PART I GENERAL

Citation, commencement and extent1.

(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.

Interpretation2.

(1)

In these Regulations, unless the context otherwise requires–

  • “the Act” means the Environmental Protection Act 1990 M1;

  • “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;

  • F1“approved product” means a product consisting of or including genetically modified organisms which—

    1. (a)

      is permitted to be marketed in Scotland in pursuance of—

      1. (i)

        a consent granted by the Scottish Ministers under section 111(1) of the Act, or

      2. (ii)

        an authorisation under the Food and Feed Regulation, or

    2. (b)

      is a pre-exit approved product,

  • F2...

  • “community council” means a community council constituted under section 51 of the Local Government (Scotland) Act 1973 M2;

  • F3...

  • F4“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 F5, as last amended by Commission Directive (EU) 2018/350;

  • F6“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on the deliberate release into the environment of genetically modified organisms, as it had effect before it was repealed by Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and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 M3;

  • “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;

  • F7“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,

  • F8“the Food and Feed Regulation” means Council Regulation (EC) No 1829/2003 on genetically modified food and feed,

  • F9“genetically modified feed” means–

    1. (a)

      feed containing or consisting of genetically modified organisms;

    2. (b)

      feed derived in whole or in part from, but not containing or consisting of genetically modified organisms; or

    3. (c)

      genetically modified organisms that may be used as feed or as a source material for the production of feed;

  • F9“genetically modified food” means–

    1. (a)

      food containing or consisting of genetically modified organisms;

    2. (b)

      food, or food containing ingredients, derived in whole or in part from genetically modified organisms, but not containing or consisting of genetically modified organisms; or

    3. (c)

      genetically modified organisms that may be used as food or as a source material for the production of food;

  • “F10Food Standards Scotland” means F10Food Standards Scotland established under section 1 of the F11Food (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 M4;

  • “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 M5;

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

  • F12“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—

    1. (a)

      Article 15(3), 17(6) or 18(2) of the Deliberate Release Directive, or

    2. (b)

      Article 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;

  • F13...

  • “the 1992 Regulations” means the Genetically Modified Organisms (Deliberate Release) Regulations 1992 M6.

(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.3.

(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.4.

(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 modification5.

(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) M7 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:

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–

  1. (i)

    mutagenesis; or

    1. (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 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):

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).

Annotations:
Marginal Citations

M7Section 106(4) is amended by regulation 3(3) and section 106(4A) to (4D) is inserted by regulation 3(4).

Environmental risk assessment6.

(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 F14schedule 1 and contain the conclusions required in F15Part 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 consent7.

(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 release8.

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 activities9.

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 F16, which is permitted to be marketed for a use in pursuance of its consent F17or authorisation, is released in accordance with the F18limitations, conditions and restrictions to which F19that use of the product is subject.

Applications for consent to release – general provisions10.

(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 release11.

(1)

An application for a consent to release genetically modified organisms must contain–

F20(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 F21under section 111(1) of the Act (in relation to any part of the United Kingdom) or to any competent authority of F22a member State F23... 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 F24... of the information contained in the application F25, 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 release12.

(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 the applicant sends that application to the Scottish Ministers, cause to be published in any newspaper to be specified by the Scottish Ministers a notice approved by the Scottish Ministers 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 of the release;

(e)

a statement that information about the application will be placed on the register by the Scottish Ministers within 12 days of their receipt of the application;

(f)

the means by which the register can be inspected; and

(g)

a statement that the Scottish Ministers shall, within a period which they shall specify in accordance with these Regulations, have regard to any representations made to them in writing relating to risks of damage to the environment M8 posed by the release of the genetically modified organisms,

and that person shall–

(i)

immediately send to the Scottish Ministers confirmation that such information was placed in such newspaper and the date on which the information was published in the newspaper; and

(ii)

if requested to do so by the Scottish Ministers, send a copy of such newspaper containing the advertisement to them.

(2)

A notice published under paragraph (1) need not contain the information referred to in subparagraphs (c) and (d) of that paragraph insofar as the First Simplified Procedure (crop plants) Decision does not require that information to be submitted with the application and that information is not submitted with the application.

(3)

An applicant for consent shall ascertain from the Scottish Ministers the level of detail on the location of the release which will be placed on the register and shall include the same level of detail in the notice to be published under paragraph (1).

(4)

A person who makes an application for a consent to release genetically modified organisms shall, subject to paragraph (5), not more than ten days after that person sends that application to the Scottish Ministers, give to the following persons notice in writing that the application has been made and the information prescribed in paragraph (1)(a) to (g) (save insofar as paragraph (2) permits such information to be excluded from the notice referred to in paragraph (1)):–

(a)

the local authority and community council for the area of each proposed release;

(b)

the owner of the site of each proposed release, if such person is not the applicant;

F26(c)

any person, or a genetic modification safety committee, from whom advice must be obtained under regulation 8 of the Genetically Modified Organisms (Contained Use) Regulations 2014,

(d)

any National Park Authority designated under section 6 of the National Parks (Scotland) Act 2000 M9 for the area of each proposed release;

(e)

Scottish Natural Heritage established under section 1 of the Natural Heritage (Scotland) Act 1991 M10; and

(f)

such other body as the Scottish Ministers may notify the applicant that they consider appropriate,

and shall immediately send to the Scottish Ministers copies of the notices given under this paragraph.

(5)

Notwithstanding paragraph (4), the applicant shall give any body which the Scottish Ministers consider appropriate, for the purposes of paragraph (4)(f), the notice referred to in paragraph (4) within ten days of receipt by the applicant of the notification of such body as the Scottish Ministers consider appropriate.

Transitional provisions in respect of applications to releaseF2713.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART III MARKETING ORGANISMS

Requirement for consent to market14.

The cases and circumstances prescribed for the purposes of section 111(1)(a) of the Act in relation to marketing genetically modified organisms are all cases and circumstances in relation to the marketing of genetically modified organisms.

Exempt activities15.

