International Regulatory Regimes for Nanotechnology

This paper represents a very early stage of a collaborative research project on transnational NT regulation. In this project, we seek to apply a multidisciplinary perspective to the question of regulation of nanotechnology (NT). We begin in Section I by considering the nature of NT and some risks it may pose as it is more fully developed and utilized over time. We next consider the nature of transnational "regulation," suggesting the range of legal, institutional and substantive forms this term can encompass. Because NT and its regulation are (like our project) at such early stages of development, we emphasize the importance of regulatory flexibility. In Section II, we consider a series of strategic choices that must be faced in designing transnational regulation in any issue area, including NT; these include the level and scope of regulation, the actors authorized to promulgate regulatory norms, the legal and institutional form of regulation, and finally its substantive content. In Section III, we argue that it is useful, although not definitive, to study models of transnational regulation developed for similar issues arising out of other forms of technology. While few if any of these models will be directly applicable to the unique characteristics of NT, the designers of these regulatory regimes faced similar strategic choices as well as similar problems, and the models they created can offer useful lessons. We briefly discuss a few potential models to illustrate the approach. Our larger research project will expand the study of transnational models beyond those discussed here, with a view to developing more specific recommendations for NT regulation. Consistent with our emphasis on regulatory flexibility, we conclude by tentatively suggesting a sequencing of regulatory approaches designed to allow NT regulation to develop over time into broader, more elaborate and more highly legalized form as we gain greater knowledge of, and experience with, the benefits and costs of NT

International Regulatory Regimes for Nanotechnology

This paper represents a very early stage of a collaborative research project on transnational NT regulation. In this project, we seek to apply a multidisciplinary perspective to the question of regulation of nanotechnology (NT). We begin in Section I by considering the nature of NT and some risks it may pose as it is more fully developed and utilized over time. We next consider the nature of transnational "regulation," suggesting the range of legal, institutional and substantive forms this term can encompass. Because NT and its regulation are (like our project) at such early stages of development, we emphasize the importance of regulatory flexibility. In Section II, we consider a series of strategic choices that must be faced in designing transnational regulation in any issue area, including NT; these include the level and scope of regulation, the actors authorized to promulgate regulatory norms, the legal and institutional form of regulation, and finally its substantive content. In Section III, we argue that it is useful, although not definitive, to study models of transnational regulation developed for similar issues arising out of other forms of technology. While few if any of these models will be directly applicable to the unique characteristics of NT, the designers of these regulatory regimes faced similar strategic choices as well as similar problems, and the models they created can offer useful lessons. We briefly discuss a few potential models to illustrate the approach. Our larger research project will expand the study of transnational models beyond those discussed here, with a view to developing more specific recommendations for NT regulation. Consistent with our emphasis on regulatory flexibility, we conclude by tentatively suggesting a sequencing of regulatory approaches designed to allow NT regulation to develop over time into broader, more elaborate and more highly legalized form as we gain greater knowledge of, and experience with, the benefits and costs of NT

Nevirapine- Versus Lopinavir/Ritonavir-Based Initial Therapy for HIV-1 Infection among Women in Africa: A Randomized Trial

In a randomized control trial, Shahin Lockman and colleagues compare nevirapine-based therapy with lopinavir/ritonavir-based therapy for HIV-infected women without previous exposure to antiretroviral treatment

High spatial resolution analysis of ferromanganese concretions by LA-ICP-MS†

A procedure was developed for the determination of element distributions in cross-sections of ferromanganese concretions using laser ablation inductively coupled plasma mass spectrometry (LA-ICP-MS). The effects of carrier flow rates, rf forward power, ablation energy, ablation spot size, repetition rate and number of shots per point on analyte intensity were studied. It is shown that different carrier gas flow rates are required in order to obtain maximum sensitivities for different groups of elements, thus complicating the optimisation of ICP parameters. On the contrary, LA parameters have very similar effects on almost all elements studied, thus providing a common optimum parameter set for the entire mass range. However, for selected LA parameters, the use of compromise conditions was necessary in order to compensate for relatively slow data acquisition by ICP-MS and maintain high spatial resolution without sacrificing the multielemental capabilities of the technique. Possible variations in ablation efficiency were corrected for mathematically using the sum of Fe and Mn intensities. Quantification by external calibration against matrix-matched standards was successfully used for more than 50 elements. These standards, in the form of pressed pellets (no binder), were prepared in-house using ferromanganese concentrates from a deep-sea nodule reference material as well as from shallow-marine concretions varying in size and having different proportions of three major phases: aluminosilicates, Fe- and Mn-oxyhydroxides. Element concentrations in each standard were determined by means of conventional solution nebulisation ICP-MS following acid digestion. Examples of selected inter-element correlations in distribution patterns along the cross-section of a concretion are given

