Regulatory Purposes Research Articles

Efektívnosť a super-efektívnosť bankových sektorov vo vybraných krajinách Európskej únie

The European banking sector is vital to the European Union (EU) for several reasons, given its central role in the economy, its influence on financial stability, and its contribution to the EU’s integration and development. European banking sectors provide essential credit to businesses, households, and governments, driving economic growth. The contribution attempts to measure and compare technical efficiency scores of 26 European banking systems in 2020 and 2021 by using Data Envelopment Analysis. This paper differs from the so far published literature, as it extends the application of a non-radial model and a super-efficiency model (Tone, 2001, 2002) on the whole banking systems of EU countries, not on individual banks or bank branches. Achieved results also reveal that in the year 2020, among 26 European banking systems under evaluation, 10 banking systems were efficient and the super-efficient was the banking sector of Luxembourg (score of efficiency 1.472). In the year 2021, 14 banking systems were efficient and the super-efficient was the banking sector of Croatia (score of efficiency 2.064). The implications of gained results are then drawn for managerial and regulatory purposes.

A new metrology tool: using transmission Kikuchi diffraction (TKD) to identify and separate nanoparticles for regulatory purposes

Abstract The development of methods for characterising nanoparticles (NPs) at the nanometric scale is a major challenge facing metrology researchers today. The characterisation of the crystal structure of NPs for regulatory purposes is urgent as mixtures of NPs are frequently found in consumer products and this physicochemical parameter contributes to the understanding of potential health and environmental risks. Using the methods currently available, NPs cannot be individually identified and their size distribution cannot be correlated to crystallographic phases. Instead, a general identification of crystallographic phases is possible. New methods must be developed that identify individual particles on the nanoscale. This paper introduces transmission Kikuchi diffraction, an electron backscattered diffraction (EBSD) technique as a method for comprehensively characterizing a mixture of iron oxide NPs by crystal structure. After identifying the crystal structure of three different iron oxide powders using x-ray Diffraction, the samples were characterised by TKD. The results underline the relevance of TKD, which has sufficient spatial resolution to determine the crystal structure of individual NPs. This study also demonstrates the possibility of electron backscattered diffraction analysis on unpolished samples, something atypical for EBSD and TKD. The powders were then mixed and the individual NPs were correctly identified in a scanning electron microscope (SEM) using TKD. The results show that TKD can be used to correctly identify and classify NPs within a mixture and can be combined with SEM imaging to build size distribution histograms according to the NP crystal structure.

Estimating safety factor for femoral plates subjected to in vivo loads

Abstract Fatigue behaviour is a crucial aspect of mandatory mechanical tests for regulatory purposes, aimed at determining the load at which the bone plate withstands under a specific number of cycles, known as the runout condition. However, current test standards, such as ASTM F382, provide setup configurations without explicit guidelines on required fatigue strength. The determination of the minimum level of in vivo performance that the plate must fulfil remains an open issue, which is frequently addressed by the direct comparison with predicate devices. To address this gap, this study proposes an in silico framework to estimate maximum stress on implanted femoral plates for comparison with four-point bending tests described in the ASTM standard, deriving appropriate safety factors. As case studies, three femoral plates were assessed, and results showed safety factors above 1.1, indicating the reliability of the implanted plates.

Prompt photocatalytic purification of dye wastewater using zinc doped nickel oxide nanostructures and Artima salina model for acute toxicity screening

Industrial organic contaminates in water bodies are toxic not only to aquatic plants and animals but also to the entire ecosystem. The present study focuses on eradicating these industrial pollutants using zinc ions doped nickel oxide nano photocatalysts. Ultrasonication-aided co-precipitation method was used to synthesize Zn doped NiO nanoparticles which were further analyzed for their structural, optical, morphological, elemental, and photocatalytic abilities. Bragg diffraction patterns of synthesized samples revealed that zinc ions were successfully loaded in the NiO lattice as cubic nano-crystallites with Fm3m, space-group. FTIR study supported the formation of Zn –Ni linkages and Ni-O stretching vibrations. Tauc plot found that optical band gap energy decreases from 3.2 to 2.7 eV. PL study revealed the charge recombination process delayed by an intermediate band to enhance photocatalytic activity. The formation and reduction of clear rectangular rod structures by increasing zinc dopant materials and the composition of Ni, Zn, and O elements were explored in SEM-EDX images. XPS, TEM and SAED patterns corresponded quite well with the XRD results. Pseudo-first-order kinetics of photocatalytic degradation analysis predicted that Zn doped NiO nanostructures show their suitableness for preventing Rhodamine B and 4-Nitrophenol contaminates (up to 95 % and 80 %) in aquatic media under direct sunlight. Further, detox and practical usage of Zn doped NiO were confirmed by the Artemia salina organism’s considerable lifespan in the treated water using a toxicity evaluation model. Based on these observations, it is expected to facilitate an expedited remedy of toxicity screening for regulatory purposes.

