Regulating Genetically Modified Organisms in Ireland – Laissez faire approach?

This chapter examines the legal framework applicable to genetically modified organisms (GMOs) in Ireland, bearing in mind the limited presence of GMOs. As a member of the European Union (EU), a specific, process-based regime applies regarding the authorisation and regulation of GMOs. This is intended to ensure a high level of environmental and human health protection and also enable producer and consumer choice. This regime is highly harmonized, but allows some flexibility regarding its implementation and, soon, the potential to opt-out from cultivation in part or entirely. Although, Ireland has only legislated on the area to the extent and in the manner required by the EU, it may avail of the opt-out in future – understandable in light of the lack of any cultivation currently and the green image of Ireland.
Complementary horizontal legislation and common law principles, relevant to labelling and varying forms of liability, deal with most issues that might arise quite comprehensively. However, they are quite complicated, overlapping and untailored and it is worth considering whether specific legislation should be developed to deal with liability related to GMOs.
Overall, Ireland holds varying stances to different forms of GMOs, with the greatest acceptance and use of GM-feed for pragmatic reasons. It has not developed a specific Irish approach, copy-pasting EU legislation and relying upon existing law to deal with any issues. This is understandable in light of the high level of harmonization and limited presence of GMOs in Ireland, but nonetheless will need to be developed as the availability of GMOs increases.

Attaining Subsidiarity-Based Multilevel Governance of Genetically Modified Cultivation?

The cultivation of genetically modified (GM) crops in the EU is highly harmonised, but with persisting conflicts over authority. The Commission responded to internal and external pressures with a more flexible approach to coexistence, a proposed opt-out clause and a promise to review the existing EU GM regime, providing an opportunity to consider and suggest paths of development. This article considers the post-authorisation policy-making powers of Member States and subnational regions, in light of subsidiarity-based multilevel governance. It considers the different approaches to risk-centred issues and more general policy choices. Overall, the developments occurring at the EU level are strengthening subsidiarity-based multilevel governance within the GM cultivation regime, but with significant opportunities to improve it further through focussing on the complementary powers, coordination and the regional levels in particular.

Justifying accounting change through global discourses and legitimation strategies. The case of the UK central government.

Accounting has been viewed, especially through the lens of the recent managerial reforms, as a neutral technology that, in the hands of rational managers, can support effective and efficient decision making. However, the introduction of new accounting practices can be framed in a variety of ways, from value-neutral procedures to ideologically-charged instruments. Focusing on financial accounting, budgeting and performance management changes in the UK central government, and through extensive textual analysis and interviews in three government departments, this paper investigates: how accounting changes are discussed and introduced at the political level through the use of global discourses; and what strategies organisational actors subsequently use to talk about and legitimate such discourses at different organisational levels. The results shows that in political discussions there is a consistency between the discourses (largely NPM) and the accounting-related changes that took place. The research suggests that a cocktail of legitimation strategies was used by organisational actors to construct a sense of the changes, with authorisation, often in combination with, at the very least, rationalisation strategies most widely utilised. While previous literature posits that different actors tend to use the same rhetorical sequences during periods of change, this study highlights differences at different organisational levels.

O âmbito de aplicação material da legislação de proteção de dados pessoais e o tratamento de imagem por pessoa singular

