Risk analysis in manufacturing footprint decisions

A key aspect in the manufacturing footprint analysis is the risk and sensitivity analysis of critical parameters. In order to contribute to efficient industrial methods and tools for making well-founded strategic decisions regarding manufacturing footprint this paper aims to describe the main risks that need to be considered while locating manufacturing activities, and what risk mitigation techniques and strategies that are proper in order to deal with these risks. It is also proposed how the risk analysis should be included in the manufacturing location decision process

Genome editing in food and feed production – implications for risk assessment. Scientific Opinion of the Scientific Steering Committee of the Norwegian Scientific Committee for Food and Environment

The Norwegian Scientific Committee for Food and Environment (VKM) initiated this work to examine the extent to which organisms developed by genome-editing technologies pose new challenges in terms of risk assessment. This report considers whether the risk assessment guidance on genetically modified organisms, developed by the European Food Safety Authority (EFSA), can be applied to evaluate potential risks of organisms developed by genome editing. Background Gene technology has allowed for the transfer of genes between organisms and species, and thereby to design altered genotypes with novel traits, i.e. GMOs. A new paradigm started in the early 2000s with the development of genome-editing techniques. Unlike traditional genetic modification techniques resulting in insertion of foreign DNA fragments at random locations in the genome, the new genome-editing techniques additionally open for a few single nucleotide edits or short insertions/deletions at a targeted site in an organism’s genome. These new techniques can be applied to most types of organisms, including plants, animals and microorganisms of commercial interest. An important question is how the novel, genome-edited organisms should be evaluated with respect to risks to health and the environment. The European Court of Justice decided in 2018 to include genome-edited organisms in the GMO definition and hence in the regulatory system already in place. This implies that all products developed by genome-editing techniques must be risk-assessed within the existing regulatory framework for GMOs. The European and Norwegian regulatory frameworks regulate the production, import and placing on the market of food and feed containing, consisting of or produced from GMOs, as well as the release of GMOs into the environment. The assessment draws on guidance documents originally developed by EFSA for risk assessment of GMOs, which were drawn up mainly to address risks regarding insertion of transgenes. The new genome-editing techniques, however, provide a new continuum of organisms ranging from those only containing a minor genetic alteration to organisms containing insertion or deletion of larger genomic regions. Risk assessment of organisms developed by genome editing The present discourse on how new genome-editing techniques should be regulated lacks an analysis of whether risk assessment methodologies for GMOs are adequate for risk assessment of organisms developed through the use of the new genome-editing techniques. Therefore, this report describes the use of genome-editing techniques in food and feed production and discusses challenges in risk assessment with the regulatory framework. Specifically, this report poses the question as to whether the EFSA guidance documents are sufficient for evaluating risks to health and environment posed by genome-edited plants, animals and microorganisms. To address these questions, the report makes use of case examples relevant for Norway. These examples, intended for food and feed, include oilseed rape with a modified fatty acid profile, herbicide-tolerant and pest-resistant crops, sterile salmon, virus-resistant pigs and hornless cattle. The report considers all aspects of the stepwise approach as described in the EFSA guidance documents. Conclusions The inherent flexibility of the EFSA guidance makes it suitable to cover health and environmental risk assessments of a wide range of organisms with various traits and intended uses. Combined with the embedded case-by-case approach the guidance is applicable to genome-edited organisms. The evaluation of the guidance demonstrates that the parts of the health and environmental risk assessment concerned with novel traits (i.e. the phenotype of the organism) may be fully applied to all categories of genome-edited organisms. ............publishedVersio

Genome editing in food and feed production – implications for risk assessment. Scientific Opinion of the Scientific Steering Committee of the Norwegian Scientific Committee for Food and Environment

