Weight of evidence needed to substantiate a health effect for probiotics and prebiotics: regulatory considerations in Canada, EU, and US

Successful and responsible introduction of probiotic and prebiotic products into the worldwide marketplace requires labelling for health benefits that meets consumer needs, adheres to regulatory standards and does not overextend scientific evidence. Regulations differ among countries, but underlying all is an emphasis on scientific credibility of any statements of health benefits. This paper considers the value of different types of evidence offered in substantiation of efficacy and reviews different regulatory approaches to labelling for health claims. Limitations of in vitro, animal and different types of human studies used for efficacy substantiation for probiotics and prebiotics are discussed.

Enforcing international financial standards in Brazil: limits and possibilities for adoption of IOSCO principles

Foreign capital and institutional investors play a key role in the Brazilian capital and financial markets. Internationally promoted regulatory patterns, especially IOSCO principles, have been increasingly influencing administrative rule making by the Brazilian Securities and Exchange Commission (CVM) as well as the adoption of transnational rules in Brazil by means of self-regulatory activity. Even though there is a certain level of convergence of market regulatory standards at the transnational level, implementation and enforcement of rules remains essentially domestic. We analyze two case studies regarding the transposition of international standards into the Brazilian legal system, which illustrate this tension between the transnational and domestic dimensions of financial markets regulation. The first case concerns a CVM rule on disclosure of executive compensation and the its interpretation by local courts. The second case refers to the adoption of suitability rules.

Safety standards on small passenger aircraft - with nine or fewer seats - are significantly less stringent than on larger aircraft. Comptroller General's report to the Congress.

Mode of access: Internet.

Selected views and issues related to regulatory reform in the transportation industry.

Mode of access: Internet.

Incompatibility of standards used in: qualifying drivers, building highways, designing vehicles - a report to the Secretary of Transportation by the National Highway Safety Advisory Committee.

Mode of access: Internet.

Notice of proposed amendments to design standards for highways - FHWA docket no. 80-2 [Submission].

Mode of access: Internet.

Targeted drug delivery to the skin and deeper tissues: Role of physiology, solute structure and disease

1. Drug delivery through the skin has been used to target the epidermis, dermis and deeper tissues and for systemic delivery, The major barrier for the transport of drugs through the skin is the stratum corneum, with most transport occurring through the intercellular region, The polarity of the intercellular region appears to be similar to butanol, with the diffusion of solutes being hindered by saturable hydrogen bonding to the polar head groups of the ceramides, fatty acids and other intercellular lipids, Accordingly, the permeability of the more lipophilic solutes is greatest from aqueous solutions, whereas polar solute permeability is favoured by hydrocarbon-based vehicles. 2. The skin is capable of metabolizing many substances and, through its microvasculature, limits the transport of most substances into regions below the dermis. 3. Although the flux of solutes through the skin should be identical for different vehicles when the solute exists as a saturated solution, the fluxes vary in accordance with the skin penetration enhancement properties of the vehicle. It is therefore desirable that the regulatory standards required for the bioequivalence of topical products include skin studies. 4. Deep tissue penetration can be related to solute protein binding, solute molecular size and dermal blood flow. 5. Iontophoresis is a promising area of skin drug delivery, especially for ionized solutes and when a rapid effect is required. 6. In general, psoriasis and other skin diseases facilitate drug delivery through the skin. 7. It is concluded that the variability in skin permeability remains an obstacle in optimizing drug delivery by this route.

