Background materials linked to the Guidance on Risk Assessment of Living Modified Organisms

1. Roadmap for risk assessment of living modified organisms (2) ▼

1.1. Background (2) ▼

1.2. Introduction (44) ▼

41493		UNEP International Technical Guidelines for Safety in Biotechnology [1995]
		These technical Guidelines are intended as a contribution to the implementation of Agenda 21 commitments and aim to assist Governments, intergovernmental, private sector and other organizations in...
41537		Genetically Modified Organisms and Biosafety - A background paper for decision-makers and others to assist in consideration of GMO issues [2004]
		Biosafety and genetically modified organisms (GMOs) are amongst the most complex of biodiversity issues: from species conservation, to sustainable livelihoods, to socio-cultural policy.
41545		Environmental risk and the precautionary principle: A Bayesian view applied to genetically modified organisms [2003]
		This paper discusses the consequences for the ecosystem due to field releases of genetically modified crops.
41549		Genetically engineered organisms and the environment: Current status and recommendations [2005]
		The Ecological Society of America has evaluated the ecological effects of current and potential uses of field-released genetically engineered organisms (GEOs), as described in this Position Paper.
41590		Guiding Principles for Development and Deployment of Genetically Engineered Organisms [2008]
		Guiding principles for development and deployment of Genetically Engineered Organisms.
41608		Risk Assessment Searching Mechanism (RASM)
		This website provides an online collection of Risk Assessment documents related to official government decisions concerning commercial release of GMOs irrespective of the individual authority’s CBD...
41647		Guidelines for Ecological Risk Assessment [1998]
		These guidelines are provided to improve the quality and consistency of Environmental Protection Agency`s ecological risk assessments.
41652		Approach to Risk: Position Paper on the Approach to Risk, Methodologies for Dealing with this and the Technical and Community Information Required for Implementation [2002]
		This paper provides a background to the concepts of attitude to risk and uncertainty, a summary of current thinking in developing approaches to risk, and an overview of existing data sources in New...
41670		Enabling the Safe Use of Biotechnology. Principles and Practice [1996]
		This report describes and suggests an enabling environment required by a country to acquire new tools of biotechnology and to assess their potential usefulness.
41701		National Guidelines for the Release of Genetically Modified Organisms (GMOs) into the Environment [2004]
		This document is the Kenya National Guidelines for the Release of Genetically Modified Organisms (GMOs) into the Environment.
41802		Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada [2001]
		This Report is a response to a request to the Royal Society of Canada from Health Canada, the Canadian Food Inspection Agency and Environment Canada that an Expert Panel be assembled to provide...
41940		Release of Genetically Modified Organisms in the Environment: is it a Health Hazard? [2000]
		The WHO/EURO seminar on "Release of Genetically Modified Organisms in the Environment: is it a Health Hazard?" was held at the World Health Organization (WHO) Regional Office for Europe, European...
41954		Singapore Guidelines on the Release of Agriculture-Related Genetically Modified Organisms (GMOs) [1999]
		These Guidelines are established to ensure the safe movement and use in Singapore of agriculture-related GMOs and provide a common framework for: (a) assessment of risks of agriculture-related GMOs...
41956		Risk Analysis Framework [2005]
		This Risk Analysis Framework (RAF) is a key explanatory document that provides guidance on how the Australian Gene Technology Regulator approaches risk analysis of genetically modified organisms...
41966		The Indian Recombinant DNA Safety Guidelines and Regulations [1998]
		These guidelines cover areas of research involving: i) Genetically engineered organisms, ii) Genetic transformation of green plants, animals, iii) rDNA technology in vaccine development, and iv)...
41986		LMOS and the Environment Proceedings of an International Conference [2001]
		These Proceedings reflect the breadth of topics presented in the Conference "LMOs and the Environment" and include a few additional contributed papers that subsequently were developed by participants.
42010		Biosafety Guidelines in Genetic Engineering and Biotechnology For Field Work and Planned Release [1996]
		The scope of these guidelines embraces all work related to gene manipulation employing r-DNA technology for all purposes including the development of transgenic plants, animals and microorganisms,...
42031		The Deliberate Release of Transgenic Plants - Biology, Hazards and Safety [1998]
		This report is a collection of articles published by the Agency BATS in scientific journals, on the safety issues pertaining to the deliberate release of transgenic plants.
42092		Preparing information on risks, costs and benefits for applications under the Hazardous Substances and New Organisms Act 1996 [2000]
		This guide is part of a series of technical guides produced by ERMA New Zealand to help people involved with the HSNO Act.
42104		Identifying risks for applications under the Hazardous Substances and New Organisms Act 1996 [2009]
		This guide is part of a series of technical guides produced by ERMA New Zealand to help people involved with the HSNO Act.
42105		Nigeria Biosafety Guidelines [2001]
		It is generally accepted that biotechnology both traditional and modern could contribute substantially to sustainable development by improvements in the fields of agriculture, food and feed...
42106		Sustainability, benefit to the community and ethics in the assessment of genetically modified organisms [2009]
		The purpose of the Norwegian Gene Technology Act is "to ensure that the production and use of genetically modified organisms takes place in an ethically and socially justifiable way, in accordance...
42112		Directive 94-08 (Dir94-08): Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits [2004]
		Directive 94-08, entitled "Assessment Criteria for Determining Environmental Safety of Plant with Novel Traits", has been prepared to provide guidance regarding the submission of an application for...
42115		Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms [2001]
		This Directive follows the precautionary principle and has as objective to approximate the laws, regulations and administrative provisions of the Member States and to protect human health and the...
42117		Biosafety Guidelines for Bangladesh [1999]
		Framework for field testing for GM plants and for GM microorganisms by type (annex 6); Potential risk management measures listed by type of LMO (plants, animals, microorganisms); Discussion of...
42118		China - Biosafety Regulations of Agricultural Genetically Modified Organisms, 2002 [2001]
		Describes a classification system for safety of agricultural GMOs. Appendices list detailed information requirements for GM plants, GM animals, and GM microorganisms.
42186		Risk Assessment and Management of Genetically Modified Organisms under Australia's Gene Technology Act: Considerations for Regulatory Development [2006]
		This paper examines some of the potential regulatory issues that may be affecting the slow review process and approval of transgenic technologies in Australia as follows: *A brief introduction to...
42205		Resource Book for Biosafety & Biotechnology in East Africa
		Contains chapters on (1) Biosafety Regulatory Frameworks, (2) Biosafety Risk Assessment, (3) Biosafety Risk Management, (4) Biosafety Monitoring & Enforcement, (5) Biosafety Communication, (6)...
42215		Asean Guidelines on Risk Assessment of Agriculture Related Genetically Modified Organisms (GMOs) [1999]
		These guidelines focus on a science-based risk assessment of agriculture-related GMOs and provide a common framework for ASEAN (Association of Southeast Asian Nations) Member Countries to undertake...
44042		Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation [2002]
		Transgenic crops offer the promise of increased agricultural productivity and better quality foods. But they also raise the specter of harmful environmental effects.
44302		Environmental Risk Assessment of Genetically Modified Organisms. Volume 3: Methodologies for Transgenic Fish [2007]
		This is the third book in a series on Environmental Risk Assessment of Genetically Modified Organism and provides detailed information relevant for biosafety policy, regulatory frameworks, capacity...
44569		Technical and Technological Aspects of Biosafety [2004]
		The contents of this document are based on the Terms of References (TOR) provided by the National Biosafety Framework Development Project of Ministry of Environment & Natural Resources of Sri Lanka.
47374		The SACGM Compendium of Guidance - Guidance from the Scientific Advisory Committee on Genetic Modification [2007]
		This is guidance prepared, in consultation with HSE, by the SAGCM which was appointed by the Health and Safety Commission as part of its formal advisory structure.
48125		Biosafety First - Holistic Approaches to Risk and Uncertainty in Genetic Engineering and Genetically Modified Organisms [2007]
		The Table of Contents is as follows: PREFACE INTRODUCTION BY THE EDITORS PART ONE Chapter 1 LIFE ON EARTH Terje Traavik and Thomas Bøhn Chapter 2 INTRODUCTION TO SOME BASIC FEATURES OF GENETIC...
48165		Organismos Vivos Modificados. Guía para la evaluación y Gestión de Riesgos [2006]
		El objetivo de esta guía es proporcionar a las entidades solicitantes de las autorizaciones de seguridad biológica, la información relevante para trabajar con OVMs, y a los evaluadores del órgano...
48486		The Guidance of Implementation of Assessment of Adverse Effect on Biological Diversity of Type 1 Use of Living Modified Organisms [2009]
		This guidance sets the necessary steps to ensure that the assessment of potential adverse effects on biodiversity is done in accordance with the Japanese Law concerning the Conservation and...
48487		Recombinant DNA Safety Considerations - Safety considerations for industrial, agricultural and environmental applications of organisms derived by recombinant DNA techniques [1986]
		This document is the result of a study undertaken as a follow-up to the OECD report Biotechnology: International Trends and Perspectives.
48516		Science and Decisions: Advancing Risk Assessment [2008]
		This book is a complement to the 1983 National Academies book, Risk Assessment in the Federal Government.
101038		Genetically Engineered Organisms - Assessing Environmental and Human Health Effects [2001]
		This resource contains a number of chapters regarding the risk assessment of transgenic organisms.
101366		Public research in plant biotechnology (PRRI Briefing Paper) [2010]
		The Briefing Paper is divided into the following sections: I. Introduction II. Background and history III. Potential applications IV. Public research in modern plant biotechnology V.
101380		Agenda 21 [1992]
		Agenda 21 is a comprehensive plan of action to be taken globally, nationally and locally by organizations of the United Nations System, Governments, and Major Groups in every area in which human...
102000		Biosafety Resource Book [2011]
		Abstract: During the period 2002-10, FAO undertook an intense activity of biosafety capacity development, largely centred on enhancing the capacities of regulators and other technical staff involved...
103361		UNIDO Biosafety Roadmap [2010]
		The Table of Contents is as follows: Introduction part I: the international context relevant to biosafety a.
103430		Genetically Engineered Plants and Foods: A Scientist’s Analysis of the Issues (Part II) [2009]
		Abstract: Genetic engineering provides a means to introduce genes into plants via mechanisms that are different in some respects from classical breeding.

