Current Risk Assessment Approaches Research Articles

Composite power system risk evaluation considering the accurate model of renewable power output

The fluctuation of renewable energy will threaten the reliable operation of the composite transmission and generation power system, so the risk level of the composite system with renewable energy attached must be studied. However, the accuracy of the renewable energy model has typically been overlooked in current risk assessment approaches. Therefore, this study provides an accurate hybrid wind/solar power output model that takes the wind farm’s seasonal and spatial characteristics, as well as the correlation between wind and solar PV power into account. For the first, build the seasonal Weibull model of the wind speed and correct the speed captured by each wind turbine considering different spatial characteristics of the wind farm. Secondly, build the probability distribution function of the solar power based on the kernel density estimation method. In the next, construct the joint probability distribution function considering the correlation between wind and solar PV power based on copula theory. Then, using the suggested accurate renewable energy model, the sequential Cross-entropy (SCE) technique is utilized to evaluate the risk indices of the composite system with renewable energy. To validate the models and technique, the modified IEEE-RTS79 is studied. The findings indicate that the accuracy of the renewable energy model influences the risk assessment outcomes.

Deep learning-based pathology image analysis predicts cancer progression risk in patients with oral leukoplakia.

Oral leukoplakia (OL) is associated with an increased risk for oral cancer (OC) development. Prediction of OL cancer progression may contribute to decreased OC morbidity and mortality by favoring early intervention. Current OL progression risk assessment approaches face large interobserver variability and is weakly prognostic. We hypothesized that convolutional neural networks (CNN)-basedhistology image analyses could accelerate the discovery of better OC progression risk models. Our CNN-based oral mucosa risk stratification model (OMRS) was trained to classify a set of nondysplastic oral mucosa (OM) and a set of OC H&E slides. As a result, the OMRS model couldidentify abnormal morphological features of the oral epithelium. By applying this model to OL slides, we hypothesized that the extent of OC-like features identified in the OL epithelium would correlate with its progression risk. The OMRS model scored and categorized the OL cohort (n=62) into high- and low-risk groups. OL patients classified as high-risk (n=31) were 3.98 (95% CI 1.36-11.7) times more likely to develop OC than low-risk ones (n=31). Time-to-progression significantly differedbetween high- and low-risk groups (p=0.003). The 5-year OC development probability was 21.3% for low-risk and 52.5% for high-risk patients. The predictivepower of the OMRS model was sustained even after adjustment for age, OL site, and OL dysplasia grading (HR=4.52, 1.5-13.7). The ORMS model successfully identified OL patients with a high risk of OC development and can potentially benefit OC early diagnosis and prevention policies.

Considering developmental neurotoxicity invitro data for human health risk assessment using physiologically-based kinetic modeling: deltamethrin case study.

Developmental neurotoxicity (DNT) is a potential hazard of chemicals. Recently, an in vitro testing battery (DNT IVB) was established to complement existing rodent in vivo approaches. Deltamethrin (DLT), a pyrethroid with a well-characterized neurotoxic mode of action, has been selected as a reference chemical to evaluate the performance of the DNT IVB. The present study provides context for evaluating the relevance of these DNT IVB results for the human health risk assessment of DLT by estimating potential human fetal brain concentrations after maternal exposure to DLT. We developed a physiologically based kinetic (PBK) model for rats which was then translated to humans considering realistic in vivo exposure conditions (acceptable daily intake [ADI] for DLT). To address existing uncertainties, we designed case studies considering the most relevant drivers of DLT uptake and distribution. Calculated human fetal brain concentrations were then compared with the lowest benchmark concentration achieved in the DNT IVB. The developed rat PBK model was validated on in vivo rat toxicokinetic data of DLT over a broad range of doses. The uncertainty based case study evaluation confirmed that repeated exposure to DLT at an ADI level would likely result in human fetal brain concentrations far below the in vitro benchmark. The presented results indicate that DLT concentrations in the human fetal brain are highly unlikely to reach concentrations associated with in vitro findings under realistic exposure conditions. Therefore, the new in vitro DNT results are considered to have no impact on the current risk assessment approach.

