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Global support and standardization of regulation for biosimilars approval owes much of its legacy to the World Health Organization (WHO), since the first guidance by the organization on the matter was released in 2009. Since then, and with over a decade of research, the 2022 revision provides opportunities for time and financial savings to pharmaceutical manufacturers aiming to prove similarity of a potential biosimilar product to some reference product, particularly by clarifying that the use of a non-local reference product as a comparator in certain studies is permissible. This declaration has important implications, particularly in the emerging biological markets of the Middle East and North Africa region, where WHO guidelines have been integral to the regulatory framework of over a dozen countries for more than a decade. This article aims to review the impact of this revision on these countries and relevant policies on non-local comparator usage. Since 2022, this revision has been adopted only in Egypt. Many North African countries are yet to adopt a first draft of the formalized guidance. This analysis revealed that, although many of these countries reference the WHO guidelines, hesitation remains in terms of sourcing comparator products outside the US or European countries. This likely translates to slow regional development and cooperation of functioning, sustainable biosimilars markets. Future studies will be necessary to evaluate the continued development of guidance within these countries and changes in comparator sourcing norms as more time is allowed for their policies to mature and adapt to new standards.

This project convened a series of meetings and workshops to prioritize listening to multi-sector stakeholders from local government, advocacy, and industry in US cities where autonomous vehicles are operating. The objective was to listen and learn from all stakeholders, raise issues surrounding accessibility and equity, and to solicit responses. Key findings from the workshops include a consensus across the three sectors on the need for good channels of multi-stakeholder communication, and voices across all sectors agreed on the importance of disability access and serving diverse populations. Many parties, representing voices from all sectors, recognized that federal regulatory activities appear to be moving too slowly. Preventing any roadway incidents is a priority for many stakeholders, and some suggest a playbook for handling day-to-day roadway issues and common standards for first-responder interactions. Disability access is a high priority across all sectors, and there many see nearer term to accommodations for blind, hearing-impaired riders, but the timeline for providing service to people with non-folding wheelchairs is less clear. There is also ongoing debate surrounding the limits of regulatory purview, the role for cities, and how to actualize equitable expansion into rural areas. There is more work to do to advance a multi-sector dialogue around the role for local governments and community-based organizations in shepherding a safe, equitable and sustainable expansion of autonomous vehicles.

The vast majority of all global species have circadian rhythm cycles that allow them to adapt to natural environments. These regular rhythms are regulated by core clock genes and recent studies have also implicated roles for microRNAs in this regulation. Oviposition is an important circadian behavior in the reproductive cycle of insect vectors of diseases, and little is known about the rhythm or its regulation in mosquitoes. Aedes albopictus is a diurnal mosquito that transmits arboviruses and is the major cause of outbreaks of dengue fever in China. We analyzed the oviposition rhythm patterns of A. albopictus under different light/dark conditions and show that the mosquitoes have an oviposition peak between zeitgeber time 9 (ZT 9) and ZT 12. Furthermore, the antagomir-mediated knockdown of expression of the microRNA miR-2940-1 affected the oviposition rhythm of A. albopictus. These data support the conclusion that miR-2940-1 is involved in the regulation of oviposition rhythm in A. albopictus and provide a foundation for using oviposition rhythms as a new target for vector mosquito control.

Advanced air mobility (AAM) is a broad concept that enables consumers access to air mobility, goods delivery, and emergency services through an integrated and connected multimodal transportation network. AAM can provide short-range urban, suburban, and rural flights of about 50-miles and mid-range regional flights up to a several hundred miles. State law delegates responsibility for oversight in aviation primarily to the California Department of Transportation (Caltrans). This white paper presents an overview of the state of the market, such as the aircraft under development and forecast market growth and discusses factors that could facilitate the development of AAM or pose risks to its deployment or to the public, including the safety and the regulatory environment, airspace and air traffic management, security, environmental impacts, weather, infrastructure and multimodal integration, workforce and economic development, social equity, and community engagement and social acceptance. It concludes by recommending actions that Caltrans and other state agencies can take to facilitate the development of AAM.

BackgroundElectronic health records (EHRs) are a cost-effective approach to provide the necessary foundations for clinical trial research. The ability to use EHRs in real-world clinical settings allows for pragmatic approaches to intervention studies with the emerging adult HIV population within these settings; however, the regulatory components related to the use of EHR data in multisite clinical trials poses unique challenges that researchers may find themselves unprepared to address, which may result in delays in study implementation and adversely impact study timelines, and risk noncompliance with established guidance.ObjectiveAs part of the larger Adolescent Trials Network (ATN) for HIV/AIDS Interventions Protocol 162b (ATN 162b) study that evaluated clinical-level outcomes of an intervention including HIV treatment and pre-exposure prophylaxis services to improve retention within the emerging adult HIV population, the objective of this study is to highlight the regulatory process and challenges in the implementation of a multisite pragmatic trial using EHRs to assist future researchers conducting similar studies in navigating the often time-consuming regulatory process and ensure compliance with adherence to study timelines and compliance with institutional and sponsor guidelines.MethodsEight sites were engaged in research activities, with 4 sites selected from participant recruitment venues as part of the ATN, who participated in the intervention and data extraction activities, and an additional 4 sites were engaged in data management and analysis. The ATN 162b protocol team worked with site personnel to establish the necessary regulatory infrastructure to collect EHR data to evaluate retention in care and viral suppression, as well as para-data on the intervention component to assess the feasibility and acceptability of the mobile health intervention. Methods to develop this infrastructure included site-specific training activities and the development of both institutional reliance and data use agreements.ResultsDue to variations in site-specific activities, and the associated regulatory implications, the study team used a phased approach with the data extraction sites as phase 1 and intervention sites as phase 2. This phased approach was intended to address the unique regulatory needs of all participating sites to ensure that all sites were properly onboarded and all regulatory components were in place. Across all sites, the regulatory process spanned 6 months for the 4 data extraction and intervention sites, and up to 10 months for the data management and analysis sites.ConclusionsThe process for engaging in multisite clinical trial studies using EHR data is a multistep, collaborative effort that requires proper advanced planning from the proposal stage to adequately implement the necessary training and infrastructure. Planning, training, and understanding the various regulatory aspects, including the necessity of data use agreements, reliance agreements, external institutional review board review, and engagement with clinical sites, are foremost considerations to ensure successful implementation and adherence to pragmatic trial timelines and outcomes.

