bluuebunny/crossref_metadata_2025 huggingface dataset:
Transgenesis in Farm Animals: Ethical Implications for Public Policy
Authors: Mepham T. B.
Published: February 2017

There is currently considerable investment in research aimed at producing transgenic farm animals with enhanced productive capacities. This article submits these prospective technologies to critical ethical evaluation. The analysis provided, focusing on issues relevant to public policy, suggests the need to introduce additional regulations governing the use of these technologies. Should their use be permitted in principle, specific legislation would seem to be required: (1) to protect the welfare of transgenic animals produced/kept in commercial enterprises; (2) to ensure the freedom of choice of purchasers of food and other products derived from transgenic animals by provision of adequate information on the source of the products; and (3) to provide a mechanism for limiting the use of transgenic technologies to those that are in the public interest.
Prophylactic Defenses against Toxin Weapons: A Double-Edged Shield
Authors: Tucker Jonathan B.
Published: February 2017

The term “dual-use” toxins refers to a number of naturally occurring poisons that are finding increasing application in medical therapeutics and biomedical research but also have the potential for misuse as weapons of war and terrorism. Dr. Harsanyi's thought-provoking critique of my recent article on dual-use toxins deserves a detailed response. First, I apologize for quoting him out of context. In my defense, however, his referenced article (Harsanyi, 1992) does not make a clear distinction between the potential diversion of dual-use toxins by the intended customers—physicians and research scientists—or by toxin manufacturers. It is a subset of the latter, of course, that pose the greatest risk with respect to the potential misuse of toxins for nefarious purposes.
UNSCOM and the UNSCOM Experience in Iraq
Authors: Zilinskas Raymond A.
Published: February 2017

This paper has five parts: (1) a historical background to UNSCOM; (2) an explanation of how I came to work for UNSCOM as a staffer and inspector; (3) a description and analysis of the UNSCOM experience in Iraq; (4) a review of seven verification measures employed by UNSCOM; and (5) concluding thoughts on the wider applicability of the UNSCOM experience.
On-Site Inspection Measures and Interviews
Authors: Huxsoll David L.
Published: February 2017

In April 1991, the United Nations Security Council adopted Resolution 687, which established the terms and conditions for a formal cease-fire between Iraq and the coalition of Member States. Resolution 687 states that Iraq shall unconditionally accept the destruction, removal, or rendering harmless—under international supervision—of all chemical and biological weapons; all stocks of agents, and all related subsystems and components; and all related research, development, support, and manufacturing facilities. The resolution further states that Iraq shall unconditionally undertake not to use, develop, construct, or acquire any of the items mentioned above, and it calls for the development of a plan for ongoing monitoring and verification of Iraq's compliance. To accomplish these objectives, Resolution 687 provided for the establishment of a Special Commission to carry out immediate on-site inspections of Iraq's capabilities, based on Iraq's declarations and the designation of any additional locations by the United Nations Special Commission (UNSCOM) itself. Soon after it was established, the commission initiated a series of unprecedented inspections to eliminate Iraq's weapons of mass destruction.
Remote Monitoring of Dual-Capable Biological Facilities in Iraq
Authors: Tucker Jonathan B.
Published: February 2017

Under the ongoing monitoring and verification (OMV) program mandated by Security Council Resolution 715, the United Nations Special Commission on Iraq (UNSCOM) has installed more than a hundred remote-controlled video cameras at Iraqi “dual-capable” facilities—that is, facilities that have legitimate commercial applications but that could also be misused to produce nuclear, chemical, or biological weapons and long-range ballistic missiles. Since January 1995, these cameras have collected optical data for analysis at UNSCOM's Baghdad Monitoring and Verification Center, located on the third floor of the former Canal Hotel (Smith, 1994).
The Human Genome Organization (HUGO)
Authors: Knoppers Bartha Maria , Luther Lori
Published: February 2017

The Human Genome Organisation (HUGO) is an international membership organization (with 965 current members in 50 countries) whose goal is to coordinate and enhance efforts in the Human Genome Project (HGP). Formally established in 1989 by a group of the world's leading scientists in order to promote genome activities internationally, HUGO operates as a global coordinating organization to create the networks and channels through which genome information, initiatives, and ideas can flow and be disseminated.
The Kankakee Wetlands: A Case Study in Ethics and Public Policy
Authors: Roberts Sarah E.
Published: February 2017

