A systematic guide to product design and safety from an ethical engineering perspective This hands-on textbook offers a holistic approach to product safety and engineering ethics across many products, fields, and industries. The book shows, step by step, how to “design in” safety characteristics early in the engineering process using design for product safety (DfPS) methods. Written by a P.E. and skilled educator with industry experience, Engineering Ethics and Design for Product (...) class='Hi'>Safety addresses all aspects of the product system from the perspective of an active product-safety engineering manager. You will get detailed case studies, real-world examples, and side discussions that provide a deep dive into key topics. Coverage includes: Product safety Engineering ethics Product-safety components Hazards, risks, accidents, and outcomes A product-design process Product-safety engineering Engineering-design guidance Product-safety facilitators Product-safety engineering methods Product-safety defects and recalls. (shrink)

Firms that wish to be morally responsible in providing products that meet a high standard of safety may face problems competing against firms that make unsafe products and sell these products at cheap prices; these problems may be compounded when consumers do not accurately process information about safety and risk. This paper presents a conceptual argument that the tort system may serve to promulgate information which makes it feasible for firms to market safe products even in the face (...) of these competitive obstacles.To corroborate the conceptual argument, the paper presents the results of an experimental study about the impact of negligence liability information on consumer product safety evaluation. The results show that provision of negligence information heightens consumer concern for safety and firms' ethical behavior, and increases the proportion of consumer choices in favors of the brands sold by manufacturers with a favorable track record for quality. More importantly, they indicate that provision of negligence information reduces the likelihood that brands which conform to inferior safety standards will be chosen by consumers who care about safety standards. (shrink)

For at least the past three decades, injuries have been recognized as an important public health problem in the United States. In 2001, there were approximately 157,000 deaths due to injuries in the US. There were also almost 30 million non-fatal injury incidents.Injuries have been defined as: “…any unintentional or intentional damage to the body resulting from acute exposure to thermal, mechanical, electrical, or chemical energy or from the absence of such essentials as heat or oxygen”. Within public health, the (...) field of injury prevention and control is dedicated to reducing the burden of injuries on the lives of people around the world.Injury prevention seeks to reduce injuries by: 1) identifying risk factors, 2) designing interventions to address the risk factors, 3) implementing those interventions, 4) evaluating their effectiveness, and 5) replicating those that work. As with many other public health problems, interventions can target factors associated with the human or host, vehicle or vector, and the physical or social environment. (shrink)

For at least the past three decades, injuries have been recognized as an important public health problem in the United States. In 2001, there were approximately 157,000 deaths due to injuries in the US. There were also almost 30 million non-fatal injury incidents.Injuries have been defined as: “…any unintentional or intentional damage to the body resulting from acute exposure to thermal, mechanical, electrical, or chemical energy or from the absence of such essentials as heat or oxygen”. Within public health, the (...) field of injury prevention and control is dedicated to reducing the burden of injuries on the lives of people around the world.Injury prevention seeks to reduce injuries by: 1) identifying risk factors, 2) designing interventions to address the risk factors, 3) implementing those interventions, 4) evaluating their effectiveness, and 5) replicating those that work. As with many other public health problems, interventions can target factors associated with the human or host, vehicle or vector, and the physical or social environment. (shrink)

Public concern over major agricultural product safety incidents, such as swine flu and avian flu, can intensify financial losses in the livestock and poultry industries. Crawler technology were applied to reviewed the Weibo social media discussions on the African Swine Fever incident in China that was reported on 3 August 2018, and used content analysis and network analysis to specifically examine the online public opinion network dissemination characteristics of verified individual users, institutional users and ordinary users. It was (...) found that: attention paid to topics related to “epidemic,” “treatment,” “effect” and “prevent” decrease in turn, with the interest in “prevent” increasing significantly when human infections were possible; verified individual users were most concerned about epidemic prevention and control and play a supervisory role, the greatest concern of institutional users and ordinary users were issues related to agricultural industry and agricultural products price fluctuations respectively; among institutional users, media was the main opinion leader, and among non-institutional users, elites from all walks of life, especially the food safety personnel acted as opinion leaders. Based on these findings, some policy suggestions are given: determine the nature of the risk to human health of the safety incident, stabilizing prices of relevant agricultural products, and giving play to the role of information dissemination of relevant institutions. (shrink)

A key focus for agri-food scholars today pertains to emerging “alternative food movements,” particularly their long-term viability, and their potential to induce transitions in our prevailing conventional global agri-food systems. One under-studied element in recent research on sustainability transitions more broadly is the role of disruptive events in the emergence or expansion of these movements. We present the findings of a case study of the effect of a sudden acute food safety crisis—bovine spongiform encephalopathy, or mad cow disease—on alternative (...) beef production in the Province of Alberta, Canada. Employing the conceptual lens of Sustainability Transition Theory, we explore the perspectives of conventional and alternative beef producers, treating alternative beef production as a niche operating within the dominant regime of global industrial agri-business. Three key findings are presented here. First, food safety risks and disruptive events can emerge as a direct consequence of the socio-ecological contradictions embedded in industrial agriculture, representing an opportunity for expansion of agricultural niches. Second, certain features of socio-economic regimes can also contribute to niche emergence, such as an economic system that disenfranchises beef-producing families. Finally, our study highlights the high level of diversity among niche agents and the complex and nuanced nature of their support for the niche. (shrink)

