File #2718: "2019_Book_RegulationOfGenomeEditingInPla.pdf"
Text
1|Preface|5
1|Contents|7
1|Contributors|8
1|Chapter 1: Introduction: Regulation of Plants Derived from Genome Editing-What Lessons To Be Learned from Other Countries?|11
2|1.1 Introduction|11
2|1.2 Specific Characteristics of the Regulatory Approaches|13
3|1.2.1 Argentina|13
3|1.2.2 Australia|14
3|1.2.3 Canada|15
3|1.2.4 European Union|15
3|1.2.5 Japan|16
3|1.2.6 United States|17
2|1.3 Identification of Best Practices|18
3|1.3.1 Voluntary Early Consultation Procedure|19
3|1.3.2 Single Point or Multiple Point of Entry|20
3|1.3.3 One-Door-One-Key Principle|21
3|1.3.4 Mandatory Upstream Procedure|22
3|1.3.5 Product-Based Approach|23
2|1.4 Conclusions|24
2|References|25
1|Chapter 2: Regulation of Genome Editing in Plant Biotechnology: Argentina|28
2|2.1 Introduction|29
2|2.2 The Regulatory Framework for Genetically Modified Organisms (GMOs): An Overview|30
3|2.2.1 Overview, Applicable Laws and Regulations|30
3|2.2.2 Authorities and Responsible Agencies|32
2|2.3 Regulatory Status of Genome Edited Plants|33
3|2.3.1 Applicability of the Regulatory Framework for GMOs|33
3|2.3.2 Regulatory Classification of Genome Editing/Genome Edited Plants|34
2|2.4 Regulatory Prerequisites for Activities Relating to Genome Edited Plants|39
3|2.4.1 Contained/Confined Use of GM Plants|39
3|2.4.2 Marketing of GM Plants and Foodstuffs|40
3|2.4.3 Conventional (Non-GM) New Varieties|41
2|2.5 Status Quo of Genome Edited Plants and Products Derived from Them|42
2|2.6 Reform Efforts|42
2|2.7 Low Level Presence|43
2|2.8 Labelling|44
2|2.9 Identity Preservation System (Coexistence)|45
2|2.10 Liability|47
2|2.11 Perception of Genome Editing|49
3|2.11.1 Position of Public Authorities|49
3|2.11.2 Public Opinion|49
2|2.12 Treatment of Other New Breeding Technologies|50
2|2.13 Other Regulations in the Region|50
2|2.14 Conclusion|52
2|Annex 1: First NBT Regulations from LA Countries|53
3|Resolution No. 173/2015 (Argentina)|53
3|Resolution No. 16/2018 (Brazil)|56
2|Annex 2|58
2|Annex 3|59
3|Guidance on the Applicability de Resolution no. 1.523/2001 (Chile)|60
3|Draft Resolution (Colombia)|63
2|References|68
1|Chapter 3: Regulation of Genome Editing in Plant Biotechnology: Australia|72
2|3.1 Introduction|72
2|3.2 The Regulatory Framework for GMOs: An Overview (Table 3.1)|74
2|3.3 Regulatory Status of Genome Edited Plants|75
3|3.3.1 Applicability of the Regulatory Framework for GMOs|75
4|3.3.1.1 Gene Technology|75
5|3.3.1.1.1 Triggers for Gene Technology Regulatory Framework|78
4|3.3.1.2 Food|82
5|3.3.1.2.1 Triggers for Food Regulatory Framework|83
4|3.3.1.3 Agricultural and Veterinary Chemicals|84
3|3.3.2 Regulatory Classification of Genome Editing/Genome Edited Plants (Table 3.2)|85
4|3.3.2.1 Gene Technology|85
5|3.3.2.1.1 Genome Editing Using SDN Is Gene Technology|86
5|3.3.2.1.2 Removal of DNA from a Plant Does Not Create a GMO (Provided the Construct and Vector Are No Longer Present)|87
5|3.3.2.1.3 Addition of DNA to an Organism´s Genome Is Not Sufficient of Itself to Create a GMO|87
5|3.3.2.1.4 Use of a Template to Guide Modifications Results in GMOs That Are Subject to Regulation|87
4|3.3.2.2 Food|88
2|3.4 Regulatory Prerequisites for Activities Relating to Genome Edited Plants|90
3|3.4.1 Gene Technology|90
3|3.4.2 Food|92
3|3.4.3 Agricultural and Veterinary Chemicals|94
