Bottom-up risk regulation? How nanotechnology risk knowledge gaps challenge federal and state environmental agencies

Nanotechnologies have been called the "Next Industrial Revolution." At the same time, scientists are raising concerns about the potential health and environmental risks related to the nano-sized materials used in nanotechnologies. Analyses suggest that current U.S. federal regulatory structures are not likely to adequately address these risks in a proactive manner. Given these trends, the premise of this paper is that state and local-level agencies will likely deal with many "end-of-pipe" issues as nanomaterials enter environmental media without prior toxicity testing, federal standards, or emissions controls. In this paper we (1) briefly describe potential environmental risks and benefits related to emerging nanotechnologies; (2) outline the capacities of the Toxic Substances Control Act, the Clean Air Act, the Clean Water Act, and the Resources Conservation and Recovery Act to address potential nanotechnology risks, and how risk data gaps challenge these regulations; (3) outline some of the key data gaps that challenge state-level regulatory capacities to address nanotechnologies' potential risks, using Wisconsin as a case study; and (4) discuss advantages and disadvantages of state versus federal approaches to nanotechnology risk regulation. In summary, we suggest some ways government agencies can be better prepared to address nanotechnology risk knowledge gaps and risk management.

The missing ingredient:inter-municipal cooperation and central-local relations in the UK

The thrust of the argument presented in this chapter is that inter-municipal cooperation (IMC) in the United Kingdom reflects local government's constitutional position and its exposure to the exigencies of Westminster (elected central government) and Whitehall (centre of the professional civil service that services central government). For the most part councils are without general powers of competence and are restricted in what they can do by Parliament. This suggests that the capacity for locally driven IMC is restricted and operates principally within a framework constructed by central government's policy objectives and legislation and the political expediencies of the governing political party. In practice, however, recent examples of IMC demonstrate that the practices are more complex than this initial analysis suggests. Central government may exert top-down pressures and impose hierarchical directives, but there are important countervailing forces. Constitutional changes in Scotland and Wales have shifted the locus of central- local relations away from Westminster and Whitehall. In England, the seeding of English government regional offices in 1994 has evolved into an important structural arrangement that encourages councils to work together. Within the local government community there is now widespread acknowledgement that to achieve the ambitious targets set by central government, councils are, by necessity, bound to cooperate and work with other agencies. In recent years, the fragmentation of public service delivery has affected the scope of IMC. Elected local government in the UK is now only one piece of a complex jigsaw of agencies that provides services to the public; whether it is with non-elected bodies, such as health authorities, public protection authorities (police and fire), voluntary nonprofit organisations or for-profit bodies, councils are expected to cooperate widely with agencies in their localities. Indeed, for projects such as regeneration and community renewal, councils may act as the coordinating agency but the success of such projects is measured by collaboration and partnership working (Davies 2002). To place these developments in context, IMC is an example of how, in spite of the fragmentation of traditional forms of government, councils work with other public service agencies and other councils through the medium of interagency partnerships, collaboration between organisations and a mixed economy of service providers. Such an analysis suggests that, following changes to the system of local government, contemporary forms of IMC are less dependent on vertical arrangements (top-down direction from central government) as they are replaced by horizontal modes (expansion of networks and partnership arrangements). Evidence suggests, however that central government continues to steer local authorities through the agency of inspectorates and regulatory bodies, and through policy initiatives, such as local strategic partnerships and local area agreements (Kelly 2006), thus questioning whether, in the case of UK local government, the shift from hierarchy to network and market solutions is less differentiated and transformation less complete than some literature suggests. Vertical or horizontal pressures may promote IMC, yet similar drivers may deter collaboration between local authorities. An example of negative vertical pressure was central government's change of the systems of local taxation during the 1980s. The new taxation regime replaced a tax on property with a tax on individual residency. Although the community charge lasted only a few years, it was a highpoint of the then Conservative government policy that encouraged councils to compete with each other on the basis of the level of local taxation. In practice, however, the complexity of local government funding in the UK rendered worthless any meaningful ambition of councils competing with each other, especially as central government granting to local authorities is predicated (however imperfectly) on at least notional equalisation between those areas with lower tax yields and the more prosperous locations. Horizontal pressures comprise factors such as planning decisions. Over the last quarter century, councils have competed on the granting of permission to out-of-town retail and leisure complexes, now recognised as detrimental to neighbouring authorities because economic forces prevail and local, independent shops are unable to compete with multiple companies. These examples illustrate tensions at the core of the UK polity of whether IMC is feasible when competition between local authorities heightened by local differences reduces opportunities for collaboration. An alternative perspective on IMC is to explore whether specific purposes or functions promote or restrict it. Whether in the principle areas of local government responsibilities relating to social welfare, development and maintenance of the local infrastructure or environmental matters, there are examples of IMC. But opportunities have diminished considerably as councils lost responsibility for services provision as a result of privatisation and transfer of powers to new government agencies or to central government. Over the last twenty years councils have lost their role in the provision of further-or higher-education, public transport and water/sewage. Councils have commissioning power but only a limited presence in providing housing needs, social care and waste management. In other words, as a result of central government policy, there are, in practice, currently far fewer opportunities for councils to cooperate. Since 1997, the New Labour government has promoted IMC through vertical drivers and the development; the operation of these policy initiatives is discussed following the framework of the editors. Current examples of IMC are notable for being driven by higher tiers of government, working with subordinate authorities in principal-agent relations. Collaboration between local authorities and intra-interand cross-sectoral partnerships are initiated by central government. In other words, IMC is shaped by hierarchical drivers from higher levels of government but, in practice, is locally varied and determined less by formula than by necessity and function. © 2007 Springer.

