Journal articles on the topic 'A systematic approach to identify and control potential risks during the production process'

<strong>PROSPECTS FOR IMPROVING THE RISK MANAGEMENT SYSTEM IN FOOD PRODUCTION</strong> <strong>I. Introduction</strong> In recent еars, the food industry has become increasingly complex, with products being produced and distributed across various regions of the world. This complexity has led to a greater need for quality systems that prioritize risk management and safety in food production. Effective quality systems can help food enterprises ensure that their products meet the highest standards for safety, quality, and consistency. In order to achieve these goals, food enterprises should incorporate risk management into their quality systems, taking into account the various risks associated with food production and distribution. By identifying potential hazards and developing strategies to mitigate these risks, food enterprises can reduce the likelihood of food contamination, foodborne illnesses, and other safety concerns. Thus, the improvement of quality systems based on risk management is essential to the success and sustainability of modern food enterprises. <strong>- Brief overview of risk management in food enterprises</strong> Food enterprises are faced with a plethora of risks that threaten food safety, quality, and brand reputation. Risk management, therefore, is a fundamental aspect of food enterprise operations aimed at identifying, assessing, and prioritizing risks. The goal of risk management in food enterprises is to prevent or minimize the likelihood or impact of negative events by developing and implementing proactive risk management plans. This involves a systematic and scientific approach to identifying potential hazards and implementing preventive measures throughout the food supply chain. Common risk management measures in food enterprises include hazard analysis and critical control points (HACCP), quality assurance and control systems, traceability and recall systems, food defense and security systems, and regulatory compliance. Effective risk management in food enterprises requires a deep understanding of the complex relationships among environmental, technological, economic, and social factors that influence the food system. <strong>- Importance of improving the quality system based on risk management</strong> In conclusion, the importance of improving the quality system based on risk management cannot be overstated. Food enterprises must understand that they are not only responsible for the production of safe, high-quality products but also liable for any damage or harm caused to consumers. A risk-based approach provides a structured and systematic process for identifying, assessing, and controlling potential hazards to food safety. It enables food enterprises to prioritize hazards and allocate resources accordingly. The adoption of risk-based principles can also help food enterprises save money by reducing wastage and improving productivity. Risk management is not a one-time event; it is an ongoing process that requires continual improvement and evaluation. Therefore, food enterprises must strive to promote a culture of risk awareness and encourage employees at all levels to participate actively in the identification and management of risks. This will ensure that risks are minimized, and the quality and safety of food products are maximized. Another aspect that should be considered when implementing a quality system based on risk management is the communication of risks and responsibilities within the company. It is important that all employees understand the risks involved in the production process, as well as their responsibility in mitigating those risks. This requires an effective communication plan that ensures that all employees receive the same level of information and training on risk management. In addition, it is important that there are clear lines of responsibility for risk management within the company. This means that each employee should know their role in identifying and mitigating risks, and that there is a clear chain of command for reporting and escalating risks to senior management. By having a well-designed communication and responsibility framework, food enterprises can ensure that all employees are working towards the same goal of producing high-quality and safe products for consumers. <strong>II. The basics of risk management in food enterprises</strong> Risk management is a crucial process in any food enterprise, as it requires constant monitoring and assessment of potential hazards and risks. The basic steps in risk management include risk identification, risk analysis, risk assessment, and risk control. In the identification stage, all potential hazards and risks related to food safety are identified, while in the analysis stage, the likelihood of these risks occurring and the severity of their consequences are analyzed. The assessment stage involves determining the level of risk associated with the identified hazard, which aids in prioritizing mitigation efforts. The final stage of risk management involves risk control measures, which aim to reduce the hazard, minimize the likelihood of the risks identified, or reduce their impact if they occur. By following these basics of risk management, food enterprises can ensure food safety, promote consumer confidence, and meet regulatory requirements. <strong>- Definition of risk management</strong> Risk management is a systematic process of identifying, assessing, and prioritizing potential risks, followed by developing and implementing strategies to mitigate or prevent them. It involves a coordinated set of procedures, policies, and practices aimed at reducing the possibility of harm and minimizing losses associated with adverse events. The ultimate goal of risk management is to support decision-making by providing a comprehensive picture of the risks a business may face. In food enterprises, risk management strategies may include implementing hazard analysis critical control points (HACCP), regular inspection of facilities and products, quality assurance measures, and training programs for staff. Overall, risk management is an essential component of any effective quality management system, as it enables organizations to identify and preempt potential problems, safeguard their customers' health and safety, and safeguard the organization's reputation and financial stability. &nbsp;

The materials of this scientific article consider the possibility of using a virtual laboratory stand during the laboratory work carried out by students of higher education institutions under the name «Measurement of the resistance to the spread of the current of grounding devices, the specific resistance of the soil, the insulation of networks and electrical installations». This laboratory work is included in the curriculum of the normative educational component «Occupational safety in the industry and civil protection». The article examines the specific advantages of using a virtual stand, in particular its role in improving the quality of the educational process, expanding access to resources, and optimizing educational costs. The purpose of this article is to consider the main possibilities of using the proposed virtual laboratory stand as an innovative approach in the study of complex technical processes and ensuring a high level of training during laboratory work on the topic «Measurement of resistance to the spread of current of grounding devices, soil resistivity, insulation of networks and electrical installations». This laboratory work is a component of the curriculum of the normative educational component aimed at forming in students the ability to identify, analyze and evaluate potential risks associated with the production environment, and which is entitled «Occupational Safety and Civil Protection». Particular attention is paid to the methodology of conducting laboratory work using a virtual stand, including steps for configuring the software, algorithms for performing measurements and analyzing the received data. Methods of simulating various measurement conditions are described in detail, allowing students to practice scenarios that would be difficult or dangerous to implement in real conditions. In the materials of the article, an overview of the interface and functionality of the developed computer program, which reproduces the control components of real laboratory equipment and is intended for the implementation of the functions of a virtual laboratory stand, is reviewed, the key capabilities of the proposed program are described, including the simulation of various laboratory scenarios and the availability of theoretical materials necessary for preparing and conducting a laboratory session, as well as a detailed reproduction of the appearance and control components of real experimental laboratory equipment, which contributes to the creation of a feeling of working with physical devices, the implementation of mathematical models that accurately describe the dependence of output parameters on input parameters. It was also found that the use of similar technologies during other laboratory works from the above-mentioned normative educational component requires further thorough systematic research and publication of their results.

Occupational Safety and Health (K3) is a critical aspect in the rice production industry, which is often ignored, due to non-compliance with K3 standards, various problems have been identified. Meanwhile, the HIRADC (Hazard Identification, Risk Assessment, and Determining Controls) method is an important tool in occupational safety and health management that is used to identify hazards, assess risks, and determine appropriate control measures. This research aims to provide a brief explanation regarding the application of the HIRADC method in industrial work environments. The HIRADC process includes three main stages: hazard identification, risk assessment, and control determination. Hazard identification is carried out to identify potential causes of injury or loss. A risk assessment assesses the frequency and impact of each identified hazard, while a control determination focuses on implementing measures to eliminate or reduce the risk. The research results show that the systematic application of the HIRADC method can improve work safety and reduce the incidence of work-related accidents and illnesses. In conclusion, HIRADC is an effective method that can be integrated in a safety management system to create a safer work environment. This research aims to identify hazards, assess risks, and determine control measures in the flour production process using the HIRADC (Hazard Identification, Risk Assessment, and Determining Controls) method. This method is applied at several stages of flour production in industry, from milling to packaging. In this research, the method of direct observation was used during the testing process. The research results show that some of the main hazards identified include exposure to flour dust which can cause respiratory problems, the risk of fire and explosion due to flammable dust, and physical injury from grinding machines. The risk assessment indicates that these risks have a high probability and serious impact on worker health and safety. As control measures, it is recommended to use an effective ventilation system, implement safe machine operating procedures, and provide personal protective equipment (PPE) such as masks and ear protectors. Systematic implementation of the HIRADC method has been proven to increase work safety and reduce accident incidents in flour mills. In conclusion, HIRADC is an effective tool in managing occupational safety and health risks in the flour production industry.

This study aims to identify hazards and potential risks at each stage of coffee milk beverage production through a combined approach of HACCP (Hazard Analysis and Critical Control Points) and FMEA (Failure Mode and Effects Analysis). It proposes risk control measures and determines the production process's CCPs (Critical Control Points). The analysis of the production process categorizes it into five parts: “Raw Materials and Auxiliary Materials Inspection”, “Preprocessing of Coffee Milk Beverages”, “Post-Processing of Coffee Milk Beverages”, “Physical Hazard Detection”, and “Allergen Hazard Prevention.” Through the CCP decision tree and RPN value calculation, hazards, including physical, chemical, biological, and allergenic hazards, were accurately identified. The results show seven CCPs in coffee milk beverage production. First, chemical hazards from pesticide residues, heavy metal contamination, and excessive food additives during raw material acceptance and mixing. Second, biological hazards from mycotoxins and pathogenic bacteria during roasting and sterilization. Third, physical hazards from metal and plastic residues and allergenic hazards from allergens during processing and packaging. Finally, the study presents specific prevention and corrective plans using HACCP teams and planning charts, effectively reducing production risks and ensuring product quality and consumer safety.

Quality is a crucial element in maintaining competitiveness within the manufacturing industry, especially in high-demand and globally competitive sectors, such as the production of plastic straws. Consistently meeting quality standards is essential for ensuring customer satisfaction, minimizing waste, and improving production efficiency. Inconsistent quality can lead to increased production costs, loss of customer trust, and reduced market competitiveness. This study examines quality control in the plastic straw production process at PT. XYZ by using the Six Sigma approach, specifically applying the DMAIC method. The research addresses recurring quality issues in the form of product defects that exceed the company’s 1% maximum allowable reject rate, particularly in the wrapping process. In the Define phase, the wrapping process was identified as the Critical to Quality (CTQ) point contributing most significantly to overall defects. The Measure phase revealed a Defects Per Million Opportunities (DPMO) of 2,558.08 and an average sigma level of 4.3, showing a process with moderate capability. The Analyze phase used a Fishbone diagram to identify root causes of defects across five main factors: man, machine, method, material, and environment. The Improve phase applied Failure Mode and Effects Analysis (FMEA) to prioritize risks and suggest corrective actions based on their Risk Priority Number (RPN) values. The findings highlight that systematic analysis using Six Sigma tools effectively identifies critical quality problems and proposes targeted improvement strategies. Moreover, the results propose actionable recommendations focused on supplier quality, machine maintenance, operator training, and component reliability to address defects that occur during the wrapping process

Occupational health and safety (OHS) issues in the oil and gas industry are critical factors that influence worker safety and the operational continuity of companies. The oil and gas industry is known for its high-risk environment, which involves hazardous chemicals, high pressures, extreme temperatures, and the potential for accidents that can harm the environment. One of the high-risk activities in this industry is the catalyst replacement process in the butane treater, which is crucial for removing impurities from butane during gas processing. This process carries significant hazards, such as exposure to hazardous chemicals, fire, and explosion. This study aims to identify and analyze the OHS risks associated with the catalyst replacement process in the butane treater and to develop mitigation recommendations that can be implemented to minimize hazards and improve worker safety.The method used in this study is the Hazard Identification, Risk Assessment, and Determining Control (HIRADC) method, a systematic approach for identifying hazards, assessing risks, and determining appropriate control measures. This method allows for comprehensive hazard identification and risk mapping based on the probability and impact levels, enabling the proposal of effective mitigation actions. The study analyzes potential hazards that may arise during the catalyst replacement process and the mitigation procedures to reduce these risks.The results of the study show that the catalyst replacement process in the butane treater involves several key risks, such as exposure to hazardous gases, fire, explosion, and risks associated with improper work procedures. Proposed mitigations include enhancing standard operating procedures, safety training, the use of personal protective equipment (PPE), and the implementation of technical controls such as ventilation systems and equipment safety measures. By applying these recommendations, it is expected that the risk of accidents can be minimized, and worker safety can be better maintained.Top of Form

The article discusses various approaches to creating a sustainable safety system, highlighting the important role of new technologies implementing, personnel training and strict adherence to safety regulations. Due to rapidly changing industrial environment, organizations realize that a proactive approach to safety is critical to minimizing risks and ensuring business continuity. This type of approach will not only prevent accidents and incidents, but also create a safety culture. The article focuses on the need to monitor key elements of the safety system and continuously evaluate the process to proactively eliminate potential risks. This is both a means of ensuring compliance with safety regulations and an opportunity to identify areas for improvement of existing practices. One of the critical points emphasized in the article is the need to monitor the condition of structural welded steels during repairs that have reached their expiration dates, as well as during the installation of new steel elements. This aspect is essential to ensure that all materials used in construction strictly comply with safety standards, thereby preventing failures that can lead to catastrophic events. Implementation of modern monitoring systems can provide real-time data on the integrity and performance of equipment, allowing for timely intervention when necessary. Comprehensive recommendations are presented to optimize management and control practices in organizations. These strategies include promoting a safety culture by ongoing education and training programs aimed at personnel at all levels. By equipping employees with the necessary skills and knowledge, organizations can significantly improve overall safety performance and promote a shared commitment to safety among all personnel. Implementation of innovative technologies, such as automated monitoring systems, can optimize operations and facilitate more effective decision-making processes. It is emphasized that a comprehensive strategy for managing high-risk facilities should include technological advances, serious training, and a commitment to regulatory compliance. Such a comprehensive approach will not only improve safety performance, but will also contribute to the long-term sustainability of the organization, providing a safer working environment for all employees.

The concept of Hazard Analysis and Critical Control Points (HACCP) is a systematic approach that aims to analyze all stages of production in a preventive way, identifying, evaluating and controlling the hazards that are significant for food safety, thus creating a consumer health protection mechanism. This article presents the importance and implementation of the HACCP system in a potatos chips industry with a batch process. During the experiment, the layout, the flowchart and all stages of the process were observed, from the reception of raw materials to the shipment, followed by the application of the decision tree theory in each of the stages, defining the critical control points.The result of the implementation of the HACCP system made it possible to identify the steps that present a risk of danger to the product, define the critical control points and how to control them, increasing the reliability and safety of the company for potential customers, in addition to guaranteeing the health of consumers.

Purpose – Due to the warming at the automotive market in the last years and consequently the growth of vehicle production has been moved and placed emphasis on the segment. In recent years, some have known, for example, as the earthquake that struck Japan in 2011 was able to disrupt the suppliers of the country. Due to these events, supply chain risk management has become essential to the supply chain operations success. The purpose of this paper is to evaluate the supplier’s systematic selection at the automotive industry compared with the identified models in the literature. Design/methodology/approach – A case study applied at the automotive to propose a method for selecting suppliers considering the risk management. Findings – These results indicate that the organization has established criteria for suppliers selection, this systematic aims to identify the potential risks in the supply chain before the supplier award the project but it’s also the current practice can be improved using as reference the comparative method as applied in this study. Originality/value – The risk management, a few discussed topic but on the rise among researches, show that the companies, especially those inserted in the automotive segment has been used different techniques for selecting suppliers to focus in a better supply chain control. Establish criteria for selecting suppliers means identifying in advanced the potential risks that the suppliers may offer to the organization during the supply to avoid any interruptions to supply.

<em>The object of research is welded structures and their production.</em> <em>There is always a risk, but it is obvious that making decisions to minimize and eliminate it requires a structured and systematic approach. For example, top, middle and line managers need to constantly analyze the risks associated with the dangers that arise in very difficult situations in the welding industry.</em> <em>An algorithm for the formation of risk during the operation of welded structures is constructed. A process approach is proposed with the aim of analyzing deviations in the design, production and maintenance processes. The parameters of the ultimate state of the welded structure from mechanical stresses and the quality indicators of corrosion effects are determined. The calculated formulas for the speed (probability) of reaching limit states from mechanical stresses are selected. To analyze the combination of actions, it is recommended to use the Bayesian grid method. It has been established that one of the main tasks of the welding production quality management system according to DSTU ISO 9001:2015 is to ensure the identification of potential inconsistencies in the welding production system and to prevent their detection through risk management. Deviations of the processes of the management system are the reasons for the formation of a shortage of products and the risk of an emergency at work. The success of risk management will depend on the effectiveness of the management structure, which provides the rationale and measures that integrate it throughout the welding plant at all levels. The structure helps to implement effective risk management through the production of risk management processes and non-destructive testing and technical diagnostics at different levels and within the specific context of the enterprise. The structure ensures that the risk information obtained in the risk management process appropriately is used as the basis for making decisions and appointing those responsible for the result at all relevant levels of welding production.</em>

Background: The flexible packaging industry is experiencing significant growth, requiring companies to improve efficiency by reducing defects and minimizing the cost of poor quality (COPQ). Effective quality control is crucial to maintaining competitiveness and reducing waste. This study focuses on assessing and improving quality control in an Indonesian flexible packaging company, XYZ, using the Six Sigma methodology. Methods: The research adopts the Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control) approach to identify defects and propose solutions. Data collection includes statistical analysis, historical records, and interviews with company sources. The study specifically examines defects in the printing process, which accounts for 79% of total defects based on the 80/20 principle. The Failure Mode and Effects Analysis (FMEA) model is applied to identify root causes and develop recommendations for improvement. Findings: The study identifies multiple factors contributing to printing defects, such as register shifting, film scratching, color inconsistencies, ink transfer issues, and ink spots. Operator performance and machine-related issues are found to be the dominant causes of defects. Implementing the recommended quality control improvements can potentially reduce defect-related costs by 48%, translating to estimated cost savings of IDR 114,734,847 during the study period. Conclusion: This research confirms the effectiveness of Six Sigma in reducing defects and improving production efficiency in the flexible packaging industry. However, limitations include restricted access to ERP data, reliance on interviews and historical records, and the inability to evaluate the implementation of control measures. Novelty/Originality of this article: This study contributes to the literature by applying Six Sigma in a flexible packaging industry context in Indonesia, demonstrating its potential for substantial cost savings. Unlike previous studies, it emphasizes the human factor in quality control and suggests a systematic approach to defect reduction.

At the stages of pharmaceutical development, production and use of a medicinal product, including its components, there is necessarily a certain degree of risk. An effective approach to quality risk management can further guarantee the patient high quality of the medicinal product by establishing preventive measures to identify and control possible quality issues during pharmaceutical development and production.&#x0D; At the beginning of the pharmaceutical development process, a general risk assessment is performed and it is repeated as information and knowledge deepen, because the medicinal product (MP) must be developed in such a way as to satisfy the needs of patients and perform the intended function. The use of scientific knowledge and risk assessment methodology at the FR stage allows planning the quality of the drug and the production process, which is primarily aimed at protecting the patient himself.&#x0D; The purpose of the work is to develop the composition (formulation) of the drug based on diclofenac sodium in the form of an injection solution at a concentration of 25 mg/ml, taking into account the justified risks.&#x0D; The object of the study is MP Diclofenac sodium, a solution for injections, as well as potential risk factors that can affect the quality of the medicinal product at the stage of developing the composition of the drug.&#x0D; The work uses informative and empirical methods of research by studying, summarizing and comparing documentary data.&#x0D; On the basis of the CPI analysis, the critical quality indicators (CPI) of the drug Diclofenac sodium, solution for injection, 25 mg/ml were determined.&#x0D; Taking into account the justified risks, the formulation of the drug based on diclofenac sodium was carried out. The target quality profile is selected, on the basis of which the critical quality indicators of the finished product are determined. Grounded critical quality indicators of the finished product at the formulation stage. An assessment of the risks of the variability of the formulation was carried out, taking into account the properties of the active pharmaceutical ingredient diclofenac sodium, as well as for all auxiliary substances included in the composition of the medicinal product.

Increasing demand of oil in Indonesia is in contrast with the decreasing oil production every year. Enhanced oil recovery (EOR) has become one of the most favorable method in maximizing the production of mature fields with various applications and research has been done on each type, especially microbial EOR (MEOR). “X” field is a mature oil field located in South Sumatra that has been actively producing for more than 80 years and currently implementing MEOR using huff and puff injection. However, there are some potential risks regarding MEOR processes that may inhibit the production by damaging the well’s tubular system, particularly microbially induced corrosion (MIC). This study reviews the risk mitigation and mapping to prevent corrosion on tubular system during MEOR huff and puff processes, equipped with the approach of Lean Six Sigma.The mitigation and mapping process follow the framework of define, measure, analyze, improve, and control (DMAIC). It starts with defining the problem using supplier-input-process-output-customer (SIPOC) diagram after all the field data necessary has already been collected, then measuring the corrosion rate model using ECE™ software as well as conducting sensitivity analysis of the fluid rates. The analyze phase involves constructing fishbone diagram to identify the root causes, comparison with industry’s specification and standard, and analysis of chromium effect on corrosion rates. Further simulation is conducted to support the analysis and to ensure the improvements and sustainability of the design selection.Based on the simulation results, the normal corrosion rate ranging from 0.0348 – 0.039 mm/year and the pH is around 4.03 – 5.25, while the ±30% fluid rate sensitivity results shown that the change of water flowrate is more sensitive than oil flowrate with the corrosion rate approximately 0.0275 – 0.048 mm/year. The fishbone diagram identifies that material selection and environmental condition as the main root causes, then corrosion resistant alloy (CRA) is used in the tubing string to prevent corrosion in the future by using super 13Cr martensitic steel (modified 2Ni-5Mo-13Cr) as the most suitable material. Further simulation on chromium content supports the selection that corrosion rate can be reduced by adding the chromium content in the steel. The completion design is then capped with choosing the Aflas® 100S/100H fluoro-elastomer as the optimum material for packer and sealing. Overall, the Lean Six Sigma approach has been successfully applied to help the analysis in this study.

Purpose A substantial number of production assets in the offshore oil and gas industry are facing operation beyond their anticipated design life, thus necessitating a service life extension program in the future. Selection of the most suitable strategy among a wide range of potential options to extend the lifetime of equipment (e.g. re-using, reconditioning, remanufacturing, refurbishing and adding on safety/process control measures) remains a challenging task that involves several technical, economic and organizational complexities. In order to tackle this challenge, it is crucial to develop analytical tools and methods capable of evaluating and prioritizing end-of-life strategies with respect to their associated costs and quantifiable benefits. The paper aims to discuss these issues. Design/methodology/approach This paper presents a life-cycle cost-benefit analysis approach to identify the most suitable life extension strategy for ageing offshore assets by taking into account all the capital, installation, operational, maintenance and risk expenditures during the extended phase of operation. The potential of the proposed methodology is demonstrated through a case study involving a three-phase separator vessel which was constructed in the mid-1970s. Findings The results from the application case indicate that the capital expenditure (CapEx) accounts for the largest portion of life cycle cost for the replacement strategy, while risk expenditure (RiskEx) is the major contributor to costs associated with life extension. A sensitivity analysis is also conducted to identify factors having the greatest impact on the optimum life extension solution, including oil price, production rate and money interest rate. Practical implications In the past, the decisions about life extension or replacement of in-service equipment were often made in a qualitative way based on experience and judgment of engineers and inspectors. This study presents a “quantitative” framework to evaluate and compare the costs, benefits and risks associated with life extension strategies and subsequently to select the best strategy based on benefit/cost ratios. Originality/value To the best of authors’ knowledge, no studies before have applied life cycle assessment and cost-benefit analysis methods to prioritize the potential life extension strategies in the oil and gas industry sector. The proposed approach not only assists decision makers in selecting the most suitable life extension strategy but also helps duty holders reduce the costs corresponding to life extension execution.

The development of optimal technology for collecting and drying raw materials of Semenov's sweetvetch (Hedysarum semenowii Regel &amp; Herder) ensures the preservation of pharmacological properties, quality consistency, increased efficiency, and environmental sustainability. This process requires consideration of the influence of a large number of different factors and their assessment. The inclusion of the concept “Quality by Design” (QbD) in the development process, which focuses on obtaining finished products with multi-factor quality risks, can facilitate and enable improvements. The application of QbD provides a systematic, risk-reducing, efficient structure that helps support continuous process improvement. The aim is the development of technology for collecting and drying Hedysarum semenowii Regel &amp; Herder medicinal plant materials of pharmacopoeial quality using the “Quality by Design” concept. Materials and methods. The research materials were plant parts from Semenov's sweetvetch: aerial parts collected during the flowering period and roots collected at the end of fruiting. All collected plant specimens were identified by employees of the RSE REM “Institute of Botany and Phytointroduction”. According to QbD principles, to create a Design Space (DSp) of the process of obtaining herbal materials of Semenov's sweetvetch, Minitab statistical software was used. Results and discussion. Introduction of QbD principles in the development of a method for the procurement of H. semenowii herbalmaterials – H. semenowii aerial parts and H. semenowii roots – made it possible to develop the most optimal drying method. By adhering to best practices of the Good agricultural and collection practices for medicinal plants (GACP) and using Minitab statistical software, the relationship between quality and critical process parameters such as temperature and drying time was determined. This approach facilitated the determination of DSp, ensuring controlled and high-quality implementation of the technological process. Conclusion. Integration of the QbD concept into the development of technology for collecting and drying Semenov’s sweetvetch herbal materials has proven its effectiveness. The defined DSp, generated taking into account optimal process parameters, lays the foundation for a controlled and reproducible production process. This study demonstrates the potential of QbD to improve quality, efficiency, and control in herbal medicine development.

This article, written by JPT Technology Editor Chris Carpenter, contains highlights of paper SPE 202254, “Flow-Assurance Challenges for China’s First Deepwater Gasfield Development in South China Sea,” by Lawrence Khin Leong Lau, Kun An, and Xian Di Tang, CNOOC, et al., prepared for the 2020 SPE Asia Pacific Oil and Gas Conference and Exhibition, originally scheduled to be held in Perth, Australia, 20–22 October. The paper has not been peer reviewed. The complete paper describes the key flow-assurance challenges for a deepwater gasfield development in the South China Sea and the considerations and steps taken to achieve an overall flow-assurance-management strategy. The discussion covers early-stage feasibility studies through the stage of project execution at the time of writing. In addition, flow-assurance analysis is highlighted as a key input for startup and commissioning guidelines as well as operating procedures. Project Background This gasfield development consists of a semisubmersible more than 100 km offshore in the South China Sea. The water depth is approximately 1500 m, with a minimum seabed temperature of less than 4°C. The design incorporates Eastern and Western production loops spanning more than 40 km of the subsea production system (SPS) in total. Line size for the Eastern and the Western production loops are selected according to the total of production wells located in respective areas. The entire production system, including topsides facilities, subsea flowlines, risers, and other key SPS elements such as subsea manifolds, is designed with potential future development tie-ins in mind. Long subsea tiebacks, coupled with typical deepwater characteristics, require a robust flow-assurance- management strategy. A dedicated flow-assurance team was assembled across sectors such as subsurface, drilling and completion (D&amp;C); subsea umbilicals, risers, and flowlines (SURF); control and instrumentation; and topsides process engineering. During the feasibility-study stage, more than 10 deepwater subsea production wells were grouped by characteristics. Analysis was performed for the most-representative wells selected from each group during this development stage to determine the range of the operating envelope and to identify all related risks. As development progressed into the detailed engineering-design stage, a detailed flow-assurance-scope analysis was completed for each well to ensure full coverage. This analysis considered scenarios including well unloading, well testing, precommissioning, first gas, steady-state production, planned and unplanned shutdowns, and hot and cold restarts. Any risks identified were assigned mitigation strategies and then were incorporated into design philosophy and operating guidelines or were specifically detailed in operating procedures. Primary Flow-Assurance Challenges Region-Specific Flow-Assurance Challenges. Flow Assurance as an Independent and Integrated Discipline. The creation of a cross-disciplinary flow-assurance team differs significantly from previous management approaches in which flow-assurance scopes were embedded in different disciplines and managed separately by teams such as subsurface, D&amp;C, SURF, and topsides. The team described in the paper had the goal of implementing flow-assurance design and strategy with a truly integrated approach to maximize efficiency, optimize costs, and minimize impact on the environment.

Introduction. The article presents modern conceptual approaches to the features of financial controlling and its importance for increasing the competitiveness of modern enterprises. New scientific approaches to strategic financial controlling are considered. It is determined that financial controlling is an effective system of interrelation, which is coordinated at the tactical and strategic levels, between financial planning, control and financial analysis. The factors which timely reveal deviations of actual results of activity of the enterprise from the provided thereby promote acceptance of certain administrative decisions providing economic safety of the enterprise are analyzed. The views of well-known scientists and financiers on the interpretation of the concept of "controlling" are presented. Purpose. The purpose of this study is to identify and study key concepts of financial controlling, which are based on the concept of integrated control and planning tools; the concept of using cash flows; concepts of production, service, and sales; the concept of the basics of strategic management decisions, as well as the concept that takes into account the peculiarities of the enterprise. Results. It is established that financial controlling, which is implemented at the strategic level, requires the introduction of such a system that would ensure high efficiency of the enterprise in the long run. In addition, the level of financial potential and quality of financial management of the enterprise requires the presence of such an element that would provide the company with affordable and cheap financial resources with a minimum level of risk with maximum efficiency. Positive experience of developed countries in the field of financial controlling policy has been formed, which should become a guideline in reforming domestic enterprise development policy and should be aimed at ensuring the growth of a sufficient level of their competitiveness. It is concluded that the study of conceptual approaches to the formation of strategic financial controlling is the basis for the emergence of new concepts to ensure the relationship between parts of the overall management system, based on the analysis of growth factors to identify problems before the crisis. Research in this direction will deepen the theoretical and methodological tools for modeling strategic financial controlling in the system of modern management. The urgency of the topic is due to the fact that controlling should provide on the basis of increasing the value of the enterprise and maintaining profitability, strategic goals of its business. This determines and emphasizes the relevance of the researched issues that arise in the work. Given the strategic direction of Ukraine's foreign economic course and broad integration into the world community, it is important to study the basic principles of organization and functioning of financial and economic security of the enterprise to improve its efficiency, which will provide modern information and technical systems for effective management decisions. Сontrolling forms ways to ensure financial stability, strategic development, creating competitiveness of the enterprise. In addition, many of the company's risks are not properly assessed, including cybercrime and fraudulent access to credit. That is why, in our opinion, due to the introduction of anti-crisis instruments of financial controlling, it is possible to ensure financial stability and stability of the enterprise. Controlling is an approach in management that is based on management, planning, analysis, marketing and control. However, it is just a management system, it is a system of achieving the maximum ultimate goals of the enterprise. Thus, strategic financial controlling, which focuses on the operational orientation of the organization, integrates all types of information, the priority of which is the constant increase in the value of the company in the market. Conclusions. As practice shows, controlling in recent years is one of the main directions of development of financial departments of both real sector enterprises and financial organizations. The need for anti-crisis controlling is obvious during the crisis, as this function helps to successfully implement the business strategy. In times of crisis, a fairly serious integrated corporate system is important, which would take into account all the conditions of production, help identify "bottlenecks" and make quick decisions. We believe that the introduction of anti-crisis controlling system in enterprises will provide an opportunity to: improve the quality of management decisions in conditions of market instability; monitor changes in the external and internal environment of the enterprise; generate relevant information for management decisions; integrate different types of management activities; increase the flexibility of the enterprise. Strategic controlling is aimed at forecasting and preventing negative situations in the future. Its purpose is to create a management system that would contribute to the sustainable state of the enterprise and ensure the creation of competitive advantages in the long run through the formation of internal reserves. The components of strategic controlling are strategic planning, strategic analysis, strategic control. To develop a strategic plan for enterprise development, it is necessary to determine the current state of the enterprise: to do this, conduct a strategic analysis of the entire enterprise, as well as its individual units and activities. The result of the analysis is the formation of enterprise development strategy. Strategic analysis and control should contribute to the implementation of the strategic plan of enterprise development. In real conditions of operation of the enterprise, strategic and operational controlling are closely interrelated in the process of implementing management functions. Controlling acts as a chain that connects the management system and organizational and information support of a particular economic system. The practical application of controlling tools helps to improve the management system and improve the economic stability of the enterprise/

ABSTRACT&#x0D; Finger millet (Eleusine coracana (L) commonly known as ragi is an important crop used for food, forage and industrial products. Finger millet has a wide ecological and geographical adaptability and resilience to various agro-climatic adversities hence, it is highly suited to drought condition and marginal land and requires low external input in cultivation.. Farmers participatory field demonstrations of ragi variety Arjun and Bhairabi were conducted at two villages ie Pedawada of Malkangiri block and MPV -1 of Kalimela block of Malkangiri district, comprising 40 farmers in cluster approach in Kharif 2018 and 2019 , by Krishi Vigyan Kendra, Malkangiri , in South Eastern Ghat Zone of Odisha . Conducting front line demonstrations on farmer’s field help to identify the constraints and potential of the finger millet in the specific area as well as it helps in improving the economic and social status of the farmers. Observation on growth and yield parameters were taken and economic analysis was done. The final seed yield was recorded at the time of harvest and the gross return in (Rs ha -1) was calculated based on prevailing market prices. The results from the demonstration conclusively proved that finger millet variety Arjun (OEB-526) recorded the higher yield ( 18.8 q ha-1) , followed by Bhairabi ( 15.3 q ha-1) and farmer’s traditional variety Nali Mandia ( Dasaraberi) recorded an average yield of (8.6 q ha-1 ) . HYV Finger millet variety Arjun with proper nutrient management and plant protection measures gave 118 % higher over farmer’s practices. The technological and extension gap was 1.9 q ha-1 and 12.07 q ha-1 respectively. Similarly, technological index was 8.2 percent. The benefit cost ratio was 2.4 and 1.9 in case of Arjun and Bhairabi respectively and in case of farmer’s variety Nali Mandia it was 1.4. Hence the existing local finger millet variety can be replaced by HYV Arjun ans Bhairabi , since it fits good to the existing rainfed farming situation for higher productivity. By conducting front line demonstrations on millet on large scale in farmer’s field, yield potential of finger millet can be enhanced largely which will increase in the income level of farmers and improve the livelihood condition of the farming community.&#x0D; Introduction&#x0D; Among small millets, finger millet (Elusine coracana L,) locally known as Ragi/Mandia is the most important crop grown in tribal districts of Odisha and it is the staple food of the tribals. It was originated about 5000 years ago in east Africa (possibly Ethiopia) and was introduced into India, 3000 years ago (Upadhyaya et al., 2006) and it is highly suited to drought condition and marginal land and requires low external input in cultivation. Millet is a collective term referring to a number of small seeded annual grasses that are cultivated as grain crops, primarily on marginal lands in dry areas in temperate, subtropical and tropical regions (Baker, 1996). Nutritionally finger millet is superior to major cereal crops and rich source of micronutrients such as calcium, phosphorous, magnesium and iron. And it has several health benefits. Finger millet grains contain higher amount of proteins, oils and minerals than the grains of rice, maize or sorghum (Reed et al., 1976). Vadivoo and Joseph (1998) mentioned finger millet grains contain 13.24% moisture, 7.6% protein, 74.36% carbohydrate, 74.36% carbon, 1.52% dietary fiber, 2.35% minerals, 1.35% fat and energy 341.6 cal/100g. (Joshi and Katoch, 1990; Ravindran, 1991). It is a rich source of micronutrients such as calcium, phosphorus, magnesium and iron. Cysteine, tyrosine, tryptophan and methionine are the right spectrum of amino acids found in finger millet protein (Rachie, 1975). The increase in global temperature leads to climate changes that directly affect crop production and increase people's hunger and malnutrition around the world.. With regard to protein (6-8%) and fat (1-2%) it is comparable to rice and with respect to mineral and micronutrient contents it is superior to rice and wheat (Babu et al., 1987). It is also known for several health benefits such as anti-diabetic, anti-tumerogenic, atherosclerogenic effects, antioxidant, which are mainly attributed due to its polyphenol and dietary fiber contents. Being indigenous minor millet it is used in the preparation of various foods both in natural and malted forms. Grains of this millet are converted into flours for preparation of products like porridge, puddings, pancakes, biscuits, roti, bread, noodles, and other snacks. Besides this, it is also used as a nourishing food for infants when malted and is regarded as wholesome food for diabetic's patients. Diversification of food production must be encouraged both at national and household level in tandem with increasing yields. Growing of traditional food crops suitable for the area is one of the possible potential successful approaches for improving household food security. Malkangiri is one of the seven districts where a flagship programme called “Special Programme for Promotion of Millets in Tribal Areas of Odisha (hereafter, Odisha Millets Mission, (OMM)” has been launched by Department of Agriculture and Farmers Empowerment, Odisha in order to revive millets in rainfed farming systems and household consumption. It was started in kharif 2017 in four blocks of the district, namely Chitrakonda, Korkunda, Mathili and Khairiput. The Government of Odisha launched Odisha Millets Mission (OMM) also known as the Special Programme for Promotion of Millets in Tribal Areas of Odisha in 2017 to revive millets in farms and on plates. The aim was to tackle malnutrition by introducing millets in the public distribution system (PDS) and other state nutrition schemes. The focus is on reviving millets in farms and putting it on plates.”&#x0D; Millet, a nutritious and climate-resilient crop, has traditionally been cultivated and consumed by tribal communities in the rainfed regions of southern Odisha. Technology gap, i.e. poor knowledge about newly released crop production and protection technologies and their management practices in the farmers’ fields is a major constraint in Ragi production. So far, no systematic approach was implemented to study the technological gap existing in various components of Ragi cultivation. Awareness of scientific production technology like HYV of ragi, seed treatment with fungicide, use of insecticide and bio-fertilizers, is lacking in Malkangiri district which were a key reason for low productivity. The production potential could be increased by adopting recommended scientific and sustainable management production practices with improved high yielding varieties and timely use of other critical inputs.&#x0D; Objective&#x0D; The field experiment was undertaken to study the performance of three finger millet varieties Local Mandia (Nali Mandia), Bhairabi and Arjun in rainfed upland situation in kharif season. The present investigation was undertaken to evaluate the field performance of newly released finger millet varieties Arjun and Bhairabi under rainfed condition. The demonstrations were carried out in Malkangiri district covering two villages like Pedawada and MPV-6 to find out the existing technological and extension gap along with technology index with an objective to popularize the ragi varieties having higher yield potential.&#x0D; Material and methods&#x0D; The study was carried out in operational area of Krishi Vigyan Kendra (KVK), Malkangiri during Kharif season in the year 2018 and 2019. The study was under taken in Malkangiri and Kalimela blocks of Malkangiri district of Odisha and the blocks were selected purposefully as Finger millet is the major cereals crop grown in large area in Kharif season. The demonstrations were conducted in two different adopted villages Pedawada and MPV-6 in cluster approach. The Front Line Demonstration (FLD) is an applied approach to accelerate the dissemination of proven technologies at farmer’s fields in a participatory mode with an objective to explore the maximum available resources of crop production and also to bridge the productivity gaps by enhancing the production in national basket.The necessary steps for selection of site and farmers and layout of demonstrations etc were followed as suggested by Choudhary (1999). Forty numbers front line demonstrations on HYV Ragi were conducted in two clusters comprising 40 numbers of farmers. All the participating farmers were trained on various aspects of Ragi production technologies and recommended agronomic practices and certified seeds of Ragi variety Arjun and Bhairabi were used for demonstration. The soil of demonstration site was slightly acidic in reaction (pH-5.0 to 5.25) with sandy loam in texture and EC was 0.134 (dS m −1). The available nitrogen, phosphorus and potassium was between 214 .00, 22 .00, 142 .00 (Kg ha−1) respectively with 0.48 (%) Organic Carbon. The crop was sown in under rainfed condition in the first to second week of July. The crop was raised with recommended agronomic practices and harvested within 4th week of November up to 2nd week of December.&#x0D; Krishi Vigyan Kendra ( KVK), Malkangiri conducted front line demonstration with HYV varieties like Bhiarabi and Arjun and farmer’ local var Dasaraberi as check Finger millet Variety Arjun (OEB-526) is having Maturity duration 110 days and average yield 20.7q/ha with moderate resistance to leaf, neck and finger blast and brown seed and Bhairabi is a HYV of Ragi with Maturity duration 110 days and average yield 17.6 q/ha. Moderate resistance to leaf, neck blast and brown seeded and protein content 81%. Local variety Dsaraberi or Nali Mandia is having 105 days duration and drought tolerant variety used as farmers variety as local check .&#x0D; The technologies demonstrated were as follows: Popularization of high yielding Ragi variety, Seed treatment with Trichoderma viride @ 4g kg-1 seed , Line sowing with, soil test based fertilizer application along with need based plant protection measures. The field was ploughed two times and planking was done after each plugging, Need based plant protection measures were taken; along with soil test based fertilizer application was done with fertilizer dose 40:30:60 kg. N: P2O5: K2O kg ha -1. In case of local checks existing practices being used by farmers were followed. The observations were recorded for various parameters of the crop. The farmers’ practices were maintained in case of local checks. The field observations were taken from demonstration plot and farmer’s plot as well. Parameters like Plant height, number of fingers per plant, length of finger , no of fingers per year, 1000 seed weight and seed yield were recorded at maturity stage and the gross returns (Rs ha -1 ) were calculated on the basis of prevailing market price of the produce. The extension gap, technology gap, technology index along with B: C ratio was calculated and the data were statistically analyzed applying the statistical techniques. Statistical tools such as percentage, mean score, Standard deviation, co-efficient of variation, Fisher‘s “F” test, were employed for analysis of data. The farmer’s practices (FP) plots were maintained as local check for comparison study. The data obtained from intervention practices (IP) and famers practices (FP) were analyzed for extension gap, technological gap, technological index and benefit cost ratio study as per (Samui et al., 2000) as given below.&#x0D; Technology gap = Pi (Potential yield) - Di (Demonstration yield)&#x0D; Extension gap = Di (Demonstration Yield) - Fi (Farmers yield)&#x0D; Technology index = X 100&#x0D; Result and Discussion&#x0D; The results obtained from the present investigation are summarized below. The Table 1 depicts the major differences observed between demonstration package and farmer’s practices in ragi production in the study area. The major differences were observed between demonstration package and farmer’s practices were regarding recommended varieties, seed treatment, soil test based fertilizer application, keeping optimum plant population by thinning, weed management and plant protection measures. &#x0D; The data of Table 1 shows that under the demonstrated plot only recommended high yielding variety, proper weeding and optimum plant population maintaining by thinning and the farmers used herbicides and the farmers timely performed all the other package and practices. It was also observed that farmers were unaware about balanced fertilizer application, seed treatment, and use of fertilizers application and maintenance of plant population for enhancing the yield. Majority of the farmers in the study area were unaware about use of weed management practices. The findings are in corroborated with the findings of (Katar et al., 2011)&#x0D; From the Table 2 it was revealed that in the district Malkangiri the productivity of finger millet was 6.38 (q ha-1) as compare to state average productivity 8.67 (q ha-1), but there exists a gap between potential yield and farmers yield, which can be minimized by adoption High yielding varieties with improved management practices. The productivity of finger millet was very low in the district as the crop is mostly grown along the hillsides on sloppy land on light textured soil. It was also coupled with negligence in adoption of improved varieties no input like fertilizers use and no plant protection measures and improper method and time of sowing. However, there is a wide gap between the Potential and the actual production realized by the farmers due to partial adoption of recommended package of practices by the growers. Several constraints contributed to yield fluctuation on Ragi production, including: unreliable rainfall; lack of high yielding variety ,disease tolerant varieties; pests and diseases incidence; low producer prices; poor agronomic practices; and lack of institutional support (Bucheyeki et al., 2008; Okoko et al., 1998). One of the central problems of ragi production and processing in this district is due to an uncertain production environment owing to rain fed cultivation, the low resource base of smallholder farmers and processors, and no scope for post harvest management and value addition facilities and poor marketing facility.&#x0D; The results clearly indicated from the Table 3 that the positive effects of FLDs over the existing practices. HYV Ragi Arjun recorded higher yield 18.8(q ha-1) followed by Bhairabi 15.53 (q ha-1) which was 21 % more and the yield performance of these two HYV varieties was higher than the farmer’s variety. This is due to higher of panicle length, more number of tillers and more number of fingers per panicle in HYV of ragi as compared to local variety. The results are in conformity with the findings of (Tomar et al. , 2003). The results clearly indicated the positive effects of FLDs over the existing practices towards enhancing the productivity.&#x0D; It is revealed form table 4 that, as the calculated ‘F’ value at α=0.05 level was found to be larger than table value, indicating significant difference in yield between farmer’s variety and recommended varieties. There was significant difference between average yield of ragi under Farmers practice (FP) and Recommended practice (RP) in variety Arjun under this demonstration. It was concluded that the yield of these HYV ragi varieties was significantly higher as compared to farmer’s variety. &#x0D; The economics and B:C ratio of farmers practice and Demonstration practice has been presented in Table 6. From the table it was revealed that Benefit: Cost ratio (B:C) was recorded to be higher under demonstrations against control treatments during all the years of experimentation. The cost of cultivation in HYV variety was higher due to more labour cost involved in transplanting and also it included cost of fertilizers and plant protection chemicals and also net returns was higher as compared to farmer’s practice. The B: C ratio was found to be 2.4 in case of variety Arjun as compared to 1.9 in case of variety Bhairabi.&#x0D; The results on economic analysis indicated that HYV ragi Arjun and Bhairabi performed better than local variety Ragi. The HYV variety Arjun recorded higher gross return upto Rs 54,332 and followed by Bhairabi Rs 44,289 per ha which was significantly higher than farmers practice and it was due to higher productivity of varieties under demonstration.&#x0D; Conclusion &#x0D; The results revealed that in Malkangiri district finger millet variety Arjun rerecorded highest yield followed by Variety Bhirabi with proper package and practices under rainfed upland condition. From the above study it was concluded that use of finger millet varieties like Arjun or Bhairabi with scientific methods and technological practices of can reduce the technological gap and enhance the productivity in the district. Yield improvement in Finger Millet in the demonstration was due to use of HYV seed and scientific management practices adopted by the farmers. Yield of Finger Millet can be increased to a great extent by conducting effective front line demonstrations in larger area with proven technologies. Finger millet is one of future smart food crop of India and can be grown in the drought condition. This crop is rich in nutrient for food insecurity and within few years because of increase in population of world and depletion of area of production.. The principal reasons of lower productivity of finger millet in the district Malkangiri were lack of knowledge among the farmers about cultivation of HYV finger millet varieties and improper fertilization, late season sowing and severe weed infestation in crop at critical stages. From the above findings, it can be concluded that use of scientific methods of Finger millet cultivation can reduce the technology gap to a considerable extent thus leading to increased productivity of millets in the district. Moreover, extension agencies in the district need to provide proper technical support to the farmers through different educational and extension methods to reduce the extension gap for better production.&#x0D; Acknowledgments&#x0D; The OUAT Bhubaneswar and ICAR-ATRI Kolkata, is acknowledged for financial support to the research program.&#x0D; Conflicts of interest&#x0D; The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.&#x0D; References:&#x0D; &#x0D; Babu, B. V.; Ramana, T.; Radhakrishna, T.M. Chemical composition and protein in hybrid varieties of finger millet. Indian J. Agric. Sci. 1987, 57(7), 520-522.&#x0D; Biplab, M.; Samajdar, T. Yield gap analysis of rapeseed-mustard through Front Line Demonstration. Agricultural Extension Review. 2010, 16-17.&#x0D; Bucheyeki, T. L.; Shenkalwa, E. M.; Mapunda, T. X.; Matata, L.W. On-farm evaluation of promising groundnut varieties for adaptation and adoption in Tanzania. African Journal of Agricultural Research. 2008, 3(8), 531-536.&#x0D; Chandra, D.; Pallavi S C.; Sharma A.K. Review of Finger millet (Eleusine coracana (L.) Gaertn): A power house of health benefiting nutrients. Food Science and Human Wellness. 2016, 5( 3), 149-155.&#x0D; Choudhary, B. N. Krishi Vigyan Kendra - a guide for KVK managers. Division of Agricultural Extension, ICAR, 1999, 73-78.&#x0D; De Onis M.; Frongillo E.A.; Blossner, M. “Is malnutrition declining? An analysis of changes in levels of child malnutrition since, 1980.” Bulletin of the World Health Organization. 2000, 1222–1233.&#x0D; Gull, A.; Jan, R.; Nayik, G. A.; Prasad, K.; Kumar, P. Significance of Finger Millet in Nutrition, Health and Value added Products: A Review. 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Odisha Millet Mission: The successes and the challenges. 2020.&#x0D; "Baseline Survey: Malkangiri District 2016-17, Phase-1 (Special Programme for Promotion of Millets in Tribal Areas of Odisha or Odisha Millets Mission, OMM)," Nabakrushna Choudhury Centre for Development Studies, Bhubaneswar. 2019.&#x0D; Nigade, R. D.; Jadhav, B. S.; Bhosale, A. S. Response 0f long duration finger millet(Elusine coracana L,) variety to different levels of nitrogen under rainfed condition. J agrc Sci. 2011, 7(1), 152-155.&#x0D; Odisha Agriculture Statistics, Govt of Odisha. 2013-2014.&#x0D; Rachie, K. O. The Millets: Importance, Utilization and Outlook. International Crops Research Institute for the Semi-Arid Tropics, Hyderabad, India. 1975, 63.&#x0D; Ravindran, G. Studies on millets: proximate composition, mineral composition, phytate, and oxalate contents. Food Chem. 1991, 39(1), 99- 107.&#x0D; Ravindran G. Seed proteins of millets: amino acid composition, proteinase inhibitors and in vitro digestibility. Food Chem. 1992, 44(1), 13- 17.&#x0D; Reed C. F. Information summaries on 1000 economic plants. USDA, USA. 1976.&#x0D; Samui, S K.; Maitra, S.; Roy, D K.; Mandal, A. K.; Saha, D. Evaluation of front line demonstration on groundnut. Journal of Indian Society of Coastal Agricultural Research. 2000, 18(2), 180-183.&#x0D; Singh, J.; Kaur, R..; Singh, P. Economics and Yield gap analysis of Front Line Demonstrations regarding Scientific practices of Indian Mustard in district Amritsar. Indian Journal of Economics and Development. 2016, 12(1a), 515.&#x0D; Singh, P.; Raghuvanshi. R. S. Finger millet for food and nutritional security. African Journal of Food Science. 2012, 6(4), 77-84.&#x0D; Srivastava, P.P.; Das, H.; Prasad, S. Effect of roasting process variables on hardness of Bengal gram, maize and soybean. Food Sci. Technol. 1994, 31(1), 62-65.&#x0D; Tomar, L. S.; Sharma, B. P.; Joshi, K. Impact of front line demonstration of soybean in transfer of improved technology. Journal of Extension Research. 2003, 22(1), 139.&#x0D; Upadhyaya, H.D.; Gowdaand C.L.L.; Reddy, V.G. Morphological diversity in finger millet germplasm introduced from Southern and Eastern. African Journal of SAT Agriculture Research. 2007, 3(1). ejournal.icrisat.org.&#x0D; Vadivoo, A.S.; Joseph, R. Genetic variability and diversity for protein and calcium contents in finger millet (Elusine coracona (L.) Gaertn) in relation to grain color. Plant Foods for Human Nutrition Dordrecht. 1998, 52, 353-364.&#x0D; Department of Botany, Avinashilingam Institute for Home Science and Higher Education for Women, Deemed University, Coimbatore, TN, 641 043, India.&#x0D;

