International Regulations Research Articles

Historical Analysis of Resilience in Spanish Desalination Companies: Period 1980–2024

This article analyzes the evolution and resilience of the Spanish desalination industry in response to shifting market conditions and technological challenges. Initially focused on domestic projects, Spanish companies leveraged the AGUA Program (Actions for the Management and Use of Water; the acronym does not correspond exactly in English, as it is translated from Spanish) to build expertise, which later facilitated their successful international expansion as local demand declined. The industry has adapted to diverse international regulations and local conditions, demonstrating both flexibility and competitiveness. In recent years, there has been an increasing focus on integrating renewable energy into desalination processes to mitigate rising energy costs and address environmental concerns. This shift not only reduces CO2 emissions but also stabilizes operational costs, underscoring the sector’s ongoing innovation and adaptability.

Condition Monitoring in Marine Oil Separation Systems Using Wavelet Packet Transform and Genetic Technique

Condition Monitoring is key to predictive maintenance and especially in the operational efficiency of the Marine Oil Separation System. These systems are crucial for environmental protection and compliance with international maritime regulations. Therefore, it is necessary to design a technique capable of analyzing the signals from sensors and estimating the remaining useful life in order to avoid breakage or unnecessary replacement. This work presents an intelligent method with signal processing based on Wavelet Packets Transform that provides energy data from vibration measurements as characteristic parameters. These values can be related to its RUL, and they are used as inputs for the training process. In particular, a Genetic Neuro-Fuzzy system is proposed as an intelligent classification technique. Once the training process is completed, it can be concluded that a good classifier has been built, since it relates the energy state of the oil separation system with its remaining useful life, and therefore, the necessary information for efficient predictive maintenance is achieved. Furthermore, a mechanism to obtain the final set of fuzzy rules has been developed, showing the correspondence between these fuzzy rules and the neural network structure.

Physiological, morphological and chemical changes in pea seeds under different storage conditions.

The loss of germination, viability, and vigor of seeds under storage conditions are the main causes of the need to multiply the seed material for leguminous crops. For crop establishment, seeds obtained in propagation fields are usually used, and the coating comes from the basic seed. In the case of leguminous species, the seeds quickly lose their viability, and in accordance with international regulations, for legumes, the number of seeds increases only in the first year of propagation. Therefore, the main objective of this study was to assess the effects of variations in the storage period, temperature and humidity on the morphophysiological and chemical traits of two pea seed varieties (Gloriosa and Kelvedon Wonder). The pea seeds were harvested at the end of June 2017, 2018 and 2019 and stored for 32, 20 and 8months at T = 4°C and H = 8%; T = 4°C and H = 12%; T = 8°C and H = 8%; T = 8°C and H = 12%; and T = 22°C and H = 65%. The results of the morphological, chemical, and biochemical analyses showed that the highest germination rate; hypocotyl length; radicle length; lipid content; dietetic fiber content; caloric value; and Ca, Mg, K, Na, Fe and Zn contents were detected in the Gloriosa and KW seeds stored for 8months at 4°C and 8% humidity. Analysis of the experimental data by statistical methods revealed that increasing the storage time had an individual significant negative influence only on the germination rate of both pea varieties and on the hypocotyl length and radicle length of the KW variety, while humidity and temperature variation had individual significant influences on the lipid content. The significant effects of humidity and temperature on the germination rate, hypocotyl length and root length of KW plants were also determined. For the remaining morphophysiological and chemical traits of pea seeds, the individual and combined effects of the factors were not statistically significant. Furthermore, the comparison of means using the Tukey test showed that storage conditions related to temperature and humidity generally used by farmers (T = 22°C × H = 65%) did not significantly affect the majority of the nutritional properties of the pea seeds. However, maintaining pea seeds under these conditions for a longer period of time significantly affects seed germination and vigor.

International and Domestic Legal Regulation of Transnational Shipments

International and Domestic Legal Regulation of Transnational Shipments

Total mercury exposure through canned tuna in water sold in Quito, Ecuador.