2|3.5 Status Quo of Genome Edited Plants and Products Derived from Them|94
2|3.6 Reform Efforts|95
3|3.6.1 Timeline re Australian Regulatory Responses to Genome Edited Plants (Table 3.5)|95
3|3.6.2 Gene Technology|96
4|3.6.2.1 Introduction|96
4|3.6.2.2 Technical Review of the Gene Technology Regulations|97
5|3.6.2.2.1 Organisms Modified Using SDN-1 Are Not GMOs|98
5|3.6.2.2.2 Organisms Modified Using SDN-2 and ODM Are GMOs|100
5|3.6.2.2.3 Organisms Derived from GMOs|100
4|3.6.2.3 GT Regulatory Scheme Review|101
3|3.6.3 Food|103
2|3.7 Low Level Presence|105
2|3.8 Labelling|106
3|3.8.1 Gene Technology|106
3|3.8.2 Food|107
2|3.9 Identity Preservation System (Coexistence)|109
2|3.10 Liability|109
2|3.11 Perception of Genome Editing|111
3|3.11.1 Position of Public Authorities|111
3|3.11.2 Public Opinion|111
2|3.12 Treatment of Other New Breeding Technologies|113
3|3.12.1 Gene Technology|113
3|3.12.2 Food|114
2|3.13 Conclusion|116
2|References|117
1|Chapter 4: Regulation of Genome Editing in Plant Biotechnology: Canada|120
2|4.1 Introduction|120
2|4.2 The Regulatory Framework for Genetically Modified Organisms: An Overview|123
2|4.3 Regulatory Status of Genome Edited Plants|124
3|4.3.1 Applicability of the Regulatory Framework for GMOs|125
3|4.3.2 Regulatory Classifications of Genome Editing/Genome Edited Plants|127
2|4.4 Regulatory Prerequisites for Activities Relating to Genome Edited Plants|127
2|4.5 Status Quo of Genome Edited Plants and Products Derived from Them|128
2|4.6 Reform Efforts|129
2|4.7 Low Level Presence|131
2|4.8 Labelling|132
2|4.9 Identity Preservation System (Coexistence)|133
2|4.10 Liability|134
2|4.11 Perception of Genome Editing|135
3|4.11.1 Position of Public Authorities|135
3|4.11.2 Public Opinion|136
2|4.12 Treatment of Other New Breeding Technologies|142
2|4.13 Conclusions|142
2|References|143
1|Chapter 5: Regulation of Genome Editing in Plant Biotechnology: European Union|145
2|5.1 Introduction|146
2|5.2 The Regulatory Framework for Genetically Modified Organisms (GMOs): An Overview|148
2|5.3 Regulatory Status of Genome Edited Plants|154
3|5.3.1 Applicability of the Regulatory Framework for GMOs|154
3|5.3.2 Regulatory Classification of Genome Edited Plants|155
4|5.3.2.1 SDN-1, SDN-2, ODM: Yield GMOs|155
4|5.3.2.2 SDN-3: Yields GMOs|158
4|5.3.2.3 Summary|159
2|5.4 Regulatory Prerequisites for Activities Relating to Genome Edited Plants|159
3|5.4.1 Step 1: Contained Use (Directive 2009/41/EC)|160
4|5.4.1.1 Authorisation Procedure; Responsible Agencies|160
4|5.4.1.2 Risk Assessment to Classify Contained Uses|160
4|5.4.1.3 Information Required for the Notification|161
4|5.4.1.4 Requirements for Granting an Approval|161
3|5.4.2 Step 2: Field Trials (Directive 2001/18/EC)|162
4|5.4.2.1 Authorisation Procedure; Responsible Agencies|162
4|5.4.2.2 Information Required for the Application|162
4|5.4.2.3 Environmental Risk Assessment|162
4|5.4.2.4 Requirements for Granting an Approval|163
3|5.4.3 Step 3: Placing on the Market|164
4|5.4.3.1 Cultivation (Directive 2001/18/EC)|164
5|5.4.3.1.1 Authorisation Procedure; Responsible Agencies|164
5|5.4.3.1.2 Information Required for the Application|165
5|5.4.3.1.3 Environmental Risk Assessment|166
5|5.4.3.1.4 Requirements for Granting an Approval|166
5|5.4.3.1.5 Member States´ Possibility to ``Opt Out´´ from GMO Cultivation|166
4|5.4.3.2 Food and Feed (Regulation (EC) No 1829/2003)|167
