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

Regulation 6(1) and schedule 2

[F1 SCHEDULE 1 S PRINCIPLES FOR ENVIRONMENTAL RISK ASSESSMENT

Textual Amendments

F1 Sch. 1 inserted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), reg. 1(2)(b), sch. 1; 2020 c. 1, Sch. 5 para. 1(1)

Introduction S

1.— (1) This schedule describes in general terms the objective to be achieved, the elements to be considered and the general principles and methodology to be followed to perform the environmental risk assessment.

(2) In this schedule—

“cumulative long-term effects” means the accumulated effects of consents on human health and the environment, including among other things flora and fauna, soil fertility, soil degradation of organic material, the feed/food chain, biological diversity, animal health and resistance problems in relation to antibiotics,

“delayed effects” means the effects on human health or the environment which may not be observed during the period of the release of the genetically modified organism, but become apparent as a direct or indirect effect either at a later stage or after termination of the release,

“direct effects” means the primary effects on human health or the environment which are a result of the genetically modified organism itself and which do not occur through a causal chain of events,

“immediate effects” means the effects on human health or the environment which are observed during the period of the release of the genetically modified organism. Immediate effects may be direct or indirect, and

“indirect effects” means the effects on human health or the environment occurring through a causal chain of events, through mechanisms such as interactions with other organisms, transfer of genetic material, or changes in use or management (observations of indirect effects are likely to be delayed).

(3) A general principle for environmental risk assessment is that an analysis of the cumulative long-term effects relevant to the release and the placing on the market of genetically modified organisms is to be carried out.

PART A S OBJECTIVE

2.   The objective of an environmental risk assessment is, on a case by case basis, to identify and evaluate potential adverse effects of the genetically modified organism, either direct and indirect, immediate or delayed, on human health and the environment which the deliberate release or the placing on the market of genetically modified organisms may have. The environmental risk assessment should be conducted with a view to identifying if there is a need for risk management and if so, the most appropriate methods to be used. S

PART B S GENERAL PRINCIPLES

3.   In accordance with the precautionary principle, the following general principles should be followed when performing the environmental risk assessment— S

(a) identified characteristics of the genetically modified organism and its use which have the potential to cause adverse effects should be compared to those presented by the non-modified organism from which it is derived and its use under corresponding situations,

(b) the environmental risk assessment should be carried out in a scientifically sound and transparent manner based on available scientific and technical data,

(c) the environmental risk assessment should be carried out on a case by case basis, meaning that the required information may vary depending on the type of the genetically modified organisms concerned, their intended use and the potential receiving environment, taking into account, among other things, genetically modified organisms already in the environment, and

(d) if new information on the genetically modified organism and its effects on human health or the environment becomes available, the environmental risk assessment may need to be readdressed in order to—

(i) determine whether the risk has changed, and

(ii) determine whether there is a need for amending the risk management accordingly.

PART C S METHODOLOGY

CHAPTER C.1 S GENERAL AND SPECIFIC CONSIDERATION FOR THE ENVIRONMENTAL RISK ASSESSMENT

Step 1: Intended and unintended changes S

4.— (1) As part of the identification and evaluation of the potential adverse effects referred to in Part A of this schedule, the environmental risk assessment must identify the intended and unintended changes resulting from the genetic modification and must evaluate their potential to cause adverse effects on human health and on the environment.

(2) Intended changes resulting from the genetic modification are changes that are designed to occur and which fulfil the original objectives of the genetic modification.

(3) Unintended changes resulting from the genetic modification are consistent changes which go beyond the intended change(s) resulting from the genetic modification.

(4) Intended and unintended changes can have either direct or indirect, and either immediate or delayed effects on human health and on the environment.

Step 2: Long-term adverse effects and cumulative long-term adverse effects in the environmental risk assessment of applications to which Part 3 of these Regulations applies S

5.— (1) Long-term effects of a genetically modified organism are effects resulting either from a delayed response by organisms or their progeny to long-term or chronic exposure to a genetically modified organism or from an extensive use of a genetically modified organism in time and space.

(2) The identification and evaluation of the potential long-term adverse effects of a genetically modified organism on human health and on the environment must take into account the following—

(a) the long-term interactions of the genetically modified organism and the receiving environment,

(b) the characteristics of the genetically modified organism which become important on a long- term basis, and

(c) data obtained from repeated deliberate releases or placings on the market of the genetically modified organism over a long period.

(3) The identification and evaluation of the potential cumulative long-term adverse effects referred to in the introduction of this schedule must also take into account the genetically modified organisms deliberately released or placed on the market in the past.

Step 3: Quality of the data S

6.— (1) In order to carry out an environmental risk assessment for an application to which Part 3 of these Regulations applies, the applicant must collate already available data from scientific literature or from other sources, including monitoring reports, and must generate the necessary data by performing, where possible, appropriate studies. Where applicable, the applicant must justify in the environmental risk assessment why generating data by studies is not possible.

(2) The environmental risk assessment for applications to which Part 2 of these Regulations applies must be based at least on already available data from scientific literature or from other sources and may be supplemented by additional data generated by the applicant.

(3) Where data generated outside the United Kingdom is provided in the environmental risk assessment, its relevance to receiving environment(s) in the United Kingdom must be justified.