Images have gained a never before seen importance. Technological changes have given the Information Society extraordinary means to capture, treat and transmit images, wheter your own or those of others, with or without a commercial purpose, with no boundaries of time or country, without “any kind of eraser”. From the several different ways natural persons may engage in image processing with no commercial purpose, the cases of sharing pictures through social networks and video surveillance assume particular relevance. Consequently there are growing legitimate concerns with the protection of one's image, since its processing may sometimes generate situations of privacy invasion or put at risk other fundamental rights. With this in mind, the present thesis arises from the question: what are the existent legal instruments in Portuguese Law that enable citizens to protect themselves from the abusive usage of their own pictures, whether because that image have been captured by a smartphone or some video surveillance camera, whether because it was massively shared through a blog or some social network? There is no question the one's right to not having his or her image used in an abusive way is protected by the Portuguese constitution, through the article 26th CRP, as well as personally right, under the article 79th of the Civil Code, and finally through criminal law, articles 192nd and 193rd of the Criminal Code. The question arises in the personal data protection context, considering that one's picture, given certain conditions, is personal data. Both the Directive 95/46/CE dated from 1995 as well as the LPD from 1998 are applicable to the processing of personal data, but both exclude situations of natural persons doing so in the pursuit of activities strictly personal or family-related. These laws demand complex procedures to natural persons, such as the preemptive formal authorisation request to the Data Protection National Commission. Failing to do so a natural person may result in the application of fines as high as €2.500,00 or even criminal charges. Consequently, the present thesis aims to study if the image processing with no commercial purposes by a natural person in the context of social networks or through video surveillance belongs to the domain of the existent personal data protection law. To that effect, it was made general considerations regarding the concept of video surveillance, what is its regimen, in a way that it may be distinguishable from Steve Mann's definition of sousveillance, and what are the associated obligations in order to better understand the concept's essence. The application of the existent laws on personal data protection to images processing by natural persons has been analysed taking into account the Directive 95/46/CE, the LPD and the General Regulation. From this analysis it is concluded that the regimen from 1995 to 1998 is out of touch with reality creating an absence of legal shielding in the personal data protection law, a flaw that doesn't exist because compensated by the right to image as a right to personality, that anyway reveals the inability of the Portuguese legislator to face the new technological challenges. It is urgent to legislate. A contrary interpretation will evidence the unconstitutionality of several rules on the LPD due to the obligations natural persons are bound to that violate the right to the freedom of speech and information, which would be inadequate and disproportionate. Considering the recently approved General Regulation and in the case it becomes the final version, the use for natural person of video surveillance of private spaces, Google Glass (in public and private places) and other similar gadgets used to recreational purposes, as well as social networks are subject to its regulation only if the images are shared without limits or existing commercial purposes. Video surveillance of public spaces in all situations is subject to General Regulation provisions.

Derecho administrativo y autorregulación: la autorregulación regulada

El objeto de esta tesis es el análisis de la autorregulación regulada, es decir, el análisis de las normas y de los controles privados que poseen relevancia para el Derecho público. A pesar de su aparente desvinculación con el Derecho Administrativo, la autorregulación es una tendencia que se percibe cada vez con mayor nitidez; es, claramente, un fenómeno que se asocia principalmente al uso de nuevas tecnologías, pero que desborda con mucho este ámbito. La autorregulación es una noción directamente relacionada con la transformación de las formas de gobernanza impulsada desde la Unión Europea; es una nueva técnica o instrumento que las normas jurídico-públicas, a través de numerosas remisiones a la autorregulación, ponen en manos de la administración para gestionar los fines que ésta tiene encomendados. Existe, sin embargo una clara disociación entre las esperanzas puestas en la autorregulación y la falta de respuestas que ofrece el derecho positivo. Un análisis exhaustivo de la jurisprudencia y de la legislación que utilizan la voz "autorregulación" me ha llegado a concluir que este vocablo es en nuestro ordenamiento, un "término sin concepto". En esta fuentes se asimila la "autorregulación" con la capacidad de autonormación de un sujeto. Es el derecho comunitario el que la autorregulación como una alternativa o un complemento a la desreglamentación estatal y como una manifestación de un traslado de funciones y responsabilidades públicas a la sociedad. Por influencia del Derecho comunitario, el legislador pretende, a través de la autorregulación, alcanzar dos finalidades aparentemente contradictorias: (a) facilitar la función de garante que tiene atribuida el Estado, mediante una intervención más extensa i más intensa en las actividades privadas; (b) hacer efectivo los objetos propuestos con la desregulación, mediante una contención del ejercicio de la potestad reglamentaria y una disminución de los controles, preventivos o represivos, realizados directamente por la Administración. Para salvar esta contradicción, es necesario que el legislador establezca una regulación adecuada de la autorregulación. Dicha regulación es, hoy por hoy, manifiestamente insuficiente. Deberían fijarse con carácter general -y no sólo puntualmente y por sectores- las medidas adecuadas para el fomento de la autorregulación; los efectos públicos que ésta posee en cada caso y, significativamente, las garantías y controles necesarios para contrarrestar tales efectos. Esto es, los principios que rigen la actividad administrativa deberían ser aplicados también a la autorregulación en aquellos casos en los que sus diversas manifestaciones poseen efectos similares a los que son propios de los reglamentos, las inspecciones o las sanciones administrativas. Esta propuesta deja abierta la cuestión acerca de la incidencia recíproca de ambas técnicas; esto es , la incidencia de la regulación pública en la autorregulación de origen privado y, a la inversa, el impacto del desarrollo de la autorregulación regulada en el ejercicio de las potestades reglamentaria, autorizatoria, y sancionadora de la Administración. Esta cuestión sólo puede ser contestada hoy caso por caso, de modo que la respuesta es distinta si se analiza una norma técnica, un código ético, un manual de buenas prácticas, una certificación privada del cumplimiento de normas técnicas, el ejercicio de la potestad disciplinaria privada o el arbritaje. De lo que no cabe duda alguna es que ni la autorregulación es sólo una actividad de interés privado, ni la regulación pública conserva hoy sus rasgos tradicionales.

Variability associated to the insertion and expression of transgenes in plants

Amb la finalitat de garantir la seguretat dels consumidors i del medi ambient, a la UE els aliments modificats genèticament (MG) estan sotmesos a un rigorós procés d'autorització que inclou: caracterització molecular del transgèn i anàlisis comparatives a nivell nutricional i agronòmic. L'ús de tècniques de profiling per avaluar la possible existència d'efectes no esperats derivats de la inserció i/o expressió del transgèn s'ha proposat com a una eina complementària per l'avaluació de la seguretat alimentària. L'objectiu de la present tesis és avaluar la variabilitat associada a la inserció i expressió de transgens en plantes, utilitzant com a exemple el blat de moro MON810. Es pretén complementar les aproximacions ja existents basades en l'estudi de paràmetres concrets mitjançant les tècniques de profiling. Des del punt de vista transcriptòmic i proteòmic, les varietats de blat de moro MON810 semblen ser substancialment equivalents a les seves varietats comparables no-MG. En conseqüència, és possible la producció de plantes MG amb el mínim d'efectes no esperats.

Europe’s New Post-Trade Infrastructure Rules. ECMI Policy Brief No. 20, 8 November 2012

After more than a decade of indecision, the EU is finally now set to implement a consistent regulatory architecture for clearing and settlement. Following the agreement on a European market infrastructure Regulation (EMIR), the European Commission has proposed harmonised rules for centralised settlement depositaries (CSDs), while the European Central Bank is moving forward with its plans for a central eurozone settlement engine. This paper analyses three components of the new post-trade infrastructure measures: 1) the regulatory framework for and supervision of central counterparties under the new EMIR legislation, 2) the authorisation requirements of trade repositories and 3) the draft CSD Regulation and the progress with the ECB’s Target 2 Securities project. It then discusses the impact of the new rules, and argues that, analogous to the unexpected impact of MiFID on trading infrastructures, a similar EMIR revolution may be on its way.

The comparative toxicity to soil invertebrates of natural chemicals and their synthetic analogues

The introduction of Registration, Evaluation and Authorisation of Chemicals (REACH), requires companies to register and risk assess all substances produced or imported in volumes of >1 tonne per year. Extrapolation methods which use existing data for estimating the effects of chemicals are attractive to industry, and comparative data are therefore increasingly in demand. Data on natural toxic chemicals could be used for extrapolation methods Such as read-across. To test this hypothesis, the toxicity of natural chemicals and their synthetic analogues were compared using standardised toxicity tests. Two chemical pairs: the napthoquinones, juglone (natural) and 1,4-naphthoquinone (synthetic); and anthraquinones, emodin (natural) and quinizarin (synthetic) were chosen, and their comparative effects on the survival and reproduction of collembolans, earthworms, enchytraeids and predatory mites were assessed. Differences in sensitivity between the species were observed with the predatory mite (Hypoaspis aculeifer) showing the least sensitivity. Within the chemical pairs, toxicity to lethal and sub-lethal endpoints was very similar for the four invertebrate species. The exception was earthworm reproduction, which showed differential sensitivity to the chemicals in both naphthoquinone and anthraquinone pairs. Differences in toxicity identified in the present study may be related to degree of exposure and/or subtle differences in the mode of toxic action for the chemicals and species tested. It may be possible to predict differences by identifying functional groups which infer increased or decreased toxicity in one or other chemical. The development of such techniques would enable the use of read-across from natural to synthetic chemicals for a wider group of compounds. (C) 2009 Elsevier Ltd. All rights reserved.

