Process-based Regulation Research Articles

The California Effect, Process-Based Regulation, and the Future of Pike Balancing

The California Effect, Process-Based Regulation, and the Future of Pike Balancing

The Effects of Procedural Justice on Obligation to Obey, and Compliance among Incarcerated Offenders in South Africa

This study explores the impacts of procedural justice on incarcerated offenders’ obligation to obey, and compliance with correctional rules and procedures in selected South African correctional centers. The Tylerian process-based regulation model holds that compliance with legal authorities is contingent upon some normative and instrumental factors. While these factors have been considered to shape compliance among inmates in correctional centers in Western societies, there is a dearth of research on compliance behavior among incarcerated offenders in correctional centers in transitional African societies, including South Africa. A cross-sectional survey of participants from selected correctional centers in South Africa assessed the effect of procedural justice and other exogenous elements on inmates’ obligation to obey and comply with correctional rules and procedures. The findings indicate, among others, that inmates who assessed correctional officials as procedurally just or fair were more likely to obey and comply with correctional rules and procedures. The implications of the findings for the effective management of incarcerated offenders are discussed.

The Object-Based and Process-Based Regulation of Genome Editing.

The article explores whether the broader regulatory framework applicable to the member states of the EU contains suitable tools to react to the rapid advances in science, especially as to the question of germline editing technologies. From the perspective of EU member states, the regulatory framework is fragmented between norms of international law, secondary EU law and national legislation. The rules and their interpretation are strongly influenced by the concept of precaution, which reflects the concern that there is not enough knowledge to assess the impact of genome editing technology on individuals, society and future populations. However, the argument of precaution loses its strength with every new scientific discovery. The expanding knowledge in the field creates the need to replace regulation, which is based on the lack of knowledge (such as precautionary moratoriums) by the regulation that is based on the actual knowledge. The article reaches a conclusion that the EU framework for advanced treatments and medicinal products is in a state where it can, in principle, address the questions associated with the safety and efficacy of germline editing technologies. The EU framework is, however, not suitable to assess the moral and societal impacts of new technology, which should be left for member states.

The California Effect, Process-Based Regulations, and the Dormant Commerce Clause

The California Effect, Process-Based Regulations, and the Dormant Commerce Clause

Disruptive life event or reflexive instrument? On the regulation of hospital mergers from a quality of care perspective

PurposeDespite the continuation of hospital mergers in many western countries, it is uncertain if and how hospital mergers impact the quality of care. This poses challenges for the regulation of mergers. The purpose of this paper is to understand: how regulators and hospitals frame the impact of merging on the quality and safety of care and how hospital mergers might be regulated, given their uncertain impact on quality and safety of care.Design/methodology/approachThis paper studies the regulation of hospital mergers in The Netherlands. In a qualitative study design, it draws on 30 semi-structured interviews with inspectors from the Dutch Health and Youth Care Inspectorate (Inspectorate) and respondents from three hospitals that merged between 2013 and 2015. This paper draws from literature on process-based regulation to understand how regulators can monitor hospital mergers.FindingsThis paper finds that inspectors and hospital respondents frame the process of merging as potentially disruptive to daily care practices. While inspectors emphasise the dangers of merging, hospital respondents report how merging stimulated them to reflect on their care practices and how it afforded learning between hospitals. Although the Inspectorate considers mergers a risk to quality of care, their regulatory practices are hesitant.Originality/valueThis qualitative study sheds light on how merging might affect key hospital processes and daily care practices. It offers opportunities for the regulation of hospital mergers that acknowledges rather than aims to dispel the uncertain and potentially ambiguous impact of mergers on quality and safety of care.

European Court of Justice delivers no justice to Europe on genome-edited crops.

European Court of Justice delivers no justice to Europe on genome-edited crops.

