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

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  1. Introductory Text

  2. PART I GENERAL

    1. 1.Citation, commencement and extent

    2. 2.Interpretation

    3. 3.Purpose of Part VI of the Act and meaning of “genetically modified organisms” etc.

    4. 4.Meaning of “damage to the environment” etc.

    5. 5.Techniques of genetic modification

    6. 6.Environmental risk assessment

    7. 7.Communication with an applicant for consent

  3. PART II RELEASING ORGANISMS FOR ANY OTHER PURPOSE THAN MARKETING

    1. 8.Requirement for consent to release

    2. 9.Exempt activities

    3. 10.Applications for consent to release – general provisions

    4. 11.Information to be contained in application for consent to release

    5. 12.Advertisement of applications for consent to release

    6. 13.Transitional provisions in respect of applications to release

  4. PART III MARKETING ORGANISMS

    1. 14.Requirement for consent to market

    2. 15.Exempt activities

    3. 16.Applications for consent to market

    4. 17.Transitional provision in respect of applications to market

    5. 17A.Transitional measures for adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation.

    6. 18.Applications for renewal of consent to market

  5. PART IV DUTIES AFTER THE MAKING OF APPLICATIONS

    1. 19.Duty of the applicant after applying for consent to release or to market

    2. 20.Duties of the Scottish Ministers in relation to applications for consent to release

    3. 21.Decisions by the Scottish Ministers on applications for consent to release

    4. 22.Variation or revocation of consents to release

    5. 23.Duties of the Scottish Ministers in relation to applications for consent to market

    6. 24.Decisions by the Scottish Ministers on applications for consent to market

    7. 25.Duties on the Scottish Ministers on receiving applications for renewal of consent to market

    8. 26.Decisions by the Scottish Ministers on applications for renewals of consents to market

    9. 26A.Demand to adjust a food or feed authorisation to prohibit the cultivation of genetically modified organisms in all or part of Scotland

    10. 26B.Request to adjust a food or feed authorisation to remove or modify a restriction or prohibition on the cultivation of genetically modified organisms in all or part of Scotland

    11. 27.Genetically modified organisms containing antibiotic resistance markers

  6. PART V GENERAL PROVISION FOR CONSENTS

    1. 28.General provisions of consents to market

    2. 29.General conditions on consents to release or market genetically modified organisms

    3. 29A.Restrictions on cultivation

    4. 29B.Removal of restrictions under regulation 29A

    5. 30.Proof of compliance with consent conditions

    6. 30A.Stop notices

    7. 31.Variation or revocation of consents to market

  7. PART VI SAFEGUARD

    1. 32.Safeguard

  8. PART VIA Inspection powers, offences and service of notices

    1. 32A.Powers of inspectors

    2. 32B.Offences and penalties

    3. 32C.Individual culpability for offending by an organisation

    4. 32D.Service of notices

  9. PART VII CONFIDENTIALITY

    1. 33.Confidentiality

  10. PART VIII REGISTER OF INFORMATION

    1. 34.Information to be included in the register

    2. 35.Keeping the register

    3. 36.Publication of representations

  11. PART IX CONSEQUENTIAL AND OTHER AMENDMENTS AND REVOCATIONS

    1. 37.Consequential and other amendments – agency arrangements

    2. 38.Revocations

  12. Signature

    1. SCHEDULE 1

      PRINCIPLES FOR ENVIRONMENTAL RISK ASSESSMENT

      1. 1.Introduction

      2. PART A OBJECTIVE

        1. 2.The objective of an environmental risk assessment is, on a...

      3. PART B GENERAL PRINCIPLES

        1. 3.In accordance with the precautionary principle, the following general principles...

      4. PART C METHODOLOGY

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

          1. 4.Step 1: Intended and unintended changes

          2. 5.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

          3. 6.Step 3: Quality of the data

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

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

          1. 8.(1) The environmental risk assessment must take into account the...

        3. CHAPTER C.3 STEPS IN THE ENVIRONMENTAL RISK ASSESSMENT

          1. 9.The environmental risk assessment must be conducted for each relevant...

          2. 10.Step 1: Problem formulation including hazard identification

          3. 11.Step 2: Hazard characterisation

          4. 12.Step 3: Exposure characterisation

          5. 13.Step 4: Risk characterisation

          6. 14.Step 5: Risk management strategies

          7. 15.Step 6: Overall risk evaluation and conclusions

      5. PART D CONCLUSIONS ON THE SPECIFIC AREAS OF RISK OF THE ENVIRONMENTAL RISK ASSESSMENT

        1. 16.Conclusions on the potential environmental impact in relevant receiving environments...