1.3. Overarching issues in the risk assessment process (4) ▼

1.3.1. Protection goals, assessment endpoints and measurement endpoints

Protection goals and centres of origin and genetic diversity

1.3.2. Quality and relevance of information (2) ▼

Information requirements in the case of field trials or experimental releases

1.3.3. Identification and consideration of uncertainty (30) ▼

41653		Debating the Precautionary Principle: “Guilty until Proven Innocent” or “Innocent until Proven Guilty”? [2003]
		This paper debates issues associated to the Precautionary Principle. A review Article with the following headings: 1. The Precautionary Principle. 2. The Logic of Pascals Wager 3.
41655		Communication from the Commission on the Precautionary Principle [2002]
		This Communication analyses the factors that trigger use of the precautionary principle and the associated measures. Further, it proposes guidelines for applying the principle.
41656		On Science and Precaution in the Management of Technological Risk: A Synthesis Report of case studies [1999]
		The aim of the present research project was to examine, in an open-minded and interdisciplinary fashion, some of the key conceptual issues arising in the application of ‘science’ and ‘precaution’ to...
41657		European Union regulation of agri-biotechnology: precautionary links between science, expertise and policy [2005]
		Abstract: Despite various institutional reforms in the European Union (EU), regulatory procedures for genetically modified (GM) products are still held up by disagreements among experts; claims...
44302		Environmental Risk Assessment of Genetically Modified Organisms. Volume 3: Methodologies for Transgenic Fish [2007]
		This is the third book in a series on Environmental Risk Assessment of Genetically Modified Organism and provides detailed information relevant for biosafety policy, regulatory frameworks, capacity...
48125		Biosafety First - Holistic Approaches to Risk and Uncertainty in Genetic Engineering and Genetically Modified Organisms [2007]
		The Table of Contents is as follows: PREFACE INTRODUCTION BY THE EDITORS PART ONE Chapter 1 LIFE ON EARTH Terje Traavik and Thomas Bøhn Chapter 2 INTRODUCTION TO SOME BASIC FEATURES OF GENETIC...
101007		Long-term effects of genetically modified (GM) crops on health and the environment (including biodiversity): Prioritization of potential risks and delimitation of uncertainties [2007]
		1) In the BEETLE study, genetically modified (GM) crops with traits already on the market in the EU or possibly so in the near future were assessed with respect to potential long-term (10-20 years)...
101029		RIVM/MNP Guidance for Uncertainty Assessment and Communication: Detailed Guidance (RIVM/MNP Guidance for Uncertainty Assessment and Communication Series, Volume 3) [2003]
		This report contains the Detailed Guidance of the RIVM/MNP Guidance for Uncertainty Assessment and Communication.
101030		RIVM/MNP Guidance for Uncertainty Assessment and Communication: Tool Catalogue for Uncertainty Assessment (RIVM/MNP Guidance for Uncertainty Assessment and Communication Series, Volume 4) [2004]
		This report contains the Tool Catalogue of the RIVM/MNP Guidance for Uncertainty Assessment and Communication.
101032		Defining Uncertainty - A Conceptual Basis for Uncertainty Management in Model-Based Decision Support [2003]
		The aim of this paper is to provide a conceptual basis for the systematic treatment of uncertainty in model-based decision support activities such as policy analysis, integrated assessment and risk...
101034		Guidance of the Scientific Committee on a request from EFSA related to Uncertainties in Dietary Exposure Assessment [2006]
		The Scientific Committee has been asked by the European Food Safety authority (EFSA) to advise on harmonisation of risk assessment methodologies in the fields falling within its mission.
101035		International Programme on Chemical Safety Safety Uncertainty and Data Quality in Exposure Assessment - Part 2, Hallmarks of Data Quality in Chemical Exposure Assessment [2008]
		EXECUTIVE SUMMARY This guidance has been developed as a basis for transparently characterizing uncertainty in chemical exposure assessment to enable its full consideration in regulatory and policy...
101369		The Precautionary Principle in Biodiversity Conservation and Natural Resource Management - An issues paper for policy-makers, researchers and practitioners [2004]
		IUCN Policy and Global Change Series No. 2 This paper is divided into the following sections: I. Introduction The context of this study Background and objectives Structure 2.
101866		Guidance Notes for Lead Authors of the IPCC Fourth Assessment Report on Addressing Uncertainties [2005]
		These notes are intended to assist Lead Authors (LAs) of the Fourth Assessment Report (AR4) to deal with uncertainties consistently.
103362		Uncertainty and Variability: The Recurring and Recalcitrant Elements of Risk Assessment (Chapter 4 in 'Science and Decisions: Advancing Risk Assessment (2009')) [2009]
		The Chapter's Table of Contents as follows: 1.Introduction to the Issues and Terminology, 2.Uncertainty in Risk Assessment, 3.Variability and Vulnerability in Risk Assessment, 4.
103363		Risk Assessment and Precaution in the Biosafety Protocol [2004]
		Review article discussing the compatibility of risk assessment and precaution in the context of the CBD Biosafety Protocol The article is divided into the following sections: 1. Introduction 2.
103364		A guidance for assessing and communicating uncertainties. [2005]
		Abstract: In the daily practice of science for policy, as experienced by governmental agencies which inform the policy and the public on the state and outlook of the environment, there is a pressing...
103365		Uncertainty communication: issues and good practice (version 2.0) [2007]
		Table of contents as follows: Introduction Part I. Background information on communicating uncertainty 1. Reporting uncertainty in a gradual and custom-made form 2.
103366		Evaluating Critical Uncertainty Thresholds in a Spatial Model of Forest Pest Invasion Risk [2009]
		Abstract: Pest risk maps can provide useful decision support in invasive species management, but most do not adequately consider the uncertainty associated with predicted risk values.
103367		The Precautionary Principle in Environmental Science [2001]
		Abstract: Environmental scientists play a key role in society’s responses to environmental problems, and many of the studies they perform are intended ultimately to affect policy.
103368		Genetically Modified (GM) Crops: Precautionary Science and Conflicts of Interests [2003]
		Abstract: Risk governance of GM plants and GM food products is presently subject to heated scientiﬁc and public controversies.
103369		Reducing uncertainty in regulatory decision-making for transgenic crops: More ecological research or clearer environmental risk assessment? [2010]
		Abstract: Ecological research and environmental risk assessment are similar in that they address interesting problems by formulating and testing hypotheses.
103370		On Science and Precaution in the Management of Technological Risk: Volume 2 - Case studies [2001]
		The Table of Contents is as follows: Executive Summary Risk Evaluation and Risk Management for Institutional and regulatory Policy On 'Precautionary' and 'Science' based approaches to Risk...
103371		Beyond the precautionary principle (Public Law and Legal Theory Working Paper No. 38) [2003]
		Abstract The precautionary principle has been highly influential in legal systems all over the world.
103391		Evaluation of horizontal gene transfer monitoring experiments conducted in New Zealand between 2004 and 2009 [2011]
		Abstract: In 2002, the Environmental Risk Management Authority of New Zealand (ERMANZ or the Authority) approved an application by the company AgResearch, Ltd.
103436		Uncertainty and precaution in environmental management: insights from the UPEM conference [2006]
		Abstract: Communication across the science-policy interface is complicated by uncertainty and ignorance associated with predictions on which to base policies.
103437		Exploring the quality of evidence for complex and contested policy decision [2008]
		Abstract: Policy decisions on complex environmental risks often involve contested science. Typically there are no ‘facts’ that entail a unique correct policy.
103438		Uncertainty communication in environmental assessments: views from the Dutch science–policy interface [2008]
		Abstract: Scientific assessments of environmental problems, and policy responses to those problems, involve uncertainties of many sorts.
104786		A comparative evaluation of the regulation of GM crops or products containing dsRNA and suggested improvements to risk assessments [2013]
		ABSTRACT: Changing the nature, kind and quantity of particular regulatory-RNA molecules through genetic engineering can create biosafety risks.
109473		Biosafety report: Uncertainty and Knowledge Gaps related to Environmental Risk Assessment of GMOs [2015]
		This report provides a detailed discussion of uncertainties, knowledge gaps and research needs related to the potential use and introduction of GMOs.

1.4. Planning phase of the risk assessment (5) ▼

1.4.1. Establishing the context and scope (14) ▼

41554		Strategic Environmental Assessment: Assessing the Environmental Impact of Biotechnology [2005]
		This brief paper outlines a Strategic Environmental Assessment paradigm for biotechnology plans or programs.
41646		Robust methodologies for ecological risk assessment: Best practice and current practice in ecological risk assessment for Genetically Modified Organisms [2004]
		This report compares current practice in ecological risk assessment for genetically modified (GM) plants and microorganisms, as evidenced by eight transnational and national frameworks, with what...
42082		United States National Research Council. 1996. Understanding risk - informing decisions in a democratic society. [1996]
		This document describes principles for the conduct of risk assessment in the context of decision-making.
42208		Safety Considerations for Biotechnology, 1992 [1992]
		This report is a follow-up to the 1986 publication "Recombinant DNA Safety Considerations" (a.k.a.
44302		Environmental Risk Assessment of Genetically Modified Organisms. Volume 3: Methodologies for Transgenic Fish [2007]
		This is the third book in a series on Environmental Risk Assessment of Genetically Modified Organism and provides detailed information relevant for biosafety policy, regulatory frameworks, capacity...
48404		Problem Formulation and Options Assessment Handbook [2007]
		The Problem Formulation and Options Assessment (PFOA) provides a framework for identifying the crucial societal needs that could be satisfied by introducing a GM crop into an agricultural system, and...
101370		Amendment on public participation in decisions on deliberate release into the environment and placing on the market of genetically modified organisms (GMO amendment) [2005]
		Amendment to the Aarhus Convention
103145		Problem formulation in the environmental risk assessment for genetically modified plants [2009]
		Problem formulation is the first step in environmental risk assessment (ERA) where policy goals, scope, assessment endpoints, and methodology are distilled to an explicitly stated problem and...
103432		Problem Formulation and Hypothesis Testing for Environmental Risk Assessments of Genetically Modified Crops. [2006]
		Abstract: Environmental risk assessments can provide high confidence of minimal risk by testing theories, “risk hypotheses”, that predict the likelihood of unacceptable harmful events.
103433		Planning Environmental Risk Assessment for Genetically Modified Crops: Problem Formulation for Stress-Tolerant Crops. [2008]
		This article describes the initial steps in the environmental risk assessment process and illustrates an approach that could be taken for GM crops tolerant to an abiotic stress (e.g.
103434		Beyond Risk. A more realistic risk–benefit analysis of agricultural biotechnologies [2008]
		This article argues that limiting the ethical discussion about agricultural biotechnologies to questions of risk assessments is problematic.
103435		Improving the Utility of Risk Assessment [2009]
		The Chapter's Table of Contents as follows: 1.Beyond the Red Book, 2.A Decision-Making Framework that Maximizes the Utility of Risk Assessment, 3.The Framework: An Overview, 4.
106030		Native Crops of Guatemala and Biosafety in the Use of Living Modified Organisms (free translation) [2014]
		(free translation) The National Council of Protected Areas (CONAP) is the government agency responsible for the conservation and sustainable use of biological diversity throughout the territory of...
109473		Biosafety report: Uncertainty and Knowledge Gaps related to Environmental Risk Assessment of GMOs [2015]
		This report provides a detailed discussion of uncertainties, knowledge gaps and research needs related to the potential use and introduction of GMOs.

1.4.2. Problem formulation

1.4.3. The choice of comparators (5) ▼

1.5. Conducting the risk assessment (42) ▼

41477		Environmental Risk Assessment of Genetically Modified Organisms. Volume 2: Methodologies for Assessing Bt Cotton in Brazil [2006]
		The book focuses on transgenic cotton in Brazil and addresses both environmental and agricultural impacts.
41478		Environmental Risk Assessment of Genetically Modified Organisms. Volume 1: A Case Study of Bt Maize in Kenya [2004]
		The book aims, using the case study of Bt maize, to detail generic approaches to the evaluation of environmental impact of GM technologies. This book focuses on transgenic maize in Kenya.
41595		Maize and Biodiversity: The Effects of Transgenic Maize in Mexico. Chapter 10 - Managing Potential Risks and Enhancing Potential Benefits: Identification and Analysis of Management Tools and Policy Options [2004]
		The present chapter focuses on recommending a set of tools and policy options to manage potential risks and to enhance potential benefits derived from applications of gene modification (GM) of plants...
41647		Guidelines for Ecological Risk Assessment [1998]
		These guidelines are provided to improve the quality and consistency of Environmental Protection Agency`s ecological risk assessments.
41651		Models of Risk Analysis in Relation to GMO ERA Project Methodologies [2003]
		The purposes of this teaching material are (i) orient participants to curriculum; (ii) introduce key terms that will be used across all sections; (iii) provide a risk assessment model to unify...
41659		Non-target Environmental Risk Assessment Methodologies for GMOs
		This paper offers guidelines on assessing how to determine the potential adverse effects of a GMO on Biodiversity.
41660		Conceptualizing risk assessment methodology for genetically modified organisms [2005]
		This paper focuses on the concept of risk assessment methodology for genetically modified organisms.
41669		Proceedings of a Workshop on: Ecological Effects of Pest Resistance Genes in Managed Ecosystems [1999]
		The workshop on Ecological Effects of Pest Resistance Genes in Managed Ecosystems was organized to promote multidisciplinary discussions that would lead to synthesis of what is known and not known...
41800		Biosafety & Risk Assessment in Agricultural Biotechnology: A Workbook for Technical Training [2003]
		Designed to complement technical biosafety-assessment training courses in developing countries, this workbook provides a background for the practical application of biosafety review procedures using...
41862		Points to Consider for Consensus Documents on the Biology of Cultivated Plants [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.
41865		An Introduction to the Biosafety Consensus Documents of OECD’s Working Group for Harmonisation in Biotechnology [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.
41972		Assessment of genetically modified microorganisms and their derived products intended for food and feed use (Guidance Document of the Scientific Panel on Genetically Modified Organisms) [2006]
		This document provides guidance for the scientific risk assessment of genetically modified microorganisms (GMMs) and their derived products intended for food and feed use.
41974		Draft Guidelines for Assessment of Ecological Hazards of Herbicide and Insect Resistant Crops [2001]
		Draft guidelines describe the process of analysis and assessment of ecological hazards associated with the introduction of herbicide resistant crops (HRC) or genetically modified insect resistant (e.
42036		General advice on notifications for import and marketing of GM maize grain [2006]
		For the import and processing of grain derived from GM maize only. Scope excludes cultivation and use as food or feed.
42123		Guidelines for Pest Risk Analysis, International Standard for Phytosanitary Measures #2, 1996 [1996]
		Not specific to LMOs, but applicable to any species, strain or biotype of plant or animal or any pathogenic agent that is injurious to plants or plant products.
42137		International Standards for Phytosanitary Measures: Pest risk analysis for quarantine pests, including analysis of environmental risks and living modified organisms (2004) [2004]
		Objective: To help countries assess the risks of LMOs and determine whether some should be considered as weeds or other organisms that damage plants in order to reduce the risks of releasing LMOs...
42180		ICGEB Collection of Biosafety Reviews - Vol 1 & 2 [2003]
		The 'Collection of Biosafety Reviews' is a series of volumes that contain scientific reviews on major areas in biosafety and risk assessment.
42199		Manual for Assessing Ecological and Human Health Effects of Genetically Engineered Organisms. Part One: Introductory Materials and Supporting Text for Flowcharts & Part Two: Flowcharts and Worksheets [1998]
		A biosafety handbook created by a group of scientists from a broad range of disciplines to help consumers and policy-makers evaluate likely impacts of genetically engineered organisms in a variety of...
42204		Guidance Document for the Risk Assessment of Genetically Modified Plants and Derived Food and Feed (6-7 March 2003) [2003]
		*It should be noted that this document was updated and replaced by the 2004 document produced by the European Food Safety Authority, reviewed in BCH record 9746 available at http://bch.biodiv.
44043		Genetically Modified Pest-Protected Plants: Science and Regulation [2000]
		This book explores the risks and benefits of crops that are genetically modified for pest resistance, the urgency of establishing an appropriate regulatory framework for these products, and the...
44303		Environmental Risk Assessment of Genetically Modified Organisms. Volume 4: Challenges and Opportunities with Bt Cotton in Vietnam [2007]
		This book is the first scientific effort to synthesize information relevant to GM crops in Vietnam, taking Bt cotton as an example.
47565		Maize and Biodiversity: The Effects of Transgenic Maize in Mexico. Chapter 3 - Assessment of Effects on Genetic Diversity [2004]
		Phenotypic diversity among maize landraces is obvious in kernel color, ear and kernel shape and size, and agronomic traits such as plant height and length of the growing cycle.
48124		Guide for notifications and risk assessment for releases into the environment of genetically modified organisms. Module 1: Genetically modified crop plant (DRAFT) [2005]
		The focus of this Guide is the technical and scientific information required for notification, and in particular for risk assessment.
48487		Recombinant DNA Safety Considerations - Safety considerations for industrial, agricultural and environmental applications of organisms derived by recombinant DNA techniques [1986]
		This document is the result of a study undertaken as a follow-up to the OECD report Biotechnology: International Trends and Perspectives.
48516		Science and Decisions: Advancing Risk Assessment [2008]
		This book is a complement to the 1983 National Academies book, Risk Assessment in the Federal Government.
48544		Biosafety Assessment Tool (BAT) [2009]
		The Biosafety Assessment Tool (https://bat.genok.org/bat/) is an online resource for those identifying potential hazards and evaluating the risks of Genetically Modified/Engineered Organisms...
101079		Maize and biodiversity- the effects of transgenic maize in Mexico, key findings and recommendations [2004]
		The Table of Contents is as follows: PREFACE ACKNOWLEDGEMENTS INTRODUCTION The Context Mandate and Scope of the Study Process Frameworks and Approaches Considered in the CEC Maize Study ...
101371		Scientific Opinion on Guidance for the risk assessment of genetically modified plants used for non-food or non-feed purposes [2009]
		This Opinion discusses the risk assessment issues associated with Genetically Modified (GM) plants used for non-food or non-feed purposes (e.g.
101372		Commission Decision establishing guidance notes supplementing AnnexII to Directive 2001-18-EC on the deliberate release into the environment of genetically modified organisms [2002]
		COMMISSION DECISION of 24 July 2002 establishing guidance notes supplementing AnnexII to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the...
102000		Biosafety Resource Book [2011]
		Abstract: During the period 2002-10, FAO undertook an intense activity of biosafety capacity development, largely centred on enhancing the capacities of regulators and other technical staff involved...
102080		Environmental risk assessment of genetically modified plants - concepts and controversies [2011]
		Abstract: Background and purpose In Europe, the EU Directive 2001/18/EC lays out the main provisions of environmental risk assessment (ERA) of genetically modified (GM) organisms that are...
103076		Anticipating the Environmental Risk Assessment of crops modified to enhance or preserve yield [2010]
		Tomorrow’s crops will be required to yield more, to perform in spite of less favourable growing conditions and to limit the environmental impact of cultivation.
103132		Genetically modified crops and aquatic ecosystems: considerations for environmental risk assessment and non-target organism testing [2011]
		Environmental risk assessments (ERA) support regulatory decisions for the commercial cultivation of genetically modified (GM) crops.
103133		Problem Formulation for the Environmental Risk Assessment of RNAi Plants: Conference Proceedings [2011]
		The application of RNA interference (RNAi) to produce genetically engineered crops with improved agronomic, nutritional, industrial, and food-processing traits is becoming increasingly common.
103148		A Review of the Environmental Safety of the PAT Protein [2011]
		This document provides a comprehensive review of information and data relevant to the environmental risk assessment of the protein phosphinothricin-N-acetyl transferase (PAT) produced in genetically...
103162		A review of the environmental safety of the Cry1Ab protein [2011]
		This document provides a comprehensive review of information and data relevant to the environmental risk assessment of Cry1Ab and presents a summary statement about the environmental safety of this...
103421		ISPM No. 2: Framework for pest risk analysis. [2007]
		Scope: This standard provides a framework that describes the pest risk analysis (PRA) process within the scope of the IPPC.
103431		The Design of Risk Assessments: Risk Assessment as a design challenge [2009]
		The Chapter's Table of Contents is as follows: 1.Risk Assessment As a Design Challenge, 2.Design Considerations: Objectives, Constraints, and Tradeoffs, 3.
103525		Scrutinizing the current practice of the environmental risk assessment of GM maize applications for cultivation in the EU [2011]
		Abstract: Purpose: The prevailing controversies on the potential environmental risks of genetically modified organisms [GMOs] still fuel ongoing discussions among European Union [EU] member states,...
103574		International Programme on Chemical Safety Safety (IPCS) Risk Assessment Terminology [2004]
		TABLE OF CONTENTS FOREWORD LIST OF ACRONYMS AND ABBREVIATIONS INTRODUCTION PART 1: IPCS/OECD KEY GENERIC TERMS USED IN CHEMICAL HAZARD/RISK ASSESSMENT 1. APPROACH TO THE WORK ON GENERIC TERMS 2.
104779		A Review of the Environmental Safety of the Cry34Ab1 and Cry35Ab1 Proteins [2013]
		This document provides a comprehensive review of the information and data relevant to the environmental risk assessment of two proteins encoded by genes isolated from Bacillus thuringiensis, Cry...
105459		A Review of the Environmental Safety of the Cry3Bb1 Protein [2014]
		This document provides a comprehensive review of the information and data relevant to the environmental risk assessment of Cry3Bb1, a protein encoded by a gene isolated from Bacillus thuringiensis...

