Genetically Modified Organisms (Deliberate Release) Regulations 1992
| Jurisdiction | UK Non-devolved |
| Citation | SI 1992/3280 |
| Year | 1992 |
1992 No. 3280
ENVIRONMENTAL PROTECTION
The Genetically Modified Organisms (Deliberate Release) Regulations 1992
Made 21th December 1992
Laid before Parliament 11th January 1993
Coming into force 1st February 1993
The Secretary of State for the Environment and the Minister of Agriculture, Fisheries and Food, acting jointly, as respects England, the Secretary of State for Wales, as respects Wales, and the Secretary of State for Scotland, as respects Scotland, in exercise of the powers conferred on them by section 2(2) of the European Communities Act 19721, being the Ministers designated2for the purposes of that subsection in relation to the control and regulation of genetically modified organisms, and sections 106(4) and (5), 107(8), 111(1), (4), (5), (7) and (11), 122(1) and (4) and 126(1) of the Environmental Protection Act 19903, and the Secretary of State for the Environment, as respects England, the Secretary of State for Wales, as respects Wales, and the Secretary of State for Scotland, as respects Scotland, in exercise of the powers conferred on them by section 156 of the Environmental Protection Act 1990, hereby make the following Regulations:—
PART I
GENERAL
Citation and commencement
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.
Interpretation
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/EEC4on 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—
(a) 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,
(b) outside Greater London, a district council and the Council of the Isles of Scilly, and
(c) 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.
Artificial techniques of genetic modification
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.
Capacity of organisms for causing harm
4.—(1) For the purposes of sections 110(1), 112(5)5and (7)(a) and 117(1) of the Act there shall be disregarded—
(a)
(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)
(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)
(a) the number or activity (or both) of any organisms, or
(b)
(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) a consent granted by the Secretary of State under section 111(1) of the Act, or
(b)
(b) a written consent given by another competent authority of a member State in accordance with Article 13(4) of the Deliberate Release Directive.
PART II
RELEASING ORGANISMS
Consent to release organisms
5.—(1) Subject to paragraphs (3) and (4), the cases and circumstances prescribed under section 111(1)(a) of the Act in relation to the release of any genetically modified organisms are any cases and circumstances other than the release of an approved product in accordance with the conditions and limitations to which the use of the product is subject.
(2) An application for a consent to release genetically modified organisms must be made in writing to the Secretary of State, and must be made either—
(a)
(a) for one or more releases of one or more descriptions of genetically modified organisms on the same site for the same purpose within a limited period, or
(b)
(b) for one or more releases of one description of genetically modified organisms on one or more sites for the same purpose within a limited period.
(3) Paragraph (1) shall not apply to a person who—
(a)
(a) has notified the Health and Safety Executive, under regulation 5(1)(a) of the Genetic Manipulation Regulations 19896, of his intention to carry out an activity involving an intentional introduction into the environment, and
(b)
(b) carries out the activity in accordance with that notification before 2nd May 1993.
(4) Paragraph (1) shall not apply to a person who releases a product which was marketed in the United Kingdom before 1st February 1993 and is not an approved product.
Information to be contained in application for consent to release
6.—(1) Subject to regulation 7 (Exemptions from regulation 6), the following is the information which an application for a consent to release genetically modified organisms must contain:—
(a)
(a) the information prescribed in Schedule 1 to these Regulations, to the extent that such information is appropriate to the proposed release,
(b)
(b) information on data or results from any previous release of the organisms, or of organisms of the same description, which has been carried out by the applicant, and information from any previous application for the release of the organisms, or of organisms of the same description, which the applicant has made to the Secretary of State in accordance with the Act and these Regulations or to another competent authority of a member State in accordance with Article 5 of the Deliberate Release Directive,
(c)
(c) a statement evaluating the impacts and risks posed to human health and the environment by the release of the organisms,
(d)
(d) a statement whether the detailed description of the organisms and the details of the purpose for which the organisms will be released have been published, and the bibliographic reference for any information so published,
(e)
(e) a summary, in the format established by the Commission under Article 9(1) of the Deliberate Release Directive, of the information contained in the application.
(2) The information prescribed in Schedule 1 shall be included in the application at the level of detail which is appropriate to the nature and scale of the proposed release.
(3) Where the applicant considers, on the basis that it is not technically possible or it does not appear to the applicant to be necessary, that it is not appropriate for the application to contain the information prescribed in one or more of the paragraphs of Schedule 1, the application shall contain a statement of the reasons why the inclusion of the information is not appropriate.
(4) The application must contain the description of the methods used to obtain the information contained in the application in accordance with paragraph (1) and a bibliographic reference, or, where standardised or internationally recognised methods are used, a reference to which method was used to obtain the information and its bibliographic references, together with the name of the body or bodies responsible for carrying out the studies.
(5) The application may in addition contain data or results from an application for consent to release genetically modified organisms previously made by some other person, provided that a copy of that person’s agreement in writing is contained in the application.
Exemptions from regulation 6
7. An application for a consent to release genetically modified organisms need not contain the information prescribed in regulation 6(1)(a) and (b) if—
(a) the information was contained either—
(i) in an application which was made by the same person in relation to a previous release of those organisms or of the same description of organisms, or
(ii) in an application which was made by some other person in relation to a previous release of those organisms or of the same...
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