(4) Data provided in the environmental risk assessment for applications to which Part 3 of these Regulations applies, must comply with the following requirements—

(a) where toxicological studies carried out to assess risk to human or animal health are provided in the environmental risk assessment, the applicant must provide evidence to demonstrate that they were conducted in facilities which comply with—

(i) if carried out in the United Kingdom, retained EU law relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances,

(ii) if carried out in a member State of the EU, EU law relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances, or

(iii) if carried out elsewhere, the ‘OECD Principles on Good Laboratory Practice’,

(b) where studies other than toxicological studies are provided in the environmental risk assessment, they must—

(i) comply with the principles of Good Laboratory Practice laid down in retained EU law, where relevant, or

(ii) be conducted by organisations accredited under the relevant ISO standard, or

(iii) in the absence of a relevant ISO standard, be conducted in accordance with internationally recognised standards,

(c) information on the results obtained from the studies referred to in sub-paragraphs (a) and (b) and on the study protocols used must be reliable and comprehensive and must include the raw data in an electronic format suitable for carrying out statistical or other analysis,

(d) the applicant must specify, where possible, the size of effect that each study performed intends to detect and justify it,

(e) the selection of sites for field studies must be based on relevant receiving environments in view of the potential exposure and impact that would be observed where the genetically modified organism may be released. The selection must be justified in the environmental risk assessment, and

(f) the non-genetically modified comparator must be appropriate for the relevant receiving environment(s) and must have a genetic background comparable to the genetically modified organism. The choice of the comparator must be justified in the environmental risk assessment.

Step 4: Stacked transformation events in applications to which Part 3 of these Regulations applies S

7.   The following must apply to the environmental risk assessment of a genetically modified organism containing stacked transformation events in applications to which Part 3 of these Regulations applies—

(a) the applicant must provide an environmental risk assessment for each single transformation event in the genetically modified organism or refer to already submitted applications (or equivalent notifications) for those single transformation events,

(b) the applicant must provide an assessment of the following aspects—

(i) the stability of the transformation events,

(ii) the expression of the transformation events, and

(iii) the potential additive, synergistic or antagonistic effects resulting from the combination of the transformation events, and

(c) where the progeny of the genetically modified organism can contain various sub-combinations of the stacked transformation events, the applicant must provide a scientific rationale justifying that there is no need to provide experimental data for the concerned sub-combinations, independently of their origin, or, in the absence of such scientific rationale, must provide the relevant experimental data.

CHAPTER C.2 S CHARACTERISTICS OF THE GENETICALLY MODIFIED ORGANISM AND OF THE RELEASES

8.— (1) The environmental risk assessment must take into account the relevant technical and scientific details regarding characteristics of— S

(a) the recipient or parental organism(s),

(b) the genetic modification(s), be it insertion or deletion of genetic material, and relevant information on the vector and the donor,

(c) the genetically modified organism,

(d) the intended release or use including its scale,

(e) the potential receiving environment(s) into which the genetically modified organism will be released and into which the transgene may spread, and

(f) the interaction(s) between these characteristics.

(2) Relevant information from previous releases of the same or similar genetically modified organisms and organisms with similar traits and their biotic and abiotic interaction with similar receiving environments, including information resulting from the monitoring of such organisms, must be considered in the environmental risk assessment, subject to regulations 11(2) and 16(3).

CHAPTER C.3 S STEPS IN THE ENVIRONMENTAL RISK ASSESSMENT

9.   The environmental risk assessment must be conducted for each relevant area of risk referred to in Chapters D.1 and D.2 of Part D of this schedule in accordance with the following six steps. S

Step 1: Problem formulation including hazard identification S

10.— (1) The problem formulation must—

(a) identify any changes in the characteristics of the organism, linked to the genetic modification, by comparing the characteristics of the genetically modified organism with those of the chosen non-genetically modified comparator under corresponding conditions of release or use,

(b) identify potential adverse effects on human health or the environment which are linked to the changes that have been identified under sub-paragraph (1)(a),

(c) identify relevant assessment end-points,

(d) identify and describe the exposure pathways or other mechanisms through which adverse effects may occur,

(e) formulate testable hypotheses, and define relevant measurement end-points, to allow, where possible, a quantitative evaluation of the potential adverse effect(s), and

(f) consider possible uncertainties, including knowledge gaps and methodological limitations.

(2) For the purposes of sub-paragraph (1)(b)—

(a) potential adverse effects must not be discounted on the basis that they are unlikely to occur,

(b) potential adverse effects will vary from case to case, and may include—

(i) effects on the dynamics of populations of species in the receiving environment and the genetic diversity of each of these populations leading to a potential decline in biodiversity,

(ii) altered susceptibility to pathogens facilitating the dissemination of infectious diseases or creating new reservoirs or vectors,

(iii) compromising prophylactic or therapeutic medical, veterinary, or plant protection treatments, for example by transfer of genes conferring resistance to antibiotics used in human or veterinary medicine,

(iv) effects on biogeochemistry (biogeochemical cycles), including carbon and nitrogen recycling through changes in soil decomposition of organic material,

(v) disease affecting humans, including allergenic or toxic reactions, and

(vi) disease affecting animals and plants, including toxic, and, in the case of animals, allergenic reactions, where appropriate, and

(c) where potential long-term adverse effects of a genetically modified organism are identified, they must be assessed in the form of desk based studies using, where possible, one or more of the following—

(i) evidence from previous experiences,

(ii) available data sets or literature, or

(iii) mathematical modelling.