In the article, the authors made a thorough description of administrative and legal regulation in the field of land relations. They characterized the concepts of «regulation», «legal regulation» and «land relations». It is substantiated that land relations are one of the largest massifs of public relations regulated by legal norms, in which the absolute majority of both private and public legal entities are involved. But due to the diversity of such subjects and the differences in their legal status, the legal regulation of land relations uses methods characteristic of both civil and administrative law. In addition, within the limits of land law, the existence of its own method of legal regulation is emphasized. It was determined that «legal regulation» can be considered an institution of a general type, which includes specific characteristics that give rise to administrative and legal regulation. The formulated author's definition of «administrative-legal regulation» as a type of sectoral legal regulation, which is based on the direct effect of the norms of administrative law and is an administrative-legal instrument that affects social relations arising in the field of public administration. taking into account the peculiarities of the legislative definition of the concept of «land relations», for the purposes of scientific research it is more correct to use the term «administrative-legal regulation in the field of land relations» as opposed to the term «administrative-legal regulation of land relations». In our opinion, the term «sphere of land relations» should be understood as a set of relations, which, in addition to land relations, include relations arising in connection with the exercise of power by public administration bodies in relation to land management. The objects of these relations are land, land plots, rights to them, as well as goods and objects derived from them. «Administrative and legal regulation in the field of land legal relations» should be understood as a type of sectoral legal regulation, which is based on the direct effect of the norms of administrative, civil and land law and is a legal instrument that affects public land legal relations arising in the field of public land management affairs. [ABSTRACT FROM AUTHOR]

This article addresses the global regulation by periodic event‐triggered output feedback control for a class of feedforward nonlinear systems. Particularly, the considered systems suffer from parameter uncertainties and unknown measurement sensitivity, which entail integrating advanced compensation strategies within the event‐triggered framework. To this end, a time‐varying gain is devised to tackle uncertain nonlinearities as well as the sampling error. Subsequently, a novel periodic event‐triggered output feedback controller is constructed based on the delicate choice of design parameters. Notably, the proposed control scheme is able to avoid the continuous monitoring of the system behavior, and guarantee that all closed‐loop system states are globally bounded and ultimately converge to zero. Finally, a practical example is given to illustrate the main results. [ABSTRACT FROM AUTHOR]

Regulating secondary metabolite (SM) in Myxococcus xanthus bears the potential to influence the formation of important natural products with various biological activities. The authors of this study have previously found that the detectable levels of two proteins (4‐hydroxyphenylpyruvate dioxygenase [HppD] and a Hsp90‐like protein  [HtpG]) are affected by ROK inactivation. As evidence, the current study was designed to elucidate the possible role of these two proteins in regulating the SMs’ biosynthesis in this bacterium. To begin with, inactivation of the corresponding genes was carried out, and two mutant strains (M. xanthus hppD− and htpG−) were constructed. Subsequently, high‐performance liquid chromatography coupled with mass spectrometry analysis for the metabolic extracts of the mutants revealed a significant reduction in the production of several SMs, like DKxanthene, myxalamide A, and myxochromide A, in comparison to the wild type. Furthermore, electrophoretic mobility shift assays using purified ROK protein suggested a direct binding on the genes’ promoter region encoding the two proteins under study. It is therefore possible to conclude that hppD and htpG genes are implicated in the bacterium SMs’ biosynthetic regulatory cascade, which seems to be directly regulated by the ROK protein. The present study provides additional evidence to a previous investigation showing the pleiotropic regulatory role of ROK on the production of SMs in M. xanthus. [ABSTRACT FROM AUTHOR]

Situated within the context of increasing "adult regulatory practices" in skateboarding, this article draws attention to and interrogates the ways normative ideas of "youth," "adolescence," and "youth/adolescent development" often interplay with such efforts. In doing so, this article offers a critique, from a Critical Youth Studies perspective, of dominant, developmentalist notions of youth that typically cast young people as deficits in need of specific forms of intervention and surveillance. The article concludes with areas of inquiry emergent from critiques of dominant renderings of youth to be considered when engaging in processes of forming regulatory programs, policies, and practices related to skateboarding. [ABSTRACT FROM AUTHOR]