Livestock production today faces thedifficult task of effectively meeting emergingconsumer concerns while remaining competitive on majortarget markets. Meeting consumer concerns aboutproduct safety and animal welfare are identified askey attention points for future livestock production.The relevance of these issues pertains to productionefficiency and economic benefits and tore-establishing meat sector image and consumer trust.The current paper analyses consumer concerns about theethical issues of meat safety and animal welfare fromcurrent livestock production. The research methodologyis based on literature review, secondary data sources,and (...) primary research through focus group discussionsand a survey of 320 meat consumers in Belgium.Objectives were to assess importance attached byconsumers to product safety and animal welfare asethical issues in commercial livestock production, andto evaluate consumer perception of these issues forbeef, pork, and poultry. Significant differences inissue importance and perception are identified amongconsumer groups based on socio-demographic andbehavioral characteristics. From the analysis, meatsafety emerges as an absolute but minimum requirementfor future success of livestock and meat production.Additionally, animal welfare can be expected to becomea critical theme especially for pork and poultryacceptance. (shrink)

Transgenic plants are now being used to develop pharmaceutical and industrial products in addition to their use in crop improvement. Using confinement requirements, these transgenic plants are grown and processed under conditions that prevent intermixing with commodity crops. Regulatory agencies in the United States have provided guidance of zero tolerance of these new industrial crops with commodity crops. While this is a worthy goal, it is theoretically unattainable. In spite of the best containment practices, there is a potential risk using (...) any system of production due to unforeseen incidences including natural disasters or exposure to workers. The precautionary principle has been used for numerous regulated articles in addressing the potential risks of new products and technology based on a risk assessment in similar situations. We present here a risk assessment model that could be used as a start to develop an accepted model for the industry. The model is based on current risk models used for other regulated articles, but adapted for these types of products. This could be used to determine action levels in the event of an unintended exposure or to ensure that detection or confinement methods are adequate to avoid risks. As an example, aprotinin, a therapeutic protein now being produced in maize, was evaluated for potential risk to humans using this model. (shrink)

This book examines how regulatory and liability mechanisms have impacted upon product safety decisions in the pharmaceutical and medical devices sectors in Europe, the USA and beyond since the 1950s. Thirty-five case studies illustrate the interplay between the regulatory regimes and litigation. Observations from medical practice have been the overwhelming means of identifying post-marketing safety issues. Drug and device safety decisions have increasingly been taken by public regulators and companies within the framework of the comprehensive regulatory (...) structure that has developed since the 1960s. In general product liability cases have not identified or defined safety issues, and function merely as compensation mechanisms. This is unsurprising as the thresholds for these two systems differ considerably; regulatory action can be triggered by the possibility a product is harmful, whereas establishing liability in litigation requires proving that the product was actually harmful.As litigation normally post-dates regulatory implementation, the 'private enforcement' of public law has generally not occurred in these sectors. This has profound implications for the design of sectoral regulatory and liability regimes, including associated features such as extended liability law, class actions and contingency fees. This book forms a major contribution to the academic debate on the comparative utility of regulatory and liability systems, on public versus private enforcement, and on mechanisms of behaviour control. (shrink)

We make many decisions in our livesand we weigh the benefits against thedrawbacks. Our decisions are based on whatbenefits are most important to us and whatdrawbacks we are willing to accept. Decisionsabout what we eat are made in the same way; butwhen it comes to safety, our decisions areusually made more carefully. Food containsnatural chemicals and it can come into contactwith many natural and artificial substancesduring harvest, production, processing, andpreparation. They include microorganisms,chemicals, either naturally present or producedby cooking, environmental (...) contaminants, andpesticides. Since the chance of being harmed bythese potential hazards is called risk, riskanalysis might be better termed as the scienceof safety, because risk management is anessential part of it. It would, however, bedifficult and shortsighted to maintain thatquestions about risk and safety can have nomoral dimension. Risk and safety become mattersof moral concern when they raise furtherquestions about responsibility, accountability,and justifiability. The question of risk cannotbe ignored in any ethical investigation ofgenetic engineering, novel foods, animalwelfare, and individual choices. However, foodis more than metabolic fuel. It hasphysiological, psychological, social, cultural,and aesthetic associations that merge to form agestalt that people endanger and maintain. Thecontribution of any food towards anindividual's well being is as complex as theindividual himself. In this context, thebenefits of consuming food that containshazards may outweigh the risk. (shrink)

This article presents and evaluates arguments supporting that an approval procedure for genome-edited organisms for food or feed should include a broad assessment of societal, ethical and environmental concerns; so-called non-safety assessment. The core of analysis is the requirement of the Norwegian Gene Technology Act that the sustainability, ethical and societal impacts of a genetically modified organism should be assessed prior to regulatory approval of the novel products. The article gives an overview how this requirement has been implemented in (...) the regulatory practice, demonstrating that such assessment is feasible and justified. Even in situations where genome-edited organisms are considered comparable to non-modified organisms in terms of risk, the technology may have—in addition to social benefits—negative impacts that warrant assessments of the kind required in the Act. The main reason is the disruptive character of the genome editing technologies due to their potential for novel, ground-breaking solutions in agriculture and aquaculture combined with the economic framework shaped by the patent system. Food is fundamental for a good life, biologically and culturally, which warrants stricter assessment procedures than what is required for other industries, at least in countries like Norway with a strong tradition for national control over agricultural markets and breeding programs. (shrink)