5|5.4.3.2.1 Authorisation Procedure; Responsible Agencies|168
5|5.4.3.2.2 Information Required for the Application|169
5|5.4.3.2.3 Human and Animal Health Risk Assessment|170
5|5.4.3.2.4 Requirements for Granting an Approval|170
4|5.4.3.3 Medicinal Products (Regulation (EC) No 726/2004)|171
4|5.4.3.4 Other Products|172
3|5.4.4 General Principles and Concepts of All GMO Authorisation Regimes (Excluding Contained Use)|172
4|5.4.4.1 Division Into Risk Assessment and Risk Management|172
4|5.4.4.2 General Principles and Concepts of Risk Assessment|173
4|5.4.4.3 General Principles and Concepts of Risk Management|174
3|5.4.5 Problems Regarding the Authorisation of GEOs|175
4|5.4.5.1 Detection and Identification Techniques Required for GMO Authorisation|175
4|5.4.5.2 Risk Assessment: Safety Data Requirements Possibly Disproportionate|177
2|5.5 Status Quo of Genome Edited Plants and Products Derived from Them|178
3|5.5.1 Contained Use|178
3|5.5.2 Field Trials|178
3|5.5.3 Placing on the Market|180
2|5.6 Reform Efforts|180
3|5.6.1 Incentives and Disincentives for Reform|181
3|5.6.2 Options for Deregulation|185
4|5.6.2.1 Complete Overhaul of the EU´s GMO Regulatory Framework|185
4|5.6.2.2 Exclusion of Some Types of GEOs from the GMO Regulatory Framework|186
4|5.6.2.3 Reduction of Obligations Under the GMO Regulatory Framework for Some Types of GEOs|188
3|5.6.3 Options for More Regulation|189
3|5.6.4 Summary|189
2|5.7 Low Level Presence|189
2|5.8 Labelling|192
2|5.9 Identity Preservation System (Coexistence)|196
2|5.10 Liability|197
3|5.10.1 Criminal and Administrative Liability|197
3|5.10.2 Product Liability|198
3|5.10.3 Civil Liability|199
3|5.10.4 Environmental Liability|202
3|5.10.5 Summary|203
2|5.11 Perception of Genome Editing|204
3|5.11.1 Position of Public Authorities|204
4|5.11.1.1 EU Authorities|204
5|5.11.1.1.1 European Commission|204
5|5.11.1.1.2 European Parliament|206
5|5.11.1.1.3 Council of the European Union|206
4|5.11.1.2 Member States Authorities|207
3|5.11.2 Stakeholders´ Opinions|208
3|5.11.3 Public Opinion|210
4|5.11.3.1 Public Opinion on GMOs|210
4|5.11.3.2 Public Opinion on GEOs|211
2|5.12 Treatment of Other New Breeding Technologies|214
3|5.12.1 Regulatory Status|214
3|5.12.2 The Regulatory Framework for Non-GMOs: An Overview|219
4|5.12.2.1 Contained Use, Field Trials|219
4|5.12.2.2 Placing on the Market|219
5|5.12.2.2.1 Cultivation|219
5|5.12.2.2.2 Food and Feed|221
2|5.13 Conclusion|222
2|References|223
1|Chapter 6: Regulation of Genome Editing in Plant Biotechnology: Japan|247
2|6.1 Introduction|247
2|6.2 The Regulatory Framework for Genetically Modified Organisms (GMOs): An Overview|249
2|6.3 Regulatory Status of Genome Edited Plants|255
3|6.3.1 Applicability of the Regulatory Framework for GMOs|255
3|6.3.2 Regulatory Classification of Genome Editing/Genome Edited Plants|256
2|6.4 Status Quo of Genome Edited Plants and Products Derived from Them|258
3|6.4.1 Type 2 Use of Plant Genome Editing|258
3|6.4.2 Type 1 Use of Plant Genome Editing|258
2|6.5 Reform Efforts|260
2|6.6 GMO Labelling and Low Level Presence|263
2|6.7 Liability|265
2|6.8 Perception of Genome Editing|265
3|6.8.1 Position of Public Authorities|265
3|6.8.2 Public Opinion|266
2|6.9 Conclusion|267
2|References|268
1|Chapter 7: Genetic Engineering in the United States: Regulation of Crops and Their Food Products|271
2|7.1 Introduction|272
