A comparative evaluation of the regulation of GM crops or products containing dsRNA and suggested improvements to risk assessments

Changing the nature, kind and quantity of particular regulatory-RNA molecules through genetic engineering can create biosafety risks. While some genetically modified organisms (GMOs) are intended to produce new regulatory-RNA molecules, these may also arise in other GMOs not intended to express them. To characterise, assess and then mitigate the potential adverse effects arising from changes to RNA requires changing current approaches to food or environmental risk assessments of GMOs. We document risk assessment advice offered to government regulators in Australia, New Zealand and Brazil during official risk evaluations of GM plants for use as human food or for release into the environment (whether for field trials or commercial release), how the regulator considered those risks, and what that experience teaches us about the GMO risk assessment framework. We also suggest improvements to the process.     

Causation in risk assessment and management: models, inference, biases, and a microbial risk-benefit case study

Causal inference of exposure-response relations from data is a challenging aspect of risk assessment with important implications for public and private risk management. Such inference, which is fundamentally empirical and based on exposure (or dose)-response models, seldom arises from a single set of data; rather, it requires integrating heterogeneous information from diverse sources and disciplines including epidemiology, toxicology, and cell and molecular biology. The causal aspects we discuss focus on these three aspects: drawing sound inferences about causal relations from one or more observational studies; addressing and resolving biases that can affect a single multivariate empirical exposure-response study; and applying the results from these considerations to the microbiological risk management of human health risks and benefits of a ban on antibiotic use in animals, in the context of banning enrofloxacin or macrolides, antibiotics used against bacterial illnesses in poultry, and the effects of such bans on changing the risk of human food-borne campylobacteriosis infections. The purposes of this paper are to describe novel causal methods for assessing empirical causation and inference; exemplify how to deal with biases that routinely arise in multivariate exposure- or dose-response modeling; and provide a simplified discussion of a case study of causal inference using microbial risk analysis as an example. The case study supports the conclusion that the human health benefits from a ban are unlikely to be greater than the excess human health risks that it could create, even when accounting for uncertainty. We conclude that quantitative causal analysis of risks is a preferable to qualitative assessments because it does not involve unjustified loss of information and is sound under the inferential use of risk results by management.     

Analysis of currently available data for characterising the risk of engineered nanomaterials to the environment and human health--lessons learned from four case studies

Production volumes and the use of engineered nanomaterials in many innovative products are continuously increasing, however little is known about their potential risk for the environment and human health. We have reviewed publicly available hazard and exposure data for both, the environment and human health and attempted to carry out a basic risk assessment appraisal for four types of nanomaterials: fullerenes, carbon nanotubes, metals, and metal oxides (ENRHES project 2009(1)). This paper presents a summary of the results of the basic environmental and human health risk assessments of these case studies, highlighting the cross cutting issues and conclusions about fate and behaviour, exposure, hazard and methodological considerations. The risk assessment methodology being the basis for our case studies was that of a regulatory risk assessment under REACH (ECHA, 2008(2)), with modifications to adapt to the limited available data. If possible, environmental no-effect concentrations and human no-effect levels were established from relevant studies by applying assessment factors in line with the REACH guidance and compared to available exposure data to discuss possible risks. When the data did not allow a quantitative assessment, the risk was assessed qualitatively, e.g. for the environment by evaluating the information in the literature to describe the potential to enter the environment and to reach the potential ecological targets. Results indicate that the main risk for the environment is expected from metals and metal oxides, especially for algae and Daphnia, due to exposure to both, particles and ions. The main risks for human health may arise from chronic occupational inhalation exposure, especially during the activities of high particle release and uncontrolled exposure. The information on consumer and environmental exposure of humans is too scarce to attempt a quantitative risk characterisation. It is recognised that the currently available database for both, hazard and exposure is limited and there are high uncertainties in any conclusion on a possible risk. The results should therefore not be used for any regulatory decision making. Likewise, it is recognised that the REACH guidance was developed without considering the specific behaviour and the mode of action of nanomaterials and further work in the generation of data but also in the development of methodologies is required.     