Mercury is a toxic trace metal found in seafood products owing to its bioaccumulative and ubiquitous nature. Seafood and fish are frequently consumed, being necessary to assess its human health risk. Accordingly, this study quantified total mercury in samples of canned tuna in water from supermarkets in the Metropolitan District of Quito in Ecuador, in order to ensure that Hg content is within the maximum limits stablished in national and international regulations. Total mercury levels were measured through cold vapor atomic fluorescence spectrophotometry. Three of the most consumed tuna brands in Ecuador were analyzed, coded as A, B, and C, according to the price at which they are sold in the market (A < B < C). Results indicated that mean total mercury in different tuna brands were within the permissible limits. Total mercury concentrations were 0.14 ± 0.11mg kg-1; 0.41 ± 0.42mg kg-1; and 0.25 ± 0.22mg kg-1 for brands A, B, and C, respectively. However, for brand B the potential non-carcinogenic risk of mercury for consumers exceeded the threshold limit (> 1). When considering the highest total mercury content to which Ecuadorian population is exposed through the consumption of brand A, B, and C, the recommended weekly intake for children and adults were: A: 63g and 306g; B: 12g and 57g; C: 30g and 144g, respectively.

INTEGRATION OF SNI ISO/IEC 17024:2012 AND SNI ISO/IEC 17021-1:2015 STANDARDS IN IMPROVING THE QUALITY OF MANAGEMENT SYSTEMS AT PT QUANTUM HRM INTERNASIONAL

This study discusses the application of the integration of ISO 17024 and ISO 17021 standards in Improving the Quality of Management Systems at PT Quantum HRM International (QHRMI). The purpose of this study is to find out how to apply the integration of the two standards. This study uses qualitative research method with the type of research used, namely literature research or literature study or known as desk study where the researcher relies on various literature to obtain research data. The results of this study show that the implementation of ISO 17024 and ISO 17021 at QHRMI has strengthened objective, transparent, and reliable certification standards. In personnel certification, QHRMI prioritizes the principles of impartiality and integrity, supported by a structured management system and competent experts. Meanwhile, the implementation of ISO 17021 ensures that audits and certification of the management system of educational organizations are carried out professionally, in accordance with international standards and applicable regulations. Through the integration of these two standards, QHRMI has succeeded in improving operational efficiency by reducing duplication of documents, optimizing management coordination, and encouraging continuous improvement. The integration also strengthens QHRMI's reputation as a credible certification body, while increasing its competitiveness in the certification industry.

The application study of harmonization code in medical device adverse event reporting.

The reporting of adverse events in medical devices (MD) is a starting point of post-market surveillance and the most common source of initial safety signals. Because MD adverse events (AE) occur globally and involve high-profile international public health crises, international regulators implanted standard codes for MDAE reporting. This study aimed to assess the application of MDAE terminology and codes by providing examples of virtual events. An online survey was conducted among participants of the MD Training Program for Regulatory Authorities which provide International Medical Device Regulators Forum (IMDRF) adverse event terminology and codes, and six virtual MDAE cases. All 29 of the 72 participants were regulators. In all cases, most participants selected the broad (level 1) codes rather than the detailed (level 2 or level 3) codes. While responders selected a variety of codes for all annexes in case 1, over 50% of responders selected the intended codes in case 6. The codes for cause investigation were chosen more frequently than other annexes for device problem, components, and health effect. No differences were observed in code selection amongst different stakeholders. We identified the diversification in terminology and code selection for reporting MDAEs.

Presence of Potentially Toxic Elements in Historical Mining Areas in the North-Center of Mexico and Possible Bioremediation Strategies

This paper provides an overview of the impacts of mining-related environmental liabilities on humans, soils, sediments, surface water and groundwater across various mining districts in Zacatecas, Mexico. An analysis has been carried out on the areas of the state most affected by the presence of potentially toxic elements (PTEs) such as arsenic, lead, cadmium, copper, chromium and zinc, identifying priority areas for environmental assessment and remediation. Likewise, a review of the concentrations of PTEs reported in different environmental matrices of the state’s mining areas with the presence of environmental liabilities was carried out, most of which exceed the maximum permissible limits established by Mexican and international regulations, generating an environmental risk for the populations near these districts due to their potential incorporation into the food chain. Additionally, this study explores research focused on the biostabilization of PTEs using microorganisms with specific metabolic activities. Phytoremediation is presented as a viable tool for the stabilization and elimination of PTEs, in which endemic plants from arid–semi-arid climates have shown favorable results in terms of the phytostabilization and phytoextraction processes of the PTEs present in mining waste.