2|7.2 Production of GE Crops in the United States|275
2|7.3 Regulation of GE Crops and Food Products in the United States|278
3|7.3.1 Policy|278
3|7.3.2 Authorization|280
4|7.3.2.1 US Department of Agriculture|280
5|7.3.2.1.1 Field Trials|280
5|7.3.2.1.2 Nonregulated Status|282
4|7.3.2.2 Environmental Protection Agency|283
4|7.3.2.3 Food and Drug Administration|285
2|7.4 Recent Regulatory Initiatives|287
3|7.4.1 Policy Developments|287
3|7.4.2 Agency Activities|290
4|7.4.2.1 USDA|290
4|7.4.2.2 FDA|293
2|7.5 Protecting Non-GE Crops|293
3|7.5.1 Coexistence|293
3|7.5.2 Low-Level Presence|295
2|7.6 Labels for GE Food|297
2|7.7 Liability|301
2|7.8 US Regulation of Innovative GE Technology|302
3|7.8.1 Regulatory Uncertainty|302
3|7.8.2 USDA Regulation|303
4|7.8.2.1 Am I Regulated?|304
4|7.8.2.2 USDA Decisions|305
3|7.8.3 FDA Consultations|308
2|7.9 US Regulation of Innovative GE Technologies: What Direction?|309
2|7.10 Conclusion|313
2|References|315
1|Chapter 8: Comparative Analysis: The Regulation of Plants Derived from Genome Editing in Argentina, Australia, Canada, the Eur...|321
2|8.1 Introduction|321
2|8.2 Country Overview|322
3|8.2.1 Cultivation of GM Crops|322
4|8.2.1.1 Approved GM Plants or GM Events|322
4|8.2.1.2 Current Cultivation of GM Crops|325
4|8.2.1.3 Conclusion|330
3|8.2.2 Consumption of GMOs and Products Derived from Them|330
4|8.2.2.1 Approved GM Plant Events for Food and Feed|330
4|8.2.2.2 Import of GM Crops|331
4|8.2.2.3 Conclusion|332
3|8.2.3 Status Quo of Genome Edited Plants and Products Derived from Them|333
2|8.3 The Point of Entry into the Regulatory Framework for Genetically Modified Organisms (GMOs): Regulatory Triggers|335
3|8.3.1 Argentina|336
3|8.3.2 Australia|336
3|8.3.3 Canada|338
3|8.3.4 EU|339
3|8.3.5 Japan|340
3|8.3.6 USA|341
3|8.3.7 Comparative Analysis|343
2|8.4 Regulatory Status of Genome Edited Plants|344
3|8.4.1 Argentina|346
3|8.4.2 Australia|346
3|8.4.3 Canada|347
3|8.4.4 EU|348
3|8.4.5 Japan|348
3|8.4.6 USA|350
3|8.4.7 Comparative Analysis|352
2|8.5 Labelling|354
3|8.5.1 Argentina|354
3|8.5.2 Australia|355
3|8.5.3 Canada|355
3|8.5.4 EU|355
3|8.5.5 Japan|356
3|8.5.6 USA|356
3|8.5.7 Comparative Analysis|357
2|8.6 Identity Preservation System (Coexistence)|358
3|8.6.1 Argentina|359
3|8.6.2 Australia|360
3|8.6.3 Canada|360
3|8.6.4 EU|360
3|8.6.5 Japan|361
3|8.6.6 USA|361
3|8.6.7 Comparative Analysis|361
2|8.7 Reform Efforts|362
3|8.7.1 Argentina|362
3|8.7.2 Australia|363
3|8.7.3 Canada|364
3|8.7.4 EU|364
3|8.7.5 Japan|364
3|8.7.6 USA|365
3|8.7.7 Comparative Analysis|366
2|8.8 Conclusion|366
2|References|367
1|Appendix: Questionnaire|372
2|Country-Report: [Please state your Country]|372
3|Introduction|372
3|The Regulatory Framework for Genetically Modified Organisms (GMOs): An Overview|372
3|Regulatory Status of Genome Edited Plants|373
4|Applicability of the Regulatory Framework for GMOs|373
4|Regulatory Classification of Genome Editing/Genome Edited Plants|373
3|Regulatory Prerequisites for Activities Relating to Genome Edited Plants|374
3|Status Quo of Genome Edited Plants and Products Derived from Them|375
3|Reform Efforts|375
3|Low Level Presence|376
3|Labelling|376
3|Identity Preservation System (Coexistence)|376
3|Liability|377
3|Perception of Genome Editing|377
4|Position of Public Authorities|377
4|Public Opinion|377
3|Treatment of Other New Breeding Technologies|377
