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

Part II E+W DELIBERATE RELEASE OF ORGANISMS FOR ANY OTHER PURPOSE THAN FOR PLACING ON THE MARKET

Requirement for consent to release E+W

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

Exempt activities E+W

10.  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 F1 ... an approved product is released in accordance with the conditions and limitations to which the use of the product is subject.

Textual Amendments

F1 Words in reg. 10 omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(3); 2020 c. 1, Sch. 5 para. 1(1)

Applications for consent to release — general provisions E+W

11.—(1) An application for a consent to release genetically modified organisms must be made in writing to the National Assembly for Wales.

(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 application for consent to release E+W

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

(a) [F2 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,

F3 ...

(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 National Assembly for Wales 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 7,

(d) a summaryF4 ... of the information contained in the application [F5 in the relevant format set out in the Annex to Council Decision 2002/813/EC].

[F6 (e) summaries and results of studies referred to in the application, including an explanation of their relevance to the environmental risk assessment, as appropriate.]

[F7 (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,

(b) an indication of the information submitted in the application, the disclosure of which might harm the competitive position of the applicant and which should therefore be treated as confidential, and

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

(3) Any indication in accordance with paragraph (2)(b) must be accompanied by verifiable justification.

Textual Amendments

F2 Words in reg. 12(1)(a) inserted (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 4(a)(i)

F3 Words in reg. 12(1)(a) omitted (30.10.2019) by virtue of The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 4(a)(ii)

F4 Words in reg. 12(1)(d) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in reg. 12(1)(d) inserted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(4)(b); 2020 c. 1, Sch. 5 para. 1(1)

F6 Reg. 12(1)(e) inserted (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 4(b)

F7 Reg. 12(1A) inserted (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 4(c)

Advertisement of application for consent to release E+W

13.—(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 or she sends that application to the National Assembly for Wales, cause to be published in publications to be specified by the National Assembly for Wales 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 National Assembly for Wales within twelve days of the receipt of the application,

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

(g) a statement that the National Assembly for Wales will consider any representations made to it relating to risks of damage to the environment posed by the release of the genetically modified organisms within a period which it shall specify in accordance with these Regulations,

and shall immediately send a copy of the publications containing the advertisement to the National Assembly for Wales.

(2) A notice published under paragraph (1) above 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 National Assembly for Wales 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) above.

(4) A person who makes an application for a consent to release genetically modified organisms shall, not more than ten days after he or she sends that application to the National Assembly for Wales, give to the following persons notice in writing that he or she has made the application and shall include in such notice the information prescribed in paragraph (1)(a) to (g), save in so far as paragraph (2) permits such information to be excluded from the notice referred to in paragraph (1)—

(a) the local authority and any community 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,

[F8 (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) [F9 the Natural Resources Body for Wales],

F10 (f) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

and shall immediately send to the National Assembly for Wales copies of the notices.

Textual Amendments

F8 Reg. 13(4)(c) substituted (17.12.2018) by The Environment, Planning and Rural Affairs (Miscellaneous Amendments) (Wales) Regulations 2018 (S.I. 2018/1216), regs. 1(3), 4(3)

F9 Words in reg. 13(4)(e) substituted (1.4.2013) by The Natural Resources Body for Wales (Functions) Order 2013 (S.I. 2013/755), art. 1(2), Sch. 5 para. 16(2) (with Sch. 7)

F10 Reg. 13(4)(f) omitted (1.4.2013) by virtue of The Natural Resources Body for Wales (Functions) Order 2013 (S.I. 2013/755), art. 1(2), Sch. 5 para. 16(3) (with Sch. 7)

Transitional provisions for release E+W

14.  Where the National Assembly for Wales has received an application for consent to release genetically modified organisms before 31st December 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 National Assembly for Wales 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 17th January 2003;

(c) the application shall be treated as having been sent to the National Assembly for Wales for the purposes of regulations 13(1) and (4) and as having been received by the National Assembly for Wales for the purpose of regulation 21 on submission of the information required by paragraph (b); and

(d) if the information required by paragraph (b) has not been submitted by 17th January 2003, the National Assembly for Wales may refuse to proceed with the application.