bluuebunny/crossref_metadata_2025 huggingface dataset:
The Giving of Hostages
Authors: Smail J. Kenneth
Published: February 2017

In contrast to recent political, scholarly, and public misuse of the term, this essay articulates a more accurate definition of the hostage concept. This definition is not only consistent with a broad range of etymological sources, but is also in agreement with numerous examples from the historical and anthropological record. A possible application of the hostage idea to mid/late-twentieth-century superpower relationships, involving a distinctively different approach to nuclear deterrence, is also described. Attention is further called to the fact that the giving of hostages as confidence-building “emissaries of trust” incorporates several attributes that might be of interest to contemporary evolutionary theorists. A closer examination of the biological and behavioral underpinnings, the historical and anthropological precedents, and the political and psychological efficacy of this ancient idea might therefore prove to be a fruitful area for future empirical and theoretical research.
Bringing Science Policy into the Classroom: A Model Course
Authors: Greif Karen F.
Published: February 2017

Biological issues Have Become prominent in the national news, and the complexity of the science behind the issues has often tended to cloud the broader discussion. Examples include screening for genetic diseases and risk factors, issues of reproductive technology, and controversies over treatment of terminal illness and the “right” to die. Recent polls have indicated both intense interest in biotechnology and an often profound lack of understanding of the science behind it.
National and International Approaches to Human Germ-Line Gene Therapy
Authors: Bonnicksen Andrea L.
Published: February 2017

Germ-line gene therapy, in which genetic flaws are corrected in the DNA of externally fertilized human embryos, lies in the distant yet foreseeable future. Worries about germ-line therapy have prompted international bodies to craft guidelines that are unusual for their anticipatory nature. Motivating these guidelines is the idea that a “transnational harmonization” of principles should be reached before national policies are developed. This article reviews selected national policies and international recommendations, and it concludes that national policies should be precedents for, rather than descendants of, international normative codes. The inclination to develop morally-based codes, which is implicit in transnational harmonization, will be more useful if grounded in empirically-based medical technologies and politically-tested policies rather than on abstract principles developed well in advance of technological feasibility.
Biological Perspectives in the Social Sciences
Authors: Masters Roger D.
Published: February 2017

From July 31 to August 6, 1993, the Gruter Institute for Law and Behavioral Research and the Nelson A. Rockefeller Center for the Social Sciences at Dartmouth College cosponsored a Faculty Seminar on “Biological Perspectives in the Social Sciences” at Dartmouth. Participants included scholars and graduate students from anthropology, communications, economics, political science, psychology, and sociology, as well as representatives from business and the public sector.
Chemical/Biological Terrorism: Coping with a New Threat
Authors: Tucker Jonathan B.
Published: February 2017

In March 1995, Japanese terrorists released nerve gas on the Tokyo subway, causing eleven deaths and more than 5,000 injuries. Although terrorists have sought to acquire chemical/biological (C/B) agents in the past, and a few have employed them on a small scale, the Tokyo attack was the first large-scale terrorist use of a lethal chemical agent against unarmed civilians, weakening a long-standing psychological taboo. This tragic incident has therefore drawn worldwide attention to the emerging threat of chemical/biological terrorism. Despite significant technical hurdles associated with the production and delivery of C/B agents, such weapons are within the reach of terrorist groups that possess the necessary scientific know-how and financial resources. This article proposes a C/B counterterrorism strategy based on preemption and civil defense, and recommends several short-term and longer-term policy options for mitigating this emerging threat.
The Politics of Physician-Assisted Death: California's Proposition 161 and Attitudes of the Elderly
Authors: Clark Nina , Liebig Phoebe S.
Published: February 2017

Physician-assisted death is a particularly relevant subject for the elderly since end-of-life issues affect them sooner rather than later. This article examines both the macro (aging interest group) and micro (individual) advocacy levels, using Proposition 161, The California Death With Dignity Act, as a case study. To determine old-age interest group attitudes and activism, we explored their advocacy levels on the ballot measure. Public opinion polls and a survey that was administered exactly one week prior to the November 1992 election at the Pasadena Senior Center in Pasadena, California helped measure individual attitudes and beliefs regarding active euthanasia.
The Human Genome Diversity Project: Ethical Problems and Solutions
Authors: Resnik David B.
Published: February 2017

The goal of the Human Genome Diversity Project (HGDP) is to provide a comprehensive study of genetic diversity across different human populations. Scientists working on the HGDP plan to collect samples from all 400 to 500 geographically isolated or culturally unique human populations that desire to participate in the project. Few people have questioned the scientific merits of the HGDP and its potential contribution to our understanding of human genetics, but the project has created a storm of moral, cultural, and political controversy during its brief existence. Opponents have argued that the HGDP smacks of racism, commercialism, exploitation, and cultural imperialism. Critics have also found fault with the informed consent process proposed by organizers of the HGDP. Opposition to the HGDP has succeeded in impeding (but not derailing) this project. The essay explores some of the key moral, political, and cultural issues raised by the HGDP and argues that the project should be implemented and should be funded, provided that researchers and organizers take steps to address the issues it raises.
Finding a Forum for Bioethics in U.S. Public Policy
Authors: Hanna Kathi E. , Cook-Deegan Robert M. , Nishimi Robyn Y.
Published: February 2017