Trends in the global regulation of new breeding techniques and perspective

‘New Breeding Techniques (NBTs)’ have been one of hot issues, since their future will be affected profoundly by national as well as international regulatory landscapes. In this review, we compare characteristics of NBTs with conventional and genetic modification, and analyze genetically modified organism (GMO) regulatory systems in the context of possible regulation of NBTs. NBTs are very heterogeneous in terms of principles, methodologies, and final products. As Living Modified Organisms (LMO) is defined in the Cartagena Protocol on Biosafety (CPB) as an organism containing novel combination of genetic materials obtained by the use of modern biotechnology, CPB as well as other national legislations locate itself somewhere in the middle between product-based and process-based regulations. It is also noted that jurisdictions with regulatory systems more oriented to product-based one tend to be more productive and decide or may decide to exempt site-directed nucleases-1 from GMO regulation. In this context, Korean legislations are reviewed to clarify the commons and differences in GMO definitions. Act on Transboundary Movement of LMO Act, Food Sanitation Act and Agricultural and Fishery Products Quality Control Act are three major acts to regulate GMOs. It is noted that there are differences in the definition of LMO or GM food/products especially between the LMO Act and the Food Sanitation Act. Such differences may cause conflicts between Acts when policydecision regarding the regulation of NBTs is made. Therefore, it is necessary to reorganize legislations before policies regarding the regulation of any techniques from biotechnology are made.

DNA-Free Genome Editing of Brassica oleracea and B. rapa Protoplasts Using CRISPR-Cas9 Ribonucleoprotein Complexes.

The CRISPR/Cas9 genome editing system has already proved its efficiency, versatility and simplicity in numerous applications in human, animal, microbe and plant cells. Together with the vast amount of genome and transcriptome databases available, it represents an enormous potential for plant breeding and research. Although most changes produced with CRISPR/Cas9 do not differ from naturally occurring mutations, the use of transgenesis during varietal development can still trigger GMO legislation in countries that rely on process-based regulation. Moreover, stable integration of DNA coding for genome-editing tools into plant genomes can result in insertional mutagenesis, while its prolonged expression can cause mutations in off-target sites. These pitfalls can be avoided with the delivery of preassembled ribonucleoprotein complexes (RNPs) composed of purified recombinant enzyme Cas9 and in vitro-transcribed or synthesized sgRNA. We therefore aimed to develop a DNA-free protocol for site-directed mutagenesis of three species of the genus Brassica (B. oleracea, B. napus, and B. rapa) with the use of RNPs. We chose cabbage, rapeseed and Chinese cabbage as species representatives and introduced RNPs into their protoplasts with PEG 4000. Four sgRNAs targeting two endogenous genes (the FRI and PDS genes, two sgRNAs per gene) were introduced into all three species. No mutations were detected after transfection of rapeseed protoplasts, while we obtained mutation frequencies of 0.09 to 2.25% and 1.15 to 24.51% in cabbage and Chinese cabbage, respectively. In both species, a positive correlation was displayed between the amount (7.5, 15, 30, and 60 μg) of Cas9 enzyme and sgRNA introduced and mutation frequency. Nucleotide changes (insertions and deletions) were detected 24 h after transfection and did not differ 72 h after transfection. They were species-, gene- and locus-dependent. In summary, we demonstrated the suitability of RNP transfection into B. oleracea and B. rapa protoplasts for high-efficiency indel induction of two endogenous genes. Due to the relatively high mutation frequencies detected (up to 24.51%), this study paves the way for regeneration of precisely mutated Brassica plants without the use of transgenesis.

Gene editing in livestock: promise, prospects and policy.

Abstract Although genetically engineered livestock were first introduced in the 1980s, only three biomedical applications (ATryn®, Ruconest®, Kanuma®) and one food animal application (AquAdvantage® salmon) have been brought to market. The initial promise of this technology was hampered by low efficiency, random site integration, public resistance and regulatory hurdles. Gene editing has made it possible to precisely target changes in livestock genomes, overcoming previous challenges. Livestock and poultry editing applications include disease resistance, animal welfare, production traits, animals as bioreactors, xenotransplantation and the development of models for human diseases. The extent to which any of these applications are utilized beyond research laboratories will depend upon regulatory frameworks, uptake by livestock producers and industry, and public acceptance. The 2017 draft US Food and Drug Administration regulatory guidance for gene edited animals, which proposes to regulate 'intentional' genomic alterations introduced by editing as new animal drugs irrespective of product novelty or risk, is at odds with emerging regulations around gene edited plants. Lengthy process-based regulation triggered by human 'intention' rather than novel product risk may dissuade animal genetics companies and breeders from employing gene editing to introduce beneficial genetic alterations into livestock populations, effectively the same fate encountered by genetic engineering in animals. Goal conflicts will likely continue between genetic innovations to address problems like animal disease and welfare and concerns around the use of modern molecular genetics in food animals. The early applications that successfully navigate regulatory hurdles will influence the public discussion around gene edited animals and impact the trajectory of future applications.