F28(1)

The cases and circumstances prescribed for the purposes of F29section 111(7) of the Act in which persons are exempt from the requirements of F30... section 111(1)(a) of the Act (to obtain consent) F31... insofar as F32it relates to marketing genetically modified organisms, are all cases and circumstances in which–

(a)

an approved product F33, which is permitted to be marketed in Scotland in pursuance of an authorisation under the Food and Feed Regulation, is marketed for a use for which it has approval F34and in accordance with the limitations F35, conditions and restrictions to which F36that use of the product is subject;

F37(aa)

a pre-exit approved product is marketed during the relevant period—

(i)

for a use (other than cultivation in Scotland) for which it had marketing consent in accordance with the Deliberate Release Directive or the 1990 Directive immediately before exit day and for which it continues to have consent for that use in Scotland, and

(ii)

in accordance with the limitations and conditions to which that use of the product was subject immediately before exit day, as may be modified by virtue of these Regulations or the Act,

(b)

genetically modified micro-organisms are made available for activities regulated under F38the Genetically Modified Organisms (Contained Use) Regulations 2014 (including culture collections);

F39(c)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d)

genetically modified organisms are made available to be used exclusively for deliberate releases complying with the requirements laid down in Part II; F40and

F41(e)

a genetically modified organism is marketed which is, or is contained in, a medicinal product authorised under—

(i)

the Human Medicines Regulations 2012, or

(ii)

the Veterinary Medicines Regulations 2013.

F42(f)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F43(g)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F44(2)

For the purposes of paragraph (1), “the relevant period”, in relation to a pre-exit approved product, means the period beginning with exit day and ending with the day which immediately precedes the day on which the consent concerned ceases to be valid.

Applications for consent to market16.

(1)

An application for a consent to market genetically modified organisms under section 111(1) of the Act must be made in writing to the Scottish Ministers.

(2)

An application for a consent to market genetically modified organisms which is not an application for renewal of consent must contain the following information:–

F45(a)

the information prescribed in Part 2 of schedule 2, where the application is for consent to market 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 especially 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 market a genetically modified higher plant, summaries and results of studies referred to in the application for consent to market, including an explanation of their relevance to the environmental risk assessment referred to in sub-paragraph (c), where applicable,

(ab)

where the application is for consent to market a genetically modified higher plant, detailed information on the studies referred to in the application for consent to market, including—

(i)

a description of the methods and materials used or the reference to standardised or internationally recognised methods, and

(ii)

the name of the body or bodies responsible for carrying out the studies,

(b)

information on data or results from any previous release of the same genetically modified organisms, or of the same combination of genetically modified organisms, which has been carried out by the applicant anywhere, and information from any previous application for consent to release the same genetically modified organisms, or the same combination of genetically modified organisms, which the applicant has made F46under section 111(1) of the Act (in relation to any part of the United Kingdom);

(c)

an environmental risk assessment prepared in accordance with regulation 6;

(d)

subject to paragraph (4), the information prescribed in Schedule 4;

(e)

the proposed conditions for the marketing of the product, including specific conditions of use and handling;

(f)

a proposed period for the consent which shall not exceed ten years;

(g)

a monitoring plan prepared in accordance with F47schedule 5A which shall include a proposal for the time period of the plan which may differ from the proposed period for the consent;

(h)

a proposal for labelling which shall comply with the requirements laid down in Schedule 4;

(i)

a proposal for packaging; and

(j)

a summary of the application in the format F48set out in the Annex to Commission Decision 2002/812/EC.

(3)

The application may in addition contain–

(a)

data or results from an application for consent to release genetically modified organisms previously made by some other person, provided that if 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 relevant.

(4)

The information provided in accordance with paragraph (2)(a) and (d) shall take into account the diversity of sites of use of the genetically modified organisms and shall include information on any data or results obtained from research and developmental releases concerning the impact of the release on human health and the environment.

(5)

Where the applicant can demonstrate in the application by that person to the satisfaction of the Scottish Ministers that, on the basis of the results of any release in pursuance of and in accordance with a consent for a deliberate release granted F49under section 111(1) of the Act or a consent under Part B of either the Deliberate Release Directive or F50... the 1990 Directive, or on other substantive, reasoned scientific grounds, that the marketing and use of the product consisting of or including the genetically modified organisms do not pose a risk of damage to the environment, the applicant may omit from the application part or all of the information prescribed in Part II of Schedule 4.

Transitional provision in respect of applications to marketF5117.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Transitional measures for adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation.F5217A.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Applications for renewal of consent to market18.

(1)

Where a consent has been granted under section 111(1) of the Act to market genetically modified organisms which were first marketed in Scotland, any application to renew that consent shall be made in writing to the Scottish Ministers–

(a)

before 17th October 2006 where the consent was granted before the coming into force date of these Regulations; or

(b)

no later than nine months before the expiry of the consent in all other cases.

(2)

The application shall contain–

(a)

a copy of the consent to market the genetically modified organisms;

(b)

where the consent to market was granted–

(i)

after the coming into force date of these Regulations, a report on the results of the monitoring carried out in accordance with the requirements of regulation 28(f); or

(ii)

before that date, a report on the results of any monitoring carried out on the relevant product;

(c)

any other new information which has become available with regard to the risks of the product causing damage to the environment; and

(d)

as appropriate, a proposal for amending, complementing or adding to the conditions of the existing consent, including the conditions concerning future monitoring, and a proposal for the time limitation of the new consent.

(3)

Any consent to market genetically modified organisms first marketed in Scotland which was granted under section 111(1) of the Act before the coming into force date of these Regulations and for which no application for renewal under paragraph (1) has been received by the Scottish Ministers before 17th October 2006 shall be treated as having expired on that date.

(4)

Any consent to market genetically modified organisms marketed in Scotland which was granted under section 111(1) of the Act before the coming into force date of these Regulations and for which an application for renewal under paragraph (1) is refused shall be treated as having expired on 17th October 2006 or the date of refusal of the application, whichever is the later.

PART IV DUTIES AFTER THE MAKING OF APPLICATIONS

Duty of the applicant after applying for consent to release or to market19.

(1)

Section 111 of the Act (consents required by certain persons) is amended as follows:–

(a)

in subsection (6)–

(i)

after the word “period” where it appears for the first time insert “ and in such form and manner ”; and

(ii)

after the word “period” where it appears for the second time insert “ and in the specified form and manner ”; and

(b)

after subsection (6) (power of Scottish Ministers to require further information) insert–

“(6ZA)

A notice under subsection (6) must state the reasons for requiring the further information specified in the notice.”.