It is indicated that the armed aggression of the Russian Federation against Ukraine, which has been going on for the third year, and the progress of European integration processes taking place in our country, require overcoming challenges in the field of higher legal education. One of the important such challenges is the increase in demand from employers for qualified graduates of higher educational institutions who have modern theoretical and practical training in the fields of tax, administrative, contractual, economic and corporate law. At the same time, there is a high demand among employers for specialists who specialize in the field of corporate relations for legal support of the business activities of international corporations working in the agricultural and other sectors of the Ukrainian economy; participation in international and national arbitration and commercial courts in the consideration of corporate disputes in the interests of companies that do not fulfill their obligations in favor of counterparties that maintain relations with the aggressor state or sanctioned persons; judicial protection of corporate rights of foreign and domestic investors; protection in international arbitrations of the interests of Ukrainian business companies that supply material property for the Armed Forces of Ukraine in case of violation of their obligations to them by foreign companies; participation in legal proceedings regarding the recovery of funds and other assets from sanctioned persons in favor of Ukraine or its business entities, etc. The article examines ways of reforming higher legal education in the conditions of armed aggression of russian federation against Ukraine and its European integration into the European Union. The current requirements of employers for law graduates of higher educational institutions are analyzed. The proposed vectors of reforming the educational process, in particular, from the corporate law course, through the introduction of innovative educational programs that meet international world standards, including EU requirements in the field of higher legal education. The need to develop and use interdisciplinary educational programs for the training of lawyers is substantiated. It is recommended that a separate section in these programs provide for the teaching of a corporate law course. Suggested topics from this course include, in particular, corporate law under martial law; adaptation of Ukrainian corporate legislation to the legislation of the European Union - status and prospects; the accession of Ukraine to the European Union as a factor in its victory over russian aggressor country and other topics. A comparative analysis of EU directives and regulations and Ukrainian legislation regulating corporate relations was made. [ABSTRACT FROM AUTHOR]

Over the past 40 years, the private security sector in Belgium, along with its related policies, has undergone significant transformations, with the industry establishing itself as a crucial partner in domestic security governance. Although the political context in which private security has evolved holds considerable importance in criminological scholarship, the specific processes of framing this phenomenon have attracted much less attention. This article examines the various approaches adopted by political actors in framing private security within policy formulations and efforts to introduce new regulations. Empirical data are drawn from parliamentary records spanning the years 1980 to 2020. By focussing on the parliamentary arena, we analysed how the issue – that is, the need for regulating private security – has been discussed, motivated and framed by those in power. Our results demonstrate that six conflicting and supporting frames revolved around three overarching themes: the function and position of private security, and what the government sought to protect in society. The findings of this study provide new insights into the forms, degrees and manifestations of framing private security, along with its relation to security events over time. Consequently, it offers a deeper understanding of the political field and societal conditions under which the trajectory of private security has unfolded in Belgium. [ABSTRACT FROM AUTHOR]

Background: Regulatory processes can be stressful, anxiety provoking, and complicated for the health professional involved, the institutions they work for, and for the regulators. Methods: This paper uses a case study to describe a systems approach to comprehensively identify the agents (ie: the complainant, the health professional concerned, the regulator dedicated to the case, the institution, the healthcare profession, the public, and the regulatory authority) and 6 ethical issues that emerge during the regulatory process: potential to cause harm, not in the best interest of a person, affects autonomy, unjust, not truthful, and loss of trust. Results: A systems approach lends to a mental model in which there are dynamic interactions across these elements accompanied by positive and negative feedback loops that maintain overall stability of the whole system. Conclusions: The process can be further refined and kinder to those concerned by developing a sensitive approach to improve assessment of risks, using feedback to improve the regulatory process, adapting transparent procedures, not causing undue delays to the process, embedding regulatory activities in a patient safety system, minimizing individual blame, using non-legalistic, non-threatening and respectful communications, and directing the different actors to a support network for guidance and advice. [ABSTRACT FROM AUTHOR]

The World Health Organization has released its first comprehensive Guidance document on health practitioner regulation, addressing a critical gap in global health policy. This Commentary provides an overview of the Guidance, which aims to support countries in strengthening their regulatory systems for health practitioners. The Guidance, developed through a rigorous process involving a literature review and expert consultation, covers a broad range of health practitioners and focuses on optimizing their utilization to meet population health needs. Key highlights include the description of the global regulatory landscape, identification of regulatory challenges in all societies, and policy considerations to realize dynamic, effective, and agile regulation. The COVID-19 pandemic is cited as an important example of a catalyst for regulatory reforms that enhanced workforce availability and access. This paper, co-authored by members of the World Health Organization Technical Expert Group, emphasizes the importance of aligning regulatory systems with broader health workforce and system priorities, adopting a risk-based approach, and addressing implementation gaps. It encourages policymakers, regulators, and researchers to use the Guidance to assess and update their regulatory systems and to generate more robust evidence on the impact of health practitioner regulation on health outcomes. [ABSTRACT FROM AUTHOR]

Purpose: To identify risk and protective factors associated with physician performance in practice; to use this information to create a risk assessment scale; and, to test use of the risk assessment scale with a new population of assessed physicians. Design: Physician assessments that were completed by community-based physicians between March 2016 and February 2022 (n=2708) were gathered to determine what professional characteristics and practice context factors were associated with poor peer practice assessment (PPA). The predictive capacity of the resulting model was then tested against a new sample of physician assessments completed between March 2022 and February 2023 (n=320). Results: N=2401 physicians were eligible for inclusion in a logistic regression analysis, which resulted in an empirical model containing 11 variables that was able to account for 21.6% of the variance in the likelihood of receiving a poor PPA generated by the College of Physicians and Surgeons of British Columbia. The resulting model, when tested against 320 new cases, was able to predict good versus poor PPA performance with a sensitivity of 0.79 and specificity of 0.75. Not having undertaken peer review (OR=1.47) created a risk like that arising from a full decade passing since completion of medical school (OR=1.50). Conclusion: In addition to being the largest known study of its type, this work builds on similar studies by demonstrating the capacity to use regulator-mandated peer review to empirically identify physicians who are at risk of substandard performance using factors that are safe from claims of violating Human Rights Codes; that emphasize modifiable aspects of practice; and that can be readily updated to account for change over time. [ABSTRACT FROM AUTHOR]

