Safety Assessment of Transgenic Organisms V o OECD CONSENSUS DOCUMENTS lu m Volume 2 e 2 Safety Assessment The goal of the OECD Biosafety Consensus Documents is to identify elements of scientific information used in the environmental safety and risk assessment of transgenic organisms which are common to OECD member countries. This is intended to encourage information sharing and of Transgenic prevent duplication of effort among countries. This book offers ready access to those consensus documents which have been published Organisms thus far. As such, it should be of value to applicants for commercial uses of transgenic crops, regulators in national authorities as well as the wider scientific community. OECD CONSENSUS DOCUMENTS More information on the OECD’s work related to the biosafety of transgenic organisms is found S at BioTrack Online (www.oecd.org/biotrack). A F E Volume 2 T Y The full text of this book is available on line via these links: A S http://www.sourceoecd.org/scienceIT/9264022589 S http://www.sourceoecd.org/agriculture/9264022589 E S http://www.sourceoecd.org/environment/9264022589 S M Those with access to all OECD books on line should use this link: E N http://www.sourceoecd.org/9264022589 T Sthoisu racweOarEdC-wDi nisn itnhge sOeErvCicDe’ sa nodn lifnreee l itbrriaalrsy aosfk b yoooukrs ,li bprearriioadni,c oalrs w arnitde stota utiss taicta Sl oduatracbeaOsEeCs.D F@oor emcodr.eo irngf.ormation about OF TRANSGENIC ORGANISMS OEC BABEEBBAEABAEENGNINGIINGNOIGOIOOVORVVRSSVVRIRIIISIRRSRCASACIIIIOORAFOFURUACACEENNNLFLOOFFUTUTTTMMMEYYEUENUNLLEEE T RTRTTTEMENNMNYEEYNYNUUTTT E EV V B BARRAAAAAIININRIROGGOGGEEGGOOTTSRRSR RNNR RAEE IAIICBCCBMMFIFNINICUUUCECIEIEEOOLVLTVLTUNNUUTTTYYISISTUTUULRR L L EARTERARTATAOONNEEUEFGFGUUV N VN ERRBERBBIRIRRRMIMIITIITCCOEOOOEEOYYUUSSE SEN N EL AELAE ANMNMATTANFFFNNUUETEETGEEGVNRRVNTVTT RBRYBIETYEYTIIRRR IIIIAB BEAC OCOOOOGNIGIOOUUSSNRVNNRSSILAIALIMRCAAMCMTTFOFFFUUEUUEEEEENELLNTTTTRNNMRTTYYUUTYEEYTET RREE N EENNEBBAET VV BNBNIGIAIOIOIRIROGVOVROOSSSRSIIIRNNRAAAAICCMMFFOOFFUUEEEEEENLTNTLNNTYTYTTMTMTU YY UEERAAEEN N ERGGAANVN VRRBEGIGIRTRTIII CCOOR ORE BUUBSNNINILLACCIMIMTTOOFVUUUUEEESISNRRNRTLLAETYEATTTO FFUAUBBENEGENIIROROMTRVTSSEEIIYYRCAAE OF EFUE NAAEENLNNTTTTGGMYYUVV RER B RIIEENRRIEIINNCTCO OOVV BUUASIININRROGLALOOMMSRTTFNNAIUUCEEMEMFUERNNRTEELTNNEYTETTYTTU E B BAERAANNEIGIGGOOV VRRBRISRSIIIICCOIROAACUUSNOFFULLAMTTEENFLUUEETTTMNRRTYYUETYEE RNET D C o n -:HSTCQE=UWWZ]Y: I9S7B 2N0 0962 -0654 -10 P2258-9 www.oecd.org sensus Documents AEAAEABEBNGGIGNGNOIVORRSVRVRIIIRCSCAIIIIORRFUCUCANELLOOUFUTTTMYUEUNNLLE RRTTTNMEMEEUYUNT EE VBB RRAAINNIIRGOOEEGOTTRSS ENE RA IACBBMFFNNIUECEIIEBOOVLVTTNTUIYYIIOSSUTRR LS ERAEAOTOAANNEFFGUFN VNVEBEERIIRRRMMTIITTOCOYOEYYSUEE NN EA L ENNMMAANTFNUTETEEVGGNNTIRV RBRBRYTETIOR IIII E A AN BAOCOCONGGGIMOUSUSBVRRRNESIAALILIIIRNCCAOCMTTFOFTFUUUUSU EENEELLLATTATTMRTRNTGYUUUFYEYEERT RRRNEE I EECEANAETEBT U VBBGNBGNIYALIOIIIRGOTOOVRV ROAUSRSSSIIIIRRRNCAICGAAACEMFFFOOUFUUR EEEEBLENNTTLTLINTICYYYTTOTMUMET UUYSU NEREEAEEANNNVE LRRGAFNNI VVTVREBEERIGIIURTRTORTII OCOYEOEO RN RBSBU NNNNMNIEEALCIIMMMNETOOVFV UNUEEEEVEIISSNRNRTIRNTNRLYA ATETTOTOOAV FFEAUGANBANNIENREGGGIRMROMMVTRTRIROECSEIIIYIRYNECAECACUN OT FU EUULNNGAAM TNELLLNATTUTRTGTTMGGEYUUV UR IEBRBRR NCRRERINERIII EIIECETUNTOCOCB OU V BBIBLUAOSUSBLIINIITRGOTOOSAALILOUUOMRSASSTTFFRNAFIAARUCSUEEEEEMFFFUEAT ERTERNETEBLYTT TFYYNETETIEY YYOUEET N ASAEE BNEREETAANVNNVEGNGNIYGFOI VVVIRVRBEV RRR IAIIRSRORTIIIIIOIOCRGORYOOCNCASU NNNNMOORUEFUALMMMNETMFENINLLCUNEEEVETTTMMENNTIRNTURUYUY TETNTOEEL RRTNTNNEEM UTT ER NET Safety Assessment of Transgenic Organisms OECD CONSENSUS DOCUMENTS Volume 2 ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT The OECD is a unique forum where the governments of 30 democracies work together to address the economic, social and environmental challenges of globalisation. The OECD is also at the forefront of efforts to understand and to help governments respond to new developments and concerns, such as corporate governance, the information economy and the challenges of an ageing population. The Organisation provides a setting where governments can compare policy experiences, seek answers to common problems, identify good practice and work to co-ordinate domestic and international policies. The OECD member countries are: Australia, Austria, Belgium, Canada, the Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Korea, Luxembourg, Mexico, the Netherlands, New Zealand, Norway, Poland, Portugal, the Slovak Republic, Spain, Sweden, Switzerland, Turkey, the United Kingdom and the United States. The Commission of the European Communities takes part in the work of the OECD. OECD Publishing disseminates widely the results of the Organisation’s statistics gathering and research on economic, social and environmental issues, as well as the conventions, guidelines and standards agreed by its members. This book is published on the responsibility of the Working Group on Harmonisation of Regulatory Oversight in Biotechnology, which is a subsidiary group of the Chemicals Committee and Working