(2)

An applicant for a consent to release or to market genetically modified organisms who notifies the Scottish Ministers of any information in accordance with section 111(6A) of the Act (requirement for applicant to notify new information regarding risks of damage to the environment) M11 shall submit in writing to the Scottish Ministers a revised version of the original application for consent amended to take account of the new information.

Duties of the Scottish Ministers in relation to applications for consent to release20.

Following receipt of an application for consent to release genetically modified organisms the Scottish Ministers shall–

(a)

inform the applicant in writing of the date of receipt of the application;

(b)

invite any person by means of a request placed on the register, to make representations in writing to the Scottish Ministers relating to any risks of damage being caused to the environment M12 by the release before the end of a period to be specified which shall not be less than sixty days from the date the application was received by the Scottish Ministers;

F53(c)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d)

examine the application for its conformity with the requirements of the Act and of these Regulations;

(e)

evaluate the risks of damage being caused to the environment by the proposed release having regard to the environmental risk assessment prepared in accordance with regulation 6; and

F54(f)

take into account and give due weight to any representations made to them before the end of the period specified pursuant to paragraph (b) relating to risks of damage being caused to the environment by the release.

Decisions by the Scottish Ministers on applications for consent to release21.

(1)

The Scottish Ministers shall not grant consent to release genetically modified organisms under section 111(1) of the Act as it relates to the protection of human health without the agreement of the Health and Safety Executive.

F55(2)

The Scottish Ministers shall not grant or refuse consent to release genetically modified organisms before the end of the period specified for representations F56... in accordance with regulation 20(b) F57....

F58(3)

The Scottish Ministers must communicate in writing their decision on an application for a consent to release genetically modified organisms to the applicant before the end of a period of 90 days beginning with the day on which the application was received, and must include in any refusal of consent the reason for the decision.

(4)

The period prescribed in paragraph (3) shall not include–

(a)

any period beginning with the day on which the Scottish Ministers give notice in writing under section 111(6) of the Act that further information in respect of the application is required and ending on the day on which that information is received by the Scottish Ministers; or

(b)

any period of time during which the Scottish Ministers are considering representations submitted by any persons in accordance with regulation 20(b), provided that this consideration shall not prolong the ninety day period referred to in paragraph (3) by more than thirty days.

(5)

A consent to release genetically modified organisms shall require the applicant to send any information which might be relevant to assessing the risk of damage being caused to the environment, with, where appropriate, particular reference to any product which it is intended to market in the future, to the Scottish Ministers as soon as reasonably practicable after completion of the release and thereafter, at such intervals as the Scottish Ministers shall consider appropriate on the basis of the results of the environmental risk assessment.

F59(6)

Information submitted in accordance with paragraph (5) must be provided in the format set out in the Annex to Decision 2003/701/EC.

Variation or revocation of consents to release22.

(1)

The Scottish Ministers shall only vary or revoke a consent to release genetically modified organisms under section 111(10) of the Act without the agreement of the holder of the consent where new information has become available to them which they consider would affect the assessment of the risk of damage being caused to the environment by the release.

(2)

The Scottish Ministers shall not revoke or vary a consent to release genetically modified organisms under section 111(10) of the Act as it relates to the protection of human health without the agreement of the Health and Safety Executive.

F60Duties of the Scottish Ministers in relation to applications for consent to market23.

(1)

On receipt of an application for consent to market genetically modified organisms, the Scottish Ministers must—

(a)

inform the applicant in writing of the date of receipt of the application,

(b)

without delay examine the application for its conformity with the requirements of the Act and of these Regulations and, if necessary, request the applicant to supply additional information, and

(c)

before the end of a period of 90 days beginning with the day on which they received the application, either—

(i)

send to the applicant an assessment report prepared in accordance with schedule 5 which indicates that the genetically modified organisms should be permitted to be marketed and under which conditions, or

(ii)

refuse the application, stating reasons for their decision, supported by an assessment report prepared in accordance with schedule 5 which indicates that the genetically modified organisms should not be marketed.

(2)

The period of 90 days referred to in paragraph (1)(c) must not include any period beginning with the day on which the Scottish Ministers give notice in writing under section 111(6) of the Act that further information in respect of the application is required and ending on the day on which that information is received by the Scottish Ministers.

(3)

Where the assessment report referred to in paragraph (1)(c) indicates that the genetically modified organisms to which an application relates should be permitted to be marketed, the Scottish Ministers must invite any person, by means of a request placed on the register, to make representations on the assessment report, which must be received by the Scottish Ministers within a period of 30 days beginning with the day on which the request is placed on the register (which must not be earlier than the day on which the assessment report is placed on the register in accordance with regulation 35(7A)).

F61Decisions by the Scottish Ministers on applications for consent to market24.

(1)

The Scottish Ministers must not grant consent to market genetically modified organisms under section 111(1) of the Act as it relates to the protection of human health without the agreement of the Health and Safety Executive.

(2)

Where the Scottish Ministers invite representations under regulation 23(3) in relation to an application for consent to market genetically modified organisms, the Scottish Ministers—

(a)

must not determine whether to grant or refuse consent to market the genetically modified organisms until after the period for making representations under regulation 23(3) has ended and they have considered any representations made in accordance with that regulation, and

(b)

must, within a period of 105 days beginning with the day after the end of the period for making representations under regulation 23(3)—

(i)

determine the application, and

(ii)

notify the applicant in writing of the decision to grant or refuse consent to market the genetically modified organisms, and the reasons for the decision.

(3)

The period of 105 days referred to in paragraph (2)(b) does not include any period beginning with the day on which the Scottish Ministers give notice in writing under section 111(6) of the Act that further information in respect of the application is required and ending on the day on which that information is received by the Scottish Ministers.

(4)

Subject to paragraphs (5) and (6) and regulation 26, a consent to market genetically modified organisms may be granted by the Scottish Ministers under section 111(1) of the Act for a maximum period of up to 10 years beginning with the day on which the consent is granted.

(5)

In the case of a consent to market a genetically modified organism or any progeny of that genetically modified organism contained in a plant variety where that plant variety is intended only for the marketing of its seeds, the period of the first consent must end at the latest 10 years after the date of the first inclusion of the first plant variety containing the genetically modified organism on a National List in accordance with regulation 3 of the Seeds (National Lists of Varieties) Regulations 2001.