Procedurally just cooperation: Explaining support for due process reforms in policing

PurposeWe explore criminal justice workers' (CJW) support for due process reforms in policing. We build on and integrate four related literatures—scholarship analyzing 1) process-based regulation, 2) the generality of procedural justice, 3) the bilateral and dialogical nature of legitimacy, and 4) the tensions between the due process versus crime control models of criminal justice. We hypothesize that when citizens exercise procedural justice in their decisions about how to respond to legal authorities' inquiries and directives it enhances “rights legitimacy” and increases CJW's support for the due process model of criminal justice. MethodsWe analyze data from a nationwide sample (N=579) of CJW. We examine whether CJW's perceptions that citizens are fair and respectful toward police are associated with their support for due process reforms. ResultsProcedurally just cooperation predicts support for due process reforms among police officers and other CJW, both before and after a highly publicized negative police-citizen encounter (the police killing of Michael Brown), and regardless of respondents' race, gender or career length. ConclusionsThe findings support the generality of the process-based model and the bilateral and dialogical nature of legitimacy.

Process-based regulation of low-importance processes

No abstract available.

Accident and Design: Contemporary Debates in Risk Management

Anticipation in risk management - a stich in time...? Anticipation versus reliance, Christopher Hood, David Jones Anticipating the risk posed by natural perils, David Jones Hazard engineering, David Blockley Resilience, flexibility and diversity in managing the risks of technologies, David Collingridge. Absolution, liability and blame - pointing the finger: Absolutism versus blame, Christopher Hood, david Jones Criminal law, blame and risk: the case of corporate manslaughter, Celia Wells The problem of blame, Tom Horlick-Jones Blame, punishment and risk management, A. Neil Johnston. Quantitative risk assessment and risk management - faith in figures: The extent to which statistics are signs from God, Christopher Hood, David Jones Quantitative risk assessment and decisions about risk: an essential input into the decision process, A.V. Cohen Limits to the mathematical modelling of disasters, B. Toft. Designing institutions - a house of cards? The feasibility of institutional design in risk management, Christopher Hood, David Jones Risk and disaster: the role of communications breakdown in plane crashes and business failure, David Weir Criteria for the design of hazard mitigation instructions, Edmund Penning-Rowsell. Counting the cost: Risk reduction, but at what price? Christopher Hood, David Jones Is safety a by-product of quality management, Tom Horlick-Jones Risk management: an economist's approach, Sir Christopher Foster. Participation in risk management decisions: To what extent is risk management best left to experts, Christopher Hood, David Jones technocracy, democracy, secrecy and error, Nick Pidgeon Risk management, post-normal science and extended peer communities, Silvio O. Funtowicz, Jerome R. Ravetz Exploring the role of civic science in risk management, Timothy O'Riordan. The regulatory target - crying over spilt milk: Should regulation be targeted on physical products or institutional processes, Christopher Hood, David Jones Risk and emerging technology: the case of process-based regulation of biotechnology in Europe, Simon Shohet. Conclusion - learning from your desk lamp: Homeostatic versus collaborationist approaches to risk management, Christopher Hood, David Jones When extremes meet: sprat versus shark in public risk management, Christopher Hood.

Biotechnology in Europe: contentions in the risk-regulation debate

The technical arguments for and against process-based regulation of biotechnology are reviewed, and the positions of proponents and opponents are examined, using the UK as a case. In particular, the findings of the Royal Commission on Environmental Pollution in 1989, which was in favour of specific regulation of genetic modification, are contrasted with the recommendations of the UK House of Lords Committee on Science and Technology, which in 1993 argued strongly for the relaxation of specific regulation of biotechnology. The various contentions about process-based regulation are examined critically, and the case is put that the precautionary approach, which was the basis of rules adopted in Europe in the late 1980s, can be justified. Copyright , Beech Tree Publishing.