scholarly journals NAM-supported read-across: From case studies to regulatory guidance in safety assessment

ALTEX ◽  
2021 ◽  
pp. 140-150
Author(s):  
Costanza Rovida
Keyword(s):  
Careful Analysis ◽  
Point Of View ◽  
Regulatory Agencies ◽  
Final Conclusion ◽  
Regulatory Guidance ◽  
Consumer Safety ◽  
European Regulatory ◽  
The Usa ◽  
Expert Analysis ◽  
Optimal Approach

The use of new approach methodologies (NAMs) in support of read-across (RAx) approaches for regulatory purposes is a main goal of the EU-ToxRisk project. To bring this forward, EU-ToxRisk partners convened a workshop in close collaboration with regulatory representatives from key organizations including European regulatory agencies, such as the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA), as well as the Scientific Committee on Consumer Safety (SCCS), national agencies from several European countries, Japan, Canada and the USA, as well as the Organisation for Economic Cooperation and Development (OECD). More than a hundred people actively participated in the discussions, bringing together diverse viewpoints across academia, regulators and industry. The discussion was organized starting from five practical cases of RAx applied to specific problems that offered the oppor­tunity to consider real examples. There was general consensus that NAMs can improve confidence in RAx, in particular in defining category boundaries as well as characterizing the similarities/dissimilarities between source and target substances. In addition to describing dynamics, NAMs can be helpful in terms of kinetics and metabolism that may play an important role in the demonstration of similarity or dissimilarity among the members of a category. NAMs were also noted as effective in providing quanti­tative data correlated with traditional no observed adverse effect levels (NOAELs) used in risk assessment, while reducing the uncertainty on the final conclusion. An interesting point of view was the advice on calibrating the number of new tests that should be carefully selected, avoiding the allure of “the more, the better”. Unfortunately, yet unsurprisingly, there was no single approach befitting every case, requiring careful analysis delineating the optimal approach. Expert analysis and assessment of each specific case is still an important step in the process.

scholarly journals Bioinsecticides based on plant essential oils: a short overview

2020 ◽  
Vol 75 (7-8) ◽  
pp. 179-182
Author(s):  
Murray B. Isman
Keyword(s):  
Essential Oils ◽  
Crop Protection ◽  
Large Body ◽  
Regulatory Agencies ◽  
The European Union ◽  
Plant Essential Oils ◽  
The Past ◽  
Wide Range ◽  
The Usa ◽  
Regulatory Challenges

AbstractInterest in the discovery and development of plant essential oils for use as bioinsecticides has grown enormously in the past 20 years. However, successful commercialization and utilization of crop protection products based on essential oils has thus far lagged far behind their promise based on this large body of research, most notably because with the exceptions of the USA and Australia, such products receive no special status from regulatory agencies that approve new pesticides for use. Essential oil-based insecticides have now been used in the USA for well over a decade, and more recently have seen use in the European Union (EU), Korea, and about a dozen other countries, with demonstrated efficacy against a wide range of pests and in numerous crop systems. For the most part these products are based on commodity essential oils developed as flavor and fragrance agents for the food and cosmetic industries, as there are formidable logistic, economic, and regulatory challenges to the use of many other essential oils that otherwise possess potentially useful bioactivity against pests. In spite of these limitations, the overall prospects for biopesticides, including those based on essential oils, are encouraging as the demand for sustainably-produced and/or organic food continues to increase worldwide.

Reflective backward analysis to assess the operational performance and eco-efficiency of two industrial districts

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Andrea Appolloni ◽  
Idiano D'Adamo ◽  
Massimo Gastaldi ◽  
Morteza Yazdani ◽  
Davide Settembre-Blundo
Keyword(s):  
Economic Trend ◽  
Careful Analysis ◽  
Point Of View ◽  
Industrial Districts ◽  
Management Approach ◽  
Ceramic Tiles ◽  
Data Set ◽  
Content Type ◽  
Sectorial Analysis ◽  
Backward Analysis

PurposeThe best strategy to apply for the future cannot disregard a careful analysis of the past and is the one capable of seizing opportunities from outside. Manufacturing sectors are characterized by sudden changes, and in this work, we analyze the ceramic tiles sector characterized by a mature technology in which innovation has played a key role.Design/methodology/approachThis study aims to provide a sectorial analysis based on a historical data set (2004–2019) to highlight how an industry is performing both operationally and in terms of eco-efficiency. For this purpose, from a methodological point of view, the data envelopment analysis (DEA) was used.FindingsThe results of the analysis show that the Spanish ceramics industry shows a growing economic trend by taking advantage of lower industrial costs, while the Italian industry is characterized by a modest decline partially mitigated by exports. The industrial districts are an aggregation of companies that in the ceramic sector has allowed to combine innovation, sustainability and digitalization and is a model toward the maximization of sustainable efficiency because it is a place of aggregation of resources and ideas.Originality/valueThis study experiments with an innovative way of addressing traditional industry analysis, namely, integrating the reflective management approach with DEA-based backward analysis. This provides decision makers with the basis for new interpretations of variable trends.