(6)

In the case of a consent to market a genetically modified organism contained in forest reproductive material, the period of the first consent must end at the latest 10 years after the date of the first inclusion of basic material containing the genetically modified organism on the National Register in accordance with regulations 6 and 7 of the Forest Reproductive Material (Great Britain) Regulations 2002.

(7)

A consent to market genetically modified organisms granted by the Scottish Ministers under section 111(1) of the Act may include such limitations or conditions as they consider appropriate to restrict or prohibit the cultivation of the genetically modified organisms in all or any part of Scotland.

(8)

The Scottish Ministers may, where any such consent includes a limitation or condition referred to in paragraph (7), vary the consent to remove or modify the limitation or condition.

(9)

The Scottish Ministers must inform the holder of the consent of any variation under paragraph (8).

Duties on the Scottish Ministers on receiving applications for renewal of consent to market25.

(1)

On receipt of an application for renewal of consent to market genetically modified organisms the Scottish Ministers shall–

(a)

inform the applicant in writing of the date of receipt of the application;

(b)

examine the application for its conformity with the requirements of the Act and of these Regulations and, if necessary, request the applicant to supply additional information; F62and

(c)

either–

(i)

send to the applicant an assessment report prepared in accordance with Schedule 5 which indicates that the genetically modified organisms should continue to be permitted to be marketed and under which conditions; or

(ii)

refuse the application, stating reasons for their decision, supported by an assessment report F63prepared in accordance with schedule 5 which indicates that the genetically modified organisms should not continue to be marketed F64.

F65(d)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F66(2)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Decisions by the Scottish Ministers on applications for renewals of consents to market26.

F67(1)

The Scottish Ministers must not grant a renewal of consent under section 111(1) of the Act to market genetically modified organisms as it relates to the protection of human health without the agreement of the Health and Safety Executive.

F68(2)

The Scottish Ministers must communicate a decision on an application to renew a consent to market genetically modified organisms to the applicant as soon as possible and must include in any refusal of consent the reasons for the decision.

(3)

The renewed consent to market genetically modified organisms shall be given for ten years unless the Scottish Ministers consider that a shorter or longer period is justified, in which case they shall give their reasons therefor in writing.

(4)

The applicant may continue to market the genetically modified organisms F69in accordance with the limitations and conditions included the existing marketing consent until a final decision has been taken on the application.

F70F71(5)

A renewed consent to market genetically modified organisms granted by the Scottish Ministers under section 111(1) of the Act may include such limitations or conditions as they consider appropriate to restrict or prohibit the cultivation of the genetically modified organisms in all or any part of Scotland.

(6)

The Scottish Ministers may, F72where any such consent includes a limitation or condition referred to in paragraph (5), vary the consent to remove or modify the limitation or condition.

F73(7)

The Scottish Ministers must inform the holder of the renewed consent of any variation under paragraph (6).

F74Demand to adjust a food or feed authorisation to prohibit the cultivation of genetically modified organisms in all or part of Scotland26A.

(1)

On receipt of a relevant application Food Standards Scotland must forward a copy of the application to the Scottish Ministers.

(2)

The Scottish Ministers may, in respect of a relevant application, demand that any resulting authorisation is adjusted to ensure that genetically modified organisms are prohibited from cultivation in all or such part of Scotland as is specified in the demand.

(3)

A demand under paragraph (2) must be communicated by the Scottish Ministers to the Food Standards Scotland before it determines the application.

(4)

In this regulation, “relevant application” means an application for—

(a)

an authorisation to place on the market genetically modified organisms under Article 5 or 17 of the Food and Feed Regulation, or

(b)

renewal of an authorisation to place on the market genetically modified organisms under Article 11 or 23 of the Food and Feed Regulation.

F75Request to adjust a food or feed authorisation to remove or modify a restriction or prohibition on the cultivation of genetically modified organisms in all or part of Scotland26B.

(1)

Where an authorisation referred to in sub-paragraph (a) or (b) of regulation 26A(4) restricts or prohibits the cultivation of genetically modified organisms in all or any part of Scotland, the Scottish Ministers may request that the authorisation is adjusted to remove or modify, insofar as they consider appropriate, any such restriction or prohibition.

(2)

A request under paragraph (1) is to be made by notifying Food Standards Scotland.

Genetically modified organisms containing antibiotic resistance markers27.

(1)

The Scottish Ministers shall not grant a consent to an application for the release or marketing of genetically modified organisms containing antibiotic resistance markers which may have adverse effects on human health and the environment after–

(i)

31st December 2004 in the case of marketing; and

(ii)

31st December 2008 in the case of release.

(2)

Where prior to 31st December 2004 in the case of marketing and 31st December 2008 in the case of release, an application is made for consent to release or market genetically modified organisms containing antibiotic resistance markers, the Scottish Ministers shall evaluate the information in the environmental risk assessment accompanying the application, taking into particular consideration those antibiotic resistance markers in use for medical or veterinary treatment, with a view to identifying and phasing out the release or marketing of the genetically modified organisms referred to in paragraph (1) within the time limits specified in that paragraph.

PART V GENERAL PROVISION FOR CONSENTS

General provisions of consents to market28.

A consent to market genetically modified organisms granted by the Scottish Ministers under section 111(1) of the Act shall specify–

(a)

the scope of the consent, including the identity of the genetically modified organisms to be marketed, and their unique identifier;

(b)

the period of validity of the consent;

(c)

the conditions for marketing the product, including any specific conditions of use, handling and packaging of the genetically modified organisms, and conditions for the protection of particular ecosystems or environments or geographical areas as applicable;

(d)

that the applicant shall make control samples available to the Scottish Ministers on request;

(e)

the labelling requirements, in accordance with paragraph 8 of Schedule 4, which shall include a requirement to notify the Scottish Ministers of any new commercial name of the product after consent has been given; and

(f)

monitoring requirements which shall be in accordance with the monitoring plan, and shall include the time period of the monitoring plan, an obligation that the applicant shall submit F76monitoring reports to the Scottish Ministers in the relevant format set out in the Annexes to Decision 2009/770/EC and, where appropriate, any obligations on any person selling the product or any user of it, which may include an obligation to provide information at an appropriate level on the location of the genetically modified organisms that are grown.

General conditions on consents to release or market genetically modified organisms29.

(1)

Section 112 of the Act (consents: limitations and conditions) is amended as follows.

