpose of section 2(2) of the European Communities Act 19722in relation to the control and regulation of genetically modified organisms, in the exercise of the powers conferred on her by the said section 2 and sections 15(1), (2), (3)(b) and (c), (4)(a), (5)(b) and (9), 43(2), (4), (5) and (6), 52(2) and (3) and 82(3)(a) of, and paragraphs 1(1)(b) and (c) and (5), 4(1), 6(1), 14, 15(1), 16 and 20 of Schedule 3 to, the Health and Safety at Work etc. Act 19743(“the 1974 Act”) and of all other powers enabling her in that behalf and for the purpose of giving effect without modifications to proposals submitted to her by the Health and Safety Commission under section 11(2)(d) of the 1974 Act after the carrying out by the said Commission of consultations in accordance with section 50(3) of that Act, hereby makes the following Regulations:—
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 19894;
“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/EEC5on 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)
(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/EEC6, or
(ii) as Group II micro-organisms if they do not comply with the said criteria; or
(b)
(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) 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)
(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 19747the 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.
PART II
NOTIFICATION OF AND CONSENT FOR ACTIVITIES INVOLVING GENETIC MODIFICATION
Prohibition of certain work with genetically modified organisms outside containment
6.—(1) Subject to paragraph (2), any operation in which organisms are genetically modified or in which such genetically modified organisms are cultured, stored, used, transported, destroyed or disposed of is prohibited unless it is undertaken in conditions of contained use in accordance with these Regulations.
(2) Paragraph (1) shall not apply to any operation in which—
(a)
(a) genetically modified organisms are cultured, stored, used, transported, destroyed or disposed of, where such organisms are or are contained in a product marketed in pursuance of—
(i) a consent granted by the Secretary of State under section 111(1) of the Environmental Protection Act 19908, or
(ii) a written consent given by another competent authority of a member State in accordance with Article 13(4) of Council Directive 90/220/EEC9on the deliberate release into the environment of genetically modified organisms, and
in either case, the operation is conducted in accordance with any conditions or limitations attached to that consent
(b)
(b) genetically modified organisms are released or marketed in circumstances in which the consent of the Secretary of State is required under section 111(1) of the Environmental Protection Act 1990.
(3) In this regulation, “product” means a product consisting of or containing a genetically modified organism or a combination of genetically modified organisms.
Risk assessment
7.—(1) A person shall not—
(a)
(a) use any premises for activities involving genetic modification for the first time; or
(b)
(b) undertake any activity involving genetic modification,
unless he has ensured that, before commencing that use or activity, as the case may be, a suitable and sufficient assessment of the risks created thereby to human health and the environment has been made.
(2) Without prejudice to the generality of paragraph (1), the purposes of the assessment undertaken under that paragraph shall include—
(a)
(a) classifying any genetically modified organisms involved in the activity in accordance with the provisions of Schedule 2; and
(b)
(b) where appropriate, making decisions about the levels of containment required for the activity concerned.
(3) In making the assessment required by paragraph (1) the person undertaking that assessment...
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