Meeting the challenge of quantitative risk assessment for genetic control techniques: a framework and some methods applied to the common Carp (Cyprinus carpio) in Australia

In Australia the European carp is widespread, environmentally damaging and difficult to control. Genetic control options are being developed for this species but risk-assessment studies to support these options have been limited. The key science challenge in this context is our limited understanding of complex and highly variable ecosystems. Hierarchical models are one way to approach this complexity and heterogeneity. These models treat the factors that determine risk as a joint probability distribution that can be factored into a series of simpler conditional distributions to allow Bayesian inference following observed outcomes. Designing a risk assessment around this approach, however, requires that the assessment endpoints (such as impacts on native species) are measurable, and that monitoring strategies are carefully designed and implemented in order that risk predictions are compared to outcomes. We therefore suggest that an evidence-based framework, supported by careful hazard analysis and quantitative risk assessment, and implemented within a stage-released protocol, is the safest way to move beyond the current emphasis on contained laboratory studies and qualitative risk assessments. We highlight impediments to this approach, and use the non-target impacts of daughterless carp in Australian billabongs as a case study to illustrate three methodological tools that not only provide solutions to some of these impediments but also encourage stakeholder participation in the risk assessment process.     

污染场地土壤生态风险评估研究进展

随着我国快速城市化以及产业结构的调整,遗留下了大量的污染场地,发展和实施污染场地土壤生态风险评估是进行大规模污染场地修复行动的必要条件。本文围绕污染场地土壤生态风险评估的科学原理、框架构建及技术方法等方面的关键问题: 1)评估框架的场地实际针对性;2)概念模型的不确定性;3)土壤复合污染毒性机制;4)评估终点筛选;5)评估方法和框架构建等展开讨论,指出土壤复合污染的制毒机制,即污染物生物有效性和联合效应是污染场地土壤生态风险评估的关键科学问题。耦合美国环保局四步法和欧盟层级法的“证据-权重法”评估框架适用于野外复杂环境条件下的土壤污染生态风险评估。建议今后重点开展以下5个方面的工作: 1)污染场地土壤生态风险评估技术框架与风险管控技术框架之间的联合;2)概念模型研究;3)基于过程的场地土壤污染物反应运移模型研究;4)场地土壤复合污染生态毒理学机制研究;5)生态系统高水平生态风险评估终点研究。旨在为形成我国本土污染场地土壤生态风险评估技术指南提供理论基础和构架。     

An Assessment of Integrated Risk Assessment

In order to promote international understanding and acceptance of the integrated risk assessment process, the World Health Organization/International Programme on Chemical Safety (WHO/IPCS), in collaboration with the U.S. Environmental Protection Agency and the Organization for Economic Cooperation and Development, initiated a number of activities related to integrated risk assessment. In this project, the WHO/IPCS defines integrated risk assessment as a science-based approach that combines the processes of risk estimation for humans, biota, and natural resources in one assessment. This article explores the strengths and weaknesses of integration as identified up to this date and the degree of acceptance of this concept by the global risk assessment/risk management community. It discusses both opportunities and impediments for further development and implementation.

The major emerging opportunities for an integrated approach stem from the increasing societal and political pressure to move away from vertebrate testing leading to a demand for scientific integrated approaches to in vitro and in vivo testing, as well as to computer simulations, in so-called Intelligent Testing Strategies. In addition, by weighing the evidence from conventional mammalian toxicology, ecotoxicology, human epidemiology, and eco-epidemiology, risk assessors could better characterize mechanisms of action and the forms of the relationships of exposures to responses. It is concluded that further demonstrations of scientific, economic and regulatory benefits of an integrated approach are needed. As risk assessment is becoming more mechanistic and molecular this may create an integrated approach based on common mechanisms and a common systems-biology approach.     