3|Conclusion|378
3|Glossary|378
1|Contents|7
1|Contributors|8
1|Chapter 1: Introduction: Regulation of Plants Derived from Genome Editing-What Lessons To Be Learned from Other Countries?|11
2|1.1 Introduction|11
2|1.2 Specific Characteristics of the Regulatory Approaches|13
3|1.2.1 Argentina|13
3|1.2.2 Australia|14
3|1.2.3 Canada|15
3|1.2.4 European Union|15
3|1.2.5 Japan|16
3|1.2.6 United States|17
2|1.3 Identification of Best Practices|18
3|1.3.1 Voluntary Early Consultation Procedure|19
3|1.3.2 Single Point or Multiple Point of Entry|20
3|1.3.3 One-Door-One-Key Principle|21
3|1.3.4 Mandatory Upstream Procedure|22
3|1.3.5 Product-Based Approach|23
2|1.4 Conclusions|24
2|References|25
1|Chapter 2: Regulation of Genome Editing in Plant Biotechnology: Argentina|28
2|2.1 Introduction|29
2|2.2 The Regulatory Framework for Genetically Modified Organisms (GMOs): An Overview|30
3|2.2.1 Overview, Applicable Laws and Regulations|30
3|2.2.2 Authorities and Responsible Agencies|32
2|2.3 Regulatory Status of Genome Edited Plants|33
3|2.3.1 Applicability of the Regulatory Framework for GMOs|33
3|2.3.2 Regulatory Classification of Genome Editing/Genome Edited Plants|34
2|2.4 Regulatory Prerequisites for Activities Relating to Genome Edited Plants|39
3|2.4.1 Contained/Confined Use of GM Plants|39
3|2.4.2 Marketing of GM Plants and Foodstuffs|40
3|2.4.3 Conventional (Non-GM) New Varieties|41
2|2.5 Status Quo of Genome Edited Plants and Products Derived from Them|42
2|2.6 Reform Efforts|42
2|2.7 Low Level Presence|43
2|2.8 Labelling|44
2|2.9 Identity Preservation System (Coexistence)|45
2|2.10 Liability|47
2|2.11 Perception of Genome Editing|49
3|2.11.1 Position of Public Authorities|49
3|2.11.2 Public Opinion|49
2|2.12 Treatment of Other New Breeding Technologies|50
2|2.13 Other Regulations in the Region|50
2|2.14 Conclusion|52
2|Annex 1: First NBT Regulations from LA Countries|53
3|Resolution No. 173/2015 (Argentina)|53
3|Resolution No. 16/2018 (Brazil)|56
2|Annex 2|58
2|Annex 3|59
3|Guidance on the Applicability de Resolution no. 1.523/2001 (Chile)|60
3|Draft Resolution (Colombia)|63
2|References|68
1|Chapter 3: Regulation of Genome Editing in Plant Biotechnology: Australia|72
2|3.1 Introduction|72
2|3.2 The Regulatory Framework for GMOs: An Overview (Table 3.1)|74
2|3.3 Regulatory Status of Genome Edited Plants|75
3|3.3.1 Applicability of the Regulatory Framework for GMOs|75
4|3.3.1.1 Gene Technology|75
5|3.3.1.1.1 Triggers for Gene Technology Regulatory Framework|78
4|3.3.1.2 Food|82
5|3.3.1.2.1 Triggers for Food Regulatory Framework|83
4|3.3.1.3 Agricultural and Veterinary Chemicals|84
3|3.3.2 Regulatory Classification of Genome Editing/Genome Edited Plants (Table 3.2)|85
4|3.3.2.1 Gene Technology|85
5|3.3.2.1.1 Genome Editing Using SDN Is Gene Technology|86
5|3.3.2.1.2 Removal of DNA from a Plant Does Not Create a GMO (Provided the Construct and Vector Are No Longer Present)|87
5|3.3.2.1.3 Addition of DNA to an Organism´s Genome Is Not Sufficient of Itself to Create a GMO|87
5|3.3.2.1.4 Use of a Template to Guide Modifications Results in GMOs That Are Subject to Regulation|87
4|3.3.2.2 Food|88
2|3.4 Regulatory Prerequisites for Activities Relating to Genome Edited Plants|90
3|3.4.1 Gene Technology|90
3|3.4.2 Food|92
3|3.4.3 Agricultural and Veterinary Chemicals|94
2|3.5 Status Quo of Genome Edited Plants and Products Derived from Them|94
