Browse by: "G"

This document contains a Guidance Document (GD) on Integrated Approaches to Testing and Assessment (IATA) for Phototoxicity Testing, originally developed by Japan, reviewed, consolidated and finally approved by the Working Party of the National Coordinators of the Test Guidelines Programme. This document provides an overview and key characteristics of each individual information source available for phototoxicity testing, and their use within the IATA. The project was on the Test Guidelines Programme work plan until 2024.

This report provides an overview of green budgeting practices across OECD countries based on the 2022 OECD Green Budgeting Survey, as well as the index methodology for the Survey. It takes stock of OECD countries’ progress in bringing climate and environmental considerations into budgeting frameworks and processes. Green budgeting involves a systematic approach across all stages of the budget process, including financial reporting and budget oversight. The growth in green budgeting in OECD countries, as shown in the report, demonstrates the key role of budget offices in ensuring that policy priorities relating to climate change and the environment are taken into account when allocating resources through the budget process.

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.

A Defined Approach (DA) consists of a selection of information sources (e.g in silico predictions, in chemico, in vitro data) used in a specific combination, and resulting data are interpreted using a fixed data interpretation procedure (DIP) (e.g. a mathematical, rule-based model). DAs use methods in combination and are intended to overcome some limitations of the individual, stand-alone methods. The first three DAs included in this Guideline use combinations of OECD validated in chemico and in vitro test data, in some cases along with in silico information, to come to a rules-based conclusion on potential dermal sensitisation hazard. The DAs included in this Guideline have shown to either provide the same level of information or be more informative than the murine Local Lymph Node Assay (LLNA; OECD TG 429) for hazard identification (i.e. sensitiser versus non-sensitiser). In addition, two of the DAs provide information for sensitisation potency categorisation that is equivalent to the potency categorisation information provided by the LLNA.

The efficacy and functionality of a biocides treated article as well as the way the treated article and its benefits for the user are presented (the claim) have a public health impact. The OECD identified a public health concern, in particular because of a possible false sense of security given by the claim, or because of an incorrect interpretation of the claim by the end-users. The objective of this document is to give guidance on how claims for treated articles that may have an impact on human health can be formulated, interpreted and tested within the framework of the different legislations across OECD countries.

Government chemicals management frameworks aim to enable the safe use of chemicals and ensure their proper management. The approaches used by governments to manage chemical risks are just one aspect of a larger risk management system with industry as a principal actor. They cover a spectrum of activities varying from a government regulatory response that is command-and-control in nature to policy approaches that aim to incentivise a shift in behaviour. The approaches can be responsive, to an identified existing risk, or proactive/pre-cautionary, aiming to minimise possible future risks. Also, the approaches can be used in combination. This document provides a synthesis of the various risk management approaches and options that are used by OECD member country government chemical regulatory programmes to manage the risk of chemicals. The scope of the document focuses on the management of risks of industrial and consumer chemicals, i.e., chemicals which are not covered by specific legislations such as pesticides or pharmaceuticals. The synthesis can serve as a basis for future discussions of individual risk management approaches, either for particular types of chemicals or regarding particular risk management approaches and facilitate international alignment. It can also promote the identification of areas where governments can additionally support better chemicals management and serve as a resource for countries developing their chemicals management programmes.

This Guidance Document is intended to provide guidance to industry and regulatory authorities, on regulatory approaches that can be taken for assessment and approval of bacteriophages to be used as plant protection products. Bacteriophages (or phages) are a group of microorganisms that are viruses specifically infective to bacteria, which can be considered a niche use.