Integrated Human and Ecological Risk Assessment: A Case Study of Organophosphorous Pesticides in the Environment

This study was chosen as an example of integrated risk assessment because organophosphorous esters (OPs) share exposure characteristics for different species, including human beings and because a common mechanism of action can be identified. The “Framework for the integration of health and ecological risk assessment” is being tested against a deterministic integrated environmental health risk assessment for OPs used in a typical farming community. It is argued that the integrated approach helps both the risk manager and the risk assessor in formulating a more holistic approach toward the risk of the use of OP-esters. It avoids conclusions based on incomplete assessments or on separate assessments. The database available can be expanded and results can be expressed in a more coherent manner. In the integrated exposure assessment of OPs, the risk assessments for human beings and the environment share many communalities with regards to sources and emissions, distribution routes and exposure scenarios. The site of action of OPs, acetylcholinesterase, has been established in a vast array of species, including humans. It follows that in the integrated approach the effects assessment for various species will show communalities in reported effects and standard setting approaches. In the risk characterization, a common set of evidence, common criteria, and common interpretations of those criteria are used to determine the cause of human and ecological effects that co-occur or are apparently associated with exposure to OPs. Results of health and ecological risk assessments are presented in a common format that facilitates comparison of results. It avoids acceptable risk conclusions with regard to the environment, which are unacceptable with regard to human risk and vice versa. Risk managers will be prompted to a more balanced judgement and understanding and acceptance of risk reduction measures will be facilitated.     

Plan for an Integrated Human and Environmental Risk Assessment in the S. Domingos Mine Area (Portugal)

The need for the integration of the assessment of human and ecological risks in contaminated areas, such as derelict mines, widely increases. The risk assessment process is becoming a powerful tool to provide sound scientific bases for decision-making processes. In Portugal, the risk assessment process is in its early years and the lack of multidisciplinary teams of experts is frequently mentioned as the main obstacle to its implementation. Therefore, the majority of the reclamation actions are based on impact assessment studies that usually are characterized by few biological and toxicological considerations. In order to account for some of these constraints, the ecological risk assessment framework proposed by the U.S. Environmental Protection Agency was used to plan the assessment of human and ecological risks posed by the high concentrations of metals scattered in the vicinity of S. Domingos mine, a cuprous pyrite mine located in the Southeast Alentejo (Portugal). This study presents the problem formulation phase of the assessment. It includes all the scientific information available for the area, a conceptual model, and an analysis plan for the risk assessment process. Following a tiered approach, several tasks were planned in order to acquire chemical, toxicological, and ecological information, in order to compensate for the lack of toxicity data for site-specific species.     

Biotechnology in reproductive medicine

In this review I am summarizing the past and current progress in the field of pharmaceutical, diagnostic, therapeutic, and reproductive cloning in mammals. Several human gene products can be pharmaceutically explored in transgenic farm animals and employed for medical applications. Preimplantation genetic diagnosis (PGD) is utilizing modern molecular cloning techniques to detect genetic and chromosomal aberrations in early embryos originating from patients with inborn errors at risk for hereditary diseases or age-related risk for abnormal karyotype. Stem cell engineering from early human embryos is creating new and promising but also controversial applications for therapeutic and regenerative medicine. Potential risk factors for reproductive cloning are presented and discussed in the context of possible developmental malformations, frequently observed after embryo culture and cloning in farm animals. Future extension of biotechnology to human reproductive cloning is currently under worldwide dispute.     

我国转基因技术风险交流分析

随着生物技术的迅猛发展,发展转基因产业的战略选择与公众对转基因安全疑虑的矛盾十分突出。通过转基因舆情分析,指出我国转基因风险交流存在的不足主要为风险交流工作缺乏顶层设计,信息公开程度较低,风险交流方式和内容单调,公益机构未能发挥应有作用。在此基础上,提出了加强转基因风险交流的政策建议:(1)明确转基因风险交流的目标;(2)建立转基因风险交流协调框架;(3)建立转基因信息公开平台和信息监测平台;(4)完善管理部门和公益机构的风险交流职能;(5)改革科技项目政策。     

