The importance of precision in sampling sludges, biowastes and treated soils in a regulatory framework

As part of the European Commission (EC)'s revision of the Sewage Sludge Directive and the development of a Biowaste Directive, there was recognition of the difficulty of comparing data from Member States (MSs) because of differences in sampling and analytical procedures. The 'HORIZONTAL' initiative, funded by the EC and MSs, seeks to address these differences in approach and to produce standardised procedures in the form of CEN standards. This article is a preliminary investigation into aspects of the sampling of biosolids, composts and soils to which there is a history of biosolid application. The article provides information on the measurement uncertainty associated with sampling from heaps, large bags and pipes and soils in the landscape under a limited set of conditions, using sampling approaches in space and time and sample numbers based on procedures widely used in the relevant industries and when sampling similar materials. These preliminary results suggest that considerably more information is required before the appropriate sample design, optimum number of samples, number of samples comprising a composite, and temporal and spatial frequency of sampling might be recommended to achieve consistent results of a high level of precision and confidence. (C) 2004 Elsevier Ltd. All rights reserved.

Opportunities for reduction in acute toxicity testing via improved design

The conventional method for assessing acute oral toxicity (OECD Test Guideline 401) was designed to identify the median lethal dose (LD50), using the death of animals as an endpoint. Introduced as an alternative method (OECD Test Guideline 420), the Fixed Dose Procedure (FDP) relies on the observation of clear signs of toxicity, uses fewer animals and causes less suffering. More recently, the Acute Toxic Class method and the Up-and-Down Procedure have also been adopted as OECD test guidelines. Both of these methods also use fewer animals than the conventional method, although they still use death as an endpoint. Each of the three new methods incorporates a sequential dosing procedure, which results in increased efficiency. In 1999, with a view to replacing OECD Test Guideline 401, the OECD requested that the three new test guidelines be updated. This was to bring them in line with the regulatory needs of all OECD Member Countries, provide further reductions in the number of animals used, and introduce refinements to reduce the pain and distress experienced by the animals. This paper describes a statistical modelling approach for the evaluation of acute oral toxicity tests, by using the revised FDP for illustration. Opportunities for further design improvements are discussed.

Glucokinase Regulatory Protein genetic variant interacts with omega-3 PUFA to influence insulin resistance and inflammation in metabolic syndrome

Glucokinase Regulatory Protein (GCKR) plays a central role regulating both hepatic triglyceride and glucose metabolism. Fatty acids are key metabolic regulators, which interact with genetic factors and influence glucose metabolism and other metabolic traits. Omega-3 polyunsaturated fatty acids (n-3 PUFA) have been of considerable interest, due to their potential to reduce metabolic syndrome (MetS) risk. Objective To examine whether genetic variability at the GCKR gene locus was associated with the degree of insulin resistance, plasma concentrations of C-reactive protein (CRP) and n-3 PUFA in MetS subjects. Design Homeostasis model assessment of insulin resistance (HOMA-IR), HOMA-B, plasma concentrations of C-peptide, CRP, fatty acid composition and the GCKR rs1260326-P446L polymorphism, were determined in a cross-sectional analysis of 379 subjects with MetS participating in the LIPGENE dietary cohort. Results Among subjects with n-3 PUFA levels below the population median, carriers of the common C/C genotype had higher plasma concentrations of fasting insulin (P = 0.019), C-peptide (P = 0.004), HOMA-IR (P = 0.008) and CRP (P = 0.032) as compared with subjects carrying the minor T-allele (Leu446). In contrast, homozygous C/C carriers with n-3 PUFA levels above the median showed lower plasma concentrations of fasting insulin, peptide C, HOMA-IR and CRP, as compared with individuals with the T-allele. Conclusions We have demonstrated a significant interaction between the GCKR rs1260326-P446L polymorphism and plasma n-3 PUFA levels modulating insulin resistance and inflammatory markers in MetS subjects. Further studies are needed to confirm this gene-diet interaction in the general population and whether targeted dietary recommendations can prevent MetS in genetically susceptible individuals.