Reconstructing Paleoflood Occurrence and Magnitude from Lake Sediments

Lake sediments are a valuable archive to document past flood occurrence and magnitude, and their evolution over centuries to millennia. This information has the potential to greatly improve current flood design and risk assessment approaches, which are hampered by the shortness and scarcity of gauge records. For this reason, paleoflood hydrology from lake sediments received fast-growing attention over the last decade. This allowed an extensive development of experience and methodologies and, thereby, the reconstruction of paleoflood series with increasingly higher accuracy. In this review, we provide up-to-date knowledge on flood sedimentary processes and systems, as well as on state-of-the-art methods for reconstructing and interpreting paleoflood records. We also discuss possible perspectives in the field of paleoflood hydrology from lake sediments by highlighting the remaining challenges. This review intends to guide the research interest in documenting past floods from lake sediments. In particular, we offer here guidance supported by the literature in how: to choose the most appropriate lake in a given region, to find the best suited sedimentary environments to take the cores, to identify flood deposits in the sedimentary sequence, to distinguish them from other instantaneous deposits, and finally, to rigorously interpret the flood chronicle thus produced.

Support for Regulatory Assessment of Percutaneous Absorption of Retronecine-type Pyrrolizidine Alkaloids through Human Skin.

1,2-unsaturated pyrrolizidine alkaloids are found naturally in Symphytum officinale, well known as comfrey, which has a longstanding use for the topical treatment of painful muscle and joint complaints. Pyrrolizidine alkaloids (PA) are a relevant concern for the safety assessment due to their liver genotoxicity profile, and close attention is paid during manufacturing to minimizing their levels. Current regulatory risk assessment approaches include setting limits that derive from toxicity data coming from the oral route of exposure. This study investigated to what extent pyrrolizidine alkaloids are bioavailable following topical exposure, assessing penetration of retronecine-type PAs in an in vitro human skin model. A single comfrey root formulation was spiked with 3 different congeners (a 7R-monoester, an open-chained 7R-diester, and a cyclic diester) and percutaneous absorption measured per OECD guidelines and good laboratory practices. The measured penetration for all 3 PAs was low and compared favourably with existing in vitro data. Although consideration of different regulatory guidance influences the determination of dermally absorbed dose, these data facilitate the understanding of absorption differences following topical exposure, which in turn can be taken into account in the risk assessment.

The Miami Heart Study (MiHeart) at Baptist Health South Florida, A prospective study of subclinical cardiovascular disease and emerging cardiovascular risk factors in asymptomatic young and middle-aged adults: The Miami Heart Study: Rationale and Design

ObjectiveThe Miami Heart Study (MiHeart) at Baptist Health South Florida is an ongoing, community-based, prospective cohort study aimed at characterizing the prevalence, characteristics, and prognostic value of diverse markers of early subclinical coronary atherosclerosis and of various potential demographic, psychosocial, and metabolic risk factors. We present the study objectives, detailed research methods, and preliminary baseline results of MiHeart. MethodsMiHeart enrolled 2,459 middle-aged male and female participants from the general population of the Greater Miami Area. Enrollment occurred between May 2015 and September 2018 and was restricted to participants aged 40–65 years free of clinical cardiovascular disease (CVD). The baseline examination included assessment of demographics, lifestyles, medical history, and a detailed evaluation of psychosocial characteristics; a comprehensive physical exam; measurement of multiple blood biomarkers including measures of inflammation, advanced lipid testing, and genomics; assessment of subclinical coronary atherosclerotic plaque and vascular function using coronary computed tomography angiography, the coronary artery calcium score, carotid intima-media thickness, pulse wave velocity, and peripheral arterial tonometry; and other tests including 12-lead electrocardiography and assessment of pulmonary function. Blood samples were biobanked to facilitate future ancillary research. ResultsMiHeart enrolled 1,261 men (51.3%) and 1,198 women (48.7%). Mean age was 53 years, 85.6% participants were White and 47.4% were of Hispanic/Latino ethnicity. The study included 7% individuals with diabetes, 33% with hypertension, and 15% used statin therapy at baseline. Overweight or obese participants comprised 72% of the population and 3% were smokers. Median 10-year estimated atherosclerotic CVD risk using the Pooled Cohort Equations was 4%. ConclusionMiHeart will provide important, novel insights into the pathophysiology of early subclinical atherosclerosis and further our understanding of its role in the genesis of clinical CVD. The study findings will have important implications, further refining current cardiovascular prevention paradigms and risk assessment and management approaches moving forward.

