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

S.S.I. 2002/541 · Made 4 December 2002 · Extends to Scotland

Up to date with all changes known to legislation.gov.uk, revised to 1 January 2024.

ENVIRONMENTAL PROTECTION

Made 4th 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:

Annotations to the whole text

Marginal citations

M1

1972 c.68; section 2(2) was amended by the Scotland Act 1998 (c.46), Schedule 8, paragraph 15(3). The function conferred upon the Minister of the Crown under section 2(2) of the European Communities Act 1972, insofar as within devolved competence, was transferred to the Scottish Ministers by virtue of section 53 of the Scotland Act 1998.

Contents

  1. Part I: GENERAL
  2. 1Citation, commencement and extent
  3. 2Interpretation
  4. 3Purpose of Part VI of the Act and meaning of “genetically modified organisms” etc.
  5. 4Meaning of “damage to the environment” etc.
  6. 5Techniques of genetic modification
  7. 6Environmental risk assessment
  8. 7Communication with an applicant for consent
  9. Part II: RELEASING ORGANISMS FOR ANY OTHER PURPOSE THAN MARKETING
  10. 8Requirement for consent to release
  11. 9Exempt activities
  12. 10Applications for consent to release – general provisions
  13. 11Information to be contained in application for consent to release
  14. 12Advertisement of applications for consent to release
  15. 13Transitional provisions in respect of applications to release Repealed
  16. Part III: MARKETING ORGANISMS
  17. 14Requirement for consent to market
  18. 15Exempt activities
  19. 16Applications for consent to market
  20. 17Transitional provision in respect of applications to market Repealed
  21. 17ATransitional measures for adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation. Repealed
  22. 18Applications for renewal of consent to market
  23. Part IV: DUTIES AFTER THE MAKING OF APPLICATIONS
  24. 19Duty of the applicant after applying for consent to release or to market
  25. 20Duties of the Scottish Ministers in relation to applications for consent to release
  26. 21Decisions by the Scottish Ministers on applications for consent to release
  27. 22Variation or revocation of consents to release
  28. 23Duties of the Scottish Ministers in relation to applications for consent to market
  29. 24Decisions by the Scottish Ministers on applications for consent to market
  30. 25Duties on the Scottish Ministers on receiving applications for renewal of consent to market
  31. 26Decisions by the Scottish Ministers on applications for renewals of consents to market
  32. 26ADemand to adjust a food or feed authorisation to prohibit the cultivation of genetically modified organisms in all or part of Scotland
  33. 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
  34. 27Genetically modified organisms containing antibiotic resistance markers
  35. Part V: GENERAL PROVISION FOR CONSENTS
  36. 28General provisions of consents to market
  37. 29General conditions on consents to release or market genetically modified organisms
  38. 29ARestrictions on cultivation
  39. 29BRemoval of restrictions under regulation 29A
  40. 30Proof of compliance with consent conditions
  41. 30AStop notices
  42. 31Variation or revocation of consents to market
  43. Part VI: SAFEGUARD
  44. 32Safeguard
  45. Part VIA: Inspection powers, offences and service of notices
  46. 32APowers of inspectors
  47. 32BOffences and penalties
  48. 32CIndividual culpability for offending by an organisation
  49. 32DService of notices
  50. Part VII: CONFIDENTIALITY
  51. 33Confidentiality
  52. Part VIII: REGISTER OF INFORMATION
  53. 34Information to be included in the register
  54. 35Keeping the register
  55. 36Publication of representations
  56. Part IX: CONSEQUENTIAL AND OTHER AMENDMENTS AND REVOCATIONS
  57. 37Consequential and other amendments – agency arrangements
  58. 38Revocations
  59. Signature
  60. Schedule 1: PRINCIPLES FOR ENVIRONMENTAL RISK ASSESSMENT Repealed
  61. 1Introduction
  62. Part A: OBJECTIVE
  63. 2Paragraph 2
  64. Part B: GENERAL PRINCIPLES
  65. 3Paragraph 3
  66. Part C: METHODOLOGY
  67. Chapter C.1: GENERAL AND SPECIFIC CONSIDERATION FOR THE ENVIRONMENTAL RISK ASSESSMENT
  68. 4Step 1: Intended and unintended changes
  69. 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
  70. 6Step 3: Quality of the data
  71. 7Step 4: Stacked transformation events in applications to which Part 3 of these Regulations applies
  72. Chapter C.2: CHARACTERISTICS OF THE GENETICALLY MODIFIED ORGANISM AND OF THE RELEASES
  73. 8Paragraph 8