Developmental states are criticized for rapid “industrialization without enlightenment.” In the last 30 years, China’s breathtaking growth has been achieved at a high environmental and food safety cost. This article, utilizing a recent survey of China’s livestock industry, illustrates the initiating role of China’s developmental state in the exponential expansion of the country’s livestock production. The enthusiastic response of the livestock industry to the many state policy incentives has made China the world’s biggest animal farming nation. Shortage of meat (...) and dairy supply is history. Yet, the Chinese government is facing new challenges of no less a threat to political stability. Production intensification has created a welfare crisis impacting the world’s biggest number of farm animals. The resulting food safety incidents are affecting consumer confidence and health. Untreated waste contributes to the nation’s environmental degradation. Developmental states may have a proud record of growth in the initial stage of industrialization. Their prospects for sustained development have long been questioned. China has come to an important juncture to march towards a sustained development. (shrink)

Starting from the recent quest to investigate the human side of organizational sustainability, this study applies a variety of regression analyses to investigate the effects of Lean Operations, High Involvement Work Practices, and management behaviors on occupational safety. It tests and finds support for the hypotheses that Lean Production systems, High Involvement Work Practices, and two specific management behaviors—workers’ capability development and empowerment —positively affect occupational safety. Furthermore, empowering behaviors positively moderate the effect of Lean Operations on workers’ (...) safety. The study bridges sustainable operations literature with theories related to the ethical side of safety management, sustainable HRM, ethical leadership, and empowerment. In doing so, it contributes to the understanding of occupational safety as constitutive aspect of organizational sustainability. (shrink)

BackgroundThe complexities of the workplace environment in the downstream oil and gas industry contain several safety-risk factors. In particular, instituting stringent safety standards and management procedures are considered insufficient to address workplace safety risks. Most accident cases attribute to unsafe actions and human behaviors on the job, which raises serious concerns for safety professionals from physical to psychological particularly when the world is facing a life-threatening Pandemic situation, i.e., COVID-19. It is imperative to re-examine the (...) class='Hi'>safety management of facilities and employees’ well-being in the downstream oil and gas production sector to establish a sustainable governance system. Understanding the inherent factors better that contribute to safety behavior management could significantly improve workplace safety features.ObjectiveThis study investigates employees’ safety behavior management model for the downstream oil and gas industry to consolidate the safety, health and wellbeing of employees in times of COVID-19.MethodsNominal Group Technique was first employed to screen primary behavioral factors from 10 workplace health and safety experts from Malaysia’s downstream oil and gas industry. Consequently, 18 significant factors were identified for further inquiry. Next, the interpretive structural modeling technique was used to ascertain the complex interrelationships between these factors and proposed a Safety Behavioral Management Model for cleaner production.ResultsThis model shows that management commitment, employee knowledge and training, leadership, and regulations contribute significantly to several latent factors. Our findings support the Social Cognitive Theory, where employees, their environment, and their behaviors are related reciprocally.ConclusionIt is postulated that identifying safety factors and utilizing the proposed model guides various stakeholder groups in this industry, including practitioners and policymakers, for achieving long-term sustainability. (shrink)

Starting from the recent quest to investigate the human side of organizational sustainability, this study applies a variety of regression analyses to investigate the effects of Lean Operations, High Involvement Work Practices, and management behaviors on occupational safety. It tests and finds support for the hypotheses that Lean Production systems, High Involvement Work Practices, and two specific management behaviors—workers’ capability development and empowerment —positively affect occupational safety. Furthermore, empowering behaviors positively moderate the effect of Lean Operations on workers’ (...) safety. The study bridges sustainable operations literature with theories related to the ethical side of safety management, sustainable HRM, ethical leadership, and empowerment. In doing so, it contributes to the understanding of occupational safety as constitutive aspect of organizational sustainability. (shrink)

The article deals with the systemic-synergetic aspects of personal security in the postmodern society. The theoretical concepts of the system genesis of the structural and functional organization of a person's professional safety have been improved according to the parameters of the sphere of professional functioning, the age range and labor conditions. The article proves that the performance of professional activities in special conditions is often combined with danger to health and life. Ensuring human life in special conditions requires the (...) use of the specialist's adaptive resources, which ensure the activation of the productive processes of activity and determine the construct of the professional health of the specialist's personality. The active involvement of the individual in the professional sphere is reflected in the manifestation of professional safety as a specific indicator of the safe functioning of the individual in the course of professionalization. Understanding the security of a person at the level of the subject of acquiring professional experience contains the experience of a state of social satisfaction, which ensures the protection of the professional interests of the individual, quantified in the parameters of satisfying the urgent need for professional realization in the complex of subjective and personal qualities. (shrink)

This article argues for a Freudian theory of internal emotion, which is best characterised as key “safety valves of the psyche”. After briefly clarifying some of Freud’s metapsychology, I present an account regarding the origin of (self-)censorship and morality as internalised aggression. I then show how this conception expands and can be detailed through a defence of a hydraulic model of the psyche that has specific “safety valves” of disgust, shame, and pity constantly counteracting specific sets of Freudian (...) drives. This model is important for explicating Freud’s crucial concept of sublimation, which continues to have key therapeutic and normative relevance today, which I show through the case of jokes. I finish with the argument that largely happy, productive lives can be seen as in a dynamic between the release of too much (perversion) and too little (neurosis) psychical pressure through these mechanisms. (shrink)

