Genetically Modified Organisms (Deliberate Release) Regulations 2002

1Citation, commencement, extent and application

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 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 applications for consent to release

12Advertisement of applications for consent to release

13Transitional provisions for release

PART IIIMARKETING ORGANISMS

14Requirement for consent to market

15Exempt activities

16Applications for consent to market

17Transitional provisions for marketing

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 Secretary of State in relation to applications for consent to release

21Decisions by the Secretary of State on applications for consent to release

22Variation or revocation of consents to release

23Duties of the Secretary of State in relation to applications for consent to market

24Decisions by the Secretary of State on applications for consent to market

25Duties of the Secretary of State on receiving applications for renewal of consent to market

26Decisions by the Secretary of State on applications for renewal of consent to market

27Genetically modified organisms containing antibiotic resistance markers

PART VGENERAL PROVISIONS FOR CONSENTS

28General provisions of consents to market

29General conditions in consents to release or market

30Proof of compliance with consent conditions

31New information on risks of damage from marketing genetically modified organisms

PART VISAFEGUARD

PART VIICONFIDENTIALITY

33Confidentiality

PART VIIIREGISTER OF INFORMATION

34Information to be included in the register

35Keeping the register

36Publication of representations

PART IXMISCELLANEOUS

38Application of Part VI of the Act to territorial sea and continental shelf

39Application of Part VI of the Act: England and Wales

SCHEDULE 1Information to be included in applications for consent to release or market 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 parental or recipient plant

3The full name of the plant— (a) family name,

4Information concerning— (a) the reproduction of the plant:

5Information concerning the survivability of the plant:

6Information concerning the dissemination of the plant:

7The geographical distribution of the plant.

8Where the application relates to a plant species which is...

9Any other potential interactions, relevant to the genetically modified organism,...

PART IIIInformation relating to the genetic modification

10A description of the methods used for the genetic modification....

11The nature and source of the vector used.

12The size, intended function and name of the donor organism...

PART IVInformation relating to the genetically modified plant

13A description of the trait or traits and characteristics of...

14The following information on the sequences actually inserted or deleted:...

15The following information on the expression of the insert—

16Information on how the genetically modified plant differs from the...

17The genetic stability of the insert and phenotypic stability of...

18Any change to the ability of the genetically modified plant...

19Information on any toxic, allergenic or other harmful effects on...

20Information on the safety of the genetically modified plant to...

21The mechanism of interaction between the genetically modified plant and...

22The potential changes in the interactions of the genetically modified...

23The potential interactions with the abiotic environment.

24A description of detection and identification techniques for the genetically...

25Information about previous releases of the genetically modified plant, if...

PART VInformation relating to the site of release

(Applications for consent to release only)

26The location and size of the release site or sites....

27A description of the release site ecosystem, including climate, flora...

28Details of any sexually compatible wild relatives or cultivated plant...

29The proximity of the release sites to officially recognised biotopes...

PART VIInformation relating to the release

(Applications for consent to release only)

30The purpose of the release of the genetically modified plant,...

31The foreseen date or dates and duration of the release....

32The method by which the genetically modified plants will be...

33The method for preparing and managing the release site, prior...

34The approximate number of genetically modified plants (or plants per...

PART VIIInformation on control, monitoring, post-release and waste treatment plans

(Applications for consent to release only)

35A description of any precautions to— (a) maintain the genetically...

36A description of the methods for post-release treatment of the...

37A description of the post-release treatment methods for the genetically...

38A description of monitoring plans and techniques.

39A description of any emergency plans.

40Methods and procedures to protect the site.

PART VIIIInformation on methodology

41A description of the methods used or a reference to...

SCHEDULE 2Information 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

Characteristics 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 previous genetic modifications.

Characteristics 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...

18The degree to which the vector is limited to the...

Characteristics of the modified organisms

19The methods used for the modification.

20The methods used— (a) to construct the insert or inserts...

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...

Characteristics of the genetically modified organisms in their final form

25The description of genetic trait or traits or phenotypic characteristics...

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

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

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

29The activity of the gene product.

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 organisms....

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

PART IIIInformation relating to the conditions of release

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

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

36The preparation of the site before the release.

37The size of the site.

38The method or methods to be used for the release....

39The quantity of organisms to be released.

40The disturbance on 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 organisms...

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

The 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...

52The comparison of the natural habitat of the recipient organisms...

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

PART IVInformation relating to the interactions between the organisms and the environment

Characteristics 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.

Interactions with the environment

57The predicted habitat of the organisms.

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

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 organisms could be...

64The potential for excessive population increase of the organisms in...

65The competitive advantage of the organisms in relation to the...

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 organisms in biogeochemical...

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

PART VInformation on monitoring, control, waste treatment and emergency response plans

Monitoring techniques

73Methods for tracing the organisms and for monitoring their effects....

74Specificity (to identify the organisms, and to distinguish them from...

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

76Duration and frequency of the monitoring.

Control 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...

Waste treatment

80Type of waste generated.

81Expected amount of waste.

82Description of treatment envisaged.

Emergency response plans

83Methods and procedures for controlling the organisms in case of...

84Methods, such as eradication of the organisms, for decontamination of...

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

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

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

PART VIInformation on methodology

SCHEDULE 3Information to be included in applications for consent to market genetically modified organisms

PART IGeneral information

1The proposed commercial name of the product and names of...

2The name and address in the Community of the person...

3The name and address of the supplier or suppliers of...

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

5A description of the geographical area or areas and types...

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

7Information on the genetic modification for the purposes of placing...

8The proposed labelling, which must include, in a label or...

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 the Community.

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

SCHEDULE 4Information to be included in an assessment report

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

2A description of the way in which the characteristics of...

3An identification of any known risks of damage to the...

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

5An identification of any new risks of damage to the...

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

SCHEDULE 5REVOCATIONS

2002 No. 2443

ENVIRONMENTAL PROTECTION

Genetically Modified Organisms (Deliberate Release) Regulations 2002

Made25th September 2002

Laid before Parliament26th September 2002

Coming into force17th October 2002

The Secretary of State for Environment, Food and Rural Affairs in exercise of the powers conferred on her by section 2(2) of the European Communities Act 19721, being the Minister designated2 for the purposes of that subsection in relation to the control and regulation of genetically modified organisms, and sections 108(7), 111(1), (4), (5), (7) and (11), 122(1) and (4), 123(7), and 156 of the Environmental Protection Act 19903, having consulted the Food Standards Agency in accordance with section 126(5) of that Act, hereby makes the following Regulations:—