Frameworks and tools for risk assessment of manufactured nanomaterials

Commercialization of nanotechnologies entails a regulatory requirement for understanding their environmental, health and safety (EHS) risks. Today we face challenges to assess these risks, which emerge from uncertainties around the interactions of manufactured nanomaterials (MNs) with humans and the environment. In order to reduce these uncertainties, it is necessary to generate sound scientific data on hazard and exposure by means of relevant frameworks and tools. The development of such approaches to facilitate the risk assessment (RA) of MNs has become a dynamic area of research. The aim of this paper was to review and critically analyse these approaches against a set of relevant criteria. The analysis concluded that none of the reviewed frameworks were able to fulfill all evaluation criteria. Many of the existing modelling tools are designed to provide screening-level assessments rather than to support regulatory RA and risk management. Nevertheless, there is a tendency towards developing more quantitative, higher-tier models, capable of incorporating uncertainty into their analyses. There is also a trend towards developing validated experimental protocols for material identification and hazard testing, reproducible across laboratories. These tools could enable a shift from a costly case-by-case RA of MNs towards a targeted, flexible and efficient process, based on grouping and read-across strategies and compliant with the 3R (Replacement, Reduction, Refinement) principles. In order to facilitate this process, it is important to transform the current efforts on developing databases and computational models into creating an integrated data and tools infrastructure to support the risk assessment and management of MNs.     

Approaches for describing and communicating overall uncertainty in toxicity characterizations: U.S. Environmental Protection Agency's Integrated Risk Information System (IRIS) as a case study

Single point estimates of human health hazard/toxicity values such as a reference dose (RfD) are generally used in chemical hazard and risk assessment programs for assessing potential risks associated with site- or use-specific exposures. The resulting point estimates are often used by risk managers for regulatory decision-making, including standard setting, determination of emission controls, and mitigation of exposures to chemical substances. Risk managers, as well as stakeholders (interested and affected parties), often have limited information regarding assumptions and uncertainty factors in numerical estimates of both hazards and risks. Further, the use of different approaches for addressing uncertainty, which vary in transparency, can lead to a lack of confidence in the scientific underpinning of regulatory decision-making. The overarching goal of this paper, which was developed from an invited participant workshop, is to offer five approaches for presenting toxicity values in a transparent manner in order to improve the understanding, consideration, and informed use of uncertainty by risk assessors, risk managers, and stakeholders. The five approaches for improving the presentation and communication of uncertainty are described using U.S. Environmental Protection Agency's (EPA's) Integrated Risk Information System (IRIS) as a case study. These approaches will ensure transparency in the documentation, development, and use of toxicity values at EPA, the Agency for Toxic Substances and Disease Registry (ATSDR), and other similar assessment programs in the public and private sector. Further empirical testing will help to inform the approaches that will work best for specific audiences and situations.     

Recent trends and developments in dialogue on radioactive waste management: experience from the UK

This paper highlights some recent trends and developments in dialogue on radioactive waste management in the UK. In particular, it focuses on the use of dialogue around options for the management of risk, and describes techniques for stakeholder dialogue in the field of radioactive waste management. The paper summarises past and on-going experience in the UK, and provides an overview of some practical examples from decommissioning of the former reprocessing facility at Dounreay in Scotland. In common with developments and trend in other countries, the UK has moved to a position where there is now widespread recognition that radioactive waste management requires not only sound technical assessment of risk, but also public participation, consultation and stakeholder dialogue on proposed solutions and the associated risks. In fact, the shift of position has arguably been quite pronounced, with formal procedures to identify, clarify and integrate stakeholders' issues and concerns within the decision-making processes. Experience suggests that citizens are capable of engaging with complex technical issues such as radioactive waste. Indeed, the earlier in the decision-making process that public and stakeholder engagement (PSE) occurs--for example, on the consideration of options and alternatives--the greater the chance of reaching a successful outcome that properly reflects the values and opinions of stakeholders. In the UK, the assessment of alternative waste management options is increasingly being addressed through Best Practical Environmental Option (BPEO) studies. Responses to stakeholder engagement processes and experience of conducting BPEO studies emphasise that consultation must be open, transparent, deliberative and inclusive. However, while early consideration of generic approaches and option choices is necessary to generate a climate of openness and understanding, it remains essential to fully engage with local stakeholder and community groups to consider issues associated with proposed developments at a site-specific level. An interesting area where further attention may be warranted is the use in final decision-making of the results from participatory processes such as BPEO studies. Demonstrating clearly that participants' views have influenced decisions appears to be essential for retaining legitimacy and trust, confidence and goodwill.     

Planned retreat as a management response to coastal risk: a case study from the Fleurieu Peninsula, South Australia

Australian coastal areas have been identified as highly vulnerable to climate change, with major projected impacts including sea level rise, extreme weather events, increased erosion, and a change in coastal processes and wave patterns. Such impacts would cause coastal settlements and ecosystems to face increasingly uncertain conditions. In response to increased risk, effective coastal management at local and regional scales is needed, with governing bodies providing significant leadership. This research explores the challenges of applying effective adaptation responses to projected climate change in vulnerable coastal systems on the South Coast of the Fleurieu Peninsula, South Australia. In particular, the option of planned retreat as a management response to coastal risk is critically examined, with the incorporation of learning from Byron Bay, NSW. A mixed methods approach was undertaken by integrating documentary interrogation with the analysis of interview responses from key coastal managers. It was determined that despite the increase in adaptation planning and development of management strategy options to manage sea level rise on the Fleurieu Peninsula, there is a lack of implementation of adaptation responses. In addition, planning seems to focus largely on the implications of sea level rise on infrastructure, often overlooking other risks and possible ecological impacts. Inconsistencies in governance are reflected at all levels, indicating a need for comprehensive improvements to ensure the incorporation of appropriate risk responses into planning decisions.     

Risk identification and regulatory system design for the carbon market

Currently, the global carbon trading systems are fragmented and belong to different governments or are under the jurisdiction of different regions, resulting in a series of new problems, such as how to link dispersed trading systems, how to compare the emission reduction of various markets and other issues. Since the development of the international carbon market is relatively immature with uncertain life expectancy and volatility during its short history, and there is a lack of quantitative data on the long-term record, the market could provide few risk management tools. Meanwhile, with the launches of China’s regional carbon trading pilots in seven provinces since 2013 and combined with the national voluntary emission trading system, carbon trading will become an important mechanism for China in achieving its emission reduction target. In the first stage, the carbon finance market is at least faced with mechanism design risks, market supply risks and compliance risks. Therefore, to secure the development of the carbon market and for public interest, relevant government departments of China should identify the risks facing the market and should make the basic principles and goals, such as ensuring effective trading and pricing mechanisms to avoid fraud and price manipulation, and balancing transparency and confidentiality of information. Consequently, the governments should develop a comprehensive carbon finance regulatory system covering regulatory legislation, regulatory institutions and their authorities, regulatory scope as well as regulatory objects.     

Practical consequences of the assessment of different energy health risks

Public authorities must make decisions about energy, and the risks of alternative strategies need to be calculated including health and environmental costs. Information from various sources must be organized into a logical framework for comparing impacts. This must include the widest practicable range of health and environmental damage — public-health impact of pollution, role of accidents, disease and hazardous materials in the workplace, and odds for catastrophes. It must put each part of the energy cycle into perspective-giving particular attention to uncertainties in knowledge - to convey what is known, what is uncertain, and the importance of each factor in the overall picture. This paper gives examples of the use of health-impact assessment by decisionmakers: (1) comparative risk assessment of the health effects of coal and nuclear fuel cycles used in nuclear power plant siting and licensing hearings, and (2) health risks of acid deposition and other air-transported pollutants, carried out as part of an assessment for the U.S. Congress Office of Technology Assessment.     

Capability maturity models for offshore organisational management

The goal setting regime imposed by the UK safety regulator has important implications for an organisation's ability to manage health and safety related risks. Existing approaches to safety assurance based on risk analysis and formal safety assessments are increasingly considered unlikely to create the step change improvement in safety to which the offshore industry aspires and alternative approaches are being considered. One approach, which addresses the important issue of organisational behaviour and which can be applied at a very early stage of design, is the capability maturity model (CMM). The paper describes the development of a design safety capability maturity model, outlining the key processes considered necessary to safety achievement, definition of maturity levels and scoring methods. The paper discusses how CMM is related to regulatory mechanisms and risk based decision making together with the potential of CMM to environmental risk management.     

Evaluating efforts to build sustainable WEEE reverse logistics network design: comparison of regulatory and non-regulatory approaches

Many developing countries such as Turkey are still making an effort on building an infrastructure for waste of electrical and electronic equipment (WEEE) reverse logistic network design (RLND) processes. It is obvious that policies/laws/regulations related to WEEE management provide a sustainable framework for implementation in the RLND. The question is here: Does the implementation of WEEE directives make sense in terms of reducing the total cost of the network in the long term? This study aims to compare regulatory and non-regulatory situations of WEEE RLND in developing countries by formulating two models named as ‘regulatory’ and ‘non-regulatory’. Model 1 is considered as sustainable with economic, environmental and social goals, and the quotas imposed by the environmental directive are taken into consideration as the data of product return amount. In Model 2, only economic goal is considered, and product return amount is forecasted using Artificial Neural Network (ANN). A case study is conducted in a recycling company in order to evaluate performance of the proposed models. This study contributes to the relevant literature by (1) comparing the regulatory and non-regulatory situations RL models explicitly and (2) proposing ANN model to forecast EEE product return or WEEE quantity for non-regulatory situation.     

The implications of rural perceptions of water scarcity on differential adaptation behaviour in Rajasthan,India

Water scarcity is one of the most critical issues facing agriculture today. To understand how people manage the risk of water scarcity and growing pressures of increased climate variability, exploring perceptions of risk and how these perceptions feed into response behaviour and willingness to adapt is critical. This paper revisits existing frameworks that conceptualise perceptions of environmental risk and decision-making, and uses empirical evidence from an in-depth study conducted in Rajasthan, India, to emphasise how individual and collective memories, and experience of past extreme events shape current definitions and future expectations of climatic risks. In doing so, we demonstrate the value of recognising the role of local perceptions of water scarcity (and how they vary between and within households) in constructing social vulnerability. This expanded understanding of risk perception is critical for incentivising individual adaptation and strengthening local adaptation pathways.     

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.     

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.     

A review of regulatory decisions for environmental protection: part II - the case-study of contaminated land management in Portugal

This paper provides a case-study analysis of the challenges in the implementation of national soil policies, which was developed by the authors in Part I of the review of regulatory decisions for environmental protection [Rodrigues SM, Pereira ME, Ferreira da Silva E, Hursthouse A, Duarte AC. A review of regulatory decisions for environmental management: Part I-challenges in the implementation of national soil policies. Environ Int 2009. doi:10.1016/j.envint.2008.08.007]. The Portuguese case was selected as a case-study since specific regulatory decisions for contaminated land management are still in the early stages of development. Given the gap between the situation at the EU level and the state of Portuguese soil policy development, it is of merit to consider national contaminated land policy regimes already in place within the EU and to see if these provide a suitable basis to define the main challenges and research needs for the implementation of a Portuguese contaminated land management strategy. A framework combining the D-P-S-I-R (drivers-pressures-sources-impacts-responses) structure of policy evaluation with the Source-Pathway-Receptor approach to health risk assessment is proposed to derive an effective regulatory framework for managing contaminated land in Portugal, using available information and only to develop new data and research where knowledge gaps exist. Funding site clean-up and assigning liability were identified as relevant factors currently hampering site remediation. Most relevant research needs for the development of contaminated land management practices in Portugal are those associated to the definition of a risk assessment framework and setting guidelines for the evaluation of risks posed to both humans and ecosystems. Other relevant and innovative features are the integration of soil function analysis into site investigations and the definition of a framework that combines risk assessment with soil function analysis. The analysis of the Portuguese case also provides insight into the discussions needed for the effective development of regulatory decisions for contaminated land management in countries with no history of implementing specific soil policies.     

Evolution of electronic waste toxicity: Trends in innovation and regulation

Rapid innovation in printed circuit board, and the uncertainties surrounding quantification of the human and environmental health impacts of e-waste disposal have made it difficult to confirm the influence of evolving e-waste management strategies and regulatory policies on materials. To assess these influences, we analyzed hazardous chemicals in a market-representative set of Waste printed circuit boards (WPCBs, 1996–2010). We used standard leaching tests to characterize hazard potential and USEtox® to project impacts on human health and ecosystem. The results demonstrate that command-and-control regulations have had minimal impacts on WPCBs composition and toxicity risks; whereas technological innovation may have been influenced more by resource conservation, including a declining trend in the use of precious metals such as gold. WPCBs remain classified as hazardous under U.S. and California laws because of excessive toxic metals. Lead poses the most significant risk for cancers; zinc for non-cancer diseases; copper had the largest potential impact on ecosystem quality. Among organics, acenaphthylene, the largest risk for cancers; naphthalene for non-cancer diseases; pyrene has the highest potential for ecotoxicological impacts. These findings support the need for stronger enforcement of international policies and technology innovation to implement the strategy of design-for-the-environment and to encourage recovery, recycling, and reuse of WPCBs.     

Farm income, gender differentials and climate risk in Cameroon: typology of male and female adaptation options across agroecologies

This paper explores the response to risk of smallholder agricultural producers in the face of variable and changing climate in Cameroon. The low rainfall distribution in some regions of the country and the high inter-seasonal variability of rainfall makes crop production, on which the livelihood of rural inhabitants is based, a risky enterprise. Women farmers in Cameroon are an important group for whom risk aversion influences production outcomes and welfare. This study identifies and analyses the effect of climate risks on the productive activities and the management options of male and female farmers. Women-owned farms, on average, record profits of US620 per hectare to about US 620 per hectare to about US 935 for crop enterprises across the different agroecological zones. Comparatively static results indicate that increases in climate variability and the uncertainty of climate conditions have an explicit impact on farm profit. The impacts of increased uncertainty in climate and risk aversion are ambiguous depending on the agroecology. Ex-ante and ex-post risk management options reveal that female-owned farms in the northern Sahel savannah zone rely on more sophisticated strategies to reduce the impact of shocks. While adapting to uncertain climate positively influences profit levels, risk measured as the variance of rainfall or temperature per unit variation in profit is significant. This analysis stresses the increased importance of climate risk management as a prelude to the panoply of adaptation choice in response to expected climatic change.     

Economic costs of reduced irrigation water availability in Uzbekistan (Central Asia)

Reduced river runoff and expected upstream infrastructural developments are both potential threats to irrigation water availability for the downstream countries in Central Asia. Although it has been recurrently mentioned that a reduction in water supply will hamper irrigation in the downstream countries, the magnitude of associated economic losses, economy-wide repercussions on employment rates, and degradation of irrigated lands has not been quantified as yet. A computable general equilibrium model is used to assess the economy-wide consequences of a reduced water supply in Uzbekistan—a country that encompasses more than half of the entire irrigated croplands in Central Asia. Modeling findings showed that a 10–20 % reduction in water supply, as expected in the near future, may reduce the areas to be irrigated by 241,000–374,000 hectares and may cause unemployment to a population of 712–868,000, resulting in a loss for the national income of 3.6–4.3 %. A series of technical, financial, and institutional measures, implementable at all levels starting from the farm to the basin scale, are discussed for reducing the expected water risks. The prospects of improving the basin-wide water management governance, increasing water and energy use efficiency, and establishing the necessary legal and institutional frameworks for enhancing the introduction of needed technological and socioeconomic change are argued as options for gaining more regional water security and equity.     

The risks of risk-based regulation: insights from the environmental policy domain

Risk-based regulation has become increasingly popular in recent years. Proponents argue that it facilitates robust governance, contributing to efficient and effective use of regulatory resources and delivering interventions in proportion to risk. Critics contend that the challenges of operationalising risk-based governance mitigate its potential benefits. In this paper we start by considering what we mean by risk-based governance and discuss some of the factors shaping the adoption of such strategies. We then consider the development and operation of risk-based approaches in the environmental policy domain, focusing specifically on the regulation of contaminated land and radioactive waste. We argue that whilst risk-based approaches can offer important benefits, they face a range of epistemic, institutional and normative challenges that can play an important role in shaping the way that organisations manage both risks to society and their own institutional risks. This has profound implications for achieving regulatory objectives and, for this paper, the environmental outcomes that the regulations are designed to deliver.     

“双碳”目标下中国气候变化立法的双阶体系构造

中国在第75届联合国大会期间提出了CO2排放力争在2030年前达到峰值,在2060年前实现碳中和的"双碳"目标。"双碳"目标的确立提出了艰巨而紧迫的立法任务。由于气候变化具有全球性的特点,因此,中国未来气候变化立法的监管领域在关注国内监管空间和已有立法的同时,还应注意其国际面向的监管空间和衔接。气候变化法律具有复杂性、综合性、系统性和动态性的特点,国际上还没有通过一部气候变化法即可解决全部碳排放问题的成功先例。气候变化法律监管空间宏大,涉及领域和问题复杂多样。所涉及的领域和问题都与应对气候变化有直接或间接的关联。这决定了气候变化立法包含以实现气候政策目标为主要目的的直接立法和对气候目标实现具有支持、阻碍影响的间接立法两种类型。中国应对气候变化的立法应采用双阶体系构造模式,即直接立法加间接立法的模式。直接立法包括气候变化的框架法和专项立法,间接立法包括所有间接影响气候政策目标实现的相关法律。直接立法解决应对气候应对的目标、碳预算、管理体制、实施机制等较为集中的问题。间接立法则因为气候变化监管措施跨领域、跨部门和行业,应拓展至能源法、经济法、农业法、环境法、民商法等领域。直接立法和间接立法的有关法律制度应密切配合,彼此呼应,构成一个完整的应对气候变化的法律制度体系。以直接立法加间接立法的双阶模式构建中国的应对气候变化法律体系是应对气候变化立法模式的理性选择,并以此从不同的路径实现中国温室气体减排的目标。     

Never smoker lung cancer risks from exposure to particulate tobacco smoke

The average particulate environmental tobacco smoke (ETS) exposure of never and current smokers and the average lung cancer mortality rate for current smokers is estimated from empirical data. These estimates are used in a linear downward extrapolation of the lung cancer risk/mg of particulate ETS exposure for current smokers to calculate the average lung cancer risk for never smokers and the number of never smoker lung cancer deaths (LCD) in the U.S. in 1980 from exposure to particulate ETS. The estimated average daily inhaled particulate ETS exposure for never smokers is 0.62 mg/day for men and 0.28 mg/day for women. The average never smoker is estimated to retain 11% of the inhaled exposure, for a daily retained exposure of 0.07 mg for men and 0.03 mg for women. Other estimates are: a daily retained exposure for current smokers of 310 mg for men and 249 mg for women, a smoking-attributable lung cancer risk for current smokers in 1980 of 284 LCD/100,000 men and 121 LCD/100,000 women, and an annual retained-exposure lung cancer risk for never smokers of 0.64 LCD/100,000 men and 0.015 LCD/100,000 women. These risks and exposures estimate 12 lung cancer deaths among never smokers from exposure to particulate ETS: 8 among the 11.96 million male never smokers and 4 among the 28.85 million female never smokers in the U.S. in 1980. Conversely, between 655 and 3,610 never smoker lung cancer deaths are estimated from methods based on the average lung cancer risk observed in epidemiological studies of exposure to ETS. Three possible reasons for the discrepancy between the exposure and risk-based estimates are discussed: the excess risks observed in epidemiological studies are due to bias, the relationship between exposure and risk is supralinear, or sidestream tobacco smoke is substantially more carcinogenic than an equivalent exposure to mainstream smoke.     

Emissions trading: An improved technique for air quality management

The emissions trading program was one of the first major regulatory reform efforts at the U.S. Environmental Protection Agency under the Reagan Administration. This program is a set of guidelines for the states to develop federally approved transactions in discharge permits, called an Emission Reduction Credit. The rules governing emissions trading apply within a total ambient constraint or “pollution budget.” This paper provides a discussion of the emissions trading program as an improved technique for air quality management. The paper begins with a discussion of the concept of emissions trading and how the EPA emissions trading program fits into the U.S. Clean Air Act. It is then argued that emissions trading provides a more cost-effective set of implementation incentives in comparison to a “command and control” regulatory system. A number of important attributes of the emissions trading program are discussed, and estimates of cost reductions are provided. The current status of the implementation of the emissions trading program is discussed. The paper concludes with a discussion of several legal, technical, and administrative obstacles to obtaining the efficiencies of emissions trading.     

From comparative risk assessment to multi-criteria decision analysis and adaptive management: recent developments and applications

Environmental risk assessment and decision-making strategies over the last several decades have become increasingly more sophisticated, information-intensive, and complex, including such approaches as expert judgment, cost-benefit analysis, and toxicological risk assessment. One tool that has been used to support environmental decision-making is comparative risk assessment (CRA), but CRA lacks a structured method for arriving at an optimal project alternative. Multi-criteria decision analysis (MCDA) provides better-supported techniques for the comparison of project alternatives based on decision matrices, and it also provides structured methods for the incorporation of project stakeholders' opinions in the ranking of alternatives. We argue that the inherent uncertainty in our ability to predict ecosystem evolution and response to different management policies requires shifting from optimization-based management to an adaptive management paradigm. This paper brings together a multidisciplinary review of existing decision-making approaches at regulatory agencies in the United States and Europe and synthesizes state-of-the-art research in CRA, MCDA, and adaptive management methods applicable to environmental remediation and restoration projects. We propose a basic decision analytic framework that couples MCDA with adaptive management and its public participation and stakeholder value elicitation methods, and we demonstrate application of the framework to a realistic case study based on contaminated sediment management issues in the New York/New Jersey Harbor.