The challenges in the utilization of marine genetic resources in national and international jurisdictions from a legal perspective

This article examines the legal challenges associated with the utilization of marine genetic resources (MGR) at both the national level and beyond national jurisdiction (BBNJ). The legal challenges addressed are as follows: 1) MGR are located across various jurisdictions, encompassing both national and international domains. The analysis starts with an overview of the international regulations that govern the utilization of genetic resources (GR) and their influence on national legislation. It emphasizes the principle of state sovereignty over natural resources while defining MGR and determining ownership; 2) It further highlights the intersection of national and international laws, particularly in transboundary contexts and within Indigenous and Afro-descendant peoples (IADP) territories, analyzing how these regulations are interpreted and applied in such scenarios; 3) The legal challenges related to the use of MGR in international waters are examined. Special emphasis is placed on the recent United Nations (UN) Agreement concerning this issue. This includes an analysis of its impact and specific provisions related to the utilization of MGR, such as the quantity to be collected, the methodology employed, collection sites, among others. The article concludes by asserting that the equitable distribution of benefits from the use of GR should begin at the earliest stages of access to these resources, including project planning and sample collection, rather than being delayed until the patenting and commercialization phases. Early benefit-sharing is essential for promoting fairness and equity in the use of MGR.

THE ROLE AND SIGNIFICANCE OF INTERNATIONAL TRANSFER OF TECHNOLOGY IN THE CONDITIONS OF DEVELOPING THE NATIONAL ECONOMY OF THE COUNTRY

The purpose of the article is to study the theoretical and practical aspects of the development of international technology transfer. It has been established that today the latest technologies and innovations affect all spheres of the national economy. Participation in the international transfer of technologies becomes a necessary and imperative condition for the existence of any production, not only at the state level, but also at the global level. That is why state support for innovative activities, namely the promotion of research and development, affects the socio-economic development of modern society. The functioning and development of the world economic system takes place under the influence of the processes of integration and globalization, which leads to the acceleration of the movement of capital, financial and labor resources, goods and the growth of the intensity of information exchange. Due to the accumulation of scientific and technical potential in a number of economically developed countries, it is knowledge, intelligence and innovation that become the main driving force behind the success of individual companies in these countries in the global economy. Today, modern companies enter into a competitive struggle not so much for the level of development of the production structure and its volumes, as for the level of available innovations on the global technology market. Today, domestic science is on the brink of disaster, this state is explained by the economic crisis that occurred against the background of the military aggression of our northeastern "neighbor". In Ukraine until 2022, there were negative processes associated with the development of scientific and technological developments, as evidenced by numerous studies of the dynamics of the share of R&amp;D expenditures in GDP, it is obvious that in today's conditions this is an unacceptable trend and the state should make maximum efforts for practical and rapid accumulation of such a sector of the national economy as science. It has been proven that Ukraine should focus on the specifics of the development of international legal regulation and guarantees in the field of technology transfer, from the point of view of international obligations. Since even those norms of international regulations implemented in domestic legislation do not provide full guarantees for the formation and development of a transparent and fair international technology transfer.

Violation of the rights of older adults in Ecuador

The rights, exonerations, and benefits of older persons are violated by not being applied or executed, being contemplated in the Constitution of the Republic of Ecuador. The objectives are to guarantee the full exercise and exercise of the fundamental rights of older persons, which, in addition to being enshrined in the Constitution, are included in international human rights instruments and related laws. It is important to energize the rights and benefits of older adults, through workshops, lectures, forums, reaching out to neighborhood leaders. The Constitution guarantees good living, and this vulnerable group is protected not only by national regulations, but also by international regulations, so that any type of action that violates their rights is eradicated. For this reason, it is intended that topics of studies be exposed, that promote awareness in society, so that they are active entities with knowledge in the legal framework in favor of the elderly, and thus they can truly have a dignified old age and with the full enjoyment and fulfillment of its benefits.