2|3.6 Reform Efforts|95
3|3.6.1 Timeline re Australian Regulatory Responses to Genome Edited Plants (Table 3.5)|95
3|3.6.2 Gene Technology|96
4|3.6.2.1 Introduction|96
4|3.6.2.2 Technical Review of the Gene Technology Regulations|97
5|3.6.2.2.1 Organisms Modified Using SDN-1 Are Not GMOs|98
5|3.6.2.2.2 Organisms Modified Using SDN-2 and ODM Are GMOs|100
5|3.6.2.2.3 Organisms Derived from GMOs|100
4|3.6.2.3 GT Regulatory Scheme Review|101
3|3.6.3 Food|103
2|3.7 Low Level Presence|105
2|3.8 Labelling|106
3|3.8.1 Gene Technology|106
3|3.8.2 Food|107
2|3.9 Identity Preservation System (Coexistence)|109
2|3.10 Liability|109
2|3.11 Perception of Genome Editing|111
3|3.11.1 Position of Public Authorities|111
3|3.11.2 Public Opinion|111
2|3.12 Treatment of Other New Breeding Technologies|113
3|3.12.1 Gene Technology|113
3|3.12.2 Food|114
2|3.13 Conclusion|116
2|References|117
1|Chapter 4: Regulation of Genome Editing in Plant Biotechnology: Canada|120
2|4.1 Introduction|120
2|4.2 The Regulatory Framework for Genetically Modified Organisms: An Overview|123
2|4.3 Regulatory Status of Genome Edited Plants|124
3|4.3.1 Applicability of the Regulatory Framework for GMOs|125
3|4.3.2 Regulatory Classifications of Genome Editing/Genome Edited Plants|127
2|4.4 Regulatory Prerequisites for Activities Relating to Genome Edited Plants|127
2|4.5 Status Quo of Genome Edited Plants and Products Derived from Them|128
2|4.6 Reform Efforts|129
2|4.7 Low Level Presence|131
2|4.8 Labelling|132
2|4.9 Identity Preservation System (Coexistence)|133
2|4.10 Liability|134
2|4.11 Perception of Genome Editing|135
3|4.11.1 Position of Public Authorities|135
3|4.11.2 Public Opinion|136
2|4.12 Treatment of Other New Breeding Technologies|142
2|4.13 Conclusions|142
2|References|143
1|Chapter 5: Regulation of Genome Editing in Plant Biotechnology: European Union|145
2|5.1 Introduction|146
2|5.2 The Regulatory Framework for Genetically Modified Organisms (GMOs): An Overview|148
2|5.3 Regulatory Status of Genome Edited Plants|154
3|5.3.1 Applicability of the Regulatory Framework for GMOs|154
3|5.3.2 Regulatory Classification of Genome Edited Plants|155
4|5.3.2.1 SDN-1, SDN-2, ODM: Yield GMOs|155
4|5.3.2.2 SDN-3: Yields GMOs|158
4|5.3.2.3 Summary|159
2|5.4 Regulatory Prerequisites for Activities Relating to Genome Edited Plants|159
3|5.4.1 Step 1: Contained Use (Directive 2009/41/EC)|160
4|5.4.1.1 Authorisation Procedure; Responsible Agencies|160
4|5.4.1.2 Risk Assessment to Classify Contained Uses|160
4|5.4.1.3 Information Required for the Notification|161
4|5.4.1.4 Requirements for Granting an Approval|161
3|5.4.2 Step 2: Field Trials (Directive 2001/18/EC)|162
4|5.4.2.1 Authorisation Procedure; Responsible Agencies|162
4|5.4.2.2 Information Required for the Application|162
4|5.4.2.3 Environmental Risk Assessment|162
4|5.4.2.4 Requirements for Granting an Approval|163
3|5.4.3 Step 3: Placing on the Market|164
4|5.4.3.1 Cultivation (Directive 2001/18/EC)|164
5|5.4.3.1.1 Authorisation Procedure; Responsible Agencies|164
5|5.4.3.1.2 Information Required for the Application|165
5|5.4.3.1.3 Environmental Risk Assessment|166
5|5.4.3.1.4 Requirements for Granting an Approval|166
5|5.4.3.1.5 Member States´ Possibility to ``Opt Out´´ from GMO Cultivation|166
4|5.4.3.2 Food and Feed (Regulation (EC) No 1829/2003)|167