Projeto e implementação de um pré-regulador de fator de potência com controlo digital

Hoje em dia as fontes de alimentação possuem correção do fator de potência, devido às diversas normas regulamentares existentes, que introduziram grandes restrições no que respeita à distorção harmónica (THD) e fator de potência (FP). Este trabalho trata da análise, desenvolvimento e implementação de um Pré-Regulador de fator de potência com controlo digital. O controlo digital de conversores com recurso a processamento digital de sinal tem vindo a ser ao longo dos últimos anos, objeto de investigação e desenvolvimento, estando constantemente a surgirem modificações nas topologias existentes. Esta dissertação tem como objetivo estudar e implementar um Pré-Regulador Retificador Boost e o respetivo controlo digital. O controlo do conversor é feito através da técnica dos valores médios instantâneos da corrente de entrada, desenvolvido através da linguagem de descrição de hardware VHDL (VHSIC HDL – Very High Speed Integrated Circuit Hardware Description Language) e implementado num dispositivo FPGA (Field Programmable Gate Array) Spartan-3E. Neste trabalho são apresentadas análises matemáticas, para a obtenção das funções de transferência pertinentes ao projeto dos controladores. Para efetuar este controlo é necessário adquirir os sinais da corrente de entrada, tensão de entrada e tensão de saída. O sinal resultante do módulo de controlo é um sinal de PWM com valor de fator de ciclo variável ao longo do tempo. O projeto é simulado e validado através da plataforma MatLab/Simulink e PSIM, onde são apresentados resultados para o regime permanente e para transitórios da carga e da tensão de alimentação. Finalmente, o Pré-Regulador Retificador Boost controlado de forma digital é implementado em laboratório. Os resultados experimentais são apresentados para validar a metodologia e o projeto desenvolvidos.

Strategic Framework for Role Expansion of Nurses and Midwives: Promoting Quality Patient Care

This strategic document sets policy direction for the enhancement of nursing and midwifery roles. It builds on the achievements of the past ten years for nursing and midwifery and is set within the context of clinical and regulatory standards. The Programme for Government 2011 and policy initiatives such as legislative changes for the introduction of nurse and midwife medication prescribing create significant opportunities toexpand the role of nurses and midwives in a proactive manner.   Click here to download   PDF 1.12MB

Food security, food safety and small farmers

Some of the elements that characterize the globalization of food and agriculture are industrialization and intensification of agriculture and liberalization of agricultural markets, that favours elongation of the food chain and homogenization of food habits (nutrition transition), among other impacts. As a result, the probability of food contamination has increased with the distance and the number of “hands" that may contact the food (critical points); the nutritional quality of food has been reduced because of increased transport and longer periods of time from collection to consumption; and the number of food-related diseases due to changes in eating patterns has increased. In this context, there exist different agencies and regulations intended to ensure food safety at different levels, e.g. at the international level, Codex Alimentarius develops standards and regulations for the marketing of food in a global market. Although governments determine the legal framework, the food industry manages the safety of their products, and thus, develops its own standards for their marketing, such as the Good Agricultural Practices (GAP) programs. The participation of the private sector in the creation of regulatory standards strengthens the free trade of food products, favouring mostly large agribusiness companies. These standards are in most cases unattainable for small producers and food safety regulations are favouring removal of the peasantry and increase concentration and control in the food system by industrial actors. Particularly women, who traditionally have been in charge of the artisanal transformation process, can be more affected by these norms than men. In this project I am analysing the impcact of food safety norms over small farms, based on the case of artisanal production made by women in Spain.

Practices and ethical concerns regarding preimplantation diagnosis. Who regulates preimplantation genetic diagnosis in Brazil?

Preimplantation genetic diagnosis (PGD) was originally developed to diagnose embryo-related genetic abnormalities for couples who present a high risk of a specific inherited disorder. Because this technology involves embryo selection, the medical, bioethical, and legal implications of the technique have been debated, particularly when it is used to select features that are not related to serious diseases. Although several initiatives have attempted to achieve regulatory harmonization, the diversity of healthcare services available and the presence of cultural differences have hampered attempts to achieve this goal. Thus, in different countries, the provision of PGD and regulatory frameworks reflect the perceptions of scientific groups, legislators, and society regarding this technology. In Brazil, several texts have been analyzed by the National Congress to regulate the use of assisted reproduction technologies. Legislative debates, however, are not conclusive, and limited information has been published on how PGD is specifically regulated. The country requires the development of new regulatory standards to ensure adequate access to this technology and to guarantee its safe practice. This study examined official documents published on PGD regulation in Brazil and demonstrated how little direct oversight of PGD currently exists. It provides relevant information to encourage reflection on a particular regulation model in a Brazilian context, and should serve as part of the basis to enable further reform of the clinical practice of PGD in the country.