新加坡农业生物技术年报（2020）

目前,新加坡国内还没有任何植物生物技术投入商业化生产。截至2020年10月,新加坡共有43种转基因（genetically engineered,GE）植物产品获准用作食品或食品成分。新加坡遗传改良咨询委员会（Genetic Modification Advisory Committee,GMAC）最近修订了关于基因叠加事件的法规,采用“高覆盖低”的方法,对来源于先前GMAC认可的较低阶组合的高阶叠加事件组合豁免监管评估。     

Risk Assessment in Navy Deployment Toxicology

The risk assessment process is a critical function for deployment toxicology research. It is essential to the decision making process related to establishing risk reduction procedures and for formulating appropriate exposure levels to protect naval personnel from potentially hazardous chemicals in the military that could result in a reduction in readiness operations. These decisions must be based on quality data from well-planned laboratory animal studies that guide the judgements, which result in effective risk characterization and risk management. The process of risk assessment in deployment toxicology essentially uses the same principles as civilian risk assessment, but adds activities essential to the military mission, including intended and unintended exposure to chemicals and chemical mixtures. Risk assessment and Navy deployment toxicology data are integrated into a systematic and well-planned approach to the organization of scientific information. The purpose of this paper is to outline the analytical framework used to develop strategies to protect the health of deployed Navy forces.     

菲律宾农业生物技术年报(2011年)

菲律宾生物技术监管体系始终坚持以科学为依据,其他发展中国家逐渐将菲律宾作为生物技术政策和法规方面的楷模。第一种本地开发的转基因作物“Bt茄子”可能在2013年初前实现商业化,“金色水稻”可能紧随其后。目前没有生物技术相关的贸易中断的报道,美国出口的转基因产品在2010年继续保持增长。菲律宾农业政策仍然是以食品保障为导向,政策的制定工作一直以来保持积极态势。但是,最近批准的《菲律宾发展计划》支持了转基因产品的标签工作以及对环境风险评估采取谨慎态度。     

Regional Eco-Security Assessment Based on the Perspective of Complex System Science: A Case Study of Chongming in China

The objective of this study is to evaluate eco-security of Chongming in China and identify eco-security grades of the relevant subareas. In addition, the study aims to put forward the framework for a regional eco-security assessment system that is suitable for the analysis and evaluation of a man–land complex ecosystem. From the perspective of complex system science, this study puts forward the ANP-PRS-SENCE framework for a regional eco-security assessment. Based on the framework, a compressive assessment index system and a spatial variation assessment index system for Chongming's eco-security were established. Additionally, the eco-security threshold of Chongming was determined through the approach of system dynamics simulation. The assessment results show that in recent years the comprehensive score of eco-security has been on a gradual rise. With respect to the second-grade indices, the ecological risk and ecological protection indices are still relatively low. Therefore, in order to reduce the ecological risk, ecological construction needs to be strengthened and management measures need to be improved. The spatial variation assessment of eco-security shows that although the eco-security levels of most subareas remain between 0.3 and 0.6, regional variations are still quite obvious.     

SLE - Practical and theoretical barriers to the prevention of accelerated atherosclerosis in systemic lupus erythematosus

Accelerated atherosclerotic vascular disease (ASVD) is a major cause of death in systemic lupus erythematosus (SLE). Although many authorities are calling for aggressive assessment and management of cardiac risk factors in patients with SLE, both theoretical and practical barriers to this approach exist. It seems that SLE and/or its treatment are themselves strong risk factors for the development of ASVD and it is unclear how much this risk can be decreased by the control of traditional risk factors. Studies from several centers have shown that suboptimal risk factor management and barriers to acceptance of these measures must also be studied further.     

