EJRR 2/2014



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Issue 2/2014

Table of Contents
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Alberto Alemanno

Editorial
European Journal of Risk Regulation 2/2014: pp. 127-128
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In a world of manufactured and natural risks, the use of scientific evidence and its communication to the public is often put to the test. This is particularly the case when authorities are under great pressure to deal with atypical situations, such as volcano eruptions, tsunamis, and earthquakes like the one that shook the medieval town of L’Aquila in central Italy’s Abruzzo region.

Alberto Alemanno and Kristian Cedervall Lauta

Opening Editorial
European Journal of Risk Regulation 2/2014: pp. 129-132
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In the aftermath of the L’Aquila earthquake the world almost stopped spinning in disbelieve. What prompted surprise were not the catastrophic consequences of the earthquake, but the initiation by Italian prosecutors of a trial against six scientists and one public official for their reassurances about safety on the eve of the tragic event. The global disbelieve only grew last year as the competent tribunal sentenced each of the seven to six years’ imprisonment for manslaughter.

Alfredo Fioritto

Science, Scientist and Judges: Can Judges try Science?
European Journal of Risk Regulation 2/2014: pp. 133-136 [Article]
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Case n. 380, 22.10.2012, Victims of the earthquake v. Barberi et al., (members of the NationalCommission for the Prediction and Prevention ofMajorRisks),Tribunal of L’Aquila, grounds delivered on 29.01.2013; (first degree of judgment). Articles 113, 589, c.1and 3, 590 Criminal Code (113 – Cooperation in negligent homicide, 589 – Negligent homicide, 590 – Negligent personal injury) The Tribunal of L’Aquila condemned seven members of the National Commission for the Prediction and Prevention of Major Risks to six years in prison for manslaughter because they dismissed the role of scientists in a March 31, 2009 meeting. The meeting was convoked in L’Aquila to provide the population of L’Aquila, which was scared after a continuous series of tremors lasting three months, with serious information on a scientific base. On the contrary, the members of the Commission supported a press campaign launched by the Chief of the National Civil Protection to reassure the population. Five days after the meeting, a serious tremor took place causing more than 300 deaths.

Kristian Cedervall Lauta

New Fault Lines? On Responsibility and Disasters
European Journal of Risk Regulation 2/2014: pp. 137-145 [Article]
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This article investigates the L’Aquila decision. It aims to present a theoretical framework from contemporary disaster research and political philosophy to better understand why blame and responsibility has come to play such a prominent role in the aftermath of disasters. Furthermore, it presents a number of examples from criminal law around the world to provide context to the decision. The central claim in tthis piece is that the decision is not an extraordinary, isolated decision on responsibility following disasters; rather the decision is emblematic to an on-going development of disaster responsibility. Thus, after disaster follows a legal process aimed at identifying, and if necessary, penalizing the mistakes leading to the horrifying outcome. In that way disasters are increasingly like any other event in society with major negative implications; it is evaluated and if appropriate adjudicated.

Marta Simoncini

When Science Meets Responsibility
European Journal of Risk Regulation 2/2014: pp. 146-158 [Article]
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The Major Risks Commission and the L’Aquila Earthquake.

This article aims to analyse the role of law in the identification of the responsibility domain of ‘regulatory science’ (Jasanoff, 1990) within the risk regulatory process. The main research question is therefore,what kindof relationshipbetween science andpolicy-making lawshould design in risk regulation. In order to address this issue, this contribution focuses on the recent verdict of the Tribunal of L’Aquila. After the earthquake occurred in L’Aquila on the 6th April 2009, six Italian scientists that had participated in the Major Risks Commission’s meeting have been condemned for the multiple manslaughter of 29 people who were among the 309 victims of the earthquake, ‘for having assessed the risks related to seismic activity in the L’Aquila territory in an inaccurate, generic and ineffective way’ and for having provided ‘information which was imprecise, incomplete and contradictory as to the nature, the causes and the hazardousness and on the future development of the seismic activity’. As far as risk assessment and risk communication are concerned, firstly the tasks of the Major Risks Commission under the Italian Civil Protection law will be analysed. Against this backdrop, the issues related to this expert body’s responsibility will be addressed and the gaps in the current accountability regime will be pointed out.

