Regulatory Option Research Articles

A licence to vape: Is it time to trial of a nicotine licensing scheme to allow Australian adults controlled access to electronic cigarettes devices and refill solutions containing nicotine?

Australia has some of the most restrictive laws concerning use of nicotine in e-cigarettes. The only current legal option for Australians to legally possess and use nicotine for vaping is with a medical prescription and domestic supply is limited to compounding pharmacies that prepare medicines for specific patients. An alternative regulatory option that could be implemented under current drugs and poisons regulations is a ‘nicotine licensing’ scheme utilising current provisions for ‘dangerous poisons’. This commentary discusses how such a scheme could be used to trial access to nicotine solutions for vaping outside of a ‘medicines framework’ in Australia.

Launching reappraisal: it's less common than you might think.

Cognitive reappraisal is thought to be ubiquitous. However, no studies have quantified how frequently people reappraise (vs. letting their emotional response go unregulated). To address this issue, the authors created a laboratory decision context in which participants watched a series of negatively valenced images, and in each case had the option of electing to reappraise to decrease negative affect. Given the many benefits and few costs associated with reappraisal, we expected that most images would be reappraised. However, to our surprise, participants implemented reappraisals for only 16% of images (Study 1). Regulatory rates remained low for both low- and high-intensity images, even when another regulatory option (i.e., distraction) was available (Study 2). The authors hypothesized that participants did not proactively reappraise because there were hidden costs associated with reappraisal. They considered 2 classes of costs: overcoming default bias and cognitive effort, and they measured the percentage of trials for which participants chose to reappraise using a fully crossed 2 × 2 design that examined the effects of removing defaults and of providing support in creating reappraisals. Removing defaults, but not providing reappraisal support, increased rates of reappraisal (Study 3). Everyday decision-making frequently involves default options. These results suggest that contextual variables (such as the presence of defaults) may play a large role in the decision to regulate emotions.

Product option framing under the influence of a promotion versus prevention focus

Investigations into the option framing effect involve the use of a subtractive versus an additive option-framing method to gauge their impact on consumer behaviors. This research examines how option framing could affect choice decisions as a function of a consumer’s goal orientation. Study 1 offers convergent support for the proposition that regulatory focus moderates the option framing effect and the mediating role of action/inaction on the relationship between regulatory focus and the option framing effect. In particular, a reverse finding shows that promotion-focused consumers provided with a +OF options list tend to choose more options than those who are given a −OF option list. To explain the reverse effect, Study 2 examines and demonstrates regulatory fit as a possible moderator. The results of Study 2 also confirm our inference and echo the same results of Study 1. Finally, based on the regulatory fit theory, Study 3 examines if cognitive constraints associate with a consumer’s regulatory orientation may also account for the interaction between regulatory focus and option framing. The results of Study 3 also support the proposition.

Ensuring Freedoms and Protecting Rights in the Governance of the Internet: A Comparative Analysis on Blocking Measures and Internet Providers’ Removal of Illegal Internet Content

Removing illegal or harmful material from the internet has been pursued for more than two decades. The advent of Web 2.0, with the prominent increase and diffusion of user-generated content, amplifies the necessity for technical and legal frameworks enabling the removal of illegal material from the network. This study deals with different levels and methods of Internet ‘cleansing’ measures, comparing government regulated and Internet service provider based removals of illegal Internet content. The paper aims at putting the regulatory option of internet blocking measures into the broader perspective of the legal framework regulating the (exemption from) liability of Intermediary Service Providers (ISPs) for user-generated contents. In addition, the paper suggests proposals on which regulatory options can better ensure the respect of freedoms and the protection of rights. The paper introduces several significant cases of blocking online copyright infringing materials. Copyright related blocking techniques have been devised for business reasons – by copyright holders’ associations. It must be recalled, however, that these blocking actions cannot be enforced without the states’ intervention. These business-level actions become isolated if they are not supported by both the European Union and its Member States. Conversely, state-centred initiatives cannot work out without the private sector’s cooperation. Internet service providers play a crucial role in this cooperative framework because of their task of providing access to the Internet and hosting web contents.