The use of the Hazard Quotient approach to assess the potential risk to honeybees (Apis mellifera) posed by pesticide residues detected in bee‐relevant matrices is not appropriate

Pesticide residue data for pollen and nectar are valuable for characterizing realistic exposure of pollinators, e.g. from agricultural crops, flowering margins. Interpretation of residues relies on comparing exposure with toxicity and the Hazard Quotient (HQ) is widely utilized. However, the HQ (threshold of concern 50) was only validated for foliar sprays, based on application rate as a proxy for exposure, not measured residues in bee-relevant matrices. A review of the literature showed a range of HQ approaches and thresholds of concern used to assess non-foliar applications and residues detected in bee-relevant matrices, mostly pollen. The use of the HQ thresholds to assess risks associated with residue data or non-foliar spray application methods is not validated, does not reflect realistic exposure and the conclusions reached differ substantially from current risk assessment approaches. Re-evaluation of residue data from the first published use of the concentration-based HQ (2013) and a recent paper (2021) reduced the proportion of pesticides where a conclusion of potential risk was reached from 30 to 7% and 28% to 3-6%, respectively. An understanding of the applicability of the selected risk assessment approach to the available residue data is needed to enable robust conclusions to be drawn on the potential risk to bees. Use of the HQ approach to assess the risk posed by application methods other than foliar sprays or residues in nectar and pollen is likely to result in unreliable conclusions. An alternative approach should be used to assess the significance of measured residues.

Soil invertebrate toxicity and bioaccumulation of nano copper oxide and copper sulphate in soils, with and without biosolids amendment

The fate, toxicity and bioaccumulation of copper oxide nanoparticles (nCuO) was investigated in soil, with and without biosolids amendment, through chronic exposures using the earthworm, Eisenia andrei, and the collembolan, Folsomia candida. The effects of copper sulphate (CuSO4) were included so as to compare the behavior of nCuO to a readily soluble counterpart. The fate of nCuO was evaluated through characterization of dissolved and nano-particulate fractions (via single particle ICP-MS) as well as extractable Cu2+ throughout the duration of select tests. Neither Cu form was particularly toxic to F. candida, but effects on E. andrei reproduction were significant in all treatments (IC50 range: 98 – 149 mg Cu kg−1 dry soil). There were no significant differences in toxicity between the Cu forms, nor in extractable Cu2+ activities, indicative that particle dissolution within the soil and, subsequent activity of Cu2+ was likely the primary mode of toxicity in the nCuO exposures. The presence of biosolids did not significantly alter toxicity of nCuO, but did affect Cu2+ activity over time. Bioaccumulation of total Cu in E. andrei when exposed to nCuO (kinetic bioaccumulation factor (BAFk): 0.80 with biosolids and 0.81 without) was lower than exposure to CuSO4 (BAFk: 2.31 with biosolids and 1.12 without). Enhanced dark-field hyperspectral imaging showed accumulation of nCuO along the epidermis and gut of E. andrei, with trace amounts observed in muscle and chloragogenous tissue, providing evidence of nCuO translocation within the organism. The present study demonstrates that the current risk assessment approach for trace metals in the environment, based on substance solubility and bioavailability of the dissolved free ion, are applicable for nCuO exposure to soil invertebrates, but that the rate of particle dissolution in different soil environments is an important factor for consideration.

Potential impact of chemical stress on freshwater invertebrates: A sensitivity assessment on continental and national scale based on distribution patterns, biological traits, and relatedness.