Party on Chemicals, Pesticide and Biotechnology of the OECD. © OECD 2006 No reproduction, copy, transmission or translation of this publication may be made without written permission. Applications should be sent to OECD Publishing: [email protected] or by fax (33 1) 45 24 13 91. Permission to photocopy a portion of this work should be addressed to the Centre français d'exploitation du droit de copie, 20, rue des Grands-Augustins, 75006 Paris, France ([email protected]). Foreword FOREWORD Genetically engineered crops (also known as transgenic crops) such as maize, soybean, rapeseed and cotton have been approved for commercial use in an increasing number of countries. During the period from 1996 to 2005, for example, there was more than fifty-fold increase in the area grown with transgenic crops worldwide, reaching 90 million hectares in 20051. Such approvals usually follows a science-based risk/ safety assessment. The environmental safety/ risks of a transgenic organism have been assessed based on the information on the characteristics of the host organism, the introduced traits, the environment into which the organism is introduced, the interaction between these, and the intended application. The OECD’s Working Group on Harmonisation of Regulatory Oversight in Biotechnology decided at its first session, in June 1995, to focus its work on identifying parts of this information, which could be commonly used in countries for environmental safety/ risk assessment to encourage information sharing and prevent duplication of effort among countries. Biosafety Consensus Documents are one of the major outputs of its work. Biosafety Consensus Documents are intended to be a “snapshot” of current information on a specific host organism or trait, for use during regulatory assessments. They are not intended to be a comprehensive source of information on everything that is known about a specific host or trait; but they do address the key or core set of issues that member countries believe are relevant to risk/ safety assessment. This information is said to be mutually acceptable among member countries. To date, 25 Biosafety Consensus Documents have been published. They include documents which address the biology of crops, trees and micro- organisms as well as those which address specific traits which are used in transgenic crops. This book is a compilation of those Biosafety Consensus Documents published before February 2006. It also includes two recently published texts: the first, entitled An Introduction to the Biosafety Consensus Document of OECD’s Working Group for Harmonisation in Biotechnology, explains the purpose of the consensus documents and how they are relevant to risk/ safety assessment. It also describes the process by which the documents are drafted using a “lead country” approach. The second text is a Points to Consider for Consensus Documents on the Biology of Cultivated Plants. This is a structured checklist of “points to consider” for authors when drafting or for those evaluating a consensus document. Amongst other things, this text describes how each point is relevant to risk/ safety assessment. This book offers ready access to those consensus documents which have been published thus far. As such, it should be of value to applicants for commercial uses of transgenic crops, regulators in national authorities as well as the wider scientific community. As each of the documents may be updated in the future as new knowledge becomes available, users of this book are encouraged to provide any information or opinions regarding the contents of this book or indeed, OECD’s other harmonisation activities. If needed, a short pre-addressed questionnaire is attached at the end of this book that can be used to provide such comments. The published Consensus Documents are also available individually from OECD’s website (http://www.oecd.org/biotrack) at no cost. 1. Clive James (2005), International Service for the Acquisition of Agri-biotech Applications (http://www.isaaa.org/) 3 Table of Contents TABLE OF CONTENTS CONSENSUS DOCUMENTS ON THE BIOLOGY OF TREES................................................9 Section 1 Eastern White Pine (Pinus strobus L.).....................................................................10 Section 2 European White Birch (Betula pendula Roth).........................................................45 Section 3 Norway Spruce (Picea abies (L.) Karst)..................................................................75 Section 4 Poplar (Populus L.)................................................................................................100 Section 5 Sitka Spruce (Picea Sitchensis (Bong.) Carr.).......................................................136 Section 6 Stone Fruits (Prunus spp.)