The medieval papacy and holy war: General crusading letters and papal authority, 1145-1213

Chapter in an edited collection on the twelfth-century papacy and its authorisation of crusades to the Near East.

No asylum for “Infiltrators”: the legal predicament of Eritrean and Sudanese nationals in Israel

This article explores the precarious status of Eritrean and Sudanese nationals in Israel. Having crossed the Israeli-Egyptian border without authorisation and not through an official border crossing, Israeli law defines such individuals as ‘infiltrators’, a charged term which dates back to border-crossings into Israel by Palestinian Fedayeen in the 1950s. Eritreans and Sudanese nationals constitute over 90 percent of ‘infiltrators’ in Israel. Their livelihood is curtailed through hostility, sanctions, and detention, while (at the time of writing) Israel refrains from deporting them to their respective countries of origin, recognising that such forced removal could expose them to risks to their lives and/or freedom. Israel was the 10th state to ratify the 1951 Refugee Convention, and has acceded to its 1967 Protocol which removed the 1951 Convention’s temporal and geographic restrictions, yet it has not incorporated these treaties into its domestic law not has it enacted primary legislation that sets eligibility criteria for ‘refugee’ status and regulates the treatment of asylum-seekers. Israeli law also fails to accord subsidiary protection status to persons that the state considers to be non-removable, whether or not they satisfy the definition of a ‘refugee’ under the 1951 Convention. Absent legal recognition of ‘refugee’, ‘asylum-seeker’, and ‘beneficiary of subsidiary protection’ statuses, Eritreans and Sudanese nationals are left in legal limbo for an indefinite period qua irregular non-removable persons. This article takes stock of their legal predicament.

Population size of threatened and endemic birds of the Cerrado in Estacao Ecologica de Itirapina, a fragmented area in the State of Sao Paulo, Brazil

The pressures for land use change have led to an increasing isolation of habitat remnants throughout the world. The goal of this study was to estimate the population size and density of some endemic and threatened species in a nature reserve in the Cerrado biome. One hundred and thirty four point transects were undertaken at the Estacao Ecologica de Itirapina (EEI), one of the last natural grassland savannah remnants in Sao Paulo state, in the south-east of Brazil between September and December 2006 and densities estimated for seven species (four endemic to the Cerrado, one near-endemic and two grassland specialists). Neither species reached the minimum viable population size of 500-5000 individuals. Four species, White-banded Tanager, White-rumped Tanager, Black-throated Saltator and Sharp-tailed Tyrant have populations ranging from 112 to 248 individuals, while the other species have a low population (< 60 individuals). The mean densities of Sharp-tailed Tyrant and Cock-tailed Tyrant in the EEI grassland showed similar values to those observed in larger areas of the Cerrado, which may indicate that the EEL grassland area is well conserved. In spite of the restricted size of the EEI, small areas can maintain some endemic and threatened bird populations, thus contributing to local biodiversity and the ecological processes in the region. The capacity of fragments of Cerrado (similar to 2,000 ha) to maintain populations of endemic and threatened bird species is unlikely to be effective in the long term.

Games as Cultural Heritage: Copyright Challenges for Preserving (Orphan) Video Games in the EU

The long-term preservation of complex works such as video games comes with many challenges. Emulation, currently the most adequate preservation strategy for video games, requires several acts that are technically possible, but closely governed and restricted by copyright law and technical protection measures. Without prior authorisation from the rightsholder(s), it is therefore difficult to legally emulate these works. However, games often have several rightsholders that are in some cases near impossible to identify or locate – particularly with regard to older games. This paper therefore focuses on these so-called orphan video games and examines whether (and to what extent) they are covered by the directive on certain permitted uses of orphan works 2012/28/EU (Orphan Works Directive). As complex works with software and audiovisual components, it is difficult to classify video games in their entirety. The Orphan Works Directive, however, only covers certain categories of works. This paper therefore analyses 1) whether video games in their entirety can be considered types of works that fall under the directive, i.e. audiovisual or cinematographic works, and 2) whether the provisions of the orphan work exception are suitable for the specifics of these complex, “multimedia” works.