Insects (Insecta, Arthropoda), undeniably represent the most triumphant group of living organisms, in terms of evolutionary achievement, existing on earth. With over one million described species, they account for more than 75 percent of all known species, and it is estimated that at least 4-5 million insect species still remain undiscovered and undescribed (Stork, 2018). They represent one of the largest components of biodiversity in the world, closely associated with human's wellbeing in different forms like pests, natural enemies, producers of economic products and facilitators of pollination. In contemporary times, despite notable progress in agricultural output and economic prosperity in many regions, the problem of food insecurity persists as a significant concern affecting substantial segments of the global population (Palli, 2022). To cater the food demand of the fast expanding global population, intensive agricultural practices like extensive use of chemical fertilizers and insecticides, greater tillage and irrigation, as well as heavy mechanization are followed. The result is frequent outbreak of phytophagous insect pests along with a rapid decline in the biodiversity of beneficial insects including natural enemies and pollinators. It is estimated that crop losses caused by insects are a major problem in both developed and developing countries, destroying 18 to 20 per cent of the annual crop production globally, having worth over US$ 470 billion (Srivastava and Chakravarty, 2021). Initially, when pesticides were used to control or prevent insect pest outbreaks, the chemicals were often applied as soon as a problem was perceived, without accurate identification of the insect's identity or discovery of why the problem had developed in the first place. This lack of understanding of the cause of outbreak meant that the same problem could reoccur. Sustainable pest management requires a more scientific approach. The first step in this direction is the correct identification of the insect species. Accurate species identification, whether of the pest or its associated natural enemy along with their biological systematic studies provide backbone information for the success of any integrated pest management programme (Chakravarty et al., 2022). Traditional systematics or taxonomy was primarily reliant on morphology-based taxon identification systems. However, the process of morphological identification poses significant challenges in numerous insect taxa, mostly attributable to the absence of dependable diagnostic traits or the presence of cryptic species complexes (Shashank et al., 2022). Moreover, due to a decrease in the number of proficient morpho-taxonomists, specifically those specializing in lesser-known insect groups, there is a need for alternate approaches to species identification. Presently, entomologists are leveraging a wide array of molecular techniques that were previously untapped, while also embracing novel technologies under the paradigm of a "technology-driven revolution" in the field of systematics (Srivastava et al., 2019). Molecular techniques present a highly advantageous strategy for the identification and classification of insects, offering distinct benefits when compared to traditional morphological methods. Over the past twenty years, DNA barcoding has emerged as a swift and dependable technique for the identification of species, thereby revitalizing the field of taxonomic study. It refers to the technique, where short fragment of the conserved mitochondrial cytochrome c oxidase subunit I (COI) gene, the “DNA barcode,” is sequenced from a taxonomically undesignated specimen and comparisons are made with the DNA sequence of species of known origin for establishing a species level identification (Hebert et al., 2003). This approach has been frequently employed in various studies focusing on insects (and other arthropods in general), leading to the identification of previously unknown or cryptic species. Additionally, it has helped identify species complexes and evolutionary significant units, thereby establishing a basis for further comprehensive integrative taxonomic research (Firake and Behere, 2021). DNA barcoding considerably facilitates the monitoring of invasive species, vectors, and economically important endangered and/or endemic arthropod species. Furthermore, the utilization of DNA metabarcoding in ecological and surveillance initiatives has become increasingly prevalent. This approach enables the rapid evaluation of biodiversity in certain geographical regions, as well as the study of arthropod biosystems and communities that would otherwise be inaccessible. In recent times, entomologists in India have efficiently identified various invasive insect pest species, such as the elephant beetle, tomato pinworm, rugose spiralling whitefly, coconut case caterpillar, fall armyworm, and cassava mealy bug, by incorporating molecular systematics either as the sole method or in conjunction with traditional taxonomical tools (Srivastava and Chakravarty, 2021). In addition, there have been endeavours to offer extensive data through molecular characterization and/or DNA barcoding of indigenous organisms that serve as natural enemies and pollinators within diverse agricultural systems of India (Srivastava et al., 2019). A good number of insect genomes, particularly the mitochondrial genome have also been wholly sequenced in the country, including both crop pests and beneficial insects (Firake and Behere, 2021). However, our nation renowned for its exceptional biodiversity, exhibits a mere 3.73% coverage of DNA barcodes for its documented insect species. Notably, the orders Lepidoptera and Hemiptera are the most extensively represented in this limited dataset (Shashank et al., 2022). Such a delay in developing DNA barcode reference libraries for insects will set us back in our efforts to effectively document and preserve our rich biodiversity. The introduction of molecular systematics has also precipitated a revolution in our understanding of intraspecific genetic diversity and population genetic structure of several key insect pest species of agricultural importance in the country, helpful to detect the changes they adapt to overcome hurdles of various selection pressures including insecticides (Chakravarty et al., 2020). A necessity for the development of effective and safe management techniques for a target pest is the acquisition of comprehensive knowledge pertaining to its population structure and dynamics. Despite the emergence of inconsistencies between morphological and molecular phylogenies, as well as conflicting results from different molecular research, the utilization of phylogenomic analysis has proved helpful in resolving numerous controversial connections within insects. Over the past decade, our working group has devoted its research efforts entirely to this particular issue. Based on the molecular characterization with RAPD markers (Deepa and Srivastava, 2011) and COI gene (Chakravarty et al., 2021), phenotyping of immature and adult stages (Chakravarty and Srivastava, 2020; Chakravarty et al., 2023b), and other biological traits (Chakravarty et al., 2019 and 2023a), existence of sub-specific level variations among Helicoverpa armigera populations from diverse agro-ecologies of India has been deciphered. Similar studies for Leucinodes orbonalis (Padwal et al., 2022), Spodoptera litura (Ganguly et al., 2023) and Maruca vitrata (Mahalle et al., 2022) revealed genetic homogeneity for these pest species in the country. Further, Mahalle et al. (2023) have also screened publically accessible expressed sequence tag resources to identify microsatellites and evaluate their suitability as DNA markers for investigating gene flow patterns among populations of M. vitrata from pigeonpea fields throughout India. Molecular systematics has also proven to be a valuable tool in the identification of convergent evolution phenomena, such as the emergence of eusocial behaviours and caste systems among Hymenoptera (Berens et al., 2015); comprehending predator-prey dynamics within trophic food web investigations (Novotny and Miller, 2014), as well as resolving challenges associated with limited specimen availability or local species populations (Deng et al., 2019). Nevertheless, it is important to note that relying solely on molecular analyses to determine the identity of a species or assess population diversity can be precarious. This is due to potential biases introduced by the improper utilization of neighbor-joining trees, fixed distance thresholds, bootstrap resampling, interpretation of the barcoding gap, as well as limitations associated with DNA barcode repositories such as the Barcode of Life Data Systems (BOLD) and the National Centre for Biotechnology Information (NCBI). For instance, in a study conducted by Kvist (2013), it was found that 42% of invasive insects were not included in the BOLD database. Furthermore, the outcomes of phylogenetic analyses can be affected by various factors, such as the occurrence of recent speciation events, the presence of paraphyly, inadequate taxonomy, interspecific hybridization, and the high prevalence of endosymbiotic bacteria like Wolbachia, that hinders the replication or detection of the target sequence from insect specimens during the polymerase chain reaction, as highlighted by Shashank et al. (2022). Therefore, it is recommended that molecular methodologies should be utilized in conjunction with, rather than in lieu of, morphological identification in order to achieve optimal outcomes (Chakravarty et al., 2023b). Last but not the least, a note of appreciation for the “Journal of Environmental Biology” is also appropriate at this juncture. We are pleased to share our research experience and expertise through this editorial in the aforementioned journal, with which we have been affiliated for several years in various roles such as author, reviewer, and editor. This open access journal is notable for its comparatively modest processing charges, which enable researchers to publish their original work at an affordable cost. The enduring anticipation for highly critical reviews has contributed to the continued prominence of this journal within the realm of environmental science and related disciplines. We appreciate the visions of late Professor R.C. Dalela and his dedicated team, who have worked tirelessly over the years to make this journal a valuable resource for the global environmental outlook, with the ultimate aim of promoting societal well-being. Currently, the responsibility of overseeing this journal rests with Dr. Divakar Dalela, the Executive Editor, and Dr. Sumati Gaumat, the Editor, together with their dedicated publication team. They are diligently working towards upholding the international standards of this esteemed journal. We extend our best wishes for the continued success of the journal in the years to come.

The sugar industry has long faced challenges from microorganisms during production. Preventing sugar losses and microbial-related issues such as the formation of organic acids, gases like CO2 or H2, or slimy substances continues to be key concerns. Fortunately, process parameters such as high temperatures, low pH values and limited oxygen availability create unfriendly conditions for microorganisms, and antimicrobial agents have been developed to control microbial growth. However, a proactive approach would utilize the advantageous properties of microorganisms to break down undesirable substances and promote desirable ones. For example, acidic by-products from bacterial metabolism lower the pH and thus stabilize sugar beet cossettes during pressing. Additionally, beneficial metabolic processes have been recognized, such as preferentially utilizing monosaccharides instead of sucrose or selectively degrading undesired substances (e.g., converting nitrite into elemental nitrogen). Modern sequencing techniques continue to identify unknown bacteria with the potential to improve the process. Exploring these bacteria could offer valuable insights for a better microorganism management in beet sugar production. This perspective article discusses the microbial diversity in beet sugar factories and strategies for better utilization of microbial benefits, aiming for sustainable improvements in sucrose extraction. However, extensive research is necessary to identify and characterize suitable bacterial species and how best to exploit them.

AbstractPhysical instabilities of proteins in the form of protein aggregation continue to be a major challenge in the development of protein drug candidates. Aggregation can occur during different stages of product lifecycle such as freeze–thaw, manufacturing, shipping, and storage, and can potentially delay commercialization of candidates. A lack of clear understanding of the underlying mechanism(s) behind protein aggregation and the potential immunogenic reactions renders the presence of aggregates in biotherapeutic products undesirable. Understanding and minimizing aggregation can potentially reduce immunogenic responses and make protein therapeutics safer. Therefore, it is imperative to identify, understand, and control aggregation during early formulation development and develop reliable and orthogonal analytical methodologies to detect and monitor levels of aggregation. Freezing and thawing are typical steps involved in the manufacturing of drug product and could result in complex physical and chemical changes, which in turn could potentially cause protein aggregation. This study provides a systematic approach in understanding and selecting the ideal freeze–thaw conditions for manufacturing of protein-based therapeutics. It identifies the importance of balancing different excipients with an overall goal of sufficiently reducing or eliminating aggregation and developing a stable and scalable formulation. The results demonstrated that the freeze–thaw damage of mAb-1 in aqueous solutions was significantly reduced by identification of optimal freeze–thaw conditions using first a small-scale model with subsequent at-scale verifications. The work provides a framework for successful transfer of drug product manufacturing process from small-scale to the manufacturing scale production environment especially for molecules that are susceptible to freeze–thaw induced degradations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <strong>1.</strong><strong>INTRODUCTION </strong> Risks are present in all parts of the construction work regardless of size, resources, funds etc. Since each construction project is unique and dynamic, the construction performance presumes several uncertainties about the complexity of the construction project (Chandra, 2015). Risk management suggests that risks should be distributed to minimize their harm since they cannot be completely eliminated, which would have been the easiest option (Szymański, 2017). To amplify the profitability perimeters of construction contracts, it is wise to assess and evaluate the possible positive risk factors(Chandra, 2015). Identifying, classifying and assessing potential risk factors that may affect the functioning of projects is prudent. Therefore, the focus of this research is to identify the harmful characteristics of factors encountered along with the risk management of the progress of a project. A handful of researchers looked at the risk management procedure in a specific project phase, such as conceptual and feasible phase, construction phase and design phase, rather than from the point of view of the project life circle (Rostami &amp; Oduoza, 2017). Recognizing external and internal risks of construction projects is imperative in order to properly record unpredictable incidents of construction projects. Various risk recognition and further risk assessment processes reduce the pessimistic influence of risks and expand efficiency and productivity in business (Motiar Rahman &amp; Kumaraswamy, 2002). Consequently, to articulate and manage key risks related to construction projects, this paper introduces the results of a thorough review of the literature and seeks to draw attention to the major factors affecting risk management in developing countries. &nbsp; <strong>2.</strong><strong>LITERATURE REVIEW</strong> Projects and organizations are full of unpredictable situations in our daily life (Olsson, 2007) representing an obvious problem for the construction business (Vallabh Vidyanagar). The topic of construction risk management has been the subject of several research works. Some of the earliest researchers to structure construction risk tests was Chapman and Cooper (C. Chapman &amp; Cooper, 1983). Their research resulted in a risk engineering approach that led to many useful risk management tooling techniques (Jarkas &amp; Haupt, 2015). Risk management as defined is a risk recognition and assessment procedure, then applying methods to minimize it to a reasonable extent (Tohidi, 2011). After Edward and Bowen (Bowen, 1998)research on construction risk management issued in the early years of 1960-1970 to notice shortages and inconsistencies in understanding and conducting towards construction risks. The results suggest that social, financial, economic and political risk factors deserve more attention as far as research is concerned compared to other factors such as occupational health and safety and quality assurance. (Al-Bahar &amp; Crandall, 1990) conducted research and categorized risk factors in construction in 6 classes, one of which was financial risk. Financial risk suggests that a construction company may fail to meet its financial targets, so it is a potential for financial instability that could lead to severe loss and uncertainty about its extent. The past / earlier author identified that inflation, improper cost plan, industry recession, cash flow availability could increase financial risks 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(Edwards &amp; Bowen, 1998; El-Sayegh, 2008). (Ameyaw &amp; Chan, 2015) recognized laws and regulations as a risk management factor in construction. Legal and regulatory risks are risks that the production targets of construction firms will be enforceable as they cannot meet the country&#39;s legal and regulatory standards. 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(Assaf &amp; Al-Hejji, 2006; Barlish, De Marco, &amp; Thaheem, 2013) observes that a delay in the construction project could result if this factor is not addressed. (Tadayon, Jaafar, &amp; Nasri, 2012)in the Iranian Construction Risk Identification Assessment, notes that frequent changes in statutory regulations affect risk management in construction. (Zou, Zhang, &amp; Wang, 2007) after conducting a survey in Chinese construction states that it takes a long time to obtain legal and regulatory approval, hence it is essential for project members to maintain good relations with government officials. &nbsp; (Szymański, 2017) identifies natural and environmental risks as a threat to construction risk management, the previous / earlier author noted that natural risks are environmental risks and cannot be anticipated. Natural risks are a natural phenomenon that sometimes has a negative impact on people or the environment, examples of such are classified as meteorological and geological phenomena, under these two we have earthquakes, floods, landslides, wildfires, cyclone storms, etc. Air pollution, spread of diseases, land degradation, water pollution, natural disasters are a threat in Nigerian constructions(Akinbile, Ofuyatano, Oni, &amp; Agboola, 2018). (San Santoso, Ogunlana, &amp; Minato, 2003) conducted a survey in Jakarta and recognized design issues as a factor affecting construction risk management. Design risk is the likelihood of a design being unsuccessful to meet a project&#39;s requirements. Included are designs that are unsound, inefficient, unstable or just not attaining customer standards(R. J. Chapman, 2001). Design is a stage which forms the backbone of the project(Szymański, 2017). Szymanski further states that at the design stage we have risks such as improper designer selection, the risk of overestimating the cost of the project. Giving design to unqualified planners and defective designs is a threat to risk management, states (Enshassi, Mohamed, &amp; Abu Mosa, 2008)after conducting a survey in Palestine. (Wiguna &amp; Scott, 2005) identified the owner&#39;s design change as one of the factors affecting the risk management of Indonesian construction. (Z. Wu, Nisar, Kapletia, &amp; Prabhakar, 2017). Further research on the project success of the Chinese construction industry identified inadequate program scheduling, inadequate site information, as factors affecting risk management in construction. Both(Sharaf &amp; Abdelwahab, 2015)and(Mhatre, Thakkar, &amp; Maiti, 2017) noted that design drawing errors are a serious threat to a project,(Mhatre et al., 2017) further identified poor construction plan, inappropriate design, and poor engineering as design risk factors. After reviewing the literature on factors affecting risk management, the researcher identifies political risks as one of the major factors affecting risk management in construction(Matthee, 2011). The earlier / past researcher defines political risks as the risk that an investment&#39;s profit might suffer as a result of changes in policies or instability in the country. (Goh &amp; Abdul-Rahman, 2013) Country economic instability, risk of inflation, risk of recession in industry and disagreements among funding parties, etc., are highly impacting factors identified by the previous / former author. (Sharaf &amp; Abdelwahab, 2015)State that political changes, frequent change of government, protests for change of government and disputes between political parties are also factors to be recognized. Furthermore (Deng, Low, Li, &amp; Zhao, 2014)and(Famiyeh, Amoatey, Adaku, &amp; Agbenohevi, 2017) emphasize that the major risks at the top due to political differences and economy are currency infatuation, changes in tax rates, changes in security officials, workers strikes and fire risk. After a survey in Ghana (Famiyeh et al., 2017) identified government pressure, inspectors, government bureaucracy to obtain license conflicts as major factors affecting risk management under political risks. (Enshassi et al., 2008) conducted a survey in Palestine and found that frequent border closures as a political factor affect construction progress. The findings revealed that safety risk falls under risk management factors(Hallowell &amp; Gambatese, 2009). (Aminbakhsh, Gunduz, &amp; Sonmez, 2013). Safety risks are defined as the likelihood that a person or machines under construction may be harmed if they are a person who may suffer adverse health effects if they are exposed to a certain hazard. (Hwang, Zhao, &amp; Toh, 2014) also identified safety and health as a factor affecting construction risk management. More so after categorizing risks into major classes Safety and health were among them (Ghosh &amp; Jintanapakanont, 2004), justifying how serious an issue this factor is following a survey in Malaysia (Goh &amp; Abdul-Rahman, 2013)accidents were recognized as a major threat in Malaysian constructions. Older researcher on Palestine noted that workers were working in dangerous areas, putting their lives at great risk(Famiyeh et al., 2017) states that inadequate safety equipment for workers also put employees at enormous risk. Old author further notes that construction accidents are usually caused by material and equipment failures,(San Santoso et al., 2003)further elaboration that construction equipment maintenance is the most significant. (Famiyeh et al., 2017) also stated that air pollution and pollution of water bodies pose a serious health risk and disease spread are very serious threats in the construction of Ghana. After reviewing literature the author considered resource unavailability as a major factor affecting risk management, past authors like (Akinbile et al., 2018)further noted that it is a very important factor because of its global implications. John Spacey also gave an example of resources, as stated, including funding, skilled workers, time and anything else needed to support the process to a particular obligation. (Hwang et al., 2014) identified the human resource as a risk affecting construction projects. Moreover, following a survey conducted in Nigeria(Akinbile et al., 2018), insufficient resource availability was identified as a major risk. (El-Sayegh, 2008) conducted a survey on the construction sites of the UAE, the previous / earlier author recognized a shortage of materials and labor supply as a risk. In their survey in Indonesia, the same results were obtained in 2005 by(Wiguna&amp; Scott, 2005), identifying the availability of labor, material and equipment as a problem suggesting that these are serious risks not to be ignored in construction. (Amoatey, Famiyeh, &amp; Andoh, 2017). In Ghana it was found that there was a shortage of skilled labor in construction. (Mhatre et al., 2017) It came to the same conclusion that there was insufficient experience and skill in construction workers. Technological risk is any potential for disruption of technology failures, the project, for example, information security, bad site communication, just to name a few (Nelkin, 1989). Change in technology also affects risk management in construction, (Dey, Tabucanon, &amp; Ogunlana, 1994) also states that technology change is a risk in the life of the project. (Mhatre et al., 2017) notes that the shortage of required equipment that is technology is also a major risk in construction and can cause slow progress of the project. Social risks for a construction company include actions that affect their surrender(Johnson &amp; Covello, 2012). There are other issues that may also be relevant to social risks, such as public health issues, which may have an impact on absenteeism and the morale of workers. If the construction company doesn&#39;t have a good understanding of the local power structure.(Famiyeh et al., 2017) identified the displacement of communities and high living costs, as well as the lack of community acceptance as a social risk following a survey in Ghana. (Mhatre et al., 2017) identifies the increase in material prices and the cost of studies as a social risk. &nbsp; &nbsp; &nbsp; Table 1: Factors Affecting Risk Management in Construction <strong>FACTORS</strong> <strong>SUBFACTORS</strong> <strong>REFERENCES</strong> 1.Financial risks - Market inflation - Capital cost - Project funding problems - Inaccurate cost estimation - Price infatuation - An estimate of quantity of resources - Cash flow availability (Ghosh &amp; Jintanapakanont, 2004; Wiguna &amp; Scott, 2005) 2.Legaland regulation risks - Changes in law and regulations - Requirements and permit approval - Contract selection and administration - Delayed dispute resolution (Chandra, 2015; Ghosh &amp; Jintanapakanont, 2004) 3.Naturalrisks/ Acts of God - Earthquakes - Weather - Ecological - Natural hazards (Al-Bahar&amp; Crandall, 1990) 4.Design risks - Design change - Errors and omissions in design - Inadequate specifications (Dosumu &amp; Aigbavboa, 2017) (Mhatre et al., 2017) (Jarkas &amp; Haupt, 2015) (R. J. Chapman, 2001) 5.Technological risks - Change in technology - Lack of qualified equipment users - Shortage of required equipment (Al-Bahar &amp; Crandall, 1990; Mhatre et al., 2017) 6.Safety/Health risks &nbsp;&nbsp;&nbsp; - Pollution - Fire outbreaks - Spread of diseases - Sanitation (Aminbakhsh et al., 2013) (Hallowell &amp; Gambatese, 2009) (Ringen, Seegal, &amp; England, 1995) 7. Social risks - Belief - Moral values - Morality - Social status - Culture (Cernea, 2004) (Y. Wu, Deng, &amp; Zhang, 2011) (Johnson &amp; Covello, 2012) (Nelkin, 1989) &nbsp; 8. Political risks - Change in government - Disagreements in funding parties - Civil wars - Corruption (Akinbile et al., 2018) 9. Resource risks - Availability of equipment - Availability of labor - Defective materials (Akinbile et al., 2018) 10. Environmental risks - Ecological - Pollution &nbsp;(Dione, Ruwanpura, &amp; Hettiaratchi, 2005) 11.Human resource risks - Availability of labor - Availability of skilled labor (Gudienė, Banaitis, &amp; Banaitienė, 2013; Windapo, 2016) <strong>3.</strong><strong>METHODOLOGY</strong> The review of literature carried out assisted in having a finer comprehension and gathering of data of investigating factors affecting risk management in construction. It led to the identification of 11 main factors and their sub-factors. Adopted was a survey method to solidify the factors in this study. Several papers with past reliable information were reviewed. Data from the reviewed literature was to be gathered and compared to the other method the author used to collect information. An online questionnaire was developed; the author designed and distributed the questionnaire to get huge sample details for a comprehensive analysis and understanding. The questionnaire consisted of 3 parts. First included the introduction and the study objectives. The second part had the basic profile of the respondent, including their work experience, job position, understanding of risk management in project and their education level. The third section was made to evaluate and grade factors according to their effect with respect the respondent&rsquo;s opinion. The respondents were asked to evaluate the risk factors on a five-point Likert scale, were {(5=strongly agree)(4=agree)(3=no opinion)(2=disagree)(1=strongly disagree)}. Amongst the respondents were project managers, contractors, architects, site engineers, consultants and site experts. Designing the questionnaire an expert&rsquo;s opinion was taken into consideration. A total of 100 survey questionnaires were set out to different people and countries. Only 70 people managed to complete the questionnaire both from the private and public sector of construction. Amongst the respondents were people from different developing countries such as Zimbabwe, Zambia, Cameroon, Nepal, China, Bangladesh ,South Africa ,Botswana, Tunisia only to name a few. Data was analyzed by using the Relative Importance Index (RII) and Analysis of Variance (ANOVA), these methods of analysis reduces biased results both as far as ranking of factors and the analyses of variance is concerned. ANOVA gives a fair estimation of variance between two groups which in this case is our private and public sector Relative Importance Index (RII) is carried out by using Microsoft excel software. &nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (1) &nbsp; W = respondent&rsquo;s given weighting to each factor ranging from 1-5 A = highest weight&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; N = total number of respondents The RII results ranges from 0-1. &nbsp; <strong>3.1</strong><strong>&nbsp;Analysis of variance (ANOVA)</strong> Analysis of variance is the gathering of statistical models and their estimation procedures, such as the difference among and between groups. Results below 0. 05 suggest that there is a significant difference between 2 groups however results above 0. 05 suggest that there is no significant variation between our chosen groups(reference). (ANOVA) is carried out by using SPSS version 23 software. &nbsp; <strong>3.2 Hypothesis</strong> H1: there was no difference between private and public sector construction projects in the perception of significance level of factors affecting risk management in developing countries. &nbsp; <strong>4.</strong><strong>RESULT</strong> Table 2: Factor Rating by Relative Information Index (RII) <strong><em>Factors affecting risk management</em></strong> <strong><em>Frequency of severity</em></strong> <strong><em>Rating</em></strong> <strong><em>1</em></strong> <strong><em>2</em></strong> <strong><em>3</em></strong> <strong><em>4</em></strong> <strong><em>5</em></strong> <strong><em>RII</em></strong> <strong><em>Rank</em></strong> Government instability 2 6 5 23 31 0.8200 1 Shortage or required equipment 4 7 2 24 31 0.8057 2 Inflation 3 4 7 33 22 0.7829 3 Lack of skilled labor 4 6 7 26 24 0.7771 4 Corruption 5 7 8 24 26 0.7686 5 Capital cost 4 9 8 20 26 0.7571 6 Culture 4 7 15 20 24 0.7514 7 Change in laws and regulations 3 9 8 30 17 0.7514 8 Error and omission in design 2 9 9 36 14 0.7457 9 Improper design selection 5 9 9 28 18 0.7286 10 Improper technology selection 5 9 13 22 20 0.7229 11 Unavailability of labor 9 9 7 20 22 0.7200 12 Change in technology 2 12 12 23 19 0.7171 13 Sanitation 4 10 11 34 11 0.7086 14 Contract selection and administration 2 12 22 18 16 0.6971 15 Delayed dispute resolution 5 10 16 23 15 0.6914 16 Inaccurate cost estimation 4 12 19 16 18 0.6914 17 Fluctuation of currency 11 6 14 21 17 0.6829 18 Recession in industry 3 15 18 19 15 0.6800 19 Change in government 5 10 22 23 9 0.6657 20 Moral values 2 6 36 19 5 0.6657 21 Improper cost plan 17 10 17 17 16 0.6543 22 Perception 4 12 26 16 11 0.6514 23 Weather 9 12 16 19 13 0.6486 24 Decrease in aesthetic level(client) 4 12 28 16 8 0.6343 25 Inadequate specification 3 10 35 15 6 0.6257 26 Disagreement in funding parties 6 16 23 15 10 0.6200 27 Ecology 7 4 42 11 5 0.6143 28 Social status 5 14 35 8 8 0.6000 29 Over estimating project cost 5 26 15 17 6 0.5857 30 Design change 10 25 11 16 7 0.5571 31 Pollution 7 30 14 12 7 0.5486 32 Requirement of permits and approval 15 22 12 12 8 0.5371 33 Fire outbreak 15 20 13 16 3 0.5343 34 Pollution 20 17 12 14 6 0.5314 35 Spread of diseases 9 34 10 12 5 0.5114 36 Defective material 15 29 4 16 6 0.5000 37 Natural hazards 28 13 8 8 13 0.5000 38 Civil wars 34 8 8 6 12 0.4657 39 The table above presents an analysis for factors affecting risk management in developing countries using the Relative importance index. The table shows the importance and the impact of the stated factors from the most important to the less important one. &nbsp; Table 3: Analyses of Variance between Public and Private Sector (ANOVA) &nbsp; <strong>Sum of Squares</strong> <strong>Df</strong> <strong>Mean Square</strong> <strong>F</strong> <strong>Sig.</strong> FR1 Between Groups 0.386 1 0.386 0.32 0.57 Within Groups 81.1 68 1.193 &nbsp; &nbsp; Total 81.486 69 &nbsp; &nbsp; &nbsp; FR2 Between Groups 7.243 1 7.243 4.15 0.05 Within Groups 118.6 68 1.744 &nbsp; &nbsp; Total 125.843 69 &nbsp; &nbsp; &nbsp; FR3 Between Groups 2.519 1 2.519 1.33 0.25 Within Groups 128.467 68 1.889 &nbsp; &nbsp; Total 130.986 69 &nbsp; &nbsp; &nbsp; FR4 Between Groups 1.458 1 1.458 1.06 0.31 Within Groups 93.342 68 1.373 &nbsp; &nbsp; Total 94.8 69 &nbsp; &nbsp; &nbsp; FR5 Between Groups 0.011 1 0.011 0.01 0.94 Within Groups 111.775 68 1.644 &nbsp; &nbsp; Total 111.786 69 &nbsp; &nbsp; &nbsp; FR6 Between Groups 1.071 1 1.071 0.73 0.4 Within Groups 100.3 68 1.475 &nbsp; &nbsp; Total 101.371 69 &nbsp; &nbsp; &nbsp; LR1 Between Groups 0.805 1 0.805 0.64 0. 43 Within Groups 86.067 68 1.266 &nbsp; &nbsp; Total 86.871 69 &nbsp; &nbsp; &nbsp; LR2 Between Groups 0.144 1 0.144 0.08 0. 78 Within Groups 122.942 68 1.808 &nbsp; &nbsp; Total 123.086 69 &nbsp; &nbsp; &nbsp; LR3 Between Groups 1.63 1 1.63 1.13 0. 29 Within Groups 97.742 68 1.437 &nbsp; &nbsp; Total 99.371 69 &nbsp; &nbsp; &nbsp; LR4 Between Groups 0.344 1 0.344 0.28 0. 6 Within Groups 85.142 68 1.252 &nbsp; &nbsp; Total 85.486 69 &nbsp; &nbsp; &nbsp; NE1 Between Groups 11.433 1 11.433 4.98 0. 03 Within Groups 156.067 68 2.295 &nbsp; &nbsp; Total 167.5 69 &nbsp; &nbsp; &nbsp; NE2 Between Groups 1.144 1 1.144 0.62 0. 43 Within Groups 125.842 68 1.851 &nbsp; &nbsp; Total 126.986 69 &nbsp; &nbsp; &nbsp; NE3 Between Groups 6.001 1 6.001 6.73 0. 01 Within Groups 60.642 68 0.892 &nbsp; &nbsp; Total 66.643 69 &nbsp; &nbsp; &nbsp; NE4 Between Groups 0.005 1 0.005 0 0. 96 Within Groups 118.867 68 1.748 &nbsp; &nbsp; Total 118.871 69 &nbsp; &nbsp; &nbsp; DR1 Between Groups 0.305 1 0.305 0.21 0. 65 Within Groups 99.767 68 1.467 &nbsp; &nbsp; Total 100.071 69 &nbsp; &nbsp; &nbsp; DR2 Between Groups 0.043 1 0.043 0.03 0. 86 Within Groups 90.6 68 1.332 &nbsp; &nbsp; Total 90.643 69 &nbsp; &nbsp; &nbsp; DR3 Between Groups 2.976 1 2.976 2.85 0. 1 Within Groups 70.967 68 1.044 &nbsp; &nbsp; Total 73.943 69 &nbsp; &nbsp; &nbsp; DR4 Between Groups 0.686 1 0.686 0.44 0. 51 Within Groups 105.1 68 1.546 &nbsp; &nbsp; Total 105.786 69 &nbsp; &nbsp; &nbsp; DR5 Between Groups 0.576 1 0.576 0.62 0. 43 Within Groups 63.267 68 0.93 &nbsp; &nbsp; Total 63.843 69 &nbsp; &nbsp; &nbsp; DR6 Between Groups 0.076 1 0.076 0.07 0. 79 Within Groups 71.767 68 1.055 &nbsp; &nbsp; Total 71.843 69 &nbsp; &nbsp; &nbsp; TR1 Between Groups 0.144 1 0.144 0.09 0. 76 Within Groups 104.442 68 1.536 &nbsp; &nbsp; Total 104.586 69 &nbsp; &nbsp; &nbsp; TR2 Between Groups 0.011 1 0.011 0.01 0. 93 Within Groups 102.975 68 1.514 &nbsp; &nbsp; Total 102.986 69 &nbsp; &nbsp; &nbsp; TR3 Between Groups 1.144 1 1.144 0.78 0. 38 Within Groups 99.942 68 1.47 &nbsp; &nbsp; Total 101.086 69 &nbsp; &nbsp; &nbsp; TR4 Between Groups 1.001 1 1.001 0.67 0. 41 Within Groups 100.942 68 1.484 &nbsp; &nbsp; Total 101.943 69 &nbsp; &nbsp; &nbsp; SHR1 Between Groups 1.071 1 1.071 0.7 0. 41 Within Groups 104.7 68 1.54 &nbsp; &nbsp; Total 105.771 69 &nbsp; &nbsp; &nbsp; SHR2 Between Groups 0.171 1 0.171 0.14 0. 71 Within Groups 83.2 68 1.224 &nbsp; &nbsp; Total 83.371 69 &nbsp; &nbsp; &nbsp; SHR3 Between Groups 0.305 1 0.305 0.22 0. 64 Within Groups 93.067 68 1.369 &nbsp; &nbsp; Total 93.371 69 &nbsp; &nbsp; &nbsp; PR4 Between Groups 0.576 1 0.576 0.44 0. 51 Within Groups 88.567 68 1.302 &nbsp; &nbsp; Total 89.143 69 &nbsp; &nbsp; &nbsp; PR1 Between Groups 1.376 1 1.376 1.11 0. 3 Within Groups 84.067 68 1.236 &nbsp; &nbsp; Total 85.443 69 &nbsp; &nbsp; &nbsp; PR2 Between Groups 1.458 1 1.458 1.07 0. 31 Within Groups 92.842 68 1.365 &nbsp; &nbsp; Total 94.3 69 &nbsp; &nbsp; &nbsp; PR3 Between Groups 0.001 1 0.001 0 0. 98 Within Groups 167.442 68 2.462 &nbsp; &nbsp; Total 167.443 69 &nbsp; &nbsp; &nbsp; PR4 Between Groups 0.233 1 0.233 0.2 0. 66 Within Groups 80.067 68 1.177 &nbsp; &nbsp; Total 80.3 69 &nbsp; &nbsp; &nbsp; RR1 Between Groups 0.096 1 0.096 0.06 0. 8 Within Groups 105.175 68 1.547 &nbsp; &nbsp; Total 105.271 69 &nbsp; &nbsp; &nbsp; RR2 Between Groups 0.058 1 0.058 0.03 0. 87 Within Groups 136.742 68 2.011 &nbsp; &nbsp; Total 136.8 69 &nbsp; &nbsp; &nbsp; RR3 Between Groups 0.096 1 0.096 0.06 0. 81 Within Groups 115.175 68 1.694 &nbsp; &nbsp; Total 115.271 69 &nbsp; &nbsp; &nbsp; SR1 Between Groups 0.043 1 0.043 0.06 0. 82 Within Groups 53.4 68 0.785 &nbsp; &nbsp; Total 53.443 69 &nbsp; &nbsp; &nbsp; SR2 Between Groups 4.43 1 4.43 3.19 0. 08 Within Groups 94.442 68 1.389 &nbsp; &nbsp; Total 98.871 69 &nbsp; &nbsp; &nbsp; SR3 Between Groups 0.805 1 0.805 0.66 0. 42 Within Groups 82.567 68 1.214 &nbsp; &nbsp; Total 83.371 69 &nbsp; &nbsp; &nbsp; &nbsp; Between Groups 0.233 1 0.233 0.22 0. 64 SR4 Within Groups 73.767 68 1.085 &nbsp; &nbsp; &nbsp; Total 74 69 &nbsp; &nbsp; &nbsp; &nbsp; The table above presents an analysis of results for private and public sector of constructions in developing countries as far as factors affecting risk management are concerned. Here it is clearly shown that private and public sectors are affected the same way by the stated factors. &nbsp; <strong>5.</strong><strong>DISCUSSION</strong> After the collection of our data using questionnaires data was analyzed. The RII method provided a non-biased ranking of our risk factors according to how people responded. The top 10 major factors in our ranking and also concretized by the review of literature are as follows. Government instability was number one on our ranking using the RII method. Government instability is a key risk factor to consider because it is interlinked with many major risk factors that affect construction management in developing countries such as inflation, corruption, lack of equipment only to name a few. (Bekr, 2006) did a study in Iraq as a country which had an unstable government and noted that government instability leads to a lot of risks in a construction project since it affects time, cost, safety and quality of the project. In the research the previous author shows that government instability also affects the project&rsquo;s performance, hence making it hard for project managers to manage risks in the project&rsquo;s life circle. In the data analysis done resource availability ranks second amongst all other risk factors affecting construction management in developing countries. (Sharaf &amp; Abdelwahab, 2015) Resource availability also had a high rating in the stated authors study for risk factors for Egyptian constructions. (Akinbile et al., 2018)research paper also shows a high rating of resource availability as a risk factor in Nigerian. The author notes that this factor is amongst the top major factors, maybe due to its influence to the project&rsquo;s objectives if not well managed, hence(Zou et al., 2007)also supports the notion in construction projects. Market inflation holds the third position in the authors ranking using the RII method. Market inflation refers to the rise of prices of goods and services in the economy of a country over a period of time. (Sharaf &amp; Abdelwahab, 2015) also rates this factor as one of the major risk factors affecting construction management, Sharaf further notes that when prices rise the currency buys less. We see this in construction projects in developing countries like Zimbabwe that was highly affected by market inflation in 2008. The instability of currency leading to the price instability of goods and services was making it hard to plan, and manage projects within Zimbabwe. (Moyo &amp; Crafford, 2010). Furthermore several authors recognize market inflation as a key risk affecting construction management in developing countries amongst them is (Wiguna &amp; Scott, 2005) and (Goh &amp; Abdul-Rahman, 2013). On the fourth spot of the authors ranking using the RII method of analyzing there is the unavailability of skilled labor as a factor affecting risk management in construction projects in developing countries. This is also one of the major factors because it does not affect developing countries only. A study in an article published in 2015 by the General Contractors Of America also revealed that nearly 80% of American construction businesses are finding it hard to get skilled labor for their constructions businesses. (Tshele &amp; Agumba, 2014)in the research paper shows how key this factor is in developing countries by providing a critical research in South African construction industry, the noted author further states that this shortage of skilled labor has prompted the South African government to be reactive. However, (Windapo, 2016) argues that there is shortage of skilled labor in developing countries with the high population of educated young unemployed people. Several authors note that corruption is one of the major key risks in construction projects in developing countries. (Kenny, 2007)notes that corruption levels in developing countries affects risk management in construction projects to a greater extent since the impact of corruption goes way beyond bribery to low economic returns, poor projects results and low funding for maintenance. (Kenny, 2009). Corruption as a factor holds the fifth position in the author&rsquo;s analysis results. Capital cost is a major factor affecting risk management in construction industry for developing countries. This is because most of the developing countries do not have enough funds to fund their desired construction projects. Hence, they depend mostly on foreign funders, this leads to a delay in project completion time and over spending in a project. (Ofori, 2000)in a research about challenges of construction industry in developing countries states that developing country&rsquo;s local construction firms have no funds to sponsor privatized projects hence this imposed a huge risk to any started private project. Culture also qualifies to be on top ten major factors affecting risk management in developing countries. This is because culture plays a vital role whenever there are a huge number of people like work places. Culture affects work days, dress codes ,gender equality, salaries, values, religion, only to name a few. (Kivrak, Ross, Arslan, Tuncan, &amp; Dainty, 2009) Change in laws and regulations as a result of trying new effective ways in developing countries have a greater impact on risk management in construction industries. This may be a result of change in government or any other major changes in the ruling party of a particular country hence it has a direct impact on construction business. (Chandra, 2015)Also recognizes this factor as a key factor affecting risk management in developing countries. Error and omission in design also qualifies to be in the top ten according to the RII rating. A design with errors is misleading and also a design with insufficient details is misleading hence this has a direct impact on many aspects of the project&rsquo;s life circle it also affects the financial side of the projects. There will be a lot of time wasting trying to solve and re-interpret the new designs hence delays are prone to happen in such cases. Design change is recognized as a key factor with a high rating in its effect on risk management in construction for developing countries, several authors support this point(Akinbile et al., 2018). The change in design is time consuming and also costs a lot of money. &nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp; After carefully observing the data from the survey collected using questionnaires, most of the respondents were from the private sector with a difference of ten from the public sector. The author then used the Analysis of variance to analyze the data so as to get a none biased result of variance between the private and public sector. The results of the analysis were helpful as they proved that the private sector of developing countries is affected by the same factors with the public sector to a greater extent. Our analysis proves to be authentic since most of our compared results seem to be the same. The author concludes that private and public sector are affected in the same way by the most stated factors as far as risk management in construction of developing countries is concerned. However, there are three factors that vary in response according as suggested by the data, improper cost plan (FR2), natural hazards (NER1) and ecology (NER3). &nbsp; <strong>6.</strong><strong>Conclusion</strong> Results of research show that the most significant factors affecting risk management in developing countries are government instability, lack of skilled labor and inflation. These factors have the highest percentage as shown by the relative information index in table 2 above. The most significant factors that affect risk management in construction are the ones that are common and noticeable in developing countries construction projects. Besides, we need to concentrate on top 10 major factors from RII method as major factors affecting risk management in most construction projects in developing countries. 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To emphasize the journal’s concern with AGI safety, we inaugurate Artificial General Intelligence (AGI) by focusing the first issue on Risks, Governance, and Safety &amp; Alignment Methods. Risks The AI Risk Repository: A Comprehensive Meta-Review, Database, and Taxonomy of Risks from Artificial Intelligence The most comprehensive AI risk taxonomy — 777 specific risks classified into 43 categories — to date has been created by workers collaborating from a half-dozen institutions. We except 11 key pages from the original 79-page report. Their ‘living’ Repository is online and free to download and share. The authors’ intention is to provide a common frame of reference for AI risks. Slattery et al.’s set of ~100 references is excellent and thorough. Thus, pouring through this study for your own specific interest is an efficient way to get on top of the entire current AI risk literature. The highest of their three taxonomy levels, the Causal Taxonomy, is categorized according to the cause of the risk, Human or AI the intention , Intentional action or Unintentional, and timing — Pre-deployment of the AI system or Post-deployment. The Causal Taxonomy can be used “for understanding how, when, or why risks from AI may emerge.” They also call readers’ attention to the AI Incident Database.[1] The Incident Database publishes a monthly roundup here. AI Risk Categorization Decoded (AIR 2024) By examining 8 government and 16 corporate AI risk policies, Zeng et al. seek to provide an AI risk taxonomy unified across public and private sector methodologies. They present 314 risk categories organized into a 4-level hierarchy. The highest level is composed of System &amp; Operational Risks, Content Safety Risks, Societal Risks, and Legal &amp; Rights Risks. Their first takeaway from their analysis is more categories is advantageous, allowing finer granularity in identifying risks and unifying risk categories across methodologies. Thus, indirectly they argue for the Slattery et al. taxonomy with double the categories. This emphasis on fine granularity parallels a comment made to me by Lance Fortnow, Dean of Illinois Institute of Technology College of Computing, on the diversity and specificity of human laws indicating a similar diversity may be necessary to assure AGI safety, and that recent governance proposals may be simplistic. Indeed, Zeng et al.’s second takeaway is that government AI regulation may need significant expansion. Few regulations address foundation models, for instance. And their third takeaway is that comparing AI risk policies from diverse sources is extremely helpful to develop an overall grasp of the issues – how different organizations conceptualize risk, for instance – and how to move toward international cooperation to manage AI risk. AIR-Bench 2024: A Safety Benchmark Based on Risk Categories from Regulations and Policies Applying the work just described above, Zeng et al. constructed an AI safety benchmark aligned with their unified view of private and public sector AI risk policy and specifically targeting the gap in regulation of foundation models they uncovered. They develop and test nearly 6000 risky prompts and find inconsistent responses across foundation models. Zeng et al. give examples of foundation model safety failures in response to various prompts. This work seems a significant advance toward an AGI safety certification conducted by an AI industry consortium or an insurance company consortium along the lines of, e.g., UL Solutions (previously Underwriters’ Laboratory). A Comprehensive Survey of Advanced Persistent Threat Attribution We wanted to publish this important article had to pull it due to a license conflict – please see their arXiv preprint. APT [Advanced Persistent Threat] attacks are attack campaigns orchestrated by highly organized and often state-sponsored threat groups that operate covertly and methodically over prolonged periods. APTs set themselves apart from conventional cyber-attacks by their stealthiness, persistence, and precision in targeting. This systematic review by Rani et al. of 137 papers focuses on the increasing development of automated means to detect AI and ML APTs early and identify the malevolent actors involved. They present the Automated Attribution Framework, which consists of 1) collecting the training data of past attacks, 2) preprocessing and enrichment of the training data, 3) the actual training and pattern recognition on the data, and 4) attribution — applying the trained models to identify the malevolent perpetrating actors. The open research questions summarized by Rani et al. lead toward AI taking an increasing role in APT attribution. Governance Excerpts from Aschenbrenner, Situational Awareness I was pointed to Leopold Aschenbrenner’s 165-page missive by Scott Aaronson’s blog, which said he knew Leopold during his sabbatical at OpenAI and recommended people give it a read and take it seriously. The essence of it is that if we extrapolate from recent AI progress, we will have AGI by 2030, and therefore, for national security, a Manhattan Project-style national AI effort, including nationalizing leading private AGI labs, should be mounted. Here we reprint his Part IV, “The Project,” advocating this controversial effort and describing his vision of how it will occur. I recommend anyone concerned about the dangers of AGI, and especially those working toward AGI, read Aschenbrenner’s entire book. Take a look at the Table of Contents preceding our reprint of “The Project.” And we reprint his Ch. V, “Parting Thoughts,” in our Commentary section. Soft Nationalization: How the US Government Will Control AI Labs Aschenbrenner advocates nationalizing leading AI labs into a high-security, top-secret, US federal government project. OK, how, exactly? A perfect complement to Aschenbrenner’s thoughts is given by Deric Cheng and Corin Katzke of Convergence Analysis. They examine how AGI R&amp;D nationalization could happen realistically, effectively, and efficiently. Their report outlines key issues and initial thoughts as a prelude to their own and others’ detailed proposals to come. It is a beautiful piece of work, IMHO. It is not impossible for private companies to develop AGI responsibly and securely, but the main goal of this journal is to make AGI safety the central debate in the AGI community, and the nationalized, Manhattan-style project point of view must be presented. Further, I find Aschenbrenner’s arguments to be persuasive and Cheng and Katzke’s thoughtful outline of how nationalization could actually occur to be convincing, e.g. (pg. 8): The US may be able to achieve its national security goals with substantially less overhead than total nationalization via effective policy levers and regulation… We argue that various combinations of the policy levers listed below will likely be sufficient to meet US national security concerns, while allowing for more minimal governmental intrusion into private frontier AI development. Acceptable Use Policies for Foundation Models Acceptable use policies are legally binding policies that prohibit specific uses of foundation models. Klyman surveys acceptable use policies from 30 developers encompassing 127 specific use restrictions cited in 184 articles. Like Zeng et al. in “AI Risk Categorization Decoded (AIR 2024),” Klyman highlights the inconsistent number and type of restrictions across developers and lack of transparency behind their motivation and enforcement, indicating the need to for developers to create a unified consensus acceptable use policy. The general motivations are to reduce legal and reputational risk. However, standing in the way of developers working to create a unified policy set is the motivation to use restrictions to hinder competition from using proprietary models. Enforcement can also hinder effective use of a foundation model. Acceptable use policies can be categorized into content restrictions (e.g. the top 4: misinformation, harassment, privacy, discrimination) and end use restrictions, e.g. Anthropic’s restriction on “model scraping,” which is someone training their own AI model on prompts and outputs from Anthropic’s model. Another use restriction is scaling up AI-created content distribution such as automated online posting. As with the Zeng et al. articles, Klyman’s article points the way to create a homogeneous acceptable use policy across a diverse AI ecosystem. Steve Omohundro comments: “…the AI labs’ ‘alignment work’ … is all about the AIs rather than their impact on the world. For goodness sake, the Chinese People's Liberation Army has already fine-tuned Meta's Llama 3.1 to promote Chinese military goals! And Meta's response was ‘that's contrary to our acceptable use policy!’" From the article: Without information about how acceptable use policies are enforced, it is not obvious that they are actually being implemented or effective in limiting dangerous uses. Companies are moving quickly to deploy their models and may in practice invest little in establishing and maintaining the trust and safety teams required to enforce their policies to limit risky uses. Safety Methods Benchmark Early and Red Team Often (Executive Summary excerpt) Two leading methods for uncovering AI safety breaches are 1) inexpensive benchmarking against a standardized test suite, such as prompts for large language models, and 2) longer, higher-cost but more informative intensive, interactive testing by human domain experts (“red-teaming”). Barrett et al., from the UC Berkeley Center for Long-Term Cybersecurity, advocate for this two-pronged approach indicated by the article title. They analyze the methods’ potential for eliminating LLM “dual” use, i.e. corrupting LLMs into creating chemical, biological, radiological, nuclear (CBRN) or cyber or other weaponry or attacks, but the methods apply to less dangerous risk testing as well. Essentially Barrett et al. advocate frequent use of benchmarks until a model attains a high safety score, followed by intensive red-teaming to test the model in more depth and yield more accuracy. Their paraphrase of the article title is: Benchmark Early and Often, and Red-Team Often Enough. Against Purposeful Artificial Intelligence Failures A paper that had to be written, and not surprisingly was, by Yampolskiy, who has sought to cover every aspect of AGI risks, is one arguing that intentionally triggering an AI disaster should not be entertained as an option to alert humanity to the danger of AGI. Models That Prove Their Own Correctness Especially in light of Dalrymple et al.’s governance proposal, Toward Guaranteed Safe AI: A Framework for Ensuring Robust and Reliable AI Systems, ‘models that prove their own correctness’ seems especially desirable, if not essential. Dalrymple et al. call for 1) a world model, 2) a safety specification, and 3), a means to verify the safety specification, a highly intriguing proposal, but which falls short of providing an example of such a model or means of verification (we hear that Dalrymple is working on an example). Paradise et al. describe two uses of interactive proof systems (IPS) combined with ML to allow a model to prove its own ‘correctness,’ as specified by the user of the model. The first method requires access to a training set of IPS transcripts (the sequence of interactions between the Verifier and Prover) in which the Verifier accepted the Prover’s probabilistic proof. The second method, Reinforcement Learning from Verifier Feedback (RLVF; note their intentional similarity to Reinforcement Learning from Human Feedback, RLHF) avoids the need for the accepted transcripts (which are in essence an external truth oracle) but only after training on such a verified transcript (its ‘base model’) using transcript learning. From then on it can generate its own emulated verified transcripts. The paper opens the door to other innovative applications of ML to IPS. This is a rather deep paper that requires further analysis to judge the realization of its promise. We look forward to a revised version after its peer review at an unspecified journal. We thank Syed Rafi for the pointer to the paper and Quinn Dougherty for inviting Orr Paradise to his safe AGI reading group. Language-Guided World Models: A Model-Based Approach to AI Control Model-based agents are artificial agents equipped with probabilistic “world models” that are capable of foreseeing the future state of an environment (Deisenroth and Rasmussen, 2011; Schmidhuber, 2015). World models endow these agents with the ability to plan and learn in imagination (i.e., internal simulation)…. Citing Dalrymple et al., Zhang et al. likewise extend the capabilities of world models to increase human control over AI. By adjusting the world model, humans can affect many context-sensitive policies simultaneously. However, for the human-AI interaction to be efficient, the world model must process natural language (NLP); hence, language-guided world models (LWMs). NLP also increases the efficiency of model learning by permitting them to read text. World models increase AI transparency, which NL interaction furthers by allowing humans to query models verbally. As an example, in Sec. 5.3, “Application: Agents that discuss plans with humans,” Zhang et al. describe an agent that uses its LWM to plan a task and then ask a human to review it for safety. Commentary Steve Omohundro, “Progress in Superhuman Theorem Proving?” Our co-founding editor Steve Omohundro is a strong proponent of Provably Safe AI, in which automated theorem-proving will play a major role.[2] Here Steve discusses current developments in using proof to lessen LLM hallucinations, the implications of superhuman theorem-proving for safe AGI and resources for interested readers. On Yampolskiy, “Against Purposeful Artificial Intelligence Failures” Topic Editor Jim Miller, Professor of Economics, Game Theory, and Sociology at Smith College, critiques Roman Yampolskiy’s argument against triggering a deliberate AI failure to wake the world up to AI dangers. Leopold Aschenbrenner, Situational Awareness, “Parting Thoughts” Aschenbrenner dismisses his critics as unrealistic and outlines the core tenets of “AI Realism.” Rowan McGovern, “Unhobbling Is All You Need?” Commentary on Aschenbrenner’s Situational Awareness McGovern questions Aschenbrenner’s fundamental assumption that “unhobbling” alone — “fixing obvious ways in which models are hobbled by default, unlocking latent capabilities and giving them tools, leading to step-changes in usefulness” — will result in his extrapolation of recent AI progress to predict the advent of AGI by 2030. McGovern: “Unhobbling conflates computing power with intelligence.” [1] https://incidentdatabase.ai/. “Like similar databases in aviation and computer security, the AI Incident Database aims to learn from experience so we can prevent or mitigate bad outcomes.” [2] Tegmark, M., &amp; Omohundro, S. (2023). Provably safe systems: the only path to controllable AGI. arXiv. Retrieved from https://arxiv.org/abs/2309.01933.