......................................................................................175 Section 7 White Spruce (Picea glauca (Moench) Voss)........................................................204 CONSENSUS DOCUMENTS ON MICRO-ORGANISM.......................................................237 Section 1 Baculoviruses.........................................................................................................238 Section 2 Pseudomonas..........................................................................................................312 Section 3 Acidithiobacillus....................................................................................................394 LEAD COUNTRY AND PUBLISHED YEAR OF EACH CONSENSUS DOCUMENT......442 QUESTIONNAIRE TO RETURN TO THE OECD.................................................................443 5 Table of Contents Tables Table 3.1 Summary of successful crosses with P. strobus..................................................15 Table 3.2 Species Interactions with Eastern White Pine....................................................20 Table 3.3 The taxonomy and distribution of the 44 species in the genus Betula.................46 Table 3.4 A summary of the results on seed germination in different crosses betwwen Betula species .............................................................................................................................57 Table 3.5 Suggested classification, nomenclature and occurrence of Populus species and synonyms given by an earlier classification...........................................................................104 Table 3.6 Nomenclature of naturally occurring Populus Hybrids.....................................106 Table 3.7 Species cross compatibility with Sitka spruce...................................................142 Table 3.8 Species Interactions with Sitka Spruce..............................................................148 Table 3.9 Stone fruit production, 1989-1999.....................................................................176 Table 3.10 Interspecific hybrids with Prunuspersica.........................................................190 Table 3.11 Hybrids of the sand cherries with other species................................................191 Table 3.12 Prunus species reported as hybrids between peach and peach species..............192 Table 3.13 Species cross compatibility with White Spruce.................................................216 Table 4.1 List of assigned baculovirus species..................................................................239 Table 4.2 Restriction maps of different nucleopolyhedroviruses and granuloviruses244Error! Bookmark not defined. Table 4.3 Insect host transposons found in baculovirus....................................................266 Table 4.4 Phylogeny and current classification of the pseudomonads316Error! Bookmark not defined. Table 4.5 Examples of plasmids responsible for the metabolism of organic compounds or resistance to heavy metals in fluorescent Pseudomonas species...........................................319 Table 4.6 Examples of fluorescent species of Pseudomonas reported to have been used, or to have potential use, for bioremediation............................................................................................327 Table 4.7 Examples of plasmids encoding for drug resistances in P. aeruginosa.............338 Table 4.8 Range of plant species susceptible to infection with P. syringue......................347 Table 4.9 Some toxins produced by phytopathogenic Pseudomonas spp.........................348 Table 4.10 Phytopathogenic strains of P. syringae containing plasmids352Error! Bookmark not defined. Table 4.11 Examples of identification and detection techniques.........................................356 Table 4.12 Acidithiobacillus : Characters used in classification.........................................396 Table 4.13 Genes in Acidithiobacillusferrooxidans............................................................405 Table 4.14 Comparative % solubilisation of heavy metals in sludge..................................411 Table 4.15 Usage and environmental impacts of Acidithiobacillus416Error! Bookmark not defined. 6 Table of Contents Figures Figure 3.1 The natural range of Eastern White Pine.........................................................12 Figure 3.2 The leaf, scale, seed, stem, buds and female and male catkins of Betula pendula .........................................................................................................................47 Figure 3.3 The natural distribution of Betula pendula......................................................52 Figure 3.4 Crossability of Populus species.....................................................................112 Figure 3.5 The natural range of Sitka spruce..................................................................138 Figure 3.6 The natural range of White Spruce................................................................208 Figure 3.7 The reproductive cycle of White Spruce.......................................................210 Figure 4.1 Morphological characteristics of nucleopolyhedroviruses and granuloviruses... .......................................................................................................................241 7