This paper examines evidence regarding neoliberalization of the social organization of Canadian food safety from a series of documents produced in response to the Canadian listeriosis outbreak in 2008. The outbreak is described, then interpreted within a neoliberal context, where: (1) neoliberalism operates as an ideology (2) that enables a socio-political and economic strategy within (3) a project pursued by coalitions seeking to consolidate power through (4) a process of neoliberalization. Following Gramsci’s work on power, it is argued that (...) food safety serves as an attractor, organizing consent within a neoliberal context. Testimony before a parliamentary subcommittee, official reviews, an independent investigation, food inspection records, and media reports have been examined to identify the key factors associated with the outbreak and the process of neoliberalization. The events associated with the outbreak are described first, as activities and practices in organizational settings (governance, sanitation, and production), and secondly, as components in a food production network where consent is organized around food safety. (shrink)

We make many decisions in our livesand we weigh the benefits against thedrawbacks. Our decisions are based on whatbenefits are most important to us and whatdrawbacks we are willing to accept. Decisionsabout what we eat are made in the same way; butwhen it comes to safety, our decisions areusually made more carefully. Food containsnatural chemicals and it can come into contactwith many natural and artificial substancesduring harvest, production, processing, andpreparation. They include microorganisms,chemicals, either naturally present or producedby cooking, environmental (...) contaminants, andpesticides. Since the chance of being harmed bythese potential hazards is called risk, riskanalysis might be better termed as the scienceof safety, because risk management is anessential part of it. It would, however, bedifficult and shortsighted to maintain thatquestions about risk and safety can have nomoral dimension. Risk and safety become mattersof moral concern when they raise furtherquestions about responsibility, accountability,and justifiability. The question of risk cannotbe ignored in any ethical investigation ofgenetic engineering, novel foods, animalwelfare, and individual choices. However, foodis more than metabolic fuel. It hasphysiological, psychological, social, cultural,and aesthetic associations that merge to form agestalt that people endanger and maintain. Thecontribution of any food towards anindividual's well being is as complex as theindividual himself. In this context, thebenefits of consuming food that containshazards may outweigh the risk. (shrink)

Accidents involving large trucks result in significant economic and social costs. As technological solutions have improved, behavioral factors contributing to accidents have risen in importance. The purpose of this research is to investigate how norms, consequences, and personal attitudes influence safety-related ethical judgments and behavioral intentions. The Hunt–Vitell’s theory of ethical decision-making is adapted to test how these factors influence truck drivers’ decisions containing ethical content. Professional truck drivers evaluated decisions presented in two scenarios that included the situation, the (...) decision, and the results. The research found that drivers rely heavily on evaluations of safety norms when forming ethical judgments and behavioral intentions. Further, drivers’ attitudes toward compliance and the effectiveness of safety regulations also influenced decision-making to an extent. Overall, evidence of a refutation of the assumption that a tradeoff exists between operational productivity and safety was discovered. Drivers in this study intended to behave in a certain manner irrespective of time or money pressures. The perceived ethical component of the decision outweighed regulatory and economic consequences under a range of parameters. (shrink)

In this article, I discuss how the space of the classroom is a contested object that is constituted by historical, cultural, political, social, psychological, and discursive practices (Lefebvre in The production of space, Blackwell, Oxford, UK, 1991). I then employ Deleuze and Guattari’s notion of “assemblage” to characterize the ways in which educational spaces cohere “content and affect” quoted in Puar (Terrorist assemblages: Homonationalism in queer times, Duke University Press, Durham, 2007, 193) into discursive figures of the heteronormative and racialized (...) national “family.” Finally, I argue that in order to advance contemporary theorizing on safe space we might consider shifting the metaphor of the classroom (and/or schooling) as a situation of home (in loco parentis) to that of a metaphor of camp. As a discursive practice, “camp” is like “home” in that it has multiple associations of past histories. However, the advantage of the metaphor of classroom as camp allows for a more capacious range of past histories of association, from recreation to temporary inhabitation to forced relocation, thus foregrounding the innate political implications of theorizing space. Moreover, the metaphor of camp implies transience (whether real or imaginary) while keeping in mind the partial and situated nature of particular places and spaces. Foregrounding the transient component/feature of safe space allows us to make visible and explore the possibilities and limitations of conceptualizing relations of power as circuitous, contested and performative through competing claims to particular places as objects of safety. (shrink)

The American food system has produced both abundance and food insecurity, with production and consumption dealt with as separate issues. The new approach of community food security (CFS) seeks to re-link production and consumption, with the goal of ensuring both an adequate and accessible food supply in the present and the future. In its focus on consumption, CFS has prioritized the needs of low-income people; in its focus on production, it emphasizes local and regional food systems. These objectives are not (...) necessarily compatible and may even be contradictory. This article describes the approach of community food security and raises some questions about how the movement can meet its goals of simultaneously meeting the food needs of low-income people and developing local food systems. It explores the conceptual and political promise and pitfalls of local, community-based approaches to food security and examines alternative economic strategies such as urban agriculture and community-supported agriculture. It concludes that community food security efforts are important additions to, but not subsitutes for, a nonretractable governmental safety net that protects against food insecurity. (shrink)