Advances in biomedical research and health care simultaneously create practical benefits and ethical dilemmas. These bioethical dilemmas are the subject of intense social and political debate. Recent attempts in the United States to address these issues in a national, public policy setting have had mixed success. The absence of a single national voice has resulted in many voices at many levels. This article describes and analyzes past national bioethics bodies in an effort to find commonalities for both success and failure. It concludes that reconstitution of an Ethics Advisory Board within the Department of Health and Human Services and the formation of a President's Bioethics Commission are needed as the nation confronts new and difficult choices in research ethics and the delivery of health care.
The Duality of Human Nature
Authors: Miller Trudi C.
Published: February 2017

To update the view of human nature that undergirds eighteenth-century British/American political economy, this article reviews literature from diverse subfields of psychobiology. Findings on the structure, function, and evolution of the human brain confirm the duality between reason and passion that is at the core of the science of Hobbes. Contemporary findings across fields indicate that people become emotionally attached to objects, including verbal abstractions, through experiences with pleasure and pain. In contrast, human reasoning is essentially scientific. The duality between passionate motivation and humanity's unique capacity for reasoning makes political science important. By applying the scientific method to the subject of politics, people can design institutions that channel quasi-rational behavior toward outcomes that are mutually beneficial, rather than mutually destructive. Defining human nature correctly is the key to political science, and Smith's addition of the passion of sympathy to Hobbes's narrow definition of human motivation is essential.
Separation or Unity? A Model for Solving Ethnic Conflicts
Authors: Tullberg Jan , Tullberg Birgitta S.
Published: February 2017

This article outlines a consistent and rational model for solving ethnic conflicts. We argue that ethnic separation should be regarded as an alternative to national unity, and not simply dismissed as impossible. A decision on separation or unity should be made democratically by the group whose separation has been proposed. If separation is approved, migration over the border between the newly formed states should be part of such a solution. The article has three main parts: (1) a model for solving separationist demands; (2) an analysis of the evolutionary background to ethnic conflicts; and (3) a discussion of principal objections to the proposed model. The present international impotence in situations of ethnic conflict is to a high degree caused by seeing most solutions as impossible—either realistically or morally. This article stresses the virtue of having one model instead of the “flexibility” that currently prevails under the disguise of generally acclaimed, but contradictory ideals.
Till Death Do Them Part?
Authors: Tullberg Jan , Tullberg Birgitta
Published: February 2017

We have read the commentaries with great interest. They vary greatly regarding the possibility of achieving a general model for separatist conflict solution, and there are certainly both practical problems as well as difficult priorities of principles. Several issues are addressed by more than one commentator, so we chose a discussion by issue rather than by commentator.
Assisted Reproduction and Reproductive Rights: The Case of In Vitro Fertilization
Authors: Blank Robert H.
Published: February 2017

In vitro fertilization (IVF) and other assisted reproduction technologies (ARTs) have become widely accepted as therapy for a wide array of fertility problems and accompanied by the rapid expansion of clinics that provide a full range of ARTs. Although these technologies undoubtedly offer benefits for some individuals, they raise important questions over reproductive rights to safe and effective treatment as well as access. This article analyzes current data concerning the safety, effectiveness, and cost of IVF. It concludes that IVF and related techniques have been transformed too rapidly and easily from experimental to therapy status, despite evidence that suggests considerable caution is warranted. Unfortunately, the widespread diffusion of IVF has preceded rather than followed firm evidence of its value in extending the reproductive rights of women and couples. Resources might better be directed toward prevention of fertility problems and discovering the causes of infertility.
Evolution, Mobility, and Ethnic Group Formation
Authors: Goetze David
Published: February 2017

By drawing on ideas developed in evolutionary psychology, this article attempts to contribute to improved understanding of ethnic group formation and change. Specifically, the article asks whether and to what degree evolved mental capacities and dispositions, in interaction with human social environments, account for ethnic group formation. The central arguments are that, in recent millennia, evolved reasoning capabilities of humans have led to a revolution in the technologies of human mobility—and that this development has severed the nearly perfect association between social group formation based on functional advantages and social group formation based on perceived kinship. The scale, composition, and durability of contemporary ethnic groups are the consequence of individual tradeoffs in functionality and kinship values.
Signaling the credibility of private actors as public agents: transparency, independence, and expertise in environmental evaluations of products and companies
Authors: Bullock Graham
Published: February 2017

