Is There a Role for Risk Assessment within Precautionary Legislation?

Posing the question of whether the precautionary principle has a role in risk assessment effectively constrains any debate of the issue within a framework predicated on the assumption that application of risk assessment is inevitable in the formulation of regulatory decisions. The question can equally validly be expressed in terms of whether there is a role for risk assessment in the formulation of precautionary legislation. This allows the debate then to turn on consideration of two questions: Firstly, does the precautionary principle have a role in policy development? and secondly, is this role consistent and compatible with a risk based approach to regulation? When recast in these terms, a more holistic comparison of the aims and objectives of both approaches and of their relative power in the formulation of regulation becomes possible. This leads to the conclusion that the precautionary principle is, when defined and applied correctly, scientifically more robust than risk assessment. Precautionary approaches utilize scientific information and conform robustly to a scientific process but also explicitly incorporate indeterminacies into the decision making framework. Moreover, the precautionary principle when applied to environmental regulation, is more likely to lead to regulation consistent with global sustainability. On this premise, this paper argues that risk based approaches are essentially incompatible with approaches based on the precautionary paradigm, and that of the two, risk assessment is more likely to lead to unsustainable underprotection of the environment.     

The Aquatic Environment and Textile Mill Effluents — An Ecological Risk Assessment

Textile mill effluents (TMEs) are wastewater discharges from textile mills that are involved in wet processes such as scouring, neutralizing, desizing, mercerizing, carbonizing, fulling, bleaching, dyeing, printing and other wet finishing activities. TMEs are complex mixtures containing a wide variety of chemicals which have a range of pH, temperature, colour and oxygen demand characteristics. Most wet processing mills in Canada discharge to municipal wastewater collection systems where those effluents receive some form of wastewater treatment. This paper reports the results of a tiered assessment approach that was used to determine the impacts on the aquatic environment of whole effluents discharged by wet processing textile mills in Canada. A conservative assessment indicated that no substantial threat to the aquatic environment was associated with TMEs receiving secondary or tertiary treatment, on- site or at a municipal wastewater treatment plant, prior to discharge to receiving waters. In the case of TMEs receiving only primary treatment or no treatment prior to discharge, a weight-of-evidence risk assessment supported the conclusion that those effluents could produce significant environmental harm in aquatic environments.     

Soil Microbial Communities and Ecological Risk Assessment: Risk Assessors’ Perspective

In the past, ecological risk assessments (ERAs) have generally overlooked the soil microbial community when evaluating the impacts of contaminants in soil. However, the soil microbial community, which includes bacteria and fungi, performs functions necessary for overall ecosystem health, including nitrogen fixation, nutrient cycling, and even degradation of contaminants. The incorporation of the soil microbial community into ERA requires the compilation of adequate toxicity data to complete the hazard assessment phase of the risk assessment. A variety of soil microbial toxicity tests exist that provide rapid and inexpensive results. Surveys of the microbial community at a contaminated site may also provide insight as to their functioning in the presence of contaminants. This paper explores the use of toxicity tests and surveys to evaluate chemical toxicity to microbes. However, many questions related to the best methodological approach to an ERA of the soil microbial community have yet to be answered.     

Environmental Pathway and Risk Assessment Studies of the Musi River's Heavy Metal Contamination—A Case Study

The Musi River, in Hyderabad, the capital city of Andhra Pradesh state in India, is relatively dry for most of the year except for the four monsoon months when 700–800 mm of rain falls. Throughout the year, sewage, industrial, and hospital waste is released into the river. In the present work the Musi River from Amberpet Bridge to Nallacheruvu (8 km stretch) was assessed and monitored for heavy metal contamination attributable to sewage and industrial effluents. Twelve locations were assessed for Zn, Cr, Cu, Ni, Co, As, Hg, Cd, and Pb in soils, waters, forage grass, milk, and vegetables. A sequential extraction scheme revealed that high levels of Zn, Cr, and Cu were associated with labile fractions, making them more mobile and phytoavailable. Human risk was assessed in people exposed to pollution by analyzing metals concentrations in venous blood and urine. Results showed high amounts of Pb, Zn, Cr, and Ni compared to permissible limits, attributable to the consumption of contaminated food. Metals concentrations were monitored systematically to assess risks and support management decisions to help curtail the possible entry of metals into human food chains. An assessment was also made of a possible analysis of a remediation technology for lead-contaminated soils and water.     