A critique of the use of species and below-species taxonomic terms for viruses-time for change?

The International Committee for the Taxonomy of Viruses (ICTV) regulates assignment and names of virus species and higher taxa through its taxonomy proposal and ratification process. Despite using similar taxonomic ranks to those used elsewhere in biology, the ICTV has maintained the principle that species and other taxa are strictly categories with a formal nomenclature, whereas the viruses as objects are referenced through a parallel inventory of community-assigned virus names. This is strikingly different from common and scientific name synonyms for species used elsewhere in biology. The recent introduction of binomial names for virus species resembling biological scientific names has intensified this confusion in terms within the virology community and beyond. The ICTV taxonomy furthermore does not engage with or regulate classification below species and consequently lacks taxonomic terms or descriptions for important viral pathogens such as polioviruses, severe acute respiratory syndrome coronavirus type 2, HIV-1, and avian influenza as examples. The consequent reliance on community-adopted virus names, genotypes, and other categories often lacks clarity for clinical, biocontainment, and other regulatory purposes. This article proposes a revision of rules and procedures for species and below-species level classification. It recasts virus and virus species names as 'common' and 'scientific' names that are used in other biology nomenclature codes, each with expanded reference to both object and taxon. It further advocates the creation of a formal below-species taxonomic rank to define a new inventory of approved taxa and specified nomenclature below species. Adoption of the proposed changes will realign virus taxonomy with other biological nomenclatural codes and provide greater transparency and clarity in virology, medical, and regulatory fields.

Caenorhabditis elegans as a Model for Evaluating the Toxicology of Inorganic Nanoparticles.

Inorganic nanoparticles are nanomaterials with a central core composed of inorganic specimens, especially metals, which give them interesting applications but can impact the environment and human health. Their short- and long-term effects are not completely known and to investigate that, alternative models have been successfully used. Among these, the nematode Caenorhabditis elegans has been increasingly applied in nanotoxicology in recent years because of its many features and advantages for toxicological screening. This non-parasitic nematode may inhabit any environment where organic matter is available; therefore, it is interesting for ecotoxicological assessments. Moreover, this worm has a high genetic homology to humans, making the findings translatable. A notable number of published studies unraveled the level of toxicity of different nanoparticles, including the mechanisms by which their toxicity occurs. This narrative review collects and describes the most relevant toxicological data for inorganic nanoparticles obtained using C. elegans and also supports its application in safety assessments for regulatory purposes.

A novel integrated testing strategy (ITS) for evaluating acute fish toxicity with new approach methodologies (NAMs)

Acute fish toxicity (AFT) tests are performed in aquatic risk assessments of chemical compounds globally. However, the specific endpoint of in vivo AFT is based on the lethal concentration 50 (LC50), which is a serious challenge in terms of animal welfare. To support the 3Rs principle of replacing, reducing, and refining use of animals, integrated testing strategies (ITS) have recently been developed for environmental risk assessment. ITS efficiently integrates multiple types of information, especially new approach methodologies (NAMs), and further supports regulatory decision-making. Currently, an effective ITS framework for evaluating aquatic toxicity is lacking. Therefore, we aimed to develop a promising ITS for AFT using in silico, in vitro, and in vivo data. We established the ITS via in silico (OECD QSAR Toolbox 4.6), fish cell line acute toxicity (FCT), and fish embryo acute toxicity (FET) tests and then validated the NAMs with AFT testing. The NAM data were derived from the European Chemicals Agency (ECHA) dossier, toxicology databases, peer-reviewed research articles, and this study. For the first step in the ITS process, we aimed to design a high-throughput screening tool to identify non-toxic and toxic chemicals. We found that results of in silico, FCT, and FET tests alone were strongly correlated with AFT. Among the models, the in silico model was most suitable for identifying toxicants due to its high sensitivity and minimal animal use. Next, considering regulatory purposes and flexibility, we determined the predictive LC50 of toxic chemicals by pursuing a preference-dependent strategy, sequential testing strategy, and sensitivity-dependent strategy. All the strategies demonstrated a predictive power equal to or greater than 73%. In addition, to meet user preferences, our ITS approach has high flexibility and supports animal welfare and environmental protection. We have therefore developed multiple powerful, flexible, and more humane ITS methods for acute fish toxicity assessment by integrating NAMs.

