Reports

This document provides guidance on using efficacy and crop safety data generated in other countries and regions (as well as from other sources) and evaluations conducted by other regulatory authorities. The document does not provide guidance on the generation of data itself or related scientific principles of data assessment or extrapolation but rather discusses broad principles that may be considered and possibly assist with minor use registrations.

This document captures and examines schemes used internationally for prioritising chemicals for risk assessment and/or risk management, and identifies commonalities, differences, lessons learned and areas for improvement. Based on this analysis it offers guiding principles and best practices to consider within prioritisation schemes. The document examines, for example, how different schemes handle data poor chemicals with the lack of availability of exposure or hazard data being the most common issue encountered during prioritisation. Other important best practices and common areas for development identified include using a common data platform to facilitate data sharing (e.g., IUCLID), increased sharing of results and rationales, collaboration on the development of new approach methodologies and tools/approaches for improving the prioritisation process, including the use of automation to improve efficiencies, and a comparison of international chemical inventories.

This report calls for a better understanding of the effects of pharmaceutical residues in the environment, greater international collaboration and accountability distribution, and policy actions to prevent and remedy emerging concerns. Laboratory and field tests show traces of oral contraceptives causing the feminisation of fish and amphibians, and residues of psychiatric drugs altering fish behaviour. Antimicrobial resistance, linked to the overuse of antibiotics, has rapidly escalated into a global health crisis. Unless adequate measures are taken to manage the risks, pharmaceutical residues will increasingly be released into the environment as ageing populations, advances in healthcare, and intensification of meat and fish production spur the demand for pharmaceuticals worldwide. The report outlines a collective, life-cycle approach to managing pharmaceuticals in the environment. A policy mix of source-directed, use-orientated and end-of-pipe measures, involving several policy sectors, can help to improve health and protect the environment.

This volume compiles the consensus documents developed by the OECD Working Group for the Safety of Novel Foods and Feeds from 2015 to 2019. It deals with the composition of common bean, rice, cowpea and apple, four important crops for agriculture and food consumption worldwide. The science-based information collated here is intended for use during the regulatory assessment of food/feed products derived from modern biotechnology, i.e. issued from transgenic plants. Compositional considerations are provided for each species, including tables detailing the key nutrients, anti-nutrients, possible toxicants, allergens and other metabolites contained in the products. This essential information and solid data can be used in the comparative approach as part of the novel food/feed safety assessment. It should be of value to crop breeders and applicants for commercial uses of novel foods and feeds, to regulators and risk assessors in national authorities, as well as the wider scientific community. More information can be found at BioTrack Online.

This document is intended to provide universal Guiding Principles that should be considered when developing or augmenting systematic approaches to Weight of Evidence (WoE) for chemical evaluation and Key Elements to formulating a systematic approach to WoE. The ultimate goal is to facilitate that regulators follow a consistent, clear and transparent delivery of evidence using the Principles and Elements described in this document. This can be especially helpful for countries with no existing WoE frameworks or those looking to augment their approaches. It also allows for stakeholders to understand a WoE decision-making process, including potential for unreasonable bias. These Guiding Principles and Key Elements can be employed to develop frameworks that range from simple and pragmatic approaches to more elaborate systems, depending on the context.

This document suggests an Integrated Approach on Testing and Assessment (IATA) for serious eye damage and eye irritation hazard identification. The document also provides key information characteristics of each of the individual information sources comprising the IATA. Furthermore it provides guidance on how and when to integrate existing and/or newly generated information for decision making, including decisions on the need for further testing or final decisions on classification and labelling regarding the potential eye hazard effects of test chemicals.

This document is a complement to the Guidance Document on Emission Scenario Documents (ESDs) and aims to help writers of ESDs to identify whether emissions during service-life may be of importance and therefore need to be included. It will also give an orientation on key aspects connected to such releases that need to be considered in an exposure assessment.

The test described in this Test Guideline allows the identification of corrosive chemical substances and mixtures and it enables the identification of non-corrosive substances and mixtures when supported by a weight of evidence determination using other existing information. The test protocol may also provide an indication of the distinction between severe and less severe skin corrosives. This Test Guideline does not require the use of live animals or animal tissue for the assessment of skin corrosivity. The test material (solid or liquid) is applied uniformly and topically to a three-dimensional human skin model, comprising at least a reconstructed epidermis with a functional stratum corneum. Two tissue replicates are used for each treatment (exposure time), and for controls. Corrosive materials are identified by their ability to produce a decrease in cell viability below defined threshold levels at specified exposure periods. Coloured chemicals can also be tested by used of an HPLC procedure. The principle of the human skin model assay is based on the hypothesis that corrosive chemicals are able to penetrate the stratum corneum by diffusion or erosion, and are cytotoxic to the underlying cell layers.

This document describes good practices for the licensing of protected elements included in OECD Test Guidelines (TGs). Transparency and communication are needed around protected elements resulting from innovation in sciences and techniques that are gradually integrated in OECD TGs. This Guidance specifies the information required from a test method developer when submitting a proposal for a new TG that contains protected elements. This document contains a broad overview of the intellectual property and similar protections that affect the OECD TG Programme. Laws governing intellectual property and similar rights vary widely from jurisdiction to jurisdiction; anyone seeking to answer specific questions about the interpretation of the concepts in this paper in a specific jurisdiction must seek the advice of a specialised lawyer.

This OECD Emission Scenario Document (ESD) is a complement document to the Emission Scenario Document on Plastic Additives, ESD No. 3, and provides information on the sources, use patterns and release pathways of chemicals used as additives in plastics to assist in the estimation of releases of chemicals into the environment.