The relationship between study sponsorship,risks of bias,and research outcomes in atrazine exposure studies conducted in non-human animals: Systematic review and meta-analysis

BackgroundA critical component of systematic review methodology is the assessment of the risks of bias of studies that are included in the review. There is controversy about whether funding source should be included in a risk of bias assessment of animal toxicology studies.ObjectiveTo determine whether industry research sponsorship is associated with methodological biases, the results, or conclusions of animal studies examining the effect of exposure to atrazine on reproductive or developmental outcomes.MethodsWe searched multiple electronic databases and the reference lists of relevant articles to identify original research studies examining the effect of any dose of atrazine exposure at any life stage on reproduction or development in non-human animals. We compared methodological risks of bias, the conclusions of the studies, the statistical significance of the findings, and the magnitude of effect estimates between industry sponsored and non-industry sponsored studies.ResultsFifty-one studies met the inclusion criteria. There were no differences in methodological risks of bias in industry versus non-industry sponsored studies. 39 studies tested environmentally relevant concentrations of atrazine (11 industry sponsored, 24 non-industry sponsored, 4 with no funding disclosures). Non-industry sponsored studies (12/24, 50.0%) were more likely to conclude that atrazine was harmful compared to industry sponsored studies (2/11, 18.1%) (p value = 0.07). A higher proportion of non-industry sponsored studies reported statistically significant harmful effects (8/24, 33.3%) compared to industry-sponsored studies (1/11; 9.1%) (p value = 0.13). The association of industry sponsorship with decreased effect sizes for harm outcomes was inconclusive.ConclusionOur findings support the inclusion of research sponsorship as a risk of bias criterion in tools used to assess risks of bias in animal studies for systematic reviews. The reporting of other empirically based risk of bias criteria for animal studies, such as blinded outcome assessment, randomization, and all animals included in analyses, needs to improve to facilitate the assessment of studies for systematic reviews.     

Regional risk assessment for contaminated sites Part 2: Ranking of potentially contaminated sites

Environmental risks are traditionally assessed and presented in non spatial ways although the heterogeneity of the contaminants spatial distributions, the spatial positions and relations between receptors and stressors, as well as the spatial distribution of the variables involved in the risk assessment, strongly influence exposure estimations and hence risks. Taking into account spatial variability is increasingly being recognized as a further and essential step in sound exposure and risk assessment. To address this issue an innovative methodology which integrates spatial analysis and a relative risk approach was developed. The purpose of this methodology is to prioritize sites at regional scale where a preliminary site investigation may be required. The methodology aimed at supporting the inventory of contaminated sites was implemented within the spatial decision support sYstem for Regional rIsk Assessment of DEgraded land, SYRIADE, and was applied to the case-study of the Upper Silesia region (Poland).The developed methodology and tool are both flexible and easy to adapt to different regional contexts, allowing the user to introduce the regional relevant parameters identified on the basis of user expertise and regional data availability. Moreover, the used GIS functionalities, integrated with mathematical approaches, allow to take into consideration, all at once, the multiplicity of sources and impacted receptors within the region of concern, to assess the risks posed by all contaminated sites in the region and, finally, to provide a risk-based ranking of the potentially contaminated sites.     

