Precautionary principles: a jurisdiction-free framework for decision-making under risk

Fundamental principles of precaution are legal maxims that ask for preventive actions, perhaps as contingent interim measures while relevant information about causality and harm remains unavailable, to minimize the societal impact of potentially severe or irreversible outcomes. Such principles do not explain how to make choices or how to identify what is protective when incomplete and inconsistent scientific evidence of causation characterizes the potential hazards. Rather, they entrust lower jurisdictions, such as agencies or authorities, to make current decisions while recognizing that future information can contradict the scientific basis that supported the initial decision. After reviewing and synthesizing national and international legal aspects of precautionary principles, this paper addresses the key question: How can society manage potentially severe, irreversible or serious environmental outcomes when variability, uncertainty, and limited causal knowledge characterize their decision-making? A decision-analytic solution is outlined that focuses on risky decisions and accounts for prior states of information and scientific beliefs that can be updated as subsequent information becomes available. As a practical and established approach to causal reasoning and decision-making under risk, inherent to precautionary decision-making, these (Bayesian) methods help decision-makers and stakeholders because they formally account for probabilistic outcomes, new information, and are consistent and replicable. Rational choice of an action from among various alternatives-defined as a choice that makes preferred consequences more likely-requires accounting for costs, benefits and the change in risks associated with each candidate action. Decisions under any form of the precautionary principle reviewed must account for the contingent nature of scientific information, creating a link to the decision-analytic principle of expected value of information (VOI), to show the relevance of new information, relative to the initial ( and smaller) set of data on which the decision was based. We exemplify this seemingly simple situation using risk management of BSE. As an integral aspect of causal analysis under risk, the methods developed in this paper permit the addition of non-linear, hormetic dose-response models to the current set of regulatory defaults such as the linear, non-threshold models. This increase in the number of defaults is an important improvement because most of the variants of the precautionary principle require cost-benefit balancing. Specifically, increasing the set of causal defaults accounts for beneficial effects at very low doses. We also show and conclude that quantitative risk assessment dominates qualitative risk assessment, supporting the extension of the set of default causal models.

Incorporating international environmental legal principles into future climate change instruments

The article explores the role of international environmental legal principles and their role in future climate change instruments. The five international environmental legal principles explored in this context are: inter and intergenerational equity, the precautionary principle, common but differentiated responsibility, the polluter pays and principle and the principles of responsibility and prevention. Principles are used within regulatory frameworks to guide the interpretation and implementation of the obligations specified within the instrument. It is found that these principles provide a useful basis for the development of international adaptation and mitigation measures that are equitable and ethical in nature. This article argues that these principles must be drafted more strategically into international climate change instruments allowing them to serve as a foundational basis upon which more stringent and equitable binding duties and rights can be derived from. This article makes some recommendations as to the type of obligations that these principles could be used to inform in future climate instruments.

The legal nature of justice in REDD+

Formation of Reduced Emissions from Deforestation and Degradation (REDD+) policy within the international climate regime has raised a number of discussions about ‘justice’. REDD+ aims to provide an incentive for developing countries to preserve or increase the amount of carbon stored in their forested areas. Governance of REDD+ is multi-layered: at the international level, a guiding framework must be determined; at the national level, strong legal frameworks are a pre-requisite to ensure both public and private investor confidence and at the sub-national level, forest-dependent peoples need to agree to participate as stewards of forest carbon project areas. At the international level the overall objective of REDD+ is yet to be determined, with competing mitigation, biological and justice agendas. Existing international law pertaining to the environment (international environmental principles and law, IEL) and human rights (international human rights law, IHRL) should inform the development of international and national REDD+ policy especially in relation to ensuring the environmental integrity of projects and participation and benefit-sharing rights for forest dependent communities. National laws applicable to REDD+ must accommodate the needs of all stakeholders and articulate boundaries which define their interactions, paying particular attention to ensuring that vulnerable groups are protected. This paper i) examines justice theories and IEL and IHRL to inform our understanding of what ‘justice’ means in the context of REDD+, and ii) applies international law to create a reference tool for policy-makers dealing with the complex sub-debates within this emerging climate policy. We achieve this by: 1) Briefly outlining theories of justice (for example – perspectives offered by anthropogenic and ecocentric approaches, and views from ‘green economics’). 2) Commenting on what ‘climate justice’ means in the context of REDD+. 3) Outlining a selection of IEL and IHRL principles and laws to inform our understanding of ‘justice’ in this policy realm (for example – common but differentiated responsibilities, the precautionary principle, sovereignty and prevention drawn from the principles of IEL, the UNFCCC and CBD as relevant conventions of international environmental law; and UNDRIP and the Declaration on the Right to Development as applicable international human rights instruments) 4) Noting how this informs what ‘justice’ is for different REDD+ stakeholders 5) Considering how current law-making (at both the international and national levels) reflects these principles and rules drawn from international law 6) Presenting how international law can inform policy-making by providing a reference tool of applicable international law and how it could be applied to different issues linked to REDD+. As such, this paper will help scholars and policy-makers to understand how international law can assist us to both conceptualise and embody ‘justice’ within frameworks for REDD+ at both the international and national levels.