Private firms are increasingly being regarded as moral agents of their stakeholders and the broader public. Stakeholders can use different types of evaluation organizations to monitor this division of moral labor, but must also monitor the credibility of this second layer of moral agents. This paper uses agency, signaling, and legitimacy theory to develop a novel conceptual framework showing how both firms and evaluation organizations send signals of their credibility as moral agents to earn grants of legitimacy from their moral stakeholders. The paper also describes how three specific characteristics of ratings and certifications – transparency, expertise, and independence – may signal different forms of credibility, appeal to particular stakeholder groups, and elicit different forms of legitimacy. A content analysis of the websites of 245 eco-labels, sustainability ratings and other forms of environmental evaluations reveals the multi-dimensional nature of these three characteristics, and finds that transparency is the most commonly-sent signal of credibility, followed by independence and then expertise. These results highlight the complexity of existing signals of credibility, and suggest several strategies – including voluntary credibility standards and a virtual information marketplace – that both private and public actors can pursue to improve the quality and accessibility of these signals of credibility.
The AGOA Extension and Enhancement Act of 2015, the SA–US AGOA negotiations and the Future of AGOA
Authors: ISMAIL FAIZEL
Published: February 2017

The African Growth and Opportunity Act (AGOA) is a non-reciprocal preferential trade programme that the US offers to 49 sub-Saharan African countries. President Obama's decision to extend AGOA, which was set to expire at the end of September 2015, for another ten years (2015 to 2025), was highly controversial. The Extension and Enhancement of AGOA Act, signed into law by President Obama, on the 29 June 2015, had thus included many new provisions to incorporate the views of the US Congress on the implementation of the ten-year extension and the future trajectory of AGOA. In this paper, the new Extension and Enhancement of AGOA Act is analysed to elucidate the new and additional powers that the new AGOA Act provides the US Congress, the US Administration, and US business lobbies, and the implications of these changes for sub-Saharan African countries. At least three new trends in the 2015 AGOA Act can be identified: payment for preferences, institutional attrition, and a shift to reciprocity. These trends, it is argued in this paper, are potentially contrary to a more mutually beneficial relationship between the US and Africa. The paper offers some reflections on the future of AGOA.
Delirium in the intensive care setting: A reevaluation of the validity of the CAM–ICU and ICDSC versus the DSM–IV–TR in determining a diagnosis of delirium as part of the daily clinical routine
Authors: Boettger Soenke , Nuñez David Garcia , Meyer Rafael , Richter André , Fernandez Susana Franco , Rudiger Alain , Schubert Maria , Jenewein Josef
Published: February 2017

Background:

In the intensive care setting, delirium is a common occurrence that comes with subsequent adversities. Therefore, several instruments have been developed to screen for and detect delirium. Their validity and psychometric properties, however, remain controversial.

Method:

In this prospective cohort study, the Confusion Assessment Method for the Intensive Care Unit (CAM–ICU) and the Intensive Care Delirium Screening Checklist (ICDSC) were evaluated versus the DSM–IV–TR in the diagnosis of delirium with respect to their validity and psychometric properties.

Results:

Out of some 289 patients, 210 with matching CAM–ICU, ICDSC, and DSM–IV–TR diagnoses were included. Between the scales, the prevalence of delirium ranged from 23.3% with the CAM–ICU, to 30.5% with the ICDSC, to 43.8% with the DSM–IV–TR criteria. The CAM–ICU showed only moderate concurrent validity (Cohen's κ = 0.44) and sensitivity (50%), but high specificity (95%). The ICDSC also reached moderate agreement (Cohen's κ = 0.60) and sensitivity (63%) while being very specific (95%). Between the CAM–ICU and the ICDSC, the concurrent validity was again only moderate (Cohen's κ = 0.56); however, the ICDSC yielded higher sensitivity and specificity (78 and 83%, respectively).

Significance of Results:

In the daily clinical routine, neither the CAM–ICU nor the ICDSC, common tools used in screening and detecting delirium in the intensive care setting, reached sufficient concurrent validity; nor did they outperform the DSM–IV–TR diagnostic criteria with respect to sensitivity or positive prediction, but they were very specific. Thus, the non-prediction by the CAM–ICU or ICDSC did not refute the presence of delirium. Between the CAM–ICU and ICDSC, the ICDSC proved to be the more accurate instrument.
The Birth of the European Journal of Risk Regulation
Authors: Alemanno Alberto
Published: February 2017

I am delighted to announce the birth of the European Journal of Risk Regulation. This new academic journal reflects the growing importance of both national and European regulations intended to protect health, safety, security and the environment – as well as the accompanying institutional challenges for the European Union governance.

