Latest Documents

Volume 10 of the Series contains the consensus document on the 'Environmental Considerations for Risk/Safety Assessment for the Release of Transgenic Plants' developed by the OECD Working Party on the Harmonisation of Regulatory Oversight in Biotechnology. Transgenic plant varieties are subject to official risk/safety assessment, science-based and case-by-case, before their potential release into the environment. The document contains general information on environmental risk/safety assessment, its key concepts, structure and planning. Annexes describe seven examples of environmental considerations routinely examined by assessors and taken from experience gained during such assessment: Invasiveness and weediness; Vertical gene flow; Organisms (animals); Soil functions; Plant health; Crop management practices; and Biodiversity (protected species and habitats/ecosystems). The purpose of this document is not to elaborate new terminology or to describe how to undertake an actual risk/safety assessment, but rather to outline an approach and provide illustrative examples for helping assessors in planning and structuring an environmental risk/safety assessment. This document should be of interest to regulators and safety assessors, as well as to plant breeders and the wider scientific community. More information, including other tools for environmental risk/safety assessment such as OECD consensus documents on the biology of crop species, are found at BioTrack Online.

Several efforts have been made to track progress on environmental innovations using very different approaches. However, many lack coverage, granularity, timeliness and may involve high data collection costs, especially when conducted on a large scale. Traditional indicators also overlook commercialised innovation and breakthrough innovation. This issue is particularly relevant for environmental innovation, where scaling-up is considered key to address the climate, biodiversity and pollution crises. The paper reviews potential metrics to measure commercialised climate change-related innovation and to measure breakthrough environmental innovation. By comparing advantages and drawbacks of various options, the paper selects two families of metrics to measure commercialised climate change-related innovation: one based on patent assignments and the other one based on licensing agreements. For breakthrough environmental innovation, the paper concludes that a family of metrics based on venture capital data is currently the most promising option to pursue. The paper then develops the selected new metrics and provides trends in environmental innovation over time, across sectors and when possible across countries. The paper concludes that additional data sources should be explored to extend the application of the proposed new metrics in more countries and consider a more comprehensive set of supports to innovation.

This Adverse Outcome Pathway (AOP) describes the linkage between oxidative DNA damage and irreversible genomic damage (chromosomal aberrations and mutations). DNA damage is considered an important contributor to the adverse health effects of many environmental toxicants and this AOP may thus be of widespread use to the regulatory community. Although increase in oxidative DNA damage is the molecular initiating event for this AOP, there are numerous upstream key events that can also lead to DNA oxidation. Thus, this AOP may be expanded upstream, and could be incorporated into a variety of AOP networks. Furthermore, the AOP points to critical research gaps required to establish the quantitative associations and modulating factors that connect KEs across the AOP, and highlights the utility of novel test methods in understanding and evaluating the implications of oxidative DNA damage. This AOP is referred to as AOP 296 in the Collaborative Adverse Outcome Pathway Wiki (AOP-Wiki).

Environmental crime is on the rise and is of growing concern to policy makers, to legitimate businesses, and more broadly to the general public. It is growing rapidly worldwide on average at over 8% per year, with an estimated value between USD 110-281 billion in 2018. Emerging issues include wildlife trafficking, illegal timber, illegal mining, illegal chemicals, illegal waste trafficking, and illegal, unreported and unregulated (IUU) fishing. Environmental crime can have serious implications to human health and the environment, to the global economy, and more broadly to good governance, national security and sustainable development. Addressing these criminal activities affecting the environment is difficult exclusively at the national level as they often extend on a transnational scale. In this context, this report provides a snapshot of cross-border environmental crime and available initiatives to tackle illegal activities at a transnational scale, with a particular focus on multilateral and regional frameworks. The key message from this report is that the increasing prevalence of cross-border environmental crime is due to regulatory failures and the growing involvement of transnational organised crimes, which require an internationally co-ordinated response, both at the multilateral and regional level.

This Test guideline describes studies on phototransformation in water to determine the potential effects of solar irradiation on chemicals in surface water, considering direct photolysis only. It is designed as a tiered approach. The Tier 1 is based on a theoretical screen. The rate of decline of a test chemical in a direct photolysis study is generally assumed to follow pseudo first-order kinetics. If the maximum possible losses is estimated to be superior or equal to 50% of the initial concentration over a 30-day period, an experimental study is proceeded in Tier 2. The direct photolysis rate constants for test chemicals in the laboratory is determined using preferably a filtered xenon arc lamp capable of simulating natural sunlight in the 290 to 800 nm, or sunlight irradiation, and extrapolated to natural water. If estimated losses are superior or equal to 20%, the transformation pathway and the identities, concentrations, and rate of formation and decline of major transformation products are identified. An optional task is the additional determination of the quantum yield for various types of water bodies, seasons, and latitudes of interest. The test chemical should be directly dissolved in the aqueous media saturated in air at a concentration which should not exceed half its solubility. For linear and non-linear regressions on the test chemical data in definitive or upper tier tests, the minimum number of samples collected should be 5 and 7 respectively. The exact number of samples and the timing of their collection is determined by a preliminary range-finding. Replicates (at least 2) of each experimental determination of kinetic parameters are recommended to determine variability and reduce uncertainty in their determination.

This Test Guideline describes an in vitro screen for chemical effects on steroidogenesis, specifically the production of 17ß-estradiol (E2) and testosterone (T). The human H295R adreno-carcinoma cell line, used for the assay, expresses genes that encode for all the key enzymes for steroidogenesis. After an acclimation period of 24 h in multi-well plates, cells are exposed for 48 h to seven concentrations of the test chemical in at least triplicate. Solvent and a known inhibitor and inducer of hormone production are run at a fixed concentration as negative and positive controls. At the end of the exposure period, cell viability in each well is analyzed. Concentrations of hormones in the medium can be measured using a variety of methods including commercially available hormone measurement kits and/or instrumental techniques such as liquid chromatography-mass spectrometry. Data are expressed as fold change relative to the solvent control and the Lowest-Observed-Effect-Concentration. If the assay is negative, the highest concentration tested is reported as the No-Observed-Effect-Concentration.