Local social capital and the acceptance of Protected Area policies: An empirical study of two Ramsar river delta ecosystems in northern Greece

Managing Protected Areas (PAs) is a challenging task, and globally many instruments have been utilised for this purpose. Existing research demonstrates that the effectiveness of these instruments is highly dependent on their social acceptability among local communities resident within PAs. Consequently, investigating local attitudes and perceptions of Protected Area (PA) policies has been emphasised in recent studies. Drawing on empirical work conducted in two National Parks including river delta ecosystems designated as Ramsar wetlands in northern Greece, this paper examines local residents' perceptions of three hypothesized policy options (regulatory, market-based and participatory) for Park management. The influence of social capital elements (social trust, institutional trust and social networks) on residents' perceptions is explored. The findings reveal a high degree of importance attached by resident communities to Park designation in both PAs, though residents' perceptions of the proposed management options varied. The regulatory option was regarded as the least restrictive, while the most restrictive was perceived to be the market-based option. However, greater benefits were identified by residents from the market-based option, while the fewest benefits were considered to arise from the proposed regulatory option. Furthermore, local residents' perceptions were significantly shaped by the proposed management and decision-making structure offered under each policy option. The influence of different social capital elements on residents' perceptions also varied in the study sample, with social trust and institutional trust positively correlated with the benefits that were perceived to arise from the different policy options. Moreover, when social capital was measured as an aggregate indicator at the level of the individual, it was positively correlated with perceived environmental benefits.

Regulatory Uncertainty and Market Liquidity: The 2008 Short Sale Ban's Impact on Equity Option Markets

ABSTRACTWe examine how the September 2008 short sale restrictions and the accompanying confusion and regulatory uncertainty impacted equity option markets. We find that the short sale ban is associated with dramatically increased bid‐ask spreads for options on banned stocks. In addition, synthetic share prices for banned stocks become significantly lower than actual share prices during the ban. We find similar results for synthetic share prices of hard‐to‐borrow stocks, suggesting that the dislocation in actual and synthetic share prices is attributable to the increased hedging costs for options on banned stocks during the short sale ban.

Lands Unsuitable for Mining, a Kentucky Example

In the transfer of surface mining regulatory authority from the federal government to state governments, significant archaeological and historic sites have been, and continue to be, jeopardized. In the Commonwealth of Kentucky, primacy in this regulatory function has meant an almost total disregard for the effect of mining on cultural resources and thus the cultural impoverishment of the state and the nation at large. The Lands Unsuitable for Mining petition process offers concerned citizens a vehicle by which such inadequacies may be addressed. Lands Unsuitable for Mining Petition 83–1, the first petition to be filed in Kentucky and the first such petition in the nation to be filed solely on the grounds of potential impacts of mining on significant archaeological sites, successfully forced the issue for a 166 km 2 area in the Big Bend region of Kentucky's Green River. It must be acknowledged that use of the lands unsuitable petition process leads inevitably to a potentially volatile confrontation between archaeologists and coal operators and therefore, it represents an abysmal preservation tool. Nevertheless, in states such as Kentucky it remains the only regulatory option available to insure that significant sites are adequately considered in the permitting process.

Kosten des Europäischen Finanzstabilisierungsmechanismus (EFSM) aus deutscher Sicht / The Costs of the European Financial Stability Facility (EFSF) – The German Point of View

Summary The European Financial Stability Facility (EFSF), which is supported by the German Gesetz zur Übernahme von Gewährleistungen im Rahmen des europäischen Stabilisierungsmechanismus (StabMechG), suspends the Stability and Growth Pact as the basis of the European Economic and Monetary Union. The actual ‘suspension’ from the ’no bail-out’ restriction (Art. 125 TFEU) and the prohibition of funding national debts (Art. 123 TFEU) transfers risks and financial burdens from deeply indebted states to solvent EU member states. As a result an unauthorized „transfer union‘‘ emerges, whose Central Bank lost its independence to a political leadership and cannot focus on its objective of price stability as contracted any longer. Even without the use of financial and guarantee aids the German economy suffers from a distorted yield structure and crowding-out effects of private investments. From the economic point of view the used measures are neither appropriate nor necessary for achieving financial stability within the European Economic and Monetary Union. Much less these measures are proportionate. Of course, the alternative of accepting a ‘controlled’ national bankruptcy would not have been without its formidable costs.However, its attribution of arrangements in the line with market requirements and the adherence to EU-contract provisions would have been the more worthwhile regulatory policy option for a more solid budgetary policy in the future.