This large body of law is known as risk regulation. It seeks to reduce the risks of harm to individuals and society, stemming from all threats whether industrial or natural, voluntary or involuntary. Arguably, this portion of EU legislation already represents the most important and widespread part of the internal market acquis and, due to its international success, it contributes to make the EU a de facto global regulator. As such, it provides a new and valuable lens through which to analyse the European integration process.
What REACH can teach us about TSCA: Retrospectives of America's Failed Toxics Statute
Authors: O'Reilly James T.
Published: February 2017

Comparative risk assessments in the chemical safety field sometimes adopt a lofty view of the purposes of legislation. This personal essay is not lofty, and it is not just another professor's comparison of the purposes of the European Union's REACH with American regulatory programmes. I write today as an individual, as the last active remaining participant of the small group of industry players in 1975–76 who helped to negotiate the details of the 1976 US Toxic Substances Control Act (“TSCA”). As advocates for industry we won the key arguments over the law's terms and conditions, but the decades since have not shown TSCA to be a triumph for anyone.
Biotechnology
Authors: Varela Justo Corti
Published: February 2017

This section aims to update readers on decisions related to marketing products of modern biotechnology (e.g., GMOs, animal clones) at EU level and on national measures concerning their production. Special attention is devoted to problems of competence between Member States and the EU in regulating biotechnology issues; the institutional dynamics of decision making regarding products derived from modern biotechnology; the relationship between the EFSA and the EU institutions on green biotech-related issues; the evolution of EU regulatory framework and of national attitudes towards the risks and benefits of biotechnology derived products and their production. This section will also delve into the interaction between the EU legislation and WTO law regarding advances in the application of biotechnology within the agri-food value chain.
Pharmaceuticals
Authors: Spina Alessandro
Published: February 2017

This section updates readers on the latest developments in pharmaceutical law, giving information on legislation and case law on various matters (such as clinical and pre-clinical trials, drug approval and marketing authorisation, the role of regulatory agencies) and providing analysis on how and to what extent they might affect health and security of the individual as well as in industry.
Risk Communication
Authors: Chakraborty Sweta
Published: February 2017

This section discusses issues related to risk communication across a range of publicly perceived highrisk industries (such as pharmaceuticals, nuclear, oil, etc.). It reports critically and provides analysis on risk communication as an outcome of risk research within these industries. Contributions are intended to include methods working towards the advancement of risk perception research and describe any lessons learned for successfully communicating to the public about risk.
On How to Assess a Medicinal Product By Function
Authors: Purnhagen Kai
Published: February 2017

Article 1(2) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27 must, apart from the case of substances or combinations of substances intended for the purpose of making a medical diagnosis, be interpreted as meaning that a product which includes in its composition a substance which has a physiological effect when used in a particular dosage is not a medicinal product by function where, having regard to its content in active substances and under normal conditions of use, it constitutes a risk to health without, however, being capable of restoring, correcting or modifying physiological functions in human beings (…) (official headnote).
The first GMO Case in Front of the US Supreme Court: To Lift or Not to Lift the Alfalfa Planting Ban?
Authors: Alemanno Alberto
Published: February 2017

Alfalfa is one of the most important legumes used in agriculture and the fourth most cultivated plant behind corn, soybeans and wheat in the US. It has been grown in almost all federal states, occupies 9 million hectares and is primarily used in feed for dairy cows and beef cattle. US consumers also eat GM alfalfa as sprouts in salads and other foods. Roundup Ready alfalfa was developed by the agrobiotechnology firms Monsanto and Forage Genetics. It was originally approved in June 2005 for commercial sale by the US Department of Agriculture (USDA). Alfalfa is designed to tolerate the leading active substance in Monsanto’s trademark Roundup herbicide, glyphosate. It is also the first genetically modified perennial crop to be commercialized. As a result, its cultivation poses special environmental, agricultural and economic risks.
Providing Food Information to Consumers – Proposed Legislation under the Screening of the European Parliament
Authors: Capodieci Giuseppe Luca , Noga Zeev
Published: February 2017

This section aims at updating readers on the latest developments of risk-related aspects of food law at EU level, giving information on legislation and case law on various matters, such as food safety, new diseases, animal health and welfare and food labelling.
Synthetic Cells and Their Regulatory Challenges
Authors: Varela Justo Corti
Published: February 2017

On May 20th, Professor Daniel Gibson and his team at the J. Craig Venter Institute announced in a paper published in Science the creation of a “chemical synthesis of a living organism”. The researchers have constructed a bacterium's genetic software and transplanted it into a host cell. The resulting organism looked and behaved like the species ruled by the synthetic DNA. The main difference between this technique and traditional biotechnology is that, for the first time in history, scientists have not only manipulated existing DNA but have created synthetic DNA and introduced it into a host organism that had been rebooted previously.
Nanomaterial Safety: The Regulators' Dilemma
Authors: Jaspers Nico
Published: February 2017

This section is meant to give readers an insight into the emerging field of nanotechnologies and risk regulation. It informs and updates readers on the latest European and international developments in nanotechnologies and risk regulation across different sectors (e.g., chemicals, food, cosmetics, pharmaceuticals) and policy areas (e.g., environmental protection, occupational health and consumer product, food and drug safety). The section analyzes how existing regulatory systems deal with new kinds of risks and reviews recent regulatory developments with a focus on how best to combine scientific freedom and technological progress with a responsible development and commercialization of nanotechnologies.
Humanizing Cost-Benefit Analysis
Authors: Sunstein Cass R.
Published: February 2017

In the last twenty months, the Obama Administration has been taking an approach to regulation that is distinctive in three ways.