Regional risk assessment for contaminated sites part 2: ranking of potentially contaminated sites

Environmental risks are traditionally assessed and presented in non spatial ways although the heterogeneity of the contaminants spatial distributions, the spatial positions and relations between receptors and stressors, as well as the spatial distribution of the variables involved in the risk assessment, strongly influence exposure estimations and hence risks. Taking into account spatial variability is increasingly being recognized as a further and essential step in sound exposure and risk assessment. To address this issue an innovative methodology which integrates spatial analysis and a relative risk approach was developed. The purpose of this methodology is to prioritize sites at regional scale where a preliminary site investigation may be required. The methodology aimed at supporting the inventory of contaminated sites was implemented within the spatial decision support sYstem for Regional rIsk Assessment of DEgraded land, SYRIADE, and was applied to the case-study of the Upper Silesia region (Poland). The developed methodology and tool are both flexible and easy to adapt to different regional contexts, allowing the user to introduce the regional relevant parameters identified on the basis of user expertise and regional data availability. Moreover, the used GIS functionalities, integrated with mathematical approaches, allow to take into consideration, all at once, the multiplicity of sources and impacted receptors within the region of concern, to assess the risks posed by all contaminated sites in the region and, finally, to provide a risk-based ranking of the potentially contaminated sites.     

The risk assessment–policy gap: An example from the UK contaminated land regime

Risk-based regulation assumes that risk assessment can evaluate risks against policy objectives. However, policy goals are often ambiguous and require risk assessors to interpret them for use in risk assessment. This risk assessment-policy gap stems partly from normative and imprecise policy language but is rooted more fundamentally in society's uncertain expectations for the environment. Until this uncertainty is resolved, the democratic and regulatory effectiveness of risk regulation will be undermined by ad hoc policy decisions abdicated to risk assessors.     

Sustainability risk identification in product development

Sustainability-related issues present significant financial, strategic, compliance and operational risks to manufacturers. Many of these risks directly or indirectly result from the way a product is designed and managed across its life cycle. Assessing sustainability risk (S _R) at the product design stage is crucial for the development of products that both minimise sustainability risk exposure and are environmentally sustainable. Managing the costs associated with these risks requires risk management intervention at the design stage before these costs are committed throughout the life cycle (production, use, end-of-life). The goal of the sustainability risk assessment (SRA) methodology is to provide an approach to comparing the financial cost of a ‘sustainable product’ vs. an ‘unsustainable product’, by factoring in the effects of S _R on life-cycle cost. The SRA methodology demonstrates that, in some cases, sustainable products cost less than unsustainable products when sustainability risk is considered in the costing analysis. This paper outlines the first step of the SRA methodology, which is a process for identifying S _R inherent in the product life cycle. Once key risks are identified, the subsequent steps of the SRA assess and prioritise these risks for treatment through changes to product design and materials composition.     

Beyond contaminated land assessment: On costs and benefits of bioaccessibility prediction

Advances towards sustainable land management necessitate application of a broader portfolio of decision-support tools that improve evaluation of contaminated land. Over the last decade regulators have directed concerted effort towards rationalization of risk-based contaminated land policies recognizing bioavailability and bioaccessibility as concepts to be incorporated into risk assessments. The desire for a precise and rapid method to inform consideration of bioavailability and bioaccessibility to support risk assessment of contaminated land has never been greater. This study presents a comprehensive appraisal of both emerging non-exhaustive extraction techniques (subcritical water extraction and Brij 700 extraction) developed to reflect polycyclic aromatic hydrocarbon (PAH) bioaccessibility to microorganisms as well as formerly demonstrated methodologies (the use of cyclodextrins and butanol extraction). Application of unified evaluation criteria across different techniques enabled comparison not only from the bioaccessibility prediction perspective but also analysis of economical (cost of extraction) and practical (such as extraction time) measures. Whilst the use of cyclodextrins was the best predictor of the bioaccessible fraction for the majority of compounds, other methods appeared more cost- and time-effective. Juxtaposition of the techniques presented in this study assists establishing cost-benefit trade-offs of different non-exhaustive extraction techniques and contributes to tailoring information on contaminant bioaccessibility to support risk evaluation on contaminated sites.     

