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1. These Regulations may be cited as the Genetically Modified Organisms (Deli-berate Release) Regulations 1992 and shall come into force on 1st February 1993.
2. In these Regulations—
“the Act” means the Environmental Protection Act 1990;
“the Commission” means the Commission of the Communities;
“the Deliberate Release Directive” means Council Directive 90/220/EEC(1) on the deliberate release into the environment of genetically modified organisms;
“genetically modified organisms” means genetically modified organisms or a combination of genetically modified organisms;
“heritable genetic material” means genes or other genetic material, in any form, capable of being replicated or transferred by any means;
“local authority” means—
in Greater London, a London borough council, the Common Council of the City of London and the Sub-Treasurer of the Inner Temple and the Under- Treasurer of the Middle Temple,
outside Greater London, a district council and the Council of the Isles of Scilly, and
in Scotland, an islands or district council;
“product” means a product consisting of or including genetically modified organisms, and “approved product” means a product marketed in pursuance of and in accordance with a consent granted by the Secretary of State under section 111(1) of the Act or a written consent given by another competent authority of a member State in accordance with Article 13(4) of the Deliberate Release Directive.
3. The following techniques are prescribed as artificial techniques for the purposes of section 106(4) of the Act:
(a)the insertion by any method into a virus, bacterial plasmid or other vector system of a nucleic acid molecule, which has been produced by any method outside that virus, bacterial plasmid or other vector system, so as to produce a new combination of genetic material which is capable of being inserted into an organism in which that combination does not occur naturally and within which it will be heritable genetic material;
(b)the insertion into an organism, by micro-injection, macro-injection, micro-encapsulation or other direct means, of heritable genetic material prepared outside that organism;
(c)the fusion (including protoplast fusion) or hybridisation, by any method that does not occur naturally, of two or more cells to form cells which have new combinations of heritable genetic material and which (if derived solely from plant cells) cannot be produced by traditional breeding methods;
(d)where they involve the use of recombinant DNA molecules—
(i)in vitro fertilisation,
(ii)conjugation, transduction, transformation or any other natural process,
(iii)polyploidy induction.
4.—(1) For the purposes of sections 110(1), 112(5)(2) and (7)(a) and 117(1) of the Act there shall be disregarded—
(a)the capacity of genetically modified organisms of the description specified in paragraph (2) for causing harm of the description specified in paragraph (3), and
(b)harm, caused by genetically modified organisms of the description specified in paragraph (2), which is of the description specified in paragraph (3).
(2) The genetically modified organisms specified in this paragraph are genetically modified organisms which control—
(a)the number or activity (or both) of any organisms, or
(b)toxic wastes.
(3) The harm specified in this paragraph is harm caused to any organisms by genetically modified organisms which have been released or marketed in pursuance of and in accordance with—
(a)a consent granted by the Secretary of State under section 111(1) of the Act, or
(b)a written consent given by another competent authority of a member State in accordance with Article 13(4) of the Deliberate Release Directive.
OJ No. L117, 8.5.90, p.15.
Section 112(5)is ammended by regulation 9 of these Regulations
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