Genetically Modified Organisms (Deliberate Release) Regulations 2002

PART II RELEASING ORGANISMS FOR ANY OTHER PURPOSE THAN MARKETING

Requirement for consent to release

8.  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.

[F1 Exemption for approved products]

9.  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 F2 ... an approved product is released in accordance with the conditions and limitations to which the use of the product is subject.

Textual Amendments

F1 Reg. 9 heading substituted (11.4.2022) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022 (S.I. 2022/347), regs. 1(1), 2(3)

F2 Words in reg. 9 omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Amendment) (England) (EU Exit) Regulations 2019 (S.I. 2019/88), regs. 1(2)(b), 3(3); 2020 c. 1, Sch. 5 para. 1(1)

[F3 Exemption for release of qualifying higher plants

9A.   The cases and circumstances prescribed for the purposes of sections 108(7) and 111(7) of the Act in which persons are exempt from the requirements of section 108(1)(a) of the Act (to carry out a risk assessment) and of section 111(1)(a) of the Act (to obtain consent) respectively, insofar as those requirements relate to releasing qualifying higher plants (which includes the import or acquisition of such plants for the purpose of release), are all cases and circumstances in which a person intends to release a qualifying higher plant, other than those in relation to the marketing of such qualifying higher plants.

Textual Amendments

F3 Regs. 9A, 9B inserted (11.4.2022) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022 (S.I. 2022/347), regs. 1(1), 2(4)

Notification requirement for release of qualifying higher plants

9B.— (1) The cases and circumstances prescribed for the purposes of section 108(1)(b) of the Act in which persons intending to release a genetically modified organism must give notice to the Secretary of State of that intention and such information as may be prescribed are all cases and circumstances in which a person intends to release a qualifying higher plant, other than those in relation to the marketing of such qualifying higher plants.

(2) A person to whom paragraph (1) applies must give that notice to the Secretary of State at least 20 days before the day on which the qualifying higher plant is released.

(3) A person to whom paragraph (1) applies must give the information set out in Schedule 3A to the Secretary of State in respect of their plans concerning the release of the qualifying higher plant (“the project”) at the same time as giving notice in accordance with this regulation.]

Textual Amendments

F3 Regs. 9A, 9B inserted (11.4.2022) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022 (S.I. 2022/347), regs. 1(1), 2(4)

Applications for consent to release—general provisions

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

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

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

Information to be contained in applications for consent to release

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

(a) [F4 subject to paragraph (1A),] the information prescribed in—

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

(ii) Schedule 2 in any other case,

F5 ...

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

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

(d) a summaryF6 ... of the information contained in the application [F7 , in the relevant format set out in the Annex to Council Decision 2002/813/EC].

[F8 (e) summaries and results of studies referred to in the application, including an explanation of their relevance to the environmental risk assessment, as appropriate.]

[F9 (1A) The information specified in paragraph (1)(a) is only required to be provided if it is necessary for the completion of an environmental risk assessment in the context of a specific application, and the level of detail to be provided may vary according to the nature and the scale of the proposed deliberate release.]

(2) The application may contain—

(a) data or results from an application for consent to release genetically modified organisms previously made by some other person, provided that a copy of that person’s agreement in writing is contained in the application, and

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

Textual Amendments

F4 Words in reg. 11(1)(a) inserted (29.9.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2019 (S.I. 2019/1252), regs. 1(1), 4(a)(i)

F5 Words in reg. 11(1)(a) omitted (29.9.2019) by virtue of The Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2019 (S.I. 2019/1252), regs. 1(1), 4(a)(ii)

F6 Words in reg. 11(1)(d) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Amendment) (England) (EU Exit) Regulations 2019 (S.I. 2019/88), regs. 1(2)(b), 3(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in reg. 11(1)(d) inserted (31.12.2020) by The Genetically Modified Organisms (Amendment) (England) (EU Exit) Regulations 2019 (S.I. 2019/88), regs. 1(2)(b), 3(4)(b); 2020 c. 1, Sch. 5 para. 1(1)

F8 Reg. 11(1)(e) inserted (29.9.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2019 (S.I. 2019/1252), regs. 1(1), 4(b)

F9 Reg. 11(1A) inserted (29.9.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2019 (S.I. 2019/1252), regs. 1(1), 4(c)

Advertisement of applications for consent to release

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

(a) the name and address of the applicant,

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

(c) the location and purpose of the release,

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

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

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

(g) a statement that the Secretary of State will consider any representations made to her relating to risks of damage to the environment posed by the release of the genetically modified organisms within a period which she shall specify in accordance with these Regulations

and shall immediately send a copy of the newspaper containing the advertisement to the Secretary of State.

(2) A notice published under paragraph (1) need not contain the information referred to in sub-paragraphs (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 Secretary of State 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, not more than ten days after he sends that application to the Secretary of State, give to the following persons notice in writing that he has made the application and shall include in such notice 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 any parish councils for the area or areas of each proposed release,

(b) the owner or owners of the site or sites of each proposed release, if a person other than the applicant,

[F10 (c) any person, or member of a genetic modification safety committee, from whom advice must be obtained under regulation 8 of the Genetically Modified Organisms (Contained Use) Regulations 2014,]

(d) the Association of National Park Authorities,

(e) English Nature M1 , and

(f) the Environment Agency,

and shall immediately send to the Secretary of State copies of the notices.

Textual Amendments

F10 Reg. 12(4)(c) substituted (1.6.2018) by The Environment, Food and Rural Affairs (Miscellaneous Amendments) (England) Regulations 2018 (S.I. 2018/575), regs. 1(2), 3(3)

Marginal Citations

M1 See section 128 of the Environmental Protection Act 1990 (c.43) and section 73 of the Countryside and Rights of Way Act 2000 (c.37).

Transitional provisions for release

13.  Where the Secretary of State has received an application for consent to release genetically modified organisms before 17 October 2002 pursuant to the 1992 Regulations and has not yet determined the application—

(a) the application shall be subject to the provisions of these Regulations,

(b) the applicant shall submit to the Secretary of State such further information, additional to that already provided in connection with the application, as is necessary in order to comply with the requirements of these Regulations by 17 January 2003,

(c) the application shall be treated as having been sent to the Secretary of State for the purposes of regulations 12(1) and (4) and as having been received by the Secretary of State for the purpose of regulation 20 on submission of the information required by paragraph (b), and

(d) if the information required by paragraph (b) has not been submitted by 17 January 2003, the Secretary of State may refuse to proceed with the application.