This article examines the role of policy entrepreneurs in countering regulatory capture, a phenomenon whereby regulatory bodies influenced by industry lobbying often prioritize private over public interests. The study employs an abductive process‐tracing approach to investigate the 2013 drug pricing reform in Morocco, illustrating how substantial policy shifts can occur even in authoritarian contexts susceptible to regulatory capture. The findings underscore the pivotal role of Houcine El Ouardi, the former Minister of Health, whose strategic leadership exemplified policy entrepreneurship. His capacity to navigate and surmount industry resistance was instrumental to the reform's success, culminating in a significant reduction in drug prices. This case challenges conventional wisdom regarding regulatory capture, demonstrating that individual agency can reshape regulatory outcomes despite opposition. By elucidating how policy entrepreneurs can drive transformative change in resistant regulatory environments under authoritarian regimes, the study contributes to the literature on policy entrepreneurship and regulation. [ABSTRACT FROM AUTHOR]

Lead white (basic lead carbonate), before its effective ban in much of Europe from 1989 onwards, was among the most versatile and widespread but also one of the most harmful pigments available. This paper is a critical discussion of the regulation of lead white paint and its consequences from the point of view of conservation and artistic practice in Europe. It looks at who benefited from exemptions to bans, and whether there was resistance to them. Buildings and artworks are both taken into account. The paper discusses nuances in regulation in four European countries which have notable differences in approach (France, Austria, Germany, and the United Kingdom). The centralised regulatory framework of the United Kingdom allows data analysis on the authorised use of the paint since its restriction up to the present day. This dataset shows a steady decrease in the use of the paint by conservators across disciplines. The paper concludes by considering the professional and ethical implications of lead white paint for artists and conservators, in the context of varied regulation and a decline in use. [ABSTRACT FROM AUTHOR]

Microcapsules encapsulating payloads are one of the most promising delivery methods. The mechanical properties of microcapsules often determine their application scenarios. For example, microcapsules with low mechanical strength are more widely used in biomedical applications due to their superior biocompatibility, softness, and deformability. In contrast, microcapsules with high mechanical strength are often mixed into the matrix to enhance the material. Therefore, characterizing and regulating the mechanical properties of microcapsules is essential for their design optimization. This paper first outlines four methods for the mechanical characterization of microcapsules: nanoindentation technology, parallel plate compression technology, microcapillary technology, and deformation in flow. Subsequently, the mechanisms of regulating the mechanical properties of microcapsules and the progress of applying microcapsules with different degrees of softness and hardness in food, textile, and pharmaceutical formulations are discussed. These regulation mechanisms primarily include altering size and morphology, introducing sacrificial bonds, and construction of hybrid shells. Finally, we envision the future applications and research directions for microcapsules with tunable mechanical properties. [Display omitted] • Characterization methods of the mechanical properties of microcapsules are delineated. • Regulatory mechanisms of the mechanical properties of microcapsules are summarized. • The applications and future research directions of microcapsules with controllable mechanical properties are discussed. [ABSTRACT FROM AUTHOR]

This article introduces the concept of a Natural Dividend and describes the three types of rent that combine to produce it: a differential rent, a regulatory rent, and a locational rent. Each of these rents is associated with a classical economist (Ricardo, Marx and George, respectively), and each is shown to be a product of nature, society and/or the political authorities that manage nature on our behalf. Because the Natural Dividend is a windfall derived from our regulation of commonly held (and immobile) natural resources, it can be taxed at a higher level without distorting any underlying investment decisions. [ABSTRACT FROM AUTHOR]

The production of cellulolytic enzymes in response to inducible carbon sources is mainly regulated at the transcriptional level in filamentous fungi. We have identified a cellobiose-response regulator (ClbR) controlling the expression of cellulolytic enzyme-encoding genes in Aspergillus aculeatus. However, the engineering potential of combining the deletion of transcriptional repressors with the overexpression of transcriptional activators to enhance enzyme production has not been analyzed. Here, we investigated the effect of the deletion of the transcriptional repressor creA and the overexpression of the transcriptional activator clbR in enzyme production in A. aculeatus. Here, we verified that a combination of creA deletion and clbR overexpression (Δc&OE) improved cellulase, β-1,4-xylanase, and β-glucosidase production. Cellulase and β-1,4-xylanase production increased 3.4- and 8.0-fold in Δc&OE compared with the host strain (MR12) at 96-h incubation, respectively. β-Glucosidase production in Δ creA and Δc&OE increased approximately 5.0-fold compared with that in MR12 at 240-h incubation. Transcriptional analysis revealed that the increase in enzyme production was due to increased expression of cellobiohydrolase, endo-β-1,4-glucanase, β-1,4-xylanase, and β-glucosidase 1 (bgl1). Interestingly, bgl1 expression in Δ creA increased in a dose-dependent manner in response to glucose. Thus, combinational manipulation of transcription factors improved cellulase, xylanase, and β-glucosidase production in A. aculeatus. [ABSTRACT FROM AUTHOR]

