By Date


  • 13-April-2017

    English

    Guidance on the Incorporation of Bioavailability Concepts for Assessing the Chemical Ecological Risk and/or Environmental Threshold Values of Metals and Inorganic Metal Compounds

    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.

     

  • 13-April-2017

    English

    Guidance Document for Describing Non-Guideline In Vitro Test Methods

    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.

     

     

  • 13-April-2017

    English

    Corporate governance for process safety - Guidance for senior leaders in high hazard industries

    The Guidance on Corporate Governance for Process Safety draws attention to those at the top of industry to the need for high standards of corporate governance in relation to the management of high hazard industries. The Guidance encourages every director, CEO and President of a major hazard company and to check themselves against a set of self-assessment questions and evaluate their awareness and knowledge in process safety.

  • 13-April-2017

    English

    Report of the Workshop on a Framework for the Development and Use Of Integrated Approaches to Testing and Assessment

    This document is a report of the Workshop on a framework for the development and use of integrated approaches to testing and assessment which was held on 17-19 November 2014 in Crystal City VA, USA. This framework should provide guiding principles, and technical guidance on how results from alternative approaches (in silico, in chemico, in vitro including high throughput and high content test methods) should be interpreted for characterising (both qualitatively and quantitatively) the adverse effects in animals and humans and/ or the environment, so that they can be used for hazard identification, hazard characterisation and risk assessment. The workshop was organised in close cooperation with the World Health Organisation following a proposal from OECD member countries in June 2013.

     

  • 13-April-2017

    English

    Report on Considerations from Case Studies on Integrated Approaches for Testing and Assessment (IATA) - First Review Cycle (2015) - Case Studies on Grouping Methods as a Part of IATA

    OECD member countries have been making efforts to expand the use of alternative methods in assessing chemicals. 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). There is a need for the investigation of the practical applicability of these methods/tools for different aspects of regulatory decision-making, and to build upon case studies and assessment experience across jurisdictions. The objective of the IATA Case Studies Project is to increase experience with the use of IATA by developing case studies, which constitute examples of predictions that are fit for regulatory use. The aim is to create common understanding of using novel methodologies and the generation of considerations/guidance stemming from these case studies. This document reports the learnings and lessons obtained from the review experience of the four case studies submitted to the 2015 review cycle of the IATA Case Studies project. The topics discussed in this document include the strongest aspects and uncertainties of each case study, and the document identifies areas for developing further guidance on IATA.

  • 13-April-2017

    English

    Overview on genetic toxicology TGs

    Following a general update of the Genetic Toxicology TGs in 2015, the present Document was written to provide succinct and useful information to individuals unfamiliar with genetic toxicology testing, as well as experienced individuals wishing to obtain an overview of the recent changes that were made to the TGs during the recent round of revisions. It provides: 1) general background and historical information on the OECD genetic toxicology TGs; 2) a brief overview of the important types of genetic damage evaluated by these tests; 3) a description of the retained TGs; and 4) the issues and changes addressed therein during the revision process.

     

  • 12-April-2017

    English

    Testing Programme of Manufactured Nanomaterials

    The safety of Manufactured Nanomaterials is an important concern impacting regulatory bodies throughout the world. Due to their size, Manufactured Nanomaterials may require additional testing beyond the standard suite of tests used for other chemicals, to ensure that the impact on human health and the environment is fully understood - download Manufactured Nanomaterials Dossiers or search for Tested Endpoints.

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  • 27-March-2017

    English

    OECD Good Laboratory Practice: Frequently asked questions (FAQ)

    GLP issues raised by testing labs are covered in this comprehensive list of questions and answers, recently updated with questions related to Validation of Software Programmes which Support OECD Test Guidelines

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  • 24-March-2017

    English

    Environment, Health and Safety News

    This March newsletter provides an update on the recent events and activities of the Environment, Health and Safety Programme of the OECD.

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  • 22-March-2017

    English

    Integrated Approaches to Testing and Assessment (IATA)

    Guidance on principles for reporting defined approaches within IATA and an associated template have been published. A second guidance document illustrates how the reporting templates can be used to document a number of defined approaches (and information sources used within) in the area of skin sensitisation. This is exemplified via 12 case studies for skin sensitisation.

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