(3) For the purposes of sub-paragraph (1)(c), the potential adverse effects that could impact the identified assessment end-points must be considered in the next steps of the risk assessment.

(4) For the purposes of sub-paragraph (1)(d), adverse effects may occur directly or indirectly through exposure pathways or other mechanisms which may include—

(a) the spread of the genetically modified organism(s) in the environment,

(b) the transfer of the inserted genetic material to the same organism or other organisms, whether genetically modified or not,

(c) phenotypic and genetic instability,

(d) interactions with other organisms, and

(e) changes in management, including, where applicable, in agricultural practices.

Step 2: Hazard characterisation S

11.— (1) The magnitude of each potential adverse effect must be evaluated. This evaluation must assume that such an adverse effect will occur. The environmental risk assessment must consider that the magnitude is likely to be influenced by the receiving environment(s) into which the genetically modified organism is intended to be released and by the scale and conditions of the release.

(2) Where possible, the evaluation must be expressed in quantitative terms.

(3) Where the evaluation is expressed in qualitative terms, a categorical description (‘high’, ‘moderate’, ‘low’ or ‘negligible’) must be used and an explanation of the scale of effect represented by each category must be provided.

Step 3: Exposure characterisation S

12.— (1) The likelihood or probability of each identified potential adverse effect occurring must be evaluated to provide, where possible, a quantitative assessment of the exposure as a relative measure of probability, or otherwise a qualitative assessment of the exposure. The characteristics of the receiving environment(s) and the scope of the application must be taken into consideration.

(2) Where the evaluation is expressed in qualitative terms, a categorical description (‘high’, ‘moderate’, ‘low’ or ‘negligible’) of the exposure must be used and an explanation of the scale of effect represented by each category must be provided.

Step 4: Risk characterisation S

13.— (1) The risk must be characterised by combining, for each potential adverse effect, the magnitude with the likelihood of that adverse effect occurring to provide a quantitative or semi quantitative estimation of the risk.

(2) Where a quantitative or semi quantitative estimation is not possible, a qualitative estimation of the risk must be provided. In that case, a categorical description (‘high’, ‘moderate’, ‘low’ or ‘negligible’) of the risk must be used and an explanation of the scale of effect represented by each category must be provided.

(3) Where relevant, the uncertainty for each identified risk must be described and, where possible, expressed in quantitative terms.

Step 5: Risk management strategies S

14.— (1) Where risks are identified that require, on the basis of their characterisation, measures to manage them, a risk management strategy must be proposed for each risk.

(2) The risk management strategies must be described in terms of reducing the hazard or the exposure, or both, and must be proportionate to the intended reduction of the risk, the scale and conditions of the release and the levels of uncertainty identified in the environmental risk assessment

(3) The consequent reduction in overall risk must be quantified where possible.

Step 6: Overall risk evaluation and conclusions S

15.— (1) A qualitative and, where possible, quantitative evaluation of the overall risk of the genetically modified organism must be made taking into account the results of the risk characterisation, the proposed risk management strategies and the associated levels of uncertainty.

(2) The overall risk evaluation must include, where applicable, the risk management strategies proposed for each identified risk.

(3) The overall risk evaluation and conclusions must also propose specific requirements for the monitoring plan of the genetically modified organism and, where appropriate, the monitoring of the efficacy of the proposed risk management measures.

(4) For applications to which Part 3 of these Regulations applies, the overall risk evaluation must also include an explanation of the assumptions made during the environmental risk assessment and of the nature and magnitude of uncertainties associated with the risks, and a justification of the risk management measures proposed.

PART D S CONCLUSIONS ON THE SPECIFIC AREAS OF RISK OF THE ENVIRONMENTAL RISK ASSESSMENT

16.   Conclusions on the potential environmental impact in relevant receiving environments from the release or the placing on the market of genetically modified organisms must be drawn for each relevant area of risk listed in Chapter D.1 for genetically modified organisms other than higher plants or, as the case may be, Chapter D.2 for genetically modified higher plants, on the basis of an environmental risk assessment carried out in accordance with the principles outlined in Part B of this schedule and following the methodology described in Part C of this schedule, and on the basis of the information required pursuant to schedules 2 and 3. S

CHAPTER D.1 S GENETICALLY MODIFIED ORGANISMS OTHER THAN HIGHER PLANTS

Areas of risk S

17.— (1) Likelihood of the genetically modified organism becoming persistent and invasive in natural habitats under the conditions of the proposed release(s).

(2) Any selective advantage or disadvantage conferred to the genetically modified organism and the likelihood of this becoming realised under the conditions of the proposed release(s).

(3) Potential for gene transfer to other species under conditions of the proposed release of the genetically modified organism and any selective advantage or disadvantage conferred to those species.

(4) Potential immediate and/or delayed environmental impact of the direct and indirect interactions between the genetically modified organism and target organisms (if applicable).

(5) Potential immediate and/or delayed environmental impact of the direct and indirect interactions between the genetically modified organism with non-target organisms, including impact on population levels of competitors, prey, hosts, symbionts, predators, parasites and pathogens.

(6) Possible immediate and/or delayed effects on human health resulting from potential direct and indirect interactions of the genetically modified organism and persons working with, coming into contact with or in the vicinity of the genetically modified organism release(s).

