This newsletter provides up-to-date information on activities related to biotechnology at the Organisation for Economic Co-operation and Development (OECD). It is mainly intended for delegates to OECD meetings who are already familiar with certain aspects of OECD‟s work. We hope that it is also informative for the wider biotech community.

The IOMC Toolbox is an internet-based tool that enables countries to identify the most relevant and efficient tools to address specific national problems in chemicals management. Developed by the IOMC, this proof-of-concept focuses on a national management scheme for pesticides, an occupational health and safety system as well as a chemical accidents prevention, preparedness and response system for major hazards.

The aquatic life benchmarks (for freshwater species) are based on toxicity values reviewed by EPA and used in the Agency's most recent risk assessments developed as part of the decision-making process for pesticide registration. Each Aquatic Life Benchmark is based on the most sensitive, scientifically acceptable toxicity endpoint available for a given taxon of all scientifically acceptable toxicity data available to EPA.

This document presents the outcomes of the 3rd OECD Biopesticide Seminar, held in 2011, that focused on the topic of “botanicals” (also known as plant extracts). The Seminar reviewed a number of scientific and regulatory issues related to the “characterisation and analyses of botanicals for the use in plant protection products”.

This document includes a table which summarises descriptions of existing models and tools used for exposure assessment, as well as responses to a 2010 survey – conducted by the OECD Task Force on Exposure Assessment - upon which the table was based. The summary table and the responses are also available in the OECD Environmental Risk Assessment Toolkit (http://envriskassessmenttoolkit.oecd.org/).

This document outlines the current status of and available guidance documents/tools on the application, use and presentation of PRTR data in OECD member countries and the Commission for Environmental Co-operation based on the results of a survey conducted in November 2011.

This document outlines basic background information on release estimation techniques (RETs) for point sources and provides resources on available RETs of different national/regional Pollutant Release and Transfer Register systems. It was originally published in 2002, and has been updated to reflect new and additional information.

30/01/2013 –The first update to the third generation of the QSAR Toolbox (version 3.1) has now been released containing improved search functionalities, interface improvement, a new database for observed rat in vivo metabolism; updated auto oxidation and metabolism simulators; updated DNA binding profiler and additional ways of expressing mixtures composition.

This Biosafety Document is intended to supply basic information (biology mainly), useful in environmental risk/safety assessment. Agriculture plant species of Brassica genus are cropped worldwide as oilseeds, vegetables and for other uses.

This revised document supplies basic information (compositional considerations, key constituents), useful in risk/safety assessment of food and feed using new varieties of soybean (Glycine max.). This updated publication replaces the original issue of 2001.

This is a guidance on sample preparation and dosimetry, to which special attention should be paid when testing nanomaterials for human health and environmental safety endpoints.

This document follows on from a report entitled Important Issues on Risk Assessment of Manufactured Nanomaterials [ENV/JM/MONO(2012)8]. This report identified a range of issues which the WPMN considered important in risk assessment and which should be addressed in the future. It summarised results of a survey which was circulated to delegations of the WPMN, methodologies used to analyze the survey, and the identified priorities.

This Biosafety document aims to serve as an aid to risk assessors and regulators; providing guidance on handling the aspects of an environmental safety assessment, accessing and using information in situations of low-level presence (LLP) of transgenic plants in seed and grain commodities.

The OECD has published a revision of the 2003 Emission Scenario Document on Wood Preservatives to take into account the experience gained in working with the 2003 ESD. The document has been totally restructured, emission scenarios have been updated and new, niche scenarios have been added. The document is an essential tool for Member countries working in the area of biocidal products assessment.

This document supplies basic information useful in the risk and safety assessment of food and feed using new varieties of oyster mushroom: compositional considerations, key constituents (nutrients, anti-nutrients and toxicants). It is issued in the Novel Food and Feed Safety Series.

This new document is available as a tool for environmental safety assessment of new varieties of sugarcane derived from modern biotechnology. Given the large production of this crop worldwide, its biosafety will be an important issue for many countries.

This Bio-pesticides seminar report presents an overview of similarities and differences between species and strains within the Trichoderma genus. This fungus illustrates many general issues related to the use of micro-organisms for pest management.