This guidance provides recommendations for the design and execution of laboratory studies to evaluate the performance of biocidal products in any formulation such as a liquid, aerosol, fog, or impregnated fabric intended to repel, attract, and/or kill bed bugs (Cimex lectularius). It does not apply to repellent products applied to human skin. The guidance is based upon the American Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products (US EPA 2017, OCSPP 810.3900) and incorporates information from laboratory efficacy testing standards for biocidal products against bed bugs in the framework of the German Infectious Diseases Protection Act (18, 46). Investigators should ensure research is conducted in compliance with any applicable laws or regulations, which are independent of and additional to those cited in this guidance

This guidance provides recommendations for the design and execution of simulated-use studies to evaluate the efficacy of baits (claim “nest kill”) against tropical ants. Furthermore, this guidance deals with laboratory and simulated-use testing of tropical ant repellents (e.g. claim “reduction or prevention of invading ants in houses or sensitive areas”). The recommendations in this document refer to products for control in indoor environments.

The global community is far from achieving its objective of ending plastic pollution, unless more stringent and co-ordinated policies are implemented. A key question is: What are the plausible scenarios for the evolution of plastics in the absence of additional measures and, as well, with scaled-up policy action? The Global Plastics Outlook: Policy Scenarios to 2060 provides such a forward-looking perspective. The report presents a set of coherent projections on plastics to 2060, including plastics use, waste as well as the environmental impacts linked to plastics, especially leakage to the environment. Such an outlook on plastics can help policy makers understand the scale of the challenge to transition to a more sustainable and circular use of plastics and the need for additional policy action. By identifying two policy packages to bend the plastic curve, the Outlook allows for a better understanding of the environmental benefits and economic consequences of adopting stringent policies. This second report is a follow-up to the first report – Global Plastics Outlook: Economic Drivers, Environmental Impacts and Policy Options – which quantified current trends in plastics use, waste generation and leakage, as well as identified four policy levers to curb the environmental impacts of plastics.

The Adverse Outcome Pathway (AOP) framework has been developed to facilitate the collection of mechanistic information derived from toxicological science in a structured manner, to assist in establishing causal relationships between molecular and cellular events that lead from stressor perturbation of the biology to adverse effects, and to identify critical data gaps in the understanding of those pathways. The objective of the present document is to provide guidance on the quality standards required for the scientific review of an AOP on the AOP-Wiki. It defines the core principles associated with AOP scientific review in order to enable consistent scientific reviews to be conducted, regardless of who is doing the review, and thus will facilitate OECD endorsement.

Un marco regulatorio de plaguicidas claro, eficiente y moderno es esencial para reducir los impactos en la salud humana y el medio ambiente, respaldar un enfoque de ciclo de vida para su gestión y garantizar la protección de los cultivos y una industria agrícola sostenible. Este informe identifica las brechas, barreras, fallas de implementación e ineficiencias que afectan el marco regulatorio de plaguicidas en México. Hace un balance del marco regulatorio y las reformas recientes, e identifica tanto las áreas que plantean el mayor desafío para la regulación eficaz de los plaguicidas como aquellas en las que la regulación, o la falta de ella, afecta los objetivos de política y la actividad económica. Estos desafíos y prácticas se contrastan con principios de la OCDE y las mejores prácticas regulatorias de países OCDE, y se brindan recomendaciones para apoyar los esfuerzos de mejorar la regulación. El informe concluye que México se beneficiaría de la adopción de una estrategia de política integral para plaguicidas, reconociendo que el manejo de plaguicidas es una responsabilidad compartida entre los gobiernos nacionales y locales, la industria de plaguicidas, los usuarios de plaguicidas y el público en general.

This document provides guidance for test facilities or test sites that conduct GLP studies or GLP study phases. The guidance aims to promote a risk-based approach to the management of data that includes data risk, criticality and life cycle. Users of this document need to understand the data flows they are responsible for or involved in (as a life cycle) in order to identify data that are likely to have impact on GLP compliance. In turn, this will support the identification and the implementation of the most effective and efficient risk-based controls.

