Dynamic oversight: implementation gaps and challenges

Nanotechnology is touted as a transformative technology in that it is predicted to improve many aspects of human life. There are hundreds of products in the market that utilize nanostructures in their design, such as composite materials made out of carbon or metal oxides. Potential risks to consumers, to the environment, and to workers from the most common passive nanomaterial—carbon nanotubes—are emerging through scientific research. Newer more active nanostructures—such as cancer therapies and targeted drug systems—are also increasing in use and are raising similar risk concerns. Governing the risks to workers is the subject of this commentary. The Occupational Safety and Health Act of 1970 grants the Occupational Safety and Health Administration the legal authority to set occupational health standards to insure that no worker suffers material impairment of health from work. However, setting a standard to protect workers from nanotechnology risks may occur some time in the future because the risks to workers have not been well characterized scientifically. Alternative risk governances—such as dynamic oversight through stakeholder partnerships, “soft law” approaches, and national adoption of international consensus standards—are evaluated in this article.     

Recommendations for oversight of nanobiotechnology: dynamic oversight for complex and convergent technology

Federal oversight of nanobiotechnology in the U.S. has been fragmented and incremental. The prevailing approach has been to use existing laws and other administrative mechanisms for oversight. However, this “stay-the-course” approach will be inadequate for such a complex and convergent technology and may indeed undermine its promise. The technology demands a new, more dynamic approach to oversight. The authors are proposing a new oversight framework with three essential features: (a) the oversight trajectory needs to be able to move dynamically between “soft” and “hard” approaches as information and nano-products evolve; (b) it needs to integrate inputs from all stakeholders, with strong public engagement in decision-making to assure adequate analysis and transparency; and (c) it should include an overarching coordinating entity to assure strong inter-agency coordination and communication that can meet the challenge posed by the convergent nature of nanobiotechnology. The proposed framework arises from a detailed case analysis of several key oversight regimes relevant to nanobiotechnology and is informed by inputs from experts in academia, industry, NGOs, and government.     

Reinventing oversight in the twenty-first century: the question of capacity

This article addresses a key question emerging from this project based at the University of Minnesota: the fundamental capacity of government to engage in “dynamic oversight” of emergent technologies. This conception of oversight requires additional or new types of capacity for government agencies that must arbitrate conflicts and endow any outcomes with necessary democratic legitimacy. Rethinking oversight thus also requires consideration of the fundamental design and organizational capacity of the regulatory regime in the democratic state.     

Nanotoxicology and nanomedicine: making development decisions in an evolving governance environment

The fields of nanomedicine, risk analysis, and decision science have evolved considerably in the past decade, providing developers of nano-enabled therapies and diagnostic tools with more complete information than ever before and shifting a fundamental requisite of the nanomedical community from the need for more information about nanomaterials to the need for a streamlined method of integrating the abundance of nano-specific information into higher-certainty product design decisions. The crucial question facing nanomedicine developers that must select the optimal nanotechnology in a given situation has shifted from “how do we estimate nanomaterial risk in the absence of good risk data?” to “how can we derive a holistic characterization of the risks and benefits that a given nanomaterial may pose within a specific nanomedical application?” Many decision support frameworks have been proposed to assist with this inquiry; however, those based in multicriteria decision analysis have proven to be most adaptive in the rapidly evolving field of nanomedicine—from the early stages of the field when conditions of significant uncertainty and incomplete information dominated, to today when nanotoxicology and nano-environmental health and safety information is abundant but foundational paradigms such as chemical risk assessment, risk governance, life cycle assessment, safety-by-design, and stakeholder engagement are undergoing substantial reformation in an effort to address the needs of emerging technologies. In this paper, we reflect upon 10 years of developments in nanomedical engineering and demonstrate how the rich knowledgebase of nano-focused toxicological and risk assessment information developed over the last decade enhances the capability of multicriteria decision analysis approaches and underscores the need to continue the transition from traditional risk assessment towards risk-based decision-making and alternatives-based governance for emerging technologies.     

