Guidance For Conducting The Risk Assessment Of Genetically Modified Microorganisms Gmo As Foreseen By The Directives 90 219 Eec Contained Use And 90 220 Eec Deliberate Release

The Scientific Panel on Genetically Modified Organisms (GMO Panel) adopted its guidance document for the risk assessment of genetically modified (GM) plants and derived food and feed on 24 September 2004. The European Food Safety Authority (EFSA) and the GMO Panel have consulted stakeholders prior to the final adoption of this document. This document provides guidance for the preparation and presentation of applications submitted within the framework of Regulation (EC) 1829/2003 on GM food and feed, and of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (GMOs). This document therefore covers the full risk assessment of GM plants and derived food and feed. Issues related to risk management of GMOs (traceability, labelling, co-existence) are outside the scope of the guidance document. Guidance for the preparation of applications is given throughout the different chapters of the document. The first chapter of the guidance document clarifies the scope of the document and the legal background for the risk assessment of GMOs, GM food and feed at Community level. Chapter II describes the overall risk assessment strategy. Chapter III describes the issues to be considered when carrying out a comprehensive risk characterisation. These include molecular characterisation of the inserts, assessment of modification to the agronomic characteristics of the GM plant and evaluation of food/feed safety aspects of the GM plant and/or derived food and feed. Data on composition, toxicity, allergenicity, nutritional value and environmental impact provide, on a case-by-case basis, the cornerstones of the risk assessment process. The characterisation of risk may give rise to the need for further specific activities including post-market monitoring of the GM food/feed and/or for the environmental monitoring of GM plants. Finally, Chapter IV summaries the overall risk characterisation process.

"Genetically modified microorganisms (GMMs) are involved in the production of a variety of food and feed. The marketing of these products within the European Union falls under different legislative instruments, which establish the requirement for a risk assessment for the authorisation of the product. The present guidance describes the principles to be followed when conducting such a risk assessment, as well as the scientific information required in applications for authorisation to be evaluated by the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel). Products form four categories, depending on their nature and the level of scientific information required for their evaluation by the EFSA GMO Panel. The guidance details the data to be provided for the assessment of products of each category, providing reference to other guidance that is also applicable. This document draws on the experience gained by the EFSA GMO Panel in assessing applications for marketing food and feed involving GMMs and takes into account the input received from different stakeholders, and updates the "Guidance Document for the risk assessment of genetically modified microorganisms and their derived products intended for food and feed", adopted by the EFSA GMO Panel in 2006."--Editor.

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This guide has been prepared by the IUCN Environmental Law Programme and the Foundation for International Environmental Law and Development (FIELD), in cooperation with the World Resources Institute (WRI). The main goal of the guide is to facilitate the understanding of the obligations of Parties to the Protocol, by providing an information base on the content and origin of the Protocol provisions, accessible to the non-specialist and useful for those who will be involved in the development and implementation of national safety frameworks.

This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.

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