Current chemical risk assessment approaches rely on a standard suite of test species to assess toxicity to environmental species. Assessment factors are used to extrapolate from single species to communities and ecosystem effects. This approach is pragmatic, but lacks resolution in biological and environmental parameters. Novel modelling approaches can help improve the biological resolution of assessments by using mechanistic information to identify priority species and priority regions that are potentially most impacted by chemical stressors. In this study we developed predictive sensitivity models by combining species-specific information on acute chemical sensitivity (LC50 and EC50), traits, and taxonomic relatedness. These models were applied at two spatial scales to reveal spatial differences in the sensitivity of species assemblages towards two chemical modes of action (MOA): narcosis and acetylcholinesterase (AChE) inhibition. We found that on a relative scale, 46% and 33% of European species were ranked as more sensitive towards narcosis and AChE inhibition, respectively. These more sensitive species were distributed with higher occurrences in the south and north-eastern regions, reflecting known continental patterns of endemic macroinvertebrate biodiversity. We found contradicting sensitivity patterns depending on the MOA for UK scenarios, with more species displaying relative sensitivity to narcotic MOA in north and north-western regions, and more species with relative sensitivity to AChE inhibition MOA in south and south-western regions. Overall, we identified hotspots of species sensitive to chemical stressors at two spatial scales, and discuss data gaps and crucial technological advances required for the successful application of the proposed methodology to invertebrate scenarios, which remain underrepresented in global conservation priorities.

Herbicide risk assessments of non-target terrestrial plant communities: A graphical user interface for the plant community model IBC-grass.

Plants located adjacent to agricultural fields are important for maintaining biodiversity in semi-natural landscapes. To avoid undesired impacts on these plants due to herbicide application on the arable fields, regulatory risk assessments are conducted prior to registration to ensure proposed uses of plant protection products do not present an unacceptable risk. The current risk assessment approach for these non-target terrestrial plants (NTTPs) examines impacts at the individual-level as a surrogate approach for protecting the plant community due to the inherent difficulties of directly assessing population or community level impacts. However, modelling approaches are suitable higher tier tools to upscale individual-level effects to community level. IBC-grass is a sophisticated plant community model, which has already been applied in several studies. However, as it is a console application software, it was not deemed sufficiently user-friendly for risk managers and assessors to be conveniently operated without prior expertise in ecological models. Here, we present a user-friendly and open source graphical user interface (GUI) for the application of IBC-grass in regulatory herbicide risk assessment. It facilitates the use of the plant community model for predicting long-term impacts of herbicide applications on NTTP communities. The GUI offers two options to integrate herbicide impacts: (1) dose responses based on current standard experiments (acc. to testing guidelines) and (2) based on specific effect intensities. Both options represent suitable higher tier options for future risk assessments of NTTPs as well as for research on the ecological relevance of effects.

An evaluation of risk-based monitoring in pragmatic trials in UK Clinical Trials Units

BackgroundGood Clinical Practice guidelines issued in 2016 encourage risk-based approaches to monitoring clinical trials. This study compared current risk assessment and monitoring approaches in UK Clinical Trials Units (CTUs) with the published guidance and makes recommendations for risk-based monitoring in pragmatic trials.MethodsAn online survey of UK Clinical Research Collaboration registered CTUs was administered via email invitation. Forty-nine units were invited, and 23 responded. Respondents were also invited to share copies of risk assessment templates.ResultsMost CTUs reported using remote combined with on-site monitoring. All reported undertaking a risk assessment for Clinical Trials of Investigational Medicinal Products (CTIMPs) and 21 units did so for non-CTIMPs. Most CTIMP risk assessments used MHRA (Medicines and Healthcare products Regulatory Agency) classifications, although some also employed staff judgement. Almost all units based their monitoring on perceived risk level; this number was higher for CTIMPs (n = 22) than for non-CTIMPs (n = 19). In most cases, monitoring plans were produced. More CTUs revisited risk assessments during trials in CTIMPs (n = 21) than in non-CTIMPs (n = 18). Small numbers of units reviewed the monitoring approach always (n = 4) or sometimes (n = 9) and few used the reflection to guide future monitoring.ConclusionsA high proportion of UK CTUs are using risk-based monitoring in the UK, as recommended by guidelines, for both CTIMPs and non-CTIMPs. This has the potential to make trials more efficient and reduce costs. However, there appears to be a lack of reflection on the value of these revised approaches. There may be a benefit in CTUs collaborating nationally to improve processes for reflection and making changes during the life course of a trial.

