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In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context. To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which data are generated must adhere to defined standards to ensure resulting data are rigorous and reproducible. Good In vitro Method Practices (GIVIMP) for the development and implementation of in vitro methods for regulatory use in human safety assessment aims to help reduce the uncertainties in cell and tissue-based in vitro method derived chemical safety predictions. GIVIMP provides guidance for test method developers and end users of resulting data on key elementes of in vitro methods. GIVIMP tackles ten important aspects related to in vitro work: (1) Roles and responsibilities, (2) Quality considerations, (3) Facilities (4) Apparatus, material and reagents, (5) Test systems, (6) Test and reference/control items, (7) Standard operating procedures (SOPs), (8) Performance of the method, (9) Reporting of results, (10) Storage and retention of records and materials.
The financing for sustainable development agenda promises to bring together more actors than ever before – from businesses, governments, philanthropists, and remitting households – to address the world’s most pressing problems and achieve the Sustainable Development Goals.
Yet, in spite of this promise, the financing for sustainable development gap is growing. While needs continue to increase, resources available to developing countries have been constrained and in some cases even declining, as illustrated by the recent drop in foreign direct investments. New financial instruments and interactions have yet to mobilise much-needed new resources in sufficient volumes. And despite significant advances, we do not yet fully understand the opportunities and risks faced by the various actors in this complex new global financing system.
This report sounds a wake-up call. To fulfil the commitments of the 2030 Agenda, and lift hundreds of millions of people out of extreme poverty, the international community needs to maximise the development footprint of existing and future resources, thereby “shifting the trillions” towards the SDGs. The first in a series, this report charts a forward path for the changes required in measurement, policies, and operations to achieve these ambitious objectives.
This document provides additional detailed guidance on rotational crop residue studies conducted according to OECD TG 504: Residues in Rotational Crops with expanded flexibility in crop commodities to be tested, and approaches to mitigate additional testing. The following scope is addressed within this document: derivation of application rates for rotational crop studies; estimation of concentration levels for active ingredients and their metabolites in soil in terms of an assessment of rotational crop studies and guidance on interpretation of the study results; advice on the data requirements and procedures for MRL setting based on rotational crops and the possible use of label restrictions; use of the proportionality concept in rotational crop assessments; and clarification of the relevant situations under which rotational crop studies are needed to cover protected crop situations.
This document provides guidance to both industry and regulatory authorities in the context of the assessment of technical equivalence of micro-organisms used in plant protection products. This Guidance Document is applicable for changes to the same strain of micro-organisms only in the framework of application for authorisations for plant protection products, where the strain already has been approved. The evaluation involves comparison between two sources of technical active ingredient of the same strain of a micro-organism for several parameters, aiming to ensure that the new source is equivalent to the approved source.
This document provides guidance to both industry and regulatory authorities on how procedures and data requirements can be applied to facilitate the submission of a complete data package/dossier for semiochemical active substances in plant protection products, and the subsequent evaluation of this data package/dossier by the regulatory authorities. The document additionally provides a summary of the legal frameworks and registration procedures for semiochemical active substances as plant protection products in several OECD member countries.
As coastal area on the Baltic Sea in north-central Poland, Pomorskie faces unique challenges and opportunities associated with the transition to a green economy, a diversified economy, growing population and significant natural resources. This report focuses on the sustainable development of the oceans and coastlines surrounding the region, known as the blue economy.
Based on an OECD survey designed to capture the needs and perceptions of local employers (mostly of small- and medium-sized enterprises [SME]), this report analyses the specific skills needed to support green growth in Pomorskie, and how related labour market and training programmes can be made more effective in supporting the transition to a low-carbon economy.
Groundwater allocation determines who is able to use groundwater resources, how, when and where. It directly affects the value (economic, ecological, socio-cultural) that individuals and society obtain from groundwater, today and in the future. Building on the 2015 OECD publication Water Resources Allocation: Sharing Risks and Opportunities, this report focuses on groundwater and how its allocation can be improved in terms of economic efficiency, environmental effectiveness and social equity. Drawing on an analysis of groundwater’s distinctive features and nine case studies of groundwater allocation in a range of countries, the report provides practical policy guidance for groundwater allocation in the form of a "health check". This health check can be used to assess the performance of current arrangements and manage the transition towards improved allocation.
With a view to assisting the evaluation of integrated approaches to testing and assessment (IATA) in regulatory decision-making within OECD Member Countries, this guidance document provides guidance on the reporting of defined approaches to testing and assessment in the area of skin sensitisation using the adverse outcome pathway (AOP) as a conceptual framework. Annex 1 (page 25) outlines twelve illustrative case studies for skin sensitisation and Annex 2 (page 279) lists information sources used within the case studies.
Green growth policies need to be founded on a good understanding of the determinants of green growth and need to be supported with appropriate indicators to monitor progress. This book presents a selection of updated and new indicators that illustrate the progress that OECD and G20 countries have made since the 1990s. It updates the 2014 edition.
