scholarly journals Assessing the filtration efficiency and regulatory status of N95s and nontraditional filtering face-piece respirators available during the COVID-19 pandemic

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Deborah Plana ◽  
Enze Tian ◽  
Avilash K. Cramer ◽  
Helen Yang ◽  
Mary M. Carmack ◽  
...  
Keyword(s):  
Supply Chains ◽  
International Standards ◽  
Teaching Hospitals ◽  
The European Union ◽  
Testing Apparatus ◽  
Healthcare Settings ◽  
Regulatory Status ◽  
Counterfeit Products ◽  
Available Information ◽  
N95 Respirators

Abstract Background The COVID-19 pandemic has severely disrupted supply chains for many types of Personal Protective Equipment (PPE), particularly surgical N95 filtering facepiece respirators (FFRs; “masks”). As a consequence, an Emergency Use Authorization (EUA) from the FDA has allowed use of industrial N95 respirators and importation of N95-type masks manufactured to international standards; these include KN95 masks from China and FFP2 masks from the European Union. Methods We conducted a survey of masks in the inventory of major academic medical centers in Boston, MA to determine provenance and manufacturer or supplier. We then assembled a testing apparatus at a university laboratory and performed a modified test of filtration performance using KCl and ambient particulate matter on masks from hospital inventories; an accompanying website shows how to build and use the testing apparatus. Results Over 100 different makes and models of traditional and nontraditional filtering facepiece respirators (N95-type masks) were in the inventory of surveyed U.S. teaching hospitals as opposed to 2–5 models under normal circumstances. A substantial number of unfamiliar masks are from unknown manufacturers. Many are not correctly labelled and do not perform to accepted standards and a subset are obviously dangerous; many of these masks are likely to be counterfeit. Due to the absence of publicly available information on mask suppliers and inconsistent labeling of KN95 masks, it is difficult to distinguish between legitimate and counterfeit products. Conclusions Many FFRs available for procurement during the COVID-19 pandemic do not provide levels of fit and filtration similar to those of N95 masks and are not acceptable for use in healthcare settings. Based on these results, and in consultation with occupational health officers, we make six recommendations to assist end users in acquiring legitimate products. Institutions should always assess masks from non-traditional supply chains by checking their markings and manufacturer information against data provided by NIOSH and the latest FDA EUA Appendix A. In the absence of verifiable information on the legitimacy of mask source, institutions should consider measuring mask fit and filtration directly. We also make suggestions for regulatory agencies regarding labeling and public disclosure aimed at increasing pandemic resilience.

scholarly journals Assessing the quality of nontraditional N95 filtering face-piece respirators available during the COVID-19 pandemic

2020 ◽  
Author(s):  
Deborah Plana ◽  
Enze Tian ◽  
Avilash K. Cramer ◽  
Helen Yang ◽  
Mary M. Carmack ◽  
...  
Keyword(s):  
Supply Chains ◽  
International Standards ◽  
The European Union ◽  
Short Supply ◽  
Healthcare Settings ◽  
Medical Centers ◽  
Academic Medical ◽  
Counterfeit Products ◽  
Available Information

Background: During the current COVID-19 pandemic, supply chains for Personal Protective Equipment (PPE) have been severely disrupted and many products, particularly surgical N95 filtering facepiece respirators (FFRs; "masks") are in short supply. As a consequence, an Emergency Use Authorization (EUA) from the FDA has allowed importation of N95-type masks manufactured to international standards; these include KN95 masks from China and FFP2 masks from the European Union. Methods: We conducted a survey of mask in the inventory of major academic medical centers in Boston, MA to determine provenance and manufacturer. We then assembled a simple apparatus for performing a necessary (but not sufficient) test of filtration performance and tested masks from the inventory; an accompanying website shows how to build and use the testing apparatus. Results: Our survey showed that, seven months after the start of the COVID-19 pandemic, over 100 different makes and models of N95-type masks are in the inventory of local hospitals as opposed to 2-5 models under normal circumstances. A substantial number of unfamiliar masks are from unknown manufacturers. Many did not perform to accepted standards and are likely to be counterfeit. Due to the absence of publicly available information on mask suppliers in the FDA EUA and confusing or inconsistent labeling of KN95 masks, it is difficult to distinguish legitimate and counterfeit products. Conclusions: Many of the FFR masks available for procurement during the COVID-19 pandemic do not provide levels of fit and filtration similar to those of N95 masks and are not acceptable for use in healthcare settings. Based on these results, and in consultation with occupational health officers, we make six recommendations for end users to assist in acquiring legitimate products. In particular, institutions should always assess masks from non-traditional supply chains by checking their markings and manufacturer information against data provided by NIOSH and the latest FDA EUA Appendix A. In the absence of verifiable information on the legitimacy of mask source, institutions should consider measuring mask fit and filtration directly. We also make suggestions for U.S and Chinese regulatory agencies with regard to labeling and public disclosure aimed at increase pandemic resilience.

