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

[F1 D. Comparative analysis of agronomic and phenotypic characteristics and of composition of the genetically modified higher plant. S

54.   The following information is required, except where it is not relevant in view of the intended uses of the genetically modified organism—

(a) in respect of persistence and invasiveness including plant to plant gene transfer—

(i) an assessment of the potential for the genetically modified higher plant to become more persistent or invasive and the adverse environmental effects thereof,

(ii) an assessment of the potential for the genetically modified higher plant to transmit transgene or transgenes to sexually compatible relatives and the adverse environmental effects thereof, and

(iii) conclusions on the adverse environmental effect of persistence and invasiveness of the genetically modified higher plant including the adverse environmental effect of plant-to-plant gene transfer,

(b) in respect of plant to micro-organism gene transfer—

(i) an assessment of the potential for transfer of newly inserted DNA from the genetically modified higher plant to microorganisms and the adverse effect or effects thereof, and

(ii) the conclusions on the adverse effect or effects of the transfer of newly inserted DNA from the genetically modified higher plant to microorganisms for human and animal health and the environment,

(c) in respect of interactions of the genetically modified higher plant with target organisms, if relevant—

(i) an assessment of the potential for changes in the direct and indirect interactions between the genetically modified higher plant and target organisms and the adverse environmental effect or effects,

(ii) an assessment of the potential for evolution of resistance of the target organism to the expressed protein (based on the history of evolution of resistance to conventional pesticides or transgenic plants expressing similar traits) and any adverse environmental effect or effects thereof, and

(iii) the conclusions on adverse environmental effect or effects of interactions of the genetically modified higher plant with target organisms,

(d) the interactions of the genetically modified higher plant with non-target organisms namely—

(i) an assessment of the potential for direct and indirect interactions of the genetically modified higher plant with non-target organisms, including protected species, and the adverse effect or effects thereof,

(ii) an assessment of the potential adverse effect or effects on relevant ecosystem services and on the species providing those services,

(iii) the conclusions on adverse environmental effect or effects of the interactions of the genetically modified higher plant with non-target organisms,

(e) the impacts of the specific cultivation, management and harvesting techniques, namely—

(i) for genetically modified higher plants for cultivation, an assessment of the changes in the specific cultivation, management and harvesting techniques used for the genetically modified higher plant and the adverse environmental effect or effects thereof, and

(ii) the conclusions on the adverse environmental effect or effects of the specific cultivation, management and harvesting techniques,

(f) the effects on biogeochemical processes, namely—

(i) an assessment of the changes in the biogeochemical processes within the area in which the genetically modified higher plant is to be grown and in the wider environment, and the adverse effects thereof, and

(ii) the conclusions on adverse effects on biogeochemical processes,

(g) the effects on human and animal health, namely—

(i) an assessment of the potential direct and indirect interactions between the genetically modified higher plant and persons working with or coming into contact with the genetically modified higher plants, including through pollen or dust from a processed genetically modified higher plant, and an assessment of the adverse effects of those interactions on human health,

(ii) for genetically modified higher plants not destined for human consumption, but where the recipient or parental organism or organisms may be considered for human consumption, an assessment of the likelihood of and possible adverse effects on human health due to accidental intake,

(iii) an assessment of the potential adverse effects on animal health due to accidental consumption of the genetically modified higher plant or of material from that plant by animals,

(iv) the conclusions on the effects on human and animal health, and

(h) an overall risk evaluation and conclusions, namely a summary of all the conclusions under each area of risk taking into account—

(i) the risk characterisation in accordance with steps 1 to 4 of the methodology described in [F2 Chapter C.3 of Part C of schedule 1], and

(ii) the risk management strategies proposed in accordance with [F3 step 5 of the methodology described in that Chapter].]

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

F2 Words in sch. 2 para. 54(h)(i) 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)(e)(i); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in sch. 2 para. 54(h)(ii) 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)(e)(ii); 2020 c. 1, Sch. 5 para. 1(1)