Decision-making processes in ecological risk assessment using copper pollution of Macquarie Harbour from Mt. Lyell, Tasmania, as a case study

Ecological risk assessment is increasingly being used to make decisions on the acceptability of industrial processes, as well as on the appropriate approach to take with remediation of contaminated sites. In this approach, the risks and costs must first be determined before decisions can be made. In principle, the procedure for undertaking an ecological risk assessment for a site with existing contamination is fairly straight forward. Probability distributions are obtained for the concentration of the contaminant of concern and for the biological and/or structural impacts likely to occur in the affected habitat. The degree of overlap between these distributions determines the risk from the contaminant to the habitat. With water-borne contamination, the level of assessment can vary from a simple comparison with water quality criteria, through site specific literature surveys, to laboratory and field studies depending on the importance of the environment, the concentration and perceived nature of the contaminant,the resources available, and the likely benefit from the process to be developed. However, a number of uncertainties make this process more difficult. These include the lack of a standard methodology, availability of appropriate data and agreed definitions of acceptable risk. Thus several arbitrary or considered decisions need to be made before and during such an assessment. This paper discusses the application of an ecological risk assessment of copper pollution in Macquarie Harbour, Tasmania, using data from long-term monitoring of waters and literature searches on lethal and sub-lethal effects of copper in marine and estuarine environments. This study is part of a much larger program established to determine best methods for the remediation of the Mt. Lyell copper mine site as well as the freshwater and marine habitats downstream. The results of the assessment indicated that there was at present a probability greater than0.9 of the occurrence of anodic stripping voltametry-labile copper water concentrations harmful to 5% of all species. For total dissolved copper the probability was higher than 0.98. The upper value of total dissolved copper in Macquarie Harbour that encompassed 90% of the probable concentrations would need to be reduced by a factor of approximately 30,without the inclusion of any additional application factors, to achieve (sub-lethal) protection for 95%of species. This revised version was published online in August 2006 with corrections to the Cover Date.     

European Experience on Application of Site-Specific Ecological Risk Assessment in Terrestrial Ecosystems

This article describes the current state of the development toward a common European framework for site-specific ecological risk assessment (SS-ERA) Although common progression has been slow in the past two years, earlier activities were very promising. Results are presented of a 2001 workshop to discuss the scientific development and policy needs in preparation of such a common framework. The framework was recommended to follow a tiered approach. Other important elements for a common European framework for SS-ERA were identified to be the use of generic values in the first tier and bioassays in later tiers, to address bioavailability in the assessment, to differentiate for land use. Also, the framework should allow for negotiation between stakeholders specific to the site. These aspects are present in the Dutch approach to SS-ERA, and this article further presents some experience with the application of this framework in a large case of SS-ERA in The Netherlands. The derivation of suitable ecological parameters and assessment criteria in view of land use in a tiered approach risk assessment is focused on, and the interactive process between stakeholders and ongoing discussions concerning references and criteria for assessment are illustrated.     

Quality-by-Design II: Application of Quantitative Risk Analysis to the Formulation of Ciprofloxacin Tablets

Qualitative risk assessment methods are often used as the first step to determining design space boundaries; however, quantitative assessments of risk with respect to the design space, i.e., calculating the probability of failure for a given severity, are needed to fully characterize design space boundaries. Quantitative risk assessment methods in design and operational spaces are a significant aid to evaluating proposed design space boundaries. The goal of this paper is to demonstrate a relatively simple strategy for design space definition using a simplified Bayesian Monte Carlo simulation. This paper builds on a previous paper that used failure mode and effects analysis (FMEA) qualitative risk assessment and Plackett-Burman design of experiments to identity the critical quality attributes. The results show that the sequential use of qualitative and quantitative risk assessments can focus the design of experiments on a reduced set of critical material and process parameters that determine a robust design space under conditions of limited laboratory experimentation. This approach provides a strategy by which the degree of risk associated with each known parameter can be calculated and allocates resources in a manner that manages risk to an acceptable level.     