The European Health Data Space as a Case Study.

In May 2022, the European Commission proposed the launch of a health-specific data sharing framework called the European Health Data Space (EHDS), underpinned by legislation, for the use of electronic health data by patients and for research, innovation, policy-making, patient safety, statistics, or regulatory purposes. In this essay, I review some of its more contentious features based on the latest version of the legislative proposal. I suggest that the EHDS is a useful case study to illustrate the need for a translational bioethics approach that shines a critical analytical light on contentious aspects of large-scale research infrastructures.

Quantifying residents' exposure to agricultural pesticides using new geospatial approaches

A better understanding of environmental exposure to agricultural pesticides is crucial for public health, regulatory and management purposes. Residents in close vicinity to agricultural fields are likely to be more exposed to pesticides. In that context, an innovative geospatial approach for mapping estimates of agricultural pesticide exposure was developed in this study.Data on pesticide application rates, high-resolution annual datasets of the geographic distribution of crops, and the 100x100m grid population dataset were utilized to complete this analysis in Wallonia (Belgium) over the period 2015-2019. Pesticide exposure metrics were estimated using a buffer-based exposure model by conducting neighborhood analysis within a 1000m buffer radius. Subsequently, a population weighted method was used to ‘up-scale’ the exposure data to administrative levels. In a limited validation effort, model estimates were compared with pesticide measurements in air collected at 12 stations during the period 2015-2016.The results present the first modeling map of environmental exposure to agricultural pesticides for the whole of the Walloon region. The northern part of the Sambre-Meuse axis demonstrates more intensive agriculture and the highest pesticide weighted exposure indices. The majority of the population resides near agricultural areas, with only 4% living in regions that lack crops within a 1000m radius, primarily in the central areas of large cities. A positive trend association between pesticide measures in air and the index was observed at the different stations, nevertheless further validation efforts are needed to accurately compare the same active ingredients.This work gives a valuable basis for research and environmental health actions in Belgium. Maps highlight areas where human biomonitoring and epidemiological studies should be implemented to investigate the impact of potential environmental exposure to pesticides. This information helps policy-makers to take measures to control and reduce the load of agricultural pesticides in the environment.

Rise of the Robots: Können und sollten Roboter rechtsfähig sein?

This article examines the possibility and appropriateness of granting legal personhood to robots and autonomous machines. Given the increasing autonomy of robots, the question of responsibility for their actions arises. The paper proposes a framework to determine whether granting legal personhood to specific types of technology is feasible and sensible. The article discusses various approaches to defining artificial intelligence and emphasises the difficulty of establishing a unified definition. It argues that a technology-based approach should be pursued for regulatory purposes, as artificial intelligence is an umbrella term for many technologies. Finally, the need to develop clear criteria for assigning potential legal personhood to robots is stressed. Both technical aspects and legal and ethical considerations should be taken into account.

Standardised and Reproducible Phenotyping Using Distributed Analytics and Tools in the Data Analysis and Real World Interrogation Network (DARWIN EU).

The generation of representative disease phenotypes is important for ensuring the reliability of the findings of observational studies. The aim of this manuscript is to outline a reproducible framework for reliable and traceable phenotype generation based on real world data for use in the Data Analysis and Real-World Interrogation Network (DARWIN EU). We illustrate the use of this framework by generating phenotypes for two diseases: pancreatic cancer and systemic lupus erythematosus (SLE). The phenotyping process involves a 14-steps process based on a standard operating procedure co-created by the DARWIN EU Coordination Centre in collaboration with the European Medicines Agency. A number of bespoke R packages were utilised to generate and review codelists for two phenotypes based on real world data mapped to the OMOP Common Data Model. Codelists were generated for both pancreatic cancer and SLE, and cohorts were generated in six OMOP-mapped databases. Diagnostic checks were performed, which showed these cohorts had broadly similar incidence and prevalence figures to previously published literature, despite significant inter-database variability. Co-occurrent symptoms, conditions, and medication use were in keeping with pre-specified clinical descriptions based on previous knowledge. Our detailed phenotyping process makes use of bespoke tools and allows for comprehensive codelist generation and review, as well as large-scale exploration of the characteristics of the resulting cohorts. Wider use of structured and reproducible phenotyping methods will be important in ensuring the reliability of observational studies for regulatory purposes.