Global consumption, production, and trade of livestock products have increased rapidly in the last two decades and are expected to continue. At the same time, safety concerns regarding human and animal disease associated with livestock products are increasing. Efforts to increase public health safety standards aimed at legitimately reducing the risks of human and animal disease have focused internationally on standards to regulate the movement of livestock products. There is concern, though, that measures to regulate these standards internationally, (...) such as the WTO SPS measures that in part aim to open international markets, may marginalize small-scale poor producers. The cycle of poverty they are trying to escape through livestock production may, in fact, widen, leading to increased global poverty, malnutrition, and disease. Developing and developed nations alike should be concerned with public and private efforts to address appropriate food safety policies to reduce the likelihood of this effect. Analysis of the impact on small-scale livestock farmers is needed, as well as solutions that consider joint public and private sector initiatives. Costly farm to table tracking systems are not an option, but locally orchestrated vertically integrated systems may have merit in reducing food safety risks and in providing small-scale farmers with increased access to markets, locally and internationally. Increased scientific and technical capacity, and training of WTO officials from developing nations is also needed. (shrink)

Corporate change and employee dislocation are inevitable in a free market. However, the current employment relationship in the U.S. that affords a perceived employment safety net is contrary to the natural canon of honesty. Employees cannot be guaranteed employment when a company fails or a product is no longer viable. Attempts to provide costly employment safety nets cause a firm to allocate resources to nonproductive programs that may ultimately cause a loss of competitiveness. These strategies to provide (...) alternate employment may provide only short-term solutions. But even short-term safety nets against unemployment may be sending employees unrealistic messages ... a permanent safety net against unemployment. As a result, employees may lose incentive to be innovative in creating their own personal safety nets. The resolution is candor about the risk of employment. A false employment safety net is not what employees want or need and in the long run it may be detrimental to American competitiveness. (shrink)

Despite the enormous size of the illicit market in the United States, there is a paucity of research concerning the rights of consumers of illegal products. In this article it is argued that the illicit nature of a transaction should not deny consumers the right to safety and redress. Recognition of these rights is not only in line with the public policy goal, i.e., protecting public interests, but it can also serve as a deterrent factor for the sales of (...) illegal products. (shrink)

Patients who search for a better treatment, an increased quality of life, or even a chance to preserve life itself may claim to have an interest in accessing investigational medicinal products (IMP), particularly when no validated treatment for their disease or condition exists. For many, awaiting the uncertain and time-consuming process of converting an IMP into an approved drug may not appear a realistic option, as prognoses may be grim and a dramatic outcome may seem hard to avert. Gaining access (...) to an IMP, however, often proves to be a difficult enterprise with a highly uncertain outcome. In addition, the process of seeking access to IMP is surrounded by various ethical issues that will be explored in this article. This paper explores the ethical concerns in two potential tracks of seeking access to IMP for minors: on an individual basis, or collectively, as a patient organisation. In this discourse, several unique ethical and regulatory concerns related to the direct negotiation of access to IMP for minor patients are identified, with a focus on product safety, the recruitment of research subjects, the unnoticed entry of market mechanisms in the recruitment of research subjects, and the sidelining of third parties in the recruitment process. The paper concludes with a concise reflection on the way forward. The quest for access to investigational drugs is particularly relevant to paediatric practice, in which a significant share of the drugs prescribed has never been tested in children or labelled for use in the paediatric population. (shrink)

Advanced therapy medicinal products (ATMP) offer hope for health benefits in all situations where traditional methods of therapy fail or cannot be used for various reasons. The main purpose of this article is to analyze the concept of innovation as applied to the biotechnologies employed in ATMP. In the analysis of the concept, five main contexts of meaning that contribute to its understanding will be distinguished: a change in the way of thinking about the available spectrum of medical procedures, the (...) short time of recognition of technologies in the experimental and theoretical models, lack of clinical data in advance of used technologies, increase of technologies’ complexity and diversity of substrates used in them. The conducted analysis indicates the need to adopt an attitude of far-reaching caution in the evaluation of the safety of ATMP therapies in which innovative biotechnologies are used. (shrink)

Controversies associated with the use of Tylenol are not new to Johnson & Johnson. Reported cases of poisoning in 1982 and 1986 raised serious concerns about both the life of the analgesic and the well-being of consumers. In 1994, the results of two clinical studies raised product safety concerns about acetaminophen-based over-the-counter analgesics, suggesting development of hepatotoxicity, and an increased risk of end-stage renal disease. The alarm created by the studies is not of the same magnitude as the (...) 1980s poisonings and the circumstances differed in that the findings did not only apply to acetaminophen-based analgesics; nonetheless, the implications of the latter are equally significant. Still operating by the same company credo, how Johnson & Johnson has handled the link between acetaminophen and hepatotoxicity and ESRD is of interest ; in particular, management's efforts to reassure both consumers and company shareholders. (shrink)

Controversies associated with the use of Tylenol are not new to Johnson & Johnson. Reported cases of poisoning in 1982 and 1986 raised serious concerns about both the life of the analgesic and the well-being of consumers. In 1994, the results of two clinical studies raised product safety concerns about acetaminophen-based over-the-counter analgesics, suggesting development of hepatotoxicity, and an increased risk of end-stage renal disease. The alarm created by the studies is not of the same magnitude as the (...) 1980s poisonings and the circumstances differed in that the findings did not only apply to acetaminophen-based analgesics; nonetheless, the implications of the latter are equally significant. Still operating by the same company credo, how Johnson & Johnson has handled the link between acetaminophen and hepatotoxicity and ESRD is of interest ; in particular, management's efforts to reassure both consumers and company shareholders. (shrink)

