The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019
| Jurisdiction | Wales |
| Citation | SI 2019/1316 (W228) |
| Year | 2019 |
(1) The title of these Regulations is the Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019.(2) These Regulations come into force on 30 October 2019.The Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002
In regulation 2 (interpretation) , in the definition of “the Deliberate Release Directive” for the text from “2015/412 of the European” to “in their territory” substitute before “the information” insert omit from “to the extent” to the end, after paragraph (1) (d) insert— summaries and results of studies referred to in the application, including an explanation of their relevance to the environmental risk assessment, as appropriate.after paragraph (1) insert— 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.before “the information” insert in paragraph (i) , for “Schedule 1” substitute omit from “to the extent” to the end, in paragraph (2) , after sub-paragraph (j) insert— summaries and results of studies referred to in the application, including an explanation of their relevance to the environmental risk assessment, as appropriate,details of studies referred to in the application, including materials and methods used or reference to standardised or internationally recognised methods and the name of the body or bodies responsible for carrying out those studies.after paragraph (2) insert— The information specified in paragraph (2) (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 release resulting from the marketing of a genetically modified higher plant.(1) Schedule 1 (information to be included in applications for consent to release or market genetically modified higher plants) is amended as follows.(2) In the title, for the words following “consent to release” substitute “ genetically modified higher plants for non-marketing purposes ” .(3) For the shoulder note substitute “ Regulation 12 ” .(4) In paragraph 7, at the end insert “ in Europe ” .(5) In paragraph 8, for “in the United Kingdom” substitute “ in Europe ” .(6) For paragraph 15 substitute “ Information on parts of the plant where the insert is expressed ” .(7) After paragraph 15 insert—After Schedule 1 insert— 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.The designation and specification of the genetically modified plant, and the scope of the application, in particular whether the application is in respect of cultivation, for some other use (which must be specified) , or both.family name,genus,species,subspecies,cultivar or breeding line,common name.the mode or modes of reproduction,any specific factors affecting reproduction,generation time, andthe sexual compatibility of the plant with other cultivated or wild plant species, including the distribution in Europe of the compatible species.its ability to form structures for survival or dormancy,any specific factors affecting survivability.the means and extent (such as an estimation of how viable pollen or seeds decline with distance where applicable) of dissemination, andany specific factors affecting dissemination.The geographical distribution of the plant in Europe.Where the application relates to a plant species which is not normally grown in Europe, a description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts.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.
- (a) any change to the persistence or invasiveness of the genetically modified plant and its ability to transfer genetic material to sexually compatible relatives and the adverse environmental effects arising,
- (b) any change in the ability of the genetically modified plant to transfer genetic material to micro-organisms and the adverse environmental effects arising,
- (c) the mechanism of interaction between the genetically modified plant and target organisms, if applicable, and the adverse environmental effects arising,
- (d) potential changes in the interactions of the genetically modified plant with non-target organisms resulting from the genetic modification and the adverse environmental effects arising,
- (e) potential changes in agricultural practices and management of the genetically modified plant resulting from the genetic modification, if applicable, and the adverse environmental effects arising,
- (f) potential interactions with the abiotic environment and the adverse environmental effects arising,
- (g) any toxic, allergenic or other harmful effects on human health arising from the genetic modification,
- (h) conclusions on the specific areas of risk.
- (1) A description of any precautions to maintain spatial and, as the case may be, temporal separation of the genetically modified plant from sexually compatible plant species.
- (2) In sub-paragraph (1) “plant species” means—
- (a) wild and weedy relatives, or
- (b) crops.
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