  74. Chapter C.3: STEPS IN THE ENVIRONMENTAL RISK ASSESSMENT
  75. 9Paragraph 9
  76. 10Step 1: Problem formulation including hazard identification
  77. 11Step 2: Hazard characterisation
  78. 12Step 3: Exposure characterisation
  79. 13Step 4: Risk characterisation
  80. 14Step 5: Risk management strategies
  81. 15Step 6: Overall risk evaluation and conclusions
  82. Part D: CONCLUSIONS ON THE SPECIFIC AREAS OF RISK OF THE ENVIRONMENTAL RISK ASSESSMENT
  83. 16Paragraph 16
  84. Chapter D.1: GENETICALLY MODIFIED ORGANISMS OTHER THAN HIGHER PLANTS
  85. 17Areas of risk
  86. Chapter D.2: GENETICALLY MODIFIED HIGHER PLANTS
  87. 18Areas of risk
  88. Schedule 2: INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO RELEASE OR MARKET GENETICALLY MODIFIED HIGHER PLANTS
  89. Part 1: INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO RELEASE FOR ANY OTHER PURPOSE THAN FOR PLACING ON THE MARKET
  90. 1A. General information
  91. 2A. General information
  92. 3B. Information relating to the release
  93. 4B. Information relating to the release
  94. 5B. Information relating to the release
  95. 6B. Information relating to the release
  96. 7B. Information relating to the release
  97. 8C. Information relating to the site of release
  98. 9C. Information relating to the site of release
  99. 10C. Information relating to the site of release
  100. 11C. Information relating to the site of release
  101. 12D. Information relating to the recipient plant or, where appropriate, to the parental plants
  102. 13D. Information relating to the recipient plant or, where appropriate, to the parental plants
  103. 14D. Information relating to the recipient plant or, where appropriate, to the parental plants
  104. 15D. Information relating to the recipient plant or, where appropriate, to the parental plants
  105. 16D. Information relating to the recipient plant or, where appropriate, to the parental plants
  106. 17D. Information relating to the recipient plant or, where appropriate, to the parental plants
  107. 18D. Information relating to the recipient plant or, where appropriate, to the parental plants
  108. 19E. Molecular characterisation
  109. 20E. Molecular characterisation
  110. 21E. Molecular characterisation
  111. 22F. Information on specific areas of risk
  112. 23F. Information on specific areas of risk
  113. 24F. Information on specific areas of risk
  114. 25F. Information on specific areas of risk
  115. 26F. Information on specific areas of risk
  116. 27F. Information on specific areas of risk
  117. 28F. Information on specific areas of risk
  118. 29F. Information on specific areas of risk
  119. 30G. Information on control, monitoring, post-release and waste treatment plans
  120. 31G. Information on control, monitoring, post-release and waste treatment plans
  121. 32G. Information on control, monitoring, post-release and waste treatment plans
  122. 33G. Information on control, monitoring, post-release and waste treatment plans
  123. 34G. Information on control, monitoring, post-release and waste treatment plans
  124. 35G. Information on control, monitoring, post-release and waste treatment plans
  125. 36H. Other
  126. 37H. Other
  127. Part 2: INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO PLACE ON MARKET
  128. 38A. General information
  129. 39A. General information
  130. 40A. General information
  131. 41B. Information relating to the recipient plant or, where appropriate, to the parental plants
  132. 42B. Information relating to the recipient plant or, where appropriate, to the parental plants
  133. 43B. Information relating to the recipient plant or, where appropriate, to the parental plants
  134. 44B. Information relating to the recipient plant or, where appropriate, to the parental plants
  135. 45B. Information relating to the recipient plant or, where appropriate, to the parental plants
  136. 46B. Information relating to the recipient plant or, where appropriate, to the parental plants
  137. 47B. Information relating to the recipient plant or, where appropriate, to the parental plants
  138. 48C. Molecular Characterisation
  139. 49C. Molecular Characterisation
  140. 50C. Molecular Characterisation
  141. 51C. Molecular Characterisation
  142. 52D. Comparative analysis of agronomic and phenotypic characteristics and of composition of the genetically modified higher plant.
  143. 53D. Comparative analysis of agronomic and phenotypic characteristics and of composition of the genetically modified higher plant.
  144. 54D. Comparative analysis of agronomic and phenotypic characteristics and of composition of the genetically modified higher plant.
