Guidance Document on Overview of Residue Chemistry 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. Each of these components is described and supported by the following resources: (i) a table of raw agricultural commodities; (ii) national and regional tables of livestock feedstuffs; (iii) a glossary of Terms; (iv) comprehensive submission criteria for supervised field trials in support of registration in all OECD countries; and (v) instructions for calculating the 1x (lowest dose) pesticide oral administration level for livestock feeding studies, taking into account the various livestock diets around the world.