U.S. Emissions Trading and what it can teach us for a Post-Kyoto World

2021 ◽  
Author(s):  
Fabian Krause
Keyword(s):  
International Law ◽  
Emissions Trading ◽  
Basic Research ◽  
Point Of View ◽  
The European Union ◽  
Trade Data ◽  
Trading Systems ◽  
Republic Of China ◽  
Economic Fundamentals ◽  
The Usa

Major CO2 emitters such as individual states of the USA, the People's Republic of China and the European Union continue to rely on emissions trading systems to reduce CO2 emissions. Against this background, this thesis examines four emissions trading systems in the USA. For this purpose, the legal and economic fundamentals of emissions trading are presented in detail. Subsequently, emissions trading systems are analyzed from an economic as well as a legal point of view based on criteria defined for this purpose and the results are embedded in the context of national and international law. For this purpose, the author conducts extensive basic research by processing the available emissions and trade data.

The cost of consent: why healthcare providers must be compliant with the Montgomery principles

2020 ◽  
Vol 102-B (5) ◽  
pp. 550-555
Author(s):  
Nick Birch ◽  
Nick V. Todd
Keyword(s):  
Positive Impact ◽  
Healthcare Providers ◽  
International Comparisons ◽  
Point Of View ◽  
Public Healthcare ◽  
Health Board ◽  
Malpractice Claim ◽  
The Usa ◽  
The Uk ◽  
The Cost

The cost of clinical negligence in the UK has continued to rise despite no increase in claims numbers from 2016 to 2019. In the US, medical malpractice claim rates have fallen each year since 2001 and the payout rate has stabilized. In Germany, malpractice claim rates for spinal surgery fell yearly from 2012 to 2017, despite the number of spinal operations increasing. In Australia, public healthcare claim rates were largely static from 2008 to 2013, but private claims rose marginally. The cost of claims rose during the period. UK and Australian trends are therefore out of alignment with other international comparisons. Many of the claims in orthopaedics occur as a result of “failure to warn”, i.e. lack of adequately documented and appropriate consent. The UK and USA have similar rates (26% and 24% respectively), but in Germany the rate is 14% and in Australia only 2%. This paper considers the drivers for the increased cost of clinical negligence claims in the UK compared to the USA, Germany and Australia, from a spinal and orthopaedic point of view, with a focus on “failure to warn” and lack of compliance with the principles established in February 2015 in the Supreme Court in the case of Montgomery v Lanarkshire Health Board. The article provides a description of the prevailing medicolegal situation in the UK and also calculates, from publicly available data, the cost to the public purse of the failure to comply with the principles established. It shows that compliance with the Montgomery principles would have an immediate and lasting positive impact on the sums paid by NHS Resolution to settle negligence cases in a way that has already been established in the USA. Cite this article: Bone Joint J 2020;102-B(5):550–555.

scholarly journals Technological Progress, Globalization, and Secular Stagnation

2018 ◽  
Vol 7 (1) ◽  
pp. 59-100 ◽  
Author(s):  
Milenko Popović
Keyword(s):  
World Economy ◽  
Aggregate Demand ◽  
Careful Analysis ◽  
Developed Countries ◽  
Supply Side ◽  
Critical Survey ◽  
Technological Advancement ◽  
Secular Stagnation ◽  
Dual Economy ◽  
The Usa

AbstractAfter the 2008 crisis, despite economic recovery that started in 2009, the world economy has experienced a downward shift of its growth path and a consequent decline. As shown at the beginning of this paper, this shift and growth rate stagnation are totally attributable to the economic dynamics in developed economies, the USA and the EU. Explanations of this phenomenon can be divided into two large groups: explanations that belong to the demand side and those that belong to the supply side. The aim of this paper is to give a critical survey of the most important explanations for the ongoing growth stagnation in developed countries and consequently in the entire world economy. This ongoing prolonged stagnation can only be explained by looking at both, the demand and supply sides of the explanation, and particularly by taking a closer look at the interaction between aggregate demand and aggregate supply. In other words, secular stagnation manifests itself as a problem of the limitation of long run growth of aggregate demand. However, in order to explain the causes of those demand limitations, we have to undertake a careful analysis of the supply side dynamics, especially the dynamics of innovations, which bring us to circular and cumulative causation. In order to explain the numerous consequences of this stagnation and to solve some important puzzles, like the productivity paradox for example, a special emphasis is given to the analysis of deindustrialization and the consequent strange reoccurrence of a dual economy within most developed countries during the period of the IT revolution and hyper-globalization. It will also be shown that this new dual economy presents serious limitations for further technological advancement and economic development, quite contrary to the old dualism which contributed to an acceleration of economic growth.