Decriminalization of Health and Safety at Work in Australia

ABOUT THE BOOK As the title Safety or Profit? suggests, health and safety at work needs to be understood in the context of the wider political economy. This book brings together contributions informed by this view from internationally recognized scholars. It reviews the governance of health and safety at work, with special reference to Australia, Canada, Sweden, and the United Kingdom. Three main aspects are discussed. The restructuring of the labor market: this is considered with respect to precarious work and to gender issues and their implications for the health and safety of workers. The neoliberal agenda: this is examined with respect to the diminished power of organized labor, decriminalization, and new governance theory, including an examination of how well the health-and-safety-at-work regimes put in place in many industrial societies about forty years ago have fared and how distinctive the recent emphasis on self-regulation in several countries really is. The role of evidence: there is a dearth of evidence-based policy. The book examines how policy on health and safety at work is formulated at both company and state levels. Cases considered include the scant regard paid to evidence by an official inquiry into future strategy in Canada; the lack of evidence-based policy and the reluctance to observe the precautionary principle with respect to work-related cancer in the United Kingdom; and the failure to learn from past mistakes in the Deepwater Horizon disaster in the Gulf of Mexico. Intended Audience: Researchers; policymakers, trade union representatives, and officials interested in OHS; postgraduate students of OHS; OHS professionals; regulatory and socio-legal scholars.

Environmental regulation in the pork producing industry - bring on the research!

Over the last 20 years, environmental management in Queensland has moved from the policy backwaters of government to the front line of operations by way of regulatory enforcement, industry programs and incentives. When the new Queensland Environmental Protection Act 1994 (EPA) came into effect, the business of environmental management has become a central feature of urban and rural development activity. The concept of environmentally sustainable development (ESD), has given life to the precautionary principle as a way for planners and regulators to place relevant controls on development. The planning, development and operation of pig farming systems has been effected by the new regulatory framework. Ever more definitive standards and approval permits have emerged which endeavour to achieve ESD. With these modern planning instruments in place, rural industry sectors have become, quite legitimately, concerned about future opportunities for research and innovation. This paper asserts that the capacity to engage in research and to achieve innovation in the pork producing industry is not hindered by Queensland environmental regulation frameworks. However, in order for research and innovation to prosper within these frameworks, some protocols need to be followed by the industry. What is at stake is community confidence.

Henipaviruses - unanswered questions of lethal zoonoses.

The highly lethal Hendra and Nipah viruses have been described for little more than a decade, yet within that time have been aetiologically associated with major livestock and human health impacts, albeit on a limited scale. Do these emerging pathogens pose a broader threat, or are they inconsequential 'viral chatter'. Given their lethality, and the evident multi-generational human-to-human transmission associated with Nipah virus in Bangladesh, it seems prudent to apply the precautionary principle. While much is known of their clinical, pathogenic and epidemiologic features in livestock species and humans, a number of fundamental questions regarding the relationship between the viruses, their natural fruit-bat host and the environment remain unanswered. In this paper, we pose and probe these questions in context, and offer perspectives based primarily on our experience with Hendra virus in Australia, augmented with Nipah virus parallels.

Der Vorsorgeansatz im Fischereimanagement

Since 1988 the ‘Precautionary Principle’ for human activities in the global environment has rapidly gained recognition in UN conferences (especially UNCED, Rio de Janeiro, 1992). For fisheries the UN Agreement on the Conservation and Management of Straddling Fish Stocks and Highly Migratory Fish Stocks was a milestone for the implementation of the Precautionary Approach to fisheries management. The International Council for the Exploration of the Seas (ICES) and the Scientific Council of NAFO (Northwest Atlantic Fisheries Organisation) were requested to implement the Precautionary Approach in the advice for fisheries management. The ICES concept for implementation consists of stock specific biological and management reference points, harvest control rules and recovery plans in case of overfished stocks. The NAFO concept is similar.

