Regulatory Risk Research Articles

A Novel Approach to Integrate Human Biomonitoring Data with Model Predicted Dietary Exposures: A Crop Protection Chemical Case Study Using Lambda-Cyhalothrin.

The appropriate use of human biomonitoring data to model population chemical exposures is challenging, especially for rapidly metabolized chemicals, such as agricultural chemicals. The objective of this study is to demonstrate a novel approach integrating model predicted dietary exposures and biomonitoring data to potentially inform regulatory risk assessments. We use lambda-cyhalothrin as a case study, and for the same representative U.S. population in the National Health and Nutrition Examination Survey (NHANES), an integrated exposure and pharmacokinetic model predicted exposures are calibrated to measurements of the urinary metabolite 3-phenoxybenzoic acid (3PBA), using an approximate Bayesian computing (ABC) methodology. We demonstrate that the correlation between modeled urinary 3PBA and the NHANES 3PBA measurements more than doubled as ABC thresholding narrowed the acceptable tolerance range for predicted versus observed urinary measurements. The median predicted urinary concentrations were closer to the median measured value using ABC than using current regulatory Monte Carlo methods.

Theoretical insights into IT governance and compliance in banking: Perspectives from African and U.S. regulatory environments

This review paper provides a comprehensive comparative analysis of IT governance and compliance within the banking sectors of Africa and the U.S., highlighting the intricacies of navigating diverse regulatory environments. Through examining governance strategies, compliance mechanisms, and best practices, the paper underscores the adaptation of frameworks like COBIT, ISO/IEC 27001, and ITIL to meet regional regulatory demands and operational challenges. Key insights reveal significant differences in regulatory landscapes, technological maturity, and cybersecurity and risk management approaches. The analysis identifies best practices and lessons that can be leveraged globally, suggesting areas for future research including emerging technologies and the impact of global regulations. This work aims to enhance understanding of IT governance and compliance, offering valuable perspectives for banks, regulators, and policymakers. Keywords: IT Governance, Compliance, Banking Sector, Regulatory Environment, Cybersecurity, Emerging Technologies.

Overvoltage risk regulation strategy with distributed energy application in a distribution network based on the Stackelberg game

Along with the increasing low-carbon demand of the power system, the access of a high percentage of renewable energy resources to the distribution network has a large impact on the voltage fluctuation of the system and reduces the operational reliability. In this paper, we consider utilizing the reactive capacity of distributed resources to participate in system voltage regulation to reduce node loss of load probability (LOLP) caused by node overvoltage faults and propose an overvoltage risk regulation strategy for the interaction between distribution network operators (DSOs) and distributed users in the framework of the Stackelberg game. First, the nodes are clustered and analyzed based on the two-dimensional indexes of node voltage regulation ability, and different voltage regulation compensation tariffs are assigned. Second, the cost-benefit model of voltage regulation for the leader and follower sides and the node LOLP model are constructed to measure the reliability of the system. The Stackelberg game is used to co-optimize the two parties’ compensation tariffs and voltage regulation strategies. The optimal solution of voltage regulation under the equilibrium of the game is obtained by solving using the particle swarm optimization (PSO) algorithm. Based on the IEEE-33 node system, a case study is carried out to verify that the proposed overvoltage risk regulation strategy can maximize the benefits of the regulator participants while enhancing the operational reliability of the system.

A qualitative analysis of cascading effects of critical infrastructure service failure post torrential floods in formal & informal settlement: the study-case of Medellin city, Colombia

ABSTRACT Critical infrastructure (CI) services are crucial to the functioning of modern communities, and a single CI failure can cause cascading effects through a network of services, impacting an entire city. Challenges such as climate change and rapid urbanisation are increasing the risk of cascading effects of CI failure, particularly impacting the urban poor in peri-urban and informal settlements. This study uses a systems thinking approach to validate the hypothesis if CI services are susceptible to generating severe cascading effects in informal than formal settlements. Qualitative data was collected on cascading effects via interviews and focus group discussion in a formal and an informal settlement in Medellin, Colombia. The responses were analysed and structured using a service chain framework and a Causal Loop Diagram. Our findings show that cascading effects vary between the formal and informal contexts concerning CI service availability and accessibility and may be attributed to differences in demography, geography, socio-economic development, risk regulations, community coping capacities and other factors associated with urban development.

