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Guideline on Environmental Risk Assessment of Genetically Modified Plants
BHUTAN AGRICULTURE AND FOOD REGULATORY AUTHORITY (BAFRA) MINISTRY OF AGRICULTURE AND FORESTS
Guideline on Environmental Risk Assessment of Genetically Modified Plants
BHUTAN AGRICULTURE AND FOOD REGULATORY AUTHORITY (BAFRA) MINISTRY OF AGRICULTURE AND FORESTS
Guideline on Environmental Risk Assessment of Genetically Modified Plants
BHUTAN AGRICULTURE AND FOOD REGULATORY AUTHORITY (BAFRA) MINISTRY OF AGRICULTURE AND FORESTS
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Table of Contents
ACRONYMS 3
GLOSSARY 4
1. INTRODUCTION 7
2. STRATEGIES FOR ERA OF IMPORTED GM PLANT PRODUCTS 8
2.1. Comparative safety assessment as a general principle for the ERA 8
2.2. Objectives of the different steps of the environmental risk assessment 10
2.2.1. Step 1: Problem formulation: including hazard identification 11
2.2.2. Step 2: Hazard characterisation 13
2.2.3. Step 3: Exposure characterisation 14
2.2.4. Step 4: Risk characterisation 15
2.2.5. Step 5: Risk management strategies 16
2.2.6. Step 6: Overall risk evaluation and conclusions 17
2.3. Cross-cutting considerations: 17
3. SPECIFIC AREAS OF RISK TO BE ADDRESSED IN THE ERA 17
3.1. Fitness of unintentionally released GM plants and associated gene flow 18
3.1.1. Step 1: Problem formulation 18
3.1.2. Step 2: Hazard characterisation 22
3.1.3. Step 3: Exposure characterisation 28
3.1.4. Step 4: Risk characterisation 28
3.1.5. Step 5: Application of risk management strategies 28
3.1.6. Conclusions 29
3.2. Plant to micro-organisms horizontal gene transfer 29
3.2.1. Step 1: Problem formulation 29
3.2.2. Step 2: Hazard characterisation 30
3.2.3. Step 3: Exposure characterisation 31
3.2.4. Step 4: Risk Characterisation 31
3.2.5. Step 5: Application of risk management strategies 32
3.2.6. Conclusions 32
3.3. Interactions of the GM plant with non-target organisms 32
3.3.1. Step 1: Problem formulation 32
3.3.2. Step 2: Hazard characterisation 33
3.3.3. Step 3: Exposure characterisation 36
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3.3.4. Step 4: Risk characterisation 36
3.3.5. Step 5: Risk management strategies 37
3.3.6. Conclusions 37
3.4. Effects on human and animal health 38
3.4.1. Step 1. Problem Formulation and Hazard Identification 38
3.4.2 Step 2: Hazard Characterisation. 38
3.4.3. Step 3. Exposure assessment 40
3.4.4 Steps 4 and 5: Risk assessment and risk management for human and animal health 41
3.5. Overall risk evaluation and conclusions 41
4. ENVIRONMENTAL MANAGEMENT AND MONITORING 42
4.1 Risk Management 42
4.2 Monitoring 43
4.3. Case-specific GM plant product monitoring 44
4.4. General surveillance for unanticipated adverse effects 44
4.4.1. Approach and principles of general surveillance 45
4.5. Reporting the results of monitoring 46
4.6. Monitoring Review and adaptation 47
REFERENCES 48
APPENDICES 56
APPENDIX 1: CHOICE OF COMPARATORS 56
APPENDIX 2: GENERAL STATISTICAL PRINCIPLES 59
APPENDIX 3: LONG-TERM EFFECTS 70
APPENDIX 4: ERA OF GM PLANTS CONTAINING STACKED TRANSFORMATION EVENTS 73
APPENDIX 5: PROBLEM FORMULATION AND METHODS FOR TESTING NTOs 74
LIST OF CONTRIBUTORS 85
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List of Contributors 1. This document was prepared by Dr. Dr Jeremy Bruton Sweet, Sweet Environment
Consultants (SEC), United Kingdom.