The 2019 Directive on Copyright in the Digital Single Market represents an intriguing departure from the anticipated path of liberalisation in public policy. While it includes provisions seemingly aligned with the liberalisation of the Digital Single Market by relaxing digital copyright enforcement, it also introduces mechanisms that bolster digital copyright protection, signalling a shift towards market regulation. This paper explores why and how Jean-Claude Juncker's European Commission proposed a directive featuring robust regulatory elements despite initial promises of copyright deregulation within the Digital Single Market. Combining insights from political economy and political sociology, I examine the concept of 'political work' as the practice of promoting, defending, and implementing a choice of public action. Within this framework, I identify a managerial dimension of political work involving political practices that influence the institutional structure and management of public action. Utilising a qualitative methodology involving twelve in-depth interviews with Commission officials conducted between 2018 and 2021, alongside document analysis, I demonstrate how Jean-Claude Juncker and his cabinet's managerial political work, encompassing organisational reforms within the Commission, played a pivotal role in steering the proposed policy towards regulation. [ABSTRACT FROM AUTHOR]

For public interest advocates engaged on issues of worker health and safety and environmental protections, regulatory cost–benefit analysis has long been seen as an obstacle to meaningful progress. In November 2023, the Biden administration overhauled Circular A-4, which provides guidance to agencies on how to perform cost–benefit analyses for their rules. The reforms seek to make cost–benefit analysis less biased against worker safety, public health, environmental, and other protective safeguards. As such, the new version of Circular A-4 offers important new levers to agencies to justify more stringent protections. By extension, those in the public interest community can use agency implementation of the new Circular A-4 as part of their advocacy efforts for specific rules they are tracking. This article seeks to support this tactic by providing a roadmap for advocates on how to incorporate into their comments critiques of agencies' cost–benefit analyses based on the Circular A-4 revisions. [ABSTRACT FROM AUTHOR]

Lignocellulolytic clostridia employ multiple pairs of alternative σ/anti‐σ (SigI/RsgI) factors to regulate cellulosomal components for substrate‐specific degradation of cellulosic biomass. The current model has proposed that RsgIs use a sensor domain to bind specific extracellular lignocellulosic components and activate cognate SigIs to initiate expression of corresponding cellulosomal enzyme genes, while expression of scaffoldins can be initiated by several different SigIs. Pseudobacteroides cellulosolvens contains the most complex known cellulosome system and the highest number of SigI–RsgI regulons yet discovered. However, the function of many RsgI sensor domains and their relationship with the various enzyme types are not fully understood. Here, we report that RsgI4 from P. cellulosolvens employs a C‐terminal module that bears distant similarity to the fibronectin type III (Fn3) domain and serves as the sensor domain. Substrate‐binding analysis revealed that the Fn3‐like domain of RsgI4 represents a novel carbohydrate‐binding module (CBM) that binds to a wide range of polysaccharide types. Structure determination further revealed that the Fn3‐like domain belongs to the type B group of CBMs with a predicted concave face for substrate binding. Promoter sequence analysis of cellulosomal genes revealed that SigI4 is responsible for cellulosomal regulation of major scaffoldins rather than enzymes, consistent with the broad substrate specificity of the RsgI4 sensor domain. Notably, scaffoldins are invariably required as cellulosome components regardless of the substrate type. These findings suggest that the intricate cellulosome system of P. cellulosolvens comprises a more elaborate regulation mechanism than other bacteria and thus expands the paradigm of cellulosome regulation. [ABSTRACT FROM AUTHOR]

Kiwifruit growth and development are severely affected by various biotic and abiotic stresses, especially cold stress and the bacterial disease caused by Pseudomonas syringae pv. actinidiae (Psa). Metallothioneins (MTs) are a group of cysteine-rich proteins that play crucial roles in stress response, metal detoxification, and homeostasis in plants. However, the protective role of these MTs in kiwifruit remains to be elucidated. In the present study, four AcMT genes were identified in the Hongyang kiwifruit genome, namely, two Type 2 isoforms (AcMT2 and AcMT2a) and two Type 3 isoforms (AcMT3a and AcMT3b) located separately on four different chromosomes. The hormones and stress response cis-elements within the promoter regions of these AcMTs were characterized. It was revealed that the four AcMT genes exhibited different expression patterns in different tissues: AcMT2 and AcMT2a were expressed at much higher levels in the fruit, male flower, female flower, root, and bark, while AcMT3a was expressed mainly in the fruit and AcMT3b was expressed highly in the bark. The expression patterns of these AcMT genes after exposure to Psa infection and different phytohormones, including gibberellic acid A3(GA3), ethylene (ET), and abscisic acid (ABA), were evaluated. It was revealed that in response to Psa infection, the main AcMTs in each tissue (those with expression levels higher compared to the other MTs in that tissue) were downregulated during the early stage in kiwifruits, followed by a recovery phase. In addition, most AcMTs were downregulated after exposure to ET and GA3, while type 2 AcMTs (AcMT2 and AcMT2a) were upregulated after treatment with ABA. The overexpression of AcMTs in Escherichia coli presented a higher tolerance to H2O2, heavy metals, low temperature, and high temperature. Collectively, these findings demonstrated the protective roles of AcMTs in terms of stress resistance conferred through plant hormone-related signal pathways. [ABSTRACT FROM AUTHOR]