Possible harms of artificial intelligence and the EU AI act: fundamental rights and risk

Various actors employ the notion of risk when they discuss the future role of Artificial Intelligence (AI) in society – sometimes as a general pointer to possible unwanted consequences of the underlying technologies, sometimes oriented towards a political regulation of AI risks. Mostly discussed within a legal or ethical framework, we still lack a perspective on AI risks based on sociological risk research. Building on systems-theoretical thinking about risk and society, this article analyses the potential and limits of a risk-based regulation of AI, in particular with regard to the notion of harm to fundamental rights. Drawing on the AI Act, its earlier drafts and related documents, the paper analyses how this regulatory framework delineates harms of AI and which implications the chosen delineation has for the regulation. The results show that fundamental rights are invoked as legal rules, as values and as a foundation for trustworthiness of AI in parallel to being identified as at risk from AI. The attempt to frame all possible harms in terms of fundamental rights creates communicative paradoxes. It opens the door to a political classification of high-risk AI systems as well as a future standard-setting that is removed from systematic concerns about fundamental rights and values. The additional notion of systemic risk, addressing possible risks from general-purpose AI models, further reveals the problems with delineating harms of AI. In sum, the AI Act is unlikely to achieve what it aims to do, namely the creation of conditions for trustworthy AI.

Refinement of flavour substance intake estimates using probability of addition: A proposed method based on sales data

AbstractMost dietary intake estimates used in the regulatory risk assessment of flavouring substances assume that the flavouring substance is present in all foods at a given concentration. They do not account for the use of alternate flavouring substances for the same taste modality, nor do they consider the use of differing concentrations within a particular food category. This highly conservative assumption leads to an over‐estimation of exposure. To refine this assumption in exposure models, the probability of addition can be utilised. In this study, a methodology to estimate the probability of addition was developed, using the volume of a flavouring substance sold for flavours created for a particular food category against its total volume sold for all flavouring use. The method was trialled, as a proof of principle, using historical data sets of two test flavouring substances, benzaldehyde (a large volume/use material) and bornyl acetate (a low volume/use material), and the impact on dietary exposure assessment was assessed. The resulting exposure estimates for both flavouring substances were shown to be significantly lower than those without the incorporation of probability of addition, demonstrating that current methods are overly conservative and that the use of probability of addition provides a more realistic estimate of exposure of flavouring substances present in foods.

The role of AI capabilities in environmental management: Evidence from USA firms

This study investigates the role of Artificial Intelligence (AI) capabilities in influencing firms' greenwashing behaviors. We find a robust negative association between firms' AI capabilities and unrepresentative environmental disclosure. An instrumental variable approach is employed to establish causality. The effects are more pronounced for firms (1) with a greater exposure to regulatory climate risk, (2) managed by Republican-leaning managers, (3) with stronger governance structures, (4) possessing greater product market pricing power, (5) operating in multiple regions, and (6) with CEOs with higher pay-for-performance sensitivity. We further demonstrate that AI capabilities aid firms in transitioning to green operations through engaging in green and clean innovation. Finally, we find that AI capabilities correlate with lower greenhouse gas emissions. Overall, our findings shed light on the real impact of AI-related technologies in the energy industry.

The use of effect biomarkers in chemical mixtures risk assessment – Are they still important?

Human epidemiological studies with biomarkers of effect play an invaluable role in identifying health effects with chemical exposures and in disease prevention. Effect biomarkers that measure genetic damage are potent tools to address the carcinogenic and/or mutagenic potential of chemical exposures, increasing confidence in regulatory risk assessment decision-making processes. The micronucleus (MN) test is recognized as one of the most successful and reliable assays to assess genotoxic events, which are associated with exposures that may cause cancer. To move towards the next generation risk assessment is crucial to establish bridges between standard approaches, new approach methodologies (NAMs) and tools for increase the mechanistically-based biological plausibility in human studies, such as the adverse outcome pathways (AOPs) framework. This paper aims to highlight the still active role of MN as biomarker of effect in the evolution and applicability of new methods and approaches in human risk assessment, with the positive consequence, that the new methods provide a deeper knowledge of the mechanistically-based biology of these endpoints.

Recruiting and cultivating future leaders in laboratory science.

Technological in-vitro fertilization (IVF) advancements originate in the embryology laboratory, and are accompanied by increased regulatory oversight and risk management. Stakes have never been higher or the need greater for the recruitment and cultivation of leaders in laboratory science to navigate the direction of IVF. Current thought leaders in state-of-the-art laboratories must prioritize this mission to optimize and preserve the future of IVF. Leaders in laboratory science must be able to speak to patients, the lay public, business leaders, scientific colleagues and clinical embryologists. While technically gifted, laboratory leaders may benefit from leadership training. Recruitment of scientists into IVF is currently challenging due to a lack of branding and no clear pipeline for new scientists to enter the field. Once recruited however, cultivation of new leaders requires coaching and skill acquisition over time, in order to create multifaceted laboratory leadership. Laboratory leaders are typically recruited based on education and experience to lead teams of embryologists. These leaders will adopt new technologies in the laboratory. Therefore, laboratory leaders play a powerful role in IVF requiring leadership skills ultimately driving patient outcomes. These laboratory directors must possess innate leadership abilities or learn how to lead their teams.