Accessibility, deprivation and rural planning policies.

Since the Second World War a range of policies have been implemented by central and local government agencies, with a view to improving accessibility to facilities, housing and employment opportunities within rural areas. It has been suggested that a lack of reasonable access to a range of such facilities and opportunities constitutes a key aspect of deprivation or disadvantage for rural residents. Despite considerable interest, very few attempts have been made to assess the nature and incidence of this disadvantage or the reaction of different sections of the population of rural areas to it. Moreover, almost all previous assessments have relied on so-called 'objective' measures of accessibility and disadvantage and failed to consider the relationship between such measures and 'subjective' measures such as individual perceptions. It is this gap in knowledge that the research described in this thesis has addressed. Following a critical review of relevant literature the thesis describes the way in which data on 'objective' and 'subjective' indicators of accessibility and behavioural responses to accessibility problems was collected, in six case study areas in Shropshire. Analysis of this data indicates that planning and other government policies have failed to significantly improve rural resident's accessibility to their basic requirements, and may in some cases have exacerbated it, and that as a result certain sections of the rural population are relatively disadvantaged. Moreover, analysis shows that .certain aspects of individual subjective' assessments of such accessibility disadvantage are significantly associated with more easily-obtained 'objective' measures. By using discriminant analysis the research demonstrates that it is possible to predict the likely levels of satisfaction with access to facilities from a range of 'objective' measures. The research concludes by highlighting the potential practical applications of such indicators in policy formulation, policy appraisal and policy evaluation.

The response to and effects of microcomputers in the education sector:the introduction of an innovation in local authority secondary schools

The study addresses the introduction of an innovation of new technology into a bureaucratic profession. The organisational setting is that of local authority secondary schools at a time at which microcomputers were being introduced in both the organisational core (for teaching) and its periphery (school administration). The research studies innovation-adopting organisations within their sectoral context; key actors influencing the innovation are identified at the levels of central government, local government and schools.A review of the literature on new technology and innovation (including educational innovation), and on schools as organisations in a changing environment leads to the development of the conceptual framework of the study using a resource dependency model within a cycle of the acquisition, allocation and utilisation of financial, physical and intangible resources. The research methodology is longitudinal and draws from both positivist and interpretive traditions. lt includes an initial census of the two hundred secondary schools in four local education authorities, a final survey of the same population, and four case studies, using both interview methods and documentation. Two modes of innovation are discerned. In respect of administrative use a rationalising, controlling mode is identified, with local education authorities developing standardised computer-assisted administrative systems for use in schools. In respect of curricular use, in contrast, teachers have been able to maintain an indeterminate occupational knowledge base, derived from an ideology of professionalism in respect of the classroom use of the technology. The mode of innovation in respect of curricular use has been one of learning and enabling. The resourcing policies of central and local government agencies affect the extent of use of the technology for teaching purposes, but the way in which it is used is determined within individual schools, where staff with relevant technical expertise significantly affect the course of the innovation.

Digital business reporting standards:mapping the battle in France

Government agencies use information technology extensively to collect business data for regulatory purposes. Data communication standards form part of the infrastructure with which businesses must conform to survive. We examine the development of, and emerging competition between, two open business reporting data standards adopted by government bodies in France; EDIFACT (incumbent) and XBRL (challenger). The research explores whether an incumbent may be displaced in a setting in which the contention is unresolved. We apply Latour’s (1992) translation map to trace the enrolments and detours in the battle. We find that regulators play an important role as allies in the development of the standards. The antecedent networks in which the standards are located embed strong beliefs that become barriers to collaboration and fuel the battle. One of the key differentiating attitudes is whether speed is more important than legitimacy. The failure of collaboration encourages competition. The newness of XBRL’s technology just as regulators need to respond to an economic crisis and its adoption by French regulators not using EDIFACT create an opportunity for the challenger to make significant network gains over the longer term. ANT also highlights the importance of the preservation of key components of EDIFACT in ebXML.