Human pathogens and their indicators in biosolids: a literature review

A growing beneficial reuse of biosolids in agriculture has led to concerns about potential contamination of water resources and the food chain. In order to comprehend the potential risks of transmission of diseases to the human population, an advanced quantitative risk assessment is essential. This requires good quantitative data which is currently limited due to the methodological limitations. Consequently, further development and standardization of methodologies for the detection, enumeration and viability assessment of pathogens in biosolids is required. There is a paucity of information on the numbers and survival of enteric virus and protozoan pathogens of concern in biosolids. There is a growing urgency for the identification of more reliable alternative indicators, both index and model microorganisms, which could be used for potential public health risk assessment. In this review, we have summarized reported literature on the numbers and fate of enteric pathogens and indicators in biosolids. The advantages and limitations of the use of conventional and alternative index and model microorganisms for the prediction of pathogen presence in biosolids are also discussed.     

The risk assessment-policy gap: an example from the UK contaminated land regime

Risk-based regulation assumes that risk assessment can evaluate risks against policy objectives. However, policy goals are often ambiguous and require risk assessors to interpret them for use in risk assessment. This risk assessment-policy gap stems partly from normative and imprecise policy language but is rooted more fundamentally in society's uncertain expectations for the environment. Until this uncertainty is resolved, the democratic and regulatory effectiveness of risk regulation will be undermined by ad hoc policy decisions abdicated to risk assessors.     

Chemical plant risk assessment: Uncertainties and development needs

A brief review is given covering the development of major hazards risk assessment since the Flixborough disaster of 1974, with special reference to the introduction of new regulations. The importance of risk assessment in the management of major hazards is discussed by reference to the Canvey Island studies, and it is suggested that the problem of uncertainties in the estimation of risks by analysis has not been adequately treated. Examples are given to illustrate the magnitude of such uncertainties in the consequence modelling of accidental releases from a chemical plant. In addition to suggested development needs in risk analysis techniques, topics are suggested which call for development in the evaluation and management of risks.     

Implementing systematic review techniques in chemical risk assessment: Challenges,opportunities and recommendations

Systematic review (SR) is a rigorous, protocol-driven approach designed to minimise error and bias when summarising the body of research evidence relevant to a specific scientific question. Taking as a comparator the use of SR in synthesising research in healthcare, we argue that SR methods could also pave the way for a “step change” in the transparency, objectivity and communication of chemical risk assessments (CRA) in Europe and elsewhere. We suggest that current controversies around the safety of certain chemicals are partly due to limitations in current CRA procedures which have contributed to ambiguity about the health risks posed by these substances. We present an overview of how SR methods can be applied to the assessment of risks from chemicals, and indicate how challenges in adapting SR methods from healthcare research to the CRA context might be overcome. Regarding the latter, we report the outcomes from a workshop exploring how to increase uptake of SR methods, attended by experts representing a wide range of fields related to chemical toxicology, risk analysis and SR. Priorities which were identified include: the conduct of CRA-focused prototype SRs; the development of a recognised standard of reporting and conduct for SRs in toxicology and CRA; and establishing a network to facilitate research, communication and training in SR methods. We see this paper as a milestone in the creation of a research climate that fosters communication between experts in CRA and SR and facilitates wider uptake of SR methods into CRA.     

A systemic health risk assessment for the chromium cycle in Taiwan

Health risk assessment (HRA) has been recognized as a useful tool for identifying health risks of human activities. In particular, this method has been well applied to spatially defined units, such as a production plant, a treatment facility, and a contaminated site. However, the management strategies based on the risk information will be more efficient if the comprehensive picture of total risks from all kinds of sources is depicted. In principle, the total risks can be obtained when all risk sources are assessed individually. Apparently, this approach demands huge amount of efforts. This study develops a methodology that combines substance flow and risk estimation to facilitate examination of risk in a systemic way and provide comprehensive understanding of risk generation and distribution corresponding to flows of substances in the anthroposphere and the environment. Substance flow analysis (SFA) and HRA method is integrated to produce a systemic risk assessment method, from which substance management schemes can be derived. In this study, the chromium cycle in Taiwan is used as an example to demonstrate the method, by which the associated substance flow in the economy and the risk caused by the substance in the environmental system is determined. The concentrations of pollutants in the environmental media, the resultant risks and hazard quotients are calculated with the widely-used CalTOX multimedia model.     