In 1996, the U.S. Fish and Wildlife Service made a proposal to restore and preserve 30,000 acres of wetlands in Indiana's Kankakee River basin. Local farmers opposed this, expressing concerns about how a wildlife refuge would affect farming communities along the Kankakee River. Undergirding what seems to be a simple conflict between incompatible environmental and economic interests is a more fundamental conflict between competing ethical frameworks for evaluating public policy. One helpful approach is to examine the normative issues in the Kankakee dispute in terms of the contrast between consequentialist and non-consequentialist ethical frameworks. This article attempts to establish that a failure to recognize alternatives to the consequentialist framework has resulted in a failure of opposing parties to recognize and address each other's ethical concerns. An analysis of the Kankakee wetlands dispute will reveal why it is important for environmentalists to be cognizant of alternatives to consequentialist ethical frameworks.
Perspectives on the Self-Destructive Tendencies of Humanity: A Symposium Response
Authors: Caldwell Lynton Keith
Published: February 2017

A symposium has been defined as a collection of essays on a particular subject and as a philosophical or other focused discussion. It derives from a Greek origin meaning a drinking party. The focus of this symposium is on the published version of a plenary address given in Boston at the Eighteenth Annual Meeting of the Association for Politics and the Life Sciences, on September 4, 1998. The article, “Is Humanity Destined to Self-Destruct?” was printed in the preceding issue of this journal (1999a). Because not all readers of the present issue may have seen the article toward which the preceding commentaries are directed, a brief summary of its argument follows here:

As the twenty-first century approaches, we may identify both constructive and destructive trends that will influence the future. Which set of trends will dominate 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 elements of the environment over which humans have little control. The modem assumption of a world without end or limits risks collision with the obdurate reality called “nature.” Facing threats to its 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. The threats are both “natural” and “societal.” Humanity is an inseparable part of its planetary environment. Chaos and conflict in human society, shortsightedness and indifferences, delay the cooperative action needed to move toward a sustainable future. We do not know how much time we have to avoid catastrophic collision with the hard realities of the planet Earth. 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 inadvertently destroy itself.
Dilemmas of a Dual-Use Technology: Toxins in Medicine and Warfare
Authors: Tucker Jonathan B.
Published: February 2017

Several toxins are “dual-use” in that they have legitimate therapeutic, pharmaceutical, or scientific applications as well as potential military utility as toxin warfare (TW) agents. The growing peaceful applications of such toxins may complicate efforts to ban their use for warfare or terrorist purposes. Worldwide consumption of toxins for medical therapy and scientific research has increased from a few grams to the current level of hundreds of grams per year, and the projected future growth of toxin therapies will require tens to hundreds of kilograms of material annually, blurring the distinction between medically useful and militarily significant quantities. As a result, a proliferator might seek to acquire an offensive TW capability under the guise of “peaceful” activities permitted by the Biological and Toxin Weapons Convention (BWC) and the Chemical Weapons Convention (CWC). To examine this problem more closely, the case of ricin—a putative toxin warfare agent with expanding scientific and medical applications—is discussed in detail. Finally, an analysis of policy options for regulating dual-use toxins concludes that precise monitoring of toxin production would be impracticable in many cases, and that international efforts to achieve greater openness and transparency offer the most realistic basis for distinguishing between the legitimate and banned uses of toxins.
Response: Adolescent Sexuality and Public Policy: An UnrepentantLiberalApproach
Authors: Ross Lainie Friedman
Published: February 2017

One of the most interesting aspects of the commentaries on my article, “Adolescent Sexuality and Public Policy: ALiberalResponse” (1996a), is what is not mentioned, namely, the issue of statutory rape. In a front-page article inThe New York Times, Mireya Navarro writes about
Marine Biotechnology: a Proposal for Regulatory Reform
Authors: Balint Peter J.
Published: February 2017

Biotechnology companies are developing transgenic fish, shellfish, and microorganisms to supplement conventional marine aquaculture and aid in the bioremediation of polluted coastal waters. These products may be ready for open-environment field trials or commercial applications within two to four years. Regulatory authority in the field of marine biotechnology is poorly defined and ill prepared, however, and the science base presently available is not adequate to support credible ecological risk assessment of genetically engineered marine organisms.