Domenico Notaro

Scientists and Earthquake Risk Prediction: “Ordinary” Liability in an Extraordinary Case?
European Journal of Risk Regulation 2/2014: pp. 159-167 [Article]
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This article aims to consider whether classic criminal offences (such as manslaughter) are adequate to reprove the scientists’ behaviour when major calamities are being judged to have caused the death of people and wide destructions. The fundamental problem hinges on the role of risk-assessment and consultancy carried out by the scientists, as well as on the unknown state of major risks. Then, to establish a link of causality between the defendants’ behaviour and the death-events affecting the victims, it must be proved that: a) the scientists “psychically” influenced the victims to leave any safety precaution in relation to the risk; b) the deaths of the inhabitants are not to be considered an “extraordinary” circumstance, even by experts. The difficulties faced by the Judge to fulfil these tasks prompt us to wonder whether other types of criminal charges would be more appropriate for sanctioning scientists who are found to be derelict in their duty of risk-assessment to authorities and citizens.

Ludivine Petetin

Frankenburgers, Risks and Approval
European Journal of Risk Regulation 2/2014: pp. 168-186 [Article]
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This piece critically analyses the development of a novel food technology: the Frankenburger, a type of cultured/in vitro meat (or ‘shmeat’, which stands for ‘sheet of meat’). It assesses the risks raised by cultured meat as well as the role it could play to alleviate environmental and food security concerns. The article argues that the current EU regulatory structures for cultured meat, and for novel foods more generally, ought to be strengthened. There is a necessity to transfer and develop food innovations in partnerships with all the relevant stakeholders (the public, scientists, the food industry, policy-makers and regulators). Including interested parties from the inception of a technology as well as within the decision-making process would provide a supporting framework for cultured meat.

Kévine Kindji and Michael Faure

Shrimp Export from Benin vs Food Safety in Europe: Reconcilable Interests?
European Journal of Risk Regulation 2/2014: pp. 187-200 [Article]
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In order to secure their fishery products market share in the EU, third countries, especially the developing ones, tend to transplant EU requirements into their domestic legal order. In reality, theses transplanted laws do not correspond to measures to reach a level of protection needed by the country of destination. Based upon the case of Benin, this paper intends to show that when these legal transplants are adversely made, they can in some cases have disastrous effects. It can be argued that an unintended result of EU policy was that it contributed to the collapse of the shrimp industry in Benin. The paper moreover argues that despite the stringency of the EU requirements, the implementation of its control policy might inadequately protect European consumers of shrimp.

Eugenia Costanza Laurenza and Francesco Montanari

Biotechnology: Pest risk analysis – Recent Trends in the EU and its Trade Implications: The Citrus Black Spot case
European Journal of Risk Regulation 2/2014: pp. 201-207 [Report]
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Trade globalisation and a rising demand in the European Union (hereinafter, the EU) for fresh produce all year long are leading EU risk managers towards the adoption of increased levels of import surveillance on products of non-animal origin. Indeed, over the past years the EU has introduced a number of emergency measures on imports of fruits and vegetables for phytosanitary reasons with a view to preserving its territory from e.g. insects, fungi, viruses that are non-native in the EU.

Maria Weimer and Gaia Pisani

Biotechnology: The EU Adventures of ‘Herculex’
European Journal of Risk Regulation 2/2014: pp. 208-212 [Report]
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Report on the EU Authorization of the Genetically Modified Maize 1507

The EU authorization process of the insect-resistant maize 1507, branded by its developer company Pioneer-DuPont as ‘Herculex’, is perhaps the most interesting and emblematic example of the current regulatory crisis of GMO regulation in Europe.1 The case is particularly controversial, because it concerns the first risk assessment regarding the cultivation of a GMO issued by the European Food Safety Authority (EFSA) since its establishment in 2005.2 It involves a long and complicated authorization process marked by persistent contestation of both the EFSA’s risk assessment and the Commission’s risk management; a total of six EFSA opinions; administrative delay; and ultimately a judicial condemnation of the Commission’s behavior by the EU General Court. This case is of particular relevance, because it registers a slight yet meaningful change in the EFSA’s approach to GMO risk assessment including the way the EFSA has dealt with competing scientific opinions, risks and uncertainty involved in GMO regulation. Moreover, in the field of GMO authorizations under the new legislative framework, the European Parliament (EP) has actively intervened in the administrative authorization process. It should be noted that the outcome of this process remains unclear at the moment, given that at the time of writing the Commission has not yet taken its final decision on Maize 1507. The present report aims to offer an overview of this year-long and controversial process including the approaches taken by the relevant institutions involved therein.

Ignacio Carreño

Food: New EU Rules on the Country of Origin Labelling for Meat of Swine, Sheep, Goats and Poultry
European Journal of Risk Regulation 2/2014: pp. 213-217 [Report]
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On 13 December 2013, the European Commission adopted Implementing Regulation (EU) No 1337/2013 laying down rules for the application of Regulation (EU) No 1169/2011 of the European Parliament and of the Council as regards the indication of the country of origin or place of provenance for fresh, chilled and frozen meat of swine, sheep, goats and poultry (hereinafter, the implementing regulation)1. The new EU rules introducing country of origin labelling (hereinafter, COOL) for fresh, chilled and frozenmeat of pork, sheep, goat and poultry received a qualifiedmajority vote of EUMember States in the Standing Committee on Food Chain and Animal Health (Section: General food law, hereinafter the SCoFCAH) on 5 December 2013.