The health risks of generative AI-based wellness apps.

Artificial intelligence (AI)-enabled chatbots are increasingly being used to help people manage their mental health. Chatbots for mental health and particularly 'wellness' applications currently exist in a regulatory 'gray area'. Indeed, most generative AI-powered wellness apps will not be reviewed by health regulators. However, recent findings suggest that users of these apps sometimes use them to share mental health problems and even to seek support during crises, and that the apps sometimes respond in a manner that increases the risk of harm to the user, a challenge that the current US regulatory structure is not well equipped to address. In this Perspective, we discuss the regulatory landscape and potential health risks of AI-enabled wellness apps. Although we focus on the United States, there are similar challenges for regulators across the globe. We discuss the problems that arise when AI-based wellness apps cross into medical territory and the implications for app developers and regulatory bodies, and we outline outstanding priorities for the field.

Research on Tax Risk Regulation and Strategic Management in the Context of Big Data

With the rapid development of big data, big data has been more and more applied in all walks of life. Under the big data environment, massive big data provides convenience for regional tax risk control and strategic decision-making but also increases the difficulty of data supervision and management. By analyzing the status quo of big data and tax risk management, this paper finds many problems and puts forward effective countermeasures for tax risk supervision and strategic management by using big data.

New approach methods to assess developmental and adult neurotoxicity for regulatory use: a PARC work package 5 project.

In the European regulatory context, rodent in vivo studies are the predominant source of neurotoxicity information. Although they form a cornerstone of neurotoxicological assessments, they are costly and the topic of ethical debate. While the public expects chemicals and products to be safe for the developing and mature nervous systems, considerable numbers of chemicals in commerce have not, or only to a limited extent, been assessed for their potential to cause neurotoxicity. As such, there is a societal push toward the replacement of animal models with in vitro or alternative methods. New approach methods (NAMs) can contribute to the regulatory knowledge base, increase chemical safety, and modernize chemical hazard and risk assessment. Provided they reach an acceptable level of regulatory relevance and reliability, NAMs may be considered as replacements for specific in vivo studies. The European Partnership for the Assessment of Risks from Chemicals (PARC) addresses challenges to the development and implementation of NAMs in chemical risk assessment. In collaboration with regulatory agencies, Project 5.2.1e (Neurotoxicity) aims to develop and evaluate NAMs for developmental neurotoxicity (DNT) and adult neurotoxicity (ANT) and to understand the applicability domain of specific NAMs for the detection of endocrine disruption and epigenetic perturbation. To speed up assay time and reduce costs, we identify early indicators of later-onset effects. Ultimately, we will assemble second-generation developmental neurotoxicity and first-generation adult neurotoxicity test batteries, both of which aim to provide regulatory hazard and risk assessors and industry stakeholders with robust, speedy, lower-cost, and informative next-generation hazard and risk assessment tools.

Exploring Financial Risks and Risk Mitigation Strategies in Digital Currencies

This paper comprehensively analyzes the financial risks faced by digital currency, using digital renminbi as a case study. The risks include operational risks, privacy risks, legal and regulatory risks, currency sovereignty risks, and the impact on traditional financial systems. Corresponding risk mitigation strategies are proposed. By strengthening system architecture, employing advanced encryption technologies, enhancing legal and regulatory frameworks, maintaining policy stability, and promoting financial integration, these measures effectively mitigate financial risks associated with digital currency, fostering its sustainable development and innovation.

Stability-Indicating UPLC-PDA-QDa Methodology for Carvedilol and Felodipine in Fixed-Dose Combinations Using AQbD Principles