This document provides information on the sources, use patterns, and potential release pathways of chemicals used in the manufacture of thermal and carbonless copy paper. It presents approaches for estimating the environmental releases of and occupational exposures to additives and components used in thermal and carbonless copy paper coatings.

The OECD has published the second edition of the guidance on grouping of chemicals. This edition has been augmented with experience and examples encountered in the OECD Cooperative Chemicals Assessment Programme. It also introduces new or revised guidance on elaborating the analogue and category approach, quantitative and qualitative read-across, justifying read-across, and using bioprofiling results for grouping chemicals.

This document compiles information on the current methodologies, tools and models and helps readers identify appropriate models/ and methodologies for estimating substance-specific removal/emissions from wastewater treatment systems. It could support efforts to improve these models and tools.

The first version of the Globally Harmonised Submission and Transport Standard was published May 2014. The GHSTS is a standardised set of technical specifications used to assemble electronic files for any pesticide package in a predefined manner. Once the files are assembled according to the specifications, they can be transferred from a business entity to a regulatory authority and can be extracted for use in a regulatory process.

This document is a tool for environmental safety assessment of novel varieties of Cassava derived from modern biotechnology. Cassava is a key staple crop in Africa, Asia and Latin America, this document will be useful to many readers interested in biosafety issues.

OECD major events and activities relating to biotechnologies: latest developments are updated biannually in this Newsletter

This OECD monograph demonstrates how a chemical hazard assessment that considers and ranks all available relevant information - a so-called weight of evidence approach - can be constructed to conclude on a particular hazard endpoint for a chemical, in this case, skin sensitisation for 4-isopropylaniline.

This guidance document proposes an integrated approach on testing and assessment for skin corrosion and irritation, in view of replacing the "testing and evaluation strategy" provided in the supplement to OECD TG404 (to be updated), provides information on key performance characteristics of each information source comprising the IATA, and guidance on how to integrate information for decision making for classification and labeling.

This scoping document brings forward relevant in vitro and ex vivo thyroid assays to the attention of OECD member countries, and provide recommendations for their further development/use, and also, to identify aspects of the thyroid signalling pathway that are not covered and would require further attention

This report of a survey collates member countries’ approaches to manage and mitigate the risk of pesticide use near residential areas.

This publication is a tool for environmental safety assessment of EUCALYPTUS novel lines. Planted in the tropics and sub-tropics, E. species can be genetically-engineered for resistance to disease/drought/cold/salinity, or lower lignin content. Elements useful to biosafety evaluation are detailed, e.g. Eucalyptus taxonomy, origin, reproduction, genetics, hybridisation, ecology, allergens-toxins, beneficial chemical products, breeding.

The OECD has published a report on a pilot chemical classification exercise undertaken in 2013 and ‘14. Using a number of chemical assessments agreed in the OECD hazard assessment programme, reasons why classification proposals may differ were investigated. The report concludes on the main reasons for such differences, and recommends some measures to overcome some of them.

The OECD Advisory Group on Endocrine Disrupters Testing and Assessment met on 16-17 October 2014 in Paris to discuss the development and update of Test Guidelines and related documents for endocrine disrupters testing and assessment.

A cooperative global approach to the regulation of agricultural pesticides and sustainable pest management. Pesticides are widely used in agriculture and have considerable benefits by contributing to a sustainable production of food and feed. If used improperly or in an inappropriate manner, they also can present unacceptable risks to human and animal health and to the environment.

An addendum to the OECD Guiding Principles on Chemical Accident Prevention, Preparedness and Response to address Natural Hazards Triggering Technological Accidents (Natech) Risk Management has just been published. The addendum consists of a number of amendments to the Guiding Principles and the addition of a new Chapter to provide more detailed guidance on Natech prevention, preparedness and response.

Micro-organisms play a fundamental role in the environment. Yet their role is the result of complex biogeochemical processes by consortia of micro-organisms and the function of individual species is not clear in many cases. This publication provides an overview of the current situation and relevant developments in environmental microbiology.