In September 2012, news broke of a developing drug disaster in the United States. Health authorities had linked a fungal meningitis outbreak to a contaminated steroid made by a company called the New England Compounding Center. The contaminated steroid was a compounded drug that had not been approved by the Food and Drug Administration, differing from three others that had been approved in that it lacked preservatives present in those agents. Factory inspections revealed unsanitary conditions at NECC's drug production facility. (...) By the time the source of the outbreak was identified, an estimated fourteen thousand people had been injected with the drug. As of December 2012, thirty‐nine had died of meningitis, and hundreds more had been diagnosed with meningitis and other drug‐related conditions. Many factors contributed to this disaster. One was a 2002 Supreme Court decision holding that a law prohibiting providers of compounded drugs from promoting their products through advertising and other means impermissibly restricted commercial speech. (shrink)

Psychological safety is important for the well-being and productivity of people in the workplace. Psychological safety becomes even more important and even more difficult to maintain in times of uncertainty. Previous research mainly focused on the influence of and on interpersonal relationships. This study applies an individual perspective by investigating what is needed on an individual level in order to build psychological safety. The expectation was that self-compassion induces an individual to experience higher positive affect, and this (...) advances the development of positive relations and social acceptance. Moreover, we assumed that the mediation of the relationship between self-compassion and positive relations and social acceptance by positive affect is moderated by the level of basic need satisfaction. Participants from the Netherlands and Belgium completed an online questionnaire about their level of self-compassion, basic need satisfaction, positive affect and positive relations and social acceptance. Using hierarchical regression analyses for moderated mediation analysis, results showed that self-compassion and positive affect had a significant positive effect on positive relations and social acceptance. Positive affect significantly mediated the relationship between self-compassion and positive relations and social acceptance, when basic need satisfaction was low, but not when basic need satisfaction was high. Our research showed that individuals need either their basic needs satisfied or self-compassion so they can build the high-quality relations needed to stimulate psychological safety. This finding shifts attention from the dyadic relationship to the individual and highlights important factors at the individual level which advance the development of high-quality relationships with others. (shrink)

This article examines the regulation of nonsteroidal anti-inflammatory drugs, with particular focus on products approved for marketing in the United Kingdom, while denied marketing approval in the United States on safety grounds, and then subsequently withdrawn from the UK market on those grounds. Using international comparison of regulatory data never before accessed outside government and companies, together with interviews with relevant industry scientists and regulators, the article demonstrates the importance of regulatory expectations, deficits and paradigms. It is argued both (...) that these sociological concepts can be enriched by their application to detailed comparative case study of regulatory science, and that they provide an important policy-relevant framework with which to understand discrepant drug regulatory processes in a sociohistorical context. It is found that regulatory expectations and paradigms may be regarded as mediating factors between political culture and structural interests, on the one hand, and the outcomes of regulatory science, on the other. (shrink)

Leader behavior significantly influences employees’ safety performance. This study aimed to examine the effect of abusive supervision on the safety behaviors of subordinates. By drawing on the strength model of self-control, we predicted that abusive supervision would negatively affect safety behaviors through emotional exhaustion, and trait self-control and attentional bias toward safety would moderate the relationship between abusive supervision, emotional exhaustion, and safety behaviors. Our hypothesized model was supported by results from a sample of 159 (...) workers at a chemical product manufacturing enterprise in China. Emotional exhaustion mediated the link between abusive supervision and safety behaviors. Moreover, trait self-control moderated the relationship between abusive supervision and emotional exhaustion, and attentional bias toward safety moderated the relationship between emotional exhaustion and safety compliance. This study elucidates the effects of abusive supervision on safety behaviors through the resource depletion process. Likewise, the importance of trait self-control and attentional bias toward safety in mitigating the potentially harmful effects of abusive supervision in workplace safety is highlighted. Minimizing abusive supervision, providing self-control training, and implementing safety-specific implicit cognition intervention can effectively improve employees’ safety behaviors. (shrink)

This debate article explores how smart technologies may create a double-edged sword for patient safety and effective therapeutic relationships. Increasing utilization of health monitoring devices by patients will likely become an important aspect of self-care and preventive medicine. It may also help to enhance accurate symptom reports, diagnoses, and prompt referral to specialist care where appropriate. However, the development, marketing, and use of such technology raise significant ethical implications for therapeutic relationships and patient safety. Drawing on lessons learned (...) from other direct-to-consumer health products such as genetic testing, this article explores how smart technology can also pose regulatory challenges and encourage overutilization of healthcare services. In order for smart technology to promote safer care and effective therapeutic encounters, the technology and its utilization must be safe. This article argues for unified regulatory guidelines and better education for both healthcare providers and patients regarding the benefits and risks of these devices. (shrink)

This article argues that current data for the safety and efficacy of fecal microbiota transplants as a treatment for any indication, including recurrent Clostridioides difficile infection, is low-quality. It develops a governance proposal that encourages production of high-quality evidence by incentivizing well-designed RCTs of stool and stoolderived microbial products. The proposal would require that FDA change its current enforcement approach, but it would not require any change in statutes or regulations.

