Output on the Questionnaire on National Approaches to Monitoring, Detection, Identification of Transgenic Products (May 2003)
This document compiles the results of a questionnaire that arose from a proposal by the delegation of the European Commission together with the OECD for a project to be undertaken by the Working Group on Harmonisation of Regulatory Oversight in Biotechnology. This project is a part of the third area of the Working Group's activities, that is, Harmonisation in Biotechnology: The Next Steps. It was intended to be an information gathering exercise on the topics of detection, monitoring and identifi
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Guidance Document on Methods for Detection of Micro-organisms Introduced into the Environment: Bacteria (Jun 2004)
Guidance documents are intended to provide guidance on specific topics and issues, such as taxonomy and detection techniques that are relevant to risk/safety assessment in biotechnology. This guidance document addresses the use of methods for the detection of micro-organisms (focusing on bacteria) introduced into the environment. It is primarily intended for use by risk assessors, but it may also be useful for applicants and other stakeholders in the regulatory process.
Report of the Workshop on the Environmental Considerations of Genetically Modified Trees (2001)
This document is a compilation of the presentations and plenary session reports made at the Workshop on the Environmental Considerations of Genetically Modified Trees which was held in Norway, in September 1999. Some of these documents present a quite important data set on the organisms in question, but several member states felt some need to address the questions specific to the risk assessment of long lived species like trees.
Report of the OECD Workshop on Monitoring of Organisms Introduced into the Environment (Jan 1992)
This document provides a preliminary outline of considerations in approaches and methods for monitoring the fate and impact of organisms introduced into the environment. The utilization of appropriate approaches and methods may contribute to the safe development of the technology and to its beneficial applications. The focus for the discussion of monitoring in this Workshop report is the small-scale field introduction.
Ottawa '92: The OECD Workshop on Methods for Monitoring Organisms in the Environment (Jan 1994)
This document is the report of the OECD Workshop on Methods for Monitoring Organisms in the Environment, which was hosted by the Canadian authorities in Ottawa on 14-17 September 1992. It has been prepared by OECD’s Environment Directorate in collaboration with the Directorate for Science, Technology and Industry. The background material for the Ottawa Workshop included descriptions of 67 monitoring methods. These methods are presented in a companion document, Compendium of Methods for Monitorin
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Points to Consider for Consensus Documents on the Biology of Cultivated Plants (Jun 2006)
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 being published on the biology of certain plant species, on selected traits that may be introduced into plant species, and on biosafety issues arising from certain general types of modifications made to plants. This Points to Consider document is meant as a structured explanatory checklist, regarding both order and contents, of r
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An Introduction to the Biosafety Consensus Documents of OECD’s Working Group for Harmonisation in Biotechnology (Feb 2005)
This document describes the origin of OECD's Working Group for Harmonisation in Biotechnology and explains why biosafety consensus documents were included as part of its core work. It also addresses the purpose of these documents and their intended use as a practical contribution to the risk/ safety assessment of transgenic organisms.
Module II: Herbicide Biochemistry, Herbicide Metabolism and the Residues in Glufosinate-Ammonium (Phosphinothricin) -Tolerant Transgenic Plants (May 2002)
Consensus documents contain information for use during the regulatory assessment of a particular product. In the area of crop biosafety, consensus documents are being published on the biology of certain crop species, on selected traits that may be introduced into crop species, and on biosafety issues arising from certain general types of modifications made to crops. This document addresses glufosinateammonium (phosphinothricin) metabolites and residues in genetically modified glufosinate-toleran
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Consensus Document on General Information Concerning the Genes and Their Enzymes that Confer Tolerance to Glyphosate Herbicide (Apr 1999)
Consensus Documents contain information for use during the regulatory assessment of a particular product. In the area of plant biosafety, Consensus Documents are being developed on the biology of certain plant species, on specific genes and resulting proteins that, when introduced into a plant, result in the expression of specific traits, and on Biosafety issues arising from certain general trait modifications made to plants. This document, which addresses general information concerning the gene
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Consensus Document on General Information Concerning the Genes and Their Enzymes that Confer Tolerance to Phosphinothricin Herbicide (Jun 1999)
Consensus Documents contain information for use during the regulatory assessment of a particular product. In the area of plant biosafety, Consensus Documents are being developed on the biology of certain plant species, on specific genes and resulting proteins that, when introduced into a plant, result in the expression of specific traits, and on biosafety issues arising from certain general trait modifications made to plants. This document addresses general information concerning the genes and t
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Consensus Document on General Information concerning the Biosafety of Crop Plants Made Virus Resistant through Coat Protein Gene-Mediated Protection (Jan 1996)
These consensus documents were to contain information for use during the regulatory assessment of the particular product. In the area of plant biosafety, consensus documents would be initiated on the biology of certain crop plants and on selected traits. The first trait chosen to be reviewed was virus resistance. The Expert Group charged a task group to develop a document, and possible a workshop, that would identify information relevant to consideration of virus resistant crop plants developed
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Consensus Document on the Biology of the Native North American Larches: Subalpine Larch (<em>Larix lyalli</em>), Western Larch (<em>Larix occidentalis</em>) and Tamarack (<em>Larix laricina</em>) (2007)
Consensus Documents contain information for use during the regulatory assessment of a particular product. In the area of plant biosafety, Consensus Documents are being developed on the biology of certain plant species, on specific genes and resulting proteins that, when introduced into a plant, result in the expression of specific traits, and on biosafety issues arising from certain general trait modifications made to plants. This document, which was prepared by Norway as lead country, addresses
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Consensus Document on the Biology of <em>Pinus banksiana</em> (Jack Pine) (2006)
Consensus Documents contain information for use during the regulatory assessment of a particular product. In the area of plant biosafety, Consensus Documents are being developed on the biology of certain plant species, on specific genes and resulting proteins that, when introduced into a plant, result in the expression of specific traits, and on biosafety issues arising from certain general trait modifications made to plants. This document addresses the biology of the Jack Pine.