Integrated Risk Assessment — Results from an International Workshop

The World Health Organization's International Programme on Chemical Safety and international partners have developed a framework for integrated assessment of human health and ecological risks and four case studies. An international workshop was convened to consider how ecological and health risk assessments might be integrated, the benefits of and obstacles to integration, and the research and mechanisms needed to facilitate implementation of integrated risk assessment. Using the case studies, workshop participants identified a number of opportunities to integrate the assessment process. Improved assessment quality, efficiency, and predictive capability were considered to be principal benefits of integration. Obstacles to acceptance and implementation of integrated risk assessment included the disciplinary and organizational barriers between ecological and health disciplines. A variety of mechanisms were offered to overcome these obstacles. Research recommendations included harmonization of exposure characterization and surveillance methods and models, development of common risk endpoints across taxa, improved understanding of mechanisms of effect at multiple scales of biological organization, and development of methods to facilitate comparison of risks among endpoints.     

Improving the Applicability of Quantitative Ecological Risk Assessment Tools—Understanding Demand-Side Changes

Quantitative ecological risk assessment (ERA) methods are the tools of choice for many natural resource management agencies and practitioners. However, a number of researchers and practitioners have recently highlighted that the application of quantitative ERA tools has perhaps been somewhat limited and this has stimulated discussion on the limitations of these methods, considered to be supply-side limitations in this analysis. By contrast, it is argued here that the demand for risk assessment tools has also changed substantively and this also acts to limit the use of ERA approaches. In particular, demand has changed through an increasing expectation that quantitative ERA tools will be able to capture ecosystem-scale, and sometimes global-scale interactions to support ecosystem-based management approaches. Similarly, the burgeoning use of market-based policy instruments often underpinned by the allocation of private property rights to an increasing number of ecosystem goods and services has fundamentally changed many natural resource management issues into allocation conflicts between alternate rights-holders. These demand-side changes represent both an opportunity and a challenge for developers of quantitative ERA tools.     

Precautionary Defaults—A New Strategy for Chemical Risk Management

In order to give adequate support to risk managers, new risk assessment methods should be developed that are (1) scientifically sound, (2) simplified, and (3) suited for precautionary risk management. In this Perspective we propose that the notion of a precautionary default can be a useful tool in the development of such methods. A precautionary default is a cautious or pessimistic assumption that is used in the absence of adequate information and that should be replaced when such information is obtained. Furthermore, we point out some promising research areas for the development of such indicators, viz. connections between chemical characteristics such as persistence and effect parameters, monitoring of contaminants in polar regions, monitoring of contaminants in breast milk, application of results from (human) toxicology in ecotoxicology and vice versa, (eco)toxicological test systems that are sensitive to effects on reproduction, and the application of bioinformatic methods to complex data, both in genomic research and in ecotoxicology. We conclude that precautionary decision-making does not require less science, but to the contrary it requires more science and improved communication between scientists and risk managers.     

Ambulatory Blood Pressure Monitoring: Importance of Sampling Rate and Duration—48 Versus 24 Hours—on the Accurate Assessment of Cardiovascular Risk