First, we have approached regulatory problems not with dogma or guesswork, but with the best available evidence of how people really behave.

Second, we have used cost-benefit analysis in a highly disciplined way, not to reduce difficult questions to problems of arithmetic, but as a pragmatic tool for cataloguing, assessing, reassessing, and publicizing the human consequences of regulation – and for obtaining public comment on our analysis. This emphasis on human consequences – on reducing or eliminating unjustified burdens on the private sector and on ensuring that high costs are justified by high benefits – is especially important in a period of economic difficulty. We have worked to put into place important safeguards while also making regulation compatible with the economic recovery, and while reducing the risk that costly regulations will have adverse effects on job creation, wages, prices, and economic growth as a whole.
Regulating Catastrophic Risks by Standards
Authors: Simoncini Marta
Published: February 2017

This article analyses the role played by standards of protection in the regulation of catastrophic risks. It examines how to protect people against the occurrence of catastrophic events, considering that the related risk is highly uncertain and difficult to predict using rational methodologies. In this perspective, the article focuses on environmental risks and terrorist threats affecting common goods – namely environment and security – areas where any damage is susceptible to producing ruinous effects and huge casualties. Both natural and man-made disasters are capable of altering the normal legal relations that States are institutionally to ensure to their citizens. Therefore, the severity of the consequences of catastrophic events cannot be ignored, despite the low probability of their occurrence. However, in the absence of emergencies, exceptional measures may be adopted as a means of altering the legal framework, and thus the enjoyment, of fundamental freedoms and priorities in the allocation of public resources. No precautionary approach can escape from rational reflections about the opportunity-cost of any action, the cost-benefit analysis of countermeasures and the proportionality of every regulatory decision. In order to understand how to face those “low probability – high cost” risks, the article considers a specific method of regulating risks by resorting to standards of protection. By using thresholds of alarm, public administrations can decide upon best-fit countermeasures that will correspond to specific risk characterisations. To this end, the article analyses the administrative process of formulating standards and how they enable uncertain risks to be managed, thus promoting the development of a sound and accountable administration.
Supranational Governance and Networked Accountability Structures: Member State Oversight of EU Agencies
Authors: Saurer Johannes
Published: February 2017

The most remarkable recent development in EU administrative law is the widespread establishment of European agencies. Beginning in the early 1990s, EU agencies emerged as significant actors in a number of areas, including trademark law, pharmaceutical licensing and aviation safety. EU agencies are best understood, however, not as autonomous regulators at the federal level, but as the most recent expression of European governance through administrative networks. The regulatory intertwining of supranational and national authorities in the EU is significantly different from the division of authority between federal and state bureaucracies in the United States federal system Hence, the accountability of European agencies to the EU and to Member States has unique features that can be traced to the dynamics of European integration. Accountability is largely a function of networked institutional relations that link European administrative entities to both supranational and national forums of accountability This article concentrates on the second form of accountability through an in-depth exploration of the way Member States oversee EU agencies. Oversight, here, covers monitoring, hearings, budgetary reviews or judicial actions, as well as procedural constraints.
What's in a Name? – Defining a ‘Nanomaterial’ for Regulatory Purposes in Europe
Authors: D'Silva Joel
Published: February 2017

Attempts at suitable identification of a generally accepted definition of a ‘nanomaterial’ have been going on in Europe and worldwide for some time. Definitions are important from a regulatory perspective as “they assist in establishing the subject matter and scope of what is to be regulated”. However, considering the complexities associated with nanoscience and also the differing opinions on various definitions, this has not been an easy task. Reaching an agreement on fundamental terms and definitions such as ‘nanotechnology’, ‘nanoparticle’, ‘nanoscale’, and a ‘nanomaterial’ is both complex and contested. To date, there is no internationally recognised and accepted definition of a ‘nanomaterial’ even though several definitions have been discussed and proposed by national authorities, scientific committees, international organisations, and other bodies.
How Deep Should We Go? – Searching for an Appropriate Standard of Review in the SPS Cases
Authors: Gruszczynski Lukasz
Published: February 2017

Although the applicable standard of review under Articles 2.2/5.1 of the SPS Agreement is not de novo, an investigation of the WTO panel remains intrusive in terms of objectivity and coherence of risk assessment. Moreover, the panel's review does not end with a final conclusion reached by the WTO Member in the risk assessment. It also extends to the quality of the reasoning and the intermediate interferences that led to the conclusion. If a WTO Member exercises expert judgment in its risk assessment, this needs to be sufficiently transparent and well documented (author's headnote).

