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

PART V S GENERAL PROVISION FOR CONSENTS

General provisions of consents to market S

28.  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 the reports of monitoring to the Commission and the competent authorities of the Member States 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 organisms S

29.—(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.”.

[F1 Restrictions on cultivation S

29A.— (1) This regulation applies to—

(a) a consent given by the Scottish Ministers under section 111(1) of the Act (including a renewed consent given under regulation 26),

(b) an approved product, or

(c) an authorisation under the Food and Feed Regulation,

in respect of which the circumstances in paragraph (2) apply.

(2) The circumstances mentioned in paragraph (1) are—

(a) the Scottish Ministers did not make a demand under regulation 26A(1), or

(b) the applicant refused to agree with a demand made under regulation 26A(1) within a period of 30 days of being notified of it by the Commission.

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

(a) include a condition in the consent or renewed consent to limit its geographical scope as regards Scotland in respect of the cultivation of a genetically modified organism,

(b) issue a suspension notice in respect of a consent or renewed consent,

(c) issue a suspension notice in respect of the 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 15(a) (exempt activities), in respect of the cultivation of a specified 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 15(g), in respect of the cultivation of genetically modified food or 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 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, without prejudice to any measures adopted in respect of Article 26a of the Deliberate Release Directive,

(vi) agricultural policy objectives,

(vii) subject to paragraph (8), public policy,

(b) are in conformity with EU law,

(c) are proportional,

(d) are non-discriminatory, and

(e) do not conflict with the environmental risk assessment carried out pursuant to the Deliberate Release Directive or 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—

(a) notify the Commission of—

(i) a draft of the condition or suspension notice, and

(ii) the applicable grounds under paragraph (7)(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 condition or suspension notice to take account of comments from the Commission or another member State prior to its coming into force.

(12) The Scottish Ministers must—

(a) communicate the condition or suspension notice to the Commission, the other member States and the consent or authorisation holder without delay, and

(b) make details of the condition or suspension notice available to the public.]

Textual Amendments

F1 Regs. 29A, 29B inserted (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 13

[F1 Removal of restrictions under regulation 29A S

29B.— (1) The Scottish Ministers may, at any time, do any of the following in respect of measures adopted under regulation 29A—

(a) vary a condition in a consent to remove the limit on geographical scope in respect of the cultivation of a genetically modified organism,

(b) withdraw a suspension notice in respect of a consent,

(c) withdraw a suspension notice in respect of an 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 Commission and the other member States of any action taken under paragraph (1) without delay.]

Textual Amendments

F1 Regs. 29A, 29B inserted (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 13

Proof of compliance with consent conditions S

30.  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,”.

[F2 Stop notices S

30A.— (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 granted by the Scottish Ministers under section 111(1) of the Act or otherwise granted under the Deliberate Release Directive, or

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

(b) is cultivating or has cultivated a genetically modified organism in contravention of a limit included on the geographical scope of a consent to market under regulation 24(7) or a renewed consent to market under regulation 26(5),

(c) is cultivating or has cultivated a genetically modified organism in contravention of a condition in a consent to limit its geographical scope under 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) or (c).

(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.]

Textual Amendments

F2 Reg. 30A inserted (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 14

New information on risks of damage from marketing genetically modified organisms S

31.—(1) The Scottish Ministers shall ensure that any new information which becomes available to them which they consider could have consequences for the risks of damage being caused to the environment by marketing the genetically modified organisms shall be forwarded immediately to the Commission and the competent authority of each Member State.

(2) Where an application for consent or for renewal of consent to market genetically modified organisms has been made to the Scottish Ministers and the information referred to in paragraph (1) becomes available to them before the application has been determined, the Scottish Ministers may arrange to seek agreement with the Commission and the other Member States pursuant to Articles 15(1) or 17(7) of the Deliberate Release Directive as applicable.

(3) Subject to paragraph (4), where an application for consent or for renewal of consent to market genetically modified organisms has been made to the Scottish Ministers and the information referred to in paragraph (1) becomes available to them after the consent has been granted or renewed, the Scottish Ministers shall within sixty days after receipt of the new information, ensure that there is forwarded to the Commission an assessment report prepared in accordance with Schedule 5 indicating whether the conditions of the consent should be varied and if so, how, or whether the consent should be revoked.

(4) The Scottish Ministers shall not arrange for an assessment report to be forwarded if that assessment report indicates that the consent to market genetically modified organisms as it relates to the protection of human health should be varied or revoked without the agreement of the Health and Safety Executive.

(5) Where the Scottish Ministers have indicated that the consent should be varied or revoked and either–

(a) no reasoned objection has been raised by a Member State or by the Commission during a sixty day period beginning on the day the Commission circulated the assessment report; or

(b) a reasoned objection has been raised by a Member State or by the Commission but all outstanding issues have been resolved in accordance with Article 20(3) of the Deliberate Release Directive,

they shall vary or revoke the consent as proposed and they shall inform the applicant, and ensure that the other Member States and the Commission are informed, that they have done so within thirty days of the sixty day period specified in subparagraph (a) or of the resolution referred to in subparagraph (b), as the case may be.

(6) The Scottish Ministers shall only vary or revoke a consent to market genetically modified organisms under section 111(10) of the Act–

(a) where the information referred to in paragraph (1) has become available to them and the procedure referred to in paragraphs (3) and (5) has been complied with; or

(b) in accordance with a decision adopted by the Commission under Articles 18(1) or 23(2) of the Deliberate Release Directive.