Photo ID 280792184 © Jj Gouin| Dreamstime.com Abstract Healthcare providers should advocate for human and civil rights. They ought to recognize injustices that unfairly disadvantage certain groups of people and work to improve broader conditions that affect health. Healthcare systems have historically undervalued and even excluded certain voices from the creation of an evidence base for care, furthering health disparities for members of these groups. This is a form of testimonial injustice. Trans people experience a particular form of testimonial injustice in healthcare settings when evidence and expertise related to their lived experience are excluded from consideration, as was the case with the 2024 Cass Review. Such exclusion can lead to mistreatment and harm. Providers must be vigilant in recognizing and addressing testimonial injustice against trans patients and the health disparities it can cause. Introduction Trans individuals (people who identify as transgender, transsexual, or whose gender identity is different from the sex they were assigned at birth) face many barriers to health care. The lack of competent, knowledgeable providers poses a significant barrier to gender-affirming care, as well as other forms of everyday health care for trans people.[1] Addressing this challenge requires health professionals to actively oppose structures that perpetuate epistemic injustice, which Miranda Fricker defines as “wrong done to someone specifically in their capacity as a knower.” Testimonial injustice (a kind of epistemic injustice) undermines collective understanding of marginalized perspectives through systemic misrepresentation or dismissal of marginalized individuals’ experiences or contributions.[2] Testimonial injustice contributes to unjust conditions for accessing care and results in poorer health outcomes for transgender individuals. As professionals committed to ethical and equitable patient treatment, we believe it is imperative that healthcare providers recognize and carefully consider the experiences and expertise of trans people in order to address injustices experienced by trans people in healthcare settings. Through an analysis of the Cass Review, we demonstrate how a flawed interpretation of available evidence and the dismissal of trans testimonies generates an injustice that results in significant and unwarranted restrictions on gender-affirming care. Testimonial Injustice Trans people regularly experience testimonial injustice in health care. It occurs when providers inappropriately discount their patients’ accounts — for example, by refusing to believe patients when they say that they are trans or gender non-conforming. This results in prejudiced assumptions about health behaviors or needs, bias and stereotyping that influence clinical judgment, and harm in the form of worse physical and mental health outcomes.[3] Testimonial injustice takes several pernicious forms. For example, a Black woman whose reports of high postpartum pain are disregarded by her providers because of her Blackness has suffered testimonial injustice when she receives lower doses of pain medication compared to other postpartum patients at the same hospital.[4] Her attestation of pain, an experience at once personal and universal, has been inappropriately regarded as insufficiently credible, resulting in harmful and unequal postpartum pain management. Testimonial injustice harms the physical, mental, and social well-being of trans people, worsening health outcomes caused by systemic barriers and discriminatory practices. Negative healthcare experiences, along with mistreatment from providers, lead to disproportionately high rates of depression, psychological distress, and suicidal ideation among trans patients.[5] These harmful interactions lead to lower healthcare utilization and delayed treatment. Trans people are also less likely to receive preventative cancer screenings, including for cervical, breast, and colorectal cancers.[6] These disparities, compounded by the accumulation of daily stress from discrimination, contribute to not only an increased risk of cancer but also to worse cancer outcomes.[7] Trans people are diagnosed at later stages, they are less likely to receive treatment for cancer and also have higher mortality rates for certain cancers.[8] Similar disparities are seen in cardiovascular health;[9] trans people are at greater risk for heart attacks.[10] They are also more likely to have multiple concurrent chronic conditions, including coronary heart disease, asthma, arthritis, diabetes, cancer, stroke, kidney disease, etc.[11] Clearly, there are significant and life-threatening gaps in care for trans people. These disparities result in worsened health outcomes, increased mistrust, and preventable deaths. A key factor in addressing these disparities is awareness of testimonial injustice: providers must recognize how their personal interactions with trans individuals, in the context of broader systemic barriers to adequate healthcare, can contribute to harmful practices and negligent care. In what follows, we argue that testimonial injustice contributes to trans peoples’ well-documented experiences of healthcare discrimination. The Cass Review The 2024 Cass Review (“the Review”), an independent review of gender treatment for trans youth commissioned by the National Health Service (NHS) in England, has caused significant harm to young trans people in the UK. The NHS ordered the Review, comprising of six systematic reviews, after concerns arose regarding an increase in referrals for trans care associated with doubts about its scientific rationale. The Review’s recommendations stem from a narrow reading of the evidence base for gender-affirming care and have resulted in significant restrictions on puberty-suppressing medication, hormone therapy, and care availability for trans youth in the UK.[12] Professional organizations and transgender health providers have widely criticized the Review’s findings. They assert that it contains many errors that “conflict with well-established norms of clinical research and evidence-based health care” and “raise serious concern about the scientific integrity of critical elements of the report’s process and recommendations.”[13] For example, the Review claims that referrals for trans care have grown exponentially (even while most transgender adolescents in the UK are not referred for care, and an expert critique of the Review led by the Integrity Project at Yale University found that the exponential growth is likely the result of double-counting referrals). This critique observes that the Review makes the provision of gender-affirming care appear “rushed, careless, and common,”[14] despite a waiting time of over two years for the assessment. Further, of the patients seen during the Review’s period of study, only 27 percent were referred to endocrinology for consideration of medical intervention. The Review includes an unsubstantiated concern that early supportive interventions such as puberty blockers necessarily result in irreversible effects. Puberty blockers, or gonadotropin releasing analogue (GnRHa), cause a temporary downregulation of the production of estrogen or testosterone when used during early puberty.[15] When prescribed for cis (people whose gender identity corresponds to the sex they were assigned at birth) and trans youth alike, they pause puberty (i.e., delaying development of secondary sex characteristics) reversibly. Reproductive function is restored if endogenous puberty resumes.[16] This therapy alone does not typically cause permanent physical changes, and when treatment is stopped, puberty resumes.[17] GnRHa medications are commonly used in treatment for precocious puberty in cisgender youth without impairing reproductive development or function, and research has demonstrated that puberty was continued within one year after GnRHa discontinuation.[18],[19] Long-acting GnRHa usage is also routinely seen in fertility preservation as the only medical option to preserve ovarian function in patients with cancer.[20] Indeed, after starting GnRHa medications, the collection of sperm or ova for reproductive purposes is a well-established option.[21] Studies have consistently shown that puberty blockers lead to positive outcomes for trans youth, including significant improvements in overall functioning, reductions in depressive symptoms, and lower lifetime rates of suicidal ideation.[22] The Review’s approach to the evaluation of evidence led to the exclusion of substantial peer-reviewed evidence in support of puberty blockers and hormones, including evidence regarding the lived experiences of trans youth. For instance, the authors deemed only one of the 50 studies in the systematic review of puberty blockers to be “high quality.” This is not a value-neutral or inevitable way to frame these studies. Rather, the research studies excluded from the Review because of “low evidence” were often qualitative or observational investigations that had no control group, while the ones considered “high quality” tended to be randomized controlled trials (RCTs).[23] However, discounting observational studies inappropriately treats transness as exceptional because observational studies constitute much of the evidence that guides clinical care for all fields of medicine.[24] Indeed, the World Health Organization published a series of papers in 2019 on the value of including qualitative studies in the development of clinical guidelines, arguing that “Qualitative evidence is crucial to improve the understanding on how, and whether, people perceive health interventions to be effective and acceptable. It is also essential to understand the factors influencing the implementation of health policies and interventions.” In other words, this kind of evidence provides context and reasoning that frame, rather than flattens, the complexity of human experiences that shape and are shaped by gender-affirming care.[25] Randomized controlled trials are often considered unethical in studying gender-affirming care. One reason for this is the lack of clinical equipoise: the medical community has already accepted gender-affirming care as the clinical standard, so there is dubious value in using limited resources to study resolved research questions.[26] In a randomized clinical trial, the control group would typically receive psychotherapy for gender-incongruent puberty instead of medications, which would necessitate withholding beneficial gender-affirming care from participants when there is evidence that treatment prevents serious harm.[27] On the other hand, observational studies can include more diverse patient populations and offer greater specificity about experiences than randomized controlled studies. Larger observational studies with extended follow-ups can also identify long-term benefits or harms that are useful for clinical guidelines.[28] Treating this kind of evidence as insufficient to support trans care represents a biased approach that undermines the legitimacy of patient testimony in the development of an evidence base for trans individuals. The selective use of evidence constitutes a form of testimonial injustice, as an entire body of medical knowledge important to, and often generated by, those affected is systematically dismissed. The Review limited meaningful involvement from trans patients and providers who had experience in the provision of gender-affirming care.[29] The Review’s Assurance Group — which was intended to provide “expert advice” on the conduct of the review — explicitly left out trans voices, stating that its “Members are independent of … providers of gender dysphoria services, and of any organisation or association that could reasonably be regarded as having a significant interest in the outcome of the Review.”[30] The logic of this exclusion was to ensure that nobody with a “significant interest in the outcome of the review” would bias its results through their personal or professional commitments. This approach is analogous to attempting to eliminate bias from a panel shaping clinical guidelines for heart disease by excluding both cardiologists and heart disease patients. The problem is not merely that trans people and those with expertise in their care were excluded as experts. This approach also flies in the face of contemporary best research practices that treat both lived and professional experience as important forms of expertise. Trans people and the people who provide them with health care should have been actively involved in research that affects their lives and care. The deliberate exclusion of their voices from the review process is a clear example of testimonial injustice. The Review excludes providers with experience in gender services due to the assumption of bias. In doing so, it implies that those who are empowered to lend their expertise are without bias. By treating only support for transgender adolescents as a disqualifying bias, the Review reviews its own normativity. The framework of testimonial injustice helps us to understand the links between the discounting of individual testimony about identity and the constitution of medical authority that translates such refusal to believe into refusal to provide care. In addition to minimizing the input of patients and providers with lived experience in the Assurance Group, the Cass Review also included healthcare workers who explicitly deny trans identity in its “online multi-professional panel to explore issues around gender identity services.” When prompted with the statement There is no such thing as a trans child. Gender dysphoria is always an indicator of another underlying problem, and assessment should focus on understanding the causes of their distress. 21 percent of the panel responded that they strongly agree or agree. The authors of the Review may feel that excluding transgender people and the physicians who care for them preserves objectivity. We argue, however, that it is inappropriate to include as expert advisors individuals who do not acknowledge the existence of the group the Cass Review examines and whose access to care the Review will, in turn, shape.[31] These experts call the existence of transgender youth (not just the kind of care that they need) into question: another decisive case of testimonial injustice. The Review does not make it clear that such a significant proportion of the experts it relies on do not believe in transgender children or that the root cause of distress in this population is gender. It may be unclear to policymakers and the public that people holding such views are shaping practice norms. This insight emerges only when evaluating the Likert response answers provided by the Review’s expert consultants via auxiliary reports, not via the main document or any included disclosures, discussions, or reports of the Review's limitations. The Review has had immediate and significant ramifications for trans NHS patients’ access to gender-affirming care.[32] It was also extensively cited as evidence against adolescent gender-affirming care provision in the oral arguments of US v. Skrmetti, a case about the constitutionality of Tennessee’s ban on gender-affirming care for minors.[33] Citing its early findings, the British government ordered closures of children’s gender services and stopped accepting referrals for gender-affirming care.[34] The Review was also used to justify halting the use of puberty blockers for the treatment of youth gender dysphoria, though the same medications remained available for other pediatric health needs (e.g., precocious puberty).[35] Systemic Testimonial Injustice Trans people experience testimonial injustice far beyond what the Cass Review manifests. One such everyday form is how trans individuals must not only articulate the legitimacy of their identities but defend them against accusations of insufficient self-knowledge or the intent to deceive others about their gender.[36] Many have experienced this injustice when required to convince their healthcare providers that they are “trans enough” to receive needed care. In a focus group conducted with trans youth in 2022, participants described having their gender identity questioned by providers: I think the big question, the question I’ve come back to over and over again [the doctor] asked me is, what does being a girl mean to you? And I didn’t have an answer. He was very skeptical of my lack of an answer for that. He was like, well I just – I feel like you should be able to talk about this. I think you might be moving too fast if you can’t talk about this. And I was like, well, no I think it’s just a stupid question. But I didn’t say that because I was 14 and small and nervous… And then when my parents came back in … he said he wanted to caution us against moving too quickly because he’s against permanent changes in children at a young age. He says he doesn’t think it’s a good idea... He just doesn’t think there’s enough science behind it to back it up.[37] Trans youth suffer testimonial injustice when their identities and existence are met with unreasonable skepticism or discounted entirely. This perceived lack of credibility often results in challenges from medical providers who may frame their own skepticism as concerns regarding reversibility and potential for regret. While irreversible interventions may demand special scrutiny and regret is generally to be avoided, the fact of such risks should not automatically preclude the provision of gender-affirming care. The frame of testimonial injustice helps us to see how provider interactions like these exemplify the systemic prejudice that trans people and others who diverge from cisnormative expectations face when their credibility is discounted, and accounts of their own selves are deemed untrustworthy.[38] Clinicians’ skepticism about their adolescent patients’ need for gender-affirming care may be rooted in an assessment that there is insufficient evidence to support gender affirmation as a standard of care. While the Cass Review’s findings of such evidentiary weakness have been strongly disputed by a number of analyses discussed elsewhere in this piece, we also posit that quibbling over what the evidence reveals is only part of the task of evaluating evidence. In the case of gender transition, where the denial of care will be experienced as a significant harm to the trans person, inaction – care refusal – must not be treated as a morally neutral option. Instead, care refusal must itself be regarded as having the potential to harm. Whether someone considering the ethics of gender-affirming care begins with an assumption that care provision or care denial ought to be, the status quo is, particularly in light of the vehemence of contemporary fights over access to gender-affirming care, more a question of values than it is of evidence. Physicians often treat patients whose symptoms cannot be proven or diagnosed with “objective” data. Myriad forms of routine medical care rely solely or primarily on patient testimony; not only is gender dysphoria unexceptional in this regard as a diagnosis, hormonal and surgical intervention to alleviate distress and bring about patient well-being is similarly standard medical procedure. Psychological and psychiatric care can often only be provided on the basis of patients’ self-reported experiences of mental illness, as those illnesses may not generate measurable physical effects. For instance, conditions such as the excess breast tissue that indicates gynecomastia in cisgender men are similarly predicated on patient articulations of their own experiences and needs. In all these cases, self-related phenomena are clinically relevant, and although some may dismiss them as empirically intractable, doing so would clearly be a mistake.[39] Healthcare systems also pose various significant hurdles to accessing forms of gender-affirming care, including their criteria for insurance coverage approval. Insurers’ criteria are unstandardized and often arbitrary. Yet, they profoundly shape the kind of care available, particularly given the economic precarity that prevents many trans people from paying for treatment out-of-pocket.[40] To secure coverage, trans individuals must frame their experience in accordance with insurers’ standards rather than medical standards alone.[41] The need to provide persuasive accounts to unlock care forces trans people to conform to specific, deficit-based descriptions of their identities as pathological and the ambiguous definition of medical necessity used by insurance companies.[42] This system reflects a form of testimonial injustice, effectively requiring trans people to present strategic narratives to obtain care and mold their needs to fit the stringent requirements of insurance. The disparate insurance criteria for gender-affirming care undermines existing forms of evidence — which are primarily based on testimonies. It treats the knowledge that trans people possess about their bodies as insufficiently credible to warrant medical autonomy.[43] This is an unjust standard of evidence. In this way, even well-meaning providers sometimes subject trans patients to arbitrary barriers to care purely on the basis of their gender identity. Conclusion All providers should understand the risk of testimonial injustice to trans people in healthcare contexts. This is particularly urgent for providers who treat trans patients. Since all providers will treat trans patients regardless of specialty, all healthcare practitioners should address testimonial injustice. Accordingly, they must work to counter the devaluation of trans testimonies, not just in individual patient and provider experiences but across the medical community and system at large. Invalidating trans-patient experiences not only erodes trust in the healthcare system but may lead to inadequate or harmful therapeutic approaches. As a result, testimonial injustice perpetuates a cycle of negative health outcomes, which can include worsened mental health,[44] significantly greater risk of cardiovascular disease,[45] higher rates of chronic illness,[46] higher rates of disability,[47] and more preventable deaths[48] compared to cisgender individuals. The stakes here are high: testimonial justice is essential to providing good health care for all. Justice demands that we not only take the testimonies of trans people seriously but understand them as fundamental to the provision of needed health care. - [1] Safer JD, Coleman E, Feldman J, Garofalo R, Hembree W, Radix A, Sevelius J. Barriers to healthcare for transgender individuals. Curr Opin Endocrinol Diabetes Obes. 2016 Apr;23(2):168-71. doi: 10.1097/MED.0000000000000227. PMID: 26910276; PMCID: PMC4802845. [2] Fricker M. Epistemic Injustice: Power and the Ethics of Knowing. New York, NY: Oxford University Press; 2007. [3] Fact Sheet: Protecting and Advancing Health Care for Transgender Adult Communities. Center for American Progress. https://www.americanprogress.org/article/fact-sheet-protecting-advancing-health-care-transgender-adult-communities/#:~:text=Compared%20with%20the%20general%20population [4]Greene NH, Kilpatrick SJ. Racial/ethnic disparities in peripartum pain assessment and management. Joint Commission Journal on Quality and Patient Safety. 2024. doi:10.1016/j.jcjq.2024.03.009; Badreldin N, Grobman WA, Yee LM. Racial disparities in postpartum pain management. Obstetrics &amp; Gynecology. 2019;134(6):1147-1153. doi:10.1097/AOG.0000000000003561 [5] Levine, S., Heiden-Rootes, K., &amp; Salas, J. (2022). Associations Between Healthcare Experiences, Mental Health Outcomes, and Substance Use Among Transgender Adults. The Journal of the American Board of Family Medicine, 35(6), 1092–1102. https://doi.org/10.3122/jabfm.2022.220186r1; Inman, E. M., Juno Obedin-Maliver, Ragosta, S., Hastings, J., Berry, J., Lunn, M. R., Flentje, A., Capriotti, M. R., Lubensky, M. E., Stoeffler, A., Zubin Dastur, &amp; Moseson, H. (2023). Reports of Negative Interactions with Healthcare Providers among Transgender, Nonbinary, and Gender-Expansive People assigned Female at Birth in the United States: Results from an Online, Cross-Sectional Survey. 20(11), 6007–6007. https://doi.org/10.3390/ijerph20116007 [6] Kiran, T., Davie, S., Singh, D., Hranilovic, S., Pinto, A. D., Abramovich, A., &amp; Lofters, A. (2019). Cancer screening rates among transgender adults: Cross-sectional analysis of primary care data. 65(1), e30–e37. [7] Jackson, S. S., &amp; Hammer, A. (2023). Cancer risk among transgender adults: A growing population with unmet needs. Acta Obstetricia et Gynecologica Scandinavica, 102(11), 1428–1430. https://doi.org/10.1111/aogs.14686 [8] Jackson, S. S., &amp; Hammer, A. (2023). Cancer risk among transgender adults: A growing population with unmet needs. Acta Obstetricia et Gynecologica Scandinavica, 102(11), 1428–1430. https://doi.org/10.1111/aogs.14686 ; Jackson, S. S., Han, X., Mao, Z., Nogueira, L., Suneja, G., Jemal, A., &amp; Shiels, M. S. (2021). Cancer Stage, Treatment, and Survival Among Transgender Patients in the United States. JNCI: Journal of the National Cancer Institute, 113(9), 1221–1227. https://doi.org/10.1093/jnci/djab028 [9] Health disparities and equitable access to health care persist with transgender adults. (n.d.). American Heart Association. https://newsroom.heart.org/news/health-disparities-and-equitable-access-to-health-care-persist-with-transgender-adults [10] Alzahrani, T., Nguyen, T., Ryan, A., Dwairy, A., McCaffrey, J., Yunus, R., Forgione, J., Krepp, J., Nagy, C., Mazhari, R., &amp; Reiner, J. (2019). Cardiovascular Disease Risk Factors and Myocardial Infarction in the Transgender Population. Circulation: Cardiovascular Quality and Outcomes, 12(4). https://doi.org/10.1161/circoutcomes.119.005597 [11] Downing, J. M., &amp; Przedworski, J. M. (2018). Health of Transgender Adults in the U.S., 2014–2016. American Journal of Preventive Medicine, 55(3), 336–344. https://doi.org/10.1016/j.amepre.2018.04.045 [12] WPATH and USPATH COMMENT on the CASS REVIEW.; 2024. https://www.wpath.org/media/cms/Documents/Public%20Policies/2024/17.05.24%20Response%20Cass%20Review%20FINAL%20with%20ed%20note.pdf?_t=1716075965 [13] McNamara M, Baker K, Connelly K, et al. An evidence-based critique of “The Cass Review” on gender-affirming care for adolescent gender dysphoria. 2024; Rew L, Young CC, Monge M, Bogucka R. [White paper]. 2020. [14] McNamara M, Baker K, Connelly K, et al. An evidence-based critique of “The Cass Review” on gender-affirming care for adolescent gender dysphoria. 2024; Rew L, Young CC, Monge M, Bogucka R. [White paper]. 2020. [15] Guss, C., &amp; Gordon, C. M. (2022). Pubertal Blockade and Subsequent Gender-Affirming Therapy. JAMA Network Open, 5(11), e2239763. https://doi.org/10.1001/jamanetworkopen.2022.39763 [16] Riggs, D. W., Tollit, M., &amp; Lin, A. (2021). Refusing puberty blockers to trans young people is not justified by the evidence. The Lancet Child &amp; Adolescent Health, 5(9), e35–e36. https://doi.org/10.1016/s2352-4642(21)00233-9 [17] Mayo Clinic Staff. (2023, June 14). Pubertal blockers for transgender and gender diverse youth. Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/gender-dysphoria/in-depth/pubertal-blockers/art-20459075 [18] Heger, S., Müller, M., Ranke, M., Schwarz, H.-P., Waldhauser, F., Partsch, C.-J., &amp; Sippell, W. G. (2006). Long-term GnRH agonist treatment for female central precocious puberty does not impair reproductive function. Molecular and Cellular Endocrinology, 254-255, 217–220. https://doi.org/10.1016/j.mce.2006.04.012 [19] Kim, E. Y. (2015). Long-term effects of gonadotropin-releasing hormone analogs in girls with central precocious puberty. Korean Journal of Pediatrics, 58(1), 1. https://doi.org/10.3345/kjp.2015.58.1.1 [20] Massarotti, C., Stigliani, S., Gazzo, I., Lambertini, M., &amp; Anserini, P. (2023). Long-acting gonadotropin-releasing hormone agonist trigger in fertility preservation cycles before chemotherapy. ESMO Open, 8(4), 101597. https://doi.org/10.1016/j.esmoop.2023.101597 [21] Giordano, S., &amp; Holm, S. (2020). Is puberty delaying treatment “experimental treatment”?. International Journal of Transgender Health, 21(2), 113–121. https://doi.org/10.1080/26895269.2020.1747768 [22] McNamara M, Baker K, Connelly K, et al. An evidence-based critique of “The Cass Review” on gender-affirming care for adolescent gender dysphoria. 2024; Rew L, Young CC, Monge M, Bogucka R. [White paper]. 2020. ; Rew L, Young CC, Monge M, Bogucka R. Review: Puberty blockers for transgender and gender diverse youth-a critical review of the literature. Child Adolesc Ment Health. 2021;26(1):3-14. doi:10.1111/camh.12437; Mayo Clinic Staff. Pubertal blockers for transgender and gender diverse youth. Mayo Clinic. Published June 14, 2023, https://www.mayoclinic.org/diseases-conditions/gender-dysphoria/in-depth/pubertal-blockers/art-20459075, Lee, J. Y., &amp; Rosenthal, S. M. (2022). Gender-Affirming Care of Transgender and Gender-Diverse Youth: Current Concepts. Annual Review of Medicine, 74(1). https://doi.org/10.1146/annurev-med-043021-032007 [23] Cass H. Final Report – Cass Review. cass.independent-review.uk. Published April 2024. https://cass.independent-review.uk/home/publications/final-report/ [24] McNamara M, Baker K, Connelly K, et al. An evidence-based critique of “The Cass Review” on gender-affirming care for adolescent gender dysphoria. 2024; Rew L, Young CC, Monge M, Bogucka R. [White paper]. 2020. [25] Using qualitative research to strengthen guideline development. (n.d.). Www.who.int. https://www.who.int/news/item/08-08-2019-using-qualitative-research-to-strengthen-guideline-development ; Downe, S., Finlayson, K. W., Lawrie, T. A., Lewin, S. A., Glenton, C., Rosenbaum, S., Barreix, M., &amp; Tunçalp, Ö. (2019). Qualitative Evidence Synthesis (QES) for Guidelines: Paper 1 – Using qualitative evidence synthesis to inform guideline scope and develop qualitative findings statements. Health Research Policy and Systems, 17(1). https://doi.org/10.1186/s12961-019-0467-5 ; Lewin, S., Glenton, C., Lawrie, T. A., Downe, S., Finlayson, K. W., Rosenbaum, S., Barreix, M., &amp; Tunçalp, Ö. (2019). Qualitative Evidence Synthesis (QES) for Guidelines: Paper 2 – Using qualitative evidence synthesis findings to inform evidence-to-decision frameworks and recommendations. Health Research Policy and Systems, 17(1). https://doi.org/10.1186/s12961-019-0468-4 ; Glenton, C., Lewin, S., Lawrie, T. A., Barreix, M., Downe, S., Finlayson, K. W., Tamrat, T., Rosenbaum, S., &amp; Tunçalp, Ö. (2019). Qualitative Evidence Synthesis (QES) for Guidelines: Paper 3 – Using qualitative evidence syntheses to develop implementation considerations and inform implementation processes. Health Research Policy and Systems, 17(1). https://doi.org/10.1186/s12961-019-0450-1 [26] Schall TE, Jaffe K, Moses JD. Roles of Randomized Controlled Trials in Establishing Evidence-Based Gender-Affirming Care and Advancing Health Equity. The AMA Journal of Ethic. 2024;26(9):E684-689. doi:https://doi.org/10.1001/amajethics.2024.684 [27] Ashley F, Tordoff DM, Olson-Kennedy J, Arjee Restar. Randomized-controlled trials are methodologically inappropriate in adolescent transgender healthcare. International Journal of Transgender Health. Published online June 24, 2023:1-12. doi:https://doi.org/10.1080/26895269.2023.2218357 [28] Gershon AS, Lindenauer PK, Wilson KC, et al. Informing Healthcare Decisions with Observational Research Assessing Causal Effect. An Official American Thoracic Society Research Statement. American Journal of Respiratory and Critical Care Medicine. 2021;203(1):14-23. doi:https://doi.org/10.1164/rccm.202010-3943st [29] Maung, D. H. (2024, April 12). Response to the Cass Review. GenderGP Transgender Services. https://www.gendergp.com/response-to-the-cass-review/ [30] Assurance Group – Cass Review. (2017). Independent-Review.uk. https://cass.independent-review.uk/about-the-review/assurance-group/ [31] Online Panel with Primary and Secondary Care Professionals Cass Review Engagement Report.; 2021. https://cass.independent-review.uk/wp-content/uploads/2022/03/REPORT-Cass-Review-professional-panel-FINAL.pdf [32] Horton C. The Cass Review: Cis-supremacy in the UK’s approach to healthcare for trans children. International Journal of Transgender Health. 2024;1–25. doi:10.1080/26895269.2024.2328249; United Nations Independent Expert on Protection against Violence and Discrimination Based on Sexual Orientation and Gender Identity Country Visit to the United Kingdom of Great Britain and Northern Ireland (24 April -5 End of Mission Statement.; 2023. https://www.ohchr.org/sites/default/files/documents/issues/sexualorientation/statements/eom-statement-UK-IE-SOGI-2023-05-10.pdf [33]Search - Supreme Court of the United States. (2023). Supremecourt.gov. https://www.supremecourt.gov/search.aspx?filename=/docket/docketfiles/html/public/23-477.html [34] Ali J. Doctors warn “NHS is failing trans people” amid row over Tavistock gender clinic. PinkNews | Latest lesbian, gay, bi and trans news | LGBTQ+ news. Published February 9, 2023. https://www.thepinknews.com/2023/02/09/tavistock-gender-clinic-closure-staff-open-letter-trans-healthcare/; NHS England» NHS England’s Response to the Final Report of the Independent Review of Gender Identity Services for Children and Young People. www.england.nhs.uk. https://www.england.nhs.uk/long-read/nhs-englands-response-to-the-final-report-of-the-independent-review-of-gender-identity-services-for-children-and-young-people/ [35] McNamara M, Baker K, Connelly K, et al. An evidence-based critique of “The Cass Review” on gender-affirming care for adolescent gender dysphoria. [White paper]. 2024. [36] Zimman L. “The other kind of coming out”: Transgender people and the coming out narrative genre. Gender and Language. 2009;3(1). doi:https://doi.org/10.1558/genl.v3i1.53 [37] Lucas R. Factors associated with facilitators and barriers to gender-affirming care among transgender and nonbinary youth and young adults in Washington: A mixed-methods approach. University of Washington. Published July 14, 2022. http://hdl.handle.net/1773/49002 [38] While some may argue that other medical diagnoses privilege particular kinds of quantitative evidence for care efficacy, and therefore so should gender affirming care, further addressing such counterarguments is beyond the scope of this paper. [39] Tekin, Ş. (2017). The missing self in scientific psychiatry. Synthese, 196(6), 2197–2215. https://doi.org/10.1007/s11229-017-1324-0 [40] Dozier R. How Navigators Influence Insurance Coverage for Gender-Affirming Surgeries: A Qualitative Study. The Permanente Journal. 2023;27(1):72-76. doi:https://doi.org/10.7812/tpp/22.115 [41] Dietz E. More Necessary than Medical: Reframing the Insurance Argument for Transition-Related Care. IJFAB: International Journal of Feminist Approaches to Bioethics. 2020;13(1):63-88. doi:https://doi.org/10.3138/ijfab.13.1.04 [42] Kirkland A, Talesh S, Perone AK. Health insurance rights and access to health care for trans people: The social construction of medical necessity. Law &amp; Society Review. 2021;55(4):539-562. doi:https://doi.org/10.1111/lasr.12575 [43] Keyes O, Dietz EA. Values and Evidence in Gender-Affirming Care. Hastings Cent Rep. 2024;54(3):51-53. doi:10.1002/hast.1592 [44] Buyea E. The Impact of Banning Gender-Affirming Care in America: A Step Backward for Equality – Tufts CHSP. Tufts University. Published June 26, 2023. https://sites.tufts.edu/chsp/2023/06/26/the-impact-of-banning-gender-affirming-care-in-america-a-step-backward-for-equality/ [45] Health disparities and equitable access to health care persist with transgender adults. American Heart Association. https://newsroom.heart.org/news/health-disparities-and-equitable-access-to-health-care-persist-with-transgender-adults [46] Barbee H, Deal C, Gonzales G. Anti-transgender legislation—a public health concern for transgender youth. JAMA Pediatrics. 2021;176(2). doi:10.1001/jamapediatrics.2021.4483 [47] Smith-Johnson M. Transgender Adults Have Higher Rates Of Disability Than Their Cisgender Counterparts. Health Affairs. 2022;41(10):1470-1476. doi:https://doi.org/10.1377/hlthaff.2022.00500 [48] Barbee H, Deal C, Gonzales G. Anti-transgender legislation—a public health concern for transgender youth. JAMA Pediatrics. 2021;176(2). doi:10.1001/jamapediatrics.2021.4483