The obligations of Article 5.1 and 5.6 are distinctive and independent from each other. Therefore, a violation of the first provision does not imply infringement of the latter one (author's headnote).
The Carmen Media Case – The Expected Catalyst from Brussels for a New Approach to German Gambling Law?
Authors: Spindler Gerald , Hambach Wulf , Berberich Bernd
Published: February 2017

Billions of Euros of turnover are generated every year from games of chance. The legal framework conditions regulating this branch of the economy vary significantly within the European Union. Whilst in many countries such as Germany the state has a dominating monopoly position, other Member States, such as Denmark, France and Italy, have made moves towards a consistent partial liberalisation. These different framework conditions lead to problems, increasingly so as the European internal market is otherwise growing closer together. This is especially evident in the area of online gambling which, due to the structure of this medium, is not restricted by national boundaries, but must nevertheless not constitute a legal no man's land.

Against this background, it appears logical for the European Court of Justice (ECJ), on the occasion of the submission of cases by Member State courts pursuant to Art. 267 of the Treaty on the functioning of the European Union (TFEU) (previously Art. 234 EC), to repeatedly have called for the examination of national gambling regulations with regard to their compliance with Union law, as the ECJ's standing jurisdiction acknowledges that a (national) state monopoly for cross-border issues represents a violation of the freedom of establishment as set out in Art. 56 TFEU (previously Art. 49 EC) or the freedom of establishment as set out in Art. 49 TFEU (previously Art. 43 EC) respectively. Such restrictions of gambling activities may, however, be justified by matters of overriding general interest.
The Application of the Precautionary Principle in Practice: Comparative Dimensions, by Joakim Zander. Cambridge: Cambridge University Press, 2010, 408 pp., £60.00, Hardcover.
Authors: Arcuri Alessandra
Published: February 2017

A vast body of scholarly articles and books has been devoted to the precautionary principle, making it one of the most studied principles of our time. This wealth of attention can be explained by the fact that the question of how to manage man-made risks remains an extremely divisive issue for contemporary societies and the precautionary principle is the only principle idiosyncratic to the field of risk law. The book by Zander contributes to this scholarship by presenting a rich comparative legal analysis that gives a clear illustration of how the principle is applied at the international and European level as well as the national level, where the Swedish, UK, and US legal frameworks are discussed. The central parts of the book (chapter 3 to 7) are devoted to these comparisons. For this comparison, Zander chooses two case studies: pesticide regulation and the regulation of base stations.
Lifestyle Risks: Conceptualising an Emerging Category of Research
Authors: Planzer Simon , Alemanno Alberto
Published: February 2017

The title of our new section inevitably evokes a most basic question: What are lifestyle risks? While it is not that simple to define this broad term, in this editorial we aim at introducing the EJRR readership to this fascinating emerging area of risk studies. We shall attempt to describe the nature of lifestyle risks by identifying their main features and by raising some of the fundamental questions that are inherent to any discussion on this topic.
What Price Flexibility? – The Recent Commission Proposal to Allow for National “Opt-Outs” on GMO Cultivation under the Deliberate Release Directive and the Comitology Reform Post-Lisbon
Authors: Weimer Maria
Published: February 2017

“After a reform is before another reform.” This paraphrasing of a famous saying from the world of football seems to be a very fitting way to describe the status quo of the European policy on genetically modified organisms (GMOs).
Do Lawyers Knead the Dough? – How Law, Chaos, and Uncertainty Interact
Authors: Burri Thomas
Published: February 2017

This article deals with complex systems. It takes the reader on a journey to the origins of the paradigm shift which has taken place in the sciences since the path breaking works of Edward N. Lorenz, Benoît B. Mandelbrot, Mitchell J. Feigenbaum, and others. Gradually, linear “twodimensional” thinking has been replaced by non-linear “multi-dimensional” reasoning and multi-factorial genesis, risk, and uncertainty have come into focus. The article looks at the beginnings of the conception of complex systems — chaos theory — and reveals the implications for the law and legal science. Having explained the premises of chaos theory by means of a metaphor (the kneading of dough) the article proposes to look at the law through the lens of chaos: the law, especially case law, is perceived as a system which is itself subject to the phenomenon of chaos. The power of the image of chaos is illustrated by means of a study of the case law of the European Court of Justice on family reunification of moving persons and its projection to Switzerland in an attempt to create parallel regimes. The article also takes advantage of chaos theory to portray the broader implications for society and the law, tentatively illustrating them by thoughts on the Lisbon judgment of the German Federal Constitutional Court of 30 June 2009 and on UN Security Council Resolution 1244 of 10 June 1999 (on Kosovo).
Seizures of In Transit Generics at the EU Borders: India and Brazil v. the EU
Authors: Bonadio Enrico , Cantore Carlo Maria
Published: February 2017