Current risk assessment approaches for environmental and food and feed safety assessment.

Foundational activities at the international level underlie current risk and safety assessment approaches for genetically engineered/modified organisms (GEOs/GMOs). Early risk assessment considerations beginning with the OECD 'Blue Book' established risk/safety assessment as the characterization of the organism and its environmental release; establishment and persistence in the environment; and human and ecological effects, analyzed in principle through existing methods. Important in this context was recognition that GEOs/GMOs as a class did not represent new risks relative to products of traditional plant breeding and that any incremental risk would need to be established on a stepwise case-by-case comparative basis with existing crops and derived-foods as the baseline. Accordingly, concepts of familiarity and substantial equivalence were advanced by OECD and WHO as ways to establish a risk analysis baseline for determining whether and to what extent risk/safety assessment was needed. Regulatory implementations of this paradigm have skewed to increasingly complex portfolios of studies rather than adhering to analysis which is formulated to fit the risk/safety questions relevant to a given case. Plants produced through genome editing technology will benefit from risk analysis that implements sound problem formulation to guide the need for and nature of risk/safety assessments.

Scientific statement on the coverage of bats by the current pesticide risk assessment for birds and mammals.

Bats are an important group of mammals, frequently foraging in farmland and potentially exposed to pesticides. This statement considers whether the current risk assessment performed for birds and ground dwelling mammals exposed to pesticides is also protective of bats. Three main issues were addressed. Firstly, whether bats are toxicologically more or less sensitive than the most sensitive birds and mammals. Secondly, whether oral exposure of bats to pesticides is greater or lower than in ground dwelling mammals and birds. Thirdly, whether there are other important exposure routes relevant to bats. A large variation in toxicological sensitivity and no relationship between sensitivity of bats and bird or mammal test‐species to pesticides could be found. In addition, bats have unique traits, such as echolocation and torpor which can be adversely affected by exposure to pesticides and which are not covered by the endpoints currently selected for wild mammal risk assessment. The current exposure assessment methodology was used for oral exposure and adapted to bats using bat‐specific parameters. For oral exposure, it was concluded that for most standard risk assessment scenarios the current approach did not cover exposure of bats to pesticide residues in food. Calculations of potential dermal exposure for bats foraging during spraying operations suggest that this may be a very important exposure route. Dermal routes of exposure should be combined with inhalation and oral exposure. Based on the evidence compiled, the Panel concludes that bats are not adequately covered by the current risk assessment approach, and that there is a need to develop a bat‐specific risk assessment scheme. In general, there was scarcity of data to assess the risks for bat exposed to pesticides. Recommendations for research are made, including identification of alternatives to laboratory testing of bats to assess toxicological effects.

EFSA Scientific Colloquium 24 – 'omics in risk assessment: state of the art and next steps

In recent years, the development of innovative tools in genomics, transcriptomics, proteomics and metabolomics (designated collectively as 'omics technologies) has opened up new possibilities for applications in scientific research and led to the availability of vast amounts of analytical data. The interpretation and integration of 'omics data can provide valuable information on the functional status of an organism and on the effect of external factors such as stressors. The European Food Safety Authority's (EFSA) 24th Scientific Colloquium on 'omics in risk assessment: state of the art and next steps explored the opportunities for integration of datasets produced via specific 'omics tools within the remit of EFSA's risk assessment approaches and tried to build further towards concrete paths of implementation. Discussions focused on genomics in microbial strain characterisation, metabolomics for the comparative assessment of GM plants and the use of 'omics for toxicological and environmental risk assessment. From the Colloquium it became clear that 'omics technologies are a valuable addition in some aspects of risk assessment of food and feed products and the environment, especially now that this technology is almost mature and stable. However, a consistent reporting framework for data collection, processing, interpretation, storage and curation should be further drawn up together with national and international organisations before 'omics technologies can be routinely used in risk assessment. For 'omics datasets in chemical and environmental risk assessments, the use of 'omics technologies alongside current toxicological or environmental risk assessment approaches is needed to re-inforce confidence and expertise before implementation of these datasets as a standalone tool in risk assessment. Test cases could be worked out to enhance confidence in the use of 'omics datasets in risk assessment.

