The Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 2003

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

26

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

27

The stability of the organisms in terms of genetic traits.

28

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

29

The activity of the gene product.

30

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

31

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

32

The history of previous releases or uses of the organisms.

33

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

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

• (b) the comparison of the organisms to the donor, recipient or (where appropriate) parental organisms regarding pathogenicity,

• (c) the capacity of the organisms for colonisation, and

• (d) if the organisms are 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.

• (e) the other product hazards.

PART III — information relating to the conditions of release

The release

34

The description of the proposed deliberate release, including the initial purpose or purposes of the release and any intention to use the genetically modified organism as or in a product in the future.

35

The intended dates of the release and time planning of the experiment including frequency and duration of releases.

36

The preparation of the site before the release.

37

The size of the site.

38

The method or methods to be used for the release.

39

The quantity of organisms to be released.

40

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

41

The worker protection measures taken during the release.

42

The post-release treatment of the site.

43

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

44

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

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

45

The geographical location and national grid reference of the site or sites onto which the release will be made, or the foreseen areas of use of the product.

46

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

47

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

48

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

49

The geographical, geological and pedological characteristics.

50

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

51

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

52

The comparison of the natural habitat of the recipient organisms with the proposed site or sites of release.

53

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

PART IV — information relating to the interactions between the organisms and the environment

Characteristics affecting survival, multiplication and dissemination

54

The biological features which affect survival, multiplication and dispersal.

55

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

56

The sensitivity to specific agents.

Interactions with the environment

57

The predicted habitat of the organisms.

58

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

59

The capability of post-release transfer of genetic material –

• (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 or undesirable traits in the genetically modified organisms.

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.

62

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

63

The description of ecosystems to which the organisms could be disseminated.

64

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

65

The competitive advantage of the organisms in relation to the unmodified recipient or parental organisms.

66

The identification and description of the target organisms if applicable.

67

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

68

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

69

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

70

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

71

The known or predicted involvement of the organisms in biogeochemical processes.

72

Any other potentially significant interactions of the organisms with the environment.

PART V — information on monitoring, control, waste treatment and emergency response plans

Monitoring techniques

73

Methods for tracing the organisms and for monitoring their effects.

74

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

75

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

76

Duration and frequency of the monitoring.

Control of the release

77

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

78

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

79

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

Waste treatment

80

Type of waste generated.

81

Expected amount of waste.

82

Description of treatment envisaged.

Emergency response plans

83

Methods and procedures for controlling the organisms in case of unexpected spread.

84

Methods, such as eradication of the organisms, for decontamination of the areas affected.

85

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

86

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

87

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

PART VI — information on methodology

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.

SCHEDULE 3 — INFORMATION TO BE INCLUDED IN AN APPLICATION FOR CONSENT TO MARKET GENETICALLY MODIFIED ORGANISMS

PART I — general information

1

The proposed commercial name of the product and names of the genetically modified organisms in the product, and any specific identification, name or code used by the applicant to identify the genetically modified organism.

2

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

3

The name and address of the supplier or suppliers of control samples.

4

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

5

A description of the geographical area or areas and types of environment where the product is intended to be used within the Community, including, where possible, an estimate of the scale of use in each area.

6

A description of the intended categories of users of the product, such as industry, agriculture or consumer use by the public.

7

Information on the genetic modification for the purposes of placing on one or several registers modifications in organisms, which can be used for the detection and identification of particular products to facilitate post marketing control and inspection. This information should include where appropriate the lodging of samples of the genetically modified organism or its genetic material with the Department, and details of nucleotide sequences or other type of information which is necessary to identify the product and its progeny, for example the methodology for detecting and identifying the product, including experimental data demonstrating the specificity of the methodology. Information that cannot be placed, for confidentiality reasons, in the publicly accessible part of the register should be identified.

8

The 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 established in the Community who is responsible for the placing on the market, and how to access the information in the publicly accessible part of the register.

PART II — 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.

10

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

11

Specific instructions for carrying out monitoring and reporting to the applicant and, if required, the Department, which are consistent with Part C of Annex VII of the Deliberate Release Directive.

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.

13

The proposed packaging.

14

The estimated product in and/or imports to the Community.

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.

SCHEDULE 4 — 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.

2

A description of the way in which the characteristics of the organisms have been affected by genetic modification.

3

An identification of any known risks of damage to the environment resulting from the release into the environment of the recipient non-modified organism.

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.

5

An identification of any new risks of damage to 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.

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 and under which conditions, or should not be placed on the market, including reasons for that conclusion, and whether the views of the competent authorities and the Commission are sought for on specific aspects of the environmental risk assessment and what those aspects are.

SCHEDULE 5 — REVOCATIONS

Regulations revoked	References	Extent
The Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 1994	S.R. 1994 No. 144 as amended by the Genetically Modified Organisms (Deliberate Release) (Amendment) Regulations (NI) 1995 (S.R. 1995 No. 413), the Genetically Modified Organisms (Deliberate Release and Risk Assessment) (Amendment) Regulations (NI) 1997 (S.R. 1997 No. 534 and the Genetically Modified Organisms (Contained Use) Regulations (NI) (S.R. 2001 No. 295).	The whole Regulations
The Genetically Modified Organisms (Deliberate Release) (Amendment) Regulations (NI) 1995	S.R. 1995 No. 413	The whole Regulations
The Genetically Modified Organisms (Deliberate Release and Risk Assessment) (Amendment) Regulations (NI) 1997	S.R. 1997 No. 534	Regulation 2
The Genetically Modified Organisms (Contained Use) Regulations (NI) 2001	S.R. 2001 No. 295	Regulation 31(2)

Signed

Sealed with the Official Seal of the Department of the Environment on 12th March 2003.