scholarly journals The role of food standards in international trade: assessing the Brazilian beef chain

2006 ◽  
Vol 10 (spe) ◽  
pp. 33-51
Author(s):  
Luciana Marques Vieira
Keyword(s):  
European Union ◽  
Supply Chains ◽  
Large Scale ◽  
International Markets ◽  
International Standards ◽  
Rapid Expansion ◽  
The European Union ◽  
Full Compliance ◽  
Food Standards ◽  
Managerial Implications

The purpose of this paper is to identify how Brazilian beef managers have responded to a rapid expansion and intensification of standards for beef exports. This issue relates to how some Brazilian beef exporters are strategically repositioning themselves in the supply chains. The literature of this study reviews global chain governance and international standards. The method uses case studies consisting of six medium and large scale beef exporters who export fresh beef to the European Union. The main findings describe the kinds of governance that stimulate upgrading and transferral of the best practices and, consequently, full compliance with mandatory standards. This study suggests that standards do matter for companies trying to increase international competitiveness. These results contribute an understanding of the Brazilian beef chain, and also of other supply chains coping with demanding and changing international markets. Managerial implications show the challenges facing Brazilian beef exporters in their efforts to sustain exports to the European Union and how they are using chain governance to improve their compliance with international standards and increase competitiveness.

IFRS IMPLEMENTATION AS ONE OF THE FACTORS FOR IMPROVING THE INVESTMENT CLIMATE IN UKRAINE

2017 ◽  
Author(s):  
Kateryna Sova ◽  
◽  
Natalia Yatsenko ◽  
Denys Zagirniak ◽  
◽  
...  
Keyword(s):  
Financial Reporting ◽  
Direct Investment ◽  
Financial Statements ◽  
International Standards ◽  
Investment Climate ◽  
The European Union ◽  
Economic Activities ◽  
Financial Reporting Standards ◽  
Almost All ◽  
The Impact

The article is devoted to the study of the impact of the introduction of International Financial Reporting Standards (IFRS) on changes in the investment climate in Ukraine. The relevance of the topic is that improving the practice of applying IFRS as a tool for exchanging financial information is one of the key conditions for improving the investment climate in Ukraine. The authors have created the generalized scheme that illustrates the chronological list of enterprises that are required by law to prepare financial statements in accordance with IFRS. It was noted that in 2018, in accordance with Part 2 of Article 12 of the law on accounting and financial reporting in Ukraine and resolution of the Cabinet of Ministers of Ukraine No. 547 from 11.07.2018, the criteria of enterprises that are required to prepare financial statements in accordance with IFRS were updated. This step significantly increased the level of application of international standards due to the adoption of such a decision at the legislative level. The dynamics of the number of IFRS enterprises in Ukraine was analyzed. The analysis showed that over the past three years, the number of almost all enterprises that must apply international standards has been growing. The advantages of using IFRS for different users of financial statements were determined. It was determined that the priority users of IFRS financial statements are investors. At the same time, it was noted that the main advantage for other users of financial statements prepared in accordance with international standards is the improvement of the investment climate. The dynamics of the Investment Attractiveness Index of Ukraine based on the Likert scale in the period from 2016 to 2020 was analyzed. The direct investment receipts to Ukraine from the European Union countries were studied. The dynamics of direct investment in the Ukrainian economy was analyzed for two types of economic activities that should form financial statements in accordance with IFRS, namely, the extractive industry and quarrying, as well as financial and insurance activities.

If in Doubt, Leave it Out? EU Precaution in WTO Regulatory Space

2010 ◽  
Vol 1 (1) ◽  
pp. 20-30 ◽  
Author(s):  
James Flett
Keyword(s):  
European Union ◽  
Political Authority ◽  
The Other ◽  
The Political ◽  
International Level ◽  
Eu Law ◽  
The European Union ◽  
International Organisations ◽  
Balanced Approach ◽  
Available Information

This article reviews the way in which the concept of precaution, as commonly referenced in EU law, is received in the WTO. It argues that precaution is not a principle, but one facet of a principle of making rational judgments based on available information, the other facet of which is “that risk is worth taking”. Systematically pursuing high cost measures in response to low risks is not a balanced approach, and has probably contributed to the scepticism with which the concept is viewed in the WTO. However, this article goes on to argue that, without needing to be a principle, precaution is the determining legal feature in the SPS Agreement, because, unlike in the European Union, there is no legislative harmonisation of SPS measures at international level, WTO Members being free to set their own appropriate level of protection. In fact, the concept of precaution is relevant in the context of many other WTO provisions and is in some respects quite close to the concept of subsidiarity. Notwithstanding this, the first WTO SPS cases, driven by regulatory exporters and an interventionist WTO, have excessively emphasised scientific issues, masking policy judgments that the WTO has neither the legal nor the political authority to sustain. The article concludes that the proper way forward necessitates closer political, legal and administrative links between the WTO and other relevant international organisations, and a move away from consensus in the latter.