In response, I offer two specific public policy recommendations: (1) an accelerated program of basic and applied research in marine ecology underwritten by a combination of government and private funds, and (2) the creation of a dedicated unit within the National Marine Fisheries Service responsible for regulatory oversight of transgenic marine organisms. If implemented, these reforms will encourage development in the marine biotechnology industry while laying the groundwork for appropriate ecological risk assessment and management.
A Political Ecology Perspective on Environmental Change in Malawi with the Blantyre Fuelwood Project Area as a Case Study
Authors: Kalipeni Ezekiel , Feder Deborah
Published: February 2017

This article examines deforestation-induced environmental change in the Southern Region of Malawi. The political ecology approach is used to critique this change, assessing how colonial and postcolonial forestry policies affected the landscape. It is argued that non-participatory, “top-down” government programs disempowered Malawi's peoples and allowed the environment to degrade. The Blantyre Fuelwood Project shows how the politics of land use predicate environmental change. It is argued that government implemented, “top-down” approaches failed because they did not integrate local communities. The result has been local opposition to government programs, passive resistance, and deteriorating environmental conditions. The article critiques Malawi's forestry policies since colonial times, analyzes the political ecology of the Blantyre Fuelwood Project, and concludes with the hope that newly implemented “bottom-up” programs that incorporate local communities will make Malawi's environment more sustainable.
Observations on Teaching a Biopolitics Course
Authors: Strate John
Published: February 2017

In the winter semester of 1993, I offered on my campus a four-credit course on “Biopolitics.” The course included both advanced undergraduate and graduate students, and was conducted as a graduate level seminar. It was a first both for me and for students in political science at Wayne State University. It appears to have been successful.
Gene Therapy and AIDS: A Constitutional Politics Report
Authors: Carmen Ira H.
Published: February 2017

On May 11, 1993, the National Academy of Sciences hosted a workshop convened to address the scientific, medical, and social issues arising from attempts to enlist gene therapy experimentation in the fight against AIDS. The 100 participants represented a cross-section of federal governmental, industrial, academic, and research-practitioner expertise. I was invited presumably because I am a member of the Recombinant DNA Advisory Committee (RAC), an arm of the National Institutes of Health, which oversees (in effect, licenses) human gene therapy protocols, and because I have recently published reports bearing on that policy process (Carmen, 1992, 1993).
Transplanting Nuclei between Human Eggs: Implications for Germ-Line Genetics
Authors: Bonnicksen Andrea L.
Published: February 2017

It has been suggested that diseases linked to mutations in mitochondrial DNA (mtDNA) might be circumvented by transferring the nucleus from the egg of a woman with a mitochondrial disease to a donor egg from which the nucleus has been removed and discarded. Egg cell nuclear transfer would be a straightforward technique for preventing serious diseases, relying on a procedure used in embryo or somatic cell cloning. It might present a relatively uncontentious setting for the refinement of cloning procedures. Its proposal creates the opportunity to identify categories of germ-line interventions; explore whether ethical issues vary according to the category of germ-line intervention; and craft more precise policy guidelines in which graduated levels of germ-line interventions are recognized.
Exclusive breast-feeding promotion among HIV-infected women in South Africa: an Information–Motivation–Behavioural Skills model-based pilot intervention
Authors: Tuthill Emily L , Butler Lisa M , Pellowski Jennifer A , McGrath Jacqueline M , Cusson Regina M , Gable Robert K , Fisher Jeffrey D
Published: February 2017

Objective

Exclusive breast-feeding (EBF) provides optimal nutrition for infants and mothers. The practice of EBF while adhering to antiretroviral medication decreases the risk of mother-to-child transmission of HIV from approximately 25 % to less than 5 %. Thus the WHO recommends EBF for the first 6 months among HIV-infected women living in resource-limited settings; however, EBF rates remain low. In the present study our aim was to design and implement a pilot intervention promoting EBF among HIV-infected women.

Design

The Information–Motivation–Behavioural Skills (IMB) model was applied in a brief motivational interviewing counselling session that was tested in a small randomized controlled trial.

Setting

Pietermaritzburg, South Africa, at two comparable rural public health service clinics.

Subjects

Sixty-eight HIV-infected women in their third trimester were enrolled and completed baseline interviews between June and August 2014. Those randomized to the intervention arm received the IMB-based pilot intervention directly following baseline interviews. Follow-up interviews occurred at 6 weeks postpartum.

Results

While not significantly different between trial arms, high rates of intention and practice of EBF at 6-week follow-up were reported. Findings showed high levels of self-efficacy being significantly predictive of breast-feeding initiation and duration regardless of intervention arm.

Conclusions

Future research must account for breast-feeding self-efficacy on sustaining breast-feeding behaviour and leverage strategies to enhance self-efficacy in supportive interventions. Supporting breast-feeding behaviour through programmes that include both individual-level and multi-systems components targeting the role of health-care providers, family and community may create environments that value and support EBF behaviour.
Efficacy of school-based interventions aimed at decreasing sugar-sweetened beverage consumption among adolescents: a systematic review
Authors: Vézina-Im Lydi-Anne , Beaulieu Dominique , Bélanger-Gravel Ariane , Boucher Danielle , Sirois Caroline , Dugas Marylène , Provencher Véronique
Published: February 2017

Objective

To verify the efficacy of school-based interventions aimed at reducing sugar-sweetened beverage (SSB) consumption among adolescents in order to develop or improve public health interventions.

Design

Systematic review of interventions targeting adolescents and/or the school environment.

Setting

The following databases were investigated: MEDLINE/PubMed, PsycINFO, CINAHL and EMBASE. Proquest Dissertations and Theses was also investigated for unpublished trials.

Subjects

Adolescents were defined as individuals between the ages of 12 and 17 years.

Results

A total of thirty-six studies detailing thirty-six different interventions tested among independent samples (n152 001) were included in the review. Twenty interventions were classified as educational/behavioural and ten were classified as legislative/environmental interventions. Only six interventions targeted both individuals and their environment. Over 70 % of all interventions, regardless of whether they targeted individuals, their environment or both, were effective in decreasing SSB consumption. Legislative/environmental studies had the highest success rate (90·0 %). Educational/behavioural interventions only and interventions that combined educational/behavioural and legislative/environmental approaches were almost equally effective in reducing SSB consumption with success rates of 65·0 and 66·7 %, respectively. Among the interventions that had an educational/behavioural component, 61·5 % were theory-based. The behaviour change techniques most frequently used in interventions were providing information about the health consequences of performing the behaviour (72·2 %), restructuring the physical environment (47·2 %), behavioural goal setting (36·1 %), self-monitoring of behaviour (33·3 %), threat to health (30·6 %) and providing general social support (30·6 %).

Conclusions

School-based interventions show promising results to reduce SSB consumption among adolescents. A number of recommendations are made to improve future studies.
Industry associations, health innovation systems and politics of development: the cases of India and South Africa
Authors: Papaioannou Theo , Watkins Andrew , Kale Dinar , Mugwagwa Julius
Published: February 2017

Over the last 20 years, developing countries have witnessed the increased role of non-governmental actors such as health industry associations and umbrella organizations in the diffusion and governance of health innovation. Utilizing extensive interviews with actors in the Indian and South African health industries, this paper argues that, in a context of emerging pluralism – i.e., a dynamic context of bargaining between competing (public and private) interests and values – these associations constitute public actors that play dual roles in the politics of innovation and development. Specifically, not only do they engage downstream by diffusing knowledge to their respective health innovation systems in order to achieve common objectives, they also engage upstream with their governments to co-develop policies and regulations. This dual role of health industry associations and umbrella organizations makes them less neutral politically but more effective institutionally, and their innovative and political role should be seriously taken into account in the healthcare sector.
Optimizing Atom Probe Analysis with Synchronous Laser Pulsing and Voltage Pulsing
Authors: Zhao Lu , Normand Antoine , Houard Jonathan , Blum Ivan , Delaroche Fabien , Latry Olivier , Ravelo Blaise , Vurpillot Francois
Published: February 2017

Atom probe has been developed for investigating materials at the atomic scale and in three dimensions by using either high-voltage (HV) pulses or laser pulses to trigger the field evaporation of surface atoms. In this paper, we propose an atom probe setup with pulsed evaporation achieved by simultaneous application of both methods. This provides a simple way to improve mass resolution without degrading the intrinsic spatial resolution of the instrument. The basic principle of this setup is the combination of both modes, but with a precise control of the delay (at a femtosecond timescale) between voltage and laser pulses. A home-made voltage pulse generator and an air-to-vacuum transmission system are discussed. The shape of the HV pulse presented at the sample apex is experimentally measured. Optimizing the delay between the voltage and the laser pulse improves the mass spectrum quality.
Astrobiological implications for Perchlorates on Mars
Authors: Mancinelli R. L.
Published: February 2017

Astrobiology is the study of the past, current and future potential for life in the Universe and has been fascinated with the possibility of life on Mars since the late 1800s. Because of the potential for life on Mars it is vital to understand the role perchlorates may play in that potential.
Foundations of Risk Regulation: Science, Decision-Making, Policy Learning and Institutional Reform
Authors: Majone Giandomenico
Published: February 2017

The long subtitle of this paper, appearing in the first issue of the EJRR – a publication which fills a serious gap in the scholarly literature of the old continent – identifies what I take to be the key terms of the current debate on risk regulation. It is impossible to understand the evolution of risk regulation over the last three decades in Europe and the United States without having a good grasp of how these concepts, and their corresponding practices, interact. How, for example, does a particular institutional design affect the way scientific uncertainties are resolved? What decision rules are appropriate in situations of high scientific uncertainty? Which constitutional principles facilitate policy learning and accountability in the regulation of risk?
If in Doubt, Leave it Out? EU Precaution in WTO Regulatory Space
Authors: Flett James
Published: February 2017

This article reviews the way in which the concept of precaution, as commonly referenced in EU law, is received in the WTO. It argues that precaution is not a principle, but one facet of a principle of making rational judgments based on available information, the other facet of which is “that risk is worth taking”. Systematically pursuing high cost measures in response to low risks is not a balanced approach, and has probably contributed to the scepticism with which the concept is viewed in the WTO. However, this article goes on to argue that, without needing to be a principle, precaution is the determining legal feature in the SPS Agreement, because, unlike in the European Union, there is no legislative harmonisation of SPS measures at international level, WTO Members being free to set their own appropriate level of protection. In fact, the concept of precaution is relevant in the context of many other WTO provisions and is in some respects quite close to the concept of subsidiarity. Notwithstanding this, the first WTO SPS cases, driven by regulatory exporters and an interventionist WTO, have excessively emphasised scientific issues, masking policy judgments that the WTO has neither the legal nor the political authority to sustain. The article concludes that the proper way forward necessitates closer political, legal and administrative links between the WTO and other relevant international organisations, and a move away from consensus in the latter.
Intellectual Property
Authors: Bonadio Enrico
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.
The European Regulatory Response to the Volcanic Ash Crisis between Fragmentation and Integration
Authors: Alemanno Alberto
Published: February 2017

More than twenty years after the EU eliminated its internal land borders, the Union still lacks an integrated airspace. This seems to be the most immediate regulatory lesson of the recent volcanic ash crisis. Yet more research is needed before establishing its net effects. In this brief report, I will provide a first-hand analysis of the regulatory answer developed across Europe in the aftermath of the eruption of the Icelandic volcano Eyjafjallajökull. While reconstructing the unfolding of the events and the procedures followed by the regulators, I will attempt to address some of the questions that I have repeatedly asked myself when stranded in Washington DC between 16 and 25 April 2010. Who did the assessment of the hazard posed by volcanic ash to jetliners? Who was competent to take risk management decisions, such as the controversial flight bans? Is it true that the safe level of volcanic ash was zero? How to explain the shift to a new safety threshold (of 2,000 mg/m3) only five days after the event? Did regulators overact? To what extent did they manage the perceived risk rather than the actual one? At a time when the impact of the volcanic ash cloud crisis is being closely scrutinised by both public authorities and the affected industries, it seems particularly timely to establish what happened during the worst aviation crisis in European history. This report was written one week after the event and relied on a limited number of sources available by 30 April 2010.
Alice's Adventures in Volcano Land: The Use and Abuse of Expert Knowledge in Safety Regulation
Authors: Brannigan Vincent M.
Published: February 2017

As a volcano refugee in Frankfurt, it was rather interesting to see a slow motion regulatory science disaster taking place. On April 14 2010 the Icelandic volcano Eyjafjallajökull erupted sending millions of tons of ash into the upper atmosphere. The ash cloud, blown by the prevailing winds, moved down over northern Europe. European air traffic authorities, following well established and widely published safety protocols, began shutting down the air transport system due to the well known hazard of volcano ash. The shutdown lasted 6 days and soon became an unequal political contest between airline money on the one side and regulatory science on the other. In a classic case of shooting the messenger bringing bad news the responsible airline parties tried to shift the blame for shutdown to the regulators, while nervous governments quailed before the bullying of the airline executives.
End of the Transitional Period for Traditional Herbal Medicinal Products Coming Soon
Authors: Jablonski Tomasz
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.
Regulatory Transparency: Forthcoming Lessons from the FDA
Authors: Chakraborty Sweta , Lofstedt Ragnar E.
Published: February 2017

This section discusses issues related to risk communication across a range of publicly perceived high-risk 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.
The first 2010 Case of Highly Pathogenic Avian Influenza Virus
Authors: Mahieu Stéphanie
Published: February 2017

The recent Romanian outbreak of subtype H5N1 of the highly pathogenic avian influenza (HPAI) virus, the first detected case of H5N1 avian influenza in Europe in 2010, has reinvigorated the debate concerning risks related to the spread of avian influenza in the European Union.
How to Avoid International Trade Conflicts
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.
Interim Relief in Case of Inclusion of a Substance on the REACH Candidate List
Authors: Bergkamp Lucas , Herbatschek Nicolas
Published: February 2017

The manufacturer of a substance that is used safely and, in more than 99.9% of cases, used as an intermediate (and thereforeis exempted from the authorisation procedure) is deemed to have no legal grounds for claiming the suspension of the inclusion of that substance in the Candidate List for lack of urgency. Its mere inclusion should not automatically result in any significant damages to the manufacturer, neither should the Candidate List serve as a regulatory blacklist (official headnote).
Independence of Experts and Standards for Evaluation of Scientific Evidence under the SPS Agreement – New Directions in the SPS Case Law
Authors: Arcuri Alessandra , Gruszczynski Lukasz , Herwig Alexia
Published: February 2017

Under Section II of the Rules of Conduct for the DSU, the institutional affiliation of experts may be considered as an element that casts doubts on their impartiality and independence. Under Articles 5.1 and 5.7 of the SPS Agreement, the level of protection that a particular country is ready to tolerate may inform risk assessment and have an impact on the determination of insufficiency of scientific evidence. In a situation in which there is sufficient scientific evidence for performance of risk assessment in one of the international standard setting-organizations, one may still find insufficiency as provided by Article 5.7 if new data puts into question the relationship between the relevant scientific evidence and the conclusions in relation to risk, thereby not permitting the performance of a sufficiently objective assessment of risk (authors’ headnote).
World at Risk, edited by Ulrich Beck. English Edition, Translated by Ciaran Cronin. Cambridge/UK and Malden/MA: Polity Press, 2009, 269 pp., $24.95, Paperback.
Authors: Gabler Melissa
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.
The Case of Plain Packaging of Cigarettes
Authors: Alemanno Alberto , Bonadio Enrico
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.
International Conference on Harmonisation and Standardisation Initiatives in the Pharmaceutical Domain
Authors: Brosch Sabine , 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 of Bacterial Infection Does Not Constitute Force Majeure in Export Refunds
Authors: Baroncelli Stefania
Published: February 2017

Case C-218/09 SGS Belgium NV v. Belgisch Interventieen Restitutiebureau and Others [2010] nyr

Article 5(3) of Commission Regulation (EEC) No 3665/87 of 27 November 1987 laying down common detailed rules for the application of the system of export refunds on agricultural products, as amended by Commission Regulation (EC) No 1384/95 of 19 June 1995, must be interpreted as meaning that damage to a consignment of beef in the conditions described by the national court does not constitute force majeure within the meaning of that provision (official headnote).
Reinterpreting Patent Valuation and Evaluation: The Tricky World of Nanotechnology
Authors: Escoffier Luca
Published: February 2017

In this report, the author, an IP scholar and entrepreneur, analyses how nanotechnology will pervade all industries and therefore how important it is to find a proper method to valuate and especially evaluate nanotechnology-related inventions. Attaching a value or evaluating a technology is a fundamental task nowadays, especially when innovations are supposed to be licensed or assigned. The report focuses on the different valuation and evaluation techniques professionals usually employ, and then delves into the world of nanotechnology. It tries to develop a novel method that takes environmental and health-related issues into due consideration when attaching a value or evaluating a technology in the nano world. The novel tool envisioned in the article is particularly suitable for nanotech innovations, but it can be used for the evaluation of other technologies and patents as well. The innovative idea consists of introducing the concept of Present Value After Evaluation, which takes qualitative variables into consideration and provides a figure for the analyzed technology or patent. This method and the accompanying tool are perfectly suited for evaluation purposes when environmental and human safety concerns are at stake, because they take these variables into consideration and throughout technology's life cycle.
Internet-Based Trade and the Court of Justice: Different Sector, Different Attitude
Authors: Littler Alan
Published: February 2017