Blanca Salas

Food: Questions Raised in the Aftermath of the African Swine Fever Outbreak in the EU
European Journal of Risk Regulation 2/2014: pp. 218-222 [Report]
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Since the beginning of the year, a number of cases ofAfrican swine fever (hereinafter,ASF) inwild boar have been identified in the EU. In particular, two cases of ASF in wild boar were reported in Lithuania on 24 January 2014 and two additional cases were registered in Poland on 18 February 2014.1 ASF is most common at small farms and often spread by wild boar. There are no vaccines or drugs available forASF which, although harmless to humans, is considered one of the most dangerous diseases for pigs.

Richard P. Rozek

Intellectual Property: Risks Associated with Litigating or Settling Pharmaceutical Patent Matters
European Journal of Risk Regulation 2/2014: pp. 223-227 [Report]
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Within the context of a given patent litigation between a research based pharmaceutical company (patent holder) and a generic pharmaceutical company (alleged infringer), the research based pharmaceutical company must periodically assess the risks and rewards of continuing to litigate versus settling. I applied standard financial techniques to evaluate the business decision such a company faces regarding continuing to litigate versus settling a dispute with a generic pharmaceutical company seeking to sell a bioequivalent version of the product covered by the underlying patent.

David Azoulay and Vito Buonsante

Nanotechnology: Regulation of Nanomaterials in the EU: Proposed Measures to Fill in the Gap
European Journal of Risk Regulation 2/2014: pp. 228-235 [Report]
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This report discusses a proposal fromthe Center for International Environmental Law(CIEL), ClientEarth and Friends of the Earth Germany (Bund) on the regulation of nanomaterials in the European Union.1 It discusses in particular, the proposal for a horizontal regulation on nanomaterials (also referred to as a nano-patch for existing legislation) that would fill in the regulatory gap on nanomaterials. The proposal goes beyond a review of the REACH text and encompasses all EU legislation relevant to nanomaterials. The proposed instrument would amend the REACH text with delimitation in scope to all areas relevant to nanomaterials (on the model of Regulation 1272/2008 on the classification, labelling and packaging of chemicals). 2 The main aim of the regulation is to ensure that hazard, risk and exposure assessments for all forms and uses of such materials are adequately carried out and taken into consideration.

Riccardo Maggi

Regulatory Impact Assessment: Response to the Findings of Eurochambres 2013 SME Test Benchmark
European Journal of Risk Regulation 2/2014: pp. 236-237 [Report]
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Eurochambres 2013 “SME Test Benchmark” aims to examine whether SME impacts have been taken into consideration in recent Commission Impact Assessments (IA)1. This report is a timely contribution to the Commission's effort to strengthen its smart regulation tools. The Commission is in the process of revising its 2009 guidelines for impact assessments 2, including the operational guidance on assessing impacts onmicro-enterprises which was added in 2012.3 This will provide the opportunity to strengthen the guidance on the implementation of the “Think Small First” principle.

Sweta Chakraborty

Risk Communication: Risk and Crisis Communication Recommendations for Industry Based on Advances in Cognitive Behavioral Science Research
European Journal of Risk Regulation 2/2014: pp. 238-241 [Report]
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Advances in cognitive behavioral science have enhanced the understanding and development of both internal and external company risk communications. The gold standard for risk communication is to ensure that normative analysis identifying the information most relevant to the specific choices facing recipients has been conducted prior to any communication effort. It is all too often that this standard is not met, and particularly within private sector organizations.

Lukasz Gruszczynski

Trade, Investment and Risk: Australian Plain Packaging Law, International Litigations and Regulatory Chilling Effect
European Journal of Risk Regulation 2/2014: pp. 242-247 [Report]
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Introduction of plain packaging law by Australia in 2012 was met with strong opposition from transnational tobacco companies (TTCs).While advocates of the lawsee it as a logical step in governmental efforts to curb tobacco use and improve public health inAustralia, TTCs claim that the new law is scientifically unsound, overly intrusive and that it infringes anumber of international law provisions relating to trademark and property protection. Some TTCs, either directly or indirectly,havedecidedto test theAustralian measure before international tribunals.