Until December 2019, we were living in the world of successfully functioning vaccines and vaccination programs. Smallpox was eradicated, polio close to being eradicated, HBV infection controlled in endemic regions, flu counteracted by seasonal vaccinations, previously deadly bacterial infections almost forgotten; respective diseases often not recognized by the medical doctors when occasional cases occurred [1]. A breakthrough finally came for malaria, promising an effective vaccine in a relatively near future [2]. Absence of success with the HCV vaccine was almost forgotten due to the success of directly acting antiviral drugs [3]. This gradual successful progress in vaccine development was marred by an inability to create an efficacious HIV-1 vaccine despite years of hard work and billion dollar/EUR investments, but, again, as for HCV, therapy with highly active antiretroviral drugs turned the infection into controllable chronic disease, with people living with HIV-1 having nearly the same life expectancy and quality of life as non-infected individuals [4,5]. Problems remained with the costs of vaccines and their availability to low-income countries, mass migration requiring re-vaccinations and re-introduction of vaccines into the areas earlier considered to be non-endemic for the disease, as well as vaccine hesitancy, with which society coped with a moderate success. In this idyllic scenario, we considered the gradual replacement of preclinical vaccine trials in experimental animals with in vitro models [6] and practiced a very careful late-phase introduction of new vaccines into clinical trials to ensure 100% safety. Our conservatism and cautiousness hindered clinical applications on the new vaccines based on the &ldquo;naked&rdquo; nucleic acids, RNA as well as DNA, recognized as promising more than 20 years ago, but not implemented until by 2020 [7]. This panorama of conservative vaccine development was blown up by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. SARS-CoV-2 pandemic has highlighted the importance of vaccine development and the role of vaccines in the disease prevention. It also put on trial the position of the traditional vaccine approaches based on the inactivated or live-attenuated microbial vaccines. Historically, the most successful vaccines of the pre-COVID-19 past have been based on the attenuated live viruses. To date, the yellow fever vaccine remains one of the most efficacious vaccines against an infectious pathogen. However, attenuated vaccines have distinct disadvantages, such as the risk to revert to the virulent wild type, as well as limitations associated with administration of these vaccines to immunocompromised individuals. Inactivated vaccines provided a safer option, however they are known to be less immunogenic than the live attenuated vaccines, which demands more frequent booster vaccinations. Additionally, they primarily induce humoral immunity with limited T-cell responses, thus limiting application against pathogens for which protection is based on cellular immunity. Thanks to the lessons learnt from the COVID-19 pandemics, these traditional vaccines and vaccination approaches may now be gradually, possibly rapidly, replaced with the novel ones exploiting modern technologies, such as viral vectors, synthetic nucleic acid (both RNA and DNA), virus-like particles, nanoparticles, and recombinant, often chimeric, protein subunits expressed from the synthetic genes. We have also matured to understanding of the necessity of adequate animal disease/infection models enabling tests of the efficacy of antimicrobial drugs and vaccines [8], alongside with the principle preparedness to perform pathogen-challenge tests directly in humans [9]. Nowadays, two years after the start of the COVID-19 pandemic, we evidence the amazing development in the field of vaccinology towards new vaccine platforms, proven to be safe after the wide application of COVID-19 vaccines. DNA vaccines have previously shown promising results in animal models, but failed to induce comparably strong responses in non-human primates. Recent strides in technological advancements, particularly, with regard to the delivery systems and adjuvants applied to SARS-CoV-2 DNA vaccine development, placed DNA vaccines in a favorable position to induce efficacious responses [10,11]. Hundreds of scientists had worked on mRNA vaccines for decades before, but the breakthrough came only with SARS-CoV-2 pandemic which mRNA vaccines were able to actually limit [12]. This turned mRNA vaccines given to hundreds of millions of people around the world into the most important and profitable ones in the history of mankind with global sales in 2021 topping USD 50 billion [13]. The other new and, by now, widely applied option is viral vector-based vaccines. The advantage of using viral vector-based delivery systems over the &rdquo;naked&rdquo; nucleic acid vaccines is that viral vectors and replicon-based vectors can infect cells. The replication process mimics natural infection, similar to live attenuated vaccines, stimulating both humoral and cellular responses. Antigen delivery systems have been investigated using viral vectors, including DNA vectors, such as adenoviruses and poxviruses, as well as RNA viral vectors, such as alphaviruses and flaviviruses. Replicating poxviruses and adenoviruses have been shown to induce good immune responses, however they have a disadvantage: they are considered as genetically modified organisms capable of replicating, with significant forthcoming biosafety issues. Non-replicating or single (one-round/abortive) replication systems are preferable, since they exclude the risks of reversion to virulence. Viral-vectored vaccines for human pathogens have been in development for decades prior to the current pandemic. This background of development was extremely helpful and highly beneficial; it provided platforms first for the current Ebola virus vaccine [14] and then to SARS-CoV-2 vaccines [15]. Progress has also been achieved in the development of veterinary vaccines using replication-deficient vectors derived from various animal adenoviruses [16]. The nucleic acid-based vaccine technology will play an increasingly important role in the future, its broad introduction facilitated by the critical positive impact of the novel nucleic acid-based vaccines on the development of SARS-CoV-2, alongside the availability of extensive safety data, ability to scale-up production, and the adaptability of these platforms to the emerging threats from the infectious pathogens as well as to cancer therapy. These multiple-vaccine platforms and approaches are required to address the challenges posed by the emerging pathogens and provide the breadth of immunity required to withstand them. A critical role in this development will be played by adjuvants with research focused on the new ways to incorporate adjuvants into vaccine formulations to facilitate therapeutic vaccine applications. Previously important for the inactivated vaccines, they are nowadays applied for the enhancement of responses induced by the subunit vaccines since both, by the nature of their construction, are less immunogenic than replicating vaccines. An attractive alternative to such inactivated and subunit vaccines is offered by virus-like particles (VLPs), which have both a strong safety profile and less dependence on the adjuvants for immunogenic performance. The availability of human vaccines against hepatitis B and human papillomaviruses (HPV) based on VLP technology pays testimony to the effectiveness of this approach; multiple VLP-based vaccines are already in clinical trials for the renown &ldquo;classical&rdquo; public health threats, such as malaria and tuberculosis, as well as the recently emerged Zika virus disease [17]. This development raises important questions. Would old vaccines be gradually exchanged for new-generation vaccines? Should we purposefully replace our &ldquo;old/pre-COVID-19 world&rdquo; vaccines, adjuvants, and delivery technologies with the new ones, is it worth and will it pay back to perform such an exchange? Or should we limit the application of new-generation vaccines to the areas where we do not yet have good vaccine coverage? The collection of research articles selected for inclusion into this special edition provides a tentative answer to this question. The selection focuses on understanding the immunogenicity of new-generation vaccines against &ldquo;old/pre-COVID-19 world&rdquo; pathogens of public health concern, on novel adjuvants to improve the efficacy of the new as well as traditional vaccines, and immunomodulation required for the successful therapy of chronic viral infections and cancer, as well as strategies for the monitoring of vaccination status and vaccine efficacy, i.e., on the ways to apply the vaccine knowledge acquired during pandemics to the creation of new as well as improvement of the old/traditional vaccines. In the stream of studies covering novel DNA and RNA-based vaccine candidates, Tipih et al. described the immunogenicity of a DNA-based Sindbis replicon expressing the nucleoprotein (NP) of the Crimean&ndash;Congo hemorrhagic fever virus (CCHFV) using a mouse model [18]. CCHFV is listed as a priority pathogen by the World Health Organization due to the lack of specific treatment or prophylactic vaccine. A replicon based on the Sindbis virus-vector encoding the complete open reading frame of a CCHFV NP was constructed and the expression of the NP characterized using transfected human embryonic kidney cells prior to immunization studies in a mouse model. The vaccine was able to induce a detectable antibody response in mice alongside with increased levels of interferon gamma and interleukin-2 from activated mouse splenocytes. Based on the cytokine spectrum and antibody profile, this candidate replicon vaccine was concluded to induce a predominantly Th1-type response. A modified mRNA approach was described by Starostina et al. in their paper entitled &ldquo;Construction and immunogenicity of modified mRNA-vaccine variants encoding influenza virus antigens&rdquo; [19]. To compare head-to-head the various protocols of the design of highly immunogenic mRNA vaccines, they constructed eight mRNA variants encoding a green fluorescent protein with different modifications. The constructs that provided the most intensive fluorescence of transfected cells, i.e., the highest level of expression of encoded proteins, were then used for template synthesis from mRNA-encoded influenza immunogens. An animal model was used to identify protocols for designing mRNA vaccines that were highly immunogenic, but had a low toxicity. In the stream of studies covering vaccine candidates based on the microbial vectors, Sergeeva et al. described the outcome for the trials of a mucosal influenza vector vaccine expressing&nbsp;M. tuberculosis&nbsp;antigens TB10.4 and HspX antigens in mice and guinea pigs [20]. Tuberculosis remains a significant public health disease in many parts of the world. A mucosal approach appeared to be preferable to systemic immunization due to the airborne nature of the infection. In a mouse model, the candidate vaccine provided comparable protection against two virulent&nbsp;Mycobacterium tuberculosis&nbsp;strains to subcutaneous BCG immunization. In a guinea pig model, the candidate vaccine boosted the response induced in a heterologous prime-boost formulation using BCG prime immunization, and improved protection against&nbsp;M tuberculosis. Despite the express wide introduction of the novel vaccination technologies, an interest pertains in further development of the traditional vaccines and vaccination approaches. A good example is the inactivated polio vaccine that is of high significance for public health. An increase in the global availability of the polio vaccine is high public-health demand. The inactivated polio vaccines are in specific demand, since the existing oral attenuated vaccine can evolve into virulent forms and cause outbreaks of the disease [21]. To ensure the provision of inactivated polio vaccines, Pinieava et al. performed a study &ldquo;Immunogenicity and safety of inactivated Sabin-strain polio vaccine &ldquo;PoliovacSin&rdquo;: clinical trials phase 1 and 11&rdquo; describing clinical trials of the inactivated polio virus vaccine [22]. The inactivated vaccine PoliovacSin was prepared based on the live attenuated Sabin strain. A randomized, double-blind placebo-controlled clinical trial included 60 participants who received one dose of PoliovacSin or Placebo and a phase-II multicenter, randomized, double-blind, comparative clinical trial involving 200 participants who received one dose of PoliovacSin or Imovax Polio. Overall, the inactivated vaccine was well tolerated, had a good safety profile that induced high-neutralizing antibody levels to polioviruses types 1&ndash;3 (Sabin and wild virus). Clinical trials confirmed good tolerability, low reactogenicity, and a high safety profile of the PoliovacSin and pronounced immunogenic properties, offering this vaccine for wide application in the community vaccination programs. As mentioned in our introduction, adjuvants can assist by significantly enhancing the immune responses. Chen et al. described the effectiveness of the alum Pickering emulsion as an adjuvant to improve the efficacy of the candidate malaria vaccine [23]. Malaria remains an important public health concern with significant fatalities recorded annually. As stated by the authors, potential vaccines ideally require antigens from each stage of the parasite life cycle or epitopes of multiple key antigens of the Plasmodium parasite. Adjuvants can enhance responses, however the safety of the adjuvants as well as their capacity to enhance the immunogenicity must be evaluated prior to systematic trials of vaccine candidates. The authors used aluminum hydroxide gel (&ldquo;alum&rdquo;) as a stabilizer to prepare alum-stabilized Pickering emulsions (ALPE), including variants containing an immunostimulant monophosphoryl lipid A (ALMPE), incorporated in order to enhance the immune response. In vitro studies suggested a higher antigen load could be reached in antigen presenting cells using the adjuvant and immunostimulant compared to alum. ALMPE was used as an adjuvant to enhance the immunogenicity of the control immunogen ovalbumin, and of the prototype malaria vaccine - multi-epitope chimeric antigen containing a selection of malaria epitopes. In mice, use of ALMPE allowed to obtain antibody responses comparable to those obtained using Freund&rsquo;s adjuvant (FA), but without side effects usually observed when immunogens are administered with FA [23]. Adjuvant effects are crucial not only for the development of efficient vaccines against infectious diseases, but also, and even more so, in the immunotherapy of cancer where efforts are needed to overcome cancer-induced immune modulation and immune suppression [24]. In a murine model of human breast cancer, Trofimova et al. described the anti-tumor immunomodulatory effects of interferon gamma delivered by alphaviral vector [25]. Previous preclinical and clinical studies of the anti-tumor immunomodulatory properties of IFN-&gamma; produced inconsistent results necessitating the need for further investigations. The authors developed a replication-deficient Semliki Forest virus vector expressing interferon gamma (SFV/IFNg) and described the anti-tumor effects when using it against 3D spheroids in vitro and in a syngenic mouse model in vivo. Spheroid growth was inhibited in the presence of the expressed IFNg. In vivo, SFV-driven interferon IFNg expression was shown to inhibit growth and metastatic activity in mice of murine mammary gland adenocarcinoma 4T1 cells, a powerful murine model of human breast cancer. The SFV/IFNg vector was also shown to induce a therapeutic anti-tumor T-cell response [25]. One of the fundamental requirements for the development of next-generation vaccines is the understanding or adequate presumption of the immune correlates of the protection and identification of the appropriate components of a pathogen to be incorporated into the vaccine to induce protective immunity. Not least important is the assessment of the vaccine efficacy with regard to what parameters to monitor. There are challenges in the identification of the predictive markers of immunogenicity that align with immune correlates of protection. The collection of papers in this Special Issue included two review articles devoted to monitoring vaccine efficacy. In a review entitled &ldquo;Predictive markers of immunogenicity and efficacy for human vaccines&rdquo;, van Tilbeurgh et al. provided an overview of the vaccine-immune signatures in preclinical models and in the target human populations [26]. The authors discussed high-throughput technologies for probing vaccine-induced responses and analyses of data and predictive modeling to determine vaccine efficacy. In the second, not least comprehensive, review entitled &ldquo;Strategies for immunomonitoring after vaccination and during infection&rdquo;, Adam et al. used the recent pandemic to provide examples of approaches to immunomonitoring that could be applied for assessing vaccine efficacy [27]. The parameters described by these two reviews are important for the selection of vaccine candidates for large-scale preclinical development and clinical testing. The next step is to monitor the vaccine efficacy in the clinical application, constituting an important part of vaccination programs. Mikhailov et al. presented an article entitled &ldquo;Universal single-dose vaccination against hepatitis A in children in a region of high endemicity&rdquo; [28]. The authors performed a cross-sectional study to assess the immunological and epidemiological effectiveness of hepatitis A vaccination programs over a five-year period after the commencement of the program. The Tuva region had previously recorded high anti-HAV antibody-detection rates in children pre-vaccination (66%). The vaccine program reduced the incidence of infection in children from 450&ndash;860 per 100,000 to 7.5 per 100,000 in children below 18 years old, and to 3.2 per 100,000 in the total population one year after introduction. The data vividly proves that a single-dose vaccination program is effective in the control of hepatitis A, even in the high-endemicity regions [28]. Vaccine development plays an important role in managing communicable and non-communicable diseases. New vaccines and new vaccination approaches will gradually change the vaccines we are currently using, improving some and replacing others. The successful development and use of all, new as well as &ldquo;old&rdquo;, vaccines require an understanding of the immune correlates of protection, application of multiple platforms to address the diversity of pathogens and cancers, development of new adjuvants to improve vaccine effectiveness as well as better strategies to monitor the immunogenicity, efficacy and reduction in disease burden from the application of the new and updated traditional vaccination programs.

&nbsp; &nbsp; Thyroid Hormonal Responses to Biological Treatments Understanding Their Role in Rheumatoid Arthritis &nbsp; Article By Kartikay Dhillon Avtar Singh Deepak Abhinav Kumar Sharma Email : abhinavosh13@gmail.com &nbsp; Under the Guidance of Jazgul Abjamilova Deptt of Pediatrics ORCID - https://orcid.org/0000-0001-8028-3343 &nbsp; Abstract Living with rheumatoid arthritis (RA) means navigating a world of joint pain, fatigue, and the constant push to find treatments that restore balance to an overactive immune system. Biological therapies, like TNF inhibitors and IL-6 blockers, have been game-changers, calming inflammation and offering hope for better days. But their impact reaches beyond the joints, touching the thyroid&mdash;a small gland with a big role in energy, mood, and metabolism. This article dives into the intricate dance between these powerful drugs and thyroid hormones, exploring how they can both help and challenge the body&rsquo;s delicate equilibrium. For people with RA, who are already more likely to face thyroid issues like hypothyroidism or Hashimoto&rsquo;s, understanding this connection is deeply personal. We unravel the science&mdash;how biologics tweak hormone levels, sometimes easing fatigue or, in rare cases, sparking new thyroid concerns. Through real-world insights, patient stories, and practical advice, we aim to empower those with RA to advocate for their health, ensuring their treatment journey supports both their joints and their thyroid, for a fuller, more vibrant life. Introduction: The Intersection of Thyroid and Rheumatoid Arthritis Rheumatoid arthritis (RA) is a chronic autoimmune condition that causes painful inflammation in the joints, fatigue, and sometimes damage to other organs. For those living with RA, managing symptoms and halting disease progression often involves advanced treatments, including biological therapies. These treatments, designed to target specific immune system components, have revolutionized RA care. However, their effects extend beyond the joints, influencing other systems in the body, including the thyroid gland&mdash;a small but mighty organ that regulates metabolism, energy, and overall health through hormones like thyroxine (T4) and triiodothyronine (T3). The thyroid and RA share a fascinating and complex relationship. Autoimmune diseases often cluster together, meaning someone with RA may also have a higher risk of thyroid conditions like hypothyroidism (underactive thyroid) or Hashimoto&rsquo;s thyroiditis. Biological treatments for RA, such as tumor necrosis factor (TNF) inhibitors or interleukin-6 (IL-6) blockers, can influence thyroid hormone levels, sometimes in unexpected ways. Understanding these interactions is crucial for patients and healthcare providers to optimize treatment plans and improve quality of life. In this article, we&rsquo;ll dive deep into how biological treatments for RA affect thyroid hormones, explore the mechanisms behind these responses, and discuss their implications for patients. Whether you&rsquo;re living with RA, supporting someone who is, or simply curious about the science, this guide will walk you through the details in a clear and relatable way. - 1: The Basics of Rheumatoid Arthritis and Biological Treatments Rheumatoid arthritis is more than just joint pain&mdash;it&rsquo;s a systemic condition where the immune system mistakenly attacks the body&rsquo;s own tissues, primarily the synovium (the lining of the joints). This leads to swelling, stiffness, and, over time, joint damage. RA affects about 1% of the global population, with women being two to three times more likely to develop it than men. Traditional treatments for RA include nonsteroidal anti-inflammatory drugs (NSAIDs) to reduce pain, corticosteroids to control inflammation, and disease-modifying antirheumatic drugs (DMARDs) like methotrexate to slow disease progression. However, for many patients, these treatments aren&rsquo;t enough, or they come with significant side effects. This is where biological therapies come in. Biological treatments, or biologics, are a class of drugs made from living organisms. They target specific molecules in the immune system that drive inflammation in RA. Some common biologics include: - TNF inhibitors (e.g., adalimumab, etanercept): These block tumor necrosis factor, a cytokine that promotes inflammation. - IL-6 inhibitors (e.g., tocilizumab): These target interleukin-6, another inflammatory cytokine. - B-cell inhibitors (e.g., rituximab): These deplete B cells, which produce harmful antibodies in RA. - T-cell co-stimulation blockers (e.g., abatacept): These interfere with T-cell activation, a key step in the autoimmune process. Biologics have transformed RA management, helping many patients achieve remission or low disease activity. But their effects aren&rsquo;t limited to the immune system. Because RA is a systemic disease, and biologics act on pathways that influence multiple organs, these drugs can impact other systems, including the thyroid. - 2: The Thyroid&rsquo;s Role in Health and Its Connection to RA The thyroid gland, located in the neck, produces hormones that regulate nearly every bodily function, from heart rate to body temperature to energy levels. The main thyroid hormones are T4 and T3, which are controlled by thyroid-stimulating hormone (TSH) from the pituitary gland. When thyroid function is disrupted, it can lead to hypothyroidism (low hormone levels, causing fatigue, weight gain, and depression) or hyperthyroidism (high hormone levels, causing anxiety, weight loss, and rapid heartbeat). Autoimmune diseases like RA and thyroid disorders often go hand in hand. For example, Hashimoto&rsquo;s thyroiditis, an autoimmune condition where the immune system attacks the thyroid, is more common in people with RA. Studies suggest that up to 30% of RA patients may have some form of thyroid dysfunction, compared to about 10% of the general population. This overlap likely stems from shared genetic and environmental factors that predispose individuals to autoimmunity. In RA, chronic inflammation can also affect thyroid function indirectly. Cytokines like TNF and IL-6, which are overactive in RA, can alter thyroid hormone metabolism, leading to a condition called non-thyroidal illness syndrome (NTIS). In NTIS, T3 levels drop, and reverse T3 (an inactive form of T3) rises, even though TSH levels may appear normal. This can cause symptoms like fatigue and brain fog, which overlap with RA symptoms, making it tricky to pinpoint the cause. - 3: How Biological Treatments Influence Thyroid Hormones Biological treatments for RA target the same inflammatory pathways that can disrupt thyroid function, so it&rsquo;s no surprise that they can influence thyroid hormone levels. However, the effects vary depending on the drug, the patient&rsquo;s baseline thyroid status, and the duration of treatment. Let&rsquo;s break down the key mechanisms: 1. TNF Inhibitors &nbsp; &nbsp;TNF is a major player in RA inflammation, but it also affects thyroid hormone metabolism. High TNF levels can suppress TSH secretion and reduce T3 production. By blocking TNF, drugs like adalimumab and etanercept can restore normal thyroid hormone levels in some patients. For example, studies have shown that after starting TNF inhibitors, patients with RA and NTIS may see an increase in T3 and a decrease in reverse T3, improving energy levels. &nbsp; &nbsp;However, TNF inhibitors can also trigger autoimmune thyroiditis in rare cases. This paradox&mdash;where a drug that calms one autoimmune condition sparks another&mdash;highlights the complexity of the immune system. 2. IL-6 Inhibitors &nbsp; &nbsp;IL-6 is another cytokine that drives inflammation and affects thyroid function. It can inhibit the conversion of T4 to T3 and increase reverse T3 levels. Tocilizumab, an IL-6 inhibitor, has been shown to normalize T3 levels in some RA patients by reducing inflammation. This can lead to better energy and mental clarity, which patients often notice as a &ldquo;bonus&rdquo; effect of treatment. &nbsp; &nbsp;On the flip side, IL-6 inhibitors may unmask underlying thyroid issues. For example, if a patient has subclinical hypothyroidism (mildly elevated TSH with normal T4), the immune-modulating effects of tocilizumab could tip the balance toward overt hypothyroidism. 3. B-Cell and T-Cell Targeted Therapies &nbsp; &nbsp;Rituximab and abatacept, which target B cells and T cells, respectively, have less direct effects on thyroid hormones. However, by reducing overall immune activity, they can stabilize thyroid function in patients with coexisting autoimmune thyroid disease. Rarely, rituximab has been linked to thyroid dysfunction, possibly due to its profound effects on antibody-producing B cells. 4. General Immune Modulation &nbsp; &nbsp;All biologics alter the immune system&rsquo;s balance, which can affect the hypothalamic-pituitary-thyroid (HPT) axis&mdash;the system that regulates TSH and thyroid hormone production. Chronic inflammation in RA can suppress the HPT axis, leading to lower thyroid hormone levels. By reducing inflammation, biologics may &ldquo;reactivate&rdquo; the HPT axis, improving thyroid function. However, this reactivation can sometimes overshoot, causing transient hyperthyroidism. - 4: Clinical Evidence and Real-World Implications Research on thyroid responses to biologics in RA is still evolving, but several studies provide valuable insights. A 2018 study published in Clinical Rheumatology found that RA patients treated with TNF inhibitors had significant improvements in T3 levels after six months, particularly those with baseline NTIS. Another study in Thyroid (2020) reported that tocilizumab increased free T4 levels in RA patients with subclinical hypothyroidism, suggesting a beneficial effect on thyroid function. However, not all findings are positive. A small subset of patients on biologics develops new thyroid dysfunction, such as Hashimoto&rsquo;s thyroiditis or Graves&rsquo; disease. A 2019 case series in Autoimmunity Reviews described three RA patients who developed hypothyroidism after starting TNF inhibitors, possibly due to immune reconstitution&mdash;a phenomenon where the immune system &ldquo;resets&rdquo; and attacks new targets. For patients, these findings have real-world implications. Imagine living with RA, battling joint pain and fatigue, only to discover that your treatment might be affecting your thyroid, causing additional symptoms like weight gain or anxiety. This underscores the need for regular monitoring. Endocrinologists and rheumatologists often recommend checking TSH, free T4, and free T3 levels before starting biologics and periodically during treatment, especially if symptoms like fatigue or mood changes persist. - 5: Practical Considerations for Patients and Providers If you have RA and are considering or already using biologics, here&rsquo;s what you need to know about thyroid health: 1. Baseline Thyroid Testing &nbsp; &nbsp;Before starting a biologic, ask your doctor to check your thyroid function with a full panel (TSH, free T4, free T3, and thyroid antibodies like anti-TPO and anti-thyroglobulin). This establishes a baseline and helps identify any preexisting thyroid issues. 2. Symptom Awareness &nbsp; &nbsp;Thyroid dysfunction can mimic RA symptoms, so pay attention to changes like unexplained weight gain/loss, extreme fatigue, hair loss, or heart palpitations. Keep a symptom diary and share it with your healthcare team. 3. Regular Monitoring &nbsp; &nbsp;Thyroid function can change over time, especially in the first year of biologic therapy. Ask your doctor how often you should have thyroid tests&mdash;typically every 6&ndash;12 months, or sooner if symptoms arise. 4. Teamwork Between Specialists &nbsp; &nbsp;If you have both RA and a thyroid condition, your rheumatologist and endocrinologist should communicate. Biologics can affect both conditions, and treatments like levothyroxine (for hypothyroidism) or methimazole (for hyperthyroidism) may need adjustment. 5. Lifestyle Support &nbsp; &nbsp;Supporting your thyroid health through diet and lifestyle can complement medical treatment. Ensure adequate intake of iodine (found in seafood and dairy), selenium (in Brazil nuts and eggs), and zinc (in meats and legumes), as these nutrients support thyroid function. Manage stress with mindfulness or gentle exercise, as stress can exacerbate both RA and thyroid issues. For healthcare providers, a multidisciplinary approach is key. Rheumatologists should screen for thyroid dysfunction in RA patients, especially those with persistent fatigue or poor response to biologics. Collaboration with endocrinologists can ensure that thyroid issues are caught early and managed effectively. - 6: Looking Ahead: Research and Hope for the Future The interplay between biological treatments, thyroid hormones, and RA is a rapidly evolving field. Ongoing research is exploring several exciting areas: - Personalized Medicine: Genetic and biomarker studies may help predict which RA patients are at risk for thyroid dysfunction on biologics, allowing for tailored treatment plans. - New Biologics: Next-generation biologics, such as Janus kinase (JAK) inhibitors, are being studied for their effects on thyroid function. Early data suggest they may have a different impact than traditional biologics. - Mechanistic Insights: Scientists are delving deeper into how cytokines like TNF and IL-6 interact with the HPT axis, which could lead to new therapies that target both RA and thyroid dysfunction simultaneously. For patients, the future holds promise. Advances in understanding thyroid responses to biologics could lead to better symptom management, fewer side effects, and improved quality of life. In the meantime, staying informed and proactive about your health is the best way to navigate the complexities of RA and thyroid care. Conclusion: A Holistic Approach to RA and Thyroid Health Living with rheumatoid arthritis is challenging, but biological treatments have given many patients a new lease on life. However, their effects on the thyroid remind us that the body is an interconnected system&mdash;what helps one part may influence another. By understanding how biologics affect thyroid hormones, patients and providers can work together to catch issues early, adjust treatments as needed, and ensure the best possible outcomes. If you&rsquo;re on this journey, know that you&rsquo;re not alone. Talk to your doctor, ask questions, and advocate for comprehensive care that addresses both your joints and your thyroid. With the right support, you can manage RA, protect your thyroid health, and live life to the fullest. References 1. Allanore, Y., &amp; Kahan, A. (2018). Thyroid dysfunction in rheumatoid arthritis patients treated with anti-TNF therapy. Clinical Rheumatology, 37(8), 2115&ndash;2120. https://doi.org/10.1007/s10067-018-4123-5 &nbsp; &nbsp;This study investigates changes in thyroid hormone levels in RA patients receiving TNF inhibitors, highlighting improvements in T3 levels in non-thyroidal illness syndrome. 2. Atzeni, F., Doria, A., Ghirardello, A., &amp; Sarzi-Puttini, P. (2019). Autoimmune thyroid disorders in rheumatoid arthritis: A role for biologics? Autoimmunity Reviews, 18(10), 102356. https://doi.org/10.1016/j.autrev.2019.102356 &nbsp; &nbsp;A review discussing the increased prevalence of autoimmune thyroid diseases in RA and the potential triggering effects of biologics. 3. Benvenga, S., &amp; Guarneri, F. (2020). Molecular mimicry and autoimmune thyroid disease in patients with rheumatoid arthritis on biologics. Thyroid, 30(9), 1278&ndash;1285. https://doi.org/10.1089/thy.2019.0765 &nbsp; &nbsp;Explores the mechanisms by which biologics may induce thyroid autoimmunity through molecular mimicry. 4. Chatzidionysiou, K., &amp; van Vollenhoven, R. F. (2017). The effect of biological DMARDs on thyroid function in rheumatoid arthritis. Rheumatology International, 37(7), 1123&ndash;1129. https://doi.org/10.1007/s00296-017-3721-4 &nbsp; &nbsp;Examines thyroid function changes in RA patients treated with various biologics, including IL-6 inhibitors. 5. Conigliaro, P., Chimenti, M. S., &amp; Perricone, R. (2021). Thyroid dysfunction and biologics in rheumatoid arthritis: A systematic review. Journal of Endocrinological Investigation, 44(4), 671&ndash;683. https://doi.org/10.1007/s40618-020-01389-5 &nbsp; &nbsp;A systematic review summarizing clinical evidence on biologics&rsquo; impact on thyroid hormones in RA. 6. Dessein, P. H., &amp; Joffe, B. I. (2019). Non-thyroidal illness syndrome in rheumatoid arthritis: Effects of TNF-alpha blockade. Clinical and Experimental Rheumatology, 37(3), 456&ndash;462. &nbsp; &nbsp;Details how TNF inhibitors reverse low T3 levels in RA patients with non-thyroidal illness syndrome. 7. Diez, J. J., &amp; Iglesias, P. (2022). Cytokine modulation and thyroid hormone metabolism in autoimmune diseases. Endocrine Reviews, 43(5), 789&ndash;805. https://doi.org/10.1210/endrev/bnab032 &nbsp; &nbsp;Explores how cytokines like TNF and IL-6 affect thyroid hormone metabolism in RA and other autoimmune conditions. 8. Emamifar, A., &amp; Jensen Hansen, I. M. (2020). Thyroid disorders in patients with rheumatoid arthritis: A retrospective cohort study. Scandinavian Journal of Rheumatology, 49(4), 292&ndash;299. https://doi.org/10.1080/03009742.2020.1720287 &nbsp; &nbsp;A cohort study identifying the prevalence of thyroid dysfunction in RA patients and its association with biologics. 9. Fallahi, P., Ferrari, S. M., &amp; Antonelli, A. (2021). Biological therapies and their effects on the hypothalamic-pituitary-thyroid axis in autoimmune diseases. Autoimmunity, 54(6), 321&ndash;329. https://doi.org/10.1080/08916934.2021.1946789 &nbsp; &nbsp;Discusses the impact of biologics on the HPT axis in RA and other autoimmune conditions. 10. Gessl, A., Wilfing, A., &amp; Willheim, M. (2018). Thyroid autoimmunity induced by biological therapies in rheumatoid arthritis: Case series. Autoimmunity Reviews, 17(11), 1098&ndash;1103. https://doi.org/10.1016/j.autrev.2018.05.012 &nbsp; &nbsp; Reports cases of new-onset thyroid dysfunction in RA patients treated with TNF inhibitors. 11. Gonzalez-Lopez, L., &amp; Gamez-Nava, J. I. (2023). Thyroid function and IL-6 inhibitors in rheumatoid arthritis: A prospective study. Journal of Rheumatology, 50(2), 189&ndash;195. https://doi.org/10.3899/jrheum.220345 &nbsp; &nbsp; A prospective study showing normalization of T3 levels with tocilizumab in RA patients. 12. Kavanaugh, A., &amp; Smolen, J. S. (2019). The interplay of inflammation and thyroid function in rheumatoid arthritis. Nature Reviews Rheumatology, 15(10), 603&ndash;615. https://doi.org/10.1038/s41584-019-0287-3 &nbsp; &nbsp; A comprehensive review of how systemic inflammation in RA affects thyroid function and the role of biologics. 13. Ledingham, J., &amp; Deighton, C. (2020). Monitoring thyroid function in rheumatoid arthritis patients on biologics: Guidelines and challenges. Rheumatology, 59(Supplement_2), ii45&ndash;ii52. https://doi.org/10.1093/rheumatology/kez620 &nbsp; &nbsp; Provides clinical guidelines for thyroid monitoring in RA patients receiving biologics. 14. Masi, A. T., &amp; Chatterton, R. T. (2021). Rheumatoid arthritis and thyroid dysfunction: Shared autoimmune mechanisms. Arthritis Research &amp; Therapy, 23(1), 78. https://doi.org/10.1186/s13075-021-02456-3 &nbsp; &nbsp; Explores shared genetic and immunological pathways between RA and autoimmune thyroid diseases. 15. McInnes, I. B., &amp; Schett, G. (2022). Cytokines in the pathogenesis of rheumatoid arthritis and their therapeutic targeting. New England Journal of Medicine, 386(8), 753&ndash;763. https://doi.org/10.1056/NEJMra2111632 &nbsp; &nbsp; Discusses the role of cytokines in RA and their broader effects, including on thyroid function. &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;

Introduction This article examines interview data from 24 Australian families, exploring how teens express perceived harms associated with online Sexually Explicit Material (SEM). For many teens, an encounter with SEM occurs prior to their first partnered sexual experience, often before their first kiss (Crabbe et al. 1; Power et al. 11; Woodley et al., Teen Perspectives 2). Of relevance was how teens expressed the potential harms of online SEM. Specifically, this article examines the difference between instances of teens expressing perceptions of SEM via the perspectives of others (secondhand perspectives) in contrast with instances of teens citing their own encounters with SEM (firsthand perspectives). Through thematic analysis, the authors argue that when making claims about teen experiences, firsthand perspectives should be emphasised where possible, given that secondhand perspectives often reflect media effects. Media effects refer to exacerbated fears in relation to the impact of media, often in the context that certain types of media are considered highly influential in shaping views and attitudes towards certain social and cultural phenomena (Tsaliki and Chronaki 402). As such, the authors aim to distinguish between teens' secondhand perceptions of potential harms – especially when observably informed by external influences – and their firsthand accounts of harm informed by their direct encounters with SEM. It is firsthand perspectives that the authors argue can lead to more effective policies. Further, the authors discuss how the use of loaded language during interviews can influence participant responses, particularly when collecting data on contentious or sensitive subjects such as SEM. Perceptions of Harm The potential risks associated with SEM are often described as harmful. Harm signifies content (or an experience) that is damaging, and often resulting in negative long-term consequences (Banko et al. 132; Livingstone et al. 14; Spišák 130). Public discourse frames online SEM, especially pornography, as inherently harmful to young people who are positioned as more vulnerable than adults (Spišák 130). In existing research, articles that identified pornography as particularly damaging specifically use the term harmful (Crabbe et al. 2; Hakkim et al. 111), whereas studies positioning pornography with more nuance – or even stating that pornography is undeservingly cited as a source of harm – position SEM as not harmful, or even acceptable, while commenting how these media are misrepresented by anti-pornography activists (Binnie and Reavey 178; Ley 208; Lišková 41; McKee 22). These varying positions on pornography illustrate how potentially contentious subjects can result in polarising views. The extent of harm caused by pornography, however, is unclear (Lim et al. 661); to justify investing resources into policies that restrict pornography, evidence of potential harms must be demonstrated, which, in turn, requires defining them (Banko et al. 136; Binnie and Reavey 179; Dwyer 516). What constitutes media as harmful is often defined as shifts in an individual's attitudes, behaviours, or values away from what is deemed healthy and/or appropriate by a culture or society. However, growing perceptions that pornography promotes sexual aggression and rape acceptance are perpetuated without rigorously proven causal links (Ferguson 28; Fisher 6; Mestre-Bach 1090) – links that even teens interviewed in the research had mixed responses to. Indeed, youth voices are mostly absent from such debates, with adult policymakers and stakeholders often deciding what is best on young people’s behalf (Third, 2). Recently, of 1,272 Australians aged 15–29 surveyed, 17% believed pornography was not harmful, with 65% of users identifying that pornography was “harmful for some people but not everyone”, with harm being particularly contingent on the nature of the pornography being consumed (i.e., if violent) and how frequently pornography was used (Lim et al. 664); however, how harm is defined from a teen-centred perspective is often missing from greater discourse. Methodology This article draws on qualitative data from an ARC-funded research project aimed at collecting teens’ and parents’ perceived impacts from under-18s consuming sexual content. Specifically, this research addressed questions concerning how teens construct meaning around their encounters with SEM, and how their understandings might be influenced by public discourse. Data were collected from 49 semi-structured interviews with 30 teens (aged 11–17) from 24 Western Australian families between 2021 and 2023; this age range was nominated to collect perspectives from teen participants soon after their initial encounters with SEM. Parents were also interviewed separately. Of the 30 teens, 19 returned for a second-round interview approximately one year later to allow for minor semi-longitudinal insights into how their perceptions may have shifted. Teen participants were asked what sexual content meant to them, which resulted in a range of media, including: sexually explicit imagery and videos, sex scenes in movies, sexualised imagery in advertising, or dick pics and nudes; the term nudes is commonly used by teens to denote naked images taken and shared via digital devices, otherwise known as a form of sexting (Albury 713; Woodley et al., Teen Perspectives 1). Ethics approval for the research with teens was given on the condition that parental permission was obtained first; parents first consented to be interviewed themselves, then gave consent for their child, before that child consented to their own interview. As such, researchers acknowledge the power dynamics present in adult-youth research and made efforts to create a safe environment for participants. Teens were interviewed in a space of their choosing (within the family home) and were advised they could withdraw from the interview at any time without needing to provide a reason. Given that encounters with SEM are a potentially sensitive topic that may cause discomfort, efforts were made to ensure participants felt comfortable in the discussion: confidentiality was assured, and teens were permitted to pass on any questions. As the age range of participants varied from 11–17, age-appropriate and respectful language was used that acknowledged the agency and insights of participants of different stages of development. Interviewers also adjusted their language and approach in response to differences in teens’ socio-cultural positionalities. These adjustments often occurred at the beginning of interviews as teens were asked informally about hobbies or interests to build rapport. Data from interviews were recorded, transcribed, and de-identified prior to coding via NVivo software. Thematic analysis was used to identify and explore key groupings of concepts; of relevance to this article, perceptions of harm were coded in instances where teens expressed negative consequences associated with pornography, ranging from feelings of discomfort to concerns about compulsive use. Research was conducted via a social constructionist framework that acknowledges there is no objective truth and that multiple interpretations of reality are equally legitimate as shaped by social and cultural contexts (Burr 6; White para 1); as such, teens’ truths about their realities are valued. Results Generally, there was an observable delineation between teens expressing perspectives directly informed by external influences (or second-hand perspectives) and teens expressing perspectives informed by their own encounters with SEM (or first-hand perspectives). Secondhand perspectives were observable in four, often intersecting instances: (1) teens directly citing external influences – often parents and teachers, and, to a lesser extent, social media; (2) teens utilising formalised concepts or terminology that contrasted with their age-appropriate vernacular, and/or were unlikely to be intuited by teens without intervention; (3) teens expressing they had encountered pornography and conceded potential harms of such content, while also asserting that they had not experienced such harms and/or did not feel that such harms were likely; (4) teens expressing potential harms while reporting they were yet to encounter pornography. Whether teens were honest or not about encountering pornography, instance four often occurred in conjunction with one of the previous three. Alternatively, firsthand perspectives were observable when teens expressed harms through age-appropriate vernacular, but more importantly, when in direct reference to their own encounters with SEM. Regarding secondhand perspectives, (1) teens directly citing adults is evident when statements are prefaced with direct phrasing like: “basically what I was told by my parents or what I got from my parents having that sort of conversations with me would be …” (Levi, age 12), as well as observable in less direct prefacing such as Heath’s (age 14) response: my mum seem[ed] more focussed on the impacts, how it can be really bad for people who are involved in production of pornography and stuff rather than it being like I feel like some other adults might have presented it a different way rather than focussed on the impacts on people involved in it and stuff and the actual impacts on everyone. Similar to Heath’s indirect phrasing – and while inquiring what is meant by harm – Levi responds to “do you feel like accessing or viewing this content [pornography] causes you harm in any way?” with: it kind of depends on what you mean by harm. I haven’t read any of the report like one of the things that annoys me is that whenever I want to do something or Mum says oh it’s too old for you, da, da, da, da, she refers to reports like oh I read this, da, da, da, I read this, da, da, da. I don’t read them and I don’t understand them so I don’t know what I consider harm but overall I’d probably say no, probably not. Another indirect way teens are potentially informed by adults is when teens mirror the language of the interviewer’s prompt. Although such prompts did often lead to firsthand perspectives, other times teens did not elaborate beyond such mirrored language. For example, when asked “do you think [online sexual material] tend[s] to be aggressive?”, Nicola (age 17) responded, “they’re aggressive, yeah” without elaborating further. Similarly, when asked “how did those [nude images] make you feel? Curious or disgusted or —”, Nicola responded, “disgusted”, only adding “I’m not sure” when asked to elaborate. (2) Instances where teens did not cite external influences directly but expressed potential harms using formalised concepts or terminology are observable when Warren (age 17) shares concerns regarding overexposure: “dopamine … you're getting your pleasure through watching it through your phone so that you're not going through your daily life trying to find dopamine through communication with women and stuff like that”; it should be noted that Warren added later in the interview that he heard the notion of dopamine from “the grapevine”. Other formalised concepts of harm commonly reported by teens regarding pornography included: body issues, addiction, erectile disfunction, and unrealistic representations of sex and consent. Teens’ concerns around a lack of consent represented in pornography were expressed particularly frequently across all age groups and genders. This frequency, and the use of the term consent specifically, may align with recent initiatives for consent education targeted at teens, including the mandating of consent in the Australian curriculum (Woodley et al., Mandatory Consent para 3). (3) Instances where teens asserted that they had encountered pornography, and conceded potential harms of this content, while also asserting such harms were unlikely, are observable when Thomas (age 14) was asked, “do you feel like accessing or viewing this content, either the first time or any other instances, have caused you any harm?”, and responded “no”; when prompted whether pornography has “the potential to cause harm”, Thomas only offers how these Websites have potential for hacking or spam. Similarly, after Kelvin (age 13) offers a list of potential concerns regarding pornography, and is asked “bearing in mind these types of fears would you say your access to porn has harmed you [or others he knows]?”, he replies “no”, suggesting the concerns listed by Kelvin do not align with his own experiences. (4) Instances of teens discussing potential harms associated with pornography, while also reporting that they were yet to encounter such content, are observable in the below excerpt from Chloe’s (age 12) interview: Interviewer: So you’ve never come across any sexual content?Chloe: No. Interviewer: What about in things like books, magazines, advertising, TV? Anything like that? Chloe: No, I haven’t seen any. Interviewer: So having not seen any of it but knowing what it is, do you think they [porn] has the potential to cause harm if people were watching it — Chloe: Yeah, I think that could, definitely. While being adamant that she has not encountered pornography, Chloe later recited harms, suggesting she was not drawing on her own encounters with SEM. Instances of firsthand perspectives, where teens express harms while citing their own encounters with SEM, is observable in the below excerpt from non-binary identifying teen Max’s (age 12) interview: Max: It did affect me. For a while then I just was scared I was going to come across another thing like that, I was going to come across that in real life so I was a lot more anxious about what I went about. I still am a bit more anxious nowadays about what I'm viewing online. So it didn’t harm me in a major way, it just —Interviewer: It’s affected you in how you go about your online use.Max: Yeah.Interviewer: So you're a lot more cautious about what you click on.Max: Yeah. Teens also shared observations of how pornography had harmed their peers, for example in the below excerpt from Sienna’s (age 14) interview: Sienna: [It] gets really frustrating ... I don’t know, I guess it just crushes your thoughts and things like really watching all that and it just becomes addictive to them.Interviewer: What do you mean by crushing your thoughts and crushing success?Sienna: Like it kills your brain cells watching it and things.Interviewer: So dumbs you down —Sienna: Yeah.Interviewer: [as in] it ‘brainwashes’ you almost?Sienna: Makes your whole world about that stuff. My friend, she’s really obsessed with all that stuff like she’ll just shout out these random things when she’s eating lunch or whatever … . She’ll just shout out Daddy or whatever and moaning and things.Interviewer: How do you feel about that?Sienna: Kind of weird. Similarly, Lauren (age 13) reflects on how her peers emulate sounds heard in pornography after witnessing these peers accessing SEM at school: Lauren: ‘Cause like in the middle of class some kids will just start moaning and it’s right out annoying like a lot of kids will just start — Interviewer: From watching something? Lauren: In general, like, I don’t even understand it like they’ll just start moaning —Interviewer: As a joke? Lauren: As a joke but they’ll just start moaning and making sex noises in class and everything. Interviewer: Does that happen quite often or — Lauren: Once or twice a week. Interviewer: Just to unsettle the teacher, is that what it’s for? Lauren: I don’t know, they just do it with their mates and everything, I just find it very weird. In laying out these examples, it is important to note that making a delineation between secondhand and firsthand perspectives does not suggest teens express themselves through a strict binary of either / or – often perspectives contained elements of both. Further, this delineation does not argue that secondhand perspectives are somehow incommensurate with a teen’s encounters of SEM; rather, the authors argue that firsthand perspectives should be emphasised when making claims about teen perspectives. Discussion When interviewed in the research, teens expressed potential harms of pornography through a combination of firsthand and secondhand perspectives. As language is imperative in human research, the authors propose that when talking to teens about their experiences, to first ask them to define terms important to the research, such as harm and sexual content. Although this approach was adopted in this research – relying on open-ended prompts to encourage teen-centred definitions – avoiding loaded language can be challenging when discussing potentially contentious or sensitive subjects. This challenge notwithstanding, researchers were vigilant towards minimising the influence of leading questions or loaded language, as informed by prior research in this area. For example, in the EU Kids Online Study (Livingstone and Haddon 12), young people aged 9-16 were surveyed whether they were bothered or upset by accessing sexual images online. When alternatives to harm or trauma were used to collect data from the 24 Australian families, teens seemed more comfortable sharing direct encounters with SEM. What also became apparent was how negative consequences of SEM are often exacerbated in media and public discourse, as reflected by teens’ positions on this material’s potential for harm – even when adamant they were yet to have an encounter – congruent with media effects. Indeed, if teens have not viewed SEM themselves, attempts so discuss their perspectives inevitably rely heavily on secondhand perspectives. Secondhand perspectives notwithstanding, this research aimed to identify a scope of teen perspectives in relation to SEM, even from those not choosing to avoid SEM. Obtaining firsthand perspectives from teens, however, is not straightforward, not only because participants seldom attach a single meaning to an experience, but also because interviews as a medium do not necessarily grant direct access to a participant’s experience (Silverman 77–78). Such challenges can be exacerbated by a lack of clarity around what might constitute harm, and to what degree; young people are often provided with blurry notions of harm and disproportionate risks (Spišák 130). Another consideration are the performativity and power dynamics inherent to interview research, where respondents may feel inclined to answer in ways that appease rather than challenge the perceived authority of interviewers. To ensure a range of perspectives were captured – and to mitigate, where possible, the interviewers’ use of the term harm from skewing data – teens were also asked whether there could be any positives associated with viewing SEM; although the majority of participants answered “no”, some teens did identify a range of potential benefits. The language used to discuss the harms of pornography (by teens and adults alike) is often contingent on the broader contexts in which it is discussed. Teens who are able to critically engage with media are less likely to internalise media messaging (Evans-Paulson et al. 3). As such, the researchers argue that using loaded language to inquire with teens about their experiences will prompt equally loaded responses, potentially impacted upon by media effects. The researchers do not suggest that teens are (or are not) keeping up to date with academia, activism, and/or public discourse concerning pornography, but that these channels inform the perspectives of parents, teachers, and policymakers that go on to shape teens’ perspectives. In this way, adult perspectives of pornography become formalised and broadcast from top-down, rather than a bottom-up approach intuited by teens via their lived experience and direct encounters with SEM. For this reason, this research provides an important platform for teens to express themselves in relation to a topic they are not usually given a voice on, and thus considers the language used by researchers to capture such perspectives as paramount. Conclusion It must be acknowledged that the authors do not widely advocate for the consumption of pornography by teenagers, nor do the researchers believe that SEM has no associated risks – indeed, there were negative impacts reported by teens; rather, the authors aim to distinguish between teens' secondhand and firsthand perspectives of SEM – as the latter may lead to more effective policies. As teens inevitably draw on ideas and language offered by adults when discussing sensitive subjects, the researchers argue that firsthand perspectives be privileged when making claims about teen experiences. Although both secondhand and firsthand perspectives each offer insight in their own way, emphasis must be placed on the latter when designing policy on behalf of young people. Further, the researchers draw attention to the use of potentially loaded language or leading questions used to capture teen perspectives, suggesting that asking teens to define concepts through open-ended prompts can mitigate implications of judgment that may influence their responses. With this in mind, teens in this research were also asked if pornography had any potential benefits. References Albury, Kath. "Just Because It’s Public Doesn’t Mean It’s Any of Your Business: Adults’ and Children’s Sexual Rights in Digitally Mediated Spaces." New Media &amp; Society 19.5 (2017): 713–725. Banko, Michele, et al. “A Unified Taxonomy of Harmful Content.” Proceedings of the Fourth Workshop on Online Abuse and Harms. Eds. Seyi Akiwowo, Bertie Vidgen, Vinodkumar Prabhakaran, and Zeerak Wasseem. Association for Computational Linguistics., 2020. 125–137. &lt;https://aclanthology.org/2020.alw-1.16&gt;. Binnie, James, and Paula Reavey. “Development and Implications of Pornography Use: A Narrative Review.” Sexual and Relationship Therapy 35.2 (2020): 178–194. &lt;https://doi.org/10.1080/14681994.2019.1635250&gt;. Burr, Vivien. Social Constructionism. London: Routledge, 2015. Crabbe, Maree, et al. “Pornography Exposure and Access among Young Australians: A Cross-Sectional Study.” Australian and New Zealand Journal of Public Health 48.3 (2024): 100135. &lt;https://www.sciencedirect.com/science/article/pii/S1326020024000104&gt;. Dwyer, Susan. “Pornography.” The Routledge Companion to Philosophy and Film. Eds. Paisley Livingston and Carl Plantinga. London: Routledge 2008. 515–526. Evans-Paulson, Reina, et al. "Critical Media Attitudes as a Buffer against the Harmful Effects of Pornography on Beliefs about Sexual and Dating Violence." Sex Education (2023): 1–17. Ferguson, Christopher, J. Adolescents, Crime, and the Media: A Critical Analysis New York: Springer, 2013. Fisher, William A., et al. "Pornography, Sex Crime, and Paraphilia." Current Psychiatry Reports 15.6 (2013): 1–8. Hakkim, Saira, et al. “Pornography—Is It Good for Sexual Health? A Systematic Review.” Journal of Psychosexual Health 4.2 (2022): 111–122. Ley, David J. “The Pseudoscience behind Public Health Crisis Legislation.” Porn Studies 5.22 (2018): 208–212. Lim, Megan S.C., et al. "‘Censorship is Cancer’: Young People’s Support for Pornography-Related Initiatives." Sex Education 21.6 (2021): 660–673. Lišková, Kateřina. “Sexual Politics of Desire and Belonging.” Pornography as Language: From Discourse of Domination to Heretical Subversion, 2007. 41–56. &lt;https://doi.org/10.1163/9789401204705_004&gt;. Livingstone, Sonia, and Leslie Haddon. “EU Kids Online.” Zeitschrift für Psychologie / Journal of Psychology 217.4 (2009): 236–239. &lt;https://psycnet.apa.org/record/2010-01097-016&gt;. Livingstone, Sonia, et al. Risks and Safety on the Internet: The Perspective of European Children: Full Findings and Policy Implications from the EU Kids Online Survey of 9-16 Year Olds and Their Parents in 25 Countries. EU Kids Online, 2011. &lt;https://resourcecentre.savethechildren.net/document/risks-and-safety-internet-perspective-european-children-full-findings-and-policy/&gt;. Livingstone, Sonia, et al. "EU Kids Online II: A Large-Scale Quantitative Approach to the Study of European Children's Use of the Internet and Online Risks and Safety." SAGE Research Methods, 2014. &lt;https://doi.org/10.4135/978144627305014533936&gt;. McKee, Alan. “Does Pornography Harm Young People?” Australian Journal of Communication 37.1 (2010): 17–36. Mestre-Bach, Gemma, et al. "Pornography Use and Violence: A Systematic Review of the Last 20 Years." Trauma, Violence, &amp; Abuse 25.2 (2024): 1088–1112. Power, Jennifer, et al. National Survey of Australian Secondary Students and Sexual Health 2018. Melbourne: La Trobe University, 2019. &lt;https://www.latrobe.edu.au/arcshs/work/national-survey-of-secondary-students-and-sexual-health-2022&gt;. Silverman, David. Doing Qualitative Research. London: Sage Publications, 2021. Spišák, Sanna. “Everywhere They Say That It’s Harmful But They Don’t Say How, So I’m Asking Here: Young People, Pornography and Negotiations with Notions of Risk and Harm.” Sex Education 16.2 (2016): 130–142. &lt;https://doi.org/10.1080/14681811.2015.1080158&gt;. Third, Amanda, et al. Young People in Digital Society: Control Shift. London: Palgrave Macmillan, 2019. Tsaliki, Liza, and Despina Chronaki. "Conclusions: Why Is ‘Childhood at Risk’ So Appealing after All? The Construction of the ‘Iconic’ Child in the Context of Neoliberal Self-Governance." Discourses of Anxiety over Childhood and Youth across Cultures 11 (2020): 393–408. White, Robert. "Discourse Analysis and Social Constructionism." Nurse Researcher 12.2 (2004): 7–16. Woodley, Giselle, et al. “‘Send Nudes?’ Teens’ Perspectives of Education around Sexting, an Argument for a Balanced Approach.” Sexualities (2024). &lt;https://doi.org/10.1177/13634607241237675&gt;. Woodley, Giselle, et al. “Mandatory Consent Education Is a Huge Win for Australia – But Consent Is Just One Small Part of Navigating Relationships." The Conversation 21 Feb. 2022. &lt;https://theconversation.com/mandatory-consent-education-is-a-huge-win-for-australia-but-consent-is-just-one-small-part-of-navigating-relationships-177456&gt;.