5|5.4.3.2.1 Authorisation Procedure; Responsible Agencies|168
5|5.4.3.2.2 Information Required for the Application|169
5|5.4.3.2.3 Human and Animal Health Risk Assessment|170
5|5.4.3.2.4 Requirements for Granting an Approval|170
4|5.4.3.3 Medicinal Products (Regulation (EC) No 726/2004)|171
4|5.4.3.4 Other Products|172
3|5.4.4 General Principles and Concepts of All GMO Authorisation Regimes (Excluding Contained Use)|172
4|5.4.4.1 Division Into Risk Assessment and Risk Management|172
4|5.4.4.2 General Principles and Concepts of Risk Assessment|173
4|5.4.4.3 General Principles and Concepts of Risk Management|174
3|5.4.5 Problems Regarding the Authorisation of GEOs|175
4|5.4.5.1 Detection and Identification Techniques Required for GMO Authorisation|175
4|5.4.5.2 Risk Assessment: Safety Data Requirements Possibly Disproportionate|177
2|5.5 Status Quo of Genome Edited Plants and Products Derived from Them|178
3|5.5.1 Contained Use|178
3|5.5.2 Field Trials|178
3|5.5.3 Placing on the Market|180
2|5.6 Reform Efforts|180
3|5.6.1 Incentives and Disincentives for Reform|181
3|5.6.2 Options for Deregulation|185
4|5.6.2.1 Complete Overhaul of the EU´s GMO Regulatory Framework|185
4|5.6.2.2 Exclusion of Some Types of GEOs from the GMO Regulatory Framework|186
4|5.6.2.3 Reduction of Obligations Under the GMO Regulatory Framework for Some Types of GEOs|188
3|5.6.3 Options for More Regulation|189
3|5.6.4 Summary|189
2|5.7 Low Level Presence|189
2|5.8 Labelling|192
2|5.9 Identity Preservation System (Coexistence)|196
2|5.10 Liability|197
3|5.10.1 Criminal and Administrative Liability|197
3|5.10.2 Product Liability|198
3|5.10.3 Civil Liability|199
3|5.10.4 Environmental Liability|202
3|5.10.5 Summary|203
2|5.11 Perception of Genome Editing|204
3|5.11.1 Position of Public Authorities|204
4|5.11.1.1 EU Authorities|204
5|5.11.1.1.1 European Commission|204
5|5.11.1.1.2 European Parliament|206
5|5.11.1.1.3 Council of the European Union|206
4|5.11.1.2 Member States Authorities|207
3|5.11.2 Stakeholders´ Opinions|208
3|5.11.3 Public Opinion|210
4|5.11.3.1 Public Opinion on GMOs|210
4|5.11.3.2 Public Opinion on GEOs|211
2|5.12 Treatment of Other New Breeding Technologies|214
3|5.12.1 Regulatory Status|214
3|5.12.2 The Regulatory Framework for Non-GMOs: An Overview|219
4|5.12.2.1 Contained Use, Field Trials|219
4|5.12.2.2 Placing on the Market|219
5|5.12.2.2.1 Cultivation|219
5|5.12.2.2.2 Food and Feed|221
2|5.13 Conclusion|222
2|References|223
1|Chapter 6: Regulation of Genome Editing in Plant Biotechnology: Japan|247
2|6.1 Introduction|247
2|6.2 The Regulatory Framework for Genetically Modified Organisms (GMOs): An Overview|249
2|6.3 Regulatory Status of Genome Edited Plants|255
3|6.3.1 Applicability of the Regulatory Framework for GMOs|255
3|6.3.2 Regulatory Classification of Genome Editing/Genome Edited Plants|256
2|6.4 Status Quo of Genome Edited Plants and Products Derived from Them|258
3|6.4.1 Type 2 Use of Plant Genome Editing|258
3|6.4.2 Type 1 Use of Plant Genome Editing|258
2|6.5 Reform Efforts|260
2|6.6 GMO Labelling and Low Level Presence|263
2|6.7 Liability|265
2|6.8 Perception of Genome Editing|265
3|6.8.1 Position of Public Authorities|265
3|6.8.2 Public Opinion|266
2|6.9 Conclusion|267
2|References|268
1|Chapter 7: Genetic Engineering in the United States: Regulation of Crops and Their Food Products|271
2|7.1 Introduction|272
2|7.2 Production of GE Crops in the United States|275