E-commerce and information society services became part of the quotidian language of the European institutions in the mid-1990s, as the European institutions gazed into a crystal ball wherein electronic commerce would further the competitiveness of the internal market. Gradually increasing volumes of customers began to purchase goods and services via the internet, reflecting the development by undertakings of the internet as a sales channel and also due to the regulation of such transactions. Concurrently the internet can be characterised by its tendency to bring market actors closer together, and the case of DocMorris, concerning the sale of medicinal products via the internet, has been described as constituting an instance whereby the technological revolution which the internet embodies has “well and truly reached the doors” of the Court of Justice.
Tomra: Exclusive Dealing and Rebates in the Light (and Shadows) of Dominance
Authors: Miralles Graciela
Published: February 2017

The General Court reaffirms its traditional form-based approach to dominance (author's headnote).
The New Strategy on Coexistence in the 2010 European Commission Recommendation
Authors: Varela Justo Corti
Published: February 2017

The European Union tried to establish a “coexistence” policy for the cultivation and processing of GM and non-GM products after the political agreement that put an end to the 1999-2004 moratorium.
The Fabulous Destiny of Bisphenol A (BPA)
Authors: Alemanno Alberto
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.
“Lost in Translation”: Scientific Names of Medicine in a Globalized World
Authors: Seppia Ilaria Del
Published: February 2017

The external presentation of medicinal products is fundamental in ensuring their safe use from a regulatory perspective. Indeed, the primary purpose of labeling and packaging of medicine is the clear identification of the conditions for safe use.
Purpose-Bound Patent Protection for Genes
Authors: Lamping Matthias
Published: February 2017

Case C-428/08, Monsanto Technology [2010]

The Biotech Directive does not provide for absolute patent protection of DNA sequences. Protection is subject and restricted to the disclosed function (or purpose) of a gene; if the function is not fulfilled at the time of the alleged infringement the protection is therefore suspended. National law may not depart from the protection conferred by the Directive due to its exhaustive character (author's headnote).
Risk vs Hazard and the Two Souls of EU Risk Regulation: A Reply to Ragnar Lofstedt
Authors: Alemanno Alberto
Published: February 2017

When called upon to regulate risk, the EU carries the threefold onus to (i) protect its people(s); (ii) ensure the functioning of the internal market; and also (iii) to allocate the resources available wisely and efficiently.

This creates a number of pressures and dilemmas for the EU, notably for the Commission when initiating legislation and for the EP and the Council when co-legislating.

According to a familiar script – faithfully narrated by Ragnar Lofstedt in his opening article –, the EU has, in recent years, been subscribing to a progressive ideal of regulation based on evidence. As a result, by making a commitment to the use of optimization tools, such as risk assessment and regulatory impact assessment, the EU has been gradually developing a European risk regulation model that seems to put the EU at the forefront of a wider move towards evidence-based policy-making. Given the historical affection of the EU integration process to technocratic modes of governance, this choice is not surprising.
How Chemicals Are Regulated in the European Union: A Commentary
Authors: Jørgensen Dan
Published: February 2017

Professor Ragnar Lofstedt has written a very interesting and thought provoking paper “Risk versus Hazard Assessment – How to Regulate in the 21st Century”. The paper reflects upon the advantages and disadvantages of using risk assessments compared to hazard assessments of chemical compounds. It investigates the debate that has been going on in recent years in Europe between regulators, politicians, NGOs and industry on the subject.

This commentary will discuss some of the assumptions that the analysis rests on as well as some of the conclusions that are presented in the paper.

First, the commentary will discuss the definition and critique of the “risk assessment” approach that Lofstedt presents. The commentary here concludes that Lofstedt's analysis of risk assessment does not take sufficiently into account the fact that risks can not always be calculated in an exact way because uncertainty rather than certainty is the condition when analysing chemicals.
Comment on Risk versus Hazard – How to Regulate in the 21stCentury
Authors: Paustenbach Dennis , Panko Julie
Published: February 2017

In this issue of the journal, Dr. Ragnar Lofstedt examines the current state of the EU regulatory framework with respect to chemicals and illustrates how the hazard-based approach sealed the fate of two important chemicals in the EU market-place. He also explores how the attitudes, technical knowledge and economic influences of the individual member states determine the outcome of environmental and chemical regulations. Lastly, Dr. Lofstedt provides some recommendations to improve consistency in the European regulatory process and ensure greater scientific, as well as, risk-based regulations.
A Comment to Ragnar Lofstedt's Risk versus Hazard
Authors: Skinner Peter
Published: February 2017

It is frequently suggested that the EU in general and Parliament in particular suffer from an addiction to making rules and regulations on all things from chemicals to chocolates and from buses to booze. Classically, this is the first repost of the critic who sees the EU as legal procurator dressing up the legislative Christmas tree. Firstly, it is important to note that there are legitimate concerns that regulations passed in Europe are not always based on the best available science and perhaps even the best scientists. It is up to those with responsibility for making regulation to make it according to best verifiable evidence at hand. When you consider how important the potential implications are for industry and consumers alike then it is clearly of great importance to increase the use of risk analysis tools.

When asked to explain the difference between risk and hazard it is perhaps helpful to consider the life of a zoo keeper in charge of the Lions’ den. The animals themselves can be seen as a “hazard”, when the animals are free and uncaged, people in the surrounding area are exposed to the risk that they may be attacked. However, when the animal is caged, we’re dealing with altogether different beasts as only the zoo keeper (who knows how to handle the risk) could be exposed to certain dangers. It may remain “hazardous” but while those around it are protected there is no exposure to attack, therefore there is no risk.
Science for the Environment: Examining the Allocation of the Burden of Uncertainty
Authors: Vecchione Elisa
Published: February 2017

The aim of this paper is to review the basic literature on scientific uncertainty in its statistical paradigm in order to provide enlightenment on one pivotal facet of the precautionary principle, i.e. the allocation of the burden of proof to demonstrate that an activity is not harmful to the environment. The purpose is not to explain a new theory of statistical inference, but to show how regulatory policymaking that is properly informed by scientific expertise and designed to avoid one type of error, may actually make other errors more likely and thus expose the public to danger. This problem is explained in terms of the conceptual as well as operational conflicts that arise when knowledge about statistical-inferential methods is applied to policymaking. The paper argues that this issue can be resolved by first reconsidering the burden of proof as a burden of uncertainty.
Tobacco Regulation, International Investment Arbitration and the Fragmentation of International Law – The Grand River Enterprises Case
Authors: Pirker Benedikt
Published: February 2017

In the recent Grand River Enterprises case, United States public health regulations on protection from tobacco products successfully withstood a challenge by Canadian Native American investors under NAFTA chapter 11 arbitration. The arbitrators carefully weighed the investors’ rights and the regulatory freedom of the host state under the NAFTA rules. The treatment of other norms of international law on the protection of indigenous peoples, however, merits some criticism.
Opening Editorial to the Symposium on the Financial Crisis in the EU
Authors: Dardanelli Giorgio Tosetti
Published: February 2017

As its name suggests, the EJRR focuses on risk regulation by privileging a European perspective. This issue does not intend to depart from this characterizing feature of the journal. What would make it “special” then? The “specialty” has to be found in the type of risk which our authors deal with in their articles contributing to the symposium: the one posed by, and intrinsic to, financial markets, with a particular view to the recent (better said, current?) financial crisis.
The EU Embraces Enhanced Cooperation In Patent Matters: Towards A Unitary Patent Protection System
Authors: Bonadio Enrico
Published: February 2017

On 13 April 2011 the Commission tabled a package of two legislative proposals implementing enhanced cooperation in the field of unitary patent protection and translation arrangements. Such proposals have subsequently been agreed upon by the EU ministers in an Extraordinary Competitiveness Council on 27 June 2011. Patent protection is indeed key to the European Union (EU) and constitutes a priority in EU institutions’ agenda, as it is capable of stimulating innovation and competitiveness.
“One to Rule Them All”? – The Standardisation of Nanotechnologies
Authors: Thoreau François
Published: February 2017

Nanosciences and nanotechnologies are a field of blooming technological applications, developed or manufactured at the nanoscale (a billionth of a meter). At this scale, matter shows new and unexpected properties. These may significantly differ from one case to the other, which results in a great diversity of different industrial applications, and eventually in very heterogeneous end-user products. As a matter of fact, the generic dimension of nanotechnologies, understood as a platform or enabling technology, drives their diversity, and potentially affects almost every industrial sector.
Cognitive Neuroscience, Decision Making and the Law
Authors: Bottalico Barbara
Published: February 2017

Cognitive neuroscience was born when the theories and methods of cognitive psychology and neuropsychology were combined after a long period of parallel development. Over the last few decades, neuroscientific studies have begun to meet the challenge of understanding cognitive functions, thereby identifying the causal chain of neural events that underlies cognition. The development of powerful brain imaging technologies is now likely to present a range of opportunities in many spheres of public life, such as the criminal and civil justice system, and the business world.