(2)

In subsection (1) (power of Scottish Ministers to impose limitations and conditions) at the end insert “ for the purpose of ensuring that all appropriate measures are taken to avoid damage to the environment which may arise from the activity permitted by the consent ”.

(3)

In subsection (5) (implied condition when releasing or marketing)–

(a)

in paragraph (b) (obligation to notify Scottish Ministers of new information etc.)–

(i)

before the word “of” where it appears for the second time insert “ forthwith ”;

(ii)

omit subparagraph (ii); and

(iii)

after that subparagraph insert–

“(iii)

any unforeseen event, occurring in connection with a release by him, which might affect the risks there are of damage to the environment being caused as a result of their being released;”;

(b)

for paragraph (c) (duty as regards preventing damage to environment) substitute–

“(c)

take such measures as are necessary to prevent damage to the environment being caused as a result of the release, or, as the case may be, the marketing of the organisms;”;

and

(c)

after that paragraph insert–

“(d)

notify the Scottish Ministers forthwith of the measures (if any) taken as a result of new information becoming available or an unforeseen event occurring as described in paragraph (b)(iii); and

(e)

in a case where new information becomes available or an unforeseen event so occurs, revise the information contained in his application for a consent accordingly and supply the revised information to the Scottish Ministers in such form and manner as they may specify.”.

F77Restrictions on cultivation29A.

(1)

This regulation applies to—

(a)

a consent F78granted by the Scottish Ministers under section 111(1) of the Act (including a renewed consent F79granted under that section in accordance with regulation 26),

(b)

F80a pre-exit approved product, or

(c)

an authorisation under the Food and Feed Regulation F81.

F82...

F83(2)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3)

The Scottish Ministers may, in the circumstances prescribed in paragraph (7), do any of the following—

(a)

include F84such limitations and conditions in the consent or renewed consent as they consider appropriate to restrict or prohibit the cultivation of genetically modified organisms in all or any part of Scotland,

(b)

issue a suspension notice in respect of F85the consent or renewed consent,

(c)

issue a suspension notice in respect of the F86pre-exit approved product, or

(d)

issue a suspension notice in respect of the authorisation under the Food and Feed Regulation.

(4)

The effect of a suspension notice issued under paragraph (3)(b) is to suspend the operation of the consent in respect of the cultivation of a genetically modified organism for all or a specified geographical area of Scotland.

(5)

The effect of a suspension notice issued under paragraph (3)(c) is to suspend, so far as it applies to the requirement in section 111(1)(a) of the Act for all or a specified geographical area of Scotland, the operation of the exemption in regulation F8715(aa) (exempt activities), in respect of the cultivation of a specified F88pre-exit approved product.

(6)

The effect of a suspension notice issued under paragraph (3)(d) is to suspend, so far as it applies to the requirement in section 111(1)(a) of the Act for all or a specified geographical area of Scotland, the operation of the exemption in regulation F8915(a), in respect of the cultivation of genetically modified food or F90genetically modified feed authorised under the Food and Feed Regulation.

(7)

The prescribed circumstances are that the Scottish Ministers are of the view that it is necessary to restrict F91or, as the case may be, prohibit the cultivation of a genetically modified organism, or a group of genetically modified organisms, on the basis of compelling grounds that—

(a)

may include one or more of the following—

(i)

environmental policy objectives,

(ii)

town and country planning,

(iii)

land use,

(iv)

socio-economic impacts,

(v)

the avoidance of the presence of genetically modified organisms in other products F92...,

(vi)

agricultural policy objectives,

(vii)

subject to paragraph (8), public policy,

(b)

are in conformity with F93retained EU law,

(c)

are proportional,

(d)

are non-discriminatory, and

(e)

do not conflict with the environmental risk assessment carried out pursuant to F94retained EU law on the deliberate release into the environment of genetically modified organisms (including the Food and Feed Regulation).

(8)

Public policy can only be relied upon in combination with at least one other ground included in sub-paragraph (a)(i) to (vi) of paragraph (7).

(9)

Before taking any of the actions in paragraph (3), the Scottish Ministers must—

F95(a)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)

where they consider appropriate, in the case of a notice served under regulation 29A(3)(d), notify Food Standards Scotland, and

(c)

make the reasons for the decision to take those actions available to the public.

(10)

A condition or suspension notice under paragraph (3) must not take effect until the expiry of the period of 75 days starting on the date of the notification under paragraph (9).

(11)

The Scottish Ministers may amend a F96limitation or condition referred to in paragraph (3)(a), or a suspension notice issued under paragraph (3)(b), (c) or (d), to take account of F97any comments they receive prior to its coming into force.

(12)

The Scottish Ministers must—

(a)

communicate the F98limitation, condition or suspension notice F99, as the case may be, to F100... the consent or authorisation holder without delay, and

(b)

make details of the condition or suspension notice available to the public.

F77Removal of restrictions under regulation 29A29B.

(1)

The Scottish Ministers may, at any time, do any of the following in respect of measures adopted under regulation 29A—

(a)

vary a F101limitation or condition in a consent F102or renewed consent to remove F103or modify a restriction or prohibition on the cultivation of genetically modified organisms in all or any part of Scotland,

(b)

withdraw a suspension notice in respect of a consent F104or renewed consent,

(c)

withdraw a suspension notice in respect of F105a pre-exit approved product,

(d)

withdraw a suspension notice in respect of an authorisation under the Food and Feed Regulation.

(2)

The Scottish Ministers must notify the F106consent or authorisation holder of any action taken under paragraph (1) without delay.

Proof of compliance with consent conditions30.

In section 119 of the Act (onus of proof as regards techniques and evidence) in subsection (1) (accused to prove use of best available techniques) after “the accused to prove” insert

“the matters described in subsection (1A) below.

(1A)

The matters referred to in subsection (1) above are–

(a)

in the case of an offence under section 118(1)(c) above consisting in a failure to comply with the general condition implied by section 112(5)(c) above–

(i)

that no measures, other than the measures taken by him, were necessary to prevent damage being caused to the environment from the release or, as the case may be, marketing of the organisms, or

(ii)

in a case where he took no measures, that no measures were necessary; and

(b)

in any other case,”.

F107Stop notices30A.