Responsabilidade socioambiental da empresa de petróleo e gás

O contexto da modernização reflexiva leva ao questionamento sobre o papel das instituições tradicionais, notadamente o Poder Executivo. É possível pressupor que o modelo da sociedade de risco se reflete em alterações no direito e na economia do Brasil. Os riscos tornaram-se uma constante e exigem substituições nas formas de atuação social, o que Ulrich Beck denomina de subpolítica. A mudança é sentida especialmente em setores centrais para economia, tais como o de petróleo e gás, enquanto os riscos globais são sentidos na crise ambiental. Uma vez que as instituições, na Sociedade de Risco, são levadas a rever sua atuação, o empresariado recebe a tarefa de encontrar mecanismos para superar a crise ambiental. A responsabilidade socioambiental da empresa passa a ser exigida como contrapartida pelos lucros obtidos, especialmente para atividades potencialmente poluentes, como a petrolífera. O princípio da precaução, o desenvolvimento sustentável e a equação financeira do contrato podem ser vetores para a adoção da responsabilidade socioambiental pela indústria petrolífera. Mas para que esta possa ser vista como uma nova razão pública deve se demonstrar que ela pode motivar a evolução da sociedade como um todo. A Rio+20 definiu a economia verde como uma nova meta, principalmente para as atividades potencialmente poluentes. O objetivo central do trabalho é investigar a regulação das empresas de petróleo e gás, especialmente sobre a possibilidade de adoção da responsabilidade socioambiental. Ressalte-se que esta visa impor medidas de conservação e ações pró meio ambiente, além daquelas já estipuladas por força legal ou pelo licenciamento ambiental. A pesquisa visa apresentar possíveis soluções para os questionamentos acima, garantindo segurança jurídica para empresas de petróleo e gás, mas ao mesmo tempo visando ampliar a sustentabilidade do setor, propondo novas regras que podem ser adotadas nos editais de licitação e nos contratos de concessão e partilha de produção. Em um momento que se debate a possibilidade de direcionamento dos royalties do petróleo exclusivamente para a educação o estudo de medidas jurídicas para implementar a responsabilidade socioambiental no setor petrolífero torna-se ainda mais necessária.

Avaliaçāo preliminar do estado da exploraçāo de Kapenta (Limnothrissa miodon, Boulenger 1906), em cahora bassa com base em dados históricos de captura e esforço de 1995-2000

The fishing of kapenta (Limnothrissa miodon, Boulenger 1906) on the Cahora Bassa Dam started around 1992, when considerable stocks of this species were discovered in the lake. The species is believed to have successful established in the Dam following a natural introduction through a downstream movement from Kariba dam where it was introduced in 1967/68. Fisheries statistics on the kapenta fishery have been collected since 1993 by the Ministry of Fisheries through the Provincial Offices for Fisheries Administration of Tete (SPAP - Tete) but only data from 1995 onward are available on the database of the Ministry of Fisheries and these are the data that was used for compiling the present report on which trends of fishing effort, catch and CPUE are analyzed. Catch and effort have increased with time, from a minimum of the 4 thousand metric tons for an annual fishing effort of 36 fishing rigs in 1995 to a maximum of 12 tons for a fishing effort of 135 rigs while CPUE followed a decreasing trend during the same period. Correlation analysis between catch and effort suggests that probably environmental factors may have influence on catch variation than the increase on fishing effort. Two models were applied for calculating MSY and FMSY resulting in two pairs of roof leading to two scenario of fisheries management. 10137 tons and a FMSY of 177 fishing rigs were computed using Schaefer model while 11690 tons and a FMSY of 278 were obtained using Fox model. Considering the differences between the two results and considering the fact that the two models have no differences in terms of precision and the fact that their determination coefficient are not different it is suggested, using the precautionary principle that result from Schaefer model be a adopted for fisheries management purpose.