This study examines the polymorphous role of the Chinese provincial government in planning, financing, and constructing intercity railways in the Pearl River Delta region. Provincial governments claim absolute ownership in railway planning and land development surrounding railway stations. Informed by the state-theoretical perspective, we developed a conceptual framework that examines the city-regional governance of Chinese states with an emphasis on their capacity for regulation. Provincial governments selectively bargain with ministries and municipalities during development and they are flexible in the multi-scalar politics of railway projects. Their competence lies in their initiatives to gain knowledge of local land development. Our findings suggest that the polymorphous role of the provincial government extends beyond its usual function as a mediator in central-local relations and that its strategic nature reflects the complexity of China's state powers and regulatory regimes. Meanwhile, local authorities pursue urban growth and central ministries aspire to exert their regulations on localities. [ABSTRACT FROM AUTHOR]

The article "Big Tech Platforms: What Are the Limits to 'Big Brother' Surveillance and Influence?" by Annabelle Gawer discusses the unprecedented economic power and influence of Big Tech platforms like Google, Amazon, Apple, and Facebook. These platforms dominate various sectors, such as digital advertising, e-commerce, and social media, raising concerns about privacy, data exploitation, and manipulation of user behavior. The article highlights the need for both public regulation and self-regulation to address these issues and prevent exploitation, emphasizing the importance of users' sovereignty in decision-making within platform ecosystems. [Extracted from the article]

Does corruption ease the burden of regulation? We test this question using survey data on business managers' experience in dealing with regulation and corruption. We find that there is substantial within-country variation in the burden of regulation and that corruption is associated with worse regulatory outcomes across a range of indicators at the country, national, and firm level. These findings suggest that corruption is associated with an increase in the burden of regulation, and imposes large costs on businesses. While corruption is associated with an increased burden of regulation, this does not seem to happen through an increase in how much time senior managers must devote to regulation, suggesting that the cost of corruption-induced regulation manifests in the form of additional staff costs or professional fees. [ABSTRACT FROM AUTHOR]

Lipids are crucial for human health and reproduction and include diverse fatty acids (FAs), notably polyunsaturated FAs (PUFAs) and short-chain FAs (SCFAs) that are known for their health benefits. Bioactivities of PUFAs, including ω-6 and ω-3 FAs as well as SCFAs, have been widely studied in various tissues and diseases. Epigenetic regulation has been suggested as a significant mechanism affecting the progression of various diseases, including cancers and metabolic and inflammatory diseases. Epigenetics encompasses the reversible modulation of gene expression without altering the DNA sequence itself, mediated by mechanisms such as DNA methylation, histone acetylation, and chromatin remodeling. Bioactive FAs have been demonstrated to regulate gene expression via epigenetic modifications that are potentially important for modulating metabolic control and disease risk. This review paper discusses the evidence in support of bioactive FAs, including ω-6 and ω-3 FAs and SCFAs, eliciting various disease prevention via epigenetic regulation including methylation or acetylation. [ABSTRACT FROM AUTHOR]

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Neurotechnology and Artificial Intelligence (AI) have developed rapidly in recent years with an increasing number of applications and AI-enabled devices that are about to enter the market. While promising to substantially improve quality of life across various severe medical conditions, there are also concerns that the convergence of these technologies, e.g., in the form of intelligent neuroprostheses, may have undesirable consequences and compromise cognitive liberty, mental integrity, or mental privacy. Therefore, various international organizations, such as the Organization for Economic Cooperation and Development (OECD) or United Nations Educational, Scientific and Cultural Organization (UNESCO), have formed initiatives to tackle such questions and develop recommendations that mitigate risks while fostering innovation. In this context, a first international conference on the ethics and regulation of intelligent neuroprostheses was held in Berlin, Germany, in autumn 2023. The conference gathered leading experts in neuroscience, engineering, ethics, law, philosophy as well as representatives of industry, policy making and the media. Here, we summarize the highlights of the conference, underline the areas in which a broad consensus was found among participants, and provide an outlook on future challenges in development, deployment, and regulation of intelligent neuroprostheses. [ABSTRACT FROM AUTHOR]

Summary Reactive oxygen species (ROS) are among the most important signaling molecules, playing a significant role in plant growth, development, and responses to various environmental stresses. Respiratory burst oxidase homologs (RBOHs) are key enzymes in ROS production. Plants tightly regulate the activation and deactivation of RBOHs through various post‐translational modifications (PTMs), including phosphorylation, ubiquitination, S‐nitrosylation, and persulfidation. These PTMs fine‐tune ROS production, ensuring normal plant growth and development while facilitating rapid responses to abiotic and biotic stresses. This review discusses the effects of different PTMs on RBOH function and their biological relevance. Additionally, we examine the evolutionary conservation of PTM sites and emphasize the complex interplay between multiple PTMs regulating RBOHs. [ABSTRACT FROM AUTHOR]

Background: Health and social care employees may be involved in professional regulatory proceedings because their alleged behaviour raises health or conduct concerns. Employees, patients or service users may also be involved in a regulatory tribunal as witnesses. This study is about the role of employers in supporting them in this process. Methods: Taking an organisational support perspective, we interviewed 25 senior employees in health and social care organisations in the UK who are responsible for managing the employer's role in the proceedings. Template analysis was used to analyse the transcripts. Results: Support for patients was limited to that offered during an employer's complaints process, and only one employer gave some support during the regulatory process if the patient or service user initiated regulatory proceedings. Support for employees in tribunals was little different to that offered during an initial investigation by the employer. However, where additional support for being involved in a regulatory tribunal was offered to employees, it most often came from the senior employees' own experience of the stressfulness of being a witness in these proceedings. Employers were not aware of training resources that would better support their employees to engage with professional regulatory proceedings. Conclusions: Employers offer limited support to employees who are involved in professional regulatory proceedings, and the support offered may depend more on senior employee's individual experience of involvement in regulatory proceedings to exercise this discretion. Patients, service users and other public witnesses receive almost no support from health and social care employers during professional regulatory proceedings. [ABSTRACT FROM AUTHOR]