The role of rules-based compliance systems in the new EU regulatory landscape: perspectives of institutional change

Purpose The research objective of this study is to understand how institutional changes to the EU regulatory landscape may affect corresponding institutionalized operational practices within financial organizations. Design/methodology/approach The study adopts an Investment Management System as its case and investigates different implementations of this system within eight financial organizations, predominantly focused on investment banking and asset management activities within capital markets. At the systems vendor site, senior systems consultants and client relationship managers were interviewed. Within the financial organizations, compliance, risk and systems experts were interviewed. Findings The study empirically tests modes of institutional change. Displacement and Layering were found to be the most prevalent modes. However, the study highlights how the outcomes of Displacement and Drift may be similar in effect as both modes may cause compliance gaps. The research highlights how changes in regulations may create gaps in systems and processes which, in the short term, need to be plugged by manual processes. Practical implications Vendors abilities to manage institutional change caused by Drift, Displacement, Layering and Conversion and their ability to efficiently and quickly translate institutional variables into structured systems has the power to ease the pain and cost of compliance as well as reducing the risk of breeches by reducing the need for interim manual systems. Originality/value The study makes a contribution by applying recent theoretical concepts of institutional change to the topic of regulatory change uses this analysis to provide insight into the effects of this new environment

The 'veil' of control: exploring the attitudes and perceptions of UK design controllers

In the UK, architectural design is regulated through a system of design control for the public interest, which aims to secure and promote ‘quality’ in the built environment. Design control is primarily implemented by locally employed planning professionals with political oversight, and independent design review panels, staffed predominantly by design professionals. Design control has a lengthy and complex history, with the concept of ‘design’ offering a range of challenges for a regulatory system of governance. A simultaneously creative and emotive discipline, architectural design is a difficult issue to regulate objectively or consistently, often leading to policy that is regarded highly discretionary and flexible. This makes regulatory outcomes difficult to predict, as approaches undertaken by the ‘agents of control’ can vary according to the individual. The role of the design controller is therefore central, tasked with the responsibility of interpreting design policy and guidance, appraising design quality and passing professional judgment. However, little is really known about what influences the way design controllers approach their task, providing a ‘veil’ over design control, shrouding the basis of their decisions. This research engaged directly with the attitudes and perceptions of design controllers in the UK, lifting this ‘veil’. Using in-depth interviews and Q-Methodology, the thesis explores this hidden element of control, revealing a number of key differences in how controllers approach and implement policy and guidance, conceptualise design quality, and rationalise their evaluations and judgments. The research develops a conceptual framework for agency in design control – this consists of six variables (Regulation; Discretion; Skills; Design Quality; Aesthetics; and Evaluation) and it is suggested that this could act as a ‘heuristic’ instrument for UK controllers, prompting more reflexivity in relation to evaluating their own position, approaches, and attitudes, leading to better practice and increased transparency of control decisions.

Introducing "ecoputation": a universal systems design process

A universal systems design process is specified, tested in a case study and evaluated. It links English narratives to numbers using a categorical language framework with mathematical mappings taking the place of conjunctions and numbers. The framework is a ring of English narrative words between 1 (option) and 360 (capital); beyond 360 the ring cycles again to 1. English narratives are shown to correspond to the field of fractional numbers. The process can enable the development, presentation and communication of complex narrative policy information among communities of any scale, on a software implementation known as the "ecoputer". The information is more accessible and comprehensive than that in conventional decision support, because: (1) it is expressed in narrative language; and (2) the narratives are expressed as compounds of words within the framework. Hence option generation is made more effective than in conventional decision support processes including Multiple Criteria Decision Analysis, Life Cycle Assessment and Cost-Benefit Analysis.The case study is of a participatory workshop in UK bioenergy project objectives and criteria, at which attributes were elicited in environmental, economic and social systems. From the attributes, the framework was used to derive consequences at a range of levels of precision; these are compared with the project objectives and criteria as set out in the Case for Support. The design process is to be supported by a social information manipulation, storage and retrieval system for numeric and verbal narratives attached to the "ecoputer". The "ecoputer" will have an integrated verbal and numeric operating system. Novel design source code language will assist the development of narrative policy. The utility of the program, including in the transition to sustainable development and in applications at both community micro-scale and policy macro-scale, is discussed from public, stakeholder, corporate, Governmental and regulatory perspectives.