With a view to assisting the evaluation of integrated approaches to testing and assessment (IATA) in regulatory decision-making within OECD Member Countries, this guidance document provides a set of principles for reporting defined approaches to testing and assessment that can be used as one of the components within IATA. Templates are also provided to enable a structured approach to their documentation in order to facilitate their evaluation. A defined approach to testing and assessment consists of a fixed data interpretation procedure (DIP) applied to data generated with a defined set of information sources to derive a result that can either be used on its own, or together with other information sources within an IATA, to satisfy a specific regulatory need. Thus, a defined approach to testing and assessment can be used to support the hazard identification, hazard characterisation and/or safety assessment of chemicals. This guidance is intended to be used alongside similar guidance aimed at harmonising the reporting of other IATA components such as QSARs, grouping and read-across strategies, and non-guideline in vitro methods.
In this document a strategy is presented to facilitate the ecological risk assessment of organometallic compounds (OM) and organic metal salts (OMS), outlining key steps that are based on elucidation of the fate of these substances in the environment. This document puts forth the recommendation that the initial determination of their fate in the environment is a primary factor for deciding how these substances should be assessed recognising that regulatory and program requirements will vary with each jurisdiction.
This guidance document is part of the OECD effort to provide guidance for assessing the hazards of chemical substances while gaining efficiencies and improving animal welfare. The approach described in this guidance document is to consider closely related chemicals as a group, or category, rather than as individual chemicals. While the first edition was published in 2007, This edition has been augmented with experience and examples encountered in the OECD Cooperative
Chemicals Assessment Programme, formerly the HPV Chemicals Programme since 2007, the second edition also intends to introduce new or revised guidance on: elaborating the analogue and category approach, quantitative and qualitative read-across, justifying read-across, using bioprofiling results for grouping chemicals, and specific types of category approaches (e.g. chemicals of variable composition, and metals).
Several models, tools and methods have been published in the past 20 years to include bioavailability in risk assessment and several OECD member countries already have developed frameworks and published guidance documents for taking metal specificities into account in environmental risk assessment. The aim of the current guidance is not to replace the aforementioned frameworks or guidance documents, but rather, to provide an overarching framework on how to apply these tools depending on which data are actually available/needed to assess the bioavailability of the metal under scrutiny. Further harmonisation of these approaches and methodology, where appropriate, over the different OECD countries is recommended and could facilitate a more worldwide application and the Mutual Acceptance of Data since using common assessment approaches may help comparing and exchanging data sets, which could result in significant resource savings.
Acute toxicity tests are an area of focus for developing alternative assays and approaches to address animal welfare concerns. In the context of this document, acute toxicity studies refer to studies involving a single exposure to a test chemical and include those assessing systemic toxicity as well as those assessing local irritation, corrosion or sensitization. One approach to minimizing the use of animals for acute toxicity testing is to consider waiving a study that may be required based on scientific criteria. Another approach to reducing or eliminating animal testing is to use existing hazard information that is informative for the acute toxicity endpoint for the test chemical; this would include the use of hazard information for one or multiple similar test chemicals to characterize the hazard for another or for mixtures, the use of recognized calculation approaches and bridging concepts. This Document provides clarification on these approaches to ensure that regulatory authorities are provided with the appropriate data required for decision-making and that reduced animal testing can be undertaken without compromising the integrity of the hazard information.
This Guidance Document proposes an integrated approach on testing and assessment (IATA) for skin corrosion and irritation. It also provides consistent information on key characteristics of each of the individual information sources of the IATA, and relevant guidance on how to integrate information for decision making (including decisions on the need for further testing) for final decisions for classification and labelling.
The purpose of this guidance is to harmonise the way non-guideline in vitro methods are described and thereby facilitate an assessment of the relevance of test methods for biological activities and responses of interest, and an assessment of the quality of data produced, irrespective of whether these tests are based on manual protocols or assay protocols adapted for use on automated platforms or high-throughput screening systems (HTS). This guidance outlines the elements considered relevant for providing a comprehensive description of an in vitro method to facilitate the interpretation of results and support scientifically defensible fit-for-purpose applications.
This document provides guidance to both industry and regulatory authorities on how procedures and data requirements can be applied to facilitate the submission of a complete data package/dossier for botanical active substances used in plant protection products, and the subsequent evaluation of this data package/dossier by the regulatory authorities. The document additionally provides a summary of the legal frameworks and registration procedures for botanical active substances as plant protection products in several OECD member countries.
The OECD has been developing guidance documents and tools for the use of alternative methods such as (Q)SAR, chemical categories and Adverse Outcome Pathways (AOPs) as a part of Integrated Approaches for Testing and Assessment (IATA). However, there is a need for a systematic framework to characterise the individual biological and toxicological relevance of alternative methods in assessing chemicals in predicting toxicological endpoints. This framework could also inform their potential use in combination with other tools and methods to benefit from an integrated approach by applying mechanistic knowledge and understanding. This document outlines an approach for the use of the AOP concept in developing IATA. It builds upon the workshop held in 2014 on a framework for the development and use of IATA and experience to date with the development of IATA.
This document provides guidance to both industry and regulatory authorities on storage stability for different types of microbial pesticide formulations. It includes guidance on the physical and chemical parameters to be assessed for different formulation types before and/or after the storage period, and also describes specific and adequate criteria for the determination of storage stability.
This document provides additional detailed guidance on crop field trials conducted according to OECD TG 509 (Testing of Chemicals on Crop Field Trial) and helps in planning the trials and in interpreting the results. The publication is organised in two parts: the core document on guidance for conducting crop field trials and the three Annexes containing additional information.