Diversity and carbon storage across the tropical forest biome

Tropical forests are global centres of biodiversity and carbon storage. Many tropical countries aspire to protect forest to fulfil biodiversity and climate mitigation policy targets, but the conservation strategies needed to achieve these two functions depend critically on the tropical forest tree diversity-carbon storage relationship. Assessing this relationship is challenging due to the scarcity of inventories where carbon stocks in aboveground biomass and species identifications have been simultaneously and robustly quantified. Here, we compile a unique pan-tropical dataset of 360 plots located in structurally intact old-growth closed-canopy forest, surveyed using standardised methods, allowing a multi-scale evaluation of diversity-carbon relationships in tropical forests. Diversity-carbon relationships among all plots at 1 ha scale across the tropics are absent, and within continents are either weak (Asia) or absent (Amazonia, Africa). A weak positive relationship is detectable within 1 ha plots, indicating that diversity effects in tropical forests may be scale dependent. The absence of clear diversity-carbon relationships at scales relevant to conservation planning means that carbon-centred conservation strategies will inevitably miss many high diversity ecosystems. As tropical forests can have any combination of tree diversity and carbon stocks both require explicit consideration when optimising policies to manage tropical carbon and biodiversity.Additional co-authors: Kofi Affum-Baffoe, Shin-ichiro Aiba, Everton Cristo de Almeida, Edmar Almeida de Oliveira, Patricia Alvarez-Loayza, Esteban Álvarez Dávila, Ana Andrade, Luiz E. O. C. Aragão, Peter Ashton, Gerardo A. Aymard C., Timothy R. Baker, Michael Balinga, Lindsay F. Banin, Christopher Baraloto, Jean-Francois Bastin, Nicholas Berry, Jan Bogaert, Damien Bonal, Frans Bongers, Roel Brienen, José Luís C. Camargo, Carlos Cerón, Victor Chama Moscoso, Eric Chezeaux, Connie J. Clark, Álvaro Cogollo Pacheco, James A. Comiskey, Fernando Cornejo Valverde, Eurídice N. Honorio Coronado, Greta Dargie, Stuart J. Davies, Charles De Canniere, Marie Noel Djuikouo K., Jean-Louis Doucet, Terry L. Erwin, Javier Silva Espejo, Corneille E. N. Ewango, Sophie Fauset, Ted R. Feldpausch, Rafael Herrera, Martin Gilpin, Emanuel Gloor, Jefferson S. Hall, David J. Harris, Terese B. Hart, Kuswata Kartawinata, Lip Khoon Kho, Kanehiro Kitayama, Susan G. W. Laurance, William F. Laurance, Miguel E. Leal, Thomas Lovejoy, Jon C. Lovett, Faustin Mpanya Lukasu, Jean-Remy Makana, Yadvinder Malhi, Leandro Maracahipes, Beatriz S. Marimon, Ben Hur Marimon Junior, Andrew R. Marshall, Paulo S. Morandi, John Tshibamba Mukendi, Jaques Mukinzi, Reuben Nilus, Percy Núñez Vargas, Nadir C. Pallqui Camacho, Guido Pardo, Marielos Peña-Claros, Pascal Pétronelli, Georgia C. Pickavance, Axel Dalberg Poulsen, John R. Poulsen, Richard B. Primack, Hari Priyadi, Carlos A. Quesada, Jan Reitsma, Maxime Réjou-Méchain, Zorayda Restrepo, Ervan Rutishauser, Kamariah Abu Salim, Rafael P. Salomão, Ismayadi Samsoedin, Douglas Sheil, Rodrigo Sierra, Marcos Silveira, J. W. Ferry Slik, Lisa Steel, Hermann Taedoumg, Sylvester Tan, John W. Terborgh, Sean C. Thomas, Marisol Toledo, Peter M. Umunay, Luis Valenzuela Gamarra, Ima Célia Guimarães Vieira, Vincent A. Vos, Ophelia Wang, Simon Willcock & Lise Zemagh

Global burden and strength of evidence for 88 risk factors in 204 countries and 811 subnational locations, 1990–2021: a systematic analysis for the Global Burden of Disease Study 2021