Cellulose nanomaterial metrology: microscopy measurements.

Cellulose nanomaterials are increasingly used for a wide variety of applications. Adequate characterization of these materials is required for quality control during production, to distinguish between materials synthesized by different methods, by different suppliers or from difference cellulose biomass sources, to facilitate development of applications and for regulatory purposes. Here we review recent microscopy measurements for the three main types of cellulose nanomaterials: cellulose nanocrystals, individual cellulose nanofibrils and cellulose nanofibrils. Atomic force microscopy and both scanning and transmission electron microscopy are covered with a focus on recent studies that have metrological rigor, rather than qualitative investigations. In some cases results are compared to those obtained by other methods that are more likely to see widespread use for routine quality control measurements. Detailed studies that use microscopy to provide insight on fundamental material properties (e.g., chiral properties) are also included. Particle size and morphology are important properties but are challenging to measure for cellulose nanomaterials due to the rod or fibril shaped particles, their propensity to agglomerate and aggregate, their low contrast for electron microscopy and, for cellulose nanofibrils, the complex branched and interconnected structures. Overall, the results show that there are now a number of studies in which attention to metrological detail has resulted in measurements that allow one to compare and distinguish between different materials, although there are still examples for which it is not possible to draw conclusions on size differences. The use of detailed microscopy protocols that yield accurate and reliable results will be beneficial in material production and addressing regulatory requirements and will allow the validation of other methods that are more amenable to routine measurements.

Modern alternative research methods in genetic toxicology (literature review)

The review represents the current principles of assessment of chemicals genotoxicity. The main attention is paid to alternative research methods. The international experience of the application of alternative approaches and prospects of their use for regulatory purposes are discussed. The data for this review were collected from the Russian and foreign literature, as well as Internet resources, concerning the development of the new alternative methods for testing chemicals for genotoxicity. The OECD database, Scopus, Medline, Google Scholar, RISC, CyberLeninka were used for the information retrieval. Although the evaluation of genotoxicity of chemical substances is the well-established and based on the battery of validated methods, the studies for improving the existing tests and developing new technologies, including the alternative approaches, continue unabated up to now. In general, three trends of development of genetic toxicology can be outlined, including creating of new methods based on the whole-genome sequencing and the application of genome editing technologies; implementation of quantitative system of effects assessment in addition to the existing qualitative approach (mutagenic/non-mutagenic) and testing of various combinations of genotoxicity evaluation methods to identify a battery of tests with a greater predictive activity regarding carcinogenic effects. To use the developed alternative models for regulatory purposes, it is necessary to provide convincing evidence that the data obtained are good predictors of the organism’s actual response to the effects of toxicants/genotoxicants, validation of methods, standardization, and harmonization of research protocols, and changes to the existing regulatory framework are required.

Catastrophic risk: indication, quantitative assessment and management of rare extreme events using a non-expected utility framework

The paper develops a conceptual framework for the analysis and management of catastrophic risk. The framework serves to assess rare extreme events in systematic, quantitative and consistent ways. It dispenses with probabilistic extreme value theory, concentrating on descriptive statistics and simple probability distributions. Risk assessment is based on a recently developed axiomatic approach to non-expected utility preferences defined on the set of risky alternative courses of action available to an agent. The utility values of catastrophic risks are given an explicit algebraic representation, which shows them to be highly unstable (“elastic”) in the sense that they respond disproportionately to small perturbations of the decision outcomes and their probabilities. Various elasticity coefficients are defined for the outcome variables and utility preferences attached to them. They indicate whether a variable possibly takes on large negative values. The coefficients can also be defined as sample statistics and, thus, computed from observed data. The approach admits various applications to practical problems of disaster risk management. The applications include estimations of the effectiveness and cost-efficiency of risk management, the specification of limits of acceptance of catastrophic risk for regulatory purposes, and safety and security systems design and dimensioning.