Content validation for level of use of feature rich systems: a Delphi study of electronic medical records systems

Introduction. Feature usage is a pre-requisite to realising the benefits of investments in feature rich systems. We propose that conceptualising the dependent variable 'system use' as 'level of use' and specifying it as a formative construct has greater value for measuring the post-adoption use of feature rich systems. We then validate the content of the construct as a first step in developing a research instrument to measure it. The context of our study is the post-adoption use of electronic medical records (EMR) by primary care physicians. Method. Initially, a literature review of the empirical context defines the scope based on prior studies. Having identified core features from the literature, they are further refined with the help of experts in a consensus seeking process that follows the Delphi technique. Results.The methodology was successfully applied to EMRs, which were selected as an example of feature rich systems. A review of EMR usage and regulatory standards provided the feature input for the first round of the Delphi process. A panel of experts then reached consensus after four rounds, identifying ten task-based features that would be indicators of level of use. Conclusions. To study why some users deploy more advanced features than others, theories of post-adoption require a rich formative dependent variable that measures level of use. We have demonstrated that a context sensitive literature review followed by refinement through a consensus seeking process is a suitable methodology to validate the content of this dependent variable. This is the first step of instrument development prior to statistical confirmation with a larger sample.

Arbitragem regulatória X one size fits all: a discricionariedade na regulação bancária internacional entre Cila e Caríbdis

As peculiaridades da atividade bancária - normalmente vista como fundamental à persecução do desenvolvimento, bem como bastante influenciada pelo direito - estimularam a emergência de um regime internacional de regulação da categoria. Tal advento se deu na esteira dos trabalhos realizados por organizações internacionais, como o Comitê da Basileia (BCBS) e o Comitê de Estabilidade Financeira (FSB), e em virtude da percepção de estarmos em um mundo no qual os mercados estão muito interligados, mas permanecem nacionalmente regulados. À parte da discussão do mérito e efetividade dos padrões regulatórios propostos por essas organizações, em um contexto no qual uma série de países busca implementá-los, interessa ao presente trabalho perscrutar os elementos que definem o grau adequado de discricionariedade de implementação conferida na formulação desses. A análise de tal problema sugere a existência de dois extremos a se evitar: a arbitragem regulatória e o one size fits all. Evitar a arbitragem regulatória é uma preocupação da literatura de regulação bancária que se traduz em conter uma variação muito acentuada entre os regimes regulatórios de diferentes jurisdições. Isso enseja três vetores favoráveis a um menor grau de discricionariedade, representado por desígnios de maior coordenação, maior competitividade e de evitar uma race to the bottom regulatória entre os países. Já evitar o one size fits all é uma preocupação recorrente da literatura de direito e desenvolvimento que sugere a necessidade de se atentar para as peculiaridades locais na formulação de políticas regulatórias. Por sua vez, isso enseja outros três vetores, dessa vez em direção a um maior grau de discricionariedade. Sendo esses representados por preocupações com a eficiência das medidas adotadas, com a garantia de um espaço de manobra que respeite a autodeterminação dos países - ao menos minorando eventuais déficits democráticos da estipulação de padrões internacionais - e com a viabilidade prática do experimentalismo. A fim de analisar esse problema e levando em conta esses extremos, propõe-se uma estratégia bipartida: a construção de um enquadramento teórico e a verificação de uma hipótese de pesquisa, segundo a qual um caso específico de regulação bancária pode demonstrar como esses elementos interagem na definição do grau de discricionariedade. Assim, em um primeiro momento - após a necessária contextualização e descrição metodológica - é construído um framework teórico do problema à luz da literatura da regulação bancária e do instrumental utilizado pelas discussões acerca do impacto do direito no desenvolvimento. Discussões essas que há anos têm abordado a formulação de padrões internacionais e a sua implementação em contextos nacionais diversos. Também nesse primeiro momento e como parte da construção dos alicerces teóricos, procede-se a um excurso que busca verificar a hipótese da confiança no sistema bancário ser uma espécie de baldio (common), bem como suas possíveis consequências. Partindo desse enquadramento, elege-se o segmento de regulação bancária relativo aos garantidores de depósito para uma análise de caso. Tal análise - realizada com subsídios provenientes de pesquisa bibliográfica e empírica - busca demonstrar com que grau de discricionariedade e de que forma se deu a formulação e implementação de padrões internacionais nesse segmento. Ao fim, analisa-se como os vetores determinantes do grau de discricionariedade interagem no caso dos garantidores de depósitos, bem como as sugestões possivelmente inferíveis dessa verificação para os demais segmentos da regulação bancária.