Background: Understanding the health consequences associated with exposure to risk factors is necessary to inform public health policy and practice. To systematically quantify the contributions of risk factor exposures to specific health outcomes, the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2021 aims to provide comprehensive estimates of exposure levels, relative health risks, and attributable burden of disease for 88 risk factors in 204 countries and territories and 811 subnational locations, from 1990 to 2021. Methods: The GBD 2021 risk factor analysis used data from 54 561 total distinct sources to produce epidemiological estimates for 88 risk factors and their associated health outcomes for a total of 631 risk–outcome pairs. Pairs were included on the basis of data-driven determination of a risk–outcome association. Age-sex-location-year-specific estimates were generated at global, regional, and national levels. Our approach followed the comparative risk assessment framework predicated on a causal web of hierarchically organised, potentially combinative, modifiable risks. Relative risks (RRs) of a given outcome occurring as a function of risk factor exposure were estimated separately for each risk–outcome pair, and summary exposure values (SEVs), representing risk-weighted exposure prevalence, and theoretical minimum risk exposure levels (TMRELs) were estimated for each risk factor. These estimates were used to calculate the population attributable fraction (PAF; ie, the proportional change in health risk that would occur if exposure to a risk factor were reduced to the TMREL). The product of PAFs and disease burden associated with a given outcome, measured in disability-adjusted life-years (DALYs), yielded measures of attributable burden (ie, the proportion of total disease burden attributable to a particular risk factor or combination of risk factors). Adjustments for mediation were applied to account for relationships involving risk factors that act indirectly on outcomes via intermediate risks. Attributable burden estimates were stratified by Socio-demographic Index (SDI) quintile and presented as counts, age-standardised rates, and rankings. To complement estimates of RR and attributable burden, newly developed burden of proof risk function (BPRF) methods were applied to yield supplementary, conservative interpretations of risk–outcome associations based on the consistency of underlying evidence, accounting for unexplained heterogeneity between input data from different studies. Estimates reported represent the mean value across 500 draws from the estimate's distribution, with 95% uncertainty intervals (UIs) calculated as the 2·5th and 97·5th percentile values across the draws. Findings: Among the specific risk factors analysed for this study, particulate matter air pollution was the leading contributor to the global disease burden in 2021, contributing 8·0% (95% UI 6·7–9·4) of total DALYs, followed by high systolic blood pressure (SBP; 7·8% [6·4–9·2]), smoking (5·7% [4·7–6·8]), low birthweight and short gestation (5·6% [4·8–6·3]), and high fasting plasma glucose (FPG; 5·4% [4·8–6·0]). For younger demographics (ie, those aged 0–4 years and 5–14 years), risks such as low birthweight and short gestation and unsafe water, sanitation, and handwashing (WaSH) were among the leading risk factors, while for older age groups, metabolic risks such as high SBP, high body-mass index (BMI), high FPG, and high LDL cholesterol had a greater impact. From 2000 to 2021, there was an observable shift in global health challenges, marked by a decline in the number of all-age DALYs broadly attributable to behavioural risks (decrease of 20·7% [13·9–27·7]) and environmental and occupational risks (decrease of 22·0% [15·5–28·8]), coupled with a 49·4% (42·3–56·9) increase in DALYs attributable to metabolic risks, all reflecting ageing populations and changing lifestyles on a global scale. Age-standardised global DALY rates attributable to high BMI and high FPG rose considerably (15·7% [9·9–21·7] for high BMI and 7·9% [3·3–12·9] for high FPG) over this period, with exposure to these risks increasing annually at rates of 1·8% (1·6–1·9) for high BMI and 1·3% (1·1–1·5) for high FPG. By contrast, the global risk-attributable burden and exposure to many other risk factors declined, notably for risks such as child growth failure and unsafe water source, with age-standardised attributable DALYs decreasing by 71·5% (64·4–78·8) for child growth failure and 66·3% (60·2–72·0) for unsafe water source. We separated risk factors into three groups according to trajectory over time: those with a decreasing attributable burden, due largely to declining risk exposure (eg, diet high in trans-fat and household air pollution) but also to proportionally smaller child and youth populations (eg, child and maternal malnutrition); those for which the burden increased moderately in spite of declining risk exposure, due largely to population ageing (eg, smoking); and those for which the burden increased considerably due to both increasing risk exposure and population ageing (eg, ambient particulate matter air pollution, high BMI, high FPG, and high SBP). Interpretation: Substantial progress has been made in reducing the global disease burden attributable to a range of risk factors, particularly those related to maternal and child health, WaSH, and household air pollution. Maintaining efforts to minimise the impact of these risk factors, especially in low SDI locations, is necessary to sustain progress. Successes in moderating the smoking-related burden by reducing risk exposure highlight the need to advance policies that reduce exposure to other leading risk factors such as ambient particulate matter air pollution and high SBP. Troubling increases in high FPG, high BMI, and other risk factors related to obesity and metabolic syndrome indicate an urgent need to identify and implement interventions