Profiling the endocrine-disrupting properties of triazines, triazoles, and short-chain PFAS.

Persistent, mobile, and toxic compounds released to the environment are likely to pollute drinking water sources due to their slow environmental degradation (persistency) and high water solubility (mobility). The aim of the present study was to create in vitro hazard profiles for 16 triazoles, 9 triazines, and 11 poly- and perfluoroalkyl substances (PFAS) based on their agonistic and antagonistic effects in estrogen receptor (ER), androgen receptor (AR), and thyroid hormone receptor (TR) reporter gene assays, their ability to bind human transthyretin (TTR), and their effects on steroidogenesis. The triazole fungicides tetraconazole, bitertanol, fenbuconazole, tebuconazole, cyproconazole, difenoconazole, propiconazole, paclobutrazol, and triadimenol had agonistic or antagonistic effects on the ER and AR. Difenoconazole, propiconazole, and triadimenol were also found to be TR antagonists. The triazine herbicide ametryn was an ER, AR, and TR antagonist. The same 9 triazole fungicides and the triazines atrazine, deethyl-atrazine, and ametryn affected the secretion of steroid hormones. Furthermore, PFAS compounds PFBS, PFHxS, PFHxA, PFOS, PFOA, and GenX and the triazoles bitertanol, difenoconazole, and 4-methyl benzotriazole were found to displace T4 from TTR. These results are in line with earlier in vitro and in vivo studies on the endocrine-disrupting properties of triazines, triazoles, and PFAS. The present study demonstrates that this battery of in vitro bioassays can be used to profile compounds from different classes based on their endocrine-disrupting properties as a first step to prioritize them for further research, emission reduction, environmental remediation, and regulatory purposes.

A Comparison of European Union and Turkish Reports on the Statistics of Experimental Animal Use in Toxicity Testing.

The data on the number of animals used for experimental purposes, with a particular focus on regulatory toxicity studies, in Turkey and EU member states plus Norway (EU+), were compared for the period 2015 to 2020 (UK data after Brexit for 2020 were included too). The total number of listed vertebrates used for regulatory toxicity testing in the full 6-year reporting period in Turkey was 3.6% of that reported for the EU+. However, these numbers showed an increasing trend over the reporting period in Turkey, while the trend decreased in the EU+. In the top three most-used species for regulatory toxicology purposes in Turkey, 41% were fish (68,758 animals), followed by rats (29%; 49,975 animals), and then mice (20%; 33,292 animals). Turkey used low numbers of cats and dogs, while the corresponding number for the EU+ was more than 70-fold higher. Non-human primates were not used at all in Turkey, whereas about 34,000 were used in EU+ laboratories. The majority of toxicity tests (57%) performed in Turkey were categorised as 'Other' toxicity tests, and 27% were acute and sub-acute toxicity tests. Successful replacement alternatives (e.g. in vitro and in silico approaches) are already used in a wide range of research areas. However, although this new research and testing paradigm is underpinned by scientific evidence, the legislation and pace of acceptance of these new techniques in Turkey is considerably lagging behind other countries.

Modelling pesticide concentrations in Japanese paddy fields using the RICEWQ model

Increasing concerns about plant protection products in surface waters have highlighted the importance of pesticide monitoring and modelling, both nowadays integral components of the pesticide registration process. The Rice Water Quality (RICEWQ) model predicts the fate and transport of pesticides under various paddy environmental conditions. The model has been used widely for regulatory purpose in the U.S., while its use in Europe has been limited to regulatory submissions, despite multiple recommendations to adopt RICEWQ as a high tier assessment model for regulatory purposes. The applicability of the RICEWQ model under Japanese agricultural conditions remains unexplored. This study leverages field experimental data to evaluate the RICEWQ model's capability to simulate daily concentrations of two herbicides, mefenacet and pretilachlor, in paddy water and paddy soil in Japan.The RICEWQ model provided a reasonable level of performance for predicting the fate and transport of the two herbicides by ensuring that the simulated daily water balance corresponded with field observations and with minor pesticide-specific calibration. To further improve the performance of the simulations, we implemented a straightforward calibration framework. Calibrating the RICEWQ model improved the accuracy of all simulations; for both herbicides and in both paddy water and paddy soil compartments, the lowest Nash-Sutcliffe efficiency achieved was 0.725, demonstrating excellent performance. However, the RICEWQ model consistently underestimated the peak concentrations of herbicides in paddy water within the first three days of simulation. Simulation results suggested that approximately 50 % of the total applied herbicide was lost from the paddy system. Increasing the duration of the water holding period after pesticide application or increasing the storage capacity of the rice field via excess water storage depth management has the potential to reduce greatly herbicide loss to below 10 % of the total applied herbicide.