Violence risk assessment and management in mental health: a conceptual, empirical and practice critique

PurposeThe purpose of this paper is to examine empirical, epistemological and conceptual challenges and clinical narratives in the application of risk assessment and management in mental health.Design/methodology/approachThe authors used a narrative review of empirical, conceptual and clinical literature.FindingsThe worldwide prevalence of violence in mental health settings remains high. Risk assessment and management approaches, while well intentioned as an attempt to reduce harm and increase people’s safety, have negligible effect on both. They are invariably individual centric, ignore wider environmental, societal and behavioural influences that foment violence and have a stigmatising effect on people using mental health services. They also reinforce the myth that people who are mentally unwell threaten society and that through current risk assessment and management approaches, we can minimise this threat.Research limitations/implicationsThere is a need to reconsider the study and application of violence risk assessment in mental health.Practical implicationsThe practice of risk assessment and management in mental health is marred by an overuse of risk assessment measures that are limited in their predictive efficacy. As a result, they have little value in preventing, reducing and/or managing harm. The language of risk punishes and stigmatises service users and reinforces the image of menace. An alternative language of safety may nourish and protect. A collaborative approach to safety assessment based upon recovery-focussed principles and practices may fuse professionals and service users’ horizons. Combining service users’ self-perception, professionals’ sound clinical judgement, assisted by electronically derived risk algorithms and followed by evidence-based risk management interventions, may lessen the threat to service users, reduce harm and transform the practice of violence risk assessment and management.Social implicationsRisk appraisals discriminate against the small number of people who have a mental illness and are risky, an example of preventive detention that is ethically questionable. On the basis of the limitations of the predictive efficacy of actuarial measures, it is ethically dubious to subject people to interventions with limited benefits. Risk assessment processes tend to reinforce stigma by classifying individuals as risky, sanctioning society’s prejudices and fear through scientific authority.Originality/valueThe increasing focus on risk assessment and management to tackle violence in mental health is fraught with empirical, conceptual and practical concerns; the authors have suggested ways in which these concerns can be addressed without compromising people’s safety.

Metal Oxides in Surface Sediment Control Nickel Bioavailability to Benthic Macroinvertebrates.

In aquatic ecosystems, the cycling and toxicity of nickel (Ni) are coupled to other elemental cycles that can limit its bioavailability. Current sediment risk assessment approaches consider acid-volatile sulfide (AVS) as the major binding phase for Ni, but have not yet incorporated ligands that are present in oxic sediments. Our study aimed to assess how metal oxides play a role in Ni bioavailability in surficial sediments exposed to effluent from two mine sites. We coupled spatially explicit sediment geochemistry (i.e., separate oxic and suboxic) to the indigenous macroinvertebrate community structure. Effluent-exposed sites contained high concentrations of sediment Ni and AVS, though roughly 80% less AVS was observed in surface sediments. Iron (Fe) oxide mineral concentrations were elevated in surface sediments and bound a substantial proportion of Ni. Redundancy analysis of the invertebrate community showed surface sediment geochemistry significantly explained shifts in community abundances. Relative abundance of the dominant mayfly (Ephemeridae) was reduced in sites with greater bioavailable Ni, but accounting for Fe oxide-bound Ni greatly decreased variation in effect thresholds between the two mine sites. Our results provide field-based evidence that solid-phase ligands in oxic sediment, most notably Fe oxides, may have a critical role in controlling nickel bioavailability.

