The Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002

Made: 4th December 2002

Coming into force in accordance with regulation 1(1)

The Scottish Ministers, in exercise of the powers conferred by section 2(2) of the European Communities Act 1972 and of all other powers enabling them in that behalf hereby make the following Regulations, a draft of which has, in accordance with paragraph 2(2) of Schedule 2 to that Act been laid before, and approved by resolution of, the Scottish Parliament:

PART I — GENERAL

Citation, commencement and extent

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• (1) These Regulations may be cited as the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 and shall come into force on the day after the day on which they are made.

• (2) These Regulations extend to Scotland only.

Interpretation

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• (1) In these Regulations, unless the context otherwise requires–

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

• “the Advisory Committee on Releases to the Environment” means the committee appointed for the purposes of, and in accordance with, 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 consisting of or including genetically modified organisms which—is permitted to be marketed in Scotland in pursuance of—a consent granted by the Scottish Ministers under section 111(1) of the Act, oran authorisation under the Food and Feed Regulation, oris a pre-exit approved product,

• ...

• “community council” means a community council constituted under section 51 of the Local Government (Scotland) Act 1973 ;

• ...

• “the Deliberate Release Directive” means Directive 2001/18/EC of the European Parliament and the Council on the deliberate release into the environment of genetically modified organisms , as last amended by Commission Directive (EU) 2018/350;

• “1990 Directive” means Council Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms, as it had effect before it was repealed by Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC,

• “electronic communication” has the same meaning 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 virtue of regulation 11(1)(c) and regulation 16(2)(c) respectively;

• “the First Simplified Procedure (crop plants) Decision” means Commission Decision 94/730/EC establishing simplified procedures concerning the deliberate release into the environment of genetically modified plants pursuant to Article 6(5) of Council Directive 90/220/EEC,

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

• “genetically modified feed” means–feed containing or consisting of genetically modified organisms;feed derived in whole or in part from, but not containing or consisting of genetically modified organisms; orgenetically modified organisms that may be used as feed or as a source material for the production of feed;

• “genetically modified food” means–food containing or consisting of genetically modified organisms;food, or food containing ingredients, derived in whole or in part from genetically modified organisms, but not containing or consisting of genetically modified organisms; orgenetically modified organisms that may be used as food or as a source material for the production of food;

• “Food Standards Scotland” means Food Standards Scotland established under section 1 of the Food (Scotland) Act 2015;

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

• “the Health and Safety Executive” means the Health and Safety Executive established under section 10 of the Health and Safety at Work etc. Act 1974 ;

• “higher plant” means a plant belonging to the taxonomic group Spermatophyta (Gymnospermae or Angiospermae);

• “local authority” means a council constituted under section 2 of the Local Government etc. (Scotland) Act 1994 ;

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

• “pre-exit approved product” means a product consisting of or including genetically modified organisms which, immediately before exit day, was permitted to be marketed in Scotland in pursuance of a consent granted (other than by the Scottish Ministers under section 111(1) of the Act) in accordance with—Article 15(3), 17(6) or 18(2) of the Deliberate Release Directive, orArticle 13(2) or (4) of the 1990 Directive,

• “the register” means the public register kept by the Scottish Ministers under section 122 of the Act;

• ...

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

• (2) Expressions used in these Regulations have, unless the contrary intention appears, the meaning which they bear in Part VI of the Act and in regulations 8, 9, 14, 15, 33 and 34 the prescribing of cases, circumstances, descriptions and matters shall be treated as being cases, circumstances, descriptions and matters prescribed in accordance with and under the Act.

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

• (a) any reference to a numbered regulation or to a numbered Schedule or to a numbered Part is a reference to the regulation or Schedule or Part 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 to which that reference occurs.

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 and meaning of “genetically modified organisms” etc.) is amended as follows.

• (2) For subsection (1) (purpose of Part VI) 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)–

• (a) insert after “this Part”–

, subject to subsection (4C) below,

and

• (b) for paragraph (a) (modification of prescribed artificial technique) substitute–

(a) have been artificially modified, or

• (4) After subsection (4) insert–

(4A) subject to subsections (4B) and (4C) below, 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. (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 Scottish Ministers.

• (5) Subsections (5) (techniques which may be prescribed as genetic modification) and (6)(direct or indirect means of modification immaterial) 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 the living organisms supported by any of those media.

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

• (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 that person keeps them contained by specific measure 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 “marketed”) substitute–

(11) Genetically modified organisms of any description are “marketed” 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 made by the Scottish Ministers under section 106(4B)(a) (power to prescribe techniques, alteration by which shall be taken to be artificial modification) 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 made by the Scottish Ministers under section 106(4B)(b) (power to prescribe techniques, alteration by which shall not be taken to be artificial modification) of the Act, genes or other genetic material shall not be taken, for the purposes of subsection (4) of that section, to be artificially modified by reason only of being altered by the use of any of the following techniques:–

• (a) in vitro fertilisation;

• (b) natural processes including conjugation, transduction or transformation;

• (c) polyploidy induction:

• (3) Until the coming into force of the first regulations made by the Scottish Ministers under section 106(4C) (power to prescribe organisms which shall be taken not to be genetically modified) 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):

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 or for renewal of consent to 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 the genetically modified organisms;

• (b) be carried out in accordance with schedule 1 and contain the conclusions required in Part D of that schedule; and

• (c) include any 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 an applicant for consent

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• (1) Notwithstanding paragraph (2), 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 or in written form, whether before or after consent is granted, the applicant shall submit that document both in writing and in an electronic form acceptable to the Scottish Ministers.

• (2) A reference in these Regulations to anything done in writing or produced in written form which does not fall within the provisions of paragraph (1) includes a reference to an electronic communication which has been recorded and is consequently capable of being reproduced.

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 , which is permitted to be marketed for a use in pursuance of its consent or authorisation, is released in accordance with the limitations, conditions and restrictions to which that 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 submitted in writing to the Scottish Ministers.

• (2) The Scottish Ministers may accept that 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 application for consent to release

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

• (a) the information prescribed in Part 1 of schedule 2, where the application is for consent to release any genetically modified higher plant, or schedule 3 in any other case, to the extent that such information is—

• (i) appropriate to the nature and scale of the release or application, and

• (ii) in the case of schedule 2, relevant and necessary for the purposes of the environmental risk assessment referred to in sub-paragraph (c), in view particularly of the characteristics of the genetically modified organism and of the scale and conditions of the release or of its intended conditions of use;

• (aa) where the application is for consent to release a genetically modified higher plant, summaries and results of studies referred to in the application for consent to release, including an explanation of their relevance to the environmental risk assessment under sub-paragraph (c), where applicable,

• (b) information on data or results from any previous release of the organisms, or 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 under section 111(1) of the Act (in relation to any part of the United Kingdom) or to any competent authority of a member State ... in accordance with Article 6 of the Deliberate Release Directive or Article 5 of the 1990 Directive;

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

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

• (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 where the data or results are confidential a copy of that person’s agreement in writing is contained in the application; and

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

Advertisement of applications for consent to release

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