Testing a toolbox for impact assessment of food safety regulations: maximum levels for T-2 and HT-2 toxins in the European Union

Introduction The aim of socio-economic research in the MoniQA Network of Excellence is to develop a toolbox to support impact assessment of proposed food safety regulatory changes. Objectives The scope of this contribution is to present an initial version of such a toolbox with its application to a case study, which concerns a proposal on setting maximum levels of T-2 and HT-2 toxins in cereals and cereal products. A regulatory proposal of ‘strict’ maximum limits is compared with two alternative options: the ‘do nothing’ option and the ‘soft’ regulatory option. Methods The proposed toolbox involves a preliminary qualitative assessment of the likely impacts of each of the policy options considered, with a coding/ scoring procedure, in order to identify the greatest impacts. A feasibility filter subsequently considers the availability of data necessary for impact quantification. The subsequent quantitative assessment is performed with different methodologies for the most important impacts. Finally, a multi-criteria analysis approach – which allows for a combination of qualitative and quantitative measurements – is used to arrive at a ranking of policy options. Results The outcome of this assessment exercise is that the ‘do nothing’ option is clearly the most preferable option, and, between the two regulatory options (options 2 and 3), the setting out of ‘strict’ maximum limits is preferable to ‘soft’ maximum limits. Conclusion This case study shows the potentialities of the toolbox as support to policy makers, which will be improved and tested with additional case studies in the remaining years of the MoniQA Network of Excellence.

On the proportionality of EU spatial ex ante coexistence regulations: A comment

In their recent article in this journal, Demont et al. (2009) discuss the effects of alternative spatial ex ante coexistence regulations (SEACERs) in the context of the EU regulatory framework. We retain from Demont et al. (2009) that small pollen barriers should be considered as a possible regulatory option in all identifiable situations in which they are as effective as large isolation distances. This idea is in accordance with the proportionality principle of the 2003 EC Recommendation. But further analysis of how consumer choice and consumer welfare are affected should be conducted before supporting the idea that SEACERs should be flexible, that is that GMO farmers should always have the option of paying their non-GMO neighbours to implement the SEACERs in their own fields. We reject the authors’ argument that pollen barriers are necessarily more easily negotiable among neighbours (more “flexible”) than are isolation distances. We contest the relation of proportionality to the size of market signals for IP products. We contest the idea of shifting coexistence regulation from ex ante to ex post. We believe that any economic analysis of coexistence measures should include their welfare effects on consumers as well as on producers.

Smart Mortgages, Privacy and the Regulatory Possibility of Infomediation

This Article argues for a new regulatory approach that could both increase market efficiency and protect informational privacy in the modern information economy. It explores that approach - information intermediation, or infomediation - in the context of the current debates about re-engineering the mortgage markets in the wake of the 2008 financial crisis. In particular, the Article is the first scholarly work to introduce the concept of “smart mortgages” - loans and mortgage securities with more rich and dynamically updated information than traditional mortgage products. The Article considers recent regulatory and industry momentum behind smart mortgages and contrasts the market efficiencies created by such proposals against the individual and social privacy harms a smart mortgage system would inflict. It argues that policy makers should consider information intermediation as a regulatory option to capture the efficiency gains of smart mortgages while preserving individual informational privacy, and considers the implications of infomediation beyond the mortgage context for other similar debates about the future of privacy in an information-rich economy. In particular, the Article concludes by comparing the smart mortgage and healthcare reform debates and showing the possible role of infomediation in each. In sum, the author argues that smart mortgages done properly could be a foundational step forwards as an example of regulatory sophistication.

Concordance analysis of an in vitro micronucleus screening assay and the regulatory chromosome aberration assay using pharmaceutical drug candidates

The in vitro micronucleus assay is under consideration by regulatory agencies as a suitable alternative to the in vitro chromosome aberration (CA) assay. At Pfizer, we utilized a non-Good Laboratory practices cytokinesis-block in vitro micronucleus (CBMN) assay in CHO cells as a screen to predict the regulatory outcome of the human lymphocyte CA assay, and we have retrospectively analyzed a highly select set of 112 internal drug candidates to measure concordance. Overall, our exploratory CBMN correctly classified 97 of 112 (86.6%) compounds in the CA assay. Specificity was high with 87 of 92 (94.6%) CA negative compounds correctly classified by CBMN. Sensitivity was low at 50% with 10 of 20 CA positive compounds correctly classified by CBMN; this may be attributed to the low number of CA positives in the select set. In an attempt to improve sensitivity, we increased the number of CA positives by combining our internal set with an industrial data set previously published (Miller B et al. 1997: Mutat Res 392:45-59). When combined, concordance was 86.7% (143/165), specificity was 91.2% (114/125), and sensitivity increased to 72.5% (29/40). Because cytotoxicity is considered a confounding factor of in vitro test systems, we also examined, within the Pfizer data set, the influence of cytotoxicity in the CBMN assay, and the results indicated that seemingly low (<50%) or excessively high (>70%) levels of cytotoxicity did not significantly alter predicted CA outcome. These collective analyses contribute to growing evidence that the CBMN assay is a suitable regulatory option in the standard battery of genetic toxicology tests.