Alessandro Spina

Risk Regulation of Big Data: Has the Time Arrived for a Paradigm Shift in EU Data Protection Law?
European Journal of Risk Regulation 2/2014: pp. 248-252 [Case Note]
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Case C-293/12 and C-594/12 Digital Rights Ireland and Seitlinger and others

The management of risks implies always a trade-off between fundamental values such as economic efficiency and collective welfare, scientific innovation, protection of the environment or health. It is accepted that digital products and applications present users with privacy risks. Uploading a picture, downloading an app, or even just clicking the button “like” on a social network can trigger unwanted consequences.

Tanja Ehnert

From Procrastination to Procedural Perfectionism – A Short Story of the Long Amflora Authorisation Process
European Journal of Risk Regulation 2/2014: pp. 253-258 [Case Note]
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Case T-240/10 Hungary v. Commission [2013]

In this judgment, the General Court annulled two Commission decisions authorising the placing on the market of the GM potato Amflora. The Court did not base its decision on the arguments put forward by the applicant Hungary, which contested the underlying scientific assessment of the European Food Safety Authority, but found of its own motion a breach of an essential procedural requirement in the applicable comitology procedure.Whilst the Court’s proactive role in scrutinising the Commission’s behaviour in the authorisation procedure of GMOs is to be welcomed, the Court arguably missed an opportunity to exercise its role as a deliberative forum for normative controversies underlying the scientific risk assessment. Directive 2001/18 on the deliberate release into the environment of genetically modified organisms, OJ 2001 L 106;Regulation 1829/2003 on geneticallymodified food and feed,OJ 2003 L 268; Article 5 of Commission Decision 1999/468 laying down the procedures for the exercise of implementing powers conferred on the Commission, OJ 1999 L 184.

Simone Gabbi

The Principle of Institutional (Un)Balance after Lisbon
European Journal of Risk Regulation 2/2014: pp. 259-266 [Case Note]
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Case C-270/12 United Kingdom of Great Britain and Northern Ireland v European Parliament and Council of the European Union, Judgment of the Court (Grand Chamber) of 22 January 2014

On 22 January 2014, the Grand Chamber of the Court of Justice confirmed the validity of the powers entrusted to the European Securities Markets Agency under Article 28 of Regulation (EU) No 236/2012, upholding their compatibility with the principle of institutional balance, the Lisbon Treaty and established case law of the CJEU. This case note gives an overview of the ruling and analyses its implications for ESMA and the broader Union institutional setting, with particular regard to the interplay between EU Institutions and agencies. It concludes by highlighting some reasons for potential constitutional concerns resulting from the combination of politically unchecked agencies and highly controlled Institutions.

Camilla Buchanan

The Conferral of Power to the Commission Put to the Test
European Journal of Risk Regulation 2/2014: pp. 267-272 [Case Note]
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Case C-427/12 Commission v European Parliament and Council (not yet reported)

- Article 290 TFEU - Article 291(2) TFEU - Article 80(1) of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, OJ 2012 L 167/1 1. The EU legislature has discretion when it decides to confer a delegated power on the Commission pursuant to Article 290(1) TFEU or an implementing power pursuant to Article 291(2) TFEU. Consequently, judicial reviewis limited tomanifest errors of assessment (official headnote) 2. The Commission appears to have more liberty under Article 290 TFEU than Article 291(2) TFEU, however this may be misleading. The difference between adding “further details” (implementing act) and supplementing or amending non-essential elements to a basic act (delegated act) is difficult to gauge. Furthermore, the control foreseen to be exercised by the Member States and the Parliament and Councilmay not function as planned (author’s headnote).

Stefano Barazza

Stem Cell Lines and Destruction of Human Embryos: the EPO Shares the Perspective of the Court of Justice
European Journal of Risk Regulation 2/2014: pp. 273-277 [Case Note]
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Case T 2221/10, Culturing stem cells/TECHNION, decision of the Technical Board of Appeal of the European Patent Office, 4 February 2014.

The Technical Board of Appeal of the European Patent Office, in case T 2221/101, held that Article 53(a) and Rule 28(c) of the European Patent Convention do not merely exclude the patentability of biotechnological inventions that make use of human embryonic stem cells obtained by de novo destruction of human embryos, but also apply to inventions which employ publicly available cell lines which were initially derived by a process resulting in the destruction of human embryos. The decision relies on the judgment of the Enlarged Board of Appeal in theWARF case, falling in line with the perspective endorsed by the Court of Justice of the European Union in Oliver Brüstle v Greenpeace.

Péter Cserne, Blake Chapman

Book Reviews
European Journal of Risk Regulation 2/2014: pp. 273-277 [Book Review]
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Behavioural Public Policy

by Adam Oliver (ed.) Cambridge: Cambridge University Press, 2013, 235 pp., € 25,95; Softcover

Why Nudge? The Politics of Libertarian Paternalism

by Cass R Sunstein New Haven: Yale University Press, 2014, 195 pp., € 17,63; Softcover


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