The development of analytical procedures, in line with the recent regulatory requirements ICH Q2 (R2) and ICH Q14, is progressing, and it must be able to manage the entire life cycle of the methodology. This is also applicable to and especially challenging for combinations of drug substances and dosage form. A reliable and efficient, stability-indicating, MS-compatible, reverse-phase ultra-performance liquid chromatographic (UPLC®) method was developed for the determination of carvedilol and felodipine in a combination oral dosage form. The development of the method, performed using analytical quality by design (AQbD) principles, was in line with the future regulatory requirements. Furthermore, the fixed-dose combination dosage forms are a clear solution to the polypharmacy phenomenon in the elderly population. The main factors evaluated were the mobile phase buffer, organic modifier, column, flow, and column temperature. The optimum conditions were achieved with a Waters Acquity HSS T3 (100 × 2.1 mm i.d., 1.8 µm) column at 38 °C, using ammonium acetate buffer (5 mM, pH 4.5) (Solution A) and MeOH (Solution B) as mobile phases in gradient elution (t = 0 min, 10% B; t = 1.5 min, 10% B; t = 12.0 min, 90% B; t = 13.0 min, 10% B; t = 15.5 min, 10% B) at a flow rate of 0.2 mL/min and UV Detection of 240 and 362 nm for carvedilol (CAV) and felodipine (FLP), respectively. The linearity was demonstrated over concentration ranges of 30–650 µg/mL (R2 = 0.9984) (CAV) and 32–260 µg/mL (R2 = 0.9996) (FLP). Forced degradation studies were performed by subjecting the samples to hydrolytic (acid and base), oxidative, and thermal stress conditions. Standard solution stability was also performed. The proposed validated method was successfully used for the quantitative analysis of bulk, stability, and fixed-dose combination dosage form samples of the desired drug product. Using the AQbD principles, it is possible to generate methodologies with improved knowledge, leading to high-quality data, lower operation costs, and minimum regulatory risk. Furthermore, this work paves the way for providing a platform of robust analytical methods for the simultaneous quantification of innovative on-demand new dose combinations.

A balance sheet analysis of monetary policy effects on banks

Monetary policy operations affect bank balance sheets (BBSs). This study develops a balance sheet model to examine the impacts of monetary policy operations on banks' ability to supply funds. That ability is assessed using the balance sheet capacities provided by regulatory risk management instruments. The balance sheet approach views a monetary policy operation as a transaction between the central bank and a commercial bank, modeling the transaction as multiple changes to the BBS. This study identifies and distinguishes the effects of multiple changes in the BBS on balance sheet capacity. A balance sheet change resulting from a monetary policy operation may positively or negatively affect balance sheet capacity. Thus, a monetary policy may have a positive and a negative effect simultaneously. Positive (negative) effects result from balance sheet changes that reduce (increase) bank risks, as measured by regulations. As regulatory stringency decreases, the positive effects increase, whereas the negative effects remain unchanged. A BBS capacity channel of monetary policy is also shown.

Nanoparticles‐based double‐stranded RNA delivery as an antiviral agent in shrimp aquaculture

AbstractThe review encapsulates the comprehensive exploration of RNA interference technology's application in shrimp aquaculture, covering molecular intricacies, production methods, and practical applications. The emphasis is on exploring the stability and delivery of gene‐specific double‐stranded RNA, particularly through nanoencapsulation. This is because the susceptibility of dsRNA to degradation and limited cellular penetration, emphasising the need for effective delivery mechanisms. The review presents an in‐depth exploration of nanoparticles for the encapsulation and delivery of dsRNA, including virus‐like particles (VLPs), and non‐viral based nanoparticles such as liposomes, chitosan, and beta‐glucan. VLPs, derived from non‐infectious shrimp virus structures, exhibit biocompatibility and natural functionality, making them suitable carriers for dsRNA. The application of chitosan and its derivatives are explored for their efficacy in reducing viral infections in shrimp. Beta‐glucan particles are examined for their immunostimulant properties in shrimp aquaculture. The text emphasises the use of yeast‐based glucan particles for encapsulating dsRNA, showcasing their potential in preventing viral diseases in shrimp. The review introduces cautionary considerations for nanoparticle formulation, highlighting factors such as pH, organic solvents, metal ions, and environmental ribonuclease that can impact dsRNA stability during synthesis. In conclusion, the text discusses the potential economic worthiness and environmental risk assessment of dsRNA technology in shrimp aquaculture. While acknowledging successful applications in other environments, it underscores the need for regulatory approval and risk assessment for dsRNA‐based products in the aquaculture industry. The evaluation of dsRNA in real‐world shrimp farms is deemed necessary for commercial utilisation, taking into account income, expenses, safety, and environmental considerations.