(7) Possible immediate and/or delayed effects on animal health and consequences for the feed/food chain resulting from consumption of the genetically modified organism and any product derived from it, if it is intended to be used as animal feed.

(8) Possible immediate and/or delayed effects on biogeochemical processes resulting from potential direct and indirect interactions of the genetically modified organism and target and non-target organisms in the vicinity of the genetically modified organism release(s).

(9) Possible immediate and/or delayed, direct and indirect environmental impacts of the specific techniques used for the management of the genetically modified organism where these are different from those used for non-genetically modified organisms.

CHAPTER D.2 S GENETICALLY MODIFIED HIGHER PLANTS

Areas of risk S

18.— (1) Persistence and invasiveness of the genetically modified higher plants, including plant to plant gene transfer.

(2) Plant to micro-organisms gene transfer.

(3) Interactions of the genetically modified higher plants with target organisms.

(4) Interactions of the genetically modified higher plants with non-target organisms.

(5) Impacts of the specific cultivation, management and harvesting techniques.

(6) Effects on biogeochemical processes.

(7) Effects on human and animal health.]

Regulations 11(1) and 16(2)

[F2 SCHEDULE 2 S INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO RELEASE OR MARKET GENETICALLY MODIFIED HIGHER PLANTS

Textual Amendments

F2 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

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

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 [F3 United Kingdom].

Textual Amendments

F3 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 [F4 the United Kingdom] of the compatible species.

Textual Amendments

F4 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.

PART 2 S INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO PLACE ON MARKET

A. General information S

38.   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.

39.   The designation and specification of the genetically modified higher plant.

40.   The scope of the notification including—

(a) cultivation

(b) any other use.

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

41.   The complete name of the plant, that is—

(a) family name,

(b) genus,

(c) species,

(d) subspecies,

(e) cultivar/breeding line, and

(f) common name.

42.   The geographical distribution and cultivation of the plant within the [F5 United Kingdom].

Textual Amendments

F5 Words in sch. 2 para. 42 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)(c); 2020 c. 1, Sch. 5 para. 1(1)

43.   The reproduction of the plant, that is—

(a) the mode or modes of reproduction,

(b) any specific factors affecting reproduction,

(c) generation time, and

(d) the sexual compatibility of the plant with other cultivated or wild plant species including the distribution in the [F6 United Kingdom] of the compatible species.

Textual Amendments

F6 Words in sch. 2 para. 43 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)(c); 2020 c. 1, Sch. 5 para. 1(1)

44.   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.

45.   Information concerning the dissemination: of the plant, that is—

(a) the ways and extent of dissemination, and

(b) any specific factors affecting dissemination.

46.   Where a plant species is not normally grown in the [F7 United Kingdom], a description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts.

Textual Amendments

F7 Words in sch. 2 para. 46 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)(c); 2020 c. 1, Sch. 5 para. 1(1)

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

C. Molecular Characterisation S

48.   Information relating to the genetic modification including—

(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.

49.— (1) Information relating to the genetically modified plant, that is—

(a) a 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 detectable inserts, both partial and complete, and methods used for its characterisation,

(ii) the organisation and sequence of the inserted genetic material at each insertion site in a standardised electronic format,

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

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

(v) in the case of modifications other than insertion or deletion, the function of the modified genetic material before and after the modification, as well as direct changes in expression of genes as a result of the modification,

(vi) the sequence information in a standardised electronic format for both 5′ and 3′ flanking regions at each insertion site,

(vii) the bioinformatic analysis using up-to-date databases, to investigate possible interruptions of known genes,

(viii) all Open Reading Frames, (‘ORFs’) within the insert (either due to rearrangement or not) and those created as a result of the genetic modification at the junction sites with genomic DNA,

(ix) the bioinformatic analysis using up-to-date databases, to investigate possible similarities between the ORFs and known genes which may have adverse effects,

(x) the primary structure (amino acid sequence) and, if necessary, other structures, of the newly expressed protein, and

(xi) the bioinformatic analysis using up-to-date databases, to investigate possible sequence homologies and, if necessary, structural similarities between the newly expressed protein and known proteins or peptides which may have adverse effects.

(2) An ‘ORF’ is defined as a nucleotide sequence that contains a string of codons that is uninterrupted by the presence of a stop codon in the same reading frame.

50.   Information on the expression of the insert that is—

(a) the method or methods used for expression analysis together with their performance characteristics,

(b) any information on the developmental expression of the insert during the life cycle of the plant,

(c) the parts of the plant where the insert or modified sequence is expressed,

(d) the potential unintended expression of new ORFs identified under paragraph 49(b)(vii), which raise a safety concern,

(e) the protein expression data, including the raw data, obtained from field studies and related to the conditions in which the crop is grown and,

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

51.   The conclusions of molecular characterisation.

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

52.   The comparative analysis of agronomic and phenotypic characteristics and of composition that is—

(a) the choice of conventional counterpart and additional comparators,

(b) the choice of sites for field studies,

(c) the experimental design and statistical analysis of data from field trials for comparative analysis namely—

(i) a description of field studies design

(ii) a description of the relevant aspect of the receiving environments,

(iii) the statistical analysis,

(d) the selection of plant material for analysis, if relevant,

(e) the comparative analysis of agronomic and phenotypic characteristics,

(f) the comparative analysis of composition, if relevant, and

(g) the conclusions of the comparative analysis.

