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

1Citation, commencement and extent

2Interpretation

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

4Meaning of “damage to the environment” etc.

5Techniques of genetic modification

6Environmental risk assessment

7Communication with an applicant for consent

PART IIRELEASING ORGANISMS FOR ANY OTHER PURPOSE THAN MARKETING

8Requirement for consent to release

9Exempt activities

10Applications for consent to release – general provisions

11Information to be contained in application for consent to release

12Advertisement of applications for consent to release

13Transitional provisions in respect of applications to release

PART IIIMARKETING ORGANISMS

14Requirement for consent to market

15Exempt activities

16Applications for consent to market

17Transitional provision in respect of applications to market

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

18Applications for renewal of consent to market

PART IVDUTIES AFTER THE MAKING OF APPLICATIONS

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

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

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

22Variation or revocation of consents to release

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

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

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

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

26ADemand to adjust a food or feed authorisation to prohibit the cultivation of genetically modified organisms in all or part of Scotland

26BRequest 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

27Genetically modified organisms containing antibiotic resistance markers

PART VGENERAL PROVISION FOR CONSENTS

28General provisions of consents to market

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

29ARestrictions on cultivation

29BRemoval of restrictions under regulation 29A

30Proof of compliance with consent conditions

30AStop notices

31Variation or revocation of consents to market

PART VISAFEGUARD

PART VIAInspection powers, offences and service of notices

32APowers of inspectors

32BOffences and penalties

32CIndividual culpability for offending by an organisation

32DService of notices

PART VIICONFIDENTIALITY

33Confidentiality

PART VIIIREGISTER OF INFORMATION

34Information to be included in the register

35Keeping the register

36Publication of representations

PART IXCONSEQUENTIAL AND OTHER AMENDMENTS AND REVOCATIONS

37Consequential and other amendments – agency arrangements

SCHEDULE 1PRINCIPLES FOR ENVIRONMENTAL RISK ASSESSMENT

PART AOBJECTIVE

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

PART BGENERAL PRINCIPLES

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

PART CMETHODOLOGY

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

4Step 1: Intended and unintended changes

5Step 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

6Step 3: Quality of the data

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

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

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

CHAPTER C.3STEPS IN THE ENVIRONMENTAL RISK ASSESSMENT

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

10Step 1: Problem formulation including hazard identification

11Step 2: Hazard characterisation

12Step 3: Exposure characterisation

13Step 4: Risk characterisation

14Step 5: Risk management strategies

15Step 6: Overall risk evaluation and conclusions

PART DCONCLUSIONS ON THE SPECIFIC AREAS OF RISK OF THE ENVIRONMENTAL RISK ASSESSMENT

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

CHAPTER D.1GENETICALLY MODIFIED ORGANISMS OTHER THAN HIGHER PLANTS

17Areas of risk

CHAPTER D.2GENETICALLY MODIFIED HIGHER PLANTS

18Areas of risk

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

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

1A. General information

2The title of the project.

3B. Information relating to the release

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

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

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

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

8C. Information relating to the site of release

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

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

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

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

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

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

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

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

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

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

19E. Molecular characterisation

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

21Conclusions of the molecular characterisation

22F. Information on specific areas of risk

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

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

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

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

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

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

29Conclusions on the specific areas of risk.

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

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

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

33A description of monitoring plans and techniques.

34A description of any emergency plans.

35A description of the methods and procedures to,—

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

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

38A. General information

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

40The s cope of the notification including—

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

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

43The reproduction of the plant, that is—

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

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

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

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

48C. Molecular Characterisation

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

50Information on the expression of the insert that is—

51The conclusions of molecular characterisation.

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

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

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

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

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

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

PART IGENERAL INFORMATION

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

2The title of the project.

PART IIINFORMATION RELATING TO THE ORGANISMS

1Characteristics of donor, parental and recipient organisms

3Scientific name and taxonomy.

4Usual strain, cultivar or other name.

5Phenotypic and genetic markers.

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

7The description of identification and detection techniques.

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

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

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

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

12The following pathological, ecological and physiological traits:–

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

14The history of genetic modifications.

2Characteristics of the vector

15The nature and source of the vector.

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

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

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

3Characteristics of the modified organisms

19The methods used for the modification.

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

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

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

23The methods and criteria used for selection.

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

4Characteristics of the genetically modified organisms in their final form

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

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

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

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

29The activity of the expressed protein.

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

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

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

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

PART IIIINFORMATION RELATING TO THE CONDITIONS OF RELEASE AND THE RECEIVING ENVIRONMENT

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

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

36The preparation of the site before the release.

37The size of the site.

38The methods to be used for the release.

39The quantity of organisms to be released.

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

41The worker protection measures taken during the release.

42The post-release treatment of the site.

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

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

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

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

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

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

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

49The geographical, geological and pedological characteristics.

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

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

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

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

PART IVINFORMATION RELATING TO THE INTERACTIONS BETWEEN THE GENETICALLY MODIFIED ORGANISMS AND THE ENVIRONMENT

7Characteristics affecting survival, multiplication and dissemination

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

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

56The sensitivity to specific agents.

8Interactions with the environment

57The predicted habitat of the genetically modified organisms.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

PART VINFORMATION ON MONITORING, CONTROL, WASTE TREATMENT AND EMERGENCY RESPONSE PLANS

9Monitoring techniques

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

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

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

76Duration and frequency of the monitoring.

10Control of the release

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

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

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

11Waste treatment

80Type of waste generated.

81Expected amount of waste.

82Description of treatment envisaged.

12Emergency response plans

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

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

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

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

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

PART VIINFORMATION ON METHODOLOGY

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

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

PART IGENERAL INFORMATION

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

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

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

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

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

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

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

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

PART IIADDITIONAL RELEVANT INFORMATION

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

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

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

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

13The proposed packaging.

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

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

SCHEDULE 5INFORMATION TO BE INCLUDED IN AN ASSESSMENT REPORT

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

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

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

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

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

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

SCHEDULE 5AMONITORING PLAN

PART AOBJECTIVE

2The objective of a monitoring plan is to—

PART BGENERAL PRINCIPLES

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

PART CDESIGN OF THE MONITORING PLAN

4The design of the monitoring plan should—

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

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

SCHEDULE 7REVOCATIONS

2002 No. 541

ENVIRONMENTAL PROTECTION

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

Made4th December 2002

Coming into force in accordance with regulation 1(1)

The Scottish Ministers, in exercise of the powers conferred by section 2(2) of the European Communities Act 1972M1 and of all other powers enabling them in that behalf hereby make the following Regulations, a draft of which has, in accordance with paragraph 2(2) of Schedule 2 to that Act been laid before, and approved by resolution of, the Scottish Parliament: