bluuebunny/crossref_metadata_2025 huggingface dataset:
Tom Wiegele: Preeminent Founder
Authors: Caldwell Lynton K.
Published: February 2017

Among the founders of our interdisciplinary field of inquiry, Tom Wiegele was preeminent. He was the catalyst in drawing together in a collegial association the many of us who, from different backgrounds, had come to see the unfolding social implications of advances in the life sciences for both public policy and the study of politics. He possessed a combination of leadership skills in both concepts and organization that is rarely found in academia.
Crime in Biological, Social, and Moral Contexts edited by Lee Ellis and Harry Hoffman
Authors: Losco Joseph
Published: February 2017

Précis. The editors and contributors examine criminality from a biosocial perspective that conceptualizes criminal behavior as part of a continuum of pro/antisocial human responses that may have a common theoretical explanation. The book, divided into four major parts, includes chapters by contributors from the fields of psychiatry, sociology, psychology, criminal justice, genetics, and law.
Differences in Responses of Blacks and Whites to American Leaders
Authors: Masters Roger D.
Published: February 2017

How do members of different ethnic or racial groups differ in their responses to the same political events? Previous research has shown that when leaders are seen on television, the viewers' episodic emotional and cognitive responses can influence their attitudes and subsequent voting behavior. In an experimental replication, using excerpts of all candidates in the 1988 American presidential election, episodic emotions elicited by facial displays were again found to produce positive attitude change in white viewers. For blacks, however, the emotions felt while watching leaders—including Jesse Jackson and Michael Dukakis, who elicited highly favorable responses—did not influence posttest attitudes. This contrast between black and white viewers' emotions and attitudes differs from the effects of nonverbal behavior associated with personality or gender. These findings suggest that nonconscious factors may play an important role in the way blacks perceive and react within the American political system.
Flexible Interpretations of “Acid Rain” and the Construction of Scientific Uncertainty in Political Settings
Authors: Zehr Stephen C.
Published: February 2017

Much research in social studies of science addresses scientists' interpretative flexibility in the construction of scientific knowledge. This flexibility is readily visible among different scientists' competing knowledge-claims as well as in their accounts across different social settings. This article illustrates this process and discusses some of its implications through a case study of descriptions of acid rain in published scientific papers and Congressional testimony. As acid rain was flexibly reconstructed in Congressional testimony, its meanings and implications for control legislation became more contested. Some descriptions of acid rain that were intended to usefully clarify the phenomenon actually contributed to an impression of scientific uncertainty, and thereby further polarized debate.
Mandating Treatment for Pregnant Substance Abusers: A Compromise
Authors: Mathieu Deborah
Published: February 2017

This article considers one of the many ways in which the state might intervene in the life of a pregnant woman in order to prevent serious harm to the child she intends to bear: requiring a substance-abusing pregnant woman to live in a residential treatment center for the duration of her pregnancy. While the author agrees with those who argue that such state action is unjustifiable, she points out that the facts grounding this normative conclusion may change. Disagreeing with those who contend that, regardless of the circumstances, the state may never interfere with the activities of a pregnant woman in order to prevent harm to her future child, the author considers both the present situation and the most likely future scenario, and offers a compromise solution—civil commitment to an outpatient treatment facility.
Inventory Control of Dual-Use Equipment
Authors: Franz David R.
Published: February 2017

Proliferation of biological—as well as chemical and nuclear—weapons is a threat to the security of the U.S. in the post-Cold War era. The number of states with biological weapons (BW) programs or with a strong interest in having a BW program has increased significantly since the Biological Weapons Convention (BWC) was signed in 1972 (Office of Technology Assessment, 1993). BW programs present difficult intelligence targets. Thus, the Soviet Union was a signatory to the BWC at the time of the Sverdlovsk incident in 1979, yet we knew little of the scope of its BW program until 1991 (Meselson et al., 1994). The spread of biotechnology throughout the world in recent years has made even more governments potentially BW capable.
Detecting and Deterring Biological Weapons in Iraq: The Role of Aerial Surveillance
Authors: Zilinskas Raymond A.
Published: February 2017

This paper has four parts. First, I begin my examination of the aerial surveillance measure by reviewing the work by VEREX on this measure. Second, I discuss aerial surveillance as it relates to UNSCOM's mission in Iraq specifically. Third, I make some general observations about the applicability of this measure to detecting biological facilities and activities. Last, I comment on the utility of this measure for UNSCOM and international biological arms control.
Ritual Deception: A Window to the Hidden Determinants of Human Politics
Authors: Beahrs John O.
Published: February 2017

Political leaders of all persuasions are known to make public statements of affiliative allegiance with more form than substance, and to disavow political motivations obvious to the public. Such “ritual deceptions” are better understood in the same light as social etiquette—as partly deceptive behaviors that help to bond individuals with conflicting interests. Those who are more open and honest are often punished, more for breaking unspoken rules and taboos than for the actual content revealed. The functions of ritual deception are explicated by sociobiological theory, and the process, by understanding hypnotic transactions. Political deceptions require the active collaboration of subjects, achieved through the same skills used by experienced hypnotists. Deceptive transactions are more likely to occur in internally traumatized societies, and occur along a continuum from ritual deception to overt disinformation. Examples are taken from recent American history. That the content of ritual deception is so close to full awareness suggests its value as a focal point, both for studying the hidden determinants within human politics, and for policy intervention when appropriate.
Human Rights Watch Arms Project—Chemical and Biological Weapons Program
Authors:   Human Rights Watch
Published: February 2017

Human Rights Watch is the largest U.S.-based independent human rights organization. It conducts regular, systematic investigations of human rights abuses in some seventy countries around the world. Human Rights Watch (HRW) includes five divisions, covering Africa, the Americas, Asia, the Middle East, and the signatories of the Helsinki accords, and has four thematic projects: the Arms Project, the Women's Rights Project, the Children's Rights Project, and the Free Expression Project. HRW maintains offices in New York, Washington, Los Angeles, London, Brussels, Moscow, Rio de Janeiro, Dushanbe, and Hong Kong. Human Rights Watch is a nongovernmental organization, supported by contributions from private individuals and foundations worldwide. It accepts no government funds.
Male Age Composition and Severity of Conflicts
Authors: Mesquida Christian G. , Wiener Neil I.
Published: February 2017

From a behavioral ecology perspective, all forms of warfare are instances of collective aggression perpetrated predominantly by coalitions of young men. Such coalitions are manifestations of cross-cultural sex differences in aggressive behavior and may be conceptualized as a form of intrasexual competition, occasionally to obtain mates, but more often to acquire resources for the attraction and retention of mates. All societies have young males, yet wars are discrete events that can take place even after long periods of peace. Therefore, an additional factor is needed to explain the episodic nature of the phenomenon. We have proposed (Mesquida and Wiener, 1996) that the most reliable factor in explaining episodes of coalitional aggression is the relative abundance of young males. In this article, we present additional evidence to that effect. The ratio of the number of men ages 15 to 29 years of age versus men 30 and older in a population appears to be associated with the occurrence and severity of conflicts as measured by the number of war casualties. A series of analyses of demographic and war casualty data indicates that the relative prevalence of young men consistently accounts for more than one third of the variance in severity of conflicts.
Paternal-Fetal Conflict: An Examination of Paternal Responsibilities to the Fetus
Authors: Losco Joseph , Shublak Mark
Published: February 2017

Virtually all of the literature regarding liability for fetal health and well-being has concentrated on female behavior. Prosecution of women for “fetal abuse or neglect” has received widespread popular press coverage. Far less attention has been paid to the role of males in contributing to the health and welfare of newborns. This paper redresses this lack of attention by reviewing the ways in which males contribute to newborn health and by examining legal doctrine to determine if the same legal challenges that have been advanced against pregnant women are applicable to males as well. Questions are raised regarding the consequences of prosecuting males for their role in contributing to fetal harm.
Molecular Politics in a Global Economy
Authors: Wright Susan
Published: February 2017

Launched during the heydays of the copying machine and the U.S. sunshine laws and surrounded by controversy from its inception, genetic engineering may be the best documented technology ever to emerge from a laboratory. This essay draws on the pages that flowed forth from formal policy arenas as well as from less accessible places to examine the rise and fall of genetic engineering controls in the United States and Britain. The general argument developed here is that the settling of the issues raised by this field was achieved not through the resolution of technical problems but rather through the exertion of social interests—notably those of national governments, transnational corporations, genetic engineering firms, scientists, and sectors of the public. A synthesis of methods of analysis drawn from critiques of pluralism and from Foucault's analysis of the relation between power and discursive practice is used to assess the relative effects of these interests.
Kin Term Usage in The Federalist: Evolutionary Foundations of Publius's Rhetoric
Authors: Holper Joseph John
Published: February 2017

Theorists have recently argued that use of kin terms in patriotic speech appeals to genetically based predispositions and coefficients of relatedness, thereby moving one-time strangers to do things they might not otherwise do. This study has been designed to investigate the significance of kinship language in The Federalist, a project whose end was to persuade the people of New York to ratify the American Constitution. Three hypotheses were tested and supported. First, a wider variety and larger quantity of kinship language surfaced in patriotic than in nonpatriotic discourse on ratification. Second, kinship terms appear more often in papers that address the blessings one could expect from bonding in a potential union (a new family) and in papers that criticize the Articles of Confederation (the old family) than in the remaining papers that entail mundane descriptions of constitutional particulars. And third, kinship language appears significantly more frequently in the earlier papers of The Federalist than in the later ones, presumably to steal the audience's attention straightaway and thus form a bond among the people, the states, and the new Constitution.
Is Humanity Destined to Self-Destruct?
Authors: Caldwell Lynton Keith
Published: February 2017

As the twentieth century ends, we may identify both constructive and destructive trends that will influence the future of humanity. Which set of trends will dominate the future is uncertain. Attitudes, beliefs, and behaviors all interact to direct the flow of change over time. However, the options and constraints of human life are ultimately fixed by those cosmic elements of the environment over which humans have no control. The modern assumption of a world without end or limits risks collision with that obdurate reality. Facing threats to its long-term survival, humanity is challenged to learn how to build a sustainable future. A successful effort will require a concerted and cooperative effort among all fields of knowledge. This article identifies some of the trends that threaten humanity's future and suggests four lines of action that should be pursued in order to reduce the likelihood that humanity will destroy itself.
To Furnish a Workplace Free from Recognized Hazards: OSHA, State Occupational Safety and Health Agencies, and Fetal Protection Policies
Authors: Samuels Suzanne U.
Published: February 2017

The U.S. Supreme Court's 1991 decision in United Automobile Workers v. Johnson Controls capped a decade of adjudication of fetal protection policies under Title VII. In its decision, the Supreme Court barred the use of these policies, holding that the policies constituted unlawful gender discrimination. Prior to Johnson Controls, employers had justified these policies, which barred “fertile” women from certain workplaces, by contending that the workplace was not safe for women or their fetuses. Given this implicit disclosure by employers that their workplaces were unsafe, it is surprising that federal and state occupational safety and health agencies, charged with ensuring that employers furnish a workplace free from recognized hazards, did not play a larger role in the debate over these policies. This article examines the response of these agencies to the proliferation of fetal protection policies in the 1980s. It concludes that neither federal nor state occupational safety and health agencies crafted an adequate response to these policies during these years.
BWC Verification Measures: Technologies for the Identification of Biological Warfare Agents
Authors: Titball Richard W. , Pearson Graham S.
Published: February 2017

The future effectiveness of the 1972 Biological and Toxin Weapons Convention (BWC) will be dependent largely on the introduction of an effective verification system. If such a system is to be effective, it will need to be underpinned by the expertise and reagents that have already been used to produce battlefield detectors for biological warfare (BW) agents. Samples for analysis could range from those taken from a fermenter vessel to samples taken from the environment surrounding the suspect facility. The analysis of such samples could be carried out in the field or at specialist laboratories. Specialist laboratories would offer a wider range of tests and a higher degree of test sensitivity; however, the problem of sample transport to the laboratory will need to be addressed. In the longer term, improved fieldable verification equipment could be developed.
Ethical, Legal, and Social Implications (ELSI) Program National Center for Human Genome Research, National Institutes of Health
Authors: Langfelder Elinor J. , Juengst Eric T.
Published: February 2017

The program on the Ethical, Legal, and Social Implications (ELSI) of human genome research is a branch of the National Center for Human Genome Research (NCHGR) at the National Institutes of Health (NIH). The NCHGR is responsible, in conjunction with the Office of Health and Environment at the Department of Energy (DOE), for administration and coordination of the U.S. component of the Human Genome Project.
Physician Reimbursement Mechanisms as Social Constraints: An Historical Critique of Douglass North's Theory of Institutional Evolution
Authors: Williams Philip C.
Published: February 2017

Douglass North, in his seminal workInstitutions, Institutional Change, and Economic Performance, defined institutions as “the humanly devised constraints that shape human interaction,” existing within a hierarchical continuum ranging—in order of increasing formality—from taboos, customs, and traditions to more formal constraints such as individual contracts, specific bylaws, common laws, statutes, and constitutions. According to North, institutions evolve as piecemeal economic reactions to the high transaction costs attending greater social complexity. This article tests North's theory against an evolving system of humanly devised constraints: society's mechanism for reimbursing physicians. After examining eight reimbursement systems that range from primitive to complicated—(1) Zinacantan, Mexico, (2) Confucian China, (3) ancient Rome, (4) colonial America and seventeenth-century Britain, (5) the “guild free choice” model, (6) private third-party insurance, (7) government insurance, and (8) HMOs and managed care—I conclude that a “top-downward” model provides a better explanation of physician reimbursement constraints than does North's “bottom-upward” model.
A Balanced Paradigm of Crime Control: Programmatic and Methodological Considerations
Authors: Wolf Yuval
Published: February 2017

Bryan Vila's general paradigm for understanding criminal behavior focuses on the role of developmental factors in determining motivation for crime (1994:338). In his recent proposal in PLS, Vila states that criminality is “a predisposition that disproportionately favors criminal behavior” (1997:4). He suggests, further, that

there always are some people who are motivated to use force, fraud, or stealth to obtain resources: either to make the best out of a bad situation, or to take advantage of a good situation. That is, some individuals have competitive advantages over others within a particular niche….(1997:8)
Coming to Terms with the Microenvironment: Ending the War and Winning the Peace
Authors: Sprinkle Robert Hunt
Published: February 2017

Microenvironmental risks are largely unseen but not wholly uncontrollable. They are subject to exaggeration and misunderstanding but also to exacerbation, which can indeed be dangerous, and to amelioration, which requires a high degree of policy convergence. Technologically mediated alterations of the microenvironment have been both intentional and incidental; three types, while overlapping in mechanism and interactive in effect, may yet be distinguished by motivation: immunomodulation, chemotherapeusis and chemoprophylaxis, and species population management. Eight types of collective action are recommended to lessen microenvironmental risks. Their common feature is emphasis on ecological stability with quick identification and minimally disruptive containment of destabilizing elements on either side—microbial or human—of a highly dynamic and generally fruitful relationship. Their goal is “global microenvironmental community policing.”
Comparing intake estimations based on food composition data with chemical analysis in Malian women
Authors: Koréissi-Dembélé Yara , Doets Esmee L , Fanou-Fogny Nadia , Hulshof Paul JM , Moretti Diego , Brouwer Inge D
Published: February 2017

Objective

Food composition databases are essential for estimating nutrient intakes in food consumption surveys. The present study aimed to evaluate the Mali food composition database (TACAM) for assessing intakes of energy and selected nutrients at population level.

Design

Weighed food records and duplicate portions of all foods consumed during one day were collected. Intakes of energy, protein, fat, available carbohydrates, dietary fibre, Ca, Fe, Zn and vitamin A were assessed by: (i) estimating the nutrient intake from weighed food records based on an adjusted TACAM (a-TACAM); and (ii) chemical analysis of the duplicate portions. Agreement between the two methods was determined using the Wilcoxon signed-rank test and Bland–Altman plots.

Setting

Bamako, Mali.

Subjects

Apparently healthy non-pregnant, non-lactating women (n36) aged 15–36 years.

Results

Correlation coefficients between estimated and analysed values ranged from 0·38 to 0·61. At population level, mean estimated and analysed nutrient intakes differed significantly for carbohydrates (203·0v. 243·5 g/d), Fe (9·9v. 22·8 mg/d) and vitamin A (356v. 246 µg retinol activity equivalents). At individual level, all estimated and analysed nutrient intakes differed significantly; the differences tended to increase with higher intakes.

Conclusions

The a-TACAM is sufficiently acceptable for measuring average intakes of macronutrients, Ca and Zn at population level in low-intake populations, but not for carbohydrate, vitamin A and Fe intakes, and nutrient densities.
Competitor entry impact on jobs and wages in incumbent firms: retrospective evidence from a natural experiment
Authors: Majumdar Sumit K.
Published: February 2017

This article, situated at the interface of competition policy and labor economics literatures, examines the relationship between new competitor entry and its impact on changes in the employment levels and wage levels of incumbent telecommunications firms. The context for examining the issue is the local exchange carriers’ territories within the US. In markets with above-average competitive entry by new firms there has been a significant response by incumbent firms in increasing employment levels by 11% relative to industry average values, and wage levels have risen by 11.8% relative to average levels. In modern technologically-dynamic sectors, characterized by network effects, the impact of deregulation, competition policy changes and market entry on changes in employment and wage levels in the incumbent firms have been positive. The idea as to whether across-the-board competition leads to job losses or impacts wages negatively in incumbent firms requires re-assessment and the data suggest that promoting entry can be a powerful policy option to generate useful economic outcomes.
Financial structures, firms, and the welfare states in South Korea and Singapore
Authors: Lim Sijeong
Published: February 2017

South Korea and Singapore display distinctive patterns of social provision. The Singaporean welfare state has served as the primary provider of social infrastructure and services, whereas the South Korean welfare state has developed its primary role in supporting income maintenance. These differences are not well accounted for in the existing literature, which focuses on similarities between the two regimes. This paper shows that deep institutional legacies in the two countries’ respective financial structures powerfully shaped their unique social policy instruments. In South Korea, where financial openness was low and firms relied on relationship-based financing, the corresponding long-term perspectives on production and employment encouraged the private provision of welfare-related infrastructure and services. In Singapore, where firms have relied heavily on arm's length financing, the corresponding flexible investment and employment perspectives encouraged the utilization of private income maintenance arrangements. Each country's government prioritized the mode of social provision that the firms were less willing to engage in. These findings suggest that financial liberalization may be an important determinant of welfare regimes in developing countries.
Stakeholder pressures on corporate climate change-related accountability and disclosures: Australian evidence
Authors: Haque Shamima , Islam Muhammad Azizul
Published: February 2017

This study investigates stakeholder pressures on corporate climate change-related accountability and disclosure practices in Australia. While existing scholarship investigates stakeholder pressures on companies to discharge their broader accountability through general social and environmental disclosures, there is a lack of research investigating whether and how stakeholder pressures emerge to influence accountability and disclosure practices related to climate change. We surveyed various stakeholder groups to understand their concerns about climate change-related corporate accountability and disclosure practices. We present three primary findings: first, while NGOs and the media have some influence, institutional investors and government bodies (regulators) are perceived to be the most powerful stakeholders in generating climate change-related concern and coercive pressure on corporations to be accountable. Second, corporate climate change-related disclosures, as documented through the Carbon Disclosure Project (CDP), are positively associated with such perceived coercive pressures. Lastly, we find a positive correlation between the level of media attention to climate change and Australian corporate responses to the CDP. Our results indicate that corporations will not disclose climate change information until pressured by non-financial stakeholders. This suggests a larger role for non-financial actors than previously theorized, with several policy implications.
Metropolitan locales, global commerce, and East Indies capital and credit in the eighteenth century
Authors: Catterall Douglas
Published: February 2017

Encompassing events from 1680 to the mid 1750s, this article examines the organization and adaptation to capital and credit crises of East Indies trade participants in two metropolitan locales – one whose core bounded the North and Baltic Seas, and the other centred around the South China Sea. It shows that in both locales commercial and governmental actors relied not only on state or company, but also on decentralized, port-based practices, institutions, and networks to solve problems and support a shared information culture. Thus, the rules of what I term ‘commercial commons’, rather than an imperial conflict, characterized many East Indies endeavours of this era. East India companies operated in multiple transnational, distributed, and port-based metropolitan locales for their access to capital and credit, and to police financial failure.
The intellectual orders of a market economy
Authors: MIKE KÁROLY
Published: February 2017

Not only do ideas matter in economic development but so do the institutions of intellectual debates in which ideas are formed. Scholars usually point to intellectual debates whose institutions are largely exogenous to the economy (e.g. those of religion or science). I suggest that economists should also consider intellectual debates that are initiated by economic actors. I set out to understand the role of intellectual debate in the economy and, drawing on Polanyi's concept of ‘intellectual order’, the institutions that emerge endogenously to support it. Professional communities and public intellectual spheres are shown as the most important examples. Three historical cases are given as illustrations. I conclude that these intellectual orders should be included among the fundamental ‘institutions of capitalism’, along with the catallactic institutions of property and contract.
From constitutional rule to loosely coupled spheres of liquid authority: a reflexive approach
Authors: Zürn Michael
Published: February 2017

This article develops a reason-based social foundation of new forms of authority, which often are liquid and sectorally limited. The recognition of authority hinges, in this view, on reflexive actors who are aware of their own limits of rationality regarding the lack of either information or a perspective that allows for the pursuit of common goods. In such a reflexive concept of authority, authority takers tend to monitor the authorities closely, and the internalization of the subordinate role is not a necessary part of it. Reflexive authority is embedded in the acceptance of a knowledge order that reproduces the authority relationship. In spite of a tendency toward institutionalization, reflexive authority often comes in a liquid state of aggregation, and almost always with a restricted functional scope. Moreover, this new set-up of authority creates social dynamics that add to liquidity. First, the encompassing constitutionalized rule with majoritarian decision making as major source of legitimacy is increasingly undermined by loosely coupled spheres of specialized authorities, which are most often justified on the basis of expertise. We can observe both the rise of international authorities in the absence of coordination between them, and the rise of similar authorities within the nation state that escape control of the democratic core institutions. As a result, authority gets fragmented and different authorities need to adjust to each other. The second implication of the argument is that democratic legitimation narratives become rare, leading to an ongoing legitimatory contestation of authorities. Both these processes make authority even more liquid.
The Regulatory Challenge of Animal Cloning for Food – The Risks of Risk Regulation in the European Union
Authors: Weimer Maria
Published: February 2017

In this article I describe and analyse the current regulatory developments at EU level concerning the marketing of foods produced from cloned animals. As they are on the verge of commercialisation in countries outside the EU, especially in the United States, foods from cloned animals are likely to reach the European consumers in the foreseeable future. Yet at the moment there is no specific legal framework that regulates such products in the EU. The European institutions have, however, opened up a debate to determine the appropriate European policy approach towards animal cloning. The recent discussion reveals that the variety of potential yet very uncertain risks associated with animal cloning renders the drafting of suitable legislation difficult. At the same time, Europe's regulation of food risks also entails certain regulatory risks of its own (e.g. risks of political, economic, and legal conflicts within the EU as well as with EU's trade partners). By considering the discussion on animal cloning in the broader context of EU's regulation of genetically modified organisms and of nanotechnology, I identify the legal and political problems of current regulatory options. I argue that such problems should be openly addressed in the regulatory discussion; it is possible for them to be minimised if lessons are drawn from previous regulatory experience.
Nanomaterials under REACH: Legal Aspects
Authors: Montfort Jean-Philippe , Indirli Giovanni , Georgieva Daniela , Carrega Claire-Marie
Published: February 2017

At the time that REACH was being drawn up, the issue of nanomaterials was only in its infancy, so no specific provisions were adopted in the REACH Regulation to address them. While everyone recognises the important industrial and competitiveness potential of nanomaterials, the uncertainties over their potential impact on human health and the environment are also highlighted, triggering calls for a review and possible adaptations to the regulatory system in place. With respect to REACH, the Commission has started to consider possible legislative changes; however, these are likely to take several years to materialise. In the meantime, some Member States are considering initiatives to impose national rules, including reporting schemes and labelling requirements. The legality of these measures is questionable, however, considering that REACH today applies to nanomaterials, as also to any other chemical substance and that the REACH Regulation is regarded as totally harmonising the market access conditions for chemical substances in the EU.

Our article summarises the current regulatory status of nanomaterials under REACH and specifies the legal framework under which the legality of national initiatives contemplated by the Member States to regulate nanomaterials must be reviewed. It is the view of the authors that Member States cannot rely on the argument that REACH does not contain specific provisions on nanomaterials, nor require registration of substances manufactured or imported below 1 tonne, to consider that the matter is not totally harmonised under EU law and thus justify the adoption of national measures to regulate nanomaterials. However, Member States can use the REACH processes, including the evaluation, authorisation and restriction processes to propose conditions for or restrictions of the marketing and use of nanomaterials at the EU level, in the conditions specified in the Regulation. They can also trigger the application of the safeguard clauses of REACH and of the Treaty on the Functioning of the European Union. It is only within that strict framework that reference to the precautionary principle can be made to justify the introduction of national measures.
An Assessment of the EU Approach to Medical Device Regulation against the Backdrop of the US System
Authors: Lobmayr Bernhard
Published: February 2017

A medical device is intended to alleviate a medical condition or to substitute a body function. The use of medical devices entails risks, first and foremost for patients who usually lack the necessary information, time and ability for informed decisions. Based on this, societies choose to regulate these products. Government involvement in medical device regulation seems to be more pronounced and centralised in the US than it is in the EU, where the system involves privatised elements. A consultation, initiated by the European Commission in 2008, proposed at its centre the introduction of a European medical device agency. By this the European system would follow the US benchmark. This research discusses some fundamental questions pertaining to the risk concept in medical devices, namely how risks are currently being addressed in the two most important regulatory systems of the US and the EU, and how the European system might be adjusted in the future.
Registration Requirements for Monomer Substances Integrated in Polymers under the REACH-Regulation
Authors: Heselhaus Sebastian
Published: February 2017

1. The concept of ‘monomer substances’ in Article 6 (3) of Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No. 793/93 and Commission Regulation (EC) No. 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, relates only to reacted monomers which are integrated in polymers (official headnote).

2. Article 6 (3) of Regulation (EC) No. 1907/2006 infringes neither the principle of proportionality nor the principle of equal treatment (author's headnote).
On the Dispensation of Justice by Public Authorities
Authors: Klement Jan Henrik
Published: February 2017

The Austrian Umweltsenat is a court or tribunal for the purposes of Article 234 EC. The Environmental Impact Assessment (EIA) Directive is to be interpreted as meaning that a Member State has to subject a transboundary project to environmental impact assessment (EIA) even if the size of the project on its own territory does not reach the threshold for an assessment as defined in Annex I of the EIA Directive but the threshold is exceeded when parts of the project that are located in another State are taken into account (author’s headnote).
The Free Movement of Goods Principle Facing the Protection of National Public Health in the Absence of Harmonised Legislation: The Case of Processing Aids Used in the Manufacture of Foodstuffs
Authors: Coutrelis Nicole , Weber Isabelle
Published: February 2017

The free movement of goods is a fundamental principle under EU law: a product lawfully manufactured and/or marketed in one Member State is, in principle, entitled to be marketed in another EU Member State. Indeed, Article 34 of the Treaty on the Functioning of the European Union (TFEU) prohibits any quantitative restrictions on imports between Member States and all measures having equivalent effect.
Regulatory Impact Assessment and Sustainable Development: Towards a Common Framework?
Authors: Jacob Klaus
Published: February 2017

This section regularly examines Regulatory Impact Assessment (IA) at three levels: the EU, the Member States and internationally. Contributions aim to cover aspects such as the interface between IA and risk analysis, looking at methodologies as well as legal and political science-related issues. Contributions are meant to report and critically assess recent developments in the field, develop strategic thinking, and make constructive recommendations for improving performance in IA processes.
Member States under a Strict Obligation to Draw Up External Emergency Plans
Authors: Walkila Sonya
Published: February 2017

Case C-392/08 European Commission v. Kingdom of Spain nyr

Failing to draw up external emergency plans for all relevant establishments in accordance with Directive 96/82/EC on the control of major accident hazards involving dangerous substances may result in a Member State being deemed to have failed to fulfil its obligations under Article 11(1)(c) thereof (author's headnote).
Environmental Impact Assessment as a Duty under International Law: The International Court of Justice Judgment on Pulp Mills on the River Uruguay
Authors: Payne Cymie R.
Published: February 2017

On April 20, 2010, the International Court of Justice (ICJ) announced its judgment in a high-stakes environmental dispute between Argentina and Uruguay, concerning Uruguay's authorization for pulp mills on the banks of the Uruguay River, which forms the international boundary between the two countries.
Smart Regulation: The European Commission’s Updated Strategy
Authors: McColm Helen
Published: February 2017

On 8 October 2010, the European Commission issued a communication paper on Smart Regulation in the European Union. The paper reports on progress made, future priorities and strategy in the field of regulatory reform, for the information of interested outsiders. It is the latest in a series of such communications, issued on a regular basis since the first major, systematic action plan in 2002.

However, this most recent communication comes at a time when the context has changed noticeably. First, the financial crisis sparked by the credit crunch has altered attitudes to regulation. More attention is now being paid to the effectiveness of regulation and its overall quality than before. The Communication acknowledges this and underlines that regulation is essential to ensure that markets deliver sustainable prosperity for all. Second, a number of the Commission’s tools have been in place for some time, allowing it to draw useful lessons from its own experiences as well as from those of other countries. Its impact assessment system recently underwent a major examination by the European Court of Auditors.
Cancun, Climate Change, and Intellectual Property Rights: No News is Good News for Green Patents
Authors: Lane Eric L.
Published: February 2017

With the close of another round of United Nations Framework Convention on Climate Change (UNFCCC) treaty talks, this one held in Cancun from November 29–December 10, it is important to look at how green patents fared in the negotiations and the final agreement.

But first, some background is necessary to set the stage for Cancun.

Last year, when I became aware during the run up to the Copenhagen meeting that intellectual property IP) rights were being debated, the first question that popped into my mind was: why are IP rights even on the agenda in the climate change treaty discussions?

To me, IP seemed tangential at best to the problems of shaping policies to mitigate climate change, taking a back seat to a maximum temperature rise target, greenhouse gas emissions targets, carbon taxes, cap and trade, and other policy tools directed relating to climate change.
Risk and Regulatory Factors Affecting Location Decisions by Research-Based Pharmaceutical Companies
Authors: Rozek Richard P.
Published: February 2017

This report identifies the risk and regulatory factors that influence location decisions by research-based pharmaceutical/biotechnology companies. The primary data are from interviews with 34 senior executives representing 14 research-based pharmaceutical/biotechnology companies. These interviews provided qualitative information on the particular factors that matter and their relative importance in selecting a host country for an investment. The specific factors that influence the general willingness of companies to invest in a particular country are: industry history, the incremental nature of investments, stability, structure of the pharmaceutical marketplace, access to leading scientists and physicians, adequate supply of skilled workers, sufficient patient population for clinical trials, tax policy, and transport links both within the region served and to global headquarters.
(Re)evolution of the Test of Urgency for Interim Relief before the EU General Court – The Case of “Innocuous” Napropamide
Authors: Buchanan Camilla
Published: February 2017

The conditions of urgency for the granting of the interim suspension of a decision concerning the non-inclusion of an active substance in Annex I to Directive 91/414 should not be applied rigidly and mechanically and must be assessed in light of the specific circumstances of the case, in particular the progress of re-submission under Commission Regulation 33/2008, and be subject to a test of reasonableness (author's headnote).
A Hybrid within a Hybrid: Contextualising REACH in the Process of European Integration and Constitutionalisation
Authors: Kjaer Poul F.
Published: February 2017

REACH is a new European Community Regulation on chemicals and their safe use. This Regulation is a hybrid that combines hierarchy and heterarchy from a both a legal and an organisational perspective. Such hybridism is, however, not a feature that is particular to REACH. Rather the EU itself must be understood as a hybrid, thereby making REACH a hybrid operating within a hybrid. The hybrid structure of REACH reflects its societal function, which is to simultaneously separate and combine politics, science, economy, health and the environment within a single legal framework. The legitimacy of REACH reflects its hybrid structure in the sense that it is based on a combination of democratic, procedural and deliberative components.
Risky Apples Again? Australia – Measures Affecting the Importation of Apples from New Zealand
Authors: Arcuri Alessandra , Gruszczynski Lukasz , Herwig Alexia
Published: February 2017

The section on WTO law highlights the interface between international trade law and national risk regulation. It is meant to cover cases and other legal developments regarding the SPS, TBT and TRIPS Agreements and the general exceptions in both GATT 1994 and GATS as well as to inform about pertinent developments in recognized international standardization bodies and international law. Of recurrent interest in this area are questions of whether precautionary policies can be justified under WTO law, the standard of review with which panels and the Appellate Body assess scientific evidence and the extent to which policy can and should influence risk regulation.
Does Hazard-Based Communication Work?
Authors: Bouder Frederic
Published: February 2017

The view that risks and hazards are distinct concepts is commonly held in the scholarly literature on risk especially in the English-speaking community. The dichotomy is also enshrined in key documents commissioned or developed by Governments to help regulators conceptualise, regulate and communicate harmful events. Yet, the implications of risk-based versus hazard-based regulations have often been overlooked. Scholars have only conducted limited discussions, in contrast to the extensive debates about the respective merits of evidence-based and precautionary-based regulation. Lofstedt's article “Risk versus Hazard – How to Regulate in the 21st Century” offers a new and important perspective on the relationship between science and regulatory decisions. Lofstedt essentially argues that the conceptual distinction between hazards (the potential for a substance, activity or process to cause harm or adverse effect) and risks (a combination of likelihood and the severity of a substance, activity or process to cause harm) presents a meaningful classification to analyse regulations.
Lessons from the EU's REACH Program
Authors: Abelkop Adam , Graham John D. , Wise Lois R.
Published: February 2017

In the casual political rhetoric about environmental regulation, it is often claimed that the U.S. government regulates on the basis of risk while the European Union (or EU member states) regulates on the basis of hazard. The implication is that the U.S. government relies on a more rigorous, scientific process of assessment than does the EU, which allegedly helps explain why the EU is more pro-regulation than is the United States.

An alternative view, advanced originally by the late Professor Aaron Wildavsky of the University of California-Berkeley and amplified in a recent book by Professor Jonathan Wiener of Duke University, and colleagues, is that societies engage in a process of “risk selection.” What worries some societies does not worry others.
A Comment to Ragnar Lofstedt
Authors: Renn Ortwin
Published: February 2017

The fast development of technology and industrial processes during the last hundred years has caused increasing expectations by the public, customers and politics concerning the safety of operations and the risks of substances and activities related to production and consumption of goods. A highly differentiated and complex system of laws and regulations exists on the regional, national, and international level. In Germany alone, manufacturers are confronted with more than 10,000 regulations. Companies that trade all over the world are obliged to comply with a multitude of laws and regulations which partially are in conflict with each other.

In addition to the legal requirements, manufacturers of products and developers of technologies face increasing demands for more information and participation from the consumers, special stakeholder groups, and the public at large. The need for risk communication has been voiced since the late 1960s. The main targets have been large technical installations such as nuclear power plants or waste incinerators.
Risk versus Hazard before the EU Courts – A Comment
Authors: Zander Joakim
Published: February 2017

Professor Lofstedt presents a convincing illustration of the inconsistencies inherent in a European system of regulation where Member States choose whether to regulate based on assessments of risks or hazards depending on the product concerned. Particularly striking is the candid comment of a Swedish official who seems to marvel at the conflicting positions of his own government. The quote reminds this author of an official in the Swedish Ministry of Environment who in an interview stated that the application of regulation would be widely different if the precautionary principle as included in the Swedish Environmental Code or the precautionary principle as included in the Swedish Planning Code were to be employed.1 For a lawyer – or anyone else with an interest in the rule of law – such inconsistencies pose serious problems with regard to legal certainty. Unfortunately, those who could reasonably be expected to be most concerned with issues relating to the rule of law – national and European courts – have thus far proven reluctant to second-guess, or even criticise, decisions in the area of risk regulation.