This section is devoted to giving readers an inside view of the crossing point between intellectual property (IP) law and risk regulation. In addition to updating readers on the latest developments in IP law and policies in technological fields (including chemicals, pharmaceuticals, biotechnology, agriculture and foodstuffs), the section aims at verifying whether such laws and policies really stimulate scientific and technical progress and are capable of minimising the risks posed by on-going industrial developments to individuals’ health and safety, inter alia.
Gambling Regulation and Risk
Authors: Villeneuve Jean-Patrick
Published: February 2017

This section discusses the regulation of “lifestyle risks”, a term that can apply to both substances and behaviours. Lifestyle risks take place along the line of “abstinence – consumption – abuse – addiction”. This can concern substances such as food, alcohol or drugs, as well as behaviours such as gambling or sports. The section also addresses the question of the appropriate point of equilibrium between free choice and state intervention (regulation), as well as the question of when risks can be considered to be acceptable or tolerable. In line with the interdisciplinary scope of the journal, the section aims at updating readers on both the regulatory and the scientific developments in the field. It analyses legislative initiatives and judicial decisions and at the same time it provides insight into recent empirical studies on lifestyle risks.
Implications of the Risk Communication Guidelines for the European Union
Authors: Chakraborty Sweta , Creutzfeldt-Banda Naomi
Published: February 2017

This section discusses issues related to risk communication across a range of publicly perceived highrisk industries (such as pharmaceuticals, nuclear, oil, etc.). It reports critically and provides analysis on risk communication as an outcome of risk research within these industries. Contributions are intended to include methods working towards the advancement of risk perception research and describe any lessons learned for successfully communicating to the public about risk.
Conflicting Notifications in the EU's Rapid Alert System for Food and Feed (RASFF): ‘Destabilization’ in Food Risk Communication?
Authors: Lawless James
Published: February 2017

Case T-212/06, Bowland Dairy Products Ltd v. Commission

The Commission, as co-ordinator of the Rapid Alert System for Food and Feed (RASFF), is not entitled to refuse the circulation of a supplementary notification made by a Member State to the system, regardless of its own reservations about the content of that notification. This is in accordance with the non-hierarchical nature of RASFF as a form of risk information exchange envisaged in Article 50 of Regulation 178/2002. However, as the Commission itself is also a member of this network it may legitimately make notifications to the system which directly conflict with notifications made by Member States (author's headnote).
An Illegitimate Decision to Withdraw Medicinal Products from the Market: Any Room for Compensation?
Authors: Salvatore Vincenzo
Published: February 2017

Case T-429/05 Artegodan GmbH v. Commission

The infringement of Article 11 of Directive 65/65/EEC and of the proportionality principle are not per se sufficient to require the Commission to provide the applicant with compensation for the damages suffered if they are the result of a decision on the withdrawal of a marketing authorisation should this authorisation be deemed illegitimate and subsequently annulled by the Court (author's headnote).
Again: No Direct Effect of the Most-Favoured-Nation Clause
Authors: Simon Sven
Published: February 2017

Case C-160/09 Ioannis Katsivardas – Nikolaos Tsitsikas OE v. Ipourgos Ikonomikon

Article 4 of the Cooperation Agreement concluded between the European Economic Community, of the one part, and the Cartagena Agreement and the member countries thereof – Bolivia, Colombia, Ecuador, Peru and Venezuela – of the other part, approved by Council Regulation (EEC) No 1591/84 of 4 June 1984, is not such as to confer on individuals rights upon which they might rely before the courts of a Member State (official headnote).
Prior Authorisation Schemes: Trade Barriers in Need of Scientific Justification
Authors: van der Meulen Bernd
Published: February 2017

Case C-333/08 Commission v. French Republic ‘processing aids’ [2010] ECR-0000

French prior authorisation scheme for processing aids in food production infringes upon Article 34 TFEU

1.

A prior authorisation scheme not complying with the principle of proportionality, infringes upon Article 34 TFEU.

2.

A correct application of the precautionary principle presupposes, first, identification of the potentially negative consequences for health, and, secondly, a comprehensive assessment of the risk to health based on the most reliable scientific data available and the most recent results of international research.

3.

A Member State cannot justify a systematic and untargeted prior authorisation scheme by pleading the impossibility of carrying out more exhaustive prior examinations by reason of the considerable quantity of products which may be used or by reason of the fact that manufacturing processes are constantly changing. (author's headnotes)
Possibilities for Locus Standi and Non-Contractual Damages for Private Parties under the European Emissions Trading Scheme
Authors: van Zeben Josephine
Published: February 2017

Case T-16/04, Arcelor SA v. European Parliament and Council of the European Union nyr

1.

The applicant has failed to demonstrate that, in adopting the contested Directive, the Community legislature acted unlawfully or committed a sufficiently serious breach of a rule of law designed to confer rights on the applicant.

2.