LEGISLAÇÃO E REGULAMENTAÇÃO SOBRE A EMISSÃO DE GASES DE EFEITO ESTUFA NA NAVEGAÇÃO: ESTADO, EVOLUÇÃO E IMPACTOS NO BRASIL

This paper analyzes aspects of international and Brazilian legislation on maritime transport activities and the actions of Brazilian authorities and companies in the sector to ensure compliance with existing environmental requirements, with emphasis on the control of greenhouse gas (GHG) emissions. The paper analyzes the ongoing climate change process and international initiatives to mitigate greenhouse gas (GHG) emissions by economic activity sectors, with an emphasis on maritime transport activities in Brazil, A bibliographical research was conducted on greenhouse gas emissions through scientific articles, government websites and websites of various entities and organizations. A survey was conducted on the initiatives of companies in the sector and on the perception of shipping professionals about the state and prospects for progress in the implementation of measures to mitigate emissions on vessels. The results showed that the regional approach complements global regulations and reinforces the need for a coordinated response to address the environmental challenges posed by international shipping and that the integration of these international regulations is essential to promote sustainable practices and ensure global compliance.

Determining the usability of the ViDoc device, which integrates with smart phones, in documenting historical structures

The documentation of historical structures is considered as a crucial subject in international regulations. The accuracy and speed of documentation are among the significant factors for the qualified transmission of cultural values to future generations. In this study, the accuracy and position precision of ViDoc device, which integrates with an iPad Pro equipped with LIDAR system, have been determined. Furthermore, the advantages and disadvantages of this device have been elaborated in detail. The aim of the study is to determine whether the ViDoc device and iPad Pro can be used in documenting historical structures. The study covers the traditional method of documentation based on measurement with meter and analog devices, documentation with a total station, and documentation with the ViDoc device, using two historical fountains selected as examples. Two cultural heritage fountains located in Kastamonu province, Turkey, have been selected for documentation. Measurements of the fountains were taken using a precision meter and a laser meter in the classical method, and corner point coordinates were obtained with a total station. The measurement process was carried out in one go using a ViDoc device and a smartphone. As a result of the study, it was understood that the ViDoc device made very positive contributions to the scanning accuracy of smart devices with LIDAR sensors. When comparing the measurement values in the documentation of the structures, the accuracy precision was found to be less than 1 cm (0.7 cm), and the positioning accuracy was less than 5 cm. In the measurement conducted without using the ViDoc device, differences in position distances reached up to 79 m. This indicates that the device can be used for documentation in structures without creating disadvantages. However, it has been determined through the study that the device may not be usable for every structure. Nevertheless, the study also evaluates the device as a new alternative alongside traditional documentation, photogrammetry, and terrestrial laser scanning systems. The study is significant as it is the first to holistically determine the measurement accuracy of the device and the positioning accuracy specifically in relation to historical structures.

Circadian Alterations in Brain Metabolism Linked to Cognitive Deficits During Hepatic Ischemia-Reperfusion Injury Using [1H-13C]-NMR Metabolomics

Background: Hepatic ischemia-reperfusion injury (HIRI) is known to affect cognitive functions, with particular concern for its impact on brain metabolic dynamics. Circadian rhythms, as a crucial mechanism for internal time regulation within organisms, significantly influence metabolic processes in the brain. This study aims to explore how HIRI affects hippocampal metabolism and its circadian rhythm differences in mice, and to analyze how these changes are associated with cognitive impairments. Methods: A C57BL/6 male mouse model was used, simulating HIRI through hepatic ischemia-reperfusion surgery, with a sham operation conducted for the control group. Cognitive functions were evaluated using open field tests, Y-maze tests, and novel object recognition tests. Magnetic resonance spectroscopic imaging (MRSI) technology, combined with intravenous injection of [2-13C]-acetate and [1-13C]-glucose, was utilized to analyze metabolic changes in the hippocampus of HIRI mice at different circadian time points (Zeitgeber Time ZT0, 8:00 and ZT12, 20:00). Circadian rhythms regulate behavioral, physiological, and metabolic rhythms through transcriptional feedback loops, with ZT0 at dawn (lights on) and ZT12 at dusk (lights off). Results: HIRI mice exhibited significant cognitive impairments in behavioral tests, particularly in spatial memory and learning abilities. MRSI analysis revealed significant circadian rhythm differences in the concentration of metabolites in the hippocampus, with the enrichment concentrations of lactate, alanine, glutamate, and taurine showing different trends at ZT0 compared to ZT12, highlighting the important influence of circadian rhythms on metabolic dysregulation induced by HIRI. Conclusions: This study highlights the significant impact of HIRI on brain metabolic dynamics in mice, especially in the hippocampal area, and for the first time reveals the differences in these effects within circadian rhythms. These findings not only emphasize the association between HIRI-induced cognitive impairments and changes in brain metabolism but also point out the crucial role of circadian rhythms in this process, offering new metabolic targets and timing considerations for therapeutic strategies against HIRI-related cognitive disorders.