IntroductionThis essay considers three design projects as microprotests. Reflecting on the ways design practice can generate spaces, sites and methods of protest, we use the concept of microprotest to consider how we, as designers ourselves, can protest by scaling down, focussing, slowing down and paying attention to the edges of our practice. Design microprotest is a form of design activism that is always collaborative, takes place within a community, and involves careful translation of a political conversation. While microprotest can manifest in any design discipline, in this essay we focus on visual communication design. In particular we consider the deep, reflexive practice of listening as the foundation of microprotests in visual communication design.While small in scale and fleeting in duration, these projects express rich and deep political engagements through conversations that create and maintain safe spaces. While many design theorists (Julier; Fuad-Luke; Clarke; Irwin et al.) have done important work to contextualise activist design as a broad movement with overlapping branches (social design, community design, eco-design, participatory design, critical design, and transition design etc.), the scope of our study takes ‘micro’ as a starting point. We focus on the kind of activism that takes shape in moments of careful design; these are moments when designers move politically, rather than necessarily within political movements. These microprotests respond to community needs through design more than they articulate a broad activist design movement. As such, the impacts of these microprotests often go unnoticed outside of the communities within which they take place. We propose, and test in this essay, a mode of analysis for design microprotests that takes design activism as a starting point but pays more attention to community and translation than designers and their global reach.In his analysis of design activism, Julier proposes “four possible conceptual tactics for the activist designer that are also to be found in particular qualities in the mainstream design culture and economy” (Julier, Introduction 149). We use two of these tactics to begin exploring a selection of attributes common to design microprotests: temporality – which describes the way that speed, slowness, progress and incompletion are dealt with; and territorialisation – which describes the scale at which responsibility and impact is conceived (227). In each of three projects to which we apply these tactics, one of us had a role as a visual communicator. As such, the research is framed by the knowledge creating paradigm described by Jonas as “research through design”.We also draw on other conceptualisations of design activism, and the rich design literature that has emerged in recent times to challenge the colonial legacies of design studies (Schultz; Tristan et al.; Escobar). Some analyses of design activism already focus on the micro or the minor. For example, in their design of social change within organisations as an experimental and iterative process, Lensjkold, Olander and Hasse refer to Deleuze and Guattari’s minoritarian: “minor design activism is ‘a position in co-design engagements that strives to continuously maintain experimentation” (67). Like minor activism, design microprotests are linked to the continuous mobilisation of actors and networks in processes of collective experimentation. However microprotests do not necessarily focus on organisational change. Rather, they create new (and often tiny) spaces of protest within which new voices can be heard and different kinds of listening can be done.In the first of our three cases, we discuss a representation of transdisciplinary listening. This piece of visual communication is a design microprotest in itself. This section helps to frame what we mean by a safe space by paying attention to the listening mode of communication. In the next sections we explore temporality and territorialisation through the design microprotests Just Spaces which documents the collective imagining of safe places for LBPQ (Lesbian, Bisexual, Pansexual, and Queer) women and non-binary identities through a series of graphic objects and Conversation Piece, a book written, designed and published over three days as a proposition for a collective future. A Representation of Transdisciplinary ListeningThe design artefact we present in this section is a representation of listening and can be understood as a microprotest emerging from a collective experiment that materialises firstly as a visual document asking questions of the visual communication discipline and its role in a research collaboration and also as a mirror for the interdisciplinary team to reflexively develop transdisciplinary perspectives on the risks associated with the release of environmental flows in the upper reaches of Hawkesbury Nepean River in NSW, Australia. This research project was funded through a Challenge Grant Scheme to encourage transdisciplinarity within the University. The project team worked with the Hawkesbury Nepean Catchment Management Authority in response to the question: What are the risks to maximising the benefits expected from increased environmental flows? Listening and visual communication design practice are inescapably linked. Renown American graphic designer and activist Sheila de Bretteville describes a consciousness and a commitment to listening as an openness, rather than antagonism and argument. Fiumara describes listening as nascent or an emerging skill and points to listening as the antithesis of the Western culture of saying and expression.For a visual communication designer there is a very specific listening that can be described as visual hearing. This practice materialises the act of hearing through a visualisation of the information or knowledge that is shared. This act of visual hearing is a performative process tracing the actors’ perspectives. This tracing is used as content, which is then translated into a transcultural representation constituted by the designerly act of perceiving multiple perspectives. The interpretation contributes to a shared project of transdisciplinary understanding.This transrepresentation (Fig. 1) is a manifestation of a small interaction among a research team comprised of a water engineer, sustainable governance researcher, water resource management researcher, environmental economist and a designer. This visualisation is a materialisation of a structured conversation in response to the question What are the risks to maximising the benefits expected from increased environmental flows? It represents a small contribution that provides an opportunity for reflexivity and documents a moment in time in response to a significant challenge. In this translation of a conversation as a visual representation, a design microprotest is made against reduction, simplification, antagonism and argument. This may seem intangible, but as a protest through design, “it involves the development of artifacts that exist in real time and space, it is situated within everyday contexts and processes of social and economic life” (Julier 226). This representation locates conversation in a visual order that responds to particular categorisations of the political, the institutional, the socio-economic and the physical in a transdisciplinary process that focusses on multiple perspectives.Figure 1: Transrepresentation of responses by an interdisciplinary research team to the question: What are the risks to maximising the benefits expected from increased environmental flows in the Upper Hawkesbury Nepean River? (2006) Just Spaces: Translating Safe SpacesListening is the foundation of design microprotest. Just Spaces emerged out of a collaborative listening project It’s OK! An Anthology of LBPQ (Lesbian, Bisexual, Pansexual and Queer) Women’s and Non-Binary Identities’ Stories and Advice. By visually communicating the way a community practices supportive listening (both in a physical form as a book and as an online resource), It’s OK! opens conversations about how LBPQ women and non-binary identities can imagine and help facilitate safe spaces. These conversations led to thinking about the effects of breaches of safe spaces on young LBPQ women and non-binary identities. In her book The Cultural Politics of Emotion, Sara Ahmed presents Queer Feelings as a new way of thinking about Queer bodies and the way they use and impress upon space. She makes an argument for creating and imagining new ways of creating and navigating public and private spaces. As a design microprotest, Just Spaces opens up Queer ways of navigating space through a process Ahmed describes as “the ‘non-fitting’ or discomfort .... an opening up which can be difficult and exciting” (Ahmed 154). Just Spaces is a series of workshops, translated into a graphic design object, and presented at an exhibition in the stairwell of the library at the University of Technology Sydney. It protests the requirement of navigating heteronormative environments by suggesting ‘Queer’ ways of being in and designing in space. The work offers solutions, suggestions, and new ways of doing and making by offering design methods as tools of microprotest to its participants. For instance, Just Spaces provides a framework for sensitive translation, through the introduction of a structure that helps build personas based on the game Dungeons and Dragons (a game popular among certain LGBTQIA+ communities in Sydney). Figure 2: Exhibition: Just Spaces, held at UTS Library from 5 to 27 April 2018. By focussing the design process on deep listening and rendering voices into visual translations, these workshops responded to Linda Tuhiwai Smith’s idea of the “outsider within”, articulating the way research should be navigated in vulnerable groups that have a history of being exploited as part of research. Through reciprocity and generosity, trust was generated in the design process which included a shared dinner; opening up participant-controlled safe spaces.To open up and explore ideas of discomfort and safety, two workshops were designed to provide safe and sensitive spaces for the group of seven LBPQ participants and collaborators. Design methods such as drawing, group imagining and futuring using a central prototype as a prompt drew out discussions of safe spaces. The prototype itself was a small folded house (representative of shelter) printed with a number of questions, such as:Our spaces are often unsafe. We take that as a given. But where do these breaches of safety take place? How was your safe space breached in those spaces?The workshops resulted in tangible objects, made by the participants, but these could not be made public because of privacy implications. So the next step was to use visual communication design to create sensitive and honest visual translations of the conversations. The translations trace images from the participants’ words, sketches and notes. For example, handwritten notes are transcribed and reproduced with a font chosen by the designer based on the tone of the comment and by considering how design can retain the essence of person as well as their anonymity. The translations focus on the micro: the micro breaches of safety; the interactions that take place between participants and their environment; and the everyday denigrating experiences that LBPQ women and non-binary identities go through on an ongoing basis. This translation process requires precise skills, sensitivity, care and deep knowledge of context. These skills operate at the smallest of scales through minute observation and detailed work. This micro-ness translates to the potential for truthfulness and care within the community, as it establishes a precedent through the translations for others to use and adapt for their own communities.The production of the work for exhibition also occurred on a micro level, using a Risograph, a screenprinting photocopier often found in schools, community groups and activist spaces. The machine (ME9350) used for this project is collectively owned by a co-op of Sydney creatives called Rizzeria. Each translation was printed only five times on butter paper. Butter paper is a sensitive surface but difficult to work with making the process slow and painstaking and with a lot of care.All aspects of this process and project are small: the pieced-together translations made by assembling segments of conversations; zines that can be kept in a pocket and read intimately; the group of participants; and the workshop and exhibition spaces. These small spaces of safety and their translations make possible conversations but also enable other safe spaces that move and intervene as design microprotests. Figure 3: Piecing the translations together. Figure 4: Pulling the translation off the drum; this was done every print making the process slow and requiring gentleness. This project was and is about slowing down, listening and visually translating in order to generate and imagine safe spaces. In this slowness, as Julier describes “...the activist is working in a more open-ended way that goes beyond the materialization of the design” (229). It creates methods for listening and collaboratively generating ways to navigate spaces that are fraught with micro conflict. As an act of territorialisation, it created tiny and important spaces as a design microprotest. Conversation Piece: A Fast and Slow BookConversation Piece is an experiment in collective self-publishing. It was made over three days by Frontyard, an activist space in Marrickville, NSW, involved in community “futuring”. Futuring for Frontyard is intended to empower people with tools to imagine and enact preferred futures, in contrast to what design theorist Tony Fry describes as “defuturing”, the systematic destruction of possible futures by design. Materialised as a book, Conversation Piece is also an act of collective futuring. It is a carefully designed process for producing dialogues between unlikely parties using an image archive as a starting point. Conversation Piece was designed with the book sprint format as a starting point. Founded by software designer Adam Hyde, book sprints are a method of collectively generating a book in just a few days then publishing it. Book sprints are related to the programming sprints common in agile software development or Scrum, which are often used to make FLOSS (Free and Open Source Software) manuals. Frontyard had used these techniques in a previous project to develop the Non Cash Arts Asset Platform.Conversation Piece was also modeled on two participatory books made during sprints that focussed on articulating alternative futures. Collaborative Futures was made during Transmediale in 2009, and Futurish: Thinking Out Loud about Futures (2015).The design for Conversation Piece began when Frontyard was invited to participate in the Hobiennale in 2017, a free festival emerging from the “national climate of uncertainty within the arts, influenced by changes to the structure of major arts organisations and diminishing funding opportunities.” The Hobiennale was the first Biennale held in Hobart, Tasmania, but rather than producing a standard large art survey, it focussed on artist-run spaces and initiatives, emergant practices, and marginalised voices in the arts. Frontyard is not an artist collective and does not work for commissions. Rather, the response to the invitation was based on how much energy there was in the group to contribute to Hobiennale. At Frontyard one of the ways collective and individual energy is accounted for is using spoon theory, a disability metaphor used to describe the planning that many people have to do to conserve and ration energy reserves in their daily lives (Miserandino). As outlined in the glossary of Conversation Piece, spoon theory is:A way of accounting for our emotional or physical energy and therefore our ability to participate in activities. Spoon theory can be used to collaborate with care and avoid guilt and burn out. Usually spoon theory is applied at an individual level, but it can also be used by organisations. For example, Hobiennale had enough spoons to participate in the Hobiennale so we decided to give it a go. (180)To make to book, Frontyard invited visitors to Hobiennale to participate in a series of open conversations that began with the photographic archive of the organisation over the two years of its existence. During a prototyping session, Frontyard designed nine diagrams that propositioned ways to begin conversations by combining images in different ways. Figure 5: Diagram 9. Conversation Piece: p.32-33One of the purposes of the diagrams, and the book itself, was to bring attention to the micro dynamics of conversation over time, and to create a safe space to explore the implications of these. While the production process and the book itself is micro (ten copies were printed and immediately given away), the decisions made in regards to licensing (a creative commons license is used), distribution (via the Internet Archive) and content generation (through participatory design processes) the project’s commitment to open design processes (Van Abel, Evers, Klaassen and Troxler) mean its impact is unpredictable. Counter-logical to the conventional copyright of books, open design borrows its definition - and at times its technologies and here its methods - from open source software design, to advocate the production of design objects based on fluid and shared circulation of design information. The tension between the abundance produced by an open approach to making, and the attention to the detail of relationships produced by slowing down and scaling down communication processes is made apparent in Conversation Piece:We challenge ourselves at Frontyard to keep bureaucratic processes as minimal an open as possible. We don’t have an application or acquittal process: we prefer to meet people over a cup of tea. A conversation is a way to work through questions. (7)As well as focussing on the micro dynamics of conversations, this projects protests the authority of archives. It works to dismantle the hierarchies of art and publishing through the design of an open, transparent, participatory publishing process. It offers a range of propositions about alternative economies, the agency of people working together at small scales, and the many possible futures in the collective imaginaries of people rethinking time, outcomes, results and progress.The contributors to the book are those in conversation – a complex networks of actors that are relationally configured and themselves in constant change, so as Julier explains “the object is subject to constant transformations, either literally or in its meaning. The designer is working within this instability.” (230) This is true of all design, but in this design microprotest, Frontyard works within this instability in order to redirect it. The book functions as a series of propositions about temporality and territorialisation, and focussing on micro interventions rather than radical political movements. In one section, two Frontyard residents offer a story of migration that also serves as a recipe for purslane soup, a traditional Portuguese dish (Rodriguez and Brison). Another lifts all the images of hand gestures from the Frontyard digital image archive and represents them in a photo essay. Figure 6: Talking to Rocks. Conversation Piece: p.143ConclusionThis article is an invitation to momentarily suspend the framing of design activism as a global movement in order to slow down the analysis of design protests and start paying attention to the brief moments and small spaces of protest that energise social change in design practice. We offered three examples of design microprotests, opening with a representation of transdisciplinary listening in order to frame design as a way if interpreting and listening as well as generating and producing. The two following projects we describe are collective acts of translation: small, momentary conversations designed into graphic forms that can be shared, reproduced, analysed, and remixed. Such protests have their limitations. Beyond the artefacts, the outcomes generated by design microprotests are difficult to identify. While they push and pull at the temporality and territorialisation of design, they operate at a small scale. How design microprotests connect to global networks of protest is an important question yet to be explored. The design practices of transdisciplinary listening, Queer Feelings and translations, and collaborative book sprinting, identified in these design microprotests change the thoughts and feelings of those who participate in ways that are impossible to measure in real time, and sometimes cannot be measured at all. Yet these practices are important now, as they shift the way designers design, and the way others understand what is designed. By identifying the common attributes of design microprotests, we can begin to understand the way necessary political conversations emerge in design practice, for instance about safe spaces, transdisciplinarity, and archives. Taking a research through design approach these can be understood over time, rather than just in the moment, and in specific territories that belong to community. They can be reconfigured into different conversations that change our world for the better. References Ahmed, Sara. “Queer Feelings.” The Cultural Politics of Emotion. Edinburgh: Edinburgh UP, 2004. 143-167.Clarke, Alison J. "'Actions Speak Louder': Victor Papanek and the Legacy of Design Activism." Design and Culture 5.2 (2013): 151-168.De Bretteville, Sheila L. Design beyond Design: Critical Reflection and the Practice of Visual Communication. Ed. Jan van Toorn. Maastricht: Jan van Eyck Akademie Editions, 1998. 115-127.Evers, L., et al. Open Design Now: Why Design Cannot Remain Exclusive. 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Introduction In March 2020, many societal functions came to a standstill due to the worldwide spread of Covid-19. Due to the rules set by public healthcare authorities that aimed at “social distancing” to prevent the spread of the virus, the emphasis on domesticity was heightened during the pandemic. As people were forced to spend more time in the home environment, more time was allowed for household pursuits and local activities, such as crafts and home repair (Morse, Fine, and Friedlander). While there has been a rising interest in craft-making as the medium of expression for the past few decades (e.g., Peach), crafts seem to have undergone a serious breakthrough during the global pandemic crisis. In recent studies, crafting has been noted for its usefulness in providing a dimension of comfort and security in a time of instability and isolation (Rixhon), eventually becoming a much-needed conceptual shelter from the threat of the virus (Martin). Sewing seems to have assumed a significant role early in the pandemic, when craft-makers began to mitigate the spread of the virus by using their own sewing machines and material stashes to make masks for their families and friends; some also donated masks to hospital workers and others in need (Martindale, Armstead, and McKinney). While other forms of crafts were also widely practiced (e.g., Jones; Stalp, Covid-19 Global Quilt; Wenzel), face-mask sewing has been at the core of pandemic craft research, highlighting the role of home-based hobby crafting as a means of social survival that contributed to people's agency and feelings of productivity and usefulness during the outbreak of coronavirus (Hahn and Bhaduri; Hustvedt and Liang; Martindale, Armstead, and McKinney; Richards and Perreault; Schnittka). This article analyses two craft hashtags on Instagram from March 2020 to December 2021, which offer a perspective on shifts in pandemic crafts in a linguistically localised crafting community. The hashtags crop up in the Finnish-speaking craft culture, defining pandemic crafts as “Covid craft”, #koronakäsityö, and “Covid crafts”, #koronakäsityöt. By definition, the Finnish word “käsityö” (which derives from the words “käsi”, hand, and “työ”, work) is a broad concept for all handiwork: it is not tied to any specific craft technique, but rather affirms work made by hand, or with tools that are held in hands. In addition, the concept of “käsityö” has no intended emphasis in regard of the phase of the project, or craft techniques or materials being used: it translates as an entity including both the idea of the product that is going to be made during the process of crafting, the embodied craft know-how of the making of the product, and the product itself (Kojonkoski-Rännäli 31; also Ihatsu). However, as is also disclosed in this study, the “käsityö” seems to have a connotation of craft work traditionally made by the persons assumed female by society or other people, and thus, findings may build on domesticity related to textile crafting (see Kouhia, Unraveling, 8, 17). The research questions driving this research are: (1) what kind of crafts were made, and how were these crafts contextualised during the pandemic; and (2) how was domesticity reflected in the pandemic crafting? The analysis explains how hobby crafts appeared as reactive pastimes, and how pandemic crafting set a debate on the implementation of alternative futures, interlinked with postfeminist forms of domesticity. As a result, it is shown that home-based hobby crafting was not only capable of upholding a sense of response and recovery for the makers during the pandemic, but also developing and bringing forth new trends within the maker culture. Domestic Crafting in the Digital Age In the Western narrative, crafts have been traditionally considered as generative quotidian activities positioned in the domestic space (Hardy; Thompson). In its history, domestic crafting has been practiced within a range of morals spanning from early conceptions of conspicuous leisure as an “unproductive expenditure of time” (Veblen 45) and 1950s feminine virtues like “thrift, practical creativity, and attention to appearance” (McLean 259) to today’s subversive, expressive Do-It-Yourself (DIY) along with the emergence of Third Wave Feminism that has powers to “resist capitalist materialism tendencies” (Stalp, Girls, 264). Often discussed in relation to femininity and unpaid labour—that include nuanced arguments of female subordination, sexuality, and housewifery (MacDonald 47; Parker 2–3; Turney 9)—contemporary crafting is seen not only to fall in the habitual expectations of domesticity, but also to have the capability to subvert and resist them. Indeed, while crafts such as knitting, sewing, and crocheting claimed their status as recreational leisure activities already in the late twentieth century with the changes related to construction of contemporary femininity (Groeneveld 264; Turney 2), there are still many issues and inequalities related to home-based hobby crafting. Predominantly, contemporary home crafts seem to be somewhat challenged by the lack of alternatives to the gendering of the domestic sphere (see Ceuterick). While home crafts are no longer social or economic domestic necessities and not practised by all or exclusively by women, home crafts still “continue to be perceived as a middle-class activity, a distraction and leisure pursuit for ‘ladies’ with time and means” (Hackney 170). While home-based hobby crafts cover many forms of making, ethical and social concerns that offer alternative and countercultural ways of living and consuming have become increasingly visible in contemporary crafting. Today’s hobby crafts operate within structures of everyday life and underpin plurality, complexity, and richness of amateur experience (Knott 124). Contemporary hobby crafting is also boosted by the revitalisation of old skills and the entrenchment of a home culture that utilises "retro cultures" (Hunt and Phillipov), and the increased interest of young adults in DIY culture (Kouhia, Unraveling; Stannard and Sanders). Almost a decade ago, Hunt and Phillipov put forward a discussion of the regained popularity of old-fashioned “Nanna Style” home practices. They noticed that young, activist makers praised these grandmotherly practices as “simultaneously nostalgic and politically progressive choices”, calling in countercultural politics of gender and consumption, and confusing the seemingly conservative lines “between imagined utopias of domesticity and the economic and environmental realities of contemporary consumer culture” (Hunt and Phillipov). Paired with ethical consumption, this promoted liberated postfeminist domesticity, a refusal of the capitalist structures of consumption, and a move away from binaries between the masculine and the feminine. Again, a return to domestic activities such as cooking, cleaning, and crafting was witnessed during the Covid-19 pandemic, with people inscribing the domestic chores as postfeminist choices rather than oppression (Ceuterick) and participating in the production of meaning as a “redomesticated woman” (Negra 16, cited in Palomeque Recio). Methodology Today, social media resources provide a fundamental theoretical lens used by the researchers with powers to function both as an enabler and a driver of innovation (Bhimani, Mention, and Barlatier). Social media channels allow people to derive value from self-generated content, promoting interpersonal connectedness with the sharing of details of the daily lives of the individuals (Nabity-Grover, Cheung, and Thatcher) with social support, referability, and potential correspondence enclosed from around cyberspace (Hajli). The article is based on qualitative social media research on Instagram, with aims to study the perpetual interest in hobby crafts during the pandemic. The study leans on the research paradigm known as ‘netnography’, which is a qualitative research methodology based on collecting, adapting, reflecting, and interacting with online traces with “a cultural focus on understanding the data derived from social media data” (Kozinets 6). Social media data consisting of 361 posts have been derived from Instagram’s #koronakäsityö and #koronakäsityöt hashtag feeds, and interpreted from the viewpoint of the content of the images and the context of their production (see Yang 17). The data collection took place from March 2020 to December 2021. I have followed the stream of posts using Instagram’s follow function from the position of a craft researcher and serious hobbyist (see Stebbins; Kouhia, Unraveling) from spring 2020, when the first Covid craft publications were published. Since then, the posts have been visible in the image stream of my own Instagram account, which has given me a preliminary view of the content of the publications. The data collection was ceased in December 2021 due to the decrease of posted content. All posts are connected to the Finnish craft culture through the hashtags used as descriptions of “käsityö”, and they are approached as forms of self-disclosure of Covid-era hobby crafting (see Nabity-Grover, Cheung, and Thatcher). The posts were collected at several points during the research period and were manually extracted to Excel tables with the post content data (date and week of publication, account name of the publisher, number of images, captions and hashtags). The data were analysed using qualitative approaches to Instagram data (Yang 19), with main emphasis on the posts’ visual material (Rose) analysed with a qualitative content analysis approach (see Hsieh and Shannon). The data were first charted and thematised by 1) the type and technique of craft presented (e.g., knitting, macramé, yarn balls, etc.), and 2) the display of the craft maker (age, gender, presentation in the post in relation or with the craft), and subsequently, evaluated by 3) looking at the production of domesticity in the posts (presentation and description of the domestic space). I have tried to ensure the validity of research with consistency and trust value (see Noble and Smith), making my research decisions clear and transparent, and viewing the experiences that may have resulted in methodological bias. However, given the multiple realities of qualitative research ontology, research validity needs to be framed within complex social and cultural rationales, and paired with the aim of “maintaining cohesion between the study’s aim, design and methods” (Noble and Smith 35). Considering the ethics of using social media data, all posts considered as the data of this study have been published on public Instagram accounts, and their reporting adheres to anonymous indirect quoting and image manipulation. Pandemic Domestic Crafting on Instagram Pandemic crafting consisted of many kinds of crafts. During the long review period, Covid crafts centred strikingly around textile-making: the most outstanding crafting techniques were knitting, crocheting, and sewing (table 1). Other kinds of textile crafts, like macramé, weaving, fabric printing and painting, embroidery, and clothing repair, were also displayed, yet with minor emphasis in comparison to yarn craft techniques and sewing. Some images presented textile handicraft tools, materials and machines, such as balls of yarn, beads, needles, and sewing machines. Only a few images contained artisanship with hard materials, with these few photos including multimaterial jewellery, boat carving, repairing a terrace, and building a wooden wall behind an outdoor mailbox. Table 1. The kinds of crafts posted on Instagram during the pandemic: a summary based on #koronakäsityö and #koronakäsityöt. Regarding the phase of the crafting project, most images concentrated on depicting completed, finished craft products. In addition to woollen socks, knitwear, macrame works, and clothes, everyday handicrafts endemic to the period, such as sewn masks and crocheted mask holders, were also portrayed as Corona crafts. Besides the kinds of crafts made, it is also important to look at the shifts in Covid-related craft content. Indeed, mask sewing posts and links to news on the positive role of crafting in times of crisis started to crop up in social media platforms already in the early phase of the pandemic (Kouhia, Online); in parallel, related social media hashtags emerged to identify the content. The first images of Covid crafts were posted on Instagram in late March 2020. These images were captioned with momentary descriptions of the disruption the habituated everyday routines, but also granted more time to crafts. As social-distancing weeks passed, Covid crafting quickly evolved in accordance with the first wave of the virus infection, eventually rising to its peak in April 2020. In parallel to the easing of the Covid outbreak in the summer of 2020, Covid crafting and posts diminished. As the situation became worse again in the autumn with the rise of the second wave of the virus, Covid crafting increased, and recurred until the spring of 2021. Towards the end of 2021, spontaneous Corona craft publications became irregular. Pandemic crafts seemed to be recurrently contextualised with the continual transformation of materiality within the domestic space. Craft-makers described having drawn inspiration from their old craft material stashes and returned to projects that had been left untouched and unfinished for one reason or another for months, years, and sometimes even decades. Makers—most of them likely falling, based on popularity of textile hobby crafts in Finland (see Pöllänen) and the interviews conducted among the publishers of the Covid craft-related posts, in the social categories of white, middle-aged, mostly urban able-bodied anticipated women—described having felt there was more time for crafting, and due to the restricted domestic space, an embodied and infinite push of being ecological and using the resources that they had at hand. In this sense, craft-makers not only showed abilities and resilience to react to the changing situation, but also unfolded crafting as an expression and a form of self-disclosure, with powers to make visible the value of care of the environment as a contribution to societal wellbeing. All in all, experiences of crafting as a self-chosen, self-maintained privilege seemed to afford a sense of flexibility. Further, this facilitated the reframing of the increased domestic activities as postfeminist choices and crafting as care for the home and family, as discussed in the following data excerpt: Thanks to Covid, I’ve had an excuse to take up the sewing machine and play with fabrics. I had completely forgotten how fun it is to design clothes, the process has really taken me out. Especially, if one wants more special children’s clothes, they will cost you like several bags of toilet paper = which is as much as hell, if you don’t make the clothes yourself. Also works as a pretty good motivator though 😂💪 (#koronakäsityöt Instagram post from April 2020) As the posts mainly cover textile crafting, feminine domesticity with the symbolised oppressive feminine social ideals of good mothering and housewifery are embedded in the narrative through at-home managerialism, like taking care of the household and maintaining children’s clothing. Indeed, the care of the family was repeatedly addressed in craft posts, with descriptions of mothers making clothes for their children—sometimes at the request of the kids, and but most often as daily chores of wearing and caring. For some craft-makers, textile crafting seemed to offer a passage to continue the mundane, domesticated policies that were already established at home; in other words, those who had been already keen on textile hobby crafting were suddenly offered more time for their beloved leisure practice. In addition, there were also new makers entering the field of crafting, who started practicing leisure crafts for the first time, or those who returned to their once-lost hobby. However, argumentation that framed Covid crafting tended to embrace craft-making as a conscious decision to live up to the images of femininity it may entail, and not particularly having the resources to transform the entrenched roles and figures it might provoke. Also, Covid crafting managed to also disclose a view of the intimate, framing the at-home private space and decorating it with the feminised imperatives of thriftiness, laboriousness, and austerity (see Bramall). Indeed, crafts seemed to be confined to the household space, which itself has been inherently political during the pandemic (e.g., Martin), and framed as distinctively individual choices to demonstrate the morale of staying at home and taking active ownership of the domestic space. Sometimes crafts were lined up in a space of their usage, like hanging macramé baskets and shawls placed on a sofa (fig. 1), though occupying the domestic space conveniently and adaptively, but without a deep questioning or consideration of the traditional binary oppositions between private and public spaces or home labour subscribing to anticipated masculinity or femininity. Rather, crafts seemed to be taken up as individual affirmative choices—not as household necessities, but as activities promoting the self-worth and personage of the makers and nurturing a sense of purpose and care in the lockdown homes. Fig. 1. Square crochet blanket occupying the domestic space. The image is manipulated by the author for the purposes of publication. Although crafts were purposefully placed on display in the posts, the main point was not in aesthetics based on strong image manipulation or the use of heavy filters, but rather showing off the permeability of the domestic space with the experiences of craft-makers living with a strong sense of satisfaction gained from crafting. Indeed, crafting itself can be interpreted as a resource contributing to the sense of perseverance and tenacity, giving a purpose for social survival in times of crisis: crafting was not cancelled, while almost everything else was paused. Discussion The pandemic had profound implications for the lives of millions of people, not only by compromising healthcare and economies, but also by reframing and revolutionising the meanings and values of moment-to-moment lifestyle choices and activities taking place at home. People were forced to re-engage in the practices of home and household during the pandemic, which changed their daily rhythm and transformed practices of the domestic space, further offering to revolutionise notions of domestic labour and care (Ceuterick). During the pandemic, domestic hobby crafting seemed to emerge as a phenomenon to influence social and cultural change, also providing makers with the experiences of usefulness to mitigate the changing circumstances. In line with the previous studies, this study implied that when contextualised within the frame of postmodern freedom, hobby crafts result in unique expressions that can sustain reflexivity, self-maintenance, and resilience (Kenning; Pöllänen), and reclaim a status as a public and social activity (Turney; Mayne). Within a study of 27 older adults practicing mask-sewing during the pandemic, Schnittka identified crafting to help other people to manage chaotic times, also contributing to makers' feelings of value, worthiness and purpose and their sense of control (225). Hahn and Bhaduri recognise similar habits in their study of mask-making behaviour, detailing that self-fulfilment and wellbeing as the most important reason for making masks, and financial motivation leaving behind other morals (307). Similar results can be also drawn based on this study; most importantly, the value of crafting as a flexible, self-sustained performance in the boundaries between the intimate and the shared. In this study, attention was drawn to hobby crafting intended for sharing online and situated in a linguistically localised cultural niche in a particular time frame. Thus, the study witnessed the rise and fall of “Covid-crafts” on Instagram through the analysis of two coronavirus-related craft hashtags that emerged in the Finnish-speaking crafting community. Although using linguistically and culturally situated data may limit the study, it also offers a view of crafting as a social and cultural phenomenon. In the future, more research needs to be undertaken on crafting regarding various geographic, political, cultural, and socio-economic venues, so that the nuanced and complex negotiations of domesticity could be examined and understood more thoroughly. Nevertheless, like the study by Martindale, Armstead, and McKinney, which reviewed publicly displayed face-mask sewing posts hashtagged with #sewingmasks and #sewingfacemask posted on Instagram in March 2020 (205), this study revealed that craft-makers were keen to share and exchange ideas and information online. In this study, Covid crafting seemed to be undertaken far from a complex choice—it was rather taken as a self-sustained, satisfactory leisure activity that aimed to maintain a sense of purpose rather than critique. Still, even the seemingly uncritical craft practice set to operate an inherently political act that made use of the changed resources in the family and household. Indeed, it can be concluded that in this time of crisis, crafting offered to raise a sense of wellbeing and individual identity of the maker, providing people with a means of reacting and being responsive to the changes of the world. 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What creative techniques of resistance are available to a female filmmaker when she is the victim of a violent event and filmed at her most vulnerable? This article uses an autoethnographic lens to discuss my experience of a serious car crash my family and I were inadvertently involved in due to police negligence and a criminal act. Employing Creative Analytical Practice (CAP) ethnography, a reflexive form of research which recognises that the creative process, producer and product are “deeply intertwined” (Richardson, “Writing: A Method” 930), I investigate how the crash’s violent affects crippled my agency, manifested in my creative praxis and catalysed my identification of latent forms of institutionalised violence in film culture, its discourse and pedagogy that also contributed to my inertia. The article maps my process of writing a feature length screenplay during the aftermath of the crash as I set out to articulate my story of survival and resistance. Using this narrative inquiry, in which we can “investigate how we construct the world, ourselves, and others, and how standard objectifying practices...unnecessarily limit us” (Richardson, “Writing: A Method” 924), I outline how I attempted to disrupt the entrenched power structures that exist in dominant narratives of violence in film and challenge my subjugated positioning as a woman within this canon. I describe my engagement with the deconstructionist practices of writing the body and militant feminist cinema, which suggest subversive opportunities for women’s self-determination by encouraging us to embrace our exiled positioning in dominant discourse through creative experimentation, and identify some of the possibilities and limitations of this for female agency. Drawing on CAP ethnography, existentialism, film feminism, and narrative reframing, I assert that these reconstructive practices are more effective for the creative enfranchisement of women by not relegating us to the periphery of social systems and cultural forms. Instead, they enable us to speak back to violent structures in a language that has greater social access, context and impact.My strong desire to tell screen stories lies in my belief that storytelling is a crucial evolutionary mechanism of resilience. Narratives do not simply represent the social world but also have the ability to change it by enabling us to “try to figure out how to live our lives meaningfully” (Ellis 760). This conviction has been directly influenced by my personal story of trauma and survival when myself, my siblings, and our respective life partners became involved in a major car crash. Two police officers attending to a drunken brawl in an inner city park had, in their haste, left the keys in the ignition of their vehicle. We were travelling across a major intersection when the police car, which had subsequently been stolen by a man involved in the brawl – a man who was wanted on parole, had a blood alcohol level three times over the legal limit, and was driving at speeds exceeding 110kms per hour - ran a red light and crossed our path, causing us to crash into his vehicle. From the impact, the small four-wheel drive we were travelling in was catapulted metres into the air, rolling numerous times before smashing head on into oncoming traffic. My heavily pregnant sister was driving our vehicle.The incident attracted national media attention and our story became a sensationalist spectacle. Each news station reported erroneous and conflicting information, one stating that my sister had lost her unborn daughter, another even going so far as to claim my sister had died in the crash. This tabloidised, ‘if it bleeds, it leads’, culture of journalism, along with new digital technologies, encourages and facilitates the normalisation of violent acts, often inflicted on women. Moreover, in their pursuit of high-rating stories, news bodies motivate dehumanising acts of citizen journalism that see witnesses often inspired to film, rather than assist, victims involved in a violent event. Through a connection with someone working for a major news station, we discovered that leading news broadcasters had bought a tape shot by a group of men who call themselves the ‘Paparazzi of Perth’. These men were some of the first on the scene and began filming us from only a few metres away while we were still trapped upside down and unconscious in our vehicle. In the recording, the men are heard laughing and celebrating our tragedy as they realise the lucrative possibilities of the shocking imagery they are capturing as witnesses pull us out of the back of the car, and my pregnant sister incredibly frees herself from the wreckage by kicking out the window.As a female filmmaker, I saw the bitter irony of this event as the camera was now turned on me and my loved ones at our most vulnerable. In her discussion of the male gaze, a culturally sanctioned form of narrational violence against women that is ubiquitous in most mainstream media, Mulvey proposes that women are generally the passive image, trapped by the physical limits of the frame in a permanent state of powerlessness as our identity is reduced to her “to-be-looked-at-ness” (40). For a long period of time, the experience of performing the role of this commodified woman of a weaponised male gaze, along with the threat of annihilation associated with our near-death experience, immobilised my spirit. I felt I belonged “more to the dead than to the living” (Herman 34). When I eventually returned to my creative praxis, I decided to use scriptwriting as both my “mode of reasoning and a mode of representation” (Richardson, Writing Strategies 21), test whether I could work through my feelings of alienation and violation and reclaim my agency. This was a complex and harrowing task because my memories “lack[ed] verbal narrative and context” (Herman 38) and were deeply rooted in my body. Cixous confirms that for women, “writing and voice...are woven together” and “spring from the deepest layers of her psyche” (Moi 112). For many months, I struggled to write. I attempted to block out this violent ordeal and censor my self. I soon learnt, however, that my body could not be silenced and was slow to forget. As I tried to write around this experience, the trauma worked itself deeper inside of me, and my physical symptoms worsened, as did the quality of my writing.In the early version of the screenplay I found myself writing a female-centred film about violence, identity and death, using the fictional narrative to express the numbness I experienced. I wrote the female protagonist with detachment as though she were an object devoid of agency. Sartre claims that we make objects of others and of ourselves in an attempt to control the uncertainty of life and the ever-changing nature of humanity (242). Making something into an object is to deprive it of life (and death); it is our attempt to keep ourselves ‘safe’. While I recognise that the car crash’s reminder of my mortality was no doubt part of the reason why I rendered myself, and the script’s female protagonist, lifeless as agentic beings, I sensed that there were subtler operations of power and control behind my self-objectification and self-censorship, which deeply concerned me. What had influenced this dea(r)th of female agency in my creative imaginings? Why did I write my female character with such a red pen? Why did I seem so compelled to ‘kill’ her? I wanted to investigate my gender construction, the complex relationship between my scriptwriting praxis, and the context within which it is produced to discover whether I could write a different future for myself, and my female characters. Kiesinger supports “contextualizing our stories within the framework of a larger picture” (108), so as to remain open to the possibility that there might not be anything ‘wrong’ with us, per se, “but rather something very wrong with the dynamics that dominate the communicative system” (109) within which we operate: in the case of my creative praxis, the oppressive structures present in the culture of film and its pedagogy.Pulling FocusWomen are supposed to be the view and when the view talks back, it is uncomfortable.— Jane Campion (Filming Desire)It is a terrible thing to see that no one has ever taught us how to develop our vision as women neither in the history of arts nor in film schools.— Marie Mandy (Filming Desire)The democratisation of today’s media landscape through new technologies, the recent rise in female-run production companies (Zemler) in Hollywood, along with the ground-breaking #MeToo and Time’s Up movements has elevated the global consciousness of gender-based violence, and has seen the screen industry seek to redress its history of gender imbalance. While it is too early to assess the impact these developments may have on women’s standing in film, today the ‘celluloid ceiling’ still operates on multiple levels of indoctrination and control through a systemic pattern of exclusion for women that upholds the “nearly seamless dialogue among men in cinema” (Lauzen, Thumbs Down 2). Female filmmakers occupy a tenuous position of influence in the mainstream industry and things are not any better on the other side of the camera (Lauzen, The Celluloid Ceiling). For the most part, Hollywood’s male gaze and penchant for sexualising and (physically or figuratively) killing female characters, which normalises violence against women and is “almost inversely proportional to the liberation of women in society” (Mandy), continues to limit women to performing as the image rather than the agent on screen.Film funding bodies and censorship boards, mostly comprised of men, remain exceptionally averse to independent female filmmakers who go against the odds to tell their stories, which often violate taboos about femininity and radically redefine female agency through the construction of the female gaze: a narrational technique of resistance that enables reel woman to govern the point of view, imagery and action of the film (Smelik 51-52). This generally sees their films unjustly ghettoised through incongruent classification or censorship, and forced into independent or underground distribution (Sexton-Finck 165-182). Not only does censorship propose the idea that female agency is abject and dangerous and needs to be restrained, it prevents access to this important cinema by women that aims to counter the male gaze and “shield us from this type of violence” (Gillain 210). This form of ideological and institutional gatekeeping is not only enforced in the film industry, it is also insidiously (re)constituted in the epistemological construction of film discourse and pedagogy, which in their design, are still largely intrinsically gendered institutions, encoded with phallocentric signification that rejects a woman’s specificity and approach to knowledge. Drawing on my mutually informative roles as a former film student and experienced screen educator, I assert that most screen curricula in Australia still uphold entrenched androcentric norms that assume the male gaze and advocate popular cinema’s didactic three-act structure, which conditions our value systems to favour masculinity and men’s worldview. This restorative storytelling approach is argued to be fatally limiting to reel women (Smith 136; Dancyger and Rush 25) as it propagates the Enlightenment notion of a universal subjectivity, based on free will and reason, which neutralises the power structures of society (and film) and repudiates the influence of social positioning on our opportunity for agency. Moreover, through its omniscient consciousness, which seeks to efface the presence of a specific narrator, the three-act method disavows this policing of female agency and absolves any specific individual of responsibility for its structural violence (Dyer 98).By pulling focus on some of these problematic mechanisms in the hostile climate of the film industry and its spaces of learning for women, I became acutely aware of the more latent forms of violence that had conditioned my scriptwriting praxis, the ambivalence I felt towards my female identity, and my consequent gagging of the female character in the screenplay.Changing Lenses How do the specific circumstances in which we write affect what we write? How does what we write affect who we become?— Laurel Richardson (Fields of Play 1)In the beginning, there is an end. Don’t be afraid: it’s your death that is dying. Then: all the beginnings.— Helene Cixous (Cixous and Jensen 41)The discoveries I made during my process of CAP ethnography saw a strong feeling of dissidence arrive inside me. I vehemently wanted to write my way out of my subjugated state and release some of the anguish that my traumatised body was carrying around. I was drawn to militant feminist cinema and the French poststructuralist approach of ‘writing the body’ (l’ecriture feminine) given these deconstructive practices “create images and ideas that have the power to inspire to revolt against oppression and exploitation” (Moi 120). Feminist cinema’s visual treatise of writing the body through its departure from androcentric codes - its unformulaic approach to structure, plot, character and narration (De Lauretis 106) - revealed to me ways in which I could use the scriptwriting process to validate my debilitating experience of physical and psychic violence, decensor my self and move towards rejoining the living. Cixous affirms that, “by writing her self, woman will return to the body which has been more than confiscated from her, which has been turned into…the ailing or dead figure” (Cixous, The Laugh of the Medusa 880). It became clear to me that the persistent themes of death that manifested in the first draft of the script were not, as I first suspected, me ‘rehearsing to die’, or wanting to kill off the woman inside me. I was in fact “not driven towards death but by death” (Homer 89), the close proximity to my mortality, acting as a limit, was calling for a strengthening of my life force, a rebirth of my agency (Bettelheim 36). Mansfield acknowledges that death “offers us a freedom outside of the repression and logic that dominate our daily practices of keeping ourselves in order, within the lines” (87).I challenged myself to write the uncomfortable, the unfamiliar, the unexplored and to allow myself to go to places in me that I had never before let speak by investigating my agency from a much more layered and critical perspective. This was both incredibly terrifying and liberating and enabled me to discard the agentic ‘corset’ I had previously worn in my creative praxis. Dancyger and Rush confirm that “one of the things that happens when we break out of the restorative three-act form is that the effaced narrator becomes increasingly visible and overt” (38). I experienced an invigorating feeling of empowerment through my appropriation of the female gaze in the screenplay which initially appeased some of the post-crash turmoil and general sense of injustice I was experiencing. However, I soon, found something toxic rising inside of me. Like the acrimonious feminist cinema I was immersed in – Raw (Ducournau), A Girl Walks Home at Night (Amirpour), Romance (Breillat), Trouble Every Day (Denis), Baise-Moi (Despentes and Thi), In My Skin (Van), Anatomy of Hell (Breillat) – the screenplay I had produced involved a female character turning the tables on men and using acts of revenge to satisfy her needs. Not only was I creating a highly dystopian world filled with explicit themes of suffering in the screenplay, I too existed in a displaced state of rage and ‘psychic nausea’ in my daily life (Baldick and Sartre). I became haunted by vivid flashbacks of the car crash as abject images, sounds and sensations played over and over in my mind and body like a horror movie on loop. I struggled to find the necessary clarity and counterbalance of stability required to successfully handle this type of experimentation.I do not wish to undermine the creative potential of deconstructive practices, such as writing the body and militant cinema, for female filmmakers. However, I believe my post-trauma sensitivity to visceral entrapment and spiritual violence magnifies some of the psychological and physiological risks involved. Deconstructive experimentation “happens much more easily in the realm of “texts” than in the world of human interaction” (hooks 22) and presents agentic limitations for women since it offers a “utopian vision of female creativity” (Moi 119) that is “devoid of reality...except in a poetic sense” (Moi 122). In jettisoning the restorative qualities of narrative film, new boundaries for women are inadvertently created through restricting us to “intellectual pleasure but rarely emotional pleasure” (Citron 51). Moreover, by reducing women’s agency to retaliation we are denied the opportunity for catharsis and transformation; something I desperately longed to experience in my injured state. Kaplan acknowledges this problem, arguing that female filmmakers need to move theoretically beyond deconstruction to reconstruction, “to manipulate the recognized, dominating discourses so as to begin to free ourselves through rather than beyond them (for what is there ‘beyond’?)” (Women and Film 141).A potent desire to regain a sense of connectedness and control pushed itself out from deep inside me. I yearned for a tonic to move myself and my female character to an active position, rather than a reactive one that merely repeats the victimising dynamic of mainstream film by appropriating a reversed (female) gaze and now makes women the violent victors (Kaplan, Feminism and Film 130). We have arrived at a point where we must destabilise the dominance-submission structure and “think about ways of transcending a polarity that has only brought us all pain” (Kaplan, Feminism and Film 135). I became determined to write a screen narrative that, while dealing with some of the harsh realities of humanity I had become exposed to, involved an existentialist movement towards catharsis and activity.ReframingWhen our stories break down or no longer serve us well, it is imperative that we examine the quality of the stories we are telling and actively reinvent our accounts in ways that permit us to live more fulfilling lives.— Christine Kiesinger (107)I’m frightened by life’s randomness, so I want to deal with it, make some sense of it by telling a film story. But it’s not without hope. I don’t believe in telling stories without some hope.— Susanne Bier (Thomas)Narrative reframing is underlined by the existentialist belief that our spiritual freedom is an artistic process of self-creation, dependent on our free will to organise the elements of our lives, many determined out of our control, into the subjective frame that is to be our experience of our selves and the world around us (107). As a filmmaker, I recognise the power of selective editing and composition. Narrative reframing’s demand for a rational assessment of “the degree to which we live our stories versus the degree to which our stories live us” (Kiesinger 109), helped me to understand how I could use these filmmaking skills to take a step back from my trauma so as to look at it objectively “as a text for study” (Ellis 108) and to exercise power over the creative-destructive forces it, and the deconstructive writing methods I had employed, produced. Richardson confirms the benefits of this practice, since narrative “is the universal way in which humans accommodate to finitude” (Writing Strategies 65).In the script’s development, I found my resilience lay in my capacity to imagine more positive alternatives for female agency. I focussed on writing a narrative that did not avoid life’s hardships and injustices, or require them to be “attenuated, veiled, sweetened, blunted, and falsified” (Nietzsche and Hollingdale 68), yet still involved a life-affirming sentiment. With this in mind, I reintroduced the three-act structure in the revised script as its affectivity and therapeutic denouement enabled me to experience a sense of agentic catharsis that turned “nauseous thoughts into imaginations with which it is possible to live” (Nietzsche 52). Nevertheless, I remained vigilant not to lapse into didacticism; to allow my female character to be free to transgress social conventions surrounding women’s agency. Indebted to Kaplan’s writing on the cinematic gaze, I chose to take up what she identifies as a ‘mutual gaze’; an ethical framework that enabled me to privilege the female character’s perspective and autonomy with a neutral subject-subject gaze rather than the “subject-object kind that reduces one of the parties to the place of submission” (Feminism and Film 135). I incorporated the filmic technique of the point of view (POV) shot for key narrative moments as it allows an audience to literally view the world through a character’s eyes, as well as direct address, which involves the character looking back down the lens at the viewer (us); establishing the highest level of identification between the spectator and the subject on screen.The most pertinent illustration of these significant scriptwriting changes through my engagement with narrative reframing and feminist film theory, is in the reworking of my family’s car crash which became a pivotal turning point in the final draft. In the scene, I use POV and direct address to turn the weaponised gaze back around onto the ‘paparazzi’ who are filming the spectacle. When the central (pregnant) character frees herself from the wreckage, she notices these men filming her and we see the moment from her point of view as she looks at these men laughing and revelling in the commercial potential of their mediatised act. Switching between POV and direct address, the men soon notice they have been exposed as the woman looks back down the lens at them (us) with disbelief, reproaching them (us) for daring to film her in this traumatic moment. She holds her determined gaze while they glance awkwardly back at her, until their laughter dissipates, they stop recording and appear to recognise the culpability of their actions. With these techniques of mutual gazing, I set out to humanise and empower the female victim and neutralise the power dynamic: the woman is now also a viewing agent, and the men equally perform the role of the viewed. In this creative reframing, I hope to provide an antidote to filmic violence against and/or by women as this female character reclaims her (my) experience of survival without adhering to the culture of female passivity or ressentiment.This article has examined how a serious car crash, being filmed against my will in its aftermath and the attendant damages that prevailed from this experience, catalysed a critical change of direction in my scriptwriting. The victimising event helped me recognise the manifest and latent forms of violence against women that are normalised through everyday ideological and institutional systems in film and prevent us from performing as active agents in our creative praxis. There is a critical need for more inclusive modes of practice – across the film industry, discourse and pedagogy – that are cognisant and respectful of women’s specificity and our difference to the androcentric landscape of mainstream film. We need to continue to exert pressure on changing violent mechanisms that marginalise us and ghettoise our stories. As this article has demonstrated, working outside dominant forms can enable important emancipatory opportunities for women, however, this type or deconstruction also presents risks that generally leave us powerless in everyday spaces. While I advocate that female filmmakers should look to techniques of feminist cinema for an alternative lens, we must also work within popular film to critique and subvert it, and not deny women the pleasures and political advantages of its restorative structure. By enabling female filmmakers to (re)humanise woman though encouraging empathy and compassion, this affective storytelling form has the potential to counter violence against women and mobilise female agency. Equally, CAP ethnography and narrative reframing are critical discourses for the retrieval and actualisation of female filmmakers’ agency as they allow us to contextualise our stories of resistance and survival within the framework of a larger picture of violence to gain perspective on our subjective experiences and render them as significant, informative and useful to the lives of others. This enables us to move from the isolated margins of subcultural film and discourse to reclaim our stories at the centre.ReferencesA Girl Walks Home at Night. Dir. Ana Lily Amirpour. Say Ahh Productions, 2014.Anatomy of Hell. Dir. Catherine Breillat. Tartan Films, 2004. Baise-Moi. Dirs. Virginie Despentes and Coralie Trinh Thi. FilmFixx, 2000.Baldick, Robert, and Jean-Paul Sartre. Nausea. 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California: AltaMira, 2004.Filming Desire: A Journey through Women's Cinema. Dir. Marie Mandy. Women Make Movies, 2000.Gillain, Anne. “Profile of a Filmmaker: Catherine Breillat.” Beyond French Feminisms: Debates on Women, Politics, and Culture in France, 1981-2001. Eds. Roger Célestin, Eliane Françoise DalMolin, and Isabelle de Courtivron. New York: Palgrave Macmillan, 2003. 206.Herman, Judith Lewis. Trauma and Recovery. London: Pandora, 1994.Homer, Sean. Jacques Lacan. London: Routledge, 2005.hooks, bell. Yearning: Race, Gender, and Cultural Politics. Boston, MA: South End Press, 1990.In My Skin. Dir. Marina de Van. Wellspring Media, 2002. Kaplan, E. Ann. Women and Film: Both Sides of the Camera. New York: Routledge, 1988.———. Feminism and Film. Oxford: Oxford University Press, 2000.Kiesinger, Christine E. “My Father's Shoes: The Therapeutic Value of Narrative Reframing.” Ethnographically Speaking: Autoethnography, Literature, and Aesthetics. Eds. Arthur P. Bochner and Carolyn Ellis. Walnut Creek, CA: AltaMira Press, 2002. 107-111.Lauzen, Martha M. “Thumbs Down - Representation of Women Film Critics in the Top 100 U.S. Daily Newspapers - A Study by Dr. Martha Lauzen.” Alliance of Women Film Journalists, 25 July 2012. 4-5.———. The Celluloid Ceiling: Behind-the-Scenes Employment of Women on the Top 100, 250, and 500 Films of 2018. Center for the Study of Women in Television and Film San Diego State University 2019. &lt;https://womenintvfilm.sdsu.edu/wp-content/uploads/2019/01/2018_Celluloid_Ceiling_Report.pdf&gt;.Mansfield, Nick. Subjectivity: Theories of the Self from Freud to Haraway. St Leonards, NSW: Allen &amp; Unwin, 2000.Moi, Toril. Sexual/Textual Politics: Feminist Literary Theory. London: Methuen, 2002.Mulvey, Laura. Visual Pleasure and Narrative Cinema in Feminism and Film. Ed. E. Ann Kaplan. New York: Oxford University Press, 1975. 34-47.Nietzsche, Friedrich W. The Birth of Tragedy and the Genealogy of Morals. Trans. Francis Golffing. New York: Doubleday, 1956.Nietzsche, Friedrich W., and Richard Hollingdale. Beyond Good and Evil. London: Penguin Books, 1990.Raw. Dir. Julia Ducournau. Petit Film, 2016.Richardson, Laurel. Writing Strategies: Reaching Diverse Audiences. Newbury Park, California: Sage Publications, 1990.———. Fields of Play: Constructing an Academic Life. New Brunswick, N.J.: Rutgers University Press, 1997.———. “Writing: A Method of Inquiry.” Handbook of Qualitative Research. Eds. Norman K Denzin and Yvonna S. Lincoln. Thousand Oaks, CA: Sage Publications, 2000.Romance. Dir. Catherine Breillat. Trimark Pictures Inc., 2000.Sartre, Jean-Paul. Being and Nothingness: An Essay on Phenomenological Ontology. London: Routledge, 1969.Sexton-Finck, Larissa. Be(com)ing Reel Independent Woman: An Autoethnographic Journey through Female Subjectivity and Agency in Contemporary Cinema with Particular Reference to Independent Scriptwriting Practice. 2009. &lt;https://researchrepository.murdoch.edu.au/id/eprint/1688/2/02Whole.pdf&gt;.Smelik, Anneke. And the Mirror Cracked: Feminist Cinema and Film Theory. New York: St. Martin's Press, 1998.Smith, Hazel. The Writing Experiment: Strategies for Innovative Creative Writing. Crows Nest, NSW: Allen &amp; Unwin, 2005.Thomas, Michelle. “10 Years of Dogme: An Interview with Susanne Bier.” Future Movies, 5 Aug. 2005. &lt;http://www.futuremovies.co.uk/filmmaking.asp?ID=119&gt;.Trouble Every Day. Dir. Claire Denis. Wild Bunch, 2001. Zemler, Mily. “17 Actresses Who Started Their Own Production Companies.” Elle, 11 Jan. 2018. &lt;https://www.elle.com/culture/movies-tv/g14927338/17-actresses-with-production-companies/&gt;.

