Genetically Modified Organisms (Deliberate Release) Regulations 2002

Made: 25th September 2002

Laid before Parliament: 26th September 2002

Coming into force: 17th October 2002

The Secretary of State for Environment, Food and Rural Affairs in exercise of the powers conferred on her by section 2(2) of the European Communities Act 1972, being the Minister designated for the purposes of that subsection in relation to the control and regulation of genetically modified organisms, and sections 108(7), 111(1), (4), (5), (7) and (11), 122(1) and (4), 123(7), and 156 of the Environmental Protection Act 1990, having consulted the Food Standards Agency in accordance with section 126(5) of that Act, hereby makes the following Regulations:—

PART I — GENERAL

Citation, commencement, extent and application

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• (1) These Regulations may be cited as the Genetically Modified Organisms (Deliberate Release) Regulations 2002 and shall come into force on 17 October 2002.

• (2) Except for this regulation, regulation 38, insofar as it relates to the continental shelf, and regulation 2, insofar as it defines “the Act” for the purposes of regulation 38, these Regulations shall extend only to England and Wales.

• (3) Except for this regulation, regulations 3, 4, 19(1), 29, 30, 33(2), 38 and 39 and regulation 2, insofar as it defines “the Act” for the purposes of the regulations referred to in this paragraph, these Regulations shall apply only to England.

Interpretation

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In these Regulations—

• “the Act” means the Environmental Protection Act 1990;

• “the Advisory Committee on Releases to the Environment” means the committee appointed by the Secretary of State under section 124 of the Act;

• “antibiotic resistance markers” means genes employed in the modification of an organism to make that organism express resistance to a particular antibiotic or antibiotics;

• “application for consent to release” shall include any notification made under the First Simplified Procedure (crop plants) Decision;

• “approved product” means a product— permitted to be marketed in England by—a consent granted by the Secretary of State under section 111(1) of the Act, oran authorisation under the Food and Feed Regulation, orwhich, immediately before exit day, was permitted to be marketed by a consent granted in accordance with Article 15(3), 17(6) or 18(2) of the Deliberate Release Directive or Article 13(2) or (4) of the 1990 Directive (a “pre-exit approved product”);

• “biological matter” means anything (other than an entity mentioned in the definition of organism) which consists of or includes—tissue or cells (including gametes or propagules) or subcellular entities, of any kind, capable of replication or of transferring genetic material, orgenes or other genetic material, in any form, which are so capable,and it is immaterial, in determining if something is or is not biological matter, whether it is the product of natural or artificial processes of reproduction or whether or not it has ever been part of a whole organism;

• ...

• ...

• “the Deliberate Release Directive” means Council Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms as it applied immediately before exit day;

• “the 1990 Directive” means Council Directive 1990/220/EEC on the deliberate release into the environment of genetically modified organisms as amended by Commission Directive 1994/15/EC and Commission Directive 1997/35/EC ;

• “electronic communication” means the same as in the Electronic Communications Act 2000 ;

• “environmental risk assessment” means the environmental risk assessment required to be contained in an application for consent to release or market genetically modified organisms by regulation 11(1)(c) and regulation 16(2)(c), respectively;

• “the First Simplified Procedure (crop plants) Decision” means Commission Decision 94/730/EC as it applies immediately before exit day;

• “the Food and Feed Regulation” means Council Regulation (EC) No 1829/2003 on genetically modified food and feed;

• “genetically modified feed” means—feed containing, consisting of or produced from genetically modified organisms; orgenetically modified organisms for feed use;

• “genetically modified food” means—food containing or consisting of genetically modified organisms;food produced from, or containing ingredients produced from, genetically modified organisms; orgenetically modified organisms for food use;

• “genetically modified organisms” means a genetically modified organism or a combination of genetically modified organisms;

• “higher plant” means a plant belonging to the taxonomic groupSpermatophytae (Gymnospermae orAngiospermae);

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

• “human embryo” means an embryo within the meaning given in the provisions of the Human Fertilisation and Embryology Act 1990 (apart from section 4A) by virtue of section 1(1) and (6) of that Act; and

• “local authority” means a county council, a district council, a London borough council, the Common Council of the City of London in its capacity as a local authority, and the Council of the Isles of Scilly;

• “monitoring plan” means the plan required by regulation 16(2)(g);

• “organism” means any acellular, unicellular or multicellular entity (in any form and whether or not it is the product of natural or artificial processes of reproduction), other than humans, human embryos or human admixed embryos; and, unless the context otherwise requires, the term also includes any article or substance consisting of or including biological matter;

• ...