  145. 55D. Comparative analysis of agronomic and phenotypic characteristics and of composition of the genetically modified higher plant.
  146. 56D. Comparative analysis of agronomic and phenotypic characteristics and of composition of the genetically modified higher plant.
  147. Schedule 3: INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO RELEASE OR MARKET ORGANISMS OTHER THAN GENETICALLY MODIFIED HIGHER PLANTS
  148. Part I: GENERAL INFORMATION
  149. 1Paragraph 1
  150. 2Paragraph 2
  151. Part II: INFORMATION RELATING TO THE ORGANISMS
  152. 1Characteristics of donor, parental and recipient organisms Repealed
  153. 3Paragraph 3
  154. 4Paragraph 4
  155. 5Paragraph 5
  156. 6Paragraph 6
  157. 7Paragraph 7
  158. 8Paragraph 8
  159. 9Paragraph 9
  160. 10Paragraph 10
  161. 11Paragraph 11
  162. 12Paragraph 12
  163. 13Paragraph 13
  164. 14Paragraph 14
  165. 2Characteristics of the vector Repealed
  166. 15Paragraph 15
  167. 16Paragraph 16
  168. 17Paragraph 17
  169. 18Paragraph 18
  170. 3Characteristics of the modified organisms Repealed
  171. 19Paragraph 19
  172. 20Paragraph 20
  173. 21Paragraph 21
  174. 22Paragraph 22
  175. 23Paragraph 23
  176. 24Paragraph 24
  177. 4Characteristics of the genetically modified organisms in their final form Repealed
  178. 25Paragraph 25
  179. 26Paragraph 26
  180. 27Paragraph 27
  181. 28Paragraph 28
  182. 29Paragraph 29
  183. 30Paragraph 30
  184. 31Paragraph 31
  185. 32Paragraph 32
  186. 33Paragraph 33
  187. Part III: INFORMATION RELATING TO THE CONDITIONS OF RELEASE AND THE RECEIVING ENVIRONMENT
  188. 5The release Repealed
  189. 34Paragraph 34
  190. 35Paragraph 35
  191. 36Paragraph 36
  192. 37Paragraph 37
  193. 38Paragraph 38
  194. 39Paragraph 39
  195. 40Paragraph 40
  196. 41Paragraph 41
  197. 42Paragraph 42
  198. 43Paragraph 43
  199. 44Paragraph 44
  200. 6The environment (both on the site and in the wider environment) Repealed
  201. 45Paragraph 45
  202. 46Paragraph 46
  203. 47Paragraph 47
  204. 48Paragraph 48
  205. 49Paragraph 49
  206. 50Paragraph 50
  207. 51Paragraph 51
  208. 52Paragraph 52
  209. 53Paragraph 53
  210. Part IV: INFORMATION RELATING TO THE INTERACTIONS BETWEEN THE GENETICALLY MODIFIED ORGANISMS AND THE ENVIRONMENT
  211. 7Characteristics affecting survival, multiplication and dissemination Repealed
  212. 54Paragraph 54
  213. 55Paragraph 55
  214. 56Paragraph 56
  215. 8Interactions with the environment Repealed
  216. 57Paragraph 57
  217. 58Paragraph 58
  218. 59Paragraph 59
  219. 60Paragraph 60
  220. 61Paragraph 61
  221. 62Paragraph 62
  222. 63Paragraph 63
  223. 64Paragraph 64
  224. 65Paragraph 65
  225. 66Paragraph 66
  226. 67Paragraph 67
  227. 68Paragraph 68
  228. 69Paragraph 69
  229. 70Paragraph 70
  230. 71Paragraph 71
  231. 72Paragraph 72
  232. Part V: INFORMATION ON MONITORING, CONTROL, WASTE TREATMENT AND EMERGENCY RESPONSE PLANS
  233. 9Monitoring techniques Repealed
  234. 73Paragraph 73
  235. 74Paragraph 74
  236. 75Paragraph 75
  237. 76Paragraph 76
  238. 10Control of the release Repealed
  239. 77Paragraph 77
  240. 78Paragraph 78
  241. 79Paragraph 79
  242. 11Waste treatment Repealed
  243. 80Paragraph 80
  244. 81Paragraph 81
  245. 82Paragraph 82
  246. 12Emergency response plans Repealed
  247. 83Paragraph 83
  248. 84Paragraph 84
  249. 85Paragraph 85
  250. 86Paragraph 86
  251. 87Paragraph 87
  252. Part VI: INFORMATION ON METHODOLOGY
  253. 88Paragraph 88
  254. Schedule 4: INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO MARKET GENETICALLY MODIFIED ORGANISMS
  255. Part I: GENERAL INFORMATION
  256. 1Paragraph 1
  257. 2Paragraph 2
  258. 3Paragraph 3
  259. 4Paragraph 4
  260. 5Paragraph 5
  261. 6Paragraph 6
  262. 7Paragraph 7
  263. 8Paragraph 8
  264. Part II: ADDITIONAL RELEVANT INFORMATION
  265. 9Paragraph 9
  266. 10Paragraph 10
  267. 11Paragraph 11
  268. 12Paragraph 12
  269. 13Paragraph 13
  270. 14Paragraph 14
  271. 15Paragraph 15
  272. Schedule 5: INFORMATION TO BE INCLUDED IN AN ASSESSMENT REPORT
  273. 1Paragraph 1
  274. 2Paragraph 2
  275. 3Paragraph 3
  276. 4Paragraph 4
  277. 5Paragraph 5
  278. 6Paragraph 6
  279. Schedule 5A: MONITORING PLAN
  280. 1Introduction
  281. Part A: OBJECTIVE
  282. 2Paragraph 2
  283. Part B: GENERAL PRINCIPLES
  284. 3Paragraph 3
  285. Part C: DESIGN OF THE MONITORING PLAN
  286. 4Paragraph 4
  287. Schedule 6: AMENDMENT TO THE SCOTLAND ACT 1998 (AGENCY ARRANGEMENTS) (SPECIFICATION) (NO. 2) ORDER 2002
  288. Paragraph
  289. Schedule 7REVOCATIONS
  290. Explanatory note