The influence of long-range transported Saharan dust on the inflammatory potency of ambient PM2.5 and PM10

Although desert dust promotes morbidity and mortality, it is exempt from regulations. Its health effects have been related to its inflammatory properties, which can vary between source regions. It remains unclear which constituents cause this variability. Moreover, whether long-range transported desert dust potentiates the hazardousness of local particulate matter (PM) is still unresolved. We aimed to assess the influence of long-range transported desert dust on the inflammatory potency of PM2.5 and PM10 collected in Cape Verde and to examine associated constituents.During a reference period and two Saharan dust events, 63 PM2.5 and PM10 samples were collected at four sampling stations. The content of water-soluble ions, elements, and organic and elemental carbon was measured in all samples and endotoxins in PM10 samples. The PM-induced release of inflammatory cytokines from differentiated THP-1 macrophages was evaluated. The association of interleukin (IL)-1β release with PM composition was assessed using principal component (PC) regressions.PM2.5 from both dust events and PM10 from one event caused higher IL-1β release than PM from the reference period. PC regressions indicated an inverse relation of IL-1β release with sea spray ions in both size fractions and organic and elemental carbon in PM2.5. The PC with the higher regression coefficient suggested that iron and manganese may contribute to PM2.5-induced IL-1β release. Only during the reference period, endotoxin content strongly differed between sampling stations and correlated with inflammatory potency.Our results demonstrate that long-range transported desert dust amplifies the hazardousness of local air pollution and suggest that, in PM2.5, iron and manganese may be important. Our data indicate that endotoxins are contained in local and long-range transported PM10 but only explain the variability in inflammatory potency of local PM10. The increasing inflammatory potency of respirable and inhalable PM from desert dust events warrants regulatory measures and risk mitigation strategies.

A Study of the Relationship Between ESG Performance and Firm Valuation

This study aims to explore the impact of environmental, social, and governance (ESG) factors on company valuation, providing in-depth analysis from multiple perspectives, including investor expectations, risk management, long-term strategy and brand building, and cost-effectiveness. With the increasing importance of ESG factors in investment decisions, there is a growing demand for sustainable and responsible investments, and strong ESG performance has been shown to have a positive impact on valuation. Additionally, this study analyzes ESG risks and their potential effects on valuation, highlighting effective risk management strategies and explores how environmental sustainability can reduce regulatory risks. Furthermore, the study delves into the relationship between ESG factors and long-term strategy, brand reputation, and cost-effectiveness, supported by empirical research and case studies. Finally, the study summarizes insights for companies and provides recommendations for strategically integrating ESG practices while also discussing future research directions in the field of ESG and valuation. The findings of this study are expected to provide valuable guidance for companies in formulating strategies in ESG practices, promoting sustainable value creation.

Climate change exposure, shareholder wealth, and the adoption of the Paris agreement: A text-based approach

Taking advantage of a distinctive measure of firm-specific exposure to climate change derived from sophisticated textual analysis, we examine the effect of climate change exposure on shareholder value using the signing of the Paris climate agreement. We find that companies more exposed to climate change experience more favorable market reactions to the adoption of the agreement. Specifically, a rise in climate change exposure by one standard deviation improves market reactions by 7.3%–8.8%. Further analysis corroborates the results, including propensity score matching, entropy balancing, an instrumental-variable analysis and Oster (2019) assessment of coefficient stability. Notably and somewhat surprisingly, the positive market reactions can be more attributed to the new business opportunities associated with the actions enabled by the Paris agreement than to the reduction in the physical and regulatory risk.

The impact of conventional cigarettes, e-cigarettes, and tobacco heating systems on the oral mucosa

Relevance. Over the past few years, the popularity of nicotine-containing substances and tobacco heating systems has continued to grow, while the demand for conventional tobacco leaf cigarettes has been falling. Electronic cigarettes consist of a heating system and a liquid with various flavorings. During the operation of the heating stick, the liquid is converted into an aerosol, which the user needs to inhale. First of all, the hot steam comes into contact with the oral cavity. The aerosol components settle on the oral mucosa, the approximal surfaces of the teeth, penetrating the body with a saliva current, expose the oral cavity to prolonged exposure, causing various changes in the oral cavity and causing discomfort to the smoker. This problem is urgent and based on the above, it is necessary to study all possible effects of cigarettes and electronic nicotine delivery systems on the human body.Purpose. To assess the impact of nicotine-containing products and smokeless tobacco on the oral mucosa.Materials and methods. A cohort of 98 patients, aged 20 to 60, was recruited for the study. Participants were divided into four groups: Group 1 consisted of conventional cigarette smokers; Group 2, users of vapes; Group 3, users of IQOS; and Group 4 included patients who used all three device types interchangeably.Results. The investigation identified a direct correlation between the participant's age, the device used, and their level of oral hygiene. The poorest oral hygiene was seen in Group 4, where individuals used a combination of conventional cigarettes, vapes, and IQOS. Although a majority acknowledged the harmful effects of tobacco products, only 33 participants were aware of the negative impacts associated with vapes and IQOS.Conclusion. The lack of regulation and awareness of the health risks associated with IQOS and vaping pose substantial challenges for healthcare, indicating a need for more research into these issues.