The legacy of Myriad for gene-based diagnostics: a new policy and regulatory option

The legacy of Myriad for gene-based diagnostics: a new policy and regulatory option

Innovative regulatory approaches to reduce sodium consumption: could a cap-and-trade system work?

Many regulatory and professional organizations are calling for strict new regulations to reduce sodium consumption on a population basis. New regulations on sodium may have significant public health and economic impacts. This article explores five regulatory options to reduce sodium consumption: 1) maintaining the status quo, 2) improving risk communication and information, 3) revoking generally regarded as safe status of sodium and regulating its use in food products, 4) establishing a sodium tax, and 5) establishing a market-based, cap-and-trade system for sodium that builds on similar approaches in environmental regulatory policy. Cap-and-trade may be a promising regulatory option for sodium and other ingredients.

Modeling regulatory policies associated with offshore structure removal requirements in the Gulf of Mexico

Abstract Federal regulations require that a lease in the Outer Continental Shelf of the Gulf of Mexico be cleared of all structures within one year after production on the lease ceases, but in recent years, the Minerals Management Service has begun to encourage operators to remove idle (non-producing) structures on producing leases that are no longer “economically viable”. At the end of 2003, there were 2175 producing structures, 898 idle (non-producing) structures, and 440 auxiliary (never-producing) structures on 1356 active leases; and 329 idle structures and 65 auxiliary structures on 273 inactive leases. The purpose of this paper is to model the impact of alternative regulatory policies on the removal trends of structures and the inventory of idle iron, and to provide first-order estimates of the cost of each regulatory option. A description of the modeling framework and implementation results is presented.

Accreditation as a regulatory option for Antarctic bioprospecting

The current lack of a specific policy regime for Antarctic biological prospecting (bioprospecting) has emerged as a focus of recent discussion. Consideration has been given to the interface of the Convention on Biological Diversity (CBD), the United Nations Convention on the Law of the Sea (UNCLOS) and the Antarctic Treaty System (ATS). This paper aims to introduce the potential for industry accreditation to address existing regulatory uncertainty. The Marine Stewardship Council (MSC) accreditation for sustainable fisheries and the accreditation scheme being developed for Antarctic tour operators provide examples of industry accreditation that interplay with the Antarctic Treaty System. Accreditation may provide an avenue for industry to promote legitimate activities, demonstrate willingness to comply with existing principles and established regulations while the perception of being over-regulated is potentially reduced. Accreditation may also serve as an interim solution while more binding measures are developed. While Antarctic bioprospecting accreditation is not without its limitations, it does provide an avenue for the Antarctic Treaty Consultative Parties (ATCPs) to engage industry stakeholders, clarify existing obligations and promote a regulatory initiative in conformity with the principles of the Antarctic Treaty System.

The Three Rs in the pharmaceutical industry: perspectives of scientists and regulators

AbstractSix drug regulatory reviewers and 11 pharmaceutical industry scientists were interviewed to explore their perspectives on the obstacles and opportunities for greater implementation of the Three Rs (replacement, reduction, refinement) in drug research and development. Participants generally supported the current level of animal use in the pharmaceutical industry and viewed in vitro methods as supporting, but not replacing, the use of animals. Obstacles to greater use of the Three Rs cited by participants included the lack of non-animal alternatives; requirements for statistical validity; reluctance by industry and regulators to depart from established patterns of animal use; the priority of commercial objectives ahead of the Three Rs; and concern that less animal testing could jeopardise human safety. Opportunities identified for the Three Rs included the development of better animal models including genetically modified (GM) animals; pursuit of more basic knowledge, notably drug action on gene expression; re-use of animals; greater use of pilot studies; using sufficient numbers of animals per test to avoid repeating inconclusive studies; regular review of animal data in regulatory requirements; and following the regulatory option of combining segments of reproductive toxicology studies into one study. In some areas, greater implementation of the Three Rs seemed well aligned with industry priorities, for example, phenotypic characterisation of GM animals and validation of alternative methods. In other areas, wider use of the Three Rs may require building consensus on areas of disagreement including the usefulness of death as an endpoint; the suitability of re-using animals; and whether GM animals and the use of pilot studies contribute to reduction.