Precompetitive data sharing as a catalyst to address unmet needs in Parkinson's disease

Parkinson's disease is a complex heterogeneous disorder with urgent need for disease-modifying therapies. Progress in successful therapeutic approaches for PD will require an unprecedented level of collaboration. At a workshop hosted by Parkinson's UK and co-organized by Critical Path Institute's (C-Path) Coalition Against Major Diseases (CAMD) Consortiums, investigators from industry, academia, government and regulatory agencies agreed on the need for sharing of data to enable future success. Government agencies included EMA, FDA, NINDS/NIH and IMI (Innovative Medicines Initiative). Emerging discoveries in new biomarkers and genetic endophenotypes are contributing to our understanding of the underlying pathophysiology of PD. In parallel there is growing recognition that early intervention will be key for successful treatments aimed at disease modification. At present, there is a lack of a comprehensive understanding of disease progression and the many factors that contribute to disease progression heterogeneity. Novel therapeutic targets and trial designs that incorporate existing and new biomarkers to evaluate drug effects independently and in combination are required. The integration of robust clinical data sets is viewed as a powerful approach to hasten medical discovery and therapies, as is being realized across diverse disease conditions employing big data analytics for healthcare. The application of lessons learned from parallel efforts is critical to identify barriers and enable a viable path forward. A roadmap is presented for a regulatory, academic, industry and advocacy driven integrated initiative that aims to facilitate and streamline new drug trials and registrations in Parkinson's disease.

Lessons from natural disasters, tsunami-affected Small and Medium-Sized Enterprises(SMEs) in Sri Lanka

The main objective of this paper is to identify some of the key issues encountered by tsunami-affected small and medium-sized enterprises (SMEs) in the process of rehabilitation and re-establishment in Sri Lanka. The second objective is to assess how far these affected industries have received various benefits and supports from bodies such as government agencies, private sector firms, donors and NGOs to help them get back into business. The final objective is to recommend policies and strategies to develop the tsunami-affected SMEs in a self-sustaining manner and within a certain time period. The main database of firms for this research has been obtained from the Industrial Development Board, which conducted a survey covering 4,389 tsunami-affected micro- and SMEs. In addition to this, information from various state organizations and NGOs-based sources has been used. This paper identifies the main issues related to tsunami-affected SMEs ranging from basic infrastructure provision up to finance, marketing, machinery, technology, training, product identification and development and so forth. In fact, it is shown that there are no significant differences between issues faced by SMEs in general and tsunami-affected SMEs, apart of course from the effects of a sudden disaster (the tidal wave). Consequently, these issues can be generalized as issues relevant to SMEs in Sri Lanka as a whole. However, under the flood and rain of local and foreign assistance, there have been more pledges and promises than actual deliveries and, so, tsunami-affected SMEs have received comparatively little support and assistance in recovering and no records can be found as to where the colossal amount of foreign assistance received has actually gone. Finally, this paper recommends various types of business incubator centres and entrepreneurial enhancing skill programmes for the revamping of tsunami-affected SMEs in addition to the normal disaster risk management plan.

Organised for inward investment? Development agencies, local government, and firms in the inward investment process

Inward investment promotion and aftercare remain central aspects of local economic development for English Regional Development Agencies, Scottish and Welsh development bodies, and local authorities in Britain. In many cases, partnership and consultation mechanisms have become integral to attracting inward investment and providing aftercare. Inward investment is thus an important area in which to explore interinstitutional relations between agents operating along diverse spatial boundaries and with different responsibilities. In this paper we analyse the local and regional institutional structures and relations characterising the inward investment process in Britain using new survey data from local authorities, regional bodies, and inward investors. We find that promotional activities have clearly defined structures which are chiefly led by the regional level. Aftercare is characterised by more collaborative arrangements involving both regional bodies and local government. However, many bodies are little used, with competition and tension between partners remaining frequent within English regions, regardless of recent institutional changes designed to reduce such problems. In Scotland and Wales, however, their national institutions are not only widely used, but they create high levels of satisfaction from firms. Hence, England has yet to respond to the effective challenges of Scotland and Wales. The analysis also highlights the limited importance of all national, regional, and local public institutions in attracting inward investors and their subsequent aftercare. The critical inputs to business decisions appear to be driven chiefly by more general supply-side conditions (for example, general skills versus local public packages) and the general attractions of a particular location.