Development of a conceptual framework of holistic risk assessment — Landfill as a particular type of contaminated land

Landfills can be regarded as a particular type of contaminated land that has a potential to directly and indirectly pollute all of the four main spheres of the environment which are the lithosphere, atmosphere, hydrosphere and eventually adversely impact the biosphere. Therefore, environmental risk assessment of a landfill has to be more integrated and holistic by virtue of its nature of being a multidimensional pollutant source. Despite this, although various risk assessment approaches have been adopted for landfill waste disposal sites, there are still wide-ranging knowledge gaps and limitations which need to be addressed. One important knowledge gap and limitation of current risk assessment approaches is the inability to fully identify, categorise and aggregate all individual risks from all combinations of hazards, pathways and targets/receptors (e.g. water, air, soil and biota) in connection to a certain landfill leachate and yet at any stage of the landfill cycle. So such an approach is required that could not only integrate all possible characteristics of varying scenarios but also contain the ability to establish an overall risk picture, irrespective of the lifecycle stage of the landfill (e.g. planning stage/pre-operation, in-operation or post-operation/closed). One such approach to address the wide-breadth of landfill impact risks is by developing a more holistic risk assessment methodology, whose conceptual framework is presented in this paper for landfill leachate in a whole-system format. This conceptual framework does not only draw together various constituting factors and sub-factors of risk assessment in a logical sequence and categorical order, but also indicates the “what, why, when and how” outputs of and inputs to these factors and sub-factors can be useful. The framework is designed to identify and quantify a range of risks associated with all stages of the landfill lifecycle, and yet in a more streamlined, logical, categorical and integrated format, offering a more standardised and unified whole-system approach.

Assessing induced seismicity risk at CO2 storage projects: Recent progress and remaining challenges

It is well established that fluid injection has the potential to induce earthquakes—from microseismicity to magnitude 5+ events—by altering state-of-stress conditions in the subsurface. This paper reviews recent lessons learned regarding induced seismicity at carbon storage sites. While similar to other subsurface injection practices, CO2 injection has distinctive features that should be included in a discussion of its seismic hazard. Induced events have been observed at CO2 injection projects, though to date it has not been a major operational issue. Nevertheless, the hazard exists and experience with this issue will likely grow as new storage operations come online. This review paper focuses on specific technical difficulties that can limit the effectiveness of current risk assessment and risk management approaches, and highlights recent research aimed at overcoming them. These challenges form the heart of the induced seismicity problem, and novel solutions to them will advance our ability to responsibly deploy large-scale CO2 storage.

The Integration of LNT and Hormesis for Cancer Risk Assessment Optimizes Public Health Protection.

This paper proposes a new cancer risk assessment strategy and methodology that optimizes population-based responses by yielding the lowest disease/tumor incidence across the entire dose continuum. The authors argue that the optimization can be achieved by integrating two seemingly conflicting models; i.e., the linear no-threshold (LNT) and hormetic dose-response models. The integration would yield the optimized response at a risk of 10 with the LNT model. The integrative functionality of the LNT and hormetic dose response models provides an improved estimation of tumor incidence through model uncertainty analysis and major reductions in cancer incidence via hormetic model estimates. This novel approach to cancer risk assessment offers significant improvements over current risk assessment approaches by revealing a regulatory sweet spot that maximizes public health benefits while incorporating practical approaches for model validation.

Promoting justified risk-based decisions in contaminated land management

Decision making and regulatory policies on contaminated land management (CLM) are commonly governed by risk assessment. Risk assessment, thus, has to comply with legislation, but also provide valid information in terms of actual risks to correctly focus the potentially required measures and allocate the available resources. Hence, reliable risk assessment is a prerequisite for justified and sustainable risk management. This paper gives an introduction to the Finnish risk-based regulatory framework, outlines the challenges within the policies and the practice and provides an overview of the new guidance document to promote risk-based and sustainable CLM. We argue that the current risk assessment approaches in the policy frameworks are not necessarily efficient enough in supporting justified risk-based decisions. One of the main reasons for this is the excessive emphasis put on conservative risk assessments and on generic guideline values without contributing to their appropriate application. This paper presents how some of the challenges in risk-based decision making have been tackled in the Finnish regulatory framework on contaminated land. We believe that our study will also stimulate interest with regard to policy frameworks in other countries.