Consumer Safety

2012 ◽  
Author(s):  
David Vogel
Keyword(s):  
United States ◽  
Regulatory Policy ◽  
The United States ◽  
Pharmaceutical Regulation ◽  
Regulatory Policies ◽  
Consumer Safety ◽  
Safety Risks ◽  
European Regulatory ◽  
Drug Lag ◽  
Important Exception

This chapter analyzes European and American policies toward a range of consumer safety risks; including drugs, children's products, and cosmetics. It shows how European and American risk regulations have converged, though the dynamics through which this occurred differed substantially. Pharmaceutical regulation constitutes the most important exception to the broader pattern of increased transatlantic regulatory policy divergence. What makes this area of regulatory policy distinctive is that its political salience increased in the United States but not in Europe. Pharmaceutical regulation also represents an important exception to the dominant pattern of transatlantic regulatory policy diffusion. In this case, European regulatory policies did affect those of the United States, first by highlighting the transatlantic drug lag, and more recently by American decisions to adopt some European practices to expedite drug approvals.

Balancing Competence and Control

2020 ◽  
pp. 180-202 ◽  
Author(s):  
Felix Biermann ◽  
Berthold Rittberger
Keyword(s):  
Food Safety ◽  
Case Studies ◽  
Regulatory Networks ◽  
Focal Point ◽  
Aviation Safety ◽  
Regulatory Agencies ◽  
Member States ◽  
European Regulatory ◽  
And Control ◽  
The Eu

In recent decades the EU has witnessed a remarkable rise in the number of specialized regulatory agencies and European regulatory networks (ERNs). It is often assumed that agencies and ERNs are mutually exclusive instruments of indirect governance. As this chapter argues, however, they are often used in combination to better address competence–control tradeoffs. The chapter illustrates this argument with two case studies of regulatory policymaking in the EU. First, in the case of aviation safety, the EU and its member states created a new agency, the European Aviation Safety Agency, to overcome a control deficit which had hampered its ability to rein in existing regulatory networks. Second, in the field of food safety, the EU as collective governor sought to overcome the competence deficit of its intermediary, the European Food Safety Agency, by enlisting a second intermediary: the “Focal Point Network” (an ERN).

Indian Merchant Networks Outside India in the Nineteenth and Twentieth Centuries: A Preliminary Survey

1999 ◽  
Vol 33 (4) ◽  
pp. 883-911 ◽  
Author(s):  
Claude Markovits
Keyword(s):  
South Asian ◽  
Point Of View ◽  
Diaspora Studies ◽  
South Asian Diaspora ◽  
General Picture ◽  
Asian Diaspora ◽  
South Asian History ◽  
The Usa ◽  
Asian History ◽  
First World

In spite of the recent flowering of studies on the South Asian diaspora, we are nevertheless left with many gaps in our knowledge and many unanswered questions. The bulk of existing work is still focused on the migration of agricultural labour and the ‘Little Indias’ it spawned in various corners of the world. The recent migrations of educated professionals to the countries of the ‘First World’, particularly the USA, are also attracting increasing attention. The whole field of migration and diaspora studies remains, however, dominated by a host country perspective which tends to obliterate the general picture from the point of view of South Asian history.

scholarly journals Worldwide Regulatory Guidance Values Applied to Direct Contact Surface Soil Pesticide Contamination: Part I—Carcinogenic Pesticides

2017 ◽  
Vol 10 ◽  
pp. 117862211771193 ◽  
Author(s):  
Aaron A Jennings ◽  
Zijian Li
Keyword(s):  
Surface Soil ◽  
Risk Model ◽  
The United States ◽  
Regulatory Agencies ◽  
Pesticide Contamination ◽  
Regulatory Guidance ◽  
Bounded Set ◽  
The World ◽  
Incidence Risk ◽  
Model Coefficient

Regulatory agencies worldwide have developed regulatory guidance values (RGVs) for nearly 800 pesticides. Analysis of the residential surface soil guidance values applied to the most frequently regulated current-use agriculture, home, and garden pesticides is presented. Part I concentrates on values applied to atrazine, simazine, and trifluralin. These are unique among commonly used pesticides because they are generally considered to be human carcinogens. Their use has been banned in much of the world, but they are commonly used in the United States. Regulatory guidance values applied to these 3 pesticides vary by 8.6, 5.5, and 5.1 orders of magnitude. Risk model coefficient–bounded set uncertainty analysis is applied to help analyze this variability. Cancer risk model uncertainty bounds appear to contain 36.3%, 43.0%, and 49.5% of the RGVs. Most of the remaining values appear to exceed a lifetime cancer incidence risk of 1 × 10−6 and may not be adequately protective of human health.

Sign in / Sign up

Export Citation Format

Share Document