(1)

The Scottish Ministers may serve a notice under this regulation (a “stop notice”) on any person they have reason to believe—

(a)

is releasing or marketing a genetically modified organism, or has released or marketed a genetically modified organism, and the release or marketing of that organism is not—

(i)

pursuant to a consent F108required under section 111(1) of the Act F109..., F110...

(ii)

under and in accordance with any limitation or condition to which such a consent is subject, F111or

F112(iii)

exempt from any such requirement for consent, including by virtue of not being in accordance with any limitation or condition to which the exemption is subject,

(b)

is cultivating or has cultivated a genetically modified organism in contravention of a F113limitation or condition included in a consent to market F114pursuant to regulation 24(7) or a renewed consent to market F114pursuant to regulation 26(5),

(c)

is cultivating or has cultivated a genetically modified organism in contravention of a F115limitation or condition included in a consent or a renewed consent pursuant to regulation 29A(3)(a), or

(d)

is cultivating or has cultivated a genetically modified organism or approved product in contravention of a suspension notice issued under regulation 29A(3)(b) F116, (c) or (d).

(2)

A stop notice served on a person may—

(a)

prohibit a person from carrying out any act,

(b)

require a person to cease carrying out any act,

(c)

require a person to carry out any act,

for the purposes of ensuring, in so far as is possible, that the release, cultivation, placing on the market or marketing of the genetically modified organism is terminated.

(3)

The stop notice must—

(a)

state that the Scottish Ministers are, in relation to the person on whom it is served, of the belief mentioned in paragraph (1),

(b)

specify, for the purposes of paragraph (2), what act is to be prohibited, required or ceased and any applicable timescale, and

(c)

specify the date on which the stop notice takes effect (which may be the date of service).

(4)

The Scottish Ministers must, where they consider appropriate, notify Food Standards Scotland before serving a stop notice.

(5)

The Scottish Ministers may at any time vary or withdraw a stop notice served on any person by giving reasonable notice.

F117Variation or revocation of consents to market31.

(1)

The Scottish Ministers may only vary or revoke a consent to market genetically modified organisms under section 111(10) of the Act without the agreement of the holder of the consent where new information has become available which the Scottish Ministers consider would affect the assessment of the risk of damage being caused to the environment by the release.

(2)

The Scottish Ministers must not revoke or vary a consent to market genetically modified organisms under section 111(10) of the Act as it relates to the protection of human health without the agreement of the Health and Safety Executive.

PART VI SAFEGUARD

Safeguard32.

(1)

The Scottish Ministers may serve a prohibition notice under section 110 of the Act to prohibit an act which is authorised by a consent granted F118by them under section 111(1) of the Act F119, by an authorisation under the Food and Feed Regulation, or by a consent granted in respect of a pre-exit approved product, only if their opinion that doing such an act would involve a risk of causing damage to the environment is based on detailed grounds as the result of either–

(a)

new or additional information made available since the date of the consent which affects the environmental risk assessment in respect of that product; or

(b)

a reassessment of existing information in respect of that product on the basis of new or additional scientific information.

(2)

Where, in the circumstances described in paragraph (1), the Scottish Ministers consider that the risk of damage being caused to the environment is severe they shall serve a prohibition notice requiring such measures to be taken as they may consider appropriate and once any work required by the notice has been carried out they shall enter details of that work on the register.

F120(3)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F120(4)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F120(5)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6)

References in this regulation to the Scottish Ministers exercising a function under section 110 of the Act shall, in any case to which section 126(3) (requirement to act jointly with F121Food Standards Scotland) of the Act applies, be treated as references to the Scottish Ministers and F121Food Standards Scotland acting jointly.

F122PART VIAInspection powers, offences and service of notices

Powers of inspectors32A.

(1)

For the purpose of enforcing these Regulations, an inspector may exercise any of the powers specified in this regulation.

(2)

An inspector may, on producing if so required a duly authenticated document showing their authority, at all reasonable hours enter any land (excluding any premises used wholly or mainly as a private dwelling).

(3)

If a sheriff, on sworn information in writing, is satisfied that there are reasonable grounds for entry into any premises by an inspector under this regulation and either that—

(a)

entry has been refused or a refusal is reasonably expected, and that person has given notice to the occupier of their intention to apply for an entry warrant, or

(b)

a request for entry, or the giving of such a notice, would frustrate the object of entry, or entry is urgently required, or the premises are unoccupied, or the occupier is temporarily absent and it would frustrate the object of entry to await the occupier’s return,

the sheriff, may, by signed warrant, valid for a period of no more than one month, authorise that person, together with any person who may accompany an inspector by virtue of paragraph (4)(a), to enter the premises, if need be by reasonable force.

(4)

An inspector may—

(a)

take onto the land such other persons and such materials and equipment (including vehicles) as may be reasonably required for the purpose of assisting the inspector to exercise the power,

(b)

do anything else which is reasonably required for that purpose,

(c)

take samples of things on the land,

(d)

mark anything on the land for identification purposes,

(e)

in the case of anything on the land which appears to contain or have contained a genetically modified organism-

(i)

cause it to be dismantled or subjected to any process or test, or

(ii)

examine it,

(f)

take a photograph or any other digital record of anything on the land,

(g)

require access to, inspect and take copies of, or extracts from, any information on the land,

(h)

take away any information to enable it to be copied or kept as evidence,

(i)

require access to, inspect and check the operation of any computer and any associated apparatus or material and, for this purpose, require any person having charge of, or otherwise concerned with the operation of, any computer, apparatus or material to give the inspector such assistance as the inspector may reasonably require,

(j)

where information is kept by means of a computer, require it to be produced in a form in which it can be taken away.

(5)

If an inspector causes damage in exercising the power, they must take reasonable steps to remedy the damage.

(6)

If an inspector enters unoccupied land in exercising the power, the inspector must leave the land as effectively secured against unauthorised entry as the inspector found it.

(7)

In this regulation, “inspector” means a person appointed by the Scottish Ministers.

(8)

In this regulation, “sheriff” includes a summary sheriff.

Offences and penalties32B.