Independent prospective studies have found that ambulatory blood pressure (BP) monitoring (ABPM) is more closely correlated with target organ damage and cardiovascular disease (CVD) risk than clinic BP measurement. This is based on studies in which BP was sampled every 15–30?min for ≤24?h, without taking into account that reproducibility of any estimated parameter from a time series to be potentially used for CVD risk assessment might depend more on monitoring duration than on sampling rate. Herein, we evaluated the influence of duration (48 vs. 24?h) and sampling rate of BP measurements (form every 20–30?min up to every 2?h) on the prognostic value of ABPM-derived parameters. We prospectively studied 3344 subjects (1718 men/1626 women), 52.6?±?14.5 yrs of age, during a median follow-up of 5.6 yrs. Those with hypertension at baseline were randomized to ingest all their prescribed hypertension medications upon awakening or ≥1 of them at bedtime. At baseline, BP was measured at 20-min intervals from 07:00 to 23:00?h and at 30-min intervals at night for 48?h, and physical activity was simultaneously monitored every min by wrist actigraphy to accurately derive the awake and asleep BP means. Identical assessment was scheduled annually and more frequently (quarterly) if treatment adjustment was required. ABPM profiles were modified to generate time series of identical 48-h duration but with data sampled at 1- or 2-h intervals, or shorter, i.e., first 24?h, time series with data sampled at the original rate (daytime 20-min intervals/nighttime 30-min intervals). Bland-Altman plots indicated that the range of individual differences in the estimated awake and asleep systolic (SBP) and diastolic BP (DBP) means between the original and modified ABPM profiles was up to 3-fold smaller for data sampled every 1?h for 48?h than for data sampled every 20–30?min for the first 24?h. Reduction of ABPM duration to just 24?h resulted in error of the estimated asleep SBP mean, the most significant prognostic marker of CVD events, in the range of ?21.4 to +23.9?mm Hg. Cox proportional-hazard analyses adjusted for sex, age, diabetes, anemia, and chronic kidney disease revealed comparable hazard ratios (HRs) for mean BP values and sleep-time relative BP decline derived from the original complete 48-h ABPM profiles and those modified to simulate a sampling rate of one BP measurement every 1 or 2?h. The HRs, however, were markedly overestimated for SBP and underestimated for DBP when the duration of ABPM was reduced from 48 to only 24?h. This study on subjects evaluated prospectively by 48-h ABPM documents that reproducibility in the estimates of prognostic ABPM-derived parameters depends markedly on duration of monitoring, and only to a lesser extent on sampling rate. The HR of CVD events associated with increased ambulatory BP is poorly estimated by relying on 24-h ABPM, indicating ABPM for only 24?h may be insufficient for proper diagnosis of hypertension, identification of dipping status, evaluation of treatment efficacy, and, most important, CVD risk stratification. (Author correspondence: rhermida@uvigo.es)     

Testing Chemical Safety: What Is Needed to Ensure the Widespread Application of Non-animal Approaches?

Scientists face growing pressure to move away from using traditional animal toxicity tests to determine whether manufactured chemicals are safe. Numerous ethical, scientific, business, and legislative incentives will help to drive this shift. However, a number of hurdles must be overcome in the coming years before non-animal methods are adopted into widespread practice, particularly from regulatory, scientific, and global perspectives. Several initiatives are nevertheless underway that promise to increase the confidence in newer alternative methods, which will support the move towards a future in which less data from animal tests is required in the assessment of chemical safety.     

Repeat Cardiovascular Risk Assessment after Four Years: Is There Improvement in Risk Prediction?

Background

Framingham risk equations are widely used to predict cardiovascular disease based on health information from a single time point. Little is known regarding use of information from repeat risk assessments and temporal change in estimated cardiovascular risk for prediction of future cardiovascular events. This study was aimed to compare the discrimination and risk reclassification of approaches using estimated cardiovascular risk at single and repeat risk assessments

Methods

Using data on 12,197 individuals enrolled in EPIC-Norfolk cohort, with 12 years of follow-up, we examined rates of cardiovascular events by levels of estimated absolute risk (Framingham risk score) at the first and second health examination four years later. We calculated the area under the receiver operating characteristic curve (aROC) and risk reclassification, comparing approaches using information from single and repeat risk assessments (i.e., estimated risk at different time points).

Results

The mean Framingham risk score increased from 15.5% to 17.5% over a mean of 3.7 years from the first to second health examination. Individuals with high estimated risk (≥20%) at both health examinations had considerably higher rates of cardiovascular events than those who remained in the lowest risk category (<10%) in both health examinations (34.0 [95%CI 31.7–36.6] and 2.7 [2.2–3.3] per 1,000 person-years respectively). Using information from the most up-to-date risk assessment resulted in a small non-significant change in risk classification over the previous risk assessment (net reclassification improvement of -4.8%, p>0.05). Using information from both risk assessments slightly improved discrimination compared to information from a single risk assessment (aROC 0.76 and 0.75 respectively, p<0.001).

Conclusions

Using information from repeat risk assessments over a period of four years modestly improved prediction, compared to using data from a single risk assessment. However, this approach did not improve risk classification.     

Are There Health Risks from the Migration of Chemical Substances from Plastic Pipes into Drinking Water? A Review

Plastic pipes used to convey hot and cold drinking water are synthetic polymers containing numerous additives that enhance durability, impact strength, and toughness, and resist material degradation. Although some research studies have been conducted to evaluate the type and levels of chemical substances migrating from polymeric materials into drinking water, the potential adverse health effects associated with these compounds in potable water have not been described. This review evaluates the literature on the occurrence of regulated and unregulated substances in drinking water related to the use of plastic pipes, characterizes potential health hazards, and describes uncertainties associated with human health and exposure in need of further research. Of particular public health concern is the potential for sensitive populations to be exposed to short-term elevations in leachates during critical periods, and for co-occurring leachates targeting the same organ(s) and/or sharing a common mode of toxic action to have additive or synergistic effects. Contaminants are measured in the distribution system, not at the tap where human exposure actually occurs. For increased health protection, it is important to identify compounds that migrate from plastic pipes into drinking water and to better quantify human exposures and health hazards to these substances and their degradates.     

