{"title":"The Japanese experience with the Blue Book and subsequent activities in environmental biosafety of GM crops.","authors":"Kenichi Hayashi","doi":"10.1051/ebr:2007015","DOIUrl":"https://doi.org/10.1051/ebr:2007015","url":null,"abstract":"<p><p>The Blue Book made a big contribution to the development of the Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF) guidelines established in 1991 for almost all of the basic issues. However, the MAFF guidelines could not sufficiently cover some important areas that the Blue Book addressed well, such as potential consequences. This gap has been recovered substantially by a new law established in 2003. Japan still faces several important issues, including assessment of stacked products, potential consequences, comparative assessment, assessment of imported GM commodities and movement of concerned groups.</p>","PeriodicalId":87177,"journal":{"name":"Environmental biosafety research","volume":"5 4","pages":"237-8"},"PeriodicalIF":0.0,"publicationDate":"2006-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26837761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"9th International Symposium on the Biosafety of Genetically Modified Organisms. Session V: Estimating likelihood and exposure.","authors":"Zaida Lentini","doi":"10.1051/ebr:2007021","DOIUrl":"https://doi.org/10.1051/ebr:2007021","url":null,"abstract":"The objective of this session was to discuss information that is relevant in determining whether a potential hazard can occur and at what frequency. This session targeted setting the background for a more in-depth discussion on exposure assessment for GM crops by identifying key factors such as gene flow, frequencies and factors that affect them, as main components of exposure. Gene flow is a particularly complex subject, and estimating a frequency requires a great deal of information. Information on gene flow can be gathered using models (based on what is already known from the traditional crop), empirical data from fields, as well as molecular information, to understand gene flow from an historical perspec-","PeriodicalId":87177,"journal":{"name":"Environmental biosafety research","volume":"5 4","pages":"193-5"},"PeriodicalIF":0.0,"publicationDate":"2006-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26838935","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"9th International Symposium on the Biosafety of Genetically Modified Organisms. Session VI: Estimating likelihood and exposure, Part II.","authors":"Hector Quemada","doi":"10.1051/ebr:2007022","DOIUrl":"https://doi.org/10.1051/ebr:2007022","url":null,"abstract":"","PeriodicalId":87177,"journal":{"name":"Environmental biosafety research","volume":"5 4","pages":"197-9"},"PeriodicalIF":0.0,"publicationDate":"2006-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26838937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The OECD Blue Book on Recombinant DNA Safety Considerations: it's influence on ISBR and EFSA activities.","authors":"Joachim Schiemann","doi":"10.1051/ebr:2007014","DOIUrl":"https://doi.org/10.1051/ebr:2007014","url":null,"abstract":"<p><p>Biosafety regulatory frameworks are intended to serve as mechanisms for ensuring the safe use of biotechnology products without imposing unacceptable risk to human health or the environment, or unintended constraints to technology transfer. The OECD Blue Book on \"Recombinant DNA Safety Considerations\", setting out principles and concepts for handling genetically modified organisms safely outside of contained laboratory conditions, was a milestone in the history of biotechnology. The \"Recombinant DNA Safety Considerations\" definitively became the major resource for the formulation of national regulatory frameworks and international regulations, including the Cartagena Protocol.</p>","PeriodicalId":87177,"journal":{"name":"Environmental biosafety research","volume":"5 4","pages":"233-5"},"PeriodicalIF":0.0,"publicationDate":"2006-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26837758","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The OECD Blue Book has become a citation classic.","authors":"Ervin Balázs","doi":"10.1051/ebr:2007009","DOIUrl":"https://doi.org/10.1051/ebr:2007009","url":null,"abstract":"One of the highest accolades a scientist can achieve is to have a paper selected by the Science Citation Index of the Philadelphia Library as the most cited paper of the year. There can be no doubt that the Recombinant DNA Safety Considerations, published by the OECD in 1986, and known as the Blue Book after the color of the cover, is the resource document most frequently cited at the international level by the various stakeholders of society. I myself, who witnessed and participated in the revolution of molecular biological science and its regulation, have been frequently confronted with this fact: whenever people talk about the introduction of this new technology, the Blue Book is always referred to as the most valuable reference work. Early on, soon after the two European directives on the contained use of genetically modified organisms and on their deliberate release into the environment were issued (EC 219, EC 220), a steering committee was established for the conservation and management of the environment and natural habitats, in order to study and advise on the potential ecological impact of genetically modified organisms. This committee continued to function until the organization of a Pan-European Conference on the potential long-term ecological impacts of the dissemination of GMOs, all the documents and activities of which used the Blue Book as a major source. As both the developed and the developing world realized the value of biotechnology, regulatory activities were also begun in the US (NIH guidelines) and in other countries, all using this publication as their knowledge base. The conveners of the United Nations Conference on Environment and Development (UNCED) also included biotechnology in its agenda in the document entitled Agenda 21, and devoted a whole chapter to biotechnology (Chapter 16). This chapter and the UNEP International Technical Guidelines for Safety in Biotechnology (printed in all six official languages of the UN) reflect the spirit of the Blue Book. If a comparison is made of the efforts made by individual countries to establish national regulatory frameworks for gene technology, the footprint of the Blue Book is clearly perceptible in each case. Until the year 2000, almost all the industrialized or rapidly","PeriodicalId":87177,"journal":{"name":"Environmental biosafety research","volume":"5 