(1)

A person commits an offence if that person—

(a)

contravenes anything required of that person in a stop notice,

(b)

obstructs an inspector (or a person accompanying an inspector and acting under the inspector’s instructions) in exercise of the power conferred by regulation 32A,

(c)

supplies to an inspector (or a person accompanying an inspector and acting under the inspector’s instructions) any information knowing it to be false or misleading,

(d)

cultivates a genetically modified organism in contravention of a F123limitation or condition included in a consent to market F124pursuant to regulation 24(7) or a renewed consent to market F124pursuant to regulation 26(5),

(e)

cultivates a genetically modified organism in contravention of a F125limitation or condition included in a consent or a renewed consent pursuant to regulation 29A(3)(a), or

(f)

cultivates a genetically modified organism or approved product in contravention of a suspension notice issued under regulation 29A(3)(b),(c) or (d).

(2)

It is a defence for a person charged with an offence under paragraph (1) to show that they took all reasonable precautions and exercised all due diligence to avoid committing that offence.

(3)

A person who commits an offence under paragraph (1) is liable—

(a)

on summary conviction, to a fine not exceeding level 5 on the standard scale or to imprisonment for a term not exceeding three months, or to both, or

(b)

on conviction on indictment, to a fine or to imprisonment for a terms not exceeding 2 years or both.

Individual culpability for offending by an organisation32C.

(1)

Paragraph (2) applies where—

(a)

an offence under these regulations is committed by a relevant organisation, and

(b)

the commission of the offence involves the consent or connivance of, or is attributable to the neglect of—

(i)

a responsible official of the organisation, or

(ii)

an individual purporting to act in the capacity of a responsible official.

(2)

The responsible official (or, as the case may be, the individual purporting to act in that capacity) as well as the organisation, commits the offence.

(3)

“Relevant organisation” means—

(a)

a company,

(b)

a partnership (including a limited liability partnership),

(c)

another body or association.

(4)

“Responsible official” means—

(a)

in the case of a company—

(i)

a director, secretary, manager or similar officer, or

(i)

where the affairs of the company are managed by its members, a member,

(b)

in the case of a limited liability partnership, a member,

(c)

in the case of a partnership other than a limited liability partnership, a partner,

(d)

in the case of another body or association, a person who is concerned in the management or control of its affairs.

Service of notices32D.

(1)

Any notice required to be given to any person by the Scottish Ministers by virtue of these Regulations may be given by—

(a)

delivering it to that person,

(b)

leaving it at that person’s proper address,

(c)

sending it by post or fax to that person’s proper address, or

(d)

sending it by email to that person’s last known email address.

(2)

For the purposes of paragraph (1)(a), a notice is delivered to—

(a)

a body corporate where it is given to a relevant individual within that body,

(b)

a partnership where it is given to a partner or a person having control or management of the partnership, and

(c)

an unincorporated association where it is given to an officer or a member of the governing body of the association or any other person having management responsibilities in respect of the association.

(3)

For the purposes of paragraph (1)(b) and (c) and section 7 of the Interpretation Act 1978 (service of documents by post) in its application to this regulation, “proper address” means—

(a)

in the case of a body corporate, the registered office (if it is in the United Kingdom) or the principal office of the body in the United Kingdom,

(b)

in the case of a partnership, the principal office of the partnership,

(c)

in the case of an unincorporated association, the principal office of the association,

(d)

in any other case, a person’s last known address.

(4)

For the purposes of paragraph (1)(d), a notice is sent to an email address of—

(a)

a body corporate, where it is sent to an email address of—

(i)

the body corporate, or

(ii)

a relevant individual within that body,

where that address is supplied by that body for the conduct of the affairs of that body,

(b)

a partnership, where it is sent to an email address of—

(i)

the partnership, or

(ii)

a partner or person having control or management of that partnership,

where that address is supplied by that partnership for the conduct of the affairs of the partnership,

(c)

an unincorporated association, where it is sent to an email address of—

(i)

an officer or member of the governing body of the association, or

(ii)

any other person having management responsibilities in respect of the association,

where that address is supplied by that association for the conduct of the affairs of that association, and

(d)

a person other than a person mentioned in sub-paragraph (a), (b) or (c), where it is sent to an email address supplied by that person for the conduct of the affairs of that person.

(5)

In this regulation—

(a)

“partnership” includes a Scottish partnership, and

(b)

“relevant individual” means—

(i)

a director, manager, secretary or other similar officer of the body corporate, or

(ii)

where the affairs of the body corporate are managed by its members, a member.

PART VII CONFIDENTIALITY

Confidentiality33.

(1)

For the purposes of section 123(7) of the Act (exclusion from the register of certain information) the following descriptions of information are also information which the public interest requires to be included in the register notwithstanding that it may be commercially confidential:–

(a)

the location of the release of the genetically modified organism to which the information relates;

(b)

the intended use of the genetically modified organism to which the information relates;

(c)

the environmental risk assessment;

(d)

the methods and plans for monitoring and for responding to an emergency in relation to the genetically modified organisms to which the information relates; and

(e)

the name and address of the holder of a consent to which a prohibition notice or other information relates.

(2)

In section 123 of the Act (exclusion from register of certain information) in subsection (7) (particulars included even if commercially confidential)–

(a)

after “section 122(1)(a),” insert “ (c), ”;

(b)

in paragraph (b), after the word “the” where it appears for the first time insert “ general ”; and

(c)

paragraphs (c) and (e) are omitted.

PART VIII REGISTER OF INFORMATION

Information to be included in the register34.

(1)

The register shall contain the particulars set out in paragraphs (2) to (10).

(2)

In relation to a prohibition notice served by the Scottish Ministers under section 110 of the Act–

(a)

the name and address of the person on whom the notice is served;

(b)

the description of the genetically modified organisms in relation to which the notice is served;

(c)

the location at which the genetically modified organisms are proposed to be released;

(d)

the purpose for which the genetically modified organisms are proposed to be released or marketed;

(e)

the reason for the service of the notice; and

(f)

any date specified in the notice as the date on which the prohibition is to take effect.

(3)

Subject to paragraph (4), in relation to an application for a consent under section 111(1) of the Act–

(a)

the name and address of the applicant;

(b)

a general description of the genetically modified organisms in relation to which the application is being made;

(c)

the location at which the genetically modified organisms are proposed to be released, to the extent that this information is notified to the Scottish Ministers;

(d)

the purpose for which the genetically modified organisms are proposed to be released (including any future use to which they are intended to be put) or, in relation to a consent to market, the purpose for which they will be marketed;

(e)

the intended dates of the release;

(f)

the environmental risk assessment;

(g)

the methods and plans for monitoring the genetically modified organisms and for responding to an emergency; F126...