A Critical Review of the Traditional Methodology of Cost-Benefit Analysis and a Proposed Alternative

ABSTRACT “Risk management” is essential to the decision-making process that prescribes regulations for protecting human health. As a comprehensive decision-making approach, risk management encompasses risk assessment, risk perception, economic factors, and their respective uncertainties. Cost-benefit analysis (CBA) has long been the preferred methodology for evaluating the economic factors associated with such regulations. Within this context, CBA confirms whether or not the “benefit” of a given regulatory option is greater than its “cost.” This article proposes an alternative CBA methodology whose guiding concept is the “optimization” of outcomes for the stakeholders in regulations that aim to protect human health. This article further proposes evaluation criteria for CBA and critiques the traditional and alternative variants against this standard, ultimately to demonstrate the superiority of the latter.

Regulating Guns Through Litigation

In this chapter of Suing the Firearms Industry (T. Lytton, ed., U. of Michigan Press, 2004), I conduct a comparative institutional analysis of the regulatory competence of courts and legislatures/agencies in reducing the risks of gun-related violence. Needless to say, the gun control movement is reluctant to forswear litigation about gun risks in favor of legislative and administrative regulation. After all, they have already tried and failed in their political pursuit of the latter. Nor is it necessarily true that regulation and litigation are mutually exclusive. In this paper, I take the perspective of an Olympian designer of an optimal regime for controlling gun-related risks, one who compares the litigation option as it now exists to the regulatory option that would become viable were the gun control movement to achieve greater political success in the future. After discussing the logic of institutional comparison, I propose six analytic criteria for the comparison, each of which pertains to the institutions' propensity to develop and implement sound gun control policies. In order for an institution to make and implement policy effectively, it must (1) generate the technocratic information needed for gun-related policymaking; (2) generate the political information needed to frame an acceptable policy; (3) mobilize the array of different policy instruments necessary to establish and implement the policy; (4) promote social learning (short feedback loops) and flexible adaptation to new conditions; (5) generate predictable rules; and (6) secure and sustain the policy's legitimacy. After elaborating and applying these criteria to the problem of gun-related violence, the analysis finds that risk regulators are far better equipped than judges to address and manage the problem. In a brief conclusion, I argue that existing and proposed laws to keep guns out of the hands of those who should not have them - a Brady-plus approach - are unlikely to succeed. A more promising approach is technological in nature - making guns safer (although relatively few gun-related injuries are inflicted on or by careless, innocent users) and more easily traceable to those who fire them. An even more promising approach is the use of surveillance technology to enable the police to detect guns in public spaces and at safe distances while obviating the need for making dangerous, discriminatory, and intrusive stop-and-frisks of individuals without probable cause for suspicion. This would vastly increase the ability of police officers safely and effectively to disarm people who have no legal right to carry weapons. If it is to be deployed, however, it must safeguard individual privacy rights under the Fourth Amendment. My guess (and it is only a guess) is that the vast majority of Americans will view the use of a reliable surveillance technology limited to concealed guns in public spaces and subject to strict legal controls against unwarranted profiling and intrusion as constituting a reasonable search, one whose crime- and violence-reduction benefits would more than justify the small invasion of privacy entailed.

The Next Step for Telecom Regulation: ICT Convergence Regulation or Multisector Utilities Regulation?

This paper critically examines the multiple rationales for telecom, IT, media (ICT) convergence regulation on the one hand, and multisector utility regulation on the other, and the practical questions of implementation they pose, with a view to contributing to informed policy and regulatory decisions that are now underway in many countries. The conditions that may affect the creation of convergence and multi-sector regulation, ranging from underlying commonality of inputs and the behaviour of regulated firms to considerations that are specific to the regulatory process such as scarcity of regulatory resources and safeguards for regulatory independence, are examined. The paper concludes that ICT and media convergence issues are primarily about improving the efficiency of market economies, and how changes in regulation can facilitate this process. It is likely to be of primary interest for countries that already have an established effective independent telecom regulator. Multisector regulation issues are primarily about establishing the efficiency and effectiveness of regulation so it can be a catalyst for network and economic development. It is likely to be of primary interest to countries that have not yet established effective telecom regulation. Each regulatory option arises from an initial diagnose of different problems, and represents different priorities and pathways to achieving a very similar set of development objectives.