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The development of harmonised data requirements for microbial pesticides has been a goal of the OECD for several years. A guidance for registration requirements would facilitate access to a wider range of new, reduced risk, IPM compatible pest management tools, by making it easier for companies to submit registration applications to many countries and for regulatory agencies to benefit from each other’s reviews. This document proposes guidance for registration requirements for microbial plant protection products, as well as indicating where there are differences among countries.

The purpose of this document is to give guidance to Receiving Authorities on the evaluation of the GLP compliance status of nonclinical safety studies submitted for regulatory purposes. This guidance does not address the scientific evaluation and interpretation of the submitted data or the risk assessment based on these data.

This document was developed to serve as guidance for information requirements for the regulation of Invertebrates as Biological Control Agents (IBCAs) within OECD countries. It incorporates information requirements from a number of OECD countries for the regulation of IBCAs, including insects, mites and nematodes. In developing this regulatory approach for IBCAs, the inherent differences between these products and chemical plant protection products were taken into consideration. IBCAs are usually more target pest specific than chemical plant protection products, and generally pose lower risks to human health and the environment. IBCAs have been used successfully for many years in many OECD countries without significant harm to plants or native arthropod species. To facilitate the use of biological control agents in some of these countries, documentation on lists of IBCAs that have been used for many years (5 or more) without undesirable side-effects has been prepared and updated by government agencies.

This document contains guidance on how “retrospective” studies of a socio-economic analysis (SEA), conducted in support of a chemical risk management decision, can be carried out. That is, the guidance is intended for those who have already conducted an SEA and implemented risk management measures, and who wish to determine, for example, whether ex post impacts match the ex ante predictions made in the SEA, and how important key assumptions affecting the analysis were to the decision and to the actual outcomes of the decision.

The fields of toxicology and chemical risk assessment evaluate the safety of chemicals for humans the environment. Increasingly, modern methods seek to reduce the use of animals in chemical safety testing and predictive toxicology. In this context, the OECD has developed this guidance document on Physiologically Based Kinetic (PBK) models, with the goal of increasing confidence in the use of these models parameterised with data derived from in vitro and in silico methods. The document provides insights into how the data generated by such methods can be applied to construct PBK models and how these models can be validated. A series of cases studies illustrate the use of PBK models based on in vitro and in silico data, along with the application of the model assessment framework proposed herein. This guidance document provides a clear and consistent model assessment framework for facilitating the dialogue between the developers and proponents of PBK models and regulators who review and adopt the use of PBK models.

Baculoviruses have been explored for more than 75 years as microbial pest control agents (MPCA) and are commercially available as microbial pest control products (MPCP) for almost 50 years. Today baculoviruses are registered and used as MPCP in nearly all OECD countries. The specific focus of this guidance document lies on the developments in identification (including taxonomy and classification), biological properties including mode of action, genetic stability, host resistance, population genetics and baculovirus ecology, human health considerations, residues, environmental fate, effects on non-target organisms and conclusions for safety assessment. This document is intended to provide general and specific information on baculoviruses and guidance to industry, regulatory authorities and others who have responsibility for assessments of baculoviruses used as biological control agents.

This document presents a general guide to the analysis and evaluation of data from studies involving repeated exposures of toxicity test species to pesticides and other chemicals; and outlines the kind of information which should be included in an independent assessment of toxicity studies.

These Guidance Notes outline core concepts in order to obviate the need to consult large numbers of text books, while still pointing the reader to sources of more detailed or specific information. They are intended to complement OECD Test Guidelines and other OECD publications, including Guidance for Industry Data Submissions and Guidance for Country Data Review Reports on Plant Protection Products and their Active Substances – Monograph Guidance

Following the adoption of Council Recommendation C(2004)100 in 2004 on Environmentally Sound Management of Waste, member countries wished to reinforce the implementation of this legal Act by issuing a practical Guidance Manual. This publication aims at facilitating the implementation of an environmentally sound waste management policy by governments on one hand, and by waste treatment facilities on the other hand. Every element of the Recommendation C(2004)100 is explained in detail, as well as the different core performance criteria which characterise environmentally sound management of waste, through various types of information (such as technical, financial, regulatory). Waste management practices applied in certain member countries are presented as examples...

This Guidance Manual includes detailed explanations on how to implement the OECD Decision C(2001)107/FINAL, as amended; copies of the Decision C(2001)107/FINAL (Annex A), including Appendices 3 and 4, and Appendix 8 which have been amended by C(2008)156; the updated consolidated lists of waste subject to the Green and Amber control procedures (Annexes B and C); other relevant information to facilitate the implementation of the OECD Decision C(2001)107/FINAL, such as applicable international transport agreements and a sample contract; and queries of the interactive database aiming to facilitate the paperwork of all parties involved in transboundary movements of wastes by providing the necessary information to complete the forms for the notification and movement documents. The database includes the information required by the Decision C(2001)107/FINAL, as amended and some practical information for each OECD member country (http://www2.oecd.org/waste).

The document provides guidance to both industry and regulatory authorities in the context of pre-submission consultations prior to submission of applications for the registration of microbial biological control agents. This document describes the procedure and the information which should be submitted at a pre-submission consultation.

To keep (Q)SAR applications on a solid scientific foundation, an international effort to articulate principles for (Q)SAR technology and to develop a guidance document for use of (Q)SAR in regulatory applications. This document presents those principles and helpful guides for validating (Q)SAR technology for a variety of applications.

The purpose of this document is to provide guidance on issues related to the validation of new or updated test methods consistent with current approaches. This document provides a synopsis of the current state of test method validation, in what is a rapidly changing and evolving area. Guidance on the more general aspects of OECD Test Guideline development is provided in the OECD Guidance Document for the development of OECD Test Guidelines for the testing of chemicals. While the principles of validation as described in this document were written for biology-based tests, they may be applicable to other Test Methods.

This Guidance document focuses on the antioestrogenic protocol; it is the outcome of the experience gained during the validation test programme and the results obtained thereby with the use of a strong oestrogen receptor antagonist. Due to insufficient validation of this antioestrogenic protocol, this Guidance Document is provided for experimental purpose only. The test will provide supporting evidence in relation to antioestrogenic activity.

This document provides a description of a Harmonised System for the Classification of Chemicals which are Hazardous for the Aquatic Environment and guidance to how the system will work as well as guidance to the interpretation of data for use in applying the classification criteria.

This Guidance Document is addressed to those who are involved in risk assessment and management of chemicals called POPs (persistent organic pollutants) or PBTs (persistent and bio-accumulating toxics). It is about using multimedia models, i.e. generic evaluative models that can calculate overall environmental persistence (Pov) and potential for long-range transport (LTRP) covering multiple compartments such as air, water, sediment and soil: what models you can use to identify and characterize POPs/PBTs, what data to use, and how to use model calculations.

This document is intended to provide guidance when testing and/or evaluating effectiveness of biocide products (public health insecticides) used as baits for the control of Lasius ant colonies nesting in, or in close proximity to, buildings. This document does not deal with efficacy consideration for products used as pesticides, for example products aimed at outdoor ant elimination.

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.

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.