Ways of improving the management of environmental risks

From the public's discovery of environmental quality in the late 1960s to the present, there has been increasing recognition that a more systematic approach is required to manage risks and to achieve the gains at low cost. Such a systematic approach must begin with risk identification, then go on to risk assessment, consideration of management options, a decision analysis of the options, and an examination of strategies for reducing loss. One of the most difficult aspects of environmental risk management is setting goals. There is a tendency to engage in rhetoric about zero risks and a pristine environment. However, moving toward more realistic goals requires consideration of what is an acceptable risk level. This level cannot be defined without knowing the benefits that come with the risk and the costs of reducing the risk. More generally, the criteria for selecting a risk management strategy include the residual level of risk, efficiency in reducing risk, equity, administrative simplicity, and public acceptability. A number of frameworks are currently used by U.S. regulatory agencies to manage risk: no-risk, risk-risk, technology-based standards, risk-benefit, cost-effectiveness, regulatory budget, and benefit-cost analysis. In specifying that an agency must use one of these frameworks, the U.S. Congress is implicitly specifying the goals for risk reduction. It appears to be easier for the U.S. Congress to specify a framework than a goal. Some of the nonregulatory means of managing risk include the market, and legal mechanisms. These risk management institutions have been effective and are a necessary part of any risk management program.     

Revision and meta-analysis of selected biosphere parameter values for chlorine, iodine, neptunium, radium, radon and uranium

There is a continual supply of new experimental data that are relevant to the assessment of the potential impacts of nuclear fuel waste disposal. In the biosphere, the traditional assessment models are data intensive, and values are needed for several thousand parameters. This is augmented further when measures of central tendency, statistical dispersion, correlations and truncations are required for each parameter to allow probabilistic risk assessment. Recent reviews proposed values for 10-15 key element-specific parameters relevant to (36)Cl, (129)I, (222)Rn, (226)Ra, (237)Np and (238)U, and some highlights from this data update are summarized here. Several parameters for Np are revised downward by more than 10-fold, as is the fish/water concentration ratio for U. Soil solid/liquid partition coefficients, Kd, are revised downward by 10-770-fold for Ra. Specific parameters are discussed in detail, including degassing of I from soil; sorption of Cl in soil; categorization of plant/soil concentration ratios for U, Ra and Np; Rn transfer from soil to indoor air; Rn degassing from surface water; and the Ca dependence of Ra transfers.     

The Spatial Dimension of Landscape Sustainability

Sustainability indicators are mostly derived from parameters which are, in the spatial dimension, more or less distribution-free. In the majority of cases, the indicators are based on statistical data on production, consumption, pollutants emission, land use, etc. This statistical approach is liable to mask sustainability risks which are primarily caused by specific spatial and temporal patterns of landscape and land use structure, such as degradation of soil functions, disturbances in the landscape's water balance, and losses in functional habitat quality.Sustainability risks due to ecologically non-adapted spatial landuse patterns require measures on regional to local scales, based on disaggregated, spatially explicit indicators. Depending on the respective planning and decision level, different levels of spatial aggregation/disaggregation have to be considered.In the concept presented here, a differentiated approach is proposed. For an aggregated assessment of landscape sustainability, long term monitoring of the dynamics of water flow and matter load at the outlet point of river catchments is recommended. A prerequisite for analyzing those measurements in terms of the catchments' land cover and land use pattern, as well as changes thereof, is a Geographic Information System (GIS) holding relevant up-to-date geodata sets. For a spatially more detailed indication of sustainability risks, an approach of GIS-based functional landscape assessment was demonstrated in a regional case study.The results show GIS on regional to local scales together with satellite remote sensing data on land cover and landuse to be a powerful data basis for spatially explicit landscape evaluation, provided that suitable models for assessing specific landscape functions are applied.     