The Norwegian Scientific Committee for Food and Environment (VKM) initiated this work to examine the extent to which organisms developed by genome-editing technologies pose new challenges in terms of risk assessment. This report considers whether the risk assessment guidance on genetically modified organisms, developed by the European Food Safety Authority (EFSA), can be applied to evaluate potential risks of organisms developed by genome editing. Background Gene technology has allowed for the transfer of genes between organisms and species, and thereby to design altered genotypes with novel traits, i.e. GMOs. A new paradigm started in the early 2000s with the development of genome-editing techniques. Unlike traditional genetic modification techniques resulting in insertion of foreign DNA fragments at random locations in the genome, the new genome-editing techniques additionally open for a few single nucleotide edits or short insertions/deletions at a targeted site in an organism’s genome. These new techniques can be applied to most types of organisms, including plants, animals and microorganisms of commercial interest. An important question is how the novel, genome-edited organisms should be evaluated with respect to risks to health and the environment. The European Court of Justice decided in 2018 to include genome-edited organisms in the GMO definition and hence in the regulatory system already in place. This implies that all products developed by genome-editing techniques must be risk-assessed within the existing regulatory framework for GMOs. The European and Norwegian regulatory frameworks regulate the production, import and placing on the market of food and feed containing, consisting of or produced from GMOs, as well as the release of GMOs into the environment. The assessment draws on guidance documents originally developed by EFSA for risk assessment of GMOs, which were drawn up mainly to address risks regarding insertion of transgenes. The new genome-editing techniques, however, provide a new continuum of organisms ranging from those only containing a minor genetic alteration to organisms containing insertion or deletion of larger genomic regions. Risk assessment of organisms developed by genome editing The present discourse on how new genome-editing techniques should be regulated lacks an analysis of whether risk assessment methodologies for GMOs are adequate for risk assessment of organisms developed through the use of the new genome-editing techniques. Therefore, this report describes the use of genome-editing techniques in food and feed production and discusses challenges in risk assessment with the regulatory framework. Specifically, this report poses the question as to whether the EFSA guidance documents are sufficient for evaluating risks to health and environment posed by genome-edited plants, animals and microorganisms. To address these questions, the report makes use of case examples relevant for Norway. These examples, intended for food and feed, include oilseed rape with a modified fatty acid profile, herbicide-tolerant and pest-resistant crops, sterile salmon, virus-resistant pigs and hornless cattle. The report considers all aspects of the stepwise approach as described in the EFSA guidance documents. Conclusions The inherent flexibility of the EFSA guidance makes it suitable to cover health and environmental risk assessments of a wide range of organisms with various traits and intended uses. Combined with the embedded case-by-case approach the guidance is applicable to genome-edited organisms. The evaluation of the guidance demonstrates that the parts of the health and environmental risk assessment concerned with novel traits (i.e. the phenotype of the organism) may be fully applied to all categories of genome-edited organisms. ............acceptedVersionpublishedVersio

Interbasin Water Transfers and Water Scarcity in a Changing World: A Solution or a Pipedream?

The world is increasingly forced to face the challenge of how to ensure access to adequate water resources for expanding populations and economies, whilst maintaining healthy freshwater ecosystems and the vital services they provide. Now the growing impacts of climate change are exacerbating the problem of water scarcity in key regions of the world. One popular way for governments to distribute water more evenly across the landscape is to transfer it from areas with perceived surpluses, to those with shortages.While there is a long history of water transfers from ancient times, as many societies reach the limits of locally renewable water supplies increasingly large quantities of water are being moved over long distances, from one river basin to another. Since the beginning of dam building that marked the last half of the 1900s more that 364 large-scale interbasin water transfer schemes (IBTs) have been established that transfer around 400 km³ of water per year (Shiklomanov 1999). IBTs are now widely touted as the quick fix solution to meeting escalating water demands. One estimate suggests that the total number of largescale water transfer schemes may rise to between 760 and 1 240 by 2020 to transfer up to 800 km³ of water per year (Shiklomanov 1999).The wide range of IBT projects in place, or proposed, has provoked the preparation of this review, including seven case studies from around the globe. It builds on previous assessments and examines the costs and benefits of large scale IBTs. This report assesses related, emerging issues in sustaining water resources and ecosystems, namely the virtual water trade, expanding use of desalination, and climate change adaptation. It is based on WWF's 2007 publication "Pipedreams? Interbasin water transfers and water shortages".The report concludes that while IBTs can potentially solve water supply issues in regions of water shortage - they come with significant costs. Large scale IBTs are typically very high cost, and thus economically risky, and they usually also come with significant social and environmental costs; usually for both the river basin providing and the river basin receiving the water