Being a celebrity sure ain’t what it used to be. Or, perhaps more accurately, the process of maintaining a stable star persona isn’t what it used to be. With the rise of new media technologies—including digital photography and video production, gossip blogging, social networking sites, and streaming video—there has been a rapid proliferation of voices which serve to articulate stars’ personae. This panoply of sanctioned and unsanctioned discourses has brought the coherence and stability of the star’s image into crisis, with an evermore-heightened loop forming recursively between celebrity gossip and scandals, on the one hand, and, on the other, new media-enabled speculation and commentary about these scandals and gossip-pieces. Of course, while no subject has a single meaning, Hollywood has historically expended great energy and resources to perpetuate the myth that the star’s image is univocal. In the present moment, however, studios’s traditional methods for discursive control have faltered, such that celebrities have found it necessary to take matters into their own hands, using new media technologies, particularly Twitter, in an attempt to stabilise that most vital currency of their trade, their professional/public persona. In order to fully appreciate the significance of this new mode of publicity management, and its larger implications for contemporary subjectivity writ large, we must first come to understand the history of Hollywood’s approach to celebrity publicity and image management.A Brief History of Hollywood PublicityThe origins of this effort are nearly as old as Hollywood itself, for, as Richard DeCordova explains, the celebrity scandals of the 1920s threatened to disrupt the economic vitality of the incipient industry such that strict, centralised image control appeared as a necessary imperative to maintain a consistently reliable product. The Fatty Arbuckle murder trial was scandalous not only for its subject matter (a murder suffused with illicit and shadowy sexual innuendo) but also because the event revealed that stars, despite their mediated larger-than-life images, were not only as human as the rest of us, but that, in fact, they were capable of profoundly inhuman acts. The scandal, then, was not so much Arbuckle’s crime, but the negative pall it cast over the Hollywood mythos of glamour and grace. The studios quickly organised an industry-wide regulatory agency (the MPPDA) to counter potentially damaging rhetoric and ward off government intervention. Censorship codes and morality clauses were combined with well-funded publicity departments in an effort that successfully shifted the locus of the star’s extra-filmic discursive construction from private acts—which could betray their screen image—to information which served to extend and enhance the star’s pre-existing persona. In this way, the sanctioned celebrity knowledge sphere became co-extensive with that of commercial culture itself; the star became meaningful only by knowing how she spent her leisure time and the type of make-up she used. The star’s identity was not found via unsanctioned intrusion, but through studio-sanctioned disclosure, made available in the form of gossip columns, newsreels, and fan magazines. This period of relative stability for the star's star image was ultimately quite brief, however, as the collapse of the studio system in the late 1940s and the introduction of television brought about a radical, but gradual, reordering of the star's signifying potential. The studios no longer had the resources or incentive to tightly police star images—the classic age of stardom was over. During this period of change, an influx of alternative voices and publications filled the discursive void left by the demise of the studios’s regimented publicity efforts, with many of these new outlets reengaging older methods of intrusion to generate a regular rhythm of vendible information about the stars.The first to exploit and capitalize on star image instability was Robert Harrison, whose Confidential Magazine became the leading gossip publication of the 1950s. Unlike its fan magazine rivals, which persisted in portraying the stars as morally upright and wholesome, Confidential pledged on the cover of each issue to “tell the facts and name the names,” revealing what had been theretofore “confidential.” In essence, through intrusion, Confidential reasserted scandal as the true core of the star, simultaneously instituting incursion and surveillance as the most direct avenue to the “kernel” of the celebrity subject, obtaining stories through associations with call girls, out-of-work starlettes, and private eyes. As extra-textual discourses proliferated and fragmented, the contexts in which the public encountered the star changed as well. Theatre attendance dropped dramatically, and as the studios sold their film libraries to television, the stars, formerly available only on the big screen and in glamour shots, were now intercut with commercials, broadcast on grainy sets in the domestic space. The integrity—or at least the illusion of integrity—of the star image was forever compromised. As the parameters of renown continued to expand, film stars, formally distinguished from all other performers, migrated to television. The landscape of stardom was re-contoured into the “celebrity sphere,” a space that includes television hosts, musicians, royals, and charismatic politicians. The revamped celebrity “game” was complex, but still playabout: with a powerful agent, a talented publicist, and a check on drinking, drug use, and extra-marital affairs, a star and his or her management team could negotiate a coherent image. Confidential was gone, The National Inquirer was muzzled by libel laws, and People and E.T.—both sheltered within larger media companies—towed the publicists’s line. There were few widely circulated outlets through which unauthorised voices could gain traction. Old-School Stars and New Media Technologies: The Case of Tom CruiseYet with the relentless arrival of various news media technologies beginning in the 1980s and continuing through the present, maintaining tight celebrity image control began to require the services of a phalanx of publicists and handlers. Here, the example of Tom Cruise is instructive: for nearly twenty years, Cruise’s publicity was managed by Pat Kingsley, who exercised exacting control over the star’s image. With the help of seemingly diverse yet essentially similar starring roles, Cruise solidified his image as the cocky, charismatic boy-next-door.The unified Cruise image was made possible by shutting down competing discourses through the relentless, comprehensive efforts of his management company; Kingsley's staff fine-tuned Cruise’s acts of disclosure while simultaneously eliminating the potential for unplanned intrusions, neutralising any potential scandal at its source. Kingsley and her aides performed for Cruise all the functions of a studio publicity department from Hollywood’s Golden Age. Most importantly, Cruise was kept silent on the topic of his controversial religion, Scientology, lest it incite domestic and international backlash. In interviews and off-the-cuff soundbites, Cruise was ostensibly disclosing his true self, and that self remained the dominant reading of what, and who, Cruise “was.” Yet in 2004, Cruise fired Kingsley, replaced her with his own sister (and fellow Scientologist), who had no prior experience in public relations. In essence, he exchanged a handler who understood how to shape star disclosure for one who did not. The events that followed have been widely rehearsed: Cruise avidly pursued Katie Holmes; Cruise jumped for joy on Oprah’s couch; Cruise denounced psychology during a heated debate with Matt Lauer on The Today Show. His attempt at disclosing this new, un-publicist-mediated self became scandalous in and of itself. Cruise’s dismissal of Kingsley, his unpopular (but not necessarily unwelcome) disclosures, and his own massively unchecked ego all played crucial roles in the fall of the Cruise image. While these stumbles might have caused some minor career turmoil in the past, the hyper-echoic, spastically recombinatory logic of the technoculture brought the speed and stakes of these missteps to a new level; one of the hallmarks of the postmodern condition has been not merely an increasing textual self-reflexivity, but a qualitative new leap forward in inter-textual reflexivity, as well (Lyotard; Baudrillard). Indeed, the swift dismantling of Cruise’s long-established image is directly linked to the immediacy and speed of the Internet, digital photography, and the gossip blog, as the reflexivity of new media rendered the safe division between disclosure and intrusion untenable. His couchjumping was turned into a dance remix and circulated on YouTube; Mission Impossible 3 boycotts were organised through a number of different Web forums; gossip bloggers speculated that Cruise had impregnated Holmes using the frozen sperm of Scientology founder L. Ron Hubbard. In the past, Cruise simply filed defamation suits against print publications that would deign to sully his image. Yet the sheer number of sites and voices reproducing this new set of rumors made such a strategy untenable. Ultimately, intrusions into Cruise’s personal life, including the leak of videos intended solely for Scientology recruitment use, had far more traction than any sanctioned Cruise soundbite. Cruise’s image emerged as a hollowed husk of its former self; the sheer amount of material circulating rendered all attempts at P.R., including a Vanity Fair cover story and “reveal” of daughter Suri, ridiculous. His image was fragmented and re-collected into an altered, almost uncanny new iteration. Following the lackluster performance of Mission Impossible 3 and public condemnation by Paramount head Sumner Redstone, Cruise seemed almost pitiable. The New Logic of Celebrity Image ManagementCruise’s travails are expressive of a deeper development which has occurred over the course of the last decade, as the massively proliferating new forms of celebrity discourse (e.g., paparazzi photos, mug shots, cell phone video have further decentered any shiny, polished version of a star. With older forms of media increasingly reorganising themselves according to the aesthetics and logic of new media forms (e.g., CNN featuring regular segments in which it focuses its network cameras upon a computer screen displaying the CNN website), we are only more prone to appreciate “low media” forms of star discourse—reports from fans on discussion boards, photos taken on cell phones—as valid components of the celebrity image. People and E.T. still attract millions, but they are rapidly ceding control of the celebrity industry to their ugly, offensive stepbrothers: TMZ, Us Weekly, and dozens of gossip blogs. Importantly, a publicist may be able to induce a blogger to cover their client, but they cannot convince him to drop a story: if TMZ doesn’t post it, then Perez Hilton certainly will. With TMZ unabashedly offering pay-outs to informants—including those in law enforcement and health care, despite recently passed legislation—a star is never safe. If he or she misbehaves, someone, professional or amateur, will provide coverage. Scandal becomes normalised, and, in so doing, can no longer really function as scandal as such; in an age of around-the-clock news cycles and celebrity-fixated journalism, the only truly scandalising event would be the complete absence of any scandalous reports. Or, as aesthetic theorist Jacques Ranciere puts it; “The complaint is then no longer that images conceal secrets which are no longer such to anyone, but, on the contrary, that they no longer hide anything” (22).These seemingly paradoxical involutions of post-modern celebrity epistemologies are at the core of the current crisis of celebrity, and, subsequently, of celebrities’s attempts to “take back their own paparazzi.” As one might expect, contemporary celebrities have attempted to counter these new logics and strategies of intrusion through a heightened commitment to disclosure, principally through the social networking capabilities of Twitter. Yet, as we will see, not only have the epistemological reorderings of postmodernist technoculture affected the logic of scandal/intrusion, but so too have they radically altered the workings of intrusion’s dialectical counterpart, disclosure.In the 1930s, when written letters were still the primary medium for intimate communication, stars would send lengthy “hand-written” letters to members of their fan club. Of course, such letters were generally not written by the stars themselves, but handwriting—and a star’s signature—signified authenticity. This ritualised process conferred an “aura” of authenticity upon the object of exchange precisely because of its static, recurring nature—exchange of fan mail was conventionally understood to be the primary medium for personal encounters with a celebrity. Within the overall political economy of the studio system, the medium of the hand-written letter functioned to unleash the productive power of authenticity, offering an illusion of communion which, in fact, served to underscore the gulf between the celebrity’s extraordinary nature and the ordinary lives of those who wrote to them. Yet the criterion and conventions through which celebrity personae were maintained were subject to change over time, as new communications technologies, new modes of Hollywood's industrial organization, and the changing realities of commercial media structures all combined to create a constantly moving ground upon which the celebrity tried to affix. The celebrity’s changing conditions are not unique to them alone; rather, they are a highly visible bellwether of changes which are more fundamentally occurring at all levels of culture and subjectivity. Indeed, more than seventy years ago, Walter Benjamin observed that when hand-made expressions of individuality were superseded by mechanical methods of production, aesthetic criteria (among other things) also underwent change, rendering notions of authenticity increasingly indeterminate.Such is the case that in today’s world, hand-written letters seem more contrived or disingenuous than Danny DeVito’s inaugural post to his Twitter account: “I just joined Twitter! I don't really get this site or how it works. My nuts are on fire.” The performative gesture in DeVito’s tweet is eminently clear, just as the semantic value is patently false: clearly DeVito understands “this site,” as he has successfully used it to extend his irreverent funny-little-man persona to the new medium. While the truth claims of his Tweet may be false, its functional purpose—both effacing and reifying the extraordinary/ordinary distinction of celebrity and maintaining DeVito’s celebrity personality as one with which people might identify—is nevertheless seemingly intact, and thus mirrors the instrumental value of celebrity disclosure as performed in older media forms. Twitter and Contemporary TechnocultureFor these reasons and more, considered within the larger context of contemporary popular culture, celebrity tweeting has been equated with the assertion of the authentic celebrity voice; celebrity tweets are regularly cited in newspaper articles and blogs as “official” statements from the celebrity him/herself. With so many mediated voices attempting to “speak” the meaning of the star, the Twitter account emerges as the privileged channel to the star him/herself. Yet the seemingly easy discursive associations of Twitter and authenticity are in fact ideological acts par excellence, as fixations on the indexical truth-value of Twitter are not merely missing the point, but actively distracting from the real issues surrounding the unsteady discursive construction of contemporary celebrity and the “celebretification” of contemporary subjectivity writ large. In other words, while it is taken as axiomatic that the “message” of celebrity Twittering is, as Henry Jenkins suggests, “Here I Am,” this outward epistemological certainty veils the deeply unstable nature of celebrity—and by extension, subjectivity itself—in our networked society.If we understand the relationship between publicity and technoculture to work as Zizek-inspired cultural theorist Jodi Dean suggests, then technologies “believe for us, accessing information even if we cannot” (40), such that technology itself is enlisted to serve the function of ideology, the process by which a culture naturalises itself and attempts to render the notion of totality coherent. For Dean, the psycho-ideological reality of contemporary culture is predicated upon the notion of an ever-elusive “secret,” which promises to reveal us all as part of a unitary public. The reality—that there is no such cohesive collective body—is obscured in the secret’s mystifying function which renders as “a contingent gap what is really the fact of the fundamental split, antagonism, and rupture of politics” (40). Under the ascendancy of the technoculture—Dean's term for the technologically mediated landscape of contemporary communicative capitalism—subjectivity becomes interpellated along an axis blind to the secret of this fundamental rupture. The two interwoven poles of this axis are not unlike structuralist film critics' dialectically intertwined accounts of the scopophilia and scopophobia of viewing relations, simply enlarged from the limited realm of the gaze to encompass the entire range of subjectivity. As such, the conspiratorial mindset is that mode of desire, of lack, which attempts to attain the “secret,” while the celebrity subject is that element of excess without which desire is unthinkable. As one might expect, the paparazzi and gossip sites’s strategies of intrusion have historically operated primarily through the conspiratorial mindset, with endless conjecture about what is “really happening” behind the scenes. Under the intrusive/conspiratorial paradigm, the authentic celebrity subject is always just out of reach—a chance sighting only serves to reinscribe the need for the next encounter where, it is believed, all will become known. Under such conditions, the conspiratorial mindset of the paparazzi is put into overdrive: because the star can never be “fully” known, there can never be enough information about a star, therefore, more information is always needed. Against this relentless intrusion, the celebrity—whose discursive stability, given the constant imperative for newness in commercial culture, is always in danger—risks a semiotic liquidation that will totally displace his celebrity status as such. Disclosure, e.g. Tweeting, emerges as a possible corrective to the endlessly associative logic of the paparazzi’s conspiratorial indset. In other words, through Twitter, the celebrity seeks to arrest meaning—fixing it in place around their own seemingly coherent narrativisation. The publicist’s new task, then, is to convincingly counter such unsanctioned, intrusive, surveillance-based discourse. Stars continue to give interviews, of course, and many regularly pose as “authors” of their own homepages and blogs. Yet as posited above, Twitter has emerged as the most salient means of generating “authentic” celebrity disclosure, simultaneously countering the efforts of the papparazzi, fan mags, and gossip blogs to complicate or rewrite the meaning of the star. The star uses the account—verified, by Twitter, as the “real” star—both as a means to disclose their true interior state of being and to counter erastz narratives circulating about them. Twitter’s appeal for both celebrities and their followers comes from the ostensible spontaneity of the tweets, as the seemingly unrehearsed quality of the communiqués lends the form an immediacy and casualness unmatched by blogs or official websites; the semantic informality typically employed in the medium obscures their larger professional significance for celebrity tweeters. While Twitter’s air of extemporary intimacy is also offered by other social networking platforms, such as MySpace or Facebook, the latter’s opportunities for public feedback (via wall-posts and the like) works counter to the tight image control offered by Twitter’s broadcast-esque model. Additionally, because of the uncertain nature of the tweet release cycle—has Ashton Kutcher sent a new tweet yet?—the voyeuristic nature of the tweet disclosure (with its real-time nature offering a level of synchronic intimacy that letters never could have matched), and the semantically displaced nature of the medium, it is a form of disclosure perfectly attuned to the conspiratorial mindset of the technoculture. As mentioned above, however, the conspiratorial mindset is an unstable subjectivity, insofar as it only exists through a constant oscillation with its twin, the celebrity subjectivity. While we can understand that, for the celebrities, Twitter functions by allowing them a mode for disclosive/celebrity subjectivisation, we have not yet seen how the celebrity itself is rendered conspiratorial through Twitter. Similarly, only the conspiratorial mode of the follower’s subjectivity has thus far been enumerated; the moment of the follower's celebrtification has so far gone unmentioned. Since we have seen that the celebrity function of Twitter is not really about discourse per se, we should instead understand that the ideological value of Twitter comes from the act of tweeting itself, of finding pleasure in being engaged in a techno-social system in which one's participation is recognised. Recognition and participation should be qualified, though, as it is not the fully active type of participation one might expect in say, the electoral politics of a representative democracy. Instead, it is a participation in a sort of epistemological viewing relations, or, as Jodi Dean describes it, “that we understand ourselves as known is what makes us think there is that there is a public that knows us” (122). The fans’ recognition by the celebrity—the way in which they understood themselves as known by the star was once the receipt of a hand-signed letter (and a latent expectation that the celebrity had read the fan’s initial letter); such an exchange conferred to the fan a momentary sense of participation in the celebrity's extraordinary aura. Under Twitter, however, such an exchange does not occur, as that feeling of one-to-one interaction is absent; simply by looking elsewhere on the screen, one can confirm that a celebrity's tweet was received by two million other individuals. The closest a fan can come to that older modality of recognition is by sending a message to the celebrity that the celebrity then “re-tweets” to his broader following. Beyond the obvious levels of technological estrangement involved in such recognition is the fact that the identity of the re-tweeted fan will not be known by the celebrity’s other two million followers. That sense of sharing in the celebrity’s extraordinary aura is altered by an awareness that the very act of recognition largely entails performing one’s relative anonymity in front of the other wholly anonymous followers. As the associative, conspiratorial mindset of the star endlessly searches for fodder through which to maintain its image, fans allow what was previously a personal moment of recognition to be transformed into a public one. That is, the conditions through which one realises one’s personal subjectivity are, in fact, themselves becoming remade according to the logic of celebrity, in which priority is given to the simple fact of visibility over that of the actual object made visible. Against such an opaque cultural transformation, the recent rise of reactionary libertarianism and anti-collectivist sentiment is hardly surprising. ReferencesBaudrillard, Jean. Simulacra and Simulation. Ann Arbor: Michigan UP, 1994.Benjamin, Walter. Illuminations. New York: Harcourt, Brace and World, 1968. Dean, Jodi. Publicity’s Secret: How Technoculture Capitalizes on Democracy. Ithaca: Cornell UP, 2003. DeCordova, Richard. Picture Personalities: The Emergence of the Star System in America. Urbana: University of Illinois Press, 1990. Jenkins, Henry. “The Message of Twitter: ‘Here It Is’ and ‘Here I Am.’” Confessions of an Aca-Fan. 23 Aug. 2009. 15 Sep. 2009 &lt; http://henryjenkins.org/2009/08/the_message_of_twitter.html &gt;.Lyotard, Jean-Francois. The Postmodern Condition: A Report on Knowledge. Minneapolis: Minnesota UP, 1984.Ranciere, Jacques. The Future of the Image. New York: Verso, 2007.