1.5.1. Step 1: “Identification of any novel genotypic and phenotypic characteristics associated with the living modified organism that may have adverse effects on biological diversity in the likely potential receiving environment, taking also into account risks to human health” (133) ▼

41601		The Mutational Consequences of Plant Transformation [2006]
		Abstract: Plant transformation is a genetic engineering tool for introducing transgenes into plant genomes. It is now being used for the breeding of commercial crops.
41602		Genome Scrambling - Myth or Reality? Transformation-Induced Mutations in Transgenic Crop Plants [2004]
		Report summary: In this report we examine the mutations introduced into transgenic crop plants by plant transformation.
41642		Interferences in the Agrisystem and Environmental Risks of Herbicide Tolerant and Insect protected transgenic crops [2005]
		This article examines Risk Assessment issues, in particular interferences in the Agrisystem and Environmental Risks of Herbecide Tolerant and Insect Protected Transgenic Crops.
41643		The Environmental Effects of Genetically Modified Crops Resistant to Insects [2002]
		This review discusses the potential ecological consequences of the commercial use in agriculture of genetically modified insect resistant crops.
41676		Ecological impacts of insect-resistant Bt maize on various insects and the European corn borer [1999]
		This review evaluates scientific studies published in peer-review journals that considered ecological effects of insect resistant (Bt) and herbicide tolerant maize.
41810		Problems in monitoring horizontal gene transfer in field trials of transgenic plants [2004]
		Abstract: Transgenic crops are approved for release in some countries, while many more countries are wrestling with the issue of how to conduct risk assessments.
41859		Consensus Document on the Biology of Western White Pine (Pinus Monticola Dougl. ex D. Don) [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.
41860		Consensus Document on Information Used in the Assessment of Environmental Applications Involving Acidithiobacillus [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.
41861		Consensus Document on the Biology of the Capsicum annuum Complex (Chili peppers, Hot peppers and Sweet peppers) [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.
41863		Consensus Document on the Biology of Pleurotus spp. (Oyster Mushroom) [2005]
		Consensus documents contain information for use during the regulatory assessment of a particular product.
41864		Consensus Document on the Biology of Papaya (Carica Papaya) [2005]
		Consensus documents contain information for use during the regulatory assessment of a particular product.
41866		Consensus Document on the Biology of Helianthus annuus L. (Sunflower) [2005]
		Consensus documents contain information for use during the regulatory assessment of a particular product.
41867		Consensus Document on the Biology of European White Birch (Betula pendula Roth) [2003]
		Consensus documents contain information for use during the regulatory assessment of a particular product.
41868		Consensus document on the biology of Zea mays subsp. mays (maize) [2003]
		Consensus documents contain information for use during the regulatory assessment of a particular product.
41869		Module II: Herbicide Biochemistry, Herbicide Metabolism and the Residues in Glufosinate-Ammonium (Phosphinothricin) -Tolerant Transgenic Plants [2002]
		Consensus documents contain information for use during the regulatory assessment of a particular product.
41870		Consensus Document on the Biology of Prunus Sp. (Stone Fruits) [2002]
		Consensus documents contain information for use during the regulatory assessment of a particular product.
41871		Consensus Document on the Biology of Pinus Strobus L. (Eastern White Pine) [2002]
		Consensus documents contain information for use during the regulatory assessment of a particular product.
41872		Consensus Document on the Biology of Picea Sitchensis (Bong.) Carr. (Sitka Spruce) [2002]
		Consensus documents contain information for use during the regulatory assessment of a particular product.
41873		Consensus Document on Information Used in the Assessment of Environmental Applications Involving Baculoviruses [2002]
		Consensus documents contain information for use during the regulatory assessment of a particular product.
41874		Consensus Document on the Biology of Beta vulgaris L. (Sugar Beet) [2001]
		Consensus Documents are intended to be a snapshot of current information on a specific host organism or trait, for use during regulatory assessments.
41875		Consensus Document on the Biology of Populus L.. (Poplars) [2001]
		Consensus documents contain information for use during the regulatory assessment of a particular product. This consensus document addresses the biology of poplar species (Populus L.).
41876		Consensus Document on the Biology of Glycine max (L.) Merr. (Soybean) [2000]
		Consensus documents contain information for use during the regulatory assessment of a particular product.
41877		Consensus Document on the Biology of Oryza Sativa (Rice) [1999]
		Consensus documents contain information for use during the regulatory assessment of a particular product. This Consensus Document addresses the biology of rice (Oryza sativa).
41878		Consensus Document on the Biology of Picea glauca (Moench) Voss (White Spruce) [1999]
		Consensus Documents contain information for use during the regulatory assessment of a particular product.
41879		Consensus Document on the Biology of Picea abies (L) Karst (Noway Spruce) [1999]
		Consensus Documents contain information for use during the regulatory assessment of a particular product.
41880		Consensus Document on General Information Concerning the Genes and Their Enzymes that Confer Tolerance to Phosphinothricin Herbicide [1999]
		Consensus Documents contain information for use during the regulatory assessment of a particular product.
41881		Consensus Document on General Information Concerning the Genes and Their Enzymes that Confer Tolerance to Glyphosate Herbicide [1999]
		Consensus Documents contain information for use during the regulatory assessment of a particular product.
41882		Consensus Document on the Biology of Triticum Aestivum (Bread Wheat) [1999]
		Consensus Documents contain information for use during the regulatory assessment of a particular product.
41883		Consensus Document on the Biology of Solanum tuberosum subsp. tuberosum (Potato) [1997]
		Consensus documents contain information for use during the regulatory assessment of a particular product.
41884		Consensus Document on the Biology of Brassica napus L. (Oilseed rape) [1997]
		Consensus documents contain information for use during the regulatory assessment of a particular product.
41885		Consensus Document on information Used in the Assessment of Environmental Applications Involving Pseudomonas [1997]
		Consensus documents contain information for use during the regulatory assessment of a particular product.
41886		Consensus Document on General Information concerning the Biosafety of Crop Plants Made Virus Resistant through Coat Protein Gene-Mediated Protection [1996]
		These consensus documents were to contain information for use during the regulatory assessment of the particular product.
41888		Consensus Document on Compositional Considerations for New Varieties of Alfalfa and Other Temperate Forage Legumes: Key Feed Nutrients, Anti-Nutrients and Secondary Plant Metabolites [2005]
		Consensus documents contain information for use during the regulatory assessment of a particular food/feed product.
41889		Consensus Document on Compositional Considerations for New Varieties of Barley (Hordeum vulgare L.): Key Food and Feed Nutrients and Anti-Nutrients [2004]
		Consensus documents contain information for use during the regulatory assessment of a particular food/feed product.
41890		Consensus Document on Compositional Considerations for New Varieties of Cotton (Gossypium hirsutum and Gossypium barbadense): Key Food and Feed Nutrients and Anti-Nutrients [2004]
		Consensus documents contain information for use during the regulatory assessment of a particular food/feed product.
41891		Consensus Document on Compositional Considerations for New Varieties of Rice (Oryza sativa): Key Food and Feed Nutrients and Anti-Nutrients [2004]
		Consensus documents contain information for use during the regulatory assessment of a particular food/feed product.
41893		Consensus Document on Compositional Considerations for New Varieties of Bread Wheat (Triticum aestivum): Key Food and Feed Nutrients, Anti-Nutrients and Toxicants [2003]
		Consensus documents contain information for use during the regulatory assessment of a particular food/feed product.
41894		Consensus Document on Compositional Considerations for New Varieties of Maize (Zea Mays): Key Food and Feed Nutrients, Anti-Nutrients and Secondary Plant Metabolites [2002]
		Consensus documents contain information for use during the regulatory assessment of a particular food/feed product.
41895		Consensus Document on Compositional Considerations for New Varieties of Potatoes: Key Food and Feed Nutrients, Anti-Nutrients and Toxicants [2002]
		Consensus documents contain information for use during the regulatory assessment of a particular food/feed product.
41896		Consensus Document on Compositional Considerations for New Varieties of Sugar Beet: Key Food and Feed Nutrients and Antinutrients [2002]
		Consensus documents contain information for use during the regulatory assessment of a particular food/feed product.
41897		Consensus Document on Compositional Considerations for New Varieties of Soybean: Key Food and Feed Nutrients and Anti-Nutrients [2001]
		Consensus documents contain information for use during the regulatory assessment of a particular food/feed product.
41898		Consensus Document on Key Nutrients and Key Toxicants in Low Erucic Acid Rapeseed (Canola) [2001]
		Consensus documents contain information for use during the regulatory assessment of a particular food/feed product.
41900		Guidance Document on the Use of Taxonomy in Risk Assessment of Micro-organisms: Bacteria [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.
41976		Evaluation of Allergenicity of Genetically Modified Foods [2001]
		This is the report of a Joint FAO/WHO Expert Consultation on Foods Derived from Biotechnology on the evaluation of allergenicity of genetically modified foods.
42126		Safety Considerations for Biotechnology: Scale-Up of Crop Plants, 1993 [1993]
		Considers specific risk pathways and associated management options for GM crop plants, relevant to several aspects of annex III of the Protocol
43898		Biology Document BIO2002-01: The Biology of Beta vulgaris L. (Sugar Beet) [2002]
		The present document is a companion document to Dir94-08: Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits.
43903		Biology Document BIO2007-01: The Biology of Brassica juncea (Canola/Mustard) [2007]
		The present document is a companion document to the Dir94-08.
43904		Biology Document BIO1994-09: The Biology of Brassica napus L. (Canola/Rapeseed) [1994]
		The present document represents a companion document to the Directive 94-08 (Dir94-08), entitled "Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits".
43905		Biology Document BIO1992-02: The Biology of Brassica rapa L. [1992]
		The present document represents a companion document to Dir94-08. It is intended to provide background information on the biology of Brassica rapa L., its centres of origin and related species.
43906		Biology Document BIO1996-10: The Biology of Glycine max (L.) Merr. (Soybean) [1996]
		The present document is a companion document to Dir94-08. It is intended to provide background information on the biology of Glycine max (L.
43907		Biology Document BIO2005-01: The Biology of Helianthus annuus L. (sunflower) [2005]
		The present document is a companion document to Dir94-08. It is intended to provide background information on the biology of Helianthus annuus L.
43908		Biology Document BIO2003-12: The Biology of Lens culinaris Medikus (Lentil) [2003]
		The present document is a companion document to Dir94-08.
43909		Biology Document BIO1994-10: The Biology of Linum usitatissimum L. (Flax) [1994]
		The present document is a companion document to Dir94-08. It is intended to provide background information on the biology of Linum usitatissimum L.
43911		Biology Document Bio2005-02: The Biology of Medicago sativa L. (Alfalfa) [2005]
		The present document is a companion document to Dir94-08: Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits.
43912		Biology Document BIO1996-09: The Biology of Solanum tuberosum (L.) (Potatoes) [1996]
		The present document represents a companion document to the Directive 94-08 (Dir94-08), entitled "Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits".
43913		Biology Document BIO1999-01: The Biology of Triticum aestivum L. (Wheat) [1999]
		The present document is a companion document to the Dir94-08.
43914		Biology Document BIO2006-07: The Biology of Triticum turgidum ssp. durum (Durum Wheat) [2006]
		The present document is a companion document to the Dir94-08 Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits.
43915		Biology Document BIO1994-11: The Biology of Zea mays (L.) (Maize) [1994]
		The present document is a companion document to Dir94-08 and is intended to provide background information on the biology of Zea mays L.
44302		Environmental Risk Assessment of Genetically Modified Organisms. Volume 3: Methodologies for Transgenic Fish [2007]
		This is the third book in a series on Environmental Risk Assessment of Genetically Modified Organism and provides detailed information relevant for biosafety policy, regulatory frameworks, capacity...
44949		Weeds in fields with contrasting conventional and genetically modified herbicide-tolerant crops. I. Effects on abundance and diversity [2003]
		We compared the seedbanks, seed rains, plant densities and biomasses of weeds under two contrasting systems of management in beet, maize and spring oilseed rape.
47286		Gene flow from tree plantations and implications for transgenic risk assessment [2004]
		Authors' abstract: Gene flow is a major determinant of impacts of forest tree plantations on surrounding populations and ecosystems.
47373		Measuring and Modeling Gene Flow From Hybrid Poplar Plantations: Implications for Transgenic Risk Assessment [2002]
		Author's Abstract Hybrid poplar plantations (Populus trichocarpa x Populus deltoides) are a relatively new feature on the landscape in the Pacific Northwest of the United States, and these...
48231		ICGEB Collection of Biosafety Reviews - Vol 3 [2007]
		This volume is divided into the following sections (which are available for download in PDF format below): 1. Introduction 2.
48401		Transformation-induced mutations in transgenic plants: Analysis and biosafety implications. [2006]
		This paper reviews what is known about the effect of the plant transformation process on the plant genome.
48402		Science-based risk assessment for non-target effects of transgenic crops [2004]
		Author's Abstract: Nontarget risk assessment for transgenic crops should be case specific, depending on the plant, the transgene, and the intended release environment.
48483		Environmental Risk Assessment of Transgenic Plants - Potential Secondary and Non-target Effects
		This document, in a presentation format, describes a methodology for assessing the impacto of GM plants on non-target organisms.
48485		Canada - USA Bilateral on Agricultural Biotechnology. Appendix II: Environmental characterization data for transgenic plants intended for unconfined release [2001]
		Information contained in this document focuses on how to evaluate the differences between the way transgenic plants and their non-transgenic counterparts interact with the environment in managed and...
48490		Assessment of Toxic and Ecotoxic Properties of Novel Proteins in GMOs - Part 1: Report & Part 2: Supplement [2008]
		The overall goal of this report is to review the currently applied approaches in toxicity and ecotoxicity assessment of novel proteins in the context of genetically modified plants and to identify...
48495		Consensus Document of Safety Information on Transgenic Plants Expressing Bacillus thuringiensis-derived Control Proteins [2007]
		This document summarises the information available on the source of Bacillus thuringiensis δ- endotoxin genes, the structure and properties of the toxins they encode, unique mechanisms of action, use...
48496		OECD Consensus Documents for the Work on Harmonisation of Regulatory Oversight in Biotechnology [2003]
		This website provides links to the consensus documents published by the OECD.
48524		Consensus Document on the Biology of the Native North American Larches: Subalpine Larch (Larix lyalli), Western Larch (Larix occidentalis) and Tamarack (Larix laricina) [2007]
		Consensus Documents contain information for use during the regulatory assessment of a particular product.
48525		Consensus Document on the Biology of Pinus banksiana (Jack Pine) [2006]
		Consensus Documents contain information for use during the regulatory assessment of a particular product.
48542		A Typology of the Effects of (Trans)Gene Flow on the Conservation and Sustainable Use of Genetic Resources [2007]