4","pages":"211-2"},"PeriodicalIF":0.0,"publicationDate":"2006-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26838941","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The impact of the OECD on the development of national/international risk/safety assessment frameworks.","authors":"Helmut Gaugitsch","doi":"10.1051/ebr:2007011","DOIUrl":"https://doi.org/10.1051/ebr:2007011","url":null,"abstract":"<p><p>The role of OECD in the development of national and international risk/safety assessment frameworks is presented and discussed. The most relevant OECD bodies in this context have contributed a lot to the development of international biosafety frameworks, inter alia by organizing international conferences in the areas of food/feed and environmental safety of GMOs, focusing on practical and current scientific issues. The OECD Consensus Documents as well as the OECD Product Database have provided a good basis for risk/safety assessment frameworks and their implementation. The relevance for the OECD work in the international area is discussed, in particular, with respect to the work undertaken under the Cartagena Protocol on Biosafety, the Codex Alimentarius Commission and its work in biotechnology, as well as under the International Plant Protection Convention. An outlook and suggestions for future directions of OECD work in this area are presented.</p>","PeriodicalId":87177,"journal":{"name":"Environmental biosafety research","volume":"5 4","pages":"219-22"},"PeriodicalIF":0.0,"publicationDate":"2006-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26837755","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Perspective on OECD activities from a non-member country.","authors":"Nevena Alexandrova, Atanas Atanassov","doi":"10.1051/ebr:2007013","DOIUrl":"https://doi.org/10.1051/ebr:2007013","url":null,"abstract":"<p><p>The OECD Blue Book, \"Recombinant DNA: Safety Considerations\" was published in 1986. The developed principles and concepts on the stepwise and case-by-case approach for risk assessment in the Blue Book have been used as a foundation for building national biosafety frameworks and international instruments for the regulation of the products of modern biotechnology. Twenty years after the Blue Book was published, OECD continues its activities on unique identifier systems, information-sharing, consensus documents for the biology of crops, trees and microorganisms with respect to harmonization of regulatory oversight and those of novel food and feed safety. These activities benefit, without any doubt, the international community at large, including OECD non-member countries. In order to strengthen its position in the international arena and to better respond to the needs of the changing world, OECD would be encouraged to participate in a more active manner in the technology transfer process and co-existence debate, together with continuing the organization's efforts on information-sharing and harmonization in the field of biotechnology and biosafety.</p>","PeriodicalId":87177,"journal":{"name":"Environmental biosafety research","volume":"5 4","pages":"227-31"},"PeriodicalIF":0.0,"publicationDate":"2006-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26837757","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Beyond the Blue Book. Framework for Risk/Safety Assessment of Transgenic Plants. An overview of the workshop.","authors":"Masatoshi Kobayashi, Peter Kearns","doi":"10.1051/ebr:2007008","DOIUrl":"https://doi.org/10.1051/ebr:2007008","url":null,"abstract":"","PeriodicalId":87177,"journal":{"name":"Environmental biosafety research","volume":"5 4","pages":"207-9"},"PeriodicalIF":0.0,"publicationDate":"2006-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26838939","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"9th International Symposium on the Biosafety of Genetically Modified Organisms. Session IV: Identifying and defining hazards and potential consequences III: Concepts for problem formulation and non-target risk assessment.","authors":"Ariel Alvarez-Morales","doi":"10.1051/ebr:2007020","DOIUrl":"https://doi.org/10.1051/ebr:2007020","url":null,"abstract":"","PeriodicalId":87177,"journal":{"name":"Environmental biosafety research","volume":"5 4","pages":"189-92"},"PeriodicalIF":0.0,"publicationDate":"2006-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26838934","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"9th International Symposium on the Biosafety of Genetically Modified Organisms. Session II: Identifying and defining hazards and potential consequences I: Concepts for problem formulation and non-target risk assessment.","authors":"Franz Bigler","doi":"10.1051/ebr:2007018","DOIUrl":"https://doi.org/10.1051/ebr:2007018","url":null,"abstract":"<p><p>The scientific organizers of the symposium put much emphasis on the identification and definition of hazard and the potential consequences thereof and three full sessions with a total of 13 presentations encompassing a wide range of related themes were planned for this topic. Unfortunately, one talk had to be cancelled because of illness of the speaker (BM Khadi, India). Some presentations covered conceptual approaches for environmental risk assessment (ERA) of GM plants (problem formulation in the risk assessment framework, familiarity approach, tiered and methodological frameworks, non-target risk assessment) and the use of models in assessing invasiveness and weediness of GM plants. Other presentations highlighted the lessons learned for future ERA from case studies and commercialized GM crops, and from monitoring of unintended releases to the environment. When the moderators of the three sessions came together after the presentations to align their summaries, there was an obvious need to restructure the 12 presentations in a way that allowed for a consistent summarizing discussion. The following new organization of the 12 talks was chosen: (1) Concepts for problem formulation and non-target risk assessment, (2) Modeling as a tool for predicting invasiveness of GM plants, (3) Case-studies of ERA of large-scale release, (4) Lessons learned for ERA from a commercialized GM plant, (5) Monitoring of unintended release of Bt maize in Mexico. The new thematic structure facilitates a more in-depth discussion of the presentations related to a specific topic, and the conclusions to be drawn are thus more consistent. Each moderator agreed to take responsibility for summarizing one or more themes and to prepare the respective report.</p>","PeriodicalId":87177,"journal":{"name":"Environmental biosafety research","volume":"5 4","pages":"183-6"},"PeriodicalIF":0.0,"publicationDate":"2006-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26838936","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}