• “the register” means the public register kept by the Secretary of State under section 122 of the Act.

• “the 1992 Regulations” means the Genetically Modified Organisms (Deliberate Release) Regulations 1992 .

Purpose of Part VI of the Act and meaning of “genetically modified organisms” etc

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• (1) Section 106 of the Act (purpose of Part VI of the Act and meaning of “genetically modified organisms” etc) is amended as follows.

• (2) For subsection (1) substitute—

(1) This Part has effect for the purpose of ensuring that all appropriate measures are taken to avoid damage to the environment which may arise from the escape or release from human control of genetically modified organisms.

• (3) In subsection (4) (definition of organism which is genetically modified) for paragraph (a) (modification of prescribed artificial technique) substitute—

(a) have been artificially modified, or

• (4) After that subsection insert—

(4A) Genes or other genetic material in an organism are “artificially modified” for the purposes of subsection (4) above if they are altered otherwise than by a process which occurs naturally in mating or natural recombination. This subsection is subject to subsections (4B) and (4C) below. (4B) For the purposes of subsection (4) above— (a) genes or other genetic material shall be taken to be artificially modified if they are altered using such techniques as may be prescribed for the purposes of this paragraph; (b) genes or other genetic material shall not be regarded as artificially modified by reason only of being altered by the use of such techniques as may be prescribed for the purposes of this paragraph. (4C) An organism shall be taken not to be a genetically modified organism for the purposes of this Part if it is an organism of a prescribed description. (4D) In subsections (4B) and (4C) above “prescribed” means prescribed by regulations made by the Secretary of State.

• (5) Subsections (5) and (6) are omitted.

Meaning of “damage to the environment” etc

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• (1) Section 107 of the Act (meaning of “damage to the environment” etc) is amended as follows.

• (2) For subsection (2) (meaning of “environment”) substitute—

(2) The “environment” includes land, air and water and living organisms supported by any of those media.

• (3) In subsection (3)(meaning of “damage to the environment”) omit “to the living organisms supported by the environment”.

• (4) For subsection (6) (meaning of “harm”) substitute—

(6) “Harm” means adverse effects as regards the health of humans or the environment.

• (5) For subsection (9) (meaning of organism being under a person’s “control”) substitute—

(9) Organisms of any description are under the “control” of a person where he keeps them contained by measures designed to limit their contact with humans and the environment and to prevent or minimise the risk of harm.

• (6) For subsection (11) (meaning of organism being “marketed”) substitute—

(11) Genetically modified organisms of any description are “marketed” by a person when products consisting of or including such organisms are placed on the market by being made available to other persons, whether or not for consideration.

Techniques of genetic modification

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• (1) Until the coming into force of the first regulations under section 106(4B)(a) of the Act, genes or other genetic material shall be taken, for the purposes of subsection (4) of that section, to be artificially modified if they are altered using any of the following techniques:

• (a) recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules, produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation;

• (b) techniques involving the direct introduction into an organism of heritable material prepared outside the organism including micro-injection, macro-injection and micro-encapsulation;

• (c) cell fusion (including protoplast fusion) or hybridisation techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally.

• (2) Until the coming into force of the first regulations under section 106(4B)(b) of the Act, genes or other genetic material shall not be regarded, for the purposes of subsection (4) of that section, as artificially modified by reason only of being altered by the use of any of the following techniques:—

• (a) in vitro fertilisation,

• (b) natural processes such as conjugation, transduction and transformation,

• (c) polyploidy induction,

provided that such techniques do not involve the use of recombinant nucleic acid molecules or genetically modified organisms made by techniques or methods other than—

• (i) mutagenesis; or

• (ii) cell fusion (including protoplast fusion) of plant cells of organisms which can exchange genetic material through traditional breeding methods.

• (3) Until the coming into force of the first regulations under section 106(4C) of the Act, an organism shall be taken, for the purposes of Part VI of the Act, not to be a genetically modified organism if it is yielded from the techniques or methods listed in paragraph (2)(i) or (ii) provided that those techniques or methods did not involve the use of recombinant nucleic acid molecules or genetically modified organisms other than those made by techniques or methods listed in that paragraph.