As zonas de processamento de exportação como instrumento de desenvolvimento e redução das desigualdades regionais

The existence of inequalities among the Brazilian regions is an indeed fact along the country s history. Before this reality the constitutional legislator inserted into the Federal Constitution of 1988, as a purpose of the Federative Republic of Brazil, the reduction of regional inequalities. The development has also been included as a purpose from the State, because there is an straight relation with the reduction of regional inequalities. In both situations is searched the improvement of people s living conditions. . In pursuit of this achievement, the State must implement public policy, and, for this to happen, it needs the ingress of income inside of the public coffers and support of economic agents, therefore the importance of constitucionalization of the economic policy. The 1988 s Constitution adopted a rational capitalism regime consentaneous with current legal and social conceptions, that s why it enabled the State s intervention into economy to correct the so-called market failures or to make the established objectives fulfilled. About this last one, the intervention may happen by induction through the adoption of regulatory Standards of incentive or disincentive of economic activity. Among the possible inductive ways there are the tax assessments that aim to stimulate the economic agents behavior in view of finding that the development doesn t occur with the same intensity in all of the country s regions. Inside this context there are the Export Processing Zones (EPZs) which are special areas with different customs regime by the granting of benefits to the companies that are installed there. The EPZs have been used, by several countries, in order to develop certain regions, and economic indicators show that they promoted economic and social changes in the places where they are installed, especially because, by attracting companies, they provide job creation, industrialization and increased exports. In Brazil, they can contribute decisively to overcome major obstacles or decrease the attraction of economic agents and economic development of the country. In the case of an instrument known to be effective to achieve the goals established by the Constitution, it is duty of the Executive to push for the law that governs this customs regime is effectively applied. If the Executive doesn t fulfill this duty, incurs into unjustifiable omission, correction likely by the Judiciary, whose mission is to prevent acts or omissions contrary to constitutional order

Uma contribuição à reformulação da norma regulamentadora 13 (NR-13) na perspectiva da adoção de sistema de gestão de segurança e saúde ocupacional

This Master s Thesis deals with an analysis of the Regulatory Standards NR-9 e NR-13 on the perspective of occupational health and safety management systems (OHSMS) such as ILO deployed ILO/OSH-2001. Since the revamped OHSAS 18001:2007 complies with the ILO/OSH-2001 model it is used as benchmark to compare against the NR-9 and NR-13. The analysis suggests that the NR-9 has some important features present on the OHSAS 18001:2007 but lacks important others. The NR-13 turns out to be far from a modern model of OHSMS such as OHSAS 18001:2007 and a deep reformulation should be done in order to achieve the Brazil commitment with ILO to adopt OHSMS. Also, a small survey with companies with ISO 9000 certificates suggests that a NR-13 revised toward OHSMS would be welcome, but also that some more advanced issues present in ILO/OSH-2001 should be imposed by law in order to be achieved