scholarly journals Corporate Social Responsibility Information in Annual Reports in the EU—A Czech Case Study

2019 ◽  
Vol 11 (1) ◽  
pp. 237 ◽  
Author(s):  
Radka MacGregor Pelikánová
Keyword(s):  
Corporate Social Responsibility ◽  
Social Responsibility ◽  
International Standards ◽  
Annual Reports ◽  
The European Union ◽  
Eu Member States ◽  
Annual Reporting ◽  
Corporate Social ◽  
The Eu

The commitment of the European Union (EU) to Corporate Social Responsibility (CSR) is projected into EU law about annual reporting by businesses. Since EU member states further develop this framework by their own domestic laws, annual reporting with CSR information is not unified and only partially mandatory in the EU. Do all European businesses report CSR information and what public declaration to society do they provide with it? The two main purposes of this paper are to identify the parameters of this annual reporting duty and to study the CSR information provided by the 10 largest Czech companies in their annual statements for 2013–2017. Based on legislative research and a teleological interpretation, the current EU legislative framework with Czech particularities is presented and, via a case study exploring 50 annual reports, the data about the type, extent and depth of CSR is dynamically and comparatively assessed. It appears that, at the minimum, large Czech businesses satisfy their legal duty and e-report on CSR to a similar extent, but in a dramatically different quality. Employee matters and adherence to international standards are used as a public declaration to society more than the data on environmental protection, while social matters and research and development (R&D) are played down.

scholarly journals Legal-economic barriers to price transfers in food supply chains

2012 ◽  
Vol 6 (1-2) ◽  
pp. 27-33 ◽  
Author(s):  
Harry Bremmers ◽  
Bernd Van der Meulen ◽  
Zorica Sredojevi ◽  
Jo Wijnands
Keyword(s):  
Supply Chain ◽  
Supply Chains ◽  
Food Supply ◽  
Value Added ◽  
Price Volatility ◽  
Retail Sector ◽  
The European Union ◽  
Food Supply Chains ◽  
Industry Policy ◽  
The One

Recent price movements have put food supply chains under pressure. On the one side, upward price tendencies on commodity markets result in higher costs to processing firms. On the other side, these firms are confronted with a strong retail sector that is able to prevent compensation to protect consumers’ and own economic interests. Regulatory impediments of European law, especially with respect to foodstuffs, can adversely be utilized as barriers to protect the interest downstream the supply chain. The problem is that legal-economic instruments which can serve to smooth price volatility in supply markets can also opportunistically be used at the expense of the middlesection in food supply chains (i.e., mainly small and medium sized producers). The aim of this article is to identify the legal-economic mechanisms that effect price transfers in food supply chains in the European Union and define policy adjustments to improve pricing mechanisms, while safeguarding the interests of the processing industry. Policy alternatives to improve the smooth functioning of notably intermediate markets in food supply chains are the restructuring of competition law, improved processor information management and creating transparency of value added in the supply chain by means of labelling devices.

scholarly journals Status prawny sekt destrukcyjnych oraz nowych ruchów religijnych działających na obszarze Polski

2017 ◽  
pp. 135-149
Author(s):  
Celina M. Masek
Keyword(s):  
Legal Status ◽  
Social Institutions ◽  
International Standards ◽  
Modern World ◽  
The European Union ◽  
Negative Effects ◽  
New Members ◽  
Religious Associations ◽  
The Republic ◽  
Religious Sects

Since the beginning of the 90’s there have been strong emotions associated with the emergence of many groups called cults in Poland. These groups are accused of illicit and unethical methods to recruit new members and their psychological dependence, resulting in blind obedience to leaders. Sects, carrying out their activities in the form of various types of religious formations, religious associations, churches and other religious organizations, brought to life after 1989 in Poland, operate on the basis of three acts, which include: 1. The Constitution of the Republic of Poland of 2 April 1997 ; 2. The Act on Guarantees of freedom of conscience and religion of 17 May 1989; 3. Act of April 7, 1989 r.- Law on Associations. Given the range of opinions and concerns regarding the issue of regulation of sects in Poland this question , posed in particular by the lawyer, of the legal status of the activities of religious sects , and in a broader aspect of their place in the modern world, seems to be reasonable, what is confirmed by the media , but mostly by the facts of the activities of these groups in society. As for the international standards, nowadays there are more and more information about the negative effects of the activity of sects throughout the world, what raised interest of social institutions and the authorities of individual countries in this subject. It encouraged the authorities to create an overall analysis to assess the degree of harmfulness of newly established movements, both in a national and international level. Especially in the late eighties of the twentieth century all kinds of reports and other documents devoted to the problem of sects and new religious movements began to appear. The theme was taken also by the representatives of Communities: Council of Europe, the European Union, as well as organs of the Organization for Security and Cooperation in Europe. These acts are only recommendations. They are mainly opinion- forming acts and have no legal force. However, in countries, they are crucial, because they are issued by important authorities To sum up, the activity of sects arouses interest in Europe. Although each country has different guidelines and varied range of impact, collaboration is indispensable nowadays.