Governing nanobiotechnology: lessons from agricultural biotechnology regulation

This article uses lessons from biotechnology to help inform the design of oversight for nanobiotechnology. Those lessons suggest the following: first, oversight needs to be broadly defined, encompassing not just regulatory findings around safety and efficacy, but also public understanding and acceptance of the technology and its products. Second, the intensity of scrutiny and review should reflect not just risks but also perceptions of risk. Finally, a global marketplace argues for uniform standards or commercially practical solutions to differences in standards. One way of designing oversight to achieve these purposes is to think about it in three phases—precaution, prudence, and promotion. Precaution comes early in the technology or product’s development and reflects real and perceived uncertainties. Prudence governs when risks and hazards have been identified, containment approaches established, and benefits broadly defined. Transparency and public participation rise to the fore. The promotional phase moves toward shaping public understanding and acceptance and involves marketing issues rather than safety ones. This flexible, three-phase approach to oversight would have avoided some of the early regulatory problems with agricultural biotechnology. It also would have led to a more risk-adjusted pathway to regulatory approval. Furthermore, it would avoid some of the arbitrary, disruptive marketing issues that have arisen.     

Arnowitt–Deser–Misner representation and Hamiltonian analysis of covariant renormalizable gravity

We study the recently proposed Covariant Renormalizable Gravity (CRG), which aims to provide a generally covariant ultraviolet completion of general relativity. We obtain a spacetime decomposed form—an Arnowitt–Deser–Misner (ADM) representation—of the CRG action. The action is found to contain time derivatives of the gravitational fields up to fourth order. Some ways to reduce the order of these time derivatives are considered. The resulting action is analyzed using the Hamiltonian formalism, which was originally adapted for constrained theories by Dirac. It is shown that the theory has a consistent set of constraints. It is, however, found that the theory exhibits four propagating physical degrees of freedom. This is one degree of freedom more than in Hořava–Lifshitz (HL) gravity and two more propagating modes than in general relativity. One extra physical degree of freedom has its origin in the higher order nature of the CRG action. The other extra propagating mode is a consequence of a projectability condition similarly as in HL gravity. Some additional gauge symmetry may need to be introduced in order to get rid of the extra gravitational degrees of freedom.     

The three-boson bound state in massive QED2

We derive the (matrix-valued) Feynman rules of mass perturbation theory of the massive Schwinger model for non-zero vacuum angleϑ. Further, we discuss the properties of the three-boson bound state and compute — by a partial resummation of the mass perturbation series — its mass and its partial decay widths. This work was supported by a research stipendium of the Vienna University.     

Horses for courses: risk information and decision making in the regulation of nanomaterials

Despite the widespread commercial use of nanomaterials, regulators currently have a limited ability to characterize and manage risks. There is a paucity of data available on the current production and use of nanomaterials and extreme scientific uncertainty on most aspects of the risk assessment “causal chain.” Regulatory decisions will need to be made in the near-term in the absence formal quantitative risk assessments. The article draws on examples from three different regulatory contexts—baseline data monitoring efforts of the U.S. Environmental Protection Agency and California Department of Toxic Substances Control, prioritization of risk information in the context of environmental releases, and mitigation of occupational risks—to argue for the use of decision-analytic tools in lieu of formal risk assessment to help regulatory bodies. We advocate a “horses for courses” approach whereby existing analytical tools (such as risk ranking, multi-criteria decision analysis, and “control banding” approaches) might be adapted to regulators’ goals in particular decision contexts. While efforts to build new and modify existing tools are underway, they need greater support from funding and regulatory agencies because innovative approaches are needed for the “extreme” uncertainty problems that nanomaterials pose.     