Development and testing of a risk indexing framework to determine field-scale critical source areas of faecal bacteria on grassland.

This paper draws on lessons from a UK case study in the management of diffuse microbial pollution from grassland farm systems in the Taw catchment, south west England. We report on the development and preliminary testing of a field-scale faecal indicator organism risk indexing tool (FIORIT). This tool aims to prioritise those fields most vulnerable in terms of their risk of contributing FIOs to water. FIORIT risk indices were related to recorded microbial water quality parameters (faecal coliforms [FC] and intestinal enterococci [IE]) to provide a concurrent on-farm evaluation of the tool. There was a significant upward trend in Log[FC] and Log[IE] values with FIORIT risk score classification (r2 =0.87 and 0.70, respectively and P<0.01 for both FIOs). The FIORIT was then applied to 162 representative grassland fields through different seasons for ten farms in the case study catchment to determine the distribution of on-farm spatial and temporal risk. The high risk fields made up only a small proportion (1%, 2%, 2% and 3% for winter, spring, summer and autumn, respectively) of the total number of fields assessed (and less than 10% of the total area), but the likelihood of the hydrological connection of high FIO source areas to receiving watercourses makes them a priority for mitigation efforts. The FIORIT provides a preliminary and evolving mechanism through which we can combine risk assessment with risk communication to end-users and provides a framework for prioritising future empirical research. Continued testing of FIORIT across different geographical areas under both low and high flow conditions is now needed to initiate its long term development into a robust indexing tool

Article X: Some Building Blocks

YesThe Ad Hoc Group (AHG) of the States Parties to the Biological and Toxin Weapons Convention (BTWC) has the consideration of measures to implement Article X of the Convention as an element of its mandate agreed by the Special Conference in September 1994. The AHG has considered how to address this at each of its substantive meetings with a Friend of the Chair, initially Ambassador Jorge Berguno of Chile and subsequently, Carlos Duarte of Brazil carrying out this responsibility. As progress is being made on the development of the rolling text for the Protocol to strengthen the Convention, it is timely to consider how the implementation of Article X might contribute to the strengthening of the effectiveness of the Convention. This Briefing Paper considers some of the developments that have occurred nationally, regionally and internationally in respect of the use of bacteriological (biological) agents and toxins for peaceful purposes. It has become apparent that there is increasing awareness world-wide because of public health and environmental concerns of the need to control the handling, use, storage and transfer of such biological agents. This paper examines some of the current controls and regulations for biological agents and the international initiatives that are ongoing to strengthen biosafety around the world. These are seen as building blocks which might be considered from a point of view of strengthening the BTWC as well as contributing to the implementation of Article X although care will need to be taken in the Protocol for the AHG to avoid unnecessary duplication with other international activities. The challenging goal is to identify how these other national, regional and international activities can be utilised to contribute to the strengthening of the BTWC

An Environmental Science and Engineering Framework for Combating Antimicrobial Resistance