		This background study paper gives an overview of current research regarding the full range of possible effects of transgene flow on human health, the environment, the various stakeholders in the food...
48922		Risk Assessment and Risk Management Plan for DIR 077/2007. Limited and controlled release of wheat and barley genetically modified for enhanced tolerance to abiotic stresses or increased beta glucan [2008]
		Risk assessment and risk management report issued by the Office of the Gene Technology Regulator, Australian Government, in response to an application for release of GM wheat and barley lines that...
100876		Methods to study potential effects of genetically modified plants on soil microbial diversity and soil functioning [2009]
		Concluding remarks This report describes the variety of techniques that are available for determining the changes in the soil microbial community that may come about by the presence of GM plants.
101041		Appendix I - Molecular genetic characterization data (International agreement USDA-APHIS, Canadian Food Inspection Agency) [1998]
		INTRODUCTION In July of 1998, regulatory officials of the Canadian Food Inspection Agency (CFIA), Health Canada, and the United States Department of Agriculture’s Animal and Plant Health Inspection...
101082		Genetically modified organisms (GMOs)- The significance of gene flow through pollen transfer (Environmental issue report- No 28) [2002]
		The Table of Contents is as follows: Executive summary Project summary 1. Introduction 1.1. Aims and objectives of the report 1.2. Background 1.3.
101178		Consensus Document on the Biology of Bananas and Plantains (Musa spp.) No.48, 2009 [2009]
		The Table of Contents is as follows: ABOUT THE OECD FOREWORD TABLE OF CONTENTS PREAMBLE SECTION I. TAXONOMY AND GENOMIC GROUPS 1.1. Background 1.2. Taxonomic and genomic classifications 1.
101180		Consensus Document on Information Used in the Assessment of Environmental Applications Involving Acinetobacter No. 46, 2008 [2008]
		The Table of Contents is as follows: ABOUT THE OECD FOREWORD PREAMBLE GENERAL INTRODUCTION A. General Considerations 1. Subject of document; species included and taxonomic considerations 2.
101181		Consensus Document on the Biology of Gossypium (Cotton) No. 45, 2008 [2008]
		The Table of Contents is as follows: ABOUT THE OECD FOREWORD PREAMBLE SECTION I. INTRODUCTION: DESCRIPTION AND USES 1.1. Description 1.2. Uses SECTION II.
101182		Consensus Document on the Biology of Pinus contorta (Lodgepole Pine) No. 44, 2008 [2008]
		The Table of Contents is as follows: ABOUT THE OECD FOREWORD PREAMBLE SECTION I. TAXONOMY SECTION II. NATURAL DISTRIBUTION SECTION III. REPRODUCTIVE BIOLOGY A. Reproductive development B.
101183		Consensus Document on the Biology of Pseudotsuga menziesii (Douglas Fir) No. 43, 2008 [2008]
		ABOUT THE OECD FOREWORD PREAMBLE SUMMARY NOTE SECTION I. TAXONOMY SECTION II. NATURAL DISTRIBUTION SECTION III. REPRODUCTIVE BIOLOGY A. Reproductive development B.
101200		Procedures for Ecological Risk Assessment of Herbicide and Insect Resistant Crops [2003]
		The Table of Contents is as follows: INTRODUCTION SCOPE/OBJECTIVES OF THE PROCEDURES REFERENCES DEFINITIONS AND ABBREVIATIONS DELIMITATIONS 1. RESPONSIBILITIES 1.
101864		Consensus Document on Molecular Characterisation of Plants Derived from Modern Biotechnology (OECD 2010) [2010]
		TABLE OF CONTENTS ABOUT THE OECD FOREWORD PREAMBLE SECTION I - BACKGROUND A. Molecular Characterisation and Risk/Safety Assessment B. National and International Experience C.
103072		EVALUACIÓN DE LOS POSIBLES EFECTOS SOBRE ENTOMOFAUNA NO DIANA DEL CULTIVO DE VARIEDADES DE MAÍZ DERIVADAS DE LA LÍNEA MON 810, EN LA ZONA CENTRO [2006]
		El objetivo de este estudio ha sido evaluar los niveles de los depredadores más frecuentes, en planta y suelo, en parcelas sembradas con una variedad de maíz con la protección MON 810 (maíz Bt) y con...
103075		A baseline study of the distribution and morphology of Brassica napus L. and Brassica rapa L. in the Netherlands [2010]
		In Europe, the cultivation of genetically (living) modified (GM) Brassica napus is prohibited, but the import of GM B. napus seeds is permitted. Until March 2009 no GM B.
103077		Inventory of observed unexpected environmental effects of genetically modified crops [2010]
		In the EU, the consent holder of a particular GM crop is obliged to monitor the occurrence of unexpected adverse effects after its release on the market.
103135		A Review of the Environmental Safety of the CP4 EPSPS Protein [2010]
		This document provides a comprehensive review of information and data relevant to the environmental risk assessment of the protein 5 enolpyruvylshikimate-3-phosphate synthase isolated from...
103144		A Review of the Environmental Safety of the Cry1Ac Protein [2010]
		This document provides a comprehensive review of information and data relevant to the environmental risk assessment of Cry1Ac and presents a summary statement about the environmental safety of this...
103145		Problem formulation in the environmental risk assessment for genetically modified plants [2009]
		Problem formulation is the first step in environmental risk assessment (ERA) where policy goals, scope, assessment endpoints, and methodology are distilled to an explicitly stated problem and...
103308		Human Lactoferrin Biopharming in New Zealand: Scientific Risk Assessement [2008]
		Animals but especially plants and microbes are a source of a significant proportion of our medicines and industrial compounds.
103377		The impact of transgenic plants on natural enemies: a critical review of laboratory studies [2005]
		Abstract: We reviewed laboratory tests which studied the impact of genetically modified plants on arthropod natural enemies.
103388		Suppression of Cotton Bollworm in Multiple Crops in China in Areas with Bt Toxin–Containing Cotton [2008]
		Abstract: Transgenic cotton that has been engineered to produce insecticidal toxins from Bacillus thuringiensis (Bt) and so to resist the pest cotton bollworm (Helicoverpa armigera) has been widely...
103389		Horizontal gene transfer among genomes: The complexity hypothesis [1999]
		Abstract: Increasingly, studies of genes and genomes are indicating that considerable horizontal transfer has occurred between prokaryotes.
103390		Risks from GMOs Due to Horizontal Gene Transfer [2008]
		Abstract: Horizontal gene transfer (HGT) is the stable transfer of genetic material from one organism to another without reproduction or human intervention.
103391		Evaluation of horizontal gene transfer monitoring experiments conducted in New Zealand between 2004 and 2009 [2011]
		Abstract: In 2002, the Environmental Risk Management Authority of New Zealand (ERMANZ or the Authority) approved an application by the company AgResearch, Ltd.
103392		Global extent of horizontal gene transfer [2007]
		Abstract: Horizontal gene transfer (HGT) is thought to play an important role in the evolution of species and innovation of genomes.
103393		Setting the record straight: a rebuttal to an erroneous analysis on transgenic insecticidal crops and natural enemies. [2009]
		Rebuttal letter to the editor concerning the paper entitled: Transgenic insecticidal crops and natural enemies: a detailed review of laboratory studies (Lovei et al Environ Entomol 38:293–306 2009).
103394		Non-target organism risk assessment of MIR604 maize expressing mCry3A for control of corn rootworm [2007]
		Abstract: Event MIR604 maize expresses a modiﬁed Cry3A protein (mCry3A), for control of corn rootworm.
103396		Transgenic Insecticidal Crops and Natural Enemies: A Detailed Review of Laboratory Studies [2009]
		Abstract: This review uses a data-driven, quantitative method to summarize the published, peer-reviewed literature about the impact of genetically modified (GM) plants on arthropod natural enemies...
103399		Assessment of risk of insect-resistant transgenic crops to nontarget arthropods [2008]
		Abstract: An international initiative is developing a scientifically rigorous approach to evaluate the potential risks to nontarget arthropods (NTAs) posed by insect-resistant, genetically modified...
103400		Transgene introgression from Genetically modified crops to their wild relatives [2003]
		Abstract: Transgenes engineered into annual crops could be unintentionally introduced into the genomes of their free-living wild relatives.
103401		Are GM and conventionally bred cereals really different? [2007]
		Abstract: Concerns over the safety of GM crops have led to detailed comparisons of their composition and performance with those of conventionally bred crops, under both ﬁeld and glasshouse...
103402		Comparison of tuber proteomes of potato varieties, landraces, and genetically modified lines [2005]
		Abstract: Crop improvement by genetic modiﬁcation remains controversial, one of the major issues being the potential for unintended effects.
103404		Characterization of cry Genes in a Mexican Bacillus thuringiensis Strain Collection [1998]
		Abstract: Mexico is located in a transition zone between the Nearctic and Neotropical biogeographical regions and contains a rich and unique biodiversity.
103405		Risk assessment of toxins derived from Bacillus thuringiensis-synergism, efficacy, and selectivity [2010]
		Abstract: Background, aim, and scope This review deals with publications concerning the mode of action of Bt proteins and their potential synergism with extrinsic factors.
103406		Evaluation of potential risks associated with recombination in transgenic plants expressing viral sequences [2008]
		Abstract: Virus-resistant transgenic plants have been created primarily through the expression of viral sequences.
103408		Fitness and beyond: Preparing for the arrival of GM crops with ecologically important novel characters [2009]
		Abstract: The seemingly inexorable expansion of global human population size, significant increases in the use of biofuel crops and the growing pressures of multifunctional land-use have intensified...
103409		Transcriptome analysis reveals absence of unintended effects in drought-tolerant transgenic plants overexpressing the transcription factor ABF3 [2010]
		Abstract: Background: Plants engineered for abiotic stress tolerance may soon be commercialized.
103411		Proteomic analysis of a genetically modified maize flour carrying CRY1AB gene and comparison to the corresponding wild-type [2007]
		Abstract: Protein expression in a maize hybrid flour (hereafter called WT) and its corresponding transgenic version resistant to European corn borer (hereafter called BT and carrying a gene...
103412		Microarray analyses reveal that plant mutagenesis may induce more transcriptomic changes than transgene insertion [2008]
		Abstract: Controversy regarding genetically modified (GM) plants and their potential impact on human health contrasts with the tacit acceptance of other plants that were also modified, but not...
103414		SNP frequency, haplotype structure and linkage disequilibrium in elite maize inbred lines [2002]
		Abstract: Background: Recent studies of ancestral maize populations indicate that linkage disequilibrium tends to dissipate rapidly, sometimes within 100 bp.
103415		The stability of the Arabidopsis transcriptome in transgenic plants expressing the marker genes nptII and uidA. [2005]
		Abstract: The ATH1 Arabidopsis GeneChip from Affymetrix was used to search for transcriptome changes in Arabidopsis associated with the strong expression of transgenes regulated by constitutive...
103418		A microarray-based comparative analysis of gene expression profiles during grain development in transgenic and wild type wheat [2005]
		Abstract: Global, comparative gene expression analysis is potentially a very powerful tool in the safety assessment of transgenic plants since it allows for the detection of differences in gene...
103419		Selectable marker genes and unintended changes to the plant transcriptome [2009]
		Abstract: The intended effect of a selectable marker gene is to confer a novel trait that allows for the selection and recovery of transgenic plants.
103420		Are Mutations in Genetically Modified Plants Dangerous [2007]
		Letter to the editor discussing the data in the following articles: J. R. Latham, A. K. Wilson, and R. A.
103424		Transgenesis has less impact on the transcriptome of wheat grain than conventional breeding [2006]
		Summary: Detailed global gene expression profiles have been obtained for a series of transgenic and conventionally bred wheat lines expressing additional genes encoding HMW (high molecular weight)...
103425		Hierarchical metabolomics demonstrates substantial compositional similarity between genetically modified and conventional potato crops. [2005]
		Abstract: There is current debate whether genetically modified (GM) plants might contain unexpected, potentially undesirable changes in overall metabolite composition.
103426		Gene expression profiles of MON810 and comparable non-GM maize varieties cultured in the field are more similar than are those of conventional lines [2009]
		Abstract: Maize is a major food crop and genetically modified (GM) varieties represented 24% of the global production in 2007.
103427		Proteomics as a tool to improve investigation of substantial equivalence in genetically modified organisms: The case of a virus-resistant tomato [2004]
		Abstract: At present, the so-called “substantial equivalence” is the only widely accepted criterion for deciding whether or not a transgenic food is, from an alimentary point of view, to be...
103428		Transcriptome and metabolome profiling of fieldgrown transgenic barley lack induced differences but show cultivar-specific variances [2010]
		Abstract: The aim of the present study was to assess possible adverse effects of transgene expression in leaves of field-grown barley relative to the influence of genetic background and the effect...
103448		Detection of RNA variants transcribed from the transgene in Roundup Ready soybean [2005]
		Abstract: The acreage for genetically modified crops (GMOs)—particularly soybean—has steadily increased since 1996, when the first crop of Roundup Ready soybean (intended for food production) was...
103526		A synthesis of laboratory and field studies on the effects of transgenic Bacillus thuringiensis (Bt) maize on non-target Lepidoptera [2010]
		Abstract: One of the major applications of transgenic crops in agriculture are the so-called Bacillus thuringiensis Berliner (Bt) plants, in particular Bt maizes, which produce insecticidal Cry...
103527		General Recommendations for Soil Ecotoxicological Tests Suitable for The Environmental Risk Assessment of Genetically Modified Plants [2009]
		ABSTRACT Before a genetically modified plant (GMP) can be placed on the market in the European Union (EU), an environmental risk assessment has to be conducted according to EU Directive 2001/18/EC...
103556		Molecular profiling — a tool for addressing emerging gaps in the comparative risk assessment of GMOs [2011]
		Abstract Assessing the risks of genetically modified organisms (GMOs) is required by both international agreement and domestic legislation.
103719		Assessing the potential risks of transgenic plants for nontarget invertebrates in Europe: a review of classification approaches of the receiving environment [2011]
		Abstract: According to the current legal background for the regulation of genetically modified plants (GMPs) in Europe, an environmental risk assessment (ERA) has to be performed considering i) the...
103864		A Review of the Environmental Safety of Vip3Aa [2012]
		In 1996, a novel 88 kDa protein with insecticidal properties was isolated from Bacillus thuringiensis (Bt).
104786		A comparative evaluation of the regulation of GM crops or products containing dsRNA and suggested improvements to risk assessments [2013]
		ABSTRACT: Changing the nature, kind and quantity of particular regulatory-RNA molecules through genetic engineering can create biosafety risks.
104995		A long-term toxicology study on pigs fed a combined genetically modified (GM) soy and GM maize diet [2013]
		A significant number of genetically modified (GM) crops have been approved to enter human food and animal feed since 1996, including crops containing several GM genes 'stacked' into the one plant.
104996		A Review of the Environmental Safety of the Cry1F Protein [2013]
		This document provides a comprehensive review of the information and data relevant to the environmental risk assessment of Cry1F, a family of proteins encoded by genes isolated from Bacillus...
105104		Environmental risk assessment of GE plants under low-exposure conditions [2013]
		The requirement for environmental risk assessment (ERA) of genetically engineered (GE) plants prior to large scale or commercial introduction into the environment is well established in national laws...
106030		Native Crops of Guatemala and Biosafety in the Use of Living Modified Organisms (free translation) [2014]
		(free translation) The National Council of Protected Areas (CONAP) is the government agency responsible for the conservation and sustainable use of biological diversity throughout the territory of...
109473		Biosafety report: Uncertainty and Knowledge Gaps related to Environmental Risk Assessment of GMOs [2015]
		This report provides a detailed discussion of uncertainties, knowledge gaps and research needs related to the potential use and introduction of GMOs.