53.   For each of the seven areas of risk referred to in [F8 in Chapter D.2 of Part D of schedule 1], a description of the pathway to harm explaining in a chain of cause and effect how the release of the genetically modified higher plant could lead to harm, taking into account both hazard and exposure.

Textual Amendments

F8 Words in sch. 2 para. 53 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)(d); 2020 c. 1, Sch. 5 para. 1(1)

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 [F9 Chapter C.3 of Part C of schedule 1], and

(ii) the risk management strategies proposed in accordance with [F10 step 5 of the methodology described in that Chapter].

Textual Amendments

F9 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)

F10 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)

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

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

Regulations 11(1) and 16(2)

SCHEDULE 3 S INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO RELEASE OR MARKET ORGANISMS OTHER THAN GENETICALLY MODIFIED HIGHER PLANTS

PART I S GENERAL INFORMATION

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. S

2.  The title of the project. S

PART II S INFORMATION RELATING TO THE ORGANISMS

Characteristics of donor, parental and recipient organisms S

1.   

3.  Scientific name and taxonomy. S

4.  Usual strain, cultivar or other name. S

5.  Phenotypic and genetic markers. S

6.  The degree of relatedness between donor and recipient or between parental organisms. S

7.  The description of identification and detection techniques. S

8.  The sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques. S

9.  The description of the geographic distribution and of the natural habitat of the organisms including information on natural predators, prey, parasites and competitors, symbionts and hosts. S

10.  The organisms with which transfer of genetic material is known to occur under natural conditions. S

11.  Verification of the genetic stability of the organisms and factors affecting that stability. S

12.  The following pathological, ecological and physiological traits:– S

(a) the classification of hazard according to [F11 retained EU law] concerning the protection of human health and the environment;

(b) the generation time in natural ecosystems, sexual and asexual reproductive cycle;

(c) information on survivability, including seasonability and the ability to form survival structures, including seeds, spores and sclerotia;

(d) pathogencity, including infectivity, toxigenicity, virulence, allergenicity, carrier (vector) of pathogen, possible vectors, host range including non-target organisms and possible activation of latent viruses (proviruses) and ability to colonise other organisms;

(e) antibiotic resistance, and potential use of these antibiotics in humans and domestic organisms for prophylaxis and therapy; and

(f) involvement in environmental processes, including primary production, nutrient turnover, decomposition of organic matter and respiration.

Textual Amendments

F11 Words in sch. 3 para. 12(a) 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(26); 2020 c. 1, Sch. 5 para. 1(1)

13.  The sequence, frequency of mobilisation and specificity of indigenous vectors, and the presence in those vectors of genes which confer resistance to environmental stresses. S

14.  The history of genetic modifications. S

Characteristics of the vector S

2.   

15.  The nature and source of the vector. S

16.  The sequence of transposons, vectors and other non-coding genetic segments used to construct the genetically modified organisms and to make the introduced vector and insert function in those organisms. S

17.  The frequency of mobilisation, genetic transfer capabilities and/or methods of determination of the inserted vector. S

18.  Information on the degree to which the vector is limited to the DNA required to perform the intended function. S

Characteristics of the modified organisms S

3.   

19.  The methods used for the modification. S

20.  The methods used– S

(a) to construct inserts and to introduce them into the recipient organism; and

(b) to delete a sequence.

21.  The description of any insert and/or vector construction. S

22.  The purity of the insert from any unknown sequence and information on the degree to which the inserted sequence is limited to the DNA required to perform the intended function. S

23.  The methods and criteria used for selection. S

24.  The sequence, functional identity and location of the altered, inserted or deleted nucleic acid segment or segments in question, and in particular any known harmful sequence. S

Characteristics of the genetically modified organisms in their final form S

4.   

25.  The description of genetic traits or phenotypic characteristics and in particular any new traits and characteristics which may be expressed or no longer expressed. S

26.  The structure and amount of any vector or donor nucleic acid remaining in the final construction of the modified organism. S

27.  The stability of the organism in terms of genetic traits. S

28.  The rate and level of expression of the new genetic material in the organism, and the method and sensitivity of measurement of that rate and level. S

29.  The activity of the expressed protein. S

30.  The description of identification and detection techniques, including techniques for the identification and detection of the inserted sequence and vector. S

31.  The sensitivity, reliability (in quantitative terms), and specificity of detection and identification techniques. S

32.  The history of previous releases or uses of the genetically modified organisms. S

33.  In relation to human health, animal health and plant health– S

(a) the toxic or allergenic effects of the organisms and/or their metabolic products;

(b) the comparison of the modified organism to the donor, recipient or (where appropriate) parental organism regarding pathogenicity;

(c) the capacity of the organisms for colonisation;

(d) if the organism is pathogenic to humans who are immunocompetent–

(i) diseases caused and mechanism of pathogenicity including invasiveness and virulence;

(ii) communicability;

(iii) infective dose;

(iv) host range and possibility of alteration;

(v) possibility of survival outside of human host;

(vi) presence of vectors or means of dissemination;

(vii) biological stability;

(viii) antibiotic resistance patterns;

(ix) allergenicity; and

(x) availability of appropriate therapies; and

(e) the other product hazards.