This toolbox is a compilation of resources relevant to chemical substitution and alternatives assessments. Alternative assessments are processes for identifying, comparing and selecting safer alternatives to replace hazardous chemicals with the objective of promoting sustainable production and consumption.

The OECD has just published two new Test Guidelines on human health hazard endpoint skin sensitisation. Skin sensitisation refers to an allergic response following skin contact with the tested chemical, as defined by the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS).

In 2011, Brazil joined OECD’s Mutual Acceptance of Data (MAD) system ensuring that its chemical safety test data will be accepted by all 40 countries adhering to MAD. Originally limited to data developed in Brazil on pesticides, biocides and industrial chemicals, it now also includes veterinary products, feed additives, cosmetics, pharmaceutical products, sanitizers, wood preservative and treatments of effluents and natural ecosystems.

The new version of the IOMC Toolbox for Decision Making in Chemicals Management provides a set of interactive features allowing governments to use it as a platform for collaboration among ministries, agencies, and other stakeholders such as industry. Users can save their information, add comments, and share and discuss issues with colleagues and partners.

The OECD eChemPortal, a web portal which offers comprehensive information on chemical substances, has been updated to offer better access to chemical classifications according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

The OECD/UNEP Global PFC group has published two new reports to support efforts in the framework of the Strategic Approach to International Chemicals Management (SAICM) to improve information sharing at a global level on perfluorinated chemistries.

The OECD has published fundamental and guiding principles to facilitate the application of QSAR methods to the risk assessment of chemicals. The main focus is on the critical role of mechanistic consideration in improving various (Q)SAR approaches and possible integrative approaches of combining chemoinformatics and bioinformatics.

This new document focuses on the evaluation of test methods applied to determine the physico-chemical properties of different types of nanomaterials.

This new Advisory Document replaces the 1995 consensus document on the Application of the Principles of GLP to Computerised Systems. It retains all of the key text from the original 1995 document, but includes new text to reflect the current state-of-the art in this field.

German database Information system für gefährliche Stoffe IGS is now linked to eChemPortal. The IGS provides public access to a variety of information on chemical and microbiological substances mostly in German. The focus is on regulatory information reflecting German and European, as well as Swiss, US and selected other legislation and assessments. Beside this, information on substance data and emergency procedures is available.

Results of a joint pilot project of the OECD and the UN Sub-Committee of Exports on the Globally Harmonised System of Classification and Labelling of Chemicals (UNSCEGHS) including a report of the results of the pilot and non-biding proposed classifications for three substances.

GLP issues raised by testing labs are covered in this comprehensive list of questions and answers, recently updated with questions related to: sponsors, Contract Research Organisations (CROs), sub-contractors, archives, Information Technology (IT), Biotechnology/GMOs and other miscellaneous issues

This new council act recommends that Member countries take steps to establish, as appropriate, implement and make publicly available a pollutant release and transfer register (PRTR) system using the principles and information set forth in the OECD Guidance Documents on PRTRs.

The Decision-Recommendation on the Co-operative Investigation and Risk Reduction of Chemicals revises and replaces a 1991 Decision-Recommendation of the Council. The Decision-Recommendation is composed of two parts: Part A focuses on the development of harmonised hazard and exposure assessment methodologies for chemicals and Part B focuses on risk prevention and reduction.

The OECD Conference on Genome Editing: Applications in Agriculture – Implications for Health, Environment and Regulation will explore the regulatory considerations raised by genome edited products, with the aim to favour a coherent policy approach to facilitate innovation involving genome editing. More information on the programme and the speakers.

This guidance document was originally published in 2012 and updated in 2018 to reflect new and updated OECD test guidelines, as well as reflect on scientific advances in the use of test methods and assessment of the endocrine activity of chemicals. The document is intended to provide guidance for evaluating chemical using standardised test guidelines.

This paper reviews and compares five case studies on quantification and economic valuation of benefits in cost-benefit analyses (CBAs) of regulating phthalates, mercury, PFOA (perfluoro-octanic acid) and its salts, NMP (1 methyl-2-pyrroloidine) and formaldehyde. The case studies had all been carried out as part of the SACAME project, and the purpose of the present paper is to draw out cross-cutting findings from these studies.