Jeremy Sweet PhD, has spent the last 23 years conducting research on the risk assessment of GMOs. Much of this work was conducted at NIAB Cambridge, and has studied environmental and agronomic impacts, and gene flow to crops and wild relatives. He was coordinator of the UK BRIGHT project which studied herbicide tolerance, and he was also coordinator of the ESF programme “Assessing the Impact of GMOs” that brought together all the major research groups in this area in Europe. He was a coordinator of the EU SIGMEA project bringing together data on gene flow and gene impacts and was a participant in the EU CO-‐EXTRA programme. He is workpackage leader in the GRACE EU project on Systematic Reviewing of the impacts of GM plants. He is an advisory Board member of the Pegasus EU project on GM animals and the EU Price Project and is a partner in the EU COST Action on GM trees. He served on the Steering Committee of the Swiss NFP59 programme on GMOs. He is an author in over 40 scientific papers on GMOs and of a book. His current and recent research is directed to providing improved methods for assessing and interpreting environmental impacts of GMOs focusing on herbicide tolerant and Bt crops. He currently operates his own environmental consultancy and is a member of the EFSA GMO Environment Working Group. He was vice-‐chairman the EFSA GMO Panel and was Chairman of the Environment Working Groups on GM plants and GM fish. He is a consultant and advisor on GMOs to the European Commission, European governments, UN and scientific organisations and academies of several countries. He lectures and supervises post-‐graduate students at the Marche University (Ancona) and contributes to training programmes on GMOs.
2. This document was reviewed by the following member of Biosafety Technical Working Group, Bhutan.
-‐ Mr. Chimmi Dorji, Dy. Chief Laboratory Officer, Public Health Laboratory -‐ Mr. Karma C. Nyedrup, Environment Specialist, National Environment Commission -‐ Dr. Tshering Gyeltshen, Associate Lecturer, College of Natural Resources -‐ Dr. D.B Dhital, Specialist, Department of forests and Park Services -‐ Mr. N.K. Pradhan, Plant Protection Specialist, Council of RNR Research of Bhutan -‐ Ms. Asta Maya Tamang, Principal Biodiversity Officer, National biodiversity Center -‐ Dr. N.B. Tamang, Specialist, Department of Livestock -‐ Mr. Kezang Tshering, Specialist, RDC, Yusipang, Department of Agriculture -‐ Ms. Tashi Yangzom, Regulatory and Quarantine Officer, BAFRA
3. This document was also reviewed by the following technical officials of the Bhutan Agriculture and Food Regulatory Authority (BAFRA), MoAF
-‐ Dr. Sithar Dorjee, Dy. Chief Regulatory and Quarantine Officer, BAFRA -‐ Mr. Jambay Dorji, Officiating Chief, National Food Testing Laboratory, BAFRA -‐ Ms. Gyem Bidha, Sr. Regulatory and Quarantine Officer, BAFRA -‐ Ms. Dechen Choki, Regulatory and Quarantine Officer, BAFRA
86 PB
NATIONAL BIOSAFETY FRAME WORK PROJECT BHUTAN AGRICULTURE AND FOOD REGULATORY AUTHORITY
MINISTRY OF AGRICULTURE AND FORESTS Thimphu, Bhutan
Post Box 1071
PABX – 975-2-327031/325790/325993;Fax No. 975 – 2 - 327032/335540;
[email protected] 1, 2014
Website: www.bafra.gov.bt
NATIONAL BIOSAFETY FRAME WORK PROJECT BHUTAN AGRICULTURE AND FOOD REGULATORY AUTHORITY
MINISTRY OF AGRICULTURE AND FORESTS Thimphu, Bhutan
Post Box 1071
PABX – 975-2-327031/325790/325993;Fax No. 975 – 2 - 327032/335540;
[email protected] 1, 2014
Website: www.bafra.gov.bt
NATIONAL BIOSAFETY FRAME WORK PROJECT BHUTAN AGRICULTURE AND FOOD REGULATORY AUTHORITY
MINISTRY OF AGRICULTURE AND FORESTS Thimphu, Bhutan
Post Box 1071
PABX – 975-2-327031/325790/325993;Fax No. 975 – 2 - 327032/335540;
[email protected] 1, 2014
Website: www.bafra.gov.bt
NATIONAL BIOSAFETY FRAME WORK PROJECT BHUTAN AGRICULTURE AND FOOD REGULATORY AUTHORITY
MINISTRY OF AGRICULTURE AND FORESTS Thimphu, Bhutan
Post Box 1071
PABX – 975-2-327031/325790/325993;Fax No. 975 – 2 - 327032/335540;
[email protected] 1, 2014
Website: www.bafra.gov.bt
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