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This document provides additional detailed guidance on testing of chemicals according to OECD Test Guideline No. 505: Testing of Chemicals on Residues in Livestock. Specifically, it describes current differences in OECD countries in livestock feeding practices and diet composition and factors influencing the determination of dietary burden and dose selection, and provides guidance for interpreting results (including example calculations for dietary burdens and MRL setting) from OECD Test Guideline No. 505 studies.
This Overview Guidance Document summarises the major guidance aspects provided in the OECD Guidelines for the Testing of Chemicals, Section 5. This document also develops an approach for a Global Maximum Residue Limit (MRL) process to achieve use of a single globally acceptable feeding study for MRL setting and risk assessment for livestock food commodities that involves four key components: 1) Harmonised Guidance for the Definition of Residue; 2) Reasonable Worst Case Animal Diets/Maximum Reasonably Balanced Diet; 3) Harmonised Table of Livestock Feed Commodities; and 4) Definition of Reasonable Worst Case Livestock Feeding Levels.
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.
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.
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.
This document provides guidance to national regulatory authorities in providing greater incentives to encourage applicants (manufacturers/registrants) to register agricultural pesticides (including both synthetically and naturally derived products) for minor uses.
The Global Harmonised Submission Transport Standard (GHSTS) is a standardised set of technical specifications for assembling electronic files for pesticide registration in a predefined manner. Once assembled according to the GHSTS, the dossier files can be transferred from a business to a regulatory authority and can be used in a regulatory process.
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.
This report includes the outcomes of the workshop discussions, as well as the overall workshop conclusions (Section 4) and recommendations (Section 5) targeted at governments, all stakeholders and OECD.
This Best Practices Guidance addresses compliance and enforcement issues as they relate to pesticides and associated health and environmental risks. The objective of this document is to provide guidance for promoting and monitoring compliance and for assessing and mitigating risks of non-compliance.