Integrated testing strategy (ITS) for bioaccumulation assessment under REACH

REACH (registration, evaluation, authorisation and restriction of chemicals) regulation requires that all the chemicals produced or imported in Europe above 1 tonne/year are registered. To register a chemical, physicochemical, toxicological and ecotoxicological information needs to be reported in a dossier. REACH promotes the use of alternative methods to replace, refine and reduce the use of animal (eco)toxicity testing. Within the EU OSIRIS project, integrated testing strategies (ITSs) have been developed for the rational use of non-animal testing approaches in chemical hazard assessment. Here we present an ITS for evaluating the bioaccumulation potential of organic chemicals. The scheme includes the use of all available data (also the non-optimal ones), waiving schemes, analysis of physicochemical properties related to the end point and alternative methods (both in silico and in vitro). In vivo methods are used only as last resort. Using the ITS, in vivo testing could be waived for about 67% of the examined compounds, but bioaccumulation potential could be estimated on the basis of non-animal methods. The presented ITS is freely available through a web tool.

Apontamentos críticos à distribuição dinâmica do ônus da prova

O ônus da prova tem sido tradicionalmente distribuído no processo civil brasileiro segundo disposições legais prévias, contidas em geral no artigo 333 do Código de Processo Civil e que em geral seguem os brocados jurídicos onus probandi incumbit ei qui allegat, probatio incumbit asserenti e semper necessitas probandi incumbit illi quit agit. Nos últimos anos, no entanto, tem crescido na doutrina e na jurisprudência a tendência de atribuir o onus probandi à parte que supostamente tem mais facilidade em produzir a prova nos autos, independentemente da distribuição predeterminada pela lei. A inspiração para esta mudança vem da teoria argentina das cargas probatórias dinâmicas, introduzida pelo juiz Jorge Peyrano e que teria suas raízes, supostamente, no trabalho de Jeremy Bentham. O projeto de um novo Código de Processo Civil, que está sendo discutido no Congresso Nacional, muito provavelmente incluirá disposição autorizado expressamente que o juiz desloque o ônus da prova de uma parte para a outra quando entender que esta última tem melhores condições de produzí-la. Os riscos invocados contra esta teoria são o aumento da insegurança jurídica, da possibilidade de arbitrariedade do julgador e da dificuldade de estabelecer previsões sobre sucesso processual, impedindo que as partes possam tomar as melhores decisões sobre como se portar antes e durante um eventual processo. Também há crítica contra o enfraquecimento da imparcialidade do juiz, o que, segundo os defensores da teoria, não ocorreria. Uma análise dos argumentos contra e a favor da teoria do ônus dinâmico da prova, dos instrumentos já existentes no direito brasileiro para os problemas que esta teoria vida atacar, e das novas disposições legais a serem em breve introduzidas demonstra que existe uma linha tênue a ser traçada e seguida para que se atinjam os benefícios pretendidos, sem cair em novos problemas. É importante adotar e interpretar as novas normas processuais cuidadosa e atenciosamente, de modo a evitar prejuízo a garantias básicas dos jurisdicionados.

Authorisations under EU internal market rules. Research Paper in Law, 05/2013

From the Introduction. That the requirement of a prior authorisation, as a precondition for the exercise of any economic activity, may restrict the freedom of establishment and the free provision of services is a truism. If an authorisation is required in the Member State where establishment is to take place or the service is to be offered (host Member State), then operators who lack such authorisation are in no right to proceed to the projected activity. Therefore, as soon as it is being accepted that the EU internal market rules are not only about discriminatory measures, but also cover mere restrictions, it comes as no surprise that national authorisation systems come to be scrutinized under the Internal Market rules.