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Introduction: Plasmodium falciparum is the most damaging malaria pathogen and brings a heavy burden to global health. Host switching and morphological changes in P. falciparum are dependent on an effective gene expression regulatory system. C5 methylation of cytosines is a common RNA modification in eukaryotes, and the NSUN family are essential m5C modification executors. Currently, little is known about this family in Plasmodium spp. In this study, we focus on exploring the function of PfNSUN1 protein. Methods: An efficient CRISPR/Cas9 gene editing technique was applied to construct the PfNSUN1 knockdown strain. The knockdown efficiency was confirmed by growth curves and western blot experiments. The knockdown transcriptome data was acquired to find differentially expressed genes, and target genes of PfNSUN1 protein were identified by RNA immunoprecipitation and high-throughput sequencing experiments. Results: The efficiency of PfNSUN1 protein down-regulated was about 34%. RNA-seq data revealed that differentially expressed genes were mainly downregulated. And there were 224, 278, 556 genes that were down-regulated with more than 2-fold changes and p-adj<0.05 at ring, trophozoite and schizont stages, respectively. PfNSUN1 protein was significantly enriched on 154 target genes, including 28S ribosomal RNA and pfap2-g5 transcription factor. Discussion: PfNSUN1 is a crucial RNA post-transcriptional modification protein in P. falciparum. It plays a pivotal role in regulating gene expression and parasite growth by targeting 28S ribosomal RNA and pfap2-g5 transcription factor. [ABSTRACT FROM AUTHOR]

Ethics policies have emerged as a key aspect of the European (post)-Regulatory State. Such policies are designed to create ‘noise’, allowing media and public discourse to mobilise around the ethical lapses of those in power. The regulation of revolving doors (RD), i.e., movements in and out of government positions, is an ethics policy. However, unlike other ethics policies, RD regulation does not make transparency its central feature but constitutes what we call ‘quiet regulation’. Drawing on qualitative document analysis and interviews, we study the quiet regulation of RD for EU Commissioners. We demonstrate that quiet regulation has a dual nature: its public façade relies on independence, judicialised procedures and transparency. Conversely, its day-to-day operation is characterised by self-regulation, soft law and informality. In this way, RD regulation achieves two contradictory aims: functioning as a legitimate ethics policy while simultaneously avoiding the moral outcry that often surrounds ethics policies and the politicisation of RD, thereby normalising RD as ‘administration as usual’. [ABSTRACT FROM AUTHOR]

Following an outbreak of Cronobacter sakazakii infection in infant formula, the US Food and Drug Administration commissioned a series of reports and then undertook a major reorganization of its food program. This article describes the changes that went into effect on 1 October 2024, why those changes are likely to improve the new Human Foods Program, and additional work that must be undertaken to enhance the agency's impact upon public health. [ABSTRACT FROM AUTHOR]

This study addresses the critical need for innovation in the healthcare sector, particularly in Japan's functional food industry, amid rising chronic diseases and healthcare costs. It explores the complex relationship between regulatory design and corporate behaviour, focusing on how companies' compliance strategies influence their research and development (R&D) investments. A mixed-method approach was used, analysing data from 15 major dietary supplement companies and 74 products under Japan's Foods with Function Claims (FFCs) regulation. The study reveals a correlation between companies' engagement in the FFCs system and their preference for conducting in-house clinical trials, indicative of higher R&D investments (R = 0.66, p = 0.007), and that between the latter variable and average product sales, which is a measure of returns on regulatory compliance (R = 0.66, p = 0.008). Companies actively complying with FFCs regulations tend to conduct R&D and accumulate knowledge in-house, to innovate and differentiate their products, gaining competitive advantages. The study also highlights the role of a company's size, market presence, and industry origins in shaping regulatory strategies, with firms from other industries using FFCs regulations to explore new business opportunities. The research underscores the importance of flexible regulatory frameworks that encourage R&D investment, leading to innovation and competitive advantages in the healthcare sector. [ABSTRACT FROM AUTHOR]

AbstractThe Zrt/Irt-like protein (ZIP) family consists of ubiquitously expressed divalent d-block metal transporters that play central roles in the uptake, secretion, excretion, and distribution of several essential and toxic metals in living organisms. The past few years has witnessed rapid progress in the molecular basis of these membrane transport proteins. In this critical review, we summarize the research progress at the molecular level of the ZIP family and discuss the future prospects. Furthermore, an evolutionary path for the unique ZIP fold and a new classification of the ZIP family are proposed based on the presented structural and sequence analyses. [ABSTRACT FROM AUTHOR]