PART III S INFORMATION RELATING TO THE CONDITIONS OF RELEASE AND THE RECEIVING ENVIRONMENT

The release S

5.   

34.  The description of the proposed deliberate release, including the purpose of the release and the foreseen products of the release. S

35.  The foreseen dates of the release and time planning of the experiment including frequency and duration of releases. S

36.  The preparation of the site before the release. S

37.  The size of the site. S

38.  The methods to be used for the release. S

39.  The quantity of organisms to be released. S

40.  The disturbance of the site, including the type and method of cultivation, mining, irrigation or other activities. S

41.  The worker protection measures taken during the release. S

42.  The post-release treatment of the site. S

43.  The techniques foreseen for elimination or inactivation of the genetically modified organisms at the end of the experiment or other purpose of the release. S

44.  Information on, and the results of, previous releases of the organisms, and in particular, releases on a different scale or into different ecosystems. S

The environment (both on the site and in the wider environment) S

6.   

45.  The geographical location and national grid reference of the site onto which the release will be made, or in the case of applications for consent to market or renewed consent to market the foreseen areas of use of the product. S

46.  The physical or biological proximity of the site of the organisms to humans and other significant biota. S

47.  The proximity to significant biotopes, protected areas or drinking water supplies. S

48.  The climatic characteristics of the region or regions likely to be affected. S

49.  The geographical, geological and pedological characteristics. S

50.  The flora and fauna, including crops, livestock and migratory species. S

51.  The description of the target and non-target ecosystems likely to be affected. S

52.  A comparison of the natural habitat of the recipient organism with the proposed site or sites of release. S

53.  Any known planned developments or changes in land use in the region which could influence the environmental impact of the release. S

PART IV S INFORMATION RELATING TO THE INTERACTIONS BETWEEN THE GENETICALLY MODIFIED ORGANISMS AND THE ENVIRONMENT

Characteristics affecting survival, multiplication and dissemination S

7.   

54.  The biological features which affect survival, multiplication and dispersal. S

55.  The known or predicted environmental conditions which may affect survival, multiplication and dissemination, including wind, water, soil, temperature and pH. S

56.  The sensitivity to specific agents. S

Interactions with the environment S

8.   

57.  The predicted habitat of the genetically modified organisms. S

58.  The studies on the behaviour and characteristics of the genetically modified organisms and their ecological impact carried out in simulated natural environments, such as microcosms, growth rooms and greenhouses. S

59.  The capability of post-release transfer of genetic material– S

(a) from the genetically modified organisms into organisms in affected ecosystems;

(b) from indigenous organisms to the genetically modified organisms.

60.  The likelihood of post-release selection leading to the expression of unexpected and/or undesirable traits in the genetically modified organism. S

61.  The measures employed to ensure and to verify genetic stability, the description of genetic traits which may prevent or minimise dispersal of genetic material, and methods to verify genetic stability. S

62.  The routes of biological dispersal, known or potential modes of interaction with the disseminating agent, including inhalation, ingestion, surface contact and burrowing. S

63.  The description of ecosystems to which the genetically modified organisms could be disseminated. S

64.  The potential for excessive population increase of the genetically modified organisms in the environment. S

65.  The competitive advantage of the genetically modified organisms in relation to the unmodified recipient or parental organisms. S

66.  The identification and description of the target organisms if applicable. S

67.  The anticipated mechanism and result of interaction between the released genetically modified organisms and the target organisms, if applicable. S

68.  The identification and description of non-target organisms which may be adversely affected by the release of the genetically modified organism, and the anticipated mechanisms of any identified adverse interaction. S

69.  The likelihood of post release shifts in biological interactions or in the host range. S

70.  The known or predicted interactions with non-target organisms in the environment, including competitors, preys, hosts, symbionts, predators, parasites and pathogens. S

71.  The known or predicted involvement of the genetically modified organisms in biogeochemical processes. S

72.  Any other potential interactions of the organisms with the environment. S

PART V S INFORMATION ON MONITORING, CONTROL, WASTE TREATMENT AND EMERGENCY RESPONSE PLANS

Monitoring techniques S

9.   

73.  Methods for tracing the genetically modified organisms and for monitoring their effects. S

74.  Specificity (to identify the genetically modified organisms, and to distinguish them from the donor, recipient or, where appropriate, the parental organisms), sensitivity and reliability of the monitoring techniques. S

75.  Techniques for detecting transfer of the donated genetic material to other organisms. S

76.  Duration and frequency of the monitoring. S

Control of the release S

10.   

77.  Methods and procedures to avoid and/or minimise the spread of the genetically modified organisms beyond the site of release or the designated area for use. S

78.  Methods and procedures to protect the site from intrusion by unauthorised individuals. S

79.  Methods and procedures to prevent other organisms from entering the site. S

Waste treatment S

11.   

80.  Type of waste generated. S

81.  Expected amount of waste. S

82.  Description of treatment envisaged. S

Emergency response plans S

12.   