scholarly journals Compliance of Lebanese Pickling Industry with Lebanese and International Standards

2020 ◽  
Vol 8 (7) ◽  
pp. 1559-1563
Author(s):  
Sami Tlais ◽  
Hayat Omairi ◽  
Ali Al Khatib ◽  
Hassan HajjHussein
Keyword(s):  
European Union ◽  
Consumer Protection ◽  
New Products ◽  
International Standards ◽  
The European Union ◽  
Alert System ◽  
News Reporting ◽  
The Public ◽  
Food And Feed ◽  
Rapid Alert System

In light of recent news reporting the use of banned colorants in Lebanese-made pickled turnips exported to the European Union (EU) by the Rapid Alert System of Food and Feed (RASFF), The Lebanese Consumer Protection Association tested samples of pickled turnips being sold to the public and confirmed the use of rhodamine B. Many products were pulled off the market and were replaced with new products that were supposed to be free of any banned colorants. We selected 5 different brands of pickled turnips and tested them for pH, salinity, nitrites, and colorants. We tested the salinity using two methods: evaporation and titration. The concentration of nitrites was tested by absorbency method. The presence of colorants was determined using TLC and absorbency method. We determined that the newly released pickled turnips comply with the rules and regulations adopted by the Lebanese Standards Institution (LIBNOR) and the international standards according to the Codex Alimentarius.

scholarly journals DEVELOPMENT OF THE SYSTEM OF EUROPEAN EDUCATION IN THE FIELD OF STANDARDIZATION

2020 ◽  
pp. 93-98
Author(s):  
Olha BUKRIEIEVA ◽  
Keyword(s):  
Information And Communication Technologies ◽  
Regional Integration ◽  
Innovation Management ◽  
Action Plan ◽  
General System ◽  
Further Education ◽  
International Standards ◽  
Educational Institutions ◽  
The European Union ◽  
Technical Standards

Introduction. In connection with the recog-nized social and economic influence of standardization, expansion of global trade, regional integration, introduc-tion of information and communication technologies, standards become more and more important for gradu-ates of the technical universities, as well as for specialists from the area of management, economics, social sciences, international relations, entrepreneurship and innovation management. Purpose – to analyze development of the system of education in the field of standardization in the European Union in order to identify the areas of its modernization in Ukraine. Results. Previously education in the field of standardi-zation was understood as learning technical standards, the process of their development and influence, and was organized as short-term course of further education for engineers, specialized course for companies and general course for future engineers. Standardization is not yet a clearly defined well-established discipline in the context of theory or academics. There were many different ap-proaches and characteristics suggested by researchers in various disciplines, experts and practitioners from various countries and organizations. Later CEN, CENELEC and ETSI, having assessed the need of the European commu-nity, developed a policy, a master plan and standard study programs for education in the field of standardiza-tion. UNECE, having constant the importance of studying standardization, has developed a recommendation, in which it called the governments to include it in the pro-grams of educational institutions, as well as suggested its model program. To support these ideas ISO recommended the national standardization bodies to cooperate with higher education institutions, offering the forms and gen-eral action plan. The result was recognition of the fact that the development of competencies standardization of rele-vant specialists was one of the key interests of national standardization bodies and educational institutions. Therefore, ISO published two international standards “Competence of specialists in the field of standardization”. All these documents comprise the normative and organi-zation basis of education in the field of standardization. Originality. The conducted analysis allowed identify-ing that knowledge of standardization is a competitive advantage for graduates of engineering and non-technical study areas; standardization as a discipline must be included in their study plan at the level of bachelor’s and master’s degrees; to develop the general system of educa-tion in the field of standardization, coordinated coopera-tion of all interested parties is needed; the basis for for-mation of competencies necessary for a specialist in the field of standardization at enterprises and in standardiza-tion bodies must be international models of educational programs. Conclusion. Taking into account the European direc-tion of the development, introduction of the considered international recommendations is also needed in Ukraine. To do this, it is necessary to further analyze the system of education in the field of standardization in Ukraine, to highlight provisions requiring modernization, as well as to compose a concept for its development.

Sign in / Sign up

Export Citation Format

Share Document