This document provides guidance for aquatic (including sediment) ecotoxicity testing of Manufactured Nanomaterials (MNs) to determine their hazard. The definition of MNs as having one dimension between 1 and 100 nm is generally adopted. However, the guidance provided here should also be relevant for colloidal (nano) particles (e.g., 1 to 1000 nm) with primary or aggregate/agglomerate sizes greater than the range for MNs. The guidance focuses on freshwater aquatic and sediment toxicity test methods described by the OECD Test Guidelines. More specifically, this guidance document addresses practical aspects of carrying out valid tests with MNs including interpreting and reporting the results, and addresses the specific issues. It also addresses modifications or additions to OECD TG procedures intended to incrementally improve the accuracy, intra-laboratory repeatability, inter-laboratory reproducibility and intra-laboratory reproducibility of test results. While the focus was specifically on adapting the OECD TGs for reliable MNs testing, the methods and principles discussed herein are likely more widely applicable to aquatic toxicity test methods published by other organisations.

This document provides specific guidance for test preparation, implementation, performance, analysis and reporting using the OECD TG No. 312 for testing the mobility and retention of NMs in different types of soils. The GD is likely also relevant for colloidal materials of greater size ranges, because transport of these materials occurs via the same kinetically dominated processes that determine the fate of NMs. The document informs on necessary modifications and additions to the standard test protocol including preparation and application of the test materials, analytics and data reporting. The modifications and additions proposed in the GD are included in order to generate relevant, accurate and reproducible data on NM retention and mobility in soils. Estimations of parameters such as Koc (organic carbon normalised adsorption coefficient) and Kom (organic matter normalised distribution coefficient)as presented in the parent TG No. 312 are not applicable for NMs.

Si bien la COVID-19 ha afectado a Perú de manera particularmente dura, habiéndose registrado alrededor de 1,4 millones de casos hasta marzo de 2021, la pandemia ha puesto de relieve la importancia del agua y el saneamiento para la salud, el medioambiente y la economía. El país aún no está en camino de alcanzar las metas del ODS 6 "Agua limpia y saneamiento" para el 2030, dado que 3 millones de peruanos (9,2% de la población) carecen de acceso a servicios de agua y 8,2 millones de peruanos (25,2%) no tienen acceso a servicios de alcantarillado. Existe además una gran brecha entre las zonas urbanas y rurales. Adicionalmente, entre 2000 y 2020, las inundaciones afectaron a aproximadamente 4,43 millones de personas. Por otro lado, el inadecuado manejo de residuos solidos y algunas actividades económicas se encuentran entre las causas de la contaminación del agua, lo que genera graves problemas de salud pública y conflictos sociales. En vista del cambio climático y el crecimiento demográfico, fortalecer la gobernanza del agua en Perú es clave para mejorar la seguridad hídrica a largo plazo. Este informe presenta un análisis de la gobernanza del agua en el país e incluye recomendaciones de políticas para: fortalecer el enfoque multisectorial del manejo del agua; mejorar el uso de instrumentos económicos para proteger y utilizar de manera sostenible los recursos hídricos, sus fuentes y los servicios ecosistémicos relacionados; y fortalecer el marco regulatorio para mejorar el acceso al agua potable y el saneamiento en áreas urbanas y rurales.

This guidance document presents a standardised test evaluating the ability of honeybees (Apis mellifera) exposed to a single dose of test chemical to return to the hive; it is a semi-field test, where dietary exposure to the test chemical and bee tagging occur in the laboratory prior to release in the field until the return to the hive. The success of the homing flight is measured in exposed versus non-exposed foragers simulating field realistic conditions over the short term. Pollinators, such as honey bees, may be exposed to residues of plant protection products (PPP) or other chemicals while foraging. Oral exposure to these residues may not cause direct lethal toxicity in foragers or may not induce visible signs of intoxication, but may negatively affect honey bee behaviour, which could interfere with functions at the colony level. To address the potential risk of sublethal doses of chemicals on the foraging behaviour of free foraging honey bees, the homing flight test presented here can be used.