Addressing conflicts of interest in nanotechnology oversight: lessons learned from drug and pesticide safety testing

Financial conflicts of interest raise significant challenges for those working to develop an effective, transparent, and trustworthy oversight system for assessing and managing the potential human health and ecological hazards of nanotechnology. A recent paper in this journal by Ramachandran et al., J Nanopart Res, 13:1345–1371 (2011) proposed a two-pronged approach for addressing conflicts of interest: (1) developing standardized protocols and procedures to guide safety testing; and (2) vetting safety data under a coordinating agency. Based on past experiences with standardized test guidelines developed by the international Organization for Economic Cooperation and Development (OECD) and implemented by national regulatory agencies such as the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA), we argue that this approach still runs the risk of allowing conflicts of interest to influence toxicity tests, and it has the potential to commit regulatory agencies to outdated procedures. We suggest an alternative approach that further distances the design and interpretation of safety studies from those funding the research. In case the two-pronged approach is regarded as a more politically feasible solution, we also suggest three lessons for implementing this strategy in a more dynamic and effective manner.     

Order—disorder phase transitions in domain structures of ferrite—garnet films

Order—order and order—disorder phase transitions in the domain structure of ferrite—garnet films upon a change in temperature or magnetic field were studied. It was shown that the structure of the domain boundaries affects the type of the phase transitions.     

Emerging methods and tools for environmental risk assessment, decision-making, and policy for nanomaterials: summary of NATO Advanced Research Workshop

Nanomaterials and their associated technologies hold promising opportunities for the development of new materials and applications in a wide variety of disciplines, including medicine, environmental remediation, waste treatment, and energy conservation. However, current information regarding the environmental effects and health risks associated with nanomaterials is limited and sometimes contradictory. This article summarizes the conclusions of a 2008 NATO workshop designed to evaluate the wide-scale implications (e.g., benefits, risks, and costs) of the use of nanomaterials on human health and the environment. A unique feature of this workshop was its interdisciplinary nature and focus on the practical needs of policy decision makers. Workshop presentations and discussion panels were structured along four main themes: technology and benefits, human health risk, environmental risk, and policy implications. Four corresponding working groups (WGs) were formed to develop detailed summaries of the state-of-the-science in their respective areas and to discuss emerging gaps and research needs. The WGs identified gaps between the rapid advances in the types and applications of nanomaterials and the slower pace of human health and environmental risk science, along with strategies to reduce the uncertainties associated with calculating these risks.     

Contributed report: Flavor anarchy for Majorana neutrinos

We argue that neutrino flavor parameters may exhibit features that are very different from those of quarks and charged leptons. Specifically, within the Proggatt-Nielsen (FN) framework, charged fermion parameters depend on the ratio between two scales, while for neutrinos a third scale — that of lepton number breaking — is involved. Consequently, the selection rules for neutrinos may be different. In particular, if the scale of lepton number breaking is similar to the scale of horizontal symmetry breaking, neutrinos may become flavor-blind even if they carry different horizontal charges. This provides an attractive mechanism for neutrino flavor anarchy.     

Extreme Covariant Observables for Type I Symmetry Groups

The structure of covariant observables—normalized positive operator measures (POMs)—is studied in the case of a type I symmetry group. Such measures are completely determined by kernels which are measurable fields of positive semidefinite sesquilinear forms. We produce the minimal Kolmogorov decompositions for the kernels and determine those which correspond to the extreme covariant observables. Illustrative examples of the extremals in the case of the Abelian symmetry group are given. Dedicated to Pekka J. Lahti in honor of his sixtieth birthday     

Probabilistic Study of the Speed of Approach to Equilibrium for an Inelastic Kac Model

This paper deals with a one-dimensional model for granular materials, which boils down to an inelastic version of the Kac kinetic equation, with inelasticity parameter p>0. In particular, the paper provides bounds for certain distances—such as specific weighted χ-distances and the Kolmogorov distance—between the solution of that equation and the limit. It is assumed that the even part of the initial datum (which determines the asymptotic properties of the solution) belongs to the domain of normal attraction of a symmetric stable distribution with characteristic exponent α=2/(1+p). With such initial data, it turns out that the limit exists and is just the aforementioned stable distribution. A necessary condition for the relaxation to equilibrium is also proved. Some bounds are obtained without introducing any extra condition. Sharper bounds, of an exponential type, are exhibited in the presence of additional assumptions concerning either the behaviour, close to the origin, of the initial characteristic function, or the behaviour, at infinity, of the initial probability distribution function. Research partially supported by Ministero dell’Istruzione, dell’Università e della Ricerca (MIUR grant 2006/134526).     