Identifying potential adverse effects to human health arising through environmental exposure

Characterization of LMOs developed through RNAi-based methods

LM crops and the use of herbicides

1.5.2. Step 2: “Evaluation of the likelihood of adverse effects being realized, taking into account the level and kind of exposure of the likely potential receiving environment to the living modified organism” (14) ▼

44302		Environmental Risk Assessment of Genetically Modified Organisms. Volume 3: Methodologies for Transgenic Fish [2007]
		This is the third book in a series on Environmental Risk Assessment of Genetically Modified Organism and provides detailed information relevant for biosafety policy, regulatory frameworks, capacity...
48490		Assessment of Toxic and Ecotoxic Properties of Novel Proteins in GMOs - Part 1: Report & Part 2: Supplement [2008]
		The overall goal of this report is to review the currently applied approaches in toxicity and ecotoxicity assessment of novel proteins in the context of genetically modified plants and to identify...
48542		A Typology of the Effects of (Trans)Gene Flow on the Conservation and Sustainable Use of Genetic Resources [2007]
		This background study paper gives an overview of current research regarding the full range of possible effects of transgene flow on human health, the environment, the various stakeholders in the food...
101381		An assessment of factors affecting the likelihood of horizontal transfer of recombinant plant DNA to bacterial recipients in the soil and phytosphere [2003]
		This document summarizes the scientific knowledge on horizontal gene transfer in soil bacteria with specific reference to the putative transfer of genes from transgenic crops expressing resistance to...
101866		Guidance Notes for Lead Authors of the IPCC Fourth Assessment Report on Addressing Uncertainties [2005]
		These notes are intended to assist Lead Authors (LAs) of the Fourth Assessment Report (AR4) to deal with uncertainties consistently.
103074		Hybridization and introgression between Brassica napus and Brassica rapa in the Netherlands [2011]
		Hybridization between cultivated crops and their wild relatives can lead to introgression of genes from one species to another, providing a potential for preserving and recombining (modified) traits...
103380		Gene Flow, Invasiveness, and Ecological Impact of Genetically Modified Crops [2009]
		Abstract: The main environmental concerns about genetically modified (GM) crops are the potential weediness or invasiveness in the crop itself or in its wild or weedy relatives as a result of...
103382		Field-Evolved Insect Resistance to Bt Crops: Definition, Theory, and Data [2009]
		Abstract: Transgenic crops producing Bacillus thuringiensis (Bt) toxins for insect pest control have been successful, but their efficacy is reduced when pests evolve resistance.
103383		Genetically Engineered Plants, Endangered Species, and Risk: A Temporal and Spatial Exposure Assessment for Karner Blue Butterﬂy Larvae and Bt Maize Pollen [2006]
		Abstract: Genetically engineered maize (Zea mays) containing insecticidal endotoxin proteins from Bacillus thuringiensis (Bt) δ-endotoxin proteins has been adopted widely in the Midwestern United...
103386		A mathematical model of exposure of non-target Lepidoptera to Bt-maize pollen expressing Cry1Ab within Europe [2010]
		Abstract: Genetically modiﬁed (GM) maize MON810 expresses a Cry1Ab insecticidal protein, derived from Bacillus thuringiensis (Bt), toxic to lepidopteran target pests such as Ostrinia nubilalis.
103387		Safety assessment of transgenic plums and grapevines expressing viral coat protein genes: new insights into real environmental impact of perennial plants engineered for virus resistance [2007]
		Abstract: The potential impact of transgenic plums and grapevines expressing viral coat protein (CP) gene constructs on the diversity and dynamics of virus populations was assessed under open and...
104596		Surrogate Species Selection for Assessing Potential Adverse Environmental Impacts of Genetically Engineered Plants on Non-Target Organisms [2013]
		Most regulatory authorities require that developers of genetically engineered insect-resistant crops evaluate the potential for these crops to have adverse impacts on organisms not intended to be...
105100		Surrogate species selection for assessing potential adverse environmental impacts of genetically engineered insect-resistant plants on non-target organisms [2013]
		Most regulatory authorities require that developers of genetically engineered insect-resistant (GEIR) crops evaluate the potential for these crops to have adverse impacts on valued non-target...
105104		Environmental risk assessment of GE plants under low-exposure conditions [2013]
		The requirement for environmental risk assessment (ERA) of genetically engineered (GE) plants prior to large scale or commercial introduction into the environment is well established in national laws...