Food safety and food quality are two closely related aspects of the food management system. The difference between the two is that one keeps consumers safe while the other keeps consumers satisfied. This study examined the differences in how consumers value food safety and food quality with a focus on the influence of loss aversion on one’s psychological level and of income effect on one’s socio-demographic level. Our findings indicate that loss aversion and income effect significantly influence the (...) way consumers value food safety vs. quality labels when considering potential health risks and food price. High risk-averse and low-income consumers with strong loss aversion and a weak income effect show a higher demand for food safety labels as a way to ensure easy access to safety indications. Low risk-averse and high-income consumers with weak loss aversion and a strong income effect show a higher demand for food quality labels because they hope to gain more health benefits from high-quality food at good prices. This study provides insights that will assist public authorities and food industry in balancing food safety control and food quality improvement in order to meet the heterogeneous market demand changing alongside the transition of China’s food consumption and production. (shrink)

Results of studies that cast doubt on the safety of genetically modified crops have been published since the first GM crop approval for commercial release. These ‘alarming studies’ challenge the dominant view about the adequacy of current risk assessment practice for genetically modified organisms. Subsequent debates follow a similar and recurring pattern, in which those involved cannot agree on the significance of the results and the attached consequences. The standard response from the government—a reassessment by scientific advisory bodies—seems insufficient (...) to bring the debate to a satisfactory closure. The recurrence of the same debate every time an alarming study is published shows that science alone cannot solve the problem. We believe that further analysis is needed to investigate if and how we can prevent this repetitive cycle that creates frustration amongst all stakeholders. In this paper, we analyse the dynamics behind discussions which occur following alarming studies. We will use a selection of representative alarming GMO case studies to underpin our claim that it is likely that there will be a permanent difference in view of opinion that cannot be solved with more data or new facts. The current strategy of more research is a pitfall that is unlikely to solve this issue. Instead, the focus of the GM crop discussion should shift towards managing permanent different viewpoints and providing a platform for a broader conversation on agriculture and food production. (shrink)

Blood service organizations employ various ways to ensure transfusion blood safety, including the testing of all donations for transfusion-transmissible infections (TTI) and the exclusion of donors who are at increased risk of a recent infection. As some TTIs are more common among men who have sex with men (MSM), many jurisdictions (temporarily) defer the donation of blood by sexually active MSM. This boils down to a categorical exclusion of a large group solely on the basis of their sexual orientation, (...) which is seen as unduly discriminatory and stigmatizing. Blood service organizations in the U.K. and the Netherlands have recently changed their deferral policies for MSM. The problem of the MSM deferral involves a conflict between fundamental rights: the right of MSM to equal treatment and the right to health of the recipients of blood and blood products. We distinguish and discuss three broad alternative options to the current categorical deferral of MSM donations: (1) completely abandoning donor selection on the basis of sexual behavior, (2) individual risk assessment of the sexual activities of each potential donor, and (3) individual risk assessment of the sexual activities of MSM only. The new U.K. policy falls within the second category, and the new Dutch policy is in the third category. We argue that each approach comes with moral costs but that the most reasonable option is different from the policies of both the U.K. and the Netherlands. (shrink)

Blood service organizations employ various ways to ensure transfusion blood safety, including the testing of all donations for transfusion-transmissible infections (TTI) and the exclusion of donors who are at increased risk of a recent infection. As some TTIs are more common among men who have sex with men (MSM), many jurisdictions (temporarily) defer the donation of blood by sexually active MSM. This boils down to a categorical exclusion of a large group solely on the basis of their sexual orientation, (...) which is seen as unduly discriminatory and stigmatizing. Blood service organizations in the U.K. and the Netherlands have recently changed their deferral policies for MSM. The problem of the MSM deferral involves a conflict between fundamental rights: the right of MSM to equal treatment and the right to health of the recipients of blood and blood products. We distinguish and discuss three broad alternative options to the current categorical deferral of MSM donations: (1) completely abandoning donor selection on the basis of sexual behavior, (2) individual risk assessment of the sexual activities of each potential donor, and (3) individual risk assessment of the sexual activities of MSM only. The new U.K. policy falls within the second category, and the new Dutch policy is in the third category. We argue that each approach comes with moral costs but that the most reasonable option is different from the policies of both the U.K. and the Netherlands. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Martin Heidegger and OntologyEmmanuel Levinas (bio)The prestige of Martin Heidegger 1 and the influence of his thought on German philosophy marks both a new phase and one of the high points of the phenomenological movement. Caught unawares, the traditional establishment is obliged to clarify its position on this new teaching which casts a spell over youth and which, overstepping the bounds of permissibility, is already in vogue. For once, (...) Fame has picked one who deserves it and, for that matter, one who is still living. Anyone who has studied philosophy cannot, when confronted by Heidegger’s work, fail to recognize how the originality and force of his achievements, stemming from genius, are combined with an attentive, painstaking, and close working-out of the argument—with that craftsmanship of the patient artisan in which phenomenologists take such pride. In this study, it is important for us to understand, above all, the true intentions of our author, to illuminate what he thinks really needs to be said, and to surmise what is most critical for him.To get to the heart of Heidegger’s system, it seems fitting to begin with a problem that is generally familiar. We choose the problem of knowledge, a deeper understanding of which takes us to the very threshold of Heidegger’s thought. For this problem, central to modern philosophy, is one of the main obstacles of modern philosophy that Heidegger wishes to surmount. Neo-Kantianism, which takes knowledge as the philosophical problem of the first rank, is the movement against which Heidegger rebels with all his strength. We have, thus, every chance of gaining access to his thought by the main door, so to speak. Once inside the system we will try to trace its outlines, 2 reserving, for a second part of our work, the determination of Heidegger’s place in the history of ideas, especially in the phenomenological movement, as well as of his relations with the philosopher to whom he owes so much—Edmund Husserl. 31In its most general form, the problem of the theory of knowledge has a critical significance. It consists in delineating a domain where knowledge can be certain and in determining the criteria for the legitimate scope of knowledge. But this problem, as normal and as simple as it may appear, has deeper roots. That knowledge should need a criterion at all presupposes that truth is not identical to all that is known and that the course [End Page 11] of things can fail to correspond with the course of thought. “How does knowledge correspond to being?” is a more profound formulation of the problem of knowledge.But we are not going to touch anymore on the primordial phenomenon that generates the problem. The problem of correspondence between thing and thought presupposes a free activity of thought and its isolation in relation to the object. It is precisely this presupposition which renders their harmony and even their contact problematic. “How does the subject take leave of itself to attain the object?” is what the problem of knowledge, in the last analysis, boils down to. Its true source is thus the concept of “subject” as elaborated by modern philosophy. The cogito presided over the subject’s birth. The cogito was the affirmation of the privileged nature of the subject’s immanent sphere, of its unique place in existence; hence, the cogito was the specificity of the subject’s connection to the rest of reality, the sui generis nature which opens up the passage from immanence to transcendence, the passage from ideas contained in the thinking substance to 4 their “formal existence.”The concept of the subject, understood as a substance having a specific position in the entire domain of being, presents us with difficulties of two kinds. First, how do we understand this leave-taking from the self which the thinking substance brings about and which displays an entirely original aspect? Indeed, we could say that thought, in reaching out toward objects, does not actually take leave of itself, since its objects—considered as ideas and contents of thought—are, in a certain sense, already within it. In order to make sense of this paradox, Descartes... (shrink)