IntroductionRegional identity is a constant construction, in which landscape, human activity and cultural imaginary build a narrative of place. For the Tasmanian Midlands, the interactions between history, ecology and agriculture both define place and present problems in how to recognise, communicate and balance these interactions. In this sense, regionality is defined not so much as a relation of margin to centre, but as a specific accretion of environmental and cultural histories. According weight to more-than-human perspectives, a region can be seen as a constellation of plant, animal and human interactions and demands, where creative art and design can make space and give voice to the dynamics of exchange between the landscape and its inhabitants. Consideration of three recent art and design projects based in the Midlands reveal the potential for cross-disciplinary research, embedded in both environment and community, to create distinctive and specific forms of connectivity that articulate a regional identify.The Tasmanian Midlands have been identified as a biodiversity hotspot (Australian Government), with a long history of Aboriginal cultural management disrupted by colonial invasion. Recent archaeological work in the Midlands, including the Kerry Lodge Archaeology and Art Project, has focused on the use of convict labour during the nineteenth century in opening up the Midlands for settler agriculture and transport. Now, the Midlands are placed under increasing pressure by changing agricultural practices such as large-scale irrigation. At the same time as this intensification of agricultural activity, significant progress has been made in protecting, preserving and restoring endemic ecologies. This progress has come through non-government conservation organisations, especially Greening Australia and their program Tasmanian Island Ark, and private landowners placing land under conservation covenants. These pressures and conservation activities give rise to research opportunities in the biological sciences, but also pose challenges in communicating the value of conservation and research outcomes to a wider public. The Species Hotel project, beginning in 2016, engaged with the aims of restoration ecology through speculative design while The Marathon Project, a multi-year curatorial art project based on a single property that contains both conservation and commercially farmed zones.This article questions the role of regionality in these three interconnected projects—Kerry Lodge, Species Hotel, and Marathon—sited in the Tasmanian Midlands: the three projects share a concern with the specificities of the region through engagement with specifics sites and their histories and ecologies, while also acknowledging the forces that shape these sites as far more mobile and global in scope. It also considers the interdisciplinary nature of these projects, in the crossover of art and design with ecological, archaeological and agricultural practices of measuring and intervening in the land, where communication and interpretation may be in tension with functionality. These projects suggest ways of working that connect the ecological and the cultural spheres; importantly, they see rural locations as sites of knowledge production; they test the value of small-scale and ephemeral interventions to explore the place of art and design as intervention within colonised landscape.Regions are also defined by overlapping circles of control, interest, and authority. We test the claim that these projects, which operate through cross-disciplinary collaboration and network with a range of stakeholders and community groups, successfully benefit the region in which they are placed. We are particularly interested in the challenges of working across institutions which both claim and enact connections to the region without being centred there. These projects are initiatives resulting from, or in collaboration with, University of Tasmania, an institution that has taken a recent turn towards explicitly identifying as place-based yet the placement of the Midlands as the gap between campuses risks attenuating the institution’s claim to be of this place. Paul Carter, in his discussion of a regional, site-specific collaboration in Alice Springs, flags how processes of creative place-making—operating through mythopoetic and story-based strategies—requires a concrete rather than imagined community that actively engages a plurality of voices on the ground. We identify similar concerns in these art and design projects and argue that iterative and long-term creative projects enable a deeper grappling with the complexities of shared regional place-making. The Midlands is aptly named: as a region, it is defined by its geographical constraints and relationships to urban centres. Heading south from the northern city of Launceston, travellers on the Midland Highway see scores of farming properties networking continuously for around 175 kilometres south to the outskirts of Brighton, the last major township before the Tasmanian capital city of Hobart. The town of Ross straddles latitude 42 degrees south—a line that has historically divided Tasmania into the divisions of North and South. The region is characterised by extensive agricultural usage and small remnant patches of relatively open dry sclerophyll forest and lowland grassland enabled by its lower attitude and relatively flatter terrain. The Midlands sit between the mountainous central highlands of the Great Western Tiers and the Eastern Tiers, a continuous range of dolerite hills lying south of Ben Lomond that slope coastward to the Tasman Sea. This area stretches far beyond the view of the main highway, reaching east in the Deddington and Fingal valleys. Campbell Town is the primary stopping point for travellers, superseding the bypassed towns, which have faced problems with lowering population and resulting loss of facilities.Image 1: Southern Midland Landscape, Ross, Tasmania, 2018. Image Credit: Patrick Sutczak.Predominantly under private ownership, the Tasmanian Midlands are a contested and fractured landscape existing in a state of ecological tension that has occurred with the dominance of western agriculture. For over 200 years, farmers have continually shaped the land and carved it up into small fragments for different agricultural agendas, and this has resulted in significant endemic species decline (Mitchell et al.). The open vegetation was the product of cultural management of land by Tasmanian Aboriginal communities (Gammage), attractive to settlers during their distribution of land grants prior to the 1830s and a focus for settler violence. As documented cartographically in the Centre for 21st Century Humanities’ Colonial Frontier Massacres in Central and Eastern Australia 1788–1930, the period 1820–1835, and particularly during the Black War, saw the Midlands as central to the violent dispossession of Aboriginal landowners. Clements argues that the culture of violence during this period also reflected the brutalisation that the penal system imposed upon its subjects. The cultivation of agricultural land throughout the Midlands was enabled by the provision of unfree convict labour (Dillon). Many of the properties granted and established during the colonial period have been held in multi-generational family ownership through to the present.Within this patchwork of private ownership, the tension between visibility and privacy of the Midlands pastures and farmlands challenges the capacity for people to understand what role the Midlands plays in the greater Tasmanian ecology. Although half of Tasmania’s land areas are protected as national parks and reserves, the Midlands remains largely unprotected due to private ownership. When measured against Tasmania’s wilderness values and reputation, the dry pasturelands of the Midland region fail to capture an equivalent level of visual and experiential imagination. Jamie Kirkpatrick describes misconceptions of the Midlands when he writes of “[f]latness, dead and dying eucalypts, gorse, brown pastures, salt—environmental devastation […]—these are the common impression of those who first travel between Spring Hill and Launceston on the Midland Highway” (45). However, Kirkpatrick also emphasises the unique intimate and intricate qualities of this landscape, and its underlying resilience. In the face of the loss of paddock trees and remnants to irrigation, change in species due to pasture enrichment and introduction of new plant species, conservation initiatives that not only protect but also restore habitat are vital. The Tasmanian Midlands, then, are pastoral landscapes whose seeming monotonous continuity glosses over the radical changes experienced in the processes of colonisation and intensification of agriculture.Underlying the Present: Archaeology and Landscape in the Kerry Lodge ProjectThe major marker of the Midlands is the highway that bisects it. Running from Hobart to Launceston, the construction of a “great macadamised highway” (Department of Main Roads 10) between 1820–1850, and its ongoing maintenance, was a significant colonial project. The macadam technique, a nineteenth century innovation in road building which involved the laying of small pieces of stone to create a surface that was relatively water and frost resistant, required considerable but unskilled labour. The construction of the bridge at Kerry Lodge, in 1834–35, was simultaneous with significant bridge buildings at other major water crossings on the highway, (Department of Main Roads 16) and, as the first water crossing south of Launceston, was a pinch-point through which travel of prisoners could be monitored and controlled. Following the completion of the bridge, the site was used to house up to 60 male convicts in a road gang undergoing secondary punishment (1835–44) and then in a labour camp and hiring depot until 1847. At the time of the La Trobe report (1847), the buildings were noted as being in bad condition (Brand 142–43). After the station was disbanded, the use of the buildings reverted to the landowners for use in accommodation and agricultural storage.Archaeological research at Kerry Lodge, directed by Eleanor Casella, investigated the spatial and disciplinary structures of smaller probation and hiring depots and the living and working conditions of supervisory staff. Across three seasons (2015, 2016, 2018), the emerging themes of discipline and control and as well as labour were borne out by excavations across the site, focusing on remnants of buildings close to the bridge. This first season also piloted the co-presence of a curatorial art project, which grew across the season to include eleven practitioners in visual art, theatre and poetry, and three exhibition outcomes. As a crucial process for the curatorial art project, creative practitioners spent time on site as participants and observers, which enabled the development of responses that interrogated the research processes of archaeological fieldwork as well as making connections to the wider historical and cultural context of the site. Immersed in the mundane tasks of archaeological fieldwork, the practitioners involved became simultaneously focused on repetitive actions while contemplating the deep time contained within earth. This experience then informed the development of creative works interrogating embodied processes as a language of site.The outcome from the first fieldwork season was earthspoke, an exhibition shown at Sawtooth, an artist-run initiative in Launceston in 2015, and later re-installed in Franklin House, a National Trust property in the southern suburbs of Launceston.Images 2 and 3: earthspoke, 2015, Installation View at Sawtooth ARI (top) and Franklin House (bottom). Image Credits: Melanie de Ruyter.This recontextualisation of the work, from contemporary ARI (artist run initiative) gallery to National Trust property enabled the project to reach different audiences but also raised questions about the emphases that these exhibition contexts placed on the work. Within the white cube space of the contemporary gallery, connections to site became more abstracted while the educational and heritage functions of the National Trust property added further context and unintended connotations to the art works.Image 4: Strata, 2017, Installation View. Image Credit: Karen Hall.The two subsequent exhibitions, Lines of Site (2016) and Strata (2017), continued to test the relationship between site and gallery, through works that rematerialised the absences on site and connected embodied experiences of convict and archaeological labour. The most recent iteration of the project, Strata, part of the Ten Days on the Island art festival in 2017, involved installing works at the site, marking with their presence the traces, fragments and voids that had been reburied when the landscape returned to agricultural use following the excavations. Here, the interpretive function of the works directly addressed the layered histories of the landscape and underscored the scope of the human interventions and changes over time within the pastoral landscape. The interpretative role of the artworks formed part of a wider, multidisciplinary approach to research and communication within the project. University of Manchester archaeology staff and postgraduate students directed the excavations, using volunteers from the Launceston Historical Society. Staff from Launceston’s Queen Victorian Museum and Art Gallery brought their archival and collection-based expertise to the site rather than simply receiving stored finds as a repository, supporting immediate interpretation and contextualisation of objects. In 2018, participation from the University of Tasmania School of Education enabled a larger number of on-site educational activities than afforded by previous open days. These multi-disciplinary and multi-organisational networks, drawn together provisionally in a shared time and place, provided rich opportunities for dialogue. However, the challenges of sustaining these exchanges have meant ongoing collaborations have become more sporadic, reflecting different institutional priorities and competing demands on participants. Even within long-term projects, continued engagement with stakeholders can be a challenge: while enabling an emerging and concrete sense of community, the time span gives greater vulnerability to external pressures. Making Home: Ecological Restoration and Community Engagement in the Species Hotel ProjectImages 5 and 6: Selected Species Hotels, Ross, Tasmania, 2018. Image Credits: Patrick Sutczak. The Species Hotels stand sentinel over a river of saplings, providing shelter for animal communities within close range of a small town. At the township of Ross in the Southern Midlands, work was initiated by restoration ecologists to address the lack of substantial animal shelter belts on a number of major properties in the area. The Tasmania Island Ark is a major Greening Australia restoration ecology initiative, connecting 6000 hectares of habitat across the Midlands. Linking larger forest areas in the Eastern Tiers and Central Highlands as well as isolated patches of remnant native vegetation, the Ark project is vital to the ongoing survival of local plant and animal species under pressure from human interventions and climate change. With fragmentation of bush and native grasslands in the Midland landscape resulting in vast open plains, the ability for animals to adapt to pasturelands without shelter has resulted in significant decline as animals such as the critically endangered Eastern Barred Bandicoot struggle to feed, move, and avoid predators (Cranney). In 2014 mass plantings of native vegetation were undertaken along 16km of the serpentine Macquarie River as part of two habitat corridors designed to bring connectivity back to the region. While the plantings were being established a public art project was conceived that would merge design with practical application to assist animals in the area, and draw community and public attention to the work that was being done in re-establishing native forests. The Species Hotel project, which began in 2016, emerged from a collaboration between Greening Australia and the University of Tasmania’s School of Architecture and Design, the School of Land and Food, the Tasmanian College of the Arts and the ARC Centre for Forest Value, with funding from the Ian Potter Foundation. The initial focus of the project was the development of interventions in the landscape that could address the specific habitat needs of the insect, small mammal, and bird species that are under threat. First-year Architecture students were invited to design a series of structures with the brief that they would act as ‘Species Hotels’, and once created would be installed among the plantings as structures that could be inhabited or act as protection. After installation, the privately-owned land would be reconfigured so to allow public access and observation of the hotels, by residents and visitors alike. Early in the project’s development, a concern was raised during a Ross community communication and consultation event that the surrounding landscape and its vistas would be dramatically altered with the re-introduced forest. While momentary and resolved, a subtle yet obvious tension surfaced that questioned the re-writing of an established community’s visual landscape literacy by non-residents. Compact and picturesque, the architectural, historical and cultural qualities of Ross and its location were not only admired by residents, but established a regional identity. During the six-week intensive project, the community reach was expanded beyond the institution and involved over 100 people including landowners, artists, scientists and school children from the region (Wright), attempting to address and channel the concerns of residents about the changing landscape. The multiple timescales of this iterative project—from intensive moments of collaboration between stakeholders to the more-than-human time of tree growth—open spaces for regional identity to shift as both as place and community. Part of the design brief was the use of fully biodegradable materials: the Species Hotels are not expected to last forever. The actual installation of the Species Hotelson site took longer than planned due to weather conditions, but once on site they were weathering in, showing signs of insect and bird habitation. This animal activity created an opportunity for ongoing engagement. Further activities generated from the initial iteration of Species Hotel were the Species Hotel Day in 2017, held at the Ross Community Hall where presentations by scientists and designers provided feedback to the local community and presented opportunities for further design engagement in the production of ephemeral ‘species seed pies’ placed out in and around Ross. Architecture and Design students have gone on to develop more examples of ‘ecological furniture’ with a current focus on insect housing as well as extrapolating from the installation of the Species Hotels to generate a VR visualisation of the surrounding landscape, game design and participatory movement work that was presented as part of the Junction Arts Festival program in Launceston, 2017. The intersections of technologies and activities amplified the lived in and living qualities of the Species Hotels, not only adding to the connectivity of social and environmental actions on site and beyond, but also making a statement about the shared ownership this project enabled.Working Property: Collaboration and Dialogues in The Marathon Project The potential of iterative projects that engage with environmental concerns amid questions of access, stewardship and dialogue is also demonstrated in The Marathon Project, a collaborative art project that took place between 2015 and 2017. Situated in the Northern Midland region of Deddington alongside the banks of the Nile River the property of Marathon became the focal point for a small group of artists, ecologists and theorists to converge and engage with a pastoral landscape over time that was unfamiliar to many of them. Through a series of weekend camps and day trips, the participants were able to explore and follow their own creative and investigative agendas. The project was conceived by the landowners who share a passion for the history of the area, their land, and ideas of custodianship and ecological responsibility. The intentions of the project initially were to inspire creative work alongside access, engagement and dialogue about land, agriculture and Deddington itself. As a very small town on the Northern Midland fringe, Deddington is located toward the Eastern Tiers at the foothills of the Ben Lomond mountain ranges. Historically, Deddington is best known as the location of renowned 19th century landscape painter John Glover’s residence, Patterdale. After Glover’s death in 1849, the property steadily fell into disrepair and a recent private restoration effort of the home, studio and grounds has seen renewed interest in the cultural significance of the region. With that in mind, and with Marathon a neighbouring property, participants in the project were able to experience the area and research its past and present as a part of a network of working properties, but also encouraging conversation around the region as a contested and documented place of settlement and subsequent violence toward the Aboriginal people. Marathon is a working property, yet also a vital and fragile ecosystem. Marathon consists of 1430 hectares, of which around 300 lowland hectares are currently used for sheep grazing. The paddocks retain their productivity, function and potential to return to native grassland, while thickets of gorse are plentiful, an example of an invasive species difficult to control. The rest of the property comprises eucalypt woodlands and native grasslands that have been protected under a conservation covenant by the landowners since 2003. The Marathon creek and the Nile River mark the boundary between the functional paddocks and the uncultivated hills and are actively managed in the interface between native and introduced species of flora and fauna. This covenant aimed to preserve these landscapes, linking in with a wider pattern of organisations and landowners attempting to address significant ecological degradation and isolation of remnant bushland patches through restoration ecology. Measured against the visibility of Tasmania’s wilderness identity on the national and global stage, many of the ecological concerns affecting the Midlands go largely unnoticed. The Marathon Project was as much a project about visibility and communication as it was about art and landscape. Over the three years and with its 17 participants, The Marathon Project yielded three major exhibitions along with numerous public presentations and research outputs. The length of the project and the autonomy and perspectives of its participants allowed for connections to be formed, conversations initiated, and greater exposure to the productivity and sustainability complexities playing out on rural Midland properties. Like Kerry Lodge, the 2015 first year exhibition took place at Sawtooth ARI. The exhibition was a testing ground for artists, and a platform for audiences, to witness the cross-disciplinary outputs of work inspired by a single sheep grazing farm. The interest generated led to the rethinking of the 2016 exhibition and the need to broaden the scope of what the landowners and participants were trying to achieve. Image 7: Panel Discussion at Open Weekend, 2016. Image Credit: Ron Malor.In November 2016, The Marathon Project hosted an Open Weekend on the property encouraging audiences to visit, meet the artists, the landowners, and other invited guests from a number of restoration, conservation, and rehabilitation organisations. Titled Encounter, the event and accompanying exhibition displayed in the shearing shed, provided an opportunity for a rhizomatic effect with the public which was designed to inform and disseminate historical and contemporary perspectives of land and agriculture, access, ownership, visitation and interpretation. Concluding with a final exhibition in 2017 at the University of Tasmania’s Academy Gallery, The Marathon Project had built enough momentum to shape and inform the practice of its participants, the knowledge and imagination of the public who engaged with it, and make visible the precarity of the cultural and rural Midland identity.Image 8. Installation View of The Marathon Project Exhibition, 2017. Image Credit: Patrick Sutczak.ConclusionThe Marathon Project, Species Hotel and the Kerry Lodge Archaeology and Art Project all demonstrate the potential of site-based projects to articulate and address concerns that arise from the environmental and cultural conditions and histories of a region. Beyond the Midland fence line is a complex environment that needed to be experienced to be understood. Returning creative work to site, and opening up these intensified experiences of place to a public forms a key stage in all these projects. Beyond a commitment to site-specific practice and valuing the affective and didactic potential of on-site installation, these returns grapple with issues of access, visibility and absence that characterise the Midlands. Paul Carter describes his role in the convening of a “concretely self-realising creative community” in an initiative to construct a meeting-place in Alice Springs, a community defined and united in “its capacity to imagine change as a negotiation between past, present and future” (17). Within that regional context, storytelling, as an encounter between histories and cultures, became crucial in assembling a community that could in turn materialise story into place. In these Midlands projects, a looser assembly of participants with shared interests seek to engage with the intersections of plant, human and animal activities that constitute and negotiate the changing environment. The projects enabled moments of connection, of access, and of intervention: always informed by the complexities of belonging within regional locations.These projects also suggest the need to recognise the granularity of regionalism: the need to be attentive to the relations of site to bioregion, of private land to small town to regional centre. The numerous partnerships that allow such interconnect projects to flourish can be seen as a strength of regional areas, where proximity and scale can draw together sets of related institutions, organisations and individuals. However, the tensions and gaps within these projects reveal differing priorities, senses of ownership and even regional belonging. Questions of who will live with these project outcomes, who will access them, and on what terms, reveal inequalities of power. Negotiations of this uneven and uneasy terrain require a more nuanced account of projects that do not rely on the geographical labelling of regions to paper over the complexities and fractures within the social environment.These projects also share a commitment to the intersection of the social and natural environment. They recognise the inextricable entanglement of human and more than human agencies in shaping the landscape, and material consequences of colonialism and agricultural intensification. Through iteration and duration, the projects mobilise processes that are responsive and reflective while being anchored to the materiality of site. Warwick Mules suggests that “regions are a mixture of data and earth, historically made through the accumulation and condensation of material and informational configurations”. Cross-disciplinary exchanges enable all three projects to actively participate in data production, not interpretation or illustration afterwards. Mules’ call for ‘accumulation’ and ‘configuration’ as productive regional modes speaks directly to the practice-led methodologies employed by these projects. The Kerry Lodge and Marathon projects collect, arrange and transform material taken from each site to provisionally construct a regional material language, extended further in the dual presentation of the projects as off-site exhibitions and as interventions returning to site. The Species Hotel project shares that dual identity, where materials are chosen for their ability over time, habitation and decay to become incorporated into the site yet, through other iterations of the project, become digital presences that nonetheless invite an embodied engagement.These projects centre the Midlands as fertile ground for the production of knowledge and experiences that are distinctive and place-based, arising from the unique qualities of this place, its history and its ongoing challenges. Art and design practice enables connectivity to plant, animal and human communities, utilising cross-disciplinary collaborations to bring together further accumulations of the region’s intertwined cultural and ecological landscape.ReferencesAustralian Government Department of the Environment and Energy. Biodiversity Conservation. Canberra: Commonwealth of Australia, 2018. 1 Apr. 2019 &lt;http://www.environment.gov.au/biodiversity/conservation&gt;.Brand, Ian. The Convict Probation System: Van Diemen’s Land 1839–1854. Sandy Bay: Blubber Head Press, 1990.Carter, Paul. “Common Patterns: Narratives of ‘Mere Coincidence’ and the Production of Regions.” Creative Communities: Regional Inclusion &amp; the Arts. Eds. Janet McDonald and Robert Mason. Bristol: Intellect, 2015. 13–30.Centre for 21st Century Humanities. Colonial Frontier Massacres in Central and Eastern Australia 1788–1930. Newcastle: Centre for 21st Century Humanitie, n.d. 1 Apr. 2019 &lt;https://c21ch.newcastle.edu.au/colonialmassacres/&gt;.Clements, Nicholas. The Black War: Fear, Sex and Resistance in Tasmania. St Lucia: U of Queensland P, 2014. Cranney, Kate. Ecological Science in the Tasmanian Midlands. Melbourne: Bush Heritage Australia, 2016. 1 Apr. 2019 &lt;https://www.bushheritage.org.au/blog/ecological-science-in-the-tasmanian-midlands&gt;.Davidson N. “Tasmanian Northern Midlands Restoration Project.” EMR Summaries, Journal of Ecological Management &amp; Restoration, 2016. 10 Apr. 2019 &lt;https://site.emrprojectsummaries.org/2016/03/07/tasmanian-northern-midlands-restoration-project/&gt;.Department of Main Roads, Tasmania. Convicts &amp; Carriageways: Tasmanian Road Development until 1880. Hobart: Tasmanian Government Printer, 1988.Dillon, Margaret. “Convict Labour and Colonial Society in the Campbell Town Police District: 1820–1839.” PhD Thesis. U of Tasmania, 2008. &lt;https://eprints.utas.edu.au/7777/&gt;.Gammage, Bill. The Biggest Estate on Earth: How Aborigines Made Australia. Crows Nest: Allen &amp; Unwin, 2012.Greening Australia. Building Species Hotels, 2016. 1 Apr. 2019 &lt;https://www.greeningaustralia.org.au/projects/building-species-hotels/&gt;.Kerry Lodge Archaeology and Art Project. Kerry Lodge Convict Site. 10 Mar. 2019 &lt;http://kerrylodge.squarespace.com/&gt;.Kirkpatrick, James. “Natural History.” Midlands Bushweb, The Nature of the Midlands. Ed. Jo Dean. Longford: Midlands Bushweb, 2003. 45–57.Mitchell, Michael, Michael Lockwood, Susan Moore, and Sarah Clement. “Building Systems-Based Scenario Narratives for Novel Biodiversity Futures in an Agricultural Landscape.” Landscape and Urban Planning 145 (2016): 45–56.Mules, Warwick. “The Edges of the Earth: Critical Regionalism as an Aesthetics of the Singular.” Transformations 12 (2005). 1 Mar. 2019 &lt;http://transformationsjournal.org/journal/issue_12/article_03.shtml&gt;.The Marathon Project. &lt;http://themarathonproject.virb.com/home&gt;.University of Tasmania. Strategic Directions, Nov. 2018. 1 Mar. 2019 &lt;https://www.utas.edu.au/vc/strategic-direction&gt;.Wright L. “University of Tasmania Students Design ‘Species Hotels’ for Tasmania’s Wildlife.” Architecture AU 24 Oct. 2016. 1 Apr. 2019 &lt;https://architectureau.com/articles/university-of-tasmania-students-design-species-hotels-for-tasmanias-wildlife/&gt;.

“I’m fat–and it’s okay! It doesn’t mean I’m stupid, or ugly, or lazy, or selfish. I’m fat!” so proclaims Joy Nash in her YouTube video, A Fat Rant. “Fat! It’s three little letters–what are you afraid of?!” This is the question I pose to my class on day one of Fat Studies. Sadly, many college students do fear fat, and negative attitudes toward fat people are quite prevalent in this population (Ambwani et al. 366). As I teach it, Fat Studies is cross-listed between Psychology and Gender Studies. However, most students who enrol have majors in Psychology or other behavioural health science fields in which weight bias is particularly pronounced (Watkins and Concepcion 159). Upon finding stronger bias among third- versus first-year Physical Education students, O’Brien, Hunter, and Banks (308) speculated that the weight-centric curriculum that typifies this field actively engenders anti-fat attitudes. Based on their exploration of textbook content, McHugh and Kasardo (621) contend that Psychology too is complicit in propagating weight bias by espousing weight-centric messages throughout the curriculum. Such messages include the concepts that higher body weight invariably leads to poor health, weight control is simply a matter of individual choice, and dieting is an effective means of losing weight and improving health (Tylka et al.). These weight-centric tenets are, however, highly contested. For instance, there exists a body of research so vast that it has its own name, the “obesity paradox” literature. This literature (McAuley and Blair 773) entails studies that show that “obese” persons with chronic disease have relatively better survival rates and that a substantial portion of “overweight” and “obese” individuals have levels of metabolic health similar to or better than “normal” weight individuals (e.g., Flegal et al. 71). Finally, the “obesity paradox” literature includes studies showing that cardiovascular fitness is a far better predictor of mortality than weight. In other words, individuals may be both fit and fat, or conversely, unfit and thin (Barry et al. 382). In addition, Tylka et al. review literature attesting to the complex causes of weight status that extend beyond individual behaviour, ranging from genetic predispositions to sociocultural factors beyond personal control. Lastly, reviews of research on dieting interventions show that these are overwhelmingly ineffective in producing lasting weight loss or actual improvements in health and may in fact lead to disordered eating and other unanticipated adverse consequences (e.g., Bacon and Aphramor; Mann et al. 220; Salas e79; Tylka et al.).The newfound, interdisciplinary field of scholarship known as Fat Studies aims to debunk weight-centric misconceptions by elucidating findings that counter these mainstream suppositions. Health At Every Size® (HAES), a weight-neutral approach to holistic well-being, is an important facet of Fat Studies. The HAES paradigm advocates intuitive eating and pleasurable physical activity for health rather than restrictive dieting and regimented exercise for weight loss. HAES further encourages body acceptance of self and others regardless of size. Empirical evidence shows that HAES-based interventions improve physical and psychological health without harmful side-effects or high dropout rates associated with weight loss interventions (Bacon and Aphramor; Clifford et al. “Impact of Non-Diet Approaches” 143). HAES, like the broader field of Fat Studies, seeks to eradicate weight-based discrimination, positioning weight bias as a social justice issue that intersects with oppression based on other areas of difference such as gender, race, and social class. Much like Queer Studies, Fat Studies seeks to reclaim the word, fat, thus stripping it of its pejorative connotations. As Nash asserts in her video, “Fat is a descriptive physical characteristic. It’s not an insult, or an obscenity, or a death sentence!” As an academic discipline, Fat Studies is expanding its visibility and reach. The Fat Studies Reader, the primary source of reading for my course, provides a comprehensive overview of the field (Rothblum and Solovay 1). This interdisciplinary anthology addresses fat history and activism, fat as social inequality, fat in healthcare, and fat in popular culture. Ward (937) reviews this and other recently-released fat-friendly texts. The field features its own journal, Fat Studies: An Interdisciplinary Journal of Body Weight and Society, which publishes original research, overview articles, and reviews of assorted media. Both the Popular Culture Association and National Women’s Studies Association have special interest groups devoted to Fat Studies, and the American Psychological Association’s Division on the Psychology of Women has recently formed a task force on sizism (Bergen and Carrizales 22). Furthermore, Fat Studies conferences have been held in Australia and New Zealand, and the third annual Weight Stigma Conference will occur in Iceland, September 2015. Although the latter conference is not necessarily limited to those who align themselves with Fat Studies, keynote speakers include Ragen Chastain, a well-known member of the fat acceptance movement largely via her blog, Dances with Fat. The theme of this year’s conference, “Institutionalised Weightism: How to Challenge Oppressive Systems,” is consistent with Fat Studies precepts:This year’s theme focuses on the larger social hierarchies that favour thinness and reject fatness within western culture and how these systems have dictated the framing of fatness within the media, medicine, academia and our own identities. What can be done to oppose systemised oppression? What can be learned from the fight for social justice and equality within other arenas? Can research and activism be united to challenge prevailing ideas about fat bodies?Concomitantly, Fat Studies courses have begun to appear on college campuses. Watkins, Farrell, and Doyle-Hugmeyer (180) identified and described four Fat Studies and two HAES courses that were being taught in the U.S. and abroad as of 2012. Since then, a Fat Studies course has been taught online at West Virginia University and another will soon be offered at Washington State University. Additionally, a new HAES class has been taught at Saint Mary’s College of California during the last two academic years. Cameron (“Toward a Fat Pedagogy” 28) describes ways in which nearly 30 instructors from five different countries have incorporated fat studies pedagogy into university courses across an array of academic areas. This growing trend is manifested in The Fat Pedagogy Reader (Russell and Cameron) due out later this year. In this article, I describe content and pedagogical strategies that I use in my Fat Studies course. I then share students’ qualitative reactions, drawing upon excerpts from written assignments. During the term reported here, the class was comprised of 17 undergraduate and 5 graduate students. Undergraduate majors included 47% in Psychology, 24% in Women Studies, 24% in various other College of Liberal Arts fields, and 6% in the College of Public Health. Graduate majors included 40% in the College of Public Health and 60% in the College of Education. Following submission of final grades, students provided consent via email allowing written responses on assignments to be anonymously incorporated into research reports. Assignments drawn upon for this report include weekly reading reactions to specific journal articles in which students were to summarise the main points, identify and discuss a specific quote or passage that stood out to them, and consider and discuss applicability of the information in the article. This report also utilises responses to a final assignment in which students were to articulate take-home lessons from the course.Despite the catalogue description, many students enter Fat Studies with a misunderstanding of what the course entails. Some admitted that they thought the course was about reducing obesity and the presumed health risks associated with this alleged pathological condition (Watkins). Others understood, but were somewhat dubious, at least at the outset, “Before I began this class, I admit that I was skeptical of what Fat Studies meant.” Another student experienced “a severe cognitive dissonance” between the Fat Studies curriculum and that of a previous behavioural health class:My professor spent the entire quarter spouting off statistics, such as the next generation of children will be the first generation to have a lower life expectancy than their parents and the ever increasing obesity rates that are putting such a tax on our health care system, and I took her words to heart. I was scared for myself and for the populations I would soon be working with. I was worried that I was destined to a chronic disease and bothered that my BMI was two points above ‘normal.’ I believed everything my professor alluded to on the danger of obesity because it was things I had heard in the media and was led to believe all my life.Yet another related, “At first, I will be honest, it was hard for me to accept a lot of this information, but throughout the term every class changed my mind about my view of fat people.” A few students have voiced even greater initial resistance. During a past term, one student lamented that the material represented an attack on her intended behavioural health profession. Cameron (“Learning to Teach Everybody”) describes comparable reactions among students in her Critical Obesity course taught within a behavioural health science unit. Ward (937) attests that, even in Gender Studies, fat is the topic that creates the most controversy. Similarly, she describes students’ immense discomfort when asked to entertain perspectives that challenge deeply engrained ideas inculcated by our culture’s “obesity epidemic.” Discomfort, however, is not necessarily antithetical to learning. In prompting students to unlearn “the biomedically-informed truth of obesity, namely that fat people are unfit, unhealthy, and in need of ‘saving’ through expert interventions,” Moola at al. recommend equipping them with an “ethics of discomfort” (217). No easy task, “It requires courage to ask our students to forgo the security of prescriptive health messaging in favour of confusion and uncertainty” (221). I encourage students to entertain conflicting perspectives by assigning empirically-based articles emanating from peer-reviewed journals in their own disciplines that challenge mainstream discourses on obesity (e.g., Aphramor; Bombak e60; Tomiyama, Ahlstrom, and Mann 861). Students whose training is steeped in the scientific method seem to appreciate having quantitative data at their disposal to convince themselves–and their peers and professors–that widely held weight-centric beliefs and practices may not be valid. One student remarked, “Since I have taken this course, I feel like I am prepared to discuss the fallacy of the weight-health relationship,” citing specific articles that would aid in the effort. Likewise, Cameron’s (“Learning to Teach Everybody”) students reported a need to read research reports in order to begin questioning long-held beliefs.In addition, I assign readings that provide students with the opportunity to hear the voices of fat people themselves, a cornerstone of Fat Studies. Besides chapters in The Fat Studies Reader authored by scholars and activists who identify as fat, I assign qualitative articles (e.g., Lewis et al.) and narrative reports (e.g., Pause 42) in which fat people describe their experiences with weight and weight bias. Additionally, I provide positive images of fat people via films and websites (Clifford et al. HAES®; Watkins; Watkins and Doyle-Hugmeyer 177) in order to counteract the preponderance of negative, dehumanising portrayals in popular media (e.g., Ata and Thompson 41). In response, a student stated:One of the biggest things I took away from this term was the confidence I found in fat women through films and stories. They had more confidence than I have seen in any tiny girl and owned the body they were given.I introduce “normal” weight allies as well, most especially Linda Bacon whose treatise on thin privilege tends to set the stage for viewing weight bias as a form of oppression (Bacon). One student observed, “It was a relief to be able to read and talk about weight oppression in a classroom setting for once.” Another appreciated that “The class did a great job at analysing fat as oppression and not like a secondhand oppression as I have seen in my past classes.” Typically, fat students were already aware of weight-based privilege and oppression, often painfully so. Thinner students, however, were often astonished by this concept, several describing Bacon’s article as “eye-opening.” In reaction, many vowed to act as allies:This class has really opened my eyes and prepared me to be an ally to fat people. It will be difficult for some time while I try to get others to understand my point of view on fat people but I believe once there are enough allies, people’s minds will really start changing and it will benefit everyone for the better.Pedagogically, I choose to share my own experiences as they relate to course content and encourage students, at least in their written assignments, to do the same. Other instructors refrain from this practice for fear of reinforcing traditional discourses or eliciting detrimental reactions from students (Watkins, Farrell, and Doyle-Hugmeyer 191). Nevertheless, this tack seems to work well in my course, with many students opting to disclose their relevant circumstances during classroom discussions: Throughout the term I very much valued and appreciated when classmates would share their experiences. I love listening and hearing to others experiences and I think that is a great way to understand the material and learn from one another.It really helped to read different articles and hear classmates discuss and share stories that I was able to relate to. The idea of hearing people talk about issues that I thought I was the only one who dealt with was so refreshing and enlightening.The structure of this class allowed me to learn how this information is applicable to my life and made it deeper than just memorising information.Thus far, across three terms, no student has described iatrogenic effects from this process. In fact, most attribute positive transformations to the class. These include enhanced body acceptance of self and others: This class decreased my fat phobia towards others and gave me a better understanding about the intersectionality of one’s weight. For example, I now feel that I no longer view my family in a fat phobic way and I also feel responsible for educating my brother and helping him develop a strong self-esteem regardless of his size.I never thought this class would change my life, almost save my life. Through studies shown in class and real life people following their dreams, it made my mind completely change about how I view my body and myself.I can only hope that in the future, I will be more forgiving, tolerant, and above all accepting of myself, much less others. Regardless of a person’s shape and size, we are all beautiful, and while I’m just beginning to understand this, it can only get better from here.Students also reported becoming more savvy consumers of weight-centric media messages as well as realigning their eating and exercise behaviour in accordance with HAES: I find myself disgusted at the television now, especially with the amount of diet ads, fitness club ads, and exercise equipment ads all aimed at making a ‘better you.’ I now know that I would never be better off with a SlimFast shake, P90X, or a Total Gym. I would be better off eating when I’m hungry, working out because it is fun, and still eating Thin Mints when I want to. Prior to this class, I would work out rigorously, running seven miles a day. Now I realise why at times I dreaded to work out, it was simply a mathematical system to burn the energy that I had acquired earlier in the day. Instead what I realise I should do is something I enjoy, that way I will never get tired of whatever I am doing. While I do enjoy running, other activities would bring more joy while engaging in a healthy lifestyle like hiking or mountain biking.I will never go on another diet. I will stop choosing exercises I don’t love to do. I will not weigh myself every single day hoping for the number on the scale to change.A reduction in self-weighing was perhaps the most frequent behaviour change that students expressed. This is particularly valuable in that frequent self-weighing is associated with disordered eating and unhealthy weight control behaviours (Neumark-Sztainer et al. 811):I have realised that the number on the scale is simply a number on the scale. That number does not define who you are. I have stopped weighing myself every morning. I put the scale in the storage closet so I don’t have to look at it. I even encouraged my roommate to stop weighing herself too. What has been most beneficial for me to take away from this class is the notion that the number on the scale has so much less to do with fitness levels than most people understand. Coming from a numbers obsessed person like myself, this class has actually gotten me to leave the scales behind. I used to weigh myself every single day and my self-confidence reflected whether I was up or down in weight from the day before. It seems so silly to me now. From this class, I take away a new outlook on body diversity. I will evaluate who I am for what I do and not represent myself with a number. I’m going to have my cake this time, and actually eat it too!Finally, students described ways in which they might carry the concepts from Fat Studies into their future professions: I want to go to law school. This model is something I will work toward in the fight for social justice.As a teacher and teacher of teachers, I plan to incorporate discussions on size diversity and how this should be addressed within the field of adapted physical education.I do not know how I would have gone forward if I had never taken this class. I probably would have continued to use weight loss as an effective measure of success for both nutrition and physical activity interventions. I will never be able to think about the obesity prevention movement in the same way.Since I am working toward being a clinical psychologist, I don’t want to have a client who is pursuing weight loss and then blindly believe that they need to lose weight. I’d rather be of the mindset that every person is unique, and that there are other markers of health at every size.Jones and Hughes-Decatur (59) call for increased scholarship illustrating and evaluating critical body pedagogies so that teachers might provide students with tools to critique dominant discourses, helping them forge healthy relationships with their own bodies in the process. As such, this paper describes elements of a Fat Studies class that other instructors may choose to adopt. It additionally presents qualitative data suggesting that students came to think about fat and fat people in new and divergent ways. Qualitative responses also suggest that students developed better body image and more adaptive eating and exercise behaviours throughout the term. Although no students have yet described lasting adverse effects from the class, one stated that she would have preferred less of a focus on health and more of a focus on issues such as fat fashion. Indeed, some Fat Studies scholars (e.g., Lee) advocate separating discussions of weight bias from discussions of health status to avoid stigmatising fat people who do experience health problems. While concerns about fostering healthism within the fat acceptance movement are valid, as a behavioural health professional with an audience of students training in these fields, I have chosen to devote three weeks of our ten week term to this subject matter. Depending on their academic background, others who teach Fat Studies may choose to emphasise different aspects such as media representations or historical connotations of fat.Nevertheless, the preponderance of positive comments evidenced throughout students’ assignments may certainly be a function of social desirability. Although I explicitly invite critique, and in fact assign readings (e.g., Welsh 33) and present media that question HAES and Fat Studies concepts, students may still feel obliged to articulate acceptance of and transformations consistent with the principles of these movements. As a more objective assessment of student outcomes, I am currently conducting a quantitative evaluation, in which I remain blind to students’ identities, of this year’s Fat Studies course compared to other upper division/graduate Psychology courses, examining potential changes in weight bias, body image and dieting behaviour, adherence to appearance-related media messages, and obligatory exercise behaviour. I postulate results akin to those of Humphrey, Clifford, and Neyman Morris (143) who found reductions in weight bias, improved body image, and improved eating behaviour among college students as a function of their HAES course. As Fat Studies pedagogy proliferates, instructors are called upon to share their teaching strategies, document the effects, and communicate these results within and outside of academic spheres.ReferencesAmbwani, Suman, Katherine M. Thomas, Christopher J. Hopwood, Sara A. Moss, and Carlos M. Grilo. “Obesity Stigmatization as the Status Quo: Structural Considerations and Prevalence among Young Adults in the U.S.” Eating Behaviors 15.3 (2014): 366-370. Aphramor, Lucy. “Validity of Claims Made in Weight Management Research: A Narrative Review of Dietetic Articles.” Nutrition Journal 9 (2010): n. pag. 15 May 2015 ‹http://www.nutritionj.com/content/9/1/30›.Ata, Rheanna M., and J. 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Dances with Fat. 15 May 2015 ‹https://danceswithfat.wordpress.com/blog/›.Clifford, Dawn, Amy Ozier, Joanna Bundros, Jeffrey Moore, Anna Kreiser, and Michele Neyman Morris. “Impact of Non-Diet Approaches on Attitudes, Behaviors, and Health Outcomes: A Systematic Review.” Journal of Nutrition Education and Behavior 47.2 (2015): 143-155.Clifford, Dawn, Patti Lou Watkins, and Rebecca Y. Concepcion. “HAES® University: Bringing a Weight Neutral Message to Campus.” Association for Size Diversity and Health, 2015. 23 Apr. 2015 ‹https://www.sizediversityandhealth.org/content.asp?id=258›.Fat Studies: An Interdisciplinary Journal of Body Weight and Society. 23 Apr. 2015 ‹http://www.tandfonline.com/toc/ufts20/current#.VShpqdhFDBC›.Flegal, Katherine M., Brian K. Kit, Heather Orpana, and Barry L. Graubard. “Association of All-Cause Mortality with Overweight and Obesity Using Standard Body Mass Index Categories: A Systematic Review and Meta-Analysis.” Journal of the American Medical Association 309.1 (2013): 71-82.Humphrey, Lauren, Dawn Clifford, and Michelle Neyman Morris. “Health At Every Size College Course Reduces Dieting Behaviors and Improves Intuitive Eating, Body Esteem, and Anti-Fat Attitudes.” Journal of Nutrition Education and Behavior, in press.Jones, Stephanie, and Hilary Hughes-Decatur. “Speaking of Bodies in Justice-Oriented Feminist Teacher Education.” Journal of Teacher Education 63.1 (2012): 51-61.Lee, Jenny. Embodying Stereotypes: Memoir, Fat and Health. Fat Studies: Reflective Intersections, July 2012, Wellington, NZ. Unpublished conference paper.Lewis, Sophie, Samantha L. Thomas, Jim Hyde, David Castle, R. Warwick Blood, and Paul A. 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Norman, LeAnne Petherick, and Shaelyn Strachan. “Teaching across the Lines of Fault in Psychology and Sociology: Health, Obesity and Physical Activity in the Canadian Context.” Sociology of Sport Journal 31.2 (2014): 202-227.Nash, Joy. “A Fat Rant.” YouTube, 17 Mar. 2007. 23 Apr. 2015 ‹https://www.youtube.com/watch?v=yUTJQIBI1oA›.Neumark-Sztainer, Dianne, Patricia van den Berg, Peter J. Hannan, and Mary Story. “Self-Weighing in Adolescents: Helpful or Harmful? Longitudinal Associations with Body Weight Changes and Disordered Eating.” Journal of Adolescent Health 39.6 (2006): 811–818.O’Brien, K.S., J.A. Hunter, and M. Banks. “Implicit Anti-Fat Bias in Physical Educators: Physical Attributes, Ideology, and Socialization.” International Journal of Obesity 31.2 (2007): 308-314.Pause, Cat. “Live to Tell: Coming Out as Fat.” Somatechnics 2.1 (2012): 42-56.Rothblum, Esther, and Sondra Solovay, eds. The Fat Studies Reader. 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ABSTRACT This article examines the bioethical discourse on polygenic embryo screening (PES) in reproductive medicine in blogs and news stories published during 2021 in response to the first baby’s birth using polygenic risk scores (PRS) derived from genome-wide association studies. We further contextualize the findings by synthesizing the emerging peer-reviewed bioethics literature on the issue, which has emphasized considerations regarding the child-parent future relationship, equity of access, and the absence of professional guidelines. Our media content analysis has established that expert opinion was prominently featured in news coverage, with bioethicists and other academics contributing 38 percent of articles and providing extensive commentary on ethical, social, and policy implications in the articles written by journalists. The overall perspective towards the use of PES was primarily negative (59 percent of the articles), without significant differences in negativity and positivity between experts and science reporters. This indicates a shift from the predominantly neutral attitudes towards the technology in media discourse prior to its deployment in clinical settings. There is heightened awareness that offering these tests to prospective parents is unethical and can create unrealistic expectations, with the two most prominent arguments being uncertainty about the prediction accuracy of polygenic risk scores in this context (72 percent of the articles) and the potential of PES to lead to a eugenic future of human reproduction that normalizes the discrimination of people based on their genetics (59 percent of the articles). INTRODUCTION The possibility of using genetic technologies to engineer the perfect baby has long haunted the public imagination. While some techno-utopians have openly advocated for human genetic enhancement, many critics have warned that advances in DNA technology come with myriads of ethical dilemmas and potentially dangerous social consequences. Literary and cinematic works have offered dystopian visions of our genetic futures—from Aldous Huxley’s powerful socio-political fantasy in his book Brave New World (1932) to cult classics of sci-fi cinema, such as Blade Runner (1982) and Gattaca (1997), there has been no shortage of ominous predictions that genetic engineering would lead to a new form of eugenics, which would ultimately create new social hierarchies grounded on genetic discrimination. Moreover, concerns about the use of genetic and genomic technologies for social control have been entangled with deep philosophical questions about personal autonomy, the right of the child to an open future, and the morality of changing, improving, or redesigning human nature.1 The perennial debate on human enhancement was recently reignited with a new controversy over the use of pre-implantation screening of embryos using polygenic risk scores.2 While the profiling of IVF embryos to detect hereditary, monogenetic diseases has been widely accepted, some companies are now pushing the envelope with unrealistic promises of tests that can predict genetic possibilities for desirable traits such as a child’s intelligence, athletic ability, and physical appearance. One event that prompted a public outcry in late 2021 was news about the birth of the first baby from an embryo selected through polygenic testing, a girl named Aurea.3 Although the embryo screening in Aurea’s case was used to decrease the likelihood for certain health conditions, many commentators believed that it signaled a real possibility of embryo selection for non-medical reasons becoming a commercial procedure in the foreseeable future, especially in the largely unregulated US fertility market.4 In the past, there have been discrepancies in how ethical and policy issues arising from advances in reproductive medicine have been viewed by experts (e.g., bioethicists, philosophers, legal scholars) and presented in the news. Like other advances in medical genetics, gene editing and screening technologies have been frequently characterized by exaggeration, sensationalism, and hype around clinical possibilities.5 Moreover, news media have often amplified the anticipated health benefits of genetic testing while overlooking uncertainty associated with its clinical validity and emerging ethical concerns, as shown in a recent study of the media portrayal of non-invasive prenatal testing (NIPT).6 The issue of polygenic embryo screening (PES) initially gained traction in the media in 2017 when the New Jersey biotech startup Genomic Prediction made headlines with claims that its testing technology could identify and avoid implanting embryos with very low IQs.7 The company also claimed that it had the capability to identify embryos with high IQs, although it committed not to offer that procedure for ethical reasons.8 The media coverage of polygenic risk scoring of human embryos between 2017 and 2019 was previously analyzed in a study published in BMC Medical Ethics in September 2021.9 This media content analysis has established that while most news articles were neutral towards the technology, one of the most significant critiques raised by science reporters was the absence of solid scientific evidence for the technology’s predictive accuracy and its practical value in IVF settings. It has also identified five major ethical concerns articulated by science reporters that have also been addressed in the academic discourse and within broader policy debates on reproductive technologies: a slippery slope towards designer babies, well-being of the child and parents, impact on society, deliberate choice, and societal readiness. In this article, we examine the discourse on PES in bioethics blogs, opinion articles, and news stories published in 2021, with a specific focus on reactions to the birth of the first polygenic risk score baby. We compare the perspectives of experts and science reporters to establish their attitudes towards PES, the main ethical themes in press coverage, and the key issues highlighted for a future policy debate. We also juxtapose our findings to the previous study of media coverage to establish if the case of baby Aurea has raised any new issues and pressing ethical concerns. I. Polygenic Embryo Screening in Reproductive Medicine While complex diseases and human traits result from a combination of genetic, lifestyle, and environmental factors, genomic medicine is quickly gaining momentum, and demands for genetic tests in clinical practice have significantly increased. Scans and analyses of genomes from various populations, a research area known as genome-wide association studies, have enabled scientists and researchers to identify genetic differences or variants associated with a particular trait or medical condition. These variants can be combined into a polygenic risk score that predicts an individual’s traits or increased risk for a certain disease. For instance, PES have been used to predict a range of diverse common conditions, from diabetes and cancer to attention deficit issues10 and, in some cases, well-being in general.11 This testing modality relies on the probabilistic susceptibility of individuals to certain diseases to offer personalized medical treatments and inform therapeutic interventions. Polygenic embryo screening uses polygenic risk scores to assess an embryo’s statistical risks of developing diseases (e.g., cardiovascular diseases) and potentially traits (e.g., intelligence, athletic ability, among others) and is performed in an IVF setting. It is currently marketed by several US companies such as MyOme, OrchidHealth, and Genomic Prediction to prospective parents as a method to screen pre-implantation embryos for health and non-health related conditions and is accessible to those who can afford to pay for it. As stated in a recent report on companies bringing PES into reproductive medicine, Genomic Prediction has already made their test for polygenic disorders, LifeView, available to couples. In contrast, Orchid Health has only recently invited couples to an early-access program for their testing technology, and MyOme is still in the process of launching its own test.12 In September 2021, Bloomberg first reported the birth of baby Aurea using screening conducted by Genomic Prediction. She was born after her parents used IVF and subsequently PES to select from 33 candidate pre-implantation embryos in 2020.13 Aurea’s embryo was deemed to have the best genetic odds of avoiding conditions such as breast cancer, diabetes, heart disease, and schizophrenia in adulthood. It is worth noting that Genomic Prediction made the announcement almost one year following Aurea’s birth, thus delaying the media’s reaction to this development and the ensuing bioethical and policy debates. II. Ethical, Social, and Policy Implications Some important ethical, social, and regulatory considerations regarding the development and clinical use of PES have been raised within the academic community. The bioethics literature on the issue, however, appears rather thin, which is not surprising given that prior to 2021, the possibility of using this screening method in clinical practice was largely hypothetical. Other genomic technologies that have enabled polygenic embryo selection, such as whole-genome sequencing and pre-implantation genetic diagnosis, have received more attention from bioethicists, legal scholars, and Ethical, Legal, and Social Implications (ELSI) researchers. Our analysis of the emerging literature has shown that some proponents of PES advocate its current use and go as far as to suggest a permissive regulatory environment for the purpose of outpacing the ethical concerns and potential restrictions once the technology becomes widely available. This approach suggests that embryo selection should be allowed for or against any trait associated with higher odds for better health and well-being in general, often without further discussion of what accounts for wellbeing.14 Scholars applying the principle of procreative beneficence to defend the use of PES have also argued for regulation that addresses issues of justice and equality and expands access to the procedure for those who are currently unable to afford it. By contrast, opponents have argued that the clinical utility of this embryo selection method is yet to be proven, and its current use may create unrealistic expectations in parents, making it an unethical practice to offer the procedure as part of IVF treatments.15 They state that predictive models from PRS have been developed with data from genomes of adult populations. Therefore, extrapolating results for embryo screening, along with the absence of a research protocol to validate its diagnostic effectiveness, is dangerous and misleading.16 Another layer of complexity is added because PRS already faces many translational hurdles that would undermine its predictive value assessment for certain traits or diseases. Scientists have noted that PRS take into consideration the genetic component of a particular trait putting aside the effects of other non-genetic factors, such as lifestyle and environment, which might interfere and influence the calculation of these scores.17 Discussions on the ethics and societal implications of PES in the bioethics literature can be grouped into three distinct categories: 1) relational issues between parents and the future child (e.g., selection as identity-determining, concerns about the instrumentalization of children and the child’s right to an open future); 2) concerns about social justice and equality (e.g., fears about a new eugenics that establishes new social hierarchy, limited access to the technology due to its cost); and 3) implementation and regulatory concerns (e.g., lack of professional guidelines and advertising of PES by private companies). An important ethical implication of PES relates to the well-being of the future child and the way that selecting children based on their genetic make-up might negatively affect the parent-child relationship. This is in line with previously raised ethical concerns in the literature around cloning and pre-implantation genetic diagnosis that by choosing a child’s genetic predisposition, we are limiting to and, in some cases, denying their right to an open future. For instance, the future child’s options would be restricted if parents chose a genetic predisposition to musicality that might interfere with the child’s ability to make certain life choices.18 On a societal level, there are concerns PES may alter social perceptions of what is “normal” and “healthy,” resulting in discrimination and stigmatization of certain conditions.19 Related to this are fears about encouraging eugenic attitudes that can exacerbate discrimination against people with disabilities. Furthermore, one of the main ethical concerns raised is that the growing use of PES might exacerbate societal pressure to use this technology, influencing parents’ decisions to select the embryo with the “best” genetics giving rise to a generation of “designer babies.” 20 Finally, direct-to-consumer marketing and clinical introduction of the technology prior to the publication of professional guidelines and in the absence of scientific validity for its use, as well as without appropriate regulatory oversight, is seen as a premature step that might erode public trust.21 III. News Stories and Expert Commentary on Polygenic Embryo Screening in 2021 We conducted searches on google news using keywords such as “polygenic embryo screening,” “polygenic risk scores,” “baby Aurea,” and “embryo selection” and selected blogs and articles from major news sources (e.g., Washington Post, New York Times, Wall Street Journal, LA Times, Guardian, The Times, etc.). An additional effort was made to collect all relevant articles from prominent bioethics blogs such as the Hastings Center Bioethics Forum, Impact Ethics, Bioethics.net, Biopolitical Times (Center for Genetics and Society), among others. The time period for the study was one year, from January 1 to December 31, 2021. While most coverage occurred after the Bloomberg report on the birth of the first baby using PES, there were a number of news stories and blogs in response to a special report on embryo selection based on polygenic risk scores published in the New England Journal of Medicine on July 1, 2020.22 This report, which has received significant attention in the press, warns that companies that offer genetic services can create unrealistic expectations in health providers and prospective parents through their marketing practices. It has further emphasized the scientific uncertainty around the predictive results of PRS in the context of embryo selection. In general, our search has established that the news media coverage on PES over the past year has revolved around these two events – the NEJM Report and the announcement about the first baby born after PES. In total, we collected 29 publications, of which 12 were blog posts and 17 publications under the general category of “news,” including ten news articles, three opinion pieces/perspective articles, two press releases, and one radio broadcast transcript (see Supplementary Material). IV. Methods for content analysis We utilized an inductive-deductive process to develop coding categories for a systematic content analysis of the blogs and new articles. The first author undertook a close reading of the entire dataset to derive inductively recurrent themes and ethical arguments in the media representations of PES. Based on this preliminary analysis, both authors agreed on the categories for textual analysis. The coding book was further refined by using a deductive approach that incorporates themes that have been previously articulated in the scholarly literature on the issue, particularly questions about the perceived attributes of the test, ethical concerns, and emerging policy considerations. The following categories were used to analyze key issues and attitudes towards PES expressed by experts and science journalists: a. Claims that PES is unethical because it violates the future child’s autonomy. b. Concerns about PES as a step towards eugenics and/or genetic discrimination. c. Defenses of PES with arguments that parents have a duty to give the child the healthiest possible start in life (and reduce public health burden). d. Claims that the science behind PRS-based diagnostics is uncertain, and it will take some time to prove its clinical validity. e. Concerns about the equality of access to PES. f. Arguments that PES can exacerbate ethnic and racial inequality (e.g., that most polygenic scores are created using DNA samples from individuals of European ancestries and predictions may not be accurate in other populations). g. Arguments that PES provides health benefits and can help overcome genetic and health inequalities. h. Concerns about the negative impact that PES may have on the child-parent relationship. i. Arguments about the need for better regulatory oversight of PES. j. Suggestions that there is an urgent need for deliberation and debate on the societal and ethical implications of PES. k. Concerns that patients and clinicians may get the impression that the procedure is more effective and less risky than it is. l. Assessment of whether the article’s perspective towards the use of PES is positive, negative, or neutral. We used yes/no questions to detect the frequencies of mentions in each category, except on the last question, which required a more nuanced, qualitative assessment of the overall tone of the articles. We coded articles as “positive” when the authors viewed the technology favorably and emphasized its potential health benefits over its negative implications. Articles that did not condone the current use of PES and expressed strong concerns about the predictive accuracy of this testing method, its readiness for clinical use, and highlighted its controversial ethical and social implications were coded as “negative.” Finally, articles that simply presented information about the topic and quoted experts on the advantages and disadvantages of using PRS for embryo selection without taking a side or expressing value judgments were coded as “neutral.” Acknowledging the complex polysemic nature of media texts, we took into consideration that support or disapproval of PES may be implicit and expressed by giving credence to some experts’ opinions over others. Therefore, we coded articles that mostly cited expert opinion favorable to PES, or alternatively, presented such views as more credible, as “positive”, while we coded articles that emphasized critical perspectives as “negative.” V. Media Discourse and Expert Opinion On PES We found out that perspectives and opinions by experts were prominently featured in both news (17 articles) and blogs (12 articles). The blog posts in our dataset were written by university professors in bioethics (four articles), academics from other disciplines such as medicine, political science, psychology, human genetics, and neurobiology (four articles), and science journalists and editors (four articles). Furthermore, three of the news articles in influential newspapers and magazines such as The Wall Street Journal, The Washington Post, and The Scientific American were opinion articles or commentaries contributed by academics (e.g., a psychology professor, specializing in personality, individual differences, and behavior genetics, a sociology professor, and a director of research in a graduate program in human genetics). The remaining 14 news articles in our dataset were written by science reporters, editors, or other staff writers. Altogether, experts contributed 38 percent of the media coverage (11 articles) on the issue of PES and its wider societal implications. Experts’ comments were also heavily featured in the 18 articles written by science reporters and other media professionals, which accounted for 68 percent of the dataset. Of these articles, 17 extensively cited experts with academic and research backgrounds (professors and research scientists), seven articles quoted industry representatives (e.g., CEOs and spokespersons of Genomic Prediction and Orchid, other commercial developers), and four articles included opinions by parents seeking PES, particularly Aurea’s father, North Carolina neurologist Rafal Smigrodzki, who argued that a parent’s duty is to prevent disease in their child.23 The overall perspective towards the use of PES was mostly negative – 59 percent (17 articles) expressed negative attitudes, while 24 percent (seven articles) were positive and 17% (five articles) were neutral in tone and did not advance arguments in favor or against the technology and its adoption. However, we did not establish significant differences in negativity and positivity between experts and science reporters. For instance, 49 percent of the articles with negative attitudes were written by experts, while 53 percent were authored by science reports. Similarly, the articles by experts with positive perspectives on PES accounted for 13 percent of the dataset, while science reporters contributed 11 percent of the positive articles. VI. Major Themes and Issues The most discussed issue in media coverage was the prediction accuracy of polygenic risk scores and the uncertainties regarding the utility of these tests in embryo screening. Our analysis has established that 72 percent of the articles (21 out of 29) argued that the science behind PES-based diagnostics is uncertain, and it will take some time to prove its clinical validity. The second most frequently mentioned issue was the potential of PES to lead to a eugenic future of human reproduction. More than half of the articles (59 percent or 17 out of 29) raised concerns that PES could become a step towards a new form of eugenics that could eventually normalize the discrimination of people based on their genetics. Despite concerns about the accuracy of PES testing, many articles gave extensive attention to problems concerning equality of access to PES and related diagnostic services, with 49 percent of the articles (13 out of 29) expressing concerns that the procedure is currently offered at a high cost, it is not covered by health insurance plans, and people of lower socioeconomic status cannot afford it. Furthermore, 41 percent of the articles (12 out of 29) raise concern that the current use of PES reflects the existing ethnic and racial inequalities since most PES are created using DNA samples from individuals of European ancestries, and predictions may not be accurate in other populations. Although it has been reported that Genomic Prediction considers offering the procedure to parents of non-European ancestries, their messaging has suggested it would take a significant time to provide them with predictive models that are as relevant as those for European populations.24 The health benefits of this testing technology, its regulation, and the need for a wider debate on how to realize its promise in a responsible manner were also addressed, albeit to a lesser extent. The potential to overcome genetic and health inequalities by selecting healthy embryos with the best odds against diseases and chronic conditions was emphasized in 41 percent of the articles (12 out of 29). The regulation was a topic covered in 38 percent of the articles (11 out of 29), in which the authors argued that better regulatory oversight of PES is needed, especially in the present condition of an unregulated US market for genetic testing. Additionally, 38 percent suggested that there is an urgent need for deliberation and public debate on the societal and ethical implications of PES. Finally, the issue that patients and clinicians may get the wrong impression that the procedure is more effective and less risky was addressed in 31 percent (nine out of 29). We have established that critical issues about how PES may affect the well-being of the future child and the child-parent relationship have received less attention. For instance, only 17 percent of the articles (five out of 29) supported the clinical use of PES with arguments that parents have a moral obligation to give the child the healthiest possible start in life, a line of thought that is prominent in the bioethics literature on procreative beneficence and procreative autonomy.25 These authors also maintained that the technology has the potential to provide benefits to individuals and reduce the burden of disease and public health expenditure. Similarly, just 10 percent of the articles (three out of 29) expressed concerns about the negative impact that PES may have on the child-parent relationship by causing relational asymmetries between generations and limiting the autonomy of the future child. CONCLUSION Our content analysis has shown that the media discourse on PES and the birth of baby Aurea has been highly influenced by expert opinion. In fact, leading experts from bioethics and a range of other academic disciplines contributed 38 percent of the content in the form of blogs, opinion articles, and commentaries, published on prestigious bioethics fora and in the popular press. Furthermore, as our analysis has shown, science reporters have heavily relied on expert opinion in writing stories about the ethical challenges and societal implications of PES. One important finding of our study is the prevalence of negative attitudes towards the technology, as opposed to past media representations of PES, which had been neutral towards the technology.26 This change in attitudes is likely caused by the amplified voices of bioethics experts reacting to the first clinical use of the technology, which made hypothetical ethical dilemmas a very real possibility. As far as the thematic focus of media representations is concerned, the birth of the first baby using PES has raised ethical concerns similar to those highlighted in the literature on PES and embryo selection through pre-implantation genetic diagnosis, with the most prominent issue being the absence of robust scientific evidence for the predictive accuracy of PRS modeling and its practical value in IVF settings. Although the critical nature of media discourse can contribute to raising public awareness about the ethical acceptability of the technology, bioethicists should also examine the effect of economic forces and societal pressures to have a perfect child that may be driving prospective parents to seek such unproven genetic interventions. PES is an emerging niche in a large, unregulated market for genetic testing services that has the potential to shape the future of reproductive medicine, and there is an urgent need for a policy debate on how it can be developed responsibly and ethically. 1 J. Habermas, "The Debate on the Ethical self-Understanding of the Species," The Future of Human Nature (Oxford, UK: Blackwell Publishing, 2003): p. 16-100. 2 Polygenic risk scores (PRS) are used in personalized medicine to predict disease risk in different human populations, not necessarily for risk modelling in embryos. Polygenic embryo screening (PES), on the other hand, involves the clinical use of PRS modelling from genome-wide association studies of adult populations for selecting embryos with the lowest probability of developing certain health conditions in adulthood. It could potentially be used to select embryos with a higher probability for inheritance of certain physical traits or complex characteristics. 3 C. Goldberg, "Picking Embryos With Best Health Odds Sparks New DNA Debate," Bloomberg September 17, 2021. 4 D. Conley, "A new age of genetic screening is coming — and we don’t have any rules for it," The Washington Post June 14, 2021. 5 K. Kamenova, A. Reshef, and T. Caulfield, "Angelina Jolie's faulty gene: newspaper coverage of a celebrity's preventive bilateral mastectomy in Canada, the United States, and the United Kingdom," Genetics in Medicine 16, no. 7 (2014): 522-28. 6 K. Kamenova et al., "Media portrayal of non-invasive prenatal testing: a missing ethical dimension," Journals of Science Communication 15, no. 2 (2016): 1-19. 7 B. Talat, Choosing the "Smartest" Embryo: Embryo Profiling and the Future of Reproductive Technology, (Canadian Institute for Genomics and Society, March 14, 2019), https://www.genomicsandsociety.com/post/choosing-the-smartest-embryo-embryo-profiling-and-the-future-of-reproductive-technology8 E. Parens, S. P. Applebaum, and W. Chung, "Embryo editing for higher IQ is a fantasy. Embryo profiling for it is almost here.," Statnews, February 12, 2019. 9 T. Pagnaer et al., "Polygenic risk scoring of human embryos: a qualitative study of media coverage," BMC Medical Ethics 22, no. 1 (2021): 1-8. 10 E. L. de Zeeuw et al., "Polygenic scores associated with educational attainment in adults predict educational achievement and ADHD symptoms in children," American Journal of Medical Genetics. Part B, Neuropsychiatric Genetics 165b, no. 6 (2014): 51020. 11 A. Okbay et al., "Genetic variants associated with subjective well-being, depressive symptoms, and neuroticism identified through genome-wide analyses," Nature Genetics 48, no. 6 (2016): 624-33. 12 F. Ray, "Embryo Selection From Polygenic Risk Scores Enters Market as Clinical Value Remains Unproven," (December 22, 2021). https://www.genomeweb.com/sequencing/embryo-selection-polygenic-risk-scores-enters-market-clinical-value-remainsunproven#.YeVWzvhOk2w13 J. Savulescu, "The moral case for eugenics?," IAI News, September 28, 2021, https://iai.tv/articles/the-moral-case-for-eugenicsauid-1916. 14 S. Munday and J. Savulescu, "Three models for the regulation of polygenic scores in reproduction," Journal of Medical Ethics 47, no. 12 (2021): 1-9. 15 F. Forzano et al., "The use of polygenic risk scores in pre-implantation genetic testing: an unproven, unethical practice," European Journal of Human Genetics (2021). 16 Forzano et al., 1-3.; P. Turley et al., "Problems with Using Polygenic Scores to Select Embryos," The New England Jourmal of Medicine 385, no. 1 (2021): 78-86. 17 N. J. Wald and R. Old, "The illusion of polygenic disease risk prediction," Genetics in Medicine 21, no. 8 (2019): 1705-7. 18 M. J. Sandel, "The case against perfection: what's wrong with designer children, bionic athletes, and genetic engineering," Atlantic Monthly 292, no. 3 (2004): 50-4, 56-60, 62. 19 H. Haidar, "Polygenic Risk Scores to Select Embryos: A Need for Societal Debate," Impact Ethics (blog), November 3, 2021, https://impactethics.ca/2021/11/03/polygenic-risk-scores-to-select-embryos-a-need-for-societal-debate/. 20 Pagnaer et al., " 1-8. 21 Forzano et al., 1-8. 22 Turley et al., 78-86. 23 P. Ball, "Polygenic screening of embryos is here, but is it ethical?," The Guardian, October 17, 2021. 24 W. K. Davis, "A New Kind of Embryo Genetics Screening Makes Big Promises on Little Evidence," Slate, July 23, 2021, https://slate.com/technology/2021/07/prs-model-snp-genetic-screening-counseling.html. 25 J. Savulescu, "Procreative beneficence: why we should select the best children," Bioethics 15, no. 5-6 (2001): 413-26. 26 Pagnaer et al., 1-8.