Seed dispersal and colonization ability of plants — Assessment and implications for conservation

Seed dispersal is one of the least understood phases in plant life-cycles, despite being recognized as fundamentally important for understanding species distribution, abundance, population dynamics and life-history variation. For species living in fragmented habitats, dispersal may be crucial for regional persistence. This paper synthesizes studies performed in Swedish semi-natural grasslands and deciduous forests. The main objective was to develop a simple method to assess the dispersal and colonization ability of plants. Dispersal and colonization were considered as a series of steps: seed production, seed transport and seedling recruitment. With the use of verified assumptions on (i) a trade-off between seed production and seed size, (ii) a relatively small predictive power of seed transport for species actual dispersal and colonization, (iii) a positive effect of seed size on recruitment, and (iv) a general prevalence of recruitment limitations by seed availability, a prediction is made that dispersal and colonization ability will be highest among species with intermediate seed sizes in a given community. This prediction is supported by field data. Based on estimated dispersal and colonization ability, and the ability of local populations to persist, a scheme is suggested with four basic categories of plants. Some implications are suggested for conservation, in a landscape scale, of plants belonging to each of these four categories.     

Evaluation of a Community’s Risk for Canine Parvovirus and Distemper Using Antibody Testing and GIS Mapping of Animal Shelter Intakes

This cross-sectional study aimed to identify where dogs with negative antibody tests to canine parvovirus (CPV) and canine distemper virus (CDV) originated when entering a community shelter, using a commercially available ELISA antibody test and Geographic Information Systems mapping. Of 2745 canines entering during a three-month period, 1056 test results were obtained. Dogs or puppies weighing over 2 lb were eligible if they could be humanely, nonchemically restrained for phlebotomy. Age and minor health issues weren't exclusions. Dogs were excluded if trained personnel were concerned health would be compromised by phlebotomy. Blood samples were collected within 24 hours of entry. Four hundred and twenty-seven (40%) dogs had positive antibody test results for both viruses, 422 (40%) were positive for CPV, 37 (4%) were positive for CDV, and 170 (16%) were negative for both. Mapping revealed geographic patterns for dogs with negative antibody tests. This shelter admitted dogs with negative CPV and/or CDV antibody tests from defined community areas. Targeting vaccination efforts in communities to areas where dogs with negative antibody tests originate could be an effective wellness strategy.     

“Solution-Focused Risk Assessment”: A Proposal for the Fusion of Environmental Analysis and Action

For 30 years, more attention and resources have been expended on dissecting problems (risk assessment) than on evaluating actual solutions that reduce risks. The basic dogma holds that risk assessment must precede risk management. But there is an opposite and perhaps better way: the opening question should not be “How bad is the problem?” but “How good are the solutions we might apply to the problem?” Rethinking risk assessment in this context offers three classes of benefits over the status quo. First, it can help break the endless cycle of analysis: when the goal is to know enough to decide, rather than to know everything, natural stopping points emerge. Second, it can lead to more decisions that actually achieve risk reduction, rather than pronouncements about how much risk reduction would be optimal. Third, it can highlight ways to resolve multiple risks simultaneously, avoid needless and tragic risk-risk tradeoffs, and involve affected stakeholders in debating what should be done. Arguably, the longer the disembodied analysis of risk information is allowed to proceed, the more likely it is that the “problem” will be defined in a way that blunts the free-wheeling discussion of solutions, to the detriment of human health, the environment, and the economy.     

Can Physiological Endpoints Improve the Sensitivity of Assays with Plants in the Risk Assessment of Contaminated Soils?