Consequently, the application for damages must be rejected without there being any need to rule on the other conditions giving rise to non-contractual liability on the part of the Community or on the plea of inadmissibility raised raised by the Council in relation to certain annexes to the reply. (official headnotes)
Risk Perception, Culture and Legal Change: A Comparative Study on Food Safety in the Wake of the Mad Cow Crisis, by Matteo Ferrari. Farnham: Ashgate Publishing Limited, 2009, 216 pp., £52.25, Hardcover.
Authors: Borrás Susana
Published: February 2017

The Book Reviews section will introduce you to the latest and most interesting books on a wide range of topics pertaining to the law and policy of risk regulation. EJRR Book Reviews will strive to be present in every edition and will accept reviews from all disciplines. For further information on the submission of reviews please contact the Book Reviews Editor at david.hornsby@wits.ac.za.
A Crisis of Governance? — From Lamfalussy to de Larosière or Bridging the Gap between Law and New Governance in the EU Financial Services Sector
Authors: Chatzimanoli Despina
Published: February 2017

Modern financial law historically emerged as a patchwork of regulatory reactions to a series of financial crises. It continued to develop in sync with the ebb and flow of regulatory cycles that oscillated between periods of calm, conducive to a deregulatory frenzy, and periods of crises followed by re-regulatory fervour. Reform initiatives spurring in reaction to crises also comprise procedural/institutional reforms (i.e. those relating to the “who” and “how” of regulation, as opposed to the “what”). The latest financial crisis is no exception to this rule. This article focuses on the EU institutional reforms, which arguably represent a more radical departure from the status quo (in comparison to domestic or international initiatives) in that they involve an instance of “proper” institution-building with implications across different levels of governance. This reform is examined first against the backdrop of the existing EU agencies' legal framework and is found to constitute an important milestone in the crystallization of this framework. A closer look is then taken at the new European Supervisory Authorities' role in EU rulemaking, and to their relationship with the European Commission. Subsequently, the paper takes a further step back and offers some thoughts about the continuously mutating relationship between law and new governance practices, as illustrated in the context of EU financial regulation.
China's Milk Scandals and Its Food Risk Assessment Institutional Framework
Authors: Xiao Pinghui
Published: February 2017

Over the past years, a series of milk crises in China — culminating in the melamine milk scandal in 2008 — have seriously undermined public confidence in food safety. Drawing on international experience to strengthen its regulatory system, China recently introduced elements of risk assessment in its two main Food Safety Laws, namely the Law on the Quality and Safety of Agricultural Products and the Food Safety Law, which represent its basic legislation and institutional framework in terms of food safety. The article explores this new Chinese risk assessment framework in an international context. Specifically, given the similarities between the melamine milk scandal in China and the bovine spongiform encephalopathy (BSE) crisis in Europe in the 1990s in terms of both severity and link to respective corresponding reforms, much of the article focuses on a comparison of the food risk assessment institutions of the two jurisdictions in the aftermath of the crises.
Failure of Conciliation Talks on the Use of Animal Cloning for Food: “The Consumer's Right To Make Informed Food Choices”
Authors: Friant-Perrot Marine , Rihouey Lise
Published: February 2017

While the introduction of GMOs in food is still being debated in many Member States of the European Union, a new field of discord just appeared around the issue of animal cloning.
United States: Certain Measures Affecting Imports of Poultry from China – Just Another SPS Case?
Authors: Gruszczynski Lukasz
Published: February 2017

The SPS Agreement may apply to budgetary measures if they are motivated by SPS concerns. Equivalence-based measures are subject to regular disciplines of the SPS Agreement, including but not limited to Article 4. This means that WTO Members when engaging in the recognition process need to observe other SPS provisions such as requirement of scientific risk assessment (Articles 5.1–5.3) or quasi-consistency obligation of Article 5.5. An SPS measure which has been found inconsistent with certain provisions of the SPS Agreement (e.g. Articles 2 and 5), cannot be later justified under the general exception of Article XX(b) of the GATT 1994 (author's headnote).
No Prohibition of Dissemination of Information on Prescription-Only Medicinal Products on a Manufacturer's Website
Authors: Seitz Alexander M.
Published: February 2017

Article 88 (1) (a) of Directive 2001/83/EC must be interpreted as meaning that it does not prohibit the dissemination on a website, by a pharmaceutical undertaking, of information relating to medicinal products available on medical prescription only, where that information is accessible on the website only to someone who seeks to obtain it and that dissemination consists solely in the faithful reproduction of the packaging of the medicinal product, in accordance with Article 62 of Directive 2001/83, and in the literal and complete reproduction of the package leaflet or the summary of the product's characteristics, which have been approved by the authorities with competence in relation to medicinal products (official headnote).
The European Commission and Interest Groups: Towards a Deliberative Interpretation of Stakeholder Involvement in EU Policy-making, by Irina Tanasescu. Brussels: V.U.B. Press, 2009, 285 pp., € 38.50, Paperback.
Authors: Hardacre Alan
Published: February 2017

The interaction between organised interests and the European Union institutions has been subject to increasing study and analysis in recent years, and the relevance of this increasingly important research agenda has been highlighted by political scandals and developments in 2011.