Consensus Document on the Biology of the Capsicum annuum Complex (Chili peppers, Hot peppers and Sweet peppers) (Jun 2006)
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 being published on the biology of certain plant species, on selected traits that may be introduced into plant species, and on biosafety issues arising from certain general types of modifications made to plants. This document addresses the biology of the Capsicum annuum complex (Chili peppers, Hot peppers and Sweet peppers).
Consensus Document on Information Used in the Assessment of Environmental Applications Involving Acidithiobacillus (Apr 2006)
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 being published on the biology of certain plant species, on selected traits that may be introduced into plant species, and on biosafety issues arising from certain general types of modifications made to plants. This document addresses information of environmental applications involving the genus Acidithiobacillus.
Consensus Document on the Biology of Western White Pine (Pinus Monticola Dougl. ex D. Don) (Apr 2006)
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 being published on the biology of certain plant species, on selected traits that may be introduced into plant species, and on biosafety issues arising from certain general types of modifications made to plants. This consensus document addresses the biology of Western White Pine (Pinus Monticola Dougl. Ex D. Don). It contains info
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Consensus Document on the Biology of Helianthus annuus L. (Sunflower) (Jan 2005)
Consensus documents contain information for use during the regulatory assessment of a particular product. In the area of crop biosafety, consensus documents are being published on the biology of certain crop species, on selected traits that may be introduced into crop species, and on biosafety issues arising from certain general types of modifications made to crops. This consensus document addresses the biology of Helianthus annuus (L.) (sunflower). Included are descriptions of the taxonomy of t
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Consensus Document on the Biology of Papaya (Carica Papaya) (Oct 2005)
Consensus documents contain information for use during the regulatory assessment of a particular product. In the area of crop biosafety, consensus documents are being published on the biology of certain crop species, on selected traits that may be introduced into crop species, and on biosafety issues arising from certain general types of modifications made to crops. This consensus document addresses the biology of Carica papaya L. (Papaya). Included are descriptions of the taxonomy of the genus
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Consensus Document on the Biology of Pleurotus spp. (Oyster Mushroom) (Oct 2005)
Consensus documents contain information for use during the regulatory assessment of a particular product. In the area of crop biosafety, consensus documents are being published on the biology of certain crop species, on selected traits that may be introduced into crop species, and on biosafety issues arising from certain general types of modifications made to crops. This consensus document addresses the biology of Preaurotus spp. (L.) (Oyster Mushroom). Included are descriptions of general infor
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Guidance Document on the Use of Taxonomy in Risk Assessment of Micro-organisms: Bacteria (Aug 2003)
Guidance documents are intended to provide guidance on specific topics and issues, such as taxonomy and detection techniques that are relevant to risk/safety assessment in biotechnology. This guidance document addresses the use of microbial taxonomy in assigning or confirming the identity of a subject micro-organism. It is primarily intended for use by risk assessors, but it may also be useful for applicants and other stakeholders in the regulatory process.
Consensus document on the biology of Zea mays subsp. mays (maize) (Jul 2003)
Consensus documents contain information for use during the regulatory assessment of a particular product. In the area of crop biosafety, consensus documents are being published on the biology of certain crop species, on selected traits that may be introduced into crop species, and on biosafety issues arising from certain general types of modifications made to crops. This document addresses the biology of Zea mays subsp. mays (Maize). It contains general information as well as more specific infor
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Consensus Document on the Biology of European White Birch (Betula pendula Roth) (Jul 2003)
Consensus documents contain information for use during the regulatory assessment of a particular product. In the area of crop biosafety, consensus documents are being published on the biology of certain crop species, on selected traits that may be introduced into crop species, and on biosafety issues arising from certain general types of modifications made to crops. This document addresses the biology of European White Birch. It contains general information as well as more specific information o
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Consensus Document on Information Used in the Assessment of Environmental Applications Involving Baculoviruses (Jan 2002)
Consensus documents contain information for use during the regulatory assessment of a particular product. This document contains general information on baculoviruses such as organism characteristics, behavior in the environment, their history of use and interactions as well as environmental safety considerations.
Consensus Document on the Biology of Picea Sitchensis (Bong.) Carr. (Sitka Spruce) (Jan 2002)
Consensus documents contain information for use during the regulatory assessment of a particular product. In the area of crop biosafety, consensus documents are being published on the biology of certain crop species, on selected traits that may be introduced into crop species, and on biosafety issues arising from certain general types of modifications made to crops. This documents addresses the biology of Picea sitchensis (Bong.) Carr. (Sitika spruce). It contains general information as well as
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Consensus Document on the Biology of Pinus Strobus L. (Eastern White Pine) (Jan 2002)
Consensus documents contain information for use during the regulatory assessment of a particular product. In the area of crop biosafety, consensus documents are being published on the biology of certain crop species, on selected traits that may be introduced into crop species, and on biosafety issues arising from certain general types of modifications made to crops. This document addresses the biology of Pinus strobus L. (Eastern White Pine). It contains general information as well as more speci
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