煤炭企业跨区域扩张模式研究

跨区域扩张是煤炭企业可持续发展的必要方式.地域差异性使得扩张过程中面临很大的风险,因此企业应慎重选择扩张模式.本文根据来源将风险因素归结为外部风险和内部风险,指出外部风险属于不可控制因素,企业只能采取有效措施去应对.在此基础上,结合世界范围内的企业兼并浪潮和社会资本、战略联盟的相关研究成果,将煤炭企业跨区域扩张模式划分为独资新建、股权型扩张和契约型扩张三种类型.结合风险因素,分析了各种模式的优缺点,认为股权型扩张有利于谋求社会资本、契约型扩张较为灵活有利于应对复杂多变的环境,从而有助于规避扩张过程中的外部风险,是较为合适的扩张模式.着重归纳了契约型扩张和股权型扩张的实现方式,其中契约型扩张可以通过合同开采、承包租赁、托管等方式实现,股权型扩张可以通过合资和并购等方式实现.以兖矿集团为例介绍了其通过兼并重组、股份合作等股权型扩张实现跨区域发展的历程.     

Areas of uncertainty in comparing risks of energy systems

In the past, the safety of technology has mainly been ensured by deterministic criteria that were based on engineering principles and on experience. Recently, however, it has become necessary to include risk assessment into safety policy. This need arises due to the order of magnitude of possible health and environmental impact from normal operation or accidents, as well as the complexity of modern systems that no longer allow for intuitive understanding of possible accident sequences. Assessment of risks of technical installations is subject to large uncertainties that are caused by lack of data and inadequate quantification and evaluation methods. This paper reviews the main areas of uncertainties with regard to their importance for decisionmaking. Uncertainties are an inherent part of any risk assessment result and can never be avoided. It is thus important to pay particular attention to them including limitations of methods, sensitivity to assumptions about parameters, and site-specific considerations. All this information must be described in great detail so that it can be integrated into the decisionmaking process. If applied in this context, risk assessment is a useful tool for identifying major contributors to risk and effective actions of risk management.     

An overview of the ERICA Integrated Approach to the assessment and management of environmental risks from ionising contaminants

The ERICA project (environmental risks from ionising contaminants: assessment and management, EC contract no. FI6R-CT-2004-508847) concluded with the publication of two main outputs: the ERICA Integrated Approach to the assessment and management of environmental risks from ionising radiation, of which also introduces the user to the second main output, the ERICA Tool, which is a software programme with supporting databases, that together with its associated help will guide users through the assessment process. More than 60 European scientists contributed to the ERICA Integrated Approach. In addition, a large number of experts, policy makers, and decision-makers in different areas have contributed views on the ERICA Integrated Approach and its associated Tool from the user's perspective, through participation in the End-Users Group set up under the ERICA project. Databases on transfer, dose conversion coefficients and radiation effects on biota have been developed specifically for the purpose of the Integrated Approach, and incorporated into, or interacting with, the Tool. Species sensitivity distributions of biological effects data have been performed and did not reveal, for chronic exposure, any statistical grounds for separation between terrestrial, marine and freshwater ecosystems in terms of species sensitivity to radiation; on the basis of such analysis a universal screening dose rate criterion of 10 microGy h(-1) incremental dose rate is suggested for exiting the assessment procedure while being confident that environmental risks are negligible. This criterion is used for the two first tiers (conservative assessment with limited data requirement and various possibilities of incorporating user-defined parameter values, including the screening dose rate criterion) of the assessment methodology. Exposure situations of concern are carried through a third tier, making use of all relevant databases and with a number of issues and options listed to support and guide decision-making. This article provides an overview to the ERICA Integrated Approach, whereas further articles of this special issue describe in-depth different vital aspects of the Integrated Approach.