83.  Methods and procedures for controlling the genetically modified organisms in case of unexpected spread. S

84.  Methods, such as eradication of the genetically modified organisms, for decontamination of the areas affected. S

85.  Methods for disposal or sanitation of plants, animals, soils, and any other thing exposed during or after the spread. S

86.  Methods for the isolation of the area affected by the spread. S

87.  Plans for protecting human health and the environment in case of the occurrence of an undesirable effect. S

PART VI S INFORMATION ON METHODOLOGY

88.  A description of the methods used or a reference to standardised or internationally recognised methods used to compile the information required by this Schedule, and the name of the body or bodies responsible for carrying out the studies. S

Regulations 16(2), 16(5) and 28

SCHEDULE 4 S INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO MARKET GENETICALLY MODIFIED ORGANISMS

PART I S GENERAL INFORMATION

[F12 1.   The proposed commercial name of the product or products (which must be provided to the [F13 Scottish Ministers] after consent has been granted) and name or names of the genetically modified organism or organisms in the product or products, and a proposal for a unique identifier of the genetically modified organism developed in accordance with Commission Regulation (EC) No 65/2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms.] S

Textual Amendments

F12 Sch. 4 para. 1 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), 19(a)

F13 Words in sch. 4 para. 1 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(27)(a); 2020 c. 1, Sch. 5 para. 1(1)

2.  The name and address F14 ... of the person who is responsible for the placing on the market, whether it be the manufacturer, importer or distributor. S

Textual Amendments

F14 Words in sch. 4 para. 2 omitted (31.12.2020) by virtue of The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(27)(b); 2020 c. 1, Sch. 5 para. 1(1)

3.  The name and address of the supplier of control samples. S

4.  A description of how the product and the genetically modified organism as or in the product are intended to be used, highlighting any differences in use or management of the genetically modified organism compared to similar non-genetically modified products. S

5.  A description of the geographical area and types of environment where the product is intended to be used F15 ..., including, where possible, an estimate of the scale of use in each area. S

Textual Amendments

F15 Words in sch. 4 para. 5 omitted (31.12.2020) by virtue of The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(27)(c); 2020 c. 1, Sch. 5 para. 1(1)

6.  A description of the intended categories of users of the product, such as industry, agriculture, skilled trades or consumer use by the public at large. S

[F16 7.   Methods for the detection, identification and, where appropriate, quantification of the transformation event, samples of the genetically modified organism or organisms and their control samples, and information as to the place where the reference material can be accessed (identifying any such information that cannot be placed, for confidentiality reasons, in the [F17 register]).] S

Textual Amendments

F16 Sch. 4 para. 7 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), 19(b)

F17 Word in sch. 4 para. 7 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(27)(d); 2020 c. 1, Sch. 5 para. 1(1)

8.  Information regarding proposed labelling, which must include, in a label or an accompanying document, at least in summarised form, a commercial name of the product, a statement that “This product contains genetically modified organisms”, the name of the genetically modified organism and the name and address of the person F18 ... who is responsible for the placing on the market, and how to access the information in the publicly accessible part of the register. S

Textual Amendments

F18 Words in sch. 4 para. 8 omitted (31.12.2020) by virtue of The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(27)(e); 2020 c. 1, Sch. 5 para. 1(1)

PART II S ADDITIONAL RELEVANT INFORMATION

9.  The measures to be taken in the event of the escape of the organisms in the product or misuse of the product. S

10.  Specific instructions or recommendations for storage and handling of the product. S

11.  Specific instructions for carrying out monitoring and reporting to the applicant and, if required, the Scottish Ministers, which are consistent with [F19 Part C of schedule 5A], so that the Scottish Ministers can be effectively informed of any adverse effect. S

Textual Amendments

F19 Words in sch. 4 para. 11 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(27)(f); 2020 c. 1, Sch. 5 para. 1(1)

12.  The proposed restrictions in the approved use of the genetically modified organism, such as where the product may be used and for what purposes. S

13.  The proposed packaging. S

14.  The estimated production in and/or imports to [F20 Scotland and other parts of the United Kingdom]. S

Textual Amendments

F20 Words in sch. 4 para. 14 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(27)(g); 2020 c. 1, Sch. 5 para. 1(1)

15.  Any proposed additional labelling, which may include, at least in summarised form, the information referred to in paragraphs 4 and 5 of Part I of this Schedule, or paragraphs 9 to 12 of this Part. S

Regulations 23(1), 25(1) and 31(3)

SCHEDULE 5 S INFORMATION TO BE INCLUDED IN AN ASSESSMENT REPORT

1.  An identification of the characteristics of the recipient organism which are relevant to the assessment of the relevant genetically modified organisms. S

2.  An identification of any known risks to human health and the environment resulting from the release into the environment of the recipient non-modified organism. S

3.  A description of the result of the genetic modification in the modified organism. S

4.  An assessment of whether the genetic modification has been characterised sufficiently for the purpose of evaluating any risks to human health and the environment. S

5.  An identification of any new risks to human health and the environment that may arise from the release of the relevant genetically modified organisms as compared to the release of the corresponding non-modified organism, based on the environmental risk assessment carried out in accordance with regulation 6. S

6.  A conclusion which addresses the proposed use of the product, risk management and the proposed monitoring plan, and states whether the relevant genetically modified organisms should be placed on the market on its own or in a product and under which conditions, or not placed on the market for reasons which are specified F21 .... Where it is concluded that the genetically modified organisms should not be placed on the market the Scottish Ministers shall give reasons for their conclusion. S

Textual Amendments

F21 Words in sch. 5 para. 6 omitted (31.12.2020) by virtue of The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(28); 2020 c. 1, Sch. 5 para. 1(1)

Regulation 16(2)(g) and schedule 4

[F22 SCHEDULE 5A S MONITORING PLAN

Textual Amendments

F22 Sch. 5A inserted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), reg. 1(2)(b), sch. 2; 2020 c. 1, Sch. 5 para. 1(1)

Introduction S

1.   This schedule describes in general terms the objective to be achieved and the general principles to be followed in the design of the monitoring plan referred to in regulations 16(2)(g) and 28(f).