On June 20, 2017, members of the environmental engineering and science (EES) community convened at the Association of Environmental Engineering and Science Professors (AEESP) Biennial Conference for a workshop on antimicrobial resistance. With over 80 registered participants, discussion groups focused on the following topics: risk assessment, monitoring, wastewater treatment, agricultural systems, and synergies. In this study, we summarize the consensus among the workshop participants regarding the role of the EES community in understanding and mitigating the spread of antibiotic resistance via environmental pathways. Environmental scientists and engineers offer a unique and interdisciplinary perspective and expertise needed for engaging with other disciplines such as medicine, agriculture, and public health to effectively address important knowledge gaps with respect to the linkages between human activities, impacts to the environment, and human health risks. Recommendations that propose priorities for research within the EES community, as well as areas where interdisciplinary perspectives are needed, are highlighted. In particular, risk modeling and assessment, monitoring, and mass balance modeling can aid in the identification of “hot spots” for antibiotic resistance evolution and dissemination, and can help identify effective targets for mitigation. Such information will be essential for the development of an informed and effective policy aimed at preserving and protecting the efficacy of antibiotics for future generations

Water in the Green Economy: Capacity Development Aspects

This book discusses needs related to capacity development for water resources management, including water supply and sanitation, in the context of the green economy. It showcases theoretical and practical approaches with proven success. Most contributions come from members and partners within the interagency mechanism, UN-Water. The 11 case studies in this book range from innovative design and delivery of capacity development programs related to water in the green economy, market mechanisms, and quality control procedures supporting capacity development success towards the practical implementation of programs to enhance individual and institutional capacity

An integrated approach to supply chain risk analysis

Despite the increasing attention that supply chain risk management is receiving by both researchers and practitioners, companies still lack a risk culture. Moreover, risk management approaches are either too general or require pieces of information not regularly recorded by organisations. This work develops a risk identification and analysis methodology that integrates widely adopted supply chain and risk management tools. In particular, process analysis is performed by means of the standard framework provided by the Supply Chain Operations Reference Model, the risk identification and analysis tasks are accomplished by applying the Risk Breakdown Structure and the Risk Breakdown Matrix, and the effects of risk occurrence on activities are assessed by indicators that are already measured by companies in order to monitor their performances. In such a way, the framework contributes to increase companies' awareness and communication about risk, which are essential components of the management of modern supply chains. A base case has been developed by applying the proposed approach to a hypothetical manufacturing supply chain. An in-depth validation will be carried out to improve the methodology and further demonstrate its benefits and limitations. Future research will extend the framework to include the understanding of the multiple effects of risky events on different processe

Assessing the joint impact of DNAPL source-zone behavior and degradation products on the probabilistic characterization of human health risk

The release of industrial contaminants into the subsurface has led to a rapid degradation of groundwater resources. Contamination caused by Dense Non-Aqueous Phase Liquids (DNAPLs) is particularly severe owing to their limited solubility, slow dissolution and in many cases high toxicity. A greater insight into how the DNAPL source zone behavior and the contaminant release towards the aquifer impact human health risk is crucial for an appropriate risk management. Risk analysis is further complicated by the uncertainty in aquifer properties and contaminant conditions. This study focuses on the impact of the DNAPL release mode on the human health risk propagation along the aquifer under uncertain conditions. Contaminant concentrations released from the source zone are described using a screening approach with a set of parameters representing several scenarios of DNAPL architecture. The uncertainty in the hydraulic properties is systematically accounted for by high-resolution Monte Carlo simulations. We simulate the release and the transport of the chlorinated solvent perchloroethylene and its carcinogenic degradation products in randomly heterogeneous porous media. The human health risk posed by the chemical mixture of these contaminants is characterized by the low-order statistics and the probability density function of common risk metrics. We show that the zone of high risk (hot spot) is independent of the DNAPL mass release mode, and that the risk amplitude is mostly controlled by heterogeneities and by the source zone architecture. The risk is lower and less uncertain when the source zone is formed mostly by ganglia than by pools. We also illustrate how the source zone efficiency (intensity of the water flux crossing the source zone) affects the risk posed by an exposure to the chemical mixture. Results display that high source zone efficiencies are counter-intuitively beneficial, decreasing the risk because of a reduction in the time available for the production of the highly toxic subspecies.Peer ReviewedPostprint (author's final draft