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

          1. 17.Areas of risk

        3. CHAPTER D.2 GENETICALLY MODIFIED HIGHER PLANTS

          1. 18.Areas of risk

    2. SCHEDULE 2

      INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO RELEASE OR MARKET GENETICALLY MODIFIED HIGHER PLANTS

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

        1. 1.A. General information

        2. 2.The title of the project.

        3. 3.B. Information relating to the release

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

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

        6. 6.The method for preparing and managing the release site, prior...

        7. 7.The approximate number of genetically modified plants (or plants per...

        8. 8.C. Information relating to the site of release

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

        10. 10.The details of any sexually compatible wild relatives or cultivated...

        11. 11.The proximity of the release site or sites to officially...

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

        13. 13.The geographical distribution and cultivation of the plant within the...

        14. 14.Information concerning— (a) the reproduction of the plant, that is—...

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

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

        17. 17.Where the application relates to a plant species which is...

        18. 18.Information concerning any other potential interactions, relevant to the genetically...

        19. 19.E. Molecular characterisation

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

        21. 21.Conclusions of the molecular characterisation

        22. 22.F. Information on specific areas of risk

        23. 23.Any change to the ability of the genetically modified higher...

        24. 24.Information on the mechanism of interaction between the genetically modified...

        25. 25.Information on the potential changes in the interactions of the...

        26. 26.Information on the potential changes in agricultural practices and management...

        27. 27.Information on the potential interactions with the abiotic environment and...

        28. 28.Information on any toxic, allergenic or other harmful effects on...

        29. 29.Conclusions on the specific areas of risk.

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

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

        32. 32.A description of post-release treatment methods for the genetically modified...

        33. 33.A description of monitoring plans and techniques.

        34. 34.A description of any emergency plans.

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

        36. 36.H. Other

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

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

        1. 38.A. General information

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

        3. 40.The s cope of the notification including—

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

        5. 42.The geographical distribution and cultivation of the plant within the...

        6. 43.The reproduction of the plant, that is—

        7. 44.Information concerning the survivability of the plant, that is—

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

        9. 46.Where a plant species is not normally grown in the...

        10. 47.Information concerning any other potential interactions, relevant to the genetically...

        11. 48.C. Molecular Characterisation

        12. 49.(1) Information relating to the genetically modified plant, that is—...

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

        14. 51.The conclusions of molecular characterisation.

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

        16. 53.For each of the seven areas of risk referred to...

        17. 54.The following information is required, except where it is not...

        18. 55.A description of detection and identification techniques for the genetically...

        19. 56.Information about previous releases of the genetically modified higher plant,...

    3. SCHEDULE 3

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

      1. PART I GENERAL INFORMATION

        1. 1.The name and address of the applicant, and the name,...

        2. 2.The title of the project.

      2. PART II INFORMATION RELATING TO THE ORGANISMS

        1. 1.Characteristics of donor, parental and recipient organisms

        2. 3.Scientific name and taxonomy.

        3. 4.Usual strain, cultivar or other name.

        4. 5.Phenotypic and genetic markers.

        5. 6.The degree of relatedness between donor and recipient or between...

        6. 7.The description of identification and detection techniques.

        7. 8.The sensitivity, reliability (in quantitative terms) and specificity of detection...

        8. 9.The description of the geographic distribution and of the natural...

        9. 10.The organisms with which transfer of genetic material is known...

        10. 11.Verification of the genetic stability of the organisms and factors...

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

        12. 13.The sequence, frequency of mobilisation and specificity of indigenous vectors,...

        13. 14.The history of genetic modifications.

        14. 2.Characteristics of the vector

        15. 15.The nature and source of the vector.

        16. 16.The sequence of transposons, vectors and other non-coding genetic segments...

        17. 17.The frequency of mobilisation, genetic transfer capabilities and/or methods of...

        18. 18.Information on the degree to which the vector is limited...

        19. 3.Characteristics of the modified organisms

        20. 19.The methods used for the modification.

        21. 20.The methods used– (a) to construct inserts and to introduce...

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

        23. 22.The purity of the insert from any unknown sequence and...

        24. 23.The methods and criteria used for selection.

        25. 24.The sequence, functional identity and location of the altered, inserted...

        26. 4.Characteristics of the genetically modified organisms in their final form

        27. 25.The description of genetic traits or phenotypic characteristics and in...

        28. 26.The structure and amount of any vector or donor nucleic...

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

        30. 28.The rate and level of expression of the new genetic...

        31. 29.The activity of the expressed protein.

        32. 30.The description of identification and detection techniques, including techniques for...

        33. 31.The sensitivity, reliability (in quantitative terms), and specificity of detection...

        34. 32.The history of previous releases or uses of the genetically...

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

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

        1. 5.The release

        2. 34.The description of the proposed deliberate release, including the purpose...

        3. 35.The foreseen dates of the release and time planning of...

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

        5. 37.The size of the site.

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

        7. 39.The quantity of organisms to be released.