PART A S OBJECTIVE

2.   The objective of a monitoring plan is to— S

(a) confirm that any assumption regarding the occurrence and impact of potential adverse effects of the genetically modified organism or its use in the environmental risk assessment are correct, and

(b) identify the occurrence of adverse effects of the genetically modified organism or its use on human health or the environment which were not anticipated in the environmental risk assessment.

PART B S GENERAL PRINCIPLES

3.— (1) Monitoring takes place after the consent to the placing of a genetically modified organism on the market. S

(2) The interpretation of the data collected by monitoring should be considered in the light of other existing environmental conditions and activities. Where changes in the environment are observed, further assessment should be considered to establish whether they are a consequence of the genetically modified organism or its use, as such changes may be the result of environmental factors other than the placing of the genetically modified organism on the market.

(3) Experience and data gained through the monitoring of experimental releases of genetically modified organisms may assist in designing the post marketing monitoring regime required for the placing on the market of genetically modified organisms as or in products.

PART C S DESIGN OF THE MONITORING PLAN

4.   The design of the monitoring plan should— S

(a) be detailed on a case by case basis taking into account the environmental risk assessment,

(b) take into account the characteristics of the genetically modified organism, the characteristics and scale of its intended use and the range of relevant environmental conditions where the genetically modified organism is expected to be released,

(c) incorporate general surveillance for unanticipated adverse effects and, if necessary, (case-)specific monitoring focusing on adverse effects identified in the environmental risk assessment—

(i) whereas case-specific monitoring should be carried out for a sufficient time period to detect immediate and direct as well as, where appropriate, delayed or indirect effects which have been identified in the environmental risk assessment, and

(ii) whereas surveillance could, if appropriate, make use of already established routine surveillance practices such as the monitoring of agricultural cultivars, plant protection, or veterinary and medical products. An explanation as to how relevant information collected through established routine surveillance practices will be made available to the consent-holder should be provided,

(d) facilitate the observation, in a systematic manner, of the release of a genetically modified organism in the receiving environment and the interpretation of these observations with respect to safety to human health or the environment,

(e) identify who (applicant, users) will carry out the various tasks the monitoring plan requires and who is responsible for ensuring that the monitoring plan is set into place and carried out appropriately, and ensure that there is a route by which the consent holder and the Scottish Ministers will be informed on any observed adverse effects on human health and the environment (time points and intervals for reports on the results of the monitoring must be indicated), and

(f) give consideration to the mechanisms for identifying and confirming any observed adverse effects on human health and environment and enable the consent holder or the Scottish Ministers, where appropriate, to take the measures necessary to protect human health and the environment.]

Regulation 37

SCHEDULE 6 S AMENDMENT TO THE SCOTLAND ACT 1998 (AGENCY ARRANGEMENTS) (SPECIFICATION) (NO. 2) ORDER 2002

For paragraphs (d) and (e) of the Schedule to the Scotland Act 1998 (Agency Arrangements) (Specification) (No. 2) Order 2002 M1 substitute–

“(ca) Section 126(5)(b) of the Environmental Protection Act 1990 (function of consulting the Food Standards Agency).

(cb) Regulation 16(5) of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (function of consideration whether applicant may omit certain information from an application for consent to market genetically modified organisms).

(cc) Regulation 20 of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (functions on receiving applications for consent to release genetically modified organisms).

(cd) Regulation 23(1) of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (functions on receipt of applications for consent to market genetically modified organisms).

(ce) Regulations 23(4) and 31(4) of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (function of consulting the Health and Safety Executive).

(cf) Regulation 27(2) of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (function of evaluating information in environmental risk assessments).

(cg) Regulation 35 of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (function of maintaining the register).”.

Marginal Citations

M1 S.I. 2002/800.

Regulation 38

SCHEDULE 7 S REVOCATIONS

Regulations revoked	References	Extent
The Genetically Modified Organisms (Deliberate Release) Regulations 1992	S.I. 1992/3280 as amended by the Genetically Modified Organisms (Deliberate Release) Regulations 1993 (S.I. 1993/152), the Genetically Modified Organisms (Deliberate Release) Regulations 1995 (S.I. 1995/304), the Genetically Modified Organisms (Deliberate Release) and Risk Assessment–Amendment) Regulations 1997 (S.I. 1997/1900) and the Genetically Modified Organisms (Contained Use) Regulations 2000 (S.I. 2000/2831)	The whole Regulations other than for the purposes of regulations 9 and 13 of those Regulations
The Genetically Modified Organisms (Deliberate Release) Regulations 1993	S.I. 1993/152	The whole Regulations
The Genetically Modified Organisms (Deliberate Release) Regulations 1995	S.I. 1995/304	The whole Regulations
The Genetically Modified Organisms (Deliberate Release and Risk Assessment-Amendment) Regulations 1997	S.I. 1997/1900	Regulation 2
The Genetically Modified Organisms (Contained Use) Regulations 2000	S.I. 2000/2831	Regulation 31(2)