Ecotoxicological screening of Kenyan tannery dust using a luminescent-based bacterial biosensor

Ecotoxicological screening of dust sampled throughout a Kenyan tannery was conducted using a luminescence (lux)-based bacterial biosensor for both solid and liquid assays. This was complemented by chemical analysis in an attempt to identify possible causative toxic components. The biosensor results showed a highly significant (p <0.001) difference in both solid and liquid phase toxicity in samples collected from various identified sampling points in the tannery. A positive correlation was observed between results of the solid and liquid phase techniques, for most of the sampling points indicating that the toxic contaminants were bioavailable both in the solid and liquid state. However, the results generally indicated toxicity associated with liquid phase except certain areas in solid phase such as chemical handling, buffing area and weighing. The most toxic tannery area identified was the weighing area (p <0.001), showing the lowest bioluminescence for both the solid (0.38 +/- 2.21) and liquid phases (0.01 +/- 0.001). Chromium was the metal present in the highest concentration indicating levels higher than the stipulated regulatory requirement of 0.5 mg Cr/m3 for total Cr (highest Cr concentration was at chemical handling at 209.24 mg l(-1)) in all dust samples. The weighing area had the highest Ni concentration (1.87 mg l(-1)) and the chemical handling area showed the highest Zn concentration (31.9 mg l(-1)). These results raise environmental health concerns, as occupational exposure to dust samples from this site has been shown to give rise to elevated concentrations (above the stipulated levels) of chromium in blood, urine and some body tissues, with inhalation being the main route. Health and Safety Executive (HSE), UK, and American Conference of Governmental Industrial Hygienist (ACGIH) and National Institute for Occupational Safety and Health (NIOSH), USA stipulates an occupational exposure limit of 0.5 mg Cr/m3 (8 h TWA) for total chromium. However, schedule 1 of Controls of substances hazardous to health (COSHH) regulations developed by HSE, indicate 0.05 mg m3 (8 h TWA reference periods) to be the limit for Cr (VI) exposure. The exposure limit for individual (e.g., Cr, Zn, Ni etc.) contaminants (homogeneity) was not exceeded, but potential impact of heterogeneity (multi-element synergistic effect) on toxicity requires application of the precautionary principle.

The struggle for safe staffing levels in the USA: A political economy of evidence-based practice

This paper examines the debate over nursing staff to patient ratios through the lens of Marxist political economy, arguing that the owners and controllers of healthcare in the USA have a vested interest in opposing mandated minimum ratios, while those involved in carrying out nursing care have a vested interest in their implementation, which coincides with the interests of patients. We examine how evidence-based practice articulates with social power, and proceed to interrogate the research methods used to generate evidence for practice, noting that randomised controlled trials are not suitable for evaluating nurse/patient ratios, which means that observational studies are the primary source of evidence. Representatives of nursing managers have used the fact that observational studies, while demonstrating an association between high ratios and poor outcomes, have not established a causal relationship, to support their argument that there is not sufficient evidence for the imposition of mandatory ratios. We argue that the precautionary principle provides firm justification for mandatory ratios, unless and until a causal relationship has been disproved. We conclude that those involved in the generation of evidence have to choose between technical arguments about the inferiority of observational studies, or emphasising their sufficiency in triggering the precautionary principle.

Le droit du commerce international des organismes génétiquement modifiés (OGM) agricoles médicaux : les perspectives d'encadrement normatif

"Thèse présentée à la Faculté des études supérieures de l'Université de Montréal en vue de l'obtention du grade de Docteur en droit (LL.D.)"

L’utilisation du TENS en physiothérapie : la situation particulière des soins palliatifs oncologiques

Étude de cas / Case study

Culture d'OGM dans un marché unique : Système d'autorisation centralisée versus choix des États membres