        8. 40.The disturbance of the site, including the type and method...

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

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

        11. 43.The techniques foreseen for elimination or inactivation of the genetically...

        12. 44.Information on, and the results of, previous releases of the...

        13. 6.The environment (both on the site and in the wider environment)

        14. 45.The geographical location and national grid reference of the site...

        15. 46.The physical or biological proximity of the site of the...

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

        17. 48.The climatic characteristics of the region or regions likely to...

        18. 49.The geographical, geological and pedological characteristics.

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

        20. 51.The description of the target and non-target ecosystems likely to...

        21. 52.A comparison of the natural habitat of the recipient organism...

        22. 53.Any known planned developments or changes in land use in...

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

        1. 7.Characteristics affecting survival, multiplication and dissemination

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

        3. 55.The known or predicted environmental conditions which may affect survival,...

        4. 56.The sensitivity to specific agents.

        5. 8.Interactions with the environment

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

        7. 58.The studies on the behaviour and characteristics of the genetically...

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

        9. 60.The likelihood of post-release selection leading to the expression of...

        10. 61.The measures employed to ensure and to verify genetic stability,...

        11. 62.The routes of biological dispersal, known or potential modes of...

        12. 63.The description of ecosystems to which the genetically modified organisms...

        13. 64.The potential for excessive population increase of the genetically modified...

        14. 65.The competitive advantage of the genetically modified organisms in relation...

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

        16. 67.The anticipated mechanism and result of interaction between the released...

        17. 68.The identification and description of non-target organisms which may be...

        18. 69.The likelihood of post release shifts in biological interactions or...

        19. 70.The known or predicted interactions with non-target organisms in the...

        20. 71.The known or predicted involvement of the genetically modified organisms...

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

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

        1. 9.Monitoring techniques

        2. 73.Methods for tracing the genetically modified organisms and for monitoring...

        3. 74.Specificity (to identify the genetically modified organisms, and to distinguish...

        4. 75.Techniques for detecting transfer of the donated genetic material to...

        5. 76.Duration and frequency of the monitoring.

        6. 10.Control of the release

        7. 77.Methods and procedures to avoid and/or minimise the spread of...

        8. 78.Methods and procedures to protect the site from intrusion by...

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

        10. 11.Waste treatment

        11. 80.Type of waste generated.

        12. 81.Expected amount of waste.

        13. 82.Description of treatment envisaged.

        14. 12.Emergency response plans

        15. 83.Methods and procedures for controlling the genetically modified organisms in...

        16. 84.Methods, such as eradication of the genetically modified organisms, for...

        17. 85.Methods for disposal or sanitation of plants, animals, soils, and...

        18. 86.Methods for the isolation of the area affected by the...

        19. 87.Plans for protecting human health and the environment in case...

      6. PART VI INFORMATION ON METHODOLOGY

        1. 88.A description of the methods used or a reference to...

    4. SCHEDULE 4

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

      1. PART I GENERAL INFORMATION

        1. 1.The proposed commercial name of the product or products (which...

        2. 2.The name and address in the European Union of the...

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

        4. 4.A description of how the product and the genetically modified...

        5. 5.A description of the geographical area and types of environment...

        6. 6.A description of the intended categories of users of the...

        7. 7.Methods for the detection, identification and, where appropriate, quantification of...

        8. 8.Information regarding proposed labelling, which must include, in a label...

      2. PART II ADDITIONAL RELEVANT INFORMATION

        1. 9.The measures to be taken in the event of the...

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

        3. 11.Specific instructions for carrying out monitoring and reporting to the...

        4. 12.The proposed restrictions in the approved use of the genetically...

        5. 13.The proposed packaging.

        6. 14.The estimated production in and/or imports to Scotland and other...

        7. 15.Any proposed additional labelling, which may include, at least in...

    5. SCHEDULE 5

      INFORMATION TO BE INCLUDED IN AN ASSESSMENT REPORT

      1. 1.An identification of the characteristics of the recipient organism which...

      2. 2.An identification of any known risks to human health and...

      3. 3.A description of the result of the genetic modification in...

      4. 4.An assessment of whether the genetic modification has been characterised...

      5. 5.An identification of any new risks to human health and...

      6. 6.A conclusion which addresses the proposed use of the product,...

    6. SCHEDULE 5A

      MONITORING PLAN

      1. 1.Introduction

      2. PART A OBJECTIVE

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

      3. PART B GENERAL PRINCIPLES

        1. 3.(1) Monitoring takes place after the consent to the placing...

      4. PART C DESIGN OF THE MONITORING PLAN

        1. 4.The design of the monitoring plan should—

    7. SCHEDULE 6

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

      1. For paragraphs (d) and (e) of the Schedule to the...

    8. SCHEDULE 7

      REVOCATIONS

  14. Explanatory Note

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