Environmental risk assessment

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• (1) An environmental risk assessment contained in an application for consent to release or market genetically modified organisms shall—

• (a) identify and evaluate the potential damage to the environment, whether direct or indirect, immediate or delayed, which may arise from the release or marketing of genetically modified organisms,

• (b) be carried out in accordance with Annex II of the Deliberate Release Directive and contain the conclusions required in section D of that Annex,

• (c) include bibliographic references and indications of the methods used where applicable.

• (2) Where the genetically modified organisms contain antibiotic resistance markers, the environmental risk assessment shall include an examination of the particular risks of damage to the environment which may be posed by the deliberate release or marketing of those genetically modified organisms.

Communication with applicant for consent

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• (1) Wherever an applicant for a consent or renewal of a consent to which these Regulations apply or a holder of such consent is required under these Regulations to submit any document in writing, he is required to submit that document in both a paper and in a commonly used electronic form.

• (2) Wherever these Regulations require any communication from the Secretary of State to the applicant for a consent or renewal of a consent to be in writing, “writing” shall include an electronic communication.

• (3) Any documents required by these Regulations to be in writing which do not fall within the provisions of paragraph (1) or (2) must be in paper form.

PART II — RELEASING ORGANISMS FOR ANY OTHER PURPOSE THAN MARKETING

Requirement for consent to release

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The cases and circumstances prescribed for the purposes of section 111(1)(a) of the Act in relation to the release of any genetically modified organisms are all cases and circumstances in which genetically modified organisms are intended to be released.

Exempt Activities

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The cases and circumstances prescribed for the purposes of section 111(7) of the Act in which persons are exempt from the requirements of section 111(1)(a) of the Act, insofar as those requirements apply to the release of genetically modified organisms, are all cases and circumstances in which ... an approved product is released in accordance with the conditions and limitations to which the use of the product is subject.

Applications for consent to release—general provisions

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• (1) An application for a consent to release genetically modified organisms must be made in writing to the Secretary of State.

• (2) Proposed releases of the same genetically modified organism or of a combination of genetically modified organisms on the same site or on different sites for the same purpose and within a defined period may be notified in a single application.

• (3) Where an application for a consent to release genetically modified organisms is expressed to rely on the First Simplified Procedure (crop plants) Decision, in the event of any inconsistency in the requirements as to information to be provided under that Decision and the requirements as to information to be provided under these Regulations, the provisions of that Decision shall prevail.

Information to be contained in applications for consent to release

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• (1) An application for a consent to release genetically modified organisms must contain—

• (a) subject to paragraph (1A), the information prescribed in—

• (i) Schedule 1, where the application is for consent to release any genetically modified higher plant, or

• (ii) Schedule 2 in any other case,

...

• (b) information on data or results from any previous release of the organisms, or of the same combination of organisms, which has been carried out by the applicant, and information from any previous application for the release of the organisms, or of the same combination of organisms, which the applicant has made to the Secretary of State pursuant to the Act or to another competent authority in accordance with Article 6 of the Deliberate Release Directive,

• (c) an environmental risk assessment prepared in accordance with regulation 6,

• (d) a summary... of the information contained in the application , in the relevant format set out in the Annex to Council Decision 2002/813/EC.

• (e) summaries and results of studies referred to in the application, including an explanation of their relevance to the environmental risk assessment, as appropriate.

• (1A) The information specified in paragraph (1)(a) is only required to be provided if it is necessary for the completion of an environmental risk assessment in the context of a specific application, and the level of detail to be provided may vary according to the nature and the scale of the proposed deliberate release.

• (2) The application may contain—

• (a) 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, and

• (b) any other information that the applicant considers relevant.

Advertisement of applications for consent to release

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• (1) Subject to paragraphs (2) and (3), a person who makes an application for a consent to release genetically modified organisms shall, not more than ten days after he sends that application to the Secretary of State, cause to be published in a national newspaper to be specified by the Secretary of State a notice containing the following information—

• (a) the name and address of the applicant,

• (b) the general description of the organisms to be released,

• (c) the location and purpose of the release,

• (d) the intended date or dates of the release,

• (e) a statement that information about the application will be placed on the register by the Secretary of State within twelve days of her receipt of the application,

• (f) the means by which that register can be inspected,