In the context of Ukraine’s membership in the WTO, the functioning of a free trade area with the EU, the opportunity for agricultural producers to obtain a larger share of the value added is primarily linked to the intensification of trade in domestic livestock products and their processing products. However, their production is one of the high-risk areas and requires a set of measures aimed at ensuring proper quality. Without effective solution of the problem of quality of livestock products it (...) is impossible to ensure its competitiveness in the world market, to guarantee the rational nutrition of the population of the country, the availability of the necessary components for the vital activity of the human body. The aim of the research is to determine the socio-economic factors for ensuring the quality of livestock products in Ukraine. The scientific and specific research methods were used to solve the tasks set in the work: the historical method; abstraction method; method of comparative analysis; system-structural method. The main producer of livestock products in Ukraine are households. They do not have the capabilities to implement technologies of keeping, feeding, veterinary services, programs prerequisites for guaranteeing the safety of products, adherence to the HACCP principles. In Ukraine, real technical, economic and organizational-economic prerequisites for ensuring the safety and quality of livestock products are created only in the poultry meat sector. During 2015-2017, the trends in production of almost all types of livestock products except poultry and honey were identified. One of the reasons for this situation was, firstly, decreasing in capital investment in the livestock sector, and secondly, the low profitability of production of livestock products in the context of accelerated growth in prices for resources. It is proved that insignificant market (price) incentives should be supplemented with instruments of state assistance to improve the quality parameters of products on the basis of specialized enterprises. The necessity of state support for the production of livestock products based on small and medium-sized enterprises is substantiated. This will effectively combine the processes of increasing the production of livestock products with the environmental friendliness of production and steady improvement of quality. It is shown that the low quality of certain livestock products in Ukraine is caused by insufficient living standards of the population and low incomes of the majority of households, which cause them to consume low quality products. It is determined that the problem of guaranteeing the quality of livestock products in Ukraine has deep roots cause due to the influence of socio-economic factors. Therefore, a comprehensive approach is needed to solve it, which is not limited to improving the efficiency of the state control system and successfully harmonizing of the Ukrainian technical regulation system with the European one. The problem of low quality and the danger of livestock production requires a systematic approach for its solution, which is not limited, in particular, by measures to improve the system of state control and ensure approximation of the domestic technical regulation system to the European one. In Ukraine, major high-quality animal products are economically inaccessible to a large part of households. The projected increase in safety parameters and a certain improvement in the quality of livestock products as a result of the implementation of regulations adopted in 2014-2017, will necessarily lead to an increase in its value, and therefore may lead to a decrease in market demand and even greater inaccessibility of these products to people. All this can only aggravate the situation with guaranteeing the food security of the country, forming the prerequisites for increasing the intellectual capacity of the nation. (shrink)

_The dynamic development of medical technologies, i.e. the use of medicinal products and medical procedures, requires reflection on the ways to ensure the safety of patients and people using such methods of treatment (medical professionals) in legal and ethical terms. This applies in particular to the currently observed influence of the media on the actions taken in the health care system in Poland as well as individual decisions of patients on the use of the offered drugs and other medical (...) procedures._ _The article presents selected legal provisions defining the conditions for the use of medicinal products (drugs) and experimental medical procedures. The basic element of the considerations is to indicate the legal conditions for this type of use of medical technologies understood in this way, also in a broader context – with the characteristics of ethical conditions for „the media message”, including ensuring its proper quality for the protection of public health._. (shrink)