(h)

a summary of any advice the Scottish Ministers have received from the Advisory Committee on Releases to the Environment as to whether F127the applied for consent to release or, as the case may be, market genetically modified organisms should be granted or F128refused, and either–

(i)

the conditions or limitations in accordance with which that Committee has advised that the consent should be granted; or

(ii)

a summary of the reasons why that Committee has advised that the consent should not be granted F129, and

F130(i)

the summary of the application required by regulation 11(1)(d) or regulation 16(2)(j), as the case may be.

F131(3A)

Subject to paragraph (4) and to the information not being confidential, in relation to an application for a consent under section 111(1) of the Act to market genetically modified organisms—

(a)

the name and address of the person who is responsible for the marketing, whether manufacturer, importer or distributor,

(b)

the proposed commercial name of the product,

(c)

the names of the genetically modified organisms in the product, including the scientific and common names of, where appropriate, the parental, recipient and donor organisms,

(d)

the unique identifiers for the genetically modified organisms in the product,

(e)

an application reference code assigned by the Scottish Ministers,

(f)

the information included in the application as specified at paragraphs 3 and 7 of schedule 4, and

(g)

information on stored samples of the genetically modified organisms, including the type of material, its genetic characterisation and stability, the amount of repository material, and the conditions of appropriate storage and shelf-life.

(4)

Where the Scottish Ministers are or become aware that information regarding the genetically modified organisms or the purpose for which they will be released or marketed has been published which is more detailed than that which would satisfy the requirements of paragraph (3), they shall enter so much of that more detailed information on the register as they consider appropriate.

(5)

In relation to consents granted under section 111(1) of the Act–

(a)

a copy of the consent, and a reference to the application in respect of which it was granted;

(b)

any information supplied to the Scottish Ministers in accordance with conditions imposed on the consent;

(c)

the fact that the consent has been varied or revoked, the contents of the notice by which the consent was varied or revoked and, where applicable, a copy of the varied consent; and

(d)

a summary of any advice the Scottish Ministers have received from the Advisory Committee on Releases to the Environment as to whether a consent to release genetically modified organisms should be varied or revoked.

(6)

The following information concerning genetically modified organisms released or grown pursuant to a consent, or proposed to be released or grown pursuant to a consent, as the case may be:–

(a)

any information provided to the Scottish Ministers in accordance with section 111(6A) or 112(5)(b)(i) of the Act;

(b)

any information relating to an unforeseen event occurring in connection with a release of a genetically modified organism which might affect the risks there are of damage being caused to the environment notified to the Scottish Ministers in accordance with section 112(5)(b)(iii) M13 of the Act.

(7)

A copy of any consent to market genetically modified organisms granted F132before exit day by a competent authority of F133a F134member State F135or, at the time it was granted, the United Kingdom.

F136(7A)

A copy of any assessment report referred to in regulation 23(1)(c) or regulation 25(1)(c).

(8)

The location of any genetically modified organisms grown in Scotland pursuant to a consent to market insofar as that information is supplied to the Scottish Ministers in accordance with the monitoring requirements imposed in the consent.

(9)

Any decision adopted F137before exit day by the European Commission in accordance with Article 18 of the Deliberate Release Directive and such decisions are prescribed as matters relating to Part VI of the Act for the purposes of section 122(1)(h) of the Act.

(10)

In relation to convictions for any offence under section 118 of the Act–

(a)

the name and address of the person convicted;

(b)

the description of any genetically modified organisms in relation to which the conviction was obtained;

(c)

the offence which was committed;

(d)

the date on which the offence was committed;

(e)

the date on which the person was convicted; and

(f)

the penalty imposed and any order made by the court under section 120 of the Act (power of the court to order cause of offence to be remedied).

Keeping the register35.

(1)

The information on the register shall be made available to the public by such means as the Scottish Ministers shall consider appropriate.

(2)

The information prescribed in regulation 34(2) shall be placed on the register within twelve days of the prohibition notice being served.

(3)

The information prescribed in regulation 34(3) (a) to (g) F138and (i) shall be placed on the register within twelve days of receipt by the Scottish Ministers of the application for consent to release or market.

F139(3A)

The information prescribed in regulation 34(3A) must be placed on the register within 12 days of receipt by the Scottish Ministers of the application for consent to market.

(4)

The information prescribed in regulation 34(3)(h) shall be placed on the register within twelve days of the consent being granted or refused.

(5)

The information prescribed in regulation 34(5)(a) shall be placed on the register within twelve days of the consent being granted.

(6)

The information prescribed in regulation 34(5)(b) and (d) shall be placed on the register within twelve days of its receipt by the Scottish Ministers.

(7)

The information prescribed in regulation 34(5)(c) shall be placed on the register within fourteen days of the consent being revoked or varied.

F140(7A)

The information prescribed in regulation 34(7A) must be placed on the register within 12 days of its production.

(8)

The information prescribed in regulations 34(6) and 34(10) shall be placed on the register within fourteen days of its receipt by the Scottish Ministers.

F141(9)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(10)

The information prescribed in regulation 34(8) shall be placed on the register within fourteen days of its receipt by the Scottish Ministers.

F142(11)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(12)

The information prescribed in regulation 34(10) in relation to any particular conviction shall be removed from the register when that conviction is spent within the meaning of the Rehabilitation of Offenders Act 1974 M14.

Publication of representations36.

(1)

Subject to paragraph (2), the Scottish Ministers shall, within a period of twenty eight days after granting consent to or rejecting an application for the release of genetically modified organisms, make available to the public by whatever means they shall consider appropriate details of where, when and how copies of representations received may be inspected.

(2)

Paragraph (1) shall not require copies of representations to be made publicly available where they contain confidential information and the person making the representation has asked the Scottish Ministers to treat that information as confidential.

PART IX CONSEQUENTIAL AND OTHER AMENDMENTS AND REVOCATIONS

Consequential and other amendments – agency arrangements37.

The Scotland Act 1998 (Agency Arrangements) (Specification) (No. 2) Order 2002 M15 shall be amended in accordance with Schedule 6.

Revocations38.

The Regulations set out in column 1 of Schedule 7 are revoked to the extent specified in the corresponding entry in relation to those Regulations in column 3 of that Schedule.

ROSS FINNIE
A member of the Scottish Executive

St Andrew’s House, Edinburgh