1.5.3. Step 3: “Evaluation of the consequences should these adverse effects be realized” (25) ▼

44302		Environmental Risk Assessment of Genetically Modified Organisms. Volume 3: Methodologies for Transgenic Fish [2007]
		This is the third book in a series on Environmental Risk Assessment of Genetically Modified Organism and provides detailed information relevant for biosafety policy, regulatory frameworks, capacity...
47271		Assessing environmental risks of transgenic plants [2006]
		Author's Abstract By the end of the 1980s, a broad consensus had developed that there were potential environmental risks of transgenic plants requiring assessment and that this assessment must be...
48542		A Typology of the Effects of (Trans)Gene Flow on the Conservation and Sustainable Use of Genetic Resources [2007]
		This background study paper gives an overview of current research regarding the full range of possible effects of transgene flow on human health, the environment, the various stakeholders in the food...
101373		Biopesticides registration action document Bacillus thuringiensis Vip3Aa20 Insecticidal Protein and the Genetic Material Necessary for Its Production (via Elements of Vector pNOV1300) in Event MIR162 Maize (OECD Unique Identifier: SYN-IR162-4) [2009]
		The Table of Contents is as follows: Overview A. Executive Summary B. Use Profile C. Regulatory History II. Science Assessment A. Product Characterization B. Human Health Assessment C.
101374		White paper on tier-based testing for the effects of proteinaceous insecticidal plant-incorporated protectants on non-target invertebrates for regulatory risk assessment [2007]
		The Table of contents is as follows: REVIEWERS INTRODUCTION EPA AND USDA/APHIS REGULATORY AUTHORITY USDA-APHIS EPA NON-TARGET ARTHROPOD TESTING WITHIN THE CONTEXT OF REGULATORY REVIEW OF PIPS...
101375		Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary for its production (Vector ZMIR39) in Event MON 88017 corn (OECD Unique Identifier: MON-88Ø17-3) (006502) and Bacillus thuringiensis Cry1Ab Delta-Endotoxin and the Genetic Material Necessary for its Production in Corn (006430) [2005]
		This Fact Sheet is divided into the following sections: I. Description of the Plant-Incorporated Protectant (PIP) II. Background III. Terms and Conditions of the Registration IV.
101376		Biopesticide Registration Action Document- Bacillus Thuringiensis Cry1F Corn [2004]
		The Table of Contents is as follows: I. Overview II. Science Assessment A. PRODUCT CHARACTERIZATION B. HUMAN HEALTH ASSESSMENT C. ENVIRONMENTAL ASSESSMENT D. INSECT RESISTANCE MANAGEMENT E.
101377		Biopesticides Registration Action Document - Bacillus thuringiensis Plant-Incorporated Protectants [2001]
		The Table of Contents is as follows: I. Overview II. Science Assessment A. Product Characterization B. Human Health Assessment C. Environmental Assessment D. Insect Resistance Management E.
103074		Hybridization and introgression between Brassica napus and Brassica rapa in the Netherlands [2011]
		Hybridization between cultivated crops and their wild relatives can lead to introgression of genes from one species to another, providing a potential for preserving and recombining (modified) traits...
103134		Recommendations for the design of laboratory studies on non-target arthropods for risk assessment of genetically engineered plants [2010]
		This paper provides recommendations on experimental design for early-tier laboratory studies used in risk assessments to evaluate potential adverse impacts of arthropod-resistant genetically...
103378		Impact of Bt corn pollen on monarch butterfly populations: A risk assessment [2001]
		Abstract: A collaborative research effort by scientists in several states and in Canada has produced information to develop a formal risk assessment of the impact of Bt corn on monarch butterfly...
103379		Transgenic Crops Expressing Bacillus thuringiensis Toxins and Biological Control [2006]
		Abstract: The area devoted to growing transgenic plants expressing insecticidal Cry proteins derived from Bacillus thuringiensis (Bt) is increasing worldwide.
103381		Effects of Plants Genetically Modified for Insect Resistance on Nontarget Organisms [2005]
		Abstract: Insect resistance, based on Bacillus thuringiensis (Bt) endotoxins, is the second most widely used trait (after herbicide resistance) in commercial genetically modified (GM) crops.
103384		A Meta-analysis of Effects of Bt Cotton and Maize on Nontarget Invertebrates [2007]
		Abstract: Although scores of experiments have examined the ecological consequences of transgenic Bacillus thuringiensis (Bt) crops, debates continue regarding the nontarget impacts of this...
103385		Safety of Virus-Resistant Transgenic Plants Two Decades after Their Introduction: Lessons from Realistic Field Risk Assessment Studies [2007]
		Abstract: Potential safety issues have been raised with the development and release of virus-resistant transgenic plants.
103387		Safety assessment of transgenic plums and grapevines expressing viral coat protein genes: new insights into real environmental impact of perennial plants engineered for virus resistance [2007]
		Abstract: The potential impact of transgenic plums and grapevines expressing viral coat protein (CP) gene constructs on the diversity and dynamics of virus populations was assessed under open and...
103395		Comparing methods to evaluate the effects of Bt maize and insecticide on spider assemblages [2005]
		Abstract: In a ﬁeld study, potential adverse effects of Bt maize on plant-dwelling spiders (Araneae) were assessed in 2001 in Bavaria, South Germany.
103397		A Meta-Analysis of Effects of Bt Crops on Honey Bees (Hymenoptera: Apidae) [2008]
		Abstract: Honey bees (Apis mellifera L.) are the most important pollinators of many agricultural crops worldwide and are a key test species used in the tiered safety assessment of genetically...
103398		Modeling eﬀects of environment, insect damage, and Bt genotypes on fumonisin accumulation in maize in Argentina and the Philippines [2005]
		Abstract Fumonisins are common contaminants of maize (Zea mays L.) grain products, especially in countries where maize is a major constituent of the diet and are harmful to human and animal health.
103422		GMOs, Pesticide Use, and Alternatives. Lessons from the U.S. Experience. [2008]
		Summary of a conference presentation on GM technologies in the US.
103423		The Current Status and Environmental Impacts of Glyphosate-resistant Crops: A review [2006]
		Abstract: Glyphosate [N-(phosphonomethyl) glycine]-resistant crops (GRCs), canola (Brassica napus L.), cotton (Gossypium hirsutum L.), maize (Zea mays L.), and soybean [Glycine max (L.) Merr.
103526		A synthesis of laboratory and field studies on the effects of transgenic Bacillus thuringiensis (Bt) maize on non-target Lepidoptera [2010]
		Abstract: One of the major applications of transgenic crops in agriculture are the so-called Bacillus thuringiensis Berliner (Bt) plants, in particular Bt maizes, which produce insecticidal Cry...
103527		General Recommendations for Soil Ecotoxicological Tests Suitable for The Environmental Risk Assessment of Genetically Modified Plants [2009]
		ABSTRACT Before a genetically modified plant (GMP) can be placed on the market in the European Union (EU), an environmental risk assessment has to be conducted according to EU Directive 2001/18/EC...
104596		Surrogate Species Selection for Assessing Potential Adverse Environmental Impacts of Genetically Engineered Plants on Non-Target Organisms [2013]
		Most regulatory authorities require that developers of genetically engineered insect-resistant crops evaluate the potential for these crops to have adverse impacts on organisms not intended to be...
105100		Surrogate species selection for assessing potential adverse environmental impacts of genetically engineered insect-resistant plants on non-target organisms [2013]
		Most regulatory authorities require that developers of genetically engineered insect-resistant (GEIR) crops evaluate the potential for these crops to have adverse impacts on valued non-target...

1.5.4. Step 4: “Estimation of the overall risk posed by the living modified organism based on the evaluation of the likelihood and consequences of the identified adverse effects being realized” (6) ▼

1.5.5. Step 5: “Recommendation as to whether or not the risks are acceptable or manageable, including, where necessary, identification of strategies to manage these risks” (9) ▼

41575		Rethinking the Risk Management Process for Genetically Engineered Crop Varieties in Small-scale, Traditionally Based Agriculture [2005]
		This article emphasizes on the analysis of the potential for negative effects of GE crops in the Third World using the risk management framework.
41592		Technologies for Biological Containment of GM and Non-GM Crops [2005]
		This is a desk study to critically review effective, current and practical, as well as timely and potentially viable technologies that are aimed at reducing the dispersal of transgenes into the...
41810		Problems in monitoring horizontal gene transfer in field trials of transgenic plants [2004]
		Abstract: Transgenic crops are approved for release in some countries, while many more countries are wrestling with the issue of how to conduct risk assessments.
44040		Biological Confinement of Genetically Engineered Organisms [2004]
		"Bioconfinement", as defined by the committee writing the report are a set of biological techniques (such as induced sterility) used to prevent transgenic animals, plants, and microbes from escaping...
44302		Environmental Risk Assessment of Genetically Modified Organisms. Volume 3: Methodologies for Transgenic Fish [2007]
		This is the third book in a series on Environmental Risk Assessment of Genetically Modified Organism and provides detailed information relevant for biosafety policy, regulatory frameworks, capacity...
46584		Integrated Confinement System for Genetically Engineered Plants: A Comprehensive Approach to Biosafety for Confined Field Trials [2007]
		A country that is setting out to explore the benefits of modern agricultural biotechnology for national development must be prepared to do so in a safe, systematic, and transparent manner.
101042		Risk Management Guidelines Companion to AS/NZS 4360:2004 [2004]
		The Table of Contents is as follows: 1 Scope and general Commentary 1.1 Background to risk management 1.2 Benefits of risk management 1.3 Applications of risk management 1.
103522		Observational science in the environmental risk assessment and management of GMOs [2012]
		Abstract (Provided by Author) Where there is a long history of use of a technology or where risk assessment relies upon sciences with firm theoretical grounding for prediction, there may be...
106030		Native Crops of Guatemala and Biosafety in the Use of Living Modified Organisms (free translation) [2014]
		(free translation) The National Council of Protected Areas (CONAP) is the government agency responsible for the conservation and sustainable use of biological diversity throughout the territory of...

2. Risk assessment of living modified plants with stacked genes or traits (11) ▼

48484		Guidance Document of the Scientific Panel on Genetically Modified Organisms for the risk assessment of genetically modified plants containing stacked transformation events [2007]
		This document provides guidelines with respect to the risk assessment under Regulation (EC) No 1829/2003 and Directive 2001/18/EC of genetically modified plants containing stacked transformation...
48492		Risk Assessment of “stacked events” [2007]
		This document provides a brief overview of the risk assessment requirements for “stacked events” proposed in guidance documents and in the scientific literature available at the time when this...
101007		Long-term effects of genetically modified (GM) crops on health and the environment (including biodiversity): Prioritization of potential risks and delimitation of uncertainties [2007]
		1) In the BEETLE study, genetically modified (GM) crops with traits already on the market in the EU or possibly so in the near future were assessed with respect to potential long-term (10-20 years)...
101011		Guidelines for Genetically Modified Stacked Events to be Placed on the Market (revised version) [2007]
		This paper is divided in into the following sections: 1. Introduction 2. Molecular characterization 3. Comparative analysis 4. Environmental aspects 5. Toxicology testing 6.
101016		Review on the world wide authorization of gene stacked GMOs in relation to cGS and wGS and the basis for definition of corresponding unique genetic markers [2008]
		Position document providing the definition of gene stacking in plants, as well as its implications in relation to genetics, safety, detectability and European regulations
103145		Problem formulation in the environmental risk assessment for genetically modified plants [2009]
		Problem formulation is the first step in environmental risk assessment (ERA) where policy goals, scope, assessment endpoints, and methodology are distilled to an explicitly stated problem and...
103439		Risk assessment of GM stacked events obtained from crosses between GM events [2007]
		Abstract: The risk assessment of GM stacked events, which are considered as a new GMO in the EU, could be less extensive than the assessment of the parental GM events.
103440		Gene stacking in transgenic plants – the challenge for 21st century plant biotechnology [2005]
		Summary: One of the major technical hurdles impeding the advance of plant genetic engineering and biotechnology is the fact that the expression or manipulation of multiple genes in plants is still...
103441		Gene stacking in transgenic plants: towards compliance between definitions, terminology, and detection within the EU regulatory framework [2008]
		Abstract: The combination or stacking of different traits or genes in plants is rapidly gaining popularity in biotech crop production.
104995		A long-term toxicology study on pigs fed a combined genetically modified (GM) soy and GM maize diet [2013]
		A significant number of genetically modified (GM) crops have been approved to enter human food and animal feed since 1996, including crops containing several GM genes 'stacked' into the one plant.
104996		A Review of the Environmental Safety of the Cry1F Protein [2013]
		This document provides a comprehensive review of the information and data relevant to the environmental risk assessment of Cry1F, a family of proteins encoded by genes isolated from Bacillus...

2.1. Introduction (1) ▼

2.2. Planning phase of the risk assessment

2.2.1. The choice of comparators

2.3. Conducting the risk assessment (3) ▼

2.3.1. Sequence characteristics at the insertion sites, genotypic stability and genomic organization (1) ▼

2.3.2. Potential interactions among the stacked genes, their resulting phenotypic changes and effects on the environment and human health (1) ▼

2.3.3. Combinatorial and cumulative effects (2) ▼

2.3.4. Crossing and segregation of transgenes

2.3.5. Methods for distinguishing the combined transgenes in a stacked event from the parental LM plants (1) ▼

3. Risk assessment of living modified plants with tolerance to abiotic stress (19) ▼

45858		Novel aspects of the environmental risk assessment of drought-tolerant genetically modified maize andomega-3 fatty acid genetically modified soybean [2007]
		For this study two examples of novel generation GM plants were selected: 1.
47271		Assessing environmental risks of transgenic plants [2006]
		Author's Abstract By the end of the 1980s, a broad consensus had developed that there were potential environmental risks of transgenic plants requiring assessment and that this assessment must be...
48232		ICGEB Collection of Biosafety Reviews - Vol 4 [2008]
		This volume is divided into the following sections (which are available for download in PDF format below): 1. Introduction 2.
48542		A Typology of the Effects of (Trans)Gene Flow on the Conservation and Sustainable Use of Genetic Resources [2007]
		This background study paper gives an overview of current research regarding the full range of possible effects of transgene flow on human health, the environment, the various stakeholders in the food...
48922		Risk Assessment and Risk Management Plan for DIR 077/2007. Limited and controlled release of wheat and barley genetically modified for enhanced tolerance to abiotic stresses or increased beta glucan [2008]
		Risk assessment and risk management report issued by the Office of the Gene Technology Regulator, Australian Government, in response to an application for release of GM wheat and barley lines that...
48960		Risk Assessment and Risk Management Plan (DIR 053/2004) Field trial of genetically modified salt tolerant wheat on saline land [2005]
		Risk assessment and risk management report issued by the Office of the Gene Technology Regulator, Australian Government, in response to an application for release of GM wheat and barley lines that...
48961		Risk Assessment and Risk Management Plan for DIR 080/2007 - Limited and controlled release of wheat genetically modified for drought tolerance [2008]
		Risk assessment and risk management report issued by the Office of the Gene Technology Regulator, Australian Government, in response to an application for release of GM wheat lines that had been...
102991		Future challenges in environmental risk assessment of transgenic plants with abiotic stress tolerance [2011]
		Abstract: Environmental risk assessment of transgenic plants is a prerequisite to their release into the target environment for commercial use.
103133		Problem Formulation for the Environmental Risk Assessment of RNAi Plants: Conference Proceedings [2011]
		The application of RNA interference (RNAi) to produce genetically engineered crops with improved agronomic, nutritional, industrial, and food-processing traits is becoming increasingly common.
103145		Problem formulation in the environmental risk assessment for genetically modified plants [2009]
		Problem formulation is the first step in environmental risk assessment (ERA) where policy goals, scope, assessment endpoints, and methodology are distilled to an explicitly stated problem and...
103380		Gene Flow, Invasiveness, and Ecological Impact of Genetically Modified Crops [2009]
		Abstract: The main environmental concerns about genetically modified (GM) crops are the potential weediness or invasiveness in the crop itself or in its wild or weedy relatives as a result of...
103407		Role of plant heat-shock proteins and molecular chaperones in the abiotic stress response [2004]
		Abstract: Abiotic stresses usually cause protein dysfunction.
103408		Fitness and beyond: Preparing for the arrival of GM crops with ecologically important novel characters [2009]
		Abstract: The seemingly inexorable expansion of global human population size, significant increases in the use of biofuel crops and the growing pressures of multifunctional land-use have intensified...
103409		Transcriptome analysis reveals absence of unintended effects in drought-tolerant transgenic plants overexpressing the transcription factor ABF3 [2010]
		Abstract: Background: Plants engineered for abiotic stress tolerance may soon be commercialized.
103433		Planning Environmental Risk Assessment for Genetically Modified Crops: Problem Formulation for Stress-Tolerant Crops. [2008]
		This article describes the initial steps in the environmental risk assessment process and illustrates an approach that could be taken for GM crops tolerant to an abiotic stress (e.g.
103445		Improving Nutritional Quality of Maize Proteins by Expressing Sense and Antisense Zein Genes [2004]
		Abstract: The predominant proteins in maize grain are a family of alcohol-soluble prolamin storage proteins called zeins.
103446		Impact of genetically modified crops and their management on soil microbially mediated plant nutrient transformations [2004]
		Abstract: One of the potential environmental effects of the recent rapid increase in the global agricultural area cultivated with transgenic crops is a change in soil microbially mediated processes...
103448		Detection of RNA variants transcribed from the transgene in Roundup Ready soybean [2005]
		Abstract: The acreage for genetically modified crops (GMOs)—particularly soybean—has steadily increased since 1996, when the first crop of Roundup Ready soybean (intended for food production) was...
103515		Plant Stress
		Website serves as a meeting point for the sharing of information regarding the various types of abiotic stress to which plants are exposed.