Perspectives on environmental risk assessment

Risk is by no means a simple concept. Natural variability and definitional problems with the concept of probability complicate the measurement and use of risk as an analytical tool. Variability requires that risk assessment methods separate natural from total risk when attempting to estimate anthropogenic risk. Failure to do so results in the over estimation of anthropogenic risk and the eventual loss of credibility for risk assessment methodologies. The common frequentist approach to probability is not consistent with anything but a modelling approach to risk assessment. When combined with its ability to account for natural variability, incorporate laboratory-assay data and offer complete statistical and experimental control, modelling is a promising approach to risk assessment. Modelling, however, is not without its drawbacks. Initialization bias can result in the over, or under, estimation of both natural and anthropogenic risk. Furthermore, model estimates are time dependent. The convergence of natural and anthropogenic risk poses problems for modelling-based risk assessment and requires clear statements as to the importance of the time dimension in risk assessment. When combined, the drawbacks to modelling-based risk assessment argue that risk should never be stated as a scalar quantity. Instead, modelling-based risk assessment should provide estimates of the complete range of risk measures (total, natural, and anthropogenic) as well as indications of convergence time. Only then can the modelling-based approach be viewed as the most appropriate means of carrying out scientifically credible risk assessment.     

Import‐based Indicator for the Geopolitical Supply Risk of Raw Materials in Life Cycle Sustainability Assessments

There is a growing concern over the security and sustainable supply of raw material among businesses and governments of developed, material‐intensive countries. This has led to the development of a systematic analysis of risk incorporated with raw materials usage, often referred as criticality assessment. In principle, this concept is based on the material flow approach. The potential role of life cycle assessment (LCA) to integrate resource criticality through broadening its scope into the life cycle sustainability assessment (LCSA) framework has been discussed within the LCA communities for some time. In this article, we aim at answering the question of how to proceed toward integration of the geopolitical aspect of resource criticality into the LCSA framework. The article focuses on the assessment of the geopolitical supply risk of 14 resources imported to the seven major advanced economies and the five most relevant emerging countries. Unlike a few previous studies, we propose a new method of calculation for the geopolitical supply risk, which is differentiated by countries based on the import patterns instead of a global production distribution. Our results suggest that rare earth elements, tungsten, antimony, and beryllium generally pose high geopolitical supply risk. Results from the Monte Carlo simulation allow consideration of data uncertainties for result interpretation. Issues concerning the consideration of the full supply chain are exemplarily discussed for cobalt. Our research broadens the scope of LCA from only environmental performance to a resource supply‐risk assessment tool that includes accessibility owing to political instability and market concentration under the LCSA framework.     

Applying a weed risk assessment approach to GM crops

Current approaches to environmental risk assessment of genetically modified (GM) plants are modelled on chemical risk assessment methods, which have a strong focus on toxicity. There are additional types of harms posed by plants that have been extensively studied by weed scientists and incorporated into weed risk assessment methods. Weed risk assessment uses robust, validated methods that are widely applied to regulatory decision-making about potentially problematic plants. They are designed to encompass a broad variety of plant forms and traits in different environments, and can provide reliable conclusions even with limited data. The knowledge and experience that underpin weed risk assessment can be harnessed for environmental risk assessment of GM plants. A case study illustrates the application of the Australian post-border weed risk assessment approach to a representative GM plant. This approach is a valuable tool to identify potential risks from GM plants.     

Integrated Human and Ecological Risk Assessment: A Case Study of Ultraviolet Radiation Effects on Amphibians,Coral, Humans,and Oceanic Primary Productivity

Ultraviolet radiation (UVR) is a naturally occurring stressor to most forms of life. The sole relevant source of this stressor is the sun. The Earth's stratospheric ozone layer reduces the amount of UVR that reaches the Earth's surface. The potential for continued depletion of this ozone layer and environmental changes that increase the penetrance of aquatic habitat, both due to human activities, and the subsequent increase in UVR are global environmental concerns for both humans and ecosystems. An integrated risk assessment provides efficiency in data gathering, analysis and reporting by enabling risk assessors to use the combined knowledge from many disciplines to evaluate overall risk. This report describes the steps and example information that could be used for an integrated risk assessment but is not an actual risk assessment with all its associated calculations and conclusions. It is intended to illustrate the advantages of the integrated risk assessment approach for evaluating adverse effects of a nonchemical stressor.