Chemical Markers in Italian Propolis: Chrysin, Galangin and CAPE as Indicators of Geographic Origin

Knowledge of the chemical composition of propolis is crucial for understanding the characteristics of products of different origins, but also for quality control and regulatory purposes. To date, official monographs or official analyses that allow researchers to evaluate propolis in a proper way have not yet been released. This study focuses on the characterization of twenty-seven Italian propolis samples and the identification of chemical markers that define its geographical provenance. Total polyphenol (TP) and total flavonoid (TF) content, alongside the quantification of pinocembrin, chrysin, galangin, and caffeic acid phenethyl ester (CAPE), were identified as potential markers. Additionally, DPPH assays were conducted to evaluate the antiradical activity of propolis samples. Our findings demonstrated that TPs, TFs and pinocembrin differed in propolis of different origins, especially in samples from the islands. However, the quantification of the sum of chrysin and galangin and CAPE provided a clearer distinction of the geographical origin of the propolis samples. In contrast, the DPPH assay did not prove useful for this purpose, as most results were similar and, therefore, not significant. This study lays the groundwork for future research on propolis. These findings could contribute to the development of more refined methods for distinguishing propolis origins, enhancing the understanding, valuation and quality control of this natural product in various applications.

Consistency conditions for bank efficiency analysis in Ghana: A comparison of parametric and non-parametric techniques

This paper extends the concept of methodological crosschecking by examining whether bank efficiencies computed by the two frontier techniques, stochastic frontier analysis (SFA) and data envelopment analysis (DEA), are consistent. The study used a panel of 220 unbalanced observations from 27 Ghanaian banks between 2007 and 2016 to estimate cost and technical efficiencies and check for consistency using five criteria: efficiency distribution, ranking, ability to identify best or worst banks, stability of efficiencies, and relationship with accounting ratios. The results suggest that there is no consistency in the way parametric and non-parametric techniques rank or identify the best or worst banks. Also, there exists a weak relationship between the efficiency scores generated by both SFA and DEA and the non-frontier accounting ratios of Ghanaian banks. This suggests that the latter may contain some exogenous variables that make them weak measures of efficiency and should be used with caution, especially for bank supervision. However, the SFA approach yielded efficiency scores that were comparatively more stable over time. Therefore, the study concludes that the SFA approach is more practical and thus more appealing for regulatory purposes in Ghana due to the relatively consistent efficiency scores under the SFA approach compared to those under the DEA.

Enabling high-performance cloud computing for the Community Multiscale Air Quality Model (CMAQ) version 5.3.3: performance evaluation and benefits for the user community.

The Community Multiscale Air Quality Model (CMAQ) is a local- to hemispheric-scale numerical air quality modeling system developed by the U.S. Environmental Protection Agency (USEPA) and supported by the Community Modeling and Analysis System (CMAS) center. CMAQ is used for regulatory purposes by the USEPA program offices and state and local air agencies and is also widely used by the broader global research community to simulate and understand complex air quality processes and for computational environmental fate and transport and climate and health impact studies. Leveraging state-of-the-science cloud computing resources for high-performance computing (HPC) applications, CMAQ is now available as a fully tested, publicly available technology stack (HPC cluster and software stack) for two major cloud service providers (CSPs). Specifically, CMAQ configurations and supporting materials have been developed for use on their HPC clusters, including extensive online documentation, tutorials and guidelines to scale and optimize air quality simulations using their services. These resources allow modelers to rapidly bring together CMAQ, cloud-hosted datasets, and visualization and evaluation tools on ephemeral clusters that can be deployed quickly and reliably worldwide. Described here are considerations in CMAQ version 5.3.3 cloud use and the supported resources for each CSP, presented through a benchmark application suite that was developed as an example of a typical simulation for testing and verifying components of the modeling system. The outcomes of this effort are to provide findings from performing CMAQ simulations on the cloud using popular vendor-provided resources, to enable the user community to adapt this for their own needs, and to identify specific areas of potential optimization with respect to storage and compute architectures.