3.1. Introduction (1) ▼

3.2. Planning phase of the risk assessment

3.2.1. The choice of comparators

3.3. Conducting the risk assessment

3.3.1. Unintended characteristics, including cross-talk between stress responses (2) ▼

3.3.2. Testing the living modified plant in representative environments

3.3.3. Persistence in agricultural areas and invasiveness of natural habitats

3.3.4. Effects on the abiotic environment and ecosystem

4. Risk assessment of living modified trees (6) ▼

4.1. Background (1) ▼

4.2. Introduction (11) ▼

103698		Forestry´s fertile crescent: the application of biotechnology to forest trees. [2003]
		Summary: Relative to crop plants, the domestication of forest trees is still in its infancy.
103699		Preliminary review of biotechnology in forestry including genetic modification. [2004]
		Table of Contents: Executive summary – Nicholas Wheeler 1. Synthesis: a snapshot of the global status and trends in forest biotechnology – Nicholas Wheeler 1.1 Purpose 1.2 Background 1.
103700		Tree transgenesis: recent developments [2006]
		Table of Contents: Part A Transgenic Trees in the World 1 Field Trials with Transgenic Trees – State of the Art and Developments: MARCEL ROBISCHON 1.1 Introduction 1.
103701		Global Forest Resources Assessment update 2005: Terms and definitions. [2004]
		Table of Contents ABBREVIATIONS 1 INTRODUCTION 1.1 TERMS AND DEFINITIONS 1.2 PURPOSE OF THIS DOCUMENT 1.
103703		Recombinant DNA Technology in Apple [2007]
		Abstract: This review summarizes the achievements of almost 20 years of recombinant DNA technology applied to apple, grouping the research results into the sections: developing the technology,...
103705		Fruit Crops [2010]
		Summary: This book chapter discusses the various genetic modifications that are carried out using modern biotechnology in order to develop economically important fruit crops that can withstand a...
103708		The advantages and disadvantages of the application of genetic engineering to forest trees: a discussion. [2000]
		Abstract: This review briefly examines moral arguments for and against genetic engineering (GE) technology in trees, finding equal support for both sides of the debate.
103709		Safety Assessment of Transgenic Organisms, Volume 3, OECD Consensus Documents [2010]
		Table of Contents: Biology of trees White pine (Pinus monticola) Jack pine (Pinus banksiana) North american larches (Larix lyalli, Larix occidentalis, Larix laricina) Douglas-Fir (Pseudotsuga...
103713		Genetically modified trees – Status, trends and potential environmental risks. [2010]
		Abstract: This report provides a review on the current status and trends observed in the fields of genetic modification of trees.
103715		Exchange of Genetic Material between Cells in Plant Tissue Culture Grafts [2009]
		Abstract: Tissue grafting includes applications ranging from plant breeding to animal organ transplantation.
103716		Global Forest Resources Assessment 2010 [2010]
		Table of Content Acknowledgements Foreword Acronyms and abbreviations Executive summary Chapter 1. Introduction The reporting framework The scope of FRA 2010 The process The outputs Chapter 2.

4.3. Planning phase of the risk assessment

4.3.1. The choice of comparators (1) ▼

4.4. Conducting the risk assessment (1) ▼

4.4.1. Presence of genetic elements and propagation methods (1) ▼

4.4.2. Long life spans, genetic and phenotypic characterisation and stability of the modified genetic elements (7) ▼

4.4.3. Dispersal mechanisms (2) ▼

4.4.4. The likely potential receiving environment(s) (1) ▼

4.4.5. Exposure of the ecosystem to LM trees and potential consequences (4) ▼

4.4.6. Risk management strategies

5. Risk assessment of living modified mosquitoes species that act as vectors of human and animal diseases (52) ▼

101013		Risk Assessment for Arthropod Vectors [2003]
		This paper discusses principles of risk assessment including: Arthropods known to be free of specific pathogens Arthropods known to contain specific pathogens Arthropods containing unknown...
101015		Ecological Risk Assessment (ERA) for LM Mosquitoes
		The paper is divided into the following sections: Introduction Kinds of Adverse Effects Stressor identification A) Adverse effects associated with ecological species, habitats and ecosystem...
101019		Ecological and community considerations in engineering arthropods to suppress vector-borne disease [2002]
		The Table of Contents is as follows: 11.1 Introduction 11.2 Ethics of releasing reared vector arthropods 11.2.1 Marked organisms 11.2.2 Exotic organisms 11.3 Diversity of transgenic genes 11.
101023		Table: Diseases in Humans Caused by Arthropod-borne Viruses [2000]
		This table is part of the book "Communicable Diseases Manual" that contains the following categories of information in its columns: Virus Family, Genus, Group Name of Virus *Disease in Humans...
101027		WHO meeting documents [2009]
		This document contains the following papers: Introduction to development of internationally acceptable guidance principles for testing and deployment of GM mosquitoes (John D Mumford) Who Technical...
101037		Guidance for Contained Field Trials of Vector Mosquitoes Engineered to Contain a Gene Drive System - Recommendations of a Scientific Working Group [2008]
		These recommendations represent the response of a group of involved scientists to the need for guidance to aid researchers, government authorities, and community leaders as they consider the design...
101040		Biosafety and risk assessment in the use of genetically modified mosquitoes for disease control
		The development and implementation of the release of genetically modified mosquitoes (GMM) for interrupting pathogen transmission represent a major challenge, despite the fact that several...
101064		EEB 180: Genetic engineering in developing countries. The Cartagena Protocol and GM Mosquitoes [2009]
		The Contents is as follows: * Background * GM mosquitoes as LMOs * GM mosquitoes in transit * GM mosquitoes in contained field trials * First intentional environmental release of GM mosquitoes *...
101066		Biosafety training course for Africa related to genetically modified disease vectors: Containment issues during planned field cage trials [2008]
		The Table of Contents is as follows: Background Phased testing 1. Laboratory studies 2. Analytic or computer simulation studies 3. Contained field trials 4.
103083		Scientific Standards and the Regulation of Genetically Modified Insects [2012]
		Abstract Experimental releases of genetically modified (GM) insects are reportedly being evaluated in various countries including Brazil, the Cayman Islands (UK), France, Guatemala, India, Malaysia,...
103449		Dominant lethality and insect population control [2002]
		Abstract: Recent advances in insect genetic engineering have opened up new possibilities in the genetic control of insect vectors of human diseases.
103450		Malaria control with genetically manipulated insect vectors [2002]
		ABSTRACT: At a recent workshop, experts discussed the benefits, risks, and research priorities associated with using genetically manipulated insects in the control of vector-borne diseases.
103451		Insect population suppression using engineered insects [2008]
		Abstract: Suppression or elimination of vector populations is a tried and tested method for reducing vector borne disease and a key component of integrated control programmes.
103453		Before the Swarm: Guidelines for the Emergency Management of Mosquito-Borne Disease Outbreaks [2008]
		Table of Contents as follows: Executive summary Planning and action check-list Plan ahead Involve others Use the Best science And data Inform the public Responding to A...
103454		Australia's dengue risk driven by human adaptation to climate change [2009]
		Abstract: Background The reduced rainfall in southeast Australia has placed this region's urban and rural communities on escalating water restrictions, with anthropogenic climate change forecasts...
103455		Risk analysis of a hypothetical open field release of a self-limiting transgenic Aedes aegypti mosquito strain to combat dengue [2009]
		Abstract: A UNDP-sponsored Workshop on the Risk Assessment of Transgenic Insects (Series-1) was co-hosted in November 2008 by Malaysia’s Ministry of Natural Resources and Environment, the Institute...
103456		Deployment of innovative genetic vector control strategies: Progress on regulatory and biosafety aspects, capacity building and development of best-practice guidance [2009]
		Abstract: In the ongoing fight against vectors of human diseases, disease endemic countries (DECs) may soon benefit from innovative control strategies involving modified insect vectors.
103457		Guidelines on information requirements for the import and release of invertebrate biological control agents in European Countries [2005]
		Abstract: Several international documents have been published in recent years with the objective of providing guidance to industry, biocontrol practitioners and competent national regulatory...
103460		Restoring nature, without mosquitoes? [2004]
		Abstract: The benefits of wetlands are now widely appreciated. Less widely known is that historically many wetlands were drained to help control malaria and other deadly diseases.
103461		Mini-review: Genetic enhancements to the sterile insect technique to control mosquito populations [2009]
		Abstract: The Sterile Insect Technique (SIT) uses the mass release of sterile insects as a highly effective area-wide, environmentally safe method of pest control.
103463		Mosquito wars [2009]
		The release of genetically modified (GM) mosquitoes into the environment to fight dengue fever is about to open a new front in the war against vector-borne diseases.
103464		Use of Genetically Engineered Fruit Fly and Pink Bollworm in APHIS Plant Pest Control Programs, Final Environmental Impact Statement. [2008]
		Table of Contents: Executive Summary I. Purpose and Need A. Introduction 1. History of Infestations 2. Fruit Fly Sterile Insect Technique History 3. Fruit Fly Control Methods Development 4.
103467		Insect population control using a dominant, repressible, lethal genetic system [2000]
		ABSTRACT: A major modification to the sterile insect technique is described, in which transgenic insects homozygous for a dominant, repressible, female-specific lethal gene system are used.
103469		Ecological aspects for application of genetically modified mosquitoes [2003]
		Book Summary: New interventions are needed to reduce the burden of vector-borne diseases like malaria and denguč, which are among the most serious and prevalent infectious diseases worldwide.
103473		The biology of Mosquitoes. Volume 2: Sensory Reception and Behaviour [1999]
		Summary of Book: Mosquitoes are important as transmitters of widespread major diseases and as nuisance insects.
103474		Insecticide resistance monitoring and evaluation in disease transmitting mosquitoes [2007]
		Abstract: The emergence of mosquito species resistant to insecticides widely used in malaria and dengue control has the potential to impact severely on the control of these disease vectors.
103475		A Quantitative Risk Assessment of West Nile Virus Introduction into Barbados [2007]
		Abstract: Objective: To present a quantitative risk assessment of West Nile (WNV) virus introduction into Barbados, West Indies.
103478		Establishment of a large semi-field system for experimental study of African malaria vector ecology and control in Tanzania [2008]
		Abstract: Background Medical entomologists increasingly recognize that the ability to make inferences between laboratory experiments of vector biology and epidemiological trends observed in the...
103481		Female-specific flightless phenotype for mosquito control [2010]
		Abstract: Dengue and dengue hemorrhagic fever are increasing public health problems with an estimated 50–100 million new infections each year.
103483		A Killer–Rescue system for self-limiting gene drive of anti-pathogen constructs [2008]
		Abstract A number of genetic mechanisms have been suggested for driving anti-pathogen genes into natural populations.
103484		Population genetics of autocidal control and strain replacement [2004]
		Abstract: The concept that an insect species’ genome could be altered in a manner that would result in the control of that species (i.e.
103485		Malaria: Progress, perils and prospects for eradication [2008]
		Abstract: T here are still approximately 500 million cases of malaria and 1 million deaths from malaria each year.
103486		Dengue/dengue haemorrhagic fever: history and current status [2008]
		Summary Dengue fever (DF) is an old disease; the first record of a clinically compatible disease being recorded in a Chinese medical encyclopaedia in 992.
103487		Towards a sterile insect technique field release of Anopheles arabiensis mosquitoes in Sudan: irradiation, transportation, and field cage experimentation [2008]
		Abstract: Background: The work described in this article forms part of a study to suppress a population of the malaria vector Anopheles arabiensis in Northern State, Sudan, with the Sterile Insect...
103488		Session on: Transgenic insects for pest management programs: status and prospects [2003]
		Summary: This session was the first to cover the topic of transgenic insects in any of the International Symposia on the Biosafety of Genetically Modified Organisms.
103490		Nature beats nurture: a case study of the physiological fitness of free-living and laboratory-reared male Anopheles gambiae s.l. [2007]
		SUMMARY Laboratory experimentation forms the basis for most of our knowledge of the biology of many organisms, in particular insects.
103491		Status and risk assessment of the use of transgenic arthropods in plant protection [2006]
		Table of Contents: 1. SUMMARY 2. INTRODUCTION 3. THE MEETING 4. SUMMARIES OF WORKING PAPERS 4.1. Overview 4.2. Arthropod transgenesis 4.3. International regulation 4.4.
103492		Mosquito Molecular Genetics: The Hands That Feed Bite Back [1992]
		Reports on efforts in developing strains of mosquitoes that are resistant to parasites.
103493		Gene drive systems in mosquitoes: rules of the road [2005]
		Abstract: Population replacement strategies for controlling transmission of mosquito-borne diseases call for the introgression of antipathogen effector genes into vector populations.
103494		Lessons from the past: managing insecticide resistance in malaria control and eradication programmes [2008]
		Summary The distribution of insecticide-treated bednets to help combat the burden of malaria in sub-Saharan Africa has accelerated in the past 5 years.
103495		MalariaSphere: A greenhouse-enclosed simulation of a natural Anopheles gambiae (Diptera: Culicidae) ecosystem in western Kenya [2002]
		Abstract Background: The development and implementation of innovative vector control strategies for malaria control in Africa requires in-depth ecological studies in contained semi-field...
103496		Gene drive systems for insect disease vectors [2006]
		Abstract: The elegant mechanisms by which naturally occurring selfish genetic elements, such as transposable elements, meiotic drive genes, homing endonuclease genes and Wolbachia, spread at the...
103497		The ecology of genetically modified mosquitoes [2002]
		ABSTRACT: Ecological and population biology issues constitute serious challenges to the application of genetically modified mosquitos (GMM) for disease control.
103500		Towards genetic manipulation of wild mosquito populations to combat malaria: advances and challenges [2003]
		Abstract: Malaria kills millions of people every year, yet there has been little progress in controlling this disease.
103501		Late-acting dominant lethal genetic systems and mosquito control [2007]
		Abstract Background: Reduction or elimination of vector populations will tend to reduce or eliminate transmission of vector-borne diseases.
103503		Behavioural determinants of gene flow in malaria vector populations: Anopheles gambiae males select large females as mates [2002]
		Abstract Background: Plasmodium-refractory mosquitoes are being rapidly developed for malaria control but will only succeed if they can successfully compete for mates when released into the wild.
103505		MosqGuide: A project to develop best practice guidance for the deployment of innovative genetic vector control strategies for malaria and dengue [2009]
		Abstract: The World Health Organisation Special Programme in Research and Training in Tropical Diseases (WHO/TDR) has funded a project, designated MosqGuide, to develop guidance on the potential...
103509		Malaria control with transgenic mosquitoes [2009]
		Summary: In this review we describe some of the efforts currently underway to create genetically modified mosquitoes (GMMs) and assess some of the obstacles they face.
103510		The impact of dissociation on transposon-mediated disease control strategies [2008]
		Abstract: Vector-borne diseases such as malaria and dengue fever continue to be a major health concern through much of the world.
103511		Mosquito transgenesis: what is the fitness cost? [2006]
		Abstract: The generation of transgenic mosquitoes with a minimal fitness load is a prerequisite for the success of strategies for controlling mosquito-borne diseases using transgenic insects.
103512		Transgenic malaria-resistant mosquitoes have a fitness advantage when feeding on Plasmodium-infected blood [2007]
		Abstract: The introduction of genes that impair Plasmodium development into mosquito populations is a strategy being considered for malaria control.
103513		Bridging Laboratory and Field Research for Genetic Control of Disease Vectors [2005]
		Summary: This review may facilitate the adoption process of modern biotechnological approaches to combat vector-borne diseases and may ultimately expedite the full evaluation of these approaches...

