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- Point in Time (05/12/2002)
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PART II RELEASING ORGANISMS FOR ANY OTHER PURPOSE THAN MARKETING
PART IV DUTIES AFTER THE MAKING OF APPLICATIONS
19. Duty of the applicant after applying for consent to release or to market
20. Duties of the Scottish Ministers in relation to applications for consent to release
21. Decisions by the Scottish Ministers on applications for consent to release
23. Duties of the Scottish Ministers in relation to applications for consent to market
24. Decisions by the Scottish Ministers on applications for consents to market
25. Duties on the Scottish Ministers on receiving applications for renewal of consent to market
26. Decisions by the Scottish Ministers on applications for renewals of consents to market
27. Genetically modified organisms containing antibiotic resistance markers
PART II INFORMATION RELATING TO THE PARENTAL OR RECIPIENT PLANT
4.Information concerning– (a) the reproduction of the plant, that is–...
5.Information concerning the survivability of the plant, that is–
6.Information concerning the dissemination of the plant, that is–
8.Where the application relates to a plant species which is...
9.Information concerning any other potential interactions, relevant to the genetically...
PART IV INFORMATION RELATING TO THE GENETICALLY MODIFIED PLANT
13.A description of the trait or traits and characteristics of...
14.The following information on the sequences actually inserted or deleted:–...
15.The following information on the expression of the insert:–
16.Information on how the genetically modified plant differs from the...
17.The genetic stability of the insert and phenotypic stability of...
18.Any change to the ability of the genetically modified higher...
19.Information on any toxic, allergenic or other harmful effects on...
20.Information on the safety of the genetically modified higher plant...
21.The mechanism of interaction between the genetically modified plant and...
22.The potential changes in the interactions of the genetically modified...
24.A description of detection and identification techniques for the genetically...
25.Information about previous releases of the genetically modified plant, if...
PART V INFORMATION RELATING TO THE SITE OF RELEASE
PART VI INFORMATION RELATING TO THE RELEASE
PART VII INFORMATION ON CONTROL, MONITORING, POST-RELEASE AND WASTE TREATMENT PLANS
PART II INFORMATION RELATING TO THE ORGANISMS
1.Characteristics of donor, parental and recipient organisms
6.The degree of relatedness between donor and recipient or between...
7.The description of identification and detection techniques.
8.The sensitivity, reliability (in quantitative terms) and specificity of detection...
9.The description of the geographic distribution and of the natural...
10.The organisms with which transfer of genetic material is known...
11.Verification of the genetic stability of the organisms and factors...
12.The following pathological, ecological and physiological traits:–
13.The sequence, frequency of mobilisation and specificity of indigenous vectors,...
16.The sequence of transposons, vectors and other non-coding genetic segments...
17.The frequency of mobilisation, genetic transfer capabilities and/or methods of...
18.Information on the degree to which the vector is limited...
20.The methods used– (a) to construct inserts and to introduce...
21.The description of any insert and/or vector construction.
22.The purity of the insert from any unknown sequence and...
24.The sequence, functional identity and location of the altered, inserted...
4.Characteristics of the genetically modified organisms in their final form
25.The description of genetic traits or phenotypic characteristics and in...
26.The structure and amount of any vector or donor nucleic...
27.The stability of the organism in terms of genetic traits....
30.The description of identification and detection techniques, including techniques for...
31.The sensitivity, reliability (in quantitative terms), and specificity of detection...
32.The history of previous releases or uses of the genetically...
33.In relation to human health, animal health and plant health–...
PART III INFORMATION RELATING TO THE CONDITIONS OF RELEASE AND THE RECEIVING ENVIRONMENT
34.The description of the proposed deliberate release, including the purpose...
35.The foreseen dates of the release and time planning of...
40.The disturbance of the site, including the type and method...
43.The techniques foreseen for elimination or inactivation of the genetically...
44.Information on, and the results of, previous releases of the...
6.The environment (both on the site and in the wider environment)
45.The geographical location and national grid reference of the site...
46.The physical or biological proximity of the site of the...
47.The proximity to significant biotopes, protected areas or drinking water...
48.The climatic characteristics of the region or regions likely to...
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...
52.A comparison of the natural habitat of the recipient organism...
53.Any known planned developments or changes in land use in...
7.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,...
57.The predicted habitat of the genetically modified organisms.
58.The studies on the behaviour and characteristics of the genetically...
59.The capability of post-release transfer of genetic material–
60.The likelihood of post-release selection leading to the expression of...
61.The measures employed to ensure and to verify genetic stability,...
62.The routes of biological dispersal, known or potential modes of...
63.The description of ecosystems to which the genetically modified organisms...
64.The potential for excessive population increase of the genetically modified...
65.The competitive advantage of the genetically modified organisms in relation...
66.The identification and description of the target organisms if applicable....
67.The anticipated mechanism and result of interaction between the released...
68.The identification and description of non-target organisms which may be...
69.The likelihood of post release shifts in biological interactions or...
70.The known or predicted interactions with non-target organisms in the...
71.The known or predicted involvement of the genetically modified organisms...
72.Any other potential interactions of the organisms with the environment....
PART V INFORMATION ON MONITORING, CONTROL, WASTE TREATMENT AND EMERGENCY RESPONSE PLANS
73.Methods for tracing the genetically modified organisms and for monitoring...
74.Specificity (to identify the genetically modified organisms, and to distinguish...
75.Techniques for detecting transfer of the donated genetic material to...
77.Methods and procedures to avoid and/or minimise the spread of...
78.Methods and procedures to protect the site from intrusion by...
79.Methods and procedures to prevent other organisms from entering the...
83.Methods and procedures for controlling the genetically modified organisms in...
84.Methods, such as eradication of the genetically modified organisms, for...
85.Methods for disposal or sanitation of plants, animals, soils, and...
87.Plans for protecting human health and the environment in case...
INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO MARKET GENETICALLY MODIFIED ORGANISMS
1.The proposed commercial name of the product and names of...
3.The name and address of the supplier of control samples....
4.A description of how the product and the genetically modified...
5.A description of the geographical area and types of environment...
6.A description of the intended categories of users of the...
7.Information on the genetic modification for the purposes of placing...
8.Information regarding proposed labelling, which must include, in a label...
PART II ADDITIONAL RELEVANT INFORMATION
10.Specific instructions or recommendations for storage and handling of the...
11.Specific instructions for carrying out monitoring and reporting to the...
12.The proposed restrictions in the approved use of the genetically...
14.The estimated production in and/or imports to the Community.
15.Any proposed additional labelling, which may include, at least in...
INFORMATION TO BE INCLUDED IN AN ASSESSMENT REPORT
1.An identification of the characteristics of the recipient organism which...
2.An identification of any known risks to human health and...
3.A description of the result of the genetic modification in...
4.An assessment of whether the genetic modification has been characterised...
6.A conclusion which addresses the proposed use of the product,...
AMENDMENT TO THE SCOTLAND ACT 1998 (AGENCY ARRANGEMENTS) (SPECIFICATION) (NO. 2) ORDER 2002
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