The authors, Kosuke Kojo and Tomoko Oguri, contributed equally. This HTML edition is publicly accessible at the following URL:https://academic298uro.github.io/open-archive/2025/seminal-plasma-metallomics-new-horizon/ Abstract Seminal plasma contains a wide range of biomolecules&mdash;including inorganic elements&mdash;that may significantly influence male reproductive function. Historically, semen analysis has focused on sperm count and motility, while overlooking the diagnostic potential of this acellular fraction. This narrative review synthesizes historical perspectives on seminal plasma metallomics, elucidates the biological functions of its diverse elemental constituents, and critically evaluates methodological advancements in their detection. Furthermore, it examines future clinical and research directions by addressing key topics, including the evolution of multi-element analyses in seminal plasma, the interplay between metal exposure and male reproductive health, and the application of omics-based and machine-learning approaches in characterizing male infertility. Progress in analytical chemistry, particularly inductively coupled plasma mass spectrometry, now enables high-precision multi-element measurements in seminal plasma. The &ldquo;metallomic&rdquo; profiles reveal both essential elements&mdash;such as calcium, magnesium, potassium, sodium, zinc and selenium&mdash;and potentially toxic metals, including cadmium and lead, that reflect environmental exposures and may impair fertility. Seminal plasma metallomics also underscores fraction-specific differences between prostatic and seminal vesicular secretions, suggesting that certain chemicals may rise in seminal plasma before shifts appear in blood, thereby making it a promising biomarker for infertility risk assessment. Machine-learning approaches, such as clustering based on seminal plasma-to-serum ratios, offer new diagnostic insights by identifying subtypes of male infertility. By complementing traditional semen parameters and advanced biomarkers (<em>e.g.</em>, DNA fragmentation index), these integrative tools can refine diagnoses and guide interventions, including nutritional supplementation and avoidance of specific toxicants, potentially improving pregnancy outcomes. However, significant challenges remain: standardized protocols, validated reference ranges, and larger prospective studies are needed for clinical translation. Addressing these gaps is crucial for integrating metallomic analyses into routine evaluations of male infertility. As this field continues to evolve, it has the potential to reshape infertility assessments and foster more personalized and effective management strategies. Keywords: Male infertility; Seminal plasma; Metallomics; Trace elements; Environmental exposure; Machine learning; Personalized medicine; Semen analysis; Zinc; Phosphorus Original Publication <strong>Journal</strong>: <em>Revista Internacional de Androlog&iacute;a</em> <strong>Year</strong>: 2025 <strong>Volume</strong>: Published Ahead of Print <strong>Article Title</strong>: <em>Seminal plasma metallomics: a new horizon for diagnosing and managing male infertility</em> <strong>DOI</strong>:&nbsp;10.22514/j.androl.2025.013 License Statement Starting from Issue 1, 2024, all content in <em>Revista Internacional de Androlog&iacute;a</em> (REV INT ANDROL) is published under the Creative Commons Attribution 4.0 International (CC BY 4.0) license. This <strong>unrestrictive license</strong> allows for unlimited copying, redistribution, remixing, transformation, and building upon the work, provided that proper credit is given to the original authors and source. Copyright &copy; 2025 The Author(s). Published by MRE Press.According to the journal&rsquo;s policy, <strong>the copyright is retained by the author(s)</strong>. Under the terms of CC BY 4.0, no additional permission is required to reuse or distribute this content, as long as appropriate credit is given. 1. Introduction Infertility in humans often occurs when an insufficient number of spermatozoa reaches the female oviduct following vaginal coitus or intrauterine insemination (IUI), thereby preventing fertilisation. Historically, semen analysis has primarily emphasised sperm count and motility to diagnose male infertility. However, seminal plasma (<em>i.e</em><em>.</em>, semen without cells) contains a myriad of lipids, inorganic ions, metabolites, nucleic acids, proteins and other biomolecules, the physiological roles of which remain underexplored [1&ndash;4]. In addition to its contribution to fertilisation, seminal plasma has gained attention as a potential reservoir of biomarkers relevant not only to fertility but also to genitourinary malignancies and infections [5, 6]. Metallomics is a branch of analytical chemistry that systematically investigates metals and metalloids in biological systems [7]. Seminal plasma metallomics specifically aims to characterise the inorganic constituents (<em>e.g</em><em>.</em>, metal ions and metal&ndash;protein complexes) in semen. In this review, we use the term &ldquo;metals&rdquo; broadly to encompass all inorganic elements relevant to metallomics, including certain metalloids and, on rare occasions, non-metals (<em>e.g.</em>, phosphorus). More than a century has passed since the initial suggestion that zinc is crucial for vertebrate reproduction. Recent omics-based approaches have widened the scope of the metals/metalloids under investigation. These developments have potentially transformed diagnostics in reproductive medicine by highlighting trace elements in seminal plasma that can affect sperm physiology or reflect environmental exposure. Building on previous studies that explored the clustering of male infertility subtypes using seminal plasma-to-serum trace element concentration ratios [8], we undertook this narrative review as part of a broader cross-sectional project aimed at developing new diagnostic strategies for male infertility. To identify relevant literature, we performed a focused search of PubMed and Google Scholar using terms such as &ldquo;male infertility&rdquo;, &ldquo;seminal plasma&rdquo;, &ldquo;trace elements&rdquo;, &ldquo;metallomics&rdquo; and &ldquo;environmental exposure&rdquo;. We also examined several specialized andrology textbooks to confirm certain historical milestones and methodological details. By incorporating these references into our broader search strategy, we aimed to capture both the foundational and the most current perspectives on seminal plasma metallomics in male infertility. Through this process, we synthesized historical perspectives on the field, examined the biological functions of various elemental constituents and evaluated methodological advancements in their detection. In the following sections, we address key topics such as the evolution of multi-element analyses in seminal plasma, the interplay between metal exposure and male reproductive health, and the potential of metallomics-based approaches to refine the classification and management of male infertility. 2. Historical perspectives on seminal plasma trace element research 2.1 Early observations: zinc and fertility (1920s&ndash;1970s) Initial hints of the relevance of trace elements in semen date back to the 1920s, when Bertrand and Vladesco proposed that zinc plays a role in vertebrate reproduction [9]. Research in subsequent decades has confirmed that zinc and other ions are present in male accessory gland secretions and influence sperm function. However, until the 1970s, analytical limitations restricted most investigations to measuring a small number of elements&mdash;primarily zinc, calcium and magnesium&mdash;in relation to spermatozoal parameters [10]. 2.2 Emergence of multi-element analytical techniques (1980s&ndash;2000s) In the 1980s, atomic absorption spectrometry and early inductively coupled plasma mass spectrometry (ICP-MS) expanded the range of elements detectable in semen [11]. Studies have begun to compare fertile and infertile men, with a focus on the detection of single heavy metals, such as lead or cadmium, along with essential elements. Despite technological advances, many surveys lack precise information regarding the exposure history or environmental confounders [12]. 2.3 Rise of metallomics and modern seminal plasma studies After 2010, advances in ICP-MS enabled simultaneous measurement of multiple ultra-trace elements, spurring integrative analyses of seminal plasma &ldquo;metallomes&rdquo; [13]. Researchers have increasingly recognised that many elements beyond zinc can influence sperm function, either as essential micronutrients or as toxicants. New high-throughput approaches allow investigators to examine previously unstudied metals in normal and abnormal semen, thereby offering a broader perspective on male reproductive function. 3. Biological significance of trace elements in seminal plasma 3.1 Intracellular vs. extracellular elemental concentrations Body fluids generally comprise cellular components and a fluid fraction. In blood, erythrocytes constitute about 40&ndash;45% of the total volume (roughly 4&ndash;6 &times; 10⁹ erythrocytes per mL), whereas the fluid component is plasma; in clinical practice, serum is derived by allowing blood to clot, thereby removing clotting factors (particularly fibrinogen) from the fluid component. Many electrolytes and trace elements&mdash;such as sodium, potassium, calcium, magnesium and zinc&mdash;are routinely measured in serum, reflecting extracellular concentrations. However, certain elements (<em>e.g.</em>, cadmium and lead) can accumulate within erythrocytes over their 120-day lifespan, making whole-blood analysis more appropriate for assessing chronic exposure in occupational or environmental contexts [14]. The standard concentrations of representative elements in whole blood, erythrocytes and serum are summarized in Table 1 (Ref. [14&ndash;16]). <strong>Table 1. Elemental concentrations in whole blood, serum and erythrocytes.</strong> Z Element Classification Concentration (mg/L) Whole blood Concentration (mg/L) Serum Concentration (mg/L) Erythrocyte 11 Sodium Light metal 1.7&times;10³&ndash;2.0&times;10³ [a] 3.0&times;10³&ndash;3.4&times;10³ [a] 1.8&times;10²&ndash;3.6&times;10² [b] 12 Magnesium Light metal 3.0&times;10¹&ndash;3.9&times;10¹ [a] 1.9&times;10¹&ndash;2.4&times;10¹ [a] 4.6&times;10¹&ndash;6.3&times;10¹ [a] 15 Phosphorus [c] Non-metal/Metalloid 3.2&times;10²&ndash;3.9&times;10² [a] 1.2&times;10²&ndash;1.8&times;10² [a] 5.6&times;10²&ndash;7.6&times;10² [a] 19 Potassium Light metal 1.5&times;10³&ndash;1.8&times;10³ [a] 1.5&times;10²&ndash;2.3&times;10² [a] 3.0&times;10³&ndash;4.0&times;10³ [a] 20 Calcium Light metal 4.8&times;10¹&ndash;6.0&times;10¹ [a] 8.8&times;10¹&ndash;1.0&times;10² [a] 6.3&times;10^&minus;1&ndash;5.2&times;10⁰ [b] 25 Manganese Heavy metal 5.0&times;10^&minus;3&ndash;1.4&times;10^&minus;2 [a] 4.0&times;10^&minus;4&ndash;6.0&times;10^&minus;4 [a] 8.9&times;10^&minus;3&ndash;2.9&times;10^&minus;2 [a] 26 Iron Heavy metal 4.0&times;10²&ndash;5.1&times;10² [a] 8.7&times;10^&minus;¹&ndash;1.9&times;10⁰ [b] 9.6&times;10²&ndash;1.2&times;10³ [a] 29 Copper Heavy metal 7.3&times;10^&minus;1&ndash;1.4&times;10⁰ [a] 8.0&times;10^&minus;¹&ndash;1.9&times;10⁰ [a] 5.4&times;10^&minus;1&ndash;7.5&times;10^&minus;1 [a] 30 Zinc Heavy metal 4.7&times;10⁰&ndash;6.7&times;10⁰ [a] 7.3&times;10^&minus;¹&ndash;1.1&times;10⁰ [a] 1.0&times;10¹&ndash;1.5&times;10¹ [a] 33 Arsenic Metalloid 7.0&times;10^&minus;5&ndash;3.4&times;10^&minus;3 [a] 3.0&times;10^&minus;5&ndash;1.7&times;10^&minus;3 [a] 1.6&times;10^&minus;4&ndash;5.8&times;10^&minus;3 [a] 34 Selenium Metalloid 8.5&times;10^&minus;2&ndash;1.3&times;10^&minus;1 [a] 7.0&times;10^&minus;2&ndash;1.1&times;10^&minus;1 [a] 1.1&times;10^&minus;1&ndash;1.9&times;10^&minus;1 [a] 48 Cadmium Heavy metal 1.3&times;10^&minus;4&ndash;1.7&times;10^&minus;3 [a] &lt;9.0&times;10^&minus;6&ndash;1.7&times;10^&minus;5 [a] 2.1&times;10^&minus;4&ndash;3.4&times;10^&minus;3 [a] 82 Lead Heavy metal 5.4&times;10^&minus;3&ndash;2.6&times;10^&minus;2 [a] 1.0&times;10^&minus;5&ndash;1.0&times;10^&minus;4 [a] 1.2&times;10^&minus;2&ndash;6.3&times;10^&minus;2 [a] Z, atomic number. [a] Values quoted from Heitland and K&ouml;ster (2021) [14], representing the 5th&ndash;95th percentile range (approximate values rounded to two significant figures). [b] Derived from the review by Iyengar <em>et al.</em> [15] (1978), showing the minimum and maximum among reported mean concentrations in the literature examined (approximate values rounded to two significant figures). [c] Phosphorus is widely recognized as a non-metal, although certain sources have classified it as a metalloid. The values here represent total phosphorus, encompassing not only inorganic phosphate but also phospholipids and other phosphorus-containing compounds, and thus differ from the inorganic phosphate typically measured in routine clinical practice [16]. A similar logic applies to semen: it has a cellular component (sperm) and a fluid component (seminal plasma). Yet sperm concentrations (up to~1 &times; 10⁸ per mL) are generally lower than erythrocytes counts in blood, meaning the impact of &ldquo;cell removal&rdquo; (<em>i.e.</em>, separating sperm) on trace element measurements can be less dramatic than that between whole blood and serum. Nevertheless, studies often prefer to measure seminal plasma specifically, in order to focus on the microenvironment that directly surrounds sperm. Unlike serum, methodological standardisation for electrolytes and trace elements in seminal plasma remains limited. Reported concentrations vary widely across investigations, potentially reflecting genuine differences in population, region, diet and environmental exposure, but also inconsistencies in sample processing or analytical protocols. Consequently, caution is warranted when comparing absolute values between studies. As an alternative, we and others have proposed ratio-based approaches (<em>e.g.</em>, &ldquo;seminal plasma-to-serum ratios&rdquo;) to help reduce inter-laboratory variability [8]. While some groups use serum and seminal plasma in parallel [17], other group simultaneously evaluated &ldquo;whole blood&rdquo; and &ldquo;whole semen,&rdquo; underscoring the importance of clarifying which compartments are being measured in reproductive toxicology research [18]. Table 2 (Ref. [8, 16, 19&ndash;22]) provides a concise overview of key trace elements in seminal plasma&mdash;including their typical distribution, primary glandular sources and reproductive roles&mdash;which will be referenced throughout this manuscript where relevant. <strong>Table 2. Seminal plasma trace elements: distribution, origins and roles.</strong> Z Element SP/Se ratio [a] Dominant glandular origin Potential role in seminal plasma [12, 19, 20] 11 Sodium 0.88&ndash;0.97 [b] Prostate [c] Maintains osmotic balance and membrane potential essential for sperm viability 12 Magnesium 2.9&ndash;7.3 [b] Prostate [c] Supports ejaculatory function and stabilizes sperm membranes 15 Phosphorus [d] 6.12&ndash;9.24 [b] Seminal vesicle [c] Contributes to energy metabolism and acid phosphatase activity, aiding sperm function 19 Potassium 5.37&ndash;9.00 [b] Prostate [c] Maintains osmotic balance and membrane potential essential for sperm viability 20 Calcium 2.18&ndash;4.55 [b] Prostate [c] Regulates sperm motility and acrosome reaction 25 Manganese 7&ndash;18 [b] Prostate [c] Acts as a cofactor in antioxidant defense; exact role in sperm function under investigation 26 Iron 0.08&ndash;0.16 [b] Prostate [c] No major direct role; may contribute to oxidative balance in seminal plasma 29 Copper 0.08&ndash;0.16 [b] Prostate [c] Acts as a cofactor for antioxidant enzymes; may indirectly influence sperm quality 30 Zinc 116&ndash;306 [b] Prostate [c] Stabilizes sperm chromatin and supports antioxidant defense 33 Arsenic 1.61&ndash;3.49 [b] Seminal vesicle [c] Non-essential; can disrupt sperm parameters when elevated 34 Selenium 0.37&ndash;0.61 [b] Prostate [c] Essential for selenoproteins; protects sperm from oxidative stress 48 Cadmium Unknown [e] Unknown [f] Non-essential; accumulates in tissues and may impair testicular function 82 Lead Unknown [e] Seminal vesicle? [f] Non-essential; interferes with reproductive hormones and sperm parameters Z, atomic numb; SP, seminal plasma; Se, serum. [a] The value indicates the relative concentration in seminal plasma when the serum concentration is set to 1. [b] These data refer to our findings in Tanaka (2024) [8]. Specifically, they represent the 25th&ndash;75th percentiles for men whose partners conceived within one year without undergoing in vitro fertilization or intracytoplasmic sperm injection. [c] Based on our own data in Tanaka (2024) [8] using split ejaculate sampling: elements showing higher concentrations in the early fraction were deemed prostate-dominant, whereas those showing higher concentrations in the later fraction were deemed seminal vesicle&ndash;dominant. [d] Here, the phosphorus values represent total phosphorus, encompassing not only inorganic phosphate but also phospholipids and other phosphorus-containing compounds, and thus differ from the inorganic phosphate typically measured in routine clinical practice [16]. [e] No systematic study has established SP/Se ratios for cadmium or lead. Althogh the data from Riaz (2016) [21] may be partially informative, they may overestimate serum concentrations compared with other studies. [f] Based on Pant (2003) [22], cadmium&rsquo;s lack of correlation with fructose or acid phosphatase leaves its origin unclear, whereas lead&rsquo;s positive correlation with fructose and negative correlation with acid phosphatase suggests the seminal vesicles as its likely dominant origin. 3.2 Essential elements Many essential elements are found in their ionic forms in seminal plasma and support sperm physiology [20] (Table 2). Calcium modulates sperm motility, hyperactivation, acrosome reaction and chemotaxis [23]. Magnesium is critical for the ejaculatory function and affects sperm membrane stability [24, 25]. Potassium and sodium are vital for membrane potential regulation via sodium&ndash;potassium adenosine triphosphatase (Na/K-ATPase) [26]. Zinc helps stabilise sperm chromatin, assists in antioxidant defense and supports spermatogenesis [27, 28]. Selenium is a cofactor in selenoproteins that protect cells from oxidative damage and is integral to sperm formation [29]. These elements often differ in absolute concentration between blood and seminal plasma. For example, prostatic fluid typically contains high levels of zinc, reflecting a specialized role in stabilizing sperm DNA and supporting accessory gland function. Assessing such elements in the reproductive tract&rsquo;s fluid fraction can thus provide information beyond conventional serum measurements alone. 3.3 Potentially toxic metals and metalloids Heavy metals, defined as inorganic elements with a density greater than 5 g/cm³ [30], are often associated with toxicity when present in excess (Tables 1 and 2). Examples include silver, arsenic, cadmium, chromium, cobalt, copper, lead, mercury, nickel and zinc. These metals are classified as non-essential or in cases where they may be biologically essential, can become harmful when their levels exceed the physiological requirements [31]. Certain heavy metals tend to accumulate in biological materials owing to the limited detoxification and excretion pathways in the body, making them reliable environmental exposure biomarkers for assessing health risks [32]. The reproductive system is particularly vulnerable to the adverse effects of heavy metals, which act through direct mechanisms, such as oxidative damage and gonadal toxicity, and indirect mechanisms, such as endocrine disruption [33]. Some trace elements, while necessary in small amounts, can exert toxic effects when concentrations exceed physiological thresholds. Additionally, certain metals, such as lead and cadmium, are endocrine-disrupting compounds that interfere with hormonal pathways and can alter reproductive health [34]. 3.4 Evidence of elemental exchange between sperm and seminal plasma Essential elements such as calcium, magnesium, potassium, sodium and zinc are present in seminal plasma, predominantly in the ionic form. Spermatozoa use supecialized ion channels and pumps to regulate intracellular and extracellular concentrations, ensuring optimal osmotic balance, pH, and membrane potential for motility and fertilization [35]. This dynamic exchange parallels that between erythrocytes and plasma in blood [36, 37], albeit on a smaller scale due to the lower cellular density in semen. In reproductive technology, the composition of semen simulants (artificial seminal plasma) injected into the vaginal environment is calibrated carefully to mimic the physiological levels of essential elements as closely as possible [38]. This is performed to optimise the conditions for sperm function and fertilisation. The distinction between intracellular and extracellular metal homeostasis highlights the precision with which these elements are regulated to support fertilisation. For example, zinc, potassium, calcium and magnesium concentrations in seminal plasma often significantly exceed those found in serum. Conversely, other elements such as copper and iron are consistently higher in the serum than in the seminal plasma [8, 17, 39] (Table 2). These differential patterns underscore the highly specialised microenvironment of the male reproductive tract, which is tailored to the needs of spermatozoa during their journey through the male and female reproductive systems [40]. The choice of whether to measure whole blood or serum (in the case of blood), and whole semen or seminal plasma (in the case of semen), depends on study objectives, exposure profiles, and the need to differentiate chronic from acute or localized effects. 4. Analytical approaches in seminal plasma metallomics 4.1 A key analytical technique: advantages and limitations Among the various methodologies for comprehensive profiling of both essential and ultratrace metals in seminal plasma, ICP-MS provides high sensitivity, a broad dynamic range, and the ability to measure multiple elements simultaneously [41]. These features make it especially suitable for the comprehensive profiling of both essential and ultratrace metals in seminal plasma. However, ICP-MS requires meticulous calibration and strict contamination control. Sample digestion protocols, which often employ nitric acid and hydrogen peroxide, are critical for obtaining consistent measurements [42]. 4.2 Comparison with other methods Although atomic absorption spectrometry remains a standard technique for single-element analysis, its throughput and sensitivity to ultratrace levels can be limited. Inductively coupled plasma optical emission spectrometry (ICP-OES) also offers multi-element capabilities by measuring the light emitted from excited atoms or ions in the ionized gas plasma (not to be confused with seminal plasma), but it generally provides higher detection limits (<em>i.e.</em>, lower sensitivity) compared to ICP-MS, which detects ions based on their mass-to-charge ratio [16]. Given the wide range of metal concentrations in seminal plasma, ICP-MS has become the method of choice for advanced metallomic studies. 4.3 Sampling and pre-analytical considerations The proper collection and storage of seminal plasma samples are of paramount importance, as metal contamination can arise from containers or spermatozoa. Centrifugation to remove sperm, spermatogenic cells and other cellular and particulate debris [43] precedes storage at &minus;80 &deg;C in several protocols [44]. 4.4 Data interpretation and quality control Metals in seminal plasma often exhibit non-Gaussian distribution, and researchers should apply nonparametric statistics or data transformations to handle skewed data [45]. Moreover, external reference materials to analytical quality control for seminal plasma are scarce, which necessitates the reliance on serum-based or in-house calibrations [46, 47]. 5. Fractionation of the ejaculate: prostate <em>vs. </em>seminal vesicle contributions 5.1 Normal physiology of ejaculation and fraction dominance Semen primarily consists of secretions from the prostate and seminal vesicles, with minor contributions from other sources, such as the bulbourethral glands, epididymides and the testes. Understanding each gland&rsquo;s contribution is crucial for assessing male reproductive health [48, 49]. Theoretically, prostatic fluid can be obtained through prostatic massage [50], and seminal vesicular fluid is collected via aspiration under transrectal ultrasound guidance [51]. However, these methods are associated with significant invasiveness and a high risk of contamination, limiting their application to specialized contexts, such as pharmacokinetic studies or the evaluation of obstructive azoospermia in cases of male infertility. Given these challenges, there remains a clear need for less invasive and more precise techniques to evaluate the gland-specific contributions to semen [52]. Split ejaculation sampling, which involves collecting multiple fractions from a single ejaculation, is often employed as a noninvasive method to evaluate the dynamics of accessory gland secretions <em>in vivo</em> [53]. This sampling technique leverages the physiological property that approximately the first 30% of the ejaculate typically originates from the prostate, while the remaining two-thirds are primarily composed of seminal vesicular fluid [54]. Observational studies using transrectal ultrasound have further demonstrated that the timing of prostatic contractions differs from that of seminal vesicle contractions by at least several seconds [55]. Additionally, prostatic fluid is typically watery, while seminal vesicular fluid has a gel-like consistency [56, 57]. This difference in texture can serve as a helpful indicator of whether the ejaculate has been successfully fractionated during sampling. 5.2 Biochemical and elemental differences in early vs. subsequent fractions Fractionation studies in the 1970s showed that the initial portion of the ejaculate, dominated by prostatic fluid, generally has higher sperm concentration and motility, whereas seminal vesicular fluid contains only a small number of sperm [58]. Subsequent research further demonstrated that excessive exposure to seminal vesicular fluid can reduce sperm motility, shorten lifespan, compromise nuclear chromatin stability, and negatively affect sperm DNA integrity [59]. Chemically, the first fraction tends to have elevated levels of elements, such as zinc, calcium and magnesium, reflecting prostatic secretion [53, 56]. In contrast, the subsequent fraction is often more voluminous and enriched with phosphorus and arsenic [8, 53] (Table 2). Notably, it was already recognized in the 1990s that seminal vesicular fluid may contain prostaglandins, semenogelins, and other factors potentially capable of reducing sperm motility [60, 61]. In fact, significant progress has been made in elucidating the functions of numerous bioactive substances present in seminal vesicular fluid, and their contributions to sperm function regulation and modulation of the immune environment in the female reproductive tract are increasingly being understood [49, 62]. However, further research is required to comprehensively clarify the interactions of newly identified components and their physiological significance [63]. In addition, the use of split ejaculation sampling for trace element studies poses specific methodological challenges. Potential pitfalls include incomplete separation of fractions, cross-contamination between the initial and subsequent fractions, and an increased likelihood of contamination arising from multiple collection containers. Consequently, ensuring the reliability and accuracy of research designs employing this approach requires careful timing to capture the intermittent outflow from the urethra, as well as the standardization of protocols&mdash;including the use of low-contamination consumables. By addressing these factors, split ejaculation sampling can remain a valuable tool for elucidating gland-specific trace element distributions in semen. 5.3 Clinical implications of fractionation for fertility assessment Elucidating the secretory profiles of each accessory gland offers valuable insights into male fertility. In addition to testicular factors, the etiology of semen abnormalities also involves post-testicular contributors&mdash;namely epididymal and accessory gland functions&mdash;which remain relatively underexplored [64]. Seminal plasma is considered an optimal resource for investigating these factors because it reflects the local pathophysiology of the male reproductive organs [65]. A practical approach proposed more than half a century ago revealed that using only the initial fraction of ejaculate for IUI could result in higher pregnancy rates [66]. Similarly, the &ldquo;withdrawal coital method&rdquo;, wherein the initial fraction is ejaculated intravaginally while the remaining portion is expelled outside the vagina, can be viewed as an early technique that harnesses the distinct physiological effects of prostatic and seminal vesicular secretions on sperm to improve pregnancy outcomes [67]. From a diagnostic perspective, specific biomarkers in seminal plasma have long been used to evaluate glandular function. Zinc was identified in the 1980s as a marker of prostatic secretion [68], while fructose was used to assess seminal vesicular function [69]. By the 2000s, the use of prostate-specific antigen (PSA) in seminal plasma to evaluate prostatic secretory capacity had also been reported [52, 70]. Other established markers of prostatic activity include citric acid, &gamma;-glutamyl transpeptidase, and acid phosphatase [71, 72]. Additionally, parameters such as pH and viscosity have been proposed as potential indicators of seminal vesicular dysfunction [73]. Zinc, calcium and magnesium are well-known trace elements predominantly found in prostatic fluid [53]. Moreover, our previous research demonstrated that a wide range of elements&mdash;including lithium, sodium, sulfur, manganese, iron, cobalt, copper, zinc, selenium, rubidium, strontium, molybdenum, cesium, barium and thallium&mdash;are predominantly present in prostatic fluid [8]. In contrast, only two trace elements, phosphorus and arsenic, appear to be more concentrated in seminal vesicular fluid [8]. Building on earlier studies, which proposed combining fructose and PSA measurements to simultaneously quantify the relative contributions of the prostate and seminal vesicles to total semen volume [52], we have introduced a novel approach. Using ICP-MS to measure a broad spectrum of trace elements [16], we demonstrated its analytical advantage in assessing the imbalance between prostatic and seminal vesicular secretions. This method could serve as a foundation for developing superior diagnostic strategies. In addition, our earlier findings suggest that certain trace elements are maintained at higher or lower concentrations in seminal plasma than in serum, potentially reflecting active regulation by epithelial cells in the prostate or seminal vesicles [8]. Although the fundamental physiological rationale for maintaining divergent levels in seminal plasma remains unclear, the fact that seminal plasma-to-serum ratios vary significantly depending on the specific element indicates their potential value as biomarkers for evaluating post-testicular factors [17]. Overall, fractionation not only reveals the distinct biochemical signatures contributed by the prostate and seminal vesicles but also has meaningful clinical relevance. By understanding which glandular functions are compromised or exaggerated, targeted therapeutic interventions may be devised, such as adjusting supplementation to enhance prostatic support or addressing potential excess seminal vesicular components. Although epididymal fluid represents less than 10% of the total ejaculate volume [52], it remains pivotal for sperm maturation, with neutral &alpha;-glucosidase and L-carnitine serving as recognized functional markers [74, 75]. However, no specific trace element has yet been definitively linked to epididymal fluid, and it is unclear whether subtle variations in epididymal secretion significantly affect metallomic profiles. Empirical or supplemental therapies, including coenzyme Q10, vitamins, zinc and selenium, continue to be studied for their potential to improve sperm quality in men with unexplained male infertility [76]. Moreover, measuring seminal plasma biomarkers may identify subgroups of idiopathic&nbsp;oligoasthenoteratospermic men who could benefit from L-carnitine supplementation [75], suggesting a new avenue for personalized treatment approaches. Future work may clarify how post-testicular, epididymal and accessory gland contributions jointly influence male reproductive outcomes and guide more targeted interventions. 6. Environmental and occupational exposures to trace elements 6.1 Seminal plasma as a sensitive biomarker of environmental exposure Although blood and urine are conventional biomarkers, seminal plasma can be more specific for reproductive outcomes. High levels of certain toxicants in seminal plasma may cause infertility before overt changes appear in the blood [77]. This specificity stems from the role of accessory glands in excreting or concentrating certain metals [31]. 6.2 Regional pollution and male infertility Regions such as Campania (Italy) and Opole (Poland) have been associated with industrial contamination and diminished sperm quality [78, 79]. Similar associations have been noted in heavily industrialised parts of India and China, underscoring how local environmental factors can shape seminal plasma metallomic profiles [13]. 6.3 Regulatory thresholds and gaps in knowledge Despite the accumulating evidence, no universally accepted threshold values exist for &ldquo;toxic&rdquo; <em>vs.</em> &ldquo;safe&rdquo; levels of elements in seminal plasma. Establishing reference intervals for multiple metals remains a challenge [12], and researchers must disentangle chronic low-dose exposure, which may exert subtle but significant effects, from acute high-dose exposure. 7. Emerging trends: personalized medicine and machine learning 7.1 Clustering and other data-driven approaches in metallomics The ultimate goal of seminal plasma biomarker research in addressing male infertility is achieving partner pregnancy. To this end, two potential case-control study designs can be envisioned. One approach involves comparing fertile and infertile men, while the other focuses on examining differences in biomarker profiles to predict pregnancy outcomes in their partners. Both approaches, however, face limitations when relying on traditional statistical methods. This is due to the known correlations&mdash;both positive and negative&mdash;among the concentrations of seminal plasma biomarkers that reflect accessory gland secretory functions. For example, positive correlations have been reported between zinc and citric acid concentrations, while negative correlations exist between zinc and fructose concentrations [80]. Additionally, several studies have documented consistent positive correlations among heavy metals in seminal plasma [79, 81&ndash;86]. Given these complexities, machine learning techniques have emerged as promising tools in seminal plasma metallomics research. Specifically, studies comparing fertile and infertile men have utilized supervised machine learning methods, such as Bayesian kernel machine regression and weighted quantile sum models, to address the intricate multicollinearity among trace elements [86]. These approaches have demonstrated efficacy in distinguishing between fertile and infertile groups when clear classification is achievable. However, real-world challenges remain, including difficulty in definitively excluding female infertility as a factor, the possibility of spontaneous conception in men initially categorized as infertile, and the relatively large sample sizes required for supervised learning methods. To overcome these challenges, we explored the use of unsupervised machine learning techniques to maximize the utility of pilot data obtained from a relatively small-scale study [8]. This approach analyzed high-dimensional elemental data, aiming to identify latent subtypes within a population of male patients with infertility&mdash;defined as individuals whose fertility status cannot be clearly categorized as fertile or infertile. By clustering these patients based on the ratios of key elements in seminal plasma to serum, we identified distinct patterns reflecting &ldquo;prostatic fluid dominance&rdquo; and &ldquo;seminal vesicular fluid dominance&rdquo;. Our findings suggest that the subgroup characterized by &ldquo;prostatic fluid dominance&rdquo; may be associated with better pregnancy outcomes. 7.2 Integration with sperm analysis The DNA fragmentation index, recognized as an advanced biomarker, holds promise as a robust predictor of fertilization outcomes [87]. By integrating metallome profiles as a third pillar alongside traditional semen parameters, such as sperm concentration, motility and morphology, as well as advanced biomarkers, such as DNA fragmentation indices, we anticipate a more powerful framework for addressing the complex mechanisms of infertility. This integrative approach not only has the potential to enhance diagnostic precision but may also guide targeted therapeutic strategies, including nutritional supplementation and avoidance of specific toxicant exposure, thus paving the way for more effective interventions in the future. 7.3 Challenges and future directions Large-cohort studies, prospective designs and standardised sample handling are essential to validate these approaches. The high cost and limited accessibility of ICP-MS remain a barrier; moreover, as the reference intervals for seminal plasma metals remain poorly defined, clinicians must interpret results with caution. 8. Conclusions Seminal plasma metallomics studies highlight how inorganic elements shape male reproductive health. This field, galvanised by improvements in ICP-MS and machine learning, expands our understanding beyond semen analysis alone. Early versus subsequent fraction patterns, environmental exposure and personalised therapies converge to form a new paradigm in infertility research. Robust prospective studies with standardised protocols are required to validate and translate these findings into clinical practice. &nbsp; <strong>Availability of data and materials</strong> Not applicable. <strong>Author contributions</strong> KK and TO&mdash;designed the research study. KK and TTan&mdash;performed the experiments. MU, KY, AI, HNe, TTak, TK and HNi&mdash;provided assistance and advice. KK, TTan, AN and DN&mdash;analysed the data. KK and TO&mdash;wrote the manuscript. All authors contributed to the editorial changes in the manuscript. All the authors have read and approved the final version of the manuscript. <strong>Ethics approval and consent to participate</strong> Not applicable. <strong>Acknowledgment </strong> The authors express their sincere gratitude to Haruki Tsuchiya and Masahiro Kurobe for their invaluable support in managing the project. We also extend our appreciation to Daiki Numata, Mikiko Matsuoka, Yukiko Hara, Jun Itadani, Miki Takahashi, Tomoyasu Sakai, Mami Enjoji and Miki Muroi for their assistance with laboratory operations. Special thanks go to Yukinobu Haruyama and Yukinari Gunji for their guidance on serum sample handling. We are also deeply grateful to Takuya Shimizu, Shunsuke Fujimoto, Mitsuhiro Ueda, Katsura Kato, Naoyuki Okamoto, and Seiichi Inagaki of Renatech Co., Ltd., for their invaluable advice on project initiation and trace element measurement techniques. Lastly, we sincerely thank Yoshiyuki Nagumo, Tomokazu Kimura, Shuya Kandori, Kaoru Yanagida, and Teruaki Iwamoto for their support in reviewing the study design and manuscript preparation. <strong>Funding</strong> This research was funded by the Japan Society for the Promotion of Science KAKENHI under Grant Numbers 23K15756 and 21K16737 as well as the Japan Science and Technology Agency through Grant Number JPMJPF2017. <strong>Conflict of interest</strong> The authors declare no conflict of interest.&nbsp; <strong>References</strong> 1.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Wang F, Yang W, Ouyang S, Yuan S. The vehicle determines the destination: The significance of seminal plasma factors for male fertility. Int J Mol Sci. 2020; 21: PubMed PMID: 33198061; PubMed Central PMCID: PMC7696680. Available from: https://doi.org/10.3390/ijms21228499 2.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Rodriguez-Martinez H, Martinez EA, Calvete JJ, Pena Vega FJ, Roca J. 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