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This Guidance Document provides guidance and practical advice for applicants on the requirements for flammability testing of biocides and agricultural pesticides/plant protection products in various OECD jurisdictions. Though many of the available methods are common they can differ in small but important ways. Thus a summary of parameters can help an applicant ensure their data set is viable in all OECD countries, thereby saving resources for both the applicant and the receiving government.

In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context.  To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which data are generated must adhere to defined standards to ensure resulting data are rigorous and reproducible.  Good In vitro Method Practices (GIVIMP) for the development and implementation of in vitro methods for regulatory use in human safety assessment aims to help reduce the uncertainties in cell and tissue-based in vitro method derived chemical safety predictions.  GIVIMP provides guidance for test method developers and end users of resulting data on key elementes of in vitro methods. GIVIMP tackles ten important aspects related to in vitro work: (1) Roles and responsibilities, (2) Quality considerations, (3) Facilities (4) Apparatus, material and reagents, (5) Test systems, (6) Test and reference/control items, (7) Standard operating procedures (SOPs), (8) Performance of the method, (9) Reporting of results, (10) Storage and retention of records and materials.

This Guidance Document describes test procedures for measuring the (sub)chronic effects of chemicals on an estuarine/marine harpacticoid copepod species under semistatic conditions; the biological endpoints include survival and development rates of the early life-stages and multiple aspects of its reproduction (e.g., sexual maturation, mating success and numbers of viable offspring produced (fecundity). These procedures are applicable to most chemicals, either individually, or in formulations, commercial products, or known mixtures, that can be solubilized and measured accurately at the necessary concentration in seawater. Test chemicals that have a high oxygen demand, are highly volatile, or are rapidly biologically or chemically transformed in aqueous solutions, might not be suited for use in this test.

The purpose of this Guidance Document (GD) is to provide pathologists, toxicologists, and associated scientists with recommended guidelines for performing the pathology tasks required by the specifications of TG 412 and 413, and for optimising the value of pathology-related tasks in these studies. This document is structured to follow the specifications in TG 412 and TG 413 and to provide recommendations and supplementary information to these specifications in the temporal sequence one would encounter in planning, participating in, and reporting the results of pathology tasks in a 28 or 90 day inhalation toxicology study utilising TG 412 and TG 413. It is also intended to conform to the recommendations provided in GD 39, Guidance Document on Acute Inhalation Testing, and to the OECD Principles of Good Laboratory Practice (GLP).

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.

This document describes a honey bee brood laboratory toxicity test using repeated doses. It is based on the OECD Test Guideline 237: Honey bees (Apis mellifera) larval toxicity test, single exposure (1) ring tested in seven European laboratories, which is itself based on a method developed in France (2) (3) (4), and on methods described in the Coloss Beebook (5) that provides useful guidance for honey bee testing, breeding honey bees, studying honey bee biology and understanding honey bee pests and pathogens.

The main purpose of this document is to assist the regulated community and regulators in selecting the most appropriate acute inhalation TG so that particular data requirements can be met while reducing animal usage and suffering. This Guidance Document also contains additional supporting information on the conduct and interpretation of studies performed using the inhalation test guidelines: TG 403, TG 436, TG 433, TG 412, and TG 413. As mentioned before, for a number of Test Guidelines, such as TG 451 (carcinogenicity), TG 452 (chronic toxicity) or the Test Guidelines on reproduction and neurologic endpoints, the inhalation route of exposure may be used but this is not mentioned specifically in the guidance. If the inhalation route is chosen, the present guidance document should be consulted in the design of the studies. The second purpose of this document is to provide the necessary guidance when testing nanomaterials via inhalation in the 28-d and 90-d toxicity studies, subsequent to the high priority activity undertaken at the OECD.

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 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.

A wide range of raw agricultural commodities (RAC) are processed before consumption by the public. In fact, many RACs are consumed in multiple processed forms [e.g. grapes (RAC), raisins, grape juice, wine; potato (RAC), chips, cooked, baked and fried potato, dehydrated flakes]. The processes that are used (industrial or domestic) to produce these foods are diverse and varied. From a consumer protection point of view it is always important to know not only the residues in the RACs but also the residues in the processed commodities, i.e. in the ready-to-eat food. This information is essential for refinement of the dietary exposure. Additionally, it is important to know the residues in processed feeds to calculate the dietary burden for feeding studies and thus to estimate the probable residues in products of animal origin. Studies on the magnitude of residues in processed commodities provide data on the transfer of residues to different processed commodities from the raw agricultural commodity (RAC). Studies on the magnitude of residues are conducted in order to quantify levels of residues in processed commodities and to provide the distribution of residues (active ingredient, and/or metabolites, degradation products) in various processed products resulting from the processing of a commodity.

This document is intended to provide guidance on methodological aspects, interpretation of data and an overall approach for testing of chemicals for potential human and other mammalian reproductive toxicity. The document constitutes an essential supplement to existing OECD Test Guidelines that can be used to obtain information on the potential reproductive toxicity of chemicals. Specific OECD Test Guidelines include the one- and two-generation toxicity study (TG 415 and 416), prenatal developmental toxicity study (TG 414), developmental neurotoxicity study (TG 426) and the reproduction/developmental toxicity screening tests (TG 421 and 422). However, data from other toxicity studies e.g., repeated dose toxicity studies for systemic toxicity (TG 407, 408 and 409) may indicate potential reproductive toxicity and should be considered in the assessment as well as existing human data.

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.

This Guidance Document summarises the major guidance aspects provided in the OECD Harmonised Residue Guidelines for: 1) Metabolism in Crops; 2) Metabolism in Livestock; 3) Residues in Livestock; 4) Metabolism in Rotational Crops; and 5) Residues in Rotational Crops (Limited Field Studies). This document also develops an approach for a Global Maximum Residue Limit (MRL) process to achieve use of harmonised studies for livestock food commodities, e.g., meat, milk and eggs, which can be used by all OECD member countries.

This document provides guidance on the residue analytical methods. Analytical methods are used to generate the data for estimating dietary exposure assessments, to establish Maximum Residue Levels (MRLs), and to determine processing factors. Analytical methods are also used in enforcement of any statutory MRLs that may be established. Methods apply to all pesticides used on edible crops/livestock and subsequent produce and processed food products, and for products (e.g. meat, milk, eggs) from animals that may consume treated crops. Additionally, analytical methods are needed for conducting storage stability studies.

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.

This document contains guidance for using the summary exposure information reporting formats, which were developed by the OECD Ad Hoc Group on Reporting Summary Exposure Information. The objective of the work of this Ad Hoc Group is to develop flexible formats and guidance for the reporting of summary exposure information (quantitative and qualitative), which can be used in various chemical assessment programs.
 

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. Furthermore, it provides an update of the OECD Table of Feedstuffs Derived from Field Crops found in the Guidance Document on Overview of Residue Chemistry Studies (Series on Pesticides No. 32).

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. The following scope is addressed within this document: derivation of application rates for rotational crop studies; estimation of concentration levels for active ingredients and their metabolites in soil in terms of an assessment of rotational crop studies and guidance on interpretation of the study results; advice on the data requirements and procedures for MRL setting based on rotational crops and the possible use of label restrictions; use of the proportionality concept in rotational crop assessments; and clarification of the relevant situations under which rotational crop studies are needed to cover protected crop situations.

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. The document additionally provides a summary of the legal frameworks and registration procedures for semiochemical active substances as plant protection products in several OECD member countries.