Malgré l’incertitude quant à leur sécurité à l’égard des personnes et de l’environnement, les cultures génétiquement modifiées (GM) ont été largement diffusées à travers le monde. En outre, dans de nombreux pays la coexistence des cultures GM avec les systèmes conventionnels de production et les systèmes de production biologique est habituelle. Dans l’Union européenne (UE), cependant, l’utilisation de cette technologie a soulevé d’importantes questions. Ces réserves sont reflétées dans le développement d’un cadre réglementaire particulièrement restrictif articulé autour d’une procédure unique d’approbation de ces cultures. De la même manière, le débat sur la coexistence des cultures GM avec la production agricole conventionnelle et la production biologique a été particulièrement animé dans l’UE. La première section de ce travail est consacrée à examiner comment, du fait de la complexité des nouvelles technologies, il est nécessaire, du point de vue régulateur, de faire face à des situations dans lesquelles les scientifiques ne peuvent encore fournir aucune réponse précise. Dans ce contexte, le principe de précaution est invoqué afin de limiter les dangers potentiels, mais ceci est sans préjudice des questions qui restent encore ouvertes sur la portée et la nature de ce principe. En tant que manifestations précises de ce principe de précaution, deux aspects sont abordés dans les secondes et troisièmes parties de ce travail. Nous analysons, d’abord, la procédure d’autorisation des produits GM dans l’UE, procédure spécifique basée sur le principe de précaution dans laquelle soit les institutions communautaires soit les autorités des États membres jouent un rôle important. Par rapport à ce cadre très réglementé de l’UE, la troisième partie examine le degré d’intervention des États membres. Ceci se manifeste principalement dans la possibilité d’adopter certaines clauses de sauvegarde pour limiter l’expansion des cultures GM ainsi que dans la réglementation de la coexistence des cultures GM avec les cultures conventionnelles et la possibilité d’exclure de la culture des OGM certaines zones. Finalement, quelques conclusions sont données dans la quatrième partie.

Approbation, mise en marché et surveillance après mise en marché des dispositifs médicaux à risque élevé : examen des enjeux socio-éthiques

La littérature abordant les enjeux socio-éthiques et réglementaires associés aux médicaments est relativement abondante, ce qui n’est pas le cas des dispositifs médicaux (DM). Ce dernier secteur couvre une très large diversité de produits qui servent à de multiples applications: diagnostic, traitement, gestion des symptômes de certaines conditions physiques ou psychiatriques, restauration d’une fonction débilitante, chirurgie, etc. À tort, on a tendance à croire que les DM sont réglementés de la même manière que les médicaments, que ce soit pour les exigences concernant leur mise en marché ou des pratiques de surveillance après mise en marché. Or, au cours des dernières années, leur usage élargi, leur impact sur les coûts des soins de santé, et les rappels majeurs dont certains ont fait l’objet ont commencé à inquiéter la communauté médicale et de nombreux chercheurs. Ils interpellent les autorités réglementaires à exercer une plus grande vigilance tant au niveau de l’évaluation des nouveaux DM à risque élevé avant leur mise en marché, que dans les pratiques de surveillance après mise en marché. Une stratégie plus rigoureuse d’évaluation des nouveaux DM permettrait d’assurer un meilleur suivi des risques associés à leur utilisation, de saisir la portée des divers enjeux socio-éthiques découlant de l’utilisation de certains DM, et de préserver la confiance du public. D’emblée, il faut savoir que les autorités nationales n’ont pas pour mandat d’évaluer la portée des enjeux socio-éthiques, ou encore les coûts des DM qui font l’objet d’une demande de mise en marché. Cette évaluation est essentiellement basée sur une analyse des rapports risques-bénéfices générés par l’usage du DM pour une indication donnée. L’évaluation des impacts socio-éthiques et l’analyse coûts-bénéfices relèvent des agences d’Évaluation des technologies de santé (ÉTS). Notre recherche montre que les DM sont non seulement peu fréquemment évalués par les agences d’ÉTS, mais l’examen des enjeux socio-éthiques est trop souvent encore incomplet. En fait, les recommandations des rapports d’ÉTS sont surtout fondées sur une analyse coûts-bénéfices. Or, le secteur des DM à risque élevé est particulièrement problématique. Plusieurs sont non seulement porteurs de risques pour les patients, mais leur utilisation élargie comporte des impacts importants pour les systèmes de santé. Nous croyons que le Principisme, au cœur de l’éthique biomédicale, que ce soit au plan de l’éthique de la recherche que de l’éthique clinique, constitue un outil pour faciliter la reconnaissance et l’examen, particulièrement par les agences d’ÉTS, des enjeux socio-éthiques en jeu au niveau des DM à risque élevé. Également, le Principe de Précaution pourrait aussi servir d’outil, particulièrement au sein des agences nationales de réglementation, pour mieux cerner, reconnaître, analyser et gérer les risques associés à l’évaluation et l’utilisation de ce type de DM. Le Principisme et le Principe de Précaution pourraient servir de repères 1) pour définir les mesures nécessaires pour éliminer les lacunes observées dans pratiques associées aux processus de réglementation, et 2) pour mieux cerner et documenter les enjeux socio-éthiques spécifiques aux DM à risque élevé.