2|7.3 Regulation of GE Crops and Food Products in the United States|278
3|7.3.1 Policy|278
3|7.3.2 Authorization|280
4|7.3.2.1 US Department of Agriculture|280
5|7.3.2.1.1 Field Trials|280
5|7.3.2.1.2 Nonregulated Status|282
4|7.3.2.2 Environmental Protection Agency|283
4|7.3.2.3 Food and Drug Administration|285
2|7.4 Recent Regulatory Initiatives|287
3|7.4.1 Policy Developments|287
3|7.4.2 Agency Activities|290
4|7.4.2.1 USDA|290
4|7.4.2.2 FDA|293
2|7.5 Protecting Non-GE Crops|293
3|7.5.1 Coexistence|293
3|7.5.2 Low-Level Presence|295
2|7.6 Labels for GE Food|297
2|7.7 Liability|301
2|7.8 US Regulation of Innovative GE Technology|302
3|7.8.1 Regulatory Uncertainty|302
3|7.8.2 USDA Regulation|303
4|7.8.2.1 Am I Regulated?|304
4|7.8.2.2 USDA Decisions|305
3|7.8.3 FDA Consultations|308
2|7.9 US Regulation of Innovative GE Technologies: What Direction?|309
2|7.10 Conclusion|313
2|References|315
1|Chapter 8: Comparative Analysis: The Regulation of Plants Derived from Genome Editing in Argentina, Australia, Canada, the Eur...|321
2|8.1 Introduction|321
2|8.2 Country Overview|322
3|8.2.1 Cultivation of GM Crops|322
4|8.2.1.1 Approved GM Plants or GM Events|322
4|8.2.1.2 Current Cultivation of GM Crops|325
4|8.2.1.3 Conclusion|330
3|8.2.2 Consumption of GMOs and Products Derived from Them|330
4|8.2.2.1 Approved GM Plant Events for Food and Feed|330
4|8.2.2.2 Import of GM Crops|331
4|8.2.2.3 Conclusion|332
3|8.2.3 Status Quo of Genome Edited Plants and Products Derived from Them|333
2|8.3 The Point of Entry into the Regulatory Framework for Genetically Modified Organisms (GMOs): Regulatory Triggers|335
3|8.3.1 Argentina|336
3|8.3.2 Australia|336
3|8.3.3 Canada|338
3|8.3.4 EU|339
3|8.3.5 Japan|340
3|8.3.6 USA|341
3|8.3.7 Comparative Analysis|343
2|8.4 Regulatory Status of Genome Edited Plants|344
3|8.4.1 Argentina|346
3|8.4.2 Australia|346
3|8.4.3 Canada|347
3|8.4.4 EU|348
3|8.4.5 Japan|348
3|8.4.6 USA|350
3|8.4.7 Comparative Analysis|352
2|8.5 Labelling|354
3|8.5.1 Argentina|354
3|8.5.2 Australia|355
3|8.5.3 Canada|355
3|8.5.4 EU|355
3|8.5.5 Japan|356
3|8.5.6 USA|356
3|8.5.7 Comparative Analysis|357
2|8.6 Identity Preservation System (Coexistence)|358
3|8.6.1 Argentina|359
3|8.6.2 Australia|360
3|8.6.3 Canada|360
3|8.6.4 EU|360
3|8.6.5 Japan|361
3|8.6.6 USA|361
3|8.6.7 Comparative Analysis|361
2|8.7 Reform Efforts|362
3|8.7.1 Argentina|362
3|8.7.2 Australia|363
3|8.7.3 Canada|364
3|8.7.4 EU|364
3|8.7.5 Japan|364
3|8.7.6 USA|365
3|8.7.7 Comparative Analysis|366
2|8.8 Conclusion|366
2|References|367
1|Appendix: Questionnaire|372
2|Country-Report: [Please state your Country]|372
3|Introduction|372
3|The Regulatory Framework for Genetically Modified Organisms (GMOs): An Overview|372
3|Regulatory Status of Genome Edited Plants|373
4|Applicability of the Regulatory Framework for GMOs|373
4|Regulatory Classification of Genome Editing/Genome Edited Plants|373
3|Regulatory Prerequisites for Activities Relating to Genome Edited Plants|374
3|Status Quo of Genome Edited Plants and Products Derived from Them|375
3|Reform Efforts|375
3|Low Level Presence|376
3|Labelling|376
3|Identity Preservation System (Coexistence)|376
3|Liability|377
3|Perception of Genome Editing|377
4|Position of Public Authorities|377
4|Public Opinion|377
3|Treatment of Other New Breeding Technologies|377
3|Conclusion|378
3|Glossary|378