Framing evidence: policy design for the zero carbon home

In 2006 the UK government announced a move to zero carbon homes by 2016. The demand posed a major challenge to policy makers and construction professionals entailing a protracted process of policy design. The task of giving content to this target is used to explore the role of evidence in the policy process. Whereas much literature on policy and evidence treats evidence as an external input, independent of politics, this paper explores the ongoing mutual constitution of both. Drawing on theories of policy framing and the sociology of classification, the account follows the story of a policy for Zero Carbon Homes from the parameters and values used to specify the target. Particular attention is given to the role of Regulatory Impact Assessments (RIAs) and to the creation of a new policy venue, the Zero Carbon Hub. The analysis underlines the way in which the choices about how to model and measure the aims potentially transforms them, the importance of policy venues for transparency and the role of RIAs in the authorization of particular definitions. A more transparent, open approach to policy formulation is needed in which the framing of evidence is recognized as an integral part of the policy process.

Infection Control in design and construction work

Objective: To clarify how infection control requirements are represented, communicated, and understood in work interactions through the medical facility construction project life cycle. To assist project participants with effective infection control management by highlighting the nature of such requirements and presenting recommendations to aid practice. Background: A 4-year study regarding client requirement representation and use on National Health Service construction projects in the United Kingdom provided empirical evidence of infection control requirement communication and understanding through design and construction work interactions. Methods: An analysis of construction project resources (e.g., infection control regulations and room data sheets) was combined with semi-structured interviews with hospital client employees and design and construction professionals to provide valuable insights into the management of infection control issues. Results: Infection control requirements are representationally indistinct but also omnipresent through all phases of the construction project life cycle: Failure to recognize their nature, relevance, and significance can result in delays, stoppages, and redesign work. Construction project resources (e.g., regulatory guidance and room data sheets) can mask or obscure the meaning of infection control issues. Conclusions: A preemptive identification of issues combined with knowledge sharing activities among project stakeholders can enable infection control requirements to be properly understood and addressed. Such initiatives should also reference existing infection control regulatory guidance and advice.

Legal and regulatory barriers to effective public-private partnership governance in Kazakhstan

Purpose – The purpose of this paper is to provide a critical assessment of legal and regulatory impediments to effective governance of public-private partnerships (PPPs) in Kazakhstan. Design/methodology/approach – The qualitative study develops propositions from the PPP literature and then tests them against findings from in-depth interviews. Interviewees have been selected by a purposeful sampling from PPP projects in Kazakhstan as well as from national and regional PPP centres. Findings – The identified barriers to effective PPP management include irregularities in the PPP legal framework, such as lack of legal definition of a PPP and controversy with the government guarantee’s legal status for its long-term payments to partnerships; bureaucratic tariff setting for partnership services; non-existent opportunity for private asset ownership; and excessive government regulation of PPP workers’ wage rates. Practical implications – The partners’ opposing perspectives on a number of PPP issues show that management needs to identify and carefully reconcile stakeholder values in a partnership in order to achieve more effective PPP governance. Practitioners, particularly those in the public agencies, have to be concerned with ways to reduce the government overregulation of the private operators, which is likely to result in greater PPP flexibility in management and, ultimately, higher efficiency in delivering the public services. Originality/value – By elucidating multiple examples of overregulation and PPPs’ inefficiency, the paper demonstrates that the government dominance in PPP management is conceptually inappropriate. Instead, the government should adopt the concept of co-production and manage its relations with the private sector partner in a collaborative fashion.