Fusion is inherently safer than fission due to the absence of nuclear chain reactions. However, operating fusion power plants will not be risk free. There will still be numerous hazards that will need careful management in order to safely build, operate and ultimately decommission a fusion power plant. Ensuring a robust safety demonstration that covers all radiological and non-radiological hazards is therefore vitally important for the future permissioning and consenting of fusion power plants. The safety case for the STEP prototype plant will be developed in line with a set of safety philosophies, safety functional requirements and design safety principles to ensure that the safety case production process is consistent and robust. This article is part of the theme issue 'Delivering Fusion Energy – The Spherical Tokamak for Energy Production (STEP)'. [ABSTRACT FROM AUTHOR]

Arizona has a long history of groundwater use, and there is concern about long term groundwater sustainability across the state. We explore groundwater trends across Arizona and how they vary with respect to: (1) whether groundwater pumping is regulated, and (2) relative access to local or imported surface water. Well observations from the Arizona Department of Water Resources are used to quantify water table depth trends and groundwater drilling patterns. There are more than 85,000 groundwater wells in Arizona, and new wells are routinely being drilled. The number of new shallow wells (<200 ft) has decreased over time in all parts of the state. But midrange (200–500 ft) to deep (>500 ft) wells have increased in the past 10 years in regulated and groundwater dominated areas. Most wells are small with low pumping capacities that fall below the regulatory limit; however, there are still large wells being drilled in unregulated areas. Results show statewide decreasing water storage and groundwater levels. Groundwater declines are less severe in the parts of the state that have groundwater regulation. However, looking closer at this trend, groundwater recovery is strongest in areas receiving imported Colorado River water which also implement managed groundwater recharge with the imported water. Our findings indicate that groundwater recovery is very localized and driven more by managed recharge from surface water as opposed to decreased groundwater pumping. [ABSTRACT FROM AUTHOR]

AbstractAlthough land use planning in the United States has long privileged single-family homes, the dominance of single-family zoning is weakening. At least eight states have passed laws opening single-family neighborhoods to accessory dwelling units and, in some cases, to middle housing, such as townhouses, duplexes, triplexes, and quadplexes. Opponents of laws liberalizing single-family zoning often seek to prohibit for-profit developers from densifying single-family neighborhoods, by restricting development to owner-occupiers. Often these opponents invoke concerns about gentrification and social equity. But for recent zoning reforms to put a meaningful dent in the housing affordability problems confronting many regions, the planning profession must accept that the physical transformation of neighborhoods at scale will require significant, though by no means exclusive, involvement of for-profit builders. In this Viewpoint we explain why the relevant empirical evidence from cities such as Houston (TX), Portland (OR), and Auckland (New Zealand) indicates that single-family zoning reform can foster more affordable types of housing through for-profit development, while allaying fears concerning gentrification and displacement. Cities and states should promote equity and neighborhood stability through tools such as tenant protections, but they should eliminate owner-occupancy restrictions and other regulations that bar for-profit developers from building middle housing. [ABSTRACT FROM AUTHOR]

This article generates new insights into the changing profession of journalism. Empirically, we present the findings of 21 interviews with journalists working in the Irish and UK sports beats on their experiences of online abuse. Conceptually, we address the under-theorising of emotions in journalism by extending the utility and entanglement of emotion work and emotional labour. In doing so, we posit future lines of theoretical enquiry about individual and social regulation. Several key discoveries are presented. First, sports journalism is a distinctive profession because significant authentic emotional work is undertaken. This is only accentuated when online abuse occurs. Journalists are deeply affected by this abuse, personally and professionally. Second, online abuse towards sports journalists is now so ubiquitous as to be habitually accepted, and it has obscured the distinction between public and private spaces. Third, in response, sports journalists have been compelled to develop their own emotional strategies, including self-censorship, to cope with and manage online abuse. The findings presented here also pose practical and existential questions about the sustainability of the profession, especially in the absence of formal institutional supports or even an informal code of practice about how to cope with and respond to online abuse. [ABSTRACT FROM AUTHOR]

Many nations have food contact material (FCM) legislation purporting to protect citizens from hazardous chemicals, often specifically by regulating genotoxic carcinogens. Despite such regulations, cancers that are associated with harmful chemical exposures are highly prevalent, especially breast cancer. Using the novel Key Characteristics of Toxicants framework, Kay et al. found 921 substances that are potential mammary carcinogens. By comparing Kay et al.'s chemicals list with our own Database on migrating and extractable food contact chemicals (FCCmigex), we found that 189 (21%) of the potential mammary carcinogens have been measured in FCMs. When limiting these results to migration studies published in 2020-2022, 76 potential mammary carcinogens have been detected to migrate from FCMs sold in markets across the globe, under realistic conditions of use. This implies that chronic exposure of the entire population to potential mammary carcinogens from FCMs is the norm and highlights an important, but currently underappreciated opportunity for prevention. Reducing population-wide exposure to potential mammary carcinogens can be achieved by science-based policy amendments addressing the assessment and management of food contact chemicals. [ABSTRACT FROM AUTHOR]

The Regulation that develops the Law on Immigration is one of the legal instruments that regulates the operation and organization of the public administration in relation to immigration issues. This regulation is currently being modified and will experience a profound transformation. Recently, the draft reform has been published to be submitted to public hearing and information in order to gather the opinion of the citizens. On this occasion and using the contributions developed by the Movimiento por la Paz -MPDL-, a few observations on the main sections of this project from a human rights-based approach will be done. The comments will be focused on some of the issues in which the regulation is most harmful to the interests and rights of the migrant population. Specifically, humanitarian visas as a mechanism to stop migrant deaths, safe reporting mechanisms for undocumented migrants and, finally, forms of regularization for displaced children. [ABSTRACT FROM AUTHOR]