The Brazilian State Water Resources Councils: diagnosis of civil society participation through criteria of access to information, parity, and decision-making procedures

The aim of the article was to investigate whether the Brazilian State Water Resources Councils, including the Federal District, ensure civil society participation through access to information, parity, and decision-making procedures. In this context, verification criteria were selected, with maximum score of 1 point assigned based on their suitability for the Councils, which were classified in terms of participation adequacy. The states that were deemed suitable, in descending order, were: Paraíba (1st position), Mato Grosso do Sul, Minas Gerais, and São Paulo (2nd position), Amazonas, Pará, Paraná, Rio de Janeiro, Rio Grande do Sul, Rondônia, and Santa Catarina (3rd position), Bahia, Ceará, Federal District, Espírito Santo, and Mato Grosso (4th position), Rio Grande do Norte and Tocantins (5th position), and Alagoas (6th position). The states deemed unsuitable were: Acre and Pernambuco (7th position), Piauí and Roraima (8th position), Goiás and Sergipe (9th position), and Amapá and Maranhão (10th position). As for the criteria, the ones that scored the highest were: the presence of the website and Internal Regulations of the Councils, decision-making by the Council in plenary sessions, the presence of Meeting Minutes on the website, identification of the Technical Chambers of the Councils on these channels, adherence to the regular meeting schedule, identification of the members who make up the Councils, and parity among the three sectors that constitute them. It was concluded that the State Water Resources Councils need to ensure equal participation for civil society members in their discussions and deliberations as well as provide public access to the information generated.

Identifying and developing the roles of private business actors in international regime complexes

Abstract Business actors play increasingly important roles in global governance and international regulation. This paper considers how regime complexity influences the roles of businesses and impacts opportunities for business influence on international regulatory regimes. We conducted a scoping literature review of 243 articles from the International Regime Complexity (IRC) theory literature to explore if and how complexity affects the roles of businesses and their influence on international regulation. We found that complexity presents opportunities for businesses to regime shift and exploit knowledge asymmetry in order to influence international regulation. Further, IRC theory illustrates how the roles of businesses interact and leverage one another in order to create better opportunities for influence in specific international regulatory regimes. This paper contributes to IRC theory by building on the existing non-state actor discussions and offering specific theorization of business behavior, thus starting to bridge the gap between the empirical and theoretical understanding. Second, it contributes to existing discussions in business and politics literature by developing existing knowledge on the roles of businesses in global governance to better reflect the added dimension of complexity.

Pediatric drug regulations: A global perspective and the imperative for implementation in India

The pediatric population differs from adults in various ways, including physiological factors, pharmacokinetics, pharmacodynamics, and dosage administration. However, many medications prescribed for children are formulated for adults, necessitating dose adjustments throughout childhood. This underscores the need for pediatric drug formulations and regulations worldwide. This review delves into the intricate landscape of international pediatric drug regulations to elucidate key initiatives, challenges, and advancements shaping this field. Commencing with a historical backdrop, the review outlines the evolution of regulatory frameworks across major regions, including the United States (US), Europe, Japan, and China, while underscoring the imperative for the implementation of pediatric drug regulations in India. These regulations mandate age-appropriate dosing, rigorous clinical trials, and thorough labeling to prevent misuse. They require pediatric-specific studies to understand drug effects and dosages and enforce guidelines for off-label use. Agencies such as the US Food and Drug Administration oversee these regulations, ensuring pediatric drugs meet safety standards before approval. In addition, regulations often include provisions for informed consent and parental involvement in treatment decisions, aiming to protect children from adverse effects while providing effective therapeutic options tailored to their developmental needs. In summary, this review emphasizes the importance of global cooperation and harmonized regulations in advancing pediatric drug research. It highlights recent progress while acknowledging ongoing challenges and opportunities in this critical area.