Judena Goldring — A senior officer of the — Department of the Environment

Explanatory note

(This note is not part of the Regulations)

These Regulations implement, in respect of Northern Ireland, Council Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (“the Directive”) which replaced Council Directive 1990/220/EEC (as amended) of the same title.

The subject matter of the Directive and its predecessor is the control of the deliberate release into the environment and the placing on the market of genetically modified organisms by means of the imposition of a requirement to obtain consent for those activities and to comply with the conditions imposed on the consent. The changes introduced by the Directive strengthen the existing control regime, particularly in respect of post marketing monitoring.

Directive 1990/220/EEC was implemented partly by the provisions of the Genetically Modified Organisms (NI) Order 1991 (“the Order”) and partly by the Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 1994 (subsequently amended).

These Regulations include amendments to the Order required to implement the Directive and revoke the 1994 Regulations. The Order is also amended to take account of the Advisory Committee on Releases to the Environment.

The statutory basis for the requirement to obtain consent for the release or marketing of genetically modified organisms is Article 8 (1) of the Order. The cases and circumstances in which consent is required are prescribed in these Regulations. A general requirement to obtain consent for the release or marketing of genetically modified organisms is imposed by regulation 8 (for release) and regulation 14 (for marketing). This general requirement is subject to the exemptions provided for in regulations 9 (for release) and 15 (for marketing).

The definitions used in the provisions relating to the control regime are contained in Articles 2, 3, and 4 of the Order. Regulations 3 and 4 amend a number of these definitions to reflect the Directive. Regulation 3 also amends the power in Article 3 for the Department to prescribe techniques which result in organisms becoming “genetically modified”. However, on coming into operation of these Regulations, references in the Order to “genetically modified organisms” will be interpreted by reference to the modification techniques described in regulation 5.

Parts II and III of the Regulations impose requirements for applications for consent to release and place on the market, respectively, genetically modified organisms (including transitional provisions).

Part IV lays down the procedure for dealing with applications from their receipt to their determination (and, in the case of consents to release, their subsequent variation or revocation). For release consents this includes provisions for public consultation and for marketing consents (and renewals of such consents) their agreement at European Community level.

Part V includes general requirements for marketing consents and amends Article 9 of the Order (which imposes conditions on consents). It also provides for what should happen when new information becomes available which affects the risk assessment for the marketing of a genetically modified organism.

Part VI supplements Article 7 of the Order insofar as it allows action to be taken to prohibit the marketing of a genetically modified organism which has consent so as to bring it into line with the taking of “safeguard action” under the Directive. Part VII prescribes additional categories of information to be made public notwithstanding that they may be commercially confidential, for the purposes of Article 20(7) of the Order.

Copies of the Directive may be obtained at http://europa.eu.int/eur-lex/en/index.html and from the Stationery Office Ltd., 16 Arthur Street, Belfast, BT1 4GD

Footnotes

[^f00001]: S.I. 1991/755

[^f00002]: 1972 c. 68

[^f00003]: S.I. 1991/1714 (N.I. 19). See Article 2(2) for the definition of “the Department”. See Article 8(11) for the definition of “prescribed” in that Article

[^f00004]: O.J. No. L117, 8.5.1990, p. 1

[^f00005]: O.J. No. L106, 17.4.2001, p. 1

[^f00006]: 2001 c. 9

[^f00007]: O.J. No. L292, 12.11.1994, p. 31

[^f00008]: O.J. No. L1117, 8.5.1990, p. 15

[^f00009]: O.J. No. L103, 22.4.1994, p. 20

[^f00010]: O.J. No. L169, 27.6.1997, p. 72

[^f00011]: S.R. 1994 No. 144 as amended by the Genetically Modified Organisms (Deliberate Release) (Amendment) Regulations (Northern Ireland) 1995 (S.R. 1995 No. 413), the Genetically Modified Organisms (Deliberate Release and Risk Assessment) (Amendment) Regulations (Northern Ireland) 1997 (S.R. 1997 No. 534) and the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2001 (S.R. 2001 No. 295)

[^f00012]: 1954 c. 33 (N.I.)

[^f00013]: Article 3(4) is amended by regulation 3(3) and Article 3(4A) to 4(4D) is inserted by regulation 3(4)

[^f00014]: S.R. 2001 No. 295

[^f00015]: O.J. No. L214, 24.8.1993, p. 1

[^f00016]: O.J. No. L88, 24.3.1998, p. 7

[^f00017]: O.J. No. L43, 14.2.1977, p. 1

[^f00018]: O.J. No. L193, 20.7.2002, p. 1

[^f00019]: O.J. No. 193, 20.7.2002, p. 33

[^f00020]: Council Directive 1999/105/EC on the marketing of forest reproductive material (O.J. No. L11 15.1.2000, p. 17)

[^f00021]: See section 1 of the Food Standards Act 1999 (c. 28)

[^f00022]: 1990 c. 43