Vacuum Polarisation Effects in the Lorentz Violating Electrodynamics

In this work we reconsider the one loop calculation for the vacuum polarisation tensor in the Lorentz violating quantum electrodynamics. The electron propagator is “dressed” by a Lorentz breaking extra term in the fermion Lagrangian density. We check gauge invariance and use the Schwinger–Dyson equation to discuss the full photon propagator. After a discussion on a possible photon mass shift, we show how a finite quantum correction can be chosen in a unique way in order to ensure—in the spirit of spontaneously broken theories—the standard normalisation conditions for the vacuum polarisation tensor. Then we comment on possible observable physical consequences on the Lamb-shift.     

Duality in physical sciences and beyond

An extended meaning of duality is suggested in the context of development of major themes in physical sciences since Newton. In such a generalization,five distinct aspects of duality are sought to be identified and illustrated through concrete examples drawn from various physical concepts, old and new. These are (i) reciprocity, (ii) parallelism, (iii) alternative formulation, (iv) unification and (v) measurement incompatibility. Bohr’s view of duality and the Copenhagen Interpretation are discussed briefly in this context. Finally, duality aspects beyond physics are briefly touched upon, the philosophical link being provided by Bohr’s Complementarity Principle on the one hand, and recent attempts (notably by Capra) to draw suggestive parallels between modern science and Eastern mysticism on the other. “Be in truth eternal, beyond earthly opposites”—Bhagwat Gita. The author felicitates Prof. D S Kothari on his eightieth birthday and dedicate this paper to him on this occasion.     

光极限探测技术在空间通信中的应用

光是人类最早的科学研究对象之一,光子是光的最小能量单元,具备量子的基本特征.随着科学技术发展,人类已经能够实现对单个光子的极限探测.光的常规探测已经普遍应用于地面光纤通信中,而光的极限探测则在空间量子通信及深空超远距离光通信中具备重要的应用价值.文章介绍了光极限探测技术在空间量子科学实验、空间光子通信中的典型应用及涉及...     

Developments in high energy theory

This non-technical review article is aimed at readers with some physics background, including beginning research students. It provides a panoramic view of the main theoretical developments in high energy physics since its inception more than half a century ago, a period in which experiments have spanned an enormous range of energies, theories have been developed leading up to the Standard Model, and proposals — including the radical paradigm of String Theory — have been made to go beyond the Standard Model. The list of references provided here is not intended to properly credit all original work but rather to supply the reader with a few pointers to the literature, specifically highlighting work done by Indian authors.     

National nanotechnology partnership to protect workers

Nanotechnology is predicted to improve many aspects of human life. By 2015, it is estimated to represent $3.1 trillion in manufactured goods. Data is emerging that exposure to nanomaterials may pose a health risk to workers. If the economic promise of nanotechnology is to be achieved, ways need to be found to protect nanotechnology workers now. The Occupational Safety and Health Act of 1970 (OSHAct) gave the responsibility to protect workers to the Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH) through research, standards adoption, and standards enforcement. Since 1980, adopting new occupational health standards has grown more complex. The increased complexity has greatly slowed efforts to adopt protective standards for toxic agents that are well-known to pose significant risks. The likelihood of rapidly adopting standards to protect workers from nanomaterials, whose risks are just emerging, seems even more unlikely. Use of the OSHAct’s general duty clause to protect workers also seems uncertain at this time. In the interim, a national partnership led by NIOSH involving nanotech manufacturers and downstream users, workers, academic researchers, safety, and health practitioners is proposed. A National Nanotechnology Partnership would generate knowledge about the nature and the extent of worker risk, utilize that knowledge to develop risk control strategies to protect nanotechnology workers now, and provide an evidence base for NIOSH recommendations to OSHA for a nanotechnology program standard at a future date.