Research on the Give-Way Ships Determination Based on Field Theory

The Convention on the International Regulations for Preventing Collisions at Sea, 1972 (COLREGs) stipulates ships’ obligations when encountering each other. However, human action remains a primary cause of collision accidents. In the complex environment of mixed navigation involving MASS and manned ships, the applicability of the COLREGs for determining the give-way ship has faced certain challenges. Therefore, this study proposes a model for determining the give-way ship, combining ship characteristics and using an asymmetric Gaussian function to construct the potential field of stand-on ships from the perspective of give-way ships. It constructs the cost function based on field theory to determine the respective avoidance costs for both ships in a crossing situation, with the ship incurring the lowest cost selected as the give-way ship, followed by a case study to validate the model. The research is dedicated to coordinating avoidance action objectively, effectively reducing maritime collisions, and providing exploratory guidance for collision avoidance decision-making in future mixed navigation environments.

Comprehensive analysis of particulate matter, gaseous pollutants, and microbiological contamination in an international chain supermarket

Indoor environmental quality is of utmost importance since urban populations spend a large proportion of their life in confined spaces. Supermarkets offer a wide range of products and services that are prone to emitting several air pollutants. This study aimed to perform a comprehensive characterisation of the indoor and outdoor air quality in a multinational supermarket, encompassing not only criteria parameters but also unregulated pollutants of concern. Monitoring included measurements of comfort parameters, CO2, multiple gaseous pollutants, particulate matter (PM10) and bioburden. PM10, volatile organic compounds (VOCs) and carbonyls were subject to chemical speciation. Globally, the supermarket presented CO2, VOCs, and PM10 values below the limits imposed by international regulations. The PM10 concentration in the supermarket was 33.5±23.2 μg/m3, and the indoor-to-outdoor PM10 ratio was 1.76. Carbonaceous constituents represented PM10 mass fractions of 21.6% indoors and 15.3% outdoors. Due to the use of stainless-steel utensils, flour and fermentation processes, the bakery proved to be a pollution hotspot, presenting the highest concentrations of PM10 (73.1±9.16 μg/m3), PM10-bound elements (S, Cl, K, Ca, Ti, and Cr) and acetaldehyde (42.7 μg/m3). The maximum tetrachloroethylene level (130 μg/m3) was obtained in the cleaning products section. The highest values of colony-forming units of bacteria and fungi were recorded in the bakery, and fruit and vegetable section. The most prevalent fungal species was Penicillium sp., corresponding to 56.9% of the total colonies. In addition, other fungal species/sections with toxicological or pathogenic potential were detected (Aspergillus sections Aspergilli, Circumdati, Flavi, Mucor and Fusarium sp.).

In vitro hepatic 3D cell models and their application in genetic toxicology: a systematic review

The rapid development of new chemicals and consumer products has raised concerns about their potential genotoxic effects on human health, including DNA damage leading to serious diseases. For such new chemicals and pharmaceutical products, international regulations require genotoxicity data, initially obtained through in vitro tests, followed by in vivo experiments, if needed. Traditionally, laboratory animals have been used for this purpose, however, they are costly, ethically problematic, and often unreliable due to species differences. Therefore, innovative more accurate in vitro testing approaches are rapidly being developed to replace, refine and reduce (3R) the use of animals for experimental purposes and to improve the relevance for humans in toxicology studies. One of such innovative approaches are in vitro three-dimensional (3D) cell models, which are already being highlighted as superior alternatives to the two-dimensional (2D) cell cultures that are traditionally used as in vitro models for the safety testing of chemicals and pharmaceuticals. 3D cell models provide physiologically relevant information and more predictive data for in vivo conditions. In the review article, we provide a comprehensive overview of 3D hepatic cell models, including HepG2, HepG2/C3A, HepaRG, human primary hepatocytes, and iPSC-derived hepatocytes, and their application in the field of genotoxicology. Through a detailed literature analysis, we identified 31 studies conducted between 2007 and April 2024 that used a variety of standard methods, such as the comet assay, the micronucleus assay, and the γH2AX assay, as well as new methodological approaches, including toxicogenomics, to assess the cytotoxic and genotoxic activity of chemicals, nanoparticles and natural toxins. Based on our search, we can conclude that the use of in vitro 3D cell models for genotoxicity testing has been increasing over the years and that 3D cell models have an even greater potential for future implementation and further refinement in genetic toxicology and risk assessment.