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

[F1 PART 1 S INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO RELEASE FOR ANY OTHER PURPOSE THAN FOR PLACING ON THE MARKET

Textual Amendments

F1 Sch. 2 substituted (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 18

A. General information S

1.   The name and address of the applicant, and the name, qualifications and experience of the scientist and of every other person who will be responsible for planning and carrying out the release of the organisms, and for the supervision, monitoring and safety of the release.

2.   The title of the project.

B. Information relating to the release S

3.   The purpose of the release.

4.   The foreseen date or dates and duration of the release.

5.   The method by which the genetically modified plants will be released.

6.   The method for preparing and managing the release site, prior to, during and after the release, including cultivation practices and harvesting methods.

7.   The approximate number of genetically modified plants (or plants per square metre) to be released.

C. Information relating to the site of release S

8.   The location and size of the release site or sites.

9.   A description of the release site ecosystem, including climate, flora and fauna.

10.   The details of any sexually compatible wild relatives or cultivated plant species site or sites.

11.   The proximity of the release site or sites to officially recognised biotopes or protected areas which may be affected.

D. Information relating to the recipient plant or, where appropriate, to the parental plants S

12.   The full name of the plant, that is—

(a) family name,

(b) genus,

(c) species,

(d) subspecies,

(e) cultivar or breeding line, and

(f) common name.

13.   The geographical distribution and cultivation of the plant within the [F2 United Kingdom].

Textual Amendments

F2 Words in sch. 2 para. 13 substituted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(25)(a); 2020 c. 1, Sch. 5 para. 1(1)

14.   Information concerning—

(a) the reproduction of the plant, that is—

(i) the mode or modes of reproduction,

(ii) any specific factors affecting reproduction,

(iii) the generation time, and

(b) the sexual compatibility of the plant with other cultivated or wild plant species including the distribution in [F3 the United Kingdom] of the compatible species.

Textual Amendments

F3 Words in sch. 2 para. 14(b) substituted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(25)(b); 2020 c. 1, Sch. 5 para. 1(1)

15.   Information concerning the survivability of the plant, that is—

(a) its ability to form structures for survival or dormancy, and

(b) any specific factors affecting survivability.

16.   Information concerning the dissemination of the plant, that is—

(a) the ways and extent of dissemination, and

(b) any specific factors affecting dissemination.

17.   Where the application relates to a plant species which is not normally grown in the UK a description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts.

18.   Information concerning any other potential interactions, relevant to the genetically modified organism, of the plant with organisms in the ecosystem where it is usually grown, or elsewhere, including information on toxic effects on humans, animals and other organisms.

E. Molecular characterisation S

19.   Information relating to the genetic modification, that is—

(a) a description of the methods used for the genetic modification,

(b) the nature and source of the vector used, and

(c) the source of the nucleic acid or acids used for transformation, size, and intended function of each constituent fragment of the region intended for insertion.

20.   Information relating to the genetically modified higher plant, that is—

(a) a general description of the trait or traits and characteristics which have been introduced or modified,

(b) information on the sequences actually inserted or deleted, namely—

(i) the size and copy number of all insert or inserts and methods used for its or their characterisation,

(ii) in case of deletion, size and function of the deleted region or regions,

(iii) the subcellular location or locations of the insert or inserts in the plant cells (integrated in the nucleus, chloroplasts, mitochondria, or maintained in a non-integrated form), and methods for its/their determination,

(c) parts of the plant where the insert is expressed, and

(d) the genetic stability of the insert and phenotypic stability of the genetically modified higher plant.

21.   Conclusions of the molecular characterisation

F. Information on specific areas of risk S

22.   Any change to the persistence or invasiveness of the genetically modified higher plant, and its ability to transfer genetic material to sexually compatible relatives and the adverse environmental effects thereof.

23.   Any change to the ability of the genetically modified higher plant to transfer genetic material to microorganisms and the adverse environmental effects thereof.

24.   Information on the mechanism of interaction between the genetically modified higher plant and target organisms (if applicable) and the adverse environmental effects thereof.

25.   Information on the potential changes in the interactions of the genetically modified higher plant with non-target organisms resulting from the genetic modification and the adverse environmental effects thereof.

26.   Information on the potential changes in agricultural practices and management of the genetically modified higher plant resulting from the genetic modification and the adverse environmental effects thereof.

27.   Information on the potential interactions with the abiotic environment and the adverse environmental effects thereof.

28.   Information on any toxic, allergenic or other harmful effects on human and animal health arising from the genetic modification.

29.   Conclusions on the specific areas of risk.

G. Information on control, monitoring, post-release and waste treatment plans S

30.   Any measures taken, including—

(a) spatial and temporal isolation from sexually compatible plant species, both wild and weedy relatives and crops, and

(b) any measures to minimise or prevent the dispersal of any reproductive part of the genetically modified higher plant.

31.   A description of methods for post-release treatment of the site.

32.   A description of post-release treatment methods for the genetically modified plant material including wastes.

33.   A description of monitoring plans and techniques.

34.   A description of any emergency plans.

35.   A description of the methods and procedures to,—

(a) avoid or minimise the spread of the genetically modified higher plants beyond the site of release,

(b) protect the site from intrusion by unauthorised individuals, and

(c) prevent other organisms from entering the site or minimise such entries.

H. Other S

36.   A description of detection and identification techniques for the genetically modified higher plant.

37.   Information about previous releases of the genetically modified higher plant, if applicable.]