5.1. Introduction

5.2. Objective and scope

5.3. Planning phase of the risk assessment

5.3.1 The choice of comparators

5.4. Conducting the risk assessment

5.4.1. Characterization of the living modified mosquito

5.4.2. Unintended effects on biological diversity (species, habitats, ecosystems, and ecosystem function and services)

5.4.3. Vertical gene transfer (1) ▼

5.4.4. Horizontal gene transfer (2) ▼

5.4.5. Persistence of the transgene in the ecosystem (1) ▼

5.4.6. Evolutionary responses (especially in target mosquito vectors or pathogens of humans and animals)

5.4.7. Unintentional transboundary movement

5.4.8. Risk management strategies

5.4.9. Containment of the living modified mosquito

6. Monitoring of Living Modified Organisms Released into the Environment (36) ▼

41682		Genetically Engineered Corn and the Monarch Butterfly Controversy [2002]
		This paper reviews the chronology of the monarch butterfly controversy from the perspective of a number of key players.
41696		Guidelines for Inspection and Monitoring GMOs in Kenya [2004]
		The guidelines on biosafety in Kenya focuses on trans boundary movement of GMOs resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological...
41806		Monitoring the Environmental Consequences of Gene Flow from Transgenic Sugar Beet [2002]
		This document focuses on monitoring and environmental consequences of gene flow from transgenic sugar beet. Gene flow via seed or pollen is a basic biological principle of plant evolution.
41810		Problems in monitoring horizontal gene transfer in field trials of transgenic plants [2004]
		Abstract: Transgenic crops are approved for release in some countries, while many more countries are wrestling with the issue of how to conduct risk assessments.
41899		Guidance Document on Methods for Detection of Micro-organisms Introduced into the Environment: Bacteria [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.
41906		Ottawa '92: The OECD Workshop on Methods for Monitoring Organisms in the Environment [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.
41907		Report of the OECD Workshop on Monitoring of Organisms Introduced into the Environment [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.
41981		Farm scale evaluations of GM crops: monitoring gene flow from GM crops to non-GM equivalent crops in the vicinity [2003]
		The objective of this exercise was to test assumptions made in risk assessments concerning gene flow by pollen from the farm-scale evaluations and to ensure that the guidelines issued by the Supply...
42116		ANNEX VII to Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms: MONITORING PLAN [2001]
		Describes aspects of the principles and design of monitoring plans, expanding on paragraph 8(f) of annex III of the Protocol
44304		Farm Scale Evaluations. Managing GM crops with herbicides: Effects on farmland wildlife [2003]
		This brochure reports on the results from an independent consortium of researchers commissioned by the government to investigate how growing one kind of genetically modified (GM) crop might affect...
48513		Monitoring Protocol in accordance with the Gene Technology Act 2000 [2007]
		This monitoring protocol focuses on routine monitoring visits designed to determine whether the law and regulations have been complied with.
102000		Biosafety Resource Book [2011]
		Abstract: During the period 2002-10, FAO undertook an intense activity of biosafety capacity development, largely centred on enhancing the capacities of regulators and other technical staff involved...
102169		Guidance on the Post-Market Environmental Monitoring (PMEM) of genetically modified plants [2011]
		The European Commission asked the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) to update its 2006 scientific opinion on Post-Market Environmental...
103009		PLANES DE SEGUIMIENTO AMBIENTAL DEL CULTIVO DE MAÍZ MODIFICADO GENÉTICAMENTE EN ESPAÑA [2010]
		Manual que recoge los resultados de los estudios realizados bajo los planes de seguimiento del maíz Bt resistente a insectos lepidópteros y promovidos por el Ministerio de Medio Ambiente, y Medio...
103070		El maíz Bt en España: Experiencia tras 12 años de cultivo [2011]
		El maíz transgénico resistente a taladros (maíz Bt) se cultiva en España desde 1998 y su superficie ha ido en aumento hasta alcanzar un 22% del total de la superficie de maíz cultivado.
103071		Post-Market Monitoring Plans of Bt-176 in Spain: 1998 -2005 [2005]
		The first GM maize hybrids were registered in the Commercial Variety Register in Spain on the 26th of March, 1998.
103072		EVALUACIÓN DE LOS POSIBLES EFECTOS SOBRE ENTOMOFAUNA NO DIANA DEL CULTIVO DE VARIEDADES DE MAÍZ DERIVADAS DE LA LÍNEA MON 810, EN LA ZONA CENTRO [2006]
		El objetivo de este estudio ha sido evaluar los niveles de los depredadores más frecuentes, en planta y suelo, en parcelas sembradas con una variedad de maíz con la protección MON 810 (maíz Bt) y con...
103073		Informe final sobre el plan de seguimiento con variedades modificadas genéticamente portadoras del evento MON810 durante dos campañas consecutivas [2006]
		En el primer año de ensayos, se ha trabajado sobre las variedades modificadas genéticamente de maíz PR33P67 y DKC 6575, derivadas de las variedades convencionales P66 y Tietar respectivamente, y que...
103075		A baseline study of the distribution and morphology of Brassica napus L. and Brassica rapa L. in the Netherlands [2010]
		In Europe, the cultivation of genetically (living) modified (GM) Brassica napus is prohibited, but the import of GM B. napus seeds is permitted. Until March 2009 no GM B.
103077		Inventory of observed unexpected environmental effects of genetically modified crops [2010]
		In the EU, the consent holder of a particular GM crop is obliged to monitor the occurrence of unexpected adverse effects after its release on the market.
103295		Determining indicators, methods and sites for monitoring potential adverse effects of genetically modified plants to the environment: the legal and conceptional framework for implementation. [2008]
		According to Directive 2001/18/EC commercial cultivation of genetically modified plants (GMPs) have to be monitored.
103302		General surveillance of genetically modified plants; Possibilities for implementation in the Netherlands [2012]
		Abstract: General Surveillance of genetically modified plants in the Netherlands: European legislation stipulates that the commercial cultivation of genetically modified (GM) crops should be...
103516		General surveillance of genetically modified organisms – the importance of expected and unexpected environmental effects [2006]
		Abstract: GMO Monitoring was made mandatory in the European Union. The according regulatory practice, however, is still under development.
103518		Scientific opinion on the annual post-market environmental monitoring (PMEM) report from Monsanto Europe S.A. on the cultivation of genetically modified maize MON810 in 2009 [2011]
		ABSTRACT: Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the monitoring report for the...
103520		Scientific opinion on the annual post-market environmental monitoring (PMEM) report from BASF Plant Science Company GmbH on the cultivation of genetically modified potato EH92-527-1 in 2010 [2012]
		ABSTRACT Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the monitoring report for the...
103521		Scale implications for environmental risk assessment and monitoring of the cultivation of genetically modified herbicide-resistant sugar beet: a review [2010]
		Abstract Genetically modified herbicide-resistant (GMHR) sugar beet (Beta vulgaris L.) has been cultivated in the US for several years and an application has been submitted for cultivation in Europe.
103524		Estimation of required sampling effort for monitoring the possible effects of transgenic crops on butterflies: Lessons from long-term monitoring schemes in Switzerland. [2012]
		Abstract Butterflies (Lepidoptera) have been suggested for environmental monitoring of genetically modified organisms (GMO) due to their suitability as ecological indicators, and because of the...
103527		General Recommendations for Soil Ecotoxicological Tests Suitable for The Environmental Risk Assessment of Genetically Modified Plants [2009]
		ABSTRACT Before a genetically modified plant (GMP) can be placed on the market in the European Union (EU), an environmental risk assessment has to be conducted according to EU Directive 2001/18/EC...
103528		General Surveillance of Genetically Modified Organisms –the Importance of Expected and Unexpected Environmental Effects [2006]
		Abstract: GMO Monitoring was made mandatory in the European Union. The according regulatory practice, however, is still under development.
103529		Monitoring the environmental impacts of GM maize in South Africa. [2011]
		Table of Contents: SECTION 1: INTRODUCTION Current global status of GMOs GMOs and South Africa Regulatory framework in South Africa Genetically Modified Organisms Act The National...
103530		Integrating diverse scientific and practitioner knowledge in ecological risk analysis: A case study of biodiversity risk assessment in South Africa [2012]
		Abstract: Ecological risk analysis (ERA) is a structured evaluation of threats to species, natural communities, and ecosystem processes from pollutants and toxicants and more complicated living...
103531		Monitoring of Genetically Modified Organisms. A policy paper representing the view of the National Environment Agencies in Austria and Switzerland and the Federal Agency for Nature Conservation in Germany [2011]
		Table of Contents: ZUSAMMENFASSUNG SUMMARY 1 INTRODUCTION AND BACKGROUND 2 MONITORING IS BASED ON THE ENVIRONMENTAL RISK ASSESSMENT OF GMOS 2.1 Introduction 2.
103532		"Networks" and environmental observation programs as a tool for general surveillance - first experiences and future requirements. [2010]
		Abstract: Consent holders make use of the opportunity to involve existing observation programs or networks in the general surveillance of GMOs.
103533		Ecological monitoring of genetically modified organisms [2001]
		Table of Contents: SUMMARY INTRODUCTION 2 LEGAL PROVISIONS GOVERNING THE MONITORING OF GMOs 2.1 Monitoring according to Directive 90/220/EEC 2.2 Monitoring according to Directive 2001/18/EC 2.2.
103534		A framework for the design of general surveillance of genetically modified crops based on a concept for environmental post-market monitoring [2006]
		Abstract A framework for the design of general surveillance during commercial cultivation of genetically modified (GM) crops according to current EU legislation 2001/18/EC is presented.
103535		Setup, efforts and practical experiences of a monitoring program for genetically modified plants - an Austrian case study for oilseed rape and maize. [2011]
		Abstract: Background, aim and scope: According to the Directive 2001/18/EC, genetically modified plants [GMPs] have to be monitored for unintended ecological impacts during their release.

6.1. Introduction (2) ▼

6.2. Objective and scope (2) ▼

6.3. Monitoring and its purposes (3) ▼

6.4. Development of a monitoring plan

6.4.1. Choice of indicators and parameters for monitoring (“what to monitor?”) (2) ▼

6.4.2. Monitoring methods, baselines including reference points, and duration of monitoring (“how to monitor?”) (1) ▼

i. Selecting monitoring methods (1) ▼

ii. Establishing baselines, including reference points (1) ▼

iii. Establishing the duration of monitoring (1) ▼

6.4.3. Choice of monitoring sites (“where to monitor?”) (1) ▼

6.4.4. Reporting of monitoring results (“how to communicate?”) (1) ▼