Site-specific risk assessment of contaminated areas indicates prior areas for intervention, and provides helpful information for risk managers. This study was conducted in the Ervedosa mine area (Bragança, Portugal), where both underground and open pit exploration of tin and arsenic minerals were performed for about one century (1857 – 1969). We aimed at obtaining ecotoxicological information with terrestrial and aquatic plant species to integrate in the risk assessment of this mine area. Further we also intended to evaluate if the assessment of other parameters, in standard assays with terrestrial plants, can improve the identification of phytotoxic soils. For this purpose, soil samples were collected on 16 sampling sites distributed along four transects, defined within the mine area, and in one reference site. General soil physical and chemical parameters, total and extractable metal contents were analyzed. Assays were performed for soil elutriates and for the whole soil matrix following standard guidelines for growth inhibition assay with Lemna minor and emergence and seedling growth assay with Zea mays. At the end of the Z. mays assay, relative water content, membrane permeability, leaf area, content of photosynthetic pigments (chlorophylls and carotenoids), malondialdehyde levels, proline content, and chlorophyll fluorescence (F_v/F_m and Φ_PSII) parameters were evaluated. In general, the soils near the exploration area revealed high levels of Al, Mn, Fe and Cu. Almost all the soils from transepts C, D and F presented total concentrations of arsenic well above soils screening benchmark values available. Elutriates of several soils from sampling sites near the exploration and ore treatment areas were toxic to L. minor, suggesting that the retention function of these soils was seriously compromised. In Z. mays assay, plant performance parameters (other than those recommended by standard protocols), allowed the identification of more phytotoxic soils. The results suggest that these parameters could improve the sensitivity of the standard assays.     

Human Health Risk Assessment of Naturally Occurring Radioactive Materials in Produced Water—A Case Study

Human health effects from naturally occurring radioactive materials (NORM) in produced water are of concern due to their bioavailability and bioaccumulation characteristics in finfish and shellfish species used for human consumption. Being chemically similar to calcium, radium concentrates mostly in bones, shells, and exoskeletons. Previous studies have been based on the whole-body bioaccumulation of radium in fish where the distribution of radium in bone/exoskeleton and the edible parts of fish were not considered separately and thus the predicted risks were relatively high. In this article, the distribution of radium in the non-edible and edible parts of fish and the probability of exposure to a produced water plume have been studied in order to characterize human health risks. A probabilistic hydrodynamic model has been incorporated in this study. Using the concentration distribution approach, the mean cancer risks to humans were predicted in the range of 8.6 × 10^?7 to 9.5 × 10^?7, which were 2.6 to 2.7 times less than the risks predicted by using the whole body concentrations. The exceedence probability of maximum permissible human health cancer risk of 1 × 10^?4 is close to zero. At a risk level of 1 × 10^?6, the exceedence probability is 21% whereas in the whole body concentration approach it is between 45 to 49%. In this study, no effect on fish from exposure to NORM components in produced water was found.     

Chemical and biological consequences ofβ-decay

Summary In Part 1 of this article physical and chemical effects of-decay in labelled molecules were reviewed and their potential importance for breaking predetermined and specific bonds were pointed out. After incorporation of labelled biomolecules in living systems, such as viruses, phages or cells, the radioactive decay of the label alters the biological behaviour of the system, in the extreme case causing loss of the ability to reproduce, the extent of these consequences depending strongly on the type of radioisotope.Now Part 2 includes a brief discussion of biological effects associated with-decay, emphasizing the relative importance of local transmutation and internal radiation effects from the decay of³H,¹⁴C,³²P,³³P,³⁵S and¹²⁵I. Attempt is also made, whenever possible at the present stage of understanding, to correlate biological effects with chemical processes on a molecular level.     

The 3MRA Risk Assessment Framework—A Flexible Approach for Performing Multimedia,Multipathway, and Multireceptor Risk Assessments Under Uncertainty

A flexible framework for conducting nationwide multimedia, multipathway and multireceptor risk assessments (3MRA) under uncertainty was developed to estimate protective chemical concentration limits in a source area. The framework consists of two components: risk assessment and uncertainty analysis. The risk component utilizes linked source, fate/transport, exposure and risk assessment models to estimate the risk exposures for the receptors of concern. Both human and ecological receptors are included in the risk assessment framework. The flexibility of the framework is based on its ability to address problems varying in spatial scales from site-specific to regional and even national levels; and its ability to accommodate varying types of source, fate/transport, exposure and risk assessment models. The uncertainty component of the 3MRA framework is based on a two-stage Monte Carlo methodology. It allows the calculation of uncertainty in risk estimates, and the incorporation of the effects of uncertainty on the determination of regulatory concentration limits as a function of variability and uncertainty in input data, as well as potential errors in fate and transport and risk and exposure models. The framework can be adapted to handle a wide range of multimedia risk assessment